340 U.S. 474 (1951)

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT.

[475] By special leave of Court, Frederick R. Livingston, pro hac vice, argued the cause for petitioner. With him on the brief was James S. Hays.

[476] Mozart G. Ratner argued the cause for respondent. With him on the brief were Solicitor General Perlman, David P. Findling and Bernard Dunau.

MR. JUSTICE FRANKFURTER delivered the opinion of the Court.

The essential issue raised by this case and its companion, Labor Board v. Pittsburgh Steamship Co., post, p. 498, is the effect of the Administrative Procedure Act and the legislation colloquially known as the Taft-Hartley Act on the duty of Courts of Appeals when called upon to review orders of the National Labor Relations Board.

The Court of Appeals for the Second Circuit granted enforcement of an order directing, in the main, that petitioner reinstate with back pay an employee found to have been discharged because he gave testimony under the Wagner Act and cease and desist from discriminating against any employee who files charges or gives testimony under that Act. The court below, Judge Swan dissenting, decreed full enforcement of the order. 179 F. 2d 749. Because the views of that court regarding the effect of the new legislation on the relation between the Board and the Courts of Appeals in the enforcement of the Board's orders conflicted with those of the Court of Appeals for the Sixth Circuit^[1] we brought both cases here. 339 U. S. 951 and 339 U. S. 962. The clash of opinion obviously required settlement by this Court.

[477] I.

Want of certainty in judicial review of Labor Board decisions partly reflects the intractability of any formula to furnish definiteness of content for all the impalpable factors involved in judicial review. But in part doubts as to the nature of the reviewing power and uncertainties in its application derive from history, and to that extent an elucidation of this history may clear them away.

The Wagner Act provided: "The findings of the Board as to the facts, if supported by evidence, shall be conclusive." Act of July 5, 1935, § 10 (e), 49 Stat. 449, 454, 29 U. S. C. § 160 (e). This Court read "evidence" to mean "substantial evidence," Washington, V. & M. Coach Co. v. Labor Board, 301 U. S. 142, and we said that "[s]ubstantial evidence is more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Consolidated Edison Co. v. Labor Board, 305 U. S. 197, 229. Accordingly, it "must do more than create a suspicion of the existence of the fact to be established. . . . it must be enough to justify, if the trial were to a jury, a refusal to direct a verdict when the conclusion sought to be drawn from it is one of fact for the jury." Labor Board v. Columbian Enameling & Stamping Co., 306 U. S. 292, 300.

The very smoothness of the "substantial evidence" formula as the standard for reviewing the evidentiary validity of the Board's findings established its currency. But the inevitably variant applications of the standard to conflicting evidence soon brought contrariety of views and in due course bred criticism. Even though the whole record may have been canvassed in order to determine whether the evidentiary foundation of a determination by the Board was "substantial," the phrasing of this Court's process of review readily lent itself to the notion [478] that it was enough that the evidence supporting the Board's result was "substantial" when considered by itself. It is fair to say that by imperceptible steps regard for the fact-finding function of the Board led to the assumption that the requirements of the Wagner Act were met when the reviewing court could find in the record evidence which, when viewed in isolation, substantiated the Board's findings. Compare Labor Board v. Waterman Steamship Corp., 309 U. S. 206; Labor Board v. Bradford Dyeing Assn., 310 U. S. 318; and see Labor Board v. Nevada Consolidated Copper Corp., 316 U. S. 105. This is not to say that every member of this Court was consciously guided by this view or that the Court ever explicitly avowed this practice as doctrine. What matters is that the belief justifiably arose that the Court had so construed the obligation to review.^[2]

Criticism of so contracted a reviewing power reinforced dissatisfaction felt in various quarters with the Board's administration of the Wagner Act in the years preceding the war. The scheme of the Act was attacked as an inherently unfair fusion of the functions of prosecutor and judge.^[3] Accusations of partisan bias were not wanting.^[4] The "irresponsible admission and weighing of hearsay, opinion, and emotional speculation in place of factual evidence" was said to be a "serious menace."^[5] No doubt [479] some, perhaps even much, of the criticism was baseless and some surely was reckless.^[6] What is here relevant, however, is the climate of opinion thereby generated and its effect on Congress. Protests against "shocking injustices"^[7] and intimations of judicial "abdication"^[8] with which some courts granted enforcement of the Board's orders stimulated pressures for legislative relief from alleged administrative excesses.

The strength of these pressures was reflected in the passage in 1940 of the Walter-Logan Bill. It was vetoed by President Roosevelt, partly because it imposed unduly rigid limitations on the administrative process, and partly because of the investigation into the actual operation of the administrative process then being conducted by an experienced committee appointed by the Attorney General.^[9] It is worth noting that despite its aim to tighten control over administrative determinations of fact, the Walter-Logan Bill contented itself with the conventional formula that an agency's decision could be set aside if "the findings of fact are not supported by substantial evidence."^[10]

[480] The final report of the Attorney General's Committee was submitted in January, 1941. The majority concluded that "[d]issatisfaction with the existing standards as to the scope of judicial review derives largely from dissatisfaction with the fact-finding procedures now employed by the administrative bodies."^[11] Departure from the "substantial evidence" test, it thought, would either create unnecessary uncertainty or transfer to courts the responsibility for ascertaining and assaying matters the significance of which lies outside judicial competence. Accordingly, it recommended against legislation embodying a general scheme of judicial review.^[12]

[481] Three members of the Committee registered a dissent. Their view was that the "present system or lack of system of judicial review" led to inconsistency and uncertainty. They reported that under a "prevalent" interpretation of the "substantial evidence" rule "if what is called `substantial evidence' is found anywhere in the record to support conclusions of fact, the courts are said to be obliged to sustain the decision without reference to how heavily the countervailing evidence may preponderate—unless indeed the stage of arbitrary decision is reached. Under this interpretation, the courts need to read only one side of the case and, if they find any evidence there, the administrative action is to be sustained and the record to the contrary is to be ignored."^[13] Their view led them to recommend that Congress enact principles of review applicable to all agencies not excepted by unique characteristics. One of these principles was expressed by the formula that judicial review could extend to "findings, inferences, or conclusions of fact unsupported, upon the whole record, by substantial evidence."^[14] So far as the [482] history of this movement for enlarged review reveals, the phrase "upon the whole record" makes its first appearance in this recommendation of the minority of the Attorney General's Committee. This evidence of the close relationship between the phrase and the criticism out of which it arose is important, for the substance of this formula for judicial review found its way into the statute books when Congress with unquestioning—we might even say uncritical—unanimity enacted the Administrative Procedure Act.^[15]

[483] One is tempted to say "uncritical" because the legislative history of that Act hardly speaks with that clarity of purpose which Congress supposedly furnishes courts in order to enable them to enforce its true will. On the one hand, the sponsors of the legislation indicated that they were reaffirming the prevailing "substantial evidence" test.^[16] But with equal clarity they expressed disapproval of the manner in which the courts were applying [484] their own standard. The committee reports of both houses refer to the practice of agencies to rely upon "suspicion, surmise, implications, or plainly incredible evidence," and indicate that courts are to exact higher standards "in the exercise of their independent judgment" and on consideration of "the whole record."^[17]

Similar dissatisfaction with too restricted application of the "substantial evidence" test is reflected in the legislative history of the Taft-Hartley Act.^[18] The bill as reported to the House provided that the "findings of the Board as to the facts shall be conclusive unless it is made to appear to the satisfaction of the court either (1) that the findings of fact are against the manifest weight of the [485] evidence, or (2) that the findings of fact are not supported by substantial evidence."^[19] The bill left the House with this provision. Early committee prints in the Senate provided for review by "weight of the evidence" or "clearly erroneous" standards.^[20] But, as the Senate Committee Report relates, "it was finally decided to conform the statute to the corresponding section of the Administrative Procedure Act where the substantial evidence test prevails. In order to clarify any ambiguity in that statute, however, the committee inserted the words `questions of fact, if supported by substantial evidence on the record considered as a whole . . . .' "^[21]

This phraseology was adopted by the Senate. The House conferees agreed. They reported to the House: "It is believed that the provisions of the conference agreement [486] relating to the courts' reviewing power will be adequate to preclude such decisions as those in N. L. R. B. v. Nevada Consol. Copper Corp. (316 U. S. 105) and in the Wilson, Columbia Products, Union Pacific Stages, Hearst, Republic Aviation, and Le Tourneau, etc. cases, supra, without unduly burdening the courts."^[22] The Senate version became the law.

[487] It is fair to say that in all this Congress expressed a mood. And it expressed its mood not merely by oratory but by legislation. As legislation that mood must be respected, even though it can only serve as a standard for judgment and not as a body of rigid rules assuring sameness of application. Enforcement of such broad standards implies subtlety of mind and solidity of judgment. But it is not for us to question that Congress may assume such qualities in the federal judiciary.

From the legislative story we have summarized, two concrete conclusions do emerge. One is the identity of aim of the Administrative Procedure Act and the Taft-Hartley Act regarding the proof with which the Labor Board must support a decision. The other is that now Congress has left no room for doubt as to the kind of scrutiny which a Court of Appeals must give the record before the Board to satisfy itself that the Board's order rests on adequate proof.

It would be mischievous word-playing to find that the scope of review under the Taft-Hartley Act is any different from that under the Administrative Procedure Act. The Senate Committee which reported the review clause of the Taft-Hartley Act expressly indicated that the two standards were to conform in this regard, and the wording of the two Acts is for purposes of judicial administration identical. And so we hold that the standard of proof specifically required of the Labor Board by the Taft-Hartley Act is the same as that to be exacted by courts reviewing every administrative action subject to the Administrative Procedure Act.

Whether or not it was ever permissible for courts to determine the substantiality of evidence supporting a Labor Board decision merely on the basis of evidence which in and of itself justified it, without taking into account contradictory evidence or evidence from which conflicting inferences could be drawn, the new legislation [488] definitively precludes such a theory of review and bars its practice. The substantiality of evidence must take into account whatever in the record fairly detracts from its weight. This is clearly the significance of the requirement in both statutes that courts consider the whole record. Committee reports and the adoption in the Administrative Procedure Act of the minority views of the Attorney General's Committee demonstrate that to enjoin such a duty on the reviewing court was one of the important purposes of the movement which eventuated in that enactment.

To be sure, the requirement for canvassing "the whole record" in order to ascertain substantiality does not furnish a calculus of value by which a reviewing court can assess the evidence. Nor was it intended to negative the function of the Labor Board as one of those agencies presumably equipped or informed by experience to deal with a specialized field of knowledge, whose findings within that field carry the authority of an expertness which courts do not possess and therefore must respect. Nor does it mean that even as to matters not requiring expertise a court may displace the Board's choice between two fairly conflicting views, even though the court would justifiably have made a different choice had the matter been before it de novo. Congress has merely made it clear that a reviewing court is not barred from setting aside a Board decision when it cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the Board's view.

There remains, then, the question whether enactment of these two statutes has altered the scope of review other than to require that substantiality be determined in the light of all that the record relevantly presents. A formula for judicial review of administrative action may afford grounds for certitude but cannot assure certainty of application. [489] Some scope for judicial discretion in applying the formula can be avoided only by falsifying the actual process of judging or by using the formula as an instrument of futile casuistry. It cannot be too often repeated that judges are not automata. The ultimate reliance for the fair operation of any standard is a judiciary of high competence and character and the constant play of an informed professional critique upon its work.

Since the precise way in which courts interfere with agency findings cannot be imprisoned within any form of words, new formulas attempting to rephrase the old are not likely to be more helpful than the old. There are no talismanic words that can avoid the process of judgment. The difficulty is that we cannot escape, in relation to this problem, the use of undefined defining terms.

Whatever changes were made by the Administrative Procedure and Taft-Hartley Acts are clearly within this area where precise definition is impossible. Retention of the familiar "substantial evidence" terminology indicates that no drastic reversal of attitude was intended.

But a standard leaving an unavoidable margin for individual judgment does not leave the judicial judgment at large even though the phrasing of the standard does not wholly fence it in. The legislative history of these Acts demonstrates a purpose to impose on courts a responsibility which has not always been recognized. Of course it is a statute and not a committee report which we are interpreting. But the fair interpretation of a statute is often "the art of proliferating a purpose," Brooklyn National Corp. v. Commissioner, 157 F. 2d 450, 451, revealed more by the demonstrable forces that produced it than by its precise phrasing. The adoption in these statutes of the judicially-constructed "substantial evidence" test was a response to pressures for stricter and more uniform practice, not a reflection of approval of all existing practices. [490] To find the change so elusive that it cannot be precisely defined does not mean it may be ignored. We should fail in our duty to effectuate the will of Congress if we denied recognition to expressed Congressional disapproval of the finality accorded to Labor Board findings by some decisions of this and lower courts, or even of the atmosphere which may have favored those decisions.

We conclude, therefore, that the Administrative Procedure Act and the Taft-Hartley Act direct that courts must now assume more responsibility for the reasonableness and fairness of Labor Board decisions than some courts have shown in the past. Reviewing courts must be influenced by a feeling that they are not to abdicate the conventional judicial function. Congress has imposed on them responsibility for assuring that the Board keeps within reasonable grounds. That responsibility is not less real because it is limited to enforcing the requirement that evidence appear substantial when viewed, on the record as a whole, by courts invested with the authority and enjoying the prestige of the Courts of Appeals. The Board's findings are entitled to respect; but they must nonetheless be set aside when the record before a Court of Appeals clearly precludes the Board's decision from being justified by a fair estimate of the worth of the testimony of witnesses or its informed judgment on matters within its special competence or both.

From this it follows that enactment of these statutes does not require every Court of Appeals to alter its practice. Some—perhaps a majority—have always applied the attitude reflected in this legislation. To explore whether a particular court should or should not alter its practice would only divert attention from the application of the standard now prescribed to a futile inquiry into the nature of the test formerly used by a particular court.

Our power to review the correctness of application of the present standard ought seldom to be called into action. [491] Whether on the record as a whole there is substantial evidence to support agency findings is a question which Congress has placed in the keeping of the Courts of Appeals. This Court will intervene only in what ought to be the rare instance when the standard appears to have been misapprehended or grossly misapplied.

II.

Our disagreement with the view of the court below that the scope of review of Labor Board decisions is unaltered by recent legislation does not of itself, as we have noted, require reversal of its decision. The court may have applied a standard of review which satisfies the present Congressional requirement.

The decision of the Court of Appeals is assailed on two grounds. It is said (1) that the court erred in holding that it was barred from taking into account the report of the examiner on questions of fact insofar as that report was rejected by the Board, and (2) that the Board's order was not supported by substantial evidence on the record considered as a whole, even apart from the validity of the court's refusal to consider the rejected portions of the examiner's report.

The latter contention is easily met. It is true that two of the earlier decisions of the court below were among those disapproved by Congress.^[23] But this disapproval, we have seen, may well have been caused by unintended intimations of judicial phrasing. And in any event, it is clear from the court's opinion in this case that it in fact did consider the "record as a whole," and did not deem itself merely the judicial echo of the Board's conclusion. The testimony of the company's witnesses was inconsistent, and there was clear evidence that the complaining [492] employee had been discharged by an officer who was at one time influenced against him because of his appearance at the Board hearing. On such a record we could not say that it would be error to grant enforcement.

The first contention, however, raises serious questions to which we now turn.

III.

The Court of Appeals deemed itself bound by the Board's rejection of the examiner's findings because the court considered these findings not "as unassailable as a master's."^[24] 179 F. 2d at 752. They are not. Section 10 (c) of the Labor Management Relations Act provides that "if upon the preponderance of the testimony taken the Board shall be of the opinion that any person named in the complaint has engaged in or is engaging in any such unfair labor practice, then the Board shall state its findings of fact . . . ." 61 Stat. 147, 29 U. S. C. (Supp. III) § 160 (c). The responsibility for decision thus placed on the Board is wholly inconsistent with the notion that it has power to reverse an examiner's findings only when they are "clearly erroneous." Such a limitation would make so drastic a departure from prior administrative practice that explicitness would be required.

The Court of Appeals concluded from this premise "that, although the Board would be wrong in totally disregarding his findings, it is practically impossible for a [493] court, upon review of those findings which the Board itself substitutes, to consider the Board's reversal as a factor in the court's own decision. This we say, because we cannot find any middle ground between doing that and treating such a reversal as error, whenever it would be such, if done by a judge to a master in equity." 179 F. 2d at 753. Much as we respect the logical acumen of the Chief Judge of the Court of Appeals, we do not find ourselves pinioned between the horns of his dilemma.

We are aware that to give the examiner's findings less finality than a master's and yet entitle them to consideration in striking the account, is to introduce another and an unruly factor into the judgmatical process of review. But we ought not to fashion an exclusionary rule merely to reduce the number of imponderables to be considered by reviewing courts.

The Taft-Hartley Act provides that "The findings of the Board with respect to questions of fact if supported by substantial evidence on the record considered as a whole shall be conclusive." 61 Stat. 148, 29 U. S. C. (Supp. III) § 160 (e). Surely an examiner's report is as much a part of the record as the complaint or the testimony. According to the Administrative Procedure Act, "All decisions (including initial, recommended, or tentative decisions) shall become a part of the record . . . ." § 8 (b), 60 Stat. 242, 5 U. S. C. § 1007 (b). We found that this Act's provision for judicial review has the same meaning as that in the Taft-Hartley Act. The similarity of the two statutes in language and purpose also requires that the definition of "record" found in the Administrative Procedure Act be construed to be applicable as well to the term "record" as used in the Taft-Hartley Act.

It is therefore difficult to escape the conclusion that the plain language of the statutes directs a reviewing court to determine the substantiality of evidence on the record including the examiner's report. The conclusion [494] is confirmed by the indications in the legislative history that enhancement of the status and function of the trial examiner was one of the important purposes of the movement for administrative reform.

This aim was set forth by the Attorney General's Committee on Administrative Procedure:

"In general, the relationship upon appeal between the hearing commissioner and the agency ought to a considerable extent to be that of trial court to appellate court. Conclusions, interpretations, law, and policy should, of course, be open to full review. On the other hand, on matters which the hearing commissioner, having heard the evidence and seen the witnesses, is best qualified to decide, the agency should be reluctant to disturb his findings unless error is clearly shown."^[25]

Apparently it was the Committee's opinion that these recommendations should not be obligatory. For the bill which accompanied the Final Report required only that hearing officers make an initial decision which would become final in the absence of further agency action, and that agencies which differed on the facts from their examiners give reasons and record citations supporting their conclusion.^[26] This proposal was further moderated by the Administrative Procedure Act. It permits agencies to use examiners to record testimony but not to evaluate it, and contains the rather obscure provision that an agency which reviews an examiner's report has "all the powers which it would have in making the initial decision."^[27]

[495] But this refusal to make mandatory the recommendations of the Attorney General's Committee should not be construed as a repudiation of them. Nothing in the statutes suggests that the Labor Board should not be influenced by the examiner's opportunity to observe the witnesses he hears and sees and the Board does not. Nothing suggests that reviewing courts should not give to the examiner's report such probative force as it intrinsically commands. To the contrary, § 11 of the Administrative Procedure Act contains detailed provisions designed to maintain high standards of independence and competence in examiners. Section 10 (c) of the Labor Management Relations Act requires that examiners "shall issue . . . a proposed report, together with a recommended order." Both statutes thus evince a purpose to increase the importance of the role of examiners in the administrative process. High standards of public administration counsel that we attribute to the Labor Board's examiners both due regard for the responsibility which Congress imposes on them and the competence to discharge it.^[28]

[496] The committee reports also make it clear that the sponsors of the legislation thought the statutes gave significance to the findings of examiners. Thus, the Senate Committee responsible for the Administrative Procedure Act explained in its report that examiners' decisions "would be of consequence, for example, to the extent that material facts in any case depend on the determination of credibility of witnesses as shown by their demeanor or conduct at the hearing."^[29] The House Report reflects the same attitude;^[30] and the Senate Committee Report on the Taft-Hartley Act likewise indicates regard for the responsibility devolving on the examiner.^[31]

We do not require that the examiner's findings be given more weight than in reason and in the light of judicial experience they deserve. The "substantial evidence" standard is not modified in any way when the Board and its examiner disagree. We intend only to recognize that evidence supporting a conclusion may be less substantial when an impartial, experienced examiner who has observed the witnesses and lived with the case has drawn conclusions different from the Board's than when he has reached the same conclusion. The findings of the examiner are to be considered along with the consistency and inherent probability of testimony. The significance of his report, of course, depends largely on the importance of credibility in the particular case. To give it this significance does not seem to us materially more difficult [497] than to heed the other factors which in sum determine whether evidence is "substantial."

The direction in which the law moves is often a guide for decision of particular cases, and here it serves to confirm our conclusion. However halting its progress, the trend in litigation is toward a rational inquiry into truth, in which the tribunal considers everything "logically probative of some matter requiring to be proved." Thayer, A Preliminary Treatise on Evidence, 530; Funk v. United States, 290 U. S. 371. This Court has refused to accept assumptions of fact which are demonstrably false, United States v. Provident Trust Co., 291 U. S. 272, even when agreed to by the parties, Swift & Co. v. Hocking Valley R. Co., 243 U. S. 281. Machinery for discovery of evidence has been strengthened; the boundaries of judicial notice have been slowly but perceptibly enlarged. It would reverse this process for courts to deny examiners' findings the probative force they would have in the conduct of affairs outside a courtroom.

We therefore remand the cause to the Court of Appeals. On reconsideration of the record it should accord the findings of the trial examiner the relevance that they reasonably command in answering the comprehensive question whether the evidence supporting the Board's order is substantial. But the court need not limit its reexamination of the case to the effect of that report on its decision. We leave it free to grant or deny enforcement as it thinks the principles expressed in this opinion dictate.

Judgment vacated and cause remanded.

MR. JUSTICE BLACK and MR. JUSTICE DOUGLAS concur with parts I and II of this opinion but as to part III agree with the opinion of the court below, 179 F. 2d 749, 753.

[1] Labor Board v. Pittsburgh Steamship Co., 180 F. 2d 731, affirmed, post, p. 498. The Courts of Appeals of five circuits have agreed with the Court of Appeals for the Second Circuit that no material change was made in the reviewing power. Eastern Coal Corp. v. Labor Board, 176 F. 2d 131, 134-136 (C. A. 4th Cir.); Labor Board v. La Salle Steel Co., 178 F. 2d 829, 833-834 (C. A. 7th Cir.); Labor Board v. Minnesota Mining & Mfg. Co., 179 F. 2d 323, 325-326 (C. A. 8th Cir.); Labor Board v. Continental Oil Co., 179 F. 2d 552, 555 (C. A. 10th Cir.); Labor Board v. Booker, 180 F. 2d 727, 729 (C. A. 5th Cir.); but see Labor Board v. Caroline Mills, Inc., 167 F. 2d 212, 213 (C. A. 5th Cir.).

[2] See the testimony of Dean Stason before the Subcommittee of the Senate Committee on the Judiciary in 1941. Hearings on S. 674, 77th Cong., 1st Sess. 1355-1360.

[3] See, for example, the remarks of Laird Bell, then Chairman of the Committee on Administrative Law of the Chicago Bar Association, writing in 1940 in the American Bar Association Journal. 26 A. B. A. J. 552.

[4] See Gall, The Current Labor Problem: The View of Industry, 27 Iowa L. Rev. 381, 382.

[5] This charge was made by the majority of the Special Committee of the House appointed in 1939 to investigate the National Labor Relations Board. H. R. Rep. No. 1902, 76th Cong., 3d Sess. 76.

[6] Professor Gellhorn and Mr. Linfield reached the conclusion in 1939 after an extended investigation that "the denunciations find no support in fact." Gellhorn and Linfield, Politics and Labor Relations, 39 Col. L. Rev. 339, 394. See also Millis and Brown, From the Wagner Act to Taft-Hartley, 66-75.

[7] Wilson & Co. v. Labor Board, 126 F. 2d 114, 117.

[8] In Labor Board v. Standard Oil Co., 138 F. 2d 885, 887, Judge Learned Hand said, "We understand the law to be that the decision of the Board upon that issue is for all practical purposes not open to us at all; certainly not after we have once decided that there was `substantial' evidence that the `disestablished' union was immediately preceded by a period during which there was a `dominated' union. . . .

"[W]e recognize how momentous may be such an abdication of any power of review . . . ."

[9] 86 Cong. Rec. 13942-13943, reprinted as H. R. Doc. No. 986, 76th Cong., 3d Sess.

[10] S. 915, H. R. 6324, 76th Cong., 1st Sess., § 5 (a).

[11] Final Report, 92.

[12] Referring to proposals to enlarge the scope of review to permit inquiry whether the findings are supported by the weight of the evidence, the majority said:

"Assuming that such a change may be desirable with respect to special administrative determinations, there is serious objection to its adoption for general application.

"In the first place there is the question of how much change, if any, the amendment would produce. The respect that courts have for the judgments of specialized tribunals which have carefully considered the problems and the evidence cannot be legislated away. The line between `substantial evidence' and `weight of evidence' is not easily drawn—particularly when the court is confined to a written record, has a limited amount of time, and has no opportunity further to question witnesses on testimony which seems hazy or leaves some lingering doubts unanswered. `Substantial evidence' may well be equivalent to the `weight of evidence' when a tribunal in which one has confidence and which had greater opportunities for accurate determination has already so decided.

"In the second place the wisdom of a general change to review of the `weight of evidence' is questionable. If the change would require the courts to determine independently which way the evidence preponderates, administrative tribunals would be turned into little more than media for transmission of the evidence to the courts. It would destroy the values of adjudication of fact by experts or specialists in the field involved. It would divide the responsibility for administrative adjudications." Final Report, 91-92.

[13] Id., 210-211.

[14] The minority enumerated four "existing deficiencies" in judicial review. These were (1) "the haphazard, uncertain, and variable results of the present system or lack of system of judicial review," (2) the interpretation permitting substantiality to be determined without taking into account conflicting evidence, (3) the failure of existing formulas "to take account of differences between the various types of fact determinations," and (4) the practice of determining standards of review by "case-to-case procedure of the courts." They recommended that

"Until Congress finds it practicable to examine into the situation of particular agencies, it should provide more definitely by general legislation for both the availability and scope of judicial review in order to reduce uncertainty and variability. As the Committee recognizes in its report, there are several principal subjects of judicial review— including constitutional questions, statutory interpretation, procedure, and the support of findings of fact by adequate evidence. The last of these should, obviously we think, mean support of all findings of fact, including inferences and conclusion of fact, upon the whole record. Such a legislative provision should, however, be qualified by a direction to the courts to respect the experience, technical competence, specialized knowledge, and discretionary authority of each agency. We have framed such a provision in the appendix to this statement." Id., 210-212.

The text of the recommended provision is as follows:

"(e) Scope of review.—As to the findings, conclusions, and decisions in any case, the reviewing court, regardless of the form of the review proceeding, shall consider and decide so far as necessary to its decision and where raised by the parties, all relevant questions of: (1) constitutional right, power, privilege, or immunity; (2) the statutory authority or jurisdiction of the agency; (3) the lawfulness and adequacy of procedure; (4) findings, inferences, or conclusions of fact unsupported, upon the whole record, by substantial evidence; and (5) administrative action otherwise arbitrary or capricious. Provided, however, That upon such review due weight shall be accorded the experience, technical competence, specialized knowledge, and legislative policy of the agency involved as well as the discretionary authority conferred upon it." Id., 246-247.

[15] 60 Stat. 237, 5 U. S. C. § 1001 et seq. The form finally adopted reads as follows:

"SEC. 10. Except so far as (1) statutes preclude judicial review or (2) agency action is by law committed to agency discretion—

.....

"(e) SCOPE OF REVIEW.—So far as necessary to decision and where presented the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of any agency action. It shall (A) compel agency action unlawfully withheld or unreasonably delayed; and (B) hold unlawful and set aside agency action, findings, and conclusions found to be (1) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; (2) contrary to constitutional right, power, privilege, or immunity; (3) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; (4) without observance of procedure required by law; (5) unsupported by substantial evidence in any case subject to the requirements of sections 7 and 8 or otherwise reviewed on the record of an agency hearing provided by statute; or (6) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court. In making the foregoing determinations the court shall review the whole record or such portions thereof as may be cited by any party, and due account shall be taken of the rule of prejudicial error." 60 Stat. 243-244, 5 U. S. C. § 1009 (e). (Italics ours.)

In the form in which the bill was originally presented to Congress, clause (B) (5) read, "unsupported by competent, material, and substantial evidence upon the whole agency record as reviewed by the court in any case subject to the requirements of sections 7 and 8." H. R. 1203, 79th Cong., 1st Sess., quoted in S. Doc. No. 248, 79th Cong., 2d Sess. 155, 160. References to competency and materiality of evidence were deleted and the final sentence added by the Senate Committee. S. Rep. No. 752, 79th Cong., 1st Sess. 28; S. Doc. No. 248, supra, 39-40, 214. No reason was given for the deletion.

[16] A statement of the Attorney General appended to the Senate Report explained that the bill "is intended to embody the law as declared, for example, in Consolidated Edison Co. v. National Labor Relations Board (305 U. S. 197)." Section 10 (e) of Appendix B to S. Rep. No. 752, supra, reprinted in S. Doc. No. 248, supra, 230. Mr. McFarland, then Chairman of the American Bar Association Committee on Administrative Law, testified before the House Judiciary Committee to the same effect. Id., 85-86.

[17] The following quotation from the report of the Senate Judiciary Committee indicates the position of the sponsors. "The `substantial evidence' rule set forth in section 10 (e) is exceedingly important. As a matter of language, substantial evidence would seem to be an adequate expression of law. The difficulty comes about in the practice of agencies to rely upon (and of courts to tacitly approve) something less—to rely upon suspicion, surmise, implications, or plainly incredible evidence. It will be the duty of the courts to determine in the final analysis and in the exercise of their independent judgment, whether on the whole record the evidence in a given instance is sufficiently substantial to support a finding, conclusion, or other agency action as a matter of law. In the first instance, however, it will be the function of the agency to determine the sufficiency of the evidence upon which it acts—and the proper performance of its public duties will require it to undertake this inquiry in a careful and dispassionate manner. Should these objectives of the bill as worded fail, supplemental legislation will be required." S. Rep. No. 752, supra, 30-31. The House Committee Report is to substantially the same effect. H. R. Rep. No. 1980, 79th Cong., 2d Sess. 45. The reports are reprinted in S. Doc. No. 248, supra, 216-217, 279.

See also the response of Senator McCarran in debate, to the effect that the bill changed the "rule" that courts were "powerless to interfere" when there "was no probative evidence." Id., 322. And see the comment of Congressman Springer, a member of the House Judiciary Committee, id., 376.

[18] 61 Stat. 136, 29 U. S. C. (Supp. III) § 141 et seq.

[19] H. R. 3020, 80th Cong., 1st Sess., § 10 (e), reprinted in 1 Legislative History of the Labor Management Relations Act, 1947, p. 71.

[20] The history of the evolution of the Senate provision was given by Senator Morse. 93 Cong. Rec. 5108, reprinted in 2 Legislative History 1504-1505. The prints were not approved by the Committee.

[21] S. Rep. No. 105, 80th Cong., 1st Sess. 26-27, reprinted in 1 Legislative History 432-433. The Committee did not explain what the ambiguity might be; and it is to be noted that the phrase it italicized is indistinguishable in content from the requirement of § 10 (e) of the Administrative Procedure Act that "the court shall review the whole record or such portions thereof as may be cited by any party . . . ."

Senator Taft gave this explanation to the Senate of the meaning of the section: "In the first place, the evidence must be substantial; in the second place, it must still look substantial when viewed in the light of the entire record. That does not go so far as saying that a decision can be reversed on the weight of the evidence. It does not go quite so far as the power given to a circuit court of appeals to review a district-court decision, but it goes a great deal further than the present law, and gives the court greater opportunity to reverse an obviously unjust decision on the part of the National Labor Relations Board." 93 Cong. Rec. 3839, reprinted in 2 Legislative History 1014.

[22] H. R. Rep. No. 510, 80th Cong., 1st Sess. 56, reprinted in 1 Legislative History 560. In Labor Board v. Nevada Consolidated Copper Corp., 316 U. S. 105, 107, we reversed a judgment refusing to enforce a Board order because "upon an examination of the record we cannot say that the findings of fact of the Board are without support in the evidence." The sufficiency of evidence to support findings of fact is not involved in the three other decisions of this Court to which reference was made. Labor Board v. Hearst Publications, Inc., 322 U. S. 111; Republic Aviation Corp. v. Labor Board and Labor Board v. Le Tourneau Co., 324 U. S. 793. The language used by the court offers a probable explanation for including two of the decisions of Courts of Appeals. In Wilson & Co. v. Labor Board, 126 F. 2d 114, 117, the Court of Appeals for the Seventh Circuit sustained a finding that the employer dominated a company union after stating that it had "recognized (or tried to) that findings must be sustained, even when they are contrary to the great weight of the evidence, and we have ignored, or at least endeavored to ignore, the shocking injustices which such findings, opposed to the overwhelming weight of the evidence, produce." Labor Board v. Columbia Products Corp., 141 F. 2d 687, 688, is a per curiam decision of the Court of Appeals for the Second Circuit sustaining a finding of discriminatory discharge. The court said of the Board's decision on a question of fact, "Though it may strain our credulity, if it does not quite break it down, we must accept it . . . ." The reason for disapproval of Labor Board v. Union Pacific Stages, 99 F. 2d 153, is not apparent. The Court of Appeals for the Ninth Circuit there enforced the portion of the Board's order directing the company to disavow a policy of discrimination against union members, on the ground that there appeared "to be evidence, although disputed," that some company officials had discouraged employees from joining. 99 F. 2d at 179. The bulk of the lengthy opinion, however, is devoted to a discussion of the facts to support the court's conclusion that the Board's findings of discriminatory discharges should not be sustained.

[23] Labor Board v. Standard Oil Co., 138 F. 2d 885; Labor Board v. Columbia Products Corp., 141 F. 2d 687. See notes 8 and 22, supra.

[24] Rule 53 (e) (2), Fed. Rules Civ. Proc., gives finality to the findings of a master unless they are clearly erroneous.

The court's ruling excluding from consideration disagreement between the Board and the examiner was in apparent conflict with the views of three other circuits. Labor Board v. Ohio Calcium Co., 133 F. 2d 721, 724 (C. A. 6th Cir.); A. E. Staley Mfg. Co. v. Labor Board, 117 F. 2d 868, 878 (C. A. 7th Cir.); Wilson & Co. v. Labor Board, 123 F. 2d 411, 418 (C. A. 8th Cir.); cf. International Assn. of Machinists v. Labor Board, 71 App. D. C. 175, 180, 110 F. 2d 29, 34 (C. A. D. C. Cir.).

[25] Final Report, 51.

[26] §§ 308 (1) and 309 (2) of the proposed bill, quoted in Final Report, 200, 201.

[27] § 8 (a), 60 Stat. 242, 5 U. S. C. § 1007 (a). The quoted provision did not appear in the bill in the form in which it was introduced into the Senate. S. 7, 79th Cong., 1st Sess., § 7. It was added by the Senate Judiciary Committee. The Committee published its reasons for modifying the earlier draft, but gave no explanation for this particular change. See S. Doc. No. 248, supra, 32-33. It is likely that the sentence was intended to embody a clause in the draft prepared by the Attorney General's Committee, which provided that on review of a case decided initially by an examiner an agency should have jurisdiction to remand or to "affirm, reverse, modify, or set aside in whole or in part the decision of the hearing commissioner, or itself to make any finding which in its judgment is proper upon the record." § 309 (2), Final Report, 201. The substance of this recommendation was included in bills introduced into the House. H. R. 184, 79th Cong., 1st Sess., § 309 (2), and H. R. 339, 79th Cong., 1st Sess., § 7 (c), both quoted in S. Doc. No. 248, supra, 138, 143.

[28] Salaries of trial examiners range from $7,600 to $10,750 per year. See Appendix to the Budget of the United States Government for the fiscal year ending June 30, 1952, p. 47.

[29] S. Rep. No. 752, supra, 24, reproduced in S. Doc. No. 248, supra, 210.

[30] H. R. Rep. No. 1980, 79th Cong., 2d Sess. 38-39, reprinted in S. Doc. No. 248, supra, 272-273. The House Report added that "In a broad sense the agencies' reviewing powers are to be compared with that of courts under section 10 (e) of the bill." The language of the statute offers no support for this statement.

[31] S. Rep. No. 105, 80th Cong., 1st Sess. 9, quoted in 1 Legislative History of the Labor Management Relations Act, 1947, p. 415.

745 F.2d 677 (1984)

[678] [679] [680] P. Michael Nugent, Arlington, Va., with whom Milton R. Wessell, Ronald J. Palenski and David R. Wormser, Arlington, Va., were on the brief for petitioners.

Richard M. Ashton, Atty., Board of Governors of the Federal Reserve System, Washington, D.C., with whom Jennifer Johnson, Attorney, Board of Governors of the Federal Reserve System and J. Paul McGrath, Asst. Atty. Gen., U.S. Dept. of Justice, Washington, D.C., were on the brief for respondent.

Richard A. Whiting, Washington, D.C., with whom Charles G. Cole and David L. Roll, Washington, D.C., were on the brief for intervenor Citicorp.

Alan K. Palmer, Washington, D.C., with whom Steven S. Rosenthal, Henry D. Levine, Washington, D.C., and Deborah L. Leon, San Francisco, Cal., were on the brief for intervenors California Bankers Clearing House Association, et al., in No. 82-2108.

Before GINSBURG and SCALIA, Circuit Judges, and VAN PELT, Senior Judge of the United States District Court for the District of Nebraska.^[1]

Opinion for the Court filed by Circuit Judge SCALIA.

SCALIA, Circuit Judge:

The Association of Data Processing Service Organizations, Inc. ("ADAPSO"), a national trade association representing the data processing industry, and two of its members petition this court for review of two orders of the Board of Governors of the Federal Reserve System, pursuant to 12 U.S.C. § 1848 (1982). In No. 82-1910, they seek review of the Board's July 9, 1982 order approving Citicorp's application to establish a subsidiary, Citishare, to engage in certain data processing and transmission services. Order Approving Engaging in Data Processing and Data Transmission Activities, 68 Fed.Res.Bull. 505 (1982) ("Citicorp Order"). In No. 82-2108, they seek review of the Board's August 23, 1982 order, entered after notice and comment rulemaking, amending those portions of Regulation Y which dealt with the performance of data processing activities by bank holding companies. Data [681] Processing and Electronic Funds Transfer Activities, 47 Fed.Reg. 37,368 (1982) (as set forth at 12 C.F.R. §§ 225.4(a)(8), 225.123(e) (1983) ("Regulation Y Order").^[2] We consolidated the two appeals.

The Bank Holding Company Act of 1956, ch. 240, 70 Stat. 133 (codified as amended at 12 U.S.C. §§ 1841-50 (1982)) (the "Act"), requires all bank holding companies to seek prior regulatory approval before engaging in nonbanking activities. The restrictions do not apply to:

activities ... which the Board after due notice and opportunity for hearing has determined (by order or regulation) to be so closely related to banking or managing or controlling banks as to be a proper incident thereto.... In determining whether a particular activity is a proper incident to banking or managing or controlling banks the Board shall consider whether its performance by an affiliate of a holding company can reasonably be expected to produce benefits to the public, such as greater convenience, increased competition, or gains in efficiency, that outweigh possible adverse effects, such as undue concentration of resources, decreased or unfair competition, conflicts of interests, or unsound banking practices.

12 U.S.C. § 1843(c)(8). Section 1848, the source of our review authority, provides that "[t]he findings of the Board as to the facts, if supported by substantial evidence, shall be conclusive." Id. at § 1848.

On February 23, 1979, Citicorp applied for authority to engage, through its subsidiary Citishare, in the processing and transmission of banking, financial, and economic related data through timesharing, electronic funds transfer, home banking and other techniques. It also sought permission to sell its excess computing capacity and some computer hardware. The Board published notice of Citicorp's application, which was protested by ADAPSO, and set it for formal hearing. 45 Fed.Reg. 41,533 (July 19, 1980). Before the hearing was held, Citicorp amended its application to add certain activities and to request amendment of Regulation Y to permit the activities it had specified. The Board published an Amended Order for Hearing and invited public comments and participation. 45 Fed.Reg. 76,515 (Nov. 19, 1980). A formal hearing was held before an Administrative Law Judge in which the merits of both the application and the proposed rule were considered. In addition, more than sixty companies and individuals submitted written comments on the proposed rule. On March 29, 1982, the ALJ decided that the activities proposed by Citicorp were closely related to banking and would produce benefits to the public which would outweigh their costs. In re: Application of Citicorp to Engage in Data Processing and Transmission Activities, ALJ Recommended Decision, J.A. B-68 to B-123 ("Recommended Decision"). The ALJ also recommended amendments to Regulation Y that would permit those activities contained in the Citicorp application. On July 9, 1982, the Board adopted the ALJ's recommendation to approve the Citicorp application, with certain restrictions. On August 23, 1982, the Board adopted the ALJ's recommended amendments to Regulation Y, again with certain restrictions. ADAPSO, and two of its members, participants in the actions below, filed these petitions for review.

I. STANDARD OF REVIEW

We are faced at the outset with a dispute regarding the proper standard of review. These consolidated appeals call for us to review both an on-the-record adjudication and an informal notice and comment rulemaking. Petitioners contend that the substantial evidence standard, which presumably authorizes more rigorous judicial review, should govern our review of both orders. Petitioners' Reply Brief at 26-28. The Board agrees, noting that § 1848 applies a substantial evidence standard to factual [682] determinations. Respondent's Brief at 22. Intervenor Citicorp contends that while the substantial evidence standard should govern review of the Citicorp order, Regulation Y should be upset only if arbitrary or capricious. Citicorp Brief at 16-17. Intervenor California Bankers Clearing House Association, addressing only Regulation Y, also advocates review under the arbitrary or capricious review standard. CBCHA Brief at 8-14. The parties' submissions on this point reflect considerable confusion, which is understandable when one examines decisions defining the standard of review under this statute.

Both of the Supreme Court's opinions reviewing action of the Board in amending Regulation Y noted that the Board's determination "is entitled to the greatest deference," Board of Governors of the Federal Reserve System v. Investment Company Institute, 450 U.S. 46, 56, 101 S.Ct. 973, 981-82, 67 L.Ed.2d 36 (1981) ("ICI"); Securities Industry Association v. Board of Governors of the Federal Reserve System, ___ U.S. ___, 104 S.Ct. 3003, 3009, 82 L.Ed.2d 158 (1984) ("SIA"), but neither of them discussed the applicable standard of review, or even referred to § 1848.^[3] The courts of appeals, however, have applied the substantial evidence standard of § 1848 to Board adjudications such as the authorization in the first order here under review, Securities Industry Association v. Board of Governors of the Federal Reserve System, 716 F.2d 92, 101-02 (2d Cir.1983), aff'd, ___ U.S. ___, 104 S.Ct. 3003, 82 L.Ed.2d 158 (1984), while applying the arbitrary or capricious standard, despite § 1848, to Board rules, including specifically amendments of Regulation Y, National Courier Association v. Board of Governors of the Federal Reserve System, 516 F.2d 1229 (D.C.Cir.1975); Association of Bank Travel Bureaus v. Board of Governors of the Federal Reserve System, 568 F.2d 549 (7th Cir.1978); see Investment Company Institute v. Board of Governors of the Federal Reserve System, 551 F.2d 1270, 1281 (D.C.Cir.1977) (dicta). In fact one appellate opinion has, like this one, addressed precisely the situation in which both an adjudicatory authorization and an amendment of Regulation Y were at issue in the same case — and applied the § 1848 substantial evidence standard to the former but the arbitrary or capricious standard to the latter. Compare Alabama Association of Insurance Agents v. Board of Governors of the Federal Reserve System, 533 F.2d 224, 246 (5th Cir.1976), with id. at 240. This would make a lot of sense if, as the Board has argued in some cases, § 1848 in its totality applies only to adjudication rather than rulemaking, since it is limited to "orders" of the Board, a word which the Administrative Procedure Act ("APA") defines to mean the product of an adjudication. See 5 U.S.C. § 551(4), (6) (1982). Such a technical interpretation of the provision, however, has been uniformly and quite correctly rejected. See Investment Company Institute, supra, 551 F.2d at 1276-78; Alabama Association of Insurance Agents, supra, 533 F.2d at 234-35. That leaves the courts with the difficult task of explaining why the last sentence of § 1848, unlike all the rest of it, should be deemed to apply only to adjudication and not to rulemaking. Difficult, because there is nothing in either the text^[4] or the [683] legislative history of the section to suggest such a result. The courts applying the arbitrary or capricious standard to Board rulemaking (which, as stated above, include all the courts that have confronted the issue) dispose of this problem either by totally ignoring it, see Alabama Association of Insurance Agents, supra, 533 F.2d at 240, 246; cf. Investment Company Institute, supra, 551 F.2d at 1281, or by noting that the parties "do not appear to contest" the point, National Courier, supra,^[5] 516 F.2d at 1235 n. 8, or by the ipse dixit that "[w]e interpret [the last sentence of § 1848] to apply to findings of fact `on the record' in an adjudicatory hearing as contrasted with a rulemaking proceeding," Association of Bank Travel Bureaus, supra, 568 F.2d at 552 n. 5.

We think that there is no basis for giving the last sentence of § 1848 anything less than the general application given to the rest of the section. The Supreme Court's pronouncement that the "greatest deference" is to be given to the determinations of the Board, and the court of appeals decisions applying the arbitrary or capricious test to Board rulemaking, seem to us explicable on quite different grounds — namely, that in their application to the requirement of factual support the substantial evidence test and the arbitrary or capricious test are one and the same. The former is only a specific application of the latter, separately recited in the APA not to establish a more rigorous standard of factual support but to emphasize that in the case of formal proceedings the factual support must be found in the closed record as opposed to elsewhere. We shall elaborate upon this point because it is not uncommon for parties to expend great effort in appeals before us to establish which of the two standards is applicable where in fact their operation is precisely the same.

The "scope of review" provisions of the APA, 5 U.S.C. § 706(2),^[6] are cumulative. Thus, an agency action which is supported by the required substantial evidence may in another regard be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" — for example, because it is an abrupt and unexplained departure from agency precedent. Paragraph (A) of subsection 706(2) — the "arbitrary or capricious" provision — is a catchall, picking up administrative misconduct not covered by the other more specific paragraphs. Thus, in those situations where paragraph (E) has no application (informal rulemaking, for example, which is not governed by §§ 556 and 557 to which paragraph (E) refers), paragraph (A) takes up the slack, so to speak, enabling the courts to strike down, as arbitrary, agency action that is devoid of needed factual support. When the arbitrary or capricious standard is performing that function of assuring factual support, there is no substantive difference between what it requires and what would be required by the [684] substantial evidence test, since it is impossible to conceive of a "nonarbitrary" factual judgment supported only by evidence that is not substantial in the APA sense — i.e., not "`enough to justify, if the trial were to a jury, a refusal to direct a verdict when the conclusion sought to be drawn ... is one of fact for the jury,'" Illinois Central R.R. v. Norfolk & Western Ry., 385 U.S. 57, 66, 87 S.Ct. 255, 260, 17 L.Ed.2d 162 (1966) (quoting NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 292, 300, 59 S.Ct. 501, 505, 83 L.Ed. 660 (1939)).

We have noted on several occasions that the distinction between the substantial evidence test and the arbitrary or capricious test is "largely semantic," Aircraft Owners and Pilots Association v. FAA, 600 F.2d 965, 971 n. 28 (D.C.Cir.1979); Pacific Legal Foundation v. Department of Transportation, 593 F.2d 1338, 1343 n. 35 (D.C.Cir.1979); American Public Gas Association v. FPC, 567 F.2d 1016, 1028-29 (D.C.Cir.1977), and have indeed described that view as "the emerging consensus of the Courts of Appeals," Pacific Legal Foundation, supra, 593 F.2d at 1343 n. 35. See Associated Industries v. Department of Labor, 487 F.2d 342, 349-50 (2d Cir. 1973) (Friendly, J.); National Nutritional Foods Association v. Weinberger, 512 F.2d 688, 705 (2d Cir.1975) (Lumbard, J., concurring); Paccar, Inc. v. NHTSA, 573 F.2d 632, 636 (9th Cir.1978) (purporting to avoid the issue, but seemingly not doing so). Leading commentators agree:

Does the extent of required factual support for rules depend in part on whether the standard for review is "substantial evidence" or "arbitrary and capricious"? Although from 1946 until some time during the 1970s the dominant answer probably was yes, a change to a no answer has probably occurred during the 1970s ....

1 K. DAVIS, ADMINISTRATIVE LAW TREATISE § 6:13 at 512 (2d ed. 1978).

In review of rules of general applicability made after "notice and comment" rulemaking, [substantial evidence and arbitrary or capricious] criteria converge into a test of reasonableness.

. . . .

Review without an agency record thus comes down to review of reasonableness. [T]he question of reasonableness is also the one which the court must now ask itself in reviewing findings of fact under the post-APA substantial evidence rule.

B. SCHWARTZ, ADMINISTRATIVE LAW 604, 606 (1976).

As noted earlier, this does not consign paragraph (E) of the APA's judicial review section to pointlessness. The distinctive function of paragraph (E) — what it achieves that paragraph (A) does not — is to require substantial evidence to be found within the record of closed-record proceedings to which it exclusively applies. The importance of that requirement should not be underestimated. It is true that, as the Supreme Court said in Camp v. Pitts, 411 U.S. 138, 142, 93 S.Ct. 1241, 1244, 36 L.Ed.2d 106 (1973), even informal agency action (not governed by paragraph (E)) must be reviewed only on the basis of "the administrative record already in existence." But that is quite a different and less onerous requirement, meaning only that whether the administrator was arbitrary must be determined on the basis of what he had before him when he acted, and not on the basis of "some new record made initially in the reviewing court," id. That "administrative record" might well include crucial material that was neither shown to nor known by the private parties in the proceeding — as indeed appears to have been the situation in Camp v. Pitts itself. It is true that, in informal rulemaking, at least the most critical factual material that is used to support the agency's position on review must have been made public in the proceeding and exposed to refutation. That requirement, however, does not extend to all data, see Administrative Conference of the United States, Recommendation No. 74-4, Preenforcement Judicial Review of Rules of General Applicability, 1 C.F.R. § 305.74-4 (1975); Verkuil, Judicial Review of Informal Rulemaking, 60 VA.L. [685] REV. 185 (1974); and it only applies in rulemaking and not in other informal agency action, since it derives not from the arbitrary or capricious test but from the command of 5 U.S.C. § 553(c) that "the agency ... give interested persons an opportunity to participate in the rule making." See Portland Cement Association v. Ruckelshaus, 486 F.2d 375, 393 n. 67 (D.C.Cir. 1973).

Consolidated cases such as those before us here — involving simultaneous review of a rule (whose factual basis is governed only by paragraph (A)'s catch-all control against "arbitrary or capricious" action) and of a formal adjudication dealing with the same subject (whose factual basis is governed by paragraph (E)'s requirement of substantial evidence) — demonstrate why the foregoing interpretation of the two standards is the only interpretation that makes sense. If the standards were substantively different (and leaving aside for the moment consideration of any special effect of § 1848), the Citicorp order, authorizing one bank holding company's data processing services, would be subject to more rigorous judicial review of factual support than the Regulation Y order which, due to its general applicability, would affect the operations of every bank holding company in the nation. Or, to put the point another way: If the Board had never issued any Regulation Y, and simply determined in the context of a particular application that the provision of timesharing services is "closely related" to banking, that determination, which could be reconsidered and revised in the context of the next adjudication, would require more factual support than the same determination in a rulemaking, which would have immediate nationwide application and, until amended by further rulemaking, would have to be applied to all subsequent applications.

This seemingly upside-down application of varying standards is not an issue in the present case since, as we have observed, § 1848 makes it clear that only one standard — the substantial evidence test — applies to review of all Board actions. The relevance of the foregoing discussion here is to determine what that standard means. What we have said suggests that the normal (APA) meaning of the "substantial evidence" terminology connotes a substantive standard no different from the arbitrary or capricious test. One cannot dismiss out of hand, however, the possibility that, in this particular statute, a different meaning was intended — in which case that different standard would govern review of both rulemaking and adjudication. A number of "substantial evidence" review provisions have been attached to rulemaking authority, particularly in recent years. See, e.g., 29 U.S.C. § 655(f) (1982) (Occupational Safety and Health Act); 30 U.S.C. § 816(a) (1982) (Federal Coal Mine Health and Safety Act); 15 U.S.C. § 1193(e)(3) (1982) (Flammable Fabrics Act); 15 U.S.C. § 57a(e)(3)(A) (1982) (FTC Improvement Act of 1975). It is conceivable that some of these were intended, as the Fifth Circuit found with regard to such a provision in the Consumer Product Safety Act, 15 U.S.C. § 2060 (1982), to require the courts "to scrutinize [agency] actions more closely than an `arbitrary and capricious' standard would allow." Aqua Slide `N' Dive Corp. v. CPSC, 569 F.2d 831, 837 (5th Cir.1978). Congress's unpropitious use of the "substantial evidence" APA language for such a purpose is plausible, since the standard has acquired a reputation for being more stringent.^[7] One should not be too quick, however, to impute such a congressional intent. There is surely little appeal to an ineffable review standard that lies somewhere in-between the quantum of factual support required to go to a jury (the traditional "substantial evidence" test) and the "preponderance of the evidence" standard that would apply in de novo review. Moreover, 5 [686] U.S.C. § 559 provides that a subsequent statute shall not be held to supersede or modify the APA provisions "except to the extent that it does so expressly." While the provision for "substantial evidence" review where the APA would otherwise require only "arbitrary or capricious" review is unquestionably an "express" alteration, surely the import of the § 559 instruction is that Congress's intent to make a substantive change be clear. This can lead to some fairly convoluted inquiries. Suppose, for example, that Congress clearly intended to switch to a stricter test, but was also clearly operating on the mistaken belief that the existing test ("arbitrary or capricious") was more lenient than the "substantial evidence" standard. Should one give effect to the congressional intent to adopt a stricter standard, or rather to the congressional intent to adopt the "substantial evidence" standard (which is in fact, as we have discussed, no stricter)? Several decisions of this court stand for the proposition that a "substantial evidence" provision in the substantive statute under consideration did not have the effect of requiring increased factual support beyond that demanded by the normal "arbitrary or capricious" rulemaking standard of review. Public Systems v. FERC, 606 F.2d 973, 980 n. 34 (D.C.Cir.1979) (interpreting the predecessors of § 19(b) of the Natural Gas Act, 15 U.S.C. § 717r(b) (1982), and the corresponding provision of the Federal Power Act, 16 U.S.C. § 825l (b) (1982)); American Public Gas Association v. FPC, supra, 567 F.2d at 1028-29 (interpreting the predecessor of § 19(b) of the Natural Gas Act). See also Aircraft Owners and Pilots Association v. FAA, supra, 600 F.2d at 971 n. 28 (not deciding the issue with regard to the "substantial evidence" provision of the Federal Aviation Act, 49 U.S.C. § 1486(e) (1976)).

Fortunately, it is not necessary to engage in these speculations with regard to the "substantial evidence" provision of § 1848. The Supreme Court has evidently rejected the notion that it alters normal APA review requirements, since the Court's opinions reviewing Board action deem the provision unworthy of mention, and specifically accord the Board "the greatest deference." See, e.g., SIA, supra, 104 S.Ct. at 3009; ICI, supra, 450 U.S. at 56-57, 101 S.Ct. at 981-982. See also National Courier, supra, 516 F.2d at 1237. We hold, therefore, that the § 1848 "substantial evidence" requirement applicable to our review here demands a quantum of factual support no different from that demanded by the substantial evidence provision of the APA, which is in turn no different from that demanded by the arbitrary or capricious standard.

II. CLOSELY RELATED TO BANKING

This appeal requires us, then, to decide whether the Board of Governors acted arbitrarily or capriciously — either because no substantial evidence existed to support its factual premises, or in any other respect — when it concluded, based on the record of the proceedings before it, that the new activities Citicorp proposed were closely related to banking. The test which the Board applied was that developed by this court in National Courier, supra, 516 F.2d at 1237:

As to what kinds of connections may qualify [as closely related to banking], at least the following seem to us within the statutory intent:

1. Banks generally have in fact provided the proposed services.

2. Banks generally provide services that are operationally or functionally so similar to the proposed services as to equip them particularly well to provide the proposed service.

3. Banks generally provide services that are so integrally related to the proposed services as to require their provision in a specialized form.

See, e.g., Citicorp Order, 68 Fed.Res.Bull. at 506 n. 3; Regulation Y Order, 47 Fed. Reg. 37,368 n. 1. These criteria are disjunctive rather than cumulative, see National Courier, supra, 516 F.2d at 1237-38, and not exclusive, see 49 Fed.Reg. 806 (1984); SIA, supra, 104 S.Ct. at 3006 n. 5.

[687] The "Data Test"

Petitioners do not contend that the National Courier criteria are in themselves erroneous (they have subsequently been approved by the Supreme Court, see SIA, supra, 104 S.Ct. at 3006 n. 5), but they do contend, preliminarily, that the Board erroneously applied them to the kinds of data involved in the proposed services, rather than to the services themselves.

The depth of confusion that surrounds this argument is suggested by the fact that the Board's brief denies that a data test was applied, Respondent's Brief at 27-33, while the briefs of intervenors supporting the Board acknowledge that, at least as to the Regulation Y order, it was applied but assert that its application was lawful, Citicorp Brief at 27-32; CBCHA Brief at 27-32. We must address the Board's contention first.

The Board is quite correct that the Citicorp order specifically examined each of the eight categories of data processing the applicant proposed to provide. But some of those categories were only described with reference to (1) the data processing technology employed and (2) the nature of the data to be provided or processed, and the Board clearly held that the former "is not determinative of whether [the] activity is permissible," Citicorp Order, 68 Fed.Res. Bull. at 507. The conclusion is therefore inescapable that, even in the Citicorp order, a data test was employed. With regard to timesharing services, for example, the applicant proposed to provide "data processing and transmission services for financial and non-financial institutions wherein the data being processed and transmitted are financial, banking or economic related." J.A. C-54. The Board approved this, with the one change (which will be discussed further in another portion of this opinion) that "economic related" was altered to "economic." Citicorp Order, 68 Fed.Res.Bull. at 507 n. 8. It is true that the application further provided some examples of the specific data processing uses to which the requested authority would be put:

Such packaged financial systems permit customers at various locations to obtain the benefit of Citicorp's financial information systems and financial analysis expertise with respect to such applications associated with banking as financial modeling, loan analysis, accounting and book-keeping, budget and profitability analysis, portfolio record-keeping and analysis, foreign exchange exposure, general ledger, bond analysis, international trade settlement, and economic forecasting.

J.A. C-54 to C-55. The Board's opinion discussed several of these examples,^[8] concluding that they in fact represented services provided by banks or were so similar to such services that banking organizations are particularly well equipped to provide them. But that can only be understood as an attempted demonstration that its data test is as successful in concrete application as it is in theory.

It is even clearer that the Regulation Y order employs a data test. No more is needed to establish this than the text of the new regulation which the order adopted. Permissible activities of bank holding companies now include:

Providing to others data processing and data transmission services, facilities (including data processing and data transmission hardware, software, documentation or operating personnel), data bases, or access to such services, facilities, or data bases by any technological means, if:

(i) The data to be processed or furnished are financial, banking, or economic, and the services are provided pursuant to a written agreement so describing and limiting the services;

(ii) The facilities are designed, marketed, and operated for the processing and [688] transmission of financial, banking, or economic data; and

(iii) The hardware provided in connection therewith is offered only in conjunction with software designed and marketed for the processing and transmission of financial, banking, or economic data, and where the general purpose hardware does not constitute more than 30 percent of the cost of any packaged offering.

12 C.F.R. § 225.25(b)(7). The Regulation Y order states that the amendment it adopts "will make it permissible for bank holding companies to engage in the data processing and transmission services the Board has approved by order in the [Citicorp] case." Regulation Y Order, 47 Fed.Reg. 37,369. But as the footnote accompanying that statement shows, this is a reference to the eight broad technological categories of service (e.g., timesharing) rather than to the particular uses within those categories (e.g., budgeting, bookkeeping, accounting) which petitioners complain a data test avoids. And when the Regulation Y order incorporates by reference "[t]he Board's findings on the permissibility of the services involved ... set forth in detail in the Board's [Citicorp] order," id., that incorporation, like the original findings themselves, must be for the purpose of exemplifying that in concrete application the data test will produce services closely related to banking.

As the insignificant nature of the textual changes in the portion of Regulation Y dealing with the current issue indicates, the present amendment does not fundamentally alter the approach of that regulation to data processing services. With regard to the data test point it is significant, we think, that the Board's staff recommendation proposing what in substance became the 1971 Regulation Y described its approach as follows:

In our view, the real issue is what kind of data should banking organizations be permitted to process. The technology employed is not the subject of the Act.

. . . .

Accordingly, we recommend that the Board shift the emphasis of its proposal from the method of processing data to the kind of data being processed. Under this recommendation, bank holding companies would be permitted to process banking, financial, or other economic data, regardless of the tool used in the processing.

Legal Division Memo to Board of Governors (June 7, 1971), Applicant's Exhibit M-2 at 6. While this is the staff's description rather than the Board's we think it an accurate representation of what the Board did in 1971 and perpetuated in the present orders.

The Board's brief suggests that the exclusiveness and allegedly impermissible generality of the data test are avoided by the fact that

[b]efore any holding company may engage in data processing services, it must file an application with the Board and receive a Board order determining that the `public benefits' test of section 4(c)(8) [of the Act] has been satisfied. 12 C.F.R. § 225.4(a), (b). Since data processing activities for a particular company are subject to Board approval upon specific application, the Board will have the opportunity to ensure that no bank holding company's activities exceed the statutory standard.

Respondent's Brief at 32. It is indeed true, as noted in the Regulation Y Order, 47 Fed.Reg. 37,371, that the Board makes the separate "public benefits" determination required under the Act^[9] by examining individual applications rather than by regulation.^[10] But it would be unlawful, in the [689] course of that case-by-case examination for that separate purpose, to deny an applicant the "closely related" qualification which the regulation generally confers. Such action would require amendment of the regulation — so that the limitation upon the data test which the Board's brief puts forward amounts to no more than the possibility that the rule can be amended to forbid what it now impermissibly (according to petitioners) permits. Reliance upon such a possibility would validate every invalid rule.

We must confront, therefore, the stark question whether the data test, as the determinant of whether data processing services are closely related to banking, is arbitrary or capricious. We think not. It would of course be preferable, from the point of view of accuracy alone, to make every "closely related" determination on a more narrow, specific, case-by-case basis — to ask, as petitioners would have the Board do, whether data processing for budget analysis, for bookkeeping, and for accounting each separately qualifies for the exemption. Indeed, it would be even more accurate to get even more specific, and to ask whether budget analysis for manufacturing entities, budget analysis for retail sales entities, and budget analysis for personal service entities each separately qualifies. But the whole point of rulemaking as opposed to adjudication (or of statutory law as opposed to case-by-case common law development) is to incur a small possibility of inaccuracy in exchange for a large increase in efficiency and predictability. What the present controversy comes down to is simply whether there is reasonable assurance that the activities embraced within the data test — not all of which have been individually examined or even yet foreseen — will be closely related to banking under one or more of the broad National Courier tests. We think that there is.

As a theoretical matter, to begin with, the test is appealing. The record of this proceeding amply demonstrates, if any demonstration is needed, that banks regularly develop and process for their customers large amounts of banking, financial and economic data, and that they do so (and will presumably continue to do so) through the most advanced technological means. Once that is acknowledged, it is difficult to envision how any provision of data processing services dealing with data of that particular type would not meet at least the second of the National Courier tests:

Banks generally provide services that are operationally or functionally so similar to the proposed services as to equip them particularly well to provide the proposed service.

National Courier, supra, 516 F.2d at 1237. Perhaps it may not be in the public interest for them to provide one or another of such services, for anticompetitive or other reasons. But that relates to the "public benefits" determination, which is made case-by-case rather than in the amended Regulation Y, and whose resolution in the Citicorp order is not under challenge on this appeal.

In addition to its theoretical reasonableness, there is the fact that the Board, in the course of this proceeding, considered specific applications of the principle to various specific data processing uses proposed by Citicorp — finding all of them to be within one of the National Courier criteria, and many to be within the most rudimentary criterion that "[b]anks generally have in fact provided the proposed services," id. We find adequate support in the record for those conclusions.^[11]

[690] It is significant that petitioners have not proposed any alternative to the data test, evidently demanding instead that each new data processing technology, and even each new use of data processing (such as budgeting, financial modeling, accounting) be separately examined and approved for its "closely relatedness." In a field such as data processing, this will not do; the predictability of a rulemaking approach to the issue is vital. As the ALJ in the present proceeding found:

In view of rapid technological evolution, it is virtually impossible for any firm to predict the data processing services which will be available or offered in the coming years.

Recommended Decision at 10, J.A. B-81. And as the Comptroller of the Currency noted in a rulemaking proceeding dealing with the data processing activities of national banks:

In addition to being difficult to draft, acceptable specific lists or examples of permissible activities would be very difficult to keep current. This difficulty is due to the rapidly changing nature of the data processing field. The current rate of change virtually ensures that any acceptable list would quickly be rendered obsolete. Thus, any acceptable list or set of examples would require repeated updating. Perhaps more significantly, such a list may discourage the development by national banks of new data processing services which, although part of the business of banking, are not on a list of permitted activities or similar in nature to those in a set of examples of permitted activities.

Data Processing by National Banks, 47 Fed.Reg. 46,526, 46,529 (1982). We think these considerations amply justify the approach the Board has taken, an approach to which the petitioners have suggested no feasible alternative.

Economic Data

We turn next to an objection of petitioners that relates not to the data test as such, but to the types of data which the data test embraces.

The previous version of Regulation Y permitted bank holding companies to engage in "storing and processing other banking, financial, or related economic data, such as performing payroll, accounts receivable or payable or billing services." 12 C.F.R. § 225.4(a)(8)(ii) (1972) (emphasis added). In the combined adjudication-rulemaking here at issue, the ALJ's Recommended Decision accepted Citicorp's proposal that this be expanded to include the processing and transmission of "banking, financial and economic related data." Recommended Decision at 49, J.A. B-120 (emphasis added). The Board rejected that [691] recommendation, agreeing with petitioners here that "economic related data" was "too broad a category and includes data that are not closely related to banking." Regulation Y Order, 47 Fed.Reg. 37,369; Citicorp Order, 68 Fed.Res.Bull. at 507 n. 8. It adopted, however, an expansion of the previous language to "banking, financial and economic [as opposed to economic-related] data," and permitted Citicorp to engage in such activities. Id. This expansion of prior authority was based upon its conclusion that "the record in this proceeding supports a finding that banks process economic data." Regulation Y Order, 47 Fed.Reg. 37,369. See also Citicorp Order, 68 Fed.Res.Bull. at 507 n. 8 ("[t]he record supports a finding that banks engage in the processing and transmission of economic data").

We agree. The testimony amply establishes the proposition that banks have long served their customers by developing and making available information regarding the national and international economy, including economic projections useful for investment decisions. The existing Regulation Y itself permitted the provision of "general economic information and advice, general economic statistical forecasting services and industry studies." 12 C.F.R. § 225.4(a)(5)(iv) (1982). The current amendment of Regulation Y, which merely enables banks to make such information available in a new and more useful fashion, thus clearly meets the second of the National Courier criteria, and perhaps the first as well. Petitioners complain that "[n]owhere in the record has there been any demonstration that banks have historically provided economic services even approaching the sophistication, scale and business mode approved by the Board in its Orders." Petitioners' Brief at 42. Perhaps so, but that is progress. It is not the purpose of the Bank Holding Company Act restrictions to confine banks to the same level, or crudeness, or technological simplicity of services previously provided — but merely to services of a closely related nature.

We also reject petitioners' complaint that the Board has not defined "economic data." Petitioners' Brief at 35-36. In the context of these orders the meaning of the term is clear enough. It includes, as petitioners fear, "agricultural matters, retail sales matters, housing matters, corporate profit matters and anything `of value in banking and financial decisions.'" Id. at 36 (quoting Citicorp Reply Brief before the Board at 13 & n. 17).

Timesharing Services

Until the 1970s, data processing was performed in the "batch" mode, that is, the application of a computer program was applied to data recorded (keypunched) on small cards, which were physically delivered to the computer. Batch processing requires expensive data pick-up and delivery, often involves lengthy overall turnaround time, and permits only one job to be performed at a time. Technological advances now enable data to be transmitted electronically, typically over a telephone line, to and from the central processing unit and the user's terminal. That capability plus other technological advances permit "timesharing" — the simultaneous use of a computer by many users, each of whom can interact with the computer, i.e., ask yes-no questions and receive immediate responses. The ALJ found timesharing particularly well suited to economic, financial, and banking operations. Recommended Decision at 9, J.A. B-80.

Timesharing was approved in both the Citicorp and the Regulation Y Orders, 68 Fed.Res.Bull. at 507; 47 Fed.Reg. 37,369. Of course one of petitioners' objections to this action is that the approval of this new service on the basis of the data test was impermissible; we have addressed that in a more general context above. Petitioners also claim, however, that timesharing, particularly when combined with customer use (which the orders permit) of applications software for such functions as modeling, forecasting and statistical analysis residing on holding company computers (as opposed to requiring customer creation and use of [692] their own applications software) enables customers to use bank computer systems for "open-ended and general, non-financial services," Petitioners' Brief at 28, such as "race track handicapping or employee evaluation," id. at 27.

This objection is unfounded. To begin with, the Act places a limitation upon the services that bank holding companies can offer, not upon the uses to which others choose to put them. If the services proposed here were so well adapted to such uses unrelated to banking as employee evaluation that it could reasonably be thought that the services were offered for that purpose it would be one thing; but these services are no more invalidated by the mere possibility of such use, "unknown even to the holding company itself," Petitioners' Brief at 29, than was the service which we approved in National Courier invalidated by the obvious possibility that a customer might include some nonfinancial material in the courier packages. And such a possibility (at most) is all that petitioners established. They brought forward not a single instance of actual use of such services for such purposes. Even their theoretical horrible was refuted by testimony asserting that it would be prohibitively expensive to use financial programs for such nonfinancial purposes. Nov. 17, 1981 Tr. at 1178-79, 1214-15.

Moreover, as undocumented and as unrealistic as the petitioners' fears on this score appear to be, the Board nonetheless included provisions in its orders to calm this concern. In the Citicorp order the Board required that "all proposed data processing services provided by Citicorp to others outside the holding company for banking, financial and economic data must be provided pursuant to a written agreement so describing and limiting the services." Citicorp Order, 68 Fed.Res.Bull. at 507. The approval conferred by the amended Regulation Y applies only when "the data to be processed or furnished are financial, banking, or economic, and the services are provided pursuant to a written agreement so describing and limiting the services." 12 C.F.R. § 225.25(b)(7)(i). These agreements will be subject to scrutiny in connection with the Board's case-by-case "public benefits" determination. In addition, the amended Regulation Y specifically requires that the offered facilities (by which the Board means "data processing and transmission hardware, systems software, documentation and operating personnel," Citicorp Order, 68 Fed.Res.Bull. at 507 n. 12) be "designed, marketed, and operated for the processing and transmission of financial, banking, or economic data," 12 C.F.R. § 225.25(b)(7)(ii), and the Citicorp order makes it clear that this imposes the obligation to "take the technical steps necessary to ensure" this result. 68 Fed.Res.Bull. at 508. It is unthinkable that any more should be required.

Hardware

In both the Citicorp order and the Regulation Y order, the Board approved bank holding company provision of data processing hardware to their customers. Hardware is the equipment used in data processing systems, such as the mainframe computer, terminals, printers, memory devices, and the like. Software is the coded instructions which control the way data is processed, for example, individual programs. See Recommended Decision at 6-7, J.A. B-77 to B-78. For present purposes, data processing hardware provided by bank holding companies can be divided into two types, which were approved subject to different conditions and must be discussed separately.

Specialized hardware is specifically designed "to provide a permissible data processing or transmission service[], and is not likely to be used, to any significant extent, for nonfinancial purposes." Citicorp Order, 68 Fed.Res.Bull. at 508 n. 14. The prime example is the automated teller machine (ATM), which is designed to execute banking transactions and has special security features appropriate to that purpose. The Board found that such hardware, when "offered only in conjunction with software designed and marketed for [693] the processing and transmission of financial, banking, or economic data," 12 C.F.R. § 225.25(b)(7)(iii), meets the third National Courier test. Citicorp Order, 68 Fed.Res. Bull. at 508 & n. 14, 509; Regulation Y Order, 47 Fed.Reg. 37,370. As noted earlier, that test reads as follows:

Banks generally provide services that are so integrally related to the proposed services as to require their provision in a specialized form.

516 F.2d at 1237. Petitioners make several attacks upon this finding, none of which seems to us well taken.

First, they assert that the third National Courier test could not conceivably apply because by its terms it pertains to "services," which the provision of computer hardware is not. Petitioners' Brief at 54. But surely National Courier is not to be interpreted in that fashion. Since the case dealt with services (courier services) it framed all its tests in those terms. But the object of the tests was to determine what are, within the words of the Act, "activities ... closely related to banking," 12 U.S.C. § 1843(c)(8) (emphasis added), and they are obviously meant to apply, mutatis mutandis, to all activities, including not just services but also sale of material and equipment. It cannot seriously be thought that a bank holding company's sale of checkbooks stands in a less favored position, under National Courier than its provision of courier services.

Next, petitioners argue that the third National Courier test is not met because it requires that the new services (or, as we have said, other activities) be integrally related to "traditional bank services" such as "check collection, credit extension and deposit gathering." Petitioners' Brief at 53. As far as we can determine, this limitation has been created out of whole cloth. It does not appear in National Courier, which only requires that the integrally related services be services that "banks generally provide." If one were to hang upon this phraseology, the issue would presumably come down to whether the relevant integrally related services are data processing services in general (which banks now do generally provide) or the new types of data processing services authorized by these orders (at least the most futuristic of which banks now do not generally provide). Or it might be argued, as intervenor Citicorp does, Citicorp Brief at 61, that "services which banks generally provide" really means, as shown by language elsewhere in the National Courier opinion,^[12] "services which banks are authorized to provide."

But at this point it begins to become foolish to devote one's analytic energy to a parsing of the National Courier tests as though they were the statute itself, instead of referring to the underlying intent of the "closely related" requirement of which National Courier is, and only purports to be, a partial elaboration. That is to say, surely one of the most significant elements of the National Courier criterion is its prologue. After noting that the 1970 amendments to the Bank Holding Company Act (which slightly altered the text of the "closely related" provision and added the "public benefits" requirement) mean that the "closely related" test "no longer bears the full load, and may now be thought of as setting off as forbidden to banks those activities which are so clearly of a purely commercial nature that the predominantly adverse effects of a bank's engaging in them may be presumed," 516 F.2d at 1237, we continued:

Against this background, and reminding ourselves that the matter is one expressly committed by the statute to the Board, we think we owe considerable deference to the Board's judgment that a particular activity is "closely related to banking." Rather than define that term with any precision, therefore, we simply require that the Board go about making its "closely related" decision in a reasoned [694] fashion consistent with the legislative intent.

The Board must, we think, articulate the ways in which banking activities and the proposed activities are assertedly connected, and must determine, not arbitrarily or capriciously, that the connections are close. As to what kinds of connections may qualify, at least the following seem to us within the statutory intent....

Id. (emphasis added).

Whether or not the provision of specialized computer hardware comes within the third National Courier test, we think the Board came to its decision in a reasoned fashion consistent with the legislative intent, and that that decision is not arbitrary or capricious. The Board noted, with adequate record support, that customers do not buy software and hardware but data processing. Citicorp Order, 68 Fed. Res.Bull. at 508-09; Regulation Y Order, 47 Fed.Reg. 37,370. Moreover, the Recommended Decision which the Board adopted discussed the impact of large scale integrated (LSI) circuits upon data processing technology, which now permit simple software functions, and in the future will permit more complex software functions, to be built into the hardware; and enable some of the computing function to be removed from the central computer and located in a customized "micro-processor" or "minicomputer" located at the point of use. Recommended Decision at 7-8, J.A. B-78 to B-79. This is the way some data processing is conducted now, and much more will be conducted in the future. Finally, the Recommended Decision also noted, with adequate record support, that a software producer marketing a "package" of software plus hardware is able to get a manufacturer's discount on the hardware, and is thus able to provide the full service to the purchaser at a more competitive price. Recommended Decision at 8, J.A. B-79. On the basis of these factors the Board concluded that "the activity of providing software without the corresponding authority to provide related hardware is of questionable economic feasibility." Citicorp Order, 68 Fed.Res.Bull. at 508 (footnote omitted). It is not the economic infeasibility in itself that impresses us, but the underlying cause of that infeasibility, recognized by the Board — that in both market contemplation and technological reality the service in question is a unitary one. The issue boils down, as Citicorp suggests, Citicorp Brief at 58, to almost "a tautology." In effect, to authorize the provision of banking, financial and economic data processing is to authorize the provision of banking, financial and economic hardware and software. Whether it be considered "integrally related" to the authorized service or, perhaps more realistically, simply part of it, the provision of specialized hardware is reasonably included.

General purpose hardware is, as the name would suggest, hardware that is designed to perform data processing functions in addition to banking, financial and economic. The Board approved bank holding company provision of this hardware, subject to the same condition that it be offered only in conjunction with banking, financial or economic data software, and subject to the additional condition that it "not constitute more than 30 percent of the cost of any packaged offering." 12 C.F.R. § 225.25(b)(7)(iii).^[13] The Board acknowledged that the sale of general purpose hardware "is not itself an activity that is closely related to banking," but found that with the limitations the Board imposed it would be permissible as "incidental" to the provision of permissible data processing services, Citicorp Order, 68 Fed.Res.Bull. [695] at 508; see also Regulation Y Order, 47 Fed.Reg. 37,370.

The notion of permissibility of "any incidental activities that are necessary to carry on" activities closely related to banking has been embodied in Regulation Y since 1971. 12 C.F.R. § 225.21(a)(2). We approved it in National Courier, noting that "[i]n enumerating the activities that could be carried on, [Congress] certainly could not have meant to forbid engagement in such other `incidental' activities as were reasonably necessary to carrying out those that were enumerated." 516 F.2d at 1240. We disapproved its application to bank courier handling of nonfinancial materials for the following reason:

The justification for the `incidental' courier services ... is not, as far as we can tell, that the carriage of non-financially related material is in any way necessary to the successful operation of the courier service affiliates. Rather, it is that the provision of such service would serve `the convenience of the public.'

Id. (footnote omitted). Here, by contrast, the Board's justification was precisely that the provision of banking, financial and economic data processing services could not be successful unless they were offered in conjunction with the necessary hardware. Even where the hardware itself was not required to be specialized or to contain any software — so that the hardware could not be regarded as in itself the provision of banking, financial or economic data processing — the nature of the data processing market was such, the Board found, that hardware and software were a single package. The provision of data processing software in isolation, even where no specialized or software-inclusive hardware was required, was "of questionable economic feasibility." Citicorp Order, 68 Fed.Res.Bull. at 508, referred to in Regulation Y Order, 47 Fed.Reg. 37,370. There was record evidence to support this conclusion, and, as the excerpt from National Courier above suggests, the conclusion is sufficient to support the Board's action. Indeed, the Fifth Circuit Court of Appeals has permitted an even lesser connection to sustain bank holding company provision of liability insurance as "incidental" to the closely-related-to-banking activity of providing property damage insurance for the collateral in bank loans. Alabama Association of Insurance Agents, supra. While that court found evidence to sustain the proposition that, "from the consumer's point of view, packaged property damage and liability policies are more desirable than the same policies separately sold," 533 F.2d at 245, it did not make the further finding that the sale of the one had been shown to be "of questionable economic feasibility" without the sale of the other. In that respect, Alabama Association goes further than we were prepared to go in National Courier, though there was, it must be acknowledged, the added factor that liability insurance in itself to some degree increased the security of the banks' loans. In any case, we think that the reasoning of both National Courier and Alabama Association supports the proposition that the economic necessity of offering a service that is not closely related to banking in order to sell another service that is, justifies the provision of the one as "incidental" to the other.

There is an obvious limitation upon this principle: At some point the tail begins to wag the dog. If it should be found, for example, that data processing services cannot be sold in an economically feasible manner without manufacturing data processing hardware; and if the banks' profits from the latter should exceed their profits from the former; surely the provision of data processing services would be incidental to hardware manufacture rather than vice-versa. But the Board has adequately taken that limitation into account, by specifying, as described above, that the cost of the hardware (including both specialized and general purpose hardware) cannot exceed 30 percent of the cost of the package. The Board derived this figure by noting from the record that hardware costs for the data processing industry as a whole represent about 25 percent of total costs, Citicorp Order, 68 Fed.Res.Bull. at 509, — so that a "package" in which hardware accounted [696] for about that percentage of the cost could reasonably be considered primarily a sale of data processing rather than a sale of processing hardware. We think that a reasonable way to proceed, and we cannot say that an element of a permissible service which constitutes less than one-third the cost of that service is not "incidental."

III. PROCEDURAL OBJECTION

Petitioners raise a procedural objection to the Citicorp order. They claim that the Board approved Citicorp's request without stating its holding or reasoning regarding four components of that request, in violation of the APA's requirement that agency orders in formal proceedings address "all the material issues of fact, law, or discretion presented on the record." 5 U.S.C. § 557(c). They complain that the Board did not address the sale of applications software products, the provision of facilities management services, the sale of turnkey systems products, and the provision of software-related services.

We do not agree. What is a "material issue" that must be separately addressed obviously depends upon one's view of the logical or operational differences between various aspects of the problem in question. If an appellant before this court chooses to analyze a freedom-of-speech issue by discussing verbs, nouns, adjectives and pronouns separately, our decision will not necessarily disregard a "material issue" if it ignores this distinction. So also here, petitioners cannot insist upon imposing their structure of analysis upon the Board. The characteristic feature of petitioners' approach throughout this proceeding has been the insistence that each separate element of the provision of data processing services be analyzed separately; this is simply contrary to the Board's view, which we have found reasonable, that "the particular technology by which a data processing activity is provided is not determinative" and the "permissible data processing activities may be provided by any technologically feasible method." Regulation Y Order, 47 Fed.Reg. 37,369. The Board's decision in the Citicorp order clearly disposed of the various elements petitioners complain of here, whether or not it addressed each of them separately; and the reasons for its dispositions are fully set forth. That is all that reason or even the APA requires.

Applications software, which petitioners define as software that provides instructions for the performance of specific tasks, is part of the software included in on-site data processing, electronic funds transfer, and authentication programs, all of which were approved and fully discussed. Facilities management by employees of the bank holding company and "turnkey" systems (that is, systems including both hardware and software in which control is turned over to the purchaser) were described by the ALJ as the two modes of providing on-site data processing, Recommended Decision at 7-8, 12-13, J.A. B-78 to B-79, B-83 to B-84; that activity, in all of its modes, was approved and fully discussed. Citicorp Order, 68 Fed.Res.Bull. at 508-09. Finally, as to software related services, such as consulting and systems analysis: Citicorp's application did not include these services as a separate activity, and neither we nor, judging by its brief, the Board, see Board's Brief at 63, regards the operation of a consulting service to give advice regarding data processing to be the same thing as data processing, which is all that the orders approve. Of course some consultation and advice will be necessary as an incident to the sale of data processing, but authorization for that was neither separately sought nor is separately required, since it is obviously included within Regulation Y's existing authorization for "incidental activities," discussed above. We therefore reject the procedural objection to the Board's action.

* * * * * *

The challenge which the Board faced in the current proceeding was the perennial regulator's problem of adjusting the outlines of regulation to accommodate technological change. Virtually unprecedented difficulties of adjustment are presented by [697] the torrent of recent scientific innovation in the fields of electronics and telecommunications, which possess a peculiar capability to destroy the categories of enterprise upon which regulation is based. Communications merges into data processing and data processing into banking. Intervenor California Bankers Clearing House Association perceptively observes, CBCHA Brief at 29 n. 20, that this proceeding parallels the Federal Communications Commission's Second Computer Inquiry, the order resulting from which we upheld in Computer and Communications Industry Association v. FCC, 693 F.2d 198 (D.C.Cir.1982).

The record of the present proceeding displays a careful and conscientious effort by the Board to cope with these difficulties. We are not inclined to complicate its task further by attempting to exercise close and necessarily inexpert supervision of its judgments. That would be particularly inappropriate under a governing statute such as this one, which commits it to the Board to apply a standard of such inherent imprecision ("closely related to banking") that a discretion of almost legislative scope was necessarily contemplated. If there is a problem in such broad delegation, it would assuredly not be solved by effectively taking the delegation from the Board and placing it in our own hands. Having assured ourselves that the Board has acted reasonably, consistently and with procedural regularity in giving content to the statutory standard, our task is at an end.

In addition to the major points discussed above, we have considered the other objections urged by petitioners and find them insubstantial. For these reasons, the petitions are

Denied.

[1] Sitting by designation pursuant to 28 U.S.C. § 294(d) (1982).

[2] 12 C.F.R. § 225.25(b)(7) (1984) is the slightly revised successor to 12 C.F.R. § 225.4(a)(8) (1983). Since the revisions are minor and do not affect this opinion, all references are to the 1984 Code.

[3] In SIA, the Court noted that the Board's "factual findings ... are substantially supported by the record," 104 S.Ct. at 3009, but as will appear below that may be a description of the requirements of the arbitrary or capricious standard.

[4] 12 U.S.C. § 1848 reads as follows:

Any party aggrieved by an order of the Board under this chapter may obtain a review of such order in the United States Court of Appeals within any circuit wherein such party has its principal place of business or in the Court of Appeals in the District of Columbia, by filing in the court, within thirty days after the entry of the Board's order, a petition praying that the order of the Board be set aside. A copy of such petition shall be forthwith transmitted to the Board by the clerk of the court, and thereupon the Board shall file in the court the record made before the Board, as provided in section 2112 of title 28. Upon the filing of such petition the court shall have the jurisdiction to affirm, set aside, or modify the order of the Board and to require the Board to take such action with regard to the matter under review as the court deems proper. The findings of the Board as to the facts, if supported by substantial evidence, shall be conclusive.

[5] National Courier's failure even to refer to § 1848 was noted in a later decision of this court which applied the "substantial evidence" provision of another statute to informal (as opposed to formal) adjudication. Aircraft Owners and Pilots Association v. FAA, 600 F.2d 965, 971 n. 26 (D.C.Cir.1979). Our decision today explains why National Courier, in ignoring the provision, and Aircraft Owners, in applying it, were not reaching different results. Aircraft Owners acknowledged this possibility in a footnote, 600 F.2d at 971 n. 28.

[6] Subsection 706(2) reads as follows:

[The reviewing court shall —]

(2) hold unlawful and set aside agency action, findings, and conclusions found to be —

(A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law;

(B) contrary to constitutional right, power, privilege, or immunity;

(C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right;

(D) without observance of procedure required by law;

(E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by the statute; or

(F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court.

[7] See, e.g., the quotation from K. DAVIS, supra, page 684. The reason for this reputation, one may surmise, is that under the APA the substantial evidence test applies almost exclusively to formal adjudication (formal rulemaking is rare), which is, by contrast to rulemaking, characteristically long on facts and short on policy — so that the inadequacy of factual support is typically the central issue in the judicial appeal and is the most common reason for reversal.

[8] There is no doubt that the Board understood them to be, as they were phrased, merely examples of the data processing uses that would be made available. Where its opinion meant to limit the applicant to the specific uses that were recited as currently contemplated, it said so. See the portion of the Citicorp order dealing with home banking services, 68 Fed.Res.Bull. at 509-10, the conclusion of which is reflected in the Regulation Y Order, 47 Fed.Reg. 37,370.

[9] Although the language of the statute is subject to the interpretation that the "public benefits" finding is merely part of the finding that the activity is "so closely related to banking ... as to be a proper incident thereto," 12 U.S.C. § 1843(c)(8), it is now well established that they are "two separate determinations," SIA, supra, 104 S.Ct. at 3006.

[10] This is required by the Board's regulations, 12 C.F.R. § 225.21(a)(2). The Supreme Court has intimated that it is also required by law, saying that the Board "must [make the determination] on a case-by-case basis," and citing for that proposition a portion of the legislative history, H.R.Conf.Rep. No. 1747, 91st Cong., 2d Sess. 16-18, reprinted in 1970 U.S.CODE CONG. & AD. NEWS 5561, 5567-69. SIA, supra, 104 S.Ct. at 3006.

[11] The petitioners' challenge to the evidentiary support for the Board's approval of budget and accounting services, which they present as a separate challenge to the orders, Petitioners' Brief at 46-47, is in reality merely a challenge to this pragmatic validation of the data test. We digress briefly to address that challenge. The Board concluded that "[t]he record of this proceeding demonstrates that banks in fact provide data processing services that assist banks in performing their own credit functions and that perform financial bookkeeping and accounting operations for other businesses." Citicorp Order, 68 Fed.Res.Bull. at 507. While this specific finding was made only in the Citicorp order, the Regulation Y order incorporated it by reference when it noted that "[t]he Board's findings on the permissibility of the services involved are set forth in detail in the Board's Citishare order." Regulation Y Order, 47 Fed.Reg. 37,369.

Neither the Board nor the intervenors cited us any portion of the record that supports this finding. The reason, apparently, is that with the exception of the provision of economic data (discussed later in this opinion) the evidence in the present proceeding focused upon the technological means of delivering data processing services, rather than upon the subjects those services covered. The latter had been extensively considered in the 1971 rulemaking that produced the prior version of Regulation Y — in which proceeding, we may note, ADAPSO participated. Thus, for evidence to support the Board's statement on this score its brief refers to an American Bankers Association survey introduced in the 1971 proceeding. Respondent's Brief at 43 n. 46, 48 (citing Supplemental Statement of American Bankers Association, Apr. 30, 1971, Appendix I at 4). We have been unable to find the survey in the record. We think it unnecessary to examine or rely upon the survey itself, however, since the Applicant's Exhibits include a June 7, 1971 Memorandum to the Board from its Legal Division which provides information based upon the survey. See page 686, supra. It shows that since the 1950s banks have performed such functions as payroll service, account reconciliation, sales analysis and inventory analysis, which seem to us unquestionably bookkeeping and accounting functions. While that information is not extensive (as the full survey itself presumably is) we think it adequate, in the absence of any contradiction regarding such functions from petitioners, to provide the necessary record support.

[12] There is no question that courier service for data processing material has been found "closely related to banking" not because of its connection to banking per se but because of its relation to financial data processing, an activity banks are permitted to engage in.

516 F.2d at 1239.

[13] This means cost to the bank holding company. See Regulation Y Order, 47 Fed.Reg. 37,370. The Citicorp order, and the text of the Regulation Y order (as opposed to the language of the amended regulation) say "approximately 30 per cent." Citicorp Order, 68 Fed.Res.Bull. at 509; Regulation Y Order, 47 Fed.Reg. 37,370 (emphasis added). The Citicorp order also concedes that "in individual cases, the cost of hardware may exceed the percentage limitation," so long as hardware sales do not "consistently exceed" it. Citicorp Order, 68 Fed.Res.Bull. at 509.

400 F.3d 530 (2005)

[531] Scott E. Bratton (argued), Wong & Associates, Cleveland, OH, for Petitioner.

Karen Lundgren, Dept. of Homeland Security Office of the District Counsel, Chicago, IL, Anthony W. Norwood (argued), Terri J. Scadron, Dept. of Justice Civil Division, Immigration Litigation, Washington, DC, for Respondent.

Before POSNER, MANION, and WOOD, Circuit Judges.

POSNER, Circuit Judge.

An immigration judge ordered the petitioner, a citizen of China seeking asylum in the United States, to be removed (deported) from the United States, and the Board of Immigration Appeals affirmed without opinion. The basis of the immigration judge's ruling was that the petitioner is not entitled to asylum because she lacks a well-founded fear of being persecuted by the Chinese government should she return to China.

A woman in her early 20s, Li arrived in the United States in 2000. At the removal hearing she testified through an interpreter that she had begun to practice Falun Gong in China and — the Chinese government having outlawed Falun Gong in 1999 — that police and village officials had learned of her activity (probably through her employer) and decided to investigate. Village officials made repeated visits to the house in which she lived with her parents to tell her to abandon Falun Gong, but she eluded them by residing mainly in her aunt's house. Police visited the parents' home and delivered a summons commanding Li to come to the police station for an interview. She did not comply with the summons. They kept coming back to the home, looking for her, and she fled the country.

Since arriving in the United States, Li has, again according to her testimony, practiced Falun Gong in Chicago (where she lives) and has also participated in street demonstrations against the Chinese government's persecution of the movement. When she arrived in this country she knew the name of the founder of Falun Gong (Li Hongzhi, now in exile in the United States) and had done the physical exercises that are the primary manifestation of adherence to Falun Gong, but she was vague about its doctrines and unfamiliar with its symbol. She has since become more familiar with the movement's doctrines and symbol. At the hearing before the immigration judge she presented letters from her mother in China, and the Chinese man who had introduced her to Falun Gong there, corroborating her testimony.

Falun Gong is an international movement, though primarily Chinese, that is often referred to as a "religion" (or, by its critics, as a "cult"), though it is not a religion in the Western sense. Like other Asian "religions," such as Buddhism and Confucianism — on both of which Falun Gong draws — there is no deity. The emphasis is on spiritual self-perfection through prescribed physical exercises; in [532] this respect the movement has affinities with traditional Chinese medicine.

The government acknowledges that China persecutes adherents to Falun Gong and that an applicant for asylum need not have experienced persecution (Li has not) in order to have a well-founded fear of future persecution, Diallo v. Ashcroft, 381 F.3d 687, 699 (7th Cir.2004); Sivaainkaran v. INS, 972 F.2d 161, 165 n. 2 (7th Cir.1992); Knezevic v. Ashcroft, 367 F.3d 1206, 1212 (9th Cir.2004), which suffices for a claim of asylum. Capric v. Ashcroft, 355 F.3d 1075, 1084-85 (7th Cir.2004); Yadegar-Sargis v. INS, 297 F.3d 596, 601-02 (7th Cir.2002); Krastev v. INS, 292 F.3d 1268, 1270 (10th Cir.2002). As Falun Gong is neither theistic nor, so far as appears, political, the ferocious antipathy to it by the Chinese government — that government's determination to eradicate it root and branch — is mysterious, but undeniable. See, e.g., Zhang v. Ashcroft, 388 F.3d 713, 716, 719 (9th Cir.2004) (per curiam). If Li practiced Falun Gong in China, as she testified she did, or if she attempted to practice it upon returning to China, she would face a substantial likelihood of persecution. She might be able to conceal her adherence to Falun Gong from the authorities, but the fact that a person might avoid persecution through concealment of the activity that places her at risk of being persecuted is in no wise inconsistent with her having a well-founded fear of persecution. Id. at 719 ("to require Zhang to practice his beliefs in secret is contrary to our basic principles of religious freedom and the protection of religious refugees"); Muhur v. Ashcroft, 355 F.3d 958, 960-61 (7th Cir.2004). On the contrary, it is the existence of such a fear that motivates the concealment.

The immigration judge gave five reasons for nevertheless denying Li's application for asylum. The first is that she was not persecuted in China. But she does not claim to have been; it is a nonissue. The fifth reason is that her brother, who lives in the United States, is a follower of Falun Gong yet failed to submit an affidavit attesting that his sister is too. The judge misread the record; the brother is not a follower of Falun Gong.

Reasons 2 through 4 overlap. Reason 2 is that Li failed to present persuasive evidence that she is a follower of the movement, because in her testimony she was "quite vague concerning her beliefs." For example, she didn't know that Falun Gong has a symbol (the "Falun Wheel" composed of reverse swastikas, a Buddhist symbol). But the heart of Falun Gong observance is the exercises, which she testified without contradiction that she does.

Reason 3 was that there were inconsistencies in her testimony about the visits of the police to her home. This was not, as the immigration judge thought, an independent reason for denying the application for asylum; rather, it was a reason not to credit her testimony about being a member of Falun Gong. The inconsistencies were trivial, however, and may well have been due to the fact that Li was testifying through an interpreter who appears not to have had a good command of English. When Li testified about the delivery of the summons to her home by the police, the immigration judge asked her whether she had had any prior "confrontations" with the government and she said no, but later explained that although the police didn't start coming to her home until they served the summons, village officials had visited earlier. Were these "confrontations"? She was never at home when they visited. And goodness knows how the interpreter translated "confrontations" into Chinese.

Reason 4 was that when interviewed by an asylum officer at the time she first applied for asylum, Li testified that after [533] the village officials got wind of her involvement with Falun Gong she "went into hiding at different locations and never went back home." The immigration judge said that she "did not specifically testify in this manner (e.g. that she went into hiding) nor does the rest of the record support this statement." That is not correct. Although Li (more precisely, the interpreter) did not use the word "hiding," she said she wasn't at home when the police visited and that sometimes she was "at my aunt that I mentioned at her house." Apparently the village officials and police visited her home repeatedly, and since she was never there when they showed up it is a logical inference, supported also by her mother's letter, that she was indeed trying to evade the authorities.

The immigration judge's opinion cannot be regarded as reasoned; and there was no opinion by the Board of Immigration Appeals. So we have to vacate the decision and send the matter back to the immigration service. We do not decide that Li is entitled to asylum; that is a decision for the immigration authorities to make. But she is entitled to a rational analysis of the evidence by them.

The number of followers of Falun Gong in China is estimated to be in the tens of millions, all of them subject to persecution. And among the other billion Chinese there are doubtless many who would prefer to live in the United States than in China. Falun Gong, unlike, say, Judaism or Roman Catholicism or Jehovah's Witnesses, does not appear to have any formal requirements for membership; indeed, it has no membership. Anyone, we suppose, can get hold of a book of Li Hongzhi's teachings, start doing the exercises, and truthfully declare himself or herself a bona fide adherent to Falun Gong. The implications for potential Chinese immigration to the United States may be significant, though in this circuit there have been only two litigated applications for asylum based on fear of persecution for being an adherent (or for being believed by the Chinese authorities to be an adherent) of Falun Gong, Liu v. Ashcroft, 380 F.3d 307 (7th Cir.2004); Yu v. Ashcroft, No. 03-3965, 2004 WL 3103070 (7th Cir. Dec.28, 2004) (unpublished order), and in the federal courts as a whole there have been only a couple of dozen such cases since 2003. The United States has every right to control immigration. But Congress has not authorized the immigration service to do so by denying asylum applications in unreasoned decisions.

We close by noting six disturbing features of the handling of this case that bulk large in the immigration cases that we are seeing:

1. A lack of familiarity with relevant foreign cultures. Yi-Tu Lian v. Ashcroft, 379 F.3d 457, 459 (7th Cir.2004); Joanna Ruppel, "The Need for a Benefit of the Doubt Standard in Credibility Evaluation of Asylum Applicants," 23 Colum. Human Rts. L.Rev. 1, 14-15 (1992). The immigration judge offered no justification for regarding a person's lack of knowledge of Falun Gong doctrines as evidence of a false profession of faith. Different religions attach different weights to different aspects of the faith. Falun Gong, remember, is not theistic; nor is it hierarchical. So far as appears, what is central is neither doctrine nor symbol, but the exercises. Benoit Vermander, "Looking at China Through the Mirror of Falun Gong," 35 China Perspectives 4 (May-June 2001), http://www.cefc.com.hk/uk/pc/articles/ art_ligne.php?num_art_ ligne=3501 ("the absence of any formal rituals and organisation would make it impossible to consider Falun Gong precisely as a religion. Where rituals are concerned, however, it seems to us that one must consider the [534] communal practice of exercises, alternated with peaceful protests, as the movement's own ritual arsenal"); Anne S. Y. Cheung, "In Search of a Theory of Cult and Freedom of Religion in China: The Case of Falun Gong," 13 Pac. Rim L. & Policy J. 1, 28 (2004) ("those who believe in Falun Gong dedicate themselves to the exclusive practice of this exercise as a means to achieve enlightenment. In this sense, manifestation and belief are united").

2. An exaggerated notion of how much religious people know about their religion. Muhur v. Ashcroft, supra, 355 F.3d at 959-60. Of course a purported Christian who didn't know who Jesus Christ was, or a purported Jew who had never heard of Moses, would be instantly suspect; but many deeply religious people know very little about the origins, doctrines, or even observances of their faith.

3. An exaggerated notion of the availability, especially in poor nations, of documentary evidence of religious membership. Id.; Qiu v. Ashcroft, 329 F.3d 140, 154 (2d Cir.2003). An acephalous, illegal religious movement is particularly unlikely to issue membership cards. The immigration judge's zeal for documentation reached almost comical proportions when after Li had testified at length and in considerable detail about locations, including the street in front of the Chinese consulate in Chicago, in which she had participated in demonstrations against the persecution of Falun Gong, he upbraided her for having "failed to submit to the Court any letters or photographs or any other evidence whatsoever to corroborate these claims." Since the demonstrators are mainly Chinese who might one day want or be forced to return to China, they are hardly likely to be taking photos of each other demonstrating, or to be creating other documentary proof of participating in demonstrations of which the Chinese government deeply disapproves.

4. Insensitivity to the possibility of misunderstandings caused by the use of translators of difficult languages such as Chinese, and relatedly, insensitivity to the difficulty of basing a determination of credibility on the demeanor of a person from a culture remote from the American, such as the Chinese. E.g., Lin v. Ashcroft, 385 F.3d 748, 756 n. 1 (7th Cir.2004); Ememe v. Ashcroft, 358 F.3d 446, 451-53 (7th Cir.2004); Mendoza Manimbao v. Ashcroft, 329 F.3d 655, 662 (9th Cir.2003); He v. Ashcroft, 328 F.3d 593, 598 (9th Cir.2003); Deborah E. Anker, "Determining Asylum Claims in the United States: A Case Study on the Implementation of Legal Norms in an Unstructured Adjudicatory Environment," 19 N.Y.U. Rev. L. & Social Change 433, 505-27 (1992); Neal P. Pfeiffer, "Credibility Findings in INS Asylum Adjudications: A Realistic Assessment," 23 Tex. Int'l L.J. 139 (1988). Behaviors that in our culture are considered evidence of unreliability, such as refusing to look a person in the eyes when he is talking to you, are in Asian cultures a sign of respect.

5. Reluctance to make clean determinations of credibility. Gontcharova v. Ashcroft, 384 F.3d 873, 877 (7th Cir.2004); Diallo v. Ashcroft, supra, 381 F.3d at 698-700; Mendoza Manimbao v. Ashcroft, supra, 329 F.3d at 660-61; Diallo v. INS, 232 F.3d 279, 287 (2d Cir.2000). When an immigration judge says not that he believes the asylum seeker or he disbelieves her but instead that she hasn't carried her burden of proof, the reviewing court is left in the dark as to whether the judge thinks the asylum seeker failed to carry her burden of proof because her testimony was not credible, or for some other reason.

6. Affirmances by the Board of Immigration Appeals either with no opinion or [535] with a very short, unhelpful, boilerplate opinion, even when, as in this case, the immigration judge's opinion contains manifest errors of fact and logic.

We do not offer these points in a spirit of criticism. The cases that we see are not a random sample of all asylum cases, and the problems that the cases raise may not be representative. Even if they are representative, given caseload pressures and, what is the other side of that coin, resource constraints, it is possible that nothing better can realistically be expected than what we are seeing in this and like cases. But we are not authorized to affirm unreasoned decisions even when we understand why they are unreasoned.

The petition for review is granted and the matter returned to the immigration service for further proceedings consistent with this opinion.

[1] This is the name that appears in the final order of the Board of Immigration Appeals and in the docket and briefs in this court. But the record reveals that the petitioner's name is actually Xiuzhen Li, and that is the name we'll use in the opinion.

322 U.S. 111 (1944)

CERTIORARI TO THE CIRCUIT COURT OF APPEALS FOR THE NINTH CIRCUIT.^[1]

[113] Mr. Alvin J. Rockwell, with whom Solicitor General Fahy, Messrs. Robert L. Stern and Frank Donner, and Miss Ruth Weyand were on the brief, for petitioner.

Mr. John M. Hall, with whom Mr. Oscar Lawler was on the brief; Mr. Lewis B. Binford, with whom Mr. Thomas S. Tobin was on the brief; Mr. Edward L. Compton, with whom Mr. H.S. Mac Kay, Jr., was on the brief; and Mr. T.B. Cosgrove, with whom Mr. John N. Cramer was on the brief, — for respondents in Nos. 336, 337, 338, and 339, respectively.

Mr. Arthur W.A. Cowan filed a brief on behalf of the International Printing Pressmen & Assistants' Union, as amicus curiae, in support of petitioner.

MR. JUSTICE RUTLEDGE delivered the opinion of the Court.

These cases arise from the refusal of respondents, publishers of four Los Angeles daily newspapers, to bargain collectively with a union representing newsboys who distribute their papers on the streets of that city. Respondents' contention that they were not required to bargain because the newsboys are not their "employees" within the meaning of that term in the National Labor Relations Act, 49 Stat. 450, 29 U.S.C. § 152,^[2] presents the important question which we granted certiorari^[3] to resolve.

[114] The proceedings before the National Labor Relations Board were begun with the filing of four petitions for investigation and certification^[4] by Los Angeles Newsboys Local Industrial Union No. 75. Hearings were held in a consolidated proceeding^[5] after which the Board made findings of fact and concluded that the regular full-time newsboys selling each paper were employees within the Act and that questions affecting commerce concerning the representation of employees had arisen. It designated appropriate units and ordered elections. 28 N.L.R.B. 1006.^[6] At these the union was selected as their representative by majorities of the eligible newsboys. After the union was appropriately certified, 33 N.L.R.B. 941, 36 N.L.R.B. 285, the respondents refused to bargain with it. Thereupon proceedings under § 10, 49 Stat. 453-455, 29 U.S.C. § 160, were instituted, a hearing^[7] was held and respondents were found to have violated §§ 8 (1) and 8 (5) of the Act, 49 Stat. 452-453, 29 U.S.C. § 158 (1), (5). They were ordered to cease and desist from such violations and to bargain collectively with the union upon request. 39 N.L.R.B. 1245, 1256.

Upon respondents' petitions for review and the Board's petitions for enforcement, the Circuit Court of Appeals, one judge dissenting, set aside the Board's orders. Rejecting [115] the Board's analysis, the court independently examined the question whether the newsboys are employees within the Act, decided that the statute imports common-law standards to determine that question, and held the newsboys are not employees. 136 F.2d 608.

The findings of the Board disclose that the Los Angeles Times and the Los Angeles Examiner, published daily and Sunday,^[8] are morning papers. Each publishes several editions which are distributed mn the streets during the evening before their dateline, between about 6:00 or 6:30 p.m. and 1:00 a.m., and other editions distributed during the following morning until about 10:00 o'clock. The Los Angeles Evening Herald and Express, published every day but Sunday, is an evening paper, which has six editions on the presses between 9:00 a.m. and 5:30 p. m.^[9] The News, also published every day but Sunday, is a twenty-four hour paper with ten editions.^[10]

The papers are distributed to the ultimate consumer through a variety of channels, including independent dealers and newsstands often attached to drug, grocery or confectionery stores, carriers who make home deliveries, and newsboys who sell on the streets of the city and its suburbs. Only the last of these are involved in this case.

The newsboys work under varying terms and conditions. They may be "bootjackers," selling to the general public at places other than established corners, or they may sell [116] at fixed "spots." They may sell only casually or part-time, or full-time; and they may be employed regularly and continuously or only temporarily. The units which the Board determined to be appropriate are composed of those who sell full-time at established spots. Those vendors, misnamed boys, are generally mature men, dependent upon the proceeds of their sales for their sustenance, and frequently supporters of families. Working thus as news vendors on a regular basis, often for a number of years, they form a stable group with relatively little turnover, in contrast to schoolboys and others who sell as bootjackers, temporary and casual distributors.

Over-all circulation and distribution of the papers are under the general qupervision of circulation managers. But for purposes of street distribution each paper has divided metropolitan Los Angeles into geographic districts. Each district is under the direct and close supervision of a district manager. His function in the mechanics of distribution is to supply the newsboys in his district with papers which he obtains from the publisher and to turn over to the publisher the receipts which he collects from their sales, either directly or with the assistance of "checkmen" or "main spot" boys.^[11] The latter, stationed at the important corners or "spots" in the district, are newsboys who, among other things, receive delivery of the papers, redistribute them to other newsboys stationed at less important corners, and collect receipts from their sales.^[12] For that service, which occupies a minor portion [117] of their working day, the checkmen receive a small salary from the publisher.^[13] The bulk of their day, however, they spend in hawking papers at their "spots" like other full-time newsboys. A large part of the appropriate units selected by the Board for the News and the Herald are checkmen who, in that capacity, clearly are employees of those papers.

The newsboys' compensation consists in the difference between the prices at which they sell the papers and the prices they pay for them. The former are fixed by the publishers and the latter are fixed either by the publishers or, in the case of the News, by the district manager.^[14] In practice the newsboys receive their papers on credit. They pay for those sold either sometime during or after the close of their selling day, returning for credit all unsold papers.^[15] Lost or otherwise unreturned papers, however, must be paid for as though sold. Not only is the "profit" per paper thus effectively fixed by the publisher, but substantial control of the newsboys' total "take home" can be effected through the ability to designate their sales areas and the power to determine the number of papers allocated to each. While as a practical matter this power is not exercised fully, the newsboys' "right" to decide how many papers they will take is also not absolute. In practice, the Board found, they cannot determine the size of their established order without the cooperation of the district manager. And often the number of papers they must take is determined unilaterally by the district managers.

In addition to effectively fixing the compensation, respondents in a variety of ways prescribe, if not the [118] minutiae of daily activities, at least the broad terms and conditions of work. This is accomplished largely through the supervisory efforts of the district managers, who serve as the nexus between the publishers and the newsboys.^[16] The district managers assign "spots" or corners to which the newsboys are expected to confine their selling activities.^[17] Transfers from one "spot" to another may be ordered by the district manager for reasons of discipline or efficiency or other cause. Transportation to the spots from the newspaper building is offered by each of respondents. Hours of work on the spots are determined not simply by the impersonal pressures of the market, but to a real extent by explicit instructions from the district managers. Adherence to the prescribed hours is observed closely by the district managers or other supervisory agents of the publishers. Sanctions, varying in severity [119] from reprimand to dismissal, are visited on the tardy and the delinquent. By similar supervisory controls minimum standards of diligence and good conduct while at work are sought to be enforced. However wide may be the latitude for individual initiative beyond those standards, district managers' instructions in what the publishers apparently regard as helpful sales technique are expected to be followed. Such varied items as the manner of displaying the paper, of emphasizing current features and headlines, and of placing advertising placards, or the advantages of soliciting customers at specific stores or in the traffic lanes are among the subjects of this instruction. Moreover, newsboys are furnished with sales equipment, such as racks, boxes and change aprons, and advertising placards by the publishers. In this pattern of employment the Board found that the newsboys are an integral part of the publishers' distribution system and circulation organization. And the record discloses that the newsboys and checkmen feel they are employees of the papers; and respondents' supervisory employees, if not respondents themselves, regard them as such.

In addition to questioning the sufficiency of the evidence to sustain these findings, respondents point to a number of other attributes characterizing their relationship with the newsboys^[18] and urge that on the entire [120] record the latter cannot be considered their employees. They base this conclusion on the argument that by common-law standards the extent of their control and direction of the newsboys' working activities creates no more than an "independent contractor" relationship and that common-law standards determine the "employee" relationship under the Act. They further urge that the Board's selection of a collective bargaining unit is neither appropriate nor supported by substantial evidence.^[19]

I.

The principal question is whether the newsboys are "employees." Because Congress did not explicitly define the term, respondents say its meaning must be determined by reference to common-law standards. In their view "common-law standards" are those the courts have applied in distinguishing between "employees" and "independent contractors" when working out various problems unrelated to the Wagner Act's purposes and provisions.

The argument assumes that there is some simple, uniform and easily applicable test which the courts have used, in dealing with such problems, to determine whether persons doing work for others fall in one class or the other. Unfortunately this is not true. Only by a long and tortuous history was the simple formulation worked out which has been stated most frequently as "the test" for deciding whether one who hires another is responsible in tort for his wrongdoing.^[20] But this formula has been by no means [121] exclusively controlling in the solution of other problems. And its simplicity has been illusory because it is more largely simplicity of formulation than of application. Few problems in the law have given greater variety of application and conflict in results than the cases arising in the borderland between what is clearly an employer-employee relationship and what is clearly one of independent, entrepreneurial dealing.^[21] This is true within the limited field of determining vicarious liability in tort. It becomes more so when the field is expanded to include all of the possible applications of the distinction.

It is hardly necessary to stress particular instances of these variations or to emphasize that they have arisen principally, first, in the struggle of the courts to work out common-law liabilities where the legislature has given no guides for judgment,^[22] more recently also under statutes which have posed the same problem for solution in the light of the enactment's particular terms and purposes.^[23] [122] It is enough to point out that, with reference to an identical problem, results may be contrary over a very considerable region of doubt in applying the distinction, depending upon the state or jurisdiction where the determination is made;^[24] and that within a single jurisdiction a person who, for instance, is held to be an "independent contractor" for the purpose of imposing vicarious liability in tort may be an "employee" for the purposes of particular legislation, quch as unemployment compensation. See, e.g., Globe Grain & Milling Co. v. Industrial Comm'n, 98 Utah 36, 91 P.2d 512. In short, the assumed simplicity and uniformity, resulting from application of "common-law standards," does not exist.

Mere reference to these possible variations as characterizing the application of the Wagner Act in the treatment of persons identically situated in the facts surrounding their employment and in the influences tending to disrupt it, would be enough to require pause before accepting a thesis which would introduce them into its administration. This would be true, even if the statute itself had indicated less clearly than it does the intent they should not apply.

Two possible consequences could follow. One would be to refer the decision of who are employees to local state law. The alternative would be to make it turn on a sort of pervading general essence distilled from state law. Congress obviously did not intend the former result. It [123] would introduce variations into the statute's operation as wide as the differences the forty-eight states and other local jurisdictions make in applying the distinction for wholly different purposes. Persons who might be "employees" in one state would be "independent contractors" in another. They would be within or without the statute's protection depending not on whether their situation falls factually within the ambit Congress had in mind, but upon the accidents of the location of their work and the attitude of the particular local jurisdiction in casting doubtful cases one way or the other. Persons working across state lines might fall in one class or the other, possibly both, depending on whether the Board and the courts would be required to give effect to the law of one state or of the adjoining one, or to that of each in relation to the portion of the work done within its borders.

Both the terms and the purposes of the statute, as well as the legislative history, show that Congress had in mind no such patchwork plan for securing freedom of employees' organization and of collective bargaining. The Wagner Act is federal legislation, administered by a national agency intended to solve a national problem on a national scale. Cf. e.g., Sen. Rep. No. 573, 74th Cong., 1st Sess. 2-4. It is an Act, therefore, in reference to which it is not only proper but necessary for us to assume, "in the absence of a plain indication to the contrary, that Congress . . . is not making the application of the federal act dependent on state law." Jerome v. United States, 318 U.S. 101, 104. Nothing in the statute's background, history, terms or purposes indicates its scope is to be limited by such varying local conceptions, either statutory or judicial, or that it is to be administered in accordance with whatever different standards the respective states may see fit to adopt for the disposition of unrelated, local problems. Consequently, so far as the meaning of "employee" in this statute is concerned, "the federal law must prevail no matter what name is given to the interest or [124] right by state law." Morgan v. Commissioner, 309 U.S. 78, 81; cf. Labor Board v. Blount, 131 F.2d 585 (C.C.A.).

II.

Whether, given the intended national uniformity, the term "employee" includes such workers as these newsboys must be answered primarily from the history, terms and purposes of the legislation. The word "is not treated by Congress as a word of art having a definite meaning. . . ." Rather "it takes color from its surroundings . . . [in] the statute where it appears," United States v. American Trucking Assns., 310 U.S. 534, 545, and derives meaning from the context of that statute, which "must be read in the light of the mischief to be corrected and the end to be attained." South Chicago Coal & Dock Co. v. Bassett, 309 U.S. 251, 259; cf. New Negro Alliance v. Sanitary Grocery Co., 303 U.S. 552; Drivers' Union v. Lake Valley Co., 311 U.S. 91.

Congress, on the one hand, was not thinking solely of the immediate technical relation of employer and employee. It had in mind at least some other persons than those standing in the proximate legal relation of employee to the particular employer involved in the labor dispute.^[25] It cannot be taken, however, that the purpose was to include all other persons who may perform service for another or was to ignore entirely legal classifications made for other purposes. Congress had in mind a wider field than the narrow technical legal relation of "master and servant," as the common law had worked this out in all its variations, and at the same time a narrower one than the entire area of rendering service to others. The question comes down therefore to how much was included of the intermediate [125] region between what is clearly and unequivocally "employment," by any appropriate test, and what is as clearly entrepreneurial enterprise and not employment.

It will not do, for deciding this question as one of uniform national application, to import wholesale the traditional common-law conceptions or some distilled essence of their local variations as exclusively controlling limitations upon the scope of the statute's effectiveness. To do this would be merely to select some of the local, hairline variations for nation-wide application and thus to reject others for coverage under the Act. That result hardly would be consistent with the statute's broad terms and purposes.

Congress was not seeking to solve the nationally harassing problems with which the statute deals by solutions only partially effective. It rather sought to find a broad solution, one that would bring industrial peace by substituting, so far as its power could reach, the rights of workers to self-organization and collective bargaining for the industrial strife which prevails where these rights are not effectively established. Yet only partial solutions would be provided if large segments of workers about whose technical legal position such local differences exist should be wholly excluded from coverage by reason of such differences. Yet that result could not be avoided, if choice must be made among them and controlled by them in deciding who are "employees" within the Act's meaning. Enmeshed in such distinctions, the administration of the statute soon might become encumbered by the same sort of technical legal refinement as has characterized the long evolution of the employee - independent contractor dichotomy in the courts for other purposes. The consequences would be ultimately to defeat, in part at least, the achievement of the statute's objectives. Congress no more intended to [126] import this mass of technicality as a controlling "standard" for uniform national application than to refer decision of the question outright to the local law.

The Act, as its first section states, was designed to avert the "substantial obstructions to the free flow of commerce" which result from "strikes and other forms of industrial strife or unrest" by eliminating the causes of that unrest. It is premised on explicit findings that strikes and industrial strife themselves result in large measure from the refusal of employers to bargain collectively and the inability of individual workers to bargain successfully for improvements in their "wages, hours or other working conditions" with employers who are "organized in the corporate or other forms of ownership association." Hence the avowed and interrelated purposes of the Act are to encourage collective bargaining and to remedy the individual worker's inequality of bargaining power by "protecting the exercise . . . of full freedom of association, self-organization, and designation of representatives of their own choosing, for the purpose of negotiating the terms and conditions of their employment or other mutual aid or protection." 49 Stat. 449, 450.

The mischief at which the Act is aimed and the remedies it offers are not confined exclusively to "employees" within the traditional legal distinctions separating them from "independent contractors." Myriad forms of service relationship, with infinite and subtle variations in the terms of employment, blanket the nation's economy. Some are within this Act, others beyond its coverage. Large numbers will fall clearly on one side or on the other, by whatever test may be applied. But intermediate there will be many, the incidents of whose employment partake in part of the one group, in part of the other, in varying proportions of weight. And consequently the legal pendulum, for purposes of applying the statute, may swing one way [127] or the other, depending upon the weight of this balance and its relation to the special purpose at hand.

Unless the common-law tests are to be imported and made exclusively controlling, without regard to the statute's purposes, it cannot be irrelevant that the particular workers in these cases are subject, as a matter of economic fact, to the evils the statute was designed to eradicate and that the remedies it affords are appropriate for preventing them or curing their harmful effects in the special situation. Interruption of commerce through strikes and unrest may stem as well from labor disputes between some who, for other purposes, are technically "independent contractors" and their employers as from disputes between persons who, for those purposes, are "employees" and their employers. Cf. Drivers' Union v. Lake Valley Co., 311 U.S. 91. Inequality of bargaining power in controversies over wages, hours and working conditions may as well characterize the status of the one group as of the other. The former, when acting alone, may be as "helpless in dealing with an employer," as "dependent . . . on his daily wage" and as "unable to leave the employ and to resist arbitrary and unfair treatment" as the latter. For each, "union . . . [may be] essential to give . . . opportunity to deal on equality with their employer."^[26] And for each, collective bargaining may be appropriate and effective for the "friendly adjustment of industrial disputes arising out of differences as to wages, hours, or other working conditions."^[27] 49 Stat. 449. In [128] short, when the particular situation of employment combines these characteristics, so that the economic facts of the relation make it more nearly one of employment than of independent business enterprise with respect to the ends sought to be accomplished by the legislation, those characteristics may outweigh technical legal classification for purposes unrelated to the statute's objectives and bring the relation within its protections.

To eliminate the causes of Labor disputes and industrial strife, Congress thought it necessary to create a balance of forces in certain types of economic relationships. These do not embrace simply employment associations in which controversies could be limited to disputes over proper "physical conduct in the performance of the service."^[28] On the contrary, Congress recognized those economic relationships cannot be fitted neatly into the containers designated "employee" and "employer" which an earlier law had shaped for different purposes. Its Reports on the bill disclose clearly the understanding that "employers and employees not in proximate relationship may be drawn into common controversies by economic forces,"^[29] and that the very disputes sought to be avoided might involve [129] "employees [who] are at times brought into an economic relationship with employers who are not their employers."^[30] In this light, the broad language of the Act's definitions, which in terms reject conventional limitations on such conceptions as "employee," "employer," and "labor dispute,"^[31] leaves no doubt that its applicability is to be determined broadly, in doubtful situations, by underlying economic facts rather than technically and exclusively by previously established legal classifications. Cf. Labor Board v. Blount, supra.

Hence "technical concepts pertinent to an employer's legal responsibility to third persons for acts of his servants" have been rejected in various applications of this Act both here (International Association of Machinists v. Labor Board, 311 U.S. 72, 80-81; H.J. Heinz Co. v. Labor Board, 311 U.S. 514, 520-521)^[32] and in other federal courts (Labor Board v. Condenser Corp., 128 F.2d 67 (C.C.A.); North Whittier Heights Citrus Assn. v. Labor Board, 109 F.2d 76, 82 (C.C.A.); Labor Board v. Blount, supra). There is no good reason for invoking them to restrict the scope of the term "employee" sought to be done in this case. That term, like other provisions, must be understood with reference to the purpose of the Act and the facts involved in the economic relationship.^[33] "Where all the conditions of the relation require protection, protection ought to be given."^[34]

[130] It is not necessary in this case to make a completely definitive limitation around the term "employee." That task has been assigned primarily to the agency created by Congress to administer the Act. Determination of "where all the conditions of the relation require protection" involves inquiries for the Board charged with this duty. Everyday experience in the administration of the statute gives it familiarity with the circumstances and backgrounds of employment relationships in various industries, with the abilities and needs of the workers for self-organization and collective action, and with the adaptability of collective bargaining for the peaceful settlement of their disputes with their employers. The experience thus acquired must be brought frequently to bear on the question who is an employee under the Act. Resolving that question, like determining whether unfair labor practices have been committed, "belongs to the usual administrative routine" of the Board.^[35] Gray v. Powell, 314 U.S. 402, 411. Cf. Labor Board v. Standard Oil Co., 138 F.2d 885, 887-888.

In making that body's determinations as to the facts in these matters conclusive, if supported by evidence, Congress entrusted to it primarily the decision whether the evidence establishes the material facts. Hence in reviewing the Board's ultimate conclusions, it is not the court's function to substitute its own inferences of fact for the Board's, when the latter have support in the record. Labor Board v. Nevada Copper Corp., 316 U.S. 105; cf. Walker v. Altmeyer, 137 F.2d 531 (C.C.A.). Undoubtedly questions of statutory interpretation, especially when arising in the first instance in judicial proceedings, are for [131] the courts to resolve, giving appropriate weight to the judgment of those whose special duty is to administer the questioned statute. Norwegian-Nitrogen Products Co. v. United States, 288 U.S. 294; United States v. American Trucking Assns., 310 U.S. 534. But where the question is one of specific application of a broad statutory term in a proceeding in which the agency administering the statute must determine it initially, the reviewing court's function is limited. Like the commissioner's determination under the Longshoremen's & Harbor Workers' Act,^[36] that a man is not a "member of a crew" (South Chicago Coal & Dock Co. v. Bassett, 309 U.S. 251) or that he was injured "in the course of employment" (Parker v. Motor Boat Sales, 314 U.S. 244) and the Federal Communications Commission's determination^[37] that one company is under the "control" of another (Rochester Telephone Corp. v. United States, 307 U.S. 125), the Board's determination that specified persons are "employees" under this Act is to be accepted if it has "warrant in the record" and a reasonable basis in law.

In this case the Board found that the designated newsboys work continuously and regularly, rely upon their earnings for the support of themselves and their families, and have their total wages influenced in large measure by the publishers, who dictate their buying and selling prices, fix their markets and control their supply of papers. Their hours of work and their efforts on the job are supervised and to some extent prescribed by the publishers or their agents. Much of their sales equipment and advertising materials is furnished by the publishers with the intention that it be used for the publisher's benefit. Stating that "the primary consideration in the determination of the applicability of the statutory definition is whether [132] effectuation of the declared policy and purposes of the Act comprehend securing to the individual the rights guaranteed and protection afforded by the Act," the Board concluded that the newsboys are employees. The record sustains the Board's findings and there is ample basis in the law for its conclusion.

III.

The Board's selection of the collective bargaining units also must be upheld. The units chosen for the News and the Herald consist of all full-time^[38] newsboys and checkmen engaged to sell the papers in Los Angeles. Bootjackers, temporary, casual and part-time^[39] newsboys are excluded. The units designated for the Times and the Examiner consist of newsboys selling at established spots^[40] in Los Angeles^[41] four or more hours per day five or more days per week, except temporary newsboys.^[42]

The Board predicated its designations in part upon the finding that the units included, in general, men who were responsible workers, continuously and regularly employed as vendors and dependent upon their sales for their livelihood, [133] while schoolboys and transient or casual workers were excluded. The discretion which Congress vested in the Board to determine an appropriate unit is hardly overstepped by the choice of a unit based on a distinction so clearly consistent with the need for responsible bargaining. That the Board's selection emphasizes difference in tenure rather than function is, on this record certainly, no abuse of discretion.

Nor is there substance in the objection that the Board's designations on the one hand fail to embrace all workers who in fact come within the responsible or stable full-time category generically stated, and on the other hand fail to exclude all who in fact come within the schoolboy or more volatile part-time category. The record does not suggest that the units designated, at least so far as Los Angeles newsboys are concerned, do not substantially effectuate the Board's theory or embrace a large portion of those who would make up a stable bargaining group based on responsible tenure and full-time work. In these matters the Board cannot be held to mathematical precision. If it chooses to couch its orders in terms which for good reasons it regards effective to accomplish its stated ends, peripheral or hypothetical deviations will not defeat an otherwise appropriate order.

Another objection urged by the Times, the Herald and the Examiner is to the Board's exclusion of suburban newsboys^[43] from the units on the ground they were not organized by the union. The Board found that although all vendors in metropolitan Los Angeles were eligible for membership, the union had not been extended to the suburban groups generally and that no other labor organization was seeking to represent respondents' employees. There is no suggestion either that the union deliberately [134] excluded suburban newsboys who sought admission or that suburban newsboys have displayed any interest in collective bargaining or self-organization.

Wide variations in the forms of employee self-organization and the complexities of modern industrial organization make difficult the use of inflexible rules as the test of an appropriate unit. Congress was informed of the need for flexibility in shaping the unit to the particular case^[44] and accordingly gave the Board wide discretion in the matter. Its choice of a unit is limited specifically only by the requirement that it be an "employer unit, craft unit, plant unit, or subdivision thereof" and that the selection be made so as "to insure to employees the full benefit of their right to self-organization and to collective bargaining, and otherwise to effectuate the policies of the Act." Pittsburgh Plate Glass Co. v. Labor Board, 313 U.S. 146. The flexibility which Congress thus permitted has characterized the Board's administration of the section and has led it to resort to a wide variety of factors in case-to-case determination of the appropriate unit.^[45] Among the considerations to which it has given weight is the extent of organization of the union requesting certification or collective bargaining. This is done on the expressed theory that it is desirable in the determination of an appropriate unit to render collective bargaining of the company's employees an immediate possibility.^[46] No [135] plausible reason is suggested for withholding the benefits of the Act from those here seeking it until a group of geographically separated employees becomes interested in collective bargaining. In the circumstances disclosed by this record we cannot say the Board's conclusions are lacking in a "rational basis."

The judgments are reversed and the causes are remanded for further proceedings not inconsistent with this opinion.

Reversed.

MR. JUSTICE REED concurs in the result. He is of the opinion that the test of coverage for employees is that announced by the Board in the matter of Stockholders Publishing Company, Inc., and Los Angeles Newsboys Local Industrial Union No. 75, C.I.O., and other similar cases, decided January 9, 1941, 28 N.L.R.B. 1006, 1022-23.

MR. JUSTICE ROBERTS:

I think the judgment of the Circuit Court of Appeals should be affirmed. The opinion of that court reported in 136 F.2d 608, seems to me adequately to state the controlling facts and correctly to deal with the question of law presented for decision. I should not add anything were it not for certain arguments presented here and apparently accepted by the court.

I think it plain that newsboys are not "employees" of the respondents within the meaning and intent of the National Labor Relations Act. When Congress, in § 2 (3), said "The term `employee' shall include any employee, . . ." it stated as clearly as language could do it that the provisions of the Act were to extend to those who, as a result of decades of tradition which had become part of the common understanding of our people, bear the named relationship. Clearly also Congress did not delegate [136] to the National Labor Relations Board the function of defining the relationship of employment so as to promote what the Board understood to be the underlying purpose of the statute. The question who is an employee, so as to make the statute applicable to him, is a question of the meaning of the Act and, therefore, is a judicial and not an administrative question.

I do not think that the court below suggested that the federal courts sitting in the various states must determine whether a given person is an employee by application of either the local statutes or local state decisions. Quite the contrary. As a result of common law development, many prescriptions of federal statutes take on meaning which is uniformly ascribed to them by the federal courts, irrespective of local variance. Funk v. United States, 290 U.S. 371. This court has repeatedly resorted to just such considerations in defining the very term "employee" as used in other federal statutes, as the opinion of the court below shows. There is a general and prevailing rule throughout the Union as to the indicia of employment and the criteria of one's status as employee. Unquestionably it was to this common, general, and prevailing understanding that Congress referred in the statute and, according to that understanding, the facts stated in the opinion below, and in that of this court, in my judgment, demonstrate that the newsboys were not employees of the newspapers.

It is urged that the Act uses the term in some loose and unusual sense such as justifies the Board's decision because Congress added to the definition of employee above quoted these further words: "and shall not be limited to the employees of a particular employer, unless the Act explicitly states otherwise,. . ." The suggestion seems to be that Congress intended that the term employee should mean those who were not in fact employees, but it [137] is perfectly evident, not only from the provisions of the Act as a whole but from the Senate Committee's Report, that this phrase was added to prevent any misconception of the provisions whereby employees were to be allowed freely to combine and to be represented in collective bargaining by the representatives of their union. Congress intended to make it clear that employee organizations did not have to be organizations of the employees of any single employer. But that qualifying phrase means no more than this and was never intended to permit the Board to designate as employees those who, in traditional understanding, have no such status.

[1] Together with No. 337, National Labor Relations Board v. Stockholders Publishing Co., Inc., No. 338, National Labor Relations Board v. Hearst Publications, Inc., and No. 339, National Labor Relations Board v. Times-Mirror Co., also on writs of certiorari to the Circuit Court of Appeals for the Ninth Circuit.

[2] Section 2 (3) of the Act provides that "The term `employee' shall include any employee, and shall not be limited to the employees of a particular employer, unless the Act explicitly states otherwise, and shall include any individual whose work has ceased as a consequence of, or in connection with, any current labor dispute or because of any unfair labor practice, and who has not obtained any other regular and substantially equivalent employment, but shall not include any individual employed as an agricultural laborer, or in the domestic service of any family or person at his home, or any individual employed by his parent or spouse."

[3] 320 U.S. 728.

[4] Pursuant to § 9 (b) and (c) of the Act; 49 Stat. 451, 29 U.S.C. § 159 (b) and (c).

[5] Although it treated the four representation petitions in one consolidated proceeding and disposed of them in one opinion, the Board did not consider evidence with respect to one publisher as applicable to any of the others.

[6] Subsequently those orders were amended in various details. 29 N.L.R.B. 94, 95; 30 N.L.R.B. 696, 697; 31 N.L.R.B. 697.

[7] The record in the representation proceeding was in effect incorporated in the complaint proceeding.

[8] The Times' daily circulation is about 220,000 and its Sunday circulation is about 368,000. The Examiner's daily circulation is about 214,000 and its Sunday circulation is about 566,000.

[9] The Herald has a circulation of about 243,000. Both it and the Examiner are owned by Hearst Publications, Inc.

[10] The News has a circulation of about 195,000. Its first three and seventh editions are consigned for the most part to route delivery or suburban dealers. Its fourth edition, which goes to press at 2:45 a.m., is sold in the city during the mornings. The remaining editions, which go to press at regular intervals between 9:50 a.m. and 5:00 p.m., are sold in the city during the afternoons.

[11] The Examiner, the Herald, and the News all employ "main spot" boys or checkmen; the Times does not.

[12] The Times district managers deliver the papers directly to the newsboys and collect directly from them. On the other papers district managers may deliver bundles of papers to the checkmen or directly to the newsboys themselves. The Times customarily transports its newsboys to their "spots" from the Times building, where they first report and pick up their papers. The other respondents offer similar transportation to those of their newsboys who desire it.

[13] In the case of the Examiner these "main spot" boys, although performing services similar to those of checkmen, are less closely knit to the publisher and sometimes receive no compensation for their services.

[14] See infra, note 15.

[15] Newsboys selling the Herald in one residential area do not receive credit for all unsold papers.

[16] Admittedly the Times, Examiner, and Herald district managers are employees of their respective papers. While the News urged earnestly that its managers are not its employees, the Board found otherwise. They do not operate on a formal salary basis but they receive guaranteed minimum payments which the Board found are "no more than a fixed salary bearing another label." And while they, rather than the publisher, fix the price of the paper to the newsboy, the Board found, on substantial evidence, that they function for the News in specified districts, distribute racks, aprons, advertising placards from the News to the newsboys, give instructions as to their use, supervise the redistributing activities of the checkmen (themselves clearly employees of the News), and hand out News checks to the checkmen for their services. On this and other evidence suggesting that however different may be their formal arrangements, News district managers bear substantially the same relation to the publisher on one hand and the newsboys on the other as do the other district managers, the Board concluded that they were employees of the paper.

[17] Although from time to time these "spots" are bought and sold among the vendors themselves, without objection by district managers and publishers, this in no way negates the need for the district managers' implicit approval of a spotholder or their authority to remove vendors from their "spots" for reasons of discipline or efficiency.

[18] E.g., that there is either no evidence in the record to show, or the record explicitly negatives, that respondents carry the newsboys on their payrolls, pay "salaries" to them, keep records of their sales or locations, or register them as "employees" with the Social Security Board, or that the newsboys are covered by workmen's compensation insurance or the California Compensation Act. Furthermore, it is urged the record shows that the newsboys all sell newspapers, periodicals and other items not furnished to them by their respective publishers, assume the risk for papers lost, stolen or destroyed, purchase and sell their "spots," hire assistants and relief men and make arrangements among themselves for the sale of competing or leftover papers.

[19] They have abandoned here the contention, made in the circuit court, that the Act does not reach their controversies with the newsboys because they do not affect commerce.

[20] The so-called "control test" with which common-law judges have wrestled to secure precise and ready applications did not escape the difficulties encountered in borderland cases by its reformulation in the Restatement of the Law of Agency § 220. That even at the common law the control test and the complex of incidents evolved in applying it to distinguish an "employee" from an "independent contractor," for purposes of vicarious liability in tort, did not necessarily have the same significance in other contexts, compare Lumley v. Gye [1853] El. & Bl. 216, and see also the cases collected in 21 A.L.R. 1229 et seq.; 23 A.L.R. 984 et seq.

[21] See, e.g., Stevens, The Test of the Employment Relation (1939) 38 Mich. L. Rev. 188; Steffen, Independent Contractor and the Good Life (1935) 2 U. of Chi. L. Rev. 501; Leidy, Salesmen as Independent Contractors (1938) 28 Mich. L. Rev. 365; N.Y. Law Revision Commission Report, 1939 (1939) Legislative Document No. 65 (K).

[22] See note 20 supra.

[23] Compare, e.g., McKinley v. Payne Lumber Co., 200 Ark. 1114, 143 S.W.2d 38; Industrial Comm'n v. Northwestern Ins. Co., 103 Colo. 550, 88 P.2d 560; Schomp v. Fuller Brush Co., 124 N.J.L. 487, 12 A.2d 702; 126 N.J.L. 368, 19 A.2d 780; Unemployment Compensation Comm'n v. Jefferson Ins. Co., 215 N.C. 479, 2 S.E.2d 584; Singer Sewing Machine Co. v. Unemployment Compensation Comm'n, 167 Ore. 142, 103 P.2d 708, with McCain v. Crossett Lumber Co., 174 S.W.2d 114 (Ark.); Hill Hotel Co. v. Kinney, 138 Neb. 760, 295 N.W. 397; Washington Recorder Co. v. Ernst, 199 Wash. 176, 91 P.2d 718; Wisconsin Bridge Co. v. Industrial Comm'n, 233 Wis. 467, 290 N.W. 199. See generally Wolfe, Determination of Employer-Employee Relationships in Social Legislation (1941) 41 Col. L. Rev. 1015. And see note 23 infra.

[24] Compare Stockwell v. Morris, 46 Wyo. 1, with Auer v. Sinclair Refining Co., 103 N.J.L. 372; Schomp v. Fuller Brush Co., 124 N.J.L. 487, 126 N.J.L. 368, with Fuller Brush Co. v. Industrial Comm'n, 99 Utah 97; Stover Bedding Co. v. Industrial Comm'n, 99 Utah 423, with Maltz v. Jackoway-Katz Cap Co., 336 Mo. 1000.

[25] Cf. notes 28-30 infra and text.

[26] American Steel Foundries Co. v. Tri-City Council, 257 U.S. 184, 209, cited in H.R. Rep. No. 1147, 74th Cong., 1st Sess. 10; cf. Bakery & Pastry Drivers v. Wohl, 315 U.S. 769.

[27] The practice of self-organization and collective bargaining to resolve labor disputes has for some time been common among such varied types of "independent contractors" as musicians (How Collective Bargaining Works (20th Century Fund, 1942) 848-866; Proceedings of the 47th Annual Convention of the American Federation of Musicians (1942)), actors (see, e.g., Collective Bargaining by Actors (1926) Bureau of Labor Statistics, Bulletin No. 402; Harding, The Revolt of the Actors (1929); Ross, Stars and Strikes (1941)), and writers (see, e.g., Rosten, Hollywood (1941); Ross, Stars and Strikes (1941) 48-63), and such atypical "employees" as insurance agents, artists, architects and engineers (see, e.g., Proceedings of the 2d Convention of the UOPWA, C.I.O. (1938); Proceedings of the 3d Convention of the UOPWA, C.I.O. (1940); Handbook of American Trade Unions (1936), Bureau of Labor Statistics, Bull. No. 618, 291-293; Constitution and By-Laws of the IFTEAD of the A.F.L., 1942).

[28] Control of "physical conduct in the performance of the service" is the traditional test of the "employee relationship" at common law. Cf., e.g., Restatement of the Law of Agency § 220 (1).

[29] Sen. Rep. No. 573, 74th Cong., 1st Sess. 7.

[30] Sen. Rep. No. 573, 74th Cong., 1st Sess. 6.

[31] Cf. Phelps-Dodge Corp. v. Labor Board, 313 U.S. 177; and compare Drivers' Union v. Lake Valley Co., 311 U.S. 91, with Sen. Rep. No. 573, 74th Cong., 1st Sess. 7.

[32] Compare Labor Board v. Waterman S.S. Corp., 309 U.S. 206; Phelps-Dodge Corp. v. Labor Board, 313 U.S. 177.

[33] Cf. South Chicago Coal & Dock Co. v. Bassett, 309 U.S. 251; Lehigh Valley Coal Co. v. Yensavage, 218 F. 547, 552 (C.C.A.).

[34] Lehigh Valley Coal Co. v. Yensavage, 218 F. 547, 552 (C.C.A.).

[35] E.g., Matter of Metro-Goldwyn-Mayer Studios, 7 N.L.R.B. 662, 686-690; Matter of KMOX Broadcasting Station, 10 N.L.R.B. 479; Matter of Interstate Granite Corp., 11 N.L.R.B. 1046; Matter of Sun Life Ins. Co., 15 N.L.R.B. 817; Matter of Kelly Co., 34 N.L.R.B. 325; Matter of John Yasek, 37 N.L.R.B. 156.

[36] 44 Stat. 1424, 33 U.S.C. § 901 et seq.

[37] Under § 2 (b) of the Communications Act of 1934, 48 Stat. 1064, 1065, 47 U.S.C. § 152 (b).

[38] Full-time newsboys for the Herald includes those who regularly sell to the public five or more editions five or more days per week. Full-time newsboys for the News includes those who regularly sell to the general public the fifth, sixth, eighth, ninth and tenth, or the sixth, eighth, ninth and tenth editions five or more days per week, or the fourth and earlier editions for at least four hours daily between 4:00 a.m. and 10:00 a.m. five days per week.

[39] Part-time newsboys for the Herald means those selling less than five editions daily or for less than five days per week.

[40] Established spots are corners at which newsboys sold those papers for at least five or more days per week during at least six consecutive months.

[41] Glendale is included in the Times unit.

[42] Temporary newsboys are those selling for less than thirty-one consecutive days.

[43] Except newsboys selling the Times in Glendale.

[44] Hearings before Committee on Education and Labor on S. 1958, 74th Cong., 1st Sess. 83.

[45] E.g., see First Annual Report of the National Labor Relations Board 112-120; Second Annual Report of the National Labor Relations Board 122-140; Third Annual Report of the National Labor Relations Board 156-197; Fourth Annual Report of the National Labor Relations Board 82-97; Fifth Annual Report of the National Labor Relations Board 63-72; Sixth Annual Report of the National Labor Relations Board 63-71.

[46] Matter of Gulf Oil Corp., 4 N.L.R.B. 133.

323 U.S. 134 (1944)

CERTIORARI TO THE CIRCUIT COURT OF APPEALS FOR THE FIFTH CIRCUIT.

[135] Mr. R. Curtis McBroom, with whom Mr. Mark McGee was on the brief, for petitioners.

Mr. Beverley V. Thompson, with whom Mr. Wm. N. Strack was on the brief, for respondent.

Solicitor General Fahy, Mr. Douglas B. Maggs, and Miss Bessie Margolin filed a brief on behalf of the Administrator of the Wage and Hour Division, U.S. Department of Labor, as amicus curiae, urging reversal.

MR. JUSTICE JACKSON delivered the opinion of the Court.

Seven employees of the Swift and Company packing plant at Fort Worth, Texas, brought an action under the Fair Labor Standards Act to recover overtime, liquidated damages, and attorneys' fees, totalling approximately $77,000. The District Court rendered judgment denying this claim wholly, 53 F. Supp. 1020, and the Circuit Court of Appeals for the Fifth Circuit affirmed. 136 F.2d 112.

It is not denied that the daytime employment of these persons was working time within the Act. Two were engaged in general fire-hall duties and maintenance of fire-fighting equipment of the Swift plant. The others operated elevators or acted as relief men in fire duties. They worked from 7:00 a.m. to 3:30 p.m., with a half-hour lunch period, five days a week. They were paid weekly salaries.

Under their oral agreement of employment, however, petitioners undertook to stay in the fire hall on the Company premises, or within hailing distance, three and a half to four nights a week. This involved no task except to answer alarms, either because of fire or because the sprinkler was set off for some other reason. No fires occurred during the period in issue, the alarms were rare, and the time required for their answer rarely exceeded an hour. For each alarm answered the employees were [136] paid in addition to their fixed compensation an agreed amount, fifty cents at first, and later sixty-four cents. The Company provided a brick fire hall equipped with steam heat and air-conditioned rooms. It provided sleeping quarters, a pool table, a domino table, and a radio. The men used their time in sleep or amusement as they saw fit, except that they were required to stay in or close by the fire hall and be ready to respond to alarms. It is stipulated that "they agreed to remain in the fire hall and stay in it or within hailing distance, subject to call, in event of fire or other casualty, but were not required to perform any specific tasks during these periods of time, except in answering alarms." The trial court found the evidentiary facts as stipulated; it made no findings of fact as such as to whether under the arrangement of the parties and the circumstances of this case, which in some respects differ from those of the Armour case (ante, p. 126), the fire-hall duty or any part thereof constituted working time. It said, however, as a "conclusion of law" that "the time plaintiffs spent in the fire hall subject to call to answer fire alarms does not constitute hours worked, for which overtime compensation is due them under the Fair Labor Standards Act, as interpreted by the Administrator and the Courts," and in its opinion observed, "of course we know pursuing such pleasurable occupations or performing such personal chores, does not constitute work." The Circuit Court of Appeals affirmed.

For reasons set forth in the Armour case decided herewith we hold that no principle of law found either in the statute or in Court decisions precludes waiting time from also being working time. We have not attempted to, and we cannot, lay down a legal formula to resolve cases so varied in their facts as are the many situations in which employment involves waiting time. Whether in a concrete case such time falls within or without the Act is a question of fact to be resolved by appropriate findings of the trial [137] court. Walling v. Jacksonville Paper Co., 317 U.S. 564, 572. This involves scrutiny and construction of the agreements between the particular parties, appraisal of their practical construction of the working agreement by conduct, consideration of the nature of the service, and its relation to the waiting time, and all of the surrounding circumstances. Facts may show that the employee was engaged to wait, or they may show that he waited to be engaged. His compensation may cover both waiting and task, or only performance of the task itself. Living quarters may in some situations be furnished as a facility of the task and in another as a part of its compensation. The law does not impose an arrangement upon the parties. It imposes upon the courts the task of finding what the arrangement was.

We do not minimize the difficulty of such an inquiry where the arrangements of the parties have not contemplated the problem posed by the statute. But it does not differ in nature or in the standards to guide judgment from that which frequently confronts courts where they must find retrospectively the effect of contracts as to matters which the parties failed to anticipate or explicitly to provide for.

Congress did not utilize the services of an administrative agency to find facts and to determine in the first instance whether particular cases fall within or without the Act. Instead, it put this responsibility on the courts. Kirschbaum Co. v. Walling, 316 U.S. 517, 523. But it did create the office of Administrator, impose upon him a variety of duties, endow him with powers to inform himself of conditions in industries and employments subject to the Act, and put on him the duties of bringing injunction actions to restrain violations. Pursuit of his duties has accumulated a considerable experience in the problems of ascertaining working time in employments involving periods of inactivity and a knowledge of the customs [138] prevailing in reference to their solution. From these he is obliged to reach conclusions as to conduct without the law, so that he should seek injunctions to stop it, and that within the law, so that he has no call to interfere. He has set forth his views of the application of the Act under different circumstances in an interpretative bulletin and in informal rulings. They provide a practical guide to employers and employees as to how the office representing the public interest in its enforcement will seek to apply it. Wage and Hour Division, Interpretative Bulletin No. 13.

The Administrator thinks the problems presented by inactive duty require a flexible solution, rather than the all-in or all-out rules respectively urged by the parties in this case, and his Bulletin endeavors to suggest standards and examples to guide in particular situations. In some occupations, it says, periods of inactivity are not properly counted as working time even though the employee is subject to call. Examples are an operator of a small telephone exchange where the switchboard is in her home and she ordinarily gets several hours of uninterrupted sleep each night; or a pumper of a stripper well or watchman of a lumber camp during the off season, who may be on duty twenty-four hours a day but ordinarily "has a normal night's sleep, has ample time in which to eat his meals, and has a certain amount of time for relaxation and entirely private pursuits." Exclusion of all such hours the Administrator thinks may be justified. In general, the answer depends "upon the degree to which the employee is free to engage in personal activities during periods of idleness when he is subject to call and the number of consecutive hours that the employee is subject to call without being required to perform active work." "Hours worked are not limited to the time spent in active labor but include time given by the employee to the employer. . . ."

[139] The facts of this case do not fall within any of the specific examples given, but the conclusion of the Administrator, as expressed in the brief amicus curiae, is that the general tests which he has suggested point to the exclusion of sleeping and eating time of these employees from the workweek and the inclusion of all other on-call time: although the employees were required to remain on the premises during the entire time, the evidence shows that they were very rarely interrupted in their normal sleeping and eating time, and these are pursuits of a purely private nature which would presumably occupy the employees' time whether they were on duty or not and which apparently could be pursued adequately and comfortably in the required circumstances; the rest of the time is different because there is nothing in the record to suggest that, even though pleasurably spent, it was spent in the ways the men would have chosen had they been free to do so.

There is no statutory provision as to what, if any, deference courts should pay to the Administrator's conclusions. And, while we have given them notice, we have had no occasion to try to prescribe their influence. The rulings of this Administrator are not reached as a result of hearing adversary proceedings in which he finds facts from evidence and reaches conclusions of law from findings of fact. They are not, of course, conclusive, even in the cases with which they directly deal, much less in those to which they apply only by analogy. They do not constitute an interpretation of the Act or a standard for judging factual situations which binds a district court's processes, as an authoritative pronouncement of a higher court might do. But the Administrator's policies are made in pursuance of official duty, based upon more specialized experience and broader investigations and information than is likely to come to a judge in a particular case. They do determine the policy which will guide applications for enforcement [140] by injunction on behalf of the Government. Good administration of the Act and good judicial administration alike require that the standards of public enforcement and those for determining private rights shall be at variance only where justified by very good reasons. The fact that the Administrator's policies and standards are not reached by trial in adversary form does not mean that they are not entitled to respect. This Court has long given considerable and in some cases decisive weight to Treasury Decisions and to interpretative regulations of the Treasury and of other bodies that were not of adversary origin.

We consider that the rulings, interpretations and opinions of the Administrator under this Act, while not controlling upon the courts by reason of their authority, do constitute a body of experience and informed judgment to which courts and litigants may properly resort for guidance. The weight of such a judgment in a particular case will depend upon the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control.

The courts in the Armour case weighed the evidence in the particular case in the light of the Administrator's rulings and reached a result consistent therewith. The evidence in this case in some respects, such as the understanding as to separate compensation for answering alarms, is different. Each case must stand on its own facts. But in this case, although the District Court referred to the Administrator's Bulletin, its evaluation and inquiry were apparently restricted by its notion that waiting time may not be work, an understanding of the law which we hold to be erroneous. Accordingly, the judgment is reversed and the cause remanded for further proceedings consistent herewith.

Reversed.

529 U.S. 120 (2000)

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

[121] [122] [123] O'Connor, J., delivered the opinion of the Court, in which Rehnquist, C. J., and Scalia, Kennedy, and Thomas, JJ., joined. Breyer, J., filed a dissenting opinion, in which Stevens, Souter, and Ginsburg, JJ., joined, post, p. 161.

Solicitor General Waxman argued the cause for petitioners. With him on the briefs were Acting Assistant Attorney General Ogden, Deputy Solicitor General Kneedler, Deputy Assistant Attorney General Schultz, Irving L. Gornstein, Eugene Thirolf, Douglas Letter, Gerald C. Kell, Chris- [124] tine N. Kohl, Margaret Jane Porter, Karen E. Schifter, and Patricia J. Kaeding.

Richard M. Cooper argued the cause for respondents. With him on the brief for respondent R. J. Reynolds Tobacco Co. was Steven M. Umin. Andrew S. Krulwich, Bert W. Rein, Thomas W. Kirby, and Michael L. Robinson filed a brief for respondent Brown & Williamson Tobacco Corp. Larry B. Sitton filed a brief for respondents United States Tobacco Co. et al. William C. MacLeod filed a brief for respondents National Association of Convenience Stores et al. Peter T. Grossi, Jr., Arthur N. Levine, Jeff Richman, Richard A. Merrill, and Herbert Dym filed a brief for respondents Philip Morris Inc. et al.^[1]

[125] Justice O'Connor, delivered the opinion of the Court.

This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use. In 1996, the Food and Drug Administration (FDA), after having expressly disavowed any such authority since its inception, asserted jurisdiction to regulate tobacco products. See 61 Fed. Reg. 44619-45318. The FDA concluded that nicotine is a "drug" within the meaning of the Food, Drug, and Cosmetic Act (FDCA or Act), 52 Stat. 1040, as amended, 21 U. S. C. § 301 et seq., and that cigarettes and smokeless tobacco are "combination products" that deliver nicotine to the body. 61 Fed. Reg. 44397 (1996). Pursuant to this authority, it promulgated regulations intended to reduce tobacco consumption among children and adolescents. Id., at 44615-44618. The agency believed that, because most tobacco consumers begin their use before reaching the age of 18, curbing tobacco use by minors could substantially reduce the prevalence of addiction in future generations and thus the incidence of tobacco-related death and disease. Id., at 44398-44399.

Regardless of how serious the problem an administrative agency seeks to address, however, it may not exercise its authority "in a manner that is inconsistent with the administrative structure that Congress enacted into law." ETSI Pipeline Project v. Missouri, 484 U. S. 495, 517 (1988). And although agencies are generally entitled to deference in the interpretation of statutes that they administer, a reviewing "court, as well as the agency, must give effect to the unambiguously [126] expressed intent of Congress." Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-843 (1984). In this case, we believe that Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA's overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA's assertion of jurisdiction is impermissible.

I

The FDCA grants the FDA, as the designee of the Secretary of Health and Human Services (HHS), the authority to regulate, among other items, "drugs" and "devices." See 21 U. S. C. §§ 321(g)—(h), 393 (1994 ed. and Supp. III). The Act defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body." 21 U. S. C. § 321(g)(1)(C). It defines "device," in part, as "an instrument, apparatus, implement, machine, contrivance, . . . or other similar or related article, including any component, part, or accessory, which is . . . intended to affect the structure or any function of the body." § 321(h). The Act also grants the FDA the authority to regulate so-called "combination products," which "constitute a combination of a drug, device, or biological product." § 353(g)(1). The FDA has construed this provision as giving it the discretion to regulate combination products as drugs, as devices, or as both. See 61 Fed. Reg. 44400 (1996).

On August 11, 1995, the FDA published a proposed rule concerning the sale of cigarettes and smokeless tobacco to children and adolescents. 60 Fed. Reg. 41314-41787. The rule, which included several restrictions on the sale, distribution, and advertisement of tobacco products, was designed to reduce the availability and attractiveness of tobacco products to young people. Id., at 41314. A public comment period followed, during which the FDA received over 700,000 submissions, [127] more than "at any other time in its history on any other subject." 61 Fed. Reg. 44418 (1996).

On August 28, 1996, the FDA issued a final rule entitled "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents." Id., at 44396. The FDA determined that nicotine is a "drug" and that cigarettes and smokeless tobacco are "drug delivery devices," and therefore it had jurisdiction under the FDCA to regulate tobacco products as customarily marketed—that is, without manufacturer claims of therapeutic benefit. Id., at 44397, 44402. First, the FDA found that tobacco products "`affect the structure or any function of the body' " because nicotine "has significant pharmacological effects." Id., at 44631. Specifically, nicotine "exerts psychoactive, or mood-altering, effects on the brain" that cause and sustain addiction, have both tranquilizing and stimulating effects, and control weight. Id., at 44631-44632. Second, the FDA determined that these effects were "intended" under the FDCA because they "are so widely known and foreseeable that [they] may be deemed to have been intended by the manufacturers," id., at 44687; consumers use tobacco products "predominantly or nearly exclusively" to obtain these effects, id., at 44807; and the statements, research, and actions of manufacturers revealed that they "have `designed' cigarettes to provide pharmacologically active doses of nicotine to consumers," id., at 44849. Finally, the agency concluded that cigarettes and smokeless tobacco are "combination products" because, in addition to containing nicotine, they include device components that deliver a controlled amount of nicotine to the body, id., at 45208-45216.

Having resolved the jurisdictional question, the FDA next explained the policy justifications for its regulations, detailing the deleterious health effects associated with tobacco use. It found that tobacco consumption was "the single leading cause of preventable death in the United States." Id., at 44398. According to the FDA, "[m]ore than 400,000 [128] people die each year from tobacco-related illnesses, such as cancer, respiratory illnesses, and heart disease." Ibid. The agency also determined that the only way to reduce the amount of tobacco-related illness and mortality was to reduce the level of addiction, a goal that could be accomplished only by preventing children and adolescents from starting to use tobacco. Id., at 44398-44399. The FDA found that 82% of adult smokers had their first cigarette before the age of 18, and more than half had already become regular smokers by that age. Id., at 44398. It also found that children were beginning to smoke at a younger age, that the prevalence of youth smoking had recently increased, and that similar problems existed with respect to smokeless tobacco. Id., at 44398-44399. The FDA accordingly concluded that if "the number of children and adolescents who begin tobacco use can be substantially diminished, tobacco-related illness can be correspondingly reduced because data suggest that anyone who does not begin smoking in childhood or adolescence is unlikely ever to begin." Id., at 44399.

Based on these findings, the FDA promulgated regulations concerning tobacco products' promotion, labeling, and accessibility to children and adolescents. See id., at 44615-44618. The access regulations prohibit the sale of cigarettes or smokeless tobacco to persons younger than 18; require retailers to verify through photo identification the age of all purchasers younger than 27; prohibit the sale of cigarettes in quantities smaller than 20; prohibit the distribution of free samples; and prohibit sales through self-service displays and vending machines except in adult-only locations. Id., at 44616-44617. The promotion regulations require that any print advertising appear in a black-and-white, text-only format unless the publication in which it appears is read almost exclusively by adults; prohibit outdoor advertising within 1,000 feet of any public playground or school; prohibit the distribution of any promotional items, such as T-shirts or hats, bearing the manufacturer's brand name; and prohibit a [129] manufacturer from sponsoring any athletic, musical, artistic, or other social or cultural event using its brand name. Id., at 44617-44618. The labeling regulation requires that the statement, "A Nicotine-Delivery Device for Persons 18 or Older," appear on all tobacco product packages. Id., at 44617.

The FDA promulgated these regulations pursuant to its authority to regulate "restricted devices." See 21 U. S. C. § 360j(e). The FDA construed § 353(g)(1) as giving it the discretion to regulate "combination products" using the Act's drug authorities, device authorities, or both, depending on "how the public health goals of the act can be best accomplished." 61 Fed. Reg. 44403 (1996). Given the greater flexibility in the FDCA for the regulation of devices, the FDA determined that "the device authorities provide the most appropriate basis for regulating cigarettes and smokeless tobacco." Id., at 44404. Under 21 U. S. C. § 360j(e), the agency may "require that a device be restricted to sale, distribution, or use . . . upon such other conditions as [the FDA] may prescribe in such regulation, if, because of its potentiality for harmful effect or the collateral measures necessary to its use, [the FDA] determines that there cannot otherwise be reasonable assurance of its safety and effectiveness." The FDA reasoned that its regulations fell within the authority granted by § 360j(e) because they related to the sale or distribution of tobacco products and were necessary for providing a reasonable assurance of safety. 61 Fed. Reg. 44405-44407 (1996).

Respondents, a group of tobacco manufacturers, retailers, and advertisers, filed suit in United States District Court for the Middle District of North Carolina challenging the regulations. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (1997). They moved for summary judgment on the grounds that the FDA lacked jurisdiction to regulate tobacco products as customarily marketed, the regulations exceeded the FDA's authority under 21 U. S. C. § 360j(e), and the advertising [130] restrictions violated the First Amendment. Second Brief in Support of Plaintiffs' Motion for Summary Judgment in No. 2:95CV00591 (MDNC), in 3 Rec. in No. 97-1604 (CA4), Tab No. 40; Third Brief in Support of Plaintiffs' Motion for Summary Judgment in No. 2:95CV00591 (MDNC), in 3 Rec. in No. 97-1604 (CA4), Tab No. 42. The District Court granted respondents' motion in part and denied it in part. 966 F. Supp., at 1400. The court held that the FDCA authorizes the FDA to regulate tobacco products as customarily marketed and that the FDA's access and labeling regulations are permissible, but it also found that the agency's advertising and promotion restrictions exceed its authority under § 360j(e). Id., at 1380-1400. The court stayed implementation of the regulations it found valid (except the prohibition on the sale of tobacco products to minors) and certified its order for immediate interlocutory appeal. Id., at 1400-1401.

The Court of Appeals for the Fourth Circuit reversed, holding that Congress has not granted the FDA jurisdiction to regulate tobacco products. See 153 F. 3d 155 (1998). Examining the FDCA as a whole, the court concluded that the FDA's regulation of tobacco products would create a number of internal inconsistencies. Id., at 162-167. Various provisions of the Act require the agency to determine that any regulated product is "safe" before it can be sold or allowed to remain on the market, yet the FDA found in its rulemaking proceeding that tobacco products are "dangerous" and "unsafe." Id., at 164-167. Thus, the FDA would apparently have to ban tobacco products, a result the court found clearly contrary to congressional intent. Ibid. This apparent anomaly, the Court of Appeals concluded, demonstrates that Congress did not intend to give the FDA authority to regulate tobacco. Id., at 167. The court also found that evidence external to the FDCA confirms this conclusion. Importantly, the FDA consistently stated before 1995 that it lacked jurisdiction over tobacco, and Congress has enacted [131] several tobacco-specific statutes fully cognizant of the FDA's position. See id., at 168-176. In fact, the court reasoned, Congress has considered and rejected many bills that would have given the agency such authority. See id., at 170-171. This, along with the absence of any intent by the enacting Congress in 1938 to subject tobacco products to regulation under the FDCA, demonstrates that Congress intended to withhold such authority from the FDA. Id., at 167-176. Having resolved the jurisdictional question against the agency, the Court of Appeals did not address whether the regulations exceed the FDA's authority under 21 U. S. C. § 360j(e) or violate the First Amendment. See 153 F. 3d, at 176, n. 29.

We granted the federal parties' petition for certiorari, 526 U. S. 1086 (1999), to determine whether the FDA has authority under the FDCA to regulate tobacco products as customarily marketed.

II

The FDA's assertion of jurisdiction to regulate tobacco products is founded on its conclusions that nicotine is a "drug" and that cigarettes and smokeless tobacco are "drug delivery devices." Again, the FDA found that tobacco products are "intended" to deliver the pharmacological effects of satisfying addiction, stimulation and tranquilization, and weight control because those effects are foreseeable to any reasonable manufacturer, consumers use tobacco products to obtain those effects, and tobacco manufacturers have designed their products to produce those effects. 61 Fed. Reg. 44632-44633 (1996). As an initial matter, respondents take issue with the FDA's reading of "intended," arguing that it is a term of art that refers exclusively to claims made by the manufacturer or vendor about the product. See Brief for Respondent Brown & Williamson Tobacco Corp. 6. That is, a product is not a drug or device under the FDCA unless the manufacturer or vendor makes some express claim concerning the product's therapeutic benefits. See id., at 6-7. We [132] need not resolve this question, however, because assuming, arguendo, that a product can be "intended to affect the structure or any function of the body" absent claims of therapeutic or medical benefit, the FDA's claim to jurisdiction contravenes the clear intent of Congress.

A threshold issue is the appropriate framework for analyzing the FDA's assertion of authority to regulate tobacco products. Because this case involves an administrative agency's construction of a statute that it administers, our analysis is governed by Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). Under Chevron, a reviewing court must first ask "whether Congress has directly spoken to the precise question at issue." Id., at 842. IfCongress has done so, the inquiry is at an end; the court "must give effect to the unambiguously expressed intent of Congress." Id., at 843; see also United States v. Haggar Apparel Co., 526 U. S. 380, 392 (1999); Holly Farms Corp. v. NLRB, 517 U. S. 392, 398 (1996). But if Congress has not specifically addressed the question, a reviewing court must respect the agency's construction of the statute so long as it is permissible. See INS v. Aguirre-Aguirre, 526 U. S. 415, 424 (1999); Auer v. Robbins, 519 U. S. 452, 457 (1997). Such deference is justified because "[t]he responsibilities for assessing the wisdom of such policy choices and resolving the struggle between competing views of the public interest are not judicial ones," Chevron, supra, at 866, and because of the agency's greater familiarity with the everchanging facts and circumstances surrounding the subjects regulated, see Rust v. Sullivan, 500 U. S. 173, 187 (1991).

In determining whether Congress has specifically addressed the question at issue, a reviewing court should not confine itself to examining a particular statutory provision in isolation. The meaning—or ambiguity—of certain words or phrases may only become evident when placed in context. See Brown v. Gardner, 513 U. S. 115, 118 (1994) ("Ambiguity is a creature not of definitional possibilities but of statutory [133] context"). It is a "fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme." Davis v. Michigan Dept. of Treasury, 489 U. S. 803, 809 (1989). A court must therefore interpret the statute "as a symmetrical and coherent regulatory scheme," Gustafson v. Alloyd Co., 513 U. S. 561, 569 (1995), and "fit, if possible, all parts into an harmonious whole," FTC v. Mandel Brothers, Inc., 359 U. S. 385, 389 (1959). Similarly, the meaning of one statute may be affected by other Acts, particularly where Congress has spoken subsequently and more specifically to the topic at hand. See United States v. Estate of Romani, 523 U. S. 517, 530-531 (1998); United States v. Fausto, 484 U. S. 439, 453 (1988). In addition, we must be guided to a degree by common sense as to the manner in which Congress is likely to delegate a policy decision of such economic and political magnitude to an administrative agency. Cf. MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U. S. 218, 231 (1994).

With these principles in mind, we find that Congress has directly spoken to the issue here and precluded the FDA's jurisdiction to regulate tobacco products.

A

Viewing the FDCA as a whole, it is evident that one of the Act's core objectives is to ensure that any product regulated by the FDA is "safe" and "effective" for its intended use. See 21 U. S. C. § 393(b)(2) (1994 ed., Supp. III) (defining the FDA's mission); More Information for Better Patient Care: Hearing before the Senate Committee on Labor and Human Resources, 104th Cong., 2d Sess., 83 (1996) (statement of FDA Deputy Comm'r Schultz) ("A fundamental precept of drug and device regulation in this country is that these products must be proven safe and effective before they can be sold"). This essential purpose pervades the FDCA. For instance, 21 U. S. C. § 393(b)(2) (1994 ed., Supp. III) defines [134] the FDA's "[m]ission" to include "protect[ing] the public health by ensuring that . . . drugsare safe and effective" and that "there is reasonable assurance of the safety and effectiveness of devices intended for human use." The FDCA requires premarket approval of any new drug, with some limited exceptions, and states that the FDA "shall issue an order refusing to approve the application" of a new drug if it is not safe and effective for its intended purpose. §§ 355(d)(1)-(2), (4)-(5). If the FDA discovers after approval that a drug is unsafe or ineffective, it "shall, after due notice and opportunity for hearing to the applicant, withdraw approval" of the drug. 21 U. S. C. §§ 355(e)(1)-(3). The Act also requires the FDA to classify all devices into one of three categories. § 360c(b)(1). Regardless of which category the FDA chooses, there must be a "reasonable assurance of the safety and effectiveness of the device." 21 U. S. C. §§ 360c(a)(1)(A)(i), (B), (C) (1994 ed. and Supp. III); 61 Fed. Reg. 44412 (1996). Even the "restricted device" provision pursuant to which the FDA promulgated the regulations at issue here authorizes the agency to place conditions on the sale or distribution of a device specifically when "there cannot otherwise be reasonable assurance of its safety and effectiveness." 21 U. S. C. § 360j(e). Thus, the Act generally requires the FDA to prevent the marketing of any drug or device where the "potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit." United States v. Rutherford, 442 U. S. 544, 556 (1979).

In its rulemaking proceeding, the FDA quite exhaustively documented that "tobacco products are unsafe," "dangerous," and "cause great pain and suffering from illness." 61 Fed. Reg. 44412 (1996). It found that the consumption of tobacco products presents "extraordinary health risks," and that "tobacco use is the single leading cause of preventable death in the United States." Id., at 44398. It stated that "[m]ore than 400,000 people die each year from tobaccorelated illnesses, such as cancer, respiratory illnesses, and [135] heart disease, often suffering long and painful deaths," and that "[t]obacco alone kills more people each year in the United States than acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides, illegal drugs, suicides, and fires, combined." Ibid. Indeed, the FDA characterized smoking as "a pediatric disease," id., at 44421, because "one out of every three young people who become regular smokers . . . will die prematurely as a result," id., at 44399.

These findings logically imply that, if tobacco products were "devices" under the FDCA, the FDA would be required to remove them from the market. Consider, first, the FDCA's provisions concerning the misbranding of drugs or devices. The Act prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded." 21 U. S. C. § 331(a). In light of the FDA's findings, two distinct FDCA provisions would render cigarettes and smokeless tobacco misbranded devices. First, § 352(j) deems a drug or device misbranded "[i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." The FDA's findings make clear that tobacco products are "dangerous to health" when used in the manner prescribed. Second, a drug or device is misbranded under the Act "[u]nless its labeling bears . . . adequate directions for use . . . in such manner and form, as are necessary for the protection of users," except where such directions are "not necessary for the protection of the public health." § 352(f)(1). Given the FDA's conclusions concerning the health consequences of tobacco use, there are no directions that could adequately protect consumers. That is, there are no directions that could make tobacco products safe for obtaining their intended effects. Thus, were tobacco products within the FDA's jurisdiction, the Act would deem them misbranded devices that could not be introduced into interstate [136] commerce. Contrary to the dissent's contention, the Act admits no remedial discretion once it is evident that the device is misbranded.

Second, the FDCA requires the FDA to place all devices that it regulates into one of three classifications. See § 360c(b)(1). The agency relies on a device's classification in determining the degree of control and regulation necessary to ensure that there is "a reasonable assurance of safety and effectiveness." 61 Fed. Reg. 44412 (1996). The FDA has yet to classify tobacco products. Instead, the regulations at issue here represent so-called "general controls," which the Act entitles the agency to impose in advance of classification. See id., at 44404-44405. Although the FDCA prescribes no deadline for device classification, the FDA has stated that it will classify tobacco products "in a future rulemaking" as required by the Act. Id., at 44412. Given the FDA's findings regarding the health consequences of tobacco use, the agency would have to place cigarettes and smokeless tobacco in Class III because, even after the application of the Act's available controls, they would "presen[t] a potential unreasonable risk of illness or injury." 21 U. S. C. § 360c(a)(1)(C). As Class III devices, tobacco products would be subject to the FDCA's premarket approval process. See 21 U. S. C. § 360c(a)(1)(C) (1994 ed., Supp. III); 21 U. S. C. § 360e; 61 Fed. Reg. 44412 (1996). Under these provisions, the FDA would be prohibited from approving an application for premarket approval without "a showing of reasonable assurance that such device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." 21 U. S. C. § 360e(d)(2)(A). In view of the FDA's conclusions regarding the health effects of tobacco use, the agency would have no basis for finding any such reasonable assurance of safety. Thus, once the FDA fulfilled its statutory obligation to classify tobacco products, it could not allow them to be marketed.

[137] The FDCA's misbranding and device classification provisions therefore make evident that were the FDA to regulate cigarettes and smokeless tobacco, the Act would require the agency to ban them. In fact, based on these provisions, the FDA itself has previously taken the position that if tobacco products were within its jurisdiction, "they would have to be removed from the market because it would be impossible to prove they were safe for their intended us[e]." Public Health Cigarette Amendments of 1971: Hearings before the Commerce Subcommittee on S. 1454, 92d Cong., 2d Sess., 239 (1972) (hereinafter 1972 Hearings) (statement of FDA Comm'r Charles Edwards). See also Cigarette Labeling and Advertising: Hearings before the House Committee on Interstate and Foreign Commerce, 88th Cong., 2d Sess., 18 (1964) (hereinafter 1964 Hearings) (statement of Dept. of Health, Education, and Welfare (HEW) Secretary Anthony Celebrezze that proposed amendments to the FDCA that would have given the FDA jurisdiction over "smoking product[s]" "might well completely outlaw at least cigarettes").

Congress, however, has foreclosed the removal of tobacco products from the market. A provision of the United States Code currently in force states that "[t]he marketing of tobacco constitutes one of the greatest basic industries of the United States with ramifying activities which directly affect interstate and foreign commerce at every point, and stable conditions therein are necessary to the general welfare." 7 U. S. C. § 1311(a). More importantly, Congress has directly addressed the problem of tobacco and health through legislation on six occasions since 1965. See Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. 89-92, 79 Stat. 282; Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222, 84 Stat. 87; Alcohol and Drug Abuse Amendments of 1983, Pub. L. 98-24, 97 Stat. 175; Comprehensive Smoking Education Act, Pub. L. 98-474, 98 Stat. 2200; Comprehensive Smokeless Tobacco Health Education Act of 1986, Pub. L. 99-252, 100 Stat. 30; Alcohol, Drug Abuse, and Mental [138] Health Administration Reorganization Act, Pub. L. 102-321, § 202, 106 Stat. 394. When Congress enacted these statutes, the adverse health consequences of tobacco use were well known, as were nicotine's pharmacological effects. See, e. g., U. S. Dept. of Health, Education, and Welfare, U. S. Surgeon General's Advisory Committee, Smoking and Health 25-40, 69-75 (1964) (hereinafter 1964 Surgeon General's Report) (concluding that cigarette smoking causes lung cancer, coronary artery disease, and chronic bronchitis and emphysema, and that nicotine has various pharmacological effects, including stimulation, tranquilization, and appetite suppression); U. S. Dept. of Health and Human Services, Public Health Service, Health Consequences of Smoking for Women 7-12 (1980) (finding that mortality rates for lung cancer, chronic lung disease, and coronary heart disease are increased for both women and men smokers, and that smoking during pregnancy is associated with significant adverse health effects on the unborn fetus and newborn child); U. S. Dept. of Health and Human Services, Public Health Service, Why People Smoke Cigarettes (1983), in Smoking Prevention Education Act, Hearings on H. R. 1824 before the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, 98th Cong., 1st Sess., 32-37 (1983) (hereinafter 1983 House Hearings) (stating that smoking is "the most widespread example of drug dependence in our country," and that cigarettes "affect the chemistry of the brain and nervous system"); U. S. Dept. of Health and Human Services, Public Health Service, The Health Consequences of Smoking: Nicotine Addiction 6-9, 145-239 (1988) (hereinafter 1988 Surgeon General's Report) (concluding that tobacco products are addicting in much the same way as heroin and cocaine, and that nicotine is the drug that causes addiction). Nonetheless, Congress stopped well short of ordering a ban. Instead, it has generally regulated the labeling and advertisement of tobacco products, expressly providing that it is the policy of Congress that "commerce and the national [139] economy may be . . . protected to the maximum extent consistent with" consumers "be[ing] adequately informed about any adverse health effects." 15 U. S. C. § 1331. Congress' decisions to regulate labeling and advertising and to adopt the express policy of protecting "commerce and the national economy . . . to the maximum extent" reveal its intent that tobacco products remain on the market. Indeed, the collective premise of these statutes is that cigarettes and smokeless tobacco will continue to be sold in the United States. A ban of tobacco products by the FDA would therefore plainly contradict congressional policy.

The FDA apparently recognized this dilemma and concluded, somewhat ironically, that tobacco products are actually "safe" within the meaning of the FDCA. In promulgating its regulations, the agency conceded that "tobacco products are unsafe, as that term is conventionally understood." 61 Fed. Reg. 44412 (1996). Nonetheless, the FDA reasoned that, in determining whether a device is safe under the Act, it must consider "not only the risks presented by a product but also any of the countervailing effects of use of that product, including the consequences of not permitting the product to be marketed." Id., at 44412-44413. Applying this standard, the FDA found that, because of the high level of addiction among tobacco users, a ban would likely be "dangerous." Id., at 44413. In particular, current tobacco users could suffer from extreme withdrawal, the health care system and available pharmaceuticals might not be able to meet the treatment demands of those suffering from withdrawal, and a black market offering cigarettes even more dangerous than those currently sold legally would likely develop. Ibid. The FDA therefore concluded that, "while taking cigarettes and smokeless tobacco off the market could prevent some people from becoming addicted and reduce death and disease for others, the record does not establish that such a ban is the appropriate public health response under the act." Id., at 44398.

[140] It may well be, as the FDA asserts, that "these factors must be considered when developing a regulatory scheme that achieves the best public health result for these products." Id., at 44413. But the FDA's judgment that leaving tobacco products on the market "is more effective in achieving public health goals than a ban," ibid., is no substitute for the specific safety determinations required by the FDCA's various operative provisions. Several provisions in the Act require the FDA to determine that the product itself is safe as used by consumers. That is, the product's probable therapeutic benefits must outweigh its risk of harm. See United States v. Rutherford, 442 U. S., at 555 ("[T]he Commissioner generally considers a drug safe when the expected therapeutic gain justifies the risk entailed by its use"). In contrast, the FDA's conception of safety would allow the agency, with respect to each provision of the FDCA that requires the agency to determine a product's "safety" or "dangerousness," to compare the aggregate health effects of alternative administrative actions. This is a qualitatively different inquiry. Thus, although the FDA has concluded that a ban would be "dangerous," it has not concluded that tobacco products are "safe" as that term is used throughout the Act.

Consider 21 U. S. C. § 360c(a)(2), which specifies those factors that the FDA may consider in determining the safety and effectiveness of a device for purposes of classification, performance standards, and premarket approval. For all devices regulated by the FDA, there must at least be a "reasonable assurance of the safety and effectiveness of the device." See 21 U. S. C. §§ 360c(a)(1)(A)(i), (B), (C) (1994 ed. and Supp. III); 61 Fed. Reg. 44412 (1996). Title 21 U. S. C. § 360c(a)(2) provides that

"the safety and effectiveness of a device are to be determined—

"(A) with respect to the persons for whose use the device is represented or intended,

[141] "(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and

"(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use."

A straightforward reading of this provision dictates that the FDA must weigh the probable therapeutic benefits of the device to the consumer against the probable risk of injury. Applied to tobacco products, the inquiry is whether their purported benefits—satisfying addiction, stimulation and sedation, and weight control—outweigh the risks to health from their use. To accommodate the FDA's conception of safety, however, one must read "any probable benefit to health" to include the benefit to public health stemming from adult consumers' continued use of tobacco products, even though the reduction of tobacco use is the raison d'être of the regulations. In other words, the FDA is forced to contend that the very evil it seeks to combat is a "benefit to health." This is implausible.

The FDA's conception of safety is also incompatible with the FDCA's misbranding provision. Again, § 352(j) provides that a product is "misbranded" if "it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." According to the FDA's understanding, a product would be "dangerous to health," and therefore misbranded under § 352(j), when, in comparison to leaving the product on the market, a ban would not produce "adverse health consequences" in aggregate. Quite simply, these are different inquiries. Although banning a particular product might be detrimental to public health in aggregate, the product could still be "dangerous to health" when used as directed. Section 352(j) focuses on dangers to the consumer from use of the product, not those stemming from the agency's remedial measures.

[142] Consequently, the analogy made by the FDA and the dissent to highly toxic drugs used in the treatment of various cancers is unpersuasive. See 61 Fed. Reg. 44413 (1996); post, at 177 (opinion of Breyer, J.). Although "dangerous" in some sense, these drugs are safe within the meaning of the Act because, for certain patients, the therapeutic benefits outweigh the risk of harm. Accordingly, such drugs cannot properly be described as "dangerous to health" under 21 U. S. C. § 352(j). The same is not true for tobacco products. As the FDA has documented in great detail, cigarettes and smokeless tobacco are an unsafe means to obtaining any pharmacological effect.

The dissent contends that our conclusion means that "the FDCA requires the FDA to ban outright `dangerous' drugs or devices," post, at 174, and that this is a "perverse" reading of the statute, post, at 174, 180. This misunderstands our holding. The FDA, consistent with the FDCA, may clearly regulate many "dangerous" products without banning them. Indeed, virtually every drug or device poses dangers under certain conditions. What the FDA may not do is conclude that a drug or device cannot be used safely for any therapeutic purpose and yet, at the same time, allow that product to remain on the market. Such regulation is incompatible with the FDCA's core objective of ensuring that every drug or device is safe and effective.

Considering the FDCA as a whole, it is clear that Congress intended to exclude tobacco products from the FDA's jurisdiction. A fundamental precept of the FDCA is that any product regulated by the FDA—but not banned—must be safe for its intended use. Various provisions of the Act make clear that this refers to the safety of using the product to obtain its intended effects, not the public health ramifications of alternative administrative actions by the FDA. That is, the FDA must determine that there is a reasonable assurance that the product's therapeutic benefits outweigh the risk of harm to the consumer. According to this standard, [143] the FDA has concluded that, although tobacco products might be effective in delivering certain pharmacological effects, they are "unsafe" and "dangerous" when used for these purposes. Consequently, if tobacco products were within the FDA's jurisdiction, the Act would require the FDA to remove them from the market entirely. But a ban would contradict Congress' clear intent as expressed in its more recent, tobacco-specific legislation. The inescapable conclusion is that there is no room for tobacco products within the FDCA's regulatory scheme. If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit.

B

In determining whether Congress has spoken directly to the FDA's authority to regulate tobacco, we must also consider in greater detail the tobacco-specific legislation that Congress has enacted over the past 35 years. At the time a statute is enacted, it may have a range of plausible meanings. Over time, however, subsequent acts can shape or focus those meanings. The "classic judicial task of reconciling many laws enacted over time, and getting them to `make sense' in combination, necessarily assumes that the implications of a statute may be altered by the implications of a later statute." United States v. Fausto, 484 U. S., at 453. This is particularly so where the scope of the earlier statute is broad but the subsequent statutes more specifically address the topic at hand. As we recognized recently in United States v. Estate of Romani, "a specific policy embodied in a later federal statute should control our construction of the [earlier] statute, even though it ha[s] not been expressly amended." 523 U. S., at 530-531.

Congress has enacted six separate pieces of legislation since 1965 addressing the problem of tobacco use and human health. See supra, at 137-138. Those statutes, among other things, require that health warnings appear on all packaging and in all print and outdoor advertisements, see [144] 15 U. S. C. §§ 1331, 1333, 4402; prohibit the advertisement of tobacco products through "any medium of electronic communication" subject to regulation by the Federal Communications Commission (FCC), see §§ 1335, 4402(f); require the Secretary of HHS to report every three years to Congress on research findings concerning "the addictive property of tobacco," 42 U. S. C. § 290aa—2(b)(2); and make States' receipt of certain federal block grants contingent on their making it unlawful "for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18," § 300x—26(a)(1).

In adopting each statute, Congress has acted against the backdrop of the FDA's consistent and repeated statements that it lacked authority under the FDCA to regulate tobacco absent claims of therapeutic benefit by the manufacturer. In fact, on several occasions over this period, and after the health consequences of tobacco use and nicotine's pharmacological effects had become well known, Congress considered and rejected bills that would have granted the FDA such jurisdiction. Under these circumstances, it is evident that Congress' tobacco-specific statutes have effectively ratified the FDA's long-held position that it lacks jurisdiction under the FDCA to regulate tobacco products. Congress has created a distinct regulatory scheme to address the problem of tobacco and health, and that scheme, as presently constructed, precludes any role for the FDA.

On January 11, 1964, the Surgeon General released the report of the Advisory Committee on Smoking and Health. That report documented the deleterious health effects of smoking in great detail, concluding, in relevant part, "that cigarette smoking contributes substantially to mortality from certain specific diseases and to the overall death rate." 1964 Surgeon General's Report 31. It also identified the pharmacological effects of nicotine, including "stimulation," "tranquilization," and "suppression of appetite." Id., at 74-75. Seven days after the report's release, the Federal Trade [145] Commission (FTC) issued a notice of proposed rulemaking, see 29 Fed. Reg. 530-532 (1964), and in June 1964, the FTC promulgated a final rule requiring cigarette manufacturers "to disclose, clearly and prominently, in all advertising and on every pack, box, carton or other container . . . that cigarette smoking is dangerous to health and may cause death from cancer and other diseases," id., at 8325. The rule was to become effective January 1, 1965, but, on a request from Congress, the FTC postponed enforcement for six months. See Cipollone v. Liggett Group, Inc., 505 U. S. 504, 513-514 (1992).

In response to the Surgeon General's report and the FTC's proposed rule, Congress convened hearings to consider legislation addressing "the tobacco problem." 1964 Hearings 1. During those deliberations, FDA representatives testified before Congress that the agency lacked jurisdiction under the FDCA to regulate tobacco products. Surgeon General Terry was asked during hearings in 1964 whether HEW had the "authority to brand or label the packages of cigarettes or to control the advertising there." Id., at 56. The Surgeon General stated that "we do not have such authority in existing laws governing the . . . Food and Drug Administration." Ibid. Similarly, FDA Deputy Commissioner Rankin testified in 1965 that "[t]he Food and Drug Administration has no jurisdiction under the Food, Drug, and Cosmetic Act over tobacco, unless it bears drug claims." Cigarette Labeling and Advertising—1965: Hearings on H. R. 2248 before the House Committee on Interstate and Foreign Commerce, 89th Cong., 1st Sess., 193 (hereinafter 1965 Hearings). See also Letter to Directors of Bureaus, Divisions and Directors of Districts from FDA Bureau of Enforcement (May 24, 1963), in 1972 Hearings 240 ("[T]obacco marketed for chewing or smoking without accompanying therapeutic claims, does not meet the definitions in the Food, Drug, and Cosmetic Act for food, drug, device or cosmetic"). In fact, HEW Secretary Celebrezze urged Congress not to amend the FDCA to cover [146] "smoking products" because, in light of the findings in the Surgeon General's report, such a "provision might well completely outlaw at least cigarettes. This would be contrary to what, we understand, is intended or what, in the light of our experience with the 18th amendment, would be acceptable to the American people." 1964 Hearings 18.

The FDA's disavowal of jurisdiction was consistent with the position that it had taken since the agency's inception. As the FDA concedes, it never asserted authority to regulate tobacco products as customarily marketed until it promulgated the regulations at issue here. See Brief for Petitioners 37; see also Brief for Appellee (FDA) in Action on Smoking and Health v. Harris, 655 F. 2d 236 (CADC 1980), in 9 Rec. in No. 97-1604 (CA4), Tab No. 4, pp. 14-15 ("In the 73 years since the enactment of the original Food and Drug Act, and in the 41 years since the promulgation of the modern Food, Drug, and Cosmetic Act, the FDA has repeatedly informed Congress that cigarettes are beyond the scope of the statute absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor").

The FDA's position was also consistent with Congress' specific intent when it enacted the FDCA. Before the Act's adoption in 1938, the FDA's predecessor agency, the Bureau of Chemistry, announced that it lacked authority to regulate tobacco products under the Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768, unless they were marketed with therapeutic claims. See U. S. Dept. of Agriculture, Bureau of Chemistry, 13 Service and Regulatory Announcements 24 (Apr. 1914) (Feb. 1914 Announcements ¶ 13, Opinion of Chief of Bureau C. L. Alsberg). In 1929, Congress considered and rejected a bill "[t]o amend the Food and Drugs Act of June 30, 1906, by extending its provisions to tobacco and tobacco products." S. 1468, 71st Cong., 1st Sess., 1. See also 71 Cong. Rec. 2589 (1929) (remarks of Sen. Smoot). And, as the FDA admits, there is no evidence in the text of the FDCA or its legislative history that Congress in 1938 even considered [147] the applicability of the Act to tobacco products. See Brief for Petitioners 22, n. 4. Given the economic and political significance of the tobacco industry at the time, it is extremely unlikely that Congress could have intended to place tobacco within the ambit of the FDCA absent any discussion of the matter. Of course, whether the Congress that enacted the FDCA specifically intended the Act to cover tobacco products is not determinative; "it is ultimately the provisions of our laws rather than the principal concerns of our legislators by which we are governed." Oncale v. Sundowner Offshore Services, Inc., 523 U. S. 75, 79 (1998); see also TVA v. Hill, 437 U. S. 153, 185 (1978) ("It is not for us to speculate, much less act, on whether Congress would have altered its stance had the specific events of this case been anticipated"). Nonetheless, this intent is certainly relevant to understanding the basis for the FDA's representations to Congress and the background against which Congress enacted subsequent tobacco-specific legislation.

Moreover, before enacting the FCLAA in 1965, Congress considered and rejected several proposals to give the FDA the authority to regulate tobacco. In April 1963, Representative Udall introduced a bill "[t]o amend the Federal Food, Drug, and Cosmetic Act so as to make that Act applicable to smoking products." H. R. 5973, 88th Cong., 1st Sess., 1. Two months later, Senator Moss introduced an identical bill in the Senate. S. 1682, 88th Cong., 1st Sess. (1963). In discussing his proposal on the Senate floor, Senator Moss explained that "this amendment simply places smoking products under FDA jurisdiction, along with foods, drugs, and cosmetics." 109 Cong. Rec. 10322 (1963). In December 1963, Representative Rhodes introduced another bill that would have amended the FDCA "by striking out `food, drug, device, or cosmetic, each place where it appears therein and inserting in lieu thereof `food, drug, device, cosmetic, or smoking product.' " H. R. 9512, 88th Cong., 1st Sess., § 3 (1963). And in January 1965, five months before passage of [148] the FCLAA, Representative Udall again introduced a bill to amend the FDCA "to make that Act applicable to smoking products." H. R. 2248, 89th Cong., 1st Sess., 1. None of these proposals became law.

Congress ultimately decided in 1965 to subject tobacco products to the less extensive regulatory scheme of the FCLAA, which created a "comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health." Pub. L. 89-92, § 2, 79 Stat. 282. The FCLAA rejected any regulation of advertising, but it required the warning, "Caution: Cigarette Smoking May Be Hazardous to Your Health," to appear on all cigarette packages. Id., § 4, 79 Stat. 283. In the FCLAA's "Declaration of Policy," Congress stated that its objective was to balance the goals of ensuring that "the public may be adequately informed that cigarette smoking may be hazardous to health" and protecting "commerce and the national economy . . . to the maximum extent." Id., § 2, 79 Stat. 282 (codified at 15 U. S. C. § 1331).

Not only did Congress reject the proposals to grant the FDA jurisdiction, but it explicitly pre-empted any other regulation of cigarette labeling: "No statement relating to smoking and health, other than the statement required by . . . this Act, shall be required on any cigarette package." Pub. L. 89-92, § 5(a), 79 Stat. 283. The regulation of product labeling, however, is an integral aspect of the FDCA, both as it existed in 1965 and today. The labeling requirements currently imposed by the FDCA, which are essentially identical to those in force in 1965, require the FDA to regulate the labeling of drugs and devices to protect the safety of consumers. See 21 U. S. C. § 352; 21 U. S. C. § 352 (1964 ed. and Supp. IV). As discussed earlier, the Act requires that all products bear "adequate directions for use . . . as are necessary for the protection of users," 21 U. S. C. § 352(f)(1); 21 U. S. C. § 352(f)(1) (1964 ed.); requires that all products provide "adequate warnings against use in those pathological [149] conditions or by children where its use may be dangerous to health," 21 U. S. C. § 352(f)(2); 21 U. S. C. § 352(f)(2) (1964 ed.); and deems a product misbranded "[i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof," 21 U. S. C. § 352(j); 21 U. S. C. § 352(j) (1964 ed.). In this sense, the FCLAA was—and remains—incompatible with FDA regulation of tobacco products. This is not to say that the FCLAA's pre-emption provision by itself necessarily foreclosed FDA jurisdiction. See Cipollone v. Liggett Group, Inc., 505 U. S., at 518-519. But it is an important factor in assessing whether Congress ratified the agency's position—that is, whether Congress adopted a regulatory approach to the problem of tobacco and health that contemplated no role for the FDA.

Further, the FCLAA evidences Congress' intent to preclude any administrative agency from exercising significant policymaking authority on the subject of smoking and health. In addition to prohibiting any additional requirements for cigarette labeling, the FCLAA provided that "[n]o statement relating to smoking and health shall be required in the advertising of any cigarettes the packages of which are labeled in conformity with the provisions of this Act." Pub. L. 89-92, § 5(b), 79 Stat. 283. Thus, in reaction to the FTC's attempt to regulate cigarette labeling and advertising, Congress enacted a statute reserving exclusive control over both subjects to itself.

Subsequent tobacco-specific legislation followed a similar pattern. By the FCLAA's own terms, the prohibition on any additional cigarette labeling or advertising regulations relating to smoking and health was to expire July 1, 1969. See § 10, 79 Stat. 284. In anticipation of the provision's expiration, both the FCC and the FTC proposed rules governing the advertisement of cigarettes. See 34 Fed. Reg. 1959 (1969) (FCC proposed rule to "ban the broadcast of cigarette commercials by radio and television stations"); id., at 7917 [150] (FTC proposed rule requiring manufacturers to disclose on all packaging and in all print advertising "`that cigarette smoking is dangerous to health and may cause death from cancer, coronary heart disease, chronic bronchitis, pulmonary emphysema, and other diseases' "). After debating the proper role for administrative agencies in the regulation of tobacco, see generally Cigarette Labeling and Advertising— 1969: Hearings before the House Committee on Interstate and Foreign Commerce, 91st Cong., 1st Sess., pt. 2 (1969), Congress amended the FCLAA by banning cigarette advertisements "on any medium of electronic communication subject to the jurisdiction of the Federal Communications Commission" and strengthening the warning required to appear on cigarette packages. Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222, §§ 4, 6, 84 Stat. 88-89. Importantly, Congress extended indefinitely the prohibition on any other regulation of cigarette labeling with respect to smoking and health (again despite the importance of labeling regulation under the FDCA). § 5(a), 84 Stat. 88 (codified at 15 U. S. C. § 1334(a)). Moreover, it expressly forbade the FTC from taking any action on its pending rule until July 1, 1971, and it required the FTC, if it decided to proceed with its rule thereafter, to notify Congress at least six months in advance of the rule's becoming effective. § 7(a), 84 Stat. 89. As the chairman of the House committee in which the bill originated stated, "the Congress—the body elected by the people— must make the policy determinations involved in this legislation—and not some agency made up of appointed officials." 116 Cong. Rec. 7920 (1970) (remarks of Rep. Staggers).

Four years later, after Congress had transferred the authority to regulate substances covered by the Hazardous Substances Act (HSA) from the FDA to the Consumer Products Safety Commission (CPSC), the American Public Health Association, joined by Senator Moss, petitioned the CPSC to regulate cigarettes yielding more than 21 milligrams of tar. See Action on Smoking and Health v. Harris, 655 F. 2d 236, [151] 241 (CADC 1980); R. Kluger, Ashes to Ashes 375-376 (1996). After the CPSC determined that it lacked authority under the HSA to regulate cigarettes, a District Court held that the HSA did, in fact, grant the CPSC such jurisdiction and ordered it to reexamine the petition. See American Public Health Association v. Consumer Product Safety Commission, [1972-1975 Transfer Binder] CCH Consumer Prod. Safety Guide ¶ 75,081 (DC 1975), vacated as moot, No. 75-1863 (CADC 1976). Before the CPSC could take any action, however, Congress mooted the issue by adopting legislation that eliminated the agency's authority to regulate "tobacco and tobacco products." Consumer Product Safety Commission Improvements Act of 1976, Pub. L. 94-284, § 3(c), 90 Stat. 503 (codified at 15 U. S. C. § 1261(f)(2)). Senator Moss acknowledged that the "legislation, in effect, reverse[d]" the District Court's decision, 121 Cong. Rec. 23563 (1975), and the FDA later observed that the episode was "particularly" "indicative of the policy of Congress to limit the regulatory authority over cigarettes by Federal Agencies," Letter to Action on Smoking and Health (ASH) Executive Director Banzhaf from FDA Comm'r Goyan (Nov. 25, 1980), App. 59. A separate statement in the Senate Report underscored that the legislation's purpose was to "unmistakably reaffirm the clear mandate of the Congress that the basic regulation of tobacco and tobacco products is governed by the legislation dealing with the subject, . . . and that any further regulation in this sensitive and complex area must be reserved for specific Congressional action." S. Rep. No. 94-251, p. 43 (1975) (additional views of Sens. Hartke, Hollings, Ford, Stevens, and Beall).

Meanwhile, the FDA continued to maintain that it lacked jurisdiction under the FDCA to regulate tobacco products as customarily marketed. In 1972, FDA Commissioner Edwards testified before Congress that "cigarettes recommended for smoking pleasure are beyond the Federal Food, Drug, and Cosmetic Act." 1972 Hearings 239, 242. He further [152] stated that the FDA believed that the Public Health Cigarette Smoking Act "demonstrates that the regulation of cigarettes is to be the domain of Congress," and that "labeling or banning cigarettes is a step that can be take[n] only by the Congress. Any such move by FDA would be inconsistent with the clear congressional intent." Ibid.

In 1977, ASH filed a citizen petition requesting that the FDA regulate cigarettes, citing many of the same grounds that motivated the FDA's rulemaking here. See Citizen Petition, No. 77P-0185 (May 26, 1977), 10 Rec. in No. 97-1604 (CA4), Tab No. 22, pp. 1-10. ASH asserted that nicotine was highly addictive and had strong physiological effects on the body; that those effects were "intended" because consumers use tobacco products precisely to obtain those effects; and that tobacco causes thousands of premature deaths annually. Ibid. In denying ASH's petition, FDA Commissioner Kennedy stated that "[t]he interpretation of the Act by FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors." Letter to ASH Executive Director Banzhaf (Dec. 5, 1977), App. 47. After the matter proceeded to litigation, the FDA argued in its brief to the Court of Appeals that "cigarettes are not comprehended within the statutory definition of the term `drug' absent objective evidence that vendors represent or intend that their products be used as a drug." Brief for Appellee in Action on Smoking and Health v. Harris, 655 F. 2d 236 (CADC 1980), 9 Rec. in No. 97-1604 (CA4), Tab No. 4, at 27-28. The FDA also contended that Congress had "long been aware that the FDA does not consider cigarettes to be within its regulatory authority in the absence of health claims made on behalf of the manufacturer or vendor," and that, because "Congress has never acted to disturb the agency's interpretation," it had "acquiesced in the FDA's interpretation of the statutory limits on its authority to regulate cigarettes." Id., at 23, 27, n. 23. The Court of Appeals upheld the FDA's position, concluding that "[i]f the statute [153] requires expansion, that is the job of Congress." Action on Smoking and Health v. Harris, 655 F. 2d, at 243. In 1980, the FDA also denied a request by ASH to commence rulemaking proceedings to establish the agency's jurisdiction to regulate cigarettes as devices. See Letter to ASH Executive Director Banzhaf from FDA Comm'r Goyan (Nov. 25, 1980), App. 50-51. The agency stated that "[i]nsofar as rulemaking would relate to cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction under section 201(h) of the Act [21 U. S. C. § 321(h)]." Id., at 67.

In 1983, Congress again considered legislation on the subject of smoking and health. HHS Assistant Secretary Brandt testified that, in addition to being "a major cause of cancer," smoking is a "major cause of heart disease" and other serious illnesses, and can result in "unfavorable pregnancy outcomes." 1983 House Hearings 19-20. He also stated that it was "well-established that cigarette smoking is a drug dependence, and that smoking is addictive for many people." Id., at 20. Nonetheless, Assistant Secretary Brandt maintained that "the issue of regulation of tobacco . . . is something that Congress has reserved to itself, and we do not within the Department have the authority to regulate nor are we seeking such authority." Id., at 74. He also testified before the Senate, stating that, despite the evidence of tobacco's health effects and addictiveness, the Department's view was that "Congress has assumed the responsibility of regulating . . . cigarettes." Smoking Prevention and Education Act: Hearings on S. 772 before the Senate Committee on Labor and Human Resources, 98th Cong., 1st Sess., 56 (1983) (hereinafter 1983 Senate Hearings).

Against this backdrop, Congress enacted three additional tobacco-specific statutes over the next four years that incrementally expanded its regulatory scheme for tobacco products. In 1983, Congress adopted the Alcohol and Drug Abuse Amendments, Pub. L. 98-24, 97 Stat. 175 (codified at [154] 42 U. S. C. § 290aa et seq. ), which require the Secretary of HHS to report to Congress every three years on the "addictive property of tobacco" and to include recommendations for action that the Secretary may deem appropriate. A year later, Congress enacted the Comprehensive Smoking Education Act, Pub. L. 98-474, 98 Stat. 2200, which amended the FCLAA by again modifying the prescribed warning. Notably, during debate on the Senate floor, Senator Hawkins argued that the FCLAA was necessary in part because "[u]nder the Food, Drug and Cosmetic Act, the Congress exempted tobacco products." 130 Cong. Rec. 26953 (1984). And in 1986, Congress enacted the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA), Pub. L. 99-252, 100 Stat. 30 (codified at 15 U. S. C. § 4401 et seq. ), which essentially extended the regulatory provisions of the FCLAA to smokeless tobacco products. Like the FCLAA, the CSTHEA provided that "[n]o statement relating to the use of smokeless tobacco products and health, other than the statements required by [the Act], shall be required by any Federal agency to appear on any package . . . of a smokeless tobacco product." § 7(a), 100 Stat. 34 (codified at 15 U. S. C. § 4406(a)). Thus, as with cigarettes, Congress reserved for itself an aspect of smokeless tobacco regulation that is particularly important to the FDCA's regulatory scheme.

In 1988, the Surgeon General released a report summarizing the abundant scientific literature demonstrating that "[c]igarettes and other forms of tobacco are addicting," and that "nicotine is psychoactive" and "causes physical dependence characterized by a withdrawal syndrome that usually accompanies nicotine abstinence." 1988 Surgeon General's Report 14. The report further concluded that the "pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine." Id., at 15. In the same year, FDA Commissioner Young stated before Congress that "it doesn't look like it is possible to regulate [tobacco] under the [155] Food, Drug and Cosmetic Act even though smoking, I think, has been widely recognized as being harmful to human health." Rural Development, Agriculture, and Related Agencies Appropriations for 1989: Hearings before a Subcommittee of the House Committee on Appropriations, 100th Cong., 2d Sess., 409 (1988). At the same hearing, the FDA's General Counsel testified that "what is fairly important in FDA law is whether a product has a therapeutic purpose," and "[c]igarettes themselves are not used for a therapeutic purpose as that concept is ordinarily understood." Id., at 410. Between 1987 and 1989, Congress considered three more bills that would have amended the FDCA to grant the FDA jurisdiction to regulate tobacco products. See H. R. 3294, 100th Cong., 1st Sess. (1987); H. R. 1494, 101st Cong., 1st Sess. (1989); S. 769, 101st Cong., 1st Sess. (1989). As before, Congress rejected the proposals. In 1992, Congress instead adopted the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act, Pub. L. 102-321, § 202, 106 Stat. 394 (codified at 42 U. S. C. § 300x et seq. ), which creates incentives for States to regulate the retail sale of tobacco products by making States' receipt of certain block grants contingent on their prohibiting the sale of tobacco products to minors.

Taken together, these actions by Congress over the past 35 years preclude an interpretation of the FDCA that grants the FDA jurisdiction to regulate tobacco products. We do not rely on Congress' failure to act—its consideration and rejection of bills that would have given the FDA this authority—in reaching this conclusion. Indeed, this is not a case of simple inaction by Congress that purportedly represents its acquiescence in an agency's position. To the contrary, Congress has enacted several statutes addressing the particular subject of tobacco and health, creating a distinct regulatory scheme for cigarettes and smokeless tobacco. In doing so, Congress has been aware of tobacco's health hazards and its pharmacological effects. It has also enacted this legislation [156] against the background of the FDA repeatedly and consistently asserting that it lacks jurisdiction under the FDCA to regulate tobacco products as customarily marketed. Further, Congress has persistently acted to preclude a meaningful role for any administrative agency in making policy on the subject of tobacco and health. Moreover, the substance of Congress' regulatory scheme is, in an important respect, incompatible with FDA jurisdiction. Although the supervision of product labeling to protect consumer health is a substantial component of the FDA's regulation of drugs and devices, see 21 U. S. C. § 352 (1994 ed. and Supp. III), the FCLAA and the CSTHEA explicitly prohibit any federal agency from imposing any health-related labeling requirements on cigarettes or smokeless tobacco products, see 15 U. S. C. §§ 1334(a), 4406(a).

Under these circumstances, it is clear that Congress' tobacco-specific legislation has effectively ratified the FDA's previous position that it lacks jurisdiction to regulate tobacco. As in Bob Jones Univ. v. United States, 461 U. S. 574 (1983), "[i]t is hardly conceivable that Congress—and in this setting, any Member of Congress—was not abundantly aware of what was going on." Id., at 600-601. Congress has affirmatively acted to address the issue of tobacco and health, relying on the representations of the FDA that it had no authority to regulate tobacco. It has created a distinct scheme to regulate the sale of tobacco products, focused on labeling and advertising, and premised on the belief that the FDA lacks such jurisdiction under the FDCA. As a result, Congress' tobacco-specific statutes preclude the FDA from regulating tobacco products as customarily marketed.

Although the dissent takes issue with our discussion of the FDA's change in position, post, at 186-189, our conclusion does not rely on the fact that the FDA's assertion of jurisdiction represents a sharp break with its prior interpretation of the FDCA. Certainly, an agency's initial interpretation of a statute that it is charged with administering is not "carved [157] in stone." Chevron, 467 U. S., at 863; see also Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735, 742 (1996). As we recognized in Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29 (1983), agencies "must be given ample latitude to `adapt their rules and policies to the demands of changing circumstances.' " Id., at 42 (quoting Permian Basin Area Rate Cases, 390 U. S. 747, 784 (1968)). The consistency of the FDA's prior position is significant in this case for a different reason: It provides important context to Congress' enactment of its tobacco-specific legislation. When the FDA repeatedly informed Congress that the FDCA does not grant it the authority to regulate tobacco products, its statements were consistent with the agency's unwavering position since its inception, and with the position that its predecessor agency had first taken in 1914. Although not crucial, the consistency of the FDA's prior position bolsters the conclusion that when Congress created a distinct regulatory scheme addressing the subject of tobacco and health, it understood that the FDA is without jurisdiction to regulate tobacco products and ratified that position.

The dissent also argues that the proper inference to be drawn from Congress' tobacco-specific legislation is "critically ambivalent." Post, at 182. We disagree. In that series of statutes, Congress crafted a specific legislative response to the problem of tobacco and health, and it did so with the understanding, based on repeated assertions by the FDA, that the agency has no authority under the FDCA to regulate tobacco products. Moreover, Congress expressly pre-empted any other regulation of the labeling of tobacco products concerning their health consequences, even though the oversight of labeling is central to the FDCA's regulatory scheme. And in addressing the subject, Congress consistently evidenced its intent to preclude any federal agency from exercising significant policymaking authority in the area. Under these circumstances, we believe the appropriate [158] inference—that Congress intended to ratify the FDA's prior position that it lacks jurisdiction—is unmistakable.

The dissent alternatively argues that, even if Congress' subsequent tobacco-specific legislation did, in fact, ratify the FDA's position, that position was merely a contingent disavowal of jurisdiction. Specifically, the dissent contends that "the FDA's traditional view was largely premised on a perceived inability to prove the necessary statutory `intent' requirement." Post, at 189-190. A fair reading of the FDA's representations prior to 1995, however, demonstrates that the agency's position was essentially unconditional. See, e. g., 1972 Hearings 239, 242 (statement of Comm'r Edwards) ("[R]egulation of cigarettes is to be the domain of Congress," and "[a]ny such move by FDA would be inconsistent with the clear congressional intent"); 1983 House Hearings 74 (statement of Assistant Secretary Brandt) ("[T]he issue of regulation of tobacco . . . is something that Congress has reserved to itself"); 1983 Senate Hearings 56 (statement of Assistant Secretary Brandt) ("Congress has assumed the responsibility of regulating . . . cigarettes"); Brief for Appellee in Action on Smoking and Health v. Harris, 655 F. 2d 236 (CADC 1980), 9 Rec. in No. 97-1604 (CA4), Tab No. 4, at 27, n. 23 (because "Congress has never acted to disturb the agency's interpretation," it "acquiesced in the FDA's interpretation"). To the extent the agency's position could be characterized as equivocal, it was only with respect to the well-established exception of when the manufacturer makes express claims of therapeutic benefit. See, e. g., 1965 Hearings 193 (statement of Deputy Comm'r Rankin) ("The Food and Drug Administration has no jurisdiction under the Food, Drug, and Cosmetic Act over tobacco, unless it bears drug claims"); Letter to ASH Executive Director Banzhaf from FDA Comm'r Kennedy (Dec. 5, 1977), App. 47 ("The interpretation of the Act by FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors"); Letter to ASH Executive Director Banzhaf from [159] FDA Comm'r Goyan (Nov. 25, 1980), id., at 67 ("Insofar as rulemaking would relate to cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction"). Thus, what Congress ratified was the FDA's plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed.

C

Finally, our inquiry into whether Congress has directly spoken to the precise question at issue is shaped, at least in some measure, by the nature of the question presented. Deference under Chevron to an agency's construction of a statute that it administers is premised on the theory that a statute's ambiguity constitutes an implicit delegation from Congress to the agency to fill in the statutory gaps. See Chevron, supra, at 844. In extraordinary cases, however, there may be reason to hesitate before concluding that Congress has intended such an implicit delegation. Cf. Breyer, Judicial Review of Questions of Law and Policy, 38 Admin. L. Rev. 363, 370 (1986) ("A court may also ask whether the legal question is an important one. Congress is more likely to have focused upon, and answered, major questions, while leaving interstitial matters to answer themselves in the course of the statute's daily administration").

This is hardly an ordinary case. Contrary to its representations to Congress since 1914, the FDA has now asserted jurisdiction to regulate an industry constituting a significant portion of the American economy. In fact, the FDA contends that, were it to determine that tobacco products provide no "reasonable assurance of safety," it would have the authority to ban cigarettes and smokeless tobacco entirely. See Brief for Petitioners 35-36; Reply Brief for Petitioners 14. Owing to its unique place in American history and society, tobacco has its own unique political history. Congress, for better or for worse, has created a distinct regulatory scheme for tobacco products, squarely rejected proposals to [160] give the FDA jurisdiction over tobacco, and repeatedly acted to preclude any agency from exercising significant policymaking authority in the area. Given this history and the breadth of the authority that the FDA has asserted, we are obliged to defer not to the agency's expansive construction of the statute, but to Congress' consistent judgment to deny the FDA this power.

Our decision in MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U. S. 218 (1994), is instructive. That case involved the proper construction of the term "modify" in § 203(b) of the Communications Act of 1934. The FCC contended that, because the Act gave it the discretion to "modify any requirement" imposed under the statute, it therefore possessed the authority to render voluntary the otherwise mandatory requirement that long distance carriers file their rates. Id., at 225. We rejected the FCC's construction, finding "not the slightest doubt" that Congress had directly spoken to the question. Id., at 228. In reasoning even more apt here, we concluded that "[i]t is highly unlikely that Congress would leave the determination of whether an industry will be entirely, or even substantially, rateregulated to agency discretion—and even more unlikely that it would achieve that through such a subtle device as permission to `modify' rate-filing requirements." Id., at 231.

As in MCI, we are confident that Congress could not have intended to delegate a decision of such economic and political significance to an agency in so cryptic a fashion. To find that the FDA has the authority to regulate tobacco products, one must not only adopt an extremely strained understanding of "safety" as it is used throughout the Act—a concept central to the FDCA's regulatory scheme—but also ignore the plain implication of Congress' subsequent tobaccospecific legislation. It is therefore clear, based on the FDCA's overall regulatory scheme and the subsequent tobacco legislation, that Congress has directly spoken to the [161] question at issue and precluded the FDA from regulating tobacco products.

* * *

By no means do we question the seriousness of the problem that the FDA has sought to address. The agency has amply demonstrated that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States. Nonetheless, no matter how "important, conspicuous, and controversial" the issue, and regardless of how likely the public is to hold the Executive Branch politically accountable, post, at 190, an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress. And "`[i]n our anxiety to effectuate the congressional purpose of protecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop.' " United States v. Article of Drug . . . Bacto-Unidisk, 394 U. S. 784, 800 (1969) (quoting 62 Cases of Jam v. United States, 340 U. S. 593, 600 (1951)). Reading the FDCA as a whole, as well as in conjunction with Congress' subsequent tobaccospecific legislation, it is plain that Congress has not given the FDA the authority that it seeks to exercise here. For these reasons, the judgment of the Court of Appeals for the Fourth Circuit is affirmed.

It is so ordered.

Justice Breyer, with whom Justice Stevens, Justice Souter, and Justice Ginsburg join, dissenting.

The Food and Drug Administration (FDA) has the authority to regulate "articles (other than food) intended to affect the structure or any function of the body . . . ." Federal Food, Drug, and Cosmetic Act (FDCA), 21 U. S. C. § 321(g)(1)(C). Unlike the majority, I believe that tobacco products fit within this statutory language.

[162] In its own interpretation, the majority nowhere denies the following two salient points. First, tobacco products (including cigarettes) fall within the scope of this statutory definition, read literally. Cigarettes achieve their moodstabilizing effects through the interaction of the chemical nicotine and the cells of the central nervous system. Both cigarette manufacturers and smokers alike know of, and desire, that chemically induced result. Hence, cigarettes are "intended to affect" the body's "structure" and "function," in the literal sense of these words.

Second, the statute's basic purpose—the protection of public health—supports the inclusion of cigarettes within its scope. See United States v. Article of Drug . . . BactoUnidisk, 394 U. S. 784, 798 (1969) (FDCA "is to be given a liberal construction consistent with [its] overriding purpose to protect the public health " (emphasis added)). Unregulated tobacco use causes "[m]ore than 400,000 people [to] die each year from tobacco-related illnesses, such as cancer, respiratory illnesses, and heart disease." 61 Fed. Reg. 44398 (1996). Indeed, tobacco products kill more people in this country every year "than . . . AIDS . . . , car accidents, alcohol, homicides, illegal drugs, suicides, and fires, combined. " Ibid. (emphasis added).

Despite the FDCA's literal language and general purpose (both of which support the FDA's finding that cigarettes come within its statutory authority), the majority nonetheless reads the statute as excluding tobacco products for two basic reasons:

(1) the FDCA does not "fit" the case of tobacco because the statute requires the FDA to prohibit dangerous drugs or devices (like cigarettes) outright, and the agency concedes that simply banning the sale of cigarettes is not a proper remedy, ante, at 139-141; and (2) Congress has enacted other statutes, which, when viewed in light of the FDA's long history of denying [163] tobacco-related jurisdiction and considered together with Congress' failure explicitly to grant the agency tobacco-specific authority, demonstrate that Congress did not intend for the FDA to exercise jurisdiction over tobacco, ante, at 155-156.

In my view, neither of these propositions is valid. Rather, the FDCA does not significantly limit the FDA's remedial alternatives. See infra, at 174-181. And the later statutes do not tell the FDA it cannot exercise jurisdiction, but simply leave FDA jurisdictional law where Congress found it. See infra, at 181-186; cf. Food and Drug Administration Modernization Act of 1997, 111 Stat. 2380 (codified at note following 21 U. S. C. § 321 (1994 ed., Supp. III)) (statute "shall" not "be construed to affect the question of whether" the FDA "has any authority to regulate any tobacco product").

The bulk of the opinion that follows will explain the basis for these latter conclusions. In short, I believe that the most important indicia of statutory meaning—language and purpose—along with the FDCA's legislative history (described briefly in Part I) are sufficient to establish that the FDA has authority to regulate tobacco. The statute-specific arguments against jurisdiction that the tobacco companies and the majority rely upon (discussed in Part II) are based on erroneous assumptions and, thus, do not defeat the jurisdiction-supporting thrust of the FDCA's language and purpose. The inferences that the majority draws from later legislative history are not persuasive, since (as I point out in Part III) one can just as easily infer from the later laws that Congress did not intend to affect the FDA's tobacco-related authority at all. And the fact that the FDA changed its mind about the scope of its own jurisdiction is legally insignificant because (as Part IV establishes) the agency's reasons for changing course are fully justified. Finally, as I explain in Part V, the degree of accountability that likely will attach to the FDA's action in this case should alleviate any concern [164] that Congress, rather than an administrative agency, ought to make this important regulatory decision.

I

Before 1938, the federal Pure Food and Drug Act contained only two jurisdictional definitions of "drug":

"[1] medicines and preparations recognized in the United States Pharmacopoeia or National Formulary . . . and [2] any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease." Act of June 30, 1906, ch. 3915, § 6, 34 Stat. 769.

In 1938, Congress added a third definition, relevant here:

"(3) articles (other than food) intended to affect the structure or any function of the body . . . ." Act of June 25, 1938, ch. 675, § 201(g), 52 Stat. 1041 (codified at 21 U. S. C. § 321(g)(1)(C)).

It also added a similar definition in respect to a "device." See § 201(h), 52 Stat. 1041 (codified at 21 U. S. C. § 321(h)). As I have mentioned, the literal language of the third definition and the FDCA's general purpose both strongly support a projurisdiction reading of the statute. See supra, at 161-162.

The statute's history offers further support. The FDA drafted the new language, and it testified before Congress that the third definition would expand the FDCA's jurisdictional scope significantly. See Hearings on S. 1944 before a Subcommittee of the Senate Committee on Commerce, 73d Cong., 2d Sess., 15-16 (1933), reprinted in 1 FDA, Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments 107-108 (1979) (hereinafter Leg. Hist.). Indeed, "[t]he purpose" of the new definition was to "make possible the regulation of a great many products that have been found on the market that cannot be alleged to be treatments for diseased conditions." Id., at 108. While the drafters focused specifically upon the need to give the FDA jurisdiction [165] over "slenderizing" products such as "antifat remedies," ibid., they were aware that, in doing so, they had created what was "admittedly an inclusive, a wide definition," id., at 107. And that broad language was included deliberately, so that jurisdiction could be had over "all substances and preparations, other than food, and all devices intended to affect the structure or any function of the body . . . ." Ibid. (emphasis added); see also Hearings on S. 2800 before the Senate Committee on Commerce, 73d Cong., 2d Sess., 516 (1934), reprinted in 2 Leg. Hist. 519 (statement of then-FDA Chief Walter Campbell acknowledging that "[t]his definition of `drugs' is all-inclusive").

After studying the FDCA's history, experts have written that the statute "is a purposefully broad delegation of discretionary powers by Congress," 1 J. O'Reilly, Food and Drug Administration § 6.01, p. 6-1 (2d ed. 1995) (hereinafter O'Reilly), and that, in a sense, the FDCA "must be regarded as a constitution " that "establish[es] general principles" and "permit[s] implementation within broad parameters" so that the FDA can "implement these objectives through the most effective and efficient controls that can be devised." Hutt, Philosophy of Regulation Under the Federal Food, Drug and Cosmetic Act, 28 Food Drug Cosm. L. J. 177, 178-179 (1973) (emphasis added). This Court, too, has said that the

"historical expansion of the definition of drug, and the creation of a parallel concept of devices, clearly show . . . that Congress fully intended that the Act's coverage be as broad as its literal language indicates—and equally clearly, broader than any strict medical definition might otherwise allow." Bacto-Unidisk, 394 U. S., at 798.

That Congress would grant the FDA such broad jurisdictional authority should surprise no one. In 1938, the President and much of Congress believed that federal administrative agencies needed broad authority and would exercise that authority wisely—a view embodied in much Second New [166] Deal legislation. Cf. Gray v. Powell, 314 U. S. 402, 411-412 (1941) (Congress "could have legislated specifically" but decided "to delegate that function to those whose experience in a particular field gave promise of a better informed, more equitable" determination). Thus, at around the same time that it added the relevant language to the FDCA, Congress enacted laws granting other administrative agencies even broader powers to regulate much of the Nation's transportation and communication. See, e. g., Civil Aeronautics Act of 1938, ch. 601, § 401(d)(1), 52 Stat. 987 (Civil Aeronautics Board to regulate airlines within confines of highly general "public convenience and necessity" standard); Motor Carrier Act of 1935, ch. 498, § 204(a)(1), 49 Stat. 546 (Interstate Commerce Commission to establish "reasonable requirements" for trucking); Communications Act of 1934, ch. 652, § 201(a), 48 Stat. 1070 (Federal Communications Commission (FCC) to regulate radio, later television, within confines of even broader "public interest" standard). Why would the 1938 New Deal Congress suddenly have hesitated to delegate to so well established an agency as the FDA all of the discretionary authority that a straightforward reading of the relevant statutory language implies?

Nor is it surprising that such a statutory delegation of power could lead after many years to an assertion of jurisdiction that the 1938 legislators might not have expected. Such a possibility is inherent in the very nature of a broad delegation. In 1938, it may well have seemed unlikely that the FDA would ever bring cigarette manufacturers within the FDCA's statutory language by proving that cigarettes produce chemical changes in the body and that the makers "intended" their product chemically to affect the body's "structure" or "function." Or, back then, it may have seemed unlikely that, even assuming such proof, the FDA actually would exercise its discretion to regulate so popular a product. See R. Kluger, Ashes to Ashes 105 (1997) (in the 1930's "Americans were in love with smoking . . .").

[167] But it should not have seemed unlikely that, assuming the FDA decided to regulate and proved the particular jurisdictional prerequisites, the courts would rule such a jurisdictional assertion fully authorized. Cf. United States v. Southwestern Cable Co., 392 U. S. 157, 172 (1968) (reading Communications Act of 1934 as authorizing FCC jurisdiction to regulate cable systems while noting that "Congress could not in 1934 have foreseen the development of" advanced communications systems). After all, this Court has read more narrowly phrased statutes to grant what might have seemed even more unlikely assertions of agency jurisdiction. See, e. g., Permian Basin Area Rate Cases, 390 U. S. 747, 774-777 (1968) (statutory authority to regulate interstate "transportation" of natural gas includes authority to regulate "prices" charged by field producers); Phillips Petroleum Co. v. Wisconsin, 347 U. S. 672, 677-684 (1954) (independent gas producer subject to regulation despite Natural Gas Act's express exemption of gathering and production facilities).

I shall not pursue these general matters further, for neither the companies nor the majority denies that the FDCA's literal language, its general purpose, and its particular legislative history favor the FDA's present jurisdictional view. Rather, they have made several specific arguments in support of one basic contention: Even if the statutory delegation is broad, it is not broad enough to include tobacco. I now turn to each of those arguments.

II

A

The tobacco companies contend that the FDCA's words cannot possibly be read to mean what they literally say. The statute defines "device," for example, as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article . . . intended to affect the structure or any function of the body . . . ." 21 [168] U. S. C. § 321(h). Taken literally, this definition might include everything from room air conditioners to thermal pajamas. The companies argue that, to avoid such a result, the meaning of "drug" or "device" should be confined to medical or therapeutic products, narrowly defined. See Brief for Respondent United States Tobacco Co. 8-9.

The companies may well be right that the statute should not be read to cover room air conditioners and winter underwear. But I do not agree that we must accept their proposed limitation. For one thing, such a cramped reading contravenes the established purpose of the statutory language. See Bacto-Unidisk, 394 U. S., at 798 (third definition is "clearly, broader than any strict medical definition"); 1 Leg. Hist. 108 (definition covers products "that cannot be alleged to be treatments for diseased conditions"). For another, the companies' restriction would render the other two "drug" definitions superfluous. See 21 U. S. C. §§ 321(g)(1)(A), (g)(1)(B) (covering articles in the leading pharmacology compendia and those "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease").

Most importantly, the statute's language itself supplies a different, more suitable, limitation: that a "drug" must be a chemical agent. The FDCA's "device" definition states that an article which affects the structure or function of the body is a "device" only if it "does not achieve its primary intended purposes through chemical action within . . . the body," and "is not dependent upon being metabolized for the achievement of its primary intended purposes." § 321(h) (emphasis added). One can readily infer from this language that at least an article that does achieve its primary purpose through chemical action within the body and that is dependent upon being metabolized is a "drug," provided that it otherwise falls within the scope of the "drug" definition. And one need not hypothesize about air conditioners or thermal [169] pajamas to recognize that the chemical nicotine, an important tobacco ingredient, meets this test.

Although I now oversimplify, the FDA has determined that once nicotine enters the body, the blood carries it almost immediately to the brain. See 61 Fed. Reg. 44698-44699 (1966). Nicotine then binds to receptors on the surface of brain cells, setting off a series of chemical reactions that alter one's mood and produce feelings of sedation and stimulation. See id., at 44699, 44739. Nicotine also increases the number of nicotinic receptors on the brain's surface, and alters its normal electrical activity. See id., at 44739. And nicotine stimulates the transmission of a natural chemical that "rewards" the body with pleasurable sensations (dopamine), causing nicotine addiction. See id., at 44700, 44721-44722. The upshot is that nicotine stabilizes mood, suppresses appetite, tranquilizes, and satisfies a physical craving that nicotine itself has helped to create—all through chemical action within the body after being metabolized.

This physiology—and not simply smoker psychology— helps to explain why as many as 75% of adult smokers believe that smoking "reduce[s] nervous irritation," 60 Fed. Reg. 41579 (1995); why 73% of young people (10- to 22-yearolds) who begin smoking say they do so for "relaxation," 61 Fed. Reg. 44814 (1996); and why less than 3% of smokers succeed in quitting each year, although 70% want to quit, id., at 44704. That chemistry also helps to explain the Surgeon General's findings that smokers believe "smoking [makes them] feel better" and smoke more "in situations involving negative mood." Id., at 44814. And, for present purposes, that chemistry demonstrates that nicotine affects the "structure" and "function" of the body in a manner that is quite similar to the effects of other regulated substances. See id., at 44667 (FDA regulates Valium, NoDoz, weight-loss products). Indeed, addiction, sedation, stimulation, and weight loss are precisely the kinds of product effects that the FDA typically reviews and controls. And, since the nicotine in cigarettes [170] plainly is not a "food," its chemical effects suffice to establish that it is as a "drug" (and the cigarette that delivers it a drug-delivery "device") for the purpose of the FDCA.

B

The tobacco companies' principal definitional argument focuses upon the statutory word "intended." See 21 U. S. C. § 321(g)(1)(C). The companies say that "intended" in this context is a term of art. See Brief for Respondent Brown & Williamson Tobacco Corp. 2. They assert that the statutory word "intended" means that the product's maker has made an express claim about the effect that its product will have on the body. Ibid. Indeed, according to the companies, the FDA's inability to prove that cigarette manufacturers make such claims is precisely why that agency historically has said it lacked the statutory power to regulate tobacco. See id., at 19-20.

The FDCA, however, does not use the word "claimed"; it uses the word "intended." And the FDA long ago issued regulations that say the relevant "intent" can be shown not only by a manufacturer's "expressions," but also "by the circumstances surrounding the distribution of the article." 41 Fed. Reg. 6896 (1976) (codified at 21 CFR § 801.4 (1999)); see also 41 Fed. Reg. 6896 (1976) ("objective intent" shown if "article is, with the knowledge [of its makers], offered and used" for a particular purpose). Thus, even in the absence of express claims, the FDA has regulated products that affect the body if the manufacturer wants, and knows, that consumers so use the product. See, e. g., 60 Fed. Reg. 41527-41531 (1995) (describing agency's regulation of topical hormones, sunscreens, fluoride, tanning lamps, thyroid in food supplements, novelty condoms—all marketed without express claims); see also 1 O'Reilly § 13.04, at 13-15 ("Sometimes the very nature of the material makes it a drug . . .").

Courts ordinarily reverse an agency interpretation of this kind only if Congress has clearly answered the interpretive [171] question or if the agency's interpretation is unreasonable. Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-843 (1984). The companies, in an effort to argue the former, point to language in the legislative history tying the word "intended" to a technical concept called "intended use." But nothing in Congress' discussion either of "intended" or "intended use" suggests that an express claim (which often shows intent) is always necessary. Indeed, the primary statement to which the companies direct our attention says only that a manufacturer can determine what kind of regulation applies—"food" or "drug"—because, "through his representations in connection with its sale, [the manufacturer] can determine" whether an article is to be used as a "food," as a "drug," or as "both." S. Rep. No. 361, 74th Cong., 1st Sess., 4 (1935), reprinted in 3 Leg. Hist. 696.

Nor is the FDA's "objective intent" interpretation unreasonable. It falls well within the established scope of the ordinary meaning of the word "intended." See Agnew v. United States, 165 U. S. 36, 53 (1897) (intent encompasses the known consequences of an act). And the companies acknowledge that the FDA can regulate a drug-like substance in the ordinary circumstance, i. e., where the manufacturer makes an express claim, so it is not unreasonable to conclude that the agency retains such power where a product's effects on the body are so well known (say, like those of aspirin or calamine lotion), that there is no need for express representations because the product speaks for itself.

The companies also cannot deny that the evidence of their intent is sufficient to satisfy the statutory word "intended" as the FDA long has interpreted it. In the first place, there was once a time when they actually did make express advertising claims regarding tobacco's mood-stabilizing and weight-reducing properties—and historical representations can portend present expectations. In the late 1920's, for example, the American Tobacco Company urged weightconscious smokers to "`Reach for a Lucky instead of a [172] sweet.' " Kluger, Ashes to Ashes, at 77-78. The advertisements of R J Reynolds (RJR) emphasized mood stability by depicting a pilot remarking that "`It Takes Steady Nerves to Fly the Mail at Night . . . . That's why I smoke Camels. And I smoke plenty!' " Id., at 86. RJR also advertised the stimulating quality of cigarettes, stating in one instance that "`You get a Lift with a Camel,' " and, in another, that Camels are "`A Harmless Restoration of the Flow of Natural Body Energy.' " Id., at 87. And claims of medical proof of mildness (and of other beneficial effects) once were commonplace. See, e. g., id., at 93 (Brown & Williamson advertised Koolbrand mentholated cigarettes as "a tonic to hot, tired throats"); id., at 101, 131 (Philip Morris contended that "`[r]ecognized laboratory tests have conclusively proven the advantage of Phillip [sic] Morris' "); id., at 88 (RJR proclaimed "`For Digestion's sake, smoke Camels! . . . Camels make mealtime more pleasant—digestion is stimulated—alkalinity increased' "). Although in recent decades cigarette manufacturers have stopped making express health claims in their advertising, consumers have come to understand what the companies no longer need to express—that through chemical action cigarettes stabilize mood, sedate, stimulate, and help suppress appetite.

Second, even though the companies refused to acknowledge publicly (until only very recently) that the nicotine in cigarettes has chemically induced, and habit-forming, effects, see, e. g., Regulation of Tobacco Products (Part 1): Hearings before the House Subcommittee on Health and the Environment, 103d Cong., 2d Sess., 628 (1994) (hereinafter 1994 Hearings) (heads of seven major tobacco companies testified under oath that they believed "nicotine is not addictive" (emphasis added)), the FDA recently has gained access to solid, documentary evidence proving that cigarette manufacturers have long known tobacco produces these effects within the body through the metabolizing of chemicals, and that they [173] have long wanted their products to produce those effects in this way.

For example, in 1972, a tobacco-industry scientist explained that "`[s]moke is beyond question the most optimized vehicle of nicotine,' " and "`the cigarette is the most optimized dispenser of smoke.' " 61 Fed. Reg. 44856 (1996) (emphasis deleted). That same scientist urged company executives to

"`[t]hink of the cigarette pack as a storage container for a day's supply of nicotine. . . . Think of the cigarette as a dispenser for a dose unit of nicotine [and] [t]hink of a puff of smoke as the vehicle of nicotine.' " Ibid. (Philip Morris) (emphasis deleted).

That same year, other tobacco industry researchers told their superiors that

"`in different situations and at different dose levels, nicotine appears to act as a stimulant, depressant, tranquilizer, psychic energizer, appetite reducer, anti-fatigue agent, or energizer. . . . Therefore, [tobacco] products may, in a sense, compete with a variety of other products with certain types of drug action.' " Id., at 44669 (RJR) (emphasis deleted).

A draft report prepared by authorities at Philip Morris said that nicotine

"`is a physiologically active, nitrogen containing substance [similar to] quinine, cocaine, atropine and morphine. [And] [w]hile each of these [other] substances can be used to affect human physiology, nicotine has a particularly broad range of influence.' " Id., at 44668-44669.

And a 1980 manufacturer's study stated that

"`the pharmacological response of smokers to nicotine is believed to be responsible for an individual's smoking [174] behaviour, providing the motivation for and the degree of satisfaction required by the smoker.' " Id., at 44936 (Brown & Williamson).

With such evidence, the FDA has more than sufficiently established that the companies "intend" their products to "affect" the body within the meaning of the FDCA.

C

The majority nonetheless reaches the "inescapable conclusion" that the language and structure of the FDCA as a whole "simply do not fit" the kind of public health problem that tobacco creates. Ante, at 143. That is because, in the majority's view, the FDCA requires the FDA to ban outright "dangerous" drugs or devices (such as cigarettes); yet, the FDA concedes that an immediate and total cigarette-sale ban is inappropriate. Ibid.

This argument is curious because it leads with similarly "inescapable" force to precisely the opposite conclusion, namely, that the FDA does have jurisdiction but that it must ban cigarettes. More importantly, the argument fails to take into account the fact that a statute interpreted as requiring the FDA to pick a more dangerous over a less dangerous remedy would be a perverse statute, causing, rather than preventing, unnecessary harm whenever a total ban is likely the more dangerous response. And one can at least imagine such circumstances.

Suppose, for example, that a commonly used, mildly addictive sleeping pill (or, say, a kind of popular contact lens), plainly within the FDA's jurisdiction, turned out to pose serious health risks for certain consumers. Suppose further that many of those addicted consumers would ignore an immediate total ban, turning to a potentially more dangerous black-market substitute, while a less draconian remedy (say, adequate notice) would wean them gradually away to a safer product. Would the FDCA still force the FDA to impose [175] the more dangerous remedy? For the following reasons, I think not.

First, the statute's language does not restrict the FDA's remedial powers in this way. The FDCA permits the FDA to regulate a "combination product"—i. e., a "device" (such as a cigarette) that contains a "drug" (such as nicotine)— under its "device" provisions. 21 U. S. C. § 353(g)(1). And the FDCA's "device" provisions explicitly grant the FDA wide remedial discretion. For example, where the FDA cannot "otherwise" obtain "reasonable assurance" of a device's "safety and effectiveness," the agency may restrict by regulation a product's "sale, distribution, or use" upon "such . . . conditions as the Secretary may prescribe." § 360j(e)(1) (emphasis added). And the statutory section that most clearly addresses the FDA's power to ban (entitled "Banned devices") says that, where a device presents "an unreasonable and substantial risk of illness or injury," the Secretary "may "—not must —"initiate a proceeding . . . to make such device a banned device." § 360f(a) (emphasis added).

The Court points to other statutory subsections which it believes require the FDA to ban a drug or device entirely, even where an outright ban risks more harm than other regulatory responses. See ante, at 135-136. But the cited provisions do no such thing. It is true, as the majority contends, that "the FDCA requires the FDA to place all devices" in "one of three classifications" and that Class III devices require "premarket approval." Ante, at 136. But it is not the case that the FDA must place cigarettes in Class III because tobacco itself "presents a potential unreasonable risk of illness or injury." 21 U. S. C. § 360c(a)(1)(C). In fact, Class III applies only where regulation cannot otherwise "provide reasonable assurance of . . . safety." §§ 360c(a) (1)(A), (B) (placing a device in Class I or Class II when regulation can provide that assurance). Thus, the statute plainly allows the FDA to consider the relative, overall "safety" of [176] a device in light of its regulatory alternatives, and where the FDA has chosen the least dangerous path, i. e., the safest path, then it can—and does—provide a "reasonable assurance" of "safety" within the meaning of the statute. A good football helmet provides a reasonable assurance of safety for the player even if the sport itself is still dangerous. And the safest regulatory choice by definition offers a "reasonable" assurance of safety in a world where the other alternatives are yet more dangerous.

In any event, it is not entirely clear from the statute's text that a Class III categorization would require the FDA affirmatively to withdraw from the market dangerous devices, such as cigarettes, which are already widely distributed. See, e. g., § 360f(a) (when a device presents an "unreasonable and substantial risk of illness or injury," the Secretary "may" make it "a banned device"); § 360h(a) (when a device "presents an unreasonable risk of substantial harm to the public health," the Secretary "may" require "notification"); § 360h(b) (when a defective device creates an "unreasonable risk" of harm, the Secretary "may" order "[r]epair, replacement, or refund"); cf. 2 O'Reilly § 18.08, at 18-29 (point of Class III "premarket approval" is to allow "careful scientific review" of each "truly new" device "before it is exposed" to users (emphasis added)).

Noting that the FDCA requires banning a "misbranded" drug, the majority also points to 21 U. S. C. § 352(j), which deems a drug or device "misbranded" if "it is dangerous to health when used" as "prescribed, recommended, or suggested in the labeling." See ante, at 135. In addition, the majority mentions § 352(f)(1), which calls a drug or device "misbranded" unless "its labeling bears . . . adequate directions for use" as "are necessary for the protection of users." Ibid. But this "misbranding" language is not determinative, for it permits the FDA to conclude that a drug or device is not "dangerous to health" and that it does have "adequate" [177] directions when regulated so as to render it as harmless as possible. And surely the agency can determine that a substance is comparatively "safe" (not "dangerous") whenever it would be less dangerous to make the product available (subject to regulatory requirements) than suddenly to withdraw it from the market. Any other interpretation risks substantial harm of the sort that my sleeping pill example illustrates. See supra, at 174-175. And nothing in the statute prevents the agency from adopting a view of "safety" that would avoid such harm. Indeed, the FDA already seems to have taken this position when permitting distribution of toxic drugs, such as poisons used for chemotherapy, that are dangerous for the user but are not deemed "dangerous to health" in the relevant sense. See 61 Fed. Reg. 44413 (1996).

The tobacco companies point to another statutory provision which says that if a device "would cause serious, adverse health consequences or death, the Secretary shall issue" a cease distribution order. 21 U. S. C. § 360h(e)(1) (emphasis added). But that word "shall" in this context cannot mean that the Secretary must resort to the recall remedy whenever a device would have serious, adverse health effects. Rather, that language must mean that the Secretary "shall issue" a cease distribution order in compliance with the section's procedural requirements if the Secretary chooses in her discretion to use that particular subsection's recall remedy. Otherwise, the subsection would trump and make meaningless the same section's provision of other lesser remedies such as simple "notice" (which the Secretary similarly can impose if, but only if, she finds that the device "presents an unreasonable risk of substantial harm to the public"). § 360h(a)(1). And reading the statute to compel the FDA to "recall" every dangerous device likewise would conflict with that same subsection's statement that the recall remedy "shall be in addition to [the other] remedies provided" in the statute. § 360h(e)(3) (emphasis added).

[178] The statute's language, then, permits the agency to choose remedies consistent with its basic purpose—the overall protection of public health.

The second reason the FDCA does not require the FDA to select the more dangerous remedy, see supra, at 175, is that, despite the majority's assertions to the contrary, the statute does not distinguish among the kinds of health effects that the agency may take into account when assessing safety. The Court insists that the statute only permits the agency to take into account the health risks and benefits of the "product itself " as used by individual consumers, ante, at 140, and, thus, that the FDA is prohibited from considering that a ban on smoking would lead many smokers to suffer severe withdrawal symptoms or to buy possibly stronger, more dangerous, black market cigarettes—considerations that the majority calls "the aggregate health effects of alternative administrative actions." Ibid. But the FDCA expressly permits the FDA to take account of comparative safety in precisely this manner. See, e. g., 21 U. S. C. § 360h(e)(2)(B)(i)(II) (no device recall if "risk of recal[l]" presents "a greater health risk than" no recall); § 360h(a) (notification "unless" notification "would present a greater danger" than "no such notification").

Moreover, one cannot distinguish in this context between a "specific" health risk incurred by an individual and an "aggregate" risk to a group. All relevant risk is, at bottom, risk to an individual; all relevant risk attaches to "the product itself"; and all relevant risk is "aggregate" in the sense that the agency aggregates health effects in order to determine risk to the individual consumer. If unregulated smoking will kill 4 individuals out of a typical group of 1,000 people, if regulated smoking will kill 1 out of 1,000, and if a smoking ban (because of the black market) will kill 2 out of 1,000; then these three possibilities mean that in each group four, one, and two individuals, on average, will die respectively. And the risk to each individual consumer is 4/1,000, [179] 1/1,000, and 2/1,000 respectively. A "specific" risk to an individual consumer and "aggregate" risks are two sides of the same coin; each calls attention to the same set of facts. While there may be a theoretical distinction between the risk of the product itself and the risk related to the presence or absence of an intervening voluntary act (e. g., the search for a replacement on the black market), the majority does not rely upon any such distinction, and the FDA's history of regulating "replacement" drugs such as methadone shows that it has long taken likely actual alternative consumer behavior into account.

I concede that, as a matter of logic, one could consider the FDA's "safety" evaluation to be different from its choice of remedies. But to read the statute to forbid the agency from taking account of the realities of consumer behavior either in assessing safety or in choosing a remedy could increase the risks of harm—doubling the risk of death to each "individual user" in my example above. Why would Congress insist that the FDA ignore such realities, even if the consequent harm would occur only unusually, say, where the FDA evaluates a product (a sleeping pill; a cigarette; a contact lens) that is already on the market, potentially habit forming, or popular? I can find no satisfactory answer to this question. And that, I imagine, is why the statute itself says nothing about any of the distinctions that the Court has tried to draw. See 21 U. S. C. § 360c(a)(2) (instructing FDA to determine the safety and effectiveness of a "device" in part by weighing "any probable benefit to health . . . against any probable risk of injury or illness . . ." (emphasis added)).

Third, experience counsels against an overly rigid interpretation of the FDCA that is divorced from the statute's overall health-protecting purposes. A different set of words, added to the FDCA in 1958 by the Delaney Amendment, provides that "no [food] additive shall be deemed to be safe if it is found [after appropriate tests] to induce cancer when ingested by man or animal." § 348(c)(3). The FDA [180] once interpreted this language as requiring it to ban any food additive, no matter how small the amount, that appeared in any food product if that additive was ever found to induce cancer in any animal, no matter how large a dose needed to induce the appearance of a single carcinogenic cell. See H. R. Rep. No. 95-658, p. 7 (1977) (discussing agency's view). The FDA believed that the statute's ban mandate was absolute and prevented it from establishing a level of "safe use" or even to judge whether "the benefits of continued use outweigh the risks involved." Id., at 5. This interpretation— which in principle could have required the ban of everything from herbal teas to mushrooms—actually led the FDA to ban saccharine, see 42 Fed. Reg. 19996 (1977), though this extremely controversial regulatory response never took effect because Congress enacted, and has continually renewed, a law postponing the ban. See Saccharin Study and Labeling Act, Pub. L. 95-203, § 3, 91 Stat. 1452; e. g., Pub. L. 102-142, Tit. VI, 105 Stat. 910.

The Court's interpretation of the statutory language before us risks Delaney-type consequences with even less linguistic reason. Even worse, the view the Court advances undermines the FDCA's overall health-protecting purpose by placing the FDA in the strange dilemma of either banning completely a potentially dangerous drug or device or doing nothing at all. Saying that I have misunderstood its conclusion, the majority maintains that the FDA "may clearly regulate many `dangerous' products without banning them." Ante, at 142. But it then adds that the FDA must ban— rather than otherwise regulate—a drug or device that "cannot be used safely for any therapeutic purpose." Ibid. If I misunderstand, it is only because this linchpin of the majority's conclusion remains unexplained. Why must a widely used but unsafe device be withdrawn from the market when that particular remedy threatens the health of many and is thus more dangerous than another regulatory response? It is, indeed, a perverse interpretation that reads the FDCA [181] to require the ban of a device that has no "safe" therapeutic purpose where a ban is the most dangerous remedial alternative.

In my view, where linguistically permissible, we should interpret the FDCA in light of Congress' overall desire to protect health. That purpose requires a flexible interpretation that both permits the FDA to take into account the realities of human behavior and allows it, in appropriate cases, to choose from its arsenal of statutory remedies. A statute so interpreted easily "fit[s]" this, and other, drug- and device-related health problems.

III

In the majority's view, laws enacted since 1965 require us to deny jurisdiction, whatever the FDCA might mean in their absence. But why? Do those laws contain language barring FDA jurisdiction? The majority must concede that they do not. Do they contain provisions that are inconsistent with the FDA's exercise of jurisdiction? With one exception, see infra, at 184-185, the majority points to no such provision. Do they somehow repeal the principles of law (discussed in Part II, supra ) that otherwise would lead to the conclusion that the FDA has jurisdiction in this area? The companies themselves deny making any such claim. See Tr. of Oral Arg. 27 (denying reliance on doctrine of "partial repeal"). Perhaps the later laws "shape" and "focus" what the 1938 Congress meant a generation earlier. Ante, at 143. But this Court has warned against using the views of a later Congress to construe a statute enacted many years before. See Pension Benefit Guaranty Corporation v. LTV Corp., 496 U. S. 633, 650 (1990) (later history is a "`hazardous basis for inferring the intent of an earlier' Congress" (quoting United States v. Price, 361 U. S. 304, 313 (1960))). And, while the majority suggests that the subsequent history "control[s] our construction" of the FDCA, see ante, at 143 (citation and internal quotation marks omitted), this Court [182] expressly has held that such subsequent views are not "controlling." Haynes v. United States, 390 U. S. 85, 87-88, n. 4 (1968); accord, Southwestern Cable Co., 392 U. S., at 170 (such views have "`very little, if any, significance' "); see also Sullivan v. Finkelstein, 496 U. S. 617, 632 (1990) (Scalia, J., concurring) ("Arguments based on subsequent legislative history . . . should not be taken seriously, not even in a footnote").

Regardless, the later statutes do not support the majority's conclusion. That is because, whatever individual Members of Congress after 1964 may have assumed about the FDA's jurisdiction, the laws they enacted did not embody any such "no jurisdiction" assumption. And one cannot automatically infer an antijurisdiction intent, as the majority does, for the later statutes are both (and similarly) consistent with quite a different congressional desire, namely, the intent to proceed without interfering with whatever authority the FDA otherwise may have possessed. See, e. g., Cigarette Labeling and Advertising—1965: Hearings on H. R. 2248 et al. before the House Committee on Interstate and Foreign Commerce, 89th Cong., 1st Sess., 19 (1965) (hereinafter 1965 Hearings) (statement of Rep. Fino that the proposed legislation would not "erode" agency authority). As I demonstrate below, the subsequent legislative history is critically ambivalent, for it can be read either as (a) "ratif[ying]" a no-jurisdiction assumption, see ante, at 158, or as (b) leaving the jurisdictional question just where Congress found it. And the fact that both inferences are "equally tenable," Pension Benefit Guaranty Corp., supra, at 650 (citation and internal quotation marks omitted); Johnson v. Transportation Agency, Santa Clara Cty., 480 U. S. 616, 672 (1987) (Scalia, J., dissenting), prevents the majority from drawing from the later statutes the firm, antijurisdiction implication that it needs.

Consider, for example, Congress' failure to provide the FDA with express authority to regulate tobacco—a circumstance [183] that the majority finds significant. See ante, at 144, 147-148, 155. But cf. Southwestern Cable Co., supra, at 170 (failed requests do not prove agency "did not already possess" authority). In fact, Congress both failed to grant express authority to the FDA when the FDA denied it had jurisdiction over tobacco and failed to take that authority expressly away when the agency later asserted jurisdiction. See, e. g., S. 1262, 104th Cong., 1st Sess., § 906 (1995) (failed bill seeking to amend FDCA to say that "[n]othing in this Act or any other Act shall provide the [FDA] with any authority to regulate in any manner tobacco or tobacco products"); see also H. R. 516, 105th Cong., 1st Sess., § 2 (1997) (similar); H. R. Res. 980, reprinted in 142 Cong. Rec. 5018 (1996) (Georgia legislators unsuccessfully requested that Congress "rescind any action giving the FDA authority" over tobacco); H. R. 2283, 104th Cong., 1st Sess. (1995) (failed bill "[t]o prohibit the [FDA] regulation of the sale or use of tobacco"); H. R. 2414, 104th Cong., 1st Sess., § 2(a) (1995) (similar). Consequently, the defeat of various different proposed jurisdictional changes proves nothing. This history shows only that Congress could not muster the votes necessary either to grant or to deny the FDA the relevant authority. It neither favors nor disfavors the majority's position.

The majority also mentions the speed with which Congress acted to take jurisdiction away from other agencies once they tried to assert it. See ante, at 145, 149-151. But such a congressional response again proves nothing. On the one hand, the speedy reply might suggest that Congress somehow resented agency assertions of jurisdiction in an area it desired to reserve for itself—a consideration that supports the majority. On the other hand, Congress' quick reaction with respect to other agencies' regulatory efforts contrasts dramatically with its failure to enact any responsive law (at any speed) after the FDA asserted jurisdiction over tobacco more than three years ago. And that contrast supports the opposite conclusion.

[184] In addition, at least one post-1938 statute reveals quite a different congressional intent than the majority infers. See note following 21 U. S. C. § 321 (1994 ed., Supp. III) (FDA Modernization Act of 1997) (law "shall [not] be construed to affect the question of whether the [FDA] has any authority to regulate any tobacco product," and "[s]uch authority, if any, shall be exercised under the [FDCA] as in effect on the day before the date of [this] enactment"). Consequently, it appears that the only interpretation that can reconcile all of the subsequent statutes is the inference that Congress did not intend, either explicitly or implicitly, for its later laws to answer the question of the scope of the FDA's jurisdictional authority. See 143 Cong. Rec. S8860 (Sept. 5, 1997) (the Modernization Act will "not interfere or substantially negatively affect any of the FDA tobacco authority").

The majority's historical perspective also appears to be shaped by language in the Federal Cigarette Labeling and Advertising Act (FCLAA), 79 Stat. 282, 15 U. S. C. § 1331 et seq. See ante, at 148-149. The FCLAA requires manufacturers to place on cigarette packages, etc., health warnings such as the following:

"SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy." 15 U. S. C. § 1333(a).

The FCLAA has an express pre-emption provision which says that "[n]o statement relating to smoking and health, other than the statement required by [this Act], shall be required on any cigarette package." § 1334(a). This preemption clause plainly prohibits the FDA from requiring on "any cigarette package" any other "statement relating to smoking and health," but no one contends that the FDA has failed to abide by this prohibition. See, e. g., 61 Fed. Reg. 44399 (1996) (describing the other regulatory prescriptions). Rather, the question is whether the FCLAA's pre-emption [185] provision does more. Does it forbid the FDA to regulate at all?

This Court has already answered that question expressly and in the negative. See Cipollone v. Liggett Group, Inc., 505 U. S. 504 (1992). Cipollone held that the FCLAA's preemption provision does not bar state or federal regulation outside the provision's literal scope. Id., at 518. And it described the pre-emption provision as "merely prohibit[ing] state and federal rulemaking bodies from mandating particular cautionary statements on cigarette labels . . . ." Ibid.

This negative answer is fully consistent with Congress' intentions in regard to the pre-emption language. When Congress enacted the FCLAA, it focused upon the regulatory efforts of the Federal Trade Commission (FTC), not the FDA. See 1965 Hearings 1-2. And the Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222, § 7(c), 84 Stat. 89, expressly amended the FCLAA to provide that "[n]othing in this Act shall be construed to affirm or deny the [FTC's] holding that it has the authority to issue trade regulation rules" for tobacco. See also H. R. Conf. Rep. No. 91-897, p. 7 (1970) (statement of House Managers) (we have "no intention to resolve the question as to whether" the FTC could regulate tobacco in a different way); see also 116 Cong. Rec. 7921 (1970) (statement of Rep. Satterfield) (same). Why would one read the FCLAA's pre-emption clause—a provision that Congress intended to limit even in respect to the agency directly at issue—so broadly that it would bar a different agency from engaging in any other cigarette regulation at all? The answer is that the Court need not, and should not, do so. And, inasmuch as the Court already has declined to view the FCLAA as pre-empting the entire field of tobacco regulation, I cannot accept that that same law bars the FDA's regulatory efforts here.

When the FCLAA's narrow pre-emption provision is set aside, the majority's conclusion that Congress clearly intended for its tobacco-related statutes to be the exclusive [186] "response" to "the problem of tobacco and health," ante, at 157, is based on legislative silence. Notwithstanding the views voiced by various legislators, Congress itself has addressed expressly the issue of the FDA's tobacco-related authority only once—and, as I have said, its statement was that the statute was not to "be construed to affect the question of whether the [FDA] has any authority to regulate any tobacco product." Note following 21 U. S. C. § 321 (1994 ed., Supp. III). The proper inference to be drawn from all of the post-1965 statutes, then, is one that interprets Congress' general legislative silence consistently with this statement.

IV

I now turn to the final historical fact that the majority views as a factor in its interpretation of the subsequent legislative history: the FDA's former denials of its tobaccorelated authority.

Until the early 1990's, the FDA expressly maintained that the 1938 statute did not give it the power that it now seeks to assert. It then changed its mind. The majority agrees with me that the FDA's change of positions does not make a significant legal difference. See ante, at 156-157; see also Chevron, 467 U. S., at 863 ("An initial agency interpretation is not instantly carved in stone"); accord, Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735, 742 (1996) ("[C]hange is not invalidating"). Nevertheless, it labels those denials "important context" for drawing an inference about Congress' intent. Ante, at 157. In my view, the FDA's change of policy, like the subsequent statutes themselves, does nothing to advance the majority's position.

When it denied jurisdiction to regulate cigarettes, the FDA consistently stated why that was so. In 1963, for example, FDA administrators wrote that cigarettes did not satisfy the relevant FDCA definitions—in particular, the "intent" requirement—because cigarette makers did not sell their product with accompanying "therapeutic claims." [187] Letter to Directors of Bureaus, Divisions and Directors of Districts from FDA Bureau of Enforcement (May 24, 1963), in Public Health Cigarette Amendments of 1971: Hearings on S. 1454 before the Consumer Subcommittee of the Senate Committee on Commerce, 92d Cong., 2d Sess., 240 (1972) (hereinafter FDA Enforcement Letter). And subsequent FDA Commissioners made roughly the same assertion. One pointed to the fact that the manufacturers only "recommended" cigarettes "for smoking pleasure." Two others reiterated the evidentiary need for "health claims." Yet another stressed the importance of proving "intent," adding that "[w]e have not had sufficient evidence" of "intent with regard to nicotine." See, respectively, id., at 239 (Comm'r Edwards); Letter of Dec. 5, 1977, App. 47 (Comm'r Kennedy); 1965 Hearings 193 (Comm'r Rankin); 1994 Hearings 28 (Comm'r Kessler). Tobacco company counsel also testified that the FDA lacked jurisdiction because jurisdiction "depends on . . . intended use," which in turn "depends, in general, on the claims and representations made by the manufacturer." Health Consequences of Smoking: Nicotine Addiction, Hearing before the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, 100th Cong., 2d Sess., 288 (1988) (testimony of Richard Cooper) (emphasis added).

Other agency statements occasionally referred to additional problems. Commissioner Kessler, for example, said that the "enormous social consequences" flowing from a decision to regulate tobacco counseled in favor of obtaining specific congressional "guidance." 1994 Hearings 69; see also ante, at 153 (quoting statement of Health and Human Services Secretary Brandt to the effect that Congress wanted to make the relevant jurisdictional decision). But a fair reading of the FDA's denials suggests that the overwhelming problem was one of proving the requisite manufacturer intent. See Action on Smoking and Health v. Harris, 655 F. 2d 236, 238-239 (CADC 1980) (FDA "comments" reveal its "understanding" [188] that "the crux of FDA jurisdiction over drugs lay in manufacturers' representations as revelatory of their intent").

What changed? For one thing, the FDA obtained evidence sufficient to prove the necessary "intent" despite the absence of specific "claims." See supra, at 172-174. This evidence, which first became available in the early 1990's, permitted the agency to demonstrate that the tobacco companies knew nicotine achieved appetite-suppressing, mood-stabilizing, and habituating effects through chemical (not psychological) means, even at a time when the companies were publicly denying such knowledge.

Moreover, scientific evidence of adverse health effects mounted, until, in the late 1980's, a consensus on the seriousness of the matter became firm. That is not to say that concern about smoking's adverse health effects is a new phenomenon. See, e. g., Higginson, A New Counterblast, in Out-door Papers 179, 194 (1863) (characterizing tobacco as "`a narcotic poison of the most active class' "). It is to say, however, that convincing epidemiological evidence began to appear mid-20th century; that the first Surgeon General's Report documenting the adverse health effects appeared in 1964; and that the Surgeon General's Report establishing nicotine's addictive effects appeared in 1988. At each stage, the health conclusions were the subject of controversy, diminishing somewhat over time, until recently—and only recently—has it become clear that there is a wide consensus about the health problem. See 61 Fed. Reg. 44701-44706 (1996).

Finally, administration policy changed. Earlier administrations may have hesitated to assert jurisdiction for the reasons prior Commissioners expressed. See supra, at 186-187 and this page. Commissioners of the current administration simply took a different regulatory attitude.

Nothing in the law prevents the FDA from changing its policy for such reasons. By the mid-1990's, the evidence [189] needed to prove objective intent—even without an express claim—had been found. The emerging scientific consensus about tobacco's adverse, chemically induced, health effects may have convinced the agency that it should spend its resources on this important regulatory effort. As for the change of administrations, I agree with then-Justice Rehnquist's statement in a different case, where he wrote:

"The agency's changed view . . . seems to be related to the election of a new President of a different political party. It is readily apparent that the responsible members of one administration may consider public resistance and uncertainties to be more important than do their counterparts in a previous administration. A change in administration brought about by the people casting their votes is a perfectly reasonable basis for an executive agency's reappraisal of the costs and benefits of its programs and regulations. As long as the agency remains within the bounds established by Congress, it is entitled to assess administrative records and evaluate priorities in light of the philosophy of the administration." Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29, 59 (1983) (concurring in part and dissenting in part).

V

One might nonetheless claim that, even if my interpretation of the FDCA and later statutes gets the words right, it lacks a sense of their "music." See Helvering v. Gregory, 69 F. 2d 809, 810-811 (CA2 1934) (L. Hand, J.) ("[T]he meaning of a [statute] may be more than that of the separate words, as a melody is more than the notes . . .").Such a claim might rest on either of two grounds.

First, one might claim that, despite the FDA's legal right to change its mind, its original statements played a critical part in the enactment of the later statutes and now should play a critical part in their interpretation. But the FDA's [190] traditional view was largely premised on a perceived inability to prove the necessary statutory "intent" requirement. See, e. g., FDA Enforcement Letter 240 ("The statutory basis for the exclusion of tobacco products from FDA's jurisdiction is the fact that tobacco marketed for chewing or smoking without accompanying therapeutic claims, does not meet the definitions . . . for food, drug, device or cosmetic"). The statement, "we cannot assert jurisdiction over substance X unless it is treated as a food," would not bar jurisdiction if the agency later establishes that substance X is, and is intended to be, eaten. The FDA's denials of tobacco-related authority sufficiently resemble this kind of statement that they should not make the critical interpretive difference.

Second, one might claim that courts, when interpreting statutes, should assume in close cases that a decision with "enormous social consequences," 1994 Hearings 69, should be made by democratically elected Members of Congress rather than by unelected agency administrators. Cf. Kent v. Dulles, 357 U. S. 116, 129 (1958) (assuming Congress did not want to delegate the power to make rules interfering with exercise of basic human liberties). If there is such a background canon of interpretation, however, I do not believe it controls the outcome here.

Insofar as the decision to regulate tobacco reflects the policy of an administration, it is a decision for which that administration, and those politically elected officials who support it, must (and will) take responsibility. And the very importance of the decision taken here, as well as its attendant publicity, means that the public is likely to be aware of it and to hold those officials politically accountable. Presidents, just like Members of Congress, are elected by the public. Indeed, the President and Vice President are the only public officials whom the entire Nation elects. I do not believe that an administrative agency decision of this magnitude—one that is important, conspicuous, and controversial—can escape the kind of public scrutiny that is essential in any democracy. [191] And such a review will take place whether it is the Congress or the Executive Branch that makes the relevant decision.

* * *

According to the FDA, only 2.5% of smokers successfully stop smoking each year, even though 70% say they want to quit and 34% actually make an attempt to do so. See 61 Fed. Reg. 44704 (1996) (citing Centers for Disease Control and Prevention, Cigarette Smoking Among Adults—United States, 1993; 43 Morbidity and Mortality Weekly Report 929 (Dec. 23, 1994)). The fact that only a handful of those who try to quit smoking actually succeed illustrates a certain reality—the reality that the nicotine in cigarettes creates a powerful physiological addiction flowing from chemically induced changes in the brain. The FDA has found that the makers of cigarettes "intend" these physical effects. Hence, nicotine is a "drug"; the cigarette that delivers nicotine to the body is a "device"; and the FDCA's language, read in light of its basic purpose, permits the FDA to assert the disease-preventing jurisdiction that the agency now claims.

The majority finds that cigarettes are so dangerous that the FDCA would require them to be banned (a result the majority believes Congress would not have desired); thus, it concludes that the FDA has no tobacco-related authority. I disagree that the statute would require a cigarette ban. But even if I am wrong about the ban, the statute would restrict only the agency's choice of remedies, not its jurisdiction.

The majority also believes that subsequently enacted statutes deprive the FDA of jurisdiction. But the later laws say next to nothing about the FDA's tobacco-related authority. Previous FDA disclaimers of jurisdiction may have helped to form the legislative atmosphere out of which Congress' own tobacco-specific statutes emerged. But a legislative atmosphere is not a law, unless it is embodied in a statutory word or phrase. And the relevant words and phrases here reveal [192] nothing more than an intent not to change the jurisdictional status quo.

The upshot is that the Court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette) that the Court itself finds unsafe. Far more than most, this particular drug and device risks the life-threatening harms that administrative regulation seeks to rectify. The majority's conclusion is counterintuitive. And, for the reasons set forth, I believe that the law does not require it.

Consequently, I dissent.

[1] Briefs of amici curiae urging reversal were filed for the State of Minnesota et al. by Mike Hatch, Attorney General of Minnesota, James S. Alexander, Assistant Attorney General, Louise H. Renne, and by the Attorneys General for their respective States as follows: Bruce M. Botelho of Alaska, Janet Napolitano of Arizona, Mark Pryor of Arkansas, Bill Lockyer of California, Ken Salazar of Colorado, Richard Blumenthal of Connecticut, Robert A. Butterworth of Florida, Earl I. Anzai of Hawaii, Alan G. Lance of Idaho, James E. Ryan of Illinois, Jeffrey A. Modisett of Indiana, Thomas J. Miller of Iowa, Carla J. Stovall of Kansas, Andrew Ketterer of Maine, J. Joseph Curran, Jr., of Maryland, Thomas F. Reilly of Massachusetts, Jennifer M. Granholm of Michigan, Mike Moore of Mississippi, Jeremiah W. Nixon of Missouri, Joseph P. Mazurek of Montana, Frankie Sue Del Papa of Nevada, Philip T. McLaughlin of New Hampshire, John J. Farmer, Jr., of New Jersey, Patricia A. Madrid of New Mexico, Eliot Spitzer of New York, Heidi Heitkamp of North Dakota, Betty D. Montgomery of Ohio, W. A. Drew Edmondson of Oklahoma, Hardy Myers of Oregon, D. Michael Fisher of Pennsylvania, Sheldon Whitehouse of Rhode Island, Mark Barnett of South Dakota, John Cornyn of Texas, Jan Graham of Utah, William H. Sorrell of Vermont, Christine O. Gregoire of Washington, Darrell V. McGraw, Jr., of West Virginia, James E. Doyle of Wisconsin, and Gay Woodhouse of Wyoming; for Action on Smoking and Health by John F. Banzhaf III and Kathleen E. Scheg; for the American Cancer Society, Inc., by Russell E. Brooks, David R. Gelfand, Charles W. Westland, and William J. Dalton; for the American College of Chest Physicians by Raymond D. Cotton; and for Public Citizen, Inc., et al. by Allison M. Zieve, Alan B. Morrison, and David C. Vladeck.

Briefs of amici curiae urging affirmance were filed for the Pacific Legal Foundation by Anne M. Hayes and M. Reed Hopper; for the Product Liability Advisory Council, Inc., by Kenneth S. Geller; and for the Washington Legal Foundation et al. by Daniel J. Popeo and Richard A. Samp.

132 S.Ct. 476 (2011)

[479] Mark C. Fleming, Boston, MA, for Petitioner.

Curtis E. Gannon, Washington, DC, for Respondent.

Seth P. Waxman, Paul R.Q. Wolfson, James L. Quarles, III, Eric F. Citron, Wilmer Cutler Pickering, Hale and Dorr LLP, Washington, DC, Mark C. Fleming, Counsel of Record, Megan Barbero, Elizabeth Kent Cullen, Wilmer Cutler Pickering, Hale and Dorr LLP, Boston, MA, for Petitioner.

Donald B. Verrilli, Jr., Solicitor General Counsel of Record, Tony West, Assistant Attorney General, Edwin S. Kneedler, Deputy Solicitor General, Curtis E. Gannon, Assistant to the Solicitor General, Donald E. Keener, Alison R. Drucker, Andrew MacLachlan, Attorneys, Department of Justice, Washington, DC, for Respondent.

Justice KAGAN delivered the opinion of the Court.

This case concerns the Board of Immigration Appeals' (BIA or Board) policy for deciding when resident aliens may apply to the Attorney General for relief from deportation under a now-repealed provision of the immigration laws. We hold that the BIA's approach is arbitrary and capricious.

The legal background of this case is complex, but the principle guiding our decision is anything but. When an administrative agency sets policy, it must provide a reasoned explanation for its action. That is not a high bar, but it is an unwavering one. Here, the BIA has failed to meet it.

I

A

Federal immigration law governs both the exclusion of aliens from admission to this country and the deportation of aliens previously admitted. Before 1996, these two kinds of action occurred in different procedural settings, with an alien seeking entry (whether for the first time or upon return from a trip abroad) placed in an "exclusion proceeding" and an alien already here channeled to a "deportation proceeding." See Landon v. Plasencia, 459 U.S. 21, 25-26, 103 S.Ct. 321, 74 L.Ed.2d 21 (1982) (comparing the two). Since that time, the Government has used a unified procedure, known as a "removal proceeding," for exclusions and deportations alike. See 8 U.S.C. §§ 1229, 1229a. But the statutory bases for excluding and deporting aliens have always varied. Now, as before, the immigration laws provide two separate lists of substantive grounds, principally involving criminal offenses, for these two actions. One list specifies what kinds of crime render an alien excludable (or in the term the statute now uses, "inadmissible"), see § 1182(a) (2006 ed., Supp. IV), while another—sometimes overlapping and sometimes divergent—list specifies what kinds of crime render an alien deportable from the country, see § 1227(a).

An additional, historic difference between exclusion and deportation cases involved the ability of the Attorney General to grant an alien discretionary relief. Until [480] repealed in 1996, § 212(c) of the Immigration and Nationality Act, 66 Stat. 187, 8 U.S.C. § 1182(c) (1994 ed.), authorized the Attorney General to admit certain excludable aliens. See also § 136(p) (1926 ed.) (predecessor provision to § 212(c)). The Attorney General could order this relief when the alien had lawfully resided in the United States for at least seven years before temporarily leaving the country, unless the alien was excludable on one of two specified grounds. See § 1182(c) (1994 ed.).^[1] But by its terms, § 212(c) did not apply when an alien was being deported.

This discrepancy threatened to produce an odd result in a case called Matter of L____, 1 I. & N. Dec. 1 (1940), leading to the first-ever grant of discretionary relief in a deportation case. L- was a permanent resident of the United States who had been convicted of larceny. Although L-'s crime made him inadmissible, he traveled abroad and then returned to the United States without any immigration official's preventing his entry. A few months later, the Government caught up with L- and initiated a deportation action based on his larceny conviction. Had the Government apprehended L- at the border a short while earlier, he would have been placed in an exclusion proceeding where he could have applied for discretionary relief. But because L- was instead in a deportation proceeding, no such relief was available. Responding to this apparent anomaly, Attorney General Robert Jackson (on referral of the case from the BIA) determined that L- could receive a waiver: L-, Jackson said, "should be permitted to make the same appeal to discretion that he could have made if denied admission" when returning from his recent trip. Id., at 6. In accord with this decision, the BIA adopted a policy of allowing aliens in deportation proceedings to apply for discretionary relief under § 212(c) whenever they had left and reentered the country after becoming deportable. See Matter of S____, 6 I. & N. Dec. 392, 394-396 (1954).

But this approach created another peculiar asymmetry: Deportable aliens who had traveled abroad and returned could receive § 212(c) relief, while those who had never left could not. In Francis v. INS, 532 F.2d 268 (1976), the Court of Appeals for the Second Circuit concluded that this disparity violated equal protection. Id., at 273 ("[A]n alien whose ties with this country are so strong that he has never departed after his initial entry should receive at least as much consideration as an individual who may leave and return from time to time"). The BIA acquiesced in the Second Circuit's decision, see Matter of Silva, 16 I. & N. Dec. 26 (1976), thus applying § 212(c) in deportation proceedings regardless of an alien's travel history.

All this might have become academic when Congress repealed § 212(c) in 1996 and substituted a new discretionary remedy, known as "cancellation of removal," which is available in a narrow range of circumstances to excludable and deportable aliens alike. See 8 U.S.C. § 1229b. [481] But in INS v. St. Cyr, 533 U.S. 289, 326, 121 S.Ct. 2271, 150 L.Ed.2d 347 (2001), this Court concluded that the broader relief afforded by § 212(c) must remain available, on the same terms as before, to an alien whose removal is based on a guilty plea entered before § 212(c)'s repeal. We reasoned that aliens had agreed to those pleas with the possibility of discretionary relief in mind and that eliminating this prospect would ill comport with "`familiar considerations of fair notice, reasonable reliance, and settled expectations.'" Id., at 323, 121 S.Ct. 2271 (quoting Landgraf v. USI Film Products, 511 U.S. 244, 270, 114 S.Ct. 1483, 128 L.Ed.2d 229 (1994)). Accordingly, § 212(c) has had an afterlife for resident aliens with old criminal convictions.

When the BIA is deciding whether to exclude such an alien, applying § 212(c) is an easy matter. The Board first checks the statutory ground that the Department of Homeland Security (DHS) has identified as the basis for exclusion; the Board may note, for example, that DHS has charged the alien with previously committing a "crime involving moral turpitude," see 8 U.S.C. § 1182(a)(2)(A)(i)(I). Unless the charged ground is one of the pair falling outside § 212(c)'s scope, see n. 1, supra, the alien is eligible for discretionary relief. The Board then determines whether to grant that relief based on such factors as "the seriousness of the offense, evidence of either rehabilitation or recidivism, the duration of the alien's residence, the impact of deportation on the family, the number of citizens in the family, and the character of any service in the Armed Forces." St. Cyr, 533 U.S., at 296, n. 5, 121 S.Ct. 2271.

By contrast, when the BIA is deciding whether to deport an alien, applying § 212(c) becomes a tricky business. Recall that § 212(c) applies on its face only to exclusion decisions. So the question arises: How is the BIA to determine when an alien should receive § 212(c) relief in the deportation context?

One approach that the BIA formerly used considered how the alien would fare in an exclusion proceeding. To perform this analysis, the Board would first determine whether the criminal conviction making the alien deportable fell within a statutory ground for exclusion. Almost all convictions did so, largely because the "crime involving moral turpitude" ground encompasses so many offenses.^[2] Assuming that threshold inquiry were met, the Board would mimic its approach in exclusion cases—first making sure the statutory ground at issue was not excepted from § 212(c) and then conducting the multifactor analysis. See Matter of Tanori, 15 I. & N. Dec. 566, 567-568 (1976); In re Manzueta, No. A93 022 672, 2003 WL 23269892 (BIA, Dec. 1, 2003).

A second approach is the one challenged here; definitively adopted in 2005 (after decades of occasional use), it often is called the "comparable-grounds" rule. See, e.g., De la Rosa v. U.S. Attorney General, 579 F.3d 1327, 1332 (C.A.11 2009). That approach evaluates whether the ground for deportation charged in a case has a close analogue in the statute's list of exclusion grounds. See In re Blake, 23 I. & N. Dec. 722, 728 (2005); In re Brieva-Perez, 23 I. & N. Dec. 766, 772-773 (2005).^[3] If the deportation ground consists of a set of [482] crimes "substantially equivalent" to the set of offenses making up an exclusion ground, then the alien can seek § 212(c) relief. Blake, 23 I. & N. Dec., at 728. But if the deportation ground charged covers significantly different or more or fewer offenses than any exclusion ground, the alien is not eligible for a waiver. Such a divergence makes § 212(c) inapplicable even if the particular offense committed by the alien falls within an exclusion ground.

Two contrasting examples from the BIA's cases may help to illustrate this approach. Take first an alien convicted of conspiring to distribute cocaine, whom DHS seeks to deport on the ground that he has committed an "aggravated felony" involving "illicit trafficking in a controlled substance." 8 U.S.C. §§ 1101(a)(43)(B), 1227(a)(2)(A)(iii). Under the comparable-grounds rule, the immigration judge would look to see if that deportation ground covers substantially the same offenses as an exclusion ground. And according to the BIA in Matter of Meza, 20 I. & N. Dec. 257 (1991), the judge would find an adequate match—the exclusion ground applicable to aliens who have committed offenses "relating to a controlled substance," 8 U.S.C. §§ 1182(a)(2)(A)(i)(II) and (a)(2)(C).

Now consider an alien convicted of first-degree sexual abuse of a child, whom DHS wishes to deport on the ground that he has committed an "aggravated felony" involving "sexual abuse of a minor." §§ 1101(a)(43)(A), 1227(a)(2)(A)(iii). May this alien seek § 212(c) relief? According to the BIA, he may not do so—not because his crime is too serious (that is irrelevant to the analysis), but instead because no statutory ground of exclusion covers substantially the same offenses. To be sure, the alien's own offense is a "crime involving moral turpitude," 8 U.S.C. § 1182(a)(2)(A)(i)(I), and so fits within an exclusion ground. Indeed, that will be true of most or all offenses included in this deportation category. See supra, at 481. But on the BIA's view, the "moral turpitude" exclusion ground "addresses a distinctly different and much broader category of offenses than the aggravated felony sexual abuse of a minor charge." Blake, 23 I. & N. Dec., at 728. And the much greater sweep of the exclusion ground prevents the alien from seeking discretionary relief from deportation.^[4]

Those mathematically inclined might think of the comparable-grounds approach as employing Venn diagrams. Within one circle are all the criminal offenses composing the particular ground of deportation charged. Within other circles are the offenses composing the various exclusion grounds. When, but only when, the "deportation circle" sufficiently corresponds to one of the "exclusion circles" may an alien apply for § 212(c) relief.

B

Petitioner Joel Judulang is a native of the Philippines who entered the United States in 1974 at the age of eight. Since that time, he has lived continuously in this country as a lawful permanent resident. In 1988, Judulang took part in a fight in [483] which another person shot and killed someone. Judulang was charged as an accessory and eventually pleaded guilty to voluntary manslaughter. He received a 6-year suspended sentence and was released on probation immediately after his plea.

In 2005, after Judulang pleaded guilty to another criminal offense (this one involving theft), DHS commenced an action to deport him. DHS charged Judulang with having committed an "aggravated felony" involving "a crime of violence," based on his old manslaughter conviction. 8 U.S.C. §§ 1101(a)(43)(F), 1227(a)(2)(A)(iii).^[5] The Immigration Judge ordered Judulang's deportation, and the BIA affirmed. As part of its decision, the BIA considered whether Judulang could apply for § 212(c) relief. It held that he could not do so because the "crime of violence" deportation ground is not comparable to any exclusion ground, including the one for crimes involving moral turpitude. App. to Pet. for Cert. 8a. The Court of Appeals for the Ninth Circuit denied Judulang's petition for review in reliance on circuit precedent upholding the BIA's comparable-grounds approach. Judulang v. Gonzales, 249 Fed.Appx. 499, 502 (2007) (citing Abebe v. Gonzales, 493 F.3d 1092 (2007)).

We granted certiorari, 563 U.S. ___, 131 S.Ct. 2093, 179 L.Ed.2d 889 (2011), to resolve a circuit split on the approach's validity.^[6] We now reverse.

II

This case requires us to decide whether the BIA's policy for applying § 212(c) in deportation cases is "arbitrary [or] capricious" under the Administrative Procedure Act (APA), 5 U.S.C. § 706(2)(A).^[7] The scope of our review under this standard is "narrow"; as we have often recognized, "a court is not to substitute its judgment for that of the agency." Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983); see Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971). Agencies, the BIA among them, have expertise and experience in administering their statutes that no court can properly ignore. But courts retain a [484] role, and an important one, in ensuring that agencies have engaged in reasoned decisionmaking. When reviewing an agency action, we must assess, among other matters, "`whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment.'" State Farm, 463 U.S., at 43, 103 S.Ct. 2856 (quoting Bowman Transp., Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 285, 95 S.Ct. 438, 42 L.Ed.2d 447 (1974)). That task involves examining the reasons for agency decisions—or, as the case may be, the absence of such reasons. See FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515, 129 S.Ct. 1800, 173 L.Ed.2d 738 (2009) (noting "the requirement that an agency provide reasoned explanation for its action").

The BIA has flunked that test here. By hinging a deportable alien's eligibility for discretionary relief on the chance correspondence between statutory categories—a matter irrelevant to the alien's fitness to reside in this country—the BIA has failed to exercise its discretion in a reasoned manner.

A

The parties here spend much time disputing whether the BIA must make discretionary relief available to deportable and excludable aliens on identical terms. As this case illustrates, the comparable-grounds approach does not do so. If Judulang were seeking entry to this country, he would be eligible for § 212(c) relief; voluntary manslaughter is "a crime involving moral turpitude," and so his conviction falls within an exclusion ground. But Judulang cannot apply for relief from deportation because the "crime of violence" ground charged in his case does not match any exclusion ground (including the one for "turpitudinous" crimes). See infra, at 485-486. Judulang argues that this disparity is impermissible because any disparity between excludable and deportable aliens is impermissible: If an alien may seek § 212(c) relief in an exclusion case, he also must be able to seek such relief in a deportation case. See Brief for Petitioner 47-51.^[8] But the Government notes that the immigration laws have always drawn distinctions between exclusion and deportation. See Brief for Respondent 51. And the Government presses a policy reason for making § 212(c) relief more readily available in exclusion cases. Doing so, it argues, will provide an incentive for some resident aliens (i.e., those eligible for a waiver from exclusion, but not deportation) to report themselves to immigration officials, by applying for advance permission to exit and reenter the country. In contrast, applying § 212(c) uniformly might lead all aliens to "try to evade immigration officials for as long as possible," because [485] they could in any event "seek [discretionary] relief if caught." Id., at 52.

In the end, we think this dispute beside the point, and we do not resolve it. The BIA may well have legitimate reasons for limiting § 212(c)'s scope in deportation cases. But still, it must do so in some rational way. If the BIA proposed to narrow the class of deportable aliens eligible to seek § 212(c) relief by flipping a coin—heads an alien may apply for relief, tails he may not—we would reverse the policy in an instant. That is because agency action must be based on non-arbitrary, "`relevant factors,'" State Farm, 463 U.S., at 43, 103 S.Ct. 2856 (quoting Bowman Transp., 419 U.S., at 285, 95 S.Ct. 438), which here means that the BIA's approach must be tied, even if loosely, to the purposes of the immigration laws or the appropriate operation of the immigration system. A method for disfavoring deportable aliens that bears no relation to these matters—that neither focuses on nor relates to an alien's fitness to remain in the country—is arbitrary and capricious. And that is true regardless whether the BIA might have acted to limit the class of deportable aliens eligible for § 212(c) relief on other, more rational bases.

The problem with the comparable-grounds policy is that it does not impose such a reasonable limitation. Rather than considering factors that might be thought germane to the deportation decision, that policy hinges § 212(c) eligibility on an irrelevant comparison between statutory provisions. Recall that the BIA asks whether the set of offenses in a particular deportation ground lines up with the set in an exclusion ground. But so what if it does? Does an alien charged with a particular deportation ground become more worthy of relief because that ground happens to match up with another? Or less worthy of relief because the ground does not? The comparison in no way changes the alien's prior offense or his other attributes and circumstances. So it is difficult to see why that comparison should matter. Each of these statutory grounds contains a slew of offenses. Whether each contains the same slew has nothing to do with whether a deportable alien whose prior conviction falls within both grounds merits the ability to seek a waiver.^[9]

This case well illustrates the point. In commencing Judulang's deportation proceeding, the Government charged him with an "aggravated felony" involving a "crime of violence" based on his prior manslaughter conviction. See App. to Pet. for Cert. 11a-12a. That made him ineligible for § 212(c) relief because the "crime of violence" deportation ground does not sufficiently overlap with the most similar exclusion ground, for "crime[s] involving moral turpitude." The problem, according to the BIA, is that the "crime of violence" ground includes a few offenses—simple assault, minor burglary, and unauthorized use of a vehicle—that the "moral turpitude" ground does not. See Brieva-Perez, 23 I. & N. Dec., at 772-773; Tr. of Oral Arg. 28-29, 40-41. But this statutory difference in no way relates to Judulang—or to most other aliens charged with committing a "crime of violence." Perhaps aliens like Judulang should be eligible for § 212(c) relief, or perhaps they should not. But that determination is not sensibly made by establishing [486] that simple assaults and minor burglaries fall outside a ground for exclusion. That fact is as extraneous to the merits of the case as a coin flip would be. It makes Judulang no less deserving of the opportunity to seek discretionary relief—just as its converse (the inclusion of simple assaults and burglaries in the "moral turpitude" exclusion ground) would make him no more so.

Or consider a different headscratching oddity of the comparable-grounds approach—that it may deny § 212(c) eligibility to aliens whose deportation ground fits entirely inside an exclusion ground. The BIA's Blake decision, noted earlier, provides an example. See supra, at 481-482. The deportation ground charged was "aggravated felony" involving "sexual abuse of a minor"; the closest exclusion ground was, once again, a "crime [of] moral turpitude." 23 I. & N. Dec., at 727. Here, the BIA's problem was not that the deportation ground covered too many offenses; all or virtually all the crimes within that ground also are crimes of moral turpitude. Rather, the BIA objected that the deportation ground covered too few crimes—or put oppositely, that "the moral turpitude ground of exclusion addresses a ... much broader category of offenses." Id., at 728. But providing relief in exclusion cases to a broad class of aliens hardly justifies denying relief in deportation cases to a subset of that group.^[10] (The better argument would surely be the reverse—that giving relief in the one context supports doing so in the other.) Again, we do not say today that the BIA must give all deportable aliens meeting § 212(c)'s requirements the chance to apply for a waiver. See supra, at 484-485. The point is instead that the BIA cannot make that opportunity turn on the meaningless matching of statutory grounds.

And underneath this layer of arbitrariness lies yet another, because the outcome of the Board's comparable-grounds analysis itself may rest on the happenstance of an immigration official's charging decision. This problem arises because an alien's prior conviction may fall within a number of deportation grounds, only one of which corresponds to an exclusion ground. Consider, for example, an alien who entered the country in 1984 and committed voluntary manslaughter in 1988. That person could be charged (as Judulang was) with an "aggravated felony" involving a "crime of violence," see 8 U.S.C. §§ 1101(a)(43)(F), 1227(a)(2)(A)(iii). If so, the alien could not seek a waiver because of the absence of a comparable exclusion ground. But the alien also could be charged with "a crime involving moral turpitude committed within five years ... after the date of admission," see § 1227(a)(2)(A)(i)(I). And if that were the deportation charge, the alien could apply for relief, because the ground corresponds to the "moral turpitude" ground used in exclusion cases. See In re Salmon, 16 I. & N. Dec. 734 (1978). So everything hangs on the charge. And the Government has provided no reason to think that immigration officials must adhere to any set scheme in deciding what charges to bring, or that those officials are exercising their charging discretion with § 212(c) in mind. See Tr. of Oral Arg. 34-36. So at base everything hangs on the fortuity of an individual official's decision. An alien appearing before one official may suffer deportation; an identically situated alien appearing before another may gain the right to stay in this country.

[487] In a foundational deportation case, this Court recognized the high stakes for an alien who has long resided in this country, and reversed an agency decision that would "make his right to remain here dependent on circumstances so fortuitous and capricious." Delgadillo v. Carmichael, 332 U.S. 388, 391, 68 S.Ct. 10, 92 L.Ed. 17 (1947). We think the policy before us similarly flawed. The comparable-grounds approach does not rest on any factors relevant to whether an alien (or any group of aliens) should be deported. It instead distinguishes among aliens—decides who should be eligible for discretionary relief and who should not—solely by comparing the metes and bounds of diverse statutory categories into which an alien falls. The resulting Venn diagrams have no connection to the goals of the deportation process or the rational operation of the immigration laws. Judge Learned Hand wrote in another early immigration case that deportation decisions cannot be made a "sport of chance." See Di Pasquale v. Karnuth, 158 F.2d 878, 879 (C.A.2 1947) (quoted in Rosenberg v. Fleuti, 374 U.S. 449, 455, 83 S.Ct. 1804, 10 L.Ed.2d 1000 (1963)). That is what the comparable-grounds rule brings about, and that is what the APA's "arbitrary and capricious" standard is designed to thwart.

B

The Government makes three arguments in defense of the comparable-grounds rule—the first based on statutory text, the next on history, the last on cost. We find none of them persuasive.

1

The Government initially contends that the comparable-grounds approach is more faithful to "the statute's language," Brief for Respondent 21—or otherwise said, that "lifting that limit `would take immigration practice even further from the statutory text,'" id., at 22 (quoting Matter of Hernandez-Casillas, 20 I. & N. Dec. 262, 287 (1990)). In the Government's view, § 212(c) is "phrased in terms of waiving statutorily specified grounds of exclusion"; that phrasing, says the Government, counsels a comparative analysis of grounds when applying § 212(c) in the deportation context. Brief for Respondent 21; see Tr. of Oral Arg. 34 ("[T]he reason [the comparable-grounds approach] makes sense is because the statute only provides for relief from grounds of ... exclusion").

The first difficulty with this argument is that it is based on an inaccurate description of the statute. Section 212(c) instructs that certain resident aliens "may be admitted in the discretion of the Attorney General" notwithstanding any of "the provisions of subsection (a) ... (other than paragraphs (3) and (9)(C))." 8 U.S.C. § 1182(c) (1994 ed.). Subsection (a) contains the full list of exclusion grounds; paragraphs (3) and (9)(C) (which deal with national security and international child abduction) are two among these. What § 212(c) actually says, then, is that the Attorney General may admit any excludable alien, except if the alien is charged with two specified grounds. And that means that once the Attorney General determines that the alien is not being excluded for those two reasons, the ground of exclusion no longer matters. At that point, the alien is eligible for relief, and the thing the Attorney General waives is not a particular exclusion ground, but the simple denial of entry. So the premise of the Government's argument is wrong. And if the premise, so too the conclusion—that is, because § 212(c)'s text is not "phrased in terms of waiving statutorily specified grounds of exclusion," Brief for Respondent 21, it cannot counsel a search for corresponding grounds of deportation.

[488] More fundamentally, the comparable-grounds approach would not follow from § 212(c) even were the Government right about the section's phrasing. That is because § 212(c) simply has nothing to do with deportation: The provision was not meant to interact with the statutory grounds for deportation, any more than those grounds were designed to interact with the provision. Rather, § 212(c) refers solely to exclusion decisions; its extension to deportation cases arose from the agency's extra-textual view that some similar relief should be available in that context to avoid unreasonable distinctions. Cf., e.g., Matter of L____, 1 I. & N. Dec., at 5; see also supra, at 480-481.^[11] Accordingly, the text of § 212(c), whether or not phrased in terms of "waiving grounds of exclusion," cannot support the BIA's use of the comparable-grounds rule—or, for that matter, any other method for extending discretionary relief to deportation cases. We well understand the difficulties of operating in such a text-free zone; indeed, we appreciate the Government's yearning for a textual anchor. But § 212(c), no matter how many times read or parsed, does not provide one.

2

In disputing Judulang's contentions, the Government also emphasizes the comparable-grounds rule's vintage. See Brief for Respondent 22-23, 30-43. As an initial matter, we think this a slender reed to support a significant government policy. Arbitrary agency action becomes no less so by simple dint of repetition. (To use a prior analogy, flipping coins to determine § 212(c) eligibility would remain as arbitrary on the thousandth try as on the first.) And longstanding capriciousness receives no special exemption from the APA. In any event, we cannot detect the consistency that the BIA claims has marked its approach to this issue. To the contrary, the BIA has repeatedly vacillated in its method for applying § 212(c) to deportable aliens.

Prior to 1984, the BIA endorsed a variety of approaches. In Matter of T____, 5 I. & N. Dec. 389, 390 (1953), for example, the BIA held that an alien was not eligible for § 212(c) relief because her "ground of deportation" did not appear in the exclusion statute. That decision anticipated the comparable-grounds approach that the BIA today uses. But in Tanori, the BIA pronounced that a deportable alien could apply for a waiver because "the same facts"—in that case, a marijuana conviction—would have allowed him to seek § 212(c) relief in an exclusion proceeding. 15 I. & N. Dec., at 568. That approach is more nearly similar to the one Judulang urges here. And then, in Matter of Granados, 16 I. & N. Dec. 726, 728 (1979), the BIA tried to have it both ways: It denied § 212(c) eligibility both because the deportation ground charged did not correspond to, and because the alien's prior conviction did not fall within, a waivable ground of exclusion. In short, the BIA's cases were all over the map.

[489] The Government insists that the BIA imposed order in Matter of Wadud, 19 I. & N. Dec. 182, 185-186 (1984), when it held that a deportable alien could not seek § 212(c) relief unless the deportation ground charged had an "analogous ground of inadmissibility." See Brief for Respondent 40-41. But the BIA's settlement, if any, was fleeting. Just seven years later, the BIA adopted a new policy entirely, extending § 212(c) eligibility to "aliens deportable under any ground of deportability except those where there is a comparable ground of exclusion which has been specifically excepted from section 212(c)." Hernandez-Casillas, 20 I. & N. Dec., at 266. That new rule turned the comparable-grounds approach inside-out, allowing aliens to seek § 212(c) relief in deportation cases except when the ground charged corresponded to an exclusion ground that could not be waived. To be sure, the Attorney General (on referral of the case from the BIA), disavowed this position in favor of the more standard version of the comparable-grounds rule. Id., at 287. But even while doing so, the Attorney General stated that "an alien subject to deportation must have the same opportunity to seek discretionary relief as an alien... subject to exclusion." Ibid. That assertion is exactly the one Judulang makes in this case; it is consonant not with the comparable-grounds rule the BIA here defends, but instead with an inquiry into whether an alien's prior conviction falls within an exclusion ground.

Given these mixed signals, it is perhaps not surprising that the BIA continued to alternate between approaches in the years that followed. Immediately after the Attorney General's opinion in Hernandez-Casillas, the BIA endorsed the comparable-grounds approach on several occasions. See Meza, 20 I. & N. Dec., at 259; Matter of Montenegro, 20 I. & N. Dec. 603, 604-605 (1992); Matter of Gabryelsky, 20 I. & N. Dec. 750, 753-754 (1993); In re Esposito, 21 I. & N. Dec. 1, 6-7 (1995); In re Jimenez-Santillano, 21 I. & N. Dec. 567, 571-572 (1996). But just a few years later, the BIA issued a series of unpublishedopinions that asked only whether a deportable alien's prior conviction fell within an exclusion ground. See, e.g., In re Manzueta, No. A93 022 672, 2003 WL 23269892 (Dec. 1, 2003). Not until the BIA's decisions in Blake and Brieva-Perez did the pendulum stop swinging. That history hardly supports the Government's view of a consistent agency practice.^[12]

3

The Government finally argues that the comparable-grounds rule saves time and money. The Government claims that comparing deportation grounds to exclusion grounds can be accomplished in just a few "precedential decision[s]," which then can govern broad swaths of cases. See Brief for Respondent 46. By contrast, the Government argues, Judulang's approach would force it to determine whether each and every crime of conviction falls within an exclusion ground. Further, the Government contends that Judulang's approach would grant eligibility to a greater [490] number of deportable aliens, which in turn would force the Government to make additional individualized assessments of whether to actually grant relief. Id., at 47.

Once again, the Government's rationale comes up short. Cost is an important factor for agencies to consider in many contexts. But cheapness alone cannot save an arbitrary agency policy. (If it could, flipping coins would be a valid way to determine an alien's eligibility for a waiver.) And in any event, we suspect the Government exaggerates the cost savings associated with the comparable-grounds rule. Judulang's proposed approach asks immigration officials only to do what they have done for years in exclusion cases; that means, for one thing, that officials can make use of substantial existing precedent governing whether a crime falls within a ground of exclusion. And Judulang's proposal may not be the only alternative to the comparable-grounds rule. See supra, at 484-485. In rejecting that rule, we do not preclude the BIA from trying to devise another, equally economical policy respecting eligibility for § 212(c) relief, so long as it comports with everything held in both this decision and St. Cyr.

III

We must reverse an agency policy when we cannot discern a reason for it. That is the trouble in this case. The BIA's comparable-grounds rule is unmoored from the purposes and concerns of the immigration laws. It allows an irrelevant comparison between statutory provisions to govern a matter of the utmost importance—whether lawful resident aliens with longstanding ties to this country may stay here. And contrary to the Government's protestations, it is not supported by text or practice or cost considerations. The BIA's approach therefore cannot pass muster under ordinary principles of administrative law.

The judgment of the Ninth Circuit is hereby reversed, and the case is remanded for further proceedings consistent with this opinion.

It is so ordered.

[1] The relevant part of § 212(c), in the version of the exclusion statute all parties use, read as follows:

"Aliens lawfully admitted for permanent residence who temporarily proceeded abroad voluntarily and not under an order of deportation, and who are returning to a lawful unrelinquished domicile of seven consecutive years, may be admitted in the discretion of the Attorney General without regard to the provisions of subsection (a) of this section (other than paragraphs (3) and (9)(C))." 8 U.S.C. § 1182(c) (1994 ed.).

The parenthetical clause of this section prevented the Attorney General from waiving exclusion for aliens who posed a threat to national security, § 1182(a)(3), and aliens who engaged in international child abduction, § 1182(a)(9)(C).

[2] Firearms offenses are the most significant crimes falling outside the statutory grounds for exclusion. See Matter of Hernandez-Casillas, 20 I. & N. Dec. 262, 282, n. 4 (1990).

[3] Blake and Brieva-Perez clarified a 2004 regulation issued by the BIA stating that an alien is ineligible for § 212(c) relief when deportable "on a ground which does not have a statutory counterpart in section 212." 8 CFR § 1212.3(f)(5) (2010).

[4] Careful readers may note that the example involving controlled substances offered in the last paragraph also involves an exclusion ground that sweeps more broadly than the deportation ground charged. The deportation ground requires "trafficking" in a controlled substance, whereas the exclusion ground includes all possession offenses as well. The BIA nonetheless held in Meza that the degree of overlap between the two grounds was sufficient to make the alien eligible for § 212(c) relief. That holding reveals the broad discretion that the BIA currently exercises in deciding when two statutory grounds are comparable enough.

[5] DHS also charged two other grounds for deportation, but the BIA did not rule on those grounds and they are not before us.

[6] Compare Blake v. Carbone, 489 F.3d 88, 103 (C.A.2 2007) (rejecting the BIA's approach and holding instead that "[i]f the offense that renders [an alien] deportable would render a similarly situated [alien] excludable, the deportable [alien] is eligible for a waiver of deportation"), with Koussan v. Holder, 556 F.3d 403, 412-414 (C.A.6 2009) (upholding the comparable-grounds policy); Caroleo v. Gonzales, 476 F.3d 158, 162-163, 168 (C.A.3 2007) (same); Kim v. Gonzales, 468 F.3d 58, 62-63 (C.A.1 2006) (same).

[7] The Government urges us instead to analyze this case under the second step of the test we announced in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), to govern judicial review of an agency's statutory interpretations. See Brief for Respondent 19. Were we to do so, our analysis would be the same, because under Chevron step two, we ask whether an agency interpretation is "`arbitrary or capricious in substance.'" Mayo Foundation for Medical Ed. and Research v. United States, 562 U.S. ___, ___, 131 S.Ct. 704, 711, 178 L.Ed.2d 588 (2011) (quoting Household Credit Services, Inc. v. Pfennig, 541 U.S. 232, 242, 124 S.Ct. 1741, 158 L.Ed.2d 450 (2004)). But we think the more apt analytic framework in this case is standard "arbitrary [or] capricious" review under the APA. The BIA's comparable-grounds policy, as articulated in In re Blake, 23 I. & N. Dec. 722 (2005) and In re Brieva-Perez, 23 I. & N. Dec. 766 (2005), is not an interpretation of any statutory language—nor could it be, given that § 212(c) does not mention deportation cases, see infra, at 487-488, and n. 11.

[8] Judulang also argues that the BIA is making an impermissible distinction between two groups of deportable aliens—those who have recently left and returned to the country and those who have not. According to Judulang, the BIA is treating the former as if they were seeking admission, while applying the "comparable grounds" approach only to the latter. See Reply Brief for Petitioner 16-18. That is the kind of distinction the Second Circuit held in Francis v. INS, 532 F.2d 268 (1976), violated equal protection. See supra, at 480-481. But the Government contends that it is drawing no such line—that it is applying the comparable-grounds policy to all deportable aliens. Brief for Respondent 29. We think the available evidence tends to support the Government's representation. See In re Meza-Castillo, No. A091 366 529, 2009 WL 455596 (BIA, Feb. 9, 2009) (applying comparable-grounds analysis to a deportable alien who had left and returned to the country); In re Valenzuela-Morales, No. A40 443 512, 2008 WL 2079382 (BIA, Apr. 23, 2008) (same). But in light of our holding that the comparable-grounds approach is arbitrary and capricious, we need not resolve this dispute about the BIA's practice.

[9] The case would be different if Congress had intended for § 212(c) relief to depend on the interaction of exclusion grounds and deportation grounds. But the Government has presented us with no evidence to this effect, nor have we found any. See Blake, 489 F.3d, at 102 (Congress never contemplated, in drafting the immigration laws, "that its grounds of deportation would have any connection with the grounds of exclusion" in the application of § 212(c)); see also infra, at 487-488.

[10] Perhaps that is why the BIA declined to apply similar reasoning in Meza—a case also involving an exclusion ground that sweeps more broadly than a deportation ground (although not to the same extent as in Blake). See supra, at 481-482.

[11] Congress amended § 212(c), just five months before repealing it, to include a first-time reference to deportation cases. That amendment prohibited the Attorney General from granting discretionary relief to aliens deportable on several specified grounds. See Antiterrorism and Effective Death Penalty Act of 1996, 110 Stat. 1277 (effective Apr. 24, 1996). The change does not affect our analysis, nor does the Government argue it should. As the Government notes, the amendment "did not speak to the viability of the Board's" comparable-grounds rule, but instead made categorically ineligible for § 212(c) relief "those deportable by reason of certain crimes." Brief for Respondent 20. Presumably, Congress thought those crimes particularly incompatible with an alien's continued residence in this country.

[12] Because we find the BIA's prior practice so unsettled, we likewise reject Judulang's argument that Blake and Brieva-Perez were impermissibly retroactive. To succeed on that theory, Judulang would have to show, at a minimum, that in entering his guilty plea, he had reasonably relied on a legal rule from which Blake and Brieva-Perez departed. See Landgraf v. USI Film Products, 511 U.S. 244, 270, 114 S.Ct. 1483, 128 L.Ed.2d 229 (1994) (stating that retroactivity analysis focuses on "considerations of fair notice, reasonable reliance, and settled expectations"). The instability of the BIA's prior practice prevents Judulang from making this showing: The BIA sometimes recognized aliens in Judulang's position as eligible for § 212(c) relief, but sometimes did not.

541 F.2d 1 (1976)

[2] [3] [4] [5] [6] Joseph C. Carter, Jr., Richmond, Va., with whom John J. Adams, Washington, D. C., and David F. Peters, Washington, D. C., were on the brief, for petitioner in No. 73-2205. Arnold H. Quint, Washington, D. C., also entered an appearance for petitioner in No. 73-2205.

Daniel M. Gribbon, Washington, D. C., with whom Allan J. Topol and Charles Lister, Washington, D. C., were on the brief, for petitioners in Nos. 73-2268 and 73-2269.

Victor P. Kayser, Chicago, Ill., with whom John C. Berghoff, Jr. and Robert E. Nord, Chicago, Ill., and David Machanic and William H. Fitz, Washington, D. C., were on the brief, for petitioner in No. 73-2270.

H. Edward Dunkelberger, Jr., Washington, D. C., with whom Theodore L. Garrett, Washington, D. C., was on the brief, for petitioner in No. 74-1021.

Robert V. Zener, Gen. Counsel, Environmental Protection Agency, and Leslie A. Carothers, Atty., Environmental Protection Agency, Washington, D. C., with whom Wallace H. Johnson, Asst. Atty. Gen., and Edmund B. Clark, Martin Green, and Edward J. Shawaker, Attys., Dept. of Justice, Washington, D. C., were on the brief, for respondent. Raymond N. Zagone, Atty., Dept. of Justice, Washington, D. C., also entered an appearance for respondent in No. 73-2268.

David Schoenbrod, New York City, filed a brief on behalf of Natural Resources Defense Council, Inc. et al. as amici curiae urging affirmance.

Before BAZELON, Chief Judge, and WRIGHT, McGOWAN, TAMM, LEVENTHAL, ROBINSON, MacKINNON, ROBB, and WILKEY, Circuit Judges, sitting en banc.

Argued En Banc May 30, 1975.

Certiorari Denied June 14, 1976. See 96 S.Ct. 2662, 2663.

Opinion for the court, in which Chief Judge BAZELON and Circuit Judges McGOWAN, LEVENTHAL, and SPOTTSWOOD W. ROBINSON, III, concur, filed by Circuit Judge J. SKELLY WRIGHT.

Concurring opinion, in which Circuit Judge McGOWAN joins, filed by Chief Judge BAZELON.

Concurring statement filed by Circuit Judge LEVENTHAL.

Dissenting opinion filed by Circuit Judge MacKINNON.

Dissenting opinion, in which Circuit Judges TAMM and ROBB join, filed by Circuit Judge WILKEY.

J. SKELLY WRIGHT, Circuit Judge:

Man's ability to alter his environment has developed far more rapidly than his ability to foresee with certainty the effects of his alterations. It is only recently that we have begun to appreciate the danger posed by unregulated modification of the world around us, and have created watchdog agencies whose task it is to warn us, and protect us, when technological "advances" present dangers unappreciated—or unrevealed—by their supporters. Such agencies, unequipped with crystal balls and unable to read the future, are nonetheless charged with evaluating the effects of unprecedented environmental modifications, often made on a massive scale. Necessarily, they must deal with predictions and uncertainty, with developing evidence, with conflicting evidence, and, sometimes, with little or no evidence at all. Today we address the [7] scope of the power delegated one such watchdog, the Environmental Protection Agency (EPA). We must determine the certainty required by the Clean Air Act before EPA may act to protect the health of our populace from the lead particulate emissions of automobiles.

Section 211(c)(1)(A) of the Clean Air Act^[1] authorizes the Administrator of EPA to regulate gasoline additives whose emission products "will endanger the public health or welfare * * *." 42 U.S.C. § 1857f-6c(c)(1)(A). Acting pursuant to that power, the Administrator, after notice and comment, determined that the automotive emissions caused by leaded gasoline present "a significant risk of harm" to the public health. Accordingly, he promulgated regulations that reduce, in step-wise fashion, the lead content of leaded gasoline.^[2] We must decide whether the Administrator properly interpreted the meaning of Section 211(c)(1)(A) and the scope of his power thereunder, and, if so, whether the evidence adduced at the rule-making proceeding supports his final determination. Finding in favor of the Administrator on both grounds, and on all other grounds raised by petitioners, we affirm his determination.

I. THE FACTS, THE STATUTE, THE PROCEEDINGS, AND THE REGULATIONS

Hard on the introduction of the first gasoline-powered automobiles came the discovery that lead "antiknock" compounds, when added to gasoline, dramatically increase the fuel's octane rating. Increased octane allows for higher compression engines, which operate with greater efficiency. Since 1923 antiknocks have been regularly added to gasoline, and a large industry has developed to supply those compounds. Today, approximately 90 percent of motor gasoline manufactured in the United States contains lead additives, even though most 1975 and 1976 model automobiles are equipped with catalytic converters, which require lead-free gasoline. From the beginning, however, scientists have questioned whether the addition of lead to gasoline, and its consequent diffusion into the atmosphere from the automobile emission, poses a danger to the public health.^[3] As use of [8] automobiles, and emission of lead particulates, has accelerated in the last quarter century, this concern has mounted. The reasons for concern are obvious (and essentially undisputed by petitioners): (1) lead in high concentrations in the body is toxic; (2) lead can be absorbed into the body from the ambient air; and (3) lead particulate emissions from gasoline engines account for approximately 90 percent of the lead in our air. Despite these apparent reasons for concern, hard proof of any danger caused by lead automotive emissions has been hard to come by. Part of the reason for this lies in the multiple sources of human exposure to lead.

Lead is an ubiquitous element. It is found in the land, in the sea, in plants, in animals, and, ultimately, in humans. Traces of lead ranging from 10 to 40 micrograms per 100 grams of blood (10-40 ug/100g)^[4] are found in everyone, including those living in environments with almost no atmospheric lead. National Academy of Sciences Committee on Biologic Effects of Atmospheric Pollutants, Airborne Lead in Perspective 118 (1972) (hereinafter NAS Report). Despite its universal presence, however, lead serves no known purpose in the human body, and at higher concentrations is toxic, causing anemia, severe intestinal cramps, paralysis of nerves, fatigue, and even death. Clinical symptoms of lead poisoning appear at blood lead levels of 80-100 ug or higher, and symptomatic lead poisoning may appear at levels of 50-60 ug, particularly in the presence of anemia. EPA's Position on the Health Implications of Airborne Lead (hereinafter Third Health Document) at III-1, Joint Appendix (hereinafter JA) 54-55.

Human body lead comes from three major sources. In most people, the largest source is the diet. EPA estimates daily dietary lead intake for adults to average 200-300 ug per day, with a range of 100-500 ug a day. Third Health Document at V-2, JA 82. Absorption of dietary lead into the bloodstream is estimated at about 10 percent, although in children absorption may be as high as 50 percent. Thus the average adult adds 20-30 ug of lead to his bloodstream daily from his diet alone. This daily intake, which may be highly variable depending on individual diets, NAS Report at 50, is generally regarded as, for all practical purposes, uncontrollable.^[5]

A second major source of the body's lead burden, at least among urban children, is regarded as controllable, although effective control may be both difficult and expensive to achieve. Ingestion of lead paint by children with pica (the abnormal ingestion of non-food substances, a relatively common trait in pre-school children, particular ages 1-3) is generally regarded as "the principal environmental source in cases of severe acute lead poisoning in young children." NAS Report at 140. Lead-based paint was widely used in pre-1940 housing, for both interiors and exteriors, so children living in older housing, particularly in urban ghettos where such paint is both present and peeling, are most susceptible to this form of lead poisoning. Limited control has been achieved in that lead paints are now rarely [9] used, and are frequently banned by statute, for interior surfaces. But while some local laws require removal of existing peeling lead paints, and there is federal legislation to aid states and municipalities in such efforts, Lead-Based Paint Poisoning Prevention Act, 42 U.S.C. §§ 4801 et seq. (1970), there is no concentrated national effort at removal, and the danger to children living in dilapidated housing will remain for some time.^[6]

The last remaining major source of lead exposure for humans is the ambient air. This source is easily the most controllable, since approximately 90 percent of lead in the air comes from automobile emissions,^[7] and can be simply eliminated by removing lead from gasoline.^[8] While the extent to which such lead actually enters the body is vigorously contested by petitioners and lies at the heart of this appeal, all parties agree that, to some extent at least, airborne lead can be absorbed through the lungs as a person breathes lead-contaminated air and that it can be eaten by children with pica after larger lead particles fall to the ground and mix with dust. Once the lead is in the body, however, its source becomes irrelevant; all lead in the bloodstream, from whatever source, is essentially fungible. Thus so long as there are multiple sources of lead exposure it is virtually impossible to isolate one source and determine its particular effect on the body. The effect of any one source is meaningful only in cumulative terms.

The multiple sources of human exposure to lead explain in part why it has been difficult to pinpoint automobile lead emissions as a danger to public health. Obviously, any danger is caused only by the additive effect of lead emissions on the other, largely uncontrollable, sources of lead. For years the lead antiknock industry has refused to accept the developing evidence that lead emissions contribute significantly to the total human lead body burden. In the Clean Air Act Amendments of 1970, Pub.L. 91-604, December 31, 1970, 84 Stat. 1698-1700, however, Congress finally set up a legal mechanism by which that evidence could be weighed in a more objective tribunal. It gave the newly-created EPA authority to control or prohibit the sale or manufacture of any fuel additive whose emission products "will endanger the public health or welfare * * *." 42 U.S.C. § 1857f-6c(c)(1)(A) (1970). It is beyond question that the fuel additive Congress had in mind was lead.^[9]

Given this mandate, EPA published on January 31, 1971 advance notice of proposed rule-making. The Administrator announced he was considering possible controls on lead additives in gasolines, both because of their possible danger to health and because of their incompatibility with the newly-developed catalytic converter emission control system.^[10] 36 Fed.Reg. 1486 (1971). Proposed regulations were issued a year later, February 23, 1972, supported by a document Health Hazards of Lead^[11] (hereinafter First Health Document), [10] prepared by the EPA scientific staff. Comments were invited for a 90-day period, later reopened for an additional 30 days. 37 Fed.Reg. 11786-11787 (1972). At the same time public hearings were held in Washington, D. C., Dallas, and Los Angeles.

On January 10, 1973 the Administrator, while issuing final regulations requiring availability of some lead-free gasoline to allow implementation of the catalytic converter system, 38 Fed.Reg. 1254; approved in Amoco Oil Co. v. EPA, 163 U.S.App.D.C. 162, 501 F.2d 722 (1974), reproposed the health-based regulations now at issue. 38 Fed.Reg. 1258. The reproposal was supported by a second health document, EPA's Position on the Health Effects of Airborne Lead (hereinafter Second Health Document), JA 158, and was necessitated by a modification of EPA's analysis of the health effects of lead emissions. The Agency concluded, after considering the comments received, that it was virtually impossible to identify the precise amount of airborne lead that will endanger public health. Instead, the control strategy would concentrate on evaluating the cumulative effect of airborne lead on total human lead exposure and the significance of that contribution. 38 Fed.Reg. 1258. The reproposed regulations themselves were similar to the original proposal, requiring a phased cutback to 1.25 grams of lead per gallon of leaded gasoline, but, in recognition of the industry's lead-time problems, pushing the timetable for reduction back one year. The Agency again invited public comment, this time for a 60-day period.

On October 28, 1973, as a result of a motion filed in Natural Resources Defense Council, Inc. v. EPA, D.C.Cir. No. 72-2233, this court ordered EPA to reach within 30 days a final decision on whether lead additives should be regulated for health reasons. EPA published its final health document, entitled EPA's Position on the Health Implications of Airborne Lead, on November 28, 1973. JA 27. This document, the Third Health Document, extensively details and reviews the state of knowledge of the health effects of airborne lead. It candidly discusses the various scientific studies, both pro and con, underlying this information, and ultimately concludes that lead from automobile emissions will endanger the public health. The same day, based largely on the conclusions of the Third Health Document, EPA promulgated its final regulations, accompanied by a thorough discussion of its health conclusions, the impact of the regulations, and the alternative courses of action considered and rejected. 38 Fed.Reg. 33734. The final regulations require the same step-wise reduction of lead additives but, in response to the comments of a majority of refiners, calculate the reduction in a slightly different manner. Whereas the original and reproposed regulations set standards for permissible lead use by each refiner on the basis of grams of lead per gallon of leaded gasoline produced (leaded pool averaging), the final regulations base the standards on grams of lead per gallon of all gasoline produced (total pool averaging). The quantity of lead emitted into the atmosphere is the same under both systems; EPA simply converted its leaded pool figures into total pool figures. Under the final regulations, lead in all gasoline would be reduced over a five-year period to an average of 0.5 grams per gallon.^[12]

Petitioners, various manufacturers of lead additives and refiners of gasoline, appealed the promulgation of low-lead regulations to this court under Section 307 of the Clean Air Act, 42 U.S.C. § 1857h-5. The [11] appeal was heard by a division of the court on September 9, 1974. On December 20, 1974, the division, one judge dissenting, ordered the regulations set aside. The majority and dissenting opinions were published on January 28, 1975.^[13] Because of the importance of the issues presented, we granted EPA's petition for rehearing en banc on March 17, 1975, vacating the judgment and opinions of the division and setting the case for reargument on May 30, 1975. All parties were invited to submit supplementary briefs addressing the issues raised by the division opinions.

The regulations are challenged by petitioners on a variety of grounds, all of which will be addressed below. Their primary claims, and the ones on which the division majority based its reversal, are that the Administrator misinterpreted the statutory standard of "will endanger" and that his application of that standard is without support in the evidence and arbitrary and capricious.

II. THE STATUTORY REQUIREMENTS

Under Section 211(c)(1)(A) the Administrator may, on the basis of all the information available to him, promulgate regulations that

control or prohibit the manufacture, introduction into commerce, offering for sale, or sale of any fuel or fuel additive for use in a motor vehicle or motor vehicle engine (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare * * *.

42 U.S.C. § 1857f-6c(c)(1)(A). The Administrator cannot act under Section 211(c)(1)(A), however, until after "consideration of all relevant medical and scientific evidence available to him, including consideration of other technologically or economically feasible means of achieving emission standards under [Section 202]." Section 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A). Section 202 of the Act, 42 U.S.C. § 1857f-1, allows the Administrator to set standards for emission of pollutants from automobiles (as opposed to standards for the composition of the gasoline that produces the emissions), and is thus the preferred—although not the mandatory—alternative under the statutory scheme, presumably because it minimizes Agency interference with manufacturer prerogatives.^[14]

The Administrator is also required, before prohibiting a fuel or fuel additive under Section 211(c)(1)(A), to find, and publish the finding, that in his judgment any fuel or fuel additive likely to replace the prohibited one will not "endanger the public health or welfare to the same or greater degree * * *." Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C). It is significant [12] that this is the only conclusion the Administrator is expressly required to "find" before regulating a fuel or fuel additive for health reasons.

A. The Threshold Determination

In making his threshold determination that lead particulate emissions from motor vehicles "will endanger the public health or welfare," the Administrator provided his interpretation of the statutory language by couching his conclusion in these words: such emissions "present a significant risk of harm to the health of urban populations, particularly to the health of city children." 38 Fed.Reg. 33734. By way of further interpretation, he added that it was his view

that the statutory language * * * does not require a determination that automobile emissions alone create the endangerment on which controls may be based. Rather, the Administrator believes that in providing this authority, the Congress was aware that the public's exposure to harmful substances results from a number of sources which may have varying degrees of susceptibility to control.

Id. It is petitioners' first claim of error that the Administrator has erroneously interpreted Section 211(c)(1)(A) by not sufficiently appreciating the rigor demanded by Congress in establishing the "will endanger" standard. Therefore, petitioners argue, the Administrator's action is "short of statutory right," in violation of Section 10(e)(2)(C) of the Administrative Procedure Act (APA), 5 U.S.C. § 706(2)(C) (1970).

Petitioners argue that the "will endanger" standard requires a high quantum of factual proof, proof of actual harm rather than of a "significant risk of harm." See supplemental brief of petitioner Ethyl Corporation (hereinafter Ethyl Supp.Br.) at 20. Since, according to petitioners, regulation under Section 211(c)(1)(A) must be premised upon factual proof of actual harm, the Administrator has, in their view, no power to assess risks or make policy judgments in deciding to regulate lead additives. Moreover, petitioners argue, regulation must be based on the danger presented by lead additives "in and of themselves," so it is improper to consider, as the Administrator did, the cumulative impact of lead additives on all other sources of human exposure to lead. We have considered these arguments with care and find them to be without merit.^[15] It is our view that the Administrator's interpretation of the standard is the correct one.^[16]

[13] 1. The Precautionary Nature of "Will Endanger." Simply as a matter of plain meaning, we have difficulty crediting petitioners' reading of the "will endanger" standard. The meaning of "endanger" is not disputed. Case law and dictionary definition agree that endanger means something less than actual harm.^[17] When one is endangered, harm is threatened; no actual injury need ever occur. Thus, for example, a town may be "endangered" by a threatening plague or hurricane and yet emerge from the danger completely unscathed.^[18] A statute allowing for regulation in the face of danger is, necessarily, a precautionary statute. Regulatory action may be taken before the threatened harm occurs; indeed, the very existence of such precautionary legislation would seem to demand that regulatory action precede, and, optimally, prevent, the perceived threat. As should be apparent, the "will endanger" language of Section 211(c)(1)(A) makes it such a precautionary statute.

The Administrator read it as such, interpreting "will endanger" to mean "presents a significant risk of harm." 38 Fed.Reg. 33734. We agree with the Administrator's interpretation. This conclusion is reached not only by reference to the plain meaning of the statute, but by juxtaposition of Section 211(c)(1)(A) with other sections of the Clean Air Act and by analysis of pertinent precedent.^[19]

Petitioners support their view of the rigorous nature of the "will endanger" standard by relying on two other sections of the Clean Air Act that also allow for regulation of air pollutants for health reasons. Ethyl [14] Supp.Br. at 18-23; supplemental brief of petitioner Nalco Chemical Company (hereinafter Nalco Supp.Br.) at 20-25; NPRA Supp.Br. at 31-46. However, we find in the same sections relied upon by petitioners firm support for our view of the precautionary nature of Section 211(c)(1)(A). The provisions identified by petitioners are Sections 108 and 202 of the Act. Section 108 directs the Administrator to list, for the purpose of establishing national primary and secondary ambient air quality standards pursuant to Section 109, each air pollutant "which in his judgment has an adverse effect on public health or welfare * * *." Section 108(a)(1)(A), 42 U.S.C. § 1857c-3(a)(1)(A). Section 202 authorizes the Administrator to set standards for each automobile emission "which in his judgment causes or contributes to, or is likely to cause or to contribute to, air pollution which endangers the public health or welfare." Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1).

Petitioners suggest that the threshold decision to regulate under both Section 108 and Section 202 can be based on less evidence than required under Section 211 and that, therefore, the proof necessary for action under Section 211 must be particularly firm. Petitioners misread both sections. Section 108 requires an actual "adverse effect" on health before an air pollutant may be listed for regulation; actual harm must result.^[20] This firm threshold finding is reasonable in light of the considerable disruption caused by action under Sections 108-110. After a pollutant is listed under Section 108, the Administrator must issue national ambient air quality standards under Section 109 within a year. Promulgation of standards begins the implementation plan process of Section 110 under which the states must control, on a mandatory timetable, the listed pollutants to the extent necessary to achieve the federal standards. Section 110, 42 U.S.C. § 1857c-5. Sections 108-110 are "technology forcing" provisions; the attainment of the primary, health-based standards takes precedence over the cost and present technological feasibility of achieving the requisite control. Union Electric Co. v. EPA, 515 F.2d 206, 215-16 (8th Cir.), cert. granted, 423 U.S. 821, 96 S.Ct. 35, 46 L.Ed.2d 38, 44 U.S.L.Week 3200 (1975). Cf. Train v. Natural Resources Defense Council, 421 U.S. 60, 90-91, 95 S.Ct. 1470, 1487-1488, 43 L.Ed.2d 731, 752-753 (1975). See also S.Rep.No.91-1196, 91st Cong., 2d Sess. 1-3 (1970).

Thus, before ordering this extensive chain of action to begin, Congress demanded a threshold determination that the pollutant causes actual harm.^[21] In this sense Section 108 is not a precautionary statute at all, and so differs sharply from Section 211. However, the effects of such after-the-fact regulation are somewhat ameliorated by the Act; Congress did provide a precautionary element in standard-setting under Sections 108-110. Section 109 expressly requires that the ambient air standards ultimately issued provide for "an adequate [15] margin of safety." 42 U.S.C. § 1857c-4(b)(1). Thus, while the threshold decision to regulate under Sections 108-110 is not precautionary but rather requires proof of demonstrable harm caused by the suspect pollutant, once the decision is made the standards promulgated must be preventive in nature. Congress' choice of this scheme is in direct contrast to the procedures it established under Section 211. Under that section the decision to regulate is based on perceived danger. Unless we are to assume Congress chose its language carelessly, regulation in the face of "danger" rather than in the face of "adverse effects" must mean that the threshold decision to regulate under Section 211 is precautionary.^[22] The contrast between the standards of Sections 108-110 and of Section 211 supports our view of the precautionary nature of the "will endanger" standard.^[23]

Petitioners also rely on Section 202 to support their strict reading of Section 211. Ethyl suggests that Section 202 is more lenient than Section 211 in that it allows regulation of "likely" dangers. Ethyl Supp.Br. at 18-19. See also Nalco Supp.Br. at 20-21; NPRA Supp.Br. at 31-36. Section 202 provides that the Administrator may regulate

The emission of any air pollutant [from any new motor vehicle] which in his judgment causes or contributes to, or is likely to cause or to contribute to, air pollution which endangers the public health or welfare.

42 U.S.C. § 1857f-1(a)(1) (emphasis added). While this language may be unnecessarily opaque, we think a fair reading disproves petitioners' suggestion. The italicized language upon which petitioners rely refers not to the causal relationship between air pollution and health, but to the relationship between automobile emissions and air pollution.^[24] Thus regulation may not be premised on a threshold determination of likely danger; rather regulation must be premised on a determination of danger, a finding that "air pollution which endangers the public health" is the end product of the emission to be regulated. This is essentially the same finding of endangerment as under [16] Section 211. "Likely" enters the equation only in determining whether the emitted air pollutant, which would be regulated, contributes to the air pollution which is found dangerous. Here the statute allows for a somewhat attenuated chain of causation. Regulation may be premised on a determination that an air pollutant emitted from a new automobile is likely to contribute to air pollution which endangers the public health. In establishing this chain of causation Section 202 is more lenient than Section 211,^[25] but in making the threshold determination of danger both sections are the same:^[26] air pollution must endanger the public health before regulation is justified.^[27]

Thus the two sections of the Clean Air Act presented by petitioners in support of their stringent reading of the threshold requirement for action under Section 211 turn out, upon analysis, to be of no support at all. Section 108 only bolsters our reading of Section 211 as a precautionary statute while Section 202 includes the same standard as Section 211 and thus is of no guidance one way or the other. While petitioners have little more to offer to prove that the "will endanger" standard demands proof of actual harm and is not precautionary in nature, we may turn, in support of our interpretation, to the relevant case law. While cases interpreting the meaning of "endanger" are few in number,^[28] at least [17] one recent case is directly on point and fully in accord with our view.

In Reserve Mining Co. v. EPA, 514 F.2d 492 (8th Cir. 1975) (en banc), the Eighth Circuit addressed, among other issues, the meaning of the phrase "endangering the health or welfare of persons" under Section 112 of the Federal Water Pollution Control Act of 1970 (FWPCA), 33 U.S.C. § 1160. FWPCA and the Clean Air Act together constitute the bulk of this nation's substantive environmental protection legislation.^[29] As such, and because of their contemporaneous enactment, interpretations of provisions of one Act have frequently been applied to comparable provisions of the other. See, e. g., Natural Resources Defense Council, Inc. v. Train, 166 U.S.App.D.C. 312, 321-322, 510 F.2d 692, 701-702 (1975). Thus Reserve Mining's interpretation of "endangering" is relevant to the meaning of the term "endanger" in the Clean Air Act. Indeed, it is particularly relevant because in construing the language before it the Eighth Circuit borrowed extensively from the interpretation of the "will endanger" language of Section 211 expressed in the dissent from the division opinion in this case, the same interpretation we adopt here. See Reserve Mining Co. v. EPA, supra, 514 F.2d at 528-529. After analysis of the plain meaning of the FWPCA provision, comparison with other sections of that Act, and reference to our division's dissent, the Eighth Circuit's unanimous conclusion fully supports our view of the "will endanger" standard:

In the context of this environmental legislation, we believe that Congress used the term "endangering" in a precautionary or preventive sense, and, therefore, evidence of potential harm as well as actual harm comes within the purview of that term.

Id. at 528.

In sum, based on the plain meaning of the statute, the juxtaposition of Section 211 with Sections 108 and 202, and the Reserve Mining precedent, we conclude that the "will endanger" standard is precautionary in nature and does not require proof of actual harm before regulation is appropriate.^[30]

Perhaps because it realized that the above interpretation was the only possible reading of the statutory language, petitioner Ethyl addresses this interpretation and argues that even if actual harm is not required [18] for action under Section 211(c)(1)(A), the occurrence of the threatened harm must be "probable" before regulation is justified. Ethyl Supp.Br. 12. While the dictionary admittedly settles on "probable" as its measure of danger, we believe a more sophisticated case-by-case analysis is appropriate.^[31] Danger, the Administrator recognized, is not set by a fixed probability of harm, but rather is composed of reciprocal elements of risk and harm, or probability and severity. Cf. Carolina Environmental Study Group v. United States, 166 U.S.App.D.C. 416, 419, 510 F.2d 796, 799 (1975); Reserve Mining Co. v. EPA, supra, 514 F.2d at 519-520. That is to say, the public health may properly be found endangered both by a lesser risk of a greater harm and by a greater risk of a lesser harm.^[32] Danger depends upon the relation between the risk and harm presented by each case, and cannot legitimately be pegged to "probable" harm, regardless of whether that harm be great or small. As the Eighth Circuit found in Reserve Mining, these concepts "necessarily must apply in a determination of whether any relief should be given in cases of this kind in which proof with certainty is impossible."^[33] 514 F.2d at 520.

In Reserve Mining the issue was whether asbestiform wastes flushed into Lake Superior by the Reserve Mining Company endangered health.^[34] The polluted lake [19] waters formed the drinking supply of several surrounding communities, while a medical theory, bolstered only by inconclusive evidence, suggested that ingestion of the wastes caused cancer. See pages ___ - ___ of 176 U.S.App.D.C., pages 45-46 of 541 F.2d infra. Applying the "endangering the health or welfare of persons" standard of the FWPCA, the court found the wastes to be a danger cognizable under the Act. The court did not find that the danger was probable; rather it found the wastes to be "potentially harmful," 514 F.2d at 528, and potential harm to be embraced by the "endangering" standard, id. See page ___ of 176 U.S.App.D.C., page 17 of 541 F.2d supra. The court concluded:

The record shows that Reserve is discharging a substance into Lake Superior waters which under an acceptable but unproved medical theory may be considered as carcinogenic. As previously discussed, this discharge gives rise to a reasonable medical concern over the public health. We sustain the district court's determination that Reserve's discharge into Lake Superior constitutes pollution of waters "endangering the health or welfare of persons" within the terms of §§ 1160(c)(5) and (g)(1) of the Federal Water Pollution Control Act and is subject to abatement.

514 F.2d at 529 (footnote omitted; emphasis added). The court thus allowed regulation of the effluent on only a "reasonable" or "potential" showing of danger, hardly the "probable" finding urged by Ethyl as the proper reading of the "endanger" language in Section 211. The reason this relatively slight showing of probability of risk justified regulation is clear: the harm to be avoided, cancer, was particularly great. However, because the risk was somewhat remote, the court did not order the immediate cessation of asbestiform dumping, but rather ordered such cessation within "a reasonable time." Id. at 538.

Reserve Mining convincingly demonstrates that the magnitude of risk sufficient to justify regulation is inversely proportional to the harm to be avoided. Cf. Carolina Environmental Study Group v. United States, supra. It would be a bizarre exercise in balancing horrors to determine whether cancer or lead poisoning is a greater harm to be avoided,^[35] but fortunately such balancing is unnecessary in this case. Undoubtedly, the harm caused by lead poisoning is severe; nonetheless, the Administrator does not rely on a "potential" risk or [20] a "reasonable medical concern" to justify the regulations before us. Instead, he finds a "significant" risk of harm to health. While this finding may be less than the "probable" standard urged by Ethyl, it is considerably more certain than the risk that justified regulation in Reserve Mining of a comparably "fright-laden" harm. Cf. Environmental Defense Fund, Inc. v. EPA, 150 U.S.App.D.C. 348, 358, 465 F.2d 528, 538 (1972). Moreover, like the Reserve Mining court, in the face of this still less than certain risk the Administrator did not order the cessation of use of lead additives, but rather directed a phased step-down to a plateau level. Thus we conclude that however far the parameters of risk and harm inherent in the "will endanger" standard might reach in an appropriate case, they certainly present a "danger" that can be regulated when the harm to be avoided is widespread lead poisoning and the risk of that occurrence is "significant."^[36]

2. The Administrator's Power to Assess Risks. Petitioners argue that Section 211 requires the Administrator to make a "threshold factual determination" that automobile emissions "will endanger" the public health, Nalco Supp.Br. at 15-20; Ethyl Supp.Br. at 24-26, and dispute EPA's claim that the Administrator may make "an essentially legislative policy judgment, rather than a factual determination, concerning the relative risks of underprotection as compared to overprotection." Industrial Union Department, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331, 339, 499 F.2d 467, 475 (1974). We must reject petitioners' argument, since the power to assess risks, without relying solely on facts, flows inexorably from the nature of the "will danger" standard. We have already found that Section 211 allows the Administrator to regulate fuel content when he finds that emissions cause a significant risk of harm to the public health. Yet, how can the Administrator determine that a risk is a significant risk if he cannot assess risks? And how can he assess risks if he cannot make policy judgments? Surely reliance on "facts" as contemplated by petitioners will provide little guidance. However, sole reliance on facts was not demanded by Congress.^[37]

[21] Originally, it is true, it appeared that Congress would severely restrict the Administrator's ability to assess risks and make policy judgments to protect public health. The bill sent to the floor of the House, and eventually passed by the House, would have allowed EPA to control fuels or fuel additives only if the determination that their emission products would endanger the public health were established

on the basis of specific findings derived from relevant medical and scientific evidence, including * * * a finding that it is not otherwise technologically or economically feasible to achieve the emission standards established pursuant to section 202 of this Act.

H.R. 17255, 91st Cong., 2d Sess. § 210(g)(1) (1970) (emphasis added). The specific findings requirement had more than procedural significance. It limited the scope of evidence on which the Administrator could proceed, made alternative action under Section 202 mandatory if possible, and was widely interpreted in the House, as the extracts of debate relied upon by petitioners show, Ethyl Supp.Br. at 24; NPRA Supp.Br. at 30; Nalco Supp.Br. at 15, as requiring that any EPA action be based solely on facts.^[38]See also H.R.Rep. No. [22] 91-1146, 91st Cong., 2d Sess., at 13 (1970), U.S.Code Cong. & Admin.News 1970, p. 5356.

But the House bill did not become law. The Senate's preference for less restriction of EPA freedom in regulating fuel additives for health reasons^[39] was adopted by the conference committee and ultimately enacted into law.^[40] Although the legislative history does not expressly discuss the reasons for the change,^[41] the contrast in language is stark. As Section 211 now [23] reads, the only "finding" the Administrator is required to make is that any fuel additive that might replace one that is prohibited does not cause emissions that will pose the same or greater danger to the public health.^[42] The substantive impact of the change is clear. All of the requirements for specific findings quoted above are replaced by requirements that the Administrator "consider" the specified evidence. The mandatory deference to Section 202 is removed.^[43] And the Administrator may act based on all information available to him.^[44] As we recognized in Amoco, construing a similar change in parallel Section 211(c)(1)(B), the conference committee's decision "was a deliberated one and was meant to have significance." Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 173, 501 F.2d at 733.

In this case the decision has even more significance than it did in Amoco, for under Section 211(c)(1)(B), at issue in Amoco, the Administrator was still required to make "findings." All the conferees dropped was the adjective "specific." For regulation under Section 211(c)(1)(A), at issue here, however, the entire requirement was dropped, and no greater restriction was placed on the Administrator than that required by the "basis and purpose" statement of Section 4(b) of the APA, 5 U.S.C. § 553(c). We interpreted the meaning of the limited findings requirement for acting under Section 211(c)(1)(B) in Amoco :

[W]e read Section 211(c)(2)(B) as incorporating the commonsense approach which the courts have developed in applying Section 4(b)^[45] of the APA. Where EPA's regulations turn crucially on factual issues, we will demand sufficient attention to these in the statement to allow the fundamental rationality of the regulations to be ascertained. Where, by contrast, the regulations turn on choices of policy, on an assessment of risks, or on predictions dealing with matters on the frontiers of scientific knowledge, we will demand adequate reasons and explanations, but not "findings" of the sort familiar from the world of adjudication.

Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-741 (emphasis added). Thus the Amoco court read the limited findings necessary for action under Section 211(c)(1)(B) as a flexible requirement that demanded actual findings for questions of fact and something less—"adequate reasons and explanations"—for questions of policy.

As petitioners correctly point out, the Amoco court applied this approach by holding that the threshold determination whether to regulate at all under Section 211(c)(1)(B) was essentially a question of fact, for which a factual finding must be offered. In suggesting that such a finding is necessary for action under Section 211(c)(1)(A) as well, however, petitioners completely ignore the fact that a finding is required for action under Section 211(c)(1)(B) and is not required under Section 211(c)(1)(A). By so glossing over the language of the statute, petitioners miss a vital difference between the threshold determinations under Sections 211(c)(1)(A) and (B). Recall what the Administrator must find in order to act under Section [24] 211(c)(1)(B): that the emission products of the fuel or additive to be regulated

will impair to a significant degree the performance of any emission control device or system which is in general use, or which the Administrator finds has been developed to a point where in a reasonable time it would be in general use were such regulation to be promulgated.

42 U.S.C. § 1857f-6c(c)(1)(B). At its core, this is a peculiarly factual finding. Will the emission impair the performance of a control device? Is the device in general use, or has it the potential to be? These were the questions, highly suitable to factual proof, that the Amoco court construed. Contrary to petitioners' implication, the court did not hold that any threshold determination to regulate must be based on factual proof, but that this threshold determination must be factually based. The Section 211(c)(1)(A) threshold determination, however, is inherently unlike that of its sister section. "Endanger," as we have suggested above, is not a standard prone to factual proof alone. Danger is a risk, and so must be decided by assessment of risks as well as by proof of facts.

Thus a reason emerges for the deletion of the findings requirement for action under the "will endanger" standard. The Amoco court held the findings requirement of Section 211(c)(1)(B) no more than reiterated the minimal demands of the basis and purpose statement of the APA. Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 179, 501 F.2d at 739. What Congress was doing, then, was using the findings requirement to indicate which section demanded a factual threshold determination and which section did not. While inclusion of the phrase was unnecessary in that the APA would have demanded a factual threshold determination under Section 211(c)(1)(B) in any case, the selective use of the findings requirement served to emphasize to the Administrator the demands of the APA and the intent of the Congress. While Congress did not discuss the extent of the Administrator's power under the "will endanger" standard, its actions—the statute it enacted and the one it rejected—make the legislative intent clear. We find that deletion of the findings requirement for action under Section 211(c)(1)(A) was a recognition by Congress that a determination of endangerment to public health is necessarily a question of policy that is to be based on an assessment of risks and that should not be bound by either the procedural or the substantive rigor proper for questions of fact.

This conclusion follows not only from the language of Section 211(c)(1)(A) and its legislative history, but from the nature of the Administrator's charge: to protect the public from danger. Regulators such as the Administrator must be accorded flexibility, a flexibility that recognizes the special judicial interest in favor of protection of the health and welfare of people, even in areas where certainty does not exist. Environmental Defense Fund, Inc. v. Ruckelshaus, 142 U.S.App.D.C. 74, 88, 439 F.2d 584, 598 (1971).

Questions involving the environment are particularly prone to uncertainty. Technological man has altered his world in ways never before experienced or anticipated. The health effects of such alterations are often unknown, sometimes unknowable. While a concerned Congress has passed legislation providing for protection of the public health against gross environmental modifications,^[46] the regulators entrusted with the enforcement of such laws have not thereby been endowed with a prescience that removes all doubt from their decisionmaking. Rather, speculation, conflicts in evidence, and theoretical extrapolation typify their every action. How else can they act, given a mandate to protect the public health but only a slight or nonexistent data base upon which to draw? Never before have massive quantities of asbestiform tailings been spewed into the water we drink.^[47] [25] Never before have our industrial workers been occupationally exposed to vinyl chloride^[48] or to asbestos dust.^[49] Never before has the food we eat been permeated with DDT^[50] or the pesticides aldrin and dieldrin.^[51] And never before have hundreds of thousands of tons of lead emissions been disgorged annually into the air we breathe. Sometimes, of course, relatively certain proof of danger or harm from such modifications can be readily found. But, more commonly, "reasonable medical concerns" and theory long precede certainty. Yet the statutes—and common sense—demand regulatory action to prevent harm, even if the regulator is less than certain that harm is otherwise inevitable.

Undoubtedly, certainty is the scientific ideal—to the extent that even science can be certain of its truth.^[52] But certainty in the complexities of environmental medicine may be achievable only after the fact, when scientists have the opportunity for leisurely and isolated scrutiny of an entire mechanism. Awaiting certainty will often allow for only reactive, not preventive, regulation.^[53] Petitioners suggest that anything less than certainty, that any speculation, is irresponsible. But when statutes seek to avoid environmental catastrophe, can preventive, albeit uncertain, decisions legitimately be so labeled?

The problems faced by EPA in deciding whether lead automotive emissions pose a threat to the public health highlight the limitations of awaiting certainty. First, lead concentrations are, even to date, essentially low-level, so that the feared adverse effects would not materialize until after a lifetime of exposure. Contrary to petitioners' suggestion, however, we have not yet suffered a lifetime of exposure to lead emissions. At best, emissions at present levels have been with us for no more than 15-20 years.^[54] Second, lead exposure from the ambient air is pervasive, so that valid control groups cannot be found against which the effects of lead on our population can be measured. Third, the sources of human exposure to lead are multiple, so [26] that it is difficult to isolate the effect of automobile emissions. Lastly, significant exposure to lead is toxic, so that considerations of decency and morality limit the flexibility of experiments on humans that would otherwise accelerate lead exposure from years to months, and measure those results.^[55]Cf. Environmental Defense Fund, Inc. v. EPA (Shell), 167 U.S.App.D.C. 71, 78, 510 F.2d 1292, 1299 (1975).

The scientific techniques for attempting to overcome these limitations are several: toxicology can study the distribution and effect of lead in animals; epidemiological techniques can analyze the effects of lead emissions on entire populations; clinical studies can reproduce in laboratories atmospheric conditions and measure under controlled circumstances the effects on humans. All of these studies are of limited usefulness, however. Dr. J. H. Knelson, Director of EPA's Human Studies Laboratory, has described, in the context of setting ambient air standards, the limitations of these various investigative tools:

Each of these investigative approaches—classic toxicology, epidemiology, and clinical research has its advantages and disadvantages. The toxicologist can control the dose and use invasive or destructive techniques in measuring response in the animal, but is always faced with the problem of extrapolating results to humans. Epidemiology is most relevant because it studies phenomena actually occurring in humans under "natural" conditions, but can only draw inference from observed correlations rather than prove cause and effect relationships. Clinical research can provide the most accurate dose-response relationships in the species of interest. Precisely because the study subjects are humans, however, many experimental design problems are encountered in assuring their safety. Although the dose of an atmospheric pollutant can be carefully controlled and measured in the clinical laboratory, qualitative comparability to the multiplex variable of atmospheric pollution cannot always be assured.

The best scientific criteria for establishing air quality standards result from interactions between these disciplines. Clinical studies must be preceded by exhaustive toxicological assessment in other species; observations from population studies should play an important role in the experimental design of clinical research. Biomedical data from all these sources, taken in their entirety, should be used for the prudent definition of air pollution control needs.

JA 582-583. The best biomedical evidence will be derived from relating all three research approaches. This EPA did. That petitioners, and their scientists, find a basis to disagree is hardly surprising, since the results are still uncertain, and will be for some time. But if the statute accords the regulator flexibility to assess risks and make essentially legislative policy judgments, as we believe it does, preventive regulation based on conflicting and inconclusive evidence may be sustained. Recent cases have recognized this flexibility in similar situations.

In Industrial Union Department, AFL-CIO v. Hodgson, supra, this court considered the Secretary of Labor's delegated power under the Occupational Safety and Health Act (OSHA), 29 U.S.C. § 651 et seq., to protect the health of industrial workers by setting standards for exposure to industrial pollutants. Under review was a standard for exposure to asbestos dust, thought to be carcinogenic. Judge McGowan, writing for the division, laid down the rule:

From extensive and often conflicting evidence, the Secretary in this case made numerous factual determinations. With respect to some of those questions, the evidence was such that the task consisted primarily of evaluating the data and drawing conclusions from it. The court [27] can review that data in the record and determine whether it reflects substantial support for the Secretary's findings. But some of the questions involved in the promulgation of these standards are on the frontiers of scientific knowledge, and consequently as to them insufficient data is presently available to make a fully informed factual determination. Decision making must in that circumstance depend to a greater extent upon policy judgments and less upon purely factual analysis.18

18 Where existing methodology or research in a new area of regulation is deficient, the agency necessarily enjoys broad discretion to attempt to formulate a solution to the best of its ability on the basis of available information, Permian Basin Area Rate Cases, 390 U.S. 747, 811, 88 S.Ct. 1344, 20 L.Ed.2d 312 (1968).

162 U.S.App.D.C. at 338, 499 F.2d at 474.

This rule was likewise applied in Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir.), cert. denied, 421 U.S. 992, 95 S.Ct. 1998, 44 L.Ed.2d 482 (1975), where the Second Circuit reviewed regulations limiting industrial exposure to vinyl chloride, also considered a carcinogen:

As in Industrial Union Department, AFL-CIO v. Hodgson, supra, the ultimate facts here in dispute are "on the frontiers of scientific knowledge," and, though the factual finger points, it does not conclude. Under the command of OSHA, it remains the duty of the Secretary to act to protect the workingman, and to act even in circumstances where existing methodology or research is deficient. The Secretary, in extrapolating the MCA study's finding from mouse to man, has chosen to reduce the permissible level to the lowest detectable one. We find no error in this respect.

Id. at 1308. And in Reserve Mining the Eighth Circuit agreed. Although reviewing the determination of a District Court, not an expert Administrator, the court recognized that it must nonetheless apply the test of the preventive statute before it:

[W]e note that many of the issues in this case do not involve "historical" facts subject to the ordinary means of judicial resolution. Indeed, a number of the disputes involve conflicting theories and experimental results, about which it would be judicially presumptuous to offer conclusive findings [quoting Amoco Oil Co. v. EPA, 163 U.S.App.D.C. 181, 501 F.2d at 741, which relied on Industrial Union]. In such circumstances, the finder of fact must accept certain areas of uncertainty, and the findings themselves cannot extend further than attempting to assess or characterize the strengths and weaknesses of the opposing arguments.

514 F.2d at 507 n.20. See also id. at 529.

These cases, recognizing as they do the developing nature of environmental medicine, fortify our analysis of the "will endanger" language of Section 211.^[56] [28] Where a statute is precautionary in nature,^[57] the evidence difficult to come by, uncertain, or conflicting because it is on the frontiers of scientific knowledge, the regulations designed to protect the public health, and the decision that of an expert administrator, we will not demand rigorous step-by-step proof of cause and effect. Such proof may be impossible to obtain if the precautionary purpose of the statute is to be served. Of course, we are not suggesting that the Administrator has the power to act on hunches or wild guesses. Amoco makes it quite clear that his conclusions must be rationally justified. Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-741. However, we do hold that in such cases the Administrator may assess risks. He must take account of available facts, of course, but his inquiry does not end there. The Administrator may apply his expertise to draw conclusions from suspected, but not completely substantiated, relationships between facts, from trends among facts, from theoretical projections from imperfect data, from probative preliminary data not yet certifiable as "fact," and the like. We believe that a conclusion so drawn—a risk assessment—may, if rational, form the basis for health-related regulations under the "will endanger" language of Section 211.^[58]

[29] All of this is not to say that Congress left the Administrator free to set policy on his own terms. To the contrary, the policy guidelines are largely set, both in the statutory term "will endanger" and in the relationship of that term to other sections of the Clean Air Act. These prescriptions direct the Administrator's actions. Operating within the prescribed guidelines, he must consider all the information available to him. Some of the information will be factual, but much of it will be more speculative—scientific estimates and "guesstimates" of probable harm, hypotheses based on still-developing data, etc. Ultimately he must act, in part on "factual issues," but largely "on choices of policy, on an assessment of risks, [and] on predictions dealing with matters on the frontiers of scientific knowledge * * *." Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 181, 501 F.2d at 741. A standard of danger—fear of uncertain or unknown harm—contemplates no more.

3. Propriety of the Cumulative Impact Approach. In addition to demanding that the Administrator act solely on facts, petitioner Ethyl insists that those facts convince him that the emission product of the additive to be regulated "in and of itself," i. e., considered in isolation, endangers health. The Administrator contends that the impact of lead emissions is properly considered together with all other human exposure to lead. See page ___ of 176 U.S.App.D.C., page 12 of 541 F.2d supra. We agree.

First, Ethyl points to the language of Section 202 allowing regulation of any automobile emission that "causes or contributes to, or is likely to cause or to contribute to, air pollution which endangers the public health or welfare." Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis Ethyl's in its brief at 18). This is contrasted with Section 211's language allowing regulation of fuels or fuel additives whose "emission products * * * will endanger the public health or welfare." By italicizing the "contribute to" language of Section 202 Ethyl presumably suggests that Section 202 is more lenient, allowing use of the cumulative impact theory while Section 211 does not. This argument is but a variant on Ethyl's already rejected claim that Section 202 allows for regulation of "likely" dangers while Section 211 does not. As with the earlier argument, this reading of Section 202 must be rejected. While it is possible that Section 202's inclusion of emissions that "cause or contribute to air pollution" is more encompassing than Section 211's term "emission products," it is clear that whatever leniency Section 202 suggests only concerns the makeup of air pollution. This is irrelevant to the cumulative impact theory. However they differ, both Section 202 and Section 211 allow regulation of lead additives only on a determination that the resultant polluted air, however composed, endangers the public health.^[59] Both provisions leave open the question whether emissions or air pollution can be found to endanger the public health when the endangerment is not caused by that pollution alone.^[60]

While Ethyl's comparison suggests no answer, the question is directly raised here. The Administrator found endangerment, but recognized that the national lead exposure problem is caused, not by air pollution alone, but by an aggregate of sources, including food, water, leaded paint, and dust. [30] He believed that regulation was justified because the aggregate was dangerous, and because leaded gasoline was a significant source that was particularly suited to ready reduction. 38 Fed.Reg. 33734. To the question whether the Administrator was correct in his belief, comparison with the "contribute to" language of Section 202 provides no guidance.

The only other evidence relied upon by Ethyl for its "in and of itself" theory is a quotation, taken out of context, from Senator Baker. When the context of Ethyl's partial quotation is revealed the irrelevance of his statement to Ethyl's theory becomes clear. Senator Baker reviewed the Committee bill for the Senate:

The [Administrator] is authorized to either control or prohibit the sale of any given fuel when he finds one of two things:

First. That the combustion or evaporation of such fuel produces emissions that, in and of themselves, endanger the public health or welfare; or

Second. That such emissions prevent the operation of a system that is necessary to reduce automobile emissions to the levels required by standards issued by the [Administrator] under section 202 of the act.

116 Cong.Rec. 32920 (1970) (emphasis added). Ethyl relies on the Senator's subsequent repetition of the words "in and of themselves," italicized above. Ethyl brief at 16. But the second paragraph makes clear that Senator Baker's meaning is contrary to Ethyl's implication. He is simply emphasizing the different nature of the two provisions and thus uses the words "in and of themselves" to show that under Section 211(c)(1)(A) the Administrator may act only because of the direct effects of lead additives on a legislative goal, protection of health, while under Section 211(c)(1)(B) he may act because of their indirect effects on another goal, implementation of emission control systems.^[61]

Beyond these two points, Ethyl has nothing more to offer in support of its "in and of itself" reading. Thus it has made out no case at all, particularly in light of the realities of human exposure to lead and what Congress knew about those realities. Such consideration demonstrates both that, under Ethyl's approach, EPA regulation of lead on health grounds would be impossible and that Congress could not possibly have intended the restrictive "by itself" reading. As has been discussed more extensively above, see pages ___ - ___ of 176 U.S.App.D.C., pages 8-9 of 541 F.2d supra, lead enters the human body from multiple sources, so that the effect of any one source is meaningful only in cumulative terms. If, for example, airborne lead were the only source of the lead body burden, and it caused, by itself, a blood lead level of 30 ug, there would be no danger to the public health. But if that hypothetical 30 ug is added to a possible 30 ug attributable to dietary ingestion, the blood lead level would be 60 ug, a definite threat to health. Under Ethyl's approach, despite obvious endangerment such a cumulative finding is insufficient to justify regulation. Airborne, lead, in and of itself, may not be a threat. But the realities of human lead exposure show that no one source in and of itself (except possibly leaded paint) is a threat. Thus, under Ethyl's tunnel-like reasoning, even if parallel legislation permitted regulation of other sources of lead exposure, which it does not, no regulation could ever be justified.

Such cannot be the case. Congress understood that the body lead burden is caused by multiple sources. It understood [31] that determining the effect of lead automobile emissions, by themselves, on human health is of no more practical value than finding the incremental effect on health of the fifteenth sleeping pill swallowed by a would-be suicide.^[62] It did not mean for "endanger" to be measured only in incremental terms.^[63] This the Administrator also understood. He determined that absorption of lead automobile emissions, when added to all other human exposure to lead, raises the body lead burden to a level that will endanger health. He realized that lead automobile emissions were, far and away, the most readily reduced significant source of environmental lead. And he determined that the statute authorized him to reduce those emissions on such a finding. We find no error in the Administrator's use of the cumulative impact approach.

4. Summary of the "Will Endanger" Determination. In sum, we must reject petitioners' cramped and unrealistic interpretation of Section 211(c)(1)(A). Their reading would render the statute largely useless as a basis for health-related regulation of lead emissions. Petitioners' arguments are rebuffed by the plain meaning of the statute and the Administrator's interpretation of it,^[64] by the legislative history and the implications that can drawn from other sections of the same statute, by the relevant precedents, and by the established maxim that health-related legislation is liberally construed to achieve its purpose.^[65]

We believe the Administrator may regulate lead additives under Section 211(c)(1)(A) when he determines, based on his assessment of the risks as developed by [32] consideration of all the information available to him, and as guided by the policy judgment inherent in the statute, that lead automobile emissions significantly increase the total human exposure to lead so as to cause a significant risk of harm to the public health. Before so regulating, he must consider the possibility of regulation under Section 202.^[66] This interpretation of Section 211 does not allow for baseless or purposeless regulation, but does grant the Administrator the flexibility needed to confront realistically the public health problem presented by massive diffusion of lead emissions from automobiles.

B. Comparison with Substitute Additives

Even when the Administrator has determined that a fuel or fuel additive causes emissions which endanger the public health, he is not yet free to prohibit the substance under Section 211. He must first find, and publish his finding,

that in his judgment such prohibition will not cause the use of any other fuel or fuel additive which will produce emissions which will endanger the public health or welfare to the same or greater degree than the use of the fuel or fuel additive proposed to be prohibited.

Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C).

Preliminarily it must be noted that the section requires a finding only before the Administrator "prohibits" a fuel or fuel additive under Section 211. Since the proposed regulations only "control" lead additives, the findings requirement, on its face, does not apply to the EPA action.^[67] If the requirement is read to apply, however, it plainly demands no more than the findings [33] requirement of Section 211(c)(2)(B), as construed in Amoco, see pages ___ - ___ of 176 U.S.App.D.C., page 23 of 541 F.2d supra. This conclusion is compelled by the identical genesis of the two provisions, plus the fact that the Section 211(c)(2)(C) finding is judgmental by its own terms. Thus where the judgment turns "on factual issues" we will "demand sufficient attention to these in the statement to allow the fundamental rationality * * * to be ascertained." Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-741. By contrast, where the judgment is necessarily more speculative, we will "demand adequate reasons and explanations, but not `findings' of the sort familiar from the world of adjudication." Id., 163 U.S.App.D.C. at 181, 501 F.2d at 741.^[68]

After making the "will endanger" determination and the "substitute additives" finding, EPA has complied with the statutory mandate and is free to regulate the fuel or fuel additive under Section 211.

III. THE EVIDENCE

A. The Standard of Review

In promulgating the low-lead regulations under Section 211, EPA engaged in informal rule-making. As such, since the statute does not indicate otherwise, its procedures are conducted pursuant to Section 4 of the APA,^[69] 5 U.S.C. § 553, [34] and must be reviewed under Section 10 of the Act,^[70] 5 U.S.C. § 706(2)(A)-(D). Our review of the evidence is governed by Section 10(e)(2)(A), which requires us to strike "agency action, findings, and conclusions" that we find to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law * * *."^[71] 5 U.S.C. § 706(2)(A). This standard of review is a highly deferential one. It presumes agency action to be valid. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 823, 28 L.Ed.2d 136, 152 (1971); Pacific States Box & Basket Co. v. White, 296 U.S. 176, 185-186, 56 S.Ct. 159, 163-164, 80 L.Ed. 138, 146-147 (1935); United States v. Chemical Foundation, 272 U.S. 1, 14-15, 47 S.Ct. 1, 6, 71 L.Ed. 131, 142-143 (1926).^[72] Moreover, it forbids the court's substituting its judgment for that of the agency, Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 416, 91 S.Ct. at 823, 28 L.Ed.2d at 153, and requires affirmance if a rational basis exists for the agency's decision.^[73]Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 290, 95 S.Ct. 438, 444, 42 L.Ed.2d 447, 458 (1974). Cf. United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749, 92 S.Ct. 1941, 1946, 32 L.Ed.2d 453, 460 (1972).

This is not to say, however, that we must rubber-stamp the agency decision as correct. To do so would render the appellate process a superfluous (although time-consuming) ritual. Rather, the reviewing court must assure itself that the agency decision was "based on a consideration of the relevant factors * * *."^[74] Moreover, [35] it must engage in a "substantial inquiry" into the facts, one that is "searching and careful." Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 415, 416, 91 S.Ct. at 823, 824, 28 L.Ed.2d at 152, 153. This is particularly true in highly technical cases such as this one.

A court does not depart from its proper function when it undertakes a study of the record, hopefully perceptive, even as to the evidence on technical and specialized matters, for this enables the court to penetrate to the underlying decisions of the agency, to satisfy itself that the [36] agency has exercised a reasoned discretion, with reasons that do not deviate from or ignore the ascertainable legislative intent.

Greater Boston Television Corp. v. FCC, 143 U.S.App.D.C. 383, 392, 444 F.2d 841, 850 (1970), cert. denied, 403 U.S. 923, 91 S.Ct. 2229, 2233, 29 L.Ed.2d 701 (1971). See also Essex Chemical Corp. v. Ruckelshaus, 158 U.S.App.D.C. 360, 367, 486 F.2d 427, 434 (1973), cert. denied, 416 U.S. 969, 94 S.Ct. 1991, 40 L.Ed.2d 558 (1974); Portland Cement Assn v. Ruckelshaus, 158 U.S.App.D.C. 308, 335, 486 F.2d 375, 402 (1973), cert. denied, 417 U.S. 921, 94 S.Ct. 2628, 41 L.Ed.2d 226 (1974); International Harvester Co. v. Ruckelshaus, 155 U.S.App.D.C. 411, 444, 478 F.2d 615, 648 (1971).^[75]

There is no inconsistency between the deferential standard of review and the requirement that the reviewing court involve itself in even the most complex evidentiary matters; rather, the two indicia of arbitrary and capricious review stand in careful balance. The close scrutiny of the evidence is intended to educate the court. It must understand enough about the problem confronting the agency to comprehend the meaning of the evidence relied upon and the evidence discarded; the questions addressed by the agency and those bypassed; the choices open to the agency and those made. The more technical the case, the more intensive must be the court's effort to understand the evidence, for without an appropriate understanding of the case before it the court cannot properly perform its appellate function. But that function must be performed with conscientious awareness of its limited nature. The enforced education into the intricacies of the problem before the agency is not designed to enable the court to become a superagency that can supplant the agency's expert decision-maker. To the contrary, the court must give due deference to the agency's ability to rely on its own developed expertise. Market Street Railway v. Railroad Commission, 324 U.S. 548, 559-561, 65 S.Ct. 770, 776-777, 89 L.Ed. 1171, 1180-1182 (1945). The immersion in the evidence is designed solely to enable the court to determine whether the agency decision was rational and based on consideration of the relevant factors. Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 416, 91 S.Ct. at 823, 28 L.Ed.2d at 153; Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra, 419 U.S. at 285, 290, 95 S.Ct. at 441, 444, 42 L.Ed.2d at 455, 458. It is settled that we must affirm decisions with which we disagree so long as this test is met.^[76]Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra, 419 U.S. at 290, 95 S.Ct. at 444, 42 L.Ed.2d at 458; United States v. Allegheny-Ludlum Steel Corp., supra, 406 U.S. at 749, 92 S.Ct. at 1946, 32 L.Ed.2d at 460.

Thus, after our careful study of the record, we must take a step back from the agency decision. We must look at the decision not as the chemist, biologist or statistician that we are qualified neither by training nor experience to be, but as a reviewing court exercising our narrowly defined duty of holding agencies to certain minimal standards of rationality.^[77] "Although [our] inquiry [37] into the facts is to be searching and careful, the ultimate standard of review is a narrow one." Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 416, 91 S.Ct. at 824, 28 L.Ed.2d at 153. We must affirm unless the agency decision is arbitrary or capricious.^[78]

With the "arbitrary and capricious" standard firmly in mind, we now turn to the evidence supporting the regulations before us.

B. Overview of the Evidence

Petitioners vigorously attack both the sufficiency and the validity of the many scientific studies relied upon by the Administrator, while advancing for consideration various studies allegedly supportive of their position. The record in this case is massive—over 10,000 pages. Not surprisingly, evidence may be isolated that supports virtually any inference one might care to draw. Thus we might well have sustained a determination by the Administrator not to regulate lead additives on health grounds. That does not mean, however, that we cannot sustain his determination to so regulate. As we have indicated above, we need not decide whether his decision is supported by the preponderance of the evidence, nor, for that matter, whether it is supported by substantial evidence.^[79] To the contrary, we must sustain if it has a rational basis in the evidence. Keeping in mind the precautionary "will endanger" standard under which the Administrator acted, we have no difficulty in terming his decision rational.

A word about our approach to the evidence may be in order. Contrary to the apparent suggestion of some of the petitioners, we need not seek a single dispositive study that fully supports the Administrator's determination. Science does not work that way; nor, for that matter, does adjudicatory fact-finding. Rather, the Administrator's decision may be fully supportable if it is based, as it is, on the inconclusive [38] but suggestive results of numerous studies. By its nature, scientific evidence is cumulative: the more supporting, albeit inconclusive, evidence available, the more likely the accuracy of the conclusion.^[80] If, as petitioners suggest, one single study or bit of evidence were sufficient independently to mandate a conclusion, there would, of course, be no need for any other studies. Only rarely, however, is such limited study sufficient. Thus, after considering the inferences that can be drawn from the studies supporting the Administrator, and those opposing him, we must decide whether the cumulative effect of all this evidence, and not the effect of any single bit of it, presents a rational basis for the low-lead regulations.

While we have studied the record with great care, we do not discuss it all here; to do so would make this already lengthy opinion completely unwieldy. Instead, we shall briefly review the bases for the Administrator's conclusions that petitioners have singled out for special attack.^[81] Before we turn to those issues, however, we should note that some things appear to be uncontested. Thus petitioners seem to concede the following: that lead serves no known purpose in the human body; that lead in sufficiently high quantity is destructive to the body, causing anemia, severe intestinal cramps, paralysis, neurologic damage, and, in sufficient dosage, death, Third Health Document at III-1, 2, JA 54-55; that more than 250,000 tons of lead per year are used in production of lead additives, accounting, according to EPA, for approximately 90 percent of all airborne lead,^[82]id. at Table II-1, JA 46; that lead concentrations in the air over our largest cities are 2,000 times greater than lead concentrations in the air over the mid-Pacific, NAS Report at 205; that lead in the ambient air contributes to body blood lead levels, Nalco Supp.Br. at 37; supplemental brief of petitioners PPG Industries and E. I. duPont de Nemours & Company (hereinafter PPG/duPont Supp.Br.) at 23; and that blood lead levels are a reasonable indication of the body's lead burden. Stripped of their generalized and largely unsubstantiated claims of "bias" and "distortion of the evidence," petitioners principally challenge three EPA conclusions: (1) that, based on a preliminary determination that blood lead levels of 40 ug are indicative of danger to health, elevated blood lead levels "exist to a small but significant extent in the general adult population, and to a very great extent among children," Third Health Document at VII-3, JA at 144; (2) that airborne lead is directly absorbed in the body through respiration to a degree that constitutes a significant risk to public health; and (3) that airborne lead falls to the ground where it mixes with dust and poses a significant risk to the health of urban children.

1. Blood Lead Levels are Elevated Among the General Public

a. Blood lead levels of 40 ug are indicative of danger to health. Although recognizing that a blood lead level of 40 ug "does not represent a sharp demarcation between health and disease," the Administrator found it "prudent to regard blood lead levels over 40 ug/100g as indicators of lead intake that should be prevented." Third Health Document at III-11, JA 64. Petitioners contest this determination. Much of their argument, however, adds up to nothing more than that they are unhappy the Administrator chose to exercise his judgment and think the statute does not permit such discretion. Petitioners cite medical studies that show not that a blood lead level [39] of 40 ug is unrelated to danger, but that scientists are simply uncertain about the effect of such blood levels. Ethyl brief at 37-38 and Supp.Br. at 41-42; PPG/duPont brief at 11-12; Nalco brief at 14. But, as we have seen, exercise of reasoned discretion based on the evidence is not only permitted, but mandated, by Section 211(c)(1)(A). The administrator recognized from the outset that the health effects of varying human blood lead levels were uncertain and that continuing research was necessary.^[83] His determination of the 40 ug level is, on its face, an assessment of risks based on the known facts and not improper as such.

In addition to their generalized attack on the Administrator's power, petitioners challenge the sufficiency of the evidence to support his determination. Under the "will endanger" standard, however, we find the evidentiary basis for the Administrator's determination to be more than adequate. Petitioners do not contest the recommendation of the United States Public Health Service that 80 ug be taken as the standard of unequivocal lead poisoning, or the Service's recommendation that blood lead levels of 50-79 ug justify immediate evaluation for possible lead poisoning. Medical Aspects of Childhood Lead Poisoning, HSMHA Health Reports, 86(2), 140-143 (1971), cited in Third Health Document at IV-3, JA 71. What draws petitioners' fire is only the last of the Service's recommendations, adopted by EPA, that for older children and adults "a blood lead concentration of 40 ug or more per 100 ml of whole blood * * * be considered evidence suggestive of undue absorption of lead, either past or present." Id. While the reasonableness of establishing as a danger point a lead exposure level somewhat lower than that at which actual damage may occur seems both logically unassailable and well within the intent of the "will endanger" standard, the Administrator went beyond that sufficient conclusion. He recognized, and warned of, possible dangers, particularly to children, from lead at the 40-60 ug level, and even below, thereby suggesting that the Public Health Service's recommended danger level, designed for adults, may be set too high. Because this latter evidence was only suggestive, however, the Administrator conservatively settled on the 40 ug standard.^[84] Third Health Document III-5, 6, 7, 8, JA 58-61. Such a "prudent" determination is well within the Administrator's discretion under the "will endanger" standard. We have examined the evidence relied upon carefully and, while it is not necessary to summarize it here,^[85] we [40] find that it provides a rational basis for the Administrator's determination.

b. Blood lead levels are elevated among a small, but significant, number of adults and a considerable number of children. Again, petitioners challenge the Administrator's determination as unsupported by the evidence. The problem here is one of choosing among the items of evidence. Petitioners rely heavily on the results of the so-called Seven Cities Study,^[86] which found a very small percentage of adults with elevated (in excess of 40 ug) blood levels.^[87] PPG/duPont brief at 12-15; Nalco brief at 16. The Administrator, on the other hand, finds serious methodological flaws in the Seven Cities Study that limit its usefulness, 38 Fed.Reg. 33735, and relies instead on studies which concededly support his conclusion, Third Health Document at Tables VII-1, 2 & 3, JA 145-147, but which petitioners score as representative only of certain occupational groups. PPG/duPont brief at 15; Nalco brief at 15-16.

Having analyzed this evidence and the arguments of the parties, we would again defer to the Administrator's judgment. First we note that, while contesting the source of lead exposure, petitioners do not challenge at all the Agency's conclusion that blood lead levels are elevated in a large number of children, including a possible 25 percent of all preschool children living in substandard housing.^[88] Third Health Document at Table VII-3, JA 147.

Next, while the studies relied on by the Administrator are largely of various occupational groups, they are frequently occupations whose only exposure to lead is through the ambient air in which their workers—policemen, mailmen, service station employees, parking lot attendants, and the like—are forced to spend their working hours.^[89] Third Health Document at Table [41] VII-1, JA 145. Contrary to the arguments of petitioners, studies of occupational groups are often particularly valuable in acting as an early warning system of possible effects on the public at large. The intensive exposure in particular occupations essentially accelerates the effects of long-term exposure of the general public and provides an identifiable, highly exposed, and readily accessible group of research subjects. See D. Clark & B. MacMahon, Preventive Medicine 26 (1967) (hereinafter Clark & MacMahon). Thus much of the evidence in Reserve Mining of the danger to the general public of absorption of asbestos particles came from epidemiological studies of asbestos workers. Reserve Mining Co. v. EPA, supra, 514 F.2d at 507.^[90] Because of this the occupational data are not only in themselves indicative of high blood lead levels among a significant portion of the adult population, but they suggest the future likelihood, absent controls, of increasing high blood lead levels among even more widely dispersed portions of the public. In any case, however, the evidence relied upon by the Administrator was not only of occupational groups. Some evidence of high blood lead level relates to such "specialized" groups as "Drivers of Cars," "Male Commuters," and "Urban" residents. Third Health Document at Tables VII-1 & 2, JA 145-146.

Petitioners argue that the negative conclusions of the Seven Cities Study and several other studies should outweigh the positive indications of the studies described above. PPG/duPont Supp.Br. at 16-23; NPRA Supp.Br. at 5-8. The Administrator disagreed, and we cannot fault his conclusion. Because of the many uncontrolled variables in epidemiological studies, valid conclusions may be obscured. But, while the possibility of false negative conclusions is a real one, the possibility of false positive findings is considerably less likely. Clark & MacMahon, supra, at 100. Thus the Administrator credited the occupational and other studies reporting a small, but significant, portion of the general population with elevated blood lead levels and discounted the negative studies on which petitioners rely. Third Health Document at VII-3, JA 144. We cannot say his conclusion was arbitrary or capricious.

2. Automobile Lead Emission Products are Directly Absorbed in the Body to a Significant Extent

Since it is apparent from the face of his decision and the Third Health Document that the Administrator considered all the evidence before him, the only issue is whether he treated that evidence in a rational manner. Petitioners have now conceded that lead emissions are directly absorbed in the body from the ambient air, and they challenge only whether the extent of absorption is significant enough to justify these regulations. Nalco Supp.Br. at 37; PPG/duPont Supp.Br. at 23. The Administrator's [42] conclusion that lead absorption from the air is significant is amply supported by the record in this rule-making.

The Administrator relied on three types of evidence: theoretical, epidemiological, and clinical studies. The theoretical evidence consisted of a set of calculations designed to estimate the amount of lead in the air which, when added to an average dietary intake, would suffice to bring the blood lead burden of a "standard man" up to 40 ug.^[91] These calculations indicated that the 40 ug level can be reached by exposure to ambient air lead concentrations no greater than those now found in parts of our larger cities. Significantly, the results of two clinical experiments support the estimates derived from these theoretical calculations. The calculations, as well as petitioners' misguided attacks on their validity, are discussed in Appendix A to this opinion. See pages ___ to ___ of ___ U.S.App.D.C., pages 55 to 56 of 541 F.2d infra.

The second type of evidence relied upon by the Administrator in reaching his conclusion that airborne lead contributes significantly to the human lead body burden consisted of epidemiological research. Epidemiologists study the effects of various phenomena on humans under uncontrolled or "natural" conditions. These effects are correlated with other observed facts in an attempt to develop significant relationships among the data. The science is limited, however, in that inferences may be drawn, but relationships cannot be proved by the correlations alone. JA 583. The studies before the Administrator were of large groups of people; correlations were sought between blood lead level and exposure to lead in the ambient air. The studies were confounded, however, by the multiple sources of lead. Since diet accounts for a major portion of the body lead burden, an individual's blood lead level varies not only according to his exposure to lead in the ambient air, but according to his daily dietary intake of lead. Wide variations in dietary lead intake, which are common, can completely mask the effects of air lead absorption. Nonetheless, none of the epidemiological studies could control or measure dietary lead intake. This uncertainty in the data severely limited the usefulness of the broadly conceived epidemiological studies and led the Administrator to rely instead on data limited to situations in which dietary exposure could roughly be termed constant.

Following this rationale, the Administrator focused on the consistent relationship found between air and blood lead levels within particular metropolitan areas, rather than on the lack of such a relationship between areas.^[92]See pages ___ to ___ of [43] 176 U.S.App.D.C., pages 57 to 58 of 541 F.2d infra. The Administrator also drew support for his conclusion that lead in the air significantly affects lead in the blood from studies conducted in single neighborhoods. There, too, confounding factors were minimized by proximity, and there, too, a clear direct relationship was found. See pages ___ to ___ of ___ U.S.App.D.C., pages 59 to 61 of 541 F.2d infra. Thus the epidemiological studies, although perhaps insufficient to justify the Administrator's decision if considered singly or even collectively, were reasonably relied on as part of the basis for the low-lead rules.

The conclusions the Administrator drew from theoretical calculations and the epidemiological studies are significantly bolstered by two important clinical studies. Clinical studies are laboratory experiments on humans in which variables can be controlled and causal relationships demonstrated. Clinicians attempt to reproduce atmospheric conditions in the laboratory and measure the response to pollution of small numbers of humans chosen to represent the population at large. JA 583. Because of its necessarily significant intrusion on the subjects' lives, clinical research is limited in the number of subjects it can study. Nonetheless, the two clinical studies are especially valuable since they are the only attempts to control or account for dietary lead intake. Thus they sought to measure the contribution of respiratory absorption of lead unmasked by variations in dietary lead. Both studies found that airborne lead provided a significant portion of the lead in the blood of the experiments' subjects. Moreover, the amount of lead actually absorbed from the air during these studies corresponded closely with the amount EPA's theoretical calculations predicted would be absorbed. See pages ___ to ___ of 176 U.S.App.D.C., pages 61 to 63 of 541 F.2d infra.

While we must consider petitioners' arguments carefully, the necessary existence of limitations and inconsistencies in the data remind us to observe carefully our limited appellate function. It does not matter whether or not we agree with the Administrator's determination. Nor does it matter whether the evidence might support a conclusion contrary to that reached by the Administrator. All that is of concern to us is that there be a rational basis in the evidence for the conclusion reached. We cannot say there is not. The bulk of the evidence cited supports the Administrator. See Appendix A to this opinion. The Administrator treated all the evidence in a consistent and rational manner. This treatment disposed of most of the studies relied upon by petitioners, leaving the plain conclusion that lead emissions form a significant part of the human body burden. Particularly in light of the precautionary nature of the "will endanger" standard, we cannot find the Administrator's conclusion to be arbitrary or capricious. Accordingly, we must uphold his determination.

3. Lead Exposure from Dustfall Threatens the Health of Children

While we would have no difficulty in sustaining the low-lead regulations solely on the basis of the evidence and conclusions discussed above, the Administrator based his decision to regulate on other evidence as well. He presented a hypothesis, which he found consistent with known information, that urban children are particularly threatened by lead additives in that they are prone to ingest lead emissions that have fallen to the ground and mixed with dust. While the hypothesis is admittedly not proved as fact, we need not decide whether it would be sufficient by itself to support the low-lead regulations, for it is offered only in support of the evidence already presented. Petitioners vigorously attack the hypothesis nonetheless, but constantly confuse the issue by ignoring the flexibility [44] of the "will endanger" standard and by attempting to refute the Administrator with evidence that he both understands and has accounted for. Thus it is helpful first to set these matters straight.

First, as we have demonstrated above, see pages ___ - ___ of 176 U.S.App.D.C., pages 12-20 of 541 F.2d supra, the "will endanger" standard is a precautionary standard that embraces a wide range of permissible proof. It is therefore no objection to the dustfall hypothesis that it is merely a hypothesis. A supportable and reasonable hypothesis may well form the basis for regulations under Section 211(c)(1)(A). Indeed, the totality of evidence relied upon in the Reserve Mining case constituted no more than such a hypothesis. See pages ___ - ___ of 176 U.S.App.D.C., pages 45-46 of 541 F.2d infra.

Second, although it seems too obvious to mention, the Administrator understood and expressly recognized that leaded paint "is the primary cause of clinical lead poisoning" in children, 38 Fed.Reg. 33735. Although petitioners repeatedly try to rebut EPA conclusions by stating this fact, the Administrator was well aware of it and his evaluation of the data before him invariably accounted for it. We do not believe the importance of lead paint to the lead poisoning problem in children invalidates the Administrator's reliance on the dustfall theory. The Administrator justified his hypothesis as a basis for regulation on grounds that dustfall may be regulated far more readily than leaded paint, that dustfall contributes significantly to the threat from leaded paint by raising blood lead levels so as to make lead poisoning easier to contract, and that even when acute lead poisoning does not develop absorption of lead dustfall may cause undesirable and avoidable subclinical effects. 38 Fed.Reg. 33736-33737.^[93] We have held, see pages ___ - ___ of 176 U.S.App.D.C., pages 29-31 of 541 F.2d supra, that concern about the cumulative impact of exposure to various lead sources may justify regulation of lead additives under Section 211(c)(1)(A). Thus we cannot say that these reasons for regulation, when added to the demonstrated danger to the general public from respiratory absorption of lead emissions, see Appendix A to this opinion, and if supported by the evidence, do not form a permissible basis for the low-lead regulations under the "will endanger" standard.

With these preliminaries settled, we turn to the evidence supporting the Administrator's determination. Since the hypothesis is only a secondary basis for the regulations, and since the evidence cited goes considerably beyond that necessary to establish the hypothesis as reasonable, we shall address only the thrust of petitioners' objections and the Administrator's responses. The logical steps to the Administrator's conclusion are these:

a. High lead concentrations in dust and dirt are prevalent in urban areas.

b. In most circumstances, lead from exhausts and not lead paint or lead from stationary sources is the primary source of lead in urban dust and dirt.

c. Children prone to pica, about 50 percent of those between the ages of one and three, eat nonfood objects, including dust and dirt.

d. As a result of ingesting dust and dirt contaminated with lead fallout, children can be expected to absorb lead into their bodies.

38 Fed.Reg. 33736. If the intermediate steps are supported by the evidence, the validity of the Administrator's conclusion as a reasonable hypothesis is unassailable. Our study of the underlying evidence convinces us that it is firm and convincing, and certainly sufficient to support the Administrator's hypothesis as reasonable.

Petitioners concede that lead concentrations are high in the dust near highways and adjacent to homes with lead paint. They contest, however, that high lead concentrations [45] are otherwise prevalent in urban areas. PPG/duPont Supp.Br. at 37 n. 86. The facts rebut their argument. The NAS Panel found that "[t]he concentration of lead in street dust and surface soil of large cities is extremely high." NAS Report at 30 (emphasis added). This conclusion was based on a finding that, compared to the usual range of dust lead concentrations of 2-200 parts per million (ppm), dust lead concentrations in cities averaged 1,636 ppm and 2,413 ppm respectively for residential and commercial sites. Even in city parks lead concentrations ranged from 194 ppm to 3,357 ppm. Id. Other evidence of record shows high lead concentrations in Central Park Zoo in New York City, JA 2630, and school playgrounds in Philadelphia, JA 674.

Where does this high dust lead content come from? The Administrator concluded that since 90 percent of the lead in the ambient air is from automotive exhausts and since, as petitioners concede, PPG/duPont Reply Br. at 17, the lead eventually settles to the ground, most of the lead in dust is a product of automobile lead emissions. Petitioners do not seriously contest this; indeed their own studies suggest this by showing that lead content in soil decreases with distance from highways.^[94] Rather, they argue that "lead from paint or stationary sources is the source of lead in dust and dirt in areas where young children play." PPG/duPont Supp.Br. at 37 n. 86. This argument reflects petitioners' consistent refusal to recognize that city children play regularly in city streets, where petitioners concede lead dustfall from automobiles accumulates. PPG/duPont Reply Br. at 17. Since the Administrator's concern about dustfall is based on the harm it may cause city children, petitioners' argument that children are not exposed to automobile dustfall where they play must be rejected.

Petitioners do not contest that pica is a common phenomenon among preschool children, although they note that it "is a psychological disorder; it is not characteristic of all children * * *." PPG/duPont Supp.Br. at 37 n. 86. While this is certainly true, pica is characteristic of a significant number of children. Petitioners do not challenge the conclusion of the NAS Panel that pica occurs in at least 50 percent of both middle- and lower-class children. NAS Report at 133.

On the basis of this evidence alone it is reasonable to hypothesize that children with pica will ingest dust and dirt containing lead dustfall from automobiles. Indeed, on such limited evidence the NAS Panel accepted the dustfall hypothesis as credible:

Airborne lead wastes from such sources as automobile emissions and the weathering and demolition of old buildings can be expected to have a significant additive effect on the total intake. This would be sufficient to evoke compensatory metabolic responses that are now considered subclinical (such as increased urinary ALA), at the very least. It may be estimated that dustfall from airborne lead, if swallowed, can make a significant contribution to a small child's total lead intake and thereby contribute to the occurrence of lead poisoning, especially in urban areas. Even so, the direct ingestion of lead-pigment paints is clearly the principal environmental source in cases of severe acute lead poisoning in young children.

NAS Report at 140 (emphasis added). Again petitioners focus on the last sentence and emphasize the danger from leaded paints. Since the Administrator is in agreement with them on the point, however, their arguments are superfluous.

Petitioners' primary claims are not addressed to the evidence that establishes the dustfall hypothesis as tenable. Rather, they argue that there is no evidence that lead dustfall from automobiles is in fact swallowed by children with pica. While such proof is not necessary to establish the Administrator's hypothesis as reasonable, see pages ___ - ___ of 176 U.S.App.D.C., [46] pages 44-45 of 541 F.2d supra, we note that a considerable amount of circumstantial evidence does support his conclusion. See Appendix B to this opinion.

In any case, all the evidence suggesting that the children with pica tend to eat dust contaminated with lead fallout from automobiles takes the Administrator's theory far beyond the hypothesis stage. He offered only a tentative result, "a hypothesis consistent with information provided by a variety of studies." 38 Fed.Reg. 33736. Undoubtedly, he has shown that. Indeed, as reasonable medical hypotheses go, this one is particularly solid. This is vividly demonstrated by recalling the kind of evidence relied upon to justify similar precautionary relief in Reserve Mining.

The question in that case was the validity of the hypothesis that ingestion of asbestos fibers was dangerous to health. The reason for concern was that epidemiological studies had associated inhalation of asbestos with cancer. The evidence supporting the hypothesis was of three kinds: (1) a court-sponsored study to determine whether asbestos fibers were present in residents who drank the polluted water; (2) animal studies designed to measure whether asbestos fibers can be absorbed into the body from the stomach; and (3) epidemiological studies associating inhalation of asbestos fibers with gastrointestinal cancer and the theory that this may be due to ingestion of asbestos fibers initially inhaled. Reserve Mining Co. v. EPA, supra, 514 F.2d at 514. Upon review of the evidence the court concluded (1) asbestos fibers were not present in long-time residents; (2) the animal studies were ambiguous on whether asbestos fibers could be absorbed if ingested; and (3) the theory that asbestos workers ingested asbestos fibers as well as inhaled them was no more than a theory, id. at 514-516. Nonetheless, solely on the basis of this evidence, the court concluded that "the theory that excess cancers may be attributed to the ingestion of asbestos fibers rests on a tenable medical hypothesis," id. at 516. On the basis of this tenable hypothesis, the court accepted the further hypothesis that asbestos could be ingested from the drinking water and that, therefore, there was a "reasonable medical concern" for the public health which justified abatement of the asbestos discharge under the "endangering" language of the FWPCA. Id. at 520.

None of these uncertainties cloud the Administrator's dustfall hypothesis. Lead is present in children, and in elevated amounts. Children do ingest dust, and dust is heavily laden with lead. Animal studies prove that ingested lead dust is absorbed into the bloodstream. And epidemiological studies associate high lead concentrations in children with high lead concentrations in dirt and dust, and with proximity to automobiles. Since the automobile is the predominant source of lead in dust, the Administrator's hypothesis stands firm as reasonable, undoubtedly with more support in studies already made than the hypothesis that justified regulation in Reserve Mining. Indeed, the primary difference between this case and Reserve Mining is that the Eighth Circuit justified ordering abatement of asbestos discharges into the water solely on the basis of a hypothesis,^[95] while here the hypothesis is offered only as support for the regulations, the primary basis being the demonstrated danger to health posed by inhalation of lead emissions. In this context, and keeping in mind the precautionary nature of the "will endanger" standard, we have no difficulty in finding the dustfall hypothesis sufficiently well grounded to support the Administrator's limited reliance on it.^[96]

[47] C. Summary of the Evidence

From a vast mass of evidence the Administrator has concluded that the emission products of lead additives will endanger the public health. He has handled an extraordinarily complicated problem with great care and candor. The evidence did not necessarily always point in one direction and frequently, until EPA authorized research, there was no evidence at all.^[97] The Administrator reached his conclusion only after hearings spread over several months, consideration of thousands of pages of documents, publication of three health documents, three formal comment periods, and receipt of hundreds of comments. Each study was considered independently; its worth was assessed only after it was measured against any critical comments. From the totality of the evidence the Administrator concluded that regulation under Section 211(c)(1)(A) was warranted.^[98]

In tracking his path through the evidence we, in our appellate role, have also considered separately each study and the objections petitioners make thereto. In no case have we found the Administrator's use of the evidence to be arbitrary or capricious. Having rejected the individual objections, we also reject the overall claim of error. We find the Administrator's analysis of the evidence and assessment of the risks to be well within the flexibility allowed by the "will endanger" standard. Accordingly, we affirm his determination that lead emissions "present a significant risk of harm to the health of urban populations, particularly [48] to the health of city children." 38 Fed.Reg. 33734.

IV. EPA PROCEDURES

Petitioners' last major objection to the low-lead regulations is the claim that they are procedurally defective in that, after allowing a total of three formal comment periods, the Administrator did not allow a fourth prior to issuing the regulations.^[99] Petitioners claim this deprived them of administrative due process in contravention of the demands of Section 4 of the Administrative Procedure Act, 5 U.S.C. § 553 (1970). Ethyl Br. at 50; PPG/duPont Br. at 43; Nalco Br. at 64; NPRA Br. at 44. We find the argument to be without merit.

Section 4 requires that prior to final promulgation of a rule the agency must make public "either the terms or substance of the proposed rule or a description of the subjects and issues involved." 5 U.S.C. § 553(b)(3). The courts have added useful flesh to this statutory language. The notice should be sufficiently descriptive of the "subjects and issues involved" so that interested parties may offer informed criticism and comments. See, e. g., Portland Cement Assn v. Ruckelshaus, 158 U.S.App.D.C. 308, 325-327, 486 F.2d 375, 392-394 (1973), cert denied, 417 U.S. 921, 94 S.Ct. 2628, 41 L.Ed.2d 226 (1974); Mobil Oil Corp. v. FPC, 157 U.S.App.D.C. 235, 248 n.39, 483 F.2d 1238, 1251 n.39 (1973). But the notice need not contain "every precise proposal which [the agency] may ultimately adopt as a rule." California Citizens Band Assn v. United States, 375 F.2d 43, 48 (9th Cir.), cert. denied, 389 U.S. 844, 88 S.Ct. 96, 19 L.Ed.2d 112 (1967). This last qualification is important since the notice invites comments and the comments will frequently prompt changes in the ultimate regulations.

There is nothing in Section 4 that requires new notice whenever the agency responsibly adopts the suggestions of interested parties. Nonetheless, in this case the Administrator did just that. When, after two comment rounds, criticism of the regulations originally proposed prompted him to alter somewhat the theories on which he was acting, he did not simply promulgate final rules based on these new theories. Rather, he reproposed the regulations as amended and opened them up for a third comment round. It was only when the final regulations were issued that the Administrator omitted a fourth comment period. There was no reason for further comment. The Agency theories underlying the final regulations were identical with those of the Second Health Document and reproposed regulations. The Third Health Document differs from the Second only in that it incorporates new information received since the reproposal and responds to the comments. The only change in the regulations as issued was the switch, supported by comments from a majority of refiners, from [49] leaded pool averaging to total pool averaging.^[100]

All significant new information developed during the rule-making in this area on the frontiers of scientific knowledge was made available to petitioners and the public for comment well in advance of issuance of the final regulations on November 28, 1973.^[101] Thus both the requirements and the spirit of Section 4 were complied with. Nevertheless, the dissent vigorously and at length^[102] attacks the Administrator's use of several studies, alleging they were not made available for comment. A brief review of the record relating to these studies demonstrates that this attack is without merit.

1. The Pilot Lead Isotope Study. The pilot lead isotope study consists of two separately reported experiments which produced similar results.^[103] One of these experiments was presented in a paper delivered at the October 1-2, 1973 Conference on Low Level Lead Toxicity sponsored by EPA and HEW and has apparently not been published elsewhere. However, the results of this experiment were reported to EPA in a letter dated August 28, 1972, and placed in the public file at that time. Doc. 875.^[104] More significantly, a draft report of the companion [50] experiment was received by EPA and placed in the public file in early May of 1973. Doc. 470, dated May 5, 1973. The final version of this study, which was eventually published in November 1973, was made available to Ethyl and placed in the public file in early August 1973.^[105] Thus the pilot lead isotope study was available for comment and criticism well before the regulations were promulgated.^[106]

2. The Unpublished Japanese Study. The dissent places great stress on the fact that this unpublished and undated draft^[107] bears an inscription prohibiting citation or quotation. Dissent at ___ of 176 U.S.App.D.C., at 80 of 541 F.2d. We note first that since the study was prepared and submitted to EPA by the International Lead Zinc Research Organization, an industry group including these petitioners, Government Supp.Br. at 46, their claim of prejudice from the Administrator's use of the study rings false. Moreover, the study was placed in the public file and sent to petitioner Ethyl some four months before the Administrator's decision was announced.^[108]

3. The Chamber Study. The dissent attempts to build an argument from the fact that the Second Health Document cites the chamber study^[109] as a "preprint" whereas the Third references the study to the printed proceedings of the international symposium at which the paper was delivered. Dissent at ___, ___ of 176 U.S.App.D.C., at 80, 83 of 541 F.2d. But see id. at ___ of 176 U.S.App.D.C., at 80-81 of 541 F.2d. However, comparison of the "preprint" with the final publication shows that they are absolutely identical.^[110] Thus the chamber study was in the public realm from the beginning of the formal comment period on the reproposed regulations.

4. The Seven Cities Study. The dissent criticizes only the Administrator's reliance on an EPA reanalysis of the data on which this study was based, since it is conceded that the study itself^[111] was available at the beginning of the formal comment period. Dissent at ___ - ___, ___ - ___ of 176 U.S.App. D.C., at 80-81, 83 of 541 F.2d. Three facts vitiate this criticism of the Administrator's reliance on the Seven [51] Cities Study. First, the dissent is simply incorrect when it implies that the Administrator relied only on the "additional analysis." Dissent at ___ of 176 U.S.App.D.C., at 83 of 541 F.2d. The Administrator actually relied primarily on a finding reported in the original study. See page ___ of ___ U.S.App.D.C., & note 92 supra, page 42 of 541 F.2d, & note 92 supra. The reanalysis merely reconfirmed the validity of that finding.^[112] Second, the reanalysis itself is just EPA's effort to reexamine the study in light of the critical comments received on it.^[113] It would be unreasonable to require another formal comment period whenever an agency determines that comments received during a preceding comment period do not undermine the validity of a particular piece of evidence. Finally, EPA made the reanalysis public in February 1973.^[114]

5. The Newark, Rochester, Philadelphia, and Chicago Studies. The only clear references to these studies,^[115] which bear on the [52] validity of the dustfall hypothesis, occur in a portion of the Administrator's decision that addresses the question, "What new information has become available since reproposal of the regulation and as a result of the additional comment period?" JA 5. This section of the decision follows the Administrator's explanation and justification of his conclusion that "lead particle emissions from motor vehicles present a significant risk of harm to the health of urban populations, particularly to the health of city children." JA 2. See JA 2-5. The Administrator was required to take account of the new information by the statute which directs him to consider "all relevant medical and scientific evidence available to him." Section 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A) (emphasis added).

Moreover, as the Administrator's placement of the discussion of these studies makes clear, the studies are not needed or used to support the conclusion that the dustfall hypothesis is reasonable. That conclusion is a sufficient basis for regulation under the statute. See pages ___ _ ___, ___ of 176 U.S.App.D.C., pages 11-20, 44 of 541 F.2d supra. These additional studies, which are corroborative of the dustfall hypothesis, see pages ___ _ ___ of 176 U.S.App.D.C., pages 44-46 of 541 F.2d supra and Appendix B to this opinion, play no role in the Administrator's decision to regulate.^[116]

Finally, petitioners and the dissent suggest that even if all the new studies were made available to the public for comment well before the Administrator reached his decision, Section 4 of the APA requires still another procedural step: that the Administrator, before arriving at his decision, publicly identify the recently received studies and comments on which he intended to rely so that the public might have yet another opportunity to comment on that material. If this new round of comments provided any significant information, the Administrator would presumably be able to use that information only if he formally stated his intent to do so and allowed still another round of comments. For obvious reasons, there is no support for this novel suggestion in the Act or in the jurisprudence.^[117]

[53] The record in this case clearly demonstrates that EPA fully satisfied the requirements of administrative due process. In fact, EPA's efforts to elicit informed comment on its proposed action went far beyond the measures it was required to take. All health-related documents, including internal EPA policy memoranda, were made public upon receipt,^[118] and comments on the documents were accepted until the date of final promulgation.^[119] These documents included drafts of the Administrator's decision whose contents were very similar to the version finally published^[120] and a draft of the Third Health Document which was substantially identical to the final draft.^[121] Both the draft of the Administrator's decision and the regulations and the draft of the Third Health Document were circulated for comment, and comments were received^[122] and acted upon.^[123] On this record, we cannot find that petitioners were deprived of administrative due process by EPA procedures.^[124]

[54] V. CONCLUSION

The complex scientific questions presented by this rule-making proceeding were "resolved in the crucible of debate through the clash of informed but opposing scientific and technological viewpoints." International Harvester Co. v. Ruckelshaus, 155 U.S.App.D.C. 411, 448, 478 F.2d 615, 652 (1973) (concurring opinion of Chief Judge Bazelon). On January 31, 1971 the EPA began the debate by publishing advance notice of proposed rule-making concerning possible controls on lead additives in gasolines because of their possible danger to health. On February 23, 1972 it published the proposed regulations supported by a document, Health Hazards of Lead (First Health Document), prepared by the EPA scientific staff. It invited comment from the lead industry, the scientific community, and the concerned public. The EPA held public hearings in Washington, D.C., Dallas, and Los Angeles to give people across the country an opportunity to join the debate.

On January 10, 1973 the EPA reproposed the regulations in slightly changed form, supported by a Second Health Document which reflected the scientific comments on the first and brought the scientific information on the subject up to date. Scientific studies, pro and con, which had become available since the proposed regulations were first published were included. Again the EPA invited the parties, the scientific community, and the concerned public to comment. Finally, on November 28, 1973, [55] almost three years after the debate was joined, the EPA promulgated its regulations accompanied by a 10,000-word opinion, thoroughly and comprehensively analyzing the various scientific studies and giving its reasons why it resolved the scientific debate it had provoked in favor of protecting the public from the danger of lead emissions. A Third Health Document, extensively detailing and reviewing the current state of scientific knowledge of the health effects of airborne lead, also accompanied the regulations and the reasons for their issuance.

Because of the importance of the issues raised, we have accorded this case the most careful and exhaustive consideration. We find that in this rule-making proceeding the EPA has complied with all the statutory procedural requirements and that its reasons as stated in its opinion provide a rational basis for its action. Since we reject all of petitioners' claims of error the Agency may enforce its low-lead regulations.

Affirmed.

APPENDIX A

Evidence Relating to the Administrator's Conclusion That Automobile Lead Emission Products Are Directly Absorbed in the Body to a Significant Extent.

1. Experimental Calculations. The Administrator leads off his discussion of the relationship between airborne and blood lead levels with a set of calculations based on the experimental work of Kehoe and designed to provide a rough estimate of the dangers posed by exposure to various ambient air lead concentrations. Third Health Document, V-2 to V-9, JA 82-89. Kehoe, in his classic Harben Lectures,^[125] reported on his work in supplementing the daily lead intake of various subjects by differing amounts of lead and carefully measuring their blood lead levels over time. Subject S.W.'s normal dietary intake of 300 ug lead was supplemented by an additional 300 ug, and this total daily dietary intake of 600 ug brought him to a blood lead level of 40 ug. Since the 40 ug mark is EPA's warning level, the Agency sought to calculate, based on Kehoe's data, the amount of airborne lead needed to be absorbed to reach this level.

These calculations start with the absorption figures for ingested lead. Commonly accepted data for daily dietary intake for adults are on the order of 200-300 ug/day, with ranges of 100 to 500 ug/day. Of this amount, 10 percent is thought to be absorbed into the blood; the remainder is excreted. Thus the 600 ug daily intake of subject S.W. caused a daily absorption of 60 ug into the blood. If daily dietary lead intake averages 200-300 ug, for a daily absorption of 20-30 ug, what air lead exposure level, asked EPA, could result in an increased absorption of 30-40 ug daily, so that total absorption remained 60 ug? Third Health Document at V-6, JA 86.

Absorption of respiratory lead is dependent on three factors: air lead concentration, volume of air inhaled daily, and percent of inhaled lead absorbed. EPA based its calculations on daily respiration of 15 and 20 cubic meters (m3), and absorption of 17, 30, and 37 percent of the lead in the respired air. By this process, the Agency calculated that a "standard" man, who breathes 20 m3 of air daily, and absorbs 30 percent of the lead in the respired air would absorb 30 ug of lead daily if exposed to air lead concentrations of 5.0 ug/m3, a concentration found in parts of several of our larger cities. At this rate of respiratory absorption, a subject absorbing 30 ug of dietary lead daily would reach a blood lead level of 40 ug within a year. Third Health Document at V-4 to V-7, Figures V-1 & V-2, Tables V-1 to V-4, JA 84-87, 89-103.

These calculations suggest that the danger from lead emissions in the atmosphere is a real one. If substantiated, they warn that air lead concentrations can make a significant contribution to blood lead levels. Two clinical studies, which will be discussed in detail below, have recently provided important empirical support for this theoretical [56] conclusion. The chamber study, see pages ___ to ___ of 176 U.S.App.D.C., pages 62 to 63 of 541 F.2d infra, analyzed subjects with low dietary lead intake (approximately 100 ug/day, or 10 ug daily absorption) but high respiratory intake (approximately 49-60 ug daily absorption^[126]). The blood lead level of the experimental subjects went from 20 ug to 37 ug in a four-month period. These results are similar to those predicted by the above calculations at such elevated exposure. Third Health Document at V-8 & Table V-5, JA 88 & 102. The pilot lead isotope study, see page ___ of 176 U.S.App.D.C., page 62 of 541 F.2d infra, demonstrated that in an atmosphere of 2 ug/m3, 28 percent of a subject's lead intake was attributable to respiratory lead. This closely corresponds to the calculations made for a "standard" man in such an atmosphere; EPA's predicted value at 2 ug/m3 was 29 percent. Id. at V-3 & Table V-1, JA 83 & 100. Thus the theoretical calculations, supported by the empirical data, provide substantial support for the Administrator's conclusion that absorption of airborne lead makes a significant contribution to the body lead burden.

Petitioners' attack on the Administrator's analysis is so misguided that it is questionable whether they have even attempted to understand the purpose of these calculations. Instead, they fight again a battle they won over two years ago. Petitioners vigorously attack the Administrator's calculations as a revitalization of the so-called Goldsmith-Hexter regression equation. Nalco Supp.Br. at 39-40; PPG/duPont Supp.Br. at 32-33. As they rightly observe, EPA abandoned this approach at the time of the Second Health Document. See Second Health Document, Appendix A, JA 214-218. Petitioners do not recognize, however, that the mere fact the Administrator is once again engaged in theoretical calculations does not necessarily mean he has returned to the discredited Goldsmith-Hexter approach.

The Goldsmith-Hexter regression equation was an attempt by EPA to predict a person's blood lead level as a direct function of the air lead concentration to which he was exposed. This equation would then be used to find a "safe" air lead concentration to avoid elevated blood lead levels. First Health Document at 3-5 & Table 7, JA 294-296, 305. The approach simply made too many assumptions. In particular, it did not recognize the wide variability of dietary lead intake and thus was of no predictive value. After considering petitioners' critiques, EPA abandoned its attempt to quantify a safe level of exposure and settled on its current, more qualitative, approach to the evidence. JA 214-218.

The current analysis is much more modest in scope and does not rely at all on the Goldsmith-Hexter data or equation. Well established work has shown that blood lead levels will reach the 40 ug mark if a daily absorption of 60 ug is maintained over time. EPA simply calculates, for various specified situations, the air lead concentrations necessary to produce that daily 60 ug absorption figure. Since petitioners' objections are not addressed to this use of the Kehoe data, they can hardly be credited.^[127] On the other hand, use of predictions based on uncertain [57] data is plainly within the scope of the precautionary "will endanger" standard. Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 181, 501 F.2d at 741. And since in at least half the situations considered by EPA an elevated blood lead level would be produced in a "standard" man by airborne lead levels now present in parts of our urban environments, we cannot say the Administrator's reliance on this data, as bolstered by the clinical studies, was irrational.

2. Epidemiological Studies. The intercity correlations produced by the major epidemiological study, the Seven Cities Study, were negative. The Study was an attempt to correlate atmospheric and body lead levels in seven cities in the United States. No statistically significant correlation was found between the atmospheric lead in a city and the blood lead level of its inhabitants. As the Administrator noted in promulgating the low-lead regulations, residents of New York City had lower average blood lead levels than residents of Philadelphia, despite the fact that somewhat higher airborne lead levels were measured in New York. 38 Fed.Reg. 33735.

Petitioners rely heavily on the negative conclusion of the Seven Cities Study. PPG/duPont Supp.Br. at 24-25; Nalco Supp.Br. at 34-35; NPRA Supp.Br. at 11-12; Ethyl Supp.Br. at 45-46. The Administrator, however, discounted the significance of the Study's overall conclusion because of the intercity differences in lead intake from sources other than the air, 38 Fed.Reg. 33735, and instead relied on data in the study relating to individual metropolitan areas. In such areas climate was constant^[128] and it could more readily be assumed that the lead content of the diet was roughly comparable for all subjects, so that dietary lead's confounding influence on the data would be minimized. These data showed consistent differences between the blood lead levels of urban and suburban dwellers, with the urban residents, who were exposed to higher air lead concentrations, invariably showing higher blood lead levels. The authors of the Seven Cities Study concluded:

In a given metropolitan area, urban-suburban comparisons tend to minimize the influence of diet and climate. That airborne lead contributes to the relatively higher blood lead concentrations in center-city populations would seem to be the most probable interpretation of this consistent observation.^[129]

JA 892. Upon reanalysis of the underlying data, the Administrator concluded that while air lead was not the most influential factor affecting urban-suburban blood lead levels, it was a significant factor. 38 Fed.Reg. 33735; Third Health Document at V-9, JA 89. Petitioners do not so much attack the Administrator's reliance on this data as they argue that the intercity comparisons of the Study should be accepted. In this context, we cannot say that the Administrator's statement of reasons for crediting the suburban-urban data while discounting the intercity data was irrational.

For reasons similar to those advanced for discounting the intercity results of the Seven Cities Study, the Administrator also [58] gave only slight value to the intercity results of the duPont-sponsored Azar study^[130] of five groups of 30 subjects—two groups of taxicab drivers and three groups of duPont employees—in four cities around the United States. This study is also strongly relied upon by petitioners to show the lack of a relationship between body and air lead concentrations. Nalco Supp.Br. at 35-36; PPG/duPont Supp.Br. at 26-27; NPRA Supp.Br. at 12. The subjects' exposure to air lead was monitored continuously for two to four weeks. As in the Seven Cities Study, no significant correlation was found between air lead concentration and body lead burden among all the subjects. Nonetheless, the Administrator noted that by the duPont scientist's own assessment the "design deficiencies" of the project included

the use of different occupational groups, the use of different cities, data collection during different times of the year, lack of detailed histories and physicals, and perhaps most importantly, the lack of data relative to ingested lead intake.

JA 398-399. See Third Health Document at V-11, 12, JA 91-92.

While not according significant weight to the study for these reasons, the Administrator did observe a generally positive relationship between average blood lead values and increasing airborne lead exposure. Third Health Document at V-12, JA 92. See JA 396 (Fig. 3). This relationship is especially striking in the data for Los Angeles, the only city in the study in which two groups were evaluated. Taxi drivers exposed to air lead concentrations of 6 ug showed blood lead concentrations some 25 percent higher than office workers exposed to air lead concentrations of 3 ug. JA 392 (Table 1). This finding, again assuming some rough dietary comparability, is consistent with the urban-suburban differences of the Seven Cities Study.^[131]

The inferences the Administrator drew from the Seven Cities Study and the Azar study were bolstered by the preliminary results of a Japanese study^[132] designed to duplicate the design technique of the Seven Cities Study. Analyzing exposure to air lead concentrations in a country whose concentrations of airborne lead, averaging 0.65 ug/m3, are "far less than those observed in the U.S. cities," JA 1130 (emphasis added), the Japanese study reached an inconclusive result similar to that of the Seven Cities Study: "With the present level of lead concentration in the air it is difficult to establish any direct relationship between lead levels in the air and such levels in blood and urine." Id. 1131.

Nonetheless, once again the urban-suburban gradient clearly emerged. Even at that significantly lower air lead concentration, the study was able to find "a significant positive correlation between ambient [lead] level and blood level for workers by area," id. 1123, and to conclude that the increase of blood levels with urbanization "was statistically significant," although of small magnitude. Id. 1130. See also id. 1119, 1122-1123. Given the low levels of air lead concentration throughout Japan, the small magnitude is hardly surprising; what is surprising is that the difference is significant at all. It is for this finding that the Administrator cited the study.

Petitioners are quick to point out that the authors observe:

[59] [W]ithout monitoring personal exposure, the urban-rural differential in blood lead may not be considered to reflect the differential in air lead concentration.

JA 1124. See Nalco Supp.Br. at 36; Ethyl Supp.Br. at 47. In context, however, the statement does not have the significance petitioners ascribe to it. The authors have just observed that although air lead concentrations are generally lower in rural areas than in the cities, pockets of high and low air lead concentrations may exist in both areas. JA 1123. Thus they simply caution that without firm proof of individual exposure to air lead it is improper to conclude with certainty that the urban-suburban gradient necessarily reflects air lead differentials. JA 1124. As has been observed above, however, inability to prove conclusively cause and effect relationships is an inherent limitation of epidemiological research. The authors' warning is proper and does not detract at all from a study of this nature. It is significant, however, that immediately after this warning, the authors suggest the proper inference to be drawn from the data, "No doubt an increased respiratory exposure will contribute to an increased intake of lead into the body," id. 1124, and conclude, "A positive correlation between the lead levels in air and blood was strongly suggested * * *." Id. 1131. We think petitioners have failed to show that the Administrator's reliance on this study was improper.

Beyond the Azar and Seven Cities Studies, the only study affirmatively offered by petitioners to disprove the Administrator's conclusion is the London taxicab study, an epidemiological study of a much smaller group than any of the work discussed above. The study, conducted by Jones et al.,^[133] compared smoking and nonsmoking day-shift taxi drivers with similar night-shift drivers, and found no significant blood lead differences between them. No attempt was made, however, to measure the exposure of these drivers to airborne lead; the authors assumed the daytime drivers were exposed to more lead since they showed higher carboxyhemoglobin levels, indicating exposure to exhaust fumes. Because of the failure to measure actual air lead levels, as well as to measure smoking intensity of the smoking drivers, the Administrator found the results of this study unhelpful (although, more than with the other studies cited by petitioners, dietary lead could be assumed to be relatively constant). Third Health Document at V-12, 13, JA 92-93. The validity of the data is particularly questionable in light of its inconsistency with the Azar data, also presented by petitioners, which showed signficant differences between blood leads of taxi drivers and office workers in the same city that corresponded to significant differences in measured air lead exposure. We cannot fault the Administrator's discounting of the London taxicab study in light of the offsetting evidence to which he pointed.

The Seven Cities, Azar, and Japanese studies all were broadly based epidemiological work. Nonetheless, the Administrator found supportive evidence in all of them when he analyzed the data according to regions so that the effects of diet and climate could be, to the extent possible, minimized. Perhaps the most important epidemiological study before him, however, was the Daines study,^[134] which did not present the problems of the above studies since it was composed of two studies, each of a single neighborhood. In the first neighborhood studied, the researchers measured, over a two-year period, the blood lead levels of black females living 3.7, 38.1, and 121.9 meters from a major highway; air lead levels at these locations were 4.60, 2.41, and 2.24 ug/m3 respectively. The results showed that women living 3.7 meters from the highway, in high air lead concentrations, averaged blood lead levels of 23.1 ug, while those at the greater distances, and lesser air lead concentrations, averaged 17.4 [60] and 17.6 ug.^[135] That is, women living in air lead concentrations of 4.60 ug/m3 had blood lead concentrations 32 percent higher than comparable women living in air lead concentrations 2.23 to 2.41 ug/m.3 While, as with an epidemological work, there were uncontrolled, and possibly confounding, variables, there were far fewer here than in any of the studies cited above, and the dramatic positive results suggest their effect was minimal.

Petitioners attempt to discredit the Daines study by pointing to the results of the second neighborhood studied. There the researchers studied, for a three-month period, white women living 33.5 and 457 meters from another major highway in air lead concentrations of 1.95 and 1.73 ug/m3; these women showed blood lead levels of 15.7 and 16.1 ug respectively. Petitioners suggest this shows lack of relationship between air lead and blood lead, thus making the Daines results "equivocal," Nalco Supp.Br. at 36. Because the average blood lead at the greater distance was slightly higher than at the closer distance, petitioners even suggest that the result shows a relationship opposite to that suggested by the Administrator, PPG/duPont Supp.Br. at 31-32. To the contrary, the Administrator found the results of this study completely consistent with the results of the first neighborhood studied, and concluded that the Daines study provided major support for his position.

We cannot fault the Administrator's analysis. The suggested inverse relationship is nonexistent. The slight difference between 15.7 and 16.1 ug was analyzed by Daines and found to be insignificant. JA 467. We have been shown no reason to believe his analysis was in any way improper. Meanwhile, the data correspond closely to those found in the first neighborhood at distances beyond 100 feet (approximately 30 meters). Since the study found the air lead levels decreased by over 60 percent after the first 100 feet, JA 465, it is not surprising that no significant differences were found in either of the two neighborhoods beyond that distance.^[136]

The Administrator also drew some support from several studies conducted in communities housing lead smelters which, like automobiles, emit lead particulates into the atmosphere. One such study showed positive differences between children living in smelter and nonsmelter communities^[137] and another quantified decreasing blood lead levels corresponding with increasing distance from the smelter.^[138] Since neither study measured air lead concentrations, they could do no more than indicate in a qualitative way the relationship between blood lead levels and exposure to lead in air (and in dustfall). Third Health Document at V-13, JA 93. While petitioners argue that findings relating to inhalation of lead from lead smelters cannot be extrapolated to situations involving inhalation of automotive emissions, PPG/duPont Supp.Br. at 33, their arguments lack force given both the limited nature of the Administrator's use of these studies and various toxicological studies indicating both types of lead to be comparably absorbed in experimental [61] animals. 38 Fed.Reg. 33734, 33735; Third Health Document at VI-5, 6, JA 115-116.

These constitute the primary epidemiological studies before the Administrator. None of them attempted to control the important variable of dietary intake; such control would be impossible in a pure epidemiological study since controls destroy the "real life" nature of the experiment. Recognizing that diet is nonetheless a major factor in human lead intake, the Administrator sought data in which dietary lead could be assumed relatively constant among all subjects.^[139] Thus he relied most heavily on urban-suburban data from the Seven Cities and Japanese studies, on intracity data from the Azar study, and on the Daines and smelter community studies. In this data base, a significant correlation between air lead and blood lead consistently emerged. We cannot find the Administrator's reliance on these data, and his rejection of the London taxicab study and the intercity results of the Seven Cities and Azar studies, to be arbitrary and capricious.

3. Clinical Studies. In the Albany chamber study^[140] two groups of volunteer prisoners lived for weeks in a climate-controlled chamber where they were exposed to airborne lead levels of 10.9 ug/m3 and 3.2 ug/m3 for 23 hours a day. While dietary lead was not measured, a control group lived under similar conditions and was fed the same diet. The controls, however, were exposed to air lead concentrations of only 0.2 ug/m3, thus making valid comparisons possible between groups. Blood lead concentrations did not change significantly among the controls during the experiment. JA 593 (Fig. 1). On the other hand, blood lead levels of those exposed to air lead concentrations of 3.2 ug/m3 increased from 19 to 25 over an 11-week period. Even more dramatically, prisoners exposed to daily air lead concentrations of 10.9 ug/m3 registered enormous blood lead increases: over 18 weeks, their average blood lead almost doubled, increasing from about 20 ug to 37 ug. Besides having independent significance, these results correlate closely to the Administrator's theoretical predictions of the effect of exposure to such high air lead levels. See pages ___ to ___ of 176 U.S.App.D.C., 55 to 56 of 541 F.2d supra.

Petitioners argue that these results show little since exposure to even this high air lead level (twice that found in even the most polluted urban areas) did not cause the subjects' blood lead levels to pass the 40 ug warning point. PPG/duPont Supp.Br. at 30-31; Nalco Supp.Br. at 38. This argument misses the point. These subjects were exposed to high air lead concentrations for only 18 weeks; the Administrator, however, is concerned about the effects of exposure over a lifetime. The rapid rise of blood lead among the experimental subjects in this short period shows that air lead is a significant factor in the body lead burden and that the Administrator's concern may well be warranted. Petitioners' argument boils down to an objection that the study is flawed because it did not continue until the subjects were poisoned. We can hardly credit such a complaint.

Petitioners also argue that the study is suspect because the lead particulates to which the subjects were exposed were not identical to those emitted from automobiles. PPG/duPont Supp.Br. at 30; Nalco Supp.Br. at 38. It is true that the particles differed somewhat from those found in automobile exhausts. This was an inherent [62] limitation in the study since atmospheric lead pollution could not be precisely reproduced in a laboratory, and the authors acknowledged it as such. Doc. 385 at 17. But while the absorption of lead in the experiment "may differ" from that due to exposure to the ambient air, id., the study was, of course, designed to minimize any differences. Thus over 80 percent of the lead particles in the chamber were in the respirable range, JA 584, a figure that compares favorably with accepted data for lead particles in the ambient air, including data produced by petitioners' own Azar study (79-90 percent). JA 392 (Table 1). See also Third Health Document at II-8, JA 41. Moreover, the author of the study, when closely questioned about this point by an Ethyl witness after delivering his paper at an international lead conference in Amsterdam in 1972, suggested that the more complex lead particles present in automobile exhausts would nonetheless be absorbed in much the same way as the particles in the experiment. Doc. 111 at 399-401. The Administrator was aware of this limitation on the chamber study, but concluded that the differences in particle size "were sufficiently small so that inferences can be made regarding effects of airborne lead among the general population." Third Health Document at V-8, JA 88. Thus he considered petitioners' objection to this study and rejected it; we cannot say that rejection was arbitrary or capricious.

The second clinical study, the pilot lead isotope study,^[141] was an ambitious attempt to measure precisely a subject's total intake and output of lead. A subject was placed for 160 days in a controlled metabolic unit where he was extensively monitored. He was fed a low-lead diet and lived in an atmosphere with a lead concentration of 2 ug/m3, a level frequently found in our major cities. His diet included lead isotope tracers so that separation of dietary and respiratory lead was possible. Based on careful measurements of the quantity of isotope-labeled lead in the blood, the amount attributable to respiratory absorption could be derived. The researchers concluded that at 2 ug/m3 air lead concentration the body absorbed approximately 15 ug of lead daily from the atmosphere, so that 28 percent of the subject's blood lead was a product of airborne lead. JA 705-706. This conclusion was replicated by preliminary results on a second subject. JA 690. Together with the chamber study, this study provides important experimental support for EPA's theoretical calculations discussed above, see pages ___ to ___ of 176 U.S.App.D.C., pages 55 to 57 of 541 F.2d supra.

Certainly the project proceeds on some rough assumptions and presents data on only two subjects, as petitioners quickly point out, Nalco Supp.Br. at 38-39; PPG/duPont Supp.Br. at 27-28, and as the researchers freely conceded. JA 683, 684, 686, 688. The limited number of subjects would seem a necessary consequence of the intrusive, as well as confining and time-consuming, nature of the study. And the very magnitude of the air-blood correlation found, and the limited purpose to which the results were put—to support the independent theoretical calculations, Third Health Document at V-3, JA 83—convince us that the Administrator's reliance was not improper.

Petitioners also argue that the result is so inconsistent with the other evidence that it must be rejected. PPG/duPont Supp.Br. at 28; NPRA Supp.Br. at 12. To the contrary, the results are remarkably consistent with the evidence the Administrator credited—the Seven Cities and Japanese urban-suburban data, the Azar intracity data, the Daines study, the chamber study. All of these findings indicate a significant contribution of air lead to the body lead burden; a finding of a 28 percent contribution is consistent with that conclusion. The finding [63] is only inconsistent with the data petitioners urged the Administrator to accept but that he, properly we hold, rejected.

The two clinical studies, then, provide important support for the Administrator's conclusion. They show that exposure to high airborne lead concentrations can lead to rapid increases in blood lead levels, and that respiratory absorption of lead accounts for a significant amount of the body lead burden. These findings are consistent with the theoretical calculations and support the clear inference of the many epidemiological studies.

APPENDIX B

Evidence That Lead Dustfall from Automobiles is Swallowed by Children with Pica.

To support his conclusion that children with pica swallow dust contaminated by lead from automobile emissions, the Administrator relied on studies showing that a persistent fraction of children with lead poisoning had no contact with leaded paint, thereby implicating another source.^[142] Other work found a small but significant number of children living in good housing with no apparent exposure to lead paint to have, nonetheless, high lead levels, again suggesting another source.^[143] Meanwhile, there is evidence tying children to leaded dust. A Rochester, New York study found lead-containing dust on the hands of inner city children with elevated blood lead levels and suggested the hand-to-mouth route as a significant source of lead exposure.^[144] A study in Charleston, South Carolina found that children living in homes near high lead soil concentrations had higher blood levels than children in randomly selected homes.^[145] Epidemiological work in the smelter community of El Paso, Texas shows that elevated [64] blood leads among children decrease with distance from the smelter.^[146] This gives substantial support to the claim that children can ingest lead-contaminated dust in significant amounts. And a major epidemiological study in Newark^[147] supports this inference with evidence relating directly to automobile lead. It found children living within 100 feet of heavily traveled roadways had significantly higher blood lead levels than those living beyond that distance. When only children living near highways were considered, the study showed a direct relationship between blood lead level and traffic density; the more heavily traveled the roadway, the higher the blood lead level.^[148] The plain thrust of all these studies is that the Administrator's hypothesis is well founded, that children do ingest toxicologically significant amounts of lead dustfall from automobile emissions.

Petitioners attack these studies for various reasons. Primarily, they argue that too many variables were uncontrolled and that the Administrator cannot properly extrapolate data from lead smelter communities to urban areas in general. We have examined these objections and find them to be without merit. The variables that were uncontrolled were uncontrollable and/or were adequately accounted for by the Administrator.^[149] The use of the lead smelter data, in [65] context, was not improper. Animal toxicological studies show that lead-contaminated dust from smelters and from automobiles is comparably absorbed. Third Health Document at VI-5, 6, JA 115-116. Moreover, the studies were used to prove only that lead-contaminated dust is in fact ingested by children; the source of the contamination was irrelevant to this purpose.

We likewise reject the evidence affirmatively presented by petitioners to disprove the dustfall theory. Most of it only proves that leaded paint is the primary cause of lead poisoning in children, something the Administrator had repeatedly acknowledged.^[150] Petitioners rely primarily on the Ter Haar study,^[151] produced by an Ethyl scientist. That study was an attempt to measure the actual contributions of lead-based paint and lead dustfall in eight children suspected of having high lead body burdens. The project tested the children's feces for the presence of a lead isotope, lead-210, more prevalent in fallout dust than in leaded paint. Six of the eight children showed elevated stable lead concentrations in their feces, indicating elevated lead body burdens, but none of the children showed lead-210 concentrations higher than those in a control group of normal children.

Because of this, the authors concluded that the children suspected of elevated lead body burdens did not ingest dust.

The Administrator criticized the study for failing to measure the children's exposure to lead-210 in their diet or in the air; exposure by either of these routes could have confounded the results. Third Health Document at VI-11, 12, JA 121-122. Moreover, while positive results would have shown conclusively that some children ingested lead through dust, these negative results show only that the six children who tested positive had not eaten lead dustfall. Without some reason to believe their exposure to dustfall was typical of all children, extrapolation of the results beyond the sample studied is unwarranted—and is not suggested by the authors.^[152] We cannot say the Administrator was irrational in refusing to credit the Ter Haar study, particularly in light of the positive, contrary data on which he relied.

[66] BAZELON, Chief Judge, with whom McGOWAN, Circuit Judge, joins (concurring):

I concur in Judge Wright's opinion for the court,^[153] and wish only to further elucidate certain matters.

I agree with the court's construction of the statute that the Administrator is called upon to make "essentially legislative policy judgments" in assessing risks to public health.^[154] But I cannot agree that this automatically relieves the Administrator's decision from the "procedural . . . rigor proper for questions of fact."^[155] Quite the contrary, this case strengthens my view that^[156]

. . . in cases of great technological complexity, the best way for courts to guard against unreasonable or erroneous administrative decisions is not for the judges themselves to scrutinize the technical merits of each decision. Rather, it is to establish a decision-making process that assures a reasoned decision that can be held up to the scrutiny of the scientific community and the public.

This record provides vivid demonstration of the dangers implicit in the contrary view, ably espoused by Judge Leventhal, which would have judges "steeping" themselves "in technical matters to determine whether the agency `has exercised a reasoned discretion'".^[157] It is one thing for judges to scrutinize FCC judgments concerning diversification of media ownership to determine if they are rational. But I doubt judges contribute much to improving the quality of the difficult decisions which must be made in highly technical areas when they take it upon themselves to decide, as did the panel in this case, that "in assessing the scientific and medical data the Administrator made clear errors of judgment."^[158] The process making a de novo evaluation of the scientific evidence inevitably invites judges of opposing views to make plausible-sounding, but simplistic, judgments of the relative weight to be afforded various pieces of technical data.^[159]

[67] It is true that, where, as here, a panel has reached the result of invalidating agency action by undue involvement in the uncertainties of the typical informal rulemaking record, the court en banc will be tempted to justify its affirmation of the agency by confronting the panel on its own terms. But this is a temptation which, if not resisted, will not only impose severe strains upon the energies and resources of the court but also compound the error of the panel in making legislative policy determinations alien to its true function. We would be wiser to heed the admonition of the Supreme Court that: "[e]xperience teaches . . . that the affording of procedural safeguards, which by their nature serve to illuminate the underlying facts, in itself often operates to prevent erroneous decisions on the merits from occurring."^[160]

Because substantive review of mathematical and scientific evidence by technically illiterate judges is dangerously unreliable, I continue to believe we will do more to improve administrative decision-making by concentrating our efforts on strengthening administrative procedures:^[161]

When administrators provide a framework for principled decision-making, the result will be to diminish the importance of judicial review by enhancing the integrity of the administrative process, and to improve the quality of judicial review in those cases where judicial review is sought.

It does not follow that courts may never properly find that an administrative decision in a scientific area is irrational. But I do believe that in highly technical areas, where our understanding of the import of the evidence is attenuated, our readiness to review evidentiary support for decisions must be correspondingly restrained.

As I read the court's opinion, it severely limits judicial weighing of the evidence by construing the Administrator's decision to be a matter of "legislative policy," and consequently not subject to review with the "substantive rigor proper for questions of fact."^[162] Since this result would bar the panel's close analysis of the evidence, it satisfies my concerns.^[163]

* * * * * *

An additional matter which emerges from this record deserves comment: namely, the failure of the record to clearly disclose the procedural steps followed by EPA. As a result, an onerous, time-consuming burden was cast upon the court to reconstruct these steps by inference and surmise. It is not enough for an agency to prepare a record compiling all the evidence it relied upon for its action; it must also organize and digest it, so that a reviewing court is not forced to scour the four corners of the record to find that evidence for itself.^[164] These principles apply with no less force to judicial review of agency procedures. In informal rule-making, the record should clearly disclose when each piece of new information is received and when and how [68] it was made available for comment. If information is received too late for comment, the agency must at least clearly indicate how the substance of its consideration would be affected.

It is regrettable that EPA did not give the same care to clearly setting forth procedural matters for the record as it gave to substantive matters. It may well be that this court's 30-day order interfered with the opportunity to do so. Based on that possibility, and the court's own reconstruction of the procedural record (albeit at the expense of much judicial time and effort), I am persuaded that the petitioner's rights were not prejudiced. Ordinarily, however, I think a record which so burdens judicial review would require a remand for clarification.

Statement of Circuit Judge LEVENTHAL:

I concur without reservation in the excellent opinion for the court.

I write an additional word only because of observations in the concurring opinion authored by Chief Judge Bazelon. I would not have thought they required airing today, since they in no way relate, so far as I can see, to the court's en banc opinion. But since they have been floated I propose to bring them to earth, though I can here present only the highlights of analysis.

What does and should a reviewing court do when it considers a challenge to technical administrative decision-making? In my view, the panel opinion in this case overstepped the bounds of proper judicial supervision in its willingness to substitute its own scientific judgments for that of the EPA. In an effort to refute that approach convincingly the panel dissent may have over-reacted and responded too much in kind. In a kind of sur-rebuttal against such overzealousness, Judge Bazelon has also over-reacted. His opinion—if I read it right—advocates engaging in no substantive review at all, whenever the substantive issues at stake involve technical matters that the judges involved consider beyond their individual technical competence.

If he is not saying that, if he agrees there must be some substantive review, then I am at a loss to discern its significance. Certainly it does not help those seeking enlightenment to recognize when the difference in degree of substantive review becomes a difference in kind.

Taking the opinion in its fair implication, as a signal to judges to abstain from any substantive review, it is my view that while giving up is the easier course, it is not legitimately open to us at present. In the case of legislative enactments, the sole responsibility of the courts is constitutional due process review. In the case of agency decision-making the courts have an additional responsibility set by Congress. Congress has been willing to delegate its legislative powers broadly—and courts have upheld such delegation^[165]—because there is court review to assure that the agency exercises the delegated power within statutory limits, and that it fleshes out objectives within those limits by an administration that is not irrational or discriminatory. Nor is that envisioned judicial role ephemeral, as Overton Park^[166] makes clear.

Our present system of review assumes judges will acquire whatever technical knowledge is necessary as background for decision of the legal questions. It may be that some judges are not initially equipped for this role, just as they may not be technically equipped initially to decide issues of obviousness and infringement in patent cases. If technical difficulties loom large, Congress may push to establish specialized courts. Thus far, it has proceeded on the [69] assumption that we can both have the important values secured by generalist judges and rely on them to acquire whatever technical background is necessary.

The aim of the judges is not to exercise expertise or decide technical questions, but simply to gain sufficient background orientation. Our obligation is not to be jettisoned because our initial technical understanding may be meagre when compared to our initial grasp of FCC or freedom of speech questions. When called upon to make de novo decisions, individual judges have had to acquire the learning pertinent to complex technical questions in such fields as economics, science, technology and psychology. Our role is not as demanding when we are engaged in review of agency decisions, where we exercise restraint, and affirm even if we would have decided otherwise so long as the agency's decisionmaking is not irrational or discriminatory.

The substantive review of administrative action is modest, but it cannot be carried out in a vacuum of understanding. Better no judicial review at all than a charade that gives the imprimatur without the substance of judicial confirmation that the agency is not acting unreasonably. Once the presumption of regularity in agency action^[167] is challenged with a factual submission, and even to determine whether such a challenge has been made, the agency's record and reasoning has to be looked at. If there is some factual support for the challenge, there must be either evidence or judicial notice available explicating the agency's result, or a remand to supply the gap.^[168]

Mistakes may mar the exercise of any judicial function. While in this case the panel made such a mistake, it did not stem from judicial incompetence to deal with technical issues, but from confusion about the proper stance for substantive review of agency action in an area where the state of current knowledge does not generate customary definitiveness and certainty. In other cases the court has dealt ably with these problems, without either abandoning substantive review or ousting the agency's action for lack of factual underpinning.^[169]

On issues of substantive review, on conformance to statutory standards and requirements of rationality, the judges must act with restraint. Restraint, yes, abdication, no.

MacKINNON, Circuit Judge (dissenting):

This complex and lengthy lawsuit was foreordained when, on October 29, 1973, a panel of this court directed the Administrator of the Environmental Protection Agency to reach a final decision within 30 days^[170] on the need for and specific content of regulations on the lead content of leaded gasoline. Although the proposed rulemaking had then been in progress for nearly three years, it was patently unrealistic to believe that the agency could sift through its accumulated data, afford the public and other agencies an opportunity to review any evidence contributed since the end of the last comment period on March 11, 1973, reach a proper decision based on all the evidence and draft the complicated regulations within the required 30 days. Given the time constraints thus imposed upon the agency, it was impossible for it to comply with the notice and comment requirements [70] of the Administrative Procedure Act,^[171] and as Judge Wilkey points out they were not complied with.^[172] The result of thus forcing a hasty decision from the agency on a highly complicated matter that was still under study is the flawed regulations which we now review.

I therefore join in Part I of the dissent. Unlike Judge Wilkey, however, I would specifically remand this record back to the EPA with instructions to reconsider the regulations in light of whatever criticism is received after a suitable notice-and-comment period. The agency should be cautioned to proceed to a decision as soon as possible under the circumstances, and this court would retain jurisdiction to order further expedition of the matter on petition if a decision was not reached by the agency within a reasonable period. I would set no specific deadline for agency action, however.

If the case were to be remanded to the EPA for compliance with the Administrative Procedure Act, the Administrator should also be directed to review the evidentiary support and the rationale for his decision. I agree that section 211(c)(1)(A) of the Clean Air Act^[173] embodies strong precautionary powers, but I do not believe that it confers upon the Administrator the extreme powers to issue regulations that the majority opinion interprets the statute to allow, e. g., on a "nonexistent data base . . . ." (Majority Opinion at ___ of 176 U.S.App.D.C., at 24 of 541 F.2d). In my view the court's opinion in a number of respects exaggerates the Administrator's ability to act in the policy field without an underlying factual basis. Therefore, my general position on the powers of the Administrator lies between those expressed by the majority and the dissent. The "will endanger" standard of the Act is unquestionably a broad grant of authority, but to my mind it does require some showing of an actual danger—now or in the future—that has a rational, demonstrable basis in fact. Thus I do not agree that Congress intended to vest the Administrator with authority to act on a speculative basis to the extent the court would allow. In fact, I believe the court even overstates the authority necessary to uphold the Administrator's decision in this case. While I do not find that the evidence at this time meets the required standard, or that the Administrator has adequately supported his hypotheses, it is entirely possible on remand that the Administrator can produce a record adequate to justify his proposed regulations. Judge Wilkey perceptively examines many of the deficiencies in the Administrator's action in Part IV of his opinion. Upon a remand, the Administrator could do much to clarify the grounds upon which he bases his decision that the "will endanger" standard has been met.

WILKEY, Circuit Judge, with whom joined TAMM and ROBB, Circuit Judges (dissenting):^[174]

We are called upon in these cases, consolidated for purposes of argument and decision, [71] to review regulations promulgated by the Environmental Protection Agency (EPA) pursuant to section 211(c)(1)(A) of the Clean Air Act.^[175] The regulations provide for the phased reduction of the lead content of motor vehicle gasoline. By 1979 the regulations will permit refiners to manufacture gasoline which has an average lead content of no greater than 0.5 grams of lead per gallon.

In these cases EPA is acting under authority of section 211(c)(1)(A) of the Clean Air Act which permits EPA's Administrator to prohibit, control, or regulate a fuel or fuel additive if "any emission products of such fuel or fuel additive will endanger the public health or welfare . . . ." EPA's authority to promulgate these regulations must be distinguished from EPA's authority and action reviewed in this court's opinion in Amoco Oil Co. v. EPA.^[176] In Amoco [72] we had before us regulations which prohibited use of leaded gasoline in automobiles fitted with the catalytic converter for controlling exhaust emissions and required retail marketing of at least one grade of unleaded gasoline for the use of such automobiles.^[177] Those regulations were issued under the authority of section 211(c)(1)(B) of the Clean Air Act which permits regulation, control, or prohibition of a fuel or fuel additive ". . . if emission products of such fuel or fuel additive will impair to a significant degree the performance of any emission control device or system which is in general use, or which the Administrator finds has been developed to a point where in a reasonable time it would be in general use . . . ."^[178]

The petitioners challenge the regulations on two basic grounds. They contend the Administrator incorrectly interpreted section 211(c)(1)(A) and as a result used an improper legal standard in making the determinations upon which the regulations are based. More importantly, they also contend that the evidence in no way supports EPA's conclusion that the public health is or will be endangered, and that the case against auto lead emissions is a speculative and inconclusive one at best.^[179] On reargument the dissenting judges conclude that the disagreement with regard to the legal standard reduces itself to semantics, and while the Administrator did not couch his principal determinations in the language of the statute, the language that he did use, properly interpreted in accordance with the statute, did provide a sufficient standard for his determinations. Taking the Administrator's own phrasing of his statutory authority, we are convinced that the paucity of scientific evidence pointing to any firm conclusion, the gaps in the logic supporting the Administrator's analysis, aggravated by the faulty procedure behind the promulgation of the regulations and the Third Health Document, render the issuance of the challenged regulations arbitrary and capricious and procedurally infirm.^[180]

I. THE THREE-YEAR HISTORY OF EPA'S EFFORTS TO DEVISE ACCEPTABLE REGULATIONS

A. The Regulations and Supporting Health Documents

The regulations we are reviewing lessen the use of certain lead compounds, known as lead antiknocks, in motor vehicle gasoline.^[181] These compounds control a phenomenon known as knock—the detonation of gasoline in the cylinder prior to maximum compression. Knocking places a limitation on the efficiency and economy of the internal combustion engine because maximum power is only obtained when the explosion in the cylinder occurs at that point when fuel and air are most compressed. Lead antiknock compounds raise a fuel's resistance to knock (known as the octane of the fuel), thus permitting higher compression engines, which in turn are more efficient and economical in their use of fuel. The refiners claim that to achieve the same antiknock qualities without lead additives would require greater amounts of scarce crude oil. In addition, they claim that lead additives provide them with the flexibility to produce gasoline with differing antiknock qualities (differing octane ratings with the minimum of refining and processing equipment.

The final regulations were accompanied by a detailed health position paper, entitled "EPA's Position on the Health Implications [73] of Airborne Lead" [hereinafter referred to as the Third Health Document].^[182] The document was intended to be an authoritative examination of the ". . . pertinent evidence upon which a decision could be made as to whether or not there is a health justification to regulate lead in gasoline."^[183] We shall refer extensively to this document in reviewing the evidence in Part IV below.

The Preamble to the Regulations contains an extended discussion of EPA's health concern. It focuses separately upon adults and children. While conceding that the available evidence does not show that lead in auto emissions alone adversely affects the health of either adults or children, EPA argues that auto lead emissions make a significant cumulative contribution to human lead exposure. EPA declares that it would be "prudent" to limit this source of lead exposure, because it is a component of overall lead exposure susceptible to human control. Much of the discussion in the Preamble to the Regulations relates to whether airborne lead from auto emissions actually does get into the human body to a significant degree. (That portion of the Preamble that refers to EPA's health concern is reproduced as an appendix to this opinion.) EPA contends that airborne lead is respired by persons in certain occupational groups and contributes to their high blood lead levels. It is also contended that young children ingest dust and dirt containing lead from auto emissions which contributes to excessive blood lead levels among the young. Petitioners take issue with both forks of EPA's argument, pointing out that the evidence is inconclusive on both issues.

B. Adverse Nature of Government Expert Scientific Comment

The present section 211 was added to the Clean Air Act on 31 December 1970.^[184] Section 211(c)(1) authorizes the EPA Administrator to

control or prohibit the manufacture, introduction into commerce, offering for sale, or sale of any fuel or fuel additive for use in a motor vehicle or motor vehicle engine (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare . . . .^[185]

Within a month of the enactment of the Clean Air Act EPA issued an advance notice of proposed rulemaking.^[186]

Almost three years passed before the final regulations were promulgated. This extended gestation period has significance in itself. Implicit in the administrative record generated by this three-year delay is the recognition by EPA that available scientific data did not provide a clear and certain basis for reaching the statutorily mandated conclusion, i. e., that a "fuel additive will endanger the public health or welfare."

What the gestation period of these regulations would have been without the intervention of this court, we will never know, for the decision to issue the regulations was precipitated by the third in a series of orders of this court in Natural Resources Defense Council v. EPA^[187] on 29 October 1973, directing the agency to reach a final decision within thirty days. Out came the final regulations on 28 November, accompanied by the Third Health Document as the supporting scientific rationale for the regulations. The history of the regulations is really the history of the EPA Health Documents, a history of EPA's effort to discover somewhere, somehow, a scientific rationale which would withstand the unanimous criticism of the remainder of the government scientific community.

In February 1972, over a year after the prompt advance notice, the Administrator [74] issued a notice of proposed rulemaking under section 211(c)(1)(A).^[188] In the notice the Administrator stated the following conclusion: "that airborne lead levels exceeding two milligrams per cubic meter, averaged over a period of three months or longer, are associated with a sufficient risk of adverse physiologic effects to constitute endangerment of public health."^[189] EPA's first health document, entitled "Health Hazards of Lead," was issued contemporaneously. Subsequently, an additional paper entitled "Atmospheric Lead and Public Health" was issued by EPA to bolster further EPA's conclusion.^[190]

In the ensuing year EPA received a great deal of adverse comment as to its health position, including critical comment from every other department of the Government asked to comment thereon. We regard this of considerable significance, as each of these departments has its own independent scientific staff, and presumably is in that group of "independent" experts to which EPA itself stated (rightly or wrongly) that it would give more credence than to either industry scientists or environmental crusaders.^[191] Dr. Edward E. David, Jr., Director of the White House Office of Science and Technology, wrote:

. . . OST has reviewed the medical evidence that supposedly supports the EPA Administrator's desire to reduce lead content of gasoline. OST finds the Administrator's position in this regard unsupported by the evidence.

. . .

With respect to the medical evidence there is no correlation between airborne lead and lead levels in blood for the range of airborne lead levels encountered in rural or urban communities. . . .^[192]

In "Airborne Lead in Perspective," the National Academy of Science (NAS) made a thorough study of the scientific literature as to lead in the air and its biological effects [hereinafter referred to as the NAS Report]. After preliminary comparison of the NAS Report and EPA's health grounds, the Under Secretary of the Interior, M. J. Pecora, gave his evaluation:

After examining the National Research Council report and that of the background information of EPA, it seems that EPA's conclusions are strongly oriented toward a one-sided view of the report's findings. In general, the Research Council indicates there is no basis for restriction of lead in gasoline from a health standpoint.^[193]

The Department of Commerce commented:

It therefore appears that EPA's position that any amount of airborne lead constitutes an endangerment of public health is largely conjectural and not adequately [75] premised on available scientific or medical information.^[194]

Perhaps the most biting comment came in a letter from Dr. Merlin K. DuVal, Assistant Secretary for Health, Department of Health, Education and Welfare:

The decision having been made on grounds other than those having to do with hazard to the public health, your staff now wish to explore with us the question of whether or not hazard to the public health could be invoked as a reason for accelerating the implementation date of the primary decision. It was our firm view that there is no firm evidence, at this time, that lead poisoning in humans could be traced per se to the presence of lead in gasoline, indeed, if there were, this would have constituted justification for the elimination of lead as an additive in the first instance.^[195]

As a result EPA was forced back to basics, asking for public comment on virtually every conclusion it had reached as to lead in the air and its relation to man.^[196] On 4 [76] January 1973 a new notice of proposed rulemaking was issued, in which EPA repudiated its earlier conclusions and reached the following weakened appraisal:

Though none of the above findings viewed individually and in the context of possible experimental error can be taken as conclusive evidence that airborne lead by itself is a current public health problem, considered together, they do suggest that airborne lead is contributing to excessive total lead exposures among the general urban population. In light of this evidence, the Administrator has concluded that it would be prudent to reduce preventable lead exposures from automobile emitted "airborne" lead to the fullest extent possible.^[197]

This latest EPA position was supported by a Second Health Document.^[198]

Despite these changes in EPA's position, criticism from other governmental agencies continued. For example, Dr. Charles H. Powell, Assistant Director of the National Institute for Occupational Safety and Health of the United States Public Health Service, evaluated the reproposed regulations and the Second Health Document, as follows:

We have not been persuaded, however, that reduction in environmental lead by its reduction in gasoline will result in a significant improvement in the health of the public. This statement is based on our review of the problem and discussions with responsible scientists in the Health Services and Mental Health Administration (NIOSH and BCEM) and the Food and Drug Administration.

This position has been reconsidered by a review of the report on health effects of airborne lead submitted with your letter. The report is often speculative and is based in significant part on unpublished information, which we have not been able to review. We have been able to review some of the abstracts of the October 1972 meeting in Amsterdam, but this has not been sufficient to allow evaluation of the content of the papers.

A specific point that has been commented on in previous drafts of this paper is the description of lead absorption in greater than normal amounts, as reflected by higher than normal blood lead levels, as asymptomatic lead poisoning. In the present version, this description is attributed to unnamed clinicians and health departments, whose knowledge, reputation, and expertise cannot be evaluated. It invites unfavorable inferences.^[199]

Acting Secretary of the Interior John C. Whitaker stated, "After reviewing the reproposed regulations, we see no reason to change from our position as detailed in our enclosed analysis. . . ."^[200]

Secretary Elliot L. Richardson of Health, Education, and Welfare (HEW), in a letter to Senator Tunney, took issue with EPA's revised health justification for the regulations:

[77] Our view is:

(a) there is no firm evidence at this time that lead derived from combusted gasoline is harmful to the health of the general public, though it may, under certain circumstances, contribute to the total body burden of lead and may, as a consequence, reduce somewhat the physiologic reserve against lead poisoning from other sources . . . .^[201]

At this point it is perhaps appropriate to point out that we are not substituting our judgment for that of the Administrator; as members of a reviewing court we are saying that his procedural process was faulty, and that on the data he had available to him any conclusion could be only speculative. We are not disputing a supposed expert's conclusions on his own ground, but it is readily apparent from the recital of the other government agency comments that we would have plenty of company in our judgment if we did. Our analysis of the flaws in the Administrator's logic finds powerful support in the unanimity of conclusion of the independent scientific minds concerned throughout the Government outside of EPA itself. For the collective scientific judgment in every department or agency of the Government commenting on the first two EPA Health Documents and proposed regulations is dead against the Administrator's conclusions—and he did not risk the same fate with the Third Health Document.^[202]

On 28 November 1973 the final regulations here under review were promulgated after an order of this court directed the Administrator to reach a final decision on [78] the matter within thirty days.^[203] These final regulations were accompanied by the Third Health Document, whose subjection to public—or other government official—comments will be now explored.

C. The Opportunity for Informed Public Comment on the Third Health Document

The Administrative Procedure Act (APA) provides that the notice of rulemaking shall include "either the terms or substance of the proposed rule or a description of the subjects and issues involved."^[204] Notice was given at the outset of the three-year rulemaking period, and also early in 1973 when in response to comments EPA reproposed the regulations with slight changes. In the fall of 1973, when the change in the regulations from leaded pool averaging to total pool averaging was about to be made, EPA notified interested parties and comments were received on this. As will appear from our detailed analysis later, nearly all of the comment received in October-November 1973, so stressed by the majority opinion, related to the economic impact of the regulations and total pool averaging, not to the health issue involved on this appeal.

Pertinently, the APA also provides in section 553(c):

After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation. After consideration of the relevant matter presented, the agency shall . . . ."

Pursuant to this statutory provision, ample opportunity was given interested private parties and government agencies to comment on the original proposed regulations, the regulations reproposed with slight modifications, and the first two Health Documents. The last formal period of comment, on the Second Health Document and the reproposed regulations, closed 11 March 1973. It is for the subsequent period that the question arises as to whether the agency gave "interested persons an opportunity to participate in the rulemaking through the submission of written data, views, or arguments . . ."; more precisely, whether an opportunity was afforded to submit written data, views, or arguments specifically directed to the Third Health Document and the new studies EPA was preparing to embrace therein.

Three matters seem beyond dispute:

(1) The Third Health Document was issued simultaneously with the final regulations on 28 November 1973.

(2) No formal period of comment was announced on the Third Health Document, although a "draft Third Health Document" was apparently given at least a limited circulation on 19 October 1973.

(3) The independent scientific minds in the other government agencies, whose devastating critical comments on the first two Health Documents have been discussed above, made no comment on the Third Health Document.

It is highly significant that nowhere in the fourteen-page detailed discussion of the EPA procedures at the close of their opinion do our colleagues maintain that such independent government agency scientific comment was received by EPA, although our colleagues go to great lengths to establish notice in fact and comment by some of the private industry petitioners upon portions of the scientific studies which eventually made up the Third Health Document.

Two matters appear very much in dispute:

(1) The extent to which the Administrator relied upon new scientific data, appearing as EPA sponsored for the first time in the Third Health Document, as the basis for the final regulations.

(2) The extent to which interested private parties, some of whom are petitioners here,

[79] (a) were given or acquired actual notice of the existence of the scientific studies,

(b) were given notice as to which studies were to be relied upon by the Administrator in the Third Health Document, and

(c) commented thereon prior to the issuance of the Third Health Document itself.

We set forth the record facts on these two issues as briefly as is consistent with clarity and accuracy:

1. The extent to which the Administrator relied upon new scientific data, appearing as EPA sponsored for the first time in the Third Health Document, as the basis for the final regulations.

The Preamble to the Regulations (attached to this opinion) makes clear that when the Administrator decided, he relied materially upon studies which had not before been subjected to public criticism. In the Administrator's own words, "A discussion of the four major areas of criticism and a summary of the significant new information received since the regulations were reproposed are provided below."^[205] In this Preamble, after the Administrator posed the central evidentiary question—Is there a correlation between air lead levels and blood lead levels?—he then reviewed the critical comment received by EPA on the studies it had been using to support the existence of a correlation, and then notably made no attempt to defend the earlier studies. Instead, he "weighed against these criticisms [new] studies which have shown that airborne lead does contribute significantly to lead exposure in the general population."^[206]

The Preamble then launches into a discussion of six studies relating to lead as a hazard to the general public—two pilot isotope studies, "[a]n unpublished study in Japan," the chamber studies, the Seven Cities study, and the Daines study. These were followed by several studies relied on for the Administrator's conclusions concerning children in urban areas—the Newark studies (two parts), and the Chicago, Philadelphia, and Rochester (N.Y.) studies.

(a) Pilot Lead Isotope Studies—In the Third Health Document EPA relies on two pilot lead isotope studies by the same authors —Rabinowitz, Wetherill, and Kopple. The first of these studies is an unpublished paper presented to a scientific conference at Raleigh, North Carolina, on 1-2 October 1973.^[207] The preliminary results of this study were reported to EPA in a letter dated 28 August 1972, which was filed and indexed with the public comments at that time.^[208] This letter, however, emphasized the preliminary nature of the reported results,^[209] and there is no indication that EPA received a more complete and final version of the study before its presentation at the October 1973 conference. After the conference, on 4 October 1973, abstracts of the paper were placed in EPA's public comment file and sent to Ethyl Corporation under an [80] agreement resulting from a Freedom of Information Act (FOIA) suit brought by Ethyl.

The second pilot lead isotope study was published in the November 1973 issue of Science magazine.^[210] An early draft of this study was sent to EPA by one of its authors on 5 May 1973.^[211] The revised and final draft of this study was not received by EPA, nor sent to Ethyl under the FOIA agreement, nor placed in the public comment file until sometime after 6 August 1973.^[212] Thus, the two pilot lead isotope studies, in the forms relied upon in the Third Health Document, did not reach Ethyl under the FOIA agreement or anyone else via EPA's public comment file until at least 4 October 1973 and 6 August 1973 respectively.

(b) Unpublished Study in Japan—Significantly, the cover page of this study bears the following inscription: "Draft/Do Not Cite or Quote."^[213] This unpublished study was transmitted to Ethyl under the FOIA agreement and placed in the public comment file on 22 July 1973,^[214] but it is not even cited or referred to in the Third Health Document. Its absence from the Third Health Document is critical because the purpose of EPA's Health Documents was notice—notice of the particular items of evidence (i. e., studies) on which EPA intended to base its regulations. Only with such notice would interested parties be able to make meaningful and effective comments.

(c) The Chamber Studies—The chamber studies^[215] were cited in the Second Health Document, but were only available at that time in preprint form. The Third Health Document relies upon the printed report which is dated May 1973.^[216]

(d) The Seven Cities Study—The Preamble's discussion of blood lead levels of urban and suburban residents and between cities probably refers to both the Seven Cities study and the Daines study. The Preamble earlier had referred directly to the Seven Cities study as an example of previous EPA data which had been cited by other experts as contrary to EPA's own conclusions:

For example, the Seven Cities Study did not show a close correlation between increase in blood lead levels and simultaneous increases in air lead exposures. Blood lead levels were lower among the New York City residents studied than the Philadelphia residents, despite the fact that air lead exposures among the New York residents were actually greater than those in Philadelphia.^[217]

Both the Preamble and the Third Health Document state that "EPA has reanalyzed the Seven Cities study and has found that air lead was a significant, though not the most influential factor affecting blood lead levels."^[218] This "Additional Analyses of the Seven City Lead Study" bears a 15 March 1973 date.^[219]

The majority opinion asserts that EPA made the reanalysis public at an EPA committee meeting on 26 February 1973—thirteen days before, instead of four days after, the close of the formal comment period on the Second Health Document (11 March 1973).^[220] The majority also seems to attach [81] great importance to the fact that "[r]epresentatives of Ethyl attended the meeting, prepared a transcript of it, including critical comments by some of those in attendance, and forwarded the transcript to the Administrator."^[221] Of course, this EPA committee meeting with only one of the petitioners in this lawsuit present did not notify other interested parties (or, for that matter, even Ethyl) that EPA intended to rely on this reanalysis to support its regulations. Such a limited gesture adheres to neither the letter nor the spirit of the APA's notice provision.

(e) The Daines Study—The Daines study had been published in Industrial Medicine in October 1972. It and the chamber studies represent the only studies mentioned in the Preamble to appear in equivalent form in both the Second and Third Health Documents.

(f) The Newark Studies—This study was done in two parts by the same investigators. After studying blood levels of children in various areas of Newark, the first paper of May 1973 was unable to relate elevated blood levels to traffic or traffic density, or to any other variable source. The investigators were with EPA in spirit, though, even if not with the facts, for they wistfully reported, "We only wish our results were more positive."^[222]

Petitioners strongly attack the Newark study. They point out that in May 1973 "the investigators found no statistically significant correlation between blood lead levels and proximity to traffic or traffic density . . . ."^[223] Yet in November 1973, by "increasing the amount of data in the study through the inclusion of another group of children with blood lead levels less than 40," the investigators suddenly were able to find the statistically significant correlation that eluded them in May.^[224] EPA concedes that it was only upon the submission of new data and reanalysis that the study was able to provide support for EPA's dirt and dust hypothesis by November 1973; however, EPA contends that "[p]etitioners make no argument why this additional data may not legitimately be included."^[225] What EPA conveniently forgets is that the second paper was only in press in November 1973, and had not even been published when the regulations were issued. To our minds, if one pays any deference to primary principles of administrative procedure, this is a powerful argument against EPA's reliance on this data.

(g) The Chicago, Philadelphia, and Rochester Studies—In both the Preamble and in the Third Health Document itself heavy reliance is placed on the studies from Chicago, Philadelphia, and Rochester (N.Y.), as well as the studies from Newark.^[226] The results of the Chicago screening,^[227] the Philadelphia study,^[228] and one of the two Rochester studies^[229] were first presented in papers at the October conference in Raleigh, North Carolina. The other Rochester study,^[230] like the Newark study above, was in press at the time the regulations and the Third Health Document were promulgated by EPA.

According to the Third Health Document, "studies from Philadelphia, Chicago, and Newark discussed above provide persuasive [82] evidence to strongly suggest that sources of lead other than paint, including that resulting from the presence of lead in gasoline, play an important role in childhood lead exposure. These other sources may be especially significant at levels of exposure below overt clinical poisoning."^[231] Thus, the data allegedly supportive of the Administrator's dust and dirt hypothesis on the health hazard to children was not available until late 1973, as set forth in detail above.

These studies were absolutely crucial to the Third Health Document and to the Administrator's entire conclusions in regard to the lead danger to urban children. Each of these studies—Newark, Philadelphia, Chicago, and Rochester—came to EPA in October-November 1973 after the orders of this court and shortly before promulgation of the regulations on 28 November 1973.

2. The extent to which interested private parties, some of whom are petitioners here, were given or acquired actual notice of the existence of the scientific studies, were given notice as to which studies were to be relied upon by the Administrator in the Third Health Document, and commented thereon prior to the issuance of the Third Health Document itself.

The Administrator argues, and our colleagues confidently assert, "There is nothing in Section 4 [5 U.S.C. § 553] that requires new notice whenever the agency responsibly adopts the suggestions of interested parties."^[232] This is a salient point. The Administrator did not adopt the suggestions of the interested parties. His prior conclusions expressed in the First and Second Health Documents and in the regulations were diametrically opposed by all of the independent scientific minds in other government agencies, and by most of the affected industry, as represented by petitioners herein. Rather than adopting the suggestions of interested parties, the Administrator persisted in his conclusions as expressed in the regulations, although he did repropose the regulations (with slight modifications) on 10 January 1973 along with the Second Health Document.

More importantly, by October-November 1973 he was largely shifting his ground from the discredited scientific data of the First and Second Health Documents to the new data embraced in the Third Health Document. This is the crucial time at which informed comment from the best scientific minds in other government agencies and elsewhere should have been sought—unless EPA was irrevocably resolved to promulgate the restrictive regulations on lead which it had originally proposed years before, in spite of the barrage of unanimous critical comment from other government scientific minds, as well as interested outsiders.

With relation to the precise dates on which the scientific information later incorporated in the Third Health Document could possibly have become available to anyone, we summarize what the record shows—or fails to show.

(a) Pilot Lead Isotope Studies and

(b) Unpublished Study in Japan—Since the formal period for comment expired 11 March 1973, and since the final regulations accompanied by the Third Health Document were promulgated on 28 November 1973, the dates when the two pilot lead isotope studies and the unpublished study in Japan were first placed in EPA's "public file" and transmitted to Ethyl under a FOIA agreement—4 October 1973, 6 August 1973, and 22 July 1973, respectively—indicate the limited opportunity available for effective comment to be received by EPA. Moreover, even these late dates do not fully reveal the inadequacy of EPA's compliance with section 553 since (1) filing papers under [83] obscure headings^[233] in a so-called "public file," (2) transmitting information to one interested party under a FOIA agreement, and (3) accepting a transcript from a scientific conference can hardly be equated with the public notice and comment mandated by the APA.^[234] It is not surprising that nowhere in our colleagues' minute discussion of comments on all topics which were received by the Administrator do they claim that anyone besides Nalco, private or government, directed any comments (other than the conference transcript) to EPA on these three new studies. Yet EPA relies heavily on these studies in the Third Health Document. In fact, these are the first studies mentioned by the Administrator himself in his Preamble to the Regulations.

(c) The Chamber Studies—This study was available in preprint form at the time of the Second Health Document. However, since public access to preprints is generally quite limited, the study probably was not available to the public in a meaningful sense until it was published in May 1973.

(d) The Seven Cities Study—The critical feature here, of course, is the "Additional Analyses of the Seven City Lead Study" of 15 March 1973. Besides the one EPA committee meeting,^[235] which representatives of Ethyl attended, we do not know what, if any, opportunity for comment on the reanalysis was given other petitioners or interested parties. Since it was the "additional analysis" only which gave any statistically significant support to the Administrator's conclusions, the pertinent, relevant, and material question here is whether administrative due process was followed regarding this additional analysis after the close of comments on the Second Health Document.^[236]

We conclude that the reanalysis marked a dramatic shift in the EPA's appraisal of the Seven Cities study—not, as the majority suggests, a mere reconfirmation of the validity of earlier data or a determination "that comments received during a preceding comment period [did] not undermine the validity of a particular piece of evidence."^[237] The Preamble accentuates the importance of this shift by its reference to the Seven Cities study itself (before EPA's reanalysis) as an example of data cited by other experts as contrary to EPA's conclusions.

(e) The Daines Study—Adequate opportunity for comment was afforded because this study was in the same form in both the Second and Third Health Documents.

(f) The Newark Studies—The first part gave no support to the Administrator's conclusions, but in the second paper new and additional data was brought in. The second part was in press in November 1973 and had not even been published when the regulations were issued. It is indisputable that no opportunity for comment by anyone on this important second study was afforded.

[84] (g) The Chicago, Philadelphia, and Rochester Studies—Three of these four studies were first presented as conference papers on 1-2 October 1973, and the second Rochester study was still in press at the time the final regulations and Third Health Document issued. If any meaningful opportunity for comment on these studies was afforded, it is not reflected in the record.

Our colleagues attempt to minimize the importance of the Newark, Chicago, Philadelphia, and Rochester studies as a basis for the Administrator's conclusions, through a reading of the Administrator's Preamble designed to escape the fact that the Administrator was relying materially on these new, uncommented upon studies. The court's opinion suggests that "[t]he only clear references to these studies, which bear on the validity of the dustfall hypothesis, occur in a portion of the Administrator's decision that addresses the question, `What new information has become available since reproposal of the regulation and as a result of the additional comment period?'"^[238] Accordingly, our colleagues conclude that "[t]hese additional studies . . . play[ed] no role in the Administrator's decision to regulate."^[239]

That may be the "only clear reference" to our colleagues, but open eyes can read more. These studies were not just listed in the "new information" sections; they were discussed in the reliance portion, too. A comparison of the two critical sections of the Preamble reveals that the Administrator's language describing the evidence he is relying upon (found in subsection E of section II—entitled "Does dust lead contribute to lead poisoning in children?") is repeated virtually verbatim in section V's description of "[w]hat new information has become available since reproposal of the regulation . . . ?"^[240] Hence, we logically conclude that the Administrator is referring to the same evidence in both places.

We are as well aware as are our colleagues that practical administrative procedure requires that at some point the responsible agency emerge from the decisionmaking process, and act. By act we mean that the agency should take such action as is supported by the evidence in hand, whether that action is to change drastically the petroleum refining industry and ultimately the type automotive engine manufactured in this country, or simply to let this portion of the economy remain unchanged until and if further evidence calls for changes.

We do not contend, as our colleagues suggest, that new information brought to the agency's attention too late to be made available during the formal comment period must be ignored or that an additional formal comment period is required whenever a review of recently developed information identifies new studies the Administrator finds supportive of his conclusions.^[241]To the contrary, we only submit that a responsible Administrator would not materially rely on recently acquired, uncommented upon studies—especially when the results of previous studies had been undermined severely by the unanimous criticism of other independent government agencies. While the Clean Air Act does direct the Administrator to consider "all relevant medical and scientific evidence available to him"^[242] before he issues a regulation, this instruction must be read in context with the procedural requirements of the APA.^[243] When he "considers" medical and scientific evidence under the Clean Air Act, he "considers" [85] in accordance with the Administrative Procedure Act. The Clean Air Act contains no exemption from the APA.

Indeed, there appears to be little, if any, difference in our position on EPA's responsibilities under the APA and our colleagues' position on this subject. We are not attempting to develop a novel procedural theory or "to transmute the three-step process established by § 4 [APA § 553] into a potentially unending and fruitless series of notices, comments, and notices of intent to rely on comments."^[244] Our colleagues excuse EPA's procedural shortcomings because, in their view, all new studies were made available to the public for comment at least three months before the Administrator reached his decision.^[245] This, and not the notice and comment requirements of the APA, is the fundamental point of disagreement between the majority and the dissent in this case. As we have made abundantly clear, there was no meaningful opportunity for informed public comment on the Third Health Document. Rather than contending that "the public [must] have yet another opportunity to comment on [the new studies],"^[246] we submit only that the public is entitled to one such opportunity if the Administrator intends to rely materially on this new, uncommented upon evidence. In other words, we submit that EPA may not keep secret information important to its decision, i. e., the evidence on which it intends to rely materially. As our colleagues concede,^[247] the authorities cited at ___ _ ___ nn.78-80 of 176 U.S.App.D.C., at 85-86 nn.77-79 of 541 F.2d infra support this proposition. Final agency action must be explained in terms of a record to which all interested parties have had an opportunity to contribute informed comment.

It is important to understand that we fault EPA not because all evidence "was not specifically delivered to or called to the attention of petitioners when it arrived at EPA,"^[248] but because certain new studies, on which the Administrator intended to rely materially in the Third Health Document, were never brought to the public's attention in a manner that made informed public comment possible. EPA gave no notice indicating which studies it intended to embrace (1) by placing every shred of lead-related evidence which it received in a public file or (2) by sending all of this evidence to one interested party pursuant to a FOIA agreement. Absent some form of notice indicating on which studies EPA intended to rely (e. g., the type of notice furnished by the First and Second Health Documents), we are at a loss to understand how interested parties could formulate effective comments. Apparently our colleagues require the interested public to comment on all the evidence received by EPA or to guess which evidence the Agency will embrace and which it will ignore. In our view, the procedure, approved by a majority of this court, affords no opportunity for informed public comment.^[249]

Our position does not conflict with the following, previously stated position of this court:

In order that rule-making proceedings . . . be conducted in orderly fashion, information should generally be disclosed as to the basis of a proposed rule at the time of issuance. If this is not feasible, as in the case of statutory [or judicial] [86] time constraints, information that is material to the subject at hand should be disclosed as it becomes available, and comments received, even though subsequent to the issuance of the rule—with court authorization, where necessary.^[250]

In fact, one page earlier in the opinion containing this quotation Judge Leventhal states, "It is not consonant with the purpose of a rule-making proceeding to promulgate rules on the basis of inadequate data, or on data that, critical degree [sic], is known only to the agency."^[251] Our problem with the data described in the Preamble and the Third Health Document does not lie in the fact that this data was too recently acquired or too late, per se. Instead, we base our objections on the identical grounds articulated by Judge Leventhal in Portland Cement, i. e., EPA's data was "inadequate" (partly because of its inconclusive nature and lack of scientific validity and partly because it had not withstood the test of public scrutiny) and to a "critical degree, [was] known only to the agency."

When this court issued its order on 29 October 1973 for EPA to act within thirty days on the question of regulating lead additives in gasoline, we did not hint in what manner the Administrator should act, but presumably we intended that the Administrator should act on tested data he had been accumulating for some three years. Bearing in mind the fate EPA's previous data had suffered at the hands of the knowledgeable scientific community, it was not a responsible choice for the Administrator to resort to the most recently acquired, mostly never previously revealed, and never commented on data as the principal basis for his action.^[252] It is particularly difficult to square the majority's analysis of the procedural issues in this case with the following language from a 1974 law review article by Judge Wright:

If a particular rule rests on an extensive analysis of data or on a complex prediction . . . courts should require the agency to operate the three-step procedure of § 553 in a manner sensitive to the empirical complexities at stake . . . . Most important, the agency should not rely on any research methods or data which were not presented to the interested parties for comment or criticism.^[253]

Similarly, in an adjudicatory proceeding the Supreme Court has commented,

A party is entitled . . . to know the issues on which decision will turn and to be apprised of the factual material on which the agency relies for decision so that he may rebut it. Indeed, the Due Process Clause forbids an agency to use evidence in a way that forecloses an opportunity to offer a contrary presentation.^[254]

Much of the data described in the Preamble and the Third Health Document was data which had been shielded from adverse comment by the factor of time of acquisition. The fate of previous submissions to public scrutiny is an indication of the type comment this new data might likely have received. While agreeing that at some point the Administrator must cease deciding and act, no valid administrative procedure would countenance launching an enterprise drastically affecting a substantial portion [87] of our economy on such a shaky foundation as that relied upon in this case.^[255]

The interested private parties had some fear that just this might occur. On 19 October 1973, following the conference in early October at which several of the studies later relied on by EPA first were revealed, EPA "circulated" a "draft Third Health Document."^[256] Exactly to whom this draft was circulated, the record does not reveal. Ten days later came this court's order, making certain that some action on some basis would be taken by EPA within thirty days. On 19 November 1973 counsel for petitioner E. I. Du Pont requested that "in the event that these regulations . . are based upon different scientific and technical arguments and data than those enunciated in the January 10, 1973, statement . . . [they] be given an opportunity to comment on the new basis for the regulations in writing and at a public hearing prior to their final promulgation."^[257]

Our colleagues assert that such a request was an effort to evade the mandate of this court that regulations issue within thirty days. We think that petitioner Du Pont recognized the same point that we make here, that if indeed the Administrator had discovered a new basis for the regulations, then responsible, practical administrative procedure demanded that the interested parties be given the same opportunity to [88] comment on the new basis as they had on the old. It certainly, as a practical matter, does no good for an agency to propose an action, support it with data which is severely criticized, abandon that supporting data for new data, fail to subject the new data to informed comment, and then promulgate the same proposed regulations on the basis of the new data.^[258] Nor is it valid thereafter to claim that full opportunity for comment has been afforded.

The court's opinion also asserts that "[t]he early October preparation and circulation of a draft decision and a draft Third Health Document, both in obviously near final form, belie[s] [any] contention that this court's 30-day order . . . forced EPA to rush into a decision it was not yet ready to make."^[259] Aside from the fact that the record fails to reveal who received copies of these eleventh-hour documents, we submit that it was not at all obvious that they were in "near final form." The cover page of the draft Third Health Document carried the following inscription bearing on its finality: "DISCLAIMER: THIS DOCUMENT IS A PRELIMINARY DRAFT. IT HAS NOT BEEN FORMALLY RELEASED BY THE AGENCY AND SHOULD NOT BE CONSTRUED TO REPRESENT AGENCY POLICY . . . ."^[260] Moreover, as to the draft decisions referred to in the court's opinion, both were internal EPA briefing memoranda, one dated November 1973 and the other dated October 1973.^[261] Finally, we reject the majority's assertion that this court's thirty-day order did not force EPA to rush into a precipitate decision. On this point the shaky evidentiary foundation of the Third Health Document speaks for itself.^[262]

It is instructive to see the result of EPA's action in circulating in some quarters a draft Health Document containing new data in late October, but affording no formal comment period. According to the certified index to the record, precisely twenty persons, corporations, or entities made twenty-four written submissions to EPA during the sixty-day period up to and including 28 November 1973, the date upon [89] which the regulations were promulgated.^[263] This compares to at least 218 persons, corporations, agencies, or other entities that commented on the regulations on a prior occasion. Of the twenty-four submissions, fully nine were dated 26 November 1973 or 28 November 1973; it is thus virtually impossible for any of them to have been considered by the Administrator. Only seven submissions were dated 18 November or earlier. Only two submissions were from agencies of the federal government, a letter from the Secretary of Transportation dated 26 November 1973^[264] and two pages of comments from the Treasury Department dated 19 November 1973.^[265]

The content of these twenty-four submissions is equally illuminating. After carefully examining each of these submissions, we found only one, Nalco's review of EPA's health position dated 19 November 1973,^[266] to be a substantive critique of EPA's draft Third Health Document. In fact, it was the only submission which made any significant comment on EPA's health position at all. All but four of the other submissions focused upon the energy or economic costs of the proposed regulations. Even these comments were quite short, ranging from one page (seven of the letters or telexes) to four pages (one of the letters) in length. To the extent any of these nineteen submissions mention the health issue (most do not and the few that do merely state their disagreement), none mention or refer to the draft Third Health Document. Three of the four remaining submissions were from Ethyl's counsel. One was a letter dated 29 October 1973 calling EPA's attention to two articles which EPA had so far overlooked;^[267] one was an unedited transcript of the October conference on low-level lead effects mailed to EPA on 24 October 1973;^[268] and the third was a letter dated 12 October 1973 requesting EPA to place in its files the individual presentations made at the October conference, rather than just the abstracts.^[269] The only other health-related submission during this period was the collection of abstracts referred to in Ethyl's 12 October letter.^[270] None of these submissions mentions or comments on the draft Third Health Document.^[271]

[90] Despite this paucity of comment, our colleagues assert that "[a]ll significant new information developed during the rulemaking in this area on the frontiers of scientific knowledge was made available to petitioners and the public for comment well in advance of issuance of the final regulations on November 28, 1973. Thus both the requirements and the spirit of Section 4 [APA § 553] were complied with."^[272] With this conclusion behind them, our colleagues are able to avoid the key procedural issue raised by this record, i. e., whether the Administrator may rely on information not previously made available in any meaningful sense to the petitioners or the public without violating both the letter and the spirit of the APA.^[273] Apparently, our concept of making information available to the public well in advance of promulgation and our understanding of the compliance requirements of section 553 differ considerably from those of our colleagues.

The court's opinion strives strenuously to prove that three of the five petitioners received notice in fact of the Third Health Document, or at least portions thereof. They assert that "petitioner Ethyl was directly furnished with all such documents as a result of a Freedom of Information Act . . . suit."^[274] We do not believe that agency compliance with the APA can rest on individual interested parties filing FOIA suits. If the APA is to avoid becoming a docile paper tiger, it cannot rely on the enforcement teeth of other federal statutes.^[275]

Furthermore, of course, as shown by the dates of many critical documents relied upon by the Administrator (including, inter alia, one which was not even included in the Third Health Document;^[276] two which were mentioned in the Third Health Document, but had not even been published when the regulations were issued;^[277] and four which came to light only after the October 1973 conference^[278]) it is clear that Ethyl did not have adequate time to prepare effective comments, even if one assumes that Ethyl knew that EPA intended to rely on these documents when it promulgated the final regulations. In addition to Ethyl, our colleagues point to "comments" from petitioners NPRA and Nalco.^[279] Regarding [91] NPRA's submissions, our colleagues are not consistent in their assertions, since they seem to agree that these comments related only to the shift from leaded pool averaging to total pool averaging, and not to EPA's health position.^[280] Unlike other aspects of the regulations, the shift from leaded pool averaging to total pool averaging did not incorporate and rely on new information. Therefore, this particular change in the regulations managed to avoid the procedural infirmities that plague all other aspects of the regulations, and NPRA's comments on this change are irrelevant to the procedural issue involved in this case. On the other hand, as we indicated above, Nalco's comments represent the one and only substantive critique of the draft Third Health Document received by EPA before promulgation of the regulations.

In their attempts to demonstrate that "comments [on the Third Health Document] were received",^[281] our colleagues equate the unedited transcript of the October conference, which was submitted by Ethyl to EPA, with comment on the new studies presented at that conference.^[282] Similarly, they imply that Ethyl's submission of a transcript from the EPA committee meeting where the Seven Cities reanalysis was first discussed amounted to comment by Ethyl on the reanalysis.^[283] We simply cannot accept the court's conclusion that the submission of these unedited transcripts amounts to even a form of comment. Moreover, if these unedited transcripts can be characterized as some form of comment, surely they are not such an effective form that they prove beyond peradventure that EPA afforded the petitioners (not just Ethyl) and all other interested parties a meaningful opportunity for effective comment.

Strangely, our colleagues seem to feel that EPA "went far beyond the measures it was required to take" by placing new information in the so-called "public file" and thereby making it "available for comment and criticism."^[284] To the contrary, we submit that (1) placing information in a public file (not to mention indexing that information under obscure headings) and (2) making information "available for comment and criticism" affords interested parties no notice whatsoever that EPA will rely on this information. This intent to rely was only noticed in the Health Documents, on the last of which no effective comment was possible. We can only wonder how many thousands of pieces of paper were "placed in the public file" that EPA never mentioned in any Health Document. Conceivably, under the court's view of administrative procedure the burden of sifting through hundreds of pounds of poorly indexed paper and guessing which studies will be relied upon can be shifted from an agency to the interested parties through the simple device of a "public file."

In summary, we find the conclusion undeniable that no effective comment on EPA's revised health position took place—nor could it have taken place—in the brief period just prior to promulgation, as the court's opinion would have us believe. The absence of any comment on EPA's new health data [92] (with the sole exception of Nalco) gives rise to the inference that either circulation of the draft Third Health Document was limited to a more receptive audience than previous circulations had addressed or that the time between receipt of the draft and promulgation of the regulations was not sufficient to permit effective comment. The total absence of any comment on EPA's new health position by any government agency, the source of previous unanimous caustic criticism, is most significant.

As indicated by the heading of this opinion subsection, it is not enough under the Administrative Procedure Act merely to make the scientific data "available" to the public and all interested parties. First, the claimed "availability" here boils down to a compelled furnishing of data to one interested party under the Freedom of Information Act and the placing of hundreds of miscellaneous documents—scientific studies, papers, published articles, etc.—in a poorly indexed^[285] dust bin of a file in the public rooms of the Environmental Protection Agency. Second, there was never any notice—and our colleagues do not and cannot contend that there was—on which data out of the great miscellany EPA would rely until the Third Health Document was published simultaneously with the regulations. Third, the opportunity to comment effectively on the new data on which EPA ultimately relied was farcical, as our detailed discussion above nails down.

Since Nalco was able to prepare and submit a substantive critique of the draft Third Health Document on 19 November 1973, obviously Nalco somehow received actual notice of the existence of the draft Third Health Document and the new evidence therein. (Perhaps Nalco's representatives were luckier or more adept than the representatives of other interested parties when it came to sifting through poorly indexed documents.) The record, however, does not indicate that any other interested party received notice of the existence of this new evidence, and clearly, no interested party, including Nalco, received any notice that EPA intended to rely on these new studies. As we mentioned earlier, on its cover page, the 19 October draft bore the following notation:

DISCLAIMER:

THIS DOCUMENT IS A PRELIMINARY DRAFT. IT HAS NOT BEEN FORMALLY RELEASED BY THE AGENCY AND SHOULD NOT BE CONSTRUED TO REPRESENT AGENCY POLICY. IT IS BEING CIRCULATED FOR COMMENT ON ITS TECHNICAL ACCURACY AND POLICY IMPLICATIONS.^[286]

Accordingly, Nalco wrote in the introduction to its substantive comments, "It is understood that these documents [the draft Health Document and the draft regulations] are preliminary drafts and have not been formally released by the agency and should not be construed to represent Agency policy."^[287] On the basis of previous EPA practice in regard to the First and Second Health Documents, until EPA formally released the Third Health Document as representing the Agency's position, no one had any notice of EPA's intent to rely on new evidence.

To emphasize the gross procedural irregularities approved by the majority of this court, in the following chart we capsulize what the record reveals—or fails to reveal:

 [93] 
                           NEW EVIDENCE                                   Unpublished                                Newark, Chicago
                           Pilot Lead                 Pilot Lead          Study in             Seven Cities          Philadelphia and
                           Isotope Study              Isotope Study       Japan                Reanalsis             Rochester Studies
                                 #1                        #2
___________________________________________________________________________________________________________________________________________
Notice of   |                       |                        |                     |                      |                       |
                     |                       |                        |                     |                      |                       |
(a) the evidence's   | Ethyl (4 Oct. 1973)   | Ethyl (6 Aug. 1973)    | Ethyl (22 July 1973)| Ethyl (25 Feb. 1973) | Nalco (19 Oct. 1973)  |
    existence        | Nalco (19 Oct. 1973)  | Nalco (19 Oct. 1973)   | Other interested    | Nalco (19 Oct. 1973) | Other interested      |
                     | Other interested      | Other interested       |  parties (none)     | Other interested     | parties (none)        |
                     |  parties (none)       |  parties (none)        |                     |  parties (none)      |                       |
(b) EPA's intent     |                       |                        |                     |                      |                       |
    to rely on       |_______________________|________________________|_____________________|______________________|_______________________|
    this evidence    | none                  | none                   | none                |  none                | none                  |
                     |_______________________|________________________|_____________________|______________________|_______________________|
                     |                       |                        |                     |                      |                       |
Time Available   |                       |                        |                     |                      |                       |
 for Comment After   |                       |                        |                     |                      |                       |
Notice of       |                       |                        |                     |                      |                       |
                     |                       |                        |                     |                      |                       |
(c) the evidence's   | Ethyl (55 days)       | Ethyl (114 days)       | Ethyl (129 days)    | Ethyl (9 mos.)       | Nalco (39 days        |
    existence        | Nalco (39 days)       | Nalco (39 days)        | Other interested    | Nalco (39 days)      | Other interested      |
                     | Other interested      | Other interested       | parties (none)      | Other interested     | parties (none)        |
                     |  parties (none)       |  parties (none)        |                     |  parties (none)      |                       |
(d) EPA's intent     |_______________________|________________________|_____________________|______________________|_______________________|
    to rely on       | none                  | none                   | none                | none                 | none                  |
    this evidence    |                       |                        |                     |                      |                       |
                     |_______________________|________________________|_____________________|______________________|_______________________|

[94] In no previous case, environmental or otherwise, has this court tolerated such "public notice" and "opportunity to comment" as it sanctions here. From the pages of the court's opinion there seeps the theme that this is an environmental case; hence, the court like the agency need not labor by the usual rules. We recognize no such exemption for this or any other type case; certainly Congress did not give it to us; we know that adherence to proper prescribed procedure is the soundest route to a correct substantive result.

II. THE LEGAL STANDARD

A. The Statute—Its Interpretation

Section 211(c)(1) of the Clean Air Act authorizes the EPA Administrator to

control or prohibit the manufacture, introduction into commerce, offering for sale, or sale of any fuel or fuel additive for use in a motor vehicle or motor vehicle engine (A) if any emission products of such fuel or fuel additive will endanger the public health or welfare . . . .^[288]

The initial question presented is whether the Administrator properly interpreted this legal standard when he made the factual determinations upon which these regulations must be predicated.

The petitioners contend that the "will endanger" standard requires a determination that lead motor vehicle emissions, in and of themselves, pose a direct and provable health hazard to significant portions of the general public. By contrast, if it can only be demonstrated that lead emissions contribute to a health hazard, the Administrator is limited to acting under section 202,^[289] which deals with emission standards imposed on new car manufacturers, and sections 107 through 110 of the Clean Air Act,^[290] which deal with ambient air quality standards.

The Administrator stated his interpretation of the statutory language when he issued the regulations:

It is the Administrator's view that the statutory language quoted above does not require a determination that automobile emissions alone create the endangerment on which controls may be based. Rather, the Administrator believes that in providing this authority the Congress was aware that the public's exposure to harmful substances results from a number of sources which may have varying degrees of susceptibility to control.^[291]

As far as this statement goes, we deem it correct. To recognize lead in the ambient air as but one possible source of lead in the human body is merely to recognize undisputed fact. But to argue that, because there are multiple sources of lead, a chain of causation from lead in the air produced by auto emissions to a level of lead in the blood high enough to be dangerous to health need not be established is totally fallacious. We are not clear that the Administrator really argues this, but it is certain that our colleagues, in order to bolster the agency's position, have throughout their opinion embraced this fallacy.

Our reading of the language of the Act, its legislative history, and the administrative record lead us to the view that section 211(c)(2)(A) requires the Administrator to conclude "after consideration of all relevant medical and scientific evidence available to him" that a fuel or fuel additive causes an emission which causes a significant health hazard to a substantial portion of the general population before he can control or prohibit the use of particular fuels or fuel additives.

Logically, only if the Administrator can say that a fuel additive causes a significant health hazard can he say that controlling or prohibiting such fuel additive would reduce significantly such health hazard. Whether we term the Administrator's decision one of "assessment of risks," as our colleagues urge, or whether we emphasize that such decision must be based on "facts," the causal [95] connection between lead emissions and the harm must be established by relevant scientific and medical evidence.

When we refer to the necessity under the statute of showing that a fuel additive causes a health hazard, we do not mean that the statute requires a showing that the fuel additive (lead) causes a health hazard without consideration of other sources of lead in the human body having their determined effect also. To interpret the statute in this manner would be preposterous on its face, for as we shall discuss later in Part IV, on EPA's data most of the lead in the human body comes from dietary sources, food and drink. We think that the statute does require that, before the Administrator can prescribe the regulations involved here, he must find that the lead from auto emissions by itself or alone contributes a measurable increment of lead to the human body, and that this measurable increment causes a significant health hazard.

To repeat, only if the Administrator can say that an identifiable measurable increment of lead in the human body is derived from auto fuel additives and that this measurable increment of lead itself (taking into consideration all other sources of lead) causes a significant health hazard, can the Administrator claim that controlling or prohibiting lead would reduce significantly such health hazard.

To us all analysis leads inescapably to this conclusion, yet the court's opinion endeavors to avoid this by resorting to two obfuscating dichotomies (perhaps the same distinction expressed in two ways). First, the opinion attempts to separate actual from potential harm, and, second, to separate risk from fact. "[T]he `will endanger' standard is precautionary in nature and does not require proof of actual harm before regulation is appropriate."<sup>[292]</sup> "[T]he power to assess risks, without relying solely on facts, flows inexorably from the nature of the `will [en-]danger' standard."^[293] We submit no such separation occurs in the real world, and if the Administrator proceeded on any such fanciful theory, it is an instance of his failure to discern the intent of Congress manifested by the words "will endanger."

As to the first distinction, there is no distinction possible here between actual and potential, between past and future harm. The Administrator is dealing with a continuing situation. If there can be found potential harm from lead in exhaust emissions, the best (and only convincing) proof of such potential harm is what has occurred in the past (either in 50 years of practical usage or in laboratory experimentation), from which the Administrator can logically deduce that the same factors will produce the same harm in the future. For the court's opinion to hold that the Administrator can dispense with proof of actual harm, i. e., what has occurred in the past, and can nevertheless somehow determine potential harm, is to grant the plainest license for the wildest speculation. We have always thought scientific conclusions, above all, demanded proof by events recorded and observed.^[294]

The court's second asserted dichotomy, risks versus facts, is equally indefensible in logic. All true risk assessment is based on facts and nothing else.^[295] Those professional risk-assessors, the professional sports gambling fraternity, would smile at any other theory. To the extent that hunch and intuition enter into any final decision, these [96] are separate factors outside of any scientific risk calculation.

Our colleagues apparently find it necessary to legitimatize the Administrator playing hunches. They assert, "Danger is a risk, and so must be decided by assessment of risks as well as by proof of facts."^[296] Of course the Administrator assesses risk —from the facts as he knows them. The question here is how much he knows. To the extent the agency found it necessary to make an "assessment of risks as well as [rely on] proof of facts," the agency was frankly just speculating. No reviewing court can countenance this. If such agency decision is not "arbitrary and capricious," what decision could be? It is precisely a devotion to facts, not hunches, that distinguishes the professionals from the amateurs in assessing risks; we deem the Administrator to have been intended by Congress to be a "professional."

B. Threshold Factual Determination Required

EPA, relying upon our recent opinions in Amoco, supra, and Industrial Union Department, AFL-CIO v. Hodgson,^[297] argues:

In the present case, as in Hodgson, the EPA must determine what amount of lead it should permit to be used as additives to gasoline. Here, too, "reliable data is not currently available with respect to the precisely predictable health effects of various levels" of lead which the EPA could permit to be used. The Agency's decision to require a gradual diminution in the permissible amount of lead is, in the last analysis, a policy judgment "concerning the relative risks of underprotection as compared to overprotection."

. . .

The regulations here reflect reasoned judgment on a border area of scientific knowledge and a policy choice in favor of protecting people exposed to automobile exhausts and particularly urban children. This judgment should be upheld.^[298]

In essence, it is argued that the "will endanger the public health . . ." standard is a delegation of quasi-legislative power to the Administrator and not a requirement that he reach a reasoned determination purely on the scientific and medical data.

It is manifest that Congress wished the Administrator's threshold determination under section 211(c)(1)(A) to be a reasoned factual determination based solely on the medical and scientific evidence. This is made quite clear by subsection 211(c)(2)(A) which emphasizes that "[n]o fuel, class of fuels, or fuel additive may be controlled or prohibited by the Administrator pursuant to clause (A) of paragraph (1) except after consideration of all relevant medical and scientific evidence available to him . . . ." By directing the Administrator to consider "all relevant medical and scientific evidence" before deciding to institute controls, the Congress must have intended that such evidence act as the basis for his determination.

If the intention had been to permit him to make "an essentially legislative policy judgment, rather than a factual determination . . . ,"^[299] some indication of this should have appeared in the statute. Other sections of the Clean Air Act closely related to section 211 do contain some indication that a broad discretionary power is being vested in the Administrator. Section 108 authorizes the Administrator to set air quality criteria for each air pollutant "which in his judgment has an adverse effect on public health or welfare . . ."^[300] Section 202 authorizes the Administrator to set standards for each automobile emission "which in his judgment causes or contributes [97] to, or is likely to cause or to contribute to, air pollution which endangers the public health or welfare."^[301]

By the same token, neither section 108 nor section 202 requires the Administrator in his threshold determination to consider either scientific or medical evidence. Section 108 air quality criteria which EPA ultimately promulgated are required, however, to "reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air, in varying quantities."^[302] Section 108 therefore requires a factual determination based on "the latest scientific knowledge" in establishing criteria, while permitting wider discretion in making the original threshold determination as to which pollutants to list.

In conclusion, we believe that the threshold determination whether an emission "will endanger the public health . . ." does turn and was intended by Congress to "turn crucially on factual issues" and not upon "choices of policy."

III. SCOPE OF REVIEW

EPA in promulgating these regulations followed the informal rulemaking procedure outlined in the Administrative Procedure Act, 5 U.S.C. § 553.^[303] Since the Clean Air Act neither provides for review "on the record after opportunity for an agency hearing" nor provides specifically the standard of judicial review, our scope of review of these regulations is limited to a determination of whether "agency action, findings . . . [or] conclusions . . . [are] arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . ." or "in excess of statutory jurisdiction, authority, or limitations, or short of statutory right," or "without observance of procedure required by law."^[304]

It is well recognized that in reviewing the record we are not to substitute our judgment for that of the Administrator.^[305] Thus, we are required to affirm agency determinations with which we disagree. However, we are also under an obligation not to act as a rubber stamp of agency rulemaking action. As a result, in reviewing agency rulemaking under section 553, we are obligated to engage in a "substantial inquiry," and "inquiry into the facts is to be searching and careful . . . ."^[306] As the Supreme Court has indicated, we "must `consider whether the decision [of the administrative agency] was based on a consideration of the relevant factors and whether there has been a clear error of judgment.'"^[307]

Certainly a determination made in the absence of any evidence in the record to [98] support it would lead a reviewing court to conclude that a "clear error of judgment" had occurred. However, a reviewing court could reach a similar conclusion in the presence of some evidence supporting the agency determination.^[308] Since a court must review "the entire record," it may well be that the evidence detracting from the agency's conclusion is so overwhelming or so persuasive, or the agency's approach so one-sided, or the decision-making process so flawed, that a reviewing court must conclude that the agency erred in the exercise of its rulemaking power.^[309] Or, if there is an essential point or element missing in the logical progression toward the conclusion that the agency reaches, then the agency's action likewise may be arbitrary or capricious, because it is not supported by a logical thought process.

In these consolidated environmental protection cases the thought process by which an agency reaches its conclusion on informal rulemaking resembles a chain. If there is a link missing, then the agency, to reach the conclusion that it did, was required to [99] take an arbitrary jump in its logic to reach that conclusion. To illustrate, we have the admitted fact that there is lead in gasoline which goes into the automobile tank. At the other end of the thought progression there is the scientific conclusion that too much lead in the human blood level is harmful—although there seems to be no agreed conclusion as to exactly what that blood level is (for this case, we assume the EPA level correct). Logically, as we view the scientific evidence, the chain of transmittal of the lead in the auto tank to the lead in the bloodstream is vital on the issue before us—whether there is valid reasoning based on evidence to sustain a finding that lead additives will endanger public health. The standard of "will endanger" makes the existence or nonexistence of a scientifically demonstrated chain of transmittal (and not a mere pattern of guesswork) decisive. For if no such scientifically proved chain exists, the Administrator's decision can only be arbitrary and capricious.

The recent First Circuit case, South Terminal Corporation v. EPA,^[310] supports our application of the "clear error of judgment" standard of review to the Administrator's determination here. In South Terminal the court was called upon to review the Metropolitan Boston Air Quality Transportation Control Plan promulgated by the Administrator under section 110^[311] after the Commonwealth of Massachusetts had failed to submit an acceptable plan to implement the national primary and secondary ambient air quality standards. We quote, at length, the First Circuit's discussion of the standard of review:

Under § 706, we must determine whether EPA followed lawful procedures in evolving its plan; whether it acted within its statutory authority; and whether the plan is constitutional. If so, we must set aside the plan only if it is found to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law". 5 U.S.C. § 706 (2)(A).

In the following parts of this opinion we deal first with the procedural objections to the plan and later with the constitutional ones. In between we consider statutory objections and, most difficult of all, those objections addressed to the merits of the plan. The last objections, it is clear, are outside our province unless they show that EPA's decision was not based on consideration of relevant factors or else included a "clear error of judgment". Overton Park, supra, 401 U.S. at 416, 91 S.Ct. 814 [28 L.Ed.2d 136]. We are not empowered to substitute our judgment for that of the agency.5

5 The wisdom of the plan in the ordinary sense is outside our province. "We inquire into the soundness of the reasoning by which the [Agency] reaches its conclusions only to ascertain that the latter are rationally supported." United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749, 92 S.Ct. 1941, 1946, 32 L.Ed.2d 453 (1972).

The questions about the plan on review are of two types: the rationality of EPA's technical decisions (such as its determinations of local photochemical oxidant and carbon monoxide levels and the amount of reductions required to meet national standards), and the rationality of EPA's "control strategy", that is, the measures adopted to reduce emissions. The former present peculiar difficulties for nonexperts to evaluate. Yet "[our] inquiry into the facts is to be searching and careful", id., and we must assure ourselves as best we can that the Agency's technical conclusions no less than others are founded on supportable data and methodology and meet minimal standards of rationality. See Section III infra.

Assuming EPA's technical determinations are reasonably based, we must decide whether the selected controls are arbitrary or capricious. In so doing, we must bear in mind that Congress lodged with EPA, not the courts, the discretion [100] to choose among alternative strategies.6 Unless demonstrably capricious—such as much less costly but equally effective alternatives were rejected or the requisite technology is unavailable—the Administrator's choices may not be overturned. . . .

6 "Looking to the future, and commanded by Congress to make policy, a rule-making agency necessarily deals less with `evidentiary' disputes than with normative conflicts, projections from imperfect data, experiments and simulations, educated predictions, differing assessments of possible risks, and the like. The process is quasi-legislative in character, and one will search it in vain for those intermediate `findings' of fact which mark the midway point in an adjudicator's linear march from raw evidence to single, ultimate conclusion." Amoco Oil Co. v. EPA, [163 U.S.App.D.C. 162] 501 F.2d 722, at 734-35 (1974).^[312]

Appropriately enough, Part III of the opinion is entitled, Whether EPA Committed a Clear Error of Judgment in Computing the Need for Emission Reductions. The First Circuit's emphasis on adequate data and appropriate methodology is fully in accord with our interpretation of the "arbitrary and capricious" standard.

In the case at hand, it seems obvious that the Administrator made "clear error[s] of judgment." This conclusion is based upon a "searching and careful" inquiry into the facts underlying the determination that airborne lead will endanger the public health. At several points in the Administrator's reasoning we have found little or no evidence to support his conclusions, and at several points we have noted clear errors of a substantial nature in the Administrator's analytical and evaluative methodology and EPA's decision-making process. Several vital links in the chain are unsupported; for the Administrator to leap to the conclusion he did can only be termed arbitrary and capricious. We submit that "a clear error of judgment" has occurred,^[313] as our concluding analysis of the evidence and methodology demonstrates.

IV. THE EVIDENCE

A. This Court's Task

It is of crucial importance to recognize that this court's task on review of agency rulemaking is twofold. One of these tasks is universally acknowledged. We must explore the evidentiary record to determine whether the statements and conclusions of facts have an adequate basis in the underlying evidence. However, an equally important role is our review of agency analysis in order to determine whether it is principled and reasonable. Properly understood, our role is not to review directly the evidence, but to review the agency's treatment and analysis of the evidence. Of course, in so doing we will defer to the agency's expertise and experience in the subject matter of the decision.

In our view, the court's treatment of the evidence neglects this second, equally important function of a reviewing court. Our colleagues' extended review of the evidence (in some respects much more extensive than EPA's own Third Health Document) at several points supplies reasons, distinctions, or modes of analysis that are otherwise absent from the Administrator's discussion. Just as agency counsel cannot supply a post hoc rationalization for agency determinations, neither can a reviewing court.^[314]

[101] In order to avoid slighting either of our reviewing functions, our treatment of the evidence will track closely the Administrator's discussion and analysis of the evidence in the Preamble. To the extent necessary, the Administrator's discussion will be amplified by the Third Health Document. Rather than roving through the record looking for isolated snippets of evidence, only from these major starting points will we make the necessary comparisons with the underlying evidence.

B. "A small but significant portion of the urban adult population . . . [is] over-exposed to lead."

1. The 40 ug Demarcation

The Administrator introduces his analysis of the evidence with the following statement:

Environmental lead exposure is a major health problem in this country. A small but significant portion of the urban adult population and up to 25 percent of children in urban areas are overexposed to lead. The lead exposure problem is caused by a combination of sources including food, water, air, leaded paint, and dust. The aggregate contribution of lead from all these sources poses a significant threat to health.^[315]

Although the Preamble does not define what is meant by "overexposed to lead," Chapter Three (and to a lesser extent Chapter Four) of the Third Health Document explores the issue. The Document notes that blood lead levels, measured usually in terms of ug/100 g of blood (micrograms per hundred grams), are generally considered an appropriate index by which to assess the total lead body burden. The general population carries blood lead levels of between 10 and 30 ug/100 g.^[316] As exposure to environmental lead increases, blood lead levels increase slowly and in a nonlinear fashion. As a result, blood lead levels are a satisfactory index under constant exposure conditions but are less reliable under changing exposure conditions.^[317] Clinical symptoms of lead poisoning usually do not appear until blood lead levels reach 80 to 100 ug/100 g or higher.^[318]

The bulk of the discussion in Chapter Three relates to those studies which have attempted to identify the health effects associated with blood lead levels below those associated with lead poisoning. On the basis of those studies, EPA's staff tentatively concluded that "subclinical changes" may be associated with blood lead levels in the 40 to 60 ug/100 g range. The document is careful to emphasize that a 40 ug/100 g blood level "does not represent a sharp demarcation between health and disease." It rather represents a level above which it would be "prudent" to prevent further lead exposure.^[319]

The court's opinion states that petitioners are contesting the setting of 40 ug/100 g as [102] a precautionary level.^[320] This is not the case. Petitioners' arguments have simply sought to emphasize the precautionary nature of the 40 ug level. They especially seek to emphasize EPA's own conclusion that no known functional injury or clinical effects occur in the 40 to 60 ug range and that whatever metabolic effects occur are "slight" and without clinical significance.^[321] With these qualifications stated, petitioners seem willing to concede for its limited purposes the 40 ug level as the line between normal and elevated blood lead levels.^[322] Their central position, which we explore below, is that EPA lacks a scientific basis for asserting the existence of blood lead levels in excess of 40 ug among a significant portion of the general adult population.

2. Over-Exposure in the General Adult Population

Again we must turn directly to the Third Health Document, since the Preamble does not further amplify the basis for concluding that lead levels are indeed elevated in a significant portion of the population. As regards adults, the Health Document discusses the issue in the equivalent of one page of text and in two charts.^[323] The Health Document begins by acknowledging that "due to limitations" on prior studies, "it is impossible to make precise estimates of the number of persons having blood lead levels within a given range."^[324] These limitations include problems with the chemical procedure which analyzes lead in blood and deficiencies in quality control at laboratories. As the document concedes, "[r]eproducible results even within the same laboratory are not always obtained."^[325]

Given the limitations on the underlying data, EPA's staff was still willing to conclude that certain groups, principally ones "occupationally exposed to automobile exhaust," "frequently or characteristically" have elevated blood lead levels.^[326] Petitioners vigorously attack this conclusion on two levels. First, they point out that EPA's data only supports a conclusion that certain occupational groups have higher blood lead levels as a result of occupational exposure. It does not support a conclusion that a significant portion of the general urban population, not occupationally exposed to lead, has elevated levels. In fact, petitioners emphasize that the only comprehensive study of the general urban adult population, the Seven Cities study,^[327] found only three persons (or 0.15%) out of 1,935 persons tested had blood levels of 40 ug or higher.^[328] This study was supported and directed in part by EPA and was completed recently (in 1972). Therefore, the study is particularly credible.

In addition, petitioners point to the study of Azar, et al.,^[329] published in 1972, in which [103] five groups of thirty subjects each were tested. One group consisted of Los Angeles cab drivers exposed to air lead levels of 6.1 ug/m3. Despite these very high air lead levels, blood readings in this group averaged a normal 24.6 ug (± 4.5 ug for one standard deviation).^[330] Other groups had blood lead levels averaging from 13.8 ug to 22.4 ug. Of all 150 persons tested, only one subject showed a blood level over 40 ug and he was believed to drink moonshine whiskey.^[331]

Second, petitioners attack the Administrator's reliance upon data derived from occupational categories exposed to unusual quantities of automotive exhaust, such as those working in parking structures, traffic tunnels, and closed garages, as well as those exposed to lead from sources other than the air, such as service station attendants and garage mechanics.^[332] They question, implicitly at least, EPA's picking and choosing among the available data, choosing data in which subjects are occupationally exposed to lead and rejecting data based upon samples drawn from the general urban adult population. In effect, they argue that nation-wide restrictions upon lead additives must not be based upon merely precautionary blood levels in those occupationally exposed to unusually high amounts of lead.

We agree in substantial measure with petitioner's position. EPA has presented no evidentiary basis for concluding that a significant portion of the general urban adult population has elevated blood lead levels. Table VII-1 in the Third Health Document amply demonstrates this fact.^[333] The Azar study of taxi drivers and office workers from Los Angeles, taxi drivers from Philadelphia, and persons from Barksdale, Wisconsin, and Starke, Florida, found no one (after excluding the imbiber of moonshine) with a level of 40 ug or higher. A sample of 55 "Women Living Near Freeways" uncovered one person at 40 ug or above.^[334] Two other composite urban samples of 423 and 833, respectively, found only 0.8% and 2.7% of the subjects with precautionary levels.^[335]

Unexplained is the absence from Table VII-1 of the results of the Seven Cities study—1,935 persons tested and at most three with elevated blood levels. The court's opinion declares that "[p]etitioners rely heavily on the results of the so-called Seven Cities Study, which found a very small percentage of adults with elevated (in excess of 40 ug) blood levels. . . . The Administrator, on the other hand, finds serious methodological flaws in the Seven Cities Study that limit its usefulness, 38 Fed.Reg. 33735 . . . ."^[336] We can understand the majority's anxiety to explain EPA's rejection of the Seven Cities study; however, the Administrator never discusses the studies on which he does rely for his conclusion that a significant portion of the urban adult population is over-exposed to lead. The discussion cited by the court relates to use of the Seven Cities study in an entirely different context, the presence or absence of a correlation between air lead levels and blood lead levels. Significantly, the methodological flaw being referred to by the Administrator is the fact that ". . other sources of lead influencing blood lead levels were not adequately considered in the blood lead-air lead comparisons."^[337] Although such a flaw might arguably affect the study's reliability as to the existence of a correlation, it is quite irrelevant as regards the overall blood levels measured in the course of the study, which negate the hypothesis of over-exposure in the general adult population.

[104] The Seven Cities study clearly presents the second major defect in the Administrator's approach. The Administrator chose among the available data without any explanation as to why—why he was relying upon certain studies and rejecting others. No explanation is offered in either the Preamble or the three relevant paragraphs in the Third Health Document. This is not a case of a "clear error of judgment"; it is rather a case of a clear absence of judgment. On this score, our colleagues assert,

Petitioners argue that the negative conclusions of the Seven Cities Study and several other studies should outweigh the positive indications of [certain other studies relied upon by EPA] . . . . The Administrator disagreed, and we cannot fault his conclusion.^[338]

Thus, the court concludes that "[t]he problem here is one of choosing among the items of evidence."^[339] We respectfully disagree. The problem here is really one of choosing among the items of evidence and explaining why! The Administrator disagreed with the negative conclusions of the Seven Cities study and several other studies, but never said why he disagreed. This is why we can fault his conclusion.

The court, however, again steps into the breach to offer its analysis of the studies:

. . . [S]tudies of occupational groups are often particularly valuable in acting as an early warning system of possible effects on the public at large. The intensive exposure in particular occupations essentially accelerates the effects of long-term exposure of the general public and provides an identifiable, highly exposed, and readily accessible group of research subjects. See D. Clark & B. MacMahon, Preventive Medicine 26 (1967) . . . .^[340]

This rationalization of the Administrator's decision is purely post hoc. There is no basis for it in the Third Health Document.

The above is illustrative of the amazing lengths this court will go to to produce a decision for some uncertain, ill-defined, supposed environmental benefit. This court not only commands the Administrator to produce a decision by a certain date, but rewrites his decision to fill in the gaps when his logic falters.

The court, in addition, attempts to draw support from the fact that in the Reserve Mining case some of the evidence indicating the possibility of absorption of asbestos particles by the general public came from studies of asbestos workers. This reliance is entirely misplaced. We do not here suggest that the Administrator cannot seek to reach a conclusion about the general public on the basis of studies of occupationally exposed individuals. Rather, we believe, that, if he has so concluded, he has not adequately explained how he did it. By contrast, the Eight Circuit undertook an extensive discussion of asbestos fiber exposure, relating occupational exposure to exposure by the general public through the ambient air. There is considered analysis on this precise issue in both the Eighth Circuit's opinion and the district court's opinion.^[341]

[105] In any event, the fact that such evidence proved relevant in Reserve Mining does not mean it would be relevant in this case. The issue of relevance is one for scientific inquiry and analysis. Such analysis was undertaken by the various witnesses, including especially the court-appointed expert, in Reserve Mining. Such analysis is completely absent from the Third Health Document. This court cannot now repair that defect. We cannot perform this district court or administrative agency function.

A crucial aspect of the Administrator's decision is deficient both because of its analysis and because of the absence of an evidentiary basis. On the record before us, we fail to see how the Administrator found an endangerment to a significant portion of the general urban adult population.

C. "[A]bsorption of air lead does contribute to total lead exposure and when added to lead from other sources . . results in total exposure that is excessive."

In promulgating the regulations, the Administrator stated the basic factual question to be resolved as follows: "Is there a correlation between air lead levels and blood lead levels?"^[342] Acknowledging that the data failed to produce "consistent correlations," the Administrator nevertheless was able to reach the ultimate conclusion that auto lead emissions contributed significantly to excessive blood lead levels in adults. In our view, the record indicates that the Administrator acted arbitrarily in choosing among the data relating to a possible correlation between air and blood lead levels.

In the Preamble the Administrator explicitly relies upon the following studies to support the conclusion that there is a correlation between air lead levels and blood lead levels: the pilot lead isotope studies,^[343] the unpublished study in Japan,^[344] the chamber studies,^[345] and the Daines study.^[346] Specifically rejected is the Seven Cities study^[347] on the ground (previously noted) that "other sources of lead influencing blood lead levels were not adequately considered in the blood lead-air lead comparisons." In neither of the two epidemological studies relied upon by the Administrator, the Japanese study and the Daines study, is there any indication that other sources of lead were controlled. And yet, the Administrator in the Preamble, in an obvious reference to the Daines study, declares that "[w]hen comparable groups with similar lead intakes were studied," blood lead was higher among persons living in urban areas near highways.^[348]

This is no minor slip on the Administrator's part. His entire argument in reply to criticism about the way in which he picked and chose among the various studies is that "[s]tudies which have come to contrary conclusions have generally failed to take into account the influences of other sources of lead on blood lead levels in people being studied."^[349] The record indicates that even the studies relied upon by the Administrator failed in this same respect.

[106] With regards to the Seven Cities study, the Administrator feebly attempts to gloss over his consistently selective approach with the following equivocal comment:

[I]n the Seven Cities Study, urban-suburban differences in blood leads between comparable groups were consistently found which at least in part reflect differences in air lead exposure.^[350]

The court's opinion, however, well recognizes the gravity of the Administrator's error and as a result offers for our edification a meatier, amplified version of this explanation as to why the Administrator embraces favorable studies possessing the same deficiency as the studies he rejects:

The [epidemiological] studies before the Administrator [e. g., the Seven Cities study] were of large groups of people; correlations were sought between blood level and exposure to lead in the ambient air. The studies were confounded, however, by the multiple sources of lead. Since diet accounts for a major portion of the body lead burden, an individual's blood lead level varies not only according to his exposure to lead in the ambient air, but according to his daily dietary intake of lead. Wide variations in dietary lead intake, which are common, can completely mask the effects of air lead absorption. Nonetheless, none of the epidemiological studies could control or measure dietary lead intake. This uncertainty in the data severely limited the usefulness of the broadly conceived epidemiological studies, and led the Administrator to rely instead on data limited to situations in which dietary exposure could roughly be termed constant.

Following this rationale, the Administrator focused on the consistent relationship found between air and blood lead levels within particular metropolitan areas, rather than on the lack of such a relationship between areas. . . .^[351]

No matter whether the court or the Administrator himself first came up with this explanation for EPA's inconsistent and selective approach to the evidence, it passes our understanding how anyone can find dietary control a problem in a comparison between greater Philadelphia and greater New York (thus justifying rejection of that data), but of no importance in a comparison between Scarsdale and Harlem (thus justifying reliance on urban-suburban data from greater New York). The art of reconciling total inconsistencies has soared to new heights when this court can seriously conclude (1) that "dietary lead [can] be assumed relatively constant"^[352] between the most affluent and the least affluent neighborhoods of greater New York City and (2) that "[t]he Administrator treated all the evidence in a consistent and rational manner."^[353] The Administrator has thus utterly failed to present us with a reasoned and principled analysis of the evidence.^[354] In fact, the Third Health Document does not even discuss the studies and analyses running counter to EPA's position; as a result, it is not strange that it finds no need to distinguish or reason them away.

[107] To criticize EPA's overall analysis as arbitrary should not be construed as approval of each of the studies used by the Administrator to support his position. Petitioners have presented substantial criticisms of the methodology of those studies. They also point out that EPA has drawn inferences or conclusions from many of the studies which their authors were unwilling or unable to draw. We feel no need to discuss these criticisms in detail in light of our overall conclusion.

D. The Contribution of Auto Lead Emissions to Blood Levels in Children—The Speculative Nature of EPA's Determination

As a second subsidiary reason for adopting these regulations, EPA contends that contamination of dust and dirt by lead from automotive emissions is a significant source of lead exposure to children. This conclusion is based on the following chain of reasoning:

a. High lead concentrations in dust and dirt are prevalent in urban areas.

b. In most circumstances, lead from exhausts and not lead paint or lead from stationary sources is the primary source of lead in urban dust and dirt.

c. Children, especially those between the ages of one and three, eat non-food objects, including dust and dirt. This phenomenon is known as pica.

d. As a result of ingesting leaded dust and dirt, children "can be expected to absorb some of the lead into their bodies."

An alternative argument is also made that excessive lead levels are found among children who do not come from areas where peeling paint is common and therefore their lead levels must be accounted for by auto lead emissions.^[355]

Neither the Administrator in promulgating these regulations nor EPA's scientists in the Third Health Document have explicitly stated that auto lead emissions are a significant source of lead to children. In fact, the Administrator states: "Ingestion of peeling paint has long been recognized as the primary cause of clinical lead poisoning in children."^[356] The Administrator has quite frankly stated that the chain of reasoning outlined above is a hypothesis not yet completely proved:

Currently, the contention that lead contamination of dust and dirt by automotive emissions is a significant source of lead exposure is a hypothesis consistent with information provided by a variety of studies. However, at this time, not all links in the argument have been established beyond dispute and no single study has collectively inter-related all steps in the exposure process to conclusively inter-related all steps in the exposure process to conclusively [sic] prove or disprove the hypothesis. Despite the existing uncertainties, comments received from the majority of scientists not affiliated with industrial or environmental groups support the contention that dust is an important source of exposure.^[357]

The conclusion drawn by EPA's scientists, after reviewing all the evidence submitted in the proceedings, is even more tentative:

In conclusion, clinical experience indicates that leaded paint is primarily responsible for the great majority of overt clinical lead toxicity in children. There is, however, sufficient data to strongly suggest that sources of lead other than paint play an important role in childhood lead exposure. These other sources may be especially significant at levels of exposure below overt clinical poisoning.

Lead in the air, and particularly lead in dust, are ubiquitous sources of lead which may well be important contributing factors to the problem. Exposure to dirt and dust sufficiently contaminated by lead could reduce significantly the quantity of additional lead exposure required to produce clinical poisoning in a child [108] with other sources of exposure. Though exposure to lead contaminated dirt and dust from automobile exhaust, alone, has not been shown to be responsible for cases of overt lead poisoning, automotive lead has been related to undue lead absorption in children. At this time, it would be prudent to decrease the potential air and dust lead exposure. It should be recognized that further studies are necessary to better quantitate the sources of lead contamination in dust and dirt and the magnitude of the contribution that leaded dust and dirt make to both subclinical and clinical lead overexposure.^[358]

The Administrator has implied that the large incidence of excessive lead exposure among children "known to not reside in homes where peeling lead based paint can be found . . . indicate[s] that in some circumstances dust lead is an important factor and at times may be the primary factor contributing to excessive lead exposure associated with subclinical if not clinical effects."^[359] There is literally nothing in the record which accounts for these high lead levels among children who live outside of "the central city environment." Assuming that lead based paint was not the explanation, neither EPA's scientists nor the studies they evaluated could offer an alternative explanation, much less tie the excessive exposure to auto emissions. The Third Health Document identified "lead in food, water, pottery, toys, pencils, solder, etc." as possible explanations for excessive lead exposure in those cases where lead paint was not a problem.^[360] It also noted that "[f]urther information is required to arrive at a definitive assessment of the significance of . . . [lead contaminated dust and dirt as a] source of lead contamination."^[361]

Probably the best overall conclusion on EPA's dust and dirt hypothesis was made in one of EPA's own internal memorandums by two members of the Office of Planning and Evaluation to Dr. Kenneth Bridbord of the Office of Research and Monitoring:

The reaction of this Office to the balance of Section VI, The Mechanism of Dustfall Lead Exposure, is an ambivalent one. We basically have no objections to the content of this Section; that is, we feel that it meets satisfactory standards of objectivity and quality as a scientific report in itself. On the other hand, if the purpose of this section is to establish a direct line between lead-contaminated dust and dirt from automotive exhausts and cases of lead poisoning and to thereby support the proposed lead regulations, then we find it lacking.

The report's conclusion concerning the bio-availability of lead from ingested contaminated dust and dirt is not at issue here. However, we should like to emphasize that none of the studies cited directly implicated lead from automotive exhausts as being responsible for the harming of any human being.^[362]

Implicit in EPA's position is the premise that lead from auto emissions falls to the ground and mixes with the dust and the dirt at those places where children are likely to play or be. Petitioners concede that lead from auto emissions does fall to the ground, e. g., the center of a six-lane highway. However, they contend it does not fall in those places where significant numbers of children usually spend their time.^[363] They contend that lead paint and, in some circumstances, emissions of stationary sources account for lead in the dust and the dirt that children are likely to eat. Finally, they emphasize that lead paint (not auto emission lead) is the culprit pointed to by the available evidence.

[109] We agree with petitioners' argument, but not, as our colleagues assert, because we refuse "to recognize that city children play regularly in city streets."^[364] Rather, we reject the Administrator's dust-fall hypothesis because we refuse to recognize that preschool children (the only children in which pica is a common phenomenon)^[365] play in heavily trafficked city streets. In other words, we submit that (1) the older the child, the less likely it is that he or she will ingest the dust and dirt found in a city street, (2) the younger the child, the less likely it is that he or she will be playing in a city street —especially a heavily-trafficked city street, and (3) significant amounts of lead from auto emissions are only found in heavily trafficked city streets.

Recognizing the weakness of their position, our colleagues attempt to discount the importance of the Administrator's dustfall hypothesis,

While the [dustfall] hypothesis is admittedly not proved as fact, we need not decide whether it would be sufficient by itself to support the low-lead regulations, for it is offered only in support of the evidence already presented.^[366]

Since we, unlike our colleagues, would not sustain the low-lead regulations on the basis of "the evidence already presented" (i. e., the evidence discussed in sections IV. B. and C. supra), we cannot avoid deciding whether the Administrator's dustfall hypothesis is sufficient by itself to support the regulations. Based on the three common-sensical assumptions stated above, we conclude that it is not even more likely than not that lead dustfall from automobile emissions is swallowed by preschool children with pica. Until, and if, the Administrator can at least establish this causal connection, we should reject his dustfall hypothesis.^[367]

Based in part upon EPA's own assessment of the evidentiary record, it is undeniable that the dust and dirt hypothesis continues to be a speculative explanation of high blood lead levels among certain children. [110] There is simply no evidence in the record which directly proves (used in its scientific sense) the hypothesis. EPA has thus had to argue that its hypothesis is consistent with the evidence. The fact is that there may be some evidence in the record that may be consistent with the hypothesis, but there is also a mass of evidence (as EPA acknowledges) that is inconsistent. Once again, EPA has not even gone so far as to explain why it is relying on the "consistent" evidence and not relying on the "inconsistent" evidence. This portion of the Administrator's determination is by any definition "arbitrary and capricious."

V. CONCLUSION

The regulations on fuel additives promulgated by the Environmental Protection Administrator should be held invalid: assuming the correctness of the Administrator's interpretation of section 211(c)(1)(A) of the Clean Air Act, his analysis reflected a clear error of judgment upon the available evidence. Under the standards of review in 5 U.S.C. § 706(2)(A),(C), and (D), the regulations should be set aside.^[368]

There is an uncomfortably large body of evidence, relied upon by EPA to support these regulations, which came into its possession just days before final promulgation. Further, EPA's practice of accumulating a mass of scientific documents of all types in its "public information" file, without designating on which information it would rely until the promulgation of the Third Health Document simultaneous with the regulations, is by no means the "notice" required by the Administrative Procedure Act. Thus, interested parties had no reasonable opportunity to question the methodology of the investigators; EPA counsel can thus point to the absence of rebuttal evidence and imply that all was well in the later studies. In light of the fact that EPA had been gathering evidence on airborne lead for three years, and that after each of the previous public comment periods EPA had been forced to reconsider its health position, the fact that so many of the studies that EPA uses to support its position were reported to the Agency less than sixty days prior to promulgation of the regulations, must necessarily give pause to this court.

The Administrative Procedure Act (5 U.S.C. §§ 706 and 553)^[369] contemplates review of agency determinations after, at a minimum, an opportunity for public and governmental agency comment on all the evidence in the record. When this court mandated a decision within thirty days on a matter the Administrator had had under consideration for three years, there was no suggestion that the Administrator go to totally new, untested, and uncommented upon data as a basis for his decision. The rationale behind such an order could only have been that the court believed the Administrator already not only had the necessary data in hand, but also had afforded the opportunity for informed public and other governmental department comment required in valid agency rulemaking pursuant to section 553. If the Administrator believed that the data in the First and Second Health Documents, along with the searching criticisms received, would not support the decision he was about to make, then he could not lawfully make that decision. Nor could he make it on the basis of new and [111] untested data in the Third Health Document.^[370]

Turning from the procedure to the substantive basis of the decision, the supporting evidence, and the analytical rationale applied by the agency, EPA falters on both prongs of its argument in regard to the impact of lead emissions on the general public health and on children. We find no plausible showing that lead in the air makes a "significant contribution to elevated blood lead levels" in either the general population or among children. The Preamble to these regulations itself states, "It is generally agreed that food is the major source of lead to the general population." This is backed by the conclusion of Dr. Carl Shy of EPA, that on the basis of the Seven Cities study^[371] only three percent of the differential in blood lead levels between those who lived in urban areas and those who lived in the suburbs "can be accounted for by the air lead gradient" between the two areas.^[372] As for children, the Preamble states, "Ingestion of peeling paint has long been recognized as the primary cause of clinical lead poisoning in children." As we pointed out at the outset,^[373] only if auto lead emissions can be shown to contribute significantly to blood lead levels can it logically follow that a reduction or elimination of auto lead emissions would contribute significantly to solving the problem of lead in the human body.

We judges may be, as we are sometimes reminded, without scientific background or access to expertise, but we think this brand of administrative agency action should be readily apparent —and equally abhorrent—to any appellate judge. To detect and set aside agency action based on such shoddy foundations, not to engage in rival scientific calculations or substitute judgment, is the function of a reviewing court.

We appreciate the quandry in which the Administrator found himself after three years of pondering this question. Beset on all sides by those urging the Administrator to take action, to ban or limit drastically the use of lead in gasoline, confronted by the arguments of those who asserted that such action was completely unjustified, attempting in the First Health Document and in the Second Health Document to postulate a scientific basis for the action he had tentatively decided to take only to have the scientific bases of his action riddled by the analyses of scientists in all other departments of the Government commenting thereon, and confronted finally by an order of this court that he act one way or another in a period of thirty days, the Administrator found himself with the question "whether . . . to take arms against a sea of troubles, and by opposing end them."^[374] So the Administrator acted, in reliance primarily on data only partially analyzed by his own staff and not commented on according to the prescribed procedure or by the most knowledgeable parties. The result was, Hamlet-like, a blind stab through a curtain of ignorance, inflicting anguish, but in our judgment not rationally solving any problem.

It should be understood that our view would not prohibit EPA from regulating lead additives under section 211(c)(1)(A) at some point in the future, should evidence [112] sufficient to meet the statutory standard be developed and should action appear appropriate. On the present record, however, we cannot agree that EPA has properly decided that lead additives in gasoline will cause emissions which "will endanger the public health."

APPENDIX

Title 40—Protection of Environment Chapter I—Environmental Protection Agency Part 80—Regulation of Fuels and Fuel Additives Control of Lead Additives in Gasoline

* * * * * *

Health implications of airborne lead—Introduction. The issue concerning the contribution of automobile lead exhausts to the country's lead exposure problem is complex and controversial. In order to complete a fair assessment of this problem, EPA has made a concentrated effort to obtain and review all the medical and scientific evidence. The Agency has repeatedly requested information and comments from the medical and scientific communities as well as the general public. Since the reproposal of the regulations, information gathered through the comment period on the reproposed regulations, earlier comment periods on the originally proposed regulations, and surveys of relevant studies by EPA personnel have been thoroughly reviewed and evaluated by a task force of EPA medical experts and scientists. A paper entitled "EPA's Position on the Health Implications of Airborne Lead" sets forth in detail the Agency's evaluation that there is a health basis for reducing the use of lead in gasoline. A copy of this paper is available from the Publications Section, Environmental Protection Agency, 401 M Street SW, Room 238W, Washington, D.C. 20460.

General summary of health issue. Environmental lead exposure is a major health problem in this country. A small but significant portion of the urban adult population and up to 25 percent of children in urban areas are over-exposed to lead. The lead exposure problem is caused by a combination of sources including food, water, air, leaded paint, and dust. The aggregate contribution of lead from all these sources poses a significant threat to health. However, it is extremely difficult to determine what percentage of the problem each separate environmental factor contributes. Since there are additive sources whose importance varies considerably among individuals it is likewise difficult to determine what impact would be achieved by partial or total reduction of lead from any source. Should the lead in all sources be reduced, however, it seems clear that the situation would be substantially improved. Leaded gasoline is a source of air and dust lead which can be readily and significantly reduced in comparison to these other sources. It is also one of the few lead sources not yet subject to any controls other than EPA's lead-free gasoline regulations.

Lead from gasoline accounts for approximately 90 percent of airborne lead, total lead additive usage being well over 200,000 tons a year. Lead from stationary sources and deteriorating leaded paint from buildings, combined with lead from gasoline cause high lead levels in dirt and dust. Of these sources, lead from gasoline is the most ubiquitous source of lead found in both the air and the dirt and dust in urban areas. Human exposure to this lead takes place by inhalation and by ingestion of dirt and dust contaminated by air lead fallout. Since exposure to lead among the general population is widespread, it is reasonable that efforts be made to reduce preventable sources of lead exposure including lead emissions resulting from lead in gasoline.

Many of those disagreeing with the reproposed regulations based their comments on EPA's failure to show sufficient evidence of adverse health effects specifically caused by the use of lead additives in gasoline. While most agree that the combustion of leaded gasoline causes an increase in the amount of lead in the environment, they do not believe that lead in gasoline represents a sufficient endangerment to health or a [113] sufficient risk to the environment to warrant promulgation of controls. The arguments against the position set forth in EPA's reproposed regulations include the following: (1) EPA has failed to show a clear correlation between lead levels in the air and those in the blood of exposed individuals; (2) lead from dust and dirt does not represent a significant threat to body burden of lead; (3) leaded paint is the primary cause of childhood lead poisoning and lead in gasoline does not play an important role in and lead poisoning or excessive lead exposure; (4) lead in food and water and not airborne lead are the principal sources of lead to the general population.

A discussion of the four major areas of criticism and a summary of the significant new information received since the regulations were reproposed are provided below.

I. Is there a correlation between air lead levels and blood lead levels? A portion of the comments received were critical of EPA's reproposed regulation on the basis that consistently strong correlations have not been found between air lead and blood lead levels. The conclusion expressed by many comments is that except for persons whose occupations bring them in close contact with environmental lead, exposure to airborne lead does not contribute to increased blood lead levels and does not pose a significant threat to health.

These comments cite several studies which did not demonstrate a strong correlation between air lead and blood lead levels. For example, The Seven Cities Study did not show a close correlation between increase in blood lead levels and simultaneous increases in air lead exposures. Blood lead levels were lower among the New York City residents studies than the Philadelphia residents, despite the fact that air lead exposures among the New York residents were actually greater than those in Philadelphia. Also cited as evidence against EPA's position is the observation that despite significant increases in the use of lead in gasoline in recent years there have been no discernible increases in blood lead levels of populations so exposed.

Residential differences in blood lead levels have also not always corresponded to differences in air lead exposures. For example, studies of primitive populations, as well as studies of rural U.S. populations, have shown that the blood lead levels in some of these groups are as high or higher than those of persons living in industrial areas, even though the air lead levels in those rural areas should have been much lower. A comparison between London day and night taxi drivers has also shown no significant differences in blood lead levels but did find differences in exposure to carbon monoxide suggesting that despite the possibility that air lead exposure in the day may have been higher than at night, this was not reflected in blood lead increases. However, differences in smoking intensity, as well as actual differences in air lead exposure between groups, could explain these results and neither were measured.

In summary, a number of comments have criticized EPA's position on the basis that there is not a good correlation between air lead exposure and blood lead levels.

The Agency has weighed against these criticisms studies which have shown that airborne lead does contribute significantly to lead exposure in the general population. For example, using a pilot lead isotope approach, preliminary data show that airborne lead at 2 ug/m3 can contribute as much as 1/3to total lead exposure in man. This result is consistent with data concerning the deposition of lead particles in the pulmonary tract and the absorption of such particles into the blood stream.

An unpublished study in Japan similar to the Seven Cities Study, but which has not yet been completely analyzed, has preliminarily demonstrated that airborne lead exposures below 2 ug/m3 affect blood lead levels.

Chamber studies in carefully controlled environments, have shown significant increases in blood lead of men exposed to air lead slightly greater than 3ug/m3.

Differences in the blood lead levels between urban and suburban residents in the [114] same geographic area have been found. When comparable groups with similar lead intakes from other sources besides air were studied, blood leads were consistently higher in urban areas and near highways where air lead concentrations were greatest. Thus while correlations between blood lead levels and air leads at lower exposure levels are not always good, the evidence indicates that air lead does contribute to general population lead exposure.

Failure to find consistent correlations does not in the Administrator's judgment invalidate the above conclusions. Studies which have come to contrary conclusions have generally failed to take into account the influence of other sources of lead on blood lead levels in people being studied. In the Seven Cities Study, for example, these other sources of lead influencing blood lead levels were not adequately considered in the blood lead-air lead comparisons. EPA has re-analyzed the Seven Cities Study and has found that air lead was a significant, though not the most influential factor affecting blood lead levels. Further, in the Seven Cities Study, urban-suburban differences in blood leads between comparable groups were consistently found which at least in part reflect differences in air lead exposure.

In summary, absorption of air lead does contribute to total lead exposure and when added to lead from other sources such as food and water results in total exposure that is excessive. Thus, the partial removal of lead from the air will help to reduce the degree of excess lead exposure which currently exists among adults and children in the United States.

II. Does dust lead contribute to lead poisoning in children? Many comments received by the Agency express the viewpoint that the primary cause of lead poisoning in children is ingestion of lead-based peeling paint. Investigations of cases of clinical lead poisoning in children have repeatedly demonstrated peeling leaded paint as the major source of exposure. Since peeling leaded paint has consistently been observed in the environment of lead poisoned children, many commentors thought it unlikely that lead in dust and dirt could make a significant contribution to this problem. They also point out that lead in dust could be caused by peeling or erosion of leaded paint in or near a home.

One commentor cites X-ray studies of the abdomen among children with lead-poisoning as showing paint chips in the majority of instances. Another argues that differences in blood lead levels between Black and Puerto Rican children could not be explained by exposure to different quantities of lead in dust. Further, studies have shown that animals do not absorb lead from dust as readily as they absorb lead from paint.

Commentors have criticized the Agency for considering that the El Paso Study supports the dustfall hypothesis related to lead in gasoline. In the El Paso Study, children living near a leadsmelter were examined for blood lead levels and for sources of lead in their environment. These results showed that children living nearest the smelter had the highest blood lead levels and that dust lead was a probable major cause. Many commentators, however, considered the El Paso Study applicable only to stationary lead sources and not to lead in gasoline which is different in particle size and chemical composition from smelter-emitted lead.

EPA recognizes the importance of leaded paint as a source of lead exposure for children and that it is the primary cause of clinical lead poisoning. However, based on the evidence available to it, EPA does not believe that leaded paint is the only significant source of lead contributing to excessive lead exposures in children. The Agency's position is that numerous sources contribute to childhood exposure including lead in food, water, air, dust, and dirt as well as paint. Among these sources, contaminated dust and dirt from motor vehicles exhausts are believed to be important exposure routes.

Currently the contention that lead contamination of dust and dirt by automotive emissions is a significant source of lead exposure is a hypothesis consistent with [115] information provided by a variety of studies. However, at this time, not all links in the argument have been established beyond dispute and no single study has collectively inter-related all steps in the exposure process to conclusively prove or disprove the hypothesis. Despite the existing uncertainties, comments received from the majority of scientists not affiliated with industrial or environmental groups support the contention that dust is an important source of exposure. This is based on the following evidence:

A. Environmental sampling in a number of cities has demonstrated the ubiquitous presence of lead contaminated dust in urban areas. These measurements were taken inside and outside of buildings including homes and schools. Dust lead measurements outside homes commonly ranged from 0.1 to 0.5 percent lead by weight. Measurements well in excess of 0.5 percent have also been recorded. Inside homes, samples were found to contain lead contents ranging from 0.05 to 0.2 percent and in some instances as high as 0.5 percent. Current Federal regulations have already established that lead concentrations in paint in excess of 0.5 percent represent a definite hazard to children and serious consideration is being given to reducing the allowable level to 0.06 percent. In testimony before the United States Senate, Dr. Merlin DuVal, at the time Assistant Secretary of Health and Scientific Affairs at HEW, commented on an appropriate safe level for lead in paint:

Based on information now available to us, we are satisfied that it is technologically feasible, and desirable from a health viewpoint to more toward the .06 percent standard recommended by the American Academy of Pediatrics.

B. As was stated above, high lead concentrations in dust are prevalent in urban areas. It is not clear in all instances, which sources are contributing most to this contamination. Comments received by the agency point out that high lead levels in some cases may be caused by the chipping or peeling of leaded paint from interior and exterior surfaces. EPA agrees that this is true. In other cases, the lead dust content is clearly the result of lead emission from stationary sources such as smelters. However, EPA believes an important and the most ubiquitous source of lead in dust is the exhaust of automobiles using leaded gasoline. Annually, over 200,000 tons of lead are used as additives in gasoline. The vast majority of this lead is emitted into the environment. Although significant amounts of lead remain airborne for extended periods of time, evidence indicates that a large quantity of the exhaust lead rapidly settles to the ground within several hundred feet of the source. Measurements of lead in dust and soil further indicate that lead content decreases with increased distance from the roadway. It has also been found that dust lead levels in homes near heavily traveled roadways are significantly higher than in comparable homes located along side streets. It should be noted that the majority of studies reporting high levels of lead in dust and dirt did not associate sources of peeling leaded paint or stationary lead sources with the lead dust measurements. Accordingly, the Agency believes that in most circumstances lead from automobile exhaust is the primary source of lead in dust and soil in urban areas.

C. The general environment of urban children commonly includes dirt and dust contaminated with lead. A large percentage of children, especially between the ages of one and three years, are known to ingest non-food objects in their mouths. It has been demonstrated that children living in high dust lead environments have greater quantities of lead on their hands than children living in less contaminated environments. The existence of leaded dust on the hands of urban children has been high-lighted by the common occurrence of inadvertent lead contamination of finger prick blood lead specimens taken from these children.

D. Children who ingest leaded dust and dirt can be expected to absorb some of the lead into their bodies. Though it is difficult to determine the precise amount of lead [116] that would be absorbed, animal experiments suggest that appreciable quantities of this lead, whether from smelters, paint or gasoline exhaust, are absorbed. Further, it has also been shown that at least some children residing in environments heavily contaminated by leaded dust and dirt absorb enough to suffer from subclinical and even clinical effects of lead overexposure. This was particularly true in the case of El Paso, mentioned above. Though the lead source was a smelter, animal studies indicate that lead in dust due to leaded gasoline would be absorbed in quantities comparable to that emitted by the smelter. Another study from Charleston, South Carolina indicates that children residing in homes near high soil lead concentrations had a greater frequency of lead poisoning than children residing in less contaminated areas. This study suggests that lead from soil was absorbed, although it is not clear what sources were primarily responsible for those high soil lead levels. It should be further noted that instances such as those above, coupled with known high levels of lead in dirt and dust, indicate that children could easily ingest enough lead by this route to be significant.

E. Various studies indicate that cases of lead poisoning and significant over-exposure are not always associated with urban home environments in which sources of peeling or chipping leaded paint were observed. These studies include children residing primarily in inner city areas. Admittedly children may be exposed to peeling or chipping leaded paint in environments away from their own homes. However, since several recent studies indicate that up to 60 percent of children with excessive lead exposure are known to not reside in homes where peeling lead based paint can be found, it is unlikely that peeling paint exposure away from the homes accounts totally for this difference. Furthermore, extension of blood lead screening programs outside of slum areas indicates that the lead exposure problem is found in children residing in higher income areas where peeling paint is not frequent and exposure to this source away from the home is less likely. In conjunction with these findings, residence near roadways have been found to contain higher quantities of lead than those measured away from the road. Findings such as these indicate that in some circumstances dust lead is an important factor and at times may be the primary factor contributing to excessive lead exposure associated with subclinical if not clinical effects.

F. Clinical symptoms resulting from very high lead exposure in children are known to be associated with permanent neurologic damage. It has also long been suspected, but not proven beyond doubt that lead exposures below those sufficient to cause clinical symptoms in children are also harmful. In particular it has been observed that physiologically significant biochemical changes occur in children with excessive exposures below clinical toxicity and it has been proposed that these changes are reflective of subclinical changes that precede overt disease. Recently available scientific information, though far from completely resolving this issue, supports the view that adverse effects due to lead in children are not confined only to situations in which overt clinical symptoms of lead poisoning occur. Included in these findings are increased subtle neurological impairments among children more highly exposed to lead below levels known to cause clinical disease.

III. Will a reduction of lead in gasoline reduce the incidence of clinical lead poisoning in children? Ingestion of peeling paint has long been recognized as the primary cause of clinical lead poisoning in children. This position has been expressed in many comments received by the Agency including those from several noted authorities in the field of lead poisoning. For this reason, numerous comments have questioned the need to reduce lead in gasoline on the basis that this action would have little if any impact on reducing the incidence of clinical lead poisoning in children.

While EPA recognizes the importance of leaded paint as a source of lead for children and has supported governmental efforts to reduce this risk, the findings of several [117] studies suggest that lead poisoning can develop in the absence of significant sources of leaded paint. Though this possibility does not affirm that reducing lead in gasoline will reduce the incidence of lead poisoning in children it indicates that lead in gasoline may, in conjunction with other nonpaint sources, contribute to the development of lead poisoning. Whatever the impact this reduction may have upon clinical lead poisoning, the action will significantly reduce lead exposure among children.

EPA is also concerned about the probability that children exposed to lead at levels below those associated with clinical poisoning are also being adversely affected. Several effects identified as subclinical lead effects include impairment of fine motor functions, and altered behavior.

It is noteworthy that in a significantly large percentage of excessive lead exposure cases (up to 50 percent in some instances) peeling lead based paint in the home cannot be identified as a source of the exposure. Thus, while leaded paint is recognized as the major cause of childhood lead poisoning, it is not clear that leaded paint is singly responsible for the large degree of excess childhood lead exposure in this country.

IV. Excess lead exposure among the general population could result from a combination of lead sources, not one of which by itself is sufficient to be a problem. Under these circumstances, would it not be preferable to formulate a control strategy based upon reducing lead levels among those sources that contribute the most to this total exposure? It is generally agreed that food is the major source of lead to the general population. A World Health Organization expert committee reports that according to the results of total diet studies in the industrialized countries, the total intake of lead from food generally ranges from 200-300 ug per person per day. WHO further states that based upon available data, these levels are similar to those found in the past 30-40 years and that no upward trend in lead levels in food is evident.

This information suggests that the level of lead in food has remained relatively constant in recent times. Though lead in food would certainly contribute to total lead exposure for the general population, lead in food is probably not the source that is most readily reduced in the event that total exposure to lead is excessive. According to WHO, "Any increase in the amount of lead derived from drinking water or inhaled from the atmosphere will reduce the amount that can be tolerated in food. The lead in air is probably the contribution that is most accessible to action for reducing the total body burden of lead, especially where this fraction is large compared with that absorbed from food."

V. What new information has become available since reproposals of the regulation and as a result of the additional comment period? The majority of comments addressed the evidence presented by EPA in support of its proposed regulation and did not introduce new evidence. The number of comments received were approximately evenly divided between those in favor and those against. The bulk of comments critical of EPA's health position was submitted by industry or industry affiliated scientists. Independent scientists who commented, not affiliated directly with the industry or environmental groups, were in favor of the regulation by approximately 2/1. Most favorable comments, though often from scientists knowledgeable in the field of lead, provided testimonial support rather than new evidence. Most new data that either was presented in comments or which subsequently became available to EPA does support the need to reduce lead emissions from automobiles. Among these latest data are the following:

(1) Studies of subclinical lead effects in children continue to suggest that fine motor function and behavior are affected. Though this issue is not completely resolved, the new data emphasize the potential subclinical risk.

(2) It has been reaffirmed that high dust lead levels, up to 1% lead content, have been found in children's play areas, inside schools and in homes.

[118] (3) New evidence reaffirms that high dust lead levels can be caused by leaded gasoline. A recent study in Rochester, New York, demonstrates that high dust lead levels in homes are not always associated with peeling paint and that house dust lead levels are higher in urban than suburban homes. A study in Vermont has shown that higher concentrations of lead in house dust are found in homes located near busy roads compared to homes on sidestreets. This latter point is consistent with the previously known fact that air lead fallout decreases with increased distance from roadways. A study by EPA in New York City indicates that higher household dust and soil lead levels are found in areas with greater dust lead fallout from the air as compared to areas with little lead fallout.

(4) Young children living in homes with high dust lead contents have been found to have more lead on their hands than children in homes with low dust lead content. This finding provides an important link in the dust fall lead hypothesis. The finding is consistent with observations that finger prick blood-lead specimen taken from children are routinely contaminated by lead that is present on the fingers.

(5) Studies continue to indicate that a high degree of exposure to environmental lead is not confined to inner city areas. Cases of over-exposure continue to be reported from areas in which leaded paint would not be expected to be the predominant factor.

(6) Studies from Newark, New Jersey, observed that the frequency of lead poisoning and undue lead exposure is doubled among children living close to major roadways compared to children living farther away.

* * * * * *

38 Fed.Reg. 33734-33737 (6 December 1973); App. 2-5.

[1] All sections of the Act pertinent to this case were added by the Clean Air Amendments of 1970, Pub.L. 91-604, Dec. 31, 1970, 84 Stat. 1698-1700.

[2] The new regulations, together with regulations requiring all gasoline refiners to market at least one line of lead-free gasoline, are set out in 40 C.F.R. § 80 (1975). The lead-free regulations serve a different purpose than the low-lead regulations now before us. Leaded gasoline fouls the catalytic converter emission control system developed by the major automobile companies to meet the air pollutant emission standards set by Congress in § 202 of the Clean Air Act. 42 U.S.C. § 1857f-1. So as to allow implementation of the catalytic converter, the Administrator ordered the marketing of lead-free gasoline pursuant to his authority under § 211(c)(1)(B), the sister section to § 211(c)(1)(A) at issue here. Section 211(c)(1)(B) gives EPA authority to regulate gasoline additives whose emission products "will impair to a significant degree the performance of any emission control device or system which is in general use * * *." 42 U.S.C. § 1857f-6c(c)(1)(B). The lead-free regulations were approved by this court in Amoco Oil Co. v. EPA, 163 U.S.App.D.C. 162, 501 F.2d 722 (1974).

On March 5, 1975, the Administrator suspended the 1977 statutory standards for automobile emissions of hydrocarbons and carbon monoxide, establishing interim standards for that model year equal to those now in effect. 40 Fed.Reg. 11900. This action was taken to slow the emission reduction schedule and thereby minimize a potential health hazard posed by the gradual increase in sulfuric acid emissions produced by the catalytic converter. So far as this decision is relevant to this case, it bears noting that the lead-free gasoline regulations will continue in effect and automobiles will continue to be equipped with catalytic converters for the foreseeable future. See note 68 infra.

[3] The principal studies and symposia over the years on the subject have included Sayers et al., "Experimental Studies on the Effect of Ethyl Gasoline and Its Combustion Products," Bureau of Mines, 1927; HEW, "Public Health Aspects of Increasing Tetraethyl Lead Content in Motor Fuel," Public Health Service Pub. No. 712, 1959; Kehoe, "The Metabolism of Lead in Man in Health and Disease," The Harben Lectures, 1960, JA 500-579; HEW, "Survey of Lead in the Atmosphere of Three Urban Communities," JA 789-839; HEW, "Symposium on Environmental Lead Contamination," Public Health Service Pub. No. 1440, 1966, JA 975-984; Tepper & Levin, "A Survey of Air and Population Lead Levels in Selected American Communities," 1972, JA 840-916; National Academy of Sciences, "Airborne Lead in Perspective," 1972, JA 309-362; EPA and Commission of European Communities, Proceedings of International Symposium, "Environmental Health Aspects of Lead," Luxembourg, 1973, JA 676-677; EPA and National Institute of Environmental Health Services, Conference on "Low-Level Lead Toxicity," Raleigh, N.C., 1973.

[4] Some of the data discussed herein speak of micrograms of lead per 100 grams of blood, while other data report micograms per 100 milliliters of blood. Since the density of blood is close to 1.0, these figures are directly comparable. Therefore, lead concentrations, unless otherwise indicated, will hereafter simply be given in micrograms. See National Academy of Sciences Committee on Biologic Effects of Atmospheric Pollutants, Airborne Lead in Perspective 61 n. * (1972) (hereinafter NAS Report).

[5] Lead in food and water ultimately can be traced to lead in soil and this, of course, is uncontrollable. The NAS Report concluded that "[t]here is no evidence that the amount of lead in the diets of people has changed substantially since 1940." NAS Report at 206.

[6] A list of local laws regarding control and/or removal of lead-based paints can be found in NAS Report at 77.

[7] This is EPA's figure, Third Health Document at II-4, JA 37, and Ethyl Corporation (hereinafter Ethyl), alone among the petitioners, contests it. Supplemental brief of petitioner Ethyl Corporation (hereinafter Ethyl Supp. Br.) at 40. We cannot say that EPA's estimate is unreasonable. It was determined by discounting the NAS Panel's conclusion that "about 98% of the airborne lead that can be traced to its source comes from combustion of gasoline." NAS Report at 31. See also id. at 12-13.

[8] An alternative approach, considered and rejected by EPA, is to trap and remove lead emissions from the exhausts of automobiles using leaded gasoline. See note 66 infra.

[9] See, e. g., 116 Cong.Rec. 19207 (1970) (remarks of Rep. Skubitz) ("the Government can require that the oil companies get the lead out"); id. at 19228-19230 (colloquy between Reps. Waggoner & Staggers); id. at 19234 (remarks of Rep. Williams); id. at 19239 (remarks of Rep. Sebelius).

[10] Regulations promulgated for the latter reason were approved in Amoco Oil Co. v. EPA, supra note 2. See note 2 supra.

[11] JA 292. This document was subsequently revised by Health Hazards of Lead (Rev. April 11, 1972), JA 254; Atmospheric Lead and Public Health (April 11, 1972), JA 276, and Corrections and Additions to Health Hazards of Lead (April 27, 1972), JA 272.

[12] The reduction would proceed in the following steps:

    1.7 g/gal. after Jan. 1, 1975

    1.4 g/gal. after Jan. 1, 1976

    1.0 g/gal. after Jan. 1, 1977

    0.8 g/gal. after Jan. 1, 1978

    0.5 g/gal. after Jan. 1, 1979

40 C.F.R. § 80.20 (1975). According to EPA calculations, when the overall lead content of both leaded and unleaded gasoline averages 0.5 grams per gallon, leaded gasoline would contain an average of 1.25 grams of lead per gallon, the same as under the original regulations. See 38 Fed.Reg. at 33739 (1973).

[13] Commentators have been uniformly critical of the majority opinion. See Gardner, Federal Courts and Agencies: An Audit of the Partnership Books, 75 Colum.L.Rev. 800, 801 & n.77 (1975); Note, Judicial Review of the Facts in Informal Rulemaking: A Proposed Standard, 84 Yale L.J. 1750, 1767-68 & nn.81-82 (1975); Note, Reserve Mining—The Standard of Proof Required to Enjoin an Environmental Hazard to the Public Health, 58 Minn.L.Rev. 893, 918-19 n.116 (1975). See also Reserve Mining Co. v. EPA, 514 F.2d 492, 519-520 (8th Cir. 1975) (en banc).

[14] When EPA acts under § 211(c)(1)(A) it is essentially telling manufacturers how to make their fuels, a task Congress felt the Agency should enter upon only with trepidation. See, e. g., 116 Cong.Rec. 32920 (1970) (remarks of Sen. Baker); id. at 19229 (remarks of Reps. Rogers & Waggoner). On the other hand, when the Agency acts under § 202, it is only mandating an end product—regulated emissions. The method for achieving the required result is entirely in the hands of the manufacturers.

Nonetheless, deference to regulation under § 202 is not mandatory. The Administrator is only required to "consider" the possibility of regulating under that section instead of under § 211. This language is in sharp contrast to the version of § 211 that was passed by the House. The House version would have allowed regulation under § 211 only after the Administrator made a specific finding "that it is not otherwise technologically or economically feasible to achieve the emission standards established pursuant to section 202 of this Act." H.R. 17255, 91st Cong., 2d Sess. § 210(g)(1) (1970). This mandatory deference to § 202 regulation was removed in conference and the present more flexible language was substituted. See pages ___ - ___ of 176 U.S.App.D.C., pages 22-23 of 541 F.2d infra.

[15] At oral argument, petitioners claimed the regulations were void because the Administrator had failed to couch his ultimate finding in the language of the statute itself. See also supplemental brief of petitioner National Petroleum Refiners Association (hereinafter NPRA Supp.Br.) at 5. The short answer to the argument is that petitioners' view of the facts is erroneous. While interpreting the "will endanger" standard to mean "presents a significant risk of harm," 33 Fed.Reg. 33734, the Administrator ultimately did make his finding in the language of the statute:

These regulations are based upon a determination by the Administrator that the emission product of a fuel or additive will endanger the public health * * *.

Id. at 33741. See 40 C.F.R. § 80.1 (1974).

In any case, however, the issue is spurious. It is well established that ultimate findings do not have to be expressed at all, let alone be expressed in the language of the statute. Rather, absent compelling countervailing considerations, an ultimate finding will be implied from the action taken. Pacific States Box & Basket Co. v. White, 296 U.S. 176, 186, 56 S.Ct. 159, 163, 80 L.Ed. 138, 146 (1935); Martin v. Mott, 25 U.S. (12 Wheat.) 19, 32-33, 6 L.Ed. 537, 30-32 (1827) (Story, J.). Cf. Joseph v. FCC, 131 U.S.App.D.C. 207, 211-212, 404 F.2d 207, 211-212 (1968). The law is fully developed in 2 K. Davis, Administrative Law Treatise § 16.07 at 455-59 (1958).

[16] We note that even if we did not agree fully with the Administrator's interpretation of the Act, we would be obliged to accord it considerable deference. As the Supreme Court recently held in approving, despite the contrary views of several circuits, the Administrator's reading of another section of the Clean Air Act:

Without going so far as to hold that the Agency's construction of the Act was the only one it permissibly could have adopted, we conclude that it was at the very least sufficiently reasonable it should have been accepted by the reviewing courts.

Train v. Natural Resources Defense Council, Inc., 421 U.S. 60, 75, 95 S.Ct. 1470, 1479, 43 L.Ed.2d 731, 743 (1975). See also id. at 87, 95 S.Ct. at 1485, 43 L.Ed.2d at 750.

[17] It is linguistically clear, of course, that one can be "endangered" without actually being harmed. Nonetheless, some risk of harm is necessary. State v. Fine, 324 Mo. 194, 23 S.W.2d 7, 9 (1929). Webster defines "endanger" as "to bring into danger or peril of probable harm or loss." Webster's Third New International Dictionary 748 (1961) (emphasis added).

Not all courts have agreed that "probability" of harm is the proper determinant of danger. Where grounds for divorce are few, for instance, courts have interpreted laws allowing divorce because of inhuman treatment that "endangers the life" to require only the slightest possibility of actual loss of life. Thus action that endangers health has been held to endanger life on the theory that the former cannot be endangered without threatening the latter. See Cole v. Cole, 23 Iowa 433, 438 (1867); Beebe v. Beebe, 10 Iowa 133, 139 (1859). In one of the latest of these cases, mistreatment that deprived a spouse of needed rest and peace of mind was held to "endanger" life. Smith v. Smith, 258 Iowa 557, 561, 138 N.W.2d 453, 456 (1966). We need not decide here how remote the possibility of actual harm could be under the "will endanger" standard since we accept the Administrator's determination in this case that a "significant" risk to health falls within the statutory language. See pages ___ - ___ of 176 U.S.App.D.C., pages 17-20 of 541 F.2d infra.

[18] Petitioner Ethyl suggests that while these may indeed be examples of endangerment they differ from the threat from automotive lead emissions in that

plagues do cause death and illness; violent storms do cause damage—known facts that may be experienced by the threatened community.

Ethyl Supp.Br. at 11 (footnote omitted). We may preliminarily observe that the absorption of lead does cause lead poisoning, a known fact that may be evaluated by the public and the EPA. However, in so far as Ethyl is complaining that the mechanism by which plagues and storms cause damage is well known while the question of the relation between lead automobile emissions and the absorption of lead is less certain, Ethyl's observation only supports the reading of § 211(c)(1)(A) as a precautionary statute. The massive diffusion of airborne lead is a gross environmental modification never before experienced. Of course, there are no past disasters of the kind anticipated by the Administrator on which the community's experience may be based. This, however, is inherent in such a threat and does not imply that no danger is posed by it. We believe the precautionary language of the Act indicates quite plainly Congress' intent that regulation should precede any threatened, albeit unprecedented, disaster. Ethyl is correct that we have not had the opportunity to learn from the consequences of an environmental overdose of lead emissions; Congress, however, sought to spare us that communal experience by enacting § 211(c)(1)(A).

[19] Since Congress seemed to assume that the meaning of the threshold determination required by § 211(c)(1)(A) would be self-evident, there is a complete absence of helpful legislative history. What little there is of relevance is discussed at pages ___ - ___ of 176 U.S.App.D.C., at pages 21-23 of 541 F.2d infra. See also note 89 infra.

[20] Should there be any doubt about this conclusion, it is quickly resolved by reference to § 109. There Congress made it quite clear how it would refer to anything other than actual harm. Section 109(b)(2) provides that national secondary ambient air quality standards for pollutants listed under § 108 be prescribed with a margin of safety; they should be sufficient to protect against "any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air." 42 U.S.C. § 1857c-4(b)(2) (emphasis added). When Congress uses the phrase in § 108 without the modifier "known or anticipated" it plainly embraces only the usual meaning of adverse effects, i. e., known adverse effects or actual harm.

[21] The Administrator appears to have a measure of discretion in determining whether to list a pollutant under § 108, which, by its terms, speaks of the exercise of his "judgment." See 38 Fed.Reg. 33740 (1973). Amicus Natural Resources Defense Council (NRDC) has argued that listing of air pollutants under § 108 is mandatory. Its petition for review of these regulations raising that issue was dismissed by the division for want of jurisdiction, Natural Resources Defense Council, Inc. v. EPA, No. 74-1023 (D.C.Cir. September 11, 1974), and NRDC has since brought a successful citizen's suit under § 304 of the Act, 42 U.S.C. § 1857h-2, to compel issuance of national ambient air standards for lead. Natural Resources Defense Council, Inc. v. Train, 411 F.Supp. 864 (S.D.N.Y. 1976).

[22] Thus we must reject amicus NRDC's suggestion that the standards for action under §§ 108 and 211 are the same.

[23] Petitioners' arguments that the threshold determination under the "adverse effect" standard is less rigorous than under the "will endanger" standard are either spurious or misdirected. Nalco Chemical Company (Nalco) and Ethyl argue that the presence of the phrase "in his judgment" in § 108, and its absence in § 211, means the Administrator has greater discretionary power under the former section. Ethyl Supp.Br. at 21; Nalco Supp.Br. at 22. As we shall explain below, see note 37 infra, the Administrator retains the same (if not greater, see note 21 supra) discretionary power under § 211.

Nalco points to the "margin of safety" language of § 109 as proof of a "lower standard" under § 108, Nalco Supp.Br. at 22, without recognizing that the margin of safety refers only to the implementing requirement of formulating standards and not to the threshold decision to regulate. NPRA likewise confuses this point by suggesting that the listing requirement of § 108 is like the reporting requirements of § 211(a), so that the "margin of safety" language is comparable to § 211(c)(1)(A), only more generous. NPRA Supp.Br. at 42-43. This ignores the fact that once a pollutant is listed under § 108 the decision to regulate is made; standards under § 109 must follow. On the other hand, additives reported under § 211(a) are not necessarily regulated; regulations are premised only on a § 211(c)(1)(A) finding of endangerment. Thus, as suggested in text, the threshold determination under § 108 is properly compared to the threshold determination under § 211(c)(1)(A).

Ethyl argues that an "adverse effect" does not have as severe a connotation as "endangerment." Ethyl Supp.Br. at 19 n.27. Even if true, however, this argument has nothing to do with whether the threshold determination to regulate is, or is not, precautionary. Even if § 108 allowed regulation of less severe effects than does § 211, regulations could still be premised only on a finding of an actual effect, while § 211 regulations could still be premised on a precautionary finding of threatened, albeit more severe, harm.

[24] In essence, petitioners are suggesting § 202 is more properly read to provide for regulation of any automotive emission

which in his judgment causes or contributes to, or is likely to cause or contribute to, air pollution which causes or contributes to, or is likely to cause or contribute to, the endangerment of the public health or welfare.

Quite obviously, this is not what Congress said.

[25] Section 211 simply skips this chain of causation and requires instead that the emission products of the fuel additive to be regulated endanger the public health. This omission of a step does not support petitioners' "in and of itself" theory, see pages ___ - ___ of 176 U.S.App.D.C., pages 29-31 of 541 F.2d infra, but rather is responsive to the different intendments of §§ 101 and 211. See note 27 infra. In any case, it is plain that for regulation under § 211 the emission products must directly (although not necessarily by themselves) endanger the public health; whether they contribute to air pollution that in turn endangers the public health, as required by § 202, is irrelevant. Since the Administrator found that lead emissions directly endanger the public health, whatever leniency § 202 provides is irrelevant to this case.

Nalco takes issue with the dismissal of this question and asks sarcastically, "If causation is irrelevant to the regulation of fuel additives, why is EPA concerned about meeting any standard at all in these regulations." Nalco Supp.Br. at 20-21. Nalco is confusing two separate causation issues. There is undoubtedly a causation issue about whether lead emissions cause a danger to public health. On the other hand, however, there is no causation issue about whether lead emissions contribute to lead air pollution. There is no such issue, first, because § 211, unlike § 202, does not demand such a finding and, second, because in any case petitioners could not, and do not, contest the validity of that assertion. It is only this issue of causation, to which the "likely" language of § 202 relates, that EPA argues, and we agree, is irrelevant to this case. See EPA Supp.Br. at 17-18.

[26] Thus while Congress preferred emission regulation under § 202 to fuel content regulation under § 211, see note 14 supra, there is no reason to assume, as NPRA argues, NPRA Supp.Br. at 31-35, that in situations where § 211 regulation is proper, the Administrator must find greater potential harm before acting. Cf. note 23 supra.

[27] NPRA recognizes that a literal reading of § 202 produces the result suggested above. Thus it argues that this result is "meaningless, or at best tautological," NPRA Supp.Br. at 32, so that its "likely" danger theory emerges as an acceptable, although linguistically incorrect, alternative. Id. at 33. NPRA argues that the above reading would require

the Administrator to determine whether "the emission of any air pollutant . . . is likely to cause or to contribute to, air pollution . . .."

Id. at 32 (emphasis in original). Since under this reading, NPRA argues, the Administrator would always reach a positive conclusion, this reading must be incorrect. We agree that this reading is of little value, but we do not think it is the proper result of our analysis above. Rather, we think that to regulate under § 202 the Administrator must find that emission of the air pollutant is likely to cause or contribute to dangerous air pollution. This addition is important, for not all air pollutants contribute to dangerous air pollution and, more importantly, not all dangerous air pollution is caused by air pollutants that are, themselves, dangerous. Thus hydrocarbons, whose emission is regulated by § 202, are not themselves always dangerous, but are properly regulated because they react in sunlight to form smog, which is dangerous. See S.Rep. 89-192, 89th Cong., 1st Sess. 5-6 (1965); EPA Supp.Br. at 18 n.15. Thus, far from stating a tautology, § 202 allows for the regulation of such apparently innocent pollutants, which indirectly cause dangerous pollution.

[28] See note 17 supra. See also Environmental Defense Fund, Inc. v. EPA, 150 U.S.App.D.C. 348, 465 F.2d 528 (1972), where in interpreting the more rigorous statutory language "imminent hazard" which must be found before the registration for a pesticide may be suspended pending the conclusion of cancellation proceedings, 7 U.S.C. § 136d(c) (Supp. II 1972), we concluded, per Judge Leventhal:

It is enough if there is substantial likelihood that serious harm will be experienced during the year or two required in any realistic projection of the administrative process.

Id. at 360, 465 F.2d at 540 (emphasis added).

In another case interpreting the standards for cancellation of a pesticide under the same statute, we held, per Judge Wilkey, that a showing of "potentially great dangers from DDT" sufficed as a basis for cancellation. Environmental Defense Fund, Inc. v. EPA (Coahoma), 160 U.S.App.D.C. 123, 128, 489 F.2d 1247, 1252 (1973).

[29] Cf. Environmental Education Act, 20 U.S.C. § 1531 et seq.; Environmental Quality Improvement Act of 1970, 42 U.S.C. § 4371 et seq.; National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. § 4321 et seq. While initially the procedural requirements of NEPA consumed judicial energies most conspicuously, see e. g., Natural Resources Defense Council v. Morton, 148 U.S.App.D.C. 5, 458 F.2d 827 (1972); Calvert Cliffs' Coordinating Committee, Inc. v. AEC, 146 U.S.App.D.C. 33, 449 F.2d 1109 (1971), courts are increasingly according substantive weight to the NEPA language. See Sierra Club v. Morton, 169 U.S.App.D.C. 20, 37-39 & n.25, 514 F.2d 856, 873-875 & n.25 (1975), and cases cited therein, cert. granted, sub nom. Kleppe v. Sierra Club, 423 U.S. 1047, 96 S.Ct. 772, 46 L.Ed.2d 635 (1976).

[30] See Green, The Risk-Benefit Calculus in Safety Determinations, 43 Geo.Wash.L.Rev. 791 (1975); Handler, A Rebuttal: The Need for a Sufficient Scientific Base for Government Regulation, id. at 808. Both authors agree that government safety determinations should be preventive and based on assessment of risks. Dr. Handler differs from Professor Green in arguing that risks should be quantified before regulatory decisions are made. Professor Green believes that quantification is not always necessary or possible, and that the public health is better served by the making of value judgments, however inexact.

[31] See note 17 supra.

[32] This proposition must be confined to reasonable limits, however. In Carolina Environmental Study Group v. United States, 166 U.S.App.D.C. 416, 510 F.2d 796 (1975), a division of this court found the possibility of a Class 9 nuclear reactor disaster, a disaster of ultimate severity and horrible consequences, to be so low that the Atomic Energy Commission's minimal consideration of the effects of such a disaster in an environmental impact statement prepared for a new reactor was sufficient. Likewise, even the absolute certainty of de minimis harm might not justify government action. Under § 211 the threatened harm must be sufficiently significant to justify health-based regulation of national impact. Ultimately, of course, whether a particular combination of slight risk and great harm, or great risk and slight harm, constitutes a danger must depend on the facts of each case.

[33] Nalco devotes several pages of its brief to arguing that there is a distinction between "risk" and "danger" that EPA fails to recognize. Nalco Supp.Br. at 9-11, citing Reserve Mining Co. v. EPA, supra note 13, and Power Reactor Development Co. v. International Union of Electricians, 367 U.S. 396, 81 S.Ct. 1529, 6 L.Ed.2d 924 (1961). To the extent Nalco argues that risk and danger are not synonymous, Nalco battles with a straw man. EPA recognizes that a risk to public health is not necessarily a danger to public health; it only argues that a significant risk of widespread lead poisoning constitutes such a danger. To the extent Nalco argues there is no element of risk in danger, it is plainly wrong, as the cases it cites demonstrate. In support of its position, Nalco quotes the following language from Reserve Mining, in which the en banc court compares its present opinion with the "stay" opinion of a division of the court, Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974), in which the division stayed the District Court's injunction ordering the immediate closing of the Reserve Mining plant:

As will be evident from the discussion that follows, we adhere to our preliminary assessment that the evidence is insufficient to support the kind of demonstrable danger to the public health that would justify the immediate closing of Reserve's operations. We now address the basic question of whether the discharges pose any risk to public health and, if so, whether the risk is one which is legally cognizable.

514 F.2d at 507. The Eighth Circuit is not drawing a sharp line between "danger" and "risk," but is only contrasting degrees of danger. Nalco fails to note that the "legally cognizable" risk ultimately found was that Reserve's discharges were "endangering" the public health within the meaning of the Federal Water Pollution Control Act. See page ___ of 176 U.S.App.D.C., page 19 of 541 F.2d infra. Necessarily, "risk" is an element of "danger," and the Reserve Mining court explicitly recognized that fact. 514 F.2d at 520.

The Power Reactor case is likewise of no support to Nalco. There the Supreme Court simply recognized that when regulations juxtaposed, and ordered, findings of "undue risk" and "endanger," an "undue risk" was not intended to mean "endanger," The Court did not say that risk was not an element of danger, only that in the regulations before it an "undue" risk was not necessarily a sufficient risk to constitute a "danger."

[34] Reserve Mining involved issues not only under FWPCA, but under § 407 of the Rivers and Harbors Act of 1899, 33 U.S.C. § 401 et seq., the federal common law of public nuisance, and various Minnesota air and water pollution laws, Minn.Stat.Ann. § 116.081(1); id. § 115.07(1); id. § 105.41. Finding the evidence of danger posed by Reserve Mining's waste emissions into the air more compelling than that of the danger posed by the water emissions (since a correlation between inhalation, but not ingestion, of asbestos fibers and cancer could be found), the Eighth Circuit found the continued air emissions to be in violation of various Minnesota regulations and ordered Reserve to "promptly take all steps necessary to comply" with the law. Reserve Mining Co. v. EPA, supra note 13, 514 F.2d at 538. With respect to the water pollution, as described in text, the court found the probabilities of danger to be

low for they do not rest on a history of past health harm attributable to ingestion but on a medical theory implicating the ingestion of asbestos fibers as a causative factor in increasing the rates of gastrointestinal cancer among asbestos workers.

Id. at 536 (emphasis added). Thus the court only ordered cessation of dumping within a "reasonable time." Id. at 538.

[35] Petitioners properly point out that, unlike lead, there is no known safe human exposure level for carcinogens. Nalco Supp.Br. at 9; Ethyl Supp.Br. at 29. See Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301, 1307 (2d Cir.), cert. denied, 421 U.S. 992, 95 S.Ct. 1998, 44 L.Ed.2d 482 (1975); Industrial Union Department, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331, 499 F.2d 467 (1974). This does not, however, imply that the harm caused by lead poisoning is less significant than that caused by cancer, only that safe human exposure levels to the causes of the two diseases may differ. This the Administrator recognized. Unlike the actions of the Secretary of Labor in the above cited cases, he did not order the lead content of gasoline reduced to the lowest detectable levels, but rather directed a phased cutback to what he deemed a safe level.

In any case, however, even if cancer is considered more serious than lead poisoning, the Administrator acted based on an assessment that the risk of lead poisoning from automobile emissions was considerably greater than the cancer risk that motivated the Reserve Mining court. Thus this greater risk of an arguably lesser harm still constitutes endangerment.

[36] This conclusion that a "significant risk of harm" states a sufficient probability of occurrence to fall within the "will endanger" standard is bolstered by the fact that Congress did not employ various modifiers frequently used (in the Clean Air Act and elsewhere) to mandate more certain endangerment. Thus Congress did not require that the lead emissions "clearly endanger" the public health, cf. 21 U.S.C. § 454(c); id. § 661(c); 50 U.S.C. § 1517, or that the emissions pose an "imminent and substantial endangerment" to the public health, cf. 33 U.S.C. § 1364 (Supp. IV 1974); 42 U.S.C. § 300i(a); id. § 1857c-10(b); id. § 1857c-7(c)(1). See Reserve Mining Co. v. EPA, supra note 13, 514 F.2d at 528. We find these omissions more significant than the use of the modifier "will," which Ethyl argues adds "a particular degree of certainty to the probability that must be shown." Ethyl Supp.Br. at 12. To the contrary, "will" only makes it clear that the standard is one of danger and nothing less, a conclusion with which we agree.

Whether the evidence relied upon by the Administrator is sufficient to support his finding of a "significant risk of harm" is discussed below at pp. ___ - ___ of 176 U.S.App.D.C., at pp. 33-48 of 541 F.2d infra.

[37] Besides the arguments discussed below, petitioners support their claim that a "factual" not judgmental decision is required by pointing to the absence in § 211 of a phrase expressly allowing the Administrator to use his "judgment," in contrast to the presence of such a phrase in §§ 108 and 202. Nalco Supp.Br. at 21-22; Ethyl Supp.Br. at 21-22. The argument ignores an important difference between the cited sections and § 211. Sections 108 and 202 are mandatory in their terms; under both sections the Administrator "shall" regulate if "in his judgment" the pollutants warrant regulation. Because of the mandatory nature of the provisions, express provision for administrative discretion via the "judgment" phrase is necessary. By contrast, § 211 is permissive; the Administrator "may" regulate if emissions "will endanger" the public health. Since discretion is provided in the directive to the Administrator, the safety valve of a "judgment" phrase is unnecessary. On the other hand, since we find the exercise of judgment to be implicit in a determination of "danger," there is no need for an express statement of that power and no reason to ascribe significance to the omission of the phrase.

The irrelevancy of the omission is shown by the Amoco decision, where the court construed § 211(c)(1)(B), which, like its sister section at issue here, does not contain the phrase "in his judgment." Nonetheless, the court recognized the Administrator must, necessarily, have the power to assess risks and make policy decisions under that section whenever the determinations called for are judgmental. Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740-741, quoted in text at pp. ___ - ___ of 176 U.S.App.D.C., at p. 23 of 541 F.2d infra.

[38] Petitioner Nalco argues that if the specific requirement, and its subsequent deletion, have substantive effect at all, that effect relates not to the threshold decision to regulate, but to the subsequent implementing decisions about how to regulate. Nalco Supp.Br. at 17-20. It is true that a literal reading of the House version, proposed § 210(g)(1), suggests that specific findings are required in setting "standards" for fuel additives rather than for the threshold decision to regulate. Nonetheless, it is doubtful that the language was intended to exempt the threshold decision to regulate from the specific findings requirement, and equally doubtful that a court would ever have so interpreted it. First, as a practical matter it is questionable whether specific findings on "standard" setting could be made without a specific finding as to danger. The threshold finding would seem to be a prerequisite to any subsequent specific findings. Second, the legislative history makes it clear that the House intended the specific findings requirement to apply to the threshold regulatory decision. In presenting the proposed bill to that chamber Rep. Staggers, chairman of the committee that drafted the bill, was confronted with questions about the basis on which the Administrator could regulate fuel additives. Rep. Staggers responded that the Administrator could regulate only "[i]f he has the facts, and he has proven this by facts, that they are a danger and poisonous * * *." 116 Cong.Rec. 19229 (1970). To confirm that regulation could proceed only upon a threshold factual determination of danger, Rep. Staggers then quoted the specific findings provision that Nalco now argues is inapplicable to this question. Id. at 19230. Likewise, Rep. Rogers, a member of Rep. Staggers' committee, made clear that the threshold determination—that the gasoline additive endangers health—must be made on the basis of facts and findings. Id. at 19231. These are the only specific comments on proposed § 210(g)(1), and as they are made by knowledgeable committee members the legislative history is clear that specific findings were intended for the threshold decision to regulate.

This conclusion is bolstered by § 211(c)(1)(B) and its interpretation by the Amoco court. Section 211(c)(1)(B), unlike § 211(c)(1)(A), retains the finding requirement and the requirement is phrased as ambiguously as the specific findings requirement in the House version of § 211(c)(1)(A). The Amoco court recognized that a literal reading of this findings requirement (which it termed "awkwardly drafted," Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 179, 501 F.2d at 739), would produce an anomalous result, just as the literal reading now urged by Nalco of the deleted findings requirement would produce an anomalous result. "Thus in a literal sense the provision requires `findings with respect to' the actual items of data which the Administrator must `consider.'" Id., 163 U.S.App.D.C. at 176, 501 F.2d at 736 (emphasis in original). The court rejected this literal, nonsensical, reading and instead read the statute to require a threshold factual finding that regulation was necessary under § 211(c)(1)(B). Id., 163 U.S.App.D.C. at 176-178, 501 F.2d at 736-738.

Based on the legislative history of the House proposed § 210(g) and the Amoco precedent relating to the parallel section, it is clear that had the proposed specific findings requirement been enacted into law, it would have been interpreted, as suggested in text, as requiring a specific factual finding for the threshold decision to regulate, and not necessarily specific findings for all the subsequent implementing decisions.

[39] The original Senate version of the bill provided:

The Secretary may from time to time on the basis of information obtained under subsection (b) of this section [which required fuel manufacturers to furnish various information to the Secretary] or other information available to him, by regulation control or prohibit the introduction into commerce of any fuel or fuels for use in vehicle engines if the combustion or evaporation of such fuel produces emissions which endanger the public health or welfare * * *.

S. 4358, § 212(c)(1), 91st Cong., 2d Sess. (1970). The Senate bill drew a distinction between regulation on public health and public welfare grounds and required that regulation for the latter reason be preceded by public hearings. Id. § 212(c)(2). With minor verbal changes and deletion of the health-welfare dichotomy the Senate version became § 211(c)(1).

Petitioners argue that the Senate as well as the House contemplated a factual threshold determination. Nalco Supp.Br. at 15-16; Ethyl Supp.Br. at 24-26; NPRA Supp.Br. at 30. Their arguments are without merit. While the House debate contains several references to the need for such a determination, always coupled with discussion of the "specific findings" requirement, see notes 38 supra and 40 infra, petitioners can point to no express reference in the Senate proceedings to the need for a factual threshold finding. Instead they identify discussions of danger and suggest that these somehow imply that the assessment of danger be factually based. The implication is nonsensical; the cited discussions do no more than reiterate the language of the statute, which does not in terms require a factual finding. See S.Rep. No. 91-1196, 91st Cong., 2d Sess. 117 (1970) ("if the combustion or evaporation of such fuel produces emissions which endanger the public health or welfare"); id. at 33-34 ("emission that is a direct endangerment to the public health") (see notes 25 & 36 supra ); 116 Cong.Rec. 32921 (1970) (statement of Sen. Baker) ("emissions that, in and of themselves, endanger the public health or welfare") (see page ___ of 176 U.S.App.D.C., pages 29-30 of 541 F.2d infra). When compared with the explicit House discussion of the need for a factual finding, these statements only show that the Senate intended no such thing. Ethyl also cites this excerpt from the Senate Report:

"The [Administrator] may prohibit the use of any fuel in commerce which may provide emissions that, he finds, would endanger the public health." Sen.Rep. No. 91-1196, 91st Cong., 2d Sess. 64 (1970).

Ethyl Supp.Br. at 25 (emphasis in original). Since the Senate bill explicitly deleted the finding requirement for action under § 211(c)(1)(A), this language can hardly be taken as supporting its sub silentio inclusion. If anything, the language, which uses "finds" in its colloquial, not legal, sense, only demonstrates the judgmental nature of the Administrator's decision. See note 37 supra.

[40] For this reason, statements made in the House about the bill should be used only with great care in any attempt to assess legislative intent. House discussion centered on a significantly more rigorous bill, and statements such as those offered by petitioners from the House debate prove only the effect of the ultimate deletion of the "specific findings" requirement. See Ethyl Supp.Br. at 24; Nalco Supp.Br. at 15; NPRA Supp.Br. at 30. Rep. Staggers' statement, for instance, directly relates the need for a factual threshold determination to the "specific findings" requirement. As such, it is strong support for the conclusion that deletion of the requirement was intended to do away with such a rigorous threshold requirement. See note 38 supra.

[41] Neither the House managers' conference report nor the summary of the conference agreement prepared for the Senate address directly the effect of the changes here at issue. See Conference Agreement on the Clean Air Amendments of 1970, H.R.Rep. No. 91-1783, 91st Cong., 2d Sess. 52-53 (1970) U.S.Code Cong. & Admin.News 1970, p. 5374; Summary of the Provisions of Conference Agreement on the Clean Air Amendments of 1970, 116 Cong.Rec. 42384, 42385-42386 (1970). The most relevant discussion, which is only oblique, is in the Senate conference report, where the need for flexibility in applying § 211 is made clear:

[T]he conference committee wishes to call the attention of the Administrator to the broad environmental, esthetic and health considerations underlying the enactment of this legislation which should be kept in mind in making these determinations [to control or prohibit a fuel or fuel additive].

116 Cong.Rec. 42386 (1970). See Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 173-174, 501 F.2d at 733-734. In the absence of legislative history discussing the change, we must rely on the language of the present law and its contrast to the rejected House version.

[42] Section 211(c)(2)(C), 42 U.S.C. § 1857f-6c(c)(2)(C), quoted in text at p. ___ of 176 U.S.App.D.C., at p. 32 of 541 F.2d infra.

[43] See note 14 supra.

[44] The House bill required the Administrator to act only on the basis of the required specific findings. The Senate and final bill allows him to act on the basis of information obtained under § 211(b), which requires fuel and fuel additive manufacturers to furnish the Administrator with information about their products' content and, at his request, to conduct various tests on the compounds and furnish him with descriptions of testing techniques. The Administrator is also free to act on the basis of any "other information available to him," § 211(c)(1) (emphasis added), thus making the basis for action under § 211(c)(1)(A) unlimited.

[45] The opinion refers to § 4(c), but § 4(b), which requires the agency to "incorporate in any rules adopted a concise general statement of their basis and purpose," was obviously intended. See § 4 of the APA, 60 Stat. 239 (1946), 5 U.S.C. § 553.

[46] Clean Air Act, 42 U.S.C. § 1857 et seq.; Federal Water Pollution Control Act, 33 U.S.C. § 1151 et seq.; Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 135 et seq.

[47] Reserve Mining Co. v. EPA, supra note 13.

[48] Society of the Plastics Industry, Inc. v. OSHA, supra note 35.

[49] Industrial Union Department, AFL-CIO v. Hodgson, supra note 35.

[50] Environmental Defense Fund, Inc. v. EPA (Coahoma), supra note 28.

[51] Environmental Defense Fund, Inc. v. EPA (Shell), 167 U.S.App.D.C. 71, 510 F.2d 1292 (1975).

[52] Even scientific "facts" are not certain, but only theories with high probabilities of validity. Scientists typically speak not of certainty, but of probability; they are trained to act on probabilities that statistically constitute "certainties." See generally T. Kuhn, The Structure of Scientific Revolutions. While awaiting such statistical certainty may constitute the typical mode of scientific behavior, its appropriateness is questionable in environmental medicine, where regulators seek to prevent harm that often cannot be labeled "certain" until after it occurs. See note 58 infra.

The uncertainty of scientific fact parallels the uncertainty of all fact. In a metaphysical sense, at least, facts are themselves nothing more than risks, or statistical probabilities. See D. Hume, A Treatise of Human Nature, bk. I, pt. III, § 6, at 87 (L.A. Selby-Bigge ed. 1958).

[53] Thus this court, per Judge Wilkey, affirmed EPA's general ban on the use of DDT even though the evidence was considerably less than certain:

[T]here is a great mass of often inconsistent evidence which was developed at the hearing; this evidence is substantial enough to support the conclusions of the Administrator, although it possibly might support contrary conclusions as well. Considering the evidence in the record as a whole, we cannot say that the Administrator's decision was not based on substantial evidence, even if the hazardous nature of DDT has not been proved beyond a reasonable doubt. Sufficient evidence has been adduced to show potentially great dangers from DDT, and the Administrator's decision to cancel the DDT registrations is well within his statutory authority.

Environmental Defense Fund, Inc. v. EPA (Coahoma), supra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (emphasis added).

[54] According to the NAS Panel, present air lead concentrations, which over the largest American cities are 2,000 times greater than air lead concentrations over the mid-Pacific Ocean, have existed for 15 years. NAS Report at 205, JA 356. The Panel attributed these high concentrations primarily to automotive emissions. Id.

[55] It is for these reasons that, although lead additives have been used for over 50 years, the danger posed by lead emissions is still a question "on the frontiers of scientific knowledge." Industrial Union Department, AFL-CIO v. Hodgson, supra note 49, 162 U.S.App.D.C. at 338, 499 F.2d at 474. See note 97 infra.

[56] Ethyl argues that Industrial Union and Society of the Plastics Industry are distinguishable from this case in that under OSHA the Secretary is directed to set standards for industrial exposure to toxic substances, 29 U.S.C. § 655(b)(5), while action under § 211 is discretionary with the Administrator. Ethyl Supp.Br. at 28-30. Ethyl has merely identified the source of the flexibility granted the Secretary, while failing to set the cited cases apart from this one. Under the Clean Air Act the Administrator's flexibility is derived not from a command to act, but from a precautionary statute that necessarily includes risk assessment if its preventive purpose is to be achieved. Since there is reason to accord flexibility to the regulator under both acts, the cited cases are good support for the way in which that flexibility is to be exercised.

Nalco asserts that the cases are distinguishable in that Industrial Union and Society of the Plastics Industry involve the manner in which standards are set under OSHA, rather than the Secretary's power to set standards at all. Nalco Supp.Br. at 12. This purported distinction is no more than a factual difference between the cases. Flexibility is necessary under OSHA only in the manner of setting standards, since the command to set standards is clear. Under the Clean Air Act, on the other hand, flexibility is necessary both in standard-setting and in deciding whether to regulate. The teaching of the cases is nonetheless applicable.

Reserve Mining shows the spurious nature of both asserted distinctions. In that case, as here, there was no command to regulate, only a statutory term of a precautionary nature—"endangering"—to justify flexible decision-making (in Reserve Mining by a court rather than by an agency). Likewise, that case involved not only the manner of standard-setting, but the threshold decision to regulate as well. Nonetheless, Reserve Mining is fully consistent with Industrial Union and Society of the Plastics Industry, and all three cases support our conclusion here.

[57] Or, as with OSHA, mandatory in its command to act. See note 56 supra.

[58] It bears emphasis that what is herein described as "assessment of risk" is neither unprecedented nor unique to this area of law. To the contrary, assessment of risk is a normal part of judicial and administrative fact-finding. Thus EPA is not attempting to expand its powers; rather, petitioners seek to constrict the usual flexibility of the fact-finding process. Petitioners argue that the Administrator must decide that lead emissions "will endanger" the public health solely on "facts," or, in the words of the division majority, by a "chain of scientific facts or reasoning leading [the Administrator] ineluctably to this conclusion * * *." Division op. at 59. Petitioners demand sole reliance on scientific facts, on evidence that reputable scientific techniques certify as certain. Typically, a scientist will not so certify evidence unless the probability of error, by standard statistical measurement, is less than 5%. That is, scientific fact is at least 95% certain.

Such certainty has never characterized the judicial or the administrative process. It may be that the "beyond a reasonable doubt" standard of criminal law demands 95% certainty. Cf. McGill v. United States, 121 U.S.App.D.C. 179, 185 n.6, 348 F.2d 791, 797 n.6 (1965). But the standard of ordinary civil litigation, a preponderance of the evidence, demands only 51% certainty. A jury may weigh conflicting evidence and certify as adjudicative (although not scientific) fact that which it believes is more likely than not. Since Reserve Mining was adjudicated in court, this standard applied to the court's fact-finding. Inherently, such a standard is flexible; inherently, it allows the fact-finder to assess risks, to measure probabilities, to make subjective judgments. Nonetheless, the ultimate finding will be treated, at law, as fact and will be affirmed if based on substantial evidence, or, if made by a judge, not clearly erroneous.

The standard before administrative agencies is no less flexible. Agencies are not limited to scientific fact, to 95% certainties. Rather, they have at least the same fact-finding powers as a jury, particularly when, as here, they are engaged in rule-making.

Looking to the future, and commanded by Congress to make policy, a rule-making agency necessarily deals less with "evidentiary" disputes than with normative conflicts, projections from imperfect data, experiments and simulations, educated predictions, differing assessments of possible risks, and the like.

Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 175, 501 F.2d at 735. An agency's finding of fact differs from that of a jury or trial judge primarily in that it is accorded more deference by a reviewing court. See note 74 infra. Thus, as a matter of administrative law, the Administrator found as fact that lead emissions "will endanger" the public health. That in so doing he did not have to rely solely on proved scientific fact is inherent in the requirements of legal fact-finding. Petitioners' assertions of the need to rely on "fact" confuse the two terminologies. We must deal with the terminology of law, not science. At law, unless the administrative or judicial task is peculiarly factual in nature, or Congress expressly commands a more rigorous finding, see 21 U.S.C. § 355(d); cf. pages ___ - ___ of 176 U.S.App.D.C., pages 23-24 of 541 F.2d supra, assessment of risks as herein described typifies both the administrative and the judicial fact-finding function, and is not the novel or unprecedented theory that petitioners contend.

[59] As far as the cumulative impact theory is concerned, the relevant portions of the two provisions are as follows:

[The Administrator may regulate any automobile emission that] causes or contributes to, or is likely to cause or to contribute to, air pollution which endangers the public health or welfare.

Section 202(a)(1), 42 U.S.C. § 1857f-1(a)(1) (emphasis added).

[The Administrator may regulate a fuel or fuel additive] if any emission products of such fuel or fuel additive will endanger the public health or welfare * * *.

Section 211(c)(1)(A), 42 U.S.C. § 1857f-6c(c)(1)(A) (emphasis added).

[60] Since automobile emissions generate approximately 90% of all airborne lead, see note 7 supra and accompanying text, the danger posed by lead-polluted air is virtually identical to that posed by lead automobile emissions. As the text suggests, the non-automotive sources of lead with which the cumulative impact theory is concerned are not airborne.

[61] Ethyl actually quotes Sen. Baker's second use of the phrase, a few sentences after the one quoted in the text, see 116 Cong.Rec. 32920 (1970). It, however, is in the same context of contrasting permissible EPA action under § 211(c)(1)(A) and (B), and thus provides no more support for Ethyl's position. The implausibility of Ethyl's reading of Sen. Baker's words is heightened by the fact that the Senator himself realized the important contribution of dietary lead to the total body lead burden and so informed the Senate only sentences before the quoted language. Id.

[62] While the incremental effect of lead emissions on the total body lead burden is of no practical value in determining whether health is endangered, it is of value, of course, in deciding whether the lead exposure problem can fruitfully be attacked through control of lead additives. Moreover, even under the cumulative impact theory emissions must make more than a minimal contribution to total exposure in order to justify regulation under § 211(c)(1)(A). We accept the Administrator's determination that the contribution must be "significant" before regulation is proper. See 38 Fed.Reg. 33734.

[63] Congress had before it a complete explanation of the multiple sources of human lead exposure. It understood that lead is ubiquitous in nature, that trace elements of lead are present in everyone, and that only when lead concentration reaches higher levels would the public be endangered. It could not have thought that lead automobile emissions could, by themselves, endanger the public, although it clearly did think they could be regulated only if they provided a significant increment to the total human lead burden. See, e. g., Hearings on S. 3229, S. 2466 & S. 3546 before the Subcommittee on Air & Water Pollution of the Senate Committee on Public Works, 91st Cong., 2d Sess., pt. 1, at 433-434 (1970) (answers to Sen. Muskie's questions, supplied by the Dept. of Health, Education & Welfare); id., pt. 3, at 1177; 116 Cong.Rec. 32920 (1970) (remarks of Sen. Baker).

[64] Considerable deference is owed to the interpretation of a statute by the officer charged with its administration. Train v. Natural Resources Defense Council, Inc., 421 U.S. 60, 87, 95 S.Ct. 1470, 1485, 43 L.Ed.2d 731, 750 (1975) (Clean Air Act); Zuber v. Allen, 396 U.S. 168, 192, 90 S.Ct. 314, 327, 24 L.Ed.2d 345, 359 (1969); Udall v. Tallman, 380 U.S. 1, 16, 85 S.Ct. 792, 801, 13 L.Ed.2d 616, 625 (1965); United States v. American Trucking Assns, 310 U.S. 534, 549, 60 S.Ct. 1059, 1067, 84 L.Ed. 1345, 1354 (1940). This deference is heightened when, as here, the interpretation is of a new statute by its implementing agency. Power Reactor Development Co. v. International Union of Electricians, 367 U.S. 396, 408, 81 S.Ct. 1529, 1535, 6 L.Ed.2d 924, 932 (1961); United States v. Zucca, 351 U.S. 91, 96, 76 S.Ct. 671, 674, 100 L.Ed. 964, 970 (1956); United States v. American Trucking Assns, supra; Norwegian Nitrogen Products Co. v. United States, 288 U.S. 294, 315, 53 S.Ct. 350, 358, 77 L.Ed. 796, 807 (1933); Natural Resources Defense Council, Inc. v. Train, 166 U.S.App.D.C. 312, 326, 510 F.2d 692, 706 (1975) (Clean Air Act). See note 16 supra.

[65] See, e. g., Parke v. Bradley, 204 Ala. 455, 86 So. 28 (1920); Forbes v. Board of Health, 28 Fla. 26, 9 So. 862 (1891); People ex rel. Barmore v. Robertson, 302 Ill. 422, 134 N.E. 815, 22 A.L.R. 835 (1922); Blue v. Beach, 155 Ind. 121, 56 N.E. 89 (1900); Walker v. Sears, 245 Iowa 262, 61 N.W.2d 729 (1953); State ex rel. Anderson v. Fadely, 180 Kan. 652, 308 P.2d 537, 548 (1957); Board of Health v. Kollman, 156 Ky. 351, 160 S.W. 1052 (1913); Rock v. Carney, 216 Mich. 280, 185 N.W. 798, 22 A.L.R. 1178 (1921); State ex rel. Freeman v. Zimmerman, 86 Minn. 353, 90 N.W. 783 (1902); Crayton v. Larabee, 220 N.Y. 493, 116 N.E. 355 (1917); Salt Lake City v. Howe, 37 Utah 170, 106 P. 705 (1910).

[66] The statute demands "consideration" not only of the relevant scientific and medical evidence, but also of the possibility of regulation under § 202. Section 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A). That means, of course, no more than it says: actual good faith consideration of the specified evidence and options, as reflected in the basis and purpose statement required by § 4(b) of the APA, 5 U.S.C. § 553(c). NPRA argues that the statute demands mandatory deference to the possibility of regulation under § 202 rather than mere consideration of such a possibility. NPRA Supp.Br. at 33-35. We reject the argument. NPRA ignores the deletion of the specific findings requirement from the original bill. As pointed out above, see pages ___ - ___ of 176 U.S.App.D.C., pages 21-23 of 541 F.2d, & note 14 supra, one effect of the deletion was to eliminate mandatory deference to § 202 and substitute instead "consideration" of § 202 regulation. While Congress thus indicated its preference for regulation under § 202, it left the Administrator with full discretion to implement that preference or not. See note 14 supra.

NPRA, joined by Nalco, further argues that EPA's consideration of § 202 regulation was arbitrary and capricious because the agency rejected reliance on lead traps as a means of emission control. NPRA Supp.Br. at 35-37; Nalco Supp.Br. at 57-58. EPA did reject lead traps, but that rejection was not arbitrary and capricious. Rather, they were rejected because § 202 authorizes EPA to order emission controls only on new vehicles, which would largely be using lead-free gasoline anyway because of the catalytic converter. On new vehicles there would be no lead emissions to trap. See note 2 supra. The regulations before us seek to reduce lead emissions from in-use vehicles; for such a purpose § 202 is of no use. 38 Fed.Reg. 33737.

We find that EPA's consideration of the evidence presented and of the alternatives to regulation under § 211 meets the good faith test suggested above. See Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 823, 28 L.Ed.2d 136, 153 (1971). See also note 68 infra.

[67] This distinction is not unduly technical, since § 211(c)(1) expressly allows the Administrator to "control or prohibit" while § 211(c)(2)(C), drafted contemporaneously, repeatedly indicates that a finding is required only before a fuel or fuel additive is "prohibited." Parallel § 211(c)(2)(A) and (B), on the other hand, also expressly apply before a fuel or fuel additive may be "controlled or prohibited."

Nonetheless, the purpose behind § 211(c)(2)(C)—avoidance of counterproductive results and protection of the public health—suggests that a finding is of equal import whether the fuel or fuel additive is to be controlled or prohibited, so we do not conclude definitely that no such finding is required for control under § 211. Since the Administrator has furnished a finding such as is required by § 211(c)(2)(C), 38 Fed.Reg. 33737-33739 (1973), and we think that finding is adequate under the Amoco standards suggested below, we do not find it necessary to determine whether the finding was required in this case. See note 68 infra.

[68] Nalco argues that the Administrator's recent decision to suspend the 1977 statutory emission standards for hydrocarbons and carbon-monoxide, 40 Fed.Reg. 11900, see note 2 supra, invalidates his assessment of the impact of the substitute additive, aromatic hydrocarbons. Nalco Supp.Br. at 45-50. Cf. NPRA Supp.Br. at 48-49. This argument appears to be a challenge to the regulations based on new information. Such challenges are cognizable under § 307 of the Clean Air Act, 42 U.S.C. § 1857h-5(b)(1), but may be brought to this court only after a preliminary presentment of the new information and a request for action to the agency. Oljato Chapter of Navajo Tribe v. Train, 169 U.S.App.D.C. 195, 207-208, 515 F.2d 654, 666-667 (1975). Since Nalco has not complied with the rule of Oljato Chapter, this new information claim does not appear to be properly before us.

In any case, however, Nalco's claim is without merit. Undoubtedly high octane aromatic hydrocarbons will be used to compensate for the reduction in lead caused by the regulations and the average aromatic content of gasoline will rise from 22% to 29% (this increase includes that attributable to the lead-free regulations at issue in Amoco). Aromatics can result in emissions of polynuclear aromatic (PNA) hydrocarbons, some of which are carcinogenic.

Nonetheless, the Administrator determined that substitution of PNA emissions for lead emissions would be less dangerous to the public health because: (1) PNA emissions from automobiles, together with emissions from refineries that produce gasoline, account for only approximately 2% of PNA emissions in the ambient air; (2) PNA emissions are being reduced from automobiles by the applicable hydrocarbon standards; and (3) PNA automobile emissions will continue to decrease overall, even while the hydrocarbon content of gasoline increases, as uncontrolled automobiles are retired and replaced by those with emission control systems. 38 Fed.Reg. 33738. Thus the Administrator concluded that replacement of lead additives by increased hydrocarbons would result only in a slight slowing of the rate of decrease of PNA emissions from automobiles. We think this is a sufficient finding under § 211(c)(2)(C).

Nalco's charge that suspension of emission standards changes this calculation is untrue. Even under the suspended standards, hydrocarbons will be significantly controlled and PNA emissions will continue to decrease. EPA calculated the effect of an increase in hydrocarbon content of gasoline under several anticipated circumstances, including the assumption that the interim standards would remain in effect through 1980. In that circumstance, which may turn out to be the correct forecast, PNA emissions would still decrease 69% over 1973 levels by 1980. Without the low-lead regulations they would decrease 72%, only a 3% better rate. JA 1428-1431; see also id. 1489-1490. Thus EPA anticipated the possibility of suspended emission standards, calculated the effects of that suspension on PNA emissions, and found them to be minimal. We cannot find this substitute additive finding to be insufficient.

[69] The hybrid procedures that placed the EPA action somewhere between informal rule-making and adjudication and that caused such extended inquiry by the Amoco court are largely absent from this case. In Amoco, in addition to the "findings" requirement of § 211(c)(2)(B), the court had to deal with the same section's requirement of a public hearing. The resultant standard of review was, nonetheless, not significantly different from traditional "arbitrary and capricious" review. See Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 171-181, 501 F.2d at 731-741. In this case there is no public hearing requirement and the only "findings" requirement is that of § 211(c)(2)(C), which we have construed at pp. ___ - ___ of 176 U.S.App.D.C., at pp. 32-33 of 541 F.2d supra.

The requirement that the Administrator "consider" various evidence before acting under § 211(c)(1)(A) guides the direction, but does not affect the rigor, of "arbitrary and capricious" review. Such guidelines are typical as a prerequisite for agency action, see e. g., § 1002(e) [the Rule of Ratemaking) of the Federal Aviation Act of 1958, 49 U.S.C. § 1482(e)(1970), and assurance of agency compliance is simply one part of "arbitrary and capricious" review. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 823, 28 L.Ed.2d 136, 153 (1971) (court must determine "whether the decision was based on a consideration of the relevant factors").

[70] All the Clean Air Act says about judicial review of EPA action under § 211 is that it shall be available exclusively in this court. 42 U.S.C. § 1857h-5(b)(1).

[71] Our review of the Administrator's construction of the statute, see pages ___ - ___ of 176 U.S.App.D.C., pages 11-34 of 541 F.2d supra, is authorized by § 10(e)(2)(C), 5 U.S.C. § 706(2)(C), which allows the reviewing court to set aside agency action it finds to be "in excess of statutory jurisdiction, authority, or limitations, or short of statutory right * *." Our review of EPA procedures, see pages ___ - ___ of 176 U.S.App.D.C., pages 48-53 of 541 F.2d infra, is pursuant to § 10(e)(2)(D), 5 U.S.C. § 706(2)(D), which authorizes reversal of agency action taken "without observance of procedure required by law."

[72] NPRA seeks to attach meaning to the fact that an express presumption of validity was included in the Senate version of the Clean Air Act, and then deleted by the conference committee. NPRA Supp.Br. at 21-24. See S.Rep. No. 91-1196, 91st Cong., 2d Sess., at 41, 125 (1970). As the above cited cases make clear, however, a general presumption of validity attaches to any regulation within an agency's delegated powers. Thus the deletion is of no consequence.

[73] Of course, that basis must be expressed by the agency itself and not supplied by the court. SEC v. Chenery Corp., 332 U.S. 194, 196, 67 S.Ct. 1575, 1577, 91 L.Ed. 1995, 1999 (1947). Nonetheless, a decision of "less than ideal clarity" will be upheld if the agency's rationale "may reasonably be discerned." Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 286, 95 S.Ct. 438, 442, 42 L.Ed.2d 447, 456 (1974). See also Colorado Interstate Gas Co. v. FPC, 324 U.S. 581, 595, 65 S.Ct. 829, 836, 89 L.Ed. 1206, 1219 (1945).

[74] Overton Park also requires the reviewing court to consider "whether there has been a clear error of judgment." Citizens to Preserve Overton Park v. Volpe, supra note 69, 401 U.S. at 416, 91 S.Ct. at 824, 28 L.Ed.2d at 153, citing L. Jaffe, Judicial Control of Administrative Action 182 (1965); McBee v. Bomar, 296 F.2d 235, 237 (6th Cir. 1961); In re Josephson, 218 F.2d 174, 182 (1st Cir. 1954); Western Addition Community Organization v. Weaver, 294 F.Supp. 433 (N.D.Cal.1968); Wong Wing Hang v. INS, 360 F.2d 715, 719 (2d Cir. 1966). While as used, carefully bracketed by traditional statements of the restraint of "arbitrary and capricious" review, the phrase works no change in the law, the Court's choice of language is troublesome. The phrase sounds much like the "clearly erroneous" standard used to review the factual findings of a trial court sitting without a jury. Rule 52(a), Fed.R.Civ.P. Unlike an agency determination or a jury verdict, such findings may be fairly readily reversed. District of Columbia v. Pace, 320 U.S. 698, 702, 64 S.Ct. 406, 408, 88 L.Ed. 408, 410 (1944); 4 K. Davis, supra note 15, § 29.02, at 118-126; L. Jaffe, supra, at 615-616. See especially Orvis v. Higgins, 180 F.2d 537, 540 (2d Cir.) (Frank, J.), cert. denied, 340 U.S. 810, 71 S.Ct. 37, 95 L.Ed. 595 (1950). Indeed, under "clearly erroneous" review a court may substitute its judgment for that of the trial court and upset findings that are not unreasonable. See 4 K. Davis, supra note 15, at 121-122.

Since Overton Park expressly forbade such intrusive review, 401 U.S. at 416, 91 S.Ct. at 823, 28 L.Ed.2d at 153, it plainly did not intend to use the "clear error of judgment" phrase to replace sub silentio "arbitrary and capricious" review with "clearly erroneous" review. Nonetheless, more than linguistic echoes of "clearly erroneous" review accompany the Court's turn of phrase. To the extent the cases relied upon by the Court support consideration of "clear errors of judgment," they all involve review of trial courts', and not agencies', abuses of discretion. See cases cited supra, and compare L. Jaffe, supra, at 182 with id. at 615-616. Such review is intrusive and essentially identical with "clearly erroneous" review. See McBee v. Bomar, supra; In re Josephson, supra. On the other hand, the Court also cited a case in which Judge Friendly recognized that an agency's abuse of discretion, unlike a court's, is reviewed under the "arbitrary and capricious" standard, 5 U.S.C. § 706(2)(A), and that review in such cases should be much more deferential than under the "clearly erroneous" standard. Wong Wing Hang v. INS, supra, 360 F.2d at 718-719.

All of this makes the Court's intent in Overton Park somewhat difficult to plumb and its standard even more uncertain of application. We do not think the Court's use of the "clear error of judgment" phrase was an attempt vastly to revamp traditional "arbitrary and capricious" review. See infra. Nonetheless, we fear its use of this phrase so familiar to judges in another, and significantly more intrusive, context may unintentionally prompt judicial distortion of the "arbitrary and capricious" standard. Already at least one court has expressly indicated that it is prepared to read the Court's use of the phrase as approval of intrusive "clearly erroneous" review of agency action. Raitport v. National Bureau of Standards, 385 F.Supp. 1221, 1225 (E.D.Pa.1974). Meanwhile, other courts use the "clear error of judgment" phrase as a shorthand summary of "arbitrary and capricious" review, see, e. g., Union Electric Co. v. EPA, 515 F.2d 206, 216 (8th Cir.), cert. granted, 423 U.S. 821, 96 S.Ct. 35, 46 L.Ed.2d 38, 44 U.S.L. Week 3200 (1975); Conservation Council of North Carolina v. Froehlke, 473 F.2d 664, 665 (4th Cir. 1973); Schicke v. United States, 346 F.Supp. 417, 420, 422-423 (D.Conn.1972), while others loosely treat the phrase as synonymous with "clearly erroneous." Duke City Lumber Co. v. Butz, 382 F.Supp. 362, 374 (D.D.C.1974) ("whether the agency's threshold decision was arbitrary, capricious or otherwise clearly erroneous"); Daly v. Volpe, 350 F.Supp. 252, 255 (W.D.Wash.1972) ("it was not clearly erroneous, and therefore it was not arbitrary and capricious").

Post-Overton Park decisions, as well as the internal evidence in Overton Park itself, see supra, have made clear that the Court does not intend the "clear error of judgment" phrase to sanction review more intrusive than traditional "arbitrary and capricious" review; rather, the Court has reaffirmed that the reviewing court must defer if the agency has a rational basis for its decision. Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra note 73, 419 U.S. at 290, 95 S.Ct. at 444, 42 L.Ed.2d at 458; United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749, 92 S.Ct. 1941, 1946, 32 L.Ed.2d 453, 460 (1972). See note 79 infra. Thus it is important that courts not think themselves licensed to embark upon wide-ranging searches for "clear errors of judgment." Such searches can only distort the established appellate role in reviewing informal agency action. Rather, we think Overton Park's troublesome phrase is best read as no more than an affirmation of the traditional standard of review. Accordingly, in the context of "arbitrary and capricious" review, we shall reverse for a "clear error of judgment" only if the error is so clear as to deprive the agency's decision of a rational basis.

[75] While Greater Boston Television Corp. v. FCC, 143 U.S.App.D.C. 383, 392, 444 F.2d 841, 850 (1970), cert. denied, 403 U.S. 923, 91 S.Ct. 2229, 2233, 29 L.Ed.2d 701 (1971), was a substantial evidence case, its statement of the proper scope of a reviewing court's inquiry into the evidence has been adopted by the informal rule-making cases cited above.

[76] This rule has been most directly stated in cases involving substantial evidence review, see, e. g., Consolo v. Federal Maritime Commission, 383 U.S. 607, 620, 86 S.Ct. 1018, 1026, 16 L.Ed.2d 131, 140 (1966); Universal Camera Corp. v. NLRB, 340 U.S. 474, 488, 71 S.Ct. 456, 464, 95 L.Ed. 456, 467 (1951); Environmental Defense Fund, Inc. v. EPA (Coahoma), supra note 28, 160 U.S.App.D.C. at 130, 489 F.2d at 1254, but it is nonetheless applicable here as well. The requirement of affirming decisions with which we disagree is inherent in Overton Park's command that "[t]he court is not empowered to substitute its judgment for that of the agency." Citizens to Preserve Overton Park v. Volpe, supra note 69, 401 U.S. at 416, 91 S.Ct. at 824, 28 L.Ed.2d at 153.

[77] In a substantial evidence case Judge Wilkey has well delineated our limited role:

In the case at bar our task is made somewhat simpler than the agency's by adhering conscientiously to the proper scope of judicial review of administrative action, i. e., we as a court are confronted with a problem in administrative law, not in chemistry, biology, medicine, or ecology. It is the administrative agency which has been called upon to hear and evaluate testimony in all scientific fields relevant to its ultimate question of permission or prohibition of the sale and use of DDT. The EPA Administrator had an opportunity to make a careful study of the record of seven months of public hearings and the summaries of evidence prepared for him, heard oral argument, and now has arrived at a decision to ban most uses of DDT. It is his decision which we must review; we are not to make the same decision ourselves.

Environmental Defense Fund, Inc. v. EPA (Coahoma), supra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (emphasis in original). See also note 53 supra.

[78] In stating the scope of review of informal rule-making by the Interstate Commerce Commission, the Supreme Court succinctly summarized these principles:

We do not weigh the evidence introduced before the Commission; we do not inquire into the wisdom of the regulations that the Commission promulgates, and we inquire into the soundness of the reasoning by which the Commission reaches its conclusions only to ascertain that the latter are rationally supported.

United States v. Allegheny-Ludlum Steel Corp., supra note 74, 406 U.S. at 749, 92 S.Ct. at 1946, 32 L.Ed.2d at 460.

[79] Review for substantial evidence is mandated only for agency adjudications and formal rule-making proceedings. 5 U.S.C. § 706(2)(E). Since "arbitrary and capricious" review does not involve determining whether the agency decision is supported by substantial evidence, it is considered the more lenient form of review. Nonetheless, some have noted that in reviewing the evidence relied upon in agency proceedings, the two standards often seem to merge. Associated Industries of New York State, Inc. v. United States Department of Labor, 487 F.2d 342, 349-350 (2d Cir. 1973) (Friendly, J.). The primary difference between the two in such cases would seem to be that "substantial evidence" review is limited to evidence developed in formal hearings, while "arbitrary and capricious" review of an agency engaged in informal rule-making is not so limited, but rather may consider the agency's developed expertise and any evidence referenced by the agency or otherwise placed in the record. Market St. Ry. v. Railroad Comm'n, 324 U.S. 548, 559-561, 65 S.Ct. 770, 776-777, 89 L.Ed. 1171, 1180-1182 (1945); City of Chicago v. FPC, 147 U.S.App.D.C. 312, 322-326, 458 F.2d 731, 741-745 (1971), cert. denied, 405 U.S. 1074, 92 S.Ct. 1495, 31 L.Ed.2d 808 (1972).

[80] As Chief Justice Shaw observed over a century ago, "inferences drawn from independent sources, different from each other, but tending to the same conclusion, not only support each other, but do so with an increased weight." Commonwealth v. Webster, 59 Mass. (5 Cush.) 295, 317 (1850).

[81] Both petitioners and the Wilkey dissent (hereinafter dissent) engage in a detailed attack on the evidentiary basis for the Administrator's decision. Their arguments are considered in corresponding detail in the appendices to this opinion.

[82] See note 60 supra.

[83] Indeed, at the conclusion of Section IV of the Third Health Document, "Can an Acceptable Lead Body Burden be Defined?," the Agency suggested seven important areas for future inquiry. Third Health Document at IV-7, 8, JA 75-76. Ethyl claims these questions only demonstrate "that EPA is unable at this time to support its blood lead level theories with pertinent data * * *." Ethyl brief at 38. To the contrary, the questions only show the candor with which the Agency has approached this important issue. Sufficient data exists for the Administrator to assess risks and make a judgment within the "will endanger" standard. That further data would enable the Agency to deal more precisely with the problem does not undercut the Administrator's judgment. It is the nature of scientific inquiry that further data will always permit such refinement.

[84] Petitioners Ethyl and Nalco specially attack the Administrator's reliance on these subclinical effects of exposure to low lead levels both here and in assessing the damages from dustfall. Ethyl Supp.Br. at 45; Nalco Supp.Br. at 30-34. In fact, however, petitioners merely repeat the very qualifications on the evidence that led the Administrator to discount its value. Petitioners and the Administrator agree far more than they disagree on this issue. We cannot say it was irrational for the Administrator to note the possibility of subclinical effects, nor can we say it was irrational for him largely to discount their probability. Accordingly, we must reject petitioners' argument.

[85] A few examples indicate the kind of evidence before the Administrator:

A study by David et al. associating increased frequency of hyperactivity among children with blood lead levels of 25-55 ug. Cited in Third Health Document at III-6, 7, JA 59-60.

A study by Piomelli et al. which found that 55% of children tested with blood lead levels of 40-59 ug and 100% of those tested with blood lead levels in excess of 60 ug had demonstrable evidence of metabolic interference with heme synthesis in the bone marrow. Cited in Third Health Document at IV-3, 4, 5, JA 71-73.

A study by Tola et al. finding mild anemia in lead workers with blood lead levels in the 40-60 ug range. Cited in Third Health Document at III-6, JA 59.

A study by Pueschel et al. suggesting that in children lead body burdens below those usually associated with clinical lead poisoning may contribute to renal as well as neurological damage. Cited in Third Health Document at III-5, JA 58.

[86] Tepper & Levin, "A Survey of Air and Population Lead Levels in Selected American Communities," Dept. of Environmental Health, College of Medicine, U. Cincinnati, Ohio (EPA Contract PN 22-68-28) (Dec.1972), JA 840 (hereinafter Seven Cities Study).

[87] Ethyl also once again attacks the mere fact that the Administrator exercised his judgment. See Ethyl brief at 47.

[88] Petitioners PPG Industries, Inc. (PPG) and E. I. duPont de Nemours & Company (duPont) charge that this conclusion has no bearing on whether there is undue lead exposure among the general adult population. PPG/duPont Supp.Br. at 19. Of course it does not. It does have bearing, however, on whether blood lead levels are elevated among children and among the general population, both adult and child. It is for this purpose that the conclusion is cited.

Ethyl argues that these children have high blood lead levels primarily because of exposure to lead-based paint. Ethyl Supp.Br. at 40-41. The Administrator does not disagree. 38 Fed.Reg. 33735. What is important for his purpose is that blood lead levels are elevated in the general public; under the cumulative impact theory the source of the elevation is irrelevant in determining whether the public health is endangered by exposure to lead. See pages ___ - ___ of 176 U.S.App.D.C., pages 29-31 of 541 F.2d supra. The source becomes relevant only when deciding whether the emission products of lead additives make a significant contribution to that exposure, thereby justifying regulation under § 211(c)(1)(A).

[89] NPRA, PPG and duPont suggest that if certain occupational groups are overexposed to lead concentrations in the air, they should be protected under the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., rather than the Clean Air Act. NPRA Supp.Br. at 6-8; PPG/duPont Supp.Br. at 20. Other than by issuing mailmen, policemen, and service station attendants gas masks, we are baffled as to how special occupational regulations could protect such overexposed groups, who are overexposed only because they must work outdoors on or near busy city streets. We have no doubt, however, that the Clean Air Act was intended to protect such people. As Sen. Muskie stated "for the purposes of the record":

In setting standards, not only ambient standards but emission standards, * * * we must be concerned with the health effect upon the most vulnerable in our population * * *.

Hearings on S. 3229, S. 3455, S. 3546 before the Subcomm. on Air and Water Pollution of the Senate Comm. on Public Works, 91st Cong., 2d Sess, at 74 (1970). No less than with "particularly sensitive citizens such as bronchial asthmatics and emphysematics" who receive the special attention of the Clean Air Act, S.Rep.No.91-1196, 91st Cong., 2d Sess. 10 (1970), citizens who are occupationally exposed outdoors to otherwise uncontrollable lead concentrations in the ambient air are among "the most vulnerable in our population" and deserve to be considered when regulations under § 211(c)(1)(A) are at issue.

[90] The dissent criticizes this comparison of the Administrator's use of studies of occupational groups with the Eighth Circuit's use of similar evidence on the ground that the court explained the validity of its use of occupational data whereas the Administrator did not. Dissent at ___ of 176 U.S.App.D.C., at 104 of 541 F.2d. The Administrator, however, based his inferences on studies of occupational groups whose lead intake results from exposure, albeit for longer than average periods of time, to the same air breathed by the general public. See pp. ___ - ___ of 176 U.S.App.D.C., pp. 40-41 of 541 F.2d supra. The Eighth Circuit, by contrast, was explaining the validity of inferring a hazard to the general public from studies showing a hazard to workers and others exposed to higher levels of a somewhat different substance than that with which the court was concerned. See 514 F.2d at 511-512. In short, the Eighth Circuit was faced with a situation where differences between the hazard facing the occupationally exposed group and the hazard facing the general public required that the propriety of reaching a conclusion about the public from occupational studies be explained; the Administrator was not.

[91] EPA specifically requested comment on the figures it used in calculating the respiratory absorption of lead by a "standard man." 37 Fed.Reg. 11787 (1972), JA 21.

[92] The dissent suggests that this court, not the Administrator, first propounded this rationale for relying on the intrametropolitan results of the epidemiological studies. Dissent at ___ - ___ of 176 U.S.App.D.C., at 38 of 541 F.2d. This critique ignores the facts that the Administrator referred to this explanation at the beginning of his opinion, JA 3, and that the Third Health Document identifies the language in the Seven Cities Study which justifies the Administrator's reliance on that study's intrametropolitan area data. JA 89, quoting JA 844 (the introductory summary of the Seven Cities Study). The section of the Seven Cities Study summarized by the language quoted in the Third Health Document explicitly states the rationale relied on by the Administrator. JA 892; see pp. ___ to ___ of 176 U.S.App.D.C., pp. 57 to 58 of 541 F.2d, & note 4 infra. Clearly, the "agency's path" to its decision to credit the intrametropolitan results "may reasonably be discerned." Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra note 73, 419 U.S. at 286, 95 S.Ct. at 442, 42 L.Ed.2d at 456.

Despite its origins in the Seven Cities Study itself, the dissent rejects this explanation for the Administrator's approach to the evidence as totally irrational. The dissent argues that it is illogical to maintain that intrametropolitan dietary lead can be assumed to be relatively constant despite the income differences in a large metropolitan area. This argument, which has no foundation in any material before this court, illustrates the danger of "plausible-sounding, but simplistic, judgments of the relative weight to be afforded various pieces of technical data." Concurring op. of Chief Judge Bazelon at ___ of 176 U.S.App.D.C., at 66 of 541 F.2d. Without ourselves attempting to assume a scientific role, we note that since the main source of dietary lead is the soil, see note 5 supra, the geographical origin of foodstuffs may be a more important determinant of their lead content than is price. In any event, whatever the underlying basis for this approach might be, the important point is that we have no reason to fault the Administrator's decision to rely on the scientific expertise of the authors of the epidemiological studies before him.

[93] Petitioners' persistent refusal to recognize that these are the reasons the Administrator is concerned about lead dustfall makes their constant arguments about leaded paints completely unresponsive to the Administrator's analysis of the evidence.

[94] Ter Haar & Aronow, New Information on Lead in Dirt and Dust as Related to the Childhood Lead Problem, presented at the EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1, 1973, JA 917, 922 (Fig. 1).

[95] Since proof of the danger posed by inhalation of asbestos wastes was much stronger than proof of the danger posed by ingestion, the Reserve Mining court ordered immediate action taken with regard to the discharge of wastes into the air. See note 34 supra.

[96] The dissent states that its disagreement with the Administrator and the majority concerning the interpretation of the "will endanger" standard "reduces itself to semantics." Dissent at ___ of 176 U.S.App.D.C., at 73 of 541 F.2d. The dissent also rejects the Administrator's reliance on the dustfall hypothesis simply because it is a hypothesis. Dissent at ___ - ___ of 176 U.S.App.D.C., at 41-42 of 541 F.2d. Yet as we have demonstrated above and as the Reserve Mining court held, a reasonable hypothesis supported by evidence is a sufficient basis for regulating under the "will endanger" standard as the Administrator has interpreted that standard.

[97] This fact completely rebuts petitioners' claim that this case does not present problems "on the frontiers of scientific knowledge." Industrial Union Department, AFL-CIO v. Hodgson, supra note 35, 162 U.S.App.D.C. at 338, 499 F.2d at 474. See, e. g., NPRA Supp.Br. at 49. Although petitioners note that lead additives have been in use for over 50 years, and that questions about their safety have been raised for almost as long, see note 3 supra, the fact remains that virtually all the evidence cited by both EPA and petitioners was developed in the last five years, most of it for the purpose of supporting or opposing these regulations. Cf. note 3 supra. Moreover, both EPA and petitioners admit much more remains to be discovered. See pp. ___ - ___ of 176 U.S.App.D.C., pp. 25-26 of 541 F.2d and note 83 supra.

[98] The dissent's repeated assertion that the evidence was insufficient to convince the independent scientific community, represented by other Government agencies, is unconvincing for two reasons. First, the Department of Health, Education, and Welfare, which shares with EPA responsibility for and scientific expertise in the areas of public and environmental health, endorsed the regulations. The dissent relies on a Jan. 29, 1973 letter from then Secretary of HEW Elliot Richardson to demonstrate the Department's opposition to the lead reduction regulations. Dissent at ___ of 176 U.S.App.D.C., 76-77 of 541 F.2d. The Aug. 7, 1973 letter of Richardson's successor, Caspar Weinberger, in which the Department endorsed removing lead from gasoline provided the result would not be the introduction of more harmful additives, JA 2507, is unconvincingly discounted. Dissent at ___ - ___ of 176 U.S.App.D.C., at 76-77 of 541 F.2d n.27. We have found reasonable the Administrator's determination that reducing the lead content of gasoline would not have this perverse effect on the public health. See pp. ___ - ___ of 176 U.S.App.D.C., pp. 32-33 of 541 F.2d & notes 67-68 supra.

Second, the dissent's equation of the views of other Government agencies with the views of the independent scientific community is itself fallacious. Without in the least impugning their motivation, it may be assumed that agencies such as the Department of the Interior and the Department of Commerce, see dissent at ___, ___ of 176 U.S.App.D.C., at 74, 76-77 of 541 F.2d respond to and represent interests other than those concerned with the environment and the public health. The very existence of EPA is evidence that Congress believed the other agencies of the Government could not adequately appraise and act against environmental threats. Truly independent scientific opinion, represented by comments from those with no association with environmental groups or industry, favored the regulations by a margin of approximately two to one. JA 5.

We also note that the California Air Resources Board has recently adopted regulations imposing a more stringent lead reduction schedule than is imposed by the regulations before us. See N.Y. Times, Feb. 20, 1976, at 12 col. 3.

[99] Since EPA never stopped accepting comments on the proposed regulations, the comment period on these regulations actually lasted almost two years. All comments were made public when they were received, in accordance with the procedure established by EPA's notices of proposed rule-making. See, e. g., 38 Fed.Reg. at 1260, JA 17; 17 Fed.Reg. at 3882, JA 23. Moreover, in keeping with his statutory mandate to consider "all relevant medical and scientific evidence available to him," § 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2)(A) (emphasis added), the Administrator considered comments received throughout this extended comment period. See pp. ___ - ___ of 176 U.S.App.D.C., p. 53 of 541 F.2d & note 123 infra.

NPRA claims that placing the new studies in the public file did not satisfy EPA's obligations because "EPA did not notify the public of the availability of these documents or that it intended to rely upon them in promulgating the final regulations." NPRA Reply Br. at 17. This statement is not accurate, since EPA's public notice of the proposed low-lead rule-making, supra, stated that all new information received concerning the proposed regulations would be made available for public inspection at its Office of Public Affairs. 38 Fed.Reg. at 1260, JA 17. Moreover, NPRA's own submissions refer to documents contained in the EPA public file. See JA 1962; Doc. 1259. See also Doc. 1089 (letter from Ethyl, dated Oct. 12, 1973, requesting that certain documents not yet in the public file be placed there). Since the statute requires the Administrator to consider all evidence available to him, the complaint that petitioners could not know the Administrator would make use of the material in the public file is unimpressive.

[100] The reproposed regulations had made clear that these two alternatives were under consideration and that, at the time, the Administrator favored leaded pool averaging. 38 Fed.Reg. 1260 (1973). When the majority of industry comments favored use of the total pool system, 38 Fed.Reg. 33739 (1973), the Administrator shifted his position. While we think the notice at 38 Fed.Reg. 1260 was a sufficient basis for a change in position in the final regulations, the Administrator gave actual notice of the change to the refiners several months before the final regulations were promulgated. See NPRA letter dated Oct. 25, 1973, JA 1962. Moreover, petitioner NPRA submitted comments on that change. See id.

[101] Since all material information was made available for comment by petitioners and the public, it is not necessary for us to determine whether the Administrator may rely on information not previously made available.

[102] By contrast, the division majority allotted less than one and a half pages of its 73-page opinion to this argument. Petitioners also treated this contention as a minor part of their attack on the regulations. The major thrust of the dissent's complaint appears to be that although all of the evidence on which the Administrator relied was made available to the public at least three months before the regulations were issued, that evidence was not specifically delivered to or called to the attention of petitioners when it arrived at EPA. The dissent does not explain the origin of this supposed responsibility of the Agency. Certainly the EPA's requirement of opportunity for notice and comment is satisfied by placing evidence in a designated public access file and repeatedly announcing the existence and location of that file in the Federal Register. See note 99 supra. Thus the dissent's chart of the availability of new evidence, dissent at ___ of 176 U.S.App.D.C., at 93 of 541 F.2d, is fundamentally misleading. All interested parties had legally adequate notice of the evidence relied on by the Administrator, and of his intent to rely, see note 99 supra, from the time that evidence was placed in the public file.

The dissent attempts to avoid this fact by repeatedly lamenting that EPA's public file was "poorly indexed" (and dusty). Dissent at ___ n.34 ___, ___ - ___ of 176 U.S.App.D.C., at 79 n.34, 82, 90-91 of 541 F.2d. On examination this entire attack turns out to be based on the excuse offered by EPA's attorney for a slight delay in providing a document to this court. See id., at ___ n.34, of 176 U.S.App.D.C., at 79 n.34, of 541 F.2d. Had petitioners complained that they were not able to use the public file, we would of course have treated that complaint as a serious matter. But petitioners made no such allegation, nor did they suggest that EPA's public file procedures were in any way less adequate than the procedures customarily followed by administrative agencies. It may well be that the public reference procedures of this still relatively new agency can be improved. But we see no basis for a hypothesis, really a speculation, that persons affected are so unable to use the public file that minimal fairness is lacking. In any event that complaint was not made by able and experienced counsel for petitioners.

[103] Rabinowitz et al., "Study of human lead metabolism using stable isotope tracers," paper presented at EPA-NIEHS conference on Low Level Lead Toxicity, Raleigh, N. C., Oct. 1-2, 1973, JA 678; Rabinowitz et al., "Lead Metabolism in the Normal Human: Stable Isotope Studies," 182 Science 725-727 (1973), JA 704.

[104] See also EPA letter of Oct. 2, 1975. That letter and a letter of Sept. 26, 1975 were responses to requests for information from this court. Copies of these letters were sent by EPA to counsel for all parties to this litigation. No party commented on either letter.

[105] The final draft was received by EPA's Office of the General Counsel Aug. 6, 1975, for transmittal to Ethyl, see note 117 infra, and to the public file. EPA letter of Sept. 26, 1975.

[106] Nalco Chemical Co. submitted extensive comments on the scientific evidence, including comments directed specifically at the lead isotope study, on Nov. 19, 1973. Doc. 821 at 7. Ethyl also submitted comments on this study in the form of a transcript of the October conference. Doc. 433.

The dissent finds it strange that we consider this transcript a substantive comment on the studies discussed at the meeting. Dissent at ___, ___ of 176 U.S.App.D.C., at 89, 90-91 of 541 F.2d. In response, we simply note that the only possible interpretation of Ethyl's action in preparing and submitting the transcript was that the company wished to have the critical comments of its scientists and some others who attended the meeting brought to EPA's attention as substantive critiques of the studies. A covering letter from Ethyl's counsel which accompanied the company's submission of the transcripts of a Feb. 26 and a March 15 meeting explicitly states this purpose. See JA 986.

[107] Tsuchiya et al., Study of Lead Concentrations in Atmosphere and Population in Japan (undated), JA 1092.

[108] The study was received by EPA's Office of the General Counsel on July 22, 1973, for transmittal to Ethyl, see note 117 infra, and to the public file. EPA letter of Sept. 26, 1975. It too was commented on by Nalco. Doc. 821 at 7. Since the study was available for comment four months prior to issuance of the Administrator's decision, we find the significance of the fact that it was not cited in the Third Health Document, dissent at ___ of 176 U.S.App.D.C., at 80 of 541 F.2d, mystifying.

[109] Knelson et al., Kinetics of Respiratory Lead Intake in Humans, Proceedings of the International Symposium on Environmental Aspects of Lead 391-401 (1973), JA 596.

[110] Compare Doc. 85, JA 596-601, with Doc. 111 at 391-401. The final printed "version" differs from the "preprint" only in that the former contains a translation of the authors' summary into French and German.

[111] Tepper & Levin, "A Survey of Air and Population Lead Levels in Selected American Communities," Department of Environmental Health, College of Medicine, University of Cincinnati, Cincinnati, Ohio (1972), JA 840.

[112] The dissent's emphasis on the importance of the reanalysis of the Seven Cities Study appears to be based on a misunderstanding of the meaning of statistical significance. Statistical significance simply expresses the level of assurance we can have that certain data was not the product of random relationships. See, e. g., F. Mosteller, R. Rourke & G. Thomas, Probability With Statistical Applications 304-307 (2d ed. 1970).

Unfortunately, the word "significant" in everyday use means not only "suggestive" but also "important" and "weighty". We do not carry these everyday meanings over into statistics. * * * A statistically significant result is one that the data support as showing a real effect, as opposed to a result that might readily arise from sampling variation.

Id. at 307.

Typically, scientists refuse to certify an observed relationship as "significant" unless they are 95% certain that the data could not have been generated randomly. See note 58 supra. Thus the authors of the Seven Cities Study found the relationship between air and blood lead levels between cities "[n]ot significantly different from 0 at the 5% level," JA 902, meaning that they could not be certain that if there were no genuine relationship in the real world, the relationship that was observed in this study would be found in at most five out of every 100 randomly drawn data samples. On reanalyzing the data using more refined techniques, EPA's scientists determined that the observed relationship could be expected to be produced by chance less than one time out of 1,000. See Doc. 228 at Table 3. Similarly, the authors of the Seven Cities Study themselves recognized the implication of their "consistent observation" that blood lead levels were higher in a given metropolitan area's urban region than in its suburbs. See p. ___ of 176 U.S.App. D.C., p. 42 of 541 F.2d, & note 92 supra. The reanalysis simply demonstrated that this "consistent observation" has less than a one in 1,000 likelihood of being the product of chance. See Doc. 228 at Table 3.

There is, of course, no reason why the Administrator cannot rely on observed relationships among data which he is less than 95% certain reflect a true underlying relationship between the phenomena that the data measure. See note 58 supra. The dissent's assertion that only the reanalysis provides support for the Administrator's decision assumes that the Administrator must be 95% certain before he credits any evidence.

[113] The purpose and contents of the reanalysis are described by its first sentence: "This brief paper is an attempt to answer questions raised by reviewers about the statistical analyses performed [in the Seven Cities Study]." Doc. 228 at 1.

[114] The results and methodology of the reanalysis were presented and discussed at a meeting of the EPA Hazardous Materials Advisory Committee on Feb. 26, 1973. JA 989-992. Representatives of Ethyl attended the meeting, prepared a transcript of it, including critical comments by some of those in attendance, and forwarded the transcript to the Administrator. JA 985; see note 106 supra. The dissent strives mightily to show that the reanalysis was not in the public domain until four days after the close of the formal comment period, rather than 13 days before. Dissent at ___ of 176 U.S.App.D.C., at 80-81 of 541 F.2d. Even if this were true, the important point is that the reanalysis was available for public comment some nine months prior to issuance of the regulations.

[115] Margulis et al., Residential Location, Ambient Air Lead Pollution and Childhood Lead Poisoning, — Arch Env. Health — (in press at time record was compiled), JA 626; Sayre et al., House and Hand Dust as a Potential Source of Childhood Lead Exposure, — Am.J.Dis.Child — (in press at time record was compiled); and Vostal et al., "Lead Containing House Dust: Another Source of Increased Lead Exposure in Inner City Children," paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1-2, 1973, JA 720, 738; Needleman & Shapiro, "Dentine Lead Levels in Asymptomatic Philadelphia School Children: Subclinical Exposure in High and Low Risk Groups," paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1-2, 1973, JA 662; Sachs, "Effects of a Screening Program on Changing Patterns of Lead Poisoning," paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1-2, 1973, JA 718.

[116] Compare JA 1-5 (the text of the Administrator's decision) with JA 186-193 and JA 231-239 (discussions of the dustfall hypothesis in the Second Health Document).

[117] The dissent cites no authority at all in that part of its argument which focuses on the asserted need for notice of intent to rely. See dissent at ___ _ ___, ___ _ ___ of 176 U.S.App.D.C., at 84-85, 89-94 of 541 F.2d. The authorities cited in the same section of the dissent, see id. at ___ _ ___, and nn.78-80 of 176 U.S.App.D.C., at 85-86 and nn.78-80 of 541 F.2d, support only the proposition that an agency may not keep secret the purpose of its proceeding or information important to its decision. The citation to K. Davis, Administrative Law Treatise § 15.10 at 402 (1958), dissent at ___ n.78 of 176 U.S.App.D.C., at 86 n.78 of 541 F.2d, refers to a discussion of the "Procedures for Using and Challenging Extra-Record Facts" of which an administrative decision-maker has taken notice during an adjudicatory proceeding. Since all of the studies at issue here were disclosed by the Administrator as soon as they became available to him, not kept secret, and since there could be no allegation that any of this material was not part of the record properly before the Administrator, these authorities are of no assistance to the dissent's argument.

Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra note 73, quoted, dissent at ___ of 176 U.S.App.D.C., at 86 of 541 F.2d also offers no support for the proposition that the APA requires notice of what material received and made public after publication of a proposed rule will be relied on to support the final regulation. In the first place, Bowman was an adjudicatory proceeding, not a notice-and-comment rule-making. More importantly, in the sentence immediately following the language quoted by the dissent the Supreme Court noted that a party's right "to be apprised of the factual material on which the agency relies for decision" does "not preclude a factfinder from observing strengths and weaknesses in the evidence that no party identified." 419 U.S. at 288 n.4, 95 S.Ct. at 443 n.4, 42 L.Ed.2d at 457 n.4. The Administrator's treatment of the Seven Cities Study, as well as of the Japanese study submitted by lead industry opponents of the proposed regulation, fits squarely within this observation. Moreover, the Bowman Court also noted that the petitioners there "are not in a position to claim unfair surprise" because the Commission had offered the same rationale for its interpretation of evidence in a case decided at the time the hearings in Bowman were beginning. Id. at 289 n.4, 95 S.Ct. at 443 n.4, 42 L.Ed.2d at 457 n.4. That rationale, it should be noted, was potentially rebuttable. In the face of this conclusion, the assertion that petitioners were not on notice that the agency might rely on information in the public record of this rule-making proceeding appears frivolous.

Finally, we note that nothing in Wright, The Courts and the Rulemaking Process: The Limits of Judicial Review, 59 Cornell L.Rev. 375 (1974), supports the dissent's attempt to transmute the three-step process established by § 4 into a potentially unending and fruitless series of notices, comments, and notices of intent to rely on comments.

[118] See note 99 supra. Indeed, petitioner Ethyl was directly furnished with all such documents as a result of a Freedom of Information Act, 5 U.S.C. § 552 (1970), suit. JA 1509-1510. See Ethyl Corp. v. EPA, 478 F.2d 47 (4th Cir. 1973).

[119] The dissent's effort to demonstrate that little comment was received about the most recent of the studies relied on by the Administrator is irrelevant. All the APA requires is that there have been an opportunity to comment. The three months between the time the important new studies were placed in the public file and the time of the Administrator's decision is clearly sufficient opportunity.

[120] JA 1474; JA 1502.

[121] Doc. 141. Chapters I, II, V, VII, and VIII (the conclusions) of this draft, dated Oct. 19, 1973, differ only in minor wording changes from the final Third Health Document. Chapters III, IV, and VI of the final version contain a few additional inconsequential paragraphs and references. The cover of the Oct. 19 draft states that "[i]t is being circulated for comment on its technical accuracy and policy implications."

The early October preparation and circulation of a draft decision and a draft Third Health Document, both in obviously near final form, belie the dissents' contention that this court's 30-day order, see p. ___ of 176 U.S.App.D.C., p. 10 of 541 F.2d supra, forced EPA to rush into a decision it was not yet ready to make.

[122] See e. g., JA 2577 (Treasury Department comments); JA 2651 (letter from Secretary of Transportation); JA 2493 (Department of the Interior comments, dated Dec. 7, 1973). The Nalco comments, see note 106 supra, were addressed to both the draft Third Health Document and the draft of the Administrator's decision.

[123] See Ethyl letter dated Oct. 29, 1973, Doc. 1090, presenting evidence considered in the Third Health Document, JA 79 (ref. 11) & 140 (ref. 43). The Ethyl letter called this evidence to EPA's attention because "[t]o our knowledge these highly significant articles have not been referred to by EPA to date in its consideration of the health question * * *." Doc. 1090 supra. The timing of this letter suggests that Ethyl was referring to EPA's failure to reference these articles in the Oct. 19 draft of the Third Health Document. Ethyl would have received that draft due to its Freedom of Information Act suit. See note 118 supra.

[124] Beyond their attacks on the Administrator's interpretation of the statutory language, the evidence, and the procedures, petitioners raise a host of other objections to the final EPA regulations. We have considered above petitioners' claims that the Administrator did not properly consider the possibility of regulation under § 202, see note 66 supra, and that he did not make a valid finding that any substitute additive would be less dangerous than lead, particularly in light of his recent suspension of 1977 statutory emission standards. See notes 67-68, supra. Cf. note 2 supra. We shall briefly address petitioners' remaining contentions.

Ethyl claims a right to cross-examine agency witnesses. Ethyl Br. at 55. Not only does the Clean Air Act not require any hearings at all, but even if hearings were required cross-examination is not mandated in § 4 type proceedings, 5 U.S.C. § 553. United States v. Florida East Coast R. Co., 410 U.S. 224, 240, 93 S.Ct. 810, 818, 35 L.Ed.2d 223, 236 (1973). Petitioners were afforded a meaningful opportunity to be heard and to controvert the evidence. Fairness demands no more. See International Harvester Co. v. Ruckelshaus, 155 U.S.App.D.C. 411, 427, 478 F.2d 615, 631 (1973).

PPG, duPont and NPRA claim the Administrator was required to set ambient air standards for lead under § 108, 42 U.S.C. § 1857c-3, before acting under § 211, and his failure to do so warrants reversal. PPG/duPont Br. at 45; NPRA Supp.Br. at 37-47. There is no basis in the statute for this claim. While § 211 expressly mentions consideration of regulation under § 202, it makes no mention at all of § 108. Moreover, the Administrator claims, with some statutory support, that action under § 108 is discretionary with him. 38 Fed.Reg. 33740 (1973). Cf. note 21 supra.

Nalco, PPG and duPont all claim that the Administrator did not give sufficient consideration to the adverse economic effects of his decision to regulate lead additives. Nalco Br. at 42; PPG Br. at 40. Even if the Administrator is allowed to consider at all the economic effects of regulations issued under § 211(c)(1)(A), a question we do not address, he has plainly both well understood and considered the consequences of these regulations and found them to be minimal. 38 Fed.Reg. 33739 (1973). We cannot say his judgment was irrational.

NPRA objects to the Administrator's switch from leaded pool averaging to total pool averaging. NPRA Supp.Br. at 47-48. EPA switched in response to the comments of a majority of refiners. 38 Fed.Reg. 33739. We find nothing wrong with the use of that system. We discussed at note 100 supra the propriety of the Agency's announcing this change when promulgating its final regulations.

Lastly, Ethyl, PPG, duPont and NPRA claim that EPA was required to file an environmental impact statement under § 102(2)(C) of the National Environmental Policy Act, 42 U.S.C. § 4332(2)(C) (1970), or the functional equivalent of one. Ethyl Br. at 57; PPG Br. at 46; NPRA Br. at 53. So far as EPA regulation under § 211 is concerned, we answered this question in Amoco, and recent legislation has made the point doubly clear. An environmental impact statement from EPA does not appear necessary; a "functional equivalent" suffices. The Amoco court held that when the Administrator has considered the evidence and alternative courses of action required before action under § 211 is permitted, he has necessarily furnished the "functional equivalent" of an impact statement. Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 189-190, 501 F.2d at 749-750. Since we believe the Administrator has complied with all the demands of § 211 in this case, we believe he has likewise complied with NEPA.

Any lingering doubt in this regard has been removed by recent congressional action. The Energy Supply and Environmental Coordination Act of 1974, Pub.L.No.93-319, 88 Stat. 246 (1974) (codified at 15 U.S.C. § 791 et seq. (Supp. IV 1974)), provides: "No action taken under the Clean Air Act shall be deemed a major Federal action significantly affecting the quality of the human environment within the meaning of the National Environmental Policy Act of 1969." Id. § 7(c)(1), 15 U.S.C. § 793(c)(1). Thus Congress has expressly exempted EPA action under the Clean Air Act from NEPA's environmental impact statement requirement.

[125] R. Kehoe, The Metabolism of Lead in Man in Health and Disease: The Harben Lectures (1960), reprinted from J. Royal Inst. Public Health Hyg. 1961, JA 500.

[126] The absorption data is based on an estimated 15 m3 daily respiration (since the subjects were sedentary), 30-37% absorption of lead from air, and a lead concentration of 10.9 ug/m3. Third Health Document at Table V-5, JA 104.

[127] Petitioners' second objection is likewise without merit. Nalco claims EPA improperly assumes a straight-line correlation between air lead exposure and blood lead levels, and quotes EPA scientists:

The best fit for these [Kehoe] data may be curvilinear rather than a linear function, in which case, blood leads would level off about 40 ug/100 g rather than continuing to increase indefinitely.

JA 85, cited in Nalco Supp.Br. at 39. The EPA calculations, however, make just the adjustment suggested (which is hardly surprising since the suggestion appears in the Third Health Document). EPA calculates only the air lead levels necessary, under various circumstances, to bring blood leads to 40 ug—and no higher. Whether or not blood lead increases plateau thereafter is of no consequence for these calculations.

[128] Climate may influence both air lead levels and exposure to lead. Greater wind speed is associated with lower air lead levels, and higher readings have been associated with surface inversions. JA 854, 873. Climate also influences the amount of time spent exposed to atmospheric lead outdoors, the time spent indoors with windows open (which increases lead exposure) or air conditioners on (which decreases lead exposure). JA 400, 467. See note 11 infra. For these reasons, it may be preferable to compare blood lead levels of persons exposed to roughly similar climates.

[129] PPG and duPont argue that this conclusion is contradicted by the Philadelphia data in the Seven Cities Study. Philadelphia urban-suburban data were analyzed twice, they argue, and the second analysis turned the result around, producing higher blood lead values for suburban dwellers than for city dwellers. PPG/duPont Supp.Br. at 25. In fact, the data were analyzed three times, the first time in the Seven Cities Study itself, JA 901 (Ardmore and Rittenhouse data), and the second and third times in a submission prepared for EPA by duPont. Only on the third analysis did the turn-about result. JA 2211. Thus two out of three analyses of the Philadelphia data (one by duPont), as well as the data for the other two cities, support the Administrator's position. We cannot say his conclusion is irrational.

[130] Azar et al., Relationship of Community Levels of Air Lead and Indices of Lead Absorptions, in Proceedings of an International Symposium on Environmental Health Aspects of Lead, CEC, CID, Luxembourg, at 581-594 (May 1973), JA 387.

[131] Nalco attempts to belittle this finding by claiming that it represents "a comparison of 6 cab drivers with 2 office workers A. 392)." Nalco Supp.Br. at 35-36. Nalco is distorting the record. The cited reference, Table 1 of the Azar study, JA 392, is explicitly headed "30 subjects per group." What Nalco is apparently referring to is a line reading, "Data Per Subject, # Bloods: L.A. Cab, 6; L.A. Office, 2 * * *." Contrary to Nalco's suggested reading, this line indicates only that the 30 taxicab drivers were given 6 blood tests each, while the 30 office workers were given only 2 blood tests each.

[132] Tsuchiya et al., Study of Lead Concentrations in Atmosphere and Population in Japan (undated), JA 1092.

[133] Jones et al., Blood Lead and Carboxyhemoglobin Levels in London Taxi Drivers, 2 Lancet 302 (Aug. 12, 1972), JA 498.

[134] Daines et al., Air Levels of Lead Inside and Outside Homes, 41 Industrial Med.J. 26 (Oct. 1972), JA 465.

[135] Among those women living 3.7 meters from the highway, both air lead and blood lead levels were significantly lower in homes that were air-conditioned. JA 467; Third Health Document at V-10, JA 90. See note 4 supra.

[136] In both studies air lead concentrations were comparable and blood lead differences were insignificant at distances beyond 100 feet from the roadway. In the first study, at distances of 38.1 and 121.9 meters the air lead concentrations were 2.41 and 2.24 ug/m3 and blood lead concentrations 17.4 and 17.6 ug. In the second study, at distances of 33.5 and 457 meters the air lead concentrations were 1.95 and 1.73 ug/m3 and the blood lead concentrations 15.7 and 16.1 ug. All of this shows only that where air lead concentrations are essentially similar, there is no reason to anticipate differences in blood lead concentrations.

[137] Hammer et al., "Trace Metals in Human Hair as a Simple Epidemiologic Monitor of Environmental Exposure," Trace Substances in Environmental Health V: A Symposium 25 (D. Hemphill, ed. 1972).

[138] Nordman, Blood Lead Levels and Erythrocyte Delta-Aminolevulinic Acid Dehydratase Activity in People Living Around a Secondary Lead Smelter, 10 Work—Environment—Health 19 (1973).

[139] Petitioners accuse the Administrator of worrying about dietary lead intake only when it serves his purpose of discrediting a contradictory study, and conveniently ignoring the problem when he wants to use the data. Ethyl Supp.Br. at 52. In fact, however, the Administrator's concern is consistent. Dietary control is a problem in all the epidemiological studies. The Administrator consistently credits inferences derived from data in a single metropolitan area or where dietary absorption of lead can be deemed roughly constant. This is a principled approach to the evidence, and one which we approve.

[140] Knelson et al., Kinetics of Respiratory Lead Intake in Humans, in Proceedings of an International Symposium on Environmental Health Aspects of Lead, CEC, CID, Luxembourg, at 391-401 (May 1973), JA 596.

[141] Rabinowitz et al., "Study of human lead metabolism using stable isotope tracers," paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1-2, 1973, JA 678; Rabinowitz et al., "Lead Metabolism in the Normal Human: Stable Isotope Studies," 182 Science 725 (Nov.1973), JA 704. See Third Health Document at V-3, JA 83. See also 38 Fed.Reg. at 33735.

[142] See, e. g., NYC Bureau of Lead Poisoning Control, data submitted to EPA Aug. 31, 1972 & Sept. 12, 1972, Doc. 104; Lepow, testimony before Subcommittee on the Environment, Senate Committee on Commerce, May 8, 1972, cited in Second Health Document at V-18, JA 196.

[143] Personal communication from M. Dea, Department of Human Services, Multnomah County, Oregon, to K. Bridbord, EPA, dated March 6, 1973, Doc. 44; Gilsinn, Estimates of the Nature and Extent of Lead Paint Poisoning in the United States, NBS Technical Note 746, Dec. 1972, Doc. 61; Needleman & Shapiro, "Dentine Lead Levels in Asymptomatic Philadelphia School Children: Subclinical Exposure in High and Low Risk Groups," presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C. (Oct. 1-2, 1973), JA 662.

[144] Sayre et al., House and Hand Dust as a Potential Source of Childhood Lead Exposure, — Am.J.Dis.Child — (1973) (in press at time of insertion in record), JA 720; Vostal et al., "Lead Analysis of the House Dust: A Method for the Detection of Another Source of Lead Exposure in Inner City Children," presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C. (Oct. 1-2, 1973), JA 738.

Since only 58% of the inner-city households had lead-based paint, lead paint chips were discounted as the sole source of elevated lead levels. The study made no attempt to determine "whether the lead comes from airborne sources, chalking of paint, or from paint chips shed from walls and perhaps pulverized underfoot." JA 732.

[145] The authors concluded, "[M]ost cases of pediatric Pb [lead] poisoning occur in an area of high soil Pb values." Fairey & Gray, Soil Lead and Pediatric Lead Poisoning in Charleston, S.C., J.S.C. Med. Assn 79 (March 1970), JA 482, 485. Petitioners distort the purpose of this study and then attack the resultant straw man. As petitioners correctly note, Nalco Supp.Br. at 43-44; PPG/duPont Supp.Br. at 43; Ethyl Supp.Br. at 50, the high lead concentrations in the area studied were not thought to be a direct product of automotive exhausts. See JA 484, 485. Since the study is only cited to show that children are likely to eat lead-contaminated dust, however, petitioners' charge proves little. Third Health Document at VI-4, JA 114. On the other hand, petitioners fail to note that the study did implicate automotive exhausts to some extent:

Neither pesticides nor automobile exhausts account for the high Pb [lead] levels in Charleston, though undoubtedly they add to the contamination.

JA 484.

Petitioners attempt to rebut the Charleston findings, and those of the El Paso study, see note 5 infra and accompanying text, by relying on apparently contradictory data from England showing inconsequential increases in children's blood lead levels despite significant changes in soil lead levels. PPG/duPont Supp.Br. at 43-44; Ethyl Br. at 42, citing Barltrop & Strehlow, "The Significance of High Soil Lead Concentrations for Childhood Lead Burdens," presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C. (Oct. 1-2, 1973), JA 415. But see EPA Supp.Br. at 57 n.51. The Administrator pointed to various possible differences between American and English data that might account for the inconsistency. Third Health Document at VI-5, JA 115. We shall defer to his judgment that the American data are preferable.

[146] Within one mile of the smelter 35.2% of the children tested had blood lead levels of 40 ug or greater; beyond that the percentage dropped to around 10. Epidemiological Studies of Human and Environmental Lead Pollution: El Paso, Texas (unpublished 1972), JA 468 (Table 2). On the basis of this data the chairman of the NAS Panel concluded:

[T]he Smeltertown [El Paso] study alone lends a high degree of credibility to the hypothesis that very young children will, in fact, ingest toxicologically significant amounts of dust and dirt when it contains lead at the level of 0.1 percent and up.

Letter from Dr. Paul B. Hammond to Dr. Kenneth Bridbord, EPA, March 9, 1973, JA 2417. While petitioners cited an apparently contradictory statement from Dr. Hammond, JA 2611, he has not repudiated the observation quoted above.

[147] Margulis et al., "Residential Location, Ambient Air Lead Pollution and Childhood Lead Poisoning," — Arch. Env. Health — (in press at time record was assembled), JA 626. Petitioners suggest that something is wrong with the Newark data because preliminary results did not reach the same conclusion. Nalco Supp.Br. at 42-43; PPG/duPont Supp.Br. at 40-41. Preliminary calculations on data points only above lead levels of 40 ug produced positive, but not significant, results, so the data field was expanded to include all the evidence whereby the results suggested below were obtained. We see nothing wrong with such refinement of experimental data. See also pp. ___ _ ___ n.112 of 176 U.S.App.D.C., pp. 50-51 n.112 of 541 F.2d supra.

[148] Over 5,000 children were studied. Of those living within 100 feet of major highways, 49.3% had blood lead levels of 40-49 ug and 8.1% had levels of 60 ug or more; of children living between 100 and 200 feet from the highways, the respective percentages were 24.2 and 3.7. Margulis et al., supra note 6, at Table 2, JA 639. Dividing these children into two groups, one containing children living near highways bearing an average weekday traffic density of less than 24,000 vehicles, the other containing children living near highways bearing more than 24,000 vehicles daily, the researchers found 51.3% of the latter group had blood lead levels of 40-59 ug, and 10.8% had levels greater than 60 ug; in the former group, however, the respective percentages were only 3.6 and 5.1.

Undoubtedly, respiration of airborne lead emissions contributed to the elevated blood lead levels, but the fact that a far greater percentage of these children had elevated blood lead than comparable adults, see the Daines study discussed at pp. ___ to ___ of 176 U.S.App.D.C., pp. 59-60 of 541 F.2d supra, suggests that ingestion of lead dustfall significantly supplemented any respiratory intake.

[149] In particular, petitioners fault the Newark study for failing to correlate the children's blood lead level with exposure to leaded paint as well as distance from the roadway. Nalco Supp.Br. at 43; PPG/duPont Supp.Br. at 41-42; Ethyl Supp.Br. at 51. These data were impossible to obtain; the Newark study took advantage of a vast data base accumulated by the New Jersey College of Medicine and Dentistry in its routine measurements of childhood exposure to lead. The data contained only blood lead levels and addresses of children, thus making the lead paint variable impossible retroactively to control or measure, JA 954. However, the Administrator recognized this limitation on the study, Third Health Document at VI-17, JA 127, and determined that it did not seriously undercut its validity. Of course, the results were "only" a statistical correlation; such are the results of all epidemiological research. But the Newark study presented a strong correlation, consistent with an existing theory that makes biological sense and with existing evidence. Such data are worthy of great respect, and may even be taken as causal proof. H. Hilleboe & G. Larimore, Preventive Medicine 677-678, 687 (1959). We cannot say the Administrator's reliance on the Newark study was in error.

Petitioners also argue the El Paso data is useless since blood lead levels were elevated in adults as well, so that the high lead body burdens may have been due to inhalation rather than ingestion. Nalco Supp.Br. at 41-42. While this suggestion may undercut petitioners' argument that inhalation of airborne lead does not significantly affect the lead body burden, it does not undercut the Administrator's use of the study. While adult blood leads were indeed elevated, the Administrator noted that the frequency of elevated blood leads among young children was much higher, thus suggesting "a special exposure route for young children," i. e., ingestion. Third Health Document at VI-7, JA 117. (Petitioners overstate by at least a factor of 10 the air lead concentrations in El Paso, compare Nalco Supp.Br. at 41 with JA 117, 469, 2344.)

[150] Ter Haar & Aronow, New Information on Lead in Dirt and Dust as Related to the Childhood Lead Problem, presented at the EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1, 1973, JA 917, 922 (Fig. 1); Fine et al., Pediatric Blood Lead Levels, 221 J. A.M.A. 1475 (1972), JA 486; Conn & Anderson, D.C. Mounts Unfunded Program of Screening for Lead Poisoning, 86 H.S.M.H.A. Health Reports 409 (1971), JA 460; statement of Henrietta Sachs (Nov. 5, 1972), JA 2444.

[151] Ter Haar & Aronow, supra note 9.

[152] As the study concluded: "The results provide sound evidence that these children suspected of elevated lead body burden were not ingesting dust or air-suspended particulate." JA 918 (emphasis added).

[153] For convenience, citations to particular pages are in the form "Wright op. at ___."

[154] Wright op. at ___ of 176 U.S.App.D.C., at 26 of 541 F.2d.

[155] Id. at ___ of 176 U.S.App.D.C., at 24 of 541 F.2d.

[156] International Harvester Co. v. Ruckelshaus, 155 U.S.App.D.C. 411, 448, 478 F.2d 615, 652 (1973) (Bazelon, C. J., concurring).

[157] Portland Cement Ass'n v. Ruckelshaus, 158 U.S.App.D.C. 308, 335, 486 F.2d 375, 402 (1973), cert. denied, 417 U.S. 921, 94 S.Ct. 2628 41 L.Ed.2d 226 (1974) (Leventhal, J.), citing Greater Boston TV v. FCC, 143 U.S.App.D.C. 383, 392, 444 F.2d 841, 850, cert. denied, 403 U.S. 923, 91 S.Ct. 2229, 2233, 29 L.Ed.2d 701 (1971).

The Greater Boston TV case, from which Judge Leventhal draws this language, involved FCC non-renewal of a license in part because it was held by parties controlling a major newspaper in the area. As indicated in the text, such issues are much more amenable to judicial comprehension than the scientific judgments in a case such as the present.

While acknowledging that the general rules of administrative law might be modified, rather than imported wholesale, into scientific and technical areas, Judge Leventhal apparently concludes that encouraging judges to parse the evidence themselves is necessary if courts are to remain "fully vigilant to exercise rather than abdicate their supervisory role" in areas such as environmental law which touch fundamental interests in life and health. See Leventhal, Environmental Decisionmaking and the Role of the Courts, 122 U.Pa.L.Rev. 509, 511-12 (1974).

[158] Panel op. at 48 [quotation omitted]. See also Wilkey op. at ___ of 176 U.S.App.D.C., at 29-30 of 541 F.2d.

[159] For example, Judge Wright states little weight is to be given the absence of studies documenting actual harm from lead in auto emissions with the observation, among several others, that ". . . lead exposure from the ambient air is pervasive, so that valid control groups cannot be found against which the effects of lead on our population can be measured." Wright op. at ___ of 176 U.S.App.D.C., at 25 of 541 F.2d.

Similarly, Judge Wilkey, in his original panel opinion, discounts the value of a particular study with the observation: "Realistically, it is impossible to say that any definite scientific or medical conclusion can be drawn from the observation of one or two subjects." Panel op. at 51.

I do not know whether or not these observations are valid, although it was my impression that techniques had been devised which minimized these problems in certain cases. Be that as it may, these overt examples of homespun scientific aphorisms indicate that on more subtle, and less visible, matters of scientific judgment we judges are well beyond our institutional competency.

[160] Silver v. New York Stock Exchange, 373 U.S. 341, 366, 83 S.Ct. 1246, 1262, 10 L.Ed.2d 389, 405 (1963).

[161] Environmental Defense Fund, Inc. v. Ruckelshaus, 142 U.S.App.D.C. 74, 88, 439 F.2d 584, 598 (1971) (Bazelon, C. J.).

[162] Wright op. at ___ of 176 U.S.App.D.C., at 24 of 541 F.2d.

This construction of the proper scope of review makes unnecessary Judge Wright's exhaustive analysis of the scientific evidence, which is evidently undertaken to answer those who believe we must judge the technical data for ourselves.

[163] See International Harvester Co. v. Ruckelshaus, supra note 4; Environmental Defense Fund, Inc. v. Ruckelshaus, supra note 9.

[164] See, e. g., Washington Gas Light Co. v. Baker, 88 U.S.App.D.C. 115, 188 F.2d 11, cert. denied, 340 U.S. 952, 71 S.Ct. 571, 95 L.Ed. 686 (1950); Monrote v. Britton, 99 U.S.App.D.C. 128, 131, 237 F.2d 756 (1956); Williams v. Robinson, 139 U.S.App.D.C. 204, 208, 432 F.2d 637 (1970); Environmental Defense Fund, Inc. v. EPA, 150 U.S.App.D.C. 348, 465 F.2d 528 (1972); Citizens Ass'n of Georgetown, Inc. v. Zoning Comm. of D.C., 155 U.S.App.D.C. 233, 477 F.2d 402, 408 (1973).

[165] Amalgamated Meat Cutters & Butcher Workmen v. Connally, 337 F.Supp. 737 (D.D.C., 1971) (3-judge court).

[166] 401 U.S. 402, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971). Citizens to Preserve Overton Park v. Volpe requires the reviewing court to scrutinize the facts and consider whether the agency decision was "based on a consideration of the relevant factors" in the context of nonformalized, discretionary executive decisionmaking. A fortiori, at least that rigor of review should apply to more formal decisionmaking processes like informal rulemaking.

[167] Pacific States Box and Basket Co. v. White, 296 U.S. 176, 56 S.Ct. 159, 80 L.Ed. 138 (1935).

[168] Portland Cement Ass'n v. Ruckelshaus, 158 U.S.App.D.C. 308, 486 F.2d 375 (1973). It should be noted that the court remanded for further proceedings. It refused to vacate and set aside the agency's action, not withstanding motions filed for that specific purpose. This was made a ground for seeking certiorari. Certiorari was denied, 417 U.S. 921, 94 S.Ct. 2628, 41 L.Ed.2d 226 (1974).

[169] See e. g., Judge Wright's opinion in Amoco Oil Co. v. EPA, 163 U.S.App.D.C. 162, 501 F.2d 722 (1974); Judge McGowan's opinion in Industrial Union Dept. v. Hodgson, 162 U.S.App.D.C. 331, 499 F.2d 467 (1974).

[170] In an unreported order, this court directed the EPA to reach a final decision on the matter pending before it and to notify the court of such decision by November 27, 1973. Natural Resources Defense Council v. EPA, No. 72-2233 (D.C.Cir., Oct. 29, 1973).

[171] 5 U.S.C. § 553 (1970) provides:

§ 553. Rule making.

* * * * *

(c) After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation. After consideration of the relevant matter presented, the agency shall incorporate in the rules adopted a concise general statement of their basis and purpose. When rules are required by statute to be made on the record after opportunity for an agency hearing, sections 556 and 557 of this title apply instead of this subsection.

(d) The required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except—

(1) a substantive rule which grants or recognizes an exemption or relieves a restriction;

(2) interpretative rules and statements of policy; or

(3) as otherwise provided by the agency for good cause found and published with the rule.

* * * * * *

[172] See Part I-C of his dissenting opinion.

[173] 42 U.S.C. § 1857f—6c(c)(1)(A) (1970).

[174]

OUTLINE OF OPINION

I. The Three-Year History of EPA's Efforts to Devise Acceptable Regulations (P. ___ of 176 U.S.App.D.C., p. 72 of 541 F.2d)

A. The Regulations and Supporting Health Documents (P. ___ of 176 U.S.App.D.C., p. 72 of 541 F.2d)

B. Adverse Nature of Government Expert Scientific Comment (P. ___ of ___ U.S.App.D.C., p. 73 of 541 F.2d)

C. The Opportunity for Informed Public Comment on the Third Health Document (P. ___ of 176 U.S.App.D.C., p. 78 of 541 F.2d)

1. The extent to which the Administrator relied upon new scientific data, appearing as EPA sponsored for the first time in the Third Health Document, as the basis for the final regulations. (P. ___ of 176 U.S.App.D.C., p. 78 of 541 F.2d)

2. The extent to which interested private parties, some of whom are petitioners here, were given or acquired actual notice of the existence of the scientific studies, were given notice as to which studies were to be relied upon by the Administrator in the Third Health Document, and commented thereon prior to the issuance of the Third Health Document itself. (P. ___ of 176 U.S.App.D.C.p. 82 of 541 F.2d)

II. The Legal Standard (P. ___ of 176 U.S. App.D.C.,p. 94 of 541 F.2d)

A. The Statute—Its Interpretation (P. ___ of 176 U.S.App.D.C., p. 94 of 541 F.2d)

B. Threshold Factual Determination Required (P. ___ of 176 U.S.App.D.C., p. 96 of 541 F.2d)

III. Scope of Review (P. ___ of 176 U.S.App.D.C.p. 97 of 541 F.2d)

IV. The Evidence (P. ___ of 176 U.S.App.D.C., p. 100 of 541 F.2d)

A. This Court's Task (P. ___ of 176 U.S.App.D.C., p. 100 of 541 F.2d)

B. "A small but significant portion of the urban adult population . . . [is] over-exposed to lead." (P. ___ of 176 U.S.App.D.C., p. 101 of 541 F.2d)

1. The 40 ug Demarcation (P. ___ of 176 U.S.App.D.C., p. 101 of 541 F.2d)

2. Over-Exposure in the General Adult Population (P. ___ of 176 U.S.App.D.C., p. 102 of 541 F.2d)

C. "[A]bsorption of air lead does contribute to total lead exposure and when added to lead from other sources . . . results in total exposure that is excessive." (P. ___ of 176 U.S.App.D.C., p. 105 of 541 F.2d)

D. The Contribution of Auto Lead Emissions to Blood Levels in Children—The Speculative Nature of EPA's Determination (P. ___ of 176 U.S.App.D.C., p. 107 of 541 F.2d) V. Conclusion (P. ___ of 176 U.S.App.D.C., p. 110 of 541 F.2d)

Appendix (P. ___ of 176 U.S.App.D.C., 555 of 541 F.2d)

[175] 42 U.S.C. § 1857f—6c(c)(1)(A) (1970).

[176] 163 U.S.App.D.C. 162, 501 F.2d 722 (1974). In the Amoco catalytic converter case we were dealing entirely with un leaded gasoline and the necessity for unleaded gasoline to be used to prevent destruction of the platinum catalytic converter. The Congress and EPA directed unleaded gasoline to be used, not because it had found that leaded gasoline in any quantity was dangerous to human health, but because it had been scientifically established that leaded gasoline would destroy essential elements of the catalytic converter in a very few thousand miles of use. Now this court is concerned with the possible impact of leaded gasoline on human health. This is a matter decided by neither EPA nor this court in Amoco, nor was it decided by Congress when it enacted the legislation.

Unlike the basic facts in Amoco, we have here a situation in which leaded gasoline must necessarily be used in all pre-1975 cars and leaded gasoline may very well be used in many new cars manufactured without the platinum catalytic converter. Some of the parties before us have argued strenuously that the universality of use of the catalytic converter is by no means as certain today as when EPA promulgated its regulation. Other engineering devices to avoid the air pollution of the hydrocarbons, i. e., PNA carcinogenic poisons, may come on the market, and the number of new cars using leaded gasoline increase. Be that as it may, the catalytic converter is a device to take out the PNA carcinogenic elements from gasoline; it is not in any way a device to take out lead.

[177] Those regulations appear at 38 Fed.Reg. 1254 (10 Jan. 1973) and are reproduced in full as an Appendix to the Amoco opinion.

[178] 42 U.S.C. § 1857f—6c(c)(1)(B) (1970).

[179] Petitioners also raise other objections to the regulations which we do not need to reach. See note 194 infra.

[180] 5 U.S.C. § 706(2)(A) & (D) (1970).

[181] The regulations appear at 40 C.F.R. § 80 (1975).

[182] Doc. 7, Appendix to the Briefs [hereinafter App.] at 27 (28 Nov. 1973).

[183] Id. at 30.

[184] Clean Air Act Amendments of 1970, Pub.L.No. 91-604, § 9(a) (31 Dec. 1970).

[185] 42 U.S.C. § 1857f—6(c)(1) (1970).

[186] 36 Fed.Reg. 1486 (30 Jan. 1971).

[187] No. 72-2233 (D.C.Cir., 29 Oct. 1973) (Wright & McGowan, JJ.)

[188] 37 Fed.Reg. 3882 (23 Feb. 1972), App. at 23.

[189] Id.

[190] Doc. 12, App. at 276 (11 April 1972).

[191] Our colleagues chide us for characterizing the views of government agencies besides EPA as "independent" scientific appraisals. Yet the majority is willing to accept a view from HEW they deem somewhat favorable to their position because HEW "shares with EPA responsibility for and scientific expertise in the areas of public and environmental health . . . ." Court's opinion at ___ n.98 of 176 U.S.App.D.C., 47 n.98 of 541 F.2d. We submit that other departments of the Government (e. g., the Departments of Interior, Commerce, and Transportation) share this same responsibility. When Congress created EPA it did not intend for that agency to become the Government's sole spokesman on environmental concerns.

[192] Memorandum from Dr. Edward E. David, Jr., Office of Science and Technology, to Donald E. Crabill, Chief, Natural Resources Programs Division, Office of Management and Budget, 1 Nov. 1972, App. at 2471.

[193] Letter from M. J. Pecora, Under Secretary of the Interior to George P. Schultz, Director, Office of Management and Budget, 14 Feb. 1972, App. at 2501.

In the preface to its report the NAS panel stated that it had "decided to consider biologic effects of lead not necessarily attributable directly to atmospheric sources and not necessarily at levels of exposure as low or as prolonged as those related to general ambient air. Such consideration was necessary because lead attributable to emission and dispersion into general ambient air has no known harmful effects." NAS Report, Doc. 14, App. at 314.

[194] Letter from W. N. Letson, General Counsel, Department of Commerce, to Casper W. Weinberger, Director, Office of Management and Budget, 2 Nov. 1972, App. at 2464.

[195] Letter from Merlin K. DuVal, M.D., Assistant Secretary of Health (HEW), 17 Nov. 1972, App. at 2481.

[196] Environmental Protection Agency is attempting to gather additional health effects information by asking various members of the medical and scientific community to respond to the following questions. All other interested parties are also invited to address these questions:

(1) In the light of any criticisms you may have of the Goldsmith Hexter approach and the Environmental Protection Agency's use of a regression equation based upon it (see Figure 3-3 of "Airborne Lead in Perspective." National Academy of Sciences, 1972, and Table 7 of the "Health Hazards of Lead," Environmental Protection Agency, revised April 11, 1972, which was corrected in "Corrections and Additions to Health Hazards of Lead," April 27, 1972), what are the permissible uses and limitations in its application for obtaining reasonable estimates of blood lead levels as a function of air lead exposures?

(2) How accurate a reflection is blood lead of lead body burden? What is the effect of elevated blood leads upon lead body burden? Can small increments in blood lead be expected to result in a significant lead body burden elevation? From a public health point of view, is it permissible to allow slight increases in lead body burdens among the general population when this increment can be prevented? Can the pool of body lead stored in the bone be viewed as totally "physiologically inert"? It is known that chelation therapy of children with elevated blood leads can result in acute clinical symptoms of lead poisoning as a result of mobilizing lead from bone. Is there any evidence that subtle metabolic changes could also mobilize this lead pool under other conditions?

(3) The Environmental Protection Agency has relied upon the National Academy of Sciences (NAS) Report (Appendix C, p. 249, footnote "a") for estimates of daily respired air by an average adult in its own calculations in Table 7 of the "Health Hazards" paper. How accurate are these estimates of pulmonary physiology (a) that an adult male breathes 23 cubic meters of air per day, (b) that 30 percent of respired lead particles will be retained, and (c) that nearly 100 percent of retained lead particles will be absorbed? Is there additional evidence available in this area besides that which is cited in the NAS Report?

(4) What is an appropriate safety factor for extrapolating industrial threshold limit values (TLV) to the general population? Should such an extrapolation to the general population even be permitted? The proposed TLV for lead is due to be revised to 150 ug./m.3 for a 40-hour week. On a weekly basis, this corresponds to breathing air continually at between 35-40 ug./m.3 of lead. If TLV's can be extrapolated to the general population, what would be an appropriate safety factor for this purpose so that all groups, including those most susceptible to lead will be protected?

(5) In regard to the dustfall lead theory (p. 139 of the NAS Report): How much of a hazard is dustfall lead to children prone to pica? The Environmental Protection Agency's calculations indicate that continued ingestion of even small amounts of lead contaminated dusts and dirt containing as much as 0.25-0.35 percent lead could theoretically result in dangerously elevated blood leads among children, or could contribute significantly to additional unnecessary lead burdens in children with other known lead exposures (such as lead paint). Will the Environmental Protection Agency's proposed 60-65 percent of reduction of leaded auto emissions significantly reduce the risk of this potential contamination?

(6) Although lead paint has traditionally been considered the prime causal factor in childhood lead poisoning, how effective would reductions in other known environmental sources of lead exposure (such as dustfall) be in helping to reduce the risk of undue lead exposure among children also exposed to peeling lead paint? How clear is it that all lead poisoning in children is, in fact, caused only by lead paint? Since many years are required to solve the lead paint problem, would the risk of undue lead absorption and possible lead poisoning not be reduced by also decreasing airborne lead and consequently lead in dust?

(7) What is the consequence upon the environment in general of allowing large quantities of lead to be expelled into the atmosphere from motor vehicle exhausts? Does this environmental contamination pose any direct or indirect threat to man?

37 Fed.Reg. 11786, 11787 (14 June 1972), App. at 21.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK.

[255] John J. Loflin, Jr., argued the cause for appellant. With him on the briefs were J. Lee Rankin and Stanley Buchsbaum.

Lee A. Albert argued the cause for appellees. With him on the brief were Robert Borsody, Martin Garbus, and David Diamond.

Briefs of amici curiae were filed by Solicitor General Griswold, Assistant Attorney General Ruckelshaus, and Robert V. Zener for the United States, and by Victor G. Rosenblum and Daniel Wm. Fessler for the National Institute for Education in Law and Poverty.

MR. JUSTICE BRENNAN delivered the opinion of the Court.

The question for decision is whether a State that terminates public assistance payments to a particular recipient without affording him the opportunity for an evidentiary hearing prior to termination denies the recipient procedural due process in violation of the Due Process Clause of the Fourteenth Amendment.

This action was brought in the District Court for the Southern District of New York by residents of New [256] York City receiving financial aid under the federally assisted program of Aid to Families with Dependent Children (AFDC) or under New York State's general Home Relief program.^[1] Their complaint alleged that the New York State and New York City officials administering these programs terminated, or were about to terminate, such aid without prior notice and hearing, thereby denying them due process of law.^[2] At the time [257] the suits were filed there was no requirement of prior notice or hearing of any kind before termination of financial aid. However, the State and city adopted procedures for notice and hearing after the suits were brought, and the plaintiffs, appellees here, then challenged the constitutional adequacy of those procedures.

The State Commissioner of Social Services amended the State Department of Social Services' Official Regulations to require that local social services officials proposing to discontinue or suspend a recipient's financial aid do so according to a procedure that conforms to either subdivision (a) or subdivision (b) of § 351.26 of the regulations as amended.^[3] The City of New York [258] elected to promulgate a local procedure according to subdivision (b). That subdivision, so far as here pertinent, provides that the local procedure must include the giving of notice to the recipient of the reasons for a proposed discontinuance or suspension at least seven days prior to its effective date, with notice also that upon request the recipient may have the proposal reviewed by a local welfare official holding a position superior to that of the supervisor who approved the proposed discontinuance or suspension, and, further, that the recipient may submit, for purposes of the review, a written statement to demonstrate why his grant should not be discontinued or suspended. The decision by the reviewing official whether to discontinue or suspend aid must be made expeditiously, with written notice of the decision to the recipient. The section further expressly provides that "[a]ssistance shall not be discontinued or suspended prior to the date such notice of decision is sent to the recipient and his representative, if any, or prior to the proposed effective date of discontinuance or suspension, whichever occurs later."

Pursuant to subdivision (b), the New York City Department of Social Services promulgated Procedure No. 68-18. A caseworker who has doubts about the recipient's continued eligibility must first discuss them with the recipient. If the caseworker concludes that the recipient is no longer eligible, he recommends termination [259] of aid to a unit supervisor. If the latter concurs, he sends the recipient a letter stating the reasons for proposing to terminate aid and notifying him that within seven days he may request that a higher official review the record, and may support the request with a written statement prepared personally or with the aid of an attorney or other person. If the reviewing official affirms the determination of ineligibility, aid is stopped immediately and the recipient is informed by letter of the reasons for the action. Appellees' challenge to this procedure emphasizes the absence of any provisions for the personal appearance of the recipient before the reviewing official, for oral presentation of evidence, and for confrontation and cross-examination of adverse witnesses.^[4] However, the letter does inform the recipient that he may request a post-termination "fair hearing."^[5] This is a proceeding before an independent [260] state hearing officer at which the recipient may appear personally, offer oral evidence, confront and cross-examine the witnesses against him, and have a record made of the hearing. If the recipient prevails at the "fair hearing" he is paid all funds erroneously withheld.^[6] HEW Handbook, pt. IV, §§ 6200-6500; 18 NYCRR §§ 84.2-84.23. A recipient whose aid is not restored by a "fair hearing" decision may have judicial review. N. Y. Civil Practice Law and Rules, Art. 78 (1963). The recipient is so notified, 18 NYCRR § 84.16.

I

The constitutional issue to be decided, therefore, is the narrow one whether the Due Process Clause requires that the recipient be afforded an evidentiary hearing before the termination of benefits.^[7] The District Court held [261] that only a pre-termination evidentiary hearing would satisfy the constitutional command, and rejected the argument of the state and city officials that the combination of the post-termination "fair hearing" with the informal pre-termination review disposed of all due process claims. The court said: "While post-termination review is relevant, there is one overpowering fact which controls here. By hypothesis, a welfare recipient is destitute, without funds or assets. . . . Suffice it to say that to cut off a welfare recipient in the face of . . . `brutal need' without a prior hearing of some sort is unconscionable, unless overwhelming considerations justify it." Kelly v. Wyman, 294 F. Supp. 893, 899, 900 (1968). The court rejected the argument that the need to protect the public's tax revenues supplied the requisite "overwhelming consideration." "Against the justified desire to protect public funds must be weighed the individual's over-powering need in this unique situation not to be wrongfully deprived of assistance . . . . While the problem of additional expense must be kept in mind, it does not justify denying a hearing meeting the ordinary standards of due process. Under all the circumstances, we hold that due process requires an adequate hearing before termination of welfare benefits, and the fact that there is a later constitutionally fair proceeding does not alter the result." Id., at 901. Although state officials were party defendants in the action, only the Commissioner of Social Services of the City of New York appealed. We noted probable jurisdiction, 394 U. S. 971 (1969), to decide important issues that have been the subject of disagreement in principle between the three-judge court in the present case and that convened in Wheeler v. Montgomery, No. 14, post, p. 280, also decided today. We affirm.

Appellant does not contend that procedural due process is not applicable to the termination of welfare benefits. [262] Such benefits are a matter of statutory entitlement for persons qualified to receive them.^[8] Their termination involves state action that adjudicates important rights. The constitutional challenge cannot be answered by an argument that public assistance benefits are "a `privilege' and not a `right.' " Shapiro v. Thompson, 394 U. S. 618, 627 n. 6 (1969). Relevant constitutional restraints apply as much to the withdrawal of public assistance benefits as to disqualification for unemployment compensation, Sherbert v. Verner, 374 U. S. 398 (1963); or to denial of a tax exemption, Speiser v. Randall, 357 U. S. 513 (1958); or to discharge from public employment, Slochower v. Board of Higher Education, 350 U. S. 551 (1956).^[9] The extent to which procedural due process [263] must be afforded the recipient is influenced by the extent to which he may be "condemned to suffer grievous loss," Joint Anti-Fascist Refugee Committee v. McGrath, 341 U. S. 123, 168 (1951) (Frankfurter, J., concurring), and depends upon whether the recipient's interest in avoiding that loss outweighs the governmental interest in summary adjudication. Accordingly, as we said in Cafeteria & Restaurant Workers Union v. McElroy, 367 U. S. 886, 895 (1961), "consideration of what procedures due process may require under any given set of circumstances must begin with a determination of the precise nature of the government function involved as well as of the private interest that has been affected by governmental action." See also Hannah v. Larche, 363 U. S. 420, 440, 442 (1960).

It is true, of course, that some governmental benefits may be administratively terminated without affording the recipient a pre-termination evidentiary hearing.^[10] [264] But we agree with the District Court that when welfare is discontinued, only a pre-termination evidentiary hearing provides the recipient with procedural due process. Cf. Sniadach v. Family Finance Corp., 395 U. S. 337 (1969). For qualified recipients, welfare provides the means to obtain essential food, clothing, housing, and medical care.^[11] Cf. Nash v. Florida Industrial Commission, 389 U. S. 235, 239 (1967). Thus the crucial factor in this context—a factor not present in the case of the blacklisted government contractor, the discharged government employee, the taxpayer denied a tax exemption, or virtually anyone else whose governmental entitlements are ended—is that termination of aid pending resolution of a controversy over eligibility may deprive an eligible recipient of the very means by which to live while he waits. Since he lacks independent resources, his situation becomes immediately desperate. His need to concentrate upon finding the means for daily subsistence, in turn, adversely affects his ability to seek redress from the welfare bureaucracy.^[12]

Moreover, important governmental interests are promoted by affording recipients a pre-termination evidentiary hearing. From its founding the Nation's basic [265] commitment has been to foster the dignity and well-being of all persons within its borders. We have come to recognize that forces not within the control of the poor contribute to their poverty.^[13] This perception, against the background of our traditions, has significantly influenced the development of the contemporary public assistance system. Welfare, by meeting the basic demands of subsistence, can help bring within the reach of the poor the same opportunities that are available to others to participate meaningfully in the life of the community. At the same time, welfare guards against the societal malaise that may flow from a widespread sense of unjustified frustration and insecurity. Public assistance, then, is not mere charity, but a means to "promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity." The same governmental interests that counsel the provision of welfare, counsel as well its uninterrupted provision to those eligible to receive it; pre-termination evidentiary hearings are indispensable to that end.

Appellant does not challenge the force of these considerations but argues that they are outweighed by countervailing governmental interests in conserving fiscal and administrative resources. These interests, the argument goes, justify the delay of any evidentiary hearing until after discontinuance of the grants. Summary adjudication protects the public fisc by stopping payments promptly upon discovery of reason to believe that a recipient is no longer eligible. Since most terminations are accepted without challenge, summary adjudication also conserves both the fisc and administrative time and energy by reducing the number of evidentiary hearings actually held.

[266] We agree with the District Court, however, that these governmental interests are not overriding in the welfare context. The requirement of a prior hearing doubtless involves some greater expense, and the benefits paid to ineligible recipients pending decision at the hearing probably cannot be recouped, since these recipients are likely to be judgment-proof. But the State is not without weapons to minimize these increased costs. Much of the drain on fiscal and administrative resources can be reduced by developing procedures for prompt pre-termination hearings and by skillful use of personnel and facilities. Indeed, the very provision for a post-termination evidentiary hearing in New York's Home Relief program is itself cogent evidence that the State recognizes the primacy of the public interest in correct eligibility determinations and therefore in the provision of procedural safeguards. Thus, the interest of the eligible recipient in uninterrupted receipt of public assistance, coupled with the State's interest that his payments not be erroneously terminated, clearly outweighs the State's competing concern to prevent any increase in its fiscal and administrative burdens. As the District Court correctly concluded, "[t]he stakes are simply too high for the welfare recipient, and the possibility for honest error or irritable misjudgment too great, to allow termination of aid without giving the recipient a chance, if he so desires, to be fully informed of the case against him so that he may contest its basis and produce evidence in rebuttal." 294 F. Supp., at 904-905.

II

We also agree with the District Court, however, that the pre-termination hearing need not take the form of a judicial or quasi-judicial trial. We bear in mind that the statutory "fair hearing" will provide the recipient [267] with a full administrative review.^[14] Accordingly, the pre-termination hearing has one function only: to produce an initial determination of the validity of the welfare department's grounds for discontinuance of payments in order to protect a recipient against an erroneous termination of his benefits. Cf. Sniadach v. Family Finance Corp., 395 U. S. 337, 343 (1969) (HARLAN, J., concurring). Thus, a complete record and a comprehensive opinion, which would serve primarily to facilitate judicial review and to guide future decisions, need not be provided at the pre-termination stage. We recognize, too, that both welfare authorities and recipients have an interest in relatively speedy resolution of questions of eligibility, that they are used to dealing with one another informally, and that some welfare departments have very burdensome caseloads. These considerations justify the limitation of the pre-termination hearing to minimum procedural safeguards, adapted to the particular characteristics of welfare recipients, and to the limited nature of the controversies to be resolved. We wish to add that we, no less than the dissenters, recognize the importance of not imposing upon the States or the Federal Government in this developing field of law any procedural requirements beyond those demanded by rudimentary due process.

"The fundamental requisite of due process of law is the opportunity to be heard." Grannis v. Ordean, 234 U. S. 385, 394 (1914). The hearing must be "at a meaningful time and in a meaningful manner." Armstrong v. Manzo, 380 U. S. 545, 552 (1965). In the present context these principles require that a recipient have timely and adequate notice detailing the reasons for a [268] proposed termination, and an effective opportunity to defend by confronting any adverse witnesses and by presenting his own arguments and evidence orally. These rights are important in cases such as those before us, where recipients have challenged proposed terminations as resting on incorrect or misleading factual premises or on misapplication of rules or policies to the facts of particular cases.^[15]

We are not prepared to say that the seven-day notice currently provided by New York City is constitutionally insufficient per se, although there may be cases where fairness would require that a longer time be given. Nor do we see any constitutional deficiency in the content or form of the notice. New York employs both a letter and a personal conference with a caseworker to inform a recipient of the precise questions raised about his continued eligibility. Evidently the recipient is told the legal and factual bases for the Department's doubts. This combination is probably the most effective method of communicating with recipients.

The city's procedures presently do not permit recipients to appear personally with or without counsel before the official who finally determines continued eligibility. Thus a recipient is not permitted to present evidence to that official orally, or to confront or cross-examine adverse witnesses. These omissions are fatal to the constitutional adequacy of the procedures.

The opportunity to be heard must be tailored to the [269] capacities and circumstances of those who are to be heard.^[16] It is not enough that a welfare recipient may present his position to the decision maker in writing or secondhand through his caseworker. Written submissions are an unrealistic option for most recipients, who lack the educational attainment necessary to write effectively and who cannot obtain professional assistance. Moreover, written submissions do not afford the flexibility of oral presentations; they do not permit the recipient to mold his argument to the issues the decision maker appears to regard as important. Particularly where credibility and veracity are at issue, as they must be in many termination proceedings, written submissions are a wholly unsatisfactory basis for decision. The secondhand presentation to the decisionmaker by the caseworker has its own deficiencies; since the caseworker usually gathers the facts upon which the charge of ineligibility rests, the presentation of the recipient's side of the controversy cannot safely be left to him. Therefore a recipient must be allowed to state his position orally. Informal procedures will suffice; in this context due process does not require a particular order of proof or mode of offering evidence. Cf. HEW Handbook, pt. IV, § 6400 (a).

In almost every setting where important decisions turn on questions of fact, due process requires an opportunity to confront and cross-examine adverse witnesses. E. g., ICC v. Louisville & N. R. Co., 227 U. S. 88, 93-94 (1913); Willner v. Committee on Character & Fitness, 373 U. S. 96, 103-104 (1963). What we said in [270] Greene v. McElroy, 360 U. S. 474, 496-497 (1959), is particularly pertinent here:

"Certain principles have remained relatively immutable in our jurisprudence. One of these is that where governmental action seriously injures an individual, and the reasonableness of the action depends on fact findings, the evidence used to prove the Government's case must be disclosed to the individual so that he has an opportunity to show that it is untrue. While this is important in the case of documentary evidence, it is even more important where the evidence consists of the testimony of individuals whose memory might be faulty or who, in fact, might be perjurers or persons motivated by malice, vindictiveness, intolerance, prejudice, or jealousy. We have formalized these protections in the requirements of confrontation and cross-examination. They have ancient roots. They find expression in the Sixth Amendment . . . . This Court has been zealous to protect these rights from erosion. It has spoken out not only in criminal cases, . . . but also in all types of cases where administrative. . . actions were under scrutiny."

Welfare recipients must therefore be given an opportunity to confront and cross-examine the witnesses relied on by the department.

"The right to be heard would be, in many cases, of little avail if it did not comprehend the right to be heard by counsel." Powell v. Alabama, 287 U. S. 45, 68-69 (1932). We do not say that counsel must be provided at the pre-termination hearing, but only that the recipient must be allowed to retain an attorney if he so desires. Counsel can help delineate the issues, present the factual contentions in an orderly manner, conduct cross-examination, and generally safeguard the [271] interests of the recipient. We do not anticipate that this assistance will unduly prolong or otherwise encumber the hearing. Evidently HEW has reached the same conclusion. See 45 CFR § 205.10, 34 Fed. Reg. 1144 (1969); 45 CFR § 220.25, 34 Fed. Reg. 13595 (1969).

Finally, the decisionmaker's conclusion as to a recipient's eligibility must rest solely on the legal rules and evidence adduced at the hearing. Ohio Bell Tel. Co. v. PUC, 301 U. S. 292 (1937); United States v. Abilene & S. R. Co., 265 U. S. 274, 288-289 (1924). To demonstrate compliance with this elementary requirement, the decision maker should state the reasons for his determination and indicate the evidence he relied on, cf. Wichita R. & Light Co. v. PUC, 260 U. S. 48, 57-59 (1922), though his statement need not amount to a full opinion or even formal findings of fact and conclusions of law. And, of course, an impartial decision maker is essential. Cf. In re Murchison, 349 U. S. 133 (1955); Wong Yang Sung v. McGrath, 339 U. S. 33, 45-46 (1950). We agree with the District Court that prior involvement in some aspects of a case will not necessarily bar a welfare official from acting as a decision maker. He should not, however, have participated in making the determination under review.

Affirmed.

[For dissenting opinion of MR. CHIEF JUSTICE BURGER, see post, p. 282.]

[For dissenting opinion of MR. JUSTICE STEWART, see post, p. 285.]

MR. JUSTICE BLACK, dissenting.

In the last half century the United States, along with many, perhaps most, other nations of the world, has moved far toward becoming a welfare state, that is, a nation that for one reason or another taxes its most [272] affluent people to help support, feed, clothe, and shelter its less fortunate citizens. The result is that today more than nine million men, women, and children in the United States receive some kind of state or federally financed public assistance in the form of allowances or gratuities, generally paid them periodically, usually by the week, month, or quarter.^[17] Since these gratuities are paid on the basis of need, the list of recipients is not static, and some people go off the lists and others are added from time to time. These ever-changing lists put a constant administrative burden on government and it certainly could not have reasonably anticipated that this burden would include the additional procedural expense imposed by the Court today.

The dilemma of the ever-increasing poor in the midst of constantly growing affluence presses upon us and must inevitably be met within the framework of our democratic constitutional government, if our system is to survive as such. It was largely to escape just such pressing economic problems and attendant government repression that people from Europe, Asia, and other areas settled this country and formed our Nation. Many of those settlers had personally suffered from persecutions of various kinds and wanted to get away from governments that had unrestrained powers to make life miserable for their citizens. It was for this reason, or so I believe, that on reaching these new lands the early settlers undertook to curb their governments by confining their powers [273] within written boundaries, which eventually became written constitutions.^[18] They wrote their basic charters as nearly as men's collective wisdom could do so as to proclaim to their people and their officials an emphatic command that: "Thus far and no farther shall you go; and where we neither delegate powers to you, nor prohibit your exercise of them, we the people are left free."^[19]

Representatives of the people of the Thirteen Original Colonies spent long, hot months in the summer of 1787 in Philadelphia, Pennsylvania, creating a government of limited powers. They divided it into three departments —Legislative, Judicial, and Executive. The Judicial Department was to have no part whatever in making any laws. In fact proposals looking to vesting some power in the Judiciary to take part in the legislative process and veto laws were offered, considered, and rejected by the Constitutional Convention.^[20] In my [274] judgment there is not one word, phrase, or sentence from the beginning to the end of the Constitution from which it can be inferred that judges were granted any such legislative power. True, Marbury v. Madison, 1 Cranch 137 (1803), held, and properly, I think, that courts must be the final interpreters of the Constitution, and I recognize that the holding can provide an opportunity to slide imperceptibly into constitutional amendment and law making. But when federal judges use this judicial power for legislative purposes, I think they wander out of their field of vested powers and transgress into the area constitutionally assigned to the Congress and the people. That is precisely what I believe the Court is doing in this case. Hence my dissent.

The more than a million names on the relief rolls in New York,^[21] and the more than nine million names on the rolls of all the 50 States were not put there at random. The names are there because state welfare officials believed that those people were eligible for assistance. Probably in the officials' haste to make out the lists many names were put there erroneously in order to alleviate immediate suffering, and undoubtedly some people are drawing relief who are not entitled under the law to do so. Doubtless some draw relief checks from time to time who know they are not eligible, either because they are not actually in need or for some other reason. Many of those who thus draw undeserved gratuities are without sufficient property to enable the government to collect back from them any money they wrongfully receive. But the Court today holds that it would violate the Due Process Clause of the Fourteenth Amendment to stop paying those people weekly or monthly allowances unless the government first affords them a full "evidentiary hearing" even [275] though welfare officials are persuaded that the recipients are not rightfully entitled to receive a penny under the law. In other words, although some recipients might be on the lists for payment wholly because of deliberate fraud on their part, the Court holds that the government is helpless and must continue, until after an evidentiary hearing, to pay money that it does not owe, never has owed, and never could owe. I do not believe there is any provision in our Constitution that should thus paralyze the government's efforts to protect itself against making payments to people who are not entitled to them.

Particularly do I not think that the Fourteenth Amendment should be given such an unnecessarily broad construction. That Amendment came into being primarily to protect Negroes from discrimination, and while some of its language can and does protect others, all know that the chief purpose behind it was to protect ex-slaves. Cf. Adamson v. California, 332 U. S. 46, 71-72, and n. 5 (1947) (dissenting opinion). The Court, however, relies upon the Fourteenth Amendment and in effect says that failure of the government to pay a promised charitable installment to an individual deprives that individual of his own property, in violation of the Due Process Clause of the Fourteenth Amendment. It somewhat strains credulity to say that the government's promise of charity to an individual is property belonging to that individual when the government denies that the individual is honestly entitled to receive such a payment.

I would have little, if any, objection to the majority's decision in this case if it were written as the report of the House Committee on Education and Labor, but as an opinion ostensibly resting on the language of the Constitution I find it woefully deficient. Once the verbiage is pared away it is obvious that this Court today adopts the views of the District Court "that to cut off a welfare recipient in the face of . . . `brutal need' without a prior [276] hearing of some sort is unconscionable," and therefore, says the Court, unconstitutional. The majority reaches this result by a process of weighing "the recipient's interest in avoiding" the termination of welfare benefits against "the governmental interest in summary adjudication." Ante, at 263. Today's balancing act requires a "pre-termination evidentiary hearing," yet there is nothing that indicates what tomorrow's balance will be. Although the majority attempts to bolster its decision with limited quotations from prior cases, it is obvious that today's result does not depend on the language of the Constitution itself or the principles of other decisions, but solely on the collective judgment of the majority as to what would be a fair and humane procedure in this case.

This decision is thus only another variant of the view often expressed by some members of this Court that the Due Process Clause forbids any conduct that a majority of the Court believes "unfair," "indecent," or "shocking to their consciences." See, e. g., Rochin v. California, 342 U. S. 165, 172 (1952). Neither these words nor any like them appear anywhere in the Due Process Clause. If they did, they would leave the majority of Justices free to hold any conduct unconstitutional that they should conclude on their own to be unfair or shocking to them.^[22] Had the drafters of the Due Process Clause meant to leave judges such ambulatory power to declare [277] laws unconstitutional, the chief value of a written constitution, as the Founders saw it, would have been lost. In fact, if that view of due process is correct, the Due Process Clause could easily swallow up all other parts of the Constitution. And truly the Constitution would always be "what the judges say it is" at a given moment, not what the Founders wrote into the document.^[23] A written constitution, designed to guarantee protection against governmental abuses, including those of judges, must have written standards that mean something definite and have an explicit content. I regret very much to be compelled to say that the Court today makes a drastic and dangerous departure from a Constitution written to control and limit the government and the judges and moves toward a constitution designed to be no more and no less than what the judges of a particular social and economic philosophy declare on the one hand to be fair or on the other hand to be shocking and unconscionable.

The procedure required today as a matter of constitutional law finds no precedent in our legal system. Reduced to its simplest terms, the problem in this case is similar to that frequently encountered when two parties have an ongoing legal relationship that requires one party to make periodic payments to the other. Often the situation arises where the party "owing" the money stops paying it and justifies his conduct by arguing that the recipient is not legally entitled to payment. The recipient can, of course, disagree and go to court to compel payment. But I know of no situation in our legal system in which the person alleged to owe money to [278] another is required by law to continue making payments to a judgment-proof claimant without the benefit of any security or bond to insure that these payments can be recovered if he wins his legal argument. Yet today's decision in no way obligates the welfare recipient to pay back any benefits wrongfully received during the pre-termination evidentiary hearings or post any bond, and in all "fairness" it could not do so. These recipients are by definition too poor to post a bond or to repay the benefits that, as the majority assumes, must be spent as received to insure survival.

The Court apparently feels that this decision will benefit the poor and needy. In my judgment the eventual result will be just the opposite. While today's decision requires only an administrative, evidentiary hearing, the inevitable logic of the approach taken will lead to constitutionally imposed, time-consuming delays of a full adversary process of administrative and judicial review. In the next case the welfare recipients are bound to argue that cutting off benefits before judicial review of the agency's decision is also a denial of due process. Since, by hypothesis, termination of aid at that point may still "deprive an eligible recipient of the very means by which to live while he waits," ante, at 264, I would be surprised if the weighing process did not compel the conclusion that termination without full judicial review would be unconscionable. After all, at each step, as the majority seems to feel, the issue is only one of weighing the government's pocketbook against the actual survival of the recipient, and surely that balance must always tip in favor of the individual. Similarly today's decision requires only the opportunity to have the benefit of counsel at the administrative hearing, but it is difficult to believe that the same reasoning process would not require the appointment of counsel, for otherwise the right to counsel is a meaningless one since these [279] people are too poor to hire their own advocates. Cf. Gideon v. Wainwright, 372 U. S. 335, 344 (1963). Thus the end result of today's decision may well be that the government, once it decides to give welfare benefits, cannot reverse that decision until the recipient has had the benefits of full administrative and judicial review, including, of course, the opportunity to present his case to this Court. Since this process will usually entail a delay of several years, the inevitable result of such a constitutionally imposed burden will be that the government will not put a claimant on the rolls initially until it has made an exhaustive investigation to determine his eligibility. While this Court will perhaps have insured that no needy person will be taken off the rolls without a full "due process" proceeding, it will also have insured that many will never get on the rolls, or at least that they will remain destitute during the lengthy proceedings followed to determine initial eligibility.

For the foregoing reasons I dissent from the Court's holding. The operation of a welfare state is a new experiment for our Nation. For this reason, among others, I feel that new experiments in carrying out a welfare program should not be frozen into our constitutional structure. They should be left, as are other legislative determinations, to the Congress and the legislatures that the people elect to make our laws.

[1] AFDC was established by the Social Security Act of 1935, 49 Stat. 627, as amended, 42 U. S. C. §§ 601-610 (1964 ed. and Supp. IV). It is a categorical assistance program supported by federal grants-in-aid but administered by the States according to regulations of the Secretary of Health, Education, and Welfare. See N. Y. Social Welfare Law §§ 343-362 (1966). We considered other aspects of AFDC in King v. Smith, 392 U. S. 309 (1968), and in Shapiro v. Thompson,394 U. S. 618 (1969).

Home Relief is a general assistance program financed and administered solely by New York state and local governments. N. Y. Social Welfare Law §§ 157-165 (1966), since July 1, 1967, Social Services Law §§ 157-166. It assists any person unable to support himself or to secure support from other sources. Id., § 158.

[2] Two suits were brought and consolidated in the District Court. The named plaintiffs were 20 in number, including intervenors. Fourteen had been or were about to be cut off from AFDC, and six from Home Relief. During the course of this litigation most, though not all, of the plaintiffs either received a "fair hearing" (see infra, at 259-260) or were restored to the rolls without a hearing. However, even in many of the cases where payments have been resumed, the underlying questions of eligibility that resulted in the bringing of this suit have not been resolved. For example, Mrs. Altagracia Guzman alleged that she was in danger of losing AFDC payments for failure to cooperate with the City Department of Social Services in suing her estranged husband. She contended that the departmental policy requiring such cooperation was inapplicable to the facts of her case. The record shows that payments to Mrs. Guzman have not been terminated, but there is no indication that the basic dispute over her duty to cooperate has been resolved, or that the alleged danger of termination has been removed. Home Relief payments to Juan DeJesus were terminated because he refused to accept counselling and rehabilitation for drug addiction. Mr. DeJesus maintains that he does not use drugs. His payments were restored the day after his complaint was filed. But there is nothing in the record to indicate that the underlying factual dispute in his case has been settled.

[3] The adoption in February 1968 and the amendment in April of Regulation § 351.26 coincided with or followed several revisions by the Department of Health, Education, and Welfare of its regulations implementing 42 U. S. C. § 602 (a) (4), which is the provision of the Social Security Act that requires a State to afford a "fair hearing" to any recipient of aid under a federally assisted program before termination of his aid becomes final. This requirement is satisfied by a post-termination "fair hearing" under regulations presently in effect. See HEW Handbook of Public Assistance Administration (hereafter HEW Handbook), pt. IV, §§ 6200-6400. A new HEW regulation, 34 Fed. Reg. 1144 (1969), now scheduled to take effect in July 1970, 34 Fed. Reg. 13595 (1969), would require continuation of AFDC payments until the final decision after a "fair hearing" and would give recipients a right to appointed counsel at "fair hearings." 45 CFR § 205.10, 34 Fed. Reg. 1144 (1969); 45 CFR § 220.25, 34 Fed. Reg. 1356 (1969). For the safeguards specified at such "fair hearings" see HEW Handbook, pt. IV, §§ 6200-6400. Another recent regulation now in effect requires a local agency administering AFDC to give "advance notice of questions it has about an individual's eligibility so that a recipient has an opportunity to discuss his situation before receiving formal written notice of reduction in payment or termination of assistance." Id., pt. IV, § 2300 (d) (5). This case presents no issue of the validity or construction of the federal regulations. It is only subdivision (b) of § 351.26 of the New York State regulations and implementing procedure 68-18 of New York City that pose the constitutional question before us. Cf. Shapiro v. Thompson, 394 U. S. 618, 641 (1969). Even assuming that the constitutional question might be avoided in the context of AFDC by construction of the Social Security Act or of the present federal regulations thereunder, or by waiting for the new regulations to become effective, the question must be faced and decided in the context of New York's Home Relief program, to which the procedures also apply.

[4] These omissions contrast with the provisions of subdivision (a) of § 351.26, the validity of which is not at issue in this Court. That subdivision also requires written notification to the recipient at least seven days prior to the proposed effective date of the reasons for the proposed discontinuance or suspension. However, the notification must further advise the recipient that if he makes a request therefore he will be afforded an opportunity to appear at a time and place indicated before the official identified in the notice, who will review his case with him and allow him to present such written and oral evidence as the recipient may have to demonstrate why aid should not be discontinued or suspended. The District Court assumed that subdivision (a) would be construed to afford rights of confrontation and cross-examination and a decision based solely on the record. 294 F. Supp. 893, 906-907 (1968).

[5] N. Y. Social Welfare Law § 353 (2) (1966) provides for a post-termination "fair hearing" pursuant to 42 U. S. C. § 602 (a) (4). See n. 3, supra. Although the District Court noted that HEW had raised some objections to the New York "fair hearing" procedures, 294 F. Supp., at 898 n. 9, these objections are not at issue in this Court. Shortly before this suit was filed, New York State adopted a similar provision for a "fair hearing" in terminations of Home Relief. 18 NYCRR §§ 84.2-84.23. In both AFDC and Home Relief the "fair hearing" must be held within 10 working days of the request, § 84.6, with decision within 12 working days thereafter, § 84.15. It was conceded in oral argument that these time limits are not in fact observed.

[6] Current HEW regulations require the States to make full retroactive payments (with federal matching funds) whenever a "fair hearing" results in a reversal of a termination of assistance. HEW Handbook, pt. IV, §§ 6200 (k), 6300 (g), 6500 (a); see 18 NYCRR § 358.8. Under New York State regulations retroactive payments can also be made, with certain limitations, to correct an erroneous termination discovered before a "fair hearing" has been held. 18 NYCRR § 351.27. HEW regulations also authorize, but do not require, the States to continue AFDC payments without loss of federal matching funds pending completion of a "fair hearing." HEW Handbook, pt. IV, § 6500 (b). The new HEW regulations presently scheduled to become effective July 1, 1970, will supersede all of these provisions. See n. 3, supra.

[7] Appellant does not question the recipient's due process right to evidentiary review after termination. For a general discussion of the provision of an evidentiary hearing prior to termination, see Comment, The Constitutional Minimum for the Termination of Welfare Benefits: The Need for and Requirements of a Prior Hearing, 68 Mich. L. Rev. 112 (1969).

[8]It may be realistic today to regard welfare entitlements as more like "property" than a "gratuity." Much of the existing wealth in this country takes the form of rights that do not fall within traditional common-law concepts of property. It has been aptly noted that

"[s]ociety today is built around entitlement. The automobile dealer has his franchise, the doctor and lawyer their professional licenses, the worker his union membership, contract, and pension rights, the executive his contract and stock options; all are devices to aid security and independence. Many of the most important of these entitlements now flow from government: subsidies to farmers and businessmen, routes for airlines and channels for television stations; long term contracts for defense, space, and education; social security pensions for individuals. Such sources of security, whether private or public, are no longer regarded as luxuries or gratuities; to the recipients they are essentials, fully deserved, and in no sense a form of charity. It is only the poor whose entitlements, although recognized by public policy, have not been effectively enforced." Reich, Individual Rights and Social Welfare: The Emerging Legal Issues, 74 Yale L. J. 1245, 1255 (1965). See also Reich, The New Property, 73 Yale L. J. 733 (1964).

[9] See also Goldsmith v. United States Board of Tax Appeals, 270 U. S. 117 (1926) (right of a certified public accountant to practice before the Board of Tax Appeals); Hornsby v. Allen, 326 F. 2d 605 (C. A. 5th Cir. 1964) (right to obtain a retail liquor store license); Dixon v. Alabama State Board of Education, 294 F. 2d 150 (C. A. 5th Cir.), cert. denied, 368 U. S. 930 (1961) (right to attend a public college).

[10] One Court of Appeals has stated: "In a wide variety of situations, it has long been recognized that where harm to the public is threatened, and the private interest infringed is reasonably deemed to be of less importance, an official body can take summary action pending a later hearing." R. A. Holman & Co. v. SEC, 112 U. S. App. D. C. 43, 47, 299 F. 2d 127, 131, cert. denied, 370 U. S. 911 (1962) (suspension of exemption from stock registration requirement). See also, for example, Ewing v. Mytinger & Casselberry, Inc., 339 U. S. 594 (1950) (seizure of mislabeled vitamin product); North American Cold Storage Co. v. Chicago, 211 U. S. 306 (1908) (seizure of food not fit for human use); Yakus v. United States, 321 U. S. 414 (1944) (adoption of wartime price regulations); Gonzalez v. Freeman, 118 U. S. App. D. C. 180, 334 F. 2d 570 (1964) (disqualification of a contractor to do business with the Government). In Cafeteria & Restaurant Workers Union v. McElroy, supra, at 896, summary dismissal of a public employee was upheld because "[i]n [its] proprietary military capacity, the Federal Government. . . has traditionally exercised unfettered control," and because the case involved the Government's "dispatch of its own internal affairs." Cf. Perkins v. Lukens Steel Co., 310 U. S. 113 (1940).

[11] Administrative determination that a person is ineligible for welfare may also render him ineligible for participation in state-financed medical programs. See N. Y. Social Welfare Law § 366 (1966).

[12] His impaired adversary position is particularly telling in light of the welfare bureaucracy's difficulties in reaching correct decisions on eligibility. See Comment, Due Process and the Right to a Prior Hearing in Welfare Cases, 37 Ford. L. Rev. 604, 610-611 (1969).

[13] See, e. g., Reich, supra, n. 8, 74 Yale L. J., at 1255.

[14] Due process does not, of course, require two hearings. If, for example, a State simply wishes to continue benefits until after a "fair" hearing there will be no need for a preliminary hearing.

[15] This case presents no question requiring our determination whether due process requires only an opportunity for written submission, or an opportunity both for written submission and oral argument, where there are no factual issues in dispute or where the application of the rule of law is not intertwined with factual issues. See FCC v. WJR, 337 U. S. 265, 275-277 (1949).

[16] "[T]he prosecution of an appeal demands a degree of security, awareness, tenacity, and ability which few dependent people have." Wedemeyer & Moore, The American Welfare System, 54 Calif. L. Rev. 326, 342 (1966).

[17] This figure includes all recipients of Old-age Assistance, Aid to Families with Dependent Children, Aid to the Blind, Aid to the Permanently and Totally Disabled, and general assistance. In this case appellants are AFDC and general assistance recipients. In New York State alone there are 951,000 AFDC recipients and 108,000 on general assistance. In the Nation as a whole the comparable figures are 6,080,000 and 391,000. U. S. Bureau of the Census, Statistical Abstract of the United States: 1969 (90th ed.), Table 435, p. 297.

[18] The goal of a written constitution with fixed limits on governmental power had long been desired. Prior to our colonial constitutions, the closest man had come to realizing this goal was the political movement of the Levellers in England in the 1640's. J. Frank, The Levellers (1955). In 1647 the Levellers proposed the adoption of An Agreement of the People which set forth written limitations on the English Government. This proposal contained many of the ideas which later were incorporated in the constitutions of this Nation. Id., at 135-147.

[19]This command is expressed in the Tenth Amendment:

"The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

[20] It was proposed that members of the judicial branch would sit on a Council of Revision which would consider legislation and have the power to veto it. This proposal was rejected. J. Elliot, 1 Elliot's Debates 160, 164, 214 (Journal of the Federal Convention); 395, 398 (Yates' Minutes); vol. 5, pp. 151, 164-166, 344-349 (Madison's Notes) (Lippincott ed. 1876). It was also suggested that The Chief Justice would serve as a member of the President's executive council, but this proposal was similarly rejected. Id., vol. 5, pp. 442, 445, 446, 462.

[21] See n. 1, supra.

[22] I am aware that some feel that the process employed in reaching today's decision is not dependent on the individual views of the Justices involved, but is a mere objective search for the "collective conscience of mankind," but in my view that description is only a euphemism for an individual's judgment. Judges are as human as anyone and as likely as others to see the world through their own eyes and find the "collective conscience" remarkably similar to their own. Cf. Griswold v. Connecticut, 381 U. S. 479, 518-519 (1965) (BLACK, J., dissenting); Sniadach v. Family Finance Corp., 395 U. S. 337, 350-351 (1969) (BLACK, J., dissenting).

[23] To realize how uncertain a standard of "fundamental fairness" would be, one has only to reflect for a moment on the possible disagreement if the "fairness" of the procedure in this case were propounded to the head of the National Welfare Rights Organization, the president of the national Chamber of Commerce, and the chairman of the John Birch Society.