622 F.2d 157 (1980)

[158] Eric M. Blumberg, Stephen D. Terman, Food and Drug Adm., Rockville, Md., Robert Wiggers, John J. Powers, III, App. Section, Antitrust Div., Dept. of Justice, Washington, D.C., for Patricia Roberts Harris.

Robert T. Lasky, Susan A. Elliott, Washington, D.C., for plaintiffs-appellants.

Before WISDOM, POLITZ and SAM D. JOHNSON, Circuit Judges.

WISDOM, Circuit Judge:

This appeal poses the question whether mercury in the tissues of swordfish is an "added substance" within the meaning of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a)(1) (1975) (FDA), and is, therefore, subject to regulation under the relaxed standard appropriate to added substances. Only part of that mercury has been added by man.

In April 1977, the United States sought an injunction against Anderson Seafoods, Inc., and its president, Charles F. Anderson, to prevent them from selling swordfish containing more than 0.5 parts per million (ppm) of mercury, which it considered adulterated under the meaning of § 342(a)(1) of the FDA. Anderson responded in May 1977 by seeking a declaratory judgment that fish containing 2.0 ppm of mercury or less are not adulterated. Anderson also sought an injunction against the Food and Drug Administration commensurate with the declaratory judgment. Anderson's suit was certified as a class action, and these suits were consolidated for trial.

The district court denied the injunction that the government sought. In Anderson's suit, the court also denied an injunction, but issued a declaratory judgment that [159] swordfish containing more than 1.0 ppm mercury is adulterated under § 342(a)(1). In doing so, the court determined that mercury is an "added substance" under the Act and rejected Anderson's contention that a level of 2.0 ppm is acceptable. Anderson appealed from the judgment in the class action. The government appealed from the judgment in its enforcement action and cross-appealed in the class action. The government then withdrew its appeal and cross-appeal. This appeal now consists of Anderson's challenge to the way the district court parsed the statute and to the sufficiency of the evidence. We affirm.

I.

Section 342(a)(1) of the Act provides:

A food shall be deemed to be adulterated —(a)(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.

21 U.S.C. § 342(a)(1).

The Act does not define "added substance". Whether a substance is added or not is important because of the evidentiary showing that the Food and Drug Administration must make to succeed in an enforcement action. If a substance is deemed "added", then the Agency need show only that it "may render [the food] injurious to health" in order to regulate consumption of the food containing the substance. The "may render" standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer. See United States v. Lexington Mill & Elevator Co., 1914, 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658; Berger v. United States, 8 Cir.1952, 200 F.2d 818, 821. If, however, a substance is considered "not-added", the Agency must go further, and show that the substance would "ordinarily render [the food] injurious to health", 21 U.S.C. § 342(a)(1), before it can regulate its consumption.

In the trial of this case three theories about the meaning of the term "added" emerged. The Food and Drug Administration sponsored the first theory. It argues that an "added substance" is one that is not "inherent". According to FDA regulations:

(c) A "naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An "added poisonous or deleterious substance" is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. §§ 109.3(c), (d) (1977). Under this theory, all the mercury in swordfish is an added substance, because it results not from the creature's bodily processes but from mercury in the environment, whether natural or introduced by man.

Anderson put forward a second theory. A substance, under this theory, is not an added substance unless it is proved to be present as a result of the direct agency of man. Further, only that amount of a substance the lineage of which can be so traced is "added". If some mercury in swordfish occurs naturally, and some is the result of man-made pollution, only that percentage of the mercury in fish proved to result directly from pollution is an added substance.

The district court adopted a third theory. Under the court's theory, if a de minimis amount of the mercury in swordfish is shown to result from industrial pollution, then all of the metal in the fish is treated as an added substance and may be regulated under the statute's "may render injurious" standard. The legislative history and case law, though sparse, persuade us that this is the proper reading of the statute.

[160] The distinction between added and not-added substances comes from the "adulterated food" provisions of the original Food, Drug, and Cosmetic Act of 1906, ch. 3915, 34 Stat. 768. The legislative history shows that "added" meant attributable to acts of man, and "not-added" meant attributable to events of nature. See H.R.Rep.No. 2118, 59th Cong., 1st Sess. 6, 7, 11 (1906) (quoted in United States v. Coca Cola, 1915, 241 U.S. 265, 282-83, 36 S.Ct. 573, 578-79, 60 L.Ed. 995 ("deleterious substances added by man"); 40 Cong.Rec. 1133 (Jan. 16, 1906) ("human action") (remarks by Sen. Heyburn). That the distinction was carried through to the present Act is shown by its legislative history. S.Rep.No. 493, 73rd Cong., 2d Sess. 3 (1934) ("added by man or put there by nature ... introduced by artifice or [occurring] naturally").

The Supreme Court drew the same distinction in United States v. Coca Cola, 1915, 241 U.S. 265, 36 S.Ct. 573, 60 L.Ed. 995. Construing the "added ... ingredient" provisions of the 1906 Act, the Court said:

Congress, we think, referred to ingredients artificially introduced; these are described as `added.' The addition might be made to a natural food product or to a compound ... we think that it was the intention of Congress that the artificial introduction of ingredients of a poisonous or deleterious character which might render the article injurious to health should cause the prohibition of the statute to attach.

241 U.S. at 284, 36 S.Ct. at 579.

The Food and Drug Administration argues that there need not be any connection between man's acts and the presence of a contaminant for it to be considered an added substance. The Agency points to the rule it recently promulgated interpreting § 342(a)(1), quoted above, which defines an added substance as one which is not "an inherent natural constituent of the food", but is instead the "result of an environmental, agricultural, industrial, or other contamination". 21 C.F.R. §§ 109.3(c), (d) (1977). Under the rule, mercury in swordfish tissue deriving from the mercury naturally dissolved in sea water would be an added substance, as would any substance not produced by or essential for the life processes of the food organism. In light of the legislative history and the Coca Cola case, however, we agree with the district court that the term "added" as used in § 342(a)(1) means artificially introduced, or attributable in some degree to the acts of man. 447 F.Supp. 1151, 1155.

The Food and Drug Administration finds further support for its view in several cases in which the courts refer to not-added substances under the Act as "inherent". In Continental Chemiste Corp. v. Ruckelshaus, 9 Cir.1972, 461 F.2d 331, 337, and Certified Color Ind. Committee v. Secretary of HEW, 2 Cir.1956, 236 F.2d 866, 869, however, the courts were not defining the statutory term "added substance". That they referred to not-added substances as being inherent does not mean that all non-inherent substances are added. These cases are consistent with the proposition that some non-inherent substances, present in a food organism but unconnected to man's acts, are not-added substances under the Act. A final case, United States v. An Article of Food Consisting of Cartons of Swordfish, S.D.N.Y., 1975, 395 F.Supp. 1184, reads the Act to mean that any material obtained from the environment is an added substance. As the district court pointed out, "FDA has not urged this rather extreme position upon the court and the ruling, contrary to the legislative history of the Act and the language of the Supreme Court, is not persuasive authority." 447 F.Supp. at 1155.

Determining that man must appear on the stage before a substance is an added one does not determine the size of the role he must play before it is. The dichotomy in § 342(a)(1) is between two clear cases that bracket the present case. The Act considers added things such as lead in coloring agents or caffeine in Coca Cola. It considers not-added things like oxalic acid in rhubarb or caffeine in coffee. The Act did not contemplate, however, the perhaps rare problem of a toxin, part of which occurs [161] "naturally", and part of which results from human acts. The section is designed, of course, to insure the scrutiny of toxins introduced by man. As Senator Heyburn said of the 1906 Act:

Suppose you would say if there is poison in [a food] already it cannot do much harm to put in more. Suppose commercial cupidity should tempt someone to add to the dormant poison that is in a hundred things that we consume everyday, are they to be permitted to do it? This bill says they shall not do it.

40 Cong.Rec. 2758 (1906).

Anderson argues that when a toxin derives in part from man and in part from nature, only that part for which man is responsible may be considered added and so regulated under the "may render injurious" standard. In such a case, however, neither the statute nor FDA regulations suggest that the amount of an added toxic substance be quantified and shown to have a toxic effect of its own if the total amount of the substance in a food is sufficient to render the food potentially hazardous to health. It may be possible—as in this case—to prove that man introduced some percentage of a toxin into a food organism, but difficult or impossible to prove that percentage.

Since the purpose of the "may render injurious" standard was to facilitate regulation of food adulterated by acts of man, we think that it should apply to all of a toxic substance present in a food when any of that substance is shown to have been introduced by man. Anderson argues that this reading of the statute would result "in the anomalous situation where a substance in a food can be 90 percent natural and 10 percent added if the entire substance is considered as added". There is no anomaly, however, in such a situation. The Act's "may render it injurious to health" standard is to be applied to the food, not to the added substance. The food would not be considered adulterated under our view unless the 10 percent increment creates or increases a potentiality of injury to health. If the increment does create or increase such a potentiality, then, because the increment that triggered the potentiality was introduced by man, the Food and Drug Administration ought to be able to regulate it under the standard designed to apply to adulterations of food caused by man. Anderson's argument proves too much. Anderson would argue that if a swordfish contained 0.99 ppm of natural mercury, and 0.99 ppm of mercury from human sources, the fish could be sold although it contained nearly twice as much mercury as the district court found to be a safe level. Such a reading of the statute hardly accords with its "overriding purpose to protect the public health". United States v. Bacto-Unidisk, 1969, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726. The reading we have adopted does accord with this purpose. It may be severe in practice. It may permit the Food and Drug Administration to regulate in some cases where the amount of substance contributed by man—which triggers the potentiality of harm—is minute. But it is the only alternative that fits into the statutory scheme. Congress should amend the statute if our reading produces impracticable results.^[1]

In sum, we hold that where some portion of a toxin present in a food has been introduced by man, the entirety of that substance present in the food will be treated as an added substance and so considered under the "may render injurious to health" standard of the Act.

II.

In addition to its attack on the way the district court parsed the statute, Anderson raises a subsidiary argument. There was insufficient evidence to support the conclusion that man's acts contributed "substantial amounts" of mercury to the tissues of swordfish. And, indeed, the court did not find that the amounts were substantial, but rather that they were unknown and perhaps [162] unquantifiable. Under our reading of the statute, however, the amount of mercury that man contributes need not be "substantial". The FDA need show only that some portion of the mercury is attributable to acts of man, and that the total amount may be injurious to health.

There was sufficient evidence to show that some mercury is attributable to the acts of man. There was evidence that mercury is dumped into rivers and washes onto the continental shelf, where some of it is methylated by bacteria and taken up by plankton. It thereby enters the food chain of swordfish, for the plankton is consumed by small organisms and fish, such as copepods, herring, and hake, which are in turn eaten by larger organisms, and eventually by swordfish, a peak predator. This evidence was enough to trigger the Act's "may render injurious to health" standard.

III.

The district court set 1.0 ppm as the health limit for mercury in swordfish. It noted that the decision was:

based only on the scientific and empirical data accepted into evidence in these cases. It may be that further studies will reveal the decisions here made were based on erroneous or insufficient data.

447 F.Supp. at 1160. We noted above that the government withdrew its appeal and cross-appeal. It is apparently considering new evidence to determine whether its present action level should be reaffirmed or changed. Our decision does not engrave the district court's 1.0 ppm level in administrative stone. While the government may not now prevent the sale of swordfish containing 1.0 ppm or less of mercury, the durability of our order is founded on the evidence the district court accepted.

The order of the district court is AFFIRMED.

[1] For a review of the policy arguments favoring less regulation, see Note, Health Regulation of Naturally Hazardous Foods: The FDA Ban on Swordfish, 85 Harv.L.Rev. 1025 (1972).

674 F.2d 38 (1982)

[39] Joseph A. Artabane, Washington, D. C., with whom Robert T. Lasky and Joseph Ingrisano, Washington, D. C., were on the brief, for appellants.

Eric M. Blumberg, Associate Chief Counsel, Food and Drug Administration, Rockville, Md., with whom Jeffrey B. Springer, Acting Chief Counsel, Food and Drug Administration, Rockville, Md., John J. Powers, III and Daniel J. Conway, Attys., Dept. of Justice, Washington, D. C., were on the brief, for appellees. Charles F. C. Ruff, U. S. Atty., Washington, D. C., at the time the briefs were filed, Kenneth M. Raisler, Patricia J. Kenney and Royce C. Lamberth, Asst. U. S. Attys., Washington, D. C., also entered appearances, for appellees.

Before BAZELON, Senior Circuit Judge, and TAMM and EDWARDS, Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge BAZELON.

BAZELON, Senior Circuit Judge:

We must decide whether the Food and Drug Administration (FDA) acted lawfully in concluding that Indian shrimp contaminated with poisonous bacteria was "adulterated" within the meaning of the Food, [40] Drug and Cosmetic Act (FDCA or Act). The district court answered yes. We affirm.

I.

The Act permits the FDA to prohibit the importation of food that "appears" to be adulterated.^[1] In defining "adulterated," the Act focuses on the origin and dangers of "poisonous or deleterious substance[s]" in the food.^[2] When such substances are "added" to the food, the food is adulterated if the substance "may render it injurious to health."^[3] When, on the other hand, the substance is not added, the food is considered adulterated only if the substance would "ordinarily render it injurious to health."^[4]

Beginning in late 1978, the FDA observed that a significant proportion of shrimp arriving from India contained salmonella. Without proper cooking and storage, food containing that bacteria can cause salmonellosis, a communicable disease that produces a number of serious bodily impairments and sometimes results in death.^[5] After officials of the Indian government acknowledged that insanitary processing facilities were responsible for the high rate of contamination of Indian shrimp, the FDA decided to sample all such shrimp arriving in the United States.^[6]

In the spring of 1979, appellants offered two lots of raw, frozen Indian shrimp for import into the United States. The FDA sampled the shrimp and discovered salmonella in both lots. The importers each received a Notice of Detention and Hearing stating that the lots of shrimp would be refused admission because they "appear[] to contain a poisonous deleterious substance (Salmonella species)."^[7] Appellants were afforded a hearing at which they tried to show that the shipments were not adulterated. After reviewing the evidence offered by the importers, the FDA issued a Notice of Refusal of Admission. The Notice said [41] that the shrimp appeared to be adulterated and ordered the lots destroyed unless they were exported within ninety days. Appellants received permission to retain the shrimp in frozen storage pending the outcome of this litigation.

In their complaint in the district court, appellants contended that the import prohibition (1) was based on an incorrect interpretation of the Act's standard for "adulterated," (2) was unsupported by evidence in the record, and (3) reflected discriminatory treatment of shrimp in comparison to other foods. Based on a review of affidavits, expert testimony, and prior authority,^[8] the district court rejected all three arguments and granted summary judgment in favor of the FDA.

II.

Appellants concede that the two lots of shrimp at issue contain salmonella. The FDA, in turn, acknowledges that salmonella is not "ordinarily injurious" since its dangers can be averted through proper cooking and storage. The only issue before us,^[9] then, is whether the FDA properly concluded that the shrimp met the more relaxed standard of adulteration for "added" substances. Specifically, we must evaluate the FDA's determinations that (A) salmonella was "added" to the Indian shrimp, and (B) that the bacteria "may render" the shrimp unhealthy.^[10]

A. Is salmonella "added" to shrimp?

Appellants argue that this question was conclusively answered in the negative by our decision in American Public Health Association v. Butz ("APHA"), 511 F.2d 331 (D.C.Cir.1974). The plaintiffs in that case contended that inspection labels placed on domestic meat and poultry products by the Secretary of Agriculture were misleading since they failed to warn about the salmonella often found in those products. The court noted that inspection labels could be misleading under the Wholesome Meat Act if salmonella constituted adulteration within the meaning of that statute. Assuming that salmonella "may be inherent in the meat," the court commented: "[W]e think that the presence of salmonella in meat does not constitute adulteration within [the Wholesome Meat Acts'] definition." Id. at 334. Appellants claim this remark amounted to a judicial determination that salmonella does not adulterate food.

The observation in APHA on which appellants rely consists of dictum uttered in a different legal and factual context. The issue presented by that case was whether the inspection labels were misleading, not whether the food was adulterated. In upholding the Secretary, the court relied on its view that consumers understand the importance of proper storage and cooking of meat and poultry as well as its conclusion that Congress did not intend "microscopic examination[s]" of domestic food products by the Department of Agriculture. Id. at [42] 334-35. The court offered no evidentiary support for its additional suggestion that salmonella may not be "added" to meat. Moreover, the court's assumption about the inherent qualities of meat and poultry obviously do not bind the FDA's evaluation of shrimp.^[11] Finally, while the statutes involved in APHA define adulteration in terms similar to the FDCA,^[12] the government enjoys substantially greater discretion in preventing the import of apparently adulterated foods than it does in labelling domestic products.^[13]

Accordingly, we must determine whether the FDA's conclusion that salmonella is an "added" substance in shrimp is consistent with the provisions of the FDCA. The parties urge different interpretations of the word "added." A regulation promulgated by the FDA in 1977 defines the word to include any substance that is not an inherent, natural constituent of the food.^[14] Appellants, on the other hand, argue that "added" describes only those substances which are present due to human intervention. Citing cases that have employed that definition,^[15] appellants contend that the FDA was required to demonstrate that human intervention introduced salmonella to the shrimp at issue here. The district court declined to resolve this definitional dispute. Instead, the court held that the FDA could have deemed the salmonella "added" under either standard.

Appellants' contention that "added" refers only to substances introduced by humans was recently adopted by the Fifth Circuit in United States v. Anderson Seafoods, Inc., 622 F.2d 157 (1980). The court there concluded that the more relaxed standard for adulteration "should apply to all of a toxic substance present in a food when any of that substance is shown to have been introduced by man." Id. at 161. The court further held that a showing of human intervention could be based on general scientific knowledge about the origin of the additive in question. See id. at 162. Anderson Seafoods thus implicitly rejected the notion advanced by appellants here that the FDA must demonstrate human intervention with respect to the particular articles of food it wishes to regulate. We reject the argument explicitly. In light of the FDA's [43] broad authority to prohibit import of any food that "appears" to be adulterated, the agency need not prove that substances present in a particular lot were introduced by man.^[16]

We agree with the district court that the FDA's decision in this case satisfied appellants' definition of "added" as elaborated in Anderson Seafoods. The evidence offered by both parties indicated that salmonella in shrimp can result from human acts and can frequently be attributed to insanitary processing procedures.^[17] The FDA had ample reason to believe that the salmonella frequently observed in Indian shrimp in 1978 and 1979 resulted from insanitary conditions. Representatives of the Indian government acknowledged to the FDA that the salmonella contamination was a result of unclean handling.^[18] And several months before the administrative hearing in this case, FDA officials visited processing facilities in India and determined the nature of conditions there first hand. The district court described what the delegation saw:

[T]he delegation observed unscreened, fly-infested processing areas; inadequate icing of shrimp subjected to temperatures in excess of 90° F.; the placement of porous shrimp-holding pans on heavily-travelled floors; and the use of pitted and cracked work surfaces covered with the residue of fecal matter from previously processed frogs. At a shrimp landing area, FDA officials observed hundreds of people, mostly barefoot and dressed in soiled clothing, milling around the dock where the shrimp were unloaded; poor icing of shrimp; and the use of bamboo baskets, which are virtually impossible to sanitize, to collect shrimp.^[19]

Together with the FDA's understanding of the cause of salmonella in shrimp generally, these observations provided more than enough support for the agency's conclusions that the bacteria had been at least partly introduced by man.

B. Did the FDA show that salmonella "may render" shrimp unhealthy?

Appellants claim the evidence does not support the FDA's determination that salmonella "may render [shrimp] injurious to health." This complaint is groundless. The record indicates that ingestion of even small amounts of the bacteria can cause serious cases of food poisoning in some people.^[20] Appellants do not dispute the medical evidence; indeed, their own expert witness confirmed the danger.^[21] Instead, they rely on (1) the fact that few, if any, cases of salmonellosis traced to shrimp have been reported and (2) their expectation that consumers will properly cook and store the shrimp and thus prevent contraction of the disease.

The FDA offered several reasonable explanations for the low number of reported cases of salmonellosis from shrimp: The [44] sources of information on which appellants rely report only a small proportion of salmonella cases; reporting of "home episodes" is rare; specific cases may often be attributed to the wrong sources; and shrimp products are consumed in much smaller quantities than other foods which may contain salmonella.^[22] These explanations were supported by the record and adopted by the district court.^[23] Accordingly, we agree with the court that the "absence of documentation does not foreclose the [FDA's] discretion to determine that salmonella in shrimp may be injurious to the health of those who consume it."^[24]

Nor are we comforted by appellants' sanguine assurances that consumers will properly cook and store the shrimp. The FDA has authority to ban contaminated articles from import notwithstanding promises that the deleterious condition will be corrected. See United States v. 52 Drums of Maple Syrup, 110 F.2d 914, 915 (2d Cir. 1940). Moreover, there was evidence in the record that many people either do not cook shrimp properly^[25] or, like the patrons of Japanese restaurants, eat it raw.^[26] Under these circumstances, the FDA was well within its authority in concluding that salmonella "may render" shrimp injurious to health.

Affirmed.

[1] Section 801(a) of the Act, 21 U.S.C. § 381(a) (1976) provides in pertinent part:

The Secretary of Treasury shall deliver to the Secretary of Health, Education, and Welfare, upon his request, samples of food ... which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health, Education, and Welfare and have the right to introduce testimony.... If it appears from the examination of such samples or otherwise that ... such article is adulterated ... then such article shall be refused admission ....

[Emphasis added.]

[2] Section 402 of the Act, 21 U.S.C. § 342 (1976) provides:

A food shall be deemed to be adulterated —

(a)(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health....

[3] 21 U.S.C. § 342(a)(1) (1976) (emphasis added). See note 2 supra.

[4] 21 U.S.C. § 342(a)(1) (1976) (emphasis added). See note 2 supra.

[5] The report of the FDA Salmonella Task Force, introduced in the record by the importers, described some of the effects of salmonellosis:

The syndromes can be a diarrhea, a severe enteritis, a typhoidal picture (fever), septicemia and meningitis. In generalized infections the microorganism may localize in any tissue of the body, producing abscesses, endocarditis, pneumonia and kidney impairment.

Joint Appendix (J.A.) 81. According to one study, there are about 2,000,000 human cases of salmonellosis each year in the United States. The study calls the illness "one of the most important communicable disease problems in the United States today." National Academy of Sciences, An Evaluation of the Salmonella Problem (Report of the U.S. Dept. of Agriculture and the FDA) 6 (1969), reprinted at J.A. 71.

[6] Unless otherwise noted, the facts are undisputed and are taken from the district court's opinion, Seabrook International Foods, Inc. v. Harris, 501 F.Supp. 1086, 1088-89 (D.D.C.1980) ("D.Ct.Op.").

[7] The plaintiffs in the district court included a third importer, Seabrook International Foods, Inc., whose lot of shrimp was seized at about the same time as appellants'. See J.A. 231. Seabrook has voluntarily dismissed its appeal.

[8] In determining the basis for the FDA's actions, the district court relied on affidavits of officials involved in the decisionmaking. The importers did not object to this procedure or to the district court's examination of "the full record before the agency at the time the agency decision was made" in evaluating the informal adjudication at issue. D.Ct.Op. at 1089 n.1. See Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420, 91 S.Ct. 814, 825, 28 L.Ed.2d 136 (1971).

[9] Appellants do not challenge the propriety of the procedures employed by the FDA in reaching its decision. See D.Ct.Op. at 1090.

[10] Appellants also argue that APHA v. Butz, infra, prohibits the FDA from singling out one type of food for regulation. See 511 F.2d at 333. The FDA's action here, they contend, violated that prohibition by focusing only on imported shrimp. As we discuss below, however, APHA concerns the government's authority to label domestic products and not its power to ban foods offered for import. As the district court noted, "foreign products must of necessity be regulated differently from domestic products, because foreign processing facilities cannot be inspected by U.S. authorities." D.Ct.Op. at 1093. The FDA's action was within its long-established authority to treat imported goods differently from domestic ones. Compare 21 U.S.C. § 381(a) (1976), supra note 1, with id. § 334(a)(1) (requiring condemnation proceeding in district court before seizure of domestic foods). See Sugarman v. Forbragd, 405 F.2d 1189 (9th Cir. 1968), cert. denied, 395 U.S. 960, 89 S.Ct. 2103, 23 L.Ed.2d 747 (1969).

[11] The relevant sections of the FDCA clearly contemplate a particularized inquiry into the type of food at issue and the nature and origin of the poisonous substance. See notes 1 & 2 supra. Courts must defer to the expertise of the agency charged with exercising Congress' broad power to bar articles from import. See Sugarman v. Forbragd, 405 F.2d 1189 (9th Cir. 1968), cert. denied, 395 U.S. 960, 89 S.Ct. 2103, 23 L.Ed.2d 747 (1969). See also Board of Trustees of University of Illinois v. United States, 289 U.S. 48, 57, 53 S.Ct. 509, 77 L.Ed. 1025 (1933).

[12] Compare Poultry Products Act § 4, 21 U.S.C. § 453(g)(1) and Wholesome Meat Act § 1, 21 U.S.C. § 601(m)(1) with FDCA § 402, 21 U.S.C. § 342(a).

[13] See note 10 & text accompanying note 1 supra.

[14] The regulations define the relevant phrases in section 402 of the Act as follows:

(c) A "naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An "added poisonous or deleterious substance" is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. § 109.3 (1977). The FDA states that under its "`inherent' test, a substance is `added' to a food if its presence therein is attributable to man or, if the substance is not an inherent, natural constituent of the food." Brief for Appellees at 17 n.13 (emphasis in original). Since we conclude that the FDA has a sufficient basis for determining that salmonella is at least partly "attributable to man," we need not decide whether the agency could apply the more relaxed standard of adulteration to foods which contain dangerous substances due to unusual acts of nature. See p. 43 infra.

[15] E.g., United States v. Coca Cola Co. of Atlanta, 241 U.S. 265, 284, 36 S.Ct. 573, 579, 60 L.Ed. 995 (1916); United States v. Anderson Seafoods, Inc., 622 F.2d 157, 160 (5th Cir. 1980).

[16] See also Sugarman v. Forbragd, 267 F.Supp. 817, 824 (N.D.Cal.1967), aff'd, 405 F.2d 1189 (9th Cir. 1968), cert. denied, 395 U.S. 960, 89 S.Ct. 2103, 23 L.Ed.2d 747 (1969); Church of Scientology of California v. Richardson, 437 F.2d 214, 217 (9th Cir. 1971).

[17] See, e.g., J.A. 40-41 (plaintiffs' expert testifies that salmonella is introduced to shrimp through waters contaminated, for example, by fecal matter; notes that water far from land is not generally contaminated); id. at 75 (National Academy of Sciences publication, supra note 5, states that "[s]almonellae are not known to be indigenous" in seafoods); id. at 175-76 (FDA official testifies that "[s]everal countries routinely export salmonella-free shrimp to the United States" and that "when salmonella[e] are found in seafood, including shrimp, their presence is almost always attributable to insanitary and improper processing procedures"); id. at 251 (defendants' expert states that salmonella does not ordinarily occur in shrimp and is usually caused by "insanitary handling and/or processing practices or harvesting from polluted waters").

[18] J.A. 174.

[19] D.Ct.Op. at 1088.

[20] J.A. 72, 252.

[21] J.A. 91.

[22] See, e.g., J.A. 44, 74, 94, 129.

[23] D.Ct.Op. at 1092.

[24] Id.

[25] E.g., J.A. 73. See also J.A. 79, 95-98.

[26] See J.A. 214-24.

590 F.2d 149 (1979)

[150] Denver L. Rampey, U. S. Atty., Richard E. Nettum, Asst. U. S. Atty., Macon, Ga., Charles H. Johnson, Asst. Chief Counsel for Enforcement, Richard M. Cooper, Chief Counsel, Stuart M. Pape, Associate Chief Counsel for Foods, Food & Drug Administration, Rockville, Md., William D. Coston, Barry Grossman, John H. Shenefield, Asst. Atty. Gen., Dept. of Justice, Washington, D. C., for the U. S.

Harry J. Altman, II, Thomasville, Ga., for defendants-appellees.

Before GEWIN, COLEMAN and GOLDBERG, Circuit Judges.

GOLDBERG, Circuit Judge:

Not often does this Court deal with disputes in which the judgment is easier to pronounce than the name of the matter in controversy, but this is such a case. Our problem involves aflatoxin, a metabolic by-product of the polysyllabic mold aspergillus flavus, but our solution is a by-product of monosyllabic words and logic.

Boston Farm Center, appellee, is a grain distributor in Boston, Georgia. On November 22, 1977, the United States, appellant, applied for an injunction under section 302 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332(a), (the "Act"), seeking to halt the Center's interstate shipment of corn containing more than 20 parts per billion (ppb) of the substance aflatoxin.

Section 301(a) prohibits the interstate shipment of "adulterated" food. Adulterated food is defined as, among other things, food containing "any poisonous or deleterious substance which may render it injurious to health." 21 U.S.C. § 342(a)(1). The lower court issued a preliminary injunction against the Center, but enjoined only the Center's interstate shipment of corn containing more than 100 ppb of aflatoxin. The United States appealed the judgment of the lower court arguing that the injunction threshold should be set at the 20 ppb level it requested.

[151] The 20 ppb level proposed by the Government is the Food and Drug Administration's "action level" for aflatoxin in corn. An action level, to be defined properly, must be explained in the broader context of the FDA's general regulatory scheme. In implementing the Act, the FDA either may adopt formal regulations, 21 U.S.C. § 346, or may litigate alleged violations on a case-by-case basis. Although the Act makes illegal any amount of substance which "may render (food) injurious to health" 21 U.S.C. § 342(a)(1) the FDA is not required to seek to enjoin, prosecute or otherwise litigate "minor violations" of the Act. 21 U.S.C. § 336. To guide its prosecutorial discretion in the bringing of non-rule enforcements of the Act the FDA may establish certain in-house guidelines called action levels. Since 1969 the action level for aflatoxin in corn has been 20 ppb. This means that since 1969 the FDA's internal policy has been to try to prevent the shipment of corn containing more than 20 ppb of aflatoxin, but not of corn containing 20 ppb or less.

The FDA argues that the court should defer to this action level because it represents the expert, technical judgment of the agency. The government argues in its brief that, "[a]lthough not a regulation, an action level represents the agency's considered judgment as to the level of a contaminant that can be permitted in food without significant risk to public health or to the fitness of food for consumption." In essence, the government implies with such terms as "the agency's considered judgment" that a court should defer to an action level much as it defers to an agency regulation. Indeed, some cases approach this position. See e. g., U. S. v. 484 Bags, More or Less, 423 F.2d 839, 842 (5th Cir. 1970), and Dean Rubber Manufacturing Co. v. U. S., 356 F.2d 161 (8th Cir. 1966). We accept this argument for deference to the agency but only up to a point. The deference principle is less compelling when the agency threshold is a matter of prosecutorial discretion instead of rule-making. Congress requires considerably more fact-finding due process, most especially full notice and comment, in agency rule-making than in agency prosecutorial discretion.^[1] The fuller rule-making due process serves the purposes of accuracy and fairness. When an agency proceeds in non-rule case-by-case adjudication, much of the fact-finding process is shifted to the courts. The purposes of accuracy and fairness require that the courts not slavishly defer to the agency's in house prosecutorial guidelines arrived at without benefit of even minimal due process protections. At the extreme, the deference argument in this context sets up the blocking for an end run by the agency of the procedural checks in the statute for formal rule-making.

Nevertheless, in this circuit we have evolved a policy of considerable deference to agency action levels. Thus, in U. S. v. 484 Bags, More or Less, 423 F.2d 839, 842 (5th Cir. 1970), we wrote: [The District Court]

may accept as a judicial standard the allowable tolerances now permitted by the Secretary, whether published or not. A court may apply a stricter standard than the Secretary and hold a food substance adulterated though within the Secretary's tolerances. Considering the positive command of the statute, the power of the court to allow a greater departure from purity than the administrative tolerances is less certain.

We need not decide in this case "the power of the Court to allow a greater departure from purity than the administrative tolerance" because we find that the facts in this case are so one-sided that any finding of non-adulteration for amounts of aflatoxin between 20 ppb and 100 ppb would be clearly erroneous. Thus, even if the court were to afford no deference whatsoever to the action level set by the agency—that is, even if the court were to make a wholly independent decision as to whether the Boston [152] Farm corn was adulterated—it would still be clearly erroneous on this record to find that amounts of aflatoxin between 20 and 100 ppb do not adulterate corn. Only one expert testified before the lower court on the potential hazardousness of aflatoxin. That expert, Dr. Rodricks, testified that "there is no known level of exposure which can be considered safe, without risk to people." (Transcript, p. 29.) Dr. Rodricks cited numerous studies to support this expert opinion, including one showing the adverse effects of aflatoxin in doses as low as 15 ppb. (Tr. 25, Govt. exhibit 2, paragraph 5(b)). In addition, Dr. Rodricks testified that aflatoxin accumulates in body tissue. Thus, without statistics showing the amount of long term consumption of corn by livestock and by humans, it makes little sense to draw any bright line between doses of aflatoxin which "may" render food injurious to health and doses which are not possibly dangerous.^[2]

Aside from Dr. Rodricks' expert testimony, there was no other evidence in this record on the question of the potential harmfulness of aflatoxin. Appellees presented no evidence on the question and did not elicit from Dr. Rodricks during cross-examination any contradictory evidence on this question. Certainly there is no evidence in the Record to support the Court's assertion that "there is controversy concerning the validity of this determination, it being contended by some that injury to health is not likely unless the content exceeds approximately 400 parts per billion (ppb)."^[3]

As a result, we find the lower court was clearly erroneous in finding that amounts of aflatoxin between 20 and 100 ppb do not render corn adulterated.^[4]

We want to emphasize the limited nature of our ruling today. To an extent the statutory scheme permits the FDA to adopt a relatively ad hoc case-by-case approach to [153] regulating the poisons in our food. The statute does not demand rigid and permanent fixity in the numbers game, mainly because our social policies and scientific knowledge about dangerous food are not themselves steady and static. As scientific research and measurement progress, the digits and integers of thresholds, action levels, and tolerances will necessarily change with them. But, in this case the expert evidence is uncontradicted than 20 ppb of aflatoxin may render corn harmful. Other days and other records may yield other figures, but in this case, with this evidence, only one result is possible. The court must enjoin the corn containing more than 20 ppb of aflatoxin.

We remand to the lower court for it to enter an injunction prohibiting Boston Farms from shipping interstate any corn from the 1977 season containing more than 20 ppb aflatoxin.

REVERSED and REMANDED.

[1] For example, FDA regulations state that the agency may take regulatory action "any time after an action level is established and need not await publication of the notice." 21 C.F.R. § 109.4(b)(2). See also 21 C.F.R. § 509.4(b)(2). And see U. S. v. 484 Bags, More or Less, 423 F.2d 839 (5th Cir. 1970) (action level not yet published when litigation initiated).

[2] At best one might make distinctions on the basis of "public interest" policies, but Congress has vested such discretion in the Secretary. 21 U.S.C. § 336.

[3] Appellees argue that the 20 ppb threshold is an arbitrary figure set by the FDA solely because it is the smallest amount of aflatoxin that can be measured. But the Record shows that the FDA kept the level at 20 ppb even after it was able to measure lower amounts. Unrebutted evidence in the Record shows that the FDA could identify aflatoxin at levels of 1-5 ppb as early as 1973, (Govt. Exhibit 2, ¶ 6) and that the agency lowered the level for peanuts to 15 ppb in 1974. 39 Fed.Reg. 42748 (December 6, 1974). Moreover, it is not clear why setting a threshold at the lowest measurable amount of a poison considered dangerous in any amount is improper or irrational.

[4] Two other arguments raised by the parties should be discussed briefly.

First, appellees argue that this appeal of an order concerning only corn harvested in 1977 should be dismissed on grounds of mootness. The argument fails on two grounds. There is no evidence in this Record indicating that Boston Farm Center has disposed of all its corn from the 1977 season. And even if Boston Farm had disposed of that corn this case presents a classic example of the controversy that is "capable of repetition, yet evading review"—a common exception to the mootness doctrine. Southern Pacific Terminal Co. v. Interstate Commerce Commission, 219 U.S. 498, 515, 31 S.Ct. 279, 55 L.Ed. 310 (1911). See also Roe v. Wade, 410 U.S. 113, 124-125, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973).

Second, appellants argue that the lower court applied the wrong test in defining "adulterated" food. Specifically, appellants point to the following statement in the Court's opinion: "[C]orn containing an aflatoxin level of less than 100 ppb does not contain a deleterious substance to the degree which would render it injurious to health and, therefore [is] generally acceptable for interstate shipment." (emphasis added). The government argues that this sentence indicates the court limited its injunction on the basis of a "would render" test instead of the "may render" test established in § 342(a)(1): Food is adulterated if it "contains any poisonous or deleterious substance which may render it injurious to health." (emphasis added) However, we note that earlier in its opinion the lower court twice correctly quoted § 342 and its "may render" test. The later use of the word "would" in a single conclusory sentence does not necessarily mean that the court did not use the correct § 342 test which it explicitly stated twice before a few paragraphs above. In any case, we do not have to decide this question because we hold that, based on the evidence in the record, it would be clearly erroneous to find that corn containing between 20 and 100 ppb aflatoxin is not adulterated. Thus, the lower court must be reversed whether or not it applied the "may render" test.

179 F.Supp.2d 30 (2001)

[31] [32] [33] Charles S. Kleinberg, United States Attorney's Office, Civil Division, Brooklyn, NY, Allison M. Harnisch, Office of Consumer Litigation, U.S. Dept. of Justice, Washington, DC, for plaintiff.

Russell K. Statman, Plattsburgh, NY, for defendants.

MEMORANDUM AND ORDER

SIFTON, Senior District Judge.

The United States brings this action for injunction against defendants Blue Ribbon Smoked Fish, Inc. ("Blue Ribbon"), Jay A. Suttenberg ("Suttenberg"), Pablo Negron ("Negron"), and Susan Dozortsev ("Dozortsev") (collectively, the "defendants") under 21 U.S.C. § 332(a), the Federal Food, Drug and Cosmetic Act (the "Act" or "FDCA"). Specifically, the United States seeks to enjoin the defendants from violating 21 U.S.C. § 331(a) and (k) by introducing into interstate commerce food (1) that is adulterated within the meaning of the Act or (2) that will become adulterated after shipment.

Defendants Suttenberg, Negron, and Dozortsev (collectively, the "individual defendants") move pursuant to Fed.R.Civ.P. 12(b)(6) to dismiss the complaint against them in their individual capacities. The United States moves pursuant to Fed. R.Civ.P. 56 for summary judgment in its favor, enjoining the defendants from further violations of the FDCA on the ground that there are no material issues in dispute.

For the reasons set forth below, the individual defendants' motion is denied, and the United States' motion is granted.

BACKGROUND

The following facts are taken from the parties' submissions in connection with the present motions and are undisputed except as noted. For the purpose of the individual defendants' motion to dismiss the complaint, I assume the facts alleged in the complaint to be true. I will not consider any matters outside the pleadings submitted by either party and will not treat the individual defendants' motion as one for summary judgment. See Fed.R.Civ.P. 12(b)(6). For the purpose of plaintiff's motion for summary judgment, I assume that all uncontroverted Rule 56.1 factual assertions are not disputed. See Titan Indemnity Co. v. Triborough Bridge & Tunnel Authority, 135 F.3d 831, 835 (2d Cir.1998).

Blue Ribbon, a New York corporation, is engaged in preparing, processing, holding, and distributing a variety of seafood products, including brined fish, hot- and [34] cold-smoked fish products, and seafood salads. It's facility is located at 5901 Foster Avenue, Brooklyn, New York (the "plant"). All three individual defendants work at the plant, are co-owners of Blue Ribbon, and are corporate officers responsible for plant operations. Suttenberg is president and co-owner of Blue Ribbon with ultimate authority over the plant's operations. According to the complaint, his responsibilities include food processing, plant sanitation, product distribution, and implementation of Hazard Analysis Critical Control Point ("HACCP") plans necessary for controlling food safety hazards.^[1] Negron is vice president and co-owner of Blue Ribbon. He was previously Blue Ribbon's president, and as vice president he supervises the day-to-day operations of the plant, which includes overseeing the processing of the seafood, as well as the processes of fish thawing, brining, and smoking. Dozortsev is the secretary and treasurer of Blue Ribbon and a co-owner. Her duties, like those of Negron, include supervising the day-to-day operations of the plant, including overseeing the processing of the seafood, preparing HACCP plans, and monitoring sanitation controls.

Plaintiff alleges that the U.S. Food and Drug Administration ("FDA") and the New York State Department of Agriculture and Markets ("NYSDAM") have documented, throughout the last seven years, insanitary conditions at the facility as well as defendants' failure to establish and implement adequate HACCP plans necessary to control food safety hazards. The FDA and the NYSDAM have documented (1) numerous insanitary conditions at the plant; (2) defendant's failure to implement appropriate HACCP plans; and (3) the presence of Listeria Monocytogenes ("L.monocytogenes"), a bacteria that causes disease, in certain smoked fish products and in the plant environment.

Proper HACCP Plans

Seafood processors are required to establish and implement HACCP plans pursuant to 21 C.F.R. § 123.6(b). HACCP is a management system designed to prevent the occurrence of potential food safety problems. According to FDA regulations, a processor of fish and fishery products is required to assess biological, chemical, and physical hazards at all stages of processing, from production of the raw materials, to procurement and handling, manufacturing, distribution and consumption of the finished products. After assessing the health and safety risks that each particular food presents, the processor must determine necessary steps to control the identified risks. 21 C.F.R. § 123.6(a) & (b). A specific analysis must be done for each fish or fishery product, unless the food safety hazards, critical control points, critical limits, and procedures to be followed are identical for two or more fish products. 21 C.F.R. § 123.6(b)(2). The processor is then required to document these analyses in HACCP plans, as well as keep records to document the monitoring of the actual values and observations obtained when fish processing. 21 C.F.R. § 123.6(c)(7).

During the August 2000 inspection, the FDA found that Blue Ribbon failed to comply with FDA regulations regarding HACCP plans. According to the FDA's Establishment Inspection Report ("EIR"), the inspection team noted that "the firm lacked a written HACCP plan, a process schedule, and process monitoring records for a lot of brined and dried salmon pieces, removed from bones, used to produce a batch of cream cheese & lox." Blue Ribbon [35] recalled this lot of cream cheese and lox^[2] and promised to correct the HACCP deficiencies. In the follow-up inspection of January 2001, the FDA's EIR again noted HACCP deficiencies, stating, in part:

The firm processes cold smoked Nova Salmon with an incomplete written HACCP Plan, incomplete Monitoring Records and Verification Procedures that do not document the accuracy of temperature measuring devices or Salometers used in the brining operation. There is no verification of raw materials (incoming fish) containing levels of microorganisms that will not produce food poisoning or other disease in humans, and the firm operates with inadequate HACCP controls. There is no written HACCP Plans for Nova Salmon Bits (produced from pieces of salmon removed from bones) or smoked Sea Bass.

The EIR detailed the specific deficiencies that the inspection team observed in the HACCP plans. The following problems were identified with the cold smoked Nova salmon HACCP plan: the plan was signed but not dated, as required by 21 C.F.R. 123.6(d); it erroneously listed scombrotoxin formation as a food safety hazard relating to salmon production; there was no critical limit for internal fish temperature; no time was specified for thawing frozen fish; no procedure was included for monitoring brine solution or fish temperature during brining; it was inconsistent with the firm's written procedure for brining;^[3] there was no procedure to check the accuracy of thermometers, salometers, thermostats; and there was inadequate monitoring of critical control points. The EIR also detailed the lack of HACCP plans for Nova salmon bits and noted that this deficiency had been brought to Blue Ribbon's attention during the August 2000 inspection. It was also observed that Blue Ribbon did not have a written HACCP plan for smoked sea bass. These deficiencies were discussed with Suttenberg and Dozortsev.

Defendants do not dispute the FDA findings that the HACCP plans were inadequate or non-existent at the time of these inspections. The defendants maintain that, as of now, Blue Ribbon has implemented an effective HACCP plan, which the company now follows.

Insanitary Plant Conditions

Inspections of the plant were conducted in 1994, 1995, 1996, 1999, 2000, and 2001. According to Jerome G. Woyshner, Director, Investigations Branch, New York District, Northeast Region of the FDA, Department of Health and Human Services ("Woyshner"), the FDA conducted the most recent plant inspection from January 17 to 26, 2001. The January 2001 inspection revealed the following insanitary conditions: old seafood product residue on food contact surfaces; mold in the cooler, freezer, and ceiling of the slicing and packing room; a plastic dividing curtain that touched the floor and came into contact with fish; liquid dripping onto seafood [36] from other seafood stored above; and old dripping product residue on the walls and fan shrouds in the cold smoking/drying room. The inspection found the inadequate cleaning and sanitizing processes, including a failure to adequately sanitize and wash cutting boards, knives, and slicing machine. The inspection also revealed employees touching unclean surfaces and then touching ready-to-eat fish without sanitizing their gloves, wearing street cloths in the processing areas without protective coverings, eating and drinking in the processing areas, inadequate hand washing and sanitizing, and wearing of unrestrained hair and beards. The FDA also found that the plant's construction was not designed to prevent bacterial contamination and filth and that there were inadequate doors or barriers between the slicing and packing room and the garage and toilet, lack of control over foot traffic and product flow to prevent cross-contamination of the finished ready-to-eat product and that surfaces were in disrepair making adequate cleaning impossible.

In August 2000, the FDA conducted two inspections and found insanitary plant conditions. For instance, the ceiling in the processing room was in disrepair and rusted; condensation was dripping from the ceiling into uncovered tanks of brining fish; dried encrusted food residue was observed in processing and packing areas; and used, stained boxes for receiving raw fish were stacked on top of the table in the packing area and on top of a refrigerator. On January 12, 2000, the NYSDAM issued a final determination, based on various inspections and product sampling, revoking Blue Ribbon's food processing establishment license. After subsequent satisfactory testing and sampling by NYSDAM, Blue Ribbon was reissued its license. A joint inspection conducted by the FDA and NYSDAM in October 1999 observed an employee drop a fish on the floor that then continued to be processed, a piece of cardboard and plastic tubing hanging into a brining tank, and the ceiling in disrepair and rusted. Earlier inspections in 1994, 1995, and 1996 found similar insanitary conditions and poor employee practices.^[4]

Defendants do not dispute that the insanitary conditions observed by the FDA existed during the prior seven years of documented inspections. Defendants allege, however, that, since Suttenberg became president of Blue Ribbon on August 24, 2000, conditions at Blue Ribbon have improved. After the January 2001 inspection, Suttenberg wrote to the FDA outlining thirty corrective actions that Blue Ribbon would take to correct the conditions that had been observed. According to Suttenberg, Blue Ribbon has upgraded its physical plant, a wall has been constructed segregating the slicing area, seams in the cold smoking room were sealed and repaired, and the cutting table was replaced with a seamless frame unit. Plant walls were reinforced, and a new thermometer was installed to ensure the accuracy of existing thermostats that monitor fish temperatures. In addition, Suttenberg states that all cooler and freezer doors were painted and are scrubbed daily to keep them clean. Sanitary footpads are [37] placed at all entry points into the plant. Restrooms have been moved, new tile installed, and walls have been constructed to isolate the restrooms from the processing areas. Blue Ribbon has also designated an employee to be responsible for supervising sanitation.

Presence of L. Monocytogenes

During inspections of the plant, the FDA found instances of L. monocytogenes contamination in seafood products and in the plant environment. According to the government, L. monocytogenes is a bacterium that causes the disease listeriosis, and food contaminated with this bacterium is harmful to human health. Listeriosis can be serious and even fatal for high-risk groups such as infants, the elderly, pregnant women, and those with impaired immune systems. The most serious consequence of infections in susceptible individuals is septicemia, a condition in which bacteria enter the bloodstream and multiply, thereby poisoning the bloodstream. Complications in pregnant women include miscarriage, stillbirth, bacteria in the bloodstream of the newborn, and meningitis. In other susceptible children and adults, complications commonly include problems with the central nervous system, pneumonia, endocarditis, localized abscesses, skin lesions, and conjunctivitis. Although listeriosis can be treated with antimicrobial drugs, it can be fatal, and for susceptible individuals who become infected, the mortality rate is between 20 and 30 percent.

In recognition of the health risk associated with listeriosis, the FDA has adopted a "zero-tolerance" policy with regard to L. monocytogenes and has established procedures for fish processors to follow to eliminate and control its presence in food. According to the government's expert, Mary E. Losikoff, FDA Consumer Safety Officer, a processor must test incoming raw materials for the presence of the bacteria, implement and follow strict sanitation measures, conduct environmental monitoring, and implement testing of the finished product. These steps are required particularly in the processing of cold-smoked fish, which are not subjected to heat sufficient to eliminate L. monocytogenes. In addition, as discussed above, a processor must have and follow HACCP plans.

Defendants dispute the seriousness of the risk that small amounts of L. monocytogenes poses to human health. They note that the bacteria does not ordinarily present a risk to healthy individuals, noting that the United Nations Food and Agriculture Organization ("UNFAO") records the incidence of disease associated with the bacteria as of approximately two to ten cases per million people and that epidemiological studies show a 1 in 59 million chance of infection from a 50 gram serving of fish containing 100 bacteria per gram. While L. monocytogenes is frequently found in fish, there have been few instances of listeriosis from fish products. At least one group of researchers has stated that "[l]isteria contaminated fish products should not represent a serious impact on human health."

FDA inspections at the plant revealed the presence of L. monocytogenes in food samples and in the plant environment. During the January 2001 inspection, FDA analysis revealed the bacteria in a sample of Nova salmon bits and in floor drains in a processing area of the plant. During the August 2000 inspection, FDA analysis revealed the presence of L. monocytogenes in a sample of sliced smoked Nova salmon and a sample of cream cheese and lox, as well as on the plant floor near the brining cooler. The NYSDAM inspection at the same time found samples of whitefish salad and smoked baked salmon salad contaminated with L. monocytogenes. On the basis [38] of the FDA and NYSDAM findings in August 2000, Blue Ribbon recalled implicated lots of cream cheese and lox, frozen sliced Nova salmon, frozen deli-cut Nova boards, smoked whitefish salad, and smoked basked salmon salad. During the October 1999 joint inspection by the FDA and NYSDAM, samples of whitefish salad and smoked sable were contaminated with L. monocytogenes, as well as the cleaning room floor. In November 1999, Blue Ribbon recalled fish lots that were found to be contaminated. The FDA and NYSDAM found similarly contaminated food and plant environment samples in September 1999, November 1996, November 1995, and January 1994.

Defendants do not dispute that the FDA and NYSDAM found L. monocytogenes in food samples and in the plant. The defendants dispute that Blue Ribbon caused the contamination and suggest that L. monocytogenes is widely present in the environment, occurs naturally on raw fish, and is a problem faced by every fish processing facility, not just Blue Ribbon. Defendants point to a 1997 FDA study which found that 17.5 percent of cold-smoked fish products sampled nationwide between 1991 and 1995 tested positive for L. monocytogenes. That study found L. monocytogenes in ten of sixteen New York smoked fish processing plants. Other studies and surveys indicate that the FDA study was not an anomaly: a survey of vacuum-packed processed meats in retail stores found 53 percent of samples contaminated with the bacteria; vegetables have been found contaminated with the bacteria; and another study of food samples in the United Kingdom found an incidence rate of 6 percent. One article states that, once bacteria has contaminated the fish, contamination during subsequent processing becomes almost impossible to control, even with stringent sanitation procedures in place. Recalls of contaminated fish are not infrequent, and according to the UNFAO, between 1987 and 1992 there were 970 recalls of ready-to-eat foods from 109 firms in the United States.

In addition to occurring naturally in some raw fish, defendants also argue that it is impossible to prevent the presence of some amount of L. monocytogenes bacteria on cold-smoked fish. Lox, for example, is produced by the cold-smoking process and is not prepared by being subjected to sufficient heat to destroy L. monocytogenes. Rather, smoked salmon subjected to sufficient heat would not be recognized by consumers as lox. In light of this, defendants dispute that the FDA's "zero-tolerance" with respect to L. monocytogenes policy is appropriate. The UNFAO has taken the position that "[a]pplying a strict zero tolerance policy for this organism would effectively put a number of products out of the market, such as pre-cooked shrimp and smoked fish." Many European countries and Canada have set tolerance levels graduated with the health risk posed by the contamination.

Furthermore, defendants dispute that there are ongoing problems of L. monocytogenes contamination at the plant. NYSDAM tested Blue Ribbon samples on April 2, 2001, April 30, 2001, May 10, 2001, June 6, 2001, and August 21, 2001. NYSDAM did not notify the defendants of any contamination.

Proposed Judgment Ordering Permanent Injunction

The United States has proposed terms of a permanent injunction to be entered should it prevail on its motion for summary judgment and defendants are found to have violated Sections 331(a) and 331(k) of the FDCA. First, defendants and all directors, officers, agents, representatives, employees, successors, assigns, attorneys, and any and all persons in active concert [39] with the defendants would be permanently restrained from the processing, preparing, packing, holding, and distributing of food at the plant or at any other locations unless and until certain conditions are met. These conditions include the following:

(1) Defendants must thoroughly clean and sanitize the plant and make certain structural changes to prevent condensation from dripping onto food;

(2) Defendants must select a person, other than an employee of Blue Ribbon, to act as a "Listeria expert" who is qualified to develop a testing program, a Sanitation Standard Operation Procedure ("SSOP"), employee training procedures, and a monitoring protocol, to detect, prevent, and control the introduction and spread of L. monocytogenes in the plant environment and in the raw ingredients and processed food products, especially for food products that will not receive a heat process (like cold smoked fish products);

(3) The United States Food and Drug Administration ("USDA") must approve the raw ingredient testing and treatment program, SSOP, training program, and monitoring program developed by the Listeria expert;

(4) Defendants must, under FDA supervision and by a method detailed by the proposed permanent injunction,^[5] examine all lots of smoked and brined fishery products on hand at the plant for L. monocytogenes;

(5) For any fish or fishery products for which there is no HACCP plan, defendants must conduct a hazard analysis and develop a plan, which is to be approved by the FDA; and

(6) Prior to resuming operations, the FDA must notify defendants in writing that they are in compliance with all requirements set forth by the proposed injunction and 21 C.F.R. Parts 110 and 123.^[6]

Once defendants meet the above conditions and the FDA certifies that the defendants are in compliance with the requirements of 21 C.F.R. Pts. 110 and 123, the plant may resume operations, subject to additional conditions. These conditions require that the defendants implement and maintain a protocol to control the presence of L. monocytogenes. The protocol must include a program for treatment or testing of susceptible raw materials for food products, such as cold-brined or cold-smoked fish that do not receive a heat treatment sufficient to kill the bacteria. Similarly, the protocol must include effective and diligent sanitation procedures, environmental monitoring, and additional controls to monitor the finished product after processing. The FDA will be permitted to inspect the plant, without prior notice to defendants, to ensure continuing compliance with the permanent injunction. Pursuant to the proposed injunction, this inspection authority would be apart from, [40] and in addition to, the FDA's authority to inspect, granted by 21 U.S.C. § 374.

By the terms of the proposed injunction, in the event that the defendants and/or their agents violate Section 331(a) or (k) of the FDCA, defendants shall immediately cease the processing, preparing, packing, holding, and distributing of food. Likewise, defendants must cease production if the FDA notifies them in writing that any article of food at the plant is adulterated, that there appear to be insanitary conditions at the plant, or that the defendants are not in compliance with the terms of the injunction, FDA regulations, or the FDCA. If the FDA deems it necessary, the defendants must also recall all articles of their products, and all costs of such a recall must be borne by the defendants. In the event that the FDA requires defendants to cease production, they may not resume until the FDA certifies that the defendants are in compliance with the terms of the injunction, FDA regulations, and the FDCA.

The proposed injunction provides that all decisions specified shall be vested in the discretion of the FDA and that the decisions will be final, subject only to review by this Court under the arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A). No discovery may be had by either party. The United States as plaintiff shall recover the costs of the present action, including attorneys fees, and the costs of any subsequent action necessary to enforce the terms of the injunction, should it prevail.

DISCUSSION

This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331 and 21 U.S.C. § 332, the latter providing district courts with jurisdiction, for cause shown, to restrain violations of 21 U.S.C. § 331.

Individual Defendants' Motion to Dismiss

The individual defendants assert that the present action against them for an injunction is improper because they are distinct from Blue Ribbon, which is the corporate entity that should be the sole focus of the government's injunction, and because the complaint does not state a claim against them. A motion under Rule 12(b)(6) should be granted only if "`it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.'" Cohen v. Koenig, 25 F.3d 1168, 1172 (2d Cir.1994) (quoting Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). "The court's function on a Rule 12(b)(6) motion is not to weigh the evidence that might be presented at trial but merely to determine whether the complaint itself is legally sufficient." Goldman v. Belden, 754 F.2d 1059, 1067 (2d Cir.1985).

The Supreme Court has established that "the public interest in the purity of its food is so great as to warrant the imposition of the highest standard of care on distributors." United States v. Park, 421 U.S. 658, 671, 95 S.Ct. 1903, 44 L.Ed.2d 489 (1975) (citations and internal quotation marks omitted). Food processing companies, and not consumers, are best positioned to protect public health: "Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless." United States v. Dotterweich, 320 U.S. 277, 285, 64 S.Ct. 134, 88 L.Ed. 48 (1943). The responsibility rests on the corporate entities, as well as its agents, and as such the FDA's statutory authority empowers the government to seek relief [41] against executives, as well as legal entities, in enforcement action. See United States v. Undetermined Quantities of Articles of Drug, 145 F.Supp.2d 692, 694 (D.Md.2001) (citing Park, 421 U.S. at 672, 95 S.Ct. 1903). "[C]orporate agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act bear a `responsible relationship' to, or have a `responsible share' in, violations." Park, 421 U.S. at 672, 95 S.Ct. 1903.

Thus, to state a claim against the individual defendants, the government must allege in the complaint that Suttenberg, Negron, and Dozortsev had responsible relationships to, or responsible shares in, the furtherance of the transactions outlawed by the Act.

According to the complaint, Suttenberg is Blue Ribbon's president with "ultimate authority" and is "in charge of overall operations of Blue Ribbon." Negron is Blue Ribbon's vice president and "manages and supervises day-to-day operations of the firm, including food processing, product thawing, brining, and smoking processes." Dozortsev is secretary and treasurer and "manages and supervises day-to-day operations of the firm, including monitoring food processing, preparing HACCP plans, and monitoring sanitation controls." Assuming the facts of the complaint to be true, the government has set forth facts that establish that corporate officers Suttenberg, Negron, and Dozortsev are responsible for the sanitation of the plant and the safety of the food it produces.

The individual defendants argue that an injunction against corporate officers is unnecessary where there is an injunction against the corporate entity, because agents are generally bound by restrictions placed on the principal. Nevertheless, courts have enjoined corporate officers in civil cases brought under the FDCA, when the corporate entity was likewise enjoined. See United States v. Universal Management Serv. Inc., 191 F.3d 750 759 (6th Cir.1999) (applying Park and Dotterweich to an FDCA injunction case against corporate office due to supervisory and managerial role); cert. denied, 530 U.S. 1274, 120 S.Ct. 2740, 147 L.Ed.2d 1005 (2000); Undetermined Quantities of Articles of Drug, 145 F.Supp.2d at 694 (enjoining company president who had responsible relationship to or responsible share in FDCA violations, despite assertions that he did not personally participate in manufacture, sale, or distribution of adulterated articles); United States v. Sene X Eleemosynary Corp., 479 F.Supp. 970, 976-77 (S.D.Fla. 1979) (individual defendants' positions of authority and responsibility in the operation states a claim under the FDCA against them). While an injunction against corporate official might appear to the individual defendants to be duplicative, the Supreme Court has stated: "The requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntary assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them." Park, 421 U.S. at 672, 95 S.Ct. 1903.

The individual defendants' motion to dismiss the complaint against them is denied.

Government's Motion for Summary Judgment

Plaintiff has moved for a summary judgment pursuant to Rule 56(c) of the Federal Rules of Civil Procedure. Summary judgment must be granted if there is no genuine issue as to any material fact and if the moving party is entitled to judgment as a [42] matter of law. See Fed.R.Civ.P. 56(c). The moving party has the burden of demonstrating the absence of any disputed material facts, and the court must resolve all ambiguities and draw all inferences in favor of the party against whom summary judgment is sought. See Thompson v. Gjivoje, 896 F.2d 716, 720 (2d Cir.1990). While the court views the evidence in the light most favorable to the nonmoving party, see O'Brien v. National Gypsum Co., 944 F.2d 69, 72 (2d Cir.1991), "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment."

The FDCA, Section 331 of Title 21 of the United States Code, prohibits:

(a) The introduction or delivery for introduction into interstate commerce of any food ... that is adulterated or misbranded.

(k) [T]he doing of any ... act with respect to [] a food ... while such article is held for sale ... after shipment in interstate commerce and results in such article becoming adulterated or misbranded.

21 U.S.C. § 331(a) & (k). The elements for establishing a violation of either of these provisions are essentially the same: (1) the product in question must be a food; (2) the food must be adulterated; and (3) there must be an interstate commerce nexus. The only difference between subsections (a) and (k) of Section 331 is the timing of the interstate commerce element: Section 331(a) prohibits introducing adulterated food into interstate commerce after processing, while Section 331(k) prohibits adulterating food after its components have traveled in interstate commerce. I address these three violation elements in turn.

Defendant's Products are "Food"

The FDCA defines "food" as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321(f). Under the FDCA, a court may take judicial notice that an article is food where it is common knowledge that the article is used for food. United States v. H.B. Gregory Co., 502 F.2d 700, 704 (7th Cir.1974); United States v. O.F. Bayer & Co., 188 F.2d 555, 557 (2d Cir.1951). Moreover, defendants do not dispute that the fish products it processes and distributes are food.

Nexus to Interstate Commerce

The FDCA defines interstate commerce as "commerce between any State or Territory and any place outside thereof." 21 U.S.C. § 321(b). The FDCA also provides that "[i]n any action to enforce the requirements of [the FDCA] respecting a food ... the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist." 21 U.S.C. § 379a. The government, in addition, has submitted evidence to establish that Blue Ribbon receives raw fish to be processed from Norway, Chile, and the Faroe Islands. Blue Ribbon ships its finished product to retailers in New Jersey and Pennsylvania. Moreover, defendants do not dispute that it is engaged in interstate commerce.

Adulteration of Defendants' Products

It is a violation of the FDCA to move in interstate commerce food that has become adulterated. Food is adulterated as defined by the FDCA:

(1) [i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated [43] under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health[; or]

(4) [i]f it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

21 U.S.C. § 342(a)(1) & (4). According to the United States, defendants' products are adulterated pursuant to this definition on the basis of three alternative grounds. First, plaintiff alleges the food is adulterated as defined by Section 342(a)(4) because defendants had an inadequate HACCP plan for smoked Nova salmon and had no HACCP plans for Nova salmon bits and smoked sea bass. Second, plaintiff alleges that the FDA's and NYSDAM's continued observance of insanitary conditions at the plant, including but not limited to the detection of L. monocytogenes at the plant, demonstrates that defendants' seafood may have become contaminated with filth or otherwise rendered injurious to health pursuant to Section 342(a)(4). Plaintiff alleges a third and independent basis of adulteration pursuant to Section 342(a)(1) due to the presence of L. monocytogenes in defendants' seafood, alleged to be a "poisonous or deleterious substance which may render it injurious to health." Because the absence of a dispute of material facts presented by any one of these allegations will support plaintiff's motion for summary judgment, I will address each basis of adulteration in turn.

1. Lack of an HACCP Plan. The FDA regulations that establish the requirements of the HACCP plan states that the "[f]ailure of a processor to have an implement a HACCP plan that complies with this section whenever a HACCP plan is necessary ... shall render the fish or fishery products of that fishery of that processor adulterated under section [342(a)(4)] of the [FDCA]." 21 C.F.R. § 123.6(g). The government alleges that the HACCP plan deficiencies observed and reported by the FDA during August 2000 and January 2001 allow, as a matter of law, this Court to find Blue Ribbon's food adulterated under the FDCA.

Defendants do not dispute that the FDA has observed, documented, and warned Blue Ribbon and the individual defendants about the problems with the existing HACCP plan for smoked Nova salmon and the problematic lack of HACCP plans for Nova salmon bits and smoked sea bass. Defendants argue, in sum, that Blue Ribbon has in fact "implemented an effective HACCP Plan," which is "effective and followed by Blue Ribbon." Furthermore, defendants complain that "[i]f the Government means to allege that the HACCP Plan is somehow deficient, it has not specified what is wrong with it. Dozortsev, who is HACCP-certified, confirms that it is effective as implemented."

Defendants provide this Court with two HACCP plans, which Dozortsev declares are currently effective. Even a cursory inspection reveals these are the same HACCP plans in effect at Blue Ribbon at the time of the January 2001 inspection and found to be inadequate by the FDA. One plan is labeled cold-smoked fish and one is labeled hot-smoked fish. In handwriting on the former HACCP plan, someone has written "Product: salmon — nova." On the hot smoked fish HACCP plan, unidentified handwriting identifies the plan as operating as to whitefish, chubbs, whiting, trout, winter carp, and butter fish.

As discussed in some detail above, in August 2000, the FDA found Blue Ribbon did not have a HACCP plan for Nova salmon bits, and Blue Ribbon promised to correct this deficiency and implement a written HACCP plan. By January 2001, [44] Blue Ribbon had not implemented a HACCP plan for Nova salmon bits. At the time Dozortsev provided the current HACCP plans to this Court by declaration dated October 12, 2001, there was still no HACCP plan for Nova salmon bits. The FDA also observed, documented, and discussed with defendants the need for an HACCP plan to cover the processing of smoked sea bass. The HACCP plans provided to this Court do not encompass sea bass. Neither was the smoked Nova salmon HACCP plan amended in any way in response to the FDA's January 2001 inspection which revealed a number of critical deficiencies in the current HACCP plan, even though the FDA was assured by Suttenberg that Blue Ribbon promised to correct all HACCP plan violations.^[7] Defendants' claims that they are unaware as to the nature of any HACCP plan deficiencies is both incredible and irrelevant, given the content of the FDA inspection reports from August 2000 and January 2001, defendants' "promise" to undertake the plans' corrections, and the absence of any scienter requirement in the relevant regulations.

Because the defendants' HACCP plans are inadequate and do not comply with the FDA regulations, the food Blue Ribbon processes pursuant to them is adulterated as a matter of law, as defined by Section 342(a)(4) of the FDCA. However, because the scope of an injunction entered against Blue Ribbon to remedy FDCA violations may vary depending on the nature of adulteration of defendants' seafood, I next consider the government's other two bases for asserting adulteration.

2. Insanitary Plant Conditions. The government also contends that defendants' seafood is adulterated under 21 U.S.C. § 342(a)(4) because the undisputed facts show insanitary conditions and practices. A food is deemed adulterated under 21 U.S.C. § 342(a)(4) if "processed under insanitary conditions, whether [the food has] actually ... become dangerous to health or not." United States v. 1250 Cans, Pasteurized Frozen Whole Eggs, 339 F.Supp. 131, 140 (N.D.Ga.1972); see also United States v. Nova Scotia Food Prod. Corp., 568 F.2d 240, 247 (2d Cir.1977) ("[F]ood does not have to be actually contaminated during processing and packing but simply [shown] that `it may have been rendered injurious to health,' § 342(a)(4), by inadequate sanitary conditions of prevention."). To prove adulteration under Section 342(a)(4), the government must show a "reasonable possibility" that, by virtue of the insanitary conditions under which the food is prepared, packed, or held, an article of food may have been rendered filthy or injurious to health. See Berger v. United States, 200 F.2d 818, 821 (8th Cir.1952) ("The condition condemned by the statute ... is one which would with reasonable possibility result in contamination."); United States v. H.B. Gregory, 502 F.2d 700, 704-05 (7th Cir.1974) ("[T]he definitive `reasonable possibility' test [is] now generally accepted in cases involving adulterated food under § 342(a)(4)."). The word "filth," as used in the statute, has [45] been construed to have its usual and ordinary meaning, and is not confined to any scientific or medical definition. See United States v. Swift & Co., 53 F.Supp. 1018 (M.D.Ga.1943).

Some of the insanitary conditions observed during the course of the FDA and NYSDAM inspections since 1994 are detailed above. The defendants do not dispute that these conditions were observed and documented by the FDA and NYSDAM. The government has submitted a large bound volume of inspection reports going back as far as 1994 detailing recurring violations, laboratory results indicating the presence of L. monocytogenes in food products and the plant environment, press releases of Blue Ribbon recalls due to contaminated seafood, letters to Blue Ribbon corporate agents specifying insanitary conditions observed during inspections and warning that a seizure or injunction may result if the conditions are not rectified, and letters of assurances by Blue Ribbon agents that the insanitary conditions would be fixed.

Defendants do not deny that they have been processing seafood under insanitary conditions for the last seven years, but claim that these conditions have been rectified under Suttenberg's relatively new management of the plant presenting an issue of fact for a jury. Defendants' submit that since the January 2001 inspection, NYSDAM has tested Blue Ribbon's products for L. monocytogenes five times, have each time found no trace of the bacteria.

Defendants' "new management" defense does not present a material issue of fact for a jury with respect to the question of whether defendants' seafood products are adulterated. Whether Blue Ribbon has finally cleaned up its plant does not change the fact that between 1994 and the summer of this year the FDA and the NYSDAM documented critical deficiencies in the plant's conditions and cleanliness, sufficient to establish as a matter of law that there is a reasonable possibility that the food has become filthy or injurious to health. Moreover, while Blue Ribbon may have not tested positive for the presence of L. monocytogenes since the January 2001 inspection, numerous inspections by the NYSDAM since then have revealed continued insanitary conditions at the plant. The March 12, 2001 inspection found a number of violations including: no handwash sign; unshielded light source; soiled fan guards; dust-laden vent cover; an unscreened entrance; an uneven, soiled floor; debris and litter on the floor; a damaged freezer door gasket; the accumulation of dark residues of air curtain to processing room; exposed fish in a freezer; a lack of thermometers in some retail display cases; and improper record-keeping of internal temperatures of processing fish. A subsequent inspection by NYSDAM on April 30, 2001, revealed a "critical deficiency" caused by the improper processing of Nova smoked bits. General deficiencies were also observed, such as: soiled doors; heavy ice accumulation in freezers; employees with no hair restraints; an unscreened entrance; and dead flies and a dead beetle. NYSDAM assessed Blue Ribbon a fine of $300. During a subsequent inspection on June 6, 2001, the day after the United States filed the present complaint, NYSDAM again found both critical and general deficiencies in the plant's operation and environment, including improper fish processing procedures, and insanitary plant conditions, including mouse droppings, cockroaches, live flies, debris, and refuse. Blue Ribbon was assessed a fine of $600. On these facts, as a matter of law, there is a reasonable possibility that Blue Ribbon's food has been "prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby [46] it may have been rendered injurious to health." 21 U.S.C. § 342(a)(4).

3. Presence of L. Monocytogenes. The government argues that Blue Ribbon's seafood is adulterated because L. monocytogenes is a "poisonous or deleterious substance," the presence of which renders the seafood "injurious to health." 21 U.S.C. § 342(a)(1). If L. monocytogenes is an "added substance," according to the FDCA and the FDA's zero-tolerance policy, any trace of it in a food product renders that product adulterated. If L. monocytogenes is not an added substance, defendants' fish are adulterated only if the quantity of the bacteria "ordinarily render[s] it injurious to health." 21 U.S.C. § 342(a)(1) (emphasis added).

Defendants' argue first that L. monocytogenes is not an "added substance" and that, therefore, 21 U.S.C. § 342(a)(1) provides that food is not adulterated if it contains a quantity of L. monocytogenes not ordinarily injurious to health. Defendants argue alternatively that, if L. monocytogenes is an "added substance," the FDA's failure to set a "tolerance level" pursuant to 21 U.S.C. § 346 is a violation of the FDCA.

Added Substance

The FDCA does not define the terms "added substance," but FDA regulations define the relevant terms as follows:

(c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

21 C.F.R. § 109.3(c) & (d) (italics in original). Defendants argue that L. monocytogenes is not an added substance because it "occurs in seafood naturally in the wild." Defendants cite United States v. 1232 Cases American Beauty Brand Oysters, 43 F.Supp. 749 (W.D.Mo.1942), which held that fish bones and oyster shell fragments, while deleterious, were not artificially added substances. Id. at 750-51. Yet the defendants themselves submit evidence that readily distinguishes the occurrence of L. monocytogenes in fish and the occurrence of fish bones in fish. The UNFAO report submitted by defendants notes that fish are not born with L. monocytogenes but, rather, are contaminated with the bacteria by coming into contact with it in the environment. George W. Bierman, Ph.D., defendants' proposed expert, states that the "[FDA] and the Food Safety Inspection Service of the U.S. Department of Agriculture ("FSIS") have acknowledged that `[b]ecause L. Monocytogenes is widely present in the environment, it would be impossible to prevent animals from coming into contact with the bacteria'" and states that the same is true of raw fish. "Raw fish procured by processors are likely to have come into contact with the organism in the wild," Bierman concludes. L. monocytogenes is, thus, not an inherent natural constituent of fish but, rather, a bacterial organism present in the environment that comes into contact with, and contaminates, some fish. See United States v. Union Cheese Co., 902 F.Supp. 778, 786 (N.D.Ohio 1995) (finding L. monocytogenes not to be an inherent natural constituent of cheese but rather the result of environmental contamination); cf. United States v. An Article of Food Consisting of Cartons of Swordfish, 395 F.Supp. 1184 (S.D.N.Y. [47] 1975) (finding mercury to be an added substance because it does not occur naturally in swordfish).

Even if L. monocytogenes existed naturally in fish, it would still be considered an "added substance" under the FDCA because the spread of the bacteria to other uncontaminated fish is "increased to abnormal levels through mishandling or other intervening acts" and is therefore considered an "added substance" under the FDA regulations. 21 C.F.R. § 109.3(b). Defendants do not dispute but rather advance the argument that L. monocytogenes contamination can be spread by intervening acts of man: "Contamination takes place not only in the wild, but on fishing boats or during filleting, or potentially anywhere else in the chain from ocean to fishing boat to trade to processor to wholesaler to retailer to consumer." Defendants do not dispute the insanitary conditions observed by the FDA and NYSDAM going back as far as 1994. The government's expert, Losikoff, states without dispute that the conditions observed during the January 2001 inspection were such that could result in the cross-contamination of previously uncontaminated fish products, specifically, product residue on food contact surfaces, like the slicer and cutting boards; cutting boards and knives not sanitized before use as specified in the plant's sanitation procedures; cutting boards that were worn from use and gouged with nicks and scrapes making cleaning and sanitizing difficult; cooler and freezer door handles that were caked with residue; and plastic strips used as room-dividing curtains that touched the floor and were then allowed to drag across uncovered processed sea bass as the employee pulled a cart from one room to the next. Other employee practices observed constitute intervening acts increasing the amount of the bacteria in the plant's fish, like employees touching unclean surfaces then handling ready-to-eat fish, the lack of protective clothing over employee street clothes, and bare arms and beards. "Insanitary conditions, which are the intervening acts of humans, are sufficient grounds upon which to conclude that a deleterious substance has been `added.'" Union Cheese Co., 902 F.Supp. at 786; see also Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 43 (D.C.Cir.1982) (affirming similar holding with respect to salmonella in shrimp). Accordingly, I conclude based on the undisputed facts that L. monocytogenes is an added substance under the FDCA.

Injurious to Health

Defendants seek to raise a material and disputed issue of fact as to whether L. monocytogenes is a "poisonous or deleterious substance which may render [food] injurious to health," as required by 21 U.S.C. § 342(a)(1).

Defendants first state that "[t]he bacterium does not ordinarily present a risk to healthy individuals." (Bierman Decl. ¶ 87, 8; FDA, Center for Food Safety and Applied Nutrition, Foodborne Pathogens Microorganisms and Natural Toxins Handbook ("Bad Bug Book")). Defendants further note that "healthy people do not develop listeriosis except in extremely rare cases" and that "epidemiological studies showing a 1 in 59 million chance of infection from a 50 gram serving of fish containing 100 bacteria per gram" focus on the risk of disease to the population at large rather than to susceptible individuals such as the young, old, and pregnant. As to the susceptible population, the FDA's Bad Bug Book also states as of data from 1987 that "there are at least 1600 cases of listeriosis with 415 deaths per year in the U.S." and that "manifestations of listeriosis include septicemia, meningitis (or meningoencephalitis), encephalitis, and intrauterine [48] or cervical infections in pregnant women, which may result in spontaneous abortion ... or stillbirth." An article submitted by defendants states that "[l]isteria monocytogenes causes listeriosis, a disease that can be serious and is often fatal to susceptible individuals.... Accordingly, regulatory agencies in the United States have adopted a zero-tolerance policy towards the incidence of the organism in ready-to-eat food products." M. Eklund et al., U.S. Dept. of Commerce, NOAA, National Marine Fisheries Service, "Incidence and Sources of Listeria monocytogenes in Cold Smokes Fishery Products and Processing Plants," Journal of Food Protection, Vol. 58 (1995). The UNFAO report provided by defendants states that, "[r]ecognizing the potential for fishery products to be a vehicle for large out-breaks of listeriosis, it is prudent to seek appropriate strategies to minimize human exposure to infectious doses of [L. Monocytogenes]." United Nations Food and Agriculture Organization Fisheries Report No. 604. Another article provided by defendants states that "listeriosis is an atypical foodborne disease of major public health concern because of the severity and the nonenteric nature of the disease (meningitis, septicemia, and abortion), a high case-fatality rate (around 20 to 30% of cases), a frequently long incubation time, and a predilection for individuals who have underlying conditions which lead to impairment of T-cell-mediated immunity." J. Rocourt et al., Listeria Monocytogenes, from Food Microbiology Fundamentals and Frontiers (1997). The legal question posed by defendants' arguments is simply whether the substance must be deleterious to the entire population or simply to significant segments of the population such as the old, the young, and pregnant women. To pose the question is to answer it. Because L. monocytogenes is a poisonous or deleterious substance that may render Blue Ribbon's fish products injurious to the health of significant populations of consumers, such products are adulterated within the meaning of Section 342(a)(1) of the FDCA.

Zero-Tolerance Policy

Sections 342(a)(2)(A) and 346 of the FDCA provide that some added poisonous or added deleterious substances in food will not render the food adulterated if the quantity of the offending substance is below a "tolerance level" established by the FDA.^[8] Defendants argue that the FDA's zero-tolerance policy violates the FDCA and that the FDA must promulgate minimum tolerance levels in recognition of the prevalence of L. monocytogenes in smoked fish plants and on cold-smoked fish products. Putting aside the fact that the government need not rely on a finding that the food is adulterated pursuant to Section 342(a)(2)(A), because it can show that the added substance is actually injurious to health and adulterated as per Section 342(a)(1), the defendants' argument is without merit. According to Section 346,^[9] [49] "[a]ny quantity of added poisonous or added deleterious substance is ... "unsafe," unless the substance is required in food production or cannot be avoided by good manufacturing practice." Young, 476 U.S. at 977, 106 S.Ct. 2360 (emphasis in original). "For these latter substances, `the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health.'" Id. (citing 21 U.S.C. § 346). Since the enactment of the FDCA in 1938, "the FDA has interpreted this provision to give it the discretion to decide whether to promulgate a § 346 regulation, which is known in the administrative vernacular as a "tolerance level."" Id. The FDA is not required to promulgate a § 346 regulation to set a tolerance level for L. monocytogenes, and this Court is not permitted to second guess the agency's determination unless its decision is shown to be arbitrary and capricious and in violation of the Administrative Procedure Act, 5 U.S.C. § 706(2)(A) ("APA"), which is not the case here.^[10]See United States v. Royal Baltic Ltd., No. 94-CV-1178 (E.D.N.Y. Oct. 3, 2001) (finding that the FDA has the discretion not to set a tolerance level for L. monocytogenes).

Furthermore, the defendants' own evidence belies the assertion that it would be impossible to produce contamination-free cold-smoked products. Bierman, defendants' expert, points to a number of positive advancements in the smoked fish industry that, if properly implemented, significantly decrease the incidence of L. monocytogenes, specifically, the development and implementation of adequate HACCP plans, strict monitoring of the firm's fish processing procedures and sanitation, and the testing of raw materials before they are allowed to enter and contaminate the plant. It is a matter of undisputed fact that the defendants have failed time and time again to take these necessary precautions.

There is no factual dispute that defendants have violated Section 331(a) and (k) of the FDCA by introducing into interstate commerce food that is adulterated or by causing food to become adulterated after its introduction into interstate commerce.

Jurisdiction to Enter Permanent Injunction

The FDCA expressly authorizes district courts to grant injunctive relief [50] to enforce its provisions. 21 U.S.C. § 332(a).^[11] Where the government is enforcing a statute designed to protect the public interest, it is not required to show irreparable harm to obtain injunctive relief. United States v. Diapulse Corp. of America, 457 F.2d 25, 27-28 (2d Cir.1972); United States v. Schmitt, 734 F.Supp. 1035, 1049 (E.D.N.Y.1990). The statute's enactment constitutes Congress' "implied finding that violations will harm the public and ought, if necessary, be restrained." Diapulse Corp., 457 F.2d at 28 (citing United States v. City and County of San Francisco, 310 U.S. 16, 60 S.Ct. 749, 84 L.Ed. 1050 (1940)). To enjoin future behavior, the government must show that defendants have violated the FDCA and that there is some reasonable likelihood that the violations may recur. See Diapulse Corp., 457 F.2d at 28-29; Schmitt, 734 F.Supp. at 1049. The probability of future violations may be inferred from past unlawful conduct. Commodity Futures Trading Comm'n v. British American Commodity Options Corp., 560 F.2d 135, 144 (2d Cir.1977); United States v. Odessa Union Warehouse Co-op, 833 F.2d 172, 176 (9th Cir.1987).

As established above, the evidence shows that the defendants have violated the FDCA by distributing adulterated seafood on a continued basis throughout the years. Their behavior has persisted despite a series of inspections, warnings from the state and federal government, the temporary revocation of their license by NYSDAM, and a number of monetary fines. Given the extent and numerosity of past warnings to Blue Ribbon and its agents, defendants cannot satisfy the burden to establish that "there is no reasonable expectation that the wrong will be repeated." United States v. W.T. Grant, 345 U.S. 629, 633, 73 S.Ct. 894, 97 L.Ed. 1303 (1953).

The defendants oppose the substance and form of the government's proposed permanent injunction on basically two grounds. First, defendants argue that the effect of the permanent injunction will be to shut down Blue Ribbon, causing its eleven employees, including the three defendants, to lose their jobs. The injunction, however, will not require Blue Ribbon to stop processing fish but, rather, to stop processing fish that is or has become adulterated. The Second Circuit has held that a business may not complain "that the injunction is impermissible because it will put him out of business." Diapulse Corp., 457 F.2d at 29. A business "`can have no vested interest in a business activity found to be illegal.'" Id. (citing United States v. Walsh, 331 U.S. 432, 67 S.Ct. 1283, 91 L.Ed. 1585 (1947)).^[12] Second, defendants argue that the proposed injunction would "empower [the] FDA to micro-manage Blue Ribbon's facility" and that they should not have to pay for FDA inspections to ensure their compliance with the injunction or hire an outside consultant to monitor food safety. These objections to the proposed injunction do not merit an alteration of its terms. These terms of the proposed injunction, including the responsibility for costs and monitoring by outside consultants, have been routinely accepted and imposed by other courts faced with similar proof of FDCA violations. See, e.g., United States v. Syntrax Innovations, Inc., 149 F.Supp.2d 880, 882-891 (E.D.Mo. [51] 2001) (granting government's motion on summary judgment for misbranding in violation of the FDCA and imposing permanent injunction providing for very similar terms); United States v. Union Cheese Co., 902 F.Supp. 778, 787-90 (N.D.Ohio 1995) (granting preliminary injunction against cheese factory due to presence of L. monocytogenes with almost precisely the same terms). I recognize that this Court's equitable powers "should be exercise in harmony with the overall objectives of the legislation," Commodity Futures Trading Comm'n v. Hunt, 591 F.2d 1211, 1219 (7th Cir.1979), and that the FDCA's "overriding purpose [is] to protect the public health." United States v. Article of Drug, Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969). By keeping contaminated fish processed under conditions of filth off consumers' tables, this permanent injunction will serve that important purpose.

CONCLUSION

The individual defendants' motion to dismiss the complaint against them is denied. The government's motion for summary judgment is granted. The government is directed to settle a judgment on notice within thirty days of the date of this decision.

The Clerk is directed to furnish a filed copy of the within to all parties and to the magistrate judge.

SO ORDERED.

[1] In defendants' answer, defendants deny that Suttenberg is responsible for these areas and admit only that Suttenberg is president of Blue Ribbon and that he performs his duties at the plant in Brooklyn.

[2] The press release that announced the product recall stated, in part:

It was revealed during FDA laboratory testing that [the implicated lots] may have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail elderly people, and others with weakened immune systems. Although healthy people may suffer only short-term symptoms, such as high fever, severe headache, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. To date there have been no reported illnesses.

[3] Specifically, the HACCP plan states brining time is four hours, and the firm's written procedures and monitoring records indicate brining time to be six hours.

[4] Based on the January 1994 inspection, the FDA issued a warning letter to Blue Ribbon on March 2, 1994. The warning letter documented insanitary conditions, such as live cockroaches in the customer pickup and loading areas, existence of standing water, dried and encrusted fish on racks and fans, deeply scored cutting boards, the failure of employees to properly wash their hands, whole raw salmon on the floor awaiting processing, and the presence of L. monocytogenes. On March 30, 1994, defendant Negron, as vice president, responded to the warning letter and detailed several corrective actions to be taken.

[5] Specifically, the defendants would be required to select an FDA-approved laboratory to perform the L. monocytogenes testing, and the FDA must receive written reports detailing the laboratory results within two days after the defendants receive the results. The FDA would be authorized to conduct additional analyses and examine food products and raw ingredients as it deems necessary. Any fishery products that contain L. monocytogenes would have to be destroyed or reconditioned under FDA supervision. All FDA expenses relating to supervision, analyses, and examination shall be bourne by the defendants, at rates specified in the proposed permanent injunction.

[6] 21 C.F.R. Pt. 110 details guidelines for "current good manufacturing practice in manufacturing, packing, or holding human food," and 21 C.F.R. Pt. 123 relates to fish and fishery products.

[7] As discussed earlier, the Nova smoked salmon HACCP plan did not comply with FDA regulations and continues not to comply because (1) the plan is signed but not dated as required by 21 C.F.R. 123.6(d), (2) there is no critical limit for internal fish temperature required by 21 C.F.R. § 123.6(c)(4), no time was specified for thawing frozen fish, as required by 21 C.F.R. § 123.6(c)(2)(i), no procedure was included for monitoring brine solution or fish temperature during brining required by 21 C.F.R. § 123.6(c)(4), there was no procedure to check the accuracy of thermometers, Salometers, and thermostats required by 21 C.F.R. § 123.6(c)(4), and there was inadequate monitoring of critical control points, as required by 21 C.F.R. § 123.6(c)(7).

[8] Section 342(a)(2)(A) of the FDCA provides that a food shall be deemed adulterated "if it bears or contains any added poisonous or added deleterious substance (other than [exceptions not relevant here]) that is unsafe within the meaning of section 346 of this title." 21 U.S.C. § 342(a)(2)(A).

[9] Section 346 of the FDCA states in full:

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 342(a) of this title. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

21 U.S.C. § 346.

[10] The APA provides that an agency action may be overturned only if it is "arbitrary, capricious, and an abuse of discretion, or otherwise not in accordance with the law." 5 U.S.C. § 706(2)(A); Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 375-78, 109 S.Ct. 1851, 104 L.Ed.2d 377 (1989). Although the Court may consider whether the agency has made a clear error of judgment, the Court "is not empowered to substitute its own judgment for that of the agency." Id. at 377, 109 S.Ct. 1851. Moreover, "[a] reviewing court must generally be at its most deferential when the determination is guided by the agency's scientific expertise, unless the agency's views have no basis in fact or are irrational." Henley v. FDA, 77 F.3d 616, 620 (2d Cir.1996). Here, defendants have not demonstrated that the FDA's policy is without basis in fact or is irrational.

[11] Section 332(a) of Title 21 states in full that "[t]he district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown[,] to restrain violations of section 331 of this title."

[12] In addition, it is noted that the government is not seeking a harsher remedy, like criminal penalties, pursuant to 21 U.S.C. § 333, or seizure of defendants' products, pursuant to 21 U.S.C. § 334.

Attorney for the government: Elizabeth H. Trimble.

Attorney for the defendants: James M. Kramon.

Excerpt of Bench Opinion rendered November 28, 1979, from transcript of proceedings.

Before: Herbert F. Murray, District Judge.

THE COURT: The Court would like to proceed to rule on the matter this morning while it is fresh in mind. I do want to thank counsel for their presentations in the matter which have been most thorough. Like counsel often do, I guess, they were a little optimistic in their estimates of how long the case would take, but it is a complicated matter and I can well understand that it takes some time to present, and I am certainly not being critical of counsel because I think it was presented and tried as expeditiously as possible.

I am going to read a bench opinion incorporating my views about it, but in order not to hold the parties in suspense, I will start by giving the ultimate conclusion, and that is that I would have to deny the Motion for Judgment of Acquittal renewed by Mr. Kramon at the close of all the evidence, and I would have to find in favor of the Government and against the Defendants in the case because, in the Court's judgment, the Government has established by proof beyond a reasonable doubt violations of the Act which governs in this case and, basically, therefore, the further remarks that I will make in the matter are really findings of fact and conclusions of law implementing the general finding that I have just announced.

This case involves a criminal prosecution arising under the Federal Food, Drug & Cosmetic Act, 21 U. S. C., Section 301 et seq. The indictment returned on August 7, 1979 charges Baltimore Pizza Crust, Inc., Frank F. Corbi, president of Baltimore Pizza Crust, Inc., and Joseph N. Corbi, treasurer and general manager of Baltimore Pizza Crust, Inc. with two counts of violating 21 U. S. C., Section 331(k). Count One charges that from on or about March 17, 1978 to on or about March 22, 1978, the Defendants held food for sale after shipment in interstate commerce in a building accessible to insects and caused such food to be exposed to contamination by insect filth, which resulted in the food becoming adulterated as defined in 21 U. S. C., Section 342(a)(3) and (a)(4). Count Two is similar to Count One except that Count Two involves the period from on or about December 1, 1977 to on or about December 7, 1977, and Count Two alleges adulteration only as defined in 21 U. S. C., Section 342(a) (4).

The case was tried before the Court, sitting without a jury, on November 26, 27 and 28, 1979, and the Court has heard the final arguments of both sides this morning. For the reasons to be outlined, the Court is convinced beyond a reasonable doubt that the Defendants are guilty of the offenses charged in the indictment.

The facts of the case are not the subject of serious dispute, and the Court makes the following findings with respect to the facts. Defendant Baltimore Pizza Crust, Inc. (the company) is located in Baltimore, Maryland and is engaged in the business of making pizza crust. At the times in question in this case, the company purchased its flour, a major ingredient in pizza crusts, from Seaboard Allied Milling Corporation of Culpepper, Virginia. This flour, which Defendants admit was shipped in interstate commerce, is the food substance that the indictment alleges became adulterated.

The inspection which is the basis of Count Two of the indictment took place on December 6 and 7, 1977 and apparently was a routine periodic inspection of the company by FDA. At trial, Norman Timberlake, one of the two Food and Drug Administration investigators who participated in this inspection, testified that he and his co-investigator collected seventeen subsamples from the interior and exterior of the pizza crust production system. These subsamples were analyzed at an FDA laboratory, and six of the seventeen subsamples were found to contain one or more insects and/or insect larvae. The insects found were flour beetles, silverfish, and cigarette beetles. In addition, Mr. Timberlake testified that he observed at least 25 live insects on top of one of the two bulk flour storage bins, in which flour is stored when it arrives at the plant, and at least 40 insects on top of the other storage bin (Bin #2). The inside of Bin #1 was inspected but the inside of Bin #2 was not because the investigators were told that it was empty and not in use.

Mr. Timberlake learned that the flour which was being processed during his inspection of the plant had been received from Seaboard on December 1, 1977. In discussing the results of the inspection with Defendant Joseph Corbi, Mr. Corbi told him that he thought it was possible that the flour had been received from Seaboard in a contaminated condition. Mr. Timberlake did not conduct an investigation into this allegation, nor did he recommend to anyone at FDA that this possibility should be investigated. Mr. Corbi stated that no one inspected the flour when it arrived at Baltimore Pizza Crust and that it would be too costly to train someone or to hire a specialist to inspect incoming flour.

The findings of the FDA as a result of this investigation were mailed to Defendant Frank Corbi on February 16, 1978. His attention was drawn to the fact that several prior inspections of the company had revealed similar insect infestation problems in the flour handling system, and he was advised that legal action would be considered if the problems were not corrected.

The Court notes that several documents introduced into evidence by the Government (over Defense objection) indicate that the company had been inspected on five previous occasions — twice by the State of Maryland and three times by the Food and Drug Administration. On each of these occasions, active insect infestation was found in the plant and Defendants were notified of the problem.

The inspection which is the basis for Count One of the indictment took place on March 21 to 23, 1978. Troy Williams, one of the two FDA investigators who participated in this inspection, testified that numerous live insects, dead insects, and insect larvae were found in and around the flour handling equipment. The investigators took from Storage Bin #2 a sample of flour which, upon laboratory analysis, was found to contain no evidence of insect contamination. They also took a sample consisting of 47 subsamples from various points of the system, both inside and outside. Twenty-nine of the forty-seven subsamples contained insect filth in the form of live or dead insects, larval cast skins, fragments and webbing. Mr. Williams took a number of photographs of the flour processing area which evidenced conditions that may have contributed to insect infestation.

At several places, significant amounts of static or encrusted flour had built up. This build-up was present on the machinery in the plant, on the ceiling, on ceiling crossbeams, and on at least one light fixture. One photograph shows a crack in the cinderblock wall of the building through which light is entering the building. Another photograph is described as "one of several holes at wall/floor junction apparently in connection with spaces beneath floor or walls." Two other photographs show a hole in one screen of the rotating flour sifter and a tear in another screen. These openings could conceivably let pass through the flour sifter objects, such as insects, which would then become part of the finished product. In fact, two dough balls collected as subsamples near the end of the production system were found to contain insect filth. Another possible means [of] ingress may have been an open, unscreened fan in the ceiling of the production area. This fan was not in use, but Defendant Joseph Corbi indicated that the fan had been installed only recently and would be turned on soon.

Finally, the photographs taken by Mr. Williams show that before the plant commenced operation on the morning of March 22, 1978, the flour processing equipment in many places was still encrusted with dough and flour from the previous day's operations. The inspectors had been told on March 21 that all the machinery was washed at the end of each day.

Mr. Williams testified that in his estimation the temperature in the building was at least 85 degrees Fahrenheit. Mr. Howard Green, a witness for the Defendants, stated that in his experience as an exterminator for over twenty years, higher temperatures result in a decrease in the time necessary for insect larvae to hatch. Thus, it is inferrable that the heat in the Baltimore Pizza Crust building tended to promote the rapid hatching of larvae. In fact, at the conclusion of an FDA inspection in March 1977, Joseph V. Corbi, the son of Defendant Joseph Corbi and the assistant plant manager, was informed by the FDA inspectors that the warmth of the plant was conducive to the incubation of insect larvae.

The Defendant company had an extermination services contract during the periods in question in this case with the Home Exterminating Company of Baltimore. The sanitation program included a "cracks and crevices" program of spraying until approximately early May of 1978. In April 1978, Joseph V. Corbi received from the sales manager of Home Exterminating Company a letter which stated that a substantial increase in the company's pest control program was needed. The letter stated that "After checking your plant (entire building) I found you have great need of Weevil control around your flour bins. This letter was dated eleven days after the completion of the March 1978 FDA inspection. Among the suggestions contained in the letter were the use of a pyrethum fog near the flour bins and the fumigation of the bins "to rid existing Weevil infestation."

Turning to the applicable law, Section 331(k) of 21 U. S. C. states:

"The following acts and the causing thereof are hereby prohibited:

"(k) The … doing of any … act with respect to a food … if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated."

Section 342 defines adulteration as follows:

"A food shall be deemed to be adulterated —

"(a) … (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health…"

As already pointed out, Count One of the indictment charges Defendants with a violation of Section 331(k)in that the flour held by the Defendant company at the time of the March 1978 inspection was adulterated as defined in subsections (a)(3) and (a)(4) of Section 342. Count Two charges a violation of Section 331(k) in that the flour held at the time of the December 1977 inspection was adulterated as defined in Section 342(a) (4).

With respect to Count One, it is clear to the Court beyond a reasonable doubt that the Defendant corporation and the individual Defendants as responsible officers thereof held flour (eventually processed into pizza crust) for sale after shipment in interstate commerce and that the insanitary conditions at the plant may have caused the insect infestation found in the flour and, in fact, did cause at least some of the infestation. The numerous insanitary conditions found by investigator Williams certainly "may have" contributed to the contamination found. Under Section 342(a)(4), the Government need only show that conditions in the plant were such that they "would with reasonable possibility result in contamination." Berger v. United States, 200 F. 2d 818 at 821 (8th Cir. 1952). In the Court's view, the Government has met this burden.

The Court also finds that the Government has proved that the conditions at Baltimore Pizza Crust actually caused adulteration in the flour as defined in Section 342(a)(3).

Under the terms of the statute, an (a)(3) adulteration is proven once the presence of any contamination in food is found, except perhaps a de minimis amount. See United States v. General Foods Corp., 446 F. Supp. 740 at 744 (N. D. N. Y.), aff'd, 591 F. 2d 1332 (2d Cir. 1978).

For example, uncontradicted testimony, in part by one of the Defendants' witnesses, established that the temperature at the plant was such as to facilitate the growth and hatching of insect larvae. Whether or not the larvae were introduced into the plant in the flour when it was shipped from Seaboard, as Defendants contend, the evidence indicates that Defendants maintained a condition that decreased hatching time and, thus, further contributed to the insect infestation found throughout the flour processing system.

Having found that at least on condition at the company actually caused insect infestation, the Court notes that this condition existed at least as far back as March 1977 when it was pointed out to Joseph V. Corbi. The heat problem no doubt existed in December 1977 and, thus, was, in the language of Section 342(a)(4), "an insanitary condition" which "may have" caused contamination of flour in the plant. In addition, in light of the five inspections and the results thereof prior to December 1977, the Court finds beyond a reasonable doubt that the Defendants failed to take adequate precautions against insect infestation and that such failure created an insanitary condition that may have caused contamination. See generally United States v. Park, 421 U. S. 658 at 672 (1975). Thus, the Government, in the Court's judgment, has met its burden of proof with respect to Count Two as well as with respect to Count One.

The Defendant's major contention in this case has been that the insect infestation found by the FDA Inspectors was caused not by Defendants, but by Seaboard Allied Milling Corporation in that the flour shipped by Seaboard allegedly contained insects and larvae. Defendants argue that they cannot be convicted for receiving such flour because they did not initiate the contamination and that the Government has failed to prove that they exacerbated the contamination.

Even if the Government had failed to show that conditions at the Defendants' business may have or actually initiated contamination, which the Court does not believe to be the case, the Court would not view Defendants' argument as meritorious. In United States v. Nova Scotia Food Products Corp., 417 F. Supp. 1364 (E. D. N. Y. 1976), rev'd on other grounds, 568 F. 2d 240 (2d Cir. 1977), the district court was faced with a similar argument. In that case, a processor of smoked whitefish argued that the FDA had no power under Section 342 (a)(4) to promulgate regulations prescribing methods by which fish processors must attempt to eradicate botulism from fish. The processor argued that because th bacteria occurred naturally in the fish in their native habitat and that the processor did not introduce the bacteria into the fish during processing, no "insanitary condition" had been created by the processor.

The court responded to that argument as follows:

"While Section 342(a)(4) may literally seem to deal only with conditions brought about by processing itself, the regulation under review … is specifically addressed to setting processing parameters to prevent the 'outgrowth and toxin formation of C. Botulinum Type E.' Seen in the perspective of (the regulation's) purpose and the purpose of subsection (a)(4), the use of the word 'insanitary' in subdivision (4) of Section 342(a) is, at worst, inelegant, but it is not inadequate to include preparing, packing, or holding conditions which permit a continuance of the outgrowth and toxin formation of the C. Botulinum Type E in the product under process…. It is beside the point that the bacterial infestation here is not one that invades the fish during the processing." 417 F. Supp. at 1369.

Similarly, in the present case, the Court finds it to be irrelevant whether insect infestation of the flour was introduced at Seaboard's facilities in Culpepper, Virginia. Like the court in the case just quoted, this Court believes that the language of subsection (a) (4) is flexible enough to apply to infestation that a defendant permits to continue and grow at its own natural pace, even if the defendant performs no affirmative act to encourage the continuation and growth. If the language of the statute is flexible enough to be so construed, the Court believes that it should be.

As the Supreme Court has stated in United States v. Park at Page 673 of 421 U. S.:

"Congress has seen fit to enforce the accountability of responsible corporate agents dealing with products which may affect the health of consumers by penal sanctions cast in rigorous terms, and the obligation of the court is to give them effect so long as they do not violate the Constitution."

The clear import of Park and other cases is that food and drug legislation should be liberally construed so as to further its important goal — the protection of consumers of food products who cannot protect themselves.

In U. S. v. Dotterweich, 320 U. S. 277, the Supreme Court said, speaking through Mr. Justice Frankfurter:

"The Food and Drugs Act of 1906 was an exertion by Congress of its power to keep impure and adulterated food and drugs out of the channels of commerce. By the Act of 1938, Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience. The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of legislation if it is to be treated as a working instrument of government and not merely as a collection of English words."

Finally, with respect to the liability of the individual Defendants, Joseph N. Corbi and Frank Corbi, the Court finds that the Government has proved that these Defendants had a "responsible relation" to the violations in question and that it is appropriate to find them guilty along with the corporation. As the Supreme Court said in United States v. Wisenfeld Warehouse Co., 376 U. S. 86 at Page 91 (1964):

"Food and drug legislation, concerned as it is with protecting the lives and health of human beings, under circumstances in which they might be unable to protect themselves, often 'dispenses with the conventional requirement for criminal conduct — awareness of some wrongdoing.' In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger." United States v. Balint, 258 U. S. 250 and United States v. Dotterweich, 320 U. S. 277 at 281.

Because of their respective positions at Baltimore Pizza Crust, the individual Defendants clearly stood "in responsible relation to a public danger."

The Court in this regard finally again quotes from the opinion of Mr. Justice Frankfurter speaking about the defendant Dotterweich in that case, who was president of the corporation involved. Mr. Justice Frankfurter said at Page 286 of 64 S. Ct.:

"The offense is committed … by all who … have such a responsible share in the furtherance of the transaction which the statute outlaws, namely, to put into the stream of interstate commerce adulterated or misbranded drugs (or food). Hardship there doubtless may be under a statute which thus penalizes the transaction though consciousness of wrongdoing be totally wanting. Balancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless."

For all of the reasons stated, the Court will enter a judgment order against the Defendants in the case, and I will ask the Government to submit such an order promptly.

MISS TRIMBLE: Yes, we will, Your Honor.

We will also order a presentence report for the two individual Defendants.

THE COURT: Very good. Is there anything further this morning?

MISS TRIMBLE: I don't believe so, Your Honor. They are on personal recognizance and we have no objection to that continuing, Your Honor.

THE COURT: Yes, the Court will continue both Defendants at liberty on their own personal recognizance.

I hereby certify the foregoing is a true and accurate excerpt from transcript of proceedings.

S. M. Lee Schap
Official Court Reporter

476 U.S. 974 (1986)

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

[975] Paul J. Larkin, Jr., argued the cause for petitioner. With him on the briefs were Solicitor General Fried, Assistant Attorney General Willard, Deputy Solicitor General Geller, Leonard Schaitman, Marleigh D. Dover, and Thomas Scarlett.

William B. Schultz argued the cause for respondents. With him on the brief were Alan B. Morrison and Katherine A. Meyer.^[1]

JUSTICE O'CONNOR delivered the opinion of the Court.

We granted certiorari in this case to determine whether the Court of Appeals for the District of Columbia Circuit correctly concluded that the Food and Drug Administration's longstanding interpretation of 21 U. S. C. § 346 was in conflict with the plain language of that provision. 474 U. S. 1018 (1985). We hold that, in light of the inherent ambiguity of the statutory provision and the reasonableness of the Food [976] and Drug Administration's interpretation thereof, the Court of Appeals erred. We therefore reverse.

I

A

The Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act (Act) as the designee of the Secretary of Health and Human Services. 21 U. S. C. § 371(a). See also 21 CFR § 5.10 (1986). The Act seeks to ensure the purity of the Nation's food supply, and accordingly bans "adulterated" food from interstate commerce. 21 U. S. C. § 331(a). Title 21 U. S. C. § 342(a) deems food to be "adulterated"

"(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than [exceptions not relevant here]) which is unsafe within the meaning of section 346a(a) of this title . . . ."

As this provision makes clear, food containing a poisonous or deleterious substance in a quantity that ordinarily renders the food injurious to health is adulterated. If the harmful substance in the food is an added substance, then the food is deemed adulterated, even without direct proof that the food may be injurious to health, if the added substance is "unsafe" under 21 U. S. C. § 346.

Section 346 states:

"Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this [977] title; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect . . . food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated . . . ."

Any quantity of added poisonous or added deleterious substances is therefore "unsafe," unless the substance is required in food production or cannot be avoided by good manufacturing practice. For these latter substances, "the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health." It is this provision that is the heart of the dispute in this case.

The parties do not dispute that, since the enactment of the Act in 1938, the FDA has interpreted this provision to give it the discretion to decide whether to promulgate a § 346 regulation, which is known in the administrative vernacular as a "tolerance level." Tolerance levels are set through a fairly elaborate process, similar to formal rulemaking, with evidentiary hearings. See 21 U. S. C. § 371(e). On some occasions, the FDA has instead set "action levels" through a less formal process. In setting an action level, the FDA essentially assures food producers that it ordinarily will not enforce the general adulteration provisions of the Act against them if the quantity of the harmful added substance in their food is less than the quantity specified by the action level.

B

The substance at issue in this case is aflatoxin, which is produced by a fungal mold that grows in some foods. Aflatoxin, a potent carcinogen, is indisputedly "poisonous" or [978] "deleterious" under §§ 342 and 346. The parties also agree that, although aflatoxin is naturally and unavoidably present in some foods, it is to be treated as "added" to food under § 346. As a "poisonous or deleterious substance added to any food," then, aflatoxin is a substance falling under the aegis of § 346, and therefore is at least potentially the subject of a tolerance level.

The FDA has not, however, set a § 346 tolerance level for aflatoxin. It has instead established an action level for aflatoxin of 20 parts per billion (ppb). In 1980, however, the FDA stated in a notice published in the Federal Register:

"The agency has determined that it will not recommend regulatory action for violation of the Federal Food, Drug, and Cosmetic Act with respect to the interstate shipment of corn from the 1980 crop harvested in North Carolina, South Carolina, and Virginia and which contains no more than 100 ppb aflatoxin . . . ." 46 Fed. Reg. 7448 (1981).

The notice further specified that such corn was to be used only as feed for mature, nonlactating livestock and mature poultry. Id., at 7447.

In connection with this notice, two public-interest groups and a consumer (respondents here) brought suit against the Commissioner of the FDA (petitioner here) in the United States District Court for the District of Columbia. Respondents alleged that the Act requires the FDA to set a tolerance level for aflatoxin before allowing the shipment in interstate commerce of food containing aflatoxin; that the FDA had employed insufficiently elaborate procedures to set its aflatoxin action level even if a tolerance level was not required; and that the FDA's decision to grant the 1980 exemption from the action level independently violated the Act and the FDA's own regulations.

On a motion for summary judgment, the District Court deferred to the FDA's interpretation of § 346, and therefore ruled that the FDA need not establish a tolerance level for [979] aflatoxin before allowing the shipment of aflatoxin-tainted corn in interstate commerce. The District Court also ruled against respondents on their other claims.

The Court of Appeals reversed the District Court's conclusion as to the proper interpretation of § 346. 244 U. S. App. D. C. 279, 757 F. 2d 354 (1985). The Court of Appeals determined that Congress had spoken directly and unambiguously to the precise question at issue:

"The presence of the critical word `shall' plainly suggests a directive to the Secretary to establish a tolerance, if a food with an unavoidable . . . deleterious substance is to be considered unadulterated.

.....

"It is . . . clear from the structure of the sentence at issue here that the phrase relied upon by the Secretary simply does not modify the pivotal word `shall.' " Id., at 282, 283, 757 F. 2d, at 357, 358.

After examining the entirety of § 346, the Court of Appeals also concluded that, since tolerance levels make food with added harmful substances unadulterated, tolerance levels were necessary before food could be judged unadulterated. Id., at 283, 757 F. 2d, at 358.

The Court of Appeals considered none of the other issues before the District Court, and therefore only the § 346 issue is before this Court.

II

The FDA's longstanding interpretation of the statute that it administers is that the phrase "to such extent as he finds necessary for the protection of public health" in § 346 modifies the word "shall." The FDA therefore interprets the statute to state that the FDA shall promulgate regulations to the extent that it believes the regulations necessary to protect the public health. Whether regulations are necessary to protect the public health is, under this interpretation, a determination to be made by the FDA.

[980] Respondents, in contrast, argue that the phrase "to such extent" modifies the phrase "the quantity therein or thereon" in § 346, not the word "shall." Since respondents therefore view the word "shall" as unqualified, they interpret § 346 to require the promulgation of tolerance levels for added, but unavoidable, harmful substances. The FDA under this interpretation of § 346 has discretion in setting the particular tolerance level, but not in deciding whether to set a tolerance level at all.

Our analysis must begin with Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). We there stated:

"First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter, for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. . . . [A] court may not substitute its own construction of a statutory provision for a reasonable interpretation made by the administrator of an agency." Id., at 842-844.

While we agree with the Court of Appeals that Congress in § 346 was speaking directly to the precise question at issue in this case, we cannot agree with the Court of Appeals that Congress unambiguously expressed its intent through its choice of statutory language. The Court of Appeals' reading of the statute may seem to some to be the more natural interpretation, but the phrasing of § 346 admits of either respondents' or petitioner's reading of the statute. As enemies of [981] the dangling participle well know, the English language does not always force a writer to specify which of two possible objects is the one to which a modifying phrase relates. A Congress more precise or more prescient than the one that enacted § 346 might, if it wished petitioner's position to prevail, have placed "to such extent as he finds necessary for the protection of public health" as an appositive phrase immediately after "shall" rather than as a free-floating phrase after "the quantity therein or thereon." A Congress equally fastidious and foresighted, but intending respondents' position to prevail, might have substituted the phrase "to the quantity" for the phrase "to such extent as." But the Congress that actually enacted § 346 took neither tack. In the absence of such improvements, the wording of § 346 must remain ambiguous.

The FDA has therefore advanced an interpretation of an ambiguous statutory provision.

"This view of the agency charged with administering the statute is entitled to considerable deference; and to sustain it, we need not find that it is the only permissible construction that [the agency] might have adopted but only that [the agency's] understanding of this very `complex statute' is a sufficiently rational one to preclude a court from substituting its judgment for that of [the agency]. Train, Inc. v. NRDC, 421 U. S. 60, 75, 87 (1975) . . . ." Chemical Manufacturers Assn. v. Natural Resources Defense Council, Inc., 470 U. S. 116, 125 (1985).

We find the FDA's interpretation of § 346 to be sufficiently rational to preclude a court from substituting its judgment for that of the FDA.

To read § 346 as does the FDA is hardly to endorse an absurd result. Like any other administrative agency, the FDA has been delegated broad discretion by Congress in any number of areas. To interpret Congress' statutory language to give the FDA discretion to decide whether tolerance [982] levels are necessary to protect the public health is therefore sensible.

Nor does any other portion of § 346 prohibit the FDA from allowing the shipment of aflatoxin-tainted food without a tolerance level, despite the Court of Appeals' conclusion to the contrary. The Court of Appeals stated:

"Since the existence of a regulation operates to render the food legally unadulterated, the statute, in our view, plainly requires the establishment by regulation of tolerances before aflatoxin-tainted corn may lawfully be shipped in interstate commerce." 244 U. S. App. D. C., at 283, 757 F. 2d, at 358.

The premise of the Court of Appeals is of course correct: the Act does provide that when a tolerance level has been set and a food contains an added harmful substance in a quantity below the tolerance level, the food is legally not adulterated. But one cannot logically draw from this premise, or from the Act, the Court of Appeals' conclusion that food containing substances not subject to a tolerance level must be deemed adulterated. The presence of a certain premise (i. e., tolerance levels) may imply the absence of a particular conclusion (i. e., adulteration) without the absence of the premise implying the presence of the conclusion. For example, the presence of independent and adequate state-law grounds in the decision of a state supreme court means this Court has no jurisdiction over the case, but the absence of independent and adequate state grounds does not mean that this Court necessarily has jurisdiction. The Act is silent on what specifically to do about food containing an unavoidable, harmful, added substance for which there is no tolerance level; we must therefore assume that Congress intended the general provisions of § 342(a) to apply in such a case. Section 342(a) thus remains available to the FDA to prevent the shipment of any food "[i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health." See generally United States v. Lexington Mill & Elevator Co., [983] 232 U. S. 399, 411 (1914) (discussing proper interpretation of the language that became § 342(a)).

The legislative history of the Act provides no single view about whether Congress intended § 346 to be mandatory or permissive with respect to tolerance levels. Compare, e. g., Confidential House Committee Print 2, on Interstate and Foreign Commerce, 75th Cong., 1st Sess., S. 5, § 406(a), reprinted in 5 Legislative History of the Federal Food, Drug, and Cosmetic Act and its Amendments 767, 792 (Dept. of Health, Education, and Welfare 1979) (changing, without explanation, words "is authorized to" to "shall" in relevant provision), with H. R. Rep. No. 2139, 75th Cong., 3d Sess. 6 (1938) (stating that, under the Act, "the establishment of tolerances is authorized") (emphasis added). A clearer indication of Congress' intentions with regard to tolerance levels occurred in 1954, when Congress condemned the cumbersomeness of the tolerance-level procedure as applied to pesticides. Congress fashioned a more streamlined procedure for those and other deliberately added substances. See 21 U. S. C. § 346a. But in revisiting § 346, Congress did not change the procedures governing unintentionally added substances like aflatoxin. This failure to change the scheme under which the FDA operated is significant, for a "congressional failure to revise or repeal the agency's interpretation is persuasive evidence that the interpretation is the one intended by Congress." NLRB v. Bell Aerospace, Co., 416 U. S. 267, 275 (1974). See FDIC v. Philadelphia Gear Corp., ante, at 437; Zenith Radio Corp. v. United States, 437 U. S. 443, 457 (1978). In sum, although the legislative history is not unambiguous, it certainly is no support for assertions that the FDA's interpretation of § 346 is insufficiently rational to warrant our deference.

Finally, we note that our interpretation of § 346 does not render that provision superfluous, even in light of Congress' decision to authorize the FDA to "promulgate regulations for the efficient enforcement of [the] Act." 21 U. S. C. § 371(a). [984] Section 346 gives the FDA the authority to choose whatever tolerance level is deemed "necessary for the protection of public health," and food containing a quantity of a required or unavoidable substance less than the tolerance level "shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated." Section 346 thereby creates a specific exception to § 342(a)'s general definition of adulterated food as that containing a quantity of a substance that renders the food "ordinarily . . . injurious to health." Simply because the FDA is given the choice between employing the standard of § 346 and the standard of § 342(a) does not render § 346 superfluous.

For the reasons set forth, the judgment is reversed, and the case is remanded to the Court of Appeals for the District of Columbia Circuit for further proceedings consistent with this opinion.

Reversed.

JUSTICE STEVENS, dissenting.

The parties agree that aflatoxins are added, unavoidable contaminants of food and as such are governed by the following provision of the Federal Food, Drug, and Cosmetic Act:

"[W]hen such substance . . . cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title." 21 U. S. C. § 346 (emphasis added).

To one versed in the English language, the meaning of this provision is readily apparent. The plain language of the section tells us when the Secretary's duty to promulgate regulations arises — "when such substance . . . cannot be so avoided"; it tells us the purpose of the regulations — to establish [985] a tolerance level that will enable manufacturers to know what they can lawfully produce and to enable the public to know what they can safely consume; and it tells us what standard he should employ in drafting them — "to such extent as he finds necessary for the protection of public health." For purposes of deciding this case, the parties' agreement that aflatoxins are substances that "cannot be so avoided" within the meaning of the section triggers the obligation to initiate rulemaking.

The Court's contrary conclusion reflects an absence of judgment and of judging. Before exploring either infirmity, it is worthwhile to summarize the Court's reason for reading the section to authorize, but not require, the promulgation of regulations. First, the Court declares that the qualifying language — "to such extent as he finds necessary for protection of the public health" — is a "dangling participle" that might or might not modify the words "shall promulgate regulations." Ante, at 981. Second, as between the two readings of this "ambiguous statutory provision," ibid., deference dictates that the Commissioner of the Food and Drug Administration (FDA) (to whom enforcement of the Act has been delegated) may take his pick.

The Court's finding of ambiguity is simply untenable. The antecedent of the qualifying language is quite clearly the phrase "limiting the quantity therein or thereon," which immediately precedes it, rather than the word "shall," which appears eight words before it. Thus, the Commissioner is to "limi[t] the quantity [of an added, unavoidable poisonous or deleterious substance] therein or thereon to such extent as he finds necessary for the protection of public health."^[2] By instead [986] reading the section to mean that "the Secretary shall promulgate regulations . . . to such extent as he finds necessary," the Court ignores the import of the words immediately following, which specify the effect of the "limits so fixed" — i. e., fixed by "limiting the quantity [of the poisonous substance] therein or thereon to such extent as he finds necessary for the protection of public health" — which can only mean that the qualification modifies the limits set by regulation rather than the duty to regulate. In addition, the Court's construction, by skipping over the words "limiting the quantity therein or thereon," renders them superfluous and of no operative force or effect. Indeed, the Court renders the very language it construes superfluous, because reading the provision to authorize (rather than mandate) the promulgation of regulations assigns it an office already filled by the general rulemaking authority conferred later in the Food, Drug, and Cosmetic Act. See 21 U. S. C. § 371(a).^[3] If Congress intended the Secretary to have unbridled authority to proceed with action levels, instead of with formal regulations, there was no need to enact this part of § 346 at all. This is plainly a case in which "the intent of Congress is clear [and] the court, as well as the agency, must give effect to the [987] unambiguously expressed intent of Congress." Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-843 (1984).^[4]

[988] The task of interpreting a statute requires more than merely inventing an ambiguity and invoking administrative deference. A statute is not "unclear unless we think there are decent arguments for each of two competing interpretations of it." R. Dworkin, Law's Empire 352 (1986). Thus, to say that the statute is susceptible of two meanings, as does the Court, is not to say that either is acceptable. Furthermore, to say that the Commissioner's interpretation of the statute merits deference, as does the Court, is not to say that the singularly judicial role of marking the boundaries of agency choice is at an end. As Justice Frankfurter reminds us, "[t]he purpose of construction being the ascertainment of meaning, every consideration brought to bear for the solution of that problem must be devoted to that end alone." Frankfurter, Some Reflections on the Reading of Statutes, 47 Colum. L. Rev. 527, 529 (1947). It is not "a ritual to be observed by unimaginative adherence to well-worn professional phrases." Ibid. "Nor can canons of construction save us from the anguish of judgment." Id., at 544. The Court, correctly self-conscious of the limits of the judicial role, employs a reasoning so formulaic that it trivializes the art of judging.

I respectfully dissent.

[1] Briefs of amici curiae urging reversal were filed for the State of South Carolina by Philip C. Olsson, T. Travis Medlock, Attorney General, and Brooks Shealy, Assistant Attorney General; for the American Feed Industry Association by David F. Weeda; for the Grocery Manufacturers of America, Inc., by Peter Barton Hutt; for the National Food Processors Association by H. Edward Dunkelberger, Jr.; and for the National Peanut Council, Inc., by James M. Goldberg.

[2] This interpretation is in accord with the Committee Report on the House bill, which became the Food, Drug, and Cosmetic Act of 1938. The Report states that "[t]he addition of poison to foods is prohibited except where such addition is necessary or cannot be avoided; and in such cases tolerances are provided limiting the amount of added poison to the extent necessary to safeguard the public health." H. R. Rep. No. 2139, 75th Cong., 3d Sess., pt. 1, p. 2 (1938) (emphasis added). By using the present tense, the Report makes clear that the qualifying language is operative when regulations are promulgated — to limit the amount of poison "to the extent necessary to safeguard the public health." The qualifying language thus defines the standard by which tolerances are to be determined and not the occasions on which regulations are to be promulgated.

[3] The Court does not deny that the specific language which it construes — the clause providing that "the Secretary shall promulgate regulations" setting tolerance levels — is superfluous under its view of the Act. See ante, at 983-984. It instead emphasizes that a later sentence in § 346 which prescribes the legal effect of tolerance-setting regulations remains effective. But since tolerances may be promulgated pursuant to § 371(a) as well as § 346, the Court's response merely underscores the fact that its construction of the "shall promulgate" clause to authorize rather than to require such rulemaking renders it redundant to the general rulemaking authority conferred by § 371(a).

[4] Because Congress explicitly required the Commissioner to promulgate regulations for added, unavoidable contaminants, that should be "the end of the matter." Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S., at 842. The Commissioner's "longstanding" practice to the contrary does not help his legal position. For even if it were true that the Commissioner has from time to time announced an "action level" to advise the industry when he intended to institute enforcement proceedings concerning certain deleterious substances, the fact that the FDA had never actually addressed in any detail the statutory authorization under which it took such action means that its plea for deference should fail for the reasons carefully stated in SEC v. Sloan, 436 U. S. 103, 117-118 (1978):

"The Commission next argues that its interpretation of the statute — that the statute authorizes successive suspension orders — has been both consistent and longstanding, dating from 1944. It is thus entitled to great deference. See United States v. National Assn. of Securities Dealers, 422 U. S. 694, 710 (1975); Saxbe v. Bustos, 419 U. S. 65, 74 (1974).

"While this undoubtedly is true as a general principle of law, it is not an argument of sufficient force in this case to overcome the clear contrary indications of the statute itself. In the first place it is not apparent from the record that on any of the occasions when a series of consecutive summary suspension orders was issued the Commission actually addressed in any detail the statutory authorization under which it took that action.

.....

"[S]ince this Court can only speculate as to the Commission's reasons for reaching the conclusion that it did, the mere issuance of consecutive summary suspension orders, without a concomitant exegesis of the statutory authority for doing so, obviously lacks `power to persuade' as to the existence of such authority. [Adamo Wrecking Co. v. United States, 434 U. S. 275, 287-288, n. 5 (1978)]."

As we emphasized in FMC v. Seatrain Lines, Inc., 411 U. S. 726, 745 (1973), "an agency may not bootstrap itself into an area in which it has no jurisdiction by repeatedly violating its statutory mandate." Instead, "our clear duty in such a situation is to reject the administrative interpretation of the statute." SEC v. Sloan, 436 U. S., at 119.

The Sloan case also provides an adequate answer to the argument that Congress has revisited the statute from time to time without condemning the FDA's "action level" practice:

"We are extremely hesitant to presume general congressional awareness of the Commission's construction based only upon a few isolated statements in the thousands of pages of legislative documents. That language in a Committee Report, without additional indication of more widespread congressional awareness, is simply not sufficient to invoke the presumption in a case such as this. For here its invocation would result in a construction of the statute which not only is at odds with the language of the section in question and the pattern of the statute taken as a whole, but also is extremely far reaching in terms of the virtually untrammeled and unreviewable power it would vest in a regulatory agency." Id., at 121.

818 F.2d 943 (1987)

[944] William B. Schultz, with whom Alan B. Morrison and Katherine A. Meyer, Washington, D.C., were on the brief for appellants.

Michael J. Ryan, Asst. U.S. Atty., with whom Joseph E. diGenova, U.S. Atty., Royce C. Lamberth, Craig Lawrence, Asst. U.S. Attys., Washington, D.C., Thomas Scarlett, Chief Counsel, Rockville, Md., and Michael M. Landa, Associate Chief Counsel for Enforcement, Food and Drug Admin., were on the brief for appellee. Patricia J. Kenney, Asst. U.S. Atty., Washington, D.C., Stephen D. Terman, Counsel, Food and Drug Admin., Rockville, Md., Richard K. Willard, Atty. Gen., Leonard Schaitman and John M. Rogers, Attorneys, Dept. of Justice, Washington, D.C., entered appearances for appellee.

[945] Philip C. Olsson, Washington, D.C., was on the brief for amicus curiae in support of appellee, State of South Carolina, urging affirmance of the Dist. Court decision.

Before MIKVA, EDWARDS and STARR, Circuit Judges.

Opinion PER CURIAM.

Opinion concurring in part and dissenting in part filed by Circuit Judge STARR.

PER CURIAM:

This case makes its second appearance before this court. It presents a challenge by a consortium of organizations and private citizens (collectively referred to as CNI) to the Food and Drug Administration's regulation of certain unavoidable contaminants in food, most particularly, aflatoxins in corn.^[1] Pursuant to its statutory mandate to limit the amount of "poisonous or deleterious substances" in food, see 21 U.S.C. § 346, FDA establishes "action levels" informing food producers of the allowable levels of unavoidable contaminants such as aflatoxins. Producers who sell products that are contaminated above the action level, which for aflatoxins in corn is currently set at 20 parts per billion, are subject to enforcement proceedings initiated by FDA.

CNI filed suit in federal district court, launching a three-pronged attack on FDA's action level for aflatoxins in corn: (1) in issuing the action level, FDA failed to comply with the rulemaking requirements of the Food, Drug and Cosmetic Act (FDC Act), see 21 U.S.C. § 346; (2) the action level violated the Administrative Procedure Act because it constitutes a legislative rule issued without the requisite notice-and-comment procedures, see 5 U.S.C. § 553; and (3) FDA's decision to permit adulterated corn to be blended with unadulterated corn to bring the total contamination within the action level violated the FDC Act. The District Court granted summary judgment in favor of FDA on each issue.

In our initial opinion, we confined ourselves to CNI's first argument. We concluded that the FDC Act, by stating that FDA "shall promulgate regulations," 21 U.S.C. § 346, required that FDA issue formal regulations or "tolerances," rather than informal action levels. Having invalidated the action level on this ground, we concluded that CNI's APA argument was thus rendered moot and that the blending issue stood in need of reevaluation on remand. See 757 F.2d 354 (D.C.Cir.1985).

The Supreme Court reversed our decision, ___ U.S. ___, 106 S.Ct. 2360, 90 L.Ed.2d 959, holding that the FDC Act was not so clear as to preclude FDA's interpretation of the statute under which the agency could lawfully proceed by way of action levels. 106 S.Ct. 2360 (1986). Since the Court did not reach the APA or blending issues, it remanded the case to this court for "further proceedings consistent with [its] opinion." Id. at 2366. Thus, with the first issue resolved by the High Court, we must now address the still pending APA and blending issues.

I

Under the APA, agency rules^[2] may be issued only after the familiar notice-and-comment procedures enumerated in the statute are completed. See 5 U.S.C. § 553. It is undisputed that the action level at issue here was promulgated sans those procedures. FDA, however, argues that notice-and-comment requirements do not apply by virtue of subsection (b)(3)(A) of section 553, which carves out an exception for "interpretative rules [and] general statements of policy." According to the [946] FDA, action levels represent nothing more than nonbinding statements of agency enforcement policy. CNI, on the other hand, argues that the action levels restrict enforcement discretion to such a degree as to constitute legislative rules.

The distinction between legislative rules and interpretative rules or policy statements has been described at various times as "tenuous," Chisholm v. FCC, 538 F.2d 349, 393 (D.C.Cir.), cert. denied, 429 U.S. 890, 97 S.Ct. 247, 50 L.Ed.2d 173 (1976), "fuzzy," Pacific Gas & Electric Co. v. FPC, 506 F.2d 33, 38 (D.C.Cir.1974), "blurred," Saunders, Interpretative Rules With Legislative Effect: An Analysis and a Proposal For Public Participation, 1986 Duke L.J. 346, 352, and, perhaps most picturesquely, "enshrouded in considerable smog." Noel v. Chapman, 508 F.2d 1023, 1030 (2d Cir.), cert. denied, 423 U.S. 824, 96 S.Ct. 37, 46 L.Ed.2d 40 (1975), quoted in American Bus Association v. United States, 627 F.2d 525, 529 (D.C. Cir.1980).^[3] As Professor Davis puts it, "the problem is baffling." 2 K. Davis, Administrative Law Treatise 32 (2d ed. 1979). By virtue of Congress' silence with respect to this matter, it has fallen to the courts to discern the line through the painstaking exercise of, hopefully, sound judgment. Guardian Federal Savings & Loan Ass'n v. FSLIC, 589 F.2d 658, 667 (D.C.Cir.1978).

Despite the difficulty of the terrain, prior cases do provide some useful guideposts. In this circuit, we are particularly guided by American Bus. There, in speaking for the court, Judge McGowan identified "two criteria" that courts have used in their efforts to fathom the interpretative/legislative distinction:

First, courts have said that, unless a pronouncement acts prospectively, it is a binding norm. Thus ... a statement of policy may not have a present effect: "a `general statement of policy' is one that does not impose any rights and obligations"....

The second criterion is whether a purported policy statement genuinely leaves the agency and its decisionmakers free to exercise discretion.

627 F.2d at 529 (quoting Texaco v. FPC, 412 F.2d 740, 744 (3d Cir.1969)).^[4]

In conducting our analysis of these two criteria, we consider and give some, albeit "not overwhelming," deference to an agency's characterization of its statement. Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537 (D.C.Cir.1986).^[5] As befits a principled exercise in interpretation, courts are to give far greater weight to the language actually used by the agency; we have, for example, found decisive the choice between the words "will" and "may." Compare American Bus, 627 F.2d at 532 (use of "will" indicates statement is in fact a binding norm) with Guardian Federal, 589 F.2d at 666 (use of "may" indicates statement is a "general statement of policy").

Applying these principles to the case at hand, we are persuaded that the FDA action levels are legislative rules and thus subject to the notice-and-comment requirements of section 553. While FDA [947] now characterizes the action levels as policy statements, see, e.g., Supplemental Brief for Appellee at 7 ("In sum, action levels do not bind courts, food producers or FDA."), a variety of factors, when considered in light of the criteria set out in American Bus, indicate otherwise.

First. The language employed by FDA in creating and describing action levels suggests that those levels both have a present effect and are binding. Specifically, the agency's regulations on action levels explain an action level in the following way:

[A]n action level for an added poisonous or deleterious substance ... may be established to define the level of contamination at which food will be deemed to be adulterated. An action level may prohibit any detectable amount of substance in food.

21 C.F.R. § 109.4 (1986) (emphasis added).^[6] This language, speaking as it does of an action level "defin[ing]" the acceptable level and "prohibit[ing]" substances, clearly reflects an interpretation of action levels as presently binding norms.^[7] This type of mandatory, definitive language is a powerful, even potentially dispositive, factor suggesting that action levels are substantive rules. Cf. Cathedral Bluffs, 796 F.2d at 538. Moreover, the regulations provide that an action level may appropriately be established whenever there exist the same conditions required to establish a formal tolerance, if, in addition, the "appropriateness" of the tolerance may change in the near future because, for example, of technological changes. 21 C.F.R. § 109.6(c); see also id. § 109.6(b) (requirements for establishing a tolerance).^[8]

Second. This view of action levels — as having a present, binding effect — is confirmed by the fact that FDA considers it necessary for food producers to secure exceptions to the action levels. A specific regulatory provision allows FDA to "exempt from regulatory action and permit the marketing of any food that is unlawfully contaminated with a poisonous or deleterious substance" if certain conditions exist. Id. § 109.8(a). This language implies that in the absence of an exemption, food with aflatoxin contamination over the action level is "unlawful." This putatively unlawful status can derive only from the action level, which, again, indicates that the action level is a presently binding norm. If, as the agency would have it, action levels did indeed "not bind courts, food producers or FDA," Supplemental Brief for Appellee at 7, it would scarcely be necessary to require that "exceptions" be obtained.

Third. On several occasions, in authorizing blending of adulterated with unadulterated corn, see infra Part II, the FDA has made statements indicating that action levels establish a binding form. For example, in a telegram to the Commissioner of the South Carolina Department of Agriculture, [948] in which it indicated its approval of a blending plan, the FDA stated that "[a]ny shipments made independent of this plan would, if found to exceed the 20 ppb level, be considered adulterated and subject to condemnation." Joint Appendix (J.A.) at 112 (emphasis added). But we need not resort to informal communications, cf. Ciba-Geigy Corp. v. EPA, 801 F.2d 430 (D.C.Cir.1986), where precision of draftsmanship may understandably be wanting. For, in a formal notice published in the Federal Register of a decision to permit blending and interstate shipment, FDA wrote:

Any food that contains aflatoxin in excess of 20 ppb ... is considered by FDA to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)), and therefore may not be shipped in interstate commerce.

46 Fed.Reg. 7447 (1981) (emphasis added), reprinted in J.A. at 49. Both statements, one informal and the other elaborately formal, indicate that, when judged under the American Bus criteria, action levels constitute substantive rules. The agency's own words strongly suggest that action levels are not musings about what the FDA might do in the future but rather that they set a precise level of aflatoxin contamination that FDA has presently deemed permissible. Action levels inform food producers what this level is; indeed, that is their very purpose.

We are not unmindful that in a suit to enjoin shipment of allegedly contaminated corn, it appears that FDA would be obliged to prove that the corn is "adulterated," within the meaning of the FDC Act, rather than merely prove non-compliance with the action level. See United States v. Boston Farm Center, Inc., 590 F.2d 149, 151 (5th Cir.1979).^[9] The action level thus does not bind food producers in the sense that producers are automatically subject to enforcement proceedings for violating the action level. This factor, accordingly, points in favor of the agency's characterization. But the fact that action levels do not completely bind food producers as would a more classic legislative rule (where the only issue before the court would be if the agency rule were in fact violated) is not determinative of the issue. For here, we are convinced that FDA has bound itself. As FDA conceded at oral argument, it would be daunting indeed to try to convince a court that the agency could appropriately prosecute a producer for shipping corn with less than 20 ppb aflatoxin. And this type of cabining of an agency's prosecutorial discretion can in fact rise to the level of a substantive, legislative rule. Cf. Nader v. CAB, 657 F.2d 453 (D.C.Cir.1981); Guardian Federal, 589 F.2d at 666-67 ("If it appears that a so-called policy statement is in purpose or likely effect one that narrowly limits administrative discretion, it will be taken for what it is — a binding rule of substantive law.") (emphasis added). That is exactly what has happened here.

In sum, consideration of a variety of factors leads us to conclude that the FDA's action levels are not within the section 553(b)(3)(A) exception to notice-and-comment requirements.^[10] Since all agree that [949] those procedures were not followed, the action level at issue here cannot stand.

We pause to observe that nothing in our decision today generally precludes FDA from proceeding by way of informal action levels. The Supreme Court has, of course, decided that such a course is permissible under the FDC Act. Our limited holding is that the current action levels are treated as substantive rules by FDA and, as such, can only be permitted if notice-and-comment procedures are employed. If it so chooses, FDA could proceed by action levels that are pure policy statements. But in order to do so, FDA must avoid giving action levels the kind of substantive significance that it now so plainly attaches to them.

We add one additional caveat. Our holding today in no way indicates that agencies develop written guidelines to aid their exercise of discretion only at the peril of having a court transmogrify those guidelines into binding norms. We recognize that such guidelines have the not inconsiderable benefits of apprising the regulated community of the agency's intentions as well as informing the exercise of discretion by agents and officers in the field. It is beyond question that many such statements are non-binding in nature and would thus be characterized by a court as interpretative rules or policy statements. We are persuaded that courts will appropriately reach an opposite conclusion only where, as here, the agency itself has given its rules substantive effect.

In sum, our holding today is narrow. We conclude that in the circumstances of this case, FDA by virtue of its own course of conduct has chosen to limit its discretion and promulgated action levels which it gives a present, binding effect. Having accorded such substantive significance to action levels, FDA is compelled by the APA to utilize notice-and-comment procedures in promulgating them.

II

The FDA has, on several occasions, granted exemptions to permit the blending of contaminated corn with uncontaminated corn. See, e.g., 43 Fed.Reg. 14,122 (1978), reprinted in J.A. at 41. This blending is typically permitted to help food producers cope with seasonal weather variations which may result in a particular harvest yielding corn with a higher level of aflatoxin. See Supplementary Brief of the State of South Carolina as Amicus Curiae in Support of Appellee at 1-4. In such circumstances, the FDA may permit blending to bring the total level of aflatoxin contamination in the final, blended corn within acceptable levels.

CNI contends that this blending practice causes the final product to be "adulterated" within the meaning of 21 U.S.C. § 342(a)(2)(A). This section reads, in relevant part, as follows:

A food shall be deemed to be adulterated — ... if it bears or contains any added poisonous or added deleterious substance ... which is unsafe within the meaning of section 346 of this title.

Section 346, in turn, states that

[a]ny poisonous or deleterious substance added to any food, except where such substance ... cannot be avoided ... shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a).

21 U.S.C. § 346. The intentional blending of contaminated corn obviously cannot in reason be considered unavoidable. Surely there can be little doubt that blended corn therefore stands branded as "adulterated" for purposes of the FDC Act; indeed, in its initial brief FDA conceded as much:

The Government does not dispute [CNI's] contention that use of an adulterated feed as an ingredient in another feed causes the finished (blended) feed to be adulterated.

Brief for Appellee at 36. But as FDA goes on to point out, a conclusion that a particular food product is "adulterated," in the abstract, means little other than that FDA [950] could choose to initiate enforcement proceedings. CNI does not, and could not, point to any provision in the FDC Act requiring FDA to initiate enforcement action against every food falling within the Act's definition of "adulterated." Rather, the Act makes clear that these enforcement decisions are vested, as they traditionally are, with the agency. Section 336, for example, expressly recognizes that FDA need not "report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this [Act]." 21 U.S.C. § 336.

Upon analysis, therefore, the gravamen of CNI's complaint is that FDA failed to initiate enforcement proceedings. But as the Supreme Court held in Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), FDA enjoys complete discretion not to employ the enforcement provisions of the FDC Act, and those decisions are not subject to judicial review. As this court recently concluded, the "provisions [of the FDC Act] authorize, but do not compel the FDA to undertake enforcement activity; they `commit complete discretion to the [FDA] to decide how and when they should be exercised.'" Schering Corp. v. Heckler, 779 F.2d 683, 686 (D.C.Cir.1985) (quoting Heckler v. Chaney, 105 S.Ct. at 1658). In light of this principle, CNI's arguments on the blending issue must fall.

III

In conclusion, we find FDA's action levels to be invalid in that they were issued without the requisite notice-and-comment procedures, but we reject CNI's challenge to FDA's disinclination to initiate enforcement action against certain blended corn. Accordingly, the case is remanded to the District Court for further proceedings not inconsistent with this opinion.

It is so ordered.

STARR, Circuit Judge, concurring in part and dissenting in part:

I fully concur in section II of the panel opinion, holding that FDA's decision to permit blending fell within the agency's enforcement discretion. I am also persuaded that the majority's careful treatment of the substantive rules-policy statements distinction is not unfaithful to the teachings of this circuit's more recent precedents. Nonetheless, I am constrained to conclude that the correct rule was that laid down by our court thirteen years ago in Pacific Gas & Electric Co. v. FPC, where we held:

The critical distinction between a substantive rule and a general statement of policy is the different practical effect that these two types of pronouncements have in subsequent administrative proceedings.... A properly adopted substantive rule establishes a standard of conduct which has the force of law.

506 F.2d 33, 38 (D.C.Cir.1974). The Pacific Gas-enunciated factor — whether the pronouncement has the force of law in subsequent proceedings — should be deemed determinative of the issue. Because there is no doubt that the agency pronouncements at issue here have no such effect, I respectfully dissent from section I of the panel opinion.

I

The abiding characteristic of a legislative rule is that it is law. It defines a standard of conduct that regulated individuals or entities ignore at their peril, in the face of possible enforcement action. Significantly, the only issue in any such proceeding is whether the rule applies to the facts at hand. "The underlying policy embodied in the rule is not generally subject to challenge before the agency." Id., at 38.

Before such rules are sanctioned one would think that they should be carefully crafted, with the "underlying polic[ies] embodied in the rule" recognized, openly discussed, and deliberately weighed. To return to basic civics for a moment, statutes passed by Congress have been refined in this manner by the very nature of the legislative process. Bills are considered by committees, hearings are held, debate is conducted, compromises are reached, and votes are taken. And all this is carried on in a bicameral legislative body with the final result presented to the President for [951] his approval or rejection. See INS v. Chadha, 462 U.S. 919, 103 S.Ct. 2764, 77 L.Ed.2d 317 (1983). A statute therefore possesses important attributes justifying placement of the coercive power of the state behind a particular policy framed in accordance with the process ordained at the Founding.

In the modern administrative state, many "laws" emanate not from Congress but from administrative agencies, inasmuch as Congress has seen fit to vest broad rulemaking power in the executive branch, including independent agencies. See Synar v. United States, 626 F.Supp. 1374, 1383-84 (D.D.C.) (three judge court), aff'd, ___ U.S. ___, 106 S.Ct. 3181, 92 L.Ed.2d 583 (1986); K. Davis Administrative Law Treatise § 3.8 (1982 Supp.); cf. Ticor Title Insurance Co. v. FTC, 814 F.2d 731, 732 (D.C.Cir.1987) (dismissing on procedural grounds a challenge to the delegation of law enforcement powers to an independent agency). This rulemaking power is obviously cabined by whatever requirements may exist in the particular statute delegating rulemaking authority, a subject which we treated in our initial decision in this case. See 757 F.2d 354 (D.C.Cir.1985). But Congress has also provided in the APA for certain procedural protections before that which achieves the lofty status of "law" is promulgated by an agency acting in its Congressionally authorized lawmaking capacity. Chief among these protections are the notice-and-comment requirements laid down in the familiar provision of 5 U.S.C. § 553. In a sense, notice-and-comment procedures serve as a Congressionally mandated proxy for the procedures which Congress itself employs in fashioning its "rules," as it were, thereby insuring that agency "rules" are also carefully crafted (with democratic values served by public participation) and developed only after assessment of relevant considerations. It is thus, in theory, important for APA procedures to be followed before an agency pronouncement is deemed a binding legislative rule not merely because the APA says so, but because in saying so the APA is protecting a free people from the danger of coercive state power undergirding pronouncements that lack the essential attributes of deliberativeness present in statutes. Because of the value inhering in such procedures, it is well-established that "`only reluctantly should courts recognize exceptions therefrom.'" American Bus Association v. United States, 627 F.2d 525, 528 (D.C.Cir.1980) (quoting Humana of South Carolina v. Califano, 590 F.2d 1070, 1082 (D.C.Cir.1978)).

Nonetheless, in crafting the APA, Congress directed that courts should recognize certain exceptions to the statute's notice-and-comment requirements. Specifically, Congress recognized that not all agency pronouncements, even those of considerable moment, rise to the dignity of law. Thus, the APA excepts, as the panel opinion recounts, interpretative rules and general statements of policy from the general notice-and-comment requirements. While it is no doubt true, and indeed is frequently recognized, that such agency pronouncements may have a direct effect on the regulated community, and may even be judicially reviewable, see, e.g., AFL-CIO v. Donovan, 757 F.2d 330, 341-43 (D.C.Cir.1985); cf. Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), these pronouncements still lack the dignity of "law." Before that status can be achieved, the agency must run its policies through the notice-and-comment gantlet. Perhaps in part because the agency here has avoided testing its pronouncements in this way, it must in any future proceeding defend and justify its chosen standard in the face of a challenge to that standard. Cf. United States v. Boston Farm Center, Inc., 590 F.2d 149, 151 (5th Cir.1979).

II

The majority is quite correct when it chronicles the difficulty courts have found in attempting to fathom the distinction between legislative or substantive rules on one hand, and interpretative rules or policy statements on the other.^[11] Inasmuch as our [952] decisional law over the last decade avowedly reflects considerable uncertainty in discerning the line between agency pronouncements that are "law" and those that are "policy," see Majority Opinion at 946, it seems advisable to return to the pristine teaching of Pacific Gas. In that case, this court articulated a rule which is clearly preferable to the present muddy state of the law. The wisdom of the Pacific Gas principle is in no small measure found in the fact that the case reflects the "core principles" which I sought briefly to adumbrate in the preceding section of this opinion. As I read the case, Pacific Gas deems as "critical" the effect of the agency pronouncement in future proceedings. This is as it should be, for as I discussed above, it is this element that is the essence of "law." Not only is the Pacific Gas approach therefore the most principled manner in which to draw the legislative-interpretative line (in view of the fact that the determination is whether a pronouncement is "law" or not), but it has the not insignificant practical benefit in an unclear world of providing great clarity where previously there has been "considerable smog." See American Bus, 627 F.2d at 529.

We should reembrace our Pacific Gas test as the determinative factor in analyzing whether a particular pronouncement is legislative or interpretative in nature. If the pronouncement has the force of law in future proceedings, it is a legislative rule. Unless that critical feature is present, however, the agency statement should be considered to be a lower form of pronouncement, a "non-law" as it were, or in APA terms an "interpretative rule" or "general statement of policy." The correct measure of a pronouncement's force in subsequent proceedings is a practical one: must the agency merely show that the pronouncement has been violated or must the agency, if its hand is called, show that the pronouncement itself is justified in light of the underlying statute and the facts.

Application of this test can readily be illustrated by the case at hand.^[12] Action levels offer guidance to the regulated community with respect to what products FDA deems adulterated within the meaning of the FDC Act. But in an enforcement proceeding in which FDA seeks either to impose sanctions for shipment of an adulterated product or to enjoin shipment of an adulterated product, the agency must prove the product is "adulterated." That is, FDA cannot merely show that the product at issue fails to comply with the action level. See Boston Farm Center, 590 F.2d at 151. Rather, FDA must offer scientific or other probative evidence to support its contention that the product is adulterated. Thus, the action level does not have the force of law in the subsequent proceeding. Indeed, it has no "force" at all.

Let me quickly observe that I am not encouraging rebellion and sedition within the circuit. While the law has certainly evolved since Pacific Gas, at no point has this court disavowed that decision.^[13] Quite to the contrary, the leading case since Pacific Gas, American Bus, expressly embraced the earlier decision. See 627 F.2d at [953] 529. Moreover, post-American Bus decisions grappling with the legislative rule-interpretative rule distinction have often emphasized the Pacific Gas factor. Just the other day, for example, Judge Bork, in writing for the court in The National Latino Media Coalition v. FCC, 816 F.2d 785, 788 (D.C.Cir.1987), emphasized that "an interpretative rule does not have the force of law and is not binding upon anyone" in holding that the agency pronouncements at issue there were not legislative rules and thus not subject to the APA's notice-and-comment requirements. To my eye, this represents an application, albeit not explicit, of Pacific Gas. Thus, I view Pacific Gas as not only "good" law, in the sense that it has never been overruled, but can discern in our precedents examples, including very fresh ones, of its being heartily applied. I would therefore urge that the "force of law" factor from Pacific Gas be explicitly recognized anew as the polestar guiding the legislative-interpretative determination. Such a modest step would not only be faithful to fundamental principles informing the nature of legislative rules but would have the happy practical consequence of bringing clarity to a troubled area.

While I thus view this step as warranted, I recognize a potential danger lurking in the embrace of a single-factor, Pacific Gas test. Agencies may yield to temptation and seek to shield their regulations from the scrutiny occasioned by notice-and-comment procedures, choosing instead to cast would-be regulations as interpretative rules. The rule would still, of course, be subject to scrutiny in a subsequent proceeding, but this fact may be of little comfort to prospective commentors, given the deference accorded agency views in any such proceedings. See generally Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). But upon analysis, the danger is more theoretical than real. Indeed, Congress not atypically provides agencies with a direct command to promulgate regulations, cf., e.g., Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 100 S.Ct. 2844, 65 L.Ed.2d 1010 (1980), thereby imposing a duty that would not be satisfied with issuance of an humble interpretative rule. In this case, of course, the Supreme Court has now ruled that FDA is not required by the organic statute to issue formal regulations, but can instead proceed by way of informal action levels. ___ U.S. ___, 106 S.Ct. 2360, 90 L.Ed.2d 959 (1986). But if Congress prefers a traditional model of command to the agencies to issue regulations, it can embrace that model through legislation, informed by the need, reiterated by the Supreme Court in this very case, to avoid dangling participles and other forms of that omnipresent occupational hazard of the draftsman's workshop, ambiguity. But see INS v. Cardoza-Fonseca, ___ U.S. ___, 107 S.Ct. 1207, 94 L.Ed.2d 434 (1987); Board of Governors v. Dimension Financial Corp., 474 U.S. 361, 106 S.Ct. 681, 88 L.Ed.2d 691 (1986). Because Pacific Gas, and the basic principles upon which it stands, points the way to a quite different result than that reached by my colleagues, I am constrained to dissent in part.

[1] Aflatoxins are by-products of certain common molds that grow on various crops, including corn.

[2] The APA defines "rule" as "the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy...." 5 U.S.C. § 551(4). FDA does not dispute that its action levels are indeed "rules." The notice-and-comment requirements of section 553 are thus unquestionably triggered and the only question before us is whether one of the statutory exceptions to notice and comment is applicable.

[3] See also Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 536-37 (D.C.Cir.1986) ("[T]here is no axiom to distinguish between a regulation and general statements of policy.").

[4] The first criterion from American Bus could be read as facially inconsistent with the APA. Specifically, criterion one appears to indicate that interpretative rules must be solely prospective: "[C]ourts have said that, unless a pronouncement acts prospectively, it is a binding norm." 627 F.2d at 529. Since under the APA, interpretative rules can be developed and offered as present indications of the agency's enforcement policy, this "present-is-legislative" reading of American Bus would create a conflict with the statutory definition. In our view, however, criterion one from American Bus is addressed to the binding effect of the agency pronouncement; if a statement has a present-day binding effect, it is legislative. Mere pronouncements of what the agency intends, whether for the present or for the future, which do not have a binding effect, are properly classified as interpretative rules. Thus, it is the binding effect, not the timing, which is the essence of criterion one.

[5] As now-Justice Scalia put it when writing for this court: "[T]here is deference and there is deference — and the degree accorded to the agency on a point such as this is not overwhelming." Cathedral Bluffs, 796 F.2d at 537.

[6] The conditional "may" in this provision refers only to the agency's discretion in deciding whether to establish an action level. It does not suggest that, once established, an action level is non-binding. Rather, with respect to binding effect, the regulation speaks in non-conditional terms.

[7] See also Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (FDA Publication 1980) ("Action levels and tolerances represent limits at or above which FDA will take legal action to remove adulterated products from the market.") (emphasis added), reprinted in Joint Appendix (J.A.) at 76, 77.

[8] The specific action level for aflatoxin in corn was published in the Federal Register. In Cathedral Bluffs, this court indicated that such publication did not necessarily suggest that "the matter published was meant to be a regulation, since the APA requires general statements of policy to be published as well." 796 F.2d at 539 (emphasis in original). Rather, the Cathedral Bluffs court indicated that the "real dividing point between regulations and general statements of policy is publication in the Code of Federal Regulations." Id. This factor, among others, led the court to conclude that the pronouncement at issue there was a general statement of policy. In our case, however, the line cannot be so simply drawn. While the specific action level itself was not published in the Code of Federal Regulations, FDA did publish in the C.F.R. regulations authorizing establishment of action levels which, as noted above, indicate that action levels are to have a binding effect. Thus, we deal with a mixed Federal Register-C.F.R. publication, and accordingly find ourselves unable to divine persuasive indications, one way or another, from what may be called the "publication factor."

[9] Boston Farm Center could be read to indicate that the Fifth Circuit viewed action levels as mere general statements of policy. In reviewing the Government's argument that a court should defer to the action level as positively indicating a violation of the Act, the Boston Farm Center court noted that "[t]he deference principle is less compelling when the agency threshold is a matter of prosecutorial discretion instead of rule-making." 590 F.2d at 149. But see United States v. Ewig Bros., 502 F.2d 715, 725 (7th Cir.1974) (An action level is "meant to operate more like a rule of general applicability than a mere prediction of how the agency would choose to exercise its prosecutorial discretion."), cert. denied, 420 U.S. 945, 95 S.Ct. 1324, 43 L.Ed.2d 423 (1975). We may well prefer the Seventh Circuit's characterization, but neither court was addressing the issue before us: whether action levels are within the interpretative rules/general statements of policy exception to APA notice-and-comment requirements. Thus, these casual characterizations are of limited help in our inquiry.

[10] Our conclusion is buttressed by the Supreme Court's opinion in this case, which could be read to reflect an understanding of the action levels as substantive rules. Specifically, the Court described action levels in the following terms: "In setting an action level, the FDA essentially assures food producers that it ordinarily will not enforce the general adulteration provisions of the Act against them." 106 S.Ct. at 2363. This characterization of the action levels as an agency assurance is consistent with our holding that the action levels are substantive rules subject to notice-and-comment procedures.

[11] In addition, the difficulty can be seen in attempts by courts to quite understandably make sense of this area by seeking simple, easily-applied rules. In Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 539 (D.C.Cir.1986), now-Justice Scalia intimates that "[t]he real dividing point between regulations and general statements of policy is publication in the Code of Federal Regulations." Such an approach would certainly be simple, if arguably inconsistent with the notion that the deference entitled to an agency's own characterizations of its statements is "not overwhelming." Id., at 537. I prefer the Pacific Gas approach, which has a much firmer rooting in the core principles at issue.

[12] I recognize that in many ways, nothing can be "readily" demonstrated by the case at hand; action levels, as the FDA has fashioned them, are a rather curious hybrid. Under a functionalist analysis, this form of agency action comes tantalizingly close to a substantive rule. I find particularly compelling the fact that FDA considers it necessary to grant "exceptions" to its action levels. See 21 C.F.R. § 109.8 (1986). Thus, I must confess in candor that I view the majority's approach not only as faithful to our circuit's more recent pronouncements, but as buttressed by common sanse.

[13] What seems to have taken place as the law has evolved (and arguably become obfuscated) is that the Pacific Gas factor has been consigned to a supporting role, as one aspect of what seems to be a multi-factor test.

241 U.S. 265 (1916)

ERROR TO THE CIRCUIT COURT OF APPEALS FOR THE SIXTH CIRCUIT.

[266] Mr. Assistant Attorney General Underwood, with whom Mr. Elliott Cheatham was on the brief, for the United States.

Mr. Harold Hirsch and Mr. J.B. Sizer, with whom Mr. A.W. Chambliss and Mr. W.D. Thomson were on the brief, for the defendant in error.

[270] MR. JUSTICE HUGHES delivered the opinion of the court.

This is a libel for condemnation under the Food and Drugs Act (June 30, 1906, c. 3915, 34 Stat. 768) of a certain quantity of a food product known as `Coca Cola' transported, for sale, from Atlanta, Georgia, to Chattanooga, Tennessee. It was alleged that the product was adulterated and misbranded. The allegation of adulteration was, in substance, that the product contained an added poisonous or added deleterious ingredient, caffeine, [271] which might render the product injurious to health. It was alleged to be misbranded in that the name `Coca Cola' was a representation of the presence of the substances coca and cola; that the product "contained no coca and little if any cola" and thus was an "imitation" of these substances and was offered for sale under their "distinctive name." We omit other charges which the Government subsequently withdrew. The claimant answered, admitting that the product contained as one of its ingredients "a small portion of caffeine," but denying that it was either and `added' ingredient, or a poisonous or a deleterious ingredient which might make the product injurious. It was also denied that there were substances known as coca and cola "under their own distinctive names," and it was averred that the product did contain "certain elements or substances derived from coca leaves and cola nuts." The answer also set forth, in substance, that `Coca Cola' was the `distinctive name' of the product under which it had been known and sold for more than twenty years as an article of food, with other averments negativing adulteration and misbranding under the provisions of the Act.

Jury trial was demanded, and voluminous testimony was taken. The District Judge directed a verdict for the claimant (191 Fed. Rep. 431), and judgment entered accordingly was affirmed on writ of error by the Circuit Court of Appeals (215 Fed. Rep. 535). And the Government now prosecutes this writ.

First. As to `adulteration.' The claimant, in its summary of the testimony, states that the article in question "is a syrup manufactured by the claimant . . . and sold and used as a base for soft drinks both at soda fountains and in bottles. The evidence shows that the article contains sugar, water, caffeine, glycerine, lime juice and other flavoring matters. As used by the consumer, about one ounce of this syrup is taken in a glass mixed with [272] about seven ounces of carbonated water, so that the consumer gets in an eight ounce glass or bottle of the beverage, about 1.21 grains of caffeine." It is said that in the year 1886 a pharmacist in Atlanta "compounded a syrup by a secret formula, which he called `Coca-Cola Syrup and Extract'"; that the claimant acquired "the formula, name, label and good will for the product" in 1892, and then registered "a trade-mark for the syrup consisting of the name Coca Cola" and has since manufactured and sold the syrup under that name. The proportion of caffeine was slightly diminished in the preparation of the article for bottling purposes. The claimant again registered the name `Coca Cola' as a trade-mark in 1905, averring that the mark had been "in actual use as a trade-mark of the applicant for more than ten years next preceding the passage of the act of February 20, 1905," and that it was believed such use had been exclusive. It is further stated that in manufacturing in accordance with the formula "certain extracts from the leaves of the Coca shrub and the nut kernels of the Cola tree were used for the purpose of obtaining a flavor" and that "the ingredient containing these extracts," with cocaine eliminated, is designated as "Merchandise No. 5." It appears that in the manufacturing process water and sugar are boiled to make a syrup; there are four meltings; in the second or third the caffeine is put in; after the meltings the syrup is conveyed to a cooling tank and then to a mixing tank where the other ingredients are introduced and the final combination is effected; and from the mixing tank the finished product is drawn off into barrels for shipment.

The questions with respect to the charge of `adulteration' are (1) whether the caffeine in the article was an added ingredient within the meaning of the Act (§ 7, subd. Fifth) and, if so, (2) whether it was a poisonous or deleterious ingredient which might render the article injurious to health. The decisive ruling in the courts below resulted [273] from a negative answer to the first question. Both the District Judge and the Circuit Court of Appeals assumed for the purpose of the decision that as to the second question there was a conflict of evidence which would require its submission to the jury. (191 Fed. Rep. 433; 215 Fed. Rep. 540.) But it was concluded, as the claimant contended, that the caffeine — even if it could be found by the jury to have the alleged effect — could not be deemed to be an `added ingredient' for the reason that the article was a compound, known and sold under its own distinctive name, of which the caffeine was a usual and normal constituent. The Government challenges this ruling and the construction of the statute upon which it depends; and the extreme importance of the question thus presented with respect to the application of the Act to articles of food sold under trade names is at once apparent. The Government insists that the fact that a formula has been made up and followed and a distinctive name adopted do not suffice to take an article from the reach of the statute; that the standard by which the combination in such a case is to be judged is not necessarily the combination itself; that a poisonous or deleterious ingredient with the stated injurious effect may still be an added ingredient in the statutory sense, although it is covered by the formula and made a constituent of the article sold.

The term `food' as used in the statute includes "all articles used for food, drink, confectionery, or condiment . . . whether simple, mixed, or compound" (§ 6). An article of `food' is to be deemed to be `adulterated' if it contain "any added poisonous or other added deleterious ingredient which may render such article injurious to health." (Sec. 7, subd. Fifth.^[1]) With this [274] section is to be read the proviso in § 8, to the effect that "an article of food which does not contain any added poisonous or deleterious ingredients shall not be deemed to be adulterated or misbranded" in the case of "mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names," if the distinctive name of another article is not used or imitated and the name on the label or brand is accompanied with a statement of the place of production. And § 8 concludes with a further proviso that nothing in the Act shall be construed "as requiring or compelling proprietors or manufacturers of proprietary foods which [275] contain no unwholesome added ingredient to disclose their trade formulas, except in so far as the provisions of this Act may require to secure freedom from adulteration or misbranding."^[2]

[276] In support of the ruling below, emphasis is placed upon the general purpose of the Act which it is said was to prevent deception, rather than to protect the public health by prohibiting traffic in articles which might be determined to be deleterious. But a description of the purpose of the statute would be inadequate which failed to take account of the design to protect the public from lurking dangers caused by the introduction of harmful ingredients, or which assumed that this end was sought to be achieved by simply requiring certain disclosures. The statute is entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors," etc. In the case of confectionery, we find that it is to be deemed to be adulterated if it contains certain specified substances "or other ingredient deleterious or detrimental to health." So, under § 7, subdivision Sixth, there may be adulteration of food in case the article consists in whole or in part of "any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter." In United States v. Lexington Mills Co., 232 U.S. 399, 409, it was said that "the statute upon its face shows that the primary purpose of Congress was to prevent injury to the public health by the sale and transportation [277] in interstate commerce of misbranded and adulterated foods. The legislation, as against misbranding, intended to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was and not upon misrepresentations as to character and quality. As against adulteration, the statute was intended to protect the public health from possible injury by adding to articles of food consumption poisonous and deleterious substances which might render such articles injurious to the health of consumers." See also United States v. Antikamnia Co., 231 U.S. 654, 665; H.R. Report, No. 2118, 59th Cong., 1st Sess., 6-9. It is true that in executing these purposes Congress has limited its prohibitions (Savage v. Jones, 225 U.S. 501, 529, 532) and has specifically defined what shall constitute adulteration or misbranding; but in determining the scope of specific provisions the purpose to protect the public health, as an important aim of the statute, must not be ignored.

Reading the provisions here in question in the light of the context, we observe:

(a) That the term `adulteration' is used in a special sense. For example, the product of a diseased animal may not be adulterated in the ordinary or strict meaning of the word but by reason of its being that product the article is adulterated within the meaning of the Act. The statute with respect to `adulteration' and `misbranding' has its own glossary. We cannot, therefore, assume that simply because a prepared `food' has its formula and distinctive name, it is not, as such, `adulterated.' In the case of confectionery, it is plain that the article may be `adulterated' although it is made in strict accordance with some formula and bears a fanciful trade name, if in fact it contains an `ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound or narcotic drug.' And the context clearly indicates that [278] with respect to articles of food the ordinary meaning of `adulteration' cannot be regarded as controlling.

(b) The provision in § 7, subdivision Fifth, assumes that the substance which renders the article injurious, and the introduction of which causes `adulteration,' is an ingredient of the article. It must be an `added' ingredient; but it is still an ingredient. Component parts, or constituents, of the article which is the subject of the described traffic are thus not excluded but are included in the definition. The article referred to in subdivision Fifth is the article sought to be made an article of commerce, — the article which `contains' the ingredient.

(c) `Adulteration' is not to be confused with `misbranding.' The fact that the provisions as to the latter require a statement of certain substances if contained in an article of food, in order to avoid `misbranding' does not limit the explicit provisions of § 7 as to adulteration. Both provisions are operative. Had it been the intention of Congress to confine its definition of adulteration to the introduction of the particular substances specified in the section as to misbranding, it cannot be doubted that this would have been stated, but Congress gave a broader description of ingredients in defining `adulteration.' It is `any' added poisonous or `other added deleterious ingredient,' provided it `may render such article injurious to health.'

(d) Proprietary foods, sold under distinctive names, are within the purview of the provision. Not only is `food' defined as including articles used for food or drink `whether simple, mixed or compound,' but the intention to include `proprietary foods' sold under distinctive names is manifest from the provisos in § 8 which the claimant invokes. `Mixtures or compounds' which satisfy the first paragraph of the proviso are not only `articles of food,' but are to enjoy the stated immunity only in case they do "not contain any added poisonous or deleterious [279] ingredients." By the concluding clause of § 8, it is provided that nothing in the Act shall be construed to require manufacturers of `proprietary foods' to disclose `their trade formulas' except in so far as the provisions of the Act `may require to secure freedom from adulteration or misbranding,' and the immunity is conditioned upon the fact that such foods `contain no unwholesome added ingredient.' Thus the statute contemplates that mixtures or compounds manufactured by those having trade formulas, and bearing distinctive names, may nevertheless contain `added ingredients' which are poisonous or deleterious and may make the article injurious, and, if so, the article is not taken out of the condemnation of § 7, subdivision Fifth.

(e) Again, articles of food including `proprietary foods' which fall within this condemnation are not saved because they were already on the market when the statute was passed. The Act makes no such distinction; and it is to be observed that the proviso of § 8 explicitly refers to `mixtures or compounds which may be now or from time to time hereafter known as articles of food.' Nor does the length of the period covered by the traffic, or its extent, affect the question if the article is in fact adulterated within the meaning of the Act.

Having these considerations in mind we deem it to be clear that, whatever difficulties there may be in construing the provision, the claimant's argument proves far too much. We are not now dealing with the question whether the caffeine did, or might, render the article in question injurious; that is a separate inquiry. The fundamental contention of the claimant, as we have seen, is that a constituent of a food product having a distinctive name cannot be an `added' ingredient. In such case, the standard is said to be the food product itself which the name designates. It must be, it is urged, this `finished product' that is `adulterated.' In that view, there would [280] seem to be no escape from the conclusion that however poisonous or deleterious the introduced ingredient might be, and however injurious its effect, if it be made a constituent of a product having its own distinctive name it is not within the provision. If this were so, the statute would be reduced to an absurdity. Manufacturers would be free, for example, to put arsenic or strychnine or other poisonous or deleterious ingredients with an unquestioned injurious effect into compound articles of food, provided the compound were made according to formula and sold under some fanciful name which would be distinctive. When challenged upon the ground that the poison was an `added' ingredient, the answer would be that without it the so-called food product would not be the product described by the name. Further, if an article purporting to be an ordinary food product sold under its ordinary name were condemned because of some added deleterious ingredient, it would be difficult to see why the same result could not be attained with impunity by composing a formula and giving a distinctive name to the article with the criticized substance as a component part. We think that an analysis of the statute shows such a construction of the provision to be inadmissible. Certain incongruities may follow from any definition of the word `added,' but we cannot conclude that it was the intention of Congress to afford immunity by the simple choice of a formula and a name. It does not seem to us to be a reasonable construction that in the case of `proprietary foods' manufactured under secret formulas Congress was simply concerned with additions to what such formulas might embrace. Undoubtedly, it was not desired needlessly to embarrass manufacturers of `proprietary foods' sold under distinctive names, but it was not the purpose of the Act to protect articles of this sort regardless of their character. Only such food products as contain `no unwholesome added ingredient' are within the saving clause and [281] in using the words quoted we are satisfied that Congress did not make the proprietary article its own standard.

Equally extreme and inadmissible is the suggestion that where a `proprietary food' would not be the same without the harmful ingredient, to eliminate the latter would constitute an `adulteration' under § 7, subdivision Third, by the abstraction of a `valuable constituent.' In that subdivision Congress evidently refers to articles of food which normally are not within the condemnation of the Act. Congress certainly did not intend that a poisonous or deleterious ingredient which made a proprietary food an enemy to the public health should be treated as a `valuable constituent,' or to induce the continued use of such injurious ingredients by making their elimination an adulteration subject to the penalties of the statute.

It is apparent, however, that Congress in using the word `added' had some distinction in view. In the Senate bill (for which the measure as adopted was a substitute) there was a separate clause relating to `liquors,' providing that the article should be deemed to be adulterated if it contained "any added ingredient of a poisonous or deleterious character"; while in the case of food (which was defined as excluding liquors) the article was to be deemed to be `adulterated' if it contained "any added poisonous or other ingredient which may render such article injurious to human health." Cong. Rec., 59th Cong., 1st Sess., Vol. 40, p. 897. In explaining the provision as to `liquors,' Senator Heyburn, the chairman of the Senate Committee having the bill in charge, stated to the Senate (Id., p. 2647): "The word `added,' after very mature consideration by your committee, was adopted because of the fact that there is to be found in nature's products as she produces them, poisonous substances to be determined by analysis. Nature has so combined them that they are not a danger or an evil — that is, so long as they are left in [282] the chemical connection in which nature has organized them; but when they are extracted by the artificial processes of chemistry they become a poison. You can extract poison from grain or its products and when it is extracted it is a deadly poison; but if you leave that poison as nature embodied it in the original substances it is not a dangerous poison or an active agency of poison at all. — So, in order to avoid the threat that those who produce a perfectly legitimate article from a natural product might be held liable because the product contained nature's poison it was thought sufficient to provide against the adding of any new substance that was in itself a poison, and thus emphasizing the evils of existing conditions in nature's product. That is the reason the word `added' is in the bill. Fusel oil is a poison. If you extract it, it becomes a single active agency of destruction, but allow it to remain in the combination where nature has placed it, and, while it is nominally a poison, it is a harmless one, or comparatively so." For the Senate bill, the House of Representatives substituted a measure which had the particular provisions now under consideration in substantially the same form in which they were finally enacted into law. (Section 7, subd. Fifth; § 8, subd. Fourth, provisos.) And the Committee of the House of Representatives in reporting this substituted measure said (H.R. Report, No. 2118, 59th Cong., 1st Sess., pp. 6, 7, 11): "The purpose of the pending measure is not to compel people to consume particular kinds of foods. It is not to compel manufacturers to produce particular kinds or grades of foods. One of the principal objects of the bill is to prohibit in the manufacture of foods intended for interstate commerce the addition of foreign substances poisonous or deleterious to health. The bill does not relate to any natural constituents of food products which are placed in the foods by nature itself. It is well known that in many kinds of foods in their natural state some quantity of poisonous [283] or deleterious ingredients exist. How far these substances may be deleterious to health when the food articles containing them are consumed may be a subject of dispute between the scientists, but the bill reported does not in any way consider that question. If, however, poisonous or deleterious substances are added by man to the food product, then the bill declares the article to be adulterated and forbids interstate traffic."

This statement throws light upon the intention of Congress. Illustrations are given to show possible incongruous results of the test, but they do not outweigh this deliberate declaration of purpose; nor do we find in the subsequent legislative history of the substituted measure containing the provision any opposing statement as to the significance of the phrase. It must also be noted that some of the Illustrations which are given lose their force when it is remembered that the statutory ban (§ 7, subd. Fifth) by its explicit terms only applies where the added ingredient may render the article injurious to health. See United States v. Lexington Mills Co., 232 U.S. 399, supra. It is urged, that whatever may be said of natural food products, or simple food products, to which some addition is made, a `proprietary food' must necessarily be `something else than the simple or natural article'; that it is an `artificial preparation.' It is insisted that every ingredient in such a compound cannot be deemed to be an `added' ingredient. But this argument, and the others that are advanced, do not compel the adoption of the asserted alternative as to the saving efficacy of the formula. Nor can we accept the view that the word `added' should be taken as referring to the quantity of the ingredient used. It is added ingredient which the statute describes, not added quantity of the ingredient, although of course quantity may be highly important in determining whether the ingredient may render the article harmful, and experience in the use of ordinary articles of [284] food may be of greatest value in dealing with such questions of fact.

Congress, we think, referred to ingredients artificially introduced; these it described as `added.' The addition might be made to a natural food product or to a compound. If the ingredient thus introduced was of the character and had the effect described, it was to make no difference whether the resulting mixture or combination was or was not called by a new name or did or did not constitute a proprietary food. It is said that the preparation might be `entirely new.' But Congress might well suppose that novelty would probably be sought by the use of such ingredients, and that this would constitute a means of deception and a menace to health from which the public should be protected. It may also have been supposed that, ordinarily, familiar food bases would be used for this purpose. But, however, the compound purporting to be an article of food might be made up, we think that it was the intention of Congress that the artificial introduction of ingredients of a poisonous or deleterious character which might render the article injurious to health should cause the prohibition of the statute to attach.

In the present case, the article belongs to a familiar group; it is a syrup. It was originally called `Coca Cola Syrup and Extract.' It is produced by melting sugar, — the analysis showing that 52.64 per cent. of the product is sugar and 42.63 per cent. is water. Into the syrup thus formed by boiling the sugar, there are introduced coloring, flavoring, and other ingredients, in order to give the syrup a distinctive character. The caffeine, as has been said, is introduced in the second or third `melting.' We see no escape from the conclusion that it is an `added' ingredient within the meaning of the statute.

Upon the remaining question whether the caffeine was a poisonous or deleterious ingredient which might render the article injurious to health, there was a decided conflict [285] of competent evidence. The Government's experts gave testimony to the effect that it was, and the claimant introduced evidence to show the contrary. It is sufficient to say that the question was plainly one of fact which was for the consideration of the jury. See 443 Cans of Egg Product,) 226 U.S. 172, 183.

Second. As to `misbranding.' In the second count it was charged that the expression `Coca Cola' represented the presence in the product of the substances coca and cola and that it contained "no coca and little if any cola." So far as `cola' was concerned, the charge was vague and indefinite and this seems to have been conceded by the Government at the beginning of the trial. With respect to `coca,' there was evidence on the part of the Government tending to show that there was nothing in the product obtained from the leaves of the coca plant, while on behalf of the claimant it was testified that the material called `Merchandise No. 5' (one of the ingredients) was obtained from both coca leaves and cola nuts. It was assumed on the motion for a peremptory instruction that there might be a disputed question of fact as to whether the use of the word `coca' is to be regarded "intrinsically and originally" as stating or suggesting the presence of "some material element or quality" derived from coca leaves, and it was also assumed that the evidence might be deemed to be conflicting with respect to the question whether the product actually contained anything so derived. 191 Fed. Rep. pp. 438, 439. But these issues of fact were considered not to be material. On this branch of the case, the claimant succeeded upon the ground that its article was within the protection of the proviso in § 8 as one known `under its own distinctive name.' 215 Fed. Rep. p. 544.

Section 8 (ante, p. 275), in its Fourth specification as to `food,' provides that the article shall be deemed to be `misbranded' "if the package containing it or its label shall [286] bear any statement, design, or device regarding the ingredients or the substances contained therein, which . . . shall be false or misleading in any particular." Then follows the proviso in question that an article not containing any added poisonous or deleterious ingredients "shall not be deemed to be . . . misbranded" in the case of "mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article," if the name is accompanied with a statement of the place where the article has been produced.^[3]

A distinctive name is a name that distinguishes. It may be a name in common use as a generic name, e.g., [287] coffee, flour, etc. Where there is a trade description of this sort by which a product of a given kind is distinctively known to the public, it matters not that the name had originally a different significance. Thus, soda-water is a familiar trade description of an article which now, as is well known, rarely contains soda in any form. Such a name is not be deemed either `misleading' or `false,' as it is in fact distinctive. But unless the name is truly distinctive, the immunity cannot be enjoyed; it does not extend to a case where an article is offered for sale `under the distinctive name of another article.' Thus, that which is not coffee, or is an imitation of coffee, cannot be sold as coffee; and it would not be protected by being called "X's Coffee." Similarly, that which is not lemon extract could not obtain immunity by being sold under the name of "Y's Lemon Extract." The name so used is not `distinctive' as it does not appropriately distinguish the product; it is an effort to trade under the name of an article of a different sort. So, with respect to `mixtures or compounds,' we think that the term `another article' in the proviso embraces different compounds from the compound in question. The aim of the statute is to prevent deception, and that which appropriately describes a different compound cannot secure protection as a `distinctive name.'

A `distinctive name' may also, of course, be purely arbitrary or fanciful and thus, being the trade description of the particular thing, may satisfy the statute, provided the name has not already been appropriated for something else so that its use would tend to deceive.

If, in the present case, the article had been named `Coca' and it were found that the name was actually descriptive in the sense that it fairly implied that the article was derived from the leaves of the coca plant, it could not be said that this was `its own distinctive name' if in fact it contained nothing so derived. The [288] name, if thus descriptive, would import a different product from the one to which it was actually affixed. And, in the case supposed, the name would not become the `distinctive name' of a product without any coca ingredient unless in popular acceptation it came to be regarded as identifying a product known to be of that character. It would follow that the mere sale of the product under the name `Coca,' and the fact that this was used as a trade designation of the product, would not suffice to show that it had ceased to have its original significance if it did not appear that it had become known to the public that the article contained nothing derived from coca. Until such knowledge could be attributed to the public the name would naturally continue to be descriptive in the original sense. Nor would it be controlling that at the time of the adoption of the name the coca plant was known only to foreigners and scientists, for if the name had appropriate reference to that plant and to substances derived therefrom, its use would primarily be taken in that sense by those who did know or who took pains to inform themselves of its meaning. Mere ignorance on the part of others as to the nature of the composition would not change the descriptive character of the designation. The same conclusion would be reached if the single name `Cola' had been used as the name of the product, and it were found that in fact the name imported that the product was obtained from the cola nut. The name would not be the distinctive name of a product not so derived until in usage it achieved that secondary significance.

We are thus brought to the question whether if the names coca and cola were respectively descriptive, as the Government contends, a combination of the two names constituted a `distinctive name' within the protection of the proviso in case either of the described ingredients was absent. It is said that `coca' indicates one [289] article, and `cola' another, but that the two names together did not constitute the distinctive name of any other substance or combination of substances. The contention leads far. To take the illustration suggested in argument, it would permit a manufacturer, who could not use the name chocolate to describe that which was not chocolate, or vanilla to describe that which was not vanilla, to designate a mixture as `Chocolate-Vanilla,' although it was destitute of either or both, provided the combined name had not been previously used. We think that the contention misses the point of the proviso. A mixture or compound may have a name descriptive of its ingredients or an arbitrary name. The latter (if not already appropriated) being arbitrary, designates the particular product. Names, however, which are merely descriptive of ingredients are not primarily distinctive names save as they appropriately describe the compound with such ingredients. To call the compound by a name descriptive of ingredients which are not present is not to give it `its own distinctive name' — which distinguishes it from other compounds — but to give it the name of a different compound. That, in our judgment, is not protected by the proviso, unless the name has achieved a secondary significance as descriptive of a product known to be destitute of the ingredients indicated by its primary meaning.

In the present case we are of opinion that it could not be said as matter of law that the name was not primarily descriptive of a compound with coca and cola ingredients, as charged. Nor is there basis for the conclusion that the designation had attained a secondary meaning as the name of a compound from which either coca or cola ingredients were known to be absent; the claimant has always insisted, and now insists, that its product contains both. But if the name was found to be descriptive, as charged, there was clearly a conflict of evidence with respect to the presence of any coca ingredient. We conclude [290] that the court erred in directing a verdict on the second count.

The judgment is reversed and the cause is remanded for further proceedings in conformity with this opinion.

It is so ordered.

MR. JUSTICE McREYNOLDS took no part in the consideration or decision of this case.

[1] Section 7, with respect to `confectionery' and `food' is as follows:

"Sec. 7. That for the purposes of this Act an article shall be deemed to be adulterated:

. . .

"In the case of confectionery:

"If it contains terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound or narcotic drug.

"In the case of food:

"First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength.

"Second. If any substance has been substituted wholly or in part for the article.

"Third. If any valuable constituent of the article has been wholly or in part abstracted.

"Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed.

"Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this Act shall be construed as applying only when said products are ready for consumption.

"Sixth. If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter."

[2] Section 8 provides:

"Sec. 8. That the term `misbranded,' as used herein, shall apply to all drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, . . .

"That for the purposes of this Act an article shall also be deemed to be misbranded:

* * * * * * * *

"In the case of food:

"First. If it be an imitation of or offered for sale under the distinctive name of another article.

"Second. If it be labeled or branded so as to deceive or mislead the purchaser, or purport to be a foreign product when not so, or if the contents of the package as originally put up shall have been removed in whole or in part and other contents shall have been placed in such package, or if it fail to bear a statement on the label of the quantity or proportion of any morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any of such substances contained therein.

"Third. If in package form, and the contents are stated in terms of weight or measure, they are not plainly and correctly stated on the outside of the package.

"Fourth. If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or the substances contained therein, which statement, design, or device shall be false or misleading in any particular: Provided, That an article of food which does not contain any added poisonous or deleterious ingredients shall not be deemed to be adulterated or misbranded in the following cases:

"First. In the case of mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with a statement of the place where said article has been manufactured or produced.

"Second. In the case of articles labeled, branded, or tagged so as to plainly indicate that they are compounds, imitations, or blends, and the word `compound,' `imitation,' or `blend,' as the case may be, is plainly stated on the package in which it is offered for sale: Provided, That the term blend as used herein shall be construed to mean a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only: And provided further, That nothing in this Act shall be construed as requiring or compelling proprietors or manufacturers of proprietary foods which contain no unwholesome added ingredient to disclose their trade formulas, except in so far as the provisions of this Act may require to secure freedom from adulteration or misbranding."

[3] Among the departmental regulations (adopted in October, 1906, pursuant to § 3, for the enforcement of the Act) is Regulation 20 with respect to `distinctive names' under § 8, as follows:

"(a) A `distinctive name' is a trade, arbitrary, or fancy name which clearly distinguishes a food product, mixture, or compound from any other food product, mixture, or compound.

"(b) A distinctive name shall not be one representing any single constituent of a mixture or compound.

"(c) A distinctive name shall not misrepresent any property or quality of a mixture or compound.

"(d) A distinctive name shall give no false indication of origin, character, or place of manufacture, nor lead the purchaser to suppose that it is any other food or drug product."

Regulation 27 is as follows:

"(a) The terms `mixtures' and `compounds' are interchangeable and indicate the results of putting together two or more food products.

"(b) These mixtures or compounds shall not be imitations of other articles, whether simple, mixt, or compound, or offered for sale under the name of other articles. They shall bear a distinctive name and the name of the place where the mixture or compound has been manufactured or produced.

"(c) If the name of the place be one which is found in different States, Territories, or countries, the name of the State, Territory, or country, as well as the name of the place, must be stated."

232 U.S. 399 (1914)

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

[400] Mr. Attorney General McReynolds, with whom Mr. Francis G. Caffey was on the brief, for the United States.

Mr. Edward P. Smith and Mr. Bruce S. Elliott, with whom Mr. Edward L. Scarritt, Mr. C.J. Smyth and Mr. W.C. Scarritt were on the brief, for respondent.

[404] MR. JUSTICE DAY delivered the opinion of the court.

The petitioner, the United States of America, proceeding under § 10 of the Food and Drugs Act (June 30, 1906, c. 3915, 34 Stat. 768, 771), by libel filed in the District Court of the United States for the Western District of Missouri, sought to seize and condemn 625 sacks of flour in the possession of one Terry, which had been shipped from Lexington, Nebraska, to Castle, Missouri, and which remained in original, unbroken packages. The judgment of the District Court, upon verdict, in favor of the Government, was reversed by the Circuit Court of Appeals for the Eighth Circuit (202 Fed. Rep. 615), and this writ of certiorari is to review the judgment of that court.

[405] The amended libel charged that the flour had been treated by the "Alsop Process," so called, by which nitrogen peroxide gas, generated by electricity, was mixed with atmospheric air and the mixture then brought in contact with the flour, and that it was thereby adulterated under the fourth and fifth subdivisions of § 7 of the act, namely, (1) in that the flour had been mixed, colored and stained in a manner whereby damage and inferiority were concealed and the flour given the appearance of a better grade of flour than it really was, and (2) in that the flour had been caused to contain added poisonous or other added deleterious ingredients, to-wit, nitrites or nitrite reacting material, nitrogen peroxide, nitrous acid, nitric acid and other poisonous and deleterious substances which might render the flour injurious to health. The libel also charged that the flour was adulterated under the first subdivision of § 7, and was misbranded; but the Government does not urge these features of the case here. The verdict was broad enough to cover the charge under the first subdivision of § 7, but in the view we take of the case as to the instruction of the court under subdivision 5 it need not be noticed.

The Lexington Mill & Elevator Company, the respondent herein, appeared, claiming the flour, and answered the libel, admitting that the flour had been treated by the Alsop Process, but denying that it had been adulterated and attacking the constitutionality of the act.

A special verdict to the effect that the flour was adulterated was returned and judgment of condemnation entered. The case was taken to the Circuit Court of Appeals upon writ of error. The respondent contended that, among other errors, the instructions of the trial court as to adulteration were erroneous and that the act was unconstitutional. The Circuit Court of Appeals held that the testimony was insufficient to show that by the [406] bleaching process the flour was so colored as to conceal inferiority and was thereby adulterated, within the provisions of subdivision 4. That court also held — and this holding gives rise to the principal controversy here — that the trial court erred in instructing the jury that the addition of a poisonous substance, in any quantity, would adulterate the article, for the reason that "the possibility of injury to health due to the added ingredient and in the quantity in which it is added, is plainly made an essential element of the prohibition." It did not pass upon the constitutionality of the act, in view of its rulings on the act's construction.

The case requires a construction of the Food and Drugs Act. Parts of the statute pertinent to this case are:

"SEC. 7. (34 Stat. 769.) That for the purposes of this act an article shall be deemed to be adulterated: . . .

"In the case of food:

"First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength. . . .

"Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed.

"Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health. . . .

* * * * * * * *

"SEC. 10. (34 Stat. 771.) That any article of food, drug, or liquor that is adulterated or misbranded within the meaning of this act, and is being transported from one State, Territory, district, or insular possession to another for sale, or, having been transported, remains unloaded, unsold, or in original unbroken packages, . . . shall be liable to be proceeded against in any district court of the United States within the district where the same is found, and seized for confiscation by a process of libel for [407] condemnation. And if such article is condemned as being adulterated or misbranded, or of a poisonous or deleterious character, within the meaning of this act, the same shall be disposed of by destruction or sale, as the said court may direct."

Without reciting the testimony in detail it is enough to say that for the Government it tended to show that the added poisonous substances introduced into the flour by the Alsop Process, in the proportion of 1.8 parts per million, calculated as nitrogen, may be injurious to the health of those who use the flour in bread and other forms of food. On the other hand, the testimony for the respondent tended to show that the process does not add to the flour any poisonous or deleterious ingredients which can in any manner render it injurious to the health of a consumer. On these conflicting proofs the trial court was required to submit the case to the jury. That court, after stating the claims of the parties, the Government insisting that the flour was adulterated and should be condemned if it contained any added poisonous or other added deleterious ingredient of a kind or character which was capable of rendering such article injurious to health; the respondent contending that the flour should not be condemned unless the added substances were present in such quantity that the flour would be thereby rendered injurious to health, gave certain instructions to the jury. Part of the charge, excepted to by the respondent, reads:

"The fact that poisonous substances are to be found in the bodies of human beings, in the air, in potable water, and in articles of food, such as ham, bacon, fruits, certain vegetables, and other articles, does not justify the adding of the same or other poisonous substances to articles of food, such as flour, because the statute condemns the adding of poisonous substances. Therefore the court charges you that the Government need not prove that this flour or food-stuffs made by the use of it would injure [408] the health of any consumer. It is the character — not the quantity — of the added substance, if any, which is to determine this case."

On the other hand the respondent insisted that the law is, and requested the court to charge the jury:

"That the burden is upon the prosecution to prove the truth of the charge in the libel, that by the treatment of the flour in question by the said Alsop Process it has been caused to contain added poisonous or other added deleterious ingredients, to-wit, nitrites or nitrite reacting material, which may render said flour injurious to health.

"And in this connection you are further instructed that it is incumbent upon the Government to prove that any such added poisonous or other added deleterious ingredients, if any contained in said flour, are of such a character and contained in the flour seized in such quantities, conditions and amounts as may render said flour injurious to health, and unless you find that all of such facts are so proven you cannot find against the claimant or condemn the flour in question under that charge in the libel, and if you fail to so find your verdict upon that count or charge in the libel must be in favor of the claimant or defendant.

* * * * * * * *

"The law does not prohibit the adding of nitrites or nitrite reacting material to flour, and a jury cannot find for the Government or against the claimant, even if it be shown that nitrites or nitrite reacting material was added to the flour in question, unless they believe from a preponderance of the evidence that such addition, if any, rendered said flour injurious to the health of those who might consume the bread or other foods made from said flour."

It is evident from the charge given and requests refused that the trial court regarded the addition to the flour of any poisonous ingredient as an offense within this statute, no [409] matter how small the quantity, and whether the flour might or might not injure the health of the consumer. At least such is the purport of the part of the charge above given, and if not correct, it was clearly misleading, notwithstanding other parts of the charge seem to recognize that in order to prove adulteration it is necessary to show that the flour may be injurious to health. The testimony shows that the effect of the Alsop Process is to bleach or whiten the flour and thus make it more marketable. If the testimony introduced on the part of the respondent was believed by the jury they must necessarily have found that the added ingredient, nitrites of a poisonous character, did not have the effect to make the consumption of the flour by any possibility injurious to the health of the consumer.

The statute upon its face shows, that the primary purpose of Congress was to prevent injury to the public health by the sale and transportation in interstate commerce of misbranded and adulterated foods. The legislation, as against misbranding, intended to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was and not upon misrepresentations as to character and quality. As against adulteration, the statute was intended to protect the public health from possible injury by adding to articles of food consumption poisonous and deleterious substances which might render such articles injurious to the health of consumers. If this purpose has been effected by plain and unambiguous language, and the act is within the power of Congress, the only duty of the courts is to give it effect according to its terms. This principle has been frequently recognized in this court. Lake County v. Rollins, 130 U.S. 662, 670:

"Where a law is expressed in plain and unambiguous terms, whether those terms are general or limited, the legislature should be intended to mean what they have [410] plainly expressed, and consequently no room is left for construction."

Hamilton v. Rathbone, 175 U.S. 414, 421:

"The cases are so numerous in this court to the effect that the province of construction lies wholly within the domain of ambiguity, that an extended review of them is quite unnecessary."

Furthermore all the words used in the statute should be given their proper signification and effect; Washington Market Co. v. Hoffman, 101 U.S. 112, 115:

"We are not at liberty," said Mr. Justice Strong, "to construe any statute so as to deny effect to any part of its language. It is a cardinal rule of statutory construction that significance and effect shall, if possible, be accorded to every word. As early as in Bacon's Abridgment, sec. 2, it was said that `a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word, shall be superfluous, void, or insignificant.' This rule has been repeated innumerable times."

Applying these well-known principles in considering this statute, we find that the fifth subdivision of § 7 provides that food shall be deemed to be adulterated: "If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health." The instruction of the trial court permitted this statute to be read without the final and qualifying words, concerning the effect of the article upon health. If Congress had so intended the provision would have stopped with the condemnation of food which contained any added poisonous or other added deleterious ingredient. In other words, the first and familiar consideration is that, if Congress had intended to enact the statute in that form, it would have done so by choice of apt words to express that intent. It did not do so, but only condemned food containing an added poisonous or other added deleterious ingredient when such addition might render the article of food injurious [411] to the health. Congress has here, in this statute, with its penalties and forfeitures definitely outlined its inhibition against a particular class of adulteration.

It is not required that the article of food containing added poisonous or other added deleterious ingredients must affect the public health, and it is not incumbent upon the Government in order to make out a case to establish that fact. The act has placed upon the Government the burden of establishing, in order to secure a verdict of condemnation under this statute, that the added poisonous or deleterious substances must be such as may render such article injurious to health. The word "may" is here used in its ordinary and usual signification, there being nothing to show the intention of Congress to affix to it any other meaning. It is, says Webster, "an auxiliary verb, qualifying the meaning of another verb, by expressing ability, . . ., contingency or liability, or possibility or probability." In thus describing the offense Congress doubtless took into consideration that flour may be used in many ways, in bread, cake, gravy, broth, etc. It may be consumed, when prepared as a food, by the strong and the weak, the old and the young, the well and the sick; and it is intended that if any flour, because of any added poisonous or other deleterious ingredient, may possibly injure the health of any of these, it shall come within the ban of the statute. If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such flour, though having a small addition of poisonous or deleterious ingredients, may not be condemned under the act. This is the plain meaning of the words and in our view needs no additional support by reference to reports and debates, although it may be said in passing that the meaning which we have given to the statute was well expressed by Mr. Heyburn, chairman of the committee having it in charge upon the floor of the Senate (Congressional Record, vol. 40, pt. 2, p. 1131):

[412] "As to the use of the term `poisonous,' let me state that everything which contains poison is not poison. It depends on the quantity and the combination. A very large majority of the things consumed by the human family contain, under analysis, some kind of poison, but it depends upon the combination, the chemical relation which it bears to the body in which it exists as to whether or not it is dangerous to take into the human system."

And such is the view of the English courts construing a similar statute. The English statute provides (§ 3, of the Sale of Food and Drugs Act, 1875):

"No person shall mix, color, . . . or order or permit any other person to mix, color, . . . any article of food with any ingredient or material so as to render the article injurious to health."

That section was construed in Hull v. Horsnell, 68 J.P. 591, which involved preserved peas, the color of which had been retained by the addition of sulphate of copper, charged to be a poisonous substance and injurious to health. There was a conviction in the lower court. Lord Alverstone, C.J., in reversing and remitting the case on appeal, said:

"In my opinion, if the justices convicted the appellant of an offence under § 3 of the Sale of Food and Drugs Act, 1875, on the ground that the ingredient mixed with the article of food was injurious to health, — that the sulphate of copper was injurious to health, and not on the ground that the peas by reason of the addition of sulphate of copper were rendered injurious to health, the conviction is clearly wrong. To constitute an offence under the latter part of § 3 the article of food sold must, by the addition of an ingredient, be rendered injurious to health. All the circumstances must be examined to see whether the article of food has been rendered injurious to health."

We reach the conclusion that the Circuit Court of Appeals did not err in reversing the judgment of the District [413] Court for error in its charge with reference to subdivision five of § 7.

The Circuit Court of Appeals reached the conclusion that there was no substantial proof to warrant the conviction under the fourth subdivision of § 7, that the flour was mixed, colored and stained in a manner whereby damage and inferiority was concealed. As the case is to be retried to a jury, we say nothing upon this point.

As to the objection on constitutional grounds, it is not contended that the statute as construed by the Circuit Court of Appeals and this court is unconstitutional.

It follows that the judgment of the Circuit Court of Appeals reversing the judgment of the District Court must be affirmed, and the case remanded to the District Court for a new trial.

Affirmed.