Background

Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools, and other places outside the home.1 Federal laws give food manufacturers, distributors, and retailers the basic responsibility for assuring that foods are wholesome, safe, and handled under sanitary conditions. A number of federal agencies, cooperating with state, local, and international entities, play a major role in regulating food quality and safety under these laws.

The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, the Centers for Disease Control and Prevention (CDC) reports that each year an estimated one in six Americans—a total of 48 million people—becomes sick from contaminated food foodborne illnesses caused by contamination from any one of a number of microbial pathogens.2 Of these, an estimated 128,000 cases require hospitalization and 3,000 cases result in death. In addition, experts have cited numerous other hazards to health, including the use of unapproved veterinary drugs, pesticides, and other dangerous substances in food commodities, of particular concern at a time when a growing share of the U.S. food supply is from overseas sources. These concerns, combined with the ongoing recurrence of major food safety-related incidents, have heightened public and media scrutiny of the U.S. food safety system and magnified congressional interest in the issue.

The Agencies and Their Roles

Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply. Federal responsibility for food safety rests primarily with the Food and Drug Administration (FDA), which is part of the U.S. Department of Health and Human Services (HHS), and the Food Safety and Inspection Service (FSIS), which is part of the U.S. Department of Agriculture (USDA). FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood, fish, and shellfish products. USDA’s Food Safety and Inspection Service (FSIS) regulates most meat and poultry and some egg and fish products.

The Government Accountability Office (GAO) has identified as many as 15 federal agencies, including FDA and FSIS, as collectively administering at least 30 laws related to food safety.*** State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments. This organizational complexity, and trends in U.S. food markets—for example, increasing imports as a share of U.S. food consumption and increasing consumption of fresh, often unprocessed, foods— pose ongoing challenges to ensuring food safety.

The division of food safety responsibility between FDA and USDA is rooted in the early history  of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the widespread marketing of intentionally adulterated foods, and its implementation was assigned to USDA’s Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat packing plants, and implementation was assigned to the USDA’s Bureau of Animal Industry. This bifurcated system has been perpetuated and split further into additional food safety activities  under additional agencies (for example, the Environmental Protection Agency, the National Marine Fisheries Service, and others) by a succession of statutes and executive directives. The separation of the two major food safety agencies was further reinforced when, in 1940, the President moved responsibilities for safe foods and drugs, other than meat and poultry, from USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in USDA. There has been discussion over time regarding whether this dispersal of food safety responsibilities has been problematic, or whether a reorganization would divert time and attention from other fundamental problems in the system. * * * 

Over the years, GAO has published a series of reports highlighting how food safety oversight in the United States is fragmented and recommending broad restructuring of the nation’s food safety system. These GAO reports document examples where a number of federal agencies are responsible for some aspect of food safety or product quality, resulting in split agency jurisdiction for some foods. Limited coordination and sharing of information results in often overlapping and/or duplication of efforts. Similar observations are noted in a series of food safety studies by the National Research Council (NRC) and Institute of Medicine (IOM).6 The NRC/IOM studies further recommend that the core federal food safety responsibilities should reside within a single entity/agency; have a unified administrative structure, clear mandate, and dedicated budget; and maintain full responsibility for oversight of the entire U.S. food supply.

Food and Drug Administration

FDA has primary responsibility for the safety of most (about 80%-90%) of all U.S. domestic and imported foods.7 The FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. Examples of FDA-regulated foods are produce, dairy products, and processed foods. FDA also has oversight of all seafood and shellfish products, and most fish products (except for catfish). FDA has jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of FSIS. FDA shares some responsibility for the safety of eggs with FSIS. FDA has jurisdiction over establishments that sell or serve eggs or use them as an ingredient in their products.

As described in a memorandum of understanding between FDA and FSIS:

FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and parts of the Egg Products Inspection Act [21 U.S.C. §§1031 et seq.]. In carrying out its responsibilities under these acts, FDA conducts inspections of establishments that manufacture, process, pack, or hold foods, with the exception of certain establishments that are regulated exclusively by FSIS. FDA also inspects vehicles and other conveyances, such as boats, trains, and airplanes, in which foods are transported or held in interstate commerce.

In addition, the 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353), amending the Federal Food, Drug, and Cosmetic Act (FFDCA). FSMA was the largest expansion of FDA’s food safety authorities since the 1930s.10 FSMA did not directly address meat and poultry products under USDA’s jurisdiction. New rules governing FDA’s food inspection regime of both domestic and imported foods under the agency’s jurisdiction are now being implemented. For more information, see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).

 In the Washington, DC, area, two FDA offices are the focal point for food safety-related activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for

(1) conducting and supporting food safety research; (2) developing and overseeing enforcement of food safety and quality regulations; (3) coordinating and evaluating FDA’s food surveillance and compliance programs; (4) coordinating and evaluating cooperating states’ food safety activities; and (5) developing and disseminating food safety and regulatory information to consumers and industry. FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, are properly labeled, and produce no human health hazards when used in food-producing animals.

The FDA also cooperates with over 400 state agencies across the nation to carry out a wide range of food safety regulatory activities. However, the state agencies are primarily responsible for actual inspection. FDA works with the states to set the safety standards for food establishments and commodities and evaluates the states’ performance in upholding such standards as well as any federal standards that may apply. FDA also contracts with states to use their food safety agency personnel to carry out certain field inspections in support of FDA’s own statutory responsibilities.

Food Safety and Inspection Service

 FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and imported meat and poultry and their products sold for human consumption, comprising roughly 10%-20% of the U.S. food supply.11 As described in a memorandum of understanding between FDA and FSIS, FSIS’s jurisdiction is as follows:

FSIS is responsible for implementing and enforcing the Federal Meat Inspection Act (21 U.S.C. 601, et seq.), the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), and parts of the Egg Products Inspection Act (21 U.S.C. 1031, et seq.). In carrying out its responsibilities under these acts, FSIS places inspectors in meat and poultry slaughterhouses and in meat, poultry,  and  egg  processing  plants.  FSIS  also  conducts  inspections  of  warehouses, transporters, retail stores, restaurants, and other places where meat, poultry, and egg products are handled and stored. In addition, FSIS conducts voluntary inspections under the Agriculture Marketing Act (7 U.S.C. 1621, et seq.).

The Federal Meat Inspection Act (FMIA) of 1906, as amended, requires USDA to inspect all cattle, sheep, swine, goats, horses, mules, and other equines slaughtered and processed for human consumption. The Poultry Products Inspection Act (PPIA) of 1957, as amended, gives USDA the authority to inspect poultry meat. The PPIA mandates USDA inspection of any domesticated birds (chickens, turkeys, ducks, geese, guineas, ratites [ostrich, emu, and rhea], and squab (pigeons up to one month old]) intended for use as human food. The Egg Products Inspection Act, as amended, provides USDA authority to inspect liquid, frozen, and dried egg products. Each of these laws contains provisions governing USDA’s authority to label food products under its jurisdiction.

Under the authority of the Agricultural Marketing Act of 1946 as amended, USDA’s FSIS may provide voluntary inspection for buffalo, antelope, reindeer, elk, migratory waterfowl, game birds, and rabbits. This type of inspection is performed by FSIS on a fee-for-service basis. However, these meat and poultry species are still within the purview of FDA under FFDCA, whether or not inspected under the voluntary FSIS program. FDA has jurisdiction over meat products from such species in interstate commerce, even if they bear the USDA inspection mark. FDA also has jurisdiction over shell eggs. In addition, the 2008 farm bill requires that FSIS inspect and grade farmed catfish products.

Meat and poultry animals and products undergo continuous (i.e., 100%) inspection, which may in turn act as a deterrent to fraud in some cases. FSIS inspects all meat and poultry animals to look for signs of disease, contamination, and other abnormal conditions, both before and after  slaughter (“antemortem” and “postmortem,” respectively), on a continuous basis—meaning that no animal may be slaughtered and dressed unless an inspector has examined it. One or more federal inspectors are on the line during all hours the plant is operating. Processing plants visited once every day by an FSIS inspector are considered to be under continuous inspection in keeping with the laws. Inspectors monitor operations, check sanitary conditions, examine ingredient levels and packaging, review records, verify food safety plans, and conduct statistical sampling and testing of products for pathogens and residues during their inspections.

FSIS is responsible for certifying that foreign meat and poultry plants are operating under an inspection system equivalent to the U.S. system before they can export their product to the United States. Meat and poultry imports are 100% visually inspected (process-based, documentation, labeling), although physical inspections of imports may be more random. FSIS conducts evaluations of foreign meat safety programs and visits establishments to determine whether they are providing a level of safety equivalent to that of U.S. safeguards. No foreign plant can ship meat or poultry to the United States unless its country has received such an FSIS determination.

Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS is statutorily responsible for ensuring that the states’ programs are at least equal to the federal program. Plants processing meat and poultry under state inspection can market their products only within the state. If a state chooses to discontinue its own inspection program, or if FSIS determines that it does not meet the agency’s equivalency standards, FSIS must assume the responsibility for inspection if the formerly state-inspected plants are to remain in operation. FSIS also has cooperative agreements with more than two dozen states under which state inspection personnel are authorized to carry out federal inspection in meat and/or poultry plants. Products from these plants may travel in interstate commerce. * * * 

Overview of the Threat 

The potential of terrorist attacks against agricultural targets (agroterrorism) is increasingly recognized as a national security threat, especially after the events of September 11, 2001. In this context, agroterrorism is defined as the deliberate introduction of an animal or plant disease with the goal of generating fear, causing economic losses, and/or undermining stability.

Agroterrorism is a subset of the more general issues of terrorism and bioterrorism. People more generally associate bioterrorism with outbreaks of human illness (such as from anthrax or smallpox), rather than diseases first affecting animals or plants. Agriculture has several characteristics that pose unique problems for managing the threat:

Thus, the general susceptibility of the agriculture and food industry to bioterrorism is difficult to address in a systematic way due to the highly dispersed, yet concentrated nature of the industry and the inherent biology of growing plants and raising animals.

The results of an agroterrorist attack may include major economic crises in the agricultural and food industries, loss of confidence in government, and possibly human casualties. Humans could be at risk in terms of food safety or public health, especially if the chosen disease is transmissible to humans (zoonotic). But an agroterrorist attack need not cause human casualties for it to be effective or to cause large scale economic consequences.

The production agriculture sector would suffer economically in terms of plant and animal health, and the supply of food and fiber may be reduced, especially in certain regions. The demand for certain types of food may decline based on which products are targeted in the attack (e.g., dairy, beef, pork, poultry, grains, fruit, or vegetables), while demand for other types of food may rise due to food substitutions.

An agroterrorism event would cause economic losses to individuals, businesses, and governments through costs to contain and eradicate the disease, and to dispose of contaminated products. Economic losses would accumulate throughout the farm- to-table continuum as the supply chain is disrupted, especially if domestic markets for food become unstable or if trade sanctions are imposed by other countries on U.S. exports. The economic impact can spread to farmers, input suppliers, food processors, transportation, retailers, and food service providers. 

Public opinion may be particularly sensitive to a deliberate outbreak of disease affecting the food supply. Public confidence in government could be eroded if authorities appear unable to prevent such an attack or to protect the population’s food supply. As the United States evolved away from an agrarian society during the 20th century, food and the fear of inadequate food supplies moved further from the minds of most U.S. residents. However, because food remains an important part of everyone’s daily routine and survival, significant threats to the currently-held notion of food security in the U.S. could cause a reordering of people’s priorities.

Because an agroterrorist attack may not necessarily cause human casualties, be immediately detected, or have the “shock factor” of an attack against the more visible public infrastructure or human populations, agriculture may not be a terrorist’s first choice of targets. Nonetheless, some types of agroterrorism could be relatively easily achieved and have significant economic impacts. Thus, the possibilities are treated seriously, especially in the post-September 11 world.  

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Bioterrorism Preparedness Act. The Public Health Security and Bioterrorism Preparedness and Response Act (P.L.107-188, June 12, 2002) contained several provisions important to agriculture. These provisions accomplish the following:

New FDA Rules on Food Processors and Importers. The Bioterrorism Preparedness Act responded to long-standing concerns about whether the Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) had the authority to assure food safety. FDA was instructed to implement new rules for (1) registration of food processors, (2) prior notice of food imports, (3) administrative detention of imports, and (4) record-keeping.

Proposed rules were issued in the spring 2003 followed by a comment period. On October 10, 2003, FDA published two interim final rules for registration of food facilities and prior notice of imports. Those rules were implemented on December 12, 2003, but FDA allowed flexible enforcement during a transition period. The rule on administrative detention of imports was effective upon enactment, with FDA procedures announced on May 27, 2004.    The final rule for record keeping is forthcoming.24

Registration of Food Processors. The Act required FDA to establish a one-time registration system for any domestic or foreign facility that manufactures, processes, packs, and handles food. All food facilities supplying food for the United States were required to register with the FDA by December 12, 2003. Registering involved providing information about the food products (brand names and general food categories), facility addresses, and contact information. Restaurants, certain retail stores, farms, non-profit food and feeding establishments, fishing vessels, and trucks and other motor carriers were exempt from registration requirements. However, many farms had a difficult time determining whether they needed to register based on the amount of handling or processing they performed.

Registration documents are protected from public disclosure under the Freedom of Information Act (FOIA). The registry provides, for the first time, a complete list of companies subject to FDA authority, and will enhance the agency's capability to trace contaminated food. Critics argued that registration created a record keeping burden without proof that facilities will be able to respond in an emergency. 

Federal Food Safety Inspections

As of February 2016, a reported more than 300,000 domestic and foreign food facilities were registered with the agency and are potentially subject to inspection FDA reports. Of these, about 88,000 facilities are domestic (U.S.) registrations, and 212,000 facilities are foreign registrations. Registration of domestic and foreign food facilities is required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act,” P.L. 107-188).28 Most recent available information for FY2012 indicate that FDA and the states under contract with FDA inspected 24,462 domestic food facilities and 1,342 foreign food facilities.  http://wwfda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm. 

Data compiled by FDA indicate that, on average, between 10% and 30% of all domestic facilities are inspected by FDA annually, most of which are considered “high-risk” facilities. Estimates of unannounced compliance inspections of domestic establishments by FDA officials range from once every five years to once every 10 years, on average, although the agency claims to visit about 6,000 so-called “high-risk” facilities on an annual basis. In general, FDA relies on notifications from within the industry or from other federal or state inspection personnel to alert it to situations calling for increased inspection. 

FDA inspection rates of imported foods are much lower, with a reported roughly 2% of all food import lines being physically examined by FDA. Previously, GAO reported that FDA inspections covered only about 1% of the food imported under its jurisdiction. Although FDA is not able to physically inspect a large percentage of food entering the United States, FDA electronically screens all import entries using an automated system known as Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information technology system. In addition, FDA can issue import bulletins to signal field inspectors to pay special attention to a particular product, or a range of products from a particular producer, shipper, or importer. 

Food Safety and Inspection Service

The number of regulated meat and poultry facilities under USDA’s jurisdiction is much lower and has remained mostly stable over time. Much of the agency’s work is conducted in cooperation with federal, state, and municipal agencies, as well as private industry. FSIS currently conducts inspections in 6,389 establishments. This compares to 2002, when USDA reported that it conducted inspections in about 6,000 establishments. This total includes Talmadge-Aiken plants, wherein state inspectors perform inspections under federal inspectors’ supervision. There were 350 Talmadge-Aiken plants in 2015, up from 235 in 2002.

Of the total number of meat, poultry, and egg establishments under FSIS jurisdiction, about 1,100 plants either slaughter or slaughter and process livestock or poultry. More than 4,000 facilities only process meat and poultry, and about 80 process egg products. FSIS also reinspects imported meat, poultry, and egg products at about 140 import reinspection facilities. 

Introduction

HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.

The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.

* * * 

Education and Training

The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP.

Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.

Developing a HACCP Plan

The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan.

In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.

Figure 1. Preliminary Tasks in the Development of the HACCP Plan

Assemble the HACCP Team

The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level.

Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and verification; (e) recommend appropriate corrective actions when a deviation occurs; (f) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan.

Describe the food and its distribution

The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.

Describe the intended use and consumers of the food

Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).

Develop a flow diagram which describes the process

The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.

Verify the flow diagram

The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented.

After these five preliminary tasks have been completed, the seven principles of HACCP are applied.

Conduct a hazard analysis (Principle 1)

After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.

A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed.

The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2.

The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise.

After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan.

Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.

* * * 

Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk).

For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. * * *

The hazard analysis summary could be presented in several different ways. One format is a table***. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.

Determine critical control points (CCPs) (Principle 2)

A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.

Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree***. Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge.

Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.

Establish critical limits (Principle 3)

A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.

Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (a_w), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.

An example is the cooking of beef patties * * * . The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility.* * * 

Establish monitoring procedures (Principle 4)

Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.

An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.

Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.

All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.

When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.

Most monitoring procedures need to be rapid because they relate to on-line, "real-time" processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.

Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.

With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.

Establish corrective actions (Principle 5)

The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.

Establish verification procedures (Principle 6) 

Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. * * * 

One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.

Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.

Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a significant product, process or packaging change occurs; or new hazards are recognized.

In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.

Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) ⁽³⁾.

* * *

Establish record-keeping and documentation procedures (Principle 7)

* * *

IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN

The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.

Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.

Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)

Before: HENDERSON, MILLETT and WILKINS, Circuit Judges. (foornotes omitted) 

WILKINS, Circuit Judge:

Margaret Sowerwine and Jane Foran, individual consumers of poultry, and Food & Water Watch, Inc. (“FWW”), their organizational advocate, fear that new regulations promulgated by the United States Department of Agriculture (“USDA”) may result in an increase in foodborne illness from contaminated poultry. To prevent the regulations from going into effect, Plaintiffs sought declaratory and injunctive relief. The District Court concluded that Plaintiffs failed to demonstrate an injury in fact and dismissed Plaintiffs’ claims for lack of standing.

 * * *

I.

The Poultry Products Inspection Act (“PPIA”), 21 U.S.C. §§ 451–472, was born out of a Congressional interest in protecting consumer health and welfare by enabling the Secretary of Agriculture (“Secretary”) to ensure that poultry products were “wholesome, not adulterated, and properly marked, labeled, and packaged.” 21 U.S.C. § 451. The PPIA accomplishes this goal, in part, by requiring the Secretary **371 *910 to ensure that inspectors¹ conduct a post-mortem inspection of all poultry processed for human consumption. Id. § 455(b). The PPIA also requires condemnation and destruction for human food purposes of all poultry that is found to be adulterated, unless the poultry can be reprocessed under an inspector’s supervision so that it is found to be not adulterated. Id. § 455(c). The PPIA defines “adulterated” to include various conditions, including containing, among other things, “any poisonous or deleterious substance which may render it injurious to health”; various additives that are unfit for human consumption; consisting in whole or in part of any “filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food”; or packaging in conditions where it “may have been rendered injurious to health.” Id. § 453(g). Carcasses that pass inspection receive an official legend indicating that it was inspected by the USDA. Id. § 453(h)(12); 9 C.F.R. § 381.96.

The Food Safety and Inspection Service (“FSIS”) administers the PPIA. See 7 C.F.R. §§ 2.18(a)(1)(ii)(A), 2.53(a)(2)(i). Historically, FSIS has permitted chicken and turkey—the poultry products of concern to Plaintiffs—to be inspected under one of four inspection systems: the Streamlined Inspection System, the New Line Speed Inspection System, the New Turkey Inspection System, and traditional inspection (collectively, “the existing inspection systems”). Modernization of Poultry Slaughter Inspection, 77 Fed.Reg. 4408, 4410 (proposed Jan. 27, 2012). Under the existing inspection systems, FSIS inspectors perform either an online or offline role. See id. Offline inspectors ensure compliance with food safety regulations, verify sanitation procedures, and collect samples for pathogen testing. See id. One or more online FSIS inspectors inspect each poultry carcass with its viscera² immediately following the separation of the viscera from the carcass. See id. Under the existing inspection systems, the inspectors conduct an “organoleptic” inspection, using sight, touch, and smell to evaluate the carcasses. See Brief for Appellees, Food & Water Watch, Inc. v. Vilsack, No. 15–5037 (D.C. Cir.), Doc. No. 1553589, at 3; see also 77 Fed.Reg. at 4410 (noting that inspectors “examine each eviscerated carcass for visual defects”). Poultry establishment personnel do not conduct any sorting or evaluation of carcasses; the poultry establishments provide a “helper” who takes action only upon an FSIS inspector’s direction. 77 Fed.Reg. at 4410.

The inspection method at issue in this case, the New Poultry Inspection System (“NPIS”), alters the responsibilities of the FSIS inspectors and the establishment personnel. The NPIS rules institutionalize the shift from inspector-based sorting and evaluation to establishment-based sorting and evaluation. Under the NPIS, poultry establishment personnel sort the poultry carcasses and take corrective action prior to an FSIS inspection. See id. at 4421.

*911 **372 The NPIS grew out of FSIS’s concern that agency resources were not being used in the most effective way to ensure food safety. See id. at 4410. In an effort to develop new methods to more effectively inspect poultry, in 1996 FSIS promulgated the “Pathogen Reduction/Hazard Analysis and Critical Control Points” (“HACCP”) rule. Id. at 4413; Pathogen Reduction; Hazard Analysis and Critical Control Points, 61 Fed.Reg. 38806 (July 25, 1996). HACCP required poultry establishments to develop controls to ensure product safety and empowered the establishments to make their own determinations about how to meet the FSIS regulatory requirements. 77 Fed.Reg. at 4413. FSIS subsequently announced an HACCP-based inspection models project (“HIMP”) that would allow FSIS to test and develop new inspection models. HACCP–Based Meat and Poultry Inspection Concepts, 62 Fed.Reg. 31553 (June 10, 1997). The pilot HIMP method made poultry establishment personnel “responsible for identifying and removing normal from abnormal carcasses and parts.” 77 Fed.Reg. at 4413.

The HIMP pilot was challenged as a violation of the PPIA because FSIS inspectors did not inspect poultry carcasses themselves, leaving all inspection to establishment personnel with FSIS oversight. Am. Fed’n of Gov’t Empls., AFL–CIO v. Glickman (AFGE I ), 215 F.3d 7, 9–10 (D.C.Cir.2000). This Court held that such delegation violated the PPIA. Id. at 11. In response to AFGE I, “FSIS modified HIMP to position one inspector at a fixed location near the end of the slaughter line in each poultry slaughter establishment” who was responsible for evaluating each carcass after establishment personnel had sorted and processed it. 77 Fed.Reg. at 4413. The modified HIMP program was also challenged, and this Court held that the program did not violate the PPIA. Am. Fed’n of Gov’t Empls., AFL–CIO v. Veneman, 284 F.3d 125, 130–31 (D.C.Cir.2002). However, we cautioned that “[i]f the USDA undertakes a rulemaking to adopt as a permanent change something along the lines of the modified program, experience with the program’s operation and its effectiveness will doubtless play a significant role” and warned that our opinion “may not necessarily foreshadow the outcome of judicial review of such future regulations.” Id. at 130–31.

Twenty young chicken and five turkey establishments participated in HIMP, and FSIS collected and analyzed the data from these establishments. 77 Fed.Reg. at 4414. Using this data, FSIS concluded that the HIMP procedures “improved performance related to food safety and non-food-safety standards ... especially in reducing pathogen levels” and proposed the NPIS to replace the existing inspection systems, excluding the traditional inspection system. Id. at 4421. Under the proposed NPIS rule, “establishments [would] be required to sort carcasses, to dispose of carcasses that must be condemned, and to conduct any necessary trimming or reprocessing activities before carcasses are presented to the online FSIS carcass inspector.” Id. The carcasses would pass along a production line for the online inspector at a speed of 175 birds per minute for young chickens, and 55 birds per minute for turkeys. Id. at 4423. While establishment personnel sort carcasses, FSIS inspectors would reallocate their time by increasing offline inspection activities. Id. at 4420, 4422. FSIS projected that 99.9% of young chickens and poultry would be produced under the NPIS. Id. at 4436. After a notice and comment period, FSIS adopted a final NPIS rule with a number of modifications, which included making adoption of the NPIS optional, and lowering the birds per minute speed of young chickens to 140 birds per minute. **373 *912 Modernization of Poultry Slaughter Inspection, 79 Fed.Reg. 49566, 49570 (Aug. 21, 2014). 

On September 11, 2014, Plaintiffs filed their complaint in this case, claiming that the NPIS constitutes “an unprecedented elimination of inspection resources for a secret set of young chicken and turkey slaughterhouses.” Compl. ¶ 1, J.A. 9. In this spirit, Plaintiffs alleged eight claims against Defendants: (1) violation of 21 U.S.C. § 455(c) by allowing condemnation of young chicken and turkey carcasses by NPIS establishment personnel; (2) violation of 21 U.S.C. § 455(c) by allowing reprocessing of young chickens and turkeys by NPIS establishment personnel without inspector supervision; (3) violation of 21 U.S.C. § 455(b) because each young chicken and turkey carcass will not receive a post-mortem inspection in NPIS establishments; (4) violation of the PPIA’s branding requirements; (5) violation of 21 U.S.C. § 455(b) and 9 C.F.R. § 381.1 because each chicken and turkey viscera will not be federally inspected; (6) violation of 21 U.S.C. § 463(c) for failure to provide an opportunity for oral presentation of views; (7) violation of the Administrative Procedure Act (“APA”) by failing to provide adequate opportunity for notice and comment; and (8) violation of the APA because the final NPIS rules are arbitrary and capricious. Plaintiffs sought declaratory and injunctive relief. On the same day they filed the complaint, Plaintiffs moved for a preliminary injunction on Claims 1, 2, 6, and 7. The District Court heard the motion on October 17, 2014.

On February 9, 2015, the District Court dismissed the case for lack of subject matter jurisdiction because Plaintiffs lacked standing, and denied the motion for preliminary injunction and all other pending motions as moot. Food & Water Watch, Inc. v. Vilsack, 79 F.Supp.3d 174, 206 (D.D.C.2015). With respect to the Individual Plaintiffs, the District Court found that they did not suffer an injury in fact in order to establish standing. Id. at 190–95. The District Court also found that FWW lacked standing as an organization, and that Plaintiffs did not suffer a procedural injury sufficient to establish standing. Id. at 199–206. Plaintiffs appeal the dismissal on these grounds.

* * *

 III.

Plaintiffs first contend that the Individual Plaintiffs, Sowerwine and Foran, have alleged an injury in fact. Plaintiffs also submit that FWW would have associational standing on behalf of its members. See, e.g., Sierra Club v. EPA, 754 F.3d 995, 999 (D.C.Cir.2014) (explaining that associational standing requires an organization to show, among other things, that “at least one of [the organization’s] members would have standing to sue”). Because the analyses for both the Individual Plaintiffs and FWW’s members are identical, see id., we address them jointly here.

For the Individual Plaintiffs or FWW’s individual members to establish standing, they must show (i) they have “suffered a concrete and particularized injury in fact, (ii) that was caused by or is fairly traceable to the actions of the defendant, and (iii) is capable of resolution and likely to be redressed by judicial decision.” Osborn v. Visa, 797 F.3d 1057, 1063 (D.C.Cir.2015) (internal quotation marks omitted). Here, because Plaintiffs are not directly subjected to the regulation they challenge, “standing is ‘substantially more difficult to establish.’ ” Public Citizen, Inc. v. Nat’l Highway Traffic Safety Admin. (Public Citizen I ), 489 F.3d 1279, 1289 (D.C.Cir.2007) (citing Defs. of Wildlife, 504 U.S. at 562, 112 S.Ct. 2130). In order to have suffered an injury in fact, Plaintiffs must have suffered an injury that is “(1) concrete, (2) particularized, and (3) actual or imminent.” Id. at 1292. A concrete injury is “direct, real, and palpable—not abstract.” Id. A particularized injury is “personal, individual, distinct, and differentiated—not generalized or undifferentiated.” Id. An actual or imminent injury is “certainly impending and immediate—not remote, speculative, conjectural, or hypothetical.” Id. at 1293.

Here, Plaintiffs claim their injury in fact is an increased risk of foodborne illness from unwholesome, adulterated poultry resulting from the Defendants’ regulation.⁴ Increased-risk-of-harm cases implicate the requirement that an injury be actual or imminent because “[w]ere all purely speculative increased risks deemed injurious, the entire requirement of actual or imminent injury would be rendered moot, because all hypothesized, nonimminent injuries could be dressed up as increased risk of future injury.” Id. at 1294 (quoting NRDC v. EPA (NRDC II ), 464 F.3d 1, 6 (D.C.Cir.2006)) (internal quotation marks omitted). Furthermore, “[t]he Supreme Court has repeatedly held that disputes about future events where the possibility of harm to any given individual is remote and speculative are properly left to the policymaking Branches, not the Article III courts.” Id. at 1295. As a result, this Court has limited its jurisdiction over cases alleging the possibility of increased-risk-of-harm to those where the plaintiff can show “both (i) a substantially increased risk of harm and (ii) a substantial probability of harm with that increase taken into account.” Id. at 1295 (emphasis in original); accord Susan B. Anthony List, 134 S.Ct. at 2341 (“An allegation of future injury may suffice if the threatened injury is ‘certainly impending,’ or there is a “ ‘substantial risk’ ” that the harm will occur.’ ” (quoting Clapper v. Amnesty Int’l USA, ––– U.S. ––––, 133 S.Ct. 1138, 1147 n. 5, 1150, 185 L.Ed.2d 264 (2013))). “The word ‘substantial’ of course poses questions of degree, questions far from fully **376 *915 resolved.” Va. State Corp. Comm’n v. FERC, 468 F.3d 845, 848 (D.C.Cir.2006).

Although Plaintiffs may establish standing by demonstrating an increased risk of harm, “[i]n applying the ‘substantial’ standard, we are mindful ... that the constitutional requirement of imminence ... necessarily compels a very strict understanding of what increases in risk and overall risk levels can count as ‘substantial.’ ” Public Citizen I, 489 F.3d at 1296. Accordingly, “the proper way to analyze an increased-risk-of-harm claim is to consider the ultimate alleged harm—such as death, physical injury, or property damage ...—as the concrete and particularized injury and then to determine whether the increased risk of such harm makes injury to an individual citizen sufficiently ‘imminent’ for standing purposes.” Id. at 1298.

The Individual Plaintiffs’ and FWW members’ alleged harm is the foodborne illness that would result from consuming adulterated, unwholesome chicken produced under the NPIS. In order to have standing, therefore, Plaintiffs at least need to plausibly allege that the NPIS substantially increases the risk of foodborne illness when compared to the existing inspection methods. Accordingly, in order to satisfy this Court’s two-part analysis, the Plaintiffs must demonstrate, under the relevant standard, (1) that the NPIS substantially increases the risk of contracting foodborne illness compared to the existing inspection methods, and (2) a substantial probability that the Individual Plaintiffs and FWW members will contract a foodborne illness given that increase of risk. A failure to satisfy either of these prongs would deprive this Court of jurisdiction to hear Plaintiffs’ case. See Public Citizen I, 489 F.3d at 1295.

A.

Plaintiffs argue that their complaint and submissions in support of their motion for preliminary injunction sufficiently establish that the NPIS substantially increases the risk of harm that will arise from consuming unwholesome, adulterated poultry. Defendants submit that Plaintiffs have failed to demonstrate a substantially increased risk of harm.

We find that Plaintiffs’ complaint, as well as their various submissions in support of their motion for preliminary injunction, fails to plausibly allege that the NPIS taken as a whole substantially increases the risk of foodborne illness as a result of unwholesome, adulterated poultry. First, a careful examination of Plaintiffs’ allegations demonstrates that they have not plausibly alleged that the NPIS substantially increases the risk of foodborne illness compared to the existing inspection systems. To be sure, Plaintiffs’ submissions contained detailed allegations about how HIMP, and by extension, the NPIS, differs from the existing poultry inspection systems. See Compl. ¶¶ 31–77, J.A. 16–25. The complaint is replete with what Plaintiffs argue are the NPIS’s inadequacies. See Compl. ¶¶ 78–126, J.A. 25–29. The complaint also outlines what Plaintiffs perceive are the flaws with the HIMP studies and analyses. See Compl. ¶¶ 148–61, J.A. 33–35. However, these differences and perceived flaws do not demonstrate a substantial increase in the risk of foodborne illness under the NPIS compared to the existing inspection systems. 

To the extent that the presence of adulterated, unwholesome poultry could give rise to an inference of resulting foodborne illness, these allegations still fall short because they fail to allege that the NPIS as a whole will produce significantly more adulterated, unwholesome chicken compared to the existing inspection systems. Plaintiffs’ allegations focus on certain discrete aspects of the NPIS: the reduced number of **377 *916 online federal inspectors, the speed at which the online federal inspectors must evaluate carcasses, and the substitution of establishment personnel for federal inspectors. See Compl. ¶¶ 78–121, J.A. 25–29. However, Plaintiffs’ complaint contains only a single allegation that references another key aspect the NPIS: the reallocation of resources for offline inspection. Compl. ¶ 183, J.A. 39. Under the NPIS, additional offline verification inspectors will check to see to that inspection protocols are being followed and conduct pathogen testing. See 77 Fed.Reg. at 4422. Plaintiffs’ complaint makes no allegation regarding the impact of increased offline verification inspectors on the presence of adulterated, unwholesome poultry. Although Plaintiffs fault Defendants for failing to account for a reduction in online inspectors in Defendants’ risk assessment, Plaintiffs’ failure to account for the increase in offline inspections and their attendant impact on poultry production prevents us from inferring that the NPIS as a whole substantially increases the risk of foodborne illness.

Other allegations in the complaint reveal the same problem. For example, the complaint outlines HIMP personnel’s alleged failure to catch disease-related conditions on poultry. See Compl. ¶ 177, J.A. 38 (“An FWW analysis of the data for 14 HIMP plants found that out of 229 [Noncompliance Reports] filed from March to August 2011, 208 (90 percent) were for visible fecal contamination that was missed by company employees.”). Although these allegations, at best, give rise to the inference that establishment personnel will not be as effective in identifying adulterated poultry, they do not allege how NPIS inspection as a whole will impact the amount of adulterated poultry. Notably, these allegations do not allege that these results are worse than what plants do under existing inspection systems. Thus, they fail to plausibly allege that the regulations substantially increase the risk of foodborne illness.

Plaintiffs’ submissions in support of their motion for preliminary injunction suffer from the same defect. The sworn affidavits from existing USDA inspectors go into great detail about the differences between the NPIS and existing poultry inspection systems. One inspector explained that under the existing inspection systems, they “would have 3 inspectors on each line, with 90 birds per minute split among them, so that each inspector was looking at 30 birds per minute” but under HIMP, one inspector looks “at up to 200 birds, or more, per minute.” J.A. 298. Another inspector claimed, “I know I cannot detect all of the carcasses with Food Safety defects, and it is reasonable to assume that some are going out to the public.” J.A. 306. A third inspector said, “I know the kinds of unwholesome, mutilated, and diseased chickens that are processed and shipped out for sale and I feel it is important to share this information with consumers and taxpayers” because the HIMP system “is tantamount to having the wolves watch the proverbial henhouse, but these chickens are real and they could very likely hurt or kill someone.” J.A. 317. Another inspector who worked previously for a chicken production company and serves currently as a USDA inspector outlined the various pressures that poultry production personnel are under to increase the number of birds that are shipped out to consumers. J.A. 32124. Although these statements may be alarming, even taken as true, they do not allege that there **378 *917 is a substantially increased risk of foodborne illness because they do not allege that the risk of unwholesome, adulterated poultry is higher under the NPIS as a whole than the existing inspection systems.

Plaintiffs could perhaps overcome this deficiency by providing the Court with an alternative basis from which to infer that NPIS inspection results in a substantially increased risk of unwholesome, adulterated poultry. Here, if Plaintiffs could plausibly allege through their use of statistics that NPIS poultry creates a substantial increase in the risk of foodborne illness, they would allege a sufficient injury for standing. We have, in the past, refused to require a quantitative analysis in order to establish standing in increased-risk-of-harm cases, see NRDC II, 464 F.3d at 7, and we likewise refuse to hold that statistics are required for such cases. However, we remain mindful that “[d]etermining whether a complaint states a plausible claim [of injury] is context-specific, requiring the reviewing court to draw on its experience and common sense.” Ashcroft v. Iqbal, 556 U.S. 662, 663–64, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Accordingly, where a plaintiff’s allegations incorporate statistics and the plaintiff contends that the statistics demonstrate a substantial increase in the risk of harm, the plaintiff must allege something from which the Court can infer that risk. Using our experience and common sense, we cannot make this inference from Plaintiffs’ statistics. 

A review of Plaintiffs’ statistics demonstrates their failure to plausibly allege a substantial increase in the risk of harm. Plaintiffs point to isolated statistics where Defendants found Salmonella rates to be “higher” in chicken processed in HIMP establishments than in non-HIMP establishments, but the complaint does not specify how much higher the rates were. See Compl. ¶¶ 162–164, J.A. 35–36. Plaintiffs also submitted selections from an FSIS report that found under some scenarios, “a 0.2% increase in the proportion of samples testing Campylobacter positive,” but the same page of this report concluded that under most projected scenarios, the samples testing positive for Salmonella or Campylobacter would decrease. J.A. 430. Plaintiffs also alleged that 0.1% of Campylobacter illnesses would be attributable to the NPIS “under some scenarios.” Compl. ¶ 180, J.A. 39. Plaintiffs likewise relied on Defendants’ risk assessment assumption that annual Salmonella and Campylobacter illness “attribut[able] to poultry are about 174,686 and 169,005, respectively.” J.A. 430. Plaintiffs plucked these statistics from Defendants’ studies but provide no allegations from which we can infer that the statistics reflect a substantial increase in the risk of harm. Indeed, Defendants’ risk assessment concluded under most scenarios that annual illnesses from Salmonella and Campylobacter would remain unchanged or would decrease under the NPIS. J.A. 430–31. Even Plaintiffs’ complaint acknowledges that the risk of Campylobacter increase is “ambiguous.” Compl. ¶ 180, J.A. 39. An ambiguous increase in risk is hardly a substantial increase in risk.

Plaintiffs’ statistics suffer from additional problems. First, these studies predate the final rule’s amendments. Although not necessarily a problem by itself, the rule’s amendments specifically lowered the line speeds (one of Plaintiffs’ chief criticisms) and made the transition to NPIS inspection voluntary. Plaintiffs make no allegations about the impact of these changes on their statistical claims. Furthermore, Plaintiffs fail to account for how increased allocations in offline inspections would impact the risk. In this context, Plaintiffs’ statistics do not plausibly allege that NPIS inspection as a whole substantially increases the risk that poultry will be contaminated **379 *918 with Salmonella or Campylobacter compared to the existing inspection systems. Because Plaintiffs have failed to plausibly allege that the NPIS substantially increases the risk of producing unwholesome, adulterated poultry compared to the existing inspection systems, they do not have standing. 

***

VI.

For the foregoing reasons, we hold that Plaintiffs have failed to show any cognizable injury sufficient to establish standing. Accordingly, we affirm the District Court.

So ordered. 

(Concurring Opinions of Judge Henderson and Judge Millit omitted)

FEDERALISM AND THE INTERPLAY OF FEDERAL, STATE, LOCAL, AND TRIBAL

The United States is governed using a system of federalism. This means that both the federal and state governments have their own spheres of responsibility and authority. The U.S. Constitution limits the areas over which the federal government has authority, leaving certain areas to the states to govern exclusively. The federal government is not allowed to directly govern those areas. In the areas where the federal government does have authority to govern, federal laws generally override state laws.

The interplay between state and local governments works slightly differently. Local governments do not have any express authority under the U.S. Constitution. Instead, local governments have the power given to them by their state under that state’s constitution or statutes. Thus, all states have the same amount of constitutionally-derived power and authority vis-à-vis the federal government, but they determine on their own how to apportion this state power between the state and local governments. This means that the amount and type of authority given to local governments varies greatly from state to state and, as described below, can even vary from city to city within one state. Because there is so much variation in local governments’ authority, this toolkit cannot lay out all of the specific authorities given to local governments in each state, but will help to provide you with some tools to figure out what powers your local government has.

The interplay between Native American tribal governments and state or federal government is a bit more complicated. In the U.S., Native American tribes are considered to have “tribal sovereignty,” a term that describes “the right of federally recognized tribes to govern themselves and the existence of a government- to-government relationship with the United States.” This also means that a tribal group has “the right to form its own government, adjudicate legal cases within its borders, levy taxes within its borders, establish its membership, and decide its own future fate.” As a result, tribes cannot be preempted by state laws like local governments can; however, they can be preempted by the federal government. State law can only preempt tribal law when Congress has given that state the authority to do so. While this interplay is worth noting, as the focus of this toolkit is on local governments, our analysis of tribal law is limited. * * *  

HOW LOCAL GOVERNMENT GETS THE POWER TO ACT State laws play a significant role in local government. First, because local governments do not have any power except that given to them by the state, the state constitution or state legislation must authorize local governments to act in certain ways. Second, because state laws can preempt, or bar, local authority to act on certain issues, states almost always have ultimate authority over local governments. Third, because statewide rules and regulations must generally be followed in all local areas, state laws play a significant role in local areas. When recommending policy change, food policy councils need to understand how their locality gets its authority and what types of powers it does or does not have. In order to conserve their energy to push for policy changes that are actually possible for the city or county to enact, food policy councils should be sensitive to the restrictions their municipality faces with regard to the ability to enact certain types of laws or regulations.

General Background: Dillon’s Rule & Home Rule In general, local governments have no inherent powers granted to them by the U.S. Constitution. Judge John Dillon of the Iowa Supreme Court recognized this fact over 100 years ago, which is why this lack of local power is now known as Dillon’s Rule. Dillon’s Rule holds that local governments have only those powers that are expressly given to them by the state; according to Dillon’s Rule, local governments only have those powers that are:

Therefore if the power in question is not expressly authorized by a state statute or the state constitution, or cannot be implied directly from another authorized power, it is presumed that a municipality does not have that power. States that are considered Dillon’s Rule states, or that do not give broad Home Rule powers to local areas, including Arkansas, Connecticut, and New York, generally depend on the state legislature for legislation enabling them to act. In such states, local governments generally get some authority to act from state enabling statutes, which limit the authorization of local power to a particular defined area. An enabling statute is a “law that permits what was previously prohibited or that creates new powers.” In this context, this means a statute giving local municipalities the authority to enact local ordinances on particular topics. Absent enabling legislation, cities in these states might not have the authority to enact ordinances or take action on certain food policy matters. In New York, for example, municipalities were not allowed to permit community gardens on land they held until 1978, when the legislature passed enabling legislation granting them that ability. It is worth noting though that while Dillon’s Rule was originally intended to be strictly construed, some courts have more recently interpreted the granted powers broadly. 

Home Rule, on the other hand, is a broad grant of power from the state that allows municipalities to independently handle local matters without the need for special legislation by the state, as long as the municipal laws do not conflict with state laws. This power to exercise certain functions is transferred from the state to local governments through the state’s constitution or state legislation. Whether the power originates from the former or the latter, Home Rule powers are shaped by the language of the delegation from the state legislature or the interpretation of this delegation by state courts. Thus, even though “all but few states have some form of home rule authority,” the specific details of the power granted varies from state to state. 

The majority of the states with Home Rule authorization also give municipalities the permission to enact a Home Rule Charter, which is a “local government’s organizational plan or framework, analogous to a constitution, drawn [up] by the municipality itself and adopted by popular vote of the citizenry.”  A typical Home Rule grant allows a local government to “make and enforce local police, sanitary and other regulations as are not in conflict with [the municipality’s] charter or with the [state’s] general laws,” while others provide authority over any local matter that is “not expressly denied by [the state’s] general law or [the municipality’s] charter.” Unlike with enabling statutes, under Home Rule, when authorization is vague, it is assumed that the municipality has the power unless it is explicitly denied. If your state has granted municipalities broad Home Rule authority or allowed Home Rule Charters and your municipality has enacted such a charter, your municipality will likely have greater independence, and its powers may be controlled by this charter, rather than by state enabling statutes.

As it is unclear what constitutes a “local matter,” interpreting the exact scope of the power granted to local government is usually left to the discretion of the state legislature (if Home Rule was granted through legislation) or state courts (if Home Rule was granted through the state constitution). Either way, it is clear that the scope of Home Rule authority varies greatly depending on each state’s authorizing language and how that language is interpreted. For example, it would seem that a constitutional grant of Home Rule authority would be stronger than a statutory grant; however, though Idaho allows certain Home Rule powers in its constitution, including the creation of Home Rule Charters, the scope of Idaho municipalities’ governing powers are more limited than in Indiana, where Home Rule was granted through statute. This is because Idaho’s constitution only allows for a strict construction of police powers, the powers that give cities the capacity to preserve public security, order, health, and justice. By contrast, Indiana’s law also allows municipalities some functional powers, which includes the city’s ability to choose the public goods and services it provides and at what levels.

Not only do states allow varying amounts of power depending on the particular area of the law, but they can also distinguish between the levels of local government. The powers delegated to counties may not be the same as those delegated to cities. Further, states such as Arizona, Missouri, and Delaware require a minimum population size before a municipality can create a Home Rule Charter. Thus, in some states, only certain cities are granted Home Rule authority while others are not. 

It is worth noting that, while in tension, Dillon’s Rule and Home Rule are not polar opposites; states can be considered a Dillon’s Rule State while still allowing some Home Rule authority, and vice versa. Further, while it may appear that Dillon’s Rule States have much less power available to them, this is not necessarily true. North Carolina, for example, is considered a Dillon’s Rule State, yet local governments there have the same powers, and in some cases, powers that are considered even “greater than those enjoyed by local governments in states [with Home Rule].” Thus, it important to keep in mind when assessing whether your state adheres predominantly to Dillon’s Rule or Home Rule, that it is just as significant to understand how that Rule is actually carried out in your state and locality. Further, regardless of whether your state is considered Home Rule or Dillon’s Rule, state government can still preempt local government at any time unless the local power is protected by the state’s constitution or federal laws.

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1. PHS MODEL CODES HISTORY, PURPOSE, AND AUTHORITY

 History and Purpose

Public Health Service (PHS) activities in the area of food protection began at the turn of the 20th century with studies on the role of milk in the spread of diseas These studies led to the conclusion that effective disease prevention requires the application of comprehensive food sanitation measures from production to consumption. Additional studies identified and evaluated measures which would most effectively control disease, including work which led to improved processes for pasteurization.

Next, model codes were developed to assist state and local governments in initiating and maintaining effective programs for prevention of foodborne illness.  The first of these, which is now titled Grade A Pasteurized Milk Ordinance – Recommendations of the PHS/FDA, was initially published in 1924.  Subsequently, the PHS published recommended model food codes that address the various components of the retail segment of the food industry.  These code editions are listed chronologically on pp. iii and iv. Through the years all states, hundreds of local jurisdictions, and many federal agencies have adopted some edition of model food codes recommended by the PHS.

Today, FDA's purpose in maintaining an updated model food code is to assist food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail segment of the food industry. The retail segment includes those establishments or locations in the food distribution chain where the consumer takes possession of the food.

The model Food Code is neither federal law nor federal regulation and is not preemptive.  Rather, it represents FDA's best advice for a uniform system of regulation to ensure that food at retail is safe and properly protected and presented.  Although not federal requirements (until adopted by federal bodies for use within federal jurisdictions), the model Food Code provisions are designed to be consistent with federal food laws and regulations, and are written for ease of legal adoption at all levels of government.  A list of jurisdictions that have reported to FDA their status in adopting the Food Code is available on the FDA CFSAN Web Page at: http://www.fda.gov/RetailFoodProtection. The list is self-reported and FDA has not yet evaluated whether all the adopted codes are equivalent to the model Food Code.

Providing model food codes and model code interpretations and opinions is the mechanism through which FDA, as a lead federal food control agency, promotes uniform implementation of national food regulatory policy among the several thousand federal, state, and local agencies and tribes that have primary responsibility for the regulation or oversight of retail level food operations.

 Authority

PHS authority for providing assistance to state and local governments is derived from the Public Health Service Act [42 USC 243].  Section 311(a) states in part:

"... The Secretary shall ... assist states and their political subdivisions in the prevention and suppression of communicable diseases, and with respect to other public health matters, shall cooperate with and aid state and local authorities in the enforcement of their ... health regulations and shall advise the several states on matters relating to the preservation and improvement of the public health."  Responsibility for carrying out the provisions of the Act relative to food protection was delegated within the PHS to the Commissioner of Food and Drugs in 1968 [21 CFR 5.10(a)(2) and (3)]. 

Under authority of the Economy Act, June 30, 1932 as amended [31 USC 1535], FDA provides assistance to federal agencies.

Assistance provided to local, state, and federal governmental bodies is also based on FDA's authorities and responsibilities under the Federal Food, Drug, and Cosmetic Act [21 USC 301].

2. PUBLIC HEALTH AND CONSUMER EXPECTATIONS

It is a shared responsibility of the food industry and the government to ensure that food provided to the consumer is safe and does not become a vehicle in a disease outbreak or in the transmission of communicable disease.  This shared responsibility extends to ensuring that consumer expectations are met and that food is unadulterated, prepared in a clean environment, and honestly presented.

Under FDA’s 2012 Mission Statement the agency is responsible for:

Protecting the public health by assuring the safety of our nation’s food supply…and for advancing the public health by helping the public get accurate, science-based information they need about foods to maintain and improve their health.

Accordingly, the provisions of the Food Code provide a system of prevention and overlapping safeguards designed to minimize foodborne illness; ensure employee health, industry manager knowledge, safe food, nontoxic and cleanable equipment, and acceptable levels of sanitation on food establishment premises; and promote fair dealings with the consumer. 

3. ADVANTAGE OF UNIFORM STANDARDS

The advantages of well-written, scientifically sound, and up-to-date model codes have long been recognized by industry and government officials. 

Industry conformance with acceptable procedures and practices is far more likely where regulatory officials "speak with one voice" about what is required to protect the public health, why it is important, and which alternatives for compliance may be accepted.

Model codes provide a guide for use in establishing what is required.  They are useful to business in that they provide accepted standards that can be applied in training and quality assurance programs.  They are helpful to local, state, and federal governmental bodies that are developing or updating their own codes.

The model Food Code provides guidance on food safety, sanitation, and fair dealing that can be uniformly adopted for the retail segment of the food industry.  The document is the cumulative result of the efforts and recommendations of many contributing individuals, agencies, and organizations with years of experience using earlier model code editions.  It embraces the concept that our quality of life, state of health, and the public welfare are directly affected by how we collectively provide and protect our food.

The model Food Code provisions are consistent with, and where appropriate incorporate, federal performance standards for the same products and processes. Federal performance standards in effect define public food safety expectations for the product, usually in terms of lethality to a pathogenic microorganism of particular concern.  Use of performance standards as the measure of regulatory compliance means establishments are free to use innovative approaches in producing safe products, in lieu of adherence to traditional processing approaches, such as specified cooking times and temperatures, that achieve the same end.  Federally inspected establishments demonstrate compliance with performance standards by showing that their process adheres to an appropriately designed, validated HACCP plan.

Retail processors may be given the same opportunity as federally-regulated establishments to use innovative techniques in the production of safe foods.  Retail establishments may apply to the regulatory authority for a variance to use a specific federal food safety performance standard for a product or a process in lieu of compliance with otherwise applicable specifications in the Food Code.  However, to show compliance with the federal performance standard, the retail processor must, like a federally inspected establishment, show that processing controls are in place to ensure that the standard is being met.  Thus, a request for a variance based on a federal performance standard must be supported by a validated HACCP plan with record keeping and documented verification being made available to the regulatory authority.