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Enhancing Food Safety: The Role of the Food and Drug Administration 10 Modernizing Legislation to Enhance the U.S. Food Safety System In the 1906 Pure Food and Drugs Act, for the first time Congress prohibited interstate commerce in “adulterated” food, which included, among other things, food “contain[ing] any added poisonous or other added deleterious ingredient which may render such article injurious to health” and food “consist[ing] in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance.”1 The government could enforce these and all other provisions of the 1906 act through the collection and examination of specimens, criminal prosecution, the seizure and condemnation of violative articles, and the sampling and exclusion of imported goods.2 In 1938, Congress repealed the 1906 act and replaced it with the Federal Food, Drug, and Cosmetic Act (FDCA), which, as amended, is still in effect today.3 While preserving, with a few minor changes, the 1906 adulteration provisions quoted above,4 the 1938 act enhanced the U.S. Food and Drug Administration’s (FDA’s) food safety authority in various significant ways, including (1) a provision defining a food as adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”; (2) a section empowering the FDA to establish an emergency permit system for food contaminated with microorganisms; and (3) a section providing for the establishment of tolerances for unavoid- 1 Federal Food and Drugs Act of 1906, Sec. 7. 2 Federal Food and Drugs Act of 1906, Sec. 2, 3, 10, 11. 3 Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 et seq., 1938. 4 FDCA 402(a)(1), (3).
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Enhancing Food Safety: The Role of the Food and Drug Administration able poisonous and deleterious substances.5 In addition, for food and all other regulated products, the 1938 FDCA added injunction proceedings and mandatory establishment inspection to the enforcement tools included in the 1906 act.6 Since 1938, Congress has occasionally amended the FDCA to further enhance the FDA’s power to accomplish its food safety mission. Notable examples of these amendments include the Food Additives Amendments of 1958, creating a premarket approval system for food additives; the Color Additives Amendments of 1960, creating a premarket approval system for color additives; and the Animal Drugs Amendments of 1968, creating a unified scheme for all aspects of animal drug regulation, including ensuring the safety of animal drug residues in food.7 More recently, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)8 strengthened the food safety provisions of the FDCA by, among other things, (1) authorizing the FDA to administratively detain food for which there is “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals,”9 (2) mandating the registration of food facilities,10 (3) giving the FDA access to industry records related to food that “presents a threat of serious adverse health consequences or death to humans or animals,”11 (4) empowering the FDA to require the maintenance of records needed by the agency “to identify the immediate previous sources and the immediate subsequent recipients of food,”12 and (5) requiring prior notice of imported food shipments. Finally, in 2007 Congress added a new section to the FDCA (the Food and Drug Administration Amendments Act of 2007) requiring the FDA to establish a Reportable Food Registry for the reporting of instances in which there is a “reasonable probability that the use of, or exposure to, [a] food will cause serious adverse health consequences or death to humans or animals.”13 Nevertheless, in some other fundamental respects, the law under which 5 FDCA 402(a)(4), 404, 406. 6 FDCA 302, 704. 7 Food Additives Amendment, 72 Stat. 1784 (1958); Color Additive Amendments, 74 Stat. 397 (1960); Animal Drug Amendments, 82 Stat. 342 (1968). 8 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), HR 3448, 107th Cong, 2nd sess. (FDCA 801(m)). 9 FDCA 304(h). 10 FDCA 415. 11 FDCA 414(a). 12 FDCA 414(b). 13 FDCA 417.
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Enhancing Food Safety: The Role of the Food and Drug Administration the FDA must ensure the safety of 80 percent of Americans’ food supply14 remains unchanged since 1938, despite the dramatic changes in food production and distribution patterns that have taken place since (see Chapter 2). For example, the provisions of the FDCA that the agency invokes most often in attempting to prevent and address the pathogenic infection of food read exactly the same as they did 72 years ago.15 The FDA needs to have the power to fulfill its food safety mission in the face of an increasingly complex and global food supply. In this chapter, the committee recommends some important legislative changes to this end. As shown by the length of the food safety bills currently under consideration in Congress, this chapter cannot address every area in which statutory amendments may be warranted; instead, it highlights those the committee deems most critical. For example, this chapter does not address authorities, such as embargo power16 and civil monetary penalties, that might be helpful but less essential to ensure public health than the ones discussed below. Furthermore, this chapter does not consider how much money Congress should appropriate for the FDA’s food safety activities or what funding mechanisms the agency should use. Although the committee supports increasing funding for the FDA to the extent necessary to implement the recommendations contained in this report, it is also firmly convinced that simply putting more money into the food safety system as it is currently constituted, without essential reforms, would be insufficient from a public health perspective and an inefficient expenditure of resources. Finally, the legislative recommendations in this chapter are not intended to suggest that the FDA does not already have the authority in question under current law. Various existing statutory provisions give the agency broad discretion and flexibility that might encompass the powers discussed herein. There are instances in which a specific authority has not been explicitly given to the FDA, so that legal interpretations might result in differences in opinion that would raise controversy among stakeholders. In these cases, the committee concluded that it would be helpful to provide such authorities to the FDA explicitly. For example, the committee recommends giving the FDA explicit authority to mandate that food facilities establish preventive process controls, maintain records, and provide the agency with access to these records during inspections. Yet even without such explicit statutory authority, the FDA has promulgated Hazard Analysis and Criti- 14 The term “food,” as defined in the FDCA, includes “all articles used for food or drink for man or other animals” and thus encompasses what is commonly known animal “feed.” Throughout this chapter, therefore, as throughout the rest of the report, the word “food” includes animal feed unless otherwise noted. 15 See FDCA 402(a)(1), (3), (4) (Adulterated Food); 404 (Emergency Permit Control). 16 As discussed later in the chapter, the committee does recommend that the FDA be given the power to issue cease distribution orders as part of a broader mandatory recall authority.
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Enhancing Food Safety: The Role of the Food and Drug Administration cal Control Points (HACCP) regulations that impose such requirements on seafood and juice processors. The agency issued both of these rules pursuant to section 701(a) of the FDCA (21 U.S.C. 371(a)), which gives the FDA broad “authority to promulgate regulations for the efficient enforcement of this Act.” For the juice HACCP rule, the agency also relied in part on section 361 of the Public Health Service Act (42 U.S.C. 264), under which the FDA commissioner has been delegated power to “make and enforce such regulations as in [her] judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession” (HHS/FDA, 1995, 2001).17 The seafood and juice HACCP rules have not been challenged in court as unreasonable interpretations of the statutes, and the rules might well survive such challenges if they arose. Nonetheless, the FDA should be able to impose preventive controls based on hazard analysis and risk, as defined in Chapter 3, on all food facilities—and to exercise the other powers enumerated below—free of any doubt that it has the authority do so. The agency is prone to hesitate before pursuing measures based on broad delegations of authority rather than detailed statutory provisions, and agency actions taken pursuant to such broad delegations are more vulnerable to court challenge. Hence, the committee believes it is important to revise the FDCA to expressly provide the FDA with explicit authorities in the areas of facility registration, preventive controls, performance standards, risk-based inspection, access to records, traceability, mandatory recall, reporting of adulteration, and banning of all food imports from a country if a review of its food safety system indicates that the public health is at risk. FACILITY REGISTRATION The FDA cannot have an adequate food safety program unless it knows exactly where food is being produced, processed, packed, and held. Section 415 of the FDCA, “Registration of Food Facilities,” currently requires food facilities, both domestic and foreign, to register with the FDA. Although the act requires registrants to notify the agency of changes in the submitted information, it does not mandate regular reregistration in the absence of such changes. Moreover, it does not provide for the suspension of the registration of a facility that has committed violations that threaten the public health. The act needs to be amended to include mandatory periodic reregistration and, with adequate procedural protections, FDA authority to suspend registrations. The FDCA’s definition of a “facility” subject to the registration require- 17 42 U.S.C. 264 sec. 361.
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Enhancing Food Safety: The Role of the Food and Drug Administration ment is limited to “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.”18 Many food importers, however, never physically possess the food they import and thus fall outside this definition. To enhance the FDA’s ability to trace and apply the act to imported foods, the definition of “facility” should be amended to embrace entities in the business of importing foods from foreign countries even if these entities do not “manufacture, process, pack, or hold” the foods (see Appendix E). Section 415 of the act also explicitly exempts farms, restaurants, and other retail food establishments from the definition of “facility” and thus from the current registration requirement. The committee believes that, to enhance the agency’s ability to trace food along its entire production and distribution chain, all domestic farms, restaurants, and other food service and retail food establishments ought to be required to register with the FDA. This is not to say that such establishments should be subject to the same panoply of requirements as, for example, food factories and warehouses. Congress might sensibly decide to exempt farms, restaurants, and other food service and retail food establishments from requirements other than registration imposed on all “food facilities.” Therefore, the goal of universal registration should probably not be achieved by simply amending the definition of “facility” in section 415(b)(1) to delete the exception for farms, restaurants, and retail establishments. PREVENTIVE CONTROLS As demonstrated by its promulgation of the seafood and juice HACCP rules, the FDA has found authority under current law to impose preventive process control regimes on food facilities. Nonetheless, the FDCA needs to be amended not only to make this authority explicit, but also to mandate that all registered food facilities have such controls in place. Every food facility ought to be required to conduct a hazard evaluation, identify potential hazards, implement preventive controls, monitor the controls, establish corrective actions, and maintain comprehensive records of the system’s implementation. Each facility should also be required to prepare a food safety plan that sets forth the hazard evaluation results, the identified preventive controls, and the facility’s program for monitoring the preventive controls, validating them, taking corrective action, and keeping records. In addition, the act needs to specify that the food safety plan and the implementation records must be made available to FDA inspectors. Finally, the act should state that if a facility fails to satisfy these requirements for preventive controls based on hazard analysis and risk, any food produced, 18 FDCA 415(b)(1).
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Enhancing Food Safety: The Role of the Food and Drug Administration processed, packed, or held in that facility is considered adulterated under section 402 of the act. The committee discussed the possibility of recommending mandatory testing for pathogens. However, it concluded that the FDA should address this complex issue on a case-by-case basis, pursuant to the overall risk-based food safety management approach proposed in this report. PERFORMANCE STANDARDS The FDCA needs to be amended to require the FDA to periodically issue enforceable, risk- and science-based performance standards for pathogens and other contaminants significant to public health. The agency should be required to use a risk-ranking approach to prioritize the development and issuance of those standards. RISK-BASED INSPECTION A process for making decisions about what, when, and how to inspect is essential for an efficient food safety system. In Chapter 3, the committee recommends that the FDA use a risk-based approach to make decisions and allocate resources. In Chapter 8, the committee specifically calls for a review and update of FDA inspection processes so they are consistent with a risk-based approach. Although the FDA is already thinking through its decision-making process for the conduct of inspectional activities, the committee concluded that this is one key area that requires a congressional mandate. The FDCA needs to be amended to require the FDA to adopt a risk-based approach to both the frequency and intensity of inspections. The committee also believes, however, that the law should establish minimum standards for the frequency and intensity of inspection of all food facilities, regardless of their risk ranking. Moreover, the committee believes it is important to maintain some element of randomness in the scheduling and targeting of inspections. ACCESS TO RECORDS The FDCA as currently written expressly authorizes the FDA to demand access to only four categories of records relating to food: (1) those showing
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Enhancing Food Safety: The Role of the Food and Drug Administration the movement of food in interstate commerce kept by shippers/carriers and by recipients of interstate shipments,19 (2) those kept pursuant to FDA regulations by shippers/carriers regarding sanitary transportation practices,20 (3) those relating to infant formula,21 and (4) those needed to determine whether a food is adulterated and presents a threat of serious adverse health consequences or death.22 The agency has access to documents under the fourth provision, added by the Bioterrorism Act of 2002, only if it has a “reasonable belief” that the food is adulterated and presents a threat of serious health consequences or death.23 In contrast, with respect to prescription drugs, nonprescription drugs intended for human use, and restricted devices, the FDCA provides the FDA with broad access to records bearing on whether the products are adulterated, misbranded, or otherwise in violation of the act. The committee believes that Congress needs to give the FDA similarly broad access to records in food facilities. As explained above, the effective enforcement of a food safety system based on preventive controls depends on the FDA’s having access to each facility’s food safety plan and implementation records. But in light of the fact that other categories of documents may also bear on food safety, the FDA’s access should not be limited to preventive control documents. TRACEABILITY Section 414(b) of the FDCA, added by the Bioterrorism Act of 2002, authorizes the FDA to issue regulations requiring food facilities, excluding farms and restaurants, to establish and maintain “records … needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food … in order to address credible threats of serious adverse health consequences or death to humans or animals.”23 Such regulations cannot require that facilities maintain those records for longer than 2 years. The agency issued such regulations in 2004.24 These regulations, in accordance with the statute, exempt farms and restaurants from all the requirements, and they also exempt entities that sell directly to consumers from the requirement to identify subsequent recipients. The FDA has access to these records under the same standard applicable to all records sought under 19 FDCA 703(a). 20 FDCA 703(b). 21 FDCA 704(a)(3). 22 FDCA 414(a). This category was added by the Bioterrorism Act of 2002. 23 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). 24 21 CFR 1.326-1.368.
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Enhancing Food Safety: The Role of the Food and Drug Administration the Bioterrorism Act; the agency must have a “reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.”25 The committee believes that the FDCA needs to be amended to require farms to maintain records identifying immediate subsequent recipients, other than individual consumers, and restaurants to maintain records identifying immediate previous sources. MANDATORY RECALL When confronting a food safety emergency, the FDA can often depend on state governments to use their embargo authority to stop the distribution and sale of the adulterated food. Moreover, section 304(h)(1)(A) of the FDCA gives the FDA itself the power to administratively detain any article of food if an officer or qualified employee of the agency “has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.”26 However, the FDA does not currently have explicit authority to mandate a recall of the products it regulates, with the exception of infant formula, medical devices, and biological products. In communications with the committee, the FDA maintained that it should be given the power to order a company to recall an adulterated food when necessary to protect the public health. The bills currently under consideration in Congress give the FDA the power, subject to specified procedures, to issue a cease distribution order and a subsequent recall order when there is a reasonable probability that a food will cause serious adverse health consequences or death.27 In most instances, the FDA does not need mandatory recall authority to fulfill its food safety mission. The agency has developed a sophisticated and highly successful “voluntary recall” process with respect to food as well as all other products it regulates (Title 21 CFR—“Food and Drugs,” Subpart J, “Establishment, Maintenance, and Availability of Records,” 2004; Degnan, 2006, pp. 107–113). Food companies almost always cooperate with FDA-requested recalls, and even when companies resist, the agency 25 21 CFR 1.361. 26 A detention order may be issued by an “officer or qualified employee” of the FDA, but such order must be approved by the commissioner or by an official designated by the commissioner who ranks no lower than district director (FDCA 304(h)(1)). A claimant for a detained article may appeal the detention order, and the commissioner must, after providing an opportunity for an informal hearing, confirm or terminate the order within 5 days of when the appeal is filed (FDCA 304(h)(4)(A)). 27 HR759, Food and Drug Administration Globalization Act of 2009; S510 IS, FDA Food Safety Modernization Act of 2009.
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Enhancing Food Safety: The Role of the Food and Drug Administration can usually induce cooperation through the threat of negative publicity. Indeed, the voluntary recall process is normally so efficacious that the FDA rarely uses its mandatory authority even in those areas in which it possesses such authority. For example, although the FDA has had mandatory recall authority over medical devices since 1990, the committee learned that the agency has invoked this power only ten times, and never since 1994.28 Nonetheless, the committee concludes that there may be rare circumstances, involving uncooperative food distributors, in which the FDA needs the power to formally order a party to cease distribution of an article of food and recall it. Congress thus needs to amend the statute to provide the FDA with such authority with respect to foods that are adulterated under section 402 of the FDCA and may cause serious health consequences or death. To ensure that the existence of mandatory recall authority does not undermine the carefully honed and highly effective voluntary system already in place, Congress should require the FDA to always provide the party in question an opportunity to cease distribution and recall an article voluntarily (according to terms prescribed by the agency) before it issues an order. If the party refuses to proceed voluntarily, the FDA should then have the power to order the party to cease distribution immediately, but the party should, except in instances of imminent danger, be given an opportunity for an expeditious informal hearing before the FDA modifies the order to mandate recall. REPORTING OF ADULTERATION In 2007, Congress amended the FDCA to require all registered food facilities to report to the FDA, through an electronic portal into a Reportable Food Registry, any “article of food … for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.”29 While the committee supports the concept of this registry, it is concerned that the mandatory reporting requirement may lead to a reduction in testing by food facilities reluctant to report any problems they may find. Section 417(d)(2) exempts from the reporting requirement any party that detects the adulteration prior to the transfer of the food to another party and corrects the adulteration or destroys the food. The committee believes this safe harbor ought to be extended to parties that detect adulteration even after transfer of the food to an immediately subsequent party as long 28 Personal communication, Joanna Weitershausen, Center for Devices and Radiological Health, FDA, September 30, 2009. 29 FDCA 417.
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Enhancing Food Safety: The Role of the Food and Drug Administration as the responsible party corrects the adulteration (or causes it to be corrected) or destroys the food (or causes it to be destroyed). AUTHORITY TO BAN ALL FOOD IMPORTS FROM A COUNTRY The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) administers the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act (FSIS/USDA, 2009a). Pursuant to these statutes and implementing regulations, FSIS permits imports of meat, poultry, and egg products only from countries it has certified as having inspection systems that ensure that exported food products meet American food safety standards.30 FSIS makes the determination that a country’s food regulatory system provides food safety protections equivalent to those provided by U.S. domestic regulatory programs (and thus that the country is eligible to export meat, poultry, or egg products) based on document reviews, on-site audits, and port-of-entry reinspection (FSIS/USDA, 2009b). The FDCA does not require the FDA to make a similar country-by-country equivalence determination, and the committee does not believe that such an approach would be practicable for the agency, which has jurisdiction over a much more global and diverse imported food supply relative to FSIS. Nonetheless, in administering a risk-based food safety system, the FDA might decide to review the regulatory systems of some or all of the nations that export food to the United States. In addition, the agency might conclude, based on a comprehensive risk assessment, that a particular country’s food safety regulatory system is so inadequate that all food imports from that country should be banned. The FDCA needs to be amended to empower the FDA to ban all food imports from a country if the agency concludes, in light of a review of that country’s food safety regulatory system, that such a measure is necessary to protect the public health. The committee also concluded that, rather than dramatically increasing inspectors in foreign countries, the FDA should use a risk-based approach to prioritize inspections at the border (see Chapter 3). KEY CONCLUSIONS AND RECOMMENDATIONS The FDA bears responsibility for ensuring the safety of 80 percent of the nation’s food supply. Despite the dramatic developments in food production and distribution that have occurred since the 1938 enactment of the FDCA, the main statutory provisions under which the agency carries out its food safety mission remain largely unchanged. These provisions are broad 30 See Title 9 CFR 327.2 (meat), 381.196 (poultry), 590.910 (egg products).
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Enhancing Food Safety: The Role of the Food and Drug Administration delegations of power rather than detailed grants of authority. The agency is often reluctant to take action without an explicit mandate to do so, and those actions it does take in the absence of express statutory authorization are vulnerable to court challenge. Therefore, the committee believes the FDCA needs to be revised to detail the FDA’s authorities in the areas of facility registration, preventive controls, performance standards, risk-based inspection, access to records, traceability, mandatory recall, reporting of adulteration, and banning of all food imports from a country if a review of its food safety system indicates that the public health is at risk. Recommendation 10-1: Congress should consider amending the FDCA to provide explicitly and in detail the authorities the FDA needs to fulfill its food safety mission. The following are the most critical areas in which Congress should enact amendments: mandatory reregistration of food facilities and FDA authority to suspend registrations for violations that threaten the public health, mandatory preventive controls for all food facilities, FDA authority to issue enforceable performance standards, mandatory adoption by the FDA of a risk-based approach to inspection frequency and intensity, expansion of the FDA’s access to records, FDA authority to mandate recalls, and FDA authority to identify countries with inadequate food safety systems and to ban all imports from such countries. REFERENCES Degnan, F. H. 2006. FDA’s Creative Application of the Law: Not Merely a Collection of Words (2nd edition). Washington, DC: Food and Drug Law Institute. FSIS/USDA (Food Safety and Inspection Service/U.S. Department of Agriculture). 2009a. Regulations, Directives & Notices: Acts & Authorizing Statutes. http://www.fsis.usda. gov/regulations_&_policies/acts_&_authorizing_statutes/index.asp (accessed December 9, 2009). FSIS/USDA. 2009b. Regulations & Policies/International Affairs/Import Information/Equivalence Process. http://www.fsis.usda.gov/regulations_&_policies/Equivalence_Process/index.asp (accessed December 9, 2009). HHS/FDA (U.S. Department of Health and Human Services/U.S. Food and Drug Administration). 1995. Procedures for the safe and sanitary processing and importing of fish and fishery products. Final rule. Federal Register 60(242):665905–65202 HHS/FDA. 2001. Hazard Analysis and Critical Control Point (HAACP): Procedures for the safe and sanitary processing and importing of juice. Final rule. Federal Register 66(13):6138–6202
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