Food Safety | jgersen | February 11, 2016


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Food Safety

by jgersen Show/Hide
  1. 1 Show/Hide More Introduction to Food Safety
    Original Creator: jgersen

    The CDC estimates that 48 million people get sick, 128,000 are hospitalized, and 3000 people die from foodborne illness each year in the United States. Major known pathogens account for approximately 9 million of these cases, but it is extremely difficult to link an individual illness to a particular food except during an extreme outbreak.

    Consider the problem faced by food safety institutions. The average American eats nearly 2000 pounds (1 ton) of total food each year. That figure includes about 630 pounds of dairy (milk, yogurt, cheese, and ice cream), about 185 pounds of meat and poultry, nearly 275 pounds of fruit, and 415 pounds of vegetables. Produce accounts for about half of all illnesses, most often caused by norovirus. Within this category, it was leafy vegetables that cause nearly half. Most fatal illnesses are caused by Salmonella and Listeria passed to humans by meat and poultry. Meat and poultry account for fewer illnesses, but more deaths (29%).

    America imports about 15 percent of the U.S. food supply, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood. Americans consume twice as much fruit, and three times as many vegetables, from both Mexico and Canada as they did two decades ago.

    Between foreign and domestic production, distribution, preparation, and sale of foods, the food safety challenge is immense. Roughly, these challenges might be grouped into three classes. First, food that is contaminated, diseased, or contains harmful materials that are not detected or remedied. Second, faulty storage, handling, or processing, which might either introduce risks or fail to detect risks. Third, the intentional introduction of harmful materials into the food supply including toxins, food additives, chemicals, pesticides, drugs, packaging materials, or poisons. See generally Richard A. Merrill & Jeffrey K. Francer, Organizing Federal Food Safety Regulation, 31 Seton Hall L. Rev. 61 (2000); Institute of Medicine, Ensuring Safe Food: From Product to Consumption (1998).

    For many years, there was remarkable little in the way of federal food safety legislation. In 1906, Upton Sinclair published his famous novel The Jungle, a socialist screed aimed at revealing the plight of immigrants the working poor in advanced industrial capitalism. The book, however, had a much larger impact on food safety law than on anti-capitalist sentiments. Sinclair revealed the inner workings of the Chicago slaughterhouses and meatpacking plants. The result was none too pretty. His portrait of not just unsanitary, but downright disgusting conditions and practices caused a justifiable outcry among the American public and politicians. Contemporaneous reports documented “meat shoveled from filthy wooden floors, piled on tables rarely washed, pushed from room to room in rotten box carts.” Upton Sinclair, What Life Means to Me, Cosmopolitan Mag. (Oct. 1906).

    What resulted politically was the Pure Food and Drug Act of 1906 (PFDA), 34 Stat. 768 and the Federal Meat Inspection Act (FMIA), 34 Stat. 1260 (1907). The goal of the FMIA was to protect consumers “by ensuring that meat and meat food products are wholesome, not adulterated, and properly marked labeled, and packaged.” The Act’s method was to establish sanitary standards and mandate continuous inspection of cattle, sheep, goats, and equines before, during, and after slaughter. That is, a federal inspector (or inspectors) was placed in each facility to monitor the entire production process from start to finish. Consider how much staffing would be necessary to comprehensively and effectively inspect every piece of meat sold in the United States.

    The PFDA, by contrast, mandated nothing like continuous inspection for non-meat products. Rather, the PFDA simply forbid the “adulteration” of foods in interstate commerce. Yet, because the statute did not set standards for what a particular “food” was, it was extremely difficult to prove that a given food was “adulterated.”

    After several decades of struggling with the inadequacies of the PFDA, the FDA recommended that Congress enact new legislation in the 1930s. In a remarkable bout of administrative agency activism, the FDA developed an exhibit and ultimately a book known as the Chamber of Horrors in 1936. Chamber of horrors was published by Ruth deforest Lamb, FDA’s chief educational officer. It was the historical equivalent of an expose on the food industry, revealing a range of unpalatable industry practices. Although Chamber of Horrors did not have quite the impact of The Jungle, the book, together with the death of 107 people from unknowingly consumed the drug elixir of sulfanilamide, helped prompt the enact of the Food, Drug, and Cosmetic Act of 1938, that today remains the overarching framework for the federal regulation of food, drugs, and cosmetics.

    The FDCA expanded FDA authority to inspect food manufacturing and processing facilities, prohibited the sale of food prepared in unasanitary conditions, defined adulteration to include bacteria and chemicals that are potentially harmful, and created new authorization for the FDA to set mandatory standards for food. Although amended over the years to address particular concerns—-like pesticide residue in foods (see the Miller Pesticides Amendment of 1954), the FDCA’s basic structure has proven remarkably durable.

    By the turn of the century, however, the country was overdue for a food safety law update. The Food Safety and Modernization Act of 2011 (FSMA) was heralded as a complete overhaul of our approach to food safety regulation. Once again, the Act was passed after a series of foodborne illness outbreaks from products as diverse as bagged spinach, peanut butter, cookie dough, and pot pies. Coupled with a growing concern about the safety of imported food in an age of globalization and terrorism, FSMA sought to develop a new comprehensive approach to the food safety problem.

    At the core of FSMA is a commitment to prevention. Under the prior regime, FDA’s understaffed inspectors would collect data for warning letters and enforcement actions against food producers. If inspectors found evidence of adulteration, for example, an enforcement action might be commenced. In the new regime, FDA would work with producers to ensure that everyone in the food system had an adequate plan to identify points in the production process most likely to result in unsafe food and put in place a plan to manage those risks. The statute required new FDA regulations for Hazard Analysis and Preventative Controls, the establishment of minimum standards for safe production and harvesting of fruits and vegetables, new sanitary transportation rules, and the establishment of a new Foreign Supplier Verification program to ensure that all foreign suppliers of food could ensure that imported food is safe.

    1. 2.1 Show/Hide More The Federal Food Safety System: A Primer
      Renee Johnson, The Federal Food Safety System: A Primer, Congressional Research Service RS22600 (Dec. 16 2016) (excerpt)
    2. 2.2 Show/Hide More Food Safety Modernization Act
      Original Creator: jgersen
      The 2011 Food Safety Modernization Act (FSMA) ushered in a new federal food safety regime.  After a series of disease outbreaks in the United States were linked to foods like carrot juice, peanut butter, bagged spinach, pepper, cookie dough, and even dog food, consensus grew that legal and policy change was needed.  Although there was no shortage of disagreement on particulars, consumers, producers, activists, and politicians all agreed on the need for change.  One of FSMA’s key principles is an emphasis on prevention.  To oversimplify a bit, in the old regime agencies would use establishment-by-establishment inspections to detect safety risks and then use warning letters and enforcement actions to bring the wrongdoers into compliance.  Given the number of establishments, the number of inspectors, and resources available to federal inspectors, truly protecting food safety with intermittent inspections is all but impossible.  FSMA’s so-called risk-based approach seeks to focus regulatory attention on the points in the production and distribution of food most likely to produce safety problems and to require ex ante development of hazard management plans by each food producer.    
    3. 2.3 Show/Hide More Center for Food Safety v. Hamburg
      Original Creator: jgersen
      <p>1. Compel agency action unlawfully withheld. The Administrative Procedure Act provides that federal courts may compel agency action unlawfully withheld or unreasonably delayed. 5 U.S.C. § 706 (1). Because agencies may choose to pursue a set of priorities different than a particular citizen or group or citizens prefers, courts tend to be quite deferential when evaluating such claims. In Norton v. Southern Utah Wilderness Alliance, the Supreme Court held that 706(1) only applies to discrete agency actions as opposed to general enforcement or policy priorities. Unreasonable delay challenges tend to be very difficult to win. The one exception is when a statute imposes specific deadlines for particular agency actions.</p> <p>2. Deadlines. Statutory deadlines were increasingly used by Congress over the past few decades. See Jacob E. Gersen &amp; Anne Joseph O’Connell, Deadlines in Administrative Law, 156 U. Penn. L. Rev. 924 (2008). One reason may be that deadlines allow Congress to control the agency’s policy priorities. Absent a deadline, the agency would be free to pursue other rules or regulations first, putting the statutory obligations further down the to do list. A deadline controls the order in which the agency embarks on different policies.</p> <p>2. Remedies. What is the remedy for the failure to meet a statutory deadline? Justice Scalia once argued that if an agency fails to enact a rule by the statutory deadline, the agency loses the legal authority to promulgate the rule at all. That argument, however, has failed to carry the day. In almost all cases, the remedy for failing to meet a deadline is either an order like the one issued in Hamburg—to meet with the parties and come up with a timeframe for taking the required action; or, an order to take action by a new court-ordered deadline. Such remedies are better than nothing, but when the agency failed to meet one deadline, it is hardly a sufficient remedy to impose another legal obligation to meet another deadline.</p> <p>3. First Wave and Second Wave. While challengers complained the <span class="caps">FDA</span> had failed to act quickly enough, the <span class="caps">FDA</span> argued that the new rules were complex and challenging. Rather than issue bad rules quickly, the agency sought to promulgate the required rules in stages or waves. What is wrong with the <span class="caps">FDA</span> attempting to take one step (or in this case, several steps) at a time? Should it matter if the timeline imposed by Congress is realistic? Consider that the package of financial regulation known colloquially as Dodd-Frank imposed hundreds of deadlines, the vast majority of which were missed by implementing agencies because they were unrealistic. See Jacob Gersen, Administrative Law Goes to Wall Street, 65 Admin. L. Rev. 689 (2013).</p> <p>4. Aftermath. In the aftermath of litigation, the <span class="caps">FDA</span> eventually implemented all of the new rules required by the Food Safety Modernization Act. We consider many of them later in this chapter.</p>
    4. 2.4 Show/Hide More Federal Regulatory Regime
      Original Creator: jgersen
      One of the key features of Untied States food system—indeed, of food systems in most parts of the world—is decentralization. The sheer number of individuals and organizations involved in bringing a food from start to finish is staggering. Each link in the chain of production, distribution, and consumption or what we refer to as the PDC chain creates a risk of food contamination. Notwithstanding the horrific effects of recent food born illness outbreaks, it is somewhat remarkable that outbreaks are so few. This section provides an overview of the basic tools in the federal regulatory kit.
      1. 2.4.1 Show/Hide More Food Facility Registration
        Original Creator: jgersen
        As the excerpt from the Congressional Research Service report on agroterrorism notes, the Bioterrorism Act of 2001 included a for facility registration requirement. The Act mandates domestic and foreign facilities that manufacture, process, produce, pack, or hold food for human consumption in the United States to register with the FDA. See 21 C.F.R. 1.225-1.243. These registration rules were strengthened by FSMA which amended Section 415 of the FDCA Act, see 21 U.S.C. sec. 350(d). In particular, FSMA section 102© increased the frequency of registration and also expanded the scope of information that must be disclosed in the registration.
        <p>1. Registration, Who? It is the responsibility of the owner, operator, or agent in charge of a domestic or foreign facility that must register the facility. Notably, a domestic facility must register even if its products do not enter interstate commerce. 21 C.F.R. 1.225(b). Foreign facilities must register if products are exported to the United States unless the food from that facility undergoes further processing by another foreign facility before the food is exported. 21 C.F.R. 1.226(a). <br /> 2. Registration, What? A &#8220;food facility&#8221; is defined as &#8220;any factory, warehouse, or establishment . . . that manufactures, processes, packs, or holds food.&#8221; 21 U.S.C. 350(d)(b). Note that on its face, the definition of a &#8220;food facility&#8221; is extremely broad, seemingly covering virtually any building in which food is held. The statute, however, excepts large classes of actors.</p> <p>3. Registration, Exceptions. Section 415 of the <span class="caps">FDCA</span> exempts from any registration requirement the following classes of establishment: <br /> a. Farms. Exempted farms are facilities located in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both. Some farms may be subject to the Produce Safety Rule, discussed later in this chapter. <br /> b. Restaurants. Exempted restaurants are facilities that prepare and sell food directly to consumers for immediate consumption. 21 C.F.R. 1.227(b)(10. <br /> c. Retail food Establishments. Exempted retail food establishments sell food directly to consumers as their primary function. In essence, that means that annual sales directly to consumers are greater than annual sales to other buyers. 21 C.F.R. 1.226&#169;. The largest class of exempt retail food establishments are grocery stores and convenience stores. <br /> d. Nonprofit Food Establishments. Nonprofit Food Establishments (NFEs) are charitable organizations that meet the standard of section 501&#169;(3) of the Internal Revenue Code and that prepare or serve food directly to consumers for consumption. The canonical example of an <span class="caps">NFE</span> is the so-called soup kitchen, but the exemption also applies to food banks and nonprofit food delivery services. 21 C.F.R. 1.22(b)(7).</p> <p>4. Registration, to Whom? <span class="caps">FSMA</span>, <span class="caps">FDCA</span>, and the Bioterrorism Act require registration with the <span class="caps">FDA</span>. Facilities handling only meat, poly or egg products are regulated not by the <span class="caps">FDA</span>, but the <span class="caps">USDA</span>. As a consequence, <span class="caps">USDA</span>-regulated entities are also exempt from the registration requirements.</p> <p>5. Registration, Food. Recall that the definition of &#8220;food&#8221; in the <span class="caps">FDCA</span> excludes certain food contact substances and pesticides. Thus, facilities that produce food contact substances and pesticides are also exempt from registration, unless the food contact substance is used as a direct food additive.</p> <p>6. Registration, How Often? <span class="caps">FSMA</span> increased the frequency of registration from once to biennially in each even-numbered year.</p> <p>7. Registration, Information. Facilities must provide a name, address, phone number of the facility, the parent company, and the owner, operator, or agent in charge. Foreign facilities must also provide a US agent.</p> <p>8. Registration, Enforcement. The failure to register or rent a registration may subject a food facility to criminal protection. 21 C.F.R. 1.241. If the <span class="caps">FDA</span> judges that food from a facility could cause serious adverse health consequences or death to humans or animals, <span class="caps">FDA</span> may suspend the registration. No person may import, offer to import, or introduce into interstate or intrastate commerce any food from a facility whose registration has been suspended. 21 U.S.C. 350(d)(b)(4). An article of food offered for import shall be refused admission to the United States if it is from a facility whose registration has been suspended. 21 U.S.C. 381(l).</p>
        1. Show/Hide More Agroterrorism: Threats and Preparedness
          Jim Monke, Agroterrorism: Threats and Preparedness (Congressional Research Service, RL32521, August 13, 2004) (excerpt)
        1. Show/Hide More United States v. New England Grocers Supply Co.
          Original Creator: jgersen

          <p>1. Search, Seizure, and Warrants. It is blackletter law that a warrant is required for a search to be considered reasonable under the Fourth Amendment, whether the search is of a home or a business. See See v. City of Seattle, 387 U.S. 541, 545 (1967). For businesses, however, the Court has also relaxed the requirement because there is said to be a lesser expectation of privacy. New York v. Burger, 482 U.S. 691, 699 (1987). Moreover, the warrant requirement has been further relaxed to account for administrative inspections “designed to enforce regulatory statutes.” Id. at 700.</p> <p>2. Pervasively Regulated Industries. As the Supreme Court said in United States v. Biswell, 406 U.S. 311 (1972), “When a dealer chooses to engage in a pervasively regulated business and to accept a federal license, he does so with the knowledge that his business records, . . . will be subject to effective inspection.” Biswell at 406 U.S. at 316. Biswell was a case involving warrantless inspection in the gun industry, but many circuits including the Eight, Ninth, and Sixth, have subsequently held the same is true for <span class="caps">FDCA</span> inspections. See United States v. Jamieson–McKames Pharmaceuticals, Inc., 651 F.2d 532 (8th Cir.1981) (holding drug manufacturing industry; United States v. Argent Chemical Laboratories, Inc., 93 F.3d 572 (9th Cir.1996) (finding pharmaceutical industry “closely regulated”); United States v. Acklen, 690 F.2d 70, 75 (6th Cir.1982) (same).</p> <p>3. What is Reasonable? In what is known as the Colonnade-Biswell doctrine, the Supreme Court has articulated three criteria to determine what constitutes a reasonable warrantless government inspection:</p> <p>This warrantless inspection, however, even in the context of a pervasively regulated business, will be deemed to be reasonable only so long as three criteria are met. First, there must be a “substantial” government interest that informs the regulatory scheme pursuant to which the inspection is made. See Donovan v. Dewey, 452 U.S., at 602, 101 S.Ct., at 2540 (“substantial federal interest in improving the health and safety conditions in the Nation's underground and surface mines”); United States v. Biswell, 406 U.S., at 315, 92 S.Ct., at 1596 (regulation of firearms is “of central importance to federal efforts to prevent violent crime and to assist the States in regulating the firearms traffic within their borders”); Colonnade Corp. v. United States,397 U.S., at 75, 90 S.Ct., at 776 (federal interest “in protecting the revenue against various types of fraud”).</p> <p>Second, the warrantless inspections must be “necessary to further [the] regulatory scheme.” Donovan v. Dewey, 452 U.S., at 600, 101 S.Ct., at 2539. For example, in Dewey we recognized that forcing mine inspectors to obtain a warrant before every inspection *703 might alert mine owners or operators to the impending inspection, thereby frustrating the purposes of the Mine Safety and Health Act-to detect and thus to deter safety and health violations. Id., at 603, 101 S.Ct., at 2540.</p> <p>Finally, “the statute's inspection program, in terms of the certainty and regularity of its application, [must] provid[e] a constitutionally adequate substitute for a warrant.” Ibid. In other words, the regulatory statute must perform the two basic functions of a warrant: it must advise the owner of the commercial premises that the search is being made pursuant to the law and has a properly defined scope, and it must limit the discretion of the inspecting officers. See Marshall v. Barlow's, Inc., 436 U.S., at 323, 98 S.Ct., at 1826; see also id., at 332, 98 S.Ct., at 1830 (<span class="caps">STEVENS</span>, J., dissenting). To perform this first function, the statute must be “sufficiently comprehensive and defined that the owner of commercial property cannot help but be aware that his property will be subject to periodic inspections undertaken for specific purposes.” Donovan v. Dewey,452 U.S., at 600, 101 S.Ct., at 2539. In addition, in defining how a statute limits the discretion of the inspectors, we have observed that it must be “carefully limited in time, place, and scope.” United States v. Biswell, 406 U.S., at 315, 92 S.Ct., at 1596.</p> <p>New York v. Burger, 482 U.S. 691, 702-03 (1987).</p> <p>4. From routine administrative inspection to criminal investigation. The defendants in new England Grocers Supply argued that even if no warrant was required, the inspections became unreasonable once the <span class="caps">FDA</span> agents had probable cause to suspect violations of the Act. As the court held, however, so long as the inspection is otherwise valid, there is no legal requirement to suspend the inspection and obtain a warrant once there is reason to believe violations have occurred.</p>
        2. Show/Hide More Inspections, Searches, and Seizures
          Original Creator: jgersen

          The Fourth Amendment of the U.S. Constitution states as follows:

          • The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized. 

          U.S. Const., Amend. IV.  In brief, before searching or seizing, state actors must traditionally obtain a warrant supported by probable cause that a crime has been committed.  Subject to many nuances and caveats that are beyond our topic of study, evidence obtained during an illegal—that is to say, warrantless—search may not generally be used to prosecute a criminal case.  The Fourth Amendment protects against unreasonable searches and seizures.  

          FDA and USDA have been given inspection authority by virtue of a range of federal statutes like the Meat Inspection Act.  Is such inspection authority constiututional or does it consist of a warrantless or unreasonable search.  Is an inspection the same legal entity as a search?  What if evidence of illegal activity is discovered during an inspection?  Can that evidence always, sometimes, or never be used to sanction the facility?  The next cases illustrate how courts have grappled with these questions.  

        3. Show/Hide More Federal Inspections
          Renee Johnson, The Federal Food Safety System: A Primer, Congressional Research Service RS22600 (Dec. 16 2016) (excerpt)
          <p>1. Some <span class="caps">FDA</span> Inspection Numbers. As the <span class="caps">CRS</span> Report explains, more than 300,000 domestic and foreign food facilities are registered withe the <span class="caps">FDA</span>, of which about 88,000 are domestic. Somewhere between 70-90 percent of these facilities are inspected even once in a given year. Unannounced compliance inspections range from once every five years to once every ten years. Those facilities that are judged to be &#8220;high-risk&#8221; are usually visited once per year. Some 98 percent of food import lines are not inspected by <span class="caps">FDA</span>. It is hard to avoid the conclusion that <span class="caps">FDA</span> inspections cannot possibly detect the vast majority of food safety risks. Even if the specter of a potential inspection keeps most facilities honest, an inspection every five to ten years is not the sort of threat likely to create a powerful incentive.</p> <p>2. Some <span class="caps">USDA</span> Inspection Numbers. The Food Safety and Inspection Service (<span class="caps">FSIS</span>) is an entity located within the United States Department of Agriculture (<span class="caps">USDA</span>). <span class="caps">FSIS</span> conducts inspections in about 6,000 establishments, including about 350 so-called Talmadge-Aiken plants, where are facilities in which state inspectors perform inspections under federal inspectors' supervision.</p> <p>3. Needles, Haystacks, and Illness. Needless to say, these numbers present a daunting challenge for government inspectors. Efforts in recent years have turned to methods like audits and an emphasis on ensuring facilities have adequate hazard protection plans in place, rather than relying on frequent physical inspections. If ex ante inspections are unlikely to ensure safe food, what are the other legal or technological alternatives?</p>
        4. Show/Hide More Photography
          Original Creator: jgersen
          May FDA inspectors take pictures of the facilities that are undergoing inspection? FDA has repeatedly answered the question in the affirmative, telling inspectors that photography is a critical part of the inspection process. The food industry disagrees and has argued that photographs are authorized neither by statute nor by judicial doctrine. For an overview of these issues, see Neal D. Fortin, Is a Picture Worth More than 1,000 Words? The Fourth Amendment and the FDA's Authority to Take Photographs Under the Federal Food, Drug, and Cosmetic Act, 1 J. Food L. & Pol'y 239 (2005). The following excerpt summarizes the apparent view of the courts on the matter.
        5. Show/Hide More Durovic v. Palmer
          Original Creator: jgersen

          <p>1. Statutes and the Constitution. Section 704 of the <span class="caps">FDCA</span>, 21 U.S.C. 374 authorizes inspections &#8220;at reasonable times and within reasonable limits and in a reasonable manner.&#8221; By and large this means that inspections usually occur during normal business hours rather than in midnight raids. Durovic sought to argue that an inspection outside of normal business hours is not at a reasonable time and therefore not authorized by the statute. Although this turned out to be a losing argument, note the close relationship between the statutory and constitutional tests. In order to pass constitutional muster according to the Colonnade-Biswell doctrine, the inspection must be authorized by a statute limiting discretion and providing notice. If an inspection is not authorized by statute meeting these requirements, then any occurring inspection would likely be a prohibited warrantless unreasonable search. What does section 704 authorize? Inspections occurring a reasonable times. If the actual <span class="caps">FDA</span> inspection occurred at an unreasonable time, then it is an inspection not authorized by the statute. If it is not authorized by the statute, the inspection constitutes an unconstitutional search. The constitutional validity of a given inspection then can turn on the seemingly mundane issue of what constitutes a reasonable time for an inspection.</p> <p>2. Rules of Reasonableness. Section 704 authorizes <span class="caps">FDA</span> employees to enter and inspect a food enterprise, factory, warehouse, establishment, or vehicle, after presenting appropriate credentials and a written notice. 21 U.S.C. 374(A). The statutory requirements for reasonable time, reasonable limits, and reasonable manners have been interpreted in a series of <span class="caps">FDA</span> Rules and Policies. See, e.g., U.S. Food and Drug Administration Investigations Operations manual 2014. As noted in Durovic, the &#8220;reasonable time&#8221; requirement typically means normal business hours. The &#8220;reasonable limits&#8221; requirement typically means that the area or goods inspected must be relevant to the goal of the inspection. The &#8220;reasonable manner&#8221; requirement has been interpreted to mean that inspectors must present their credentials to gain entry into the facility and must issue the firm a Notice of Inspection at the commencement of the inspection.</p> <p>3. Inspect What? In addition to equipment, storage facilities, foods, containers, and labels, <span class="caps">FDA</span> inspection authority includes the power to obtain company records of the interstate shipment of foods. <span class="caps">FDA</span>, Draft Guidance, Records Access Authority under Sections 414 and 704 Federal Food, Drug, &amp; Cosmetic Act: Questions and Answers (Feb. 2012). Excepted from the records authority are records of recipes, financial data, pricing data, personnel data, sales data, and research data. 21 U.S.C. 350&#169;. Moreover, any confidential or trade secret information is protected from public disclosure. The food industry is notoriously secretive and it is not hard to imagine the anxiety about opening recipe records to government inspectors. See generally Trade Secrets, U.S. Food &amp; Drug Administration (June 1, 2010).</p>
        6. Show/Hide More Munsell v. Dept. of Agriculture, 509 F.3d 572 (D.C. Cir. 2007).
          Munsell v. Dept. of Agriculture, 509 F.3d 572 (D.C. Cir. 2007) provides an overview the statutory history of the Meat Inspection Act, the Poultry Products Inspection Act, and the Food Safety Inspection Service—the other major federal food inspection agency. Although all of the claims brought were eventually dismissed, the case illustrates a fairly common procedural posture for those hoping to challenge the inspection regime.
          <p>1. <span class="caps">FSIS</span> Authority. <span class="caps">FSIS</span> is given inspection authority by virtue of three different statutes: the Federal Meat Inspection Act of 1906 (<span class="caps">FMIA</span>), the Poultry Products Inspection Act of 1957 (<span class="caps">PPIA</span>), and the Egg Product Inspection Act of 1970 (<span class="caps">EPIA</span>). <span class="caps">FSIS</span> carries out mandatory inspections at facilities that slaughter livestock or poultry and that process eggs.</p> <p>2. The <span class="caps">FMIA</span>, enacted in the early 1900's, requires that certain animals&#8212;cattle, sheep, swine, goats, horses and mules&#8212;be visually inspected before entering a slaughter facility. See 21 C.F.R. 603. A federal inspector must conduct both an inspection before slaughter (an antemortem inspection) and an inspection after slaughter (a postmortem inspection). 21 C.F.R. 604. At facilities that &#8220;process&#8221; meat food products, an inspector checks facilities regularly but is not constantly present. While the <span class="caps">FMIA</span> provides for both civil and criminal penalties, the simple refusal to certify the meat product tends to be a powerful tool for ensuring compliance.</p> <p>3. The <span class="caps">PPIA</span> dictates inspection for poultry and poultry products capable for use as human food. 21 C.F.R. 451. While the text of the <span class="caps">PPIA</span> does not require antemortem inspection of all poultry, <span class="caps">FSIS</span> has discretion to so require. The Act does require postmortem inspection on a bird-by-byrd basis whenever processing operations are being conducted. 21 U.S.C. 455(b). <span class="caps">USDA</span> Rules, however, provide for sampling techniques and fewer inspectors than traditionally used. The next case considers a challenge to the rule.</p> <p>4. The <span class="caps">EPIA</span> requires inspection for (a) egg products and (b) shell eggs. A shell egg or egg is defined to include eggs of the domesticated chicken, turkey, duck, goose, or guinea. 21 U.S.C. 1033(b). An &#8220;egg product&#8221; is &#8220;any dried, frozen, or liquid eggs, with or without added ingredients.&#8221; 21 U.S.C. 1033(f). The <span class="caps">USDA</span> and <span class="caps">FDA</span> share enforcement authority under the statute. How? <span class="caps">FDA</span> has authority over shell eggs, while <span class="caps">USDA</span> has authority over egg products. <span class="caps">FDA</span> inspectors inspect egg packers at least once every there months. <span class="caps">USDA</span> inspection of egg products is more rigorous and extensive. An official inspector must be present at all times when eggs are being processed. The inspector must examine the eggs both before and after breaking. 9 C.F.R. 420. U.S. egg farmers produce about 79 billion eggs each year. Approximately 30 percent go into egg products, meaning that approximately 23 billion eggs are required by law to be inspected both before and after they are cracked into egg products. We leave it to the reader to judge whether such an inspection regime is likely to be effective.</p> <p>5. Inspectors and the Constitution. One of Munsell's claims was that <span class="caps">FSIS</span> inspectors retaliated against him for complaining and pointing to ConAgra (correctly, as it turned out) as the likely source of an E Coli outbreak. He claimed to have been harassed by the agency, who threatened him with regulatory sanctions, requested unexplained changes to his hazard plan, and routinely rejected his proposed changes. Setting aside the factual merits of his allegations, his basic claim was that inspectors used their discretion to violate his constitutional rights. The remedy for such a claim, if it exists, is known as a Bivens action. As the D.C. Circuit explains, part of the judicial calculus about when to provide a Bivens remedy turns on whether there are other adequate remedies to address the underlying wrong. Did the D.C. Circuit hold there was or was not an adequate alternative remedy?</p>
      2. 2.4.3 Show/Hide More Prevention, Inspection, and Risk
        Original Creator: jgersen

        Given the enormous challenges that inspection poses as a regulatory strategy for ensuring food safety, the past sevearl decades have seen a push towards alternative tools to protect the food supply.  Three themes are commonly observed in policy debates.  First, an emphasis on risk estimation.  Although sometimes connoting particular quantitative methods, the basic idea is straightforward.  The particular risks posed to the food supply should be identified and estiamted. Without knowing—and often quantifying—what the risks of contamination or adulteration are, it is difficult to protect against them.   Second, resources should be allocated to points in the food chain that are particularly vulnerable.  Rather than inspecting every egg both before and after cracking, target locations or moments of particular vulnerability to contamination. Or, rely more extensively on auditing and sampling methods.  Third, decentralize the formulation of hazard prevention and response to regulated parties. Most food etablishments must today parepare a Hazard Analysis Critical Control Point plan. An overview is included below. While a HACCP sounds technical, it is really nothing more than working through what and where the risks to food safety are in a given facility and making a plan on how to prevent and respond.  Over time, federal agencies increasingly oversee the formulation and adoption of these private plans for food safety action rather than imposing particular requirements in rules or regulations.  One way of understanding this trend is as a shift away from command and control regulatory tools.  In the environmental policy domain, this has meant relying on performance controls that leave it up to regulated parties to decide how to best reduce pollution to a given level, rather than technology controls that demand a particular kind of scrubber be used to reduce pollution.   In the food context, rather than relying on finished product inspectino, the HACCP model is a systematic preventative appraoch to food safety that addresses physical, chemical, and biological hazards at each stage of the food production process. HACCP is thus a methodological innovation and it is used by both USDA and FDA.  

        Although HACCP has only recently found favor with government regulators, it has been around at least since the 1950s, apparently developed jointly by the Pillsbury Company and the National Aeronautics and Space Administration (NASA), who needed safe food that could be consumed in space. See Food Code 2001, Recommendations of the United States Public Health Service, Food and Drug Administration 424 (2001). Down on earth, Pillsbury introduced the HACCP system after food safety problems with their baby food. See William H. Sperber and Richard F. Stier, Happy 50th Birthday to HACCP: Retrospective and Prospective, Food Sfaety Mag. (2009/2010). In the mid 1980's, the National Academy of Sciences (NAS) wrote that “government agencies responsible for control of microbiological hazards in foods should promulgate appropriate regulations that would require industry to utilize the HACCP systems in their food protection programs.” An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients 329, National Research Council, National Academy of Sciences (1985).  FDA adopted the HACCP principles for seafood inspection in 1995, followed by the USDA for meat and poultry inspection in 1997. Roberts, Food Law at 142.       


        1. Show/Hide More American Federation of Government Employees, AFL-CIO v. Glickman, 215 F.3d 7 (D.C. Cir. 2000).
          Original Creator: jgersen
          American Federation of Government Employees entails a challenge FSIS's move to the HACCP model.
          <p>1. Text. The court holds that relying on establishment personnel rather than government employees to inspect poultry violates the text of the <span class="caps">PPIA</span>. The statutory text says that the Secretary shall cause to be made by inspectors appointed for that purpose a post-mortem examination and inspection of the carcasses and parts thereof of all [livestock] to be prepared at any slaughtering, &#8230; or similar establishment&#8230;.” 21 U.S.C. § 604). For poultry, § 455(b) of the <span class="caps">PPIA</span> states: “[t]he Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed&#8230;.” 21 U.S.C. § 455(b). Is the text of the statute so clear that an &#8220;inspector&#8221; must be a government employee?</p> <p>2. Text and Purpose. Would it matter to the court if it could be definitively shown that the new inspection regime was vastly superior to the old in terms of avoiding adulteration?</p> <p>3. Umpires and Pitchers. The court notes that the government believes an inspector can perform an inspection by watching another person perform an inspection. On this logic, urges the court, an umpire is a pitcher because an umpire watches a pitcher pitch. Does this metaphor seem on point? Surely an inspector could watch her own employees perform tasks like testing or observing chickens and still be performing the role of inspecting. Nevertheless, a unanimous panel held that the task of inspection could not be delegated to private employees without running afoul of the <span class="caps">FMIA</span> and the <span class="caps">PPIA</span>.</p>
        2. Show/Hide More Food & Water Watch, Inc v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)
          Original Creator: jgersen

          <p>1. <span class="caps">FSIS</span>, <span class="caps">PPIA</span>, and <span class="caps">NPIS</span>. As the opinion discusses in some detail, <span class="caps">FSIS</span> administers the <span class="caps">PPIA</span>. Historically, <span class="caps">FSIS</span> inspected poultry using four systems. Offline inspectors ensure compliance with food safety regulations, verify sanitation procedures, and collect samples for testing. Online inspectors inspect the actual poultry. At issue in the case was the New Poultry Inspection System (<span class="caps">NPIS</span>), which shifted from inspector-based sorting and evaluation to establishment-based sorting and evaluation. That is, <span class="caps">NPIS</span> relocates inspection responsibilities to firms rather than government personnel.</p> <p>2. Food Safety Harms. The plaintiffs in Food &amp; Water Watch alleged that the new inspection procedures would increase the risk of food borne illness and therefore sought to stop the program. To satisfy the constitutional requirements for standing in Article <span class="caps">III</span>, plaintiffs must show injury-in-fact. Directly regulated parties typically have no trouble satisfying this requirement because a given federal regulation requires them to take an action or suffer penalties. Poultry facilities would have no difficulty demonstrating standing. For third parties&#8212;individuals not directly regulated by the Rule, showing that they are or are likely to be harmed by the rule is far more difficult. Note that in practice this may mean rules deemed undesirable by regulated parties will be litigated, but rules deemed desirable by regulated parties are less likely to be litigated.</p>
      3. 2.4.4 Show/Hide More Enforcement
        Original Creator: jgersen
        Section 301 of the FDCA, Section 610 of the FMIA, Section 458 of the PPIA, and Section 1037 of the EPIA are the enforcement provisions of the major federal food safety statutes. The standard menu of agency enforcement mechanisms include inspections, warning letters, suspension of registration, recall, injunction, seizure, retention, and criminal prosecution.
          1. Show/Hide More Rogers v. Tyson Foods, Inc.
            Original Creator: jgersen

            <p>1. No private right of action. As the court explained, there is no private right of action in the <span class="caps">PPIA</span>. In In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 788 (3d Cir. 1999) holds that there is no private right of action in the <span class="caps">FDCA</span>. As a consequence, ordinary citizens may not bring suit in federal court even if they are harmed by a company's failure to comply with federal food safety requirements. That leaves two possibilities. First, agency agency enforcement. The federal agency with jurisdiction over the given facility that must elect to enforce the statutory requirements. Given the number of facilities already emphasized and the limited resources of the agencies, there is only so much enforcement possible.</p> <p>2. State Law. A second path of enforcement relies on neither federal agency enforcement, nor private rights of action in federal court, bur rather state law claims in state courts. Tyson Foods entails one example. Tyson argued that the <span class="caps">PPIA</span> preempted all state law claims even though the <span class="caps">PPIA</span> (and also the <span class="caps">FDCA</span>) do not provide a private right of action in federal court. The court disagreed, concluding that &#8220;complete preemption&#8221; can only exist when the federal law provides a private right of action. As the court notes at the end of the opinion, this does not mean that Tyson has no preemption defense. Rather, preemption may be asserted as a defense in statute court. There is no basis for federal jurisdiction, however, and no grounds for removal to federal court.</p>
    5. 2.5 Show/Hide More State and Local Food Regulation
      Original Creator: jgersen

      Absent private rights of action to enforce federal food safety laws and given the limited resources of federal agencies relative to the sheer volume of food and food facilities, the state and local law often serves as the front line in the fight against food safety. By nature, state and local legal requirements vary from jurisdiction to jurisdiction. Nevertheless, the basic structure and allocation of oversight and enforcement authority is relatively consistent across states.

      The regulation of retail food sales and distribution has been left largely to the states.  Some states delegate lincensing and inspection to local government units, while others do not.  Restaurant inspection, food trucks, farmers markets, and grocery stores are all largely controlled by state and local law.  This section contains and illustrative set of cases and legal materials.

      1. 2.5.2 Show/Hide More Model Food Code
        Original Creator: jgersen

        Although the ultimate responsibility for promulgating and enforcing state and local food laws lies with the states and municipalities, the FDA has long taken a leading role by providing guidance to states. Contrary to the conventional view the states provide “laboratories of democracy” in which different laws and policies can be implemented and evaluated, in food law there is a surprising amount of uniformity and consistency.

        At least since the 1920's with FDA's Guidance on milk pasteurization, FDA has provided guidance on virtually every segment of the retail food industry. In 1993, FDA issued the first full incarnation of its comprehensive Food Code, the most recent incarnation of which was issued in 2013.

        1. Show/Hide More Model Food Code (2013 Preface Excerpts)
          Original Creator: jgersen
          <p>1. Adoption. All fifty staes have adopted food codes patterned after the Food Code. See Real progress in Food Code Adoption, US <span class="caps">FDA</span> (2011). Some states adopt a version of the code by reference. others directly enact into into statute, regulation, or ordinance.</p> <p>2. Updating. The Federal Food Safety Working Group was convened by President Obama in 2009 to develop strategies for improving food safety. Part of the difficulty is that while the <span class="caps">FDA</span> updates the Food code every couple of years, states tend to fall behind as changing state and local law requires affirmative actions from legislators or regulators whose agendas are already quite full. State and local officials regularly cite the frequent changes to the Food Code as obstacles to its uniform implementation.</p>
  2. 3 Show/Hide More Adulteration
    Original Creator: jgersen
    The combination of the FDCA, FMIA, and PPIA prohibit the introduction of food that is adulterated. Like the term misbranded, adulterated is a legal term of art that corresponds only tangentially to the colloquial use of the term. Food is adulterated if (1) it contains a harmful substance posing a safety risk; it contains an added substance during production and exceeds acceptable levels; (3) it contains a substance that has been intentionally added to the food but has not been approved by an agency, or (4) it has been handled in unsanitary conditions that create a risk of contamination posing a safety risk.
    1. 3.1 Show/Hide More Composition
      Original Creator: jgersen

      Because of the way federal law defines adulteration, an initial question in determining whether a food is adulterated is whether it contains a substance that is either added to the food or inherent in the food. A substance is a material that comprises a food product. Consider FDCA section 402(a)(1), 21 U.S.C. § 342(a)(1).

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

      That is, merely because a food contains a poisonous or deleterious substance, it is not necessarily adulterated. If the substance naturally inheres in the food, then it is only adulterated if it satisfies the “ordinarily injurious to health” standard. If the substance is “added” then the food is adulterated it satisfies the “may render injurious” standard which establishes adulteration by proof of the possibility of harm.

      These differences are more than merely semantic. The may-render-injurious standard takes into account especially vulnerable groups like children, the elderly, or those allergic. The ordinarily-injurious-to-health standard does not, focusing instead on the effect of the substance on the food-consuming public in general.

    2. 3.2 Show/Hide More Added Substances
      Original Creator: jgersen
      The FDCA does not define added. Because the burden the FDA must carry is higher under the may-render-injurious standard, obviously the agency often prefers to use the ordinarily-injurious-to-health standard associated with “added” substances. FDA regulations define added broadly. A substance is added if it is not an inherent constituent of the food; is the result of environmental, agricultural, industrial, or other contamination; or if the natural amount of the inherent substance has been increased to abnormal levels by mishandling or other intervening acts. See 21 C.F.R. 109.3. Must the presence of a substance be attributable in whole or in part to an act of man? The following cases offer conflicting approaches to this question.
      1. 3.2.1 Show/Hide More United States v. Anderson Seafoods, Inc.
        Original Creator: jgersen
        1. Section 342(a)(1) of the Act provides:  A food shall be deemed to be adulterated —(a)(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.
        2. As the Court says, the statute does not define “added substance” but much turns on this term. The evidentiary showing that the FDA must make to succeed in an enforcement provision turns on it. If a substance is an added substance, then the Agency need show only that it “may render [the food] injurious to health” in order to regulate consumption of the food containing the substance. The “may render” standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer. If a substance is not “added” then the Agency must make a higher showing, that the substance would “ordinarily render [the food] injurious to health.” Why would such a legal regime make sense?
        3. The government’s view in the cases was that an “added substance” is one that is not “inherent.” There are two types of “poisonous or deleterious” substances on this view. Those that are “naturally occurring” are those that are not introduced into the food as a result of environmental, agricultural, industrial, or other contamination. An “added poisonous or deleterious substance” is not “natural occurring.” Yet when a naturally occurring poisonous or deleterious substance increases beyond a certain level, it then becomes an “added poisonous or deleterious substance.” On this view all mercury in fish is an added substance.
        4. Anderson’s theory was that a substance is not an added substance unless it is proved to be present as a result of the direct agency of man. And, only that amount of a substance the lineage of which can be so traced is “added.” If some mercury in swordfish occurs naturally, and some is the result of man-made pollution, only that percentage of the mercury in fish proved to result directly from pollution is an added substance. There is something intuitively appealing about this theory in that is corresponds to a common-sense view of the term added.
        5. Under the court's theory, if a de minimis amount of the mercury in swordfish is shown to result from industrial pollution, then all of the metal in the fish is treated as an added substance and may be regulated under the statute's “may render injurious” standard. The court was ultimately convinced by this theory. Was the court convinced as a matter or policy or law or both? Is it a concern that under this theory, materials naturally occurring and that naturally occurred in food are magically transformed into an “added poisonous or deleterious substance”? As the court noted, the House Report on the 1906 statute said that “added” meant “attributable to the acts of man” and “not-added” meant attributable to the events of nature.” H.R. Rep. No. 2118, 59th Cong., 1st Sess. 6, 7, 11 (1906).   Senator Heyburn, discussing this issue offered a sensible defense of the Act’s framework. Simply because a substance that could be harmful exists in a food ought not create immunity for someone who adds more of that poisonous or substance to the food.
        6. United States v. Anderson Seafood forced the FDA and the courts to confront the relationship between food law and environmental law. We consider this issue more directly elsewhere in this book. Note, however, this specific example of the more general problem. Mercury is a naturally occurring element that is present in the environment, in plants, and in animals. Various industrial activities like utility plants and waste incinerators add significant mercury to the air, ultimately water, and then small fish, which are eaten by larger fish. This process is known as “bioaccumulation” in the larger fish, and it is why larger fish are generally more dangerous to eat than smaller ones. Humans who infest mercury are at greater risk of reproductive difficulties and nervous system disorder. See EPA’s Mercury Factsheet, available at How should food law respond to environmental law’s failure to adequately control mercury emissions or vice versa? Precluding mercury from ever being considered an added substance would allow for the consumption of fish with dangerously high levels of mercury simply because some mercury is present in fish naturally. Yet, isn’t it likely that this sort of environmental addition of a substance—not by the producer or seller of food—but by industrial activity in general isn’t quite what the drafters of the FDCA had in mind when they used the term “added substance”? If so, then should the court update the FDCA? Should the legislature? What is the relevance of changing factual circumstances that render an old legal framework insufficient to address a core food-related danger?
      1. 3.3.2 Show/Hide More Community Nutrition Institute v. Young
        Original Creator: jgersen

        1. Legislative Rules.  As the court notes, section 553 of the Administrative Procedure Act requires certain minimal procedural steps prior to the issuance of a new rule of regulation.  In short, the agency must publish a Notice, take Public Comments, and issue a Concise Statement of Basis and Purpose accompanying the final rule.  This process is known as “informal rulemaking” because it does not utilize the Formal Rulemaking procedures specified in sections 556 and 557 of the APA, procedures that closely resemble a judicial trial with the presentation of evidence, cross-examination, and the like.   Section 553 contains an exception for, inter alia, “interpretative rules and general statements of policy.”  Because most rules also interpret, courts have been left to struggle with whether a particular agency document is a policy statement or interpretative rule that is exempt from notice and comment requirements or a “substantive” or “legislative” rule for which such procedures are required.  Is the FDA’s action level properly classified as a legislative rule or an exempt interpretation or policy statement? 
        2. Agencies and the APA. The APA contains a set of default procedural requirements for administrative agencies.  If an agency’s organic or creating statute (the statute granting the agency legal authority) says nothing about how the agency may exercise its power, then the APA applies.  Sometimes, however, Congress builds specific procedural requirements into an agency’s organic statute.  In that case, the specific requirements trump the default requirements.  Such is the case with the National Labor Relations Act (NLRA) and the FDCA.   
        3. Blending In Part II of the court’s opinion, it considered the blending problem. FDA has sometimes granted exemptions so that contaminated corn can be blended with uncontaminated corn to bring the total level of aflatoxin contamination below the action level.  Consumer groups argued that the corn is properly deemed adulterated.  The court agreed, but concluded that FDA maintains discretion about whether to initiate an enforcement proceeding for any adulterated food.  Because decisions about whether to enforce a particular legal obligation against a particular party is nearly unreviewable by courts, the legal conclusion that blended corn is adulterated carried no legal remedy for petitioners. Is there anything to stop FDA from deciding to never initiate enforcement proceedings against foods all parties agree are adulterated?  If not, is there something amiss with the legal regime?  Or, is this simply an inevitable feature of agency discretion about when and against whom to enforce legal obligations?
        4. Judge Starr. What is Judge Starr’s disagreement with the majority? What doctrinal test does he propose to distinguish substantive rules from policy statements? Is his test easy to administer than the smog that the majority offers? 
        5. The FDA & the APA. The FDA has continued to rely on guidance documents—facially non-binding policy statements and interpretative rules to announce agency positions and its interpretation of what is required of regulated parties.  Is policy by guidance desirable?  How ought we analyze these questions in the context of food policy?  Consider that conditions in the food industry are often changing rapidly and guidance offers the agency flexibility and speed when necessary.  By the same token, because guidance is generally issued without a transparent process of public notice, comment, and agency response, it means agency views often reflect limited input from the public. Does the majority in CNI II exacerbate or ameliorate this problem?    
        <p>1. Prosecutorial Guidelines. After the D.C. Circuit held that action levels were legislative rules and therefore had to be promulgated using notice-and-comment, the <span class="caps">FDA</span> revised its regulations, declaring that action levels were to be used as prosecutorial guidelines. The result is that the action levels remain influential, but are not binding on either the agency or industry. See Action Levels for Added Poisonous or Deleterious Substances in Food, 55 Fed. Reg. 20782 (May 21, 1990).</p> <p>2. Regulatory Limits. With tolerance levels requiring extensive procedural formality and action levels reduced to non-binding prosecutorial guidelines, <span class="caps">FDA</span> sought to craft a new tool: &#8220;regulatory limits.&#8221; Regulatory Limits are promulgated using informal rulemaking (notice-and-comment rulemaking). They are therefore binding and susceptible of review in federal court. Is there any advantage of to the regulatory limit? Is there any point to having action levels for prosecutorial guidelines and also binding regulatory limits?</p>
      1. 3.4.1 Show/Hide More United States v. Forty Barrels and Twenty Kegs of Coca Cola
        Original Creator: jgersen
        1. Adulteration in a special sense. The court notes that “adulteration” is used in the statute in “a special sense.” In what sense does the Court think adulteration is used in a special sense? The Court seems to distinguish between two sorts of foods. For naturally occurring foods, like a banana, adulteration means the introduction into the banana of something harmful. For non-naturally occurring foods like coca-cola, however, what does it mean to be adulterated? If a food is manufactured from a set of ingredients, how can it be deemed adulterated because one of those ingredients is included? Prior to its inclusion, the drink was not Coca-cola. After its addition, the drink was coca-cola, but it was not adulterated because nothing new had been added after it became coke. In any event, such was Coke’s argument. The Supreme Court, however, disagreed. A manufactured food product may be adulterated if a deleterious or harmful substance is added as part of the manufacturing product. <br /> 2. Added v. Inherent. The adulteration doctrine has developed to distinguish between substances inherent in a food and substances added to food. The same food may be adulterated when a substance is added to it, but not adulterated when the same substance occurs naturally as part of the food product. As the Court said, “[y]ou can extract poison from grain or its products and when it is extracted it is a deadly poison; but if you leave that poison as nature embodied it in the original substances it is not a dangerous poison or an active agency of poison at all.” Why does it make sense to hinge legality on whether a substance is inherent in a food or whether it is added to a food? Would not a more rational system simply ask whether the substance was harmful or injuries to human health, whether inherent or added? <br /> 3. Is caffeine added? Although the Court had little trouble concluding that caffeine is an added substance, consider the difficulty that processed foods or manufactured foods generate for the food safety regime. When a food is processed together from a set list of ingredients and has only a trade name like coca-cola, the company has a sensible argument that until all the ingredients are mixed together, it is not coke. And after all the ingredients have been mixed, nothing has been added. <br /> 4. Is caffeine a poisonous or deleterious substance? As the Supreme Court noted, the government presented evidence that caffeine is a poisonous or deleterious substance. The industry presented evidence that caffeine is safe. That question, however, is for the jury. <br /> 5. Caffeine today. One hundred years later, the <span class="caps">FDA</span> is once again inquiring whether caffeine is safe. After concluding that food products mixing alcohol and caffeine are not safe, <span class="caps">FDA</span> is inquiring whether caffeinated chewing gum is dangerous. One piece of caffeinated gum has the same amount of caffeine as half a cup of coffee. After initial <span class="caps">FDA</span> investigation, several chewing gum companies withdrew the product.
  3. 4 Show/Hide More Chemicals
    Original Creator: jgersen
    The 20th century witnesses a remarkable revolution in food production. Food processing preservation, packaging, and distribution all transformed. Although the local food movement is in many ways a reaction against these developments, the ability to preserve and transport food across enormous distances greatly changed not just the way we eat, but what we eat. One of the key facilitators of these shifts was new chemicals, ingredients and processing agents. Many of these were introduced into the food supply after World War II in the middle of the century. Although FDA did not require any advance approval for the use of food chemical technologies, both the public and Congress began growing increasingly concerned about the safety of hard-to-pronounce and largely unknown ingredients in food. Representative James Delaney of New York chaired a well-known select committee to examine their escalated use of chemicals in food. After extensive hearings, Congress eventually enacted the Food Pesticide Amendment (1954), Food Additive Amendment (1958), and the Color Additives Amendment (1960). Together, these measures increased FDA control over the ever-growing list of chemicals in food. Perhaps most famous of all these measures is what is known as the Delaney Clause, Food Additives Amendment of 1958, 72 Stat. 1784, 1785 (1958), codified at 21 U.S.C. 348© (3). The Delaney Clause provides that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” This next case considers the meaning of the Delaney Clause.
    1. 4.2 Show/Hide More GRAS
      Original Creator: jgersen

      Recall that the section 321(s) which defines the term “food additive” excludes substances Generally Recognized as Safe. The provision is reproduced below in its entirety.

      The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—

      (1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or
      (2) a pesticide chemical; or
      (3) a color additive; or
      (4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 601 et seq.];
      (5) a new animal drug; or
      (6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.
      21 U.S.C. 321(s).

      Two groups of substances qualify as GRAS. First, substances used in food prior to 1958 are grandfathered and automatically considered GRAS. 21 C.F.R. 170.30©. The FDA later extended the grandfathered substances to include substances commonly used in foods prior to 1958 outside the United States. 21 C.F.R. 170.30©(2).

      Grandfathering, or exempting an already existing class of substances or regulated parties like factories, is a common practice in regulatory policy. It is, however, worth pausing to consider the historical sequence. A massive increase in the use of chemicals in food prompts public concern, congressional investigations, and ultimately federal legislation. The federal legislation governs virtually chemicals added to foods, with one main exception—those chemicals added that are recognized as safe. Which chemicals are generally recognized as safe? All chemicals that are being commonly added to foods in the United States (and soon thereafter, anywhere in the world). Thus, the legislation stopped virtually none of the chemicals that gave rise to fear and legislation from being added to foods in the future. The the use of grandfathering as a regulatory strategy and the use of commonality as a marker of safety combined to allow almost all historical chemical additives to continue to be used in foods.

      In addition to chemicals commonly used in foods prior to 1958, a second group of substances are classified as GRAS based on scientific determination via one of two routes. First, a party may request that FDA review scientific information and conclude that a substance is GRAS. Second, a party can engage in “self-determination”—a process which typically involves convening a group of GRAS experts who review all available information about a substance and proper a report concluding that the substance is safe. The latter involves some risk that FDA will agree, but it also allows for the immediate marketing of the food and avoids what can be a time consuming pre approval process for food additives.

      1. 4.2.1 Show/Hide More Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe
        Original Creator: jgersen

        In 2010, The United States Government Accountability Office published GaO 10-246, critiquing the FDA's GRAS process. The full report is available at The report's highlights are below:

        The Food and Drug Administration (FDA), which is responsible for ensuring the safety of most of the U.S. food supply, is not required to review substances, such as spices and preservatives, added to food that are generally recognized as safe (GRAS) for their intended use. Currently, companies may determine a substance is GRAS without FDA's approval or knowledge. However, a few substances previously considered GRAS have later been banned; and concerns have been raised about the safety of other GRAS substances, including those containing engineered nanomaterials, materials manufactured at a tiny scale to take advantage of novel properties. GAO was asked to review the extent to which (1) FDA's oversight of new GRAS determinations helps ensure the safety of these substances, (2) FDA ensures the continued safety of current GRAS substances, and (3) FDA's approach to regulating engineered nanomaterials in GRAS substances helps ensure the safety of the food supply. GAO reviewed FDA data on GRAS substances and interviewed a range of stakeholders, among other things.
        FDA's oversight process does not help ensure the safety of all new GRAS determinations. FDA only reviews those GRAS determinations that companies submit to the agency's voluntary notification program—the agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them. Furthermore, FDA has not taken certain steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified. FDA has not issued guidance to companies on how to document their GRAS determinations or monitored companies to ensure that they have conducted GRAS determinations appropriately. Lastly, FDA has yet to issue a final regulation for its 1997 proposed rule that sets forth the framework and criteria for the voluntary notification program, potentially detracting from the program's credibility. FDA is not systematically ensuring the continued safety of current GRAS substances. While, according to FDA regulations, the GRAS status of a substance must be reconsidered as new scientific information emerges, the agency has not systematically reconsidered GRAS substances since the 1980s. FDA officials said they keep up with new developments in the scientific literature and, on a case-by-case basis, information brought to the agency's attention could prompt them to reconsider the safety of a GRAS substance. However, FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008. In fact, FDA has decided on the validity of these concerns in only 1 of 11 cases. In addition, FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances. FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge. While some uses of engineered nanomaterials have the potential to help ensure food safety, uncertainties remain about how to determine their safety in food. After reviewing the uncertainties associated with the safety of engineered nanomaterials, FDA has decided that it does not need additional authority to regulate products containing such materials. Rather, FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS. Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. In contrast to FDA's approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.

      2. 4.2.2 Show/Hide More Substances Generally Recognized as Safe, Final Rule, 8 Fed. Reg. 54960 (Aug. 17, 2016)
        Original Creator: jgersen


        The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.

        Executive Summary

        Purpose and Coverage of the Rule

        Although we have premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without our premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS). Since the 1970s, we have had regulations clarifying the statutory provision for eligibility for classification as GRAS. We also have had regulations governing a procedure for any person to voluntarily submit to us a petition asking us to affirm the GRAS status of a substance under the conditions of its intended use, and for us to engage in an intensive rulemaking process in response to that petition. Experience has shown that our regulations need further clarification to help stakeholders understand when a substance is eligible for classification as GRAS in human food or animal food under the conditions of its intended use. Experience also has shown that streamlining our evaluation of conclusions of GRAS status will enable us to evaluate more, and higher priority, substances. We are issuing this final rule to amend and clarify the criteria in our regulations for when a substance is GRAS under the conditions of its intended use in human food or animal food, and to replace the voluntary administrative procedure for petitioning us to affirm the GRAS status of a use of a substance in human food or animal food with a voluntary administrative procedure for notifying us about a conclusion that a substance is GRAS under the conditions of its intended use in human food or animal food.

        Summary of the Major Provisions of the Rule

        The final rule clarifies the criteria for the use of a substance to be eligible for classification as GRAS and establishes a new administrative procedure for any person to notify us of the basis for a conclusion that a substance is GRAS under the conditions of its intended use. With respect to criteria for eligibility for classification as GRAS, in the final rule we clarify that:

        • A substance cannot be classified as GRAS under the conditions of its intended use if the available data and information do not satisfy the safety standard for a food additive under the FD&C Act;
        • General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use;
        • “Common knowledge” can be based on either “scientific procedures” or on experience based on common use of a substance in food prior to January 1, 1958; and
        • General recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.

        With respect to the procedure for submitting a GRAS notice, we provide:

        • Definitions for certain terms, including amendment, GRAS notice, notified substance, notifier, qualified expert, supplement, we/our/us, and you/your;
        • A clear statement of the opportunity for any person to submit a GRAS notice;
        • Information on available formats (electronic and paper) and where to send a GRAS notice;
        • What data and other information may be incorporated into a GRAS notice;
        • General provisions applicable to a GRAS notice;
        • Specific information you must provide in your GRAS notice, including:

        ○ Signed statements and a certification (Part 1);

        ○ The identity, method of manufacture, specifications, and physical or technical effect of the notified substance (Part 2);

        ○ Dietary exposure (Part 3);

        ○ Self-limiting levels of use, in circumstances where the amount of the notified substance that can be added to human food or animal food is limited because the food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical (Part 4);

        ○ The history of consumption of the substance for food use by a significant number of consumers (or animals in the case of animal food) prior to January 1, 1958, if a conclusion of GRAS status is based on common use of the substance in food prior to 1958 (Part 5);

        ○ A narrative that provides the basis for your conclusion of GRAS status, including why the scientific data, information, methods, and principles Start Printed Page 54962described in the notice provide a basis for your conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (Part 6); and

        ○ A list of the data and information that you discuss in the narrative of your GRAS notice, specifying which of these data and information are generally available, and which of these data and information are not generally available (Part 7); and

        • Process for you to submit an amendment to your GRAS notice; and
        • Process for you to request that we cease to evaluate your GRAS notice.

        With respect to our administration of a GRAS notice, we specify:

        • Information about how we will file a GRAS notice, respond to it, and send subsequent correspondence about it;
        • Our commitment to respond within 180 days of filing of a GRAS notice, with a potential to extend our response timeframe by another 90 days;
        • Our procedures in the event the intended conditions of use of the notified substance include use in a product subject to regulation by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA); and
        • Provisions governing the public disclosure of a GRAS notice, including the actions we take to make some information regarding a GRAS notice readily accessible to the public.

        As of the effective date of the final rule, we will close the docket for any pending GRAS affirmation petition. The petitioner may incorporate the applicable petition into a new GRAS notice.


        The final rule eliminates the petition process to affirm that a substance is GRAS under the conditions of its intended use and replaces that petition process with a GRAS notification procedure. We estimate that over 10 years with a 7 percent discount rate, the present value of the total costs of the final rule range from $0.9 million to $3.3 million; with a 3 percent discount rate, the present value of the total costs range from $0.9 million to $3.4 million. The annualized costs of the rule range from $0.1 million to $0.4 million with a 7 percent discount rate and range from $0.1 million to $0.5 million with a 3 percent discount rate. We do not quantify the benefits of the final rule, but assume that firms will only participate in the GRAS notification procedure when they expect to receive a non-negative private benefit. The GRAS notification procedure will allow us to complete our evaluation within the timelines specified in the final rule. The following table includes a summary of the benefits and costs of the final rule.

        Summary of Benefits and Costs of the Final Rule

        Total benefitsPresent value of total costs with 7 percent discount rate ($ mil)Present value of total costs with 3 percent discount rate ($ mil)Total annualized costs over 10 years with 7 percent discount rate ($ mil)Total annualized costs over 10 years with 3 percent discount rate ($ mil)Not estimated$0.9 to $3.3$0.9 to $3.4$0.1 to $0.4$0.1 to $0.5.

        <p>1. The 2016 Final Rule was FDA's response to some of the long-standing criticism of the <span class="caps">GRAS</span> system and its administration. Note that the <span class="caps">GRAS</span> Rule implements very few of the reforms advocated by the 2010 <span class="caps">GAO</span> Report.</p> <p>2. The main alteration of the 2016 <span class="caps">GRAS</span> Rule was t replace the existing <span class="caps">GRAS</span> Petition process with a new <span class="caps">GRAS</span> Notification process. Under the old petition process, regulated parties could petition <span class="caps">FDA</span> to affirm that a given product was <span class="caps">GRAS</span> given its intended use. In response, the <span class="caps">FDA</span> would typically engage in what could be a fairly elaborate and time consuming rulemaking process, evaluating the petition. Under the new <span class="caps">GRAS</span> Notification procedures, regulated parties may notify <span class="caps">FDA</span> that a product is <span class="caps">GRAS</span>, according to the standards in the regulation.</p>
    2. 4.3 Show/Hide More Genetically Modified Food & GRAS
      Original Creator: jgersen

      Genetically Modified foods are discussed elsewhere in this casebook as well. Our concern in this section is the relationship between GM food and safety. As should be no surprise by this point in the book, federal administrative responsibility for addressing genetic modification of foods is split among multiple agencies. The FDA has authority for food safety issues having to do with the GE plants and animals. The EPA has authority to address health and environmental effects and pest-protected plants. The USDA has authority for the effect of GM plans on other plants and animals.

      In the 1980s, President Reagan created the Domestic Policy Council Working Group to develop a unifying framework for biotechnology. Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products 5, Pew Initiative on Food and Biotechnology (2001). The process resulted in the “Coordinated Framework for the Regulation of Biotechnology.” The organizing principle of the Coordinated Framework was that existing legal and institutional structure could adequately address any concerns about genetic modification.

      1. 4.3.1 Show/Hide More FDA 1992 GRAS Strategy
        Original Creator: jgersen

        In 1992, FDA announced a new policy under which the agency would presume that all GE foods were GRAS and therefore not subject to regulation as food additives. See Statement of Policy—Foods Derived from new Plant Varieties, 57 Fed. Reg 22984, 22986 (May 29, 1992). The policy did not require companies to submit products for review prior to bringing them to market.

        The key premise of FDA's policy is that the safety is best protected by focusing not on the means of production—genetic engineer or conventional techniques—but rather on the characteristics and features of a food. This so-called “product/process” distinction has resulted in the “substantial equivalence” doctrine. If the GE product is substantially the same as its conventional equivalent, it is not subject to differential regulation. Rather, the FDA simply advises that producers voluntarily consult with the agency prior to marketing.

    3. 4.4 Show/Hide More Pesticides
      Original Creator: jgersen

      Pesticides are “any subsatnce or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”  7 U.S.C 136(u).  Like other aspects of food law, responsibility for pesticides is split between sevearl federal agencies including the FDA, EPA, and USDA.  The EPA regualtes pesticides by virtue of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which was enacted in 1947. The statute governs the sale, distribution and use of pesticides and operates mainly through a registration mechanism.  No pesticide can be legally sold or distributed without first being registered by EPA.  EPA may only register a pesticide if the agency determines the pesticide will not cause “reasonable adverse effects on the environment”  7 U.SC 136(a). Once registered, FDA and USDA monitor “tolerances” established by EPA.

      The problem of pesticides for food safety is that pesticide residue may remain in or on food.  Wehth4er from direct treatment of a crop or processing or crop rotation or run off or spray drift or livestock eating feed with residues, pesticide residue finds its way into all manners of food for human consumption.  After years of increased concern about the health effects of pesticide residues, in 1996 Congtress passsed the Food Quality Protection Act (FQPA).  The Act amended the FDCA and FIFRa, mandating a single standard for pesticide reisdue in food and focused attention on the particular vulnerability of children to pesticides.  110 Stat 1489, 1511 (1996).  

    4. 4.5 Show/Hide More Animal Drugs
      Original Creator: jgersen
      Many animals raised for food are administered antibiotics to either prevent or treat disease. When an animal receives a drug, all of the bacteria in and on the animal are also exposed to the drug. Exposed bacteria can become resistant over time, which means that those drugs will no longer be effective against those bacteria. In the past several decades, the public health community has grown increasingly concerned about growing antibiotic resistance and the use of antibiotics for animals. Many other animal drugs, however, may also find their way into the human food supply.
  4. 5 Show/Hide More Food Products Liability
    Original Creator: jgersen

    Whether adopted by statute, regulation, or ordinance versions of the Food Code constitute so-called public law regulation of food. However, state common law has also long addressed food safety concerns as well. In fact, cases involving harms from food gave rise to modern products liability law. The cases in this section illustrate the range of common law food safety claims that are often brought under the broad rubric of food liability.  


    1. 5.8 Show/Hide More Burr v. Coca-Cola Bottling Co. of Columbia, Inc.
      Original Creator: jgersen

      <p>1. Causation. Whether brought in a negligence or strict liability action, the plaintiff still must show that their injury was caused by the food product. Causation is not always a trivial endeavor. Absent affirmative evidence or immediate temporal proximity, the causation element may not be satisfied and recovery may be barred.</p> <p>2. Traceability. In recent years, there has been a strong push towards what is sometimes called &#8220;traceability.&#8221; The basic idea is that it should be possible to trace a food back through the entire chain from production to consumption. The more traceability in the food system, the easier causation will be to satisfy.</p>
    2. 5.9 Show/Hide More Trabaudo v. Kenton Ruritan Club, Inc.
      Original Creator: jgersen

      1. Trabaudo is a case involving an ordinary state common law tort claim and an alleged violation of a state pure food statute. The state statutes is similar to the federal law, but provides a state private right of action.
      2. Defendants, who? Note that the defendant in the this case was a community organization that sold sausages as a fundraiser. The community organization, in turn, had purchased the raw pork from Meat Market to the make the sausages. Which defendant is in the best position to prevent injuries of this sort? The initial producer, the reseller, both, or neither? Commentary on tort law sometimes uses a concept known as the cheapest cost avoider. The idea is to impose the legal responsibility for avoiding an injury on the party with the party best situated to avoid the harm most easily. Is that idea at play in this case? Who is the cheapest-cost-avoider in this scenario?    
      3. Tort, what? The plaintiffs had several legal theories in this case. First, they argued that defendants were negligent in failing to inspect the pork for trichinae and in failing to warn them of the danger of eating raw pork and the methods available to render it safe. That is, they alleged the defendants failed to take a required precaution (inspection) and also failed to warn about the risk. Second, the plaintiffs argued that defendants breached an implied warranty of fitness and violated the state Uniform Deceptive Trade Practices Act, by misrepresenting the pork sausage as being wholesome. Third, plaintiffs argued that assert that defendants' sale of “adulterated” food constituted a violation of the state pure food act. What exactly is the relationship between these three claims? Is it possible to violate on of these legal obligations and not the others or is the idea that breach of anyone of these obligations would by implication generate legal liability for the other claims?

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June 05, 2017

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