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|2.2||Show/Hide More||Government Regulation: Public Health and Safety Laws and Consumer Protection|
|18.104.22.168||Show/Hide More||Food Safety Modernization Act|
|4.1||Show/Hide More||Introduction to Food Safety|
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.
|4.2.2||Show/Hide More||Food Safety Modernization Act|
|4.2.3||Show/Hide More||Center for Food Safety v. Hamburg|
|4.2.4||Show/Hide More||Federal Regulatory Regime|
|22.214.171.124||Show/Hide More||Food Facility Registration|
|126.96.36.199.1||Show/Hide More||United States v. New England Grocers Supply Co.|
|188.8.131.52.2||Show/Hide More||Inspections, Searches, and Seizures|
The Fourth Amendment of the U.S. Constitution states as follows:
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.
|184.108.40.206.3||Show/Hide More||Federal Inspections|
|220.127.116.11.6||Show/Hide More||Durovic v. Palmer|
|18.104.22.168.7||Show/Hide More||Munsell v. Dept. of Agriculture, 509 F.3d 572 (D.C. Cir. 2007).|
|22.214.171.124||Show/Hide More||Prevention, Inspection, and Risk|
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.
|126.96.36.199.2||Show/Hide More||American Federation of Government Employees, AFL-CIO v. Glickman, 215 F.3d 7 (D.C. Cir. 2000).|
|188.8.131.52.3||Show/Hide More||Supreme Beef Processors, Inc. v. U.S. Dept. of Agriculture, 275 F.3d 432 (5th Cir. 2001).|
|184.108.40.206.4||Show/Hide More||Food & Water Watch, Inc v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)|
|220.127.116.11.1.1||Show/Hide More||Rogers v. Tyson Foods, Inc.|
|4.2.5||Show/Hide More||State and Local Food Regulation|
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.
|18.104.22.168||Show/Hide More||Model Food Code|
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.
|22.214.171.124.1||Show/Hide More||Model Food Code (2013 Preface Excerpts)|
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.
|4.3.2||Show/Hide More||Added Substances|
|126.96.36.199||Show/Hide More||United States v. Anderson Seafoods, Inc.|
|4.3.3||Show/Hide More||Tolerance Levels, Action Levels, and Regulatory Limits|
|188.8.131.52||Show/Hide More||Community Nutrition Institute v. Young|
|184.108.40.206||Show/Hide More||United States v. Forty Barrels and Twenty Kegs of Coca Cola|
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.
|220.127.116.11||Show/Hide More||Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe|
In 2010, The United States Government Accountability Office published GaO 10-246, critiquing the FDA's GRAS process. The full report is available at http://www.gao.gov/assets/310/300743.pdf. 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.
|18.104.22.168||Show/Hide More||Substances Generally Recognized as Safe, Final Rule, 8 Fed. Reg. 54960 (Aug. 17, 2016)|
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.
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.
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:
With respect to the procedure for submitting a GRAS notice, we provide:
○ 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
With respect to our administration of a GRAS notice, we specify:
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 $0.5 million with a 3 percent discount rate. We do not quantify the benefits of the final rule, but assume that firms will only participate in the GRAS notification procedure when they expect to receive a non-negative private benefit. The GRAS notification procedure will allow us to complete our evaluation within the timelines specified in the final rule. The following table includes a summary of the benefits and costs of the final rule.
Summary of Benefits and Costs of the Final RuleTotal benefitsPresent value of total costs with 7 percent discount rate ($ 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.
|4.4.3||Show/Hide More||Genetically Modified Food & GRAS|
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.
|22.214.171.124||Show/Hide More||FDA 1992 GRAS Strategy|
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.
|126.96.36.199||Show/Hide More||What You Need to Know About Genetically Engineered Food|
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|
|4.5||Show/Hide More||Food Products Liability|
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.
|4.5.8||Show/Hide More||Burr v. Coca-Cola Bottling Co. of Columbia, Inc.|
|4.5.9||Show/Hide More||Trabaudo v. Kenton Ruritan Club, Inc.|
Recall that the two major federal statutes pertaining to food and drugs in the first half of the twentieth century were the 1906 Pure Food and Drug Act (PFDA) and the 1938 Food, Drug, and Cosmetic Act (FDCA). Although the 1938 statute attempted to fix many of the earlier law's failings, many legal requirements and doctrinal frameworks carried over from the PFDA to the FDCA.
The PFDA made it illegal to manufacture or transport any food that is “misbranded.” Pure Food and Drug Act of 1906, sections 1-2, 34 Stat.. 768, 768-72 (repealed 1938). The purpose of the PFDA's misbranding provision was “to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was, and not under misrepresentations and to character and quality.” United States v. Johnson, 221 U.S. 488, 497 (1911).
|188.8.131.52.1||Show/Hide More||United States v. Johnson|
|184.108.40.206.2||Show/Hide More||Hall-Baker Grain Co. v. United States|
March 08, 2016
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