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Food Safety 

Food Safety
Chapter:
Food Safety
Author(s):

Jennifer L. Pomeranz

DOI:
10.1093/med/9780190227258.003.0005
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date: 20 November 2017

Introduction

The concept of food safety can take many forms. Perhaps the most commonly thought of notion related to unsafe food is the acute illness that follows from foodborne contamination threatening the health of all users of the product. Food might also be unsafe if it contains an undisclosed ingredient that is harmful to a portion of the population, such as a common allergen. Another type of unsafe food might occur when an ingredient is unsafe to consume over time, such as trans fat, or becomes unsafe at high levels, such as caffeine. Finally, certain production practices may result in food of questionable safety, subject to inquiry and debate by scientists, as occurred with the addition of growth hormones and antibiotics to food-animal feed. These and similar topics will be discussed in this chapter.

History of Food Safety in the United States

In the 1800s, adulterated and misbranded food and drugs were a relatively accepted part of the American landscape. Harvey Washington Wiley, Chief Chemist of the Bureau of Chemistry, which later became the Food and Drug Administration, worked for years to convince Congress and the American public that a federal law was necessary to prohibit the adulteration and misbranding of food and drugs.1 During this time period, “reform-minded journalists,”2 called the Muckrakers, helped expose the dangerous qualities of food and drugs available in the marketplace. The most famous exposé was Upton Sinclair’s book, The Jungle, in which he sought to point out the atrocities of labor conditions for the “workingmen of America.”3 Ultimately, however, his vivid description of the meat packing industry shocked Americans regarding the true condition of meat sold for consumption—diseased, rat infested, and chemically treated—and is widely credited as helping to lead to the passage of the Food and Drug Act of 1906.4

The Pure Food and Drugs Act was passed by Congress on June 30, 1906, and signed into law by President Theodore Roosevelt. The Act was administered by the Bureau of Chemistry, which was housed in the Department of Agriculture at the time. The Pure Food and Drugs Act prohibited the manufacture, sale, or transportation of adulterated, misbranded, poisonous or deleterious foods, drugs, medicines, and liquors in interstate commerce.5 In 1930, the Bureau of Chemistry became the Food and Drug Administration (FDA) and the agency sought to update the 1906 law. Congress resisted, but after more than one hundred people were killed from a poisonous ingredient added to a drug, Congress passed the Food, Drug, and Cosmetic Act in 1938.6 The FDA was transferred to the Department of Health, Education, and Welfare in 1953, which became the Department of Health and Human Services in 1979.7

Today, the FDA has the regulatory authority to protect public health by overseeing the safety and labeling of food.8 The FDA is responsible for enforcing the Food Drug and Cosmetic Act (FDCA), which prohibits the introduction of adulterated food into interstate commerce. The FDCA defines food as: (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.9 The FDCA defines adulterated food as food that bears or contains any poisonous or deleterious substance that may render it injurious to health or food that bears or contains a poisonous or deleterious substance, pesticide chemical residue, food additive, or color additive that is unsafe.10

Although the FDA has primary jurisdiction over most foods, other agencies are involved in food safety. For example, although the FDA has jurisdiction over livestock intended for food, the United States Department of Agriculture (USDA) has jurisdiction over the slaughter and processing of the animals.11 Similarly, the FDA has jurisdiction over bottled water and water used as an ingredient in food, but the Environmental Protection Agency (EPA) is responsible for the safety and purity of drinking water.12 Fifteen federal agencies have responsibilities related to food safety as explained further in Table 5.1 below.

Table 5.1 Federal Agency Food Safety Responsibilities

Department and/or Agency

Responsibility

U.S. Department of Agriculture

Food Safety and Inspection Service

Ensuring the nation’s domestic and imported commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged, and for enforcing the Humane Methods of Slaughter Act of 1978, as amended; providing voluntary fee-for-service inspections for exotic animals; catfish inspection.

Animal and Plant Health Inspection Service

Preventing the introduction or dissemination of (1) plant pests and (2) livestock pests or diseases.

Grain Inspection, Packers and Stockyards Administration

Establishing quality standards, inspection procedures, and marketing of grain and other related products.

Agricultural Marketing Service

Establishing quality and condition standards for, among other things, dairy, fruits, vegetables, and livestock.

Agricultural Research Service

Providing the scientific research to help ensure that the food supply is safe and secure and that foods meet foreign and domestic regulatory requirements.

Economic Research Service

Providing analyses of the economic issues affecting the safety of the U.S. food supply.

National Agricultural Statistics Service

Providing statistical data, including agricultural chemical usage data, related to the safety of the food supply.

National Institute of Food and Agriculture

Supporting food safety projects in the land-grant university system and other partner organizations that demonstrate an integrated approach to solving problems in applied food safety research, education, or extension.

Department of Health and Human Services

Food and Drug Administration

Ensuring that all domestic and imported foods, excluding meat, poultry, and processed egg products, are safe, wholesome, sanitary, and properly labeled.

Centers for Disease Control and Prevention

Preventing the transmission, dissemination, and spread of foodborne illness to protect the public health.

Department of Commerce

National Marine Fisheries Service

Providing voluntary, fee-for-service examinations of seafood for safety and quality.

Environmental Protection Agency

Regulating the use of certain chemicals and substances that present an unreasonable risk of injury to health or the environment; issuing regulations to establish, modify, or revoke tolerances for pesticide chemical residues; setting national drinking water quality standards; and consulting with the Food and Drug Administration (FDA) before FDA promulgates regulations for quality standards for bottled water.

Department of the Treasury

Alcohol and Tobacco Tax and Trade Bureau

Regulating, enforcing, and issuing permits for the production, labeling, and distribution of alcoholic beverages.

Department of Homeland Security

Customs and Border Protection

Inspecting imports, including food products, plants, and live animals, for compliance with U.S. law and assisting all federal agencies in enforcing their regulations at the border.

Federal Trade Commission

Enforcing prohibitions against false, deceptive and unfair advertising for food products, among other things.

Source: GAO Report. GAO-15-180 Federal Food Safety Oversight. Additional Actions Needed to Improve. Table 1. http://www.gao.gov/assets/670/667656.pdf

The EPA’s role in food safety is primarily related to ensuring food is safe from harmful levels of pesticides, but it also addresses such issues as contaminated fish and harmful algae blooms, which can be toxic to humans and animals.13 Pesticides are agents used to kill or control undesired insects, weeds, rodents, fungi, bacteria, and other organisms. The EPA approves all pesticides to be used on foods and sets tolerances, or maximum residue limits, on the amount of pesticide residue that can lawfully remain on a food.14 The FDA, however, actually enforces the pesticide tolerances established by the EPA on all food under the FDA’s domain,15 and the USDA tests, samples, analyzes, and reports on pesticide residues under its Pesticide Data Program.16

In addition, state and local health departments are directly involved in food safety. The majority of local health departments engage in food safety education to food handlers, operators, and food service establishments for preventive purposes, and to the public during a recall or an outbreak.17,18 The majority of local health departments are also in charge of regulating, inspecting, and/or licensing food service establishments.19 Local health departments conduct food inspection in an array of other institutions under their authority, such as grocery stores, day-care facilities, hospitals, and schools. When a food is suspected to be contaminated, local health departments are often the first to receive the report and may initiate recalls.20 Only a small percentage of local health departments have food testing laboratory facilities, so in the majority of states the state department of health assumes this responsibility.

The Food Safety Modernization Act

In January 2011, President Obama signed the Food Safety Modernization Act (FSMA) with the goal of shifting the federal government’s focus to preventing food safety issues, rather than relying primarily on responding to problems. The FSMA is directed at the Department of Health and Human Services (HHS). Most provisions apply to the FDA or require coordination among several federal agencies.21 For example, the FDA, USDA, and Department of Homeland Security must submit to Congress on a biennial basis a joint food safety and food defense research plan.22 The FSMA also requires the FDA to collaborate with state departments of health. Select collaborations among federal agencies are outlined in Table 5.2.

Table 5.2 Selected Collaborative Mechanisms Involving the Food and Drug Administration and USDA’s Food Safety and Inspection Service

Name

Description

Foodborne Diseases Active Surveillance Network (FoodNet)

A collaboration involving the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Food Safety and Inspections Service (FSIS), and 10 state health departments. It estimates the number of foodborne illnesses, monitors trends in incidence of specific foodborne illnesses over time, and attributes illnesses to specific foods and settings, among other things.

Healthy People 2020

A national health promotion and disease prevention initiative that includes 42 topic areas, including food safety. FDA and FSIS co-lead the food safety topic area, with an objective of, among other things, reducing rates of infection caused by foodborne pathogens.

Interagency Foodborne Outbreak Response Collaboration

A collaboration involving CDC, FDA, and FSIS to coordinate foodborne illness outbreak investigations.

Interagency Food Safety Analytics Collaboration

A collaboration involving CDC, FDA, and FSIS focusing on projects related to foodborne illness source attribution, the process of estimating the most common food sources responsible for specific foodborne illnesses.

Interagency Residue Control Group

A collaboration involving the Environmental Protection Agency, FDA, FSIS, and other agencies to discuss and resolve chemical residue issues.

Interagency Risk Assessment Consortium

A collaboration involving federal agencies with food safety responsibilities. It works to promote scientific research that will facilitate risk assessments to assist regulatory agencies in fulfilling their specific food-safety risk management mandates.

National Advisory Committee on Microbiological Criteria for Foods

A collaboration involving CDC, FDA, FSIS, and other federal agencies with food safety responsibilities. It develops methodologies for assessing microbiological hazards in foods, among other things.

National Antimicrobial Resistance Monitoring System

A collaboration involving CDC, FDA, FSIS, and state and local health departments that tracks whether foodborne and other bacteria are resistant to the antibiotics used to treat and prevent the spread of illness.

PulseNet

A collaborative surveillance network involving CDC, FDA, FSIS, and public health laboratories in each state. PulseNet uses molecular fingerprinting to connect cases of foodborne infection and detect outbreaks.

Source: GAO Report. GAO-15-180 Federal Food Safety Oversight. Additional Actions Needed to Improve. Table 3 http://www.gao.gov/assets/670/667656.pdf

The FSMA contains many specific directions to the FDA; several interesting ones are noted here. Provisions of the FSMA require the FDA to engage in pilot projects to develop recommendations for improving the tracking and tracing of food and to work with the USDA to establish a product-tracing system that improves the capacity of the FDA to track and trace domestic or imported food effectively and rapidly.23 The FDA is required to enact comprehensive, science‐based preventive controls including establishing science-based, minimum standards for the safe production and harvesting of produce, overseeing food facilities’ implementation of written preventive controls plans, and issuing regulations to protect against intentional food adulteration.24

The FSMA also requires the FDA to promulgate regulations to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods designated as “high-risk foods.”25 The FDA issued a request for comments and scientific data and information in 2014 to determine which foods should be considered high-risk.26 The FSMA specifies that the designation of high-risk foods must be based on the: (1) known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention; (2) likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food; (3) point in the manufacturing process of the food where contamination is most likely to occur; (4) likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination; (5) likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and (6) likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.27

The FSMA also provided the FDA with new authority over imported food. Importers must verify that foreign food suppliers have preventive controls in place to ensure that the food they produce is safe.28 Further, the FDA can deny entry of foods if the agency is not allowed to inspect the foreign facility (or enter the country in which it is located).29

Foodborne Illness Outbreaks

The FSMA overhauled the federal government’s authority to address foodborne illness outbreaks. The Centers for Disease Control and Prevention (CDC) reports that 48 million cases of foodborne illness occur each year in the United States from people consuming contaminated food, resulting in thousands of hospitalizations and approximately 3,000 deaths.30 Food may be contaminated during the production, processing, distribution, or preparation stages.31 See Figure 5.1 for the foods associated with foodborne outbreak-associated illnesses from 2008 to 2012. The federal government defines “foodborne illness outbreak” as the occurrence of two or more cases of a similar illness resulting from the ingestion of a certain food.32


Figure 5.1 Total foodborne outbreak-associated illnesses, 2008–2012 = 81,757.

Figure 5.1 Total foodborne outbreak-associated illnesses, 2008–2012 = 81,757.

Source: CDC National Outbreak Reporting System, 2008–2012.a

The most common method for government to respond to a foodborne disease outbreak is through identification and investigation by state, local, and territorial public health departments.33 Generally an outbreak is first identified at the local level and the state health department offers assistance if it spreads across the state. If an outbreak overwhelms a state’s capabilities and resources, the state may ask the CDC for assistance. In the case of multistate outbreaks, the CDC will collaborate with the FDA, the USDA’s Food Safety and Inspection Service (FSIS), or the EPA, but the CDC generally leads the investigation. As required by the FSMA, the CDC also named the state health departments in Colorado, Florida, Minnesota, Oregon, and Tennessee as Integrated Food Safety Centers of Excellence to identify and implement best practices to assist the CDC in responding to foodborne disease outbreaks.34

The FSMA requires the FDA to inspect domestic food facilities on a regular basis, permits FDA to access the facilities’ food safety plans and records, and requires the FDA to establish a program for food laboratory testing.35 The FSMA also required the FDA to enhance the foodborne illness surveillance systems by improving the collection, analysis, reporting, and usefulness of data on foodborne illness by coordinating across agencies and with state and local systems by sharing information, developing improved epidemiological tools, and expanding the capacities of these systems.36 During an active investigation of a foodborne illness outbreak, or when the FDA determines that the following is necessary to prevent a foodborne illness outbreak, the FSMA permits the FDA to request that a farm identify potential immediate recipients, other than consumers, of any food that is or was adulterated or that presents a threat of serious adverse health consequences or death to humans or animals.37

The USDA’s FSIS operates under the authority of the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act to inspect all poultry, livestock, and egg products, analyze these products for adulterants, and set food safety standards for processing facilities. FSIS also conducts epidemiological studies and risk assessments to provide science-based information for risk management and communication.38

Once a food is identified as contaminated, the FDA or FSIS will alert the public about the contamination and issue recalls of the contaminated food.39,40 Voluntary or mandatory recall may occur due to the discovery of a contaminant or organism in food, which can cause illness, or the discovery of a major allergen in a food product that is misbranded due to failure to disclose the ingredient on the label. The FSMA gave the FDA enhanced capabilities to issue a mandatory recall when a company fails to voluntarily recall unsafe food. The FSMA also permits the FDA to suspend the registration of a food facility that the agency determines poses a reasonable probability of serious adverse health consequences.41 Under its new authority, the FDA issued its first food seizure order in September 2011 after inspections found rodent and insect infestation at a food storage and processing facility in Washington state.42

Food Allergens

Congress identified the eight major food allergens responsible for 90% of all food allergy reactions as: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.43 Food allergens are permitted in food products regulated by both the FDA and USDA as long as food companies disclose their inclusion on the food label. See Chapter 6 on this labeling requirement.

The CDC found that food allergies affect approximately 4% to 6% of children in the United States and that this is of increasingly greater concern.44 The FSMA required HHS and the Department of Education to develop voluntary guidelines to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs.45 In response to this requirement, the CDC and the Department of Education created the “Voluntary Guidelines for Managing Food Allergies In Schools and Early Care and Education Programs.” The guidelines provide practical information and planning steps for school-related administrators and staff to address food allergy management and prevention plans in their schools.46

Food Additives and Generally Recognized As Safe

In 1958, Congress passed the Food Additives Amendment, which required manufacturers of new food additives to establish the safety of the additives before they could be introduced into the food supply. Now food ingredients are categorized as either “food additives” or “generally recognized as safe.” Food additives are defined as substances for which the intended use results or may reasonably be expected to result, directly or indirectly, in their becoming a component of food or otherwise affecting the characteristics of food.47 Food companies must obtain FDA approval before marketing a food with a food additive.48 The FDA generally issues a food additive regulation prescribing its approved use and thereafter the food additive will be deemed unsafe only if it does not conform to the terms of the regulation.49

An ingredient is exempt from the definition of food additive if it is “generally recognized as safe,” or GRAS. A substance may be considered GRAS based on the views of “experts qualified by scientific training and experience to evaluate the safety of substances.”50 This may occur through two methods. First, for substances used in food prior to January 1, 1958, an ingredient could have been declared GRAS through experience based on common knowledge about the substance throughout the scientific community.51 Salt and pepper are examples of ingredients with GRAS status through this mechanism. Second, an ingredient can be declared GRAS through studies published in peer-reviewed journals, which may be corroborated by other data and information, the opinion of an ‘‘expert panel’’ convened for this purpose, or the recommendation of an authoritative body such as the National Academy of Sciences.52,53

In 1969, President Richard Nixon convened a White House Conference on Food, Nutrition, and Health. Much of the conference focused on topics such as hunger, malnutrition, and nutrition education.54 However, in response to the FDA’s 1969 decision to remove various cyclamate salts (nonnutritive sweeteners) from the GRAS list after studies revealed bladder tumors in rats fed with them, President Nixon additionally directed the FDA to re-examine the safety of GRAS substances.55 The FDA announced that it would undertake a comprehensive study of GRAS substances in 1970 to evaluate the available safety information and determine whether each item should be confirmed as GRAS or be subject to a food additive regulation.56 The FDA created administrative procedures and convened the Select Committee on GRAS Substances to make independent scientific determinations.57 By 1982, the Select Committee had produced 151 detailed reports covering over 400 substances.58

Thereafter, GRAS affirmation involved the FDA’s formal rulemaking procedure, which the agency found to be resource intensive. When a food company petitioned the FDA to confirm an ingredient should be GRAS based on its own determination that this was the case, the FDA had to engage in the following activities: (1) publish a notice in the Federal Register; (2) request comments on the petitioned request; (3) conduct a comprehensive review of the petitioner’s data and information and the comments received to determine whether the evidence established that the petitioned use of the substance is GRAS; (4) draft a detailed explanation of why the use is GRAS; and (5) publish that explanation in the Federal Register. In 1997, the FDA decided to permit food companies to self-declare an ingredient to be GRAS in order to avoid these steps and preserve its limited resources for other purposes.59 The FDA thus proposed a rule to avoid this formal process. Although the 1997 proposed rule was never finalized or subject to a complete notice and comment rulemaking at that time, the FDA has functioned under this determination since then.60

Under the 1997 proposed rule program, the FDA permits companies to determine that a substance is GRAS and based on this conclusion, the company may market the food with the ingredient without first informing the FDA.61 Instead of formally petitioning the FDA for GRAS verification, the company need only file a ‘‘GRAS exemption claim’’ describing the substance, the applicable conditions of use, and the basis for the GRAS determination; however, it does not need to submit the information or data upon which the determination was made.62

Several nonprofit groups sued the FDA in 2014, arguing that the GRAS exemption claim program is contrary to Congress’s intent in passing statutory requirements related to GRAS status, deprives the public of the right to have its comments considered as required by the Administrative Procedure Act, exposes the public to potentially hazardous substances, and raises concerns about the integrity of the process and the food industry’s determinations.63 The parties settled the lawsuit, with the FDA agreeing to finalize a GRAS rule by August 2016.64

The FDA has the power to determine that a substance is not GRAS or no longer GRAS upon its own volition. The FDA must publish a notice in the Federal Register explaining its determination that a substance is not GRAS but rather is a food additive subject to regulatory oversight by the agency.65 In 2013, the FDA determined that partially hydrogenated oils, which are the primary dietary source of trans fat, are not GRAS.

In the 1990s, studies emerged to indicate that the consumption of trans fat increases the risk of coronary heart disease. Denmark banned trans fat in 2003, New York City’s Department of Health and Mental Hygiene banned its use in restaurant foods in 2006, and California followed suit in 2008.66 The FDA initially addressed concerns over partially hydrogenated oils by requiring the disclosure of the trans fat content of food on the Nutrition Facts Panel in 2006.67

In 2013 the FDA issued a notice in the Federal Register, stating that it found that partially hydrogenated oils are “no longer GRAS under any condition of use in food and therefore are food additives.”68 The agency noted that partially hydrogenated oils have been used in food for many years based on the food industry’s self-determination that such use is GRAS.69 The agency thus sought comments on its conclusion that food manufacturers should no longer be permitted to sell partially hydrogenated oils, “either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.”70 The FDA received over 1,500 comments.71 In June 2015, the agency finalized its determination that partially hydrogenated oils are not GRAS for use in human food. The FDA gave food manufacturers three years to remove partially hydrogenated oils from their products but is permitting food companies to petition the agency to request an exemption for specific uses.

Caffeine is another substance with questionable GRAS status when added to food. See Box 5.1 for more information on caffeine and its GRAS designation.

a Food and Drug Administration. Database of Select Committee on GRAS Substances (SCOGS) Reviews. Caffeine. 1978. http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=42

b Good Manufacturing Practices are the FDA’s descriptions of the methods, equipment, facilities, and controls for producing processed food (and dietary supplements) to ensure proper quality, packaging and labeling.

c 21 CFR 182.1180.

d Food and Drug Administration. For Consumers. FDA to Investigate Added Caffeine. May 3, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm

e J. L. Pomeranz, C. Munsell, and J. L. Harris. Energy Drinks: An Emerging Public Health Hazard for Youth. Journal of Public Health Policy. 2013;34(2):254–271.

f Alcohol and Tobacco Tax and Trade Bureau. Alcohol Beverages with Added Caffeine. August 21, 2014. http://www.ttb.gov/main_pages/caffeine-added.shtml

g FDA to Examine the Safety of Caffeinated Alcoholic Beverages. November 13, 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm190364.htm

h Food and Drug Administration. Food. Background Information: Caffeinated Alcoholic Beverages. Nov 13, 2009.

i Food and Drug Administration. Food. Caffeinated Alcoholic Beverages. November 17, 2010. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm190366.htm

j Food and Drug Administration. News & Events. Update on Caffeinated Alcoholic Beverages. November 24, 2010. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm234900.htm

k Food and Drug Administration. For Consumers. FDA to Investigate Added Caffeine. May 3, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm

l Food and Drug Administration. For Consumers. FDA to Investigate Added Caffeine. May 3, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm

m Food and Drug Administration. Food. Added Caffeine in Gum. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm396885.htm

n J. L. Pomeranz, C. Munsell, J. L. Harris. Energy Drinks: An Emerging Public Health Hazard for Youth. Journal of Public Health Policy. 2013;34(2):254–271.

o Substance Abuse and Mental Health Services Administration. Center for Behavioral Health Statistics and Quality. The DAWN Report: Emergency Department Visits Involving Energy Drinks. November 22, 2011. Rockville, Maryland.

p Staff of Senator Edward J. Markey (D-MA) in coordination with the staff of Senators Richard J. Durbin (D-IL), and Richard Blumenthal (D-CT). Buzz Kill: A Survey of Popular Energy Drinks Finds Majority of the Market Unwilling to Make Commitments to Protect Adolescents. January 2015. http://www.markey.senate.gov/imo/media/doc/2014-12-30-Report_BuzzKill_EnergyDrinks_ScreenV.pdf

q Staff of Senator Edward J. Markey (D-MA) in coordination with the staff of Senators Richard J. Durbin (D-IL), and Richard Blumenthal (D-CT). Buzz Kill: A Survey of Popular Energy Drinks Finds Majority of the Market Unwilling to Make Commitments to Protect Adolescents. January 2015. http://www.markey.senate.gov/imo/media/doc/2014-12-30-Report_BuzzKill_EnergyDrinks_ScreenV.pdf

r Staff of Senator Edward J. Markey (D-MA) in coordination with the staff of Senators Richard J. Durbin (D-IL), and Richard Blumenthal (D-CT). Buzz Kill: A Survey of Popular Energy Drinks Finds Majority of the Market Unwilling to Make Commitments to Protect Adolescents. January 2015. http://www.markey.senate.gov/imo/media/doc/2014-12-30-Report_BuzzKill_EnergyDrinks_ScreenV.pdf

Color Additives

A color additive is a dye, pigment, or other substance made by a process of synthesis or that is extracted, isolated, or otherwise derived from a vegetable, animal, mineral, or other source and that, when added or applied to a food is capable of imparting color to it.72 The FDA is responsible for determining the safety of color additives based on its own independent analysis, as well as the scientific data submitted to it by the company proposing to introduce the additive into the food supply.73 The FDA defined “safe” in the context of color additives to mean “that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.”74 In addition, the FDA passed a specific regulation noting that if the information from qualified scientists suggests the possibility that a color additive has induced cancer when ingested, “no regulation may issue which permits its use.”75 The FDA may also confine its approval of color additives to certain foods.

Food companies seeking to introduce a new color additive for use in food must submit a petition for certification to the FDA or request an exemption from certification from the agency. Certifiable color additives are those that are synthetically made and are primarily derived from petroleum and coal sources.76 Companies must submit a batch of the proposed synthetic color additive to the FDA. Examples of synthetic color additives approved for use in food include FD&C Blue No. 1, FD&C Red No. 40, and FD&C Yellow No. 5.77 The category of color additives that are exempt from the certification process are those that are primarily derived from plant, animal, or mineral sources. Caramel color and annatto extract are examples of this second category approved for use in food.78 Although they are not subject to certification requirements and companies do not need to submit batches to the FDA, companies must still comply with regulatory requirements. For example, grape color extract, derived from Concord grapes, must comply with specifications regarding pesticide residues, and arsenic and lead levels, and is only approved for use in coloring “nonbeverage food.”79

The FDA requires that food packaging disclose the presence of color additives. Any color additive, whether subject to, or exempt from certification is considered an “artificial color” or “artificial coloring” by the FDA.80 Food manufacturers must list the full or abbreviated name of any FDA-certified color additive, such as FD&C Blue No. 1 or Blue 1. For noncertified color additives, manufacturers may state “Artificial Color,” “Artificial Color Added,” or “Color Added.”81,82

Debates in Animal-based Food Production Safety

Modern food production practices include methods that have engendered safety concerns among scientists or the public and thus the appropriate government response and applicable laws are subject to debate. Two such examples include the use of synthetic growth hormones in dairy cows and subtherapeutic antibiotics in animal feed.

Synthetic Growth Hormones

Bovine somatotropin, also known as bovine growth hormone, is a protein hormone produced by the pituitary gland of cows. Cow milk contains naturally occurring bovine growth hormones. Scientists recognized that a synthetic form of this growth hormone could increase milk production and they created bioengineered forms, called recombinant bovine somatotropin (rbST) and recombinant bovine growth hormone, collectively referred to as rbST. The Monsanto company created an rbST that increased milk production and the company submitted a new animal drug application to the FDA. In November 1993, the FDA approved the new animal drug application providing for the subcutaneous use of rbST in lactating dairy cows for this purpose.83 The FDA explained that it approved the drug after determining that it was safe and effective for dairy cows, that rbST-treated milk was safe for humans, and that the process would not have a significant impact on the environment.84 The FDA and a panel of experts recruited by the National Institutes of Health concluded that there was no significant difference between milk from rbST-treated and untreated cows.85,86

Members of the public were nonetheless concerned for several reasons.87 First, Monsanto, the company that bioengineered rbST, was seen as exerting undue influence over the FDA, leading to theories of agency capture.88 Further, critics argued that milk treated with rbST contained increased levels of an insulin-like growth factor substance, which had been theorized to stimulate premature growth and cancer in humans. Moreover, opponents argued that rbST increased the need for antibiotics in treated cows and the antibiotics remained in the milk, leading to a concern about antibiotic-resistant bacteria. Some dairy farmers, private companies such as Ben & Jerry’s, and the State of Vermont wanted increased labeling requirements to allow consumers to distinguish between rbST-treated and untreated milk.89

The FDA argued that it did not have the authority to require mandatory labeling for milk from treated cows because it found rbST to be safe and the milk to be the same.90 The FDA did, however, issue guidance for industry members who want to voluntarily label milk and milk products as being derived from cows not treated with rbST. Thus, the FDA explained that in order for labels to avoid being misleading, they must “disclose facts that are material in light of representations made about a product or facts that are material with respect to the consequences that may result from use of the product.”91 Therefore, the agency suggested the proper label should include the following two phrases or similar sentiment: This product is made “from cows not treated with rbST” and “No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.”92 This guidance remains in effect today. The scientific debate surrounding rbST has died down for the most part, but food companies continue to distinguish their products through these labels.

Box 5.2 discusses The Case of Pink Slime.

a Michael Moss. Safety of Beef Processing Method Is Questioned. The New York Times. December 31, 2009. http://www.nytimes.com/2009/12/31/us/31meat.html?_r=2

b Michael Moss. Safety of Beef Processing Method Is Questioned. The New York Times. December 31, 2009. http://www.nytimes.com/2009/12/31/us/31meat.html?_r=2

c Michael Moss. Safety of Beef Processing Method Is Questioned. The New York Times. December 31, 2009. http://www.nytimes.com/2009/12/31/us/31meat.html?_r=2

d 21 CFR 184.1139.

e United States Department of Agriculture. USDA Announces Additional Choices for Beef Products in the Upcoming School Year. News Release No. 0094.12 . March 15, 2012. http://www.usda.gov/wps/portal/usda/usdamediafb?contentid=2012/03/0094.xml&printable=true&contentidonly=true

h Bettina Elias Siegel. How My ‘Pink Slime’ Petition Took Off. http://www.theguardian.com/commentisfree/cifamerica/2012/apr/06/pink-slime-rebellion-beef

i United States Department of Agriculture. USDA Announces Additional Choices for Beef Products in the Upcoming School Year. News Release No. 0094.12 . March 15, 2012. http://www.usda.gov/wps/portal/usda/usdamediafb?contentid=2012/03/0094.xml&printable=true&contentidonly=true

k Jim Avila. BPI Endorses USDA Voluntary Labeling of LFTB or ‘Pink Slime’ April 3, 2012. http://abcnews.go.com/blogs/headlines/2012/04/bpi-endorses-usda-voluntary-labeling-of-lftb-or-pink-slime/

l Martinne Geller. Ammonia Used in Many Foods, Not Just “Pink Slime.” Reuters. April 4, 2012. http://www.reuters.com/article/2012/04/04/us-food-ammonia-idUSBRE8331B420120404

Antibiotics in Meat

In the 1950s, the FDA approved the use of antibiotics in animal feed.93 Farmers and ranchers engaged in animal husbandry use antibiotics to treat sick animals, as a preventive measure, and to increase an animal’s weight gain beyond normal growth patterns. The use of antibiotics for nontreatment purposes is called subtherapeutic antibiotic use. Scientists inside and outside of the government have expressed concern about antibiotic resistance developing as a result of subtherapeutic antibiotic use in animals used for human food. The CDC defines antibiotic resistance as “the ability of bacteria or other microbes to resist the effects of an antibiotic.”94 This occurs when bacteria mutate in a way that reduces or eliminates the effectiveness of drugs designed to cure or prevent infections.95

In the 1970s, the FDA convened a Task Force to study subtherapeutic antibiotic use in animals. The Task Force found that this practice increased the prevalence of antibiotic resistance in humans and it recommended restrictions be placed on this practice.96 In response to this recommendation, the FDA stated that it would propose a new rule that would limit the use of medically important antibiotics (those that are used in humans) for animal feed.97 The FDA then proposed a regulation that would revoke the previously approved subtherapeutic uses of antibiotics in animal feed by the year 1975 “unless data are submitted which resolve conclusively the issues concerning their safety to man and animals and their effectiveness.”98 Pharmaceutical companies, agricultural groups, and Congress sought to dissuade the FDA from engaging in this rulemaking.99 The FDA stated that it would hold a hearing on the topic but, like the final rulemaking, this never came to fruition.

Countries in Europe, such as Sweden and Denmark, began banning antibiotics for nontherapeutic purposes in the 1980s and 1990s.100 In 2001, the European Union began phasing out the use of antibiotics in animals for nonmedical purposes and by 2006, the European Union completely banned the use of antibiotics used for growth promotion in animal feed.101 The United States has not acted in a similar manner.

Today, 80% of antibiotics used in the United States are given to livestock and poultry for nonmedical reasons to encourage faster growth.102,103 Based on the history discussed above and research indicating that bacteria that develop resistance to antibiotics used in animal feed can pose a risk to human health, public-interest groups have petitioned the FDA to hold hearings and prohibit the use of certain antibiotics in animal feed.104 The FDA initiated certain proceedings on this topic but changed course and decided to engage in a voluntary strategy “to promote the judicious use of medically important antimicrobial drugs in food animals.”105

Several groups sued the FDA to try to require the agency to proceed with hearings to determine whether to withdraw approval for the inclusion of penicillin and tetracyclines in animal feed for subtherapeutic purposes. In 2014, the federal Second Circuit Court of Appeals found for the FDA in the case Natural Resources Defense Council v. Food and Drug Administration, in a 2–1 decision. In this case, the two questions presented to the court were whether the relevant statute and its implementing regulations require the FDA to proceed with withdrawal hearings for the antibiotics in animal feed because the FDA previously found that those uses are not safe for humans,106 and second whether the FDA’s decision to terminate such hearings was discretionary and if so whether it was arbitrary or capricious.107

The court found that the statutory text and context, the regulations, and background legal principles led to the conclusion that Congress did not require the FDA to hold hearings just because FDA officials have scientific concerns about the safety of drug use in animals and that the FDA retains the discretion to institute or terminate proceedings and to withdraw its approval by issuing or withdrawing notice for hearings.108 The court explained that the FDA is only required to act to withdraw approval for the drugs after a hearing if the Secretary of HHS finds the drug is not shown to be safe.109 The court also accepted the FDA’s determination that its voluntary compliance program “offers greater prospect for immediate and significant reductions in animal antibiotic use than the pursuit of a potentially contentious withdrawal hearing.”110

The FDA states that its current strategy is to work with industry “to help phase out the use of medically important antimicrobials in food animals for production purposes (e.g., to enhance growth or improve feed efficiency), and to bring the therapeutic uses of such drugs (to treat, control, or prevent specific diseases) under the oversight of licensed veterinarians.”111 Medically important antimicrobials are those that are important for treating human disease. In December 2013, the FDA issued a nonbinding guidance document to industry to promote the “judicious use” of medically important antimicrobial drugs in food animals and proposed a three-year phase-in period of the voluntary strategy.112 In June 2014, the FDA announced that all 26 drug manufacturers affected by the guidance document “agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs.”113

Advocates argue that there are significant weaknesses in the FDA’s voluntary program.114 Several cited include (1) the program relies on voluntary compliance by drug companies and lacks a plan to address noncompliance; (2) the FDA will continue to allow livestock farmers to provide antibiotics to their entire herds and flocks through feed and water, for the purpose of preventing rather than treating infections; this will leave the use of antibiotics unabated under the banner of disease prevention instead of growth promotion; (3) the FDA relaxed the requirements for veterinary oversight by proposing to eliminate the federal framework and replace it with state-based veterinary licensing and practicing requirements; this would eliminate the federal requirement that veterinarians must see or examine the animal prior to directing livestock to receive antibiotics; and (4) the method the FDA will use to work with drug companies lacks transparency.115

President Obama issued an Executive Order on September 18, 2014, titled, Combating Antibiotic-Resistant Bacteria. He noted that the CDC estimates that approximately two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States annually and ordered the federal government to work domestically and internationally to address this problem in all facets of health.116 The Executive Order established the Task Force for Combating Antibiotic-Resistant Bacteria, to be co-chaired by the Secretaries of Defense, Agriculture, and HHS, and required them to submit a five-year National Action Plan to the President that outlines a National Strategy for Combating Antibiotic-Resistant Bacteria. Among other items, the Task Force agencies are ordered to analyze antibiotic resistance in all types of healthcare, emergency, and nursing care delivery facilities and develop new antibacterial drugs, diagnostics, vaccines, and novel therapeutics for both the public and agricultural sectors. Relevant to food policy, the FDA is instructed to coordinate with the USDA to “continue taking steps to eliminate the use of medically important classes of antibiotics for growth promotion purposes in food-producing animals.” Finally, the Executive Order states that the USDA, EPA, and FDA shall strengthen their coordination on this topic.

The use of antibiotics in animal feed is an ongoing issue and the subject of much continued debate.117,118,119 Congress members have introduced bills in both the House120 and the Senate121 to address the topic. It remains to be seen whether the FDA’s voluntary program can address the issue successfully.

State and Local Control

State and local governments sometimes attempt to regulate farming techniques in an effort to address food safety and other issues such as environmental concerns. Preemption can be a barrier to state and local governments acting in this manner. The federal laws discussed above may preempt states from enacting their own requirements and states have preempted local governments from addressing farming practices in their own communities. Three examples of state and local governments attempting to address animal production and farming practices are discussed in this section.

Concentrated Animal Feeding Operation Laws

The industrialization of farming in the 1970s led to the creation of Animal Feeding Operations (AFOs), which are production operations where animals are raised in confined spaces for 45 days or more in any 12-month period. In AFOs, animals do not graze but rather are fed and are kept in close proximity to other animals, to their urine and excrement, and to dead animals.122 A Concentrated Animal Feeding Operation (CAFO) is a type of AFO that meets additional criteria created by the EPA based on the number of animals and the facility’s contribution of pollutants.123 CAFOs tend to be industrial-scale productions. The EPA is the primary federal regulator of CAFOs and individual states have additional laws.

The National Association of Local Boards of Health issued a report noting that the increase in CAFOs has led to growing environmental problems in many communities.124 A great many of these problems stem from the fact that CAFOs have difficulty storing or managing the excess manure, which can negatively affect ground and surface water quality and create air pollution. There are pathogens on animal manure and emissions from degrading manure and other processes produce air pollutants, including ammonia, hydrogen sulfide, methane, particulate matter, and greenhouse gases; these can negatively affect air quality in the surrounding communities and contribute to climate change. Due to health and safety concerns, many local governments have tried to regulate CAFOs. One barrier has been that all 50 states have some form of a “right-to-farm” law, which provides legal protections to farmers if they abide by certain basic requirements determined by each state. As a consequence, local governments have had mixed results in their ability to regulate CAFOs within their communities. For example, Missouri does not preempt local public health regulations so a Linn County, Missouri permitting scheme for CAFOs was not preempted.125 However, a Fort Worth County, Iowa regulation that sought to address public health issues from CAFOs was found to be preempted by Iowa’s laws regulating land use for animal farms.126 Some states have created stricter or looser right-to-farm regulations in the face of CAFOs. This is largely in response to ongoing debates regarding whether to categorize and regulate CAFOs as agricultural or industrial uses, and whether stricter rules are necessary to protect the surrounding community or whether those rules could hurt farmers.127

Egg Farmer Law

The California legislature passed a law banning the sale of shelled eggs within California unless the producers or handlers abide by state requirements. The law mandates that egg farmers implement the salmonella prevention measures required by the FDA, implement a salmonella environmental monitoring program, and maintain a vaccination program.128 The California law additionally prohibits egg farmers from confining egg-laying hens in an enclosure that does not provide a minimum square inches of floor space per bird or allow them to stand up, lay down, or turn around freely.129 The California legislature’s intent in passing the law was “to protect California consumers from the deleterious, health, safety, and welfare effects of the sale and consumption of eggs derived from egg-laying hens that are exposed to significant stress and may result in increased exposure to disease pathogens including salmonella.”130 The law went into effect in January 2015. Several states with egg farmers who sell their eggs in California sued California to prevent enforcement of the law, arguing that it violated the Commerce Clause and was preempted by the Federal Egg Products Inspection Act. The case was dismissed on procedural grounds (discussed in Chapter 8) so the court did not analyze the substantive claims. It remains to be seen whether other plaintiffs will be able to challenge the state law successfully based on these or other substantive legal arguments.

Genetic Engineering Law

Maui County, Hawaii passed an ordinance through a ballot referendum in November 2014 that placed a moratorium on the knowing propagation, cultivation, raising, growing, or testing of genetically engineered (GE) organisms within the County of Maui. The moratorium can only be amended or repealed by the Maui County Council by two-thirds vote.131 The purpose of the law was to address the finding that the GE operations and practices that occur in Maui County are unique, and therefore, “pose different circumstances, risks, and concerns” than GE food production farming because they include “the cultivation of GE seed crops, experimental GE test crops, and extensive pesticide use including the testing of experimental pesticides.”132 The text of the law states that these practices may be “causing irreparable harm to the people, Environment, and Public Trust Resources.”133 Agricultural organizations, including Monsanto, sued Maui County to enjoin the operation of the law. The plaintiffs argued that the moratorium will harm the local economy, especially local farmers, and will harm the seed companies that rely on the unique climate of Maui to breed seeds. The plaintiffs filed a lawsuit arguing that the law violates the regulatory schemes enacted by the USDA, FDA, EPA, and the State of Hawaii for genetically engineered organisms and is thus preempted by federal and state law. Further it argues that the law violates the Commerce Clause and that the Maui Charter does not permit it to exact penalties.134 In March 2015, the court enjoined Maui County from enforcing the ordinance until the court ruled on the merits of the dispute, which is expected later in 2015.135

Given the extensive federal framework for agricultural safety issues, states have had a more difficult time addressing concerns within their communities in this context than in other areas of food policy. Chapter 9 discusses numerous state and local opportunities to address the modern food environment in other ways.

Questions and Exercises for Classroom Discussion

Consider the FSMA’s requirement to designate certain foods as high-risk. Food companies do not want their foods to qualify as high-risk. Review a food company and a food trade organization’s response to the FDA’s request for comments on Regulations.gov: http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=FDA-2014-N-0053;refD=FDA-2014-N-0053-0003. What methods does the food industry use to criticize the requirement? Do you agree? What do you think of the requirement in the first place?

What should the FDA’s GRAS rule permit in terms of a company’s ability to self-declare an ingredient to be GRAS? Should the FDA be required to undertake the formal GRAS rulemaking? Why or why not?

The Pink Slime case is one where an effort to address safety issues led to what might just be considered a disgusting product. When is something just unseemly and when is it unsafe? Do you trust the government to make that distinction? Would any other entity be better to make that determination?

What is the most pressing food safety issue today? Is the government addressing it appropriately? Why or why not? What have other countries done? Should other countries’ responses have an impact on how the United States responds to food safety concerns?

Section 105 of the Animal Drug User Fee Amendments of 2008 requires antimicrobial drug sponsors to report to the FDA the amount of antimicrobial drugs they sell or distribute for use in food-producing animals on an annual basis. (Note that these sales and distribution data do not directly correlate to actual use.) The FDA publishes yearly reports summarizing this data. The report for 2013, the year before the FDA implemented its judicial use strategy, shows increasing sales of antimicrobials, including those that are considered medically important.136 Look up the report for the current year, compare it to years past, and analyze whether the FDA’s judicial use strategy is working. What could the FDA do to improve the outcome?

Notes:

1 John P. Swann. FDA’s Origin. Food and Drug Administration History Office. http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm

2 Amanda Foreman. A Brief History of Media Muckraking. The Wall Street Journal. July 25, 2014. http://www.wsj.com/articles/a-brief-history-of-media-muckraking-1406330669

3 Upton Sinclair. Dedication. The Jungle. New York, NY: Airmont Publishing Company, Inc.; 1965.

4 Roger I. Roots. A Muckraker’s Aftermath: The Jungle of Meat-packing Regulation after a Century, William Mitchell Law Review. 2001;27(4): Article 1.

5 Food and Drug Administration. Regulatory Information. Federal Food and Drugs Act of 1906. http://www.fda.gov/RegulatoryInformation/Legislation/ucm148690.htm

7 Food and Drug Administration. FDA Organizational Histories. http://www.fda.gov/AboutFDA/WhatWeDo/History/FOrgsHistory/default.htm.

8 Food and Drug Administration. FDA Basics. What does FDA do? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm

9 21 USCS § 321(f).

10 21 USC § 342.

11 Neal Fortin. Food Regulation: Law, Science, Policy, and Practice. Hoboken, NJ: John Wiley & Sons, Inc.;2009, p. 39.

12 Neal Fortin. Food Regulation: Law, Science, Policy, and Practice. Hoboken, NJ: John Wiley & Sons, Inc.;2009, pp. 39–40.

13 Environmental Protection Agency. Agriculture. Food Safety. March 13, 2013. http://www.epa.gov/agriculture/tfsy.html#pesticideinfood

14 Environmental Protection Agency. Pesticides: Topical & Chemical Fact Sheets. The EPA and Food Security. May 2012. http://www.epa.gov/pesticides/factsheets/securty.htm

15 Environmental Protection Agency. Pesticides: Topical & Chemical Fact Sheets. The EPA and Food Security. May 2012. http://www.epa.gov/pesticides/factsheets/securty.htm

16 United States Department of Agriculture. Quick Facts about the Pesticide Data Program (PDP). http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3003252

17 National Association of County and City Health Officials. Local Health Department Roles in Food Safety: Backgrounder. http://www.naccho.org/topics/environmental/foodsafety/upload/Local-Health-Department-Roles-in-Food-Safety-2-5.pdf

18 National Association of County and City Health Officials. 2013 National Profile of Local Health Departments. (Downloaded from NACCHO website).

19 National Association of County and City Health Officials. 2013 National Profile of Local Health Departments. (Downloaded from NACCHO website).

20 National Association of County and City Health Officials. Local Health Department Roles in Food Safety: Backgrounder. http://www.naccho.org/topics/environmental/foodsafety/upload/Local-Health-Department-Roles-in-Food-Safety-2-5.pdf

21 21 USC 2202.

22 21 USC 2204.

23 21 USC 2223.

24 Food and Drug Administration Background on Food Safety Modernization Act. FSMA FACTS. July 12, 2011.

25 21 USC 2223.

26 Federal Register / Vol. 79, No. 23, pages 6596-6598 (February 4, 2014).

27 Federal Register / Vol. 79, No. 23, pages 6596-6598 (February 4, 2014).

28 Food and Drug Administration Background on Food Safety Modernization Act. FSMA FACTS. July 12, 2011.

29 Food and Drug Administration Background on Food Safety Modernization Act. FSMA FACTS. July 12, 2011.

30 Centers for Disease Control and Prevention. Foodborne Outbreak Tracking and Reporting. Fast Facts and FAQs. April 24, 2014. http://www.cdc.gov/foodsafety/fdoss/faq/index.html

31 FoodSafety.gov. How Government Responds to Food Illness Outbreaks. http://www.foodsafety.gov/poisoning/responds/

32 21 USC 2224.

33 Centers for Disease Control and Prevention. Foodborne Outbreaks. Guide to Confirming a Diagnosis in Foodborne Disease. November 13, 2013. http://www.cdc.gov/foodsafety/outbreaks/investigating-outbreaks/confirming_diagnosis.html

34 Centers for Disease Control and Prevention. CDC and the Food Safety Modernization Act. September 16, 2013 http://www.cdc.gov/foodsafety/fsma.html#section399

35 Food and Drug Administration Background on Food Safety Modernization Act. FSMA FACTS. July 12, 2011.

36 21 USC 2224.

37 21 USC 2223.

38 United States Department of Agriculture Food Safety and Inspection Service. Factbook. Chapter 9. http://www.usda.gov/factbook/chapter9.htm

40 United States Department of Agriculture. http://www.usda.gov/factbook/chapter9.htm

41 Food and Drug Administration Background on Food Safety Modernization Act. FSMA FACTS. July 12, 2011.

42 Food and Drug Administration. Press Announcement. FDA: U.S. Marshals Seize Foods Stored at Washington State Facility. October 11, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm275204.htm

43 21 USCS § 321(q)(q)(1).

44 Centers for Disease Control and Prevention. Food Allergies in Schools. October 31, 2013. http://www.cdc.gov/healthyyouth/foodallergies/index.htm

45 21 USC 2205.

46 Centers for Disease Control and Prevention. Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs. http://www.cdc.gov/healthyyouth/foodallergies/pdf/13_243135_A_Food_Allergy_Web_508.pdf

47 21 CFR 170.3.

48 21 CFR 570.30.

49 Food and Drug Administration. Determining the Regulatory Status of a Food Ingredient. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm228269.htm

50 21 CFR 170.30

51 21 CFR 170.30

52 21 CFR 170.30

53 18938 Federal Register. 1997;62(74). Proposed Rules.

54 White House Conference on Food Nutrition and Health. Final Report. Remarks of the President at the Open Plenary Session on the White House Conference on Food Nutrition and Health. Sheraton Park Hotel. December 2, 1969. www.nns.nih.gov/1969/full_report/White_House_Report2_S1a.pdf

55 62 Federal Register 18938, 18939 (April 17, 1997).

56 62 Federal Register 18938, 18939 (April 17, 1997).

57 Food and Drug Administration. History of the GRAS List and SCOGS Reviews. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm084142.htm

58 Food and Drug Administration. History of the GRAS List and SCOGS Reviews. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm084142.htm

59 18938 Federal Register. 1997;62(74).Proposed Rules.

60 18938 Federal Register. 1997;62(74)Proposed Rules.

61 U.S. Government Accountability Office. FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). GAO-10-246: Published: February 3, 2010. Publicly Released: March 5, 2010.

62 18938 Federal Register. 1997;62(74). Proposed Rules.

63 Center for Food Safety v. Sebelius et al. Case No. 1:14-cv-267-RC. Complaint (D. DC March 13, 2014). http://www.centerforfoodsafety.org/files/2014-3-13-dkt-8--pls--am-compl_76904.pdf

64 Center for Food Safety. Victory! CFS Wins First Step in Major Legal Battle to Protect Food Safety. October 20, 2014. http://www.centerforfoodsafety.org/press-releases/3550/victory-cfs-wins-first-step-in-major-legal-battle-to-protect-food-safety#

65 21 CFR 570.38.

66 K. D. Brownell, J. L. Pomeranz. The Trans Fat Ban—Food Regulation and Long-Term Health. New England Journal of Medicine. 2014;370:1773–1775.

67 21 CFR 101.9(c)(2)(ii).

68 78 Federal Register 67169 (November 8, 2013).

69 78 Federal Register 67169 (November 8, 2013).

70 78 Federal Register 67169 (November 8, 2013).

71 Docket ID: FDA-2013-N-1317. Regulations.gov. http://www.regulations.gov/#!docketDetail; D=FDA-2013-N-1317

72 21 CFR 70.3(f).

73 Food and Drug Administration. Overview of Food Ingredients, Additives & Colors. April 2010. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm094211.htm

74 21 CFR 70.3(i).

75 21 CFR 70.50.

76 Food and Drug Administration. For Consumers. How Safe are Color Additives? December 10, 2007. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048951.htm

77 U.S. Government Printing Office. Electronic Code of Federal Regulations. Title 21, Chapter I, Subchapter A, Part 74. e-CFR Data is current as of December 23, 2014. http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=3f6c9146ba54b1b84f17046e27197926&tpl=/ecfrbrowse/Title21/21cfr74_main_02.tpl

78 Food and Drug Administration. For Industry. Color Additive Status List. List 4. December 2009. http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm106626.htm

79 21 CFR 73.169.

80 21 CFR 101.22(a)(4).

81 21 CFR 101.22(k).

82 Food and Drug Administration. Overview of Food Ingredients, Additives & Colors. April 2010. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm094211.htm

83 Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism. Berkeley and Los Angeles, CA: University of California Press, 2003, p. 197.

84 59 Federal Register 6279, 6279–6280 (February 17, 1994).

85 59 Federal Register 6279, 6280 (February 17, 1994).

86 Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism. Berkeley and Los Angeles, CA: University of California Press, 2003, p. 199.

87 Marion Nestle. Safe Food: Bacteria, Biotechnology, and Bioterrorism. Berkeley and Los Angeles, CA: University of California Press, 2003, pp. 197–206.

88 Agency capture, or regulatory capture, is theory that explains what happens when a regulatory agency acts in ways that benefit the industry it is supposed to be regulating, rather than the public’s interest it is supposed to be protecting. Agency staff members are thus “captured by those they are ostensibly regulating.” Clifford Rechtschaffen. Deterrence v. Cooperation and the Evolving Theory of Environmental Enforcement. 71 S. Cal. L. Rev. 1181, 1222 (1998).

89 Marion Nestle. Safe Food: Bacteria, Biotechonology, and Bioterrorism. Berkeley and Los Angeles, CA: University of California Press, 2003, pp. 202–204.

90 59 Federal Register 6279, 6280 (February 17, 1994).

91 59 Federal Register 6279, 6280 (February 17, 1994).

92 59 Federal Register 6279, 6280 (February 17, 1994).

93 NRDC, Inc. v. United States FDA, 760 F.3d 151, 153 (2nd Cir. 2014).

94 Centers for Disease Control and Prevention. Antibiotic Resistance Questions & Answers http://www.cdc.gov/getsmart/antibiotic-use/antibiotic-resistance-faqs.html#define-antibiotic-resistance

95 Centers for Disease Control and Prevention. Antibiotic Resistance Questions & Answers http://www.cdc.gov/getsmart/antibiotic-use/antibiotic-resistance-faqs.html#define-antibiotic-resistance

96 37 Federal Register 2444 (February 1, 1972).

97 37 Federal Register 2444 (February 1, 1972)..

98 21 CFR 558.15.

99 Diana R. H. Winters. Intractable Delay and the Need to Amend the Petition Provisions of the FDCA (March 3, 2014). Indiana Law Journal 2015; 90: 1047. Indiana University Robert H. McKinney School of Law Research Paper No. 2014-8. Available at SSRN: http://ssrn.com/abstract=2412662

100 Carol Cogliani, Herman Goossens, and Christina Greko. Restricting Antimicrobial Use in Food Animals: Lessons from Europe. Microbe. 2011;6: 274–279.

101 European Food Safety Authority. Antimicrobial Resistance http://www.efsa.europa.eu/en/topics/topic/amr.htm

102 NRDC, Inc. v. United States FDA, 760 F.3d 151, 153 (2nd Cir. 2014).

103 National Resources Defense Council. Food Farm Animals and Drugs. http://www.nrdc.org/food/saving-antibiotics.asp

104 NRDC, Inc. v. United States FDA, 760 F.3d 151, 153 (2nd Cir. 2014).

105 Food and Drug Administration. Animal & Veterinary FDA’s Strategy on Antimicrobial Resistance—Questions and Answers. March 28, 2014. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm

106 Food and Drug Administration. Animal & Veterinary FDA’s Strategy on Antimicrobial Resistance—Questions and Answers. March 28, 2014. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm at 157–158.

107 Food and Drug Administration. Animal & Veterinary FDA’s Strategy on Antimicrobial Resistance—Questions and Answers. March 28, 2014. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm at 175.

108 Food and Drug Administration. Animal & Veterinary FDA’s Strategy on Antimicrobial Resistance—Questions and Answers. March 28, 2014. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm at 171–172.

109 Food and Drug Administration. Animal & Veterinary FDA’s Strategy on Antimicrobial Resistance—Questions and Answers. March 28, 2014. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm at 172.

110 Food and Drug Administration. Animal & Veterinary FDA’s Strategy on Antimicrobial Resistance—Questions and Answers. March 28, 2014. http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm at 172.

112 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Guidance #213). December 2013. http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf

113 FDA Secures Full Industry Engagement on Antimicrobial Resistance Strategy. June 30, 2014. http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm403285.htm

114 Diana R. H. Winters. The inadequacy of voluntary measures to reduce the use of antimicrobials in animal feed. Petrie Flom Center Harvard Law School. October 4, 2014. http://blogs.law.harvard.edu/billofhealth/2014/10/04/the-inadequacy-of-voluntary-measures-to-reduce-the-use-of-antimicrobials-in-animal-feed/#more-12972

115 Lisa Heinzerling. The FDA’s Continuing Incapacity on Livestock Antibiotics. Stanford Environmental Law Journal. 2014;33(3): 325–350.

116 Executive Order. Combating Antibiotic-Resistant Bacteria. September 18, 2014. http://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating- antibiotic-resistant-bacteria

117 Duff Wilson and Mimi Dwyer. Veterinarians Face Conflicting Allegiances to Animals, Farmers—and Drug Companies. Dec. 23, 2014, http://www.reuters.com/investigates/special-report/farmaceuticals-the-drugs-fed-to-farm-animals-and-the-risks-posed-to-humans/

118 Public Broadcasting System. Frontline. Modern Meat. Is Your Meat Safe? Antibiotic Debate Overview. http://www.pbs.org/wgbh/pages/frontline/shows/meat/safe/overview.html

119 Ruth Reichl. The FDA’s Blatant Failure on Food. July 30, 2014 http://www.nytimes.com/2014/07/31/opinion/the-fda-blatant-failure-on-food.html?emc=eta1

120 HR1150: Preservation of Antibiotics for Medical Treatment Act of 2013 (introduced March 14, 2013).

121 S 1256: Preventing Antibiotic Resistance Act of 2013 (introduced June 27, 2013).

122 Environmental Protection Agency. What is a CAFO? http://www.epa.gov/rgytgrnj/water/cafo/index.htm

123 Environmental Protection Agency. Animal Feeding Operations Overview. http://water.epa.gov/polwaste/npdes/afo/index.cfm

124 Carrie Hribar. National Association of Local Boards of Health. Understanding Concentrated Animal Feeding Operations and Their Impact on Communities. 2010. Mark Schultz, Ed..

125 Borron v. Farrenkopf, 5 S.W.3d 618 (Court of Appeals of Missouri, Western District 1999).

126 Worth County Friends of Agriculture. v. Worth County, 688 N.W.2d 257 (Iowa 2004).

127 Tom Henry. Stricter rules for agriculture debated. Toledo Blade. August 31, 2014. http://www.toledoblade.com/local/2014/08/31/Stricter-rules-for-agriculture-debated.html

128 Missouri v. Harris, 2014 U.S. Dist. LEXIS 141337, *14 (E.D. CA 2014).

129 Missouri v. Harris, 2014 U.S. Dist. LEXIS 141337, *15 (E.D. CA 2014).

130 Missouri v. Harris, 2014 U.S. Dist. LEXIS 141337, *16 (E.D. CA 2014) (quoting Cal. Health & Safety Code § 25995).

131 Chapter 20.39 of the Maui County Code. Moratorium on the Cultivation of Genetically Engineered Organisms. Sec. 5 and Sec. 6. http://www.shakamovement.org/law/

132 A Bill Placing a Moratorium on the Cultivation of Genetically Engineered Organisms. http://www.shakamovement.org/law/

133 A Bill Placing a Moratorium on the Cultivation of Genetically Engineered Organisms. http://www.shakamovement.org/law/

135 Robert Ito Farm, Inc v. County of Maui, 2015 U.S. Dist. LEXIS 34519 (D. Haw. March 19, 2015).

136 Food and Drug Administration. 2013 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. April 2015. http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM440584.pdf