Best if printed in landscape.

History of US Food Law

This is the first section of SAFE 408/608. It begins with an overview of the history of U.S. food laws. This overview provides a foundation for understanding how and why the current laws evolved, as well as providing a sense of the direction of future food laws.

This is a long section but even a "quick read" will provide some background on how food law has evolved in the past 150 years.

Excerpts from:

Milestones in U.S. Food and Drug Law History

http://www.fda.gov/opacom/backgrounders/miles.html

This web page is based on a web page prepared by the Food Drug Administration of the U.S. government (the URL for the FDA page appears above). The FDA page is reproduced here but without the events that relate to the development of drug laws. The purpose of this page is to focus on events that primarily relate to U.S. food law.

In developing this page, commentary notes (designated as Note, italicized and indented) and information from other agency web pages have been inserted to emphasize particular events or conceptual points, and to indicate other events relating to food law.

From the beginnings of civilization, people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times ... The following chronology describes some of the milestones in the history of food ... regulation in the United States.

1862

President Lincoln appoints a chemist, Charles M. Wetherill, to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration.

Note: "In 1865, USDA Secretary Isaac Newton urged Congress to enact legislation providing for the quarantine of imported animals. The Act was passed, but jurisdiction was given to the Treasury Department. Little preventive action was taken, and imported animals continued to bring in disease. Individual states attempted to control or eradicate livestock diseases, but they were ineffective as the efforts were spasmodic. Also, states resented quarantines set by other states. Livestock owners and veterinarians were urging a national approach to meat processing." See FSIS Agency History.

The previous comment suggests the practical issues that arise when interstate commerce (business conducted in several states) is attempted to be regulated at the state level.

1880

Peter Collier, chief chemist, U.S. Department of Agriculture, recommends passage of a national food and drug law, following his own food adulteration investigations. The bill was defeated, but during the next 25 years more than 100 food and drug bills were introduced in Congress.

Note: the federal agencies (in the executive branch of government), such as the U.S. Department of Agriculture (USDA), can do nothing to directly regulate the food industry until Congress (the legislative branch of government) authorizes the agency to do so. And this is still true today because this is the type of government our ancestors established when they adopted the U.S. Constitution in the late 1700s. Without Congressional authorization, the only step government agency personnel can take is to recommend that Congress address a problem.

Generally, Congress addresses a problem by enacting a statutory law that authorizes an agency to assume specific oversight or regulatory responsibilities. However, Congress (which consists of our elected representatives) is unlikely to enact a law unless the Congressional members perceive the situation to be a problem the federal government needs to address. Thus the political process of influencing Congressional members (such as lobbying) also has a role in the decision making process.

Apparently none of these more than 100 bills were enacted by Congress during those 25 years.

Also note the mention of "food adulteration;" adulterated food (as will become clear in later materials) is still a fundamental concept in U.S. food law.

1883

Dr. Harvey W. Wiley becomes chief chemist, expanding the Bureau of Chemistry's food adulteration studies. Campaigning for a federal law, Dr. Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Act." He retired from government service in 1912 and died in 1930.

Note: the USDA Bureau of Animal Industry (forerunner to the USDA Food Safety and Inspection Service (FSIS)) was established in 1884 to prevent diseased animals from being used as food. See FSIS Agency History.

Note: The original livestock and meat inspection acts (1890 and 1891) addressed only meat and animals that were being exported. These limited steps were taken in response to U.S. producers and packers urging the government to implement an inspection program that would enable them to compete in foreign trade. See FSIS Agency History.

Note: the impact of economic pressures on the political process and resulting laws.

1897

Tea Importation Act passed, providing for Customs inspection of all tea entering U.S. ports, at the expense of the importers.

Note: the cost of the government inspection was paid for by the business being inspected. This practice is still followed for some food inspections (e.g., meat and poultry inspections).

1898

Association of Official Agricultural Chemists (now AOAC International) establishes a Committee on Food Standards headed by Dr. Wiley. States begin incorporating these standards into their food statutes.

Note: this entry mentions 1) the involvement of state government (that is, some state legislatures were enacting laws to address problems that Congress was not addressing), 2) the guidance and influence of a non-government organization, and 3) the absence of federal law.

For example, review the History of the Minnesota Department of Agriculture.

1902

Congress appropriates $5,000 to the Bureau of Chemistry to study chemical preservatives and colors and their effects on digestion and health. Dr. Wiley's studies draw widespread attention to the problem of food adulteration. Public support for passage of a federal food and drug law grows.

1906

The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.

The Meat Inspection Act is passed the same day.

Note: these first federal Acts addressing food safety prohibit "misbranded" and "adulterated" foods; two concepts that remain the foundation for U.S. food law. Also note the reference to "interstate commerce;" although it is considered a limitation to federal law (that is, federal law applies only to food in interstate commerce), the definition of interstate commerce is so broad, and our food industry is so intertwined among businesses and locations that there is little food in the U.S. that is not subject to federal law.

The distinctions, similarities and relationship between the Food and Drugs Act and the Meat Inspection Act will be addressed throughout our studies. An initial distinction is that today the Food and Drugs Act and its successive laws are primarily administered by the Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services (HHS), whereas the Meat Inspection Act and associated laws are primarily administered by the Food Safety and Inspection Service (FSIS) of the USDA.

Because Congress responded to the problem of food safety after some states had begun to address the concern, states were forced to review and revise their state laws to assure they were consistent with the federal law. The need for the states to align their laws with federal law is due to another feature of our structure of government as set forth in the U.S. Constitution; that is, federal law prevails over or preempts state law. If there is a conflict between a federal law and a state law, the federal law prevails (unless Congress has stated that the state law can conflict with the federal law). Federal preemption remains a characteristic of the U.S. form of government.

A benefit of federal regulation and preemption, though, is that businesses involved in interstate commerce have a more consistent set of legal standards or expectations that need to be met, thus making it easier to conduct business in several states..

Despite the involvement of federal government, state and some local governments (such as major cities) remain involved in food safety regulation. This situation of having various levels of government providing oversight has evolved into a complex, but generally well-organized system in which questions of government responsibility and authority are understood.

Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, … were the major problems leading to the enactment of these laws.

Note: Upton Sinclair's novel "The Jungle" (published in 1905) is often identified as one of the documents describing the unsanitary conditions that led to the Congressional action in 1906.

These events illustrate another characteristic of U.S. federal law; Congress generally does not address a situation until it has reached the level of being a problem. Accordingly, some commentators describe the U.S. government as reactionary, rather than pro-active, in addressing problems -- a characteristic that generally describes the evolution of U.S. food law.

One distinction between these two 1906 laws is that under the Meat Inspection Act, government inspectors must be present at all times that the meat processing plant is in operation and that each product item is inspected by a government authority, whereas under the Food and Drugs Act, other food businesses (and their products) are subject only to periodic government inspections. This distinction continues today.

1907

First Certified Color Regulations, requested by manufacturers and users, list seven colors found suitable for use in foods.

Note: this is an example of an issue relating to the adulteration of food.

Note: Starting in 1912, BAI (USDA) inspected eggs for the Navy, long before USDA inspected them for the market and the public. See FSIS Agency History.

1913

Gould Amendment requires that food package contents be "plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count."

Note: this is an example of an issue relating to the misbranding of food.

1914

In U.S. v. Lexington Mill and Elevator Company, the Supreme Court issues its first ruling on food additives. It ruled that in order for bleached flour with nitrite residues to be banned from foods, the government must show a relationship between the chemical additive and the harm it allegedly caused in humans. The court also noted that the mere presence of such an ingredient was not sufficient to render the food illegal.

Note: the burden was on the government to demonstrate that the food was unsafe; that is, food businesses were not required to establish that the food was safe. Watch -- does this expectation change over time to where a substance has to be recognized as safe before it can be used?

1924

In U.S. v. 95 Barrels Alleged Apple Cider Vinegar, the Supreme Court rules that the Food and Drugs Act condemns every statement, design, or device on a product's label that may mislead or deceive, even if technically true.

Note the broad definition of misbranding.

Note: International agreement was reached creating the Office International des Epizooties (OIE) based in Paris; see Short history of the OIE and Objectives. The purpose of the agreement was to encourage a common international approach to controlling animal diseases, and to safeguard world trade by publishing health standards for international trade in animals and animal products

1930

McNary-Mapes Amendment authorizes FDA standards of quality and fill-of-container for canned food, excluding meat and milk products.

Note: the exclusion of meat and milk products illustrate that another agency, such as USDA, has regulatory oversight for certain foods. This exclusion reflects the distinction that Congress created by enacting the two major pieces of legislation in 1906.

The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an agricultural appropriations act.

Note: FDA was still part of USDA at this time.

1933

FDA recommends a complete revision of the obsolete 1906 Food and Drugs Act. The first bill is introduced into the Senate, launching a five-year legislative battle.

1937

Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

1938

The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions:

• Providing that safe tolerances be set for unavoidable poisonous substances.
• Authorizing standards of identity, quality, and fill-of-container for foods.
• Authorizing factory inspections.
• Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.

Note that again Congress responds after the situation has become a problem.

Under the Wheeler-Lea Act, the Federal Trade Commission is charged with overseeing advertising associated with products otherwise regulated by FDA, with the exception of prescription drugs.

Note that the prohibition against misbranding is being applied to advertising as well as package labelling. The Federal Trade Commission (FTC) is now included in regulating certain food issues; that is, food advertising.

1939

First Food Standards issued (canned tomatoes, tomato purée, and tomato paste).

1940

FDA transferred from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.

1948

Miller Amendment affirms that the Federal Food, Drug, and Cosmetic Act applies to goods regulated by the Agency that have been transported from one state to another and have reached the consumer.

1949

FDA publishes guidance to industry for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."

1950

Oleomargarine Act requires prominent labeling of colored oleomargarine, to distinguish it from butter.

Note: the political clout of the dairy industry led to laws imposing some interesting prohibitions and limitations on a competing product, that is, margarine. Were these laws based on concerns for the safety of consumers or the economic well-being of the dairy industry? To what extent do economic interests drive the lobbying that influences the decisions of our elected officials? Will economic considerations also arise in later years as nations negotiate agreements directing the international trade of food? Are all discussions about the safety of food really focused on concern about consumers, or is food safety sometimes used as a disguise to hide economic interests?

Delaney Committee starts congressional investigation of the safety of chemicals in foods and cosmetics, laying the foundation for the 1954 Miller Pesticide Amendment, the 1958 Food Additives Amendment, and the 1960 Color Additive Amendment.

Note: International Plant Protection Convention was created in 1951; it is an international treaty relating to plant health. Restated, it is an international treaty to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control (International Standards for Phytosanitary Measures [ISPMs]). See web site for the International Plant Protection Convention.

1953

Factory Inspection Amendment clarifies previous law and requires FDA to give manufacturers written reports of conditions observed during inspections and analyses of factory samples.

Recall that FDA conducts periodic inspections of food businesses, rather than the continuous inspection that USDA is required to provide at meat processing plants.

1954

Miller Pesticide Amendment spells out procedures for setting safety limits for pesticide residues on raw agricultural commodities.

Note: although much of FDA's regulations address food manufacturers and food processing, it is recognized that food proceeds through a chain of events before it reaches the consumer. For example, a food product involves the production of agriculture commodities, processing of commodities into food products, transporting and storing the food, displaying and selling the food, and final preparation of the food. A food product could become unsafe at any point in this chain of events but the danger may not be obvious until the consumer becomes ill. This amendment begins to illustrate that food safety needs to be addressed from "farm-to-fork" -- a concept that will receive more attention in the 1990s.

Note: FDA was organized into five Bureaus in 1954, including a Bureau of Medicine (BVM); the Veterinary Medical Branch was created within this Bureau. The Branch's primary function was to determine the safety of animal drugs, both for animals and for consumers of food derived from treated animals.

First large-scale radiological examination of food carried out by FDA when it received reports that tuna suspected of being radioactive was being imported from Japan following atomic blasts in the Pacific. FDA begins monitoring around the clock to meet the emergency.

Note: Poultry Products Inspection Act (PPIA) was enacted in 1957 in response to the rapidly expanding market for dressed, ready-to-cook poultry and processed poultry products. See FSIS Agency History. The PPIA authorized USDA to inspect "all poultry products sold in interstate commerce, and [reinspect] imported products to ensure that they meet U.S. food safety standards. See http://www.fsis.usda.gov/regulations_&_policies/Acts_&_Authorizing_Statutes/index.asp.

1958

Food Additives Amendment enacted, requiring manufacturers of new food additives to establish safety.

Note: This amendment was in response to the public's concern about invisible hazards from chemicals added directly or indirectly to foods. The amendment was intended to deal with the safety of ingredients used in processed foods, including animal drug residues in meat and poultry products. See FSIS Agency History.

Note: was this amendment a reversal of the legal position taken in the 1914 decision in U.S. v. Lexington Mill and Elevator Company?

The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals.

Note: the Delaney Clause addressed carcinogens. The basic rule was that a substance cannot be added to food in detectable quantities if the substance is shown to cause cancer in test animals. Implementing this standard became more onerous during the following decades as analytical technologies advanced so that significantly smaller quantities can now be detected.

FDA publishes in the Federal Register the first list of substances generally recognized as safe (GRAS). The list contains nearly 200 substances.

1959

U.S. cranberry crop recalled three weeks before Thanksgiving for FDA tests to check for aminotriazole, a weedkiller found to cause cancer in laboratory animals. Cleared berries were allowed a label stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by FDA on a food product.

1960

Color Additive Amendment enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics.

Note: This amendment addressed the concern that some colors additives are likely to lead to allergic reactions when consumed.

Note: the question has to be asked again -- has the "table turned?" Are food businesses now required to prove the safety of a substance, rather than government having to prove that a substance is unsafe? Compare this entry to the entry for 1914.

The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.

1962

Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard.

Note: the consumers will decide what they want to consume -- not government. But consumers must have accurate information about the product to make an informed decision. This principle reiterates the broad definition of misbranding and reiterates that consumers will not be regulated. We will see in subsequent years that the focus will be on educating consumers so they are prepared to make informed decisions.

Note: in 1963 the Codex Alimentarius was initiated; see http://www.codexalimentarius.net/web/index_en.jsp; this is an international effort to address food safety.

"The Codex Alimentarius Commission was created in 1963 by FAO [Food and Agriculture Organization] and WHO [World Health Organization] to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations."

Will the international standards follow the lead of one nation, or will the standards reflect the "best" ideas from a variety of nations?

Although compliance with Codex standards is voluntary, nations have an economic incentive to comply if their international trading partners demand compliance. As nations decide to comply with international standards, will national laws (such as federal law in the United States) need to be reviewed and revised to assure they are consistent with international standards? Will state and local food laws also need to be reviewed and revised to assure they comply with the federal laws that now reflect international standards? See the note following the 1906 entry.

1966

Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods ...

Note: this law requires food processors/manufacturers to list ingredients on label by prominence (weight or volume) in product.

Note: Under the Wholesome Meat Act of 1967, States were to conduct an adequate inspection of the nation's meat. See FSIS Agency History.

1968

Animal Drug Amendments place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act-Section 512-making approval of animal drugs and medicated feeds more efficient.

Note: "These amendments were designed to ensure that animal drugs are safe and effective for their intended uses and that they do not result in unsafe residues in foods."

1969

FDA begins administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents. These responsibilities were transferred from other units of the Public Health Service.

The White House Conference on Food, Nutrition, and Health recommends systematic review of GRAS substances in light of FDA's ban of the artificial sweetener cyclamate. President Nixon orders FDA to review its GRAS list.

1970

Environmental Protection Agency established; takes over FDA program for setting pesticide tolerances.

Note: another federal agency (EPA) has been added to the food regulatory scheme. Again, attention is being given to the safety of agricultural commodities; that is, the concept of "farm-to-fork."

Egg Products Inspection Act authorized USDA to "[inspect] egg products sold in interstate commerce, and [reinspect] imported products to ensure that they meet U.S. food safety standards. In egg processing plants, inspection involves examining, before and after breaking, eggs intended for further processing and use as food." See http://www.fsis.usda.gov/regulations_&_policies/Acts_&_Authorizing_Statutes/index.asp.

1973

Low-acid food processing regulations issued, after botulism outbreaks from canned foods, to ensure that low-acid packaged foods have adequate heat treatment and are not hazardous.

Note: government reacting to a problem.

1976

Vitamins and Minerals Amendments ("Proxmire Amendments") stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.

Note: Congress limited FDA's authority to regulate the maximum level of "fortification" in food products; FDA is authorized to determine the "safe level" but industry decides how much it wants to add within the safe level.  Thus FDA cannot prohibit the sale of a supplement that provides more nutrients than the consumer needs as long as the level of the supplement is not injurious to the consumer.

1980

Infant Formula Act establishes special FDA controls to ensure necessary nutritional content and safety.

Note: government reacting to a problem. The regulation of infant formula is unique in that the regulations address the nutritional content of the product. The nutritional content of most foods is not regulated.

Note: the USDA Food Safety and Quality Service (FSQS) was redesignated as the USDA Food Safety and Inspection Service (FSIS) in 1981. FSIS would be responsible for meat and poultry products inspection. See FSIS Agency History.

1982

FDA publishes first Red Book (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.

1984

Fines Enhancement Laws of 1984 and 1987 amend the U.S. Code to greatly increase penalties for all federal offenses. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, the amounts are doubled.

Note: although food businesses are subject to fines and other enforcement actions, many violations of food safety laws are initially addressed by recalling the illegal or non-complying (that is, adulterated or misbranded) food product.

Note: the Bureau of Veterinary Medicine became the Center for Veterinary Medicine (CVM).

Note: EPA establishes a screening program in 1986 for microbial products of biotechnology. See Microbial Products of Biotechnology...

Note: USDA APHIS began regulating biotechnology in 1987. See Biotechnology, Federal Regulation, and the U.S. Department of Agriculture.

1988

Generic Animal Drug and Patent Term Restoration Act extends to veterinary products benefits given to human drugs under the 1984 Drug Price Competition and Patent Term Restoration Act. Companies can produce and sell generic versions of animal drugs approved after October 1962 without duplicating research done to prove them safe and effective. The act also authorizes extension of animal drug patents.

1990

Nutrition Labeling and Education Act requires all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services. The law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient panel, serving sizes, and terms such as "low fat" and "light" are standardized.

• Mandated nutrition labeling on food product -- no longer voluntary;
• Nutrition labeling requirements apply to imported food products as well as domestic products;
• Nutrition information on label must be based on serving size, rather than size of package.
• Federal law replaced extensive state food laws in some jurisdictions that address food misbranding; this eased compliance for interstate companies -- one standard rather than a different standard in each state; FDA sets the standards and perhaps identifies violations, but requires states to enforce the law.
• Mandated more detailed declaration of ingredients on package label to include color, peanut, and juice content;
• Defined difference between butter, margarine and spread;
• Defined difference between fruit drink and fruit juice;
• Allows combination of food ingredients that may have been prohibited by some state laws, but the ingredients must be accurately labeled (e.g., canola oil added to butter).

Note: Congress enacted the Sanitary Food Transportation Act prohibiting the transportation of food in trucks and rail cars that are used to transport non-food products.

Note: "Congress passed the Organic Foods Production Act (OFPA) of 1990 [requiring USDA] to develop national standards for organically produced agricultural products to assure consumers that agricultural products marketed as organic meet consistent, uniform standards." See USDA’s National Organic Program

1992

Nutrition facts, basic per-serving nutritional information, are required on foods under the Nutrition Labeling and Education Act of 1990. Based on the latest public health recommendations, FDA and the Food Safety and Inspection Service of the Department of Agriculture recreate the food label to list the most important nutrients in an easy-to-follow format.

Note: FDA published the Food Code in 1993 to assist state and local governments responsible for regulating food businesses. These businesses generally include the retail and food service segments of the industry, e.g., restaurants, grocery stores, and institutions such as nursing homes, schools, and colleges. State and local governments have subsequently used the Food Code as a model to develop or update their own food safety rules so they are consistent with national food regulatory policy. This note is based on FDA Food Code.

Developing the Food Code is not entirely unlike the events in 1898 when an organization offered suggestions to state and local governments as to how they may want to develop their own food regulatory laws.

Note: "FDA published a policy statement [57 FR 22984, May 29, 1992] and testing guidelines for foods developed using all methods of plant breeding, including the use of genetic engineering."

Note: an outbreak of E. coli O157:H7 occurred in the Pacific Northwest in 1993, which caused 400 illnesses and four deaths. The public demanded change for safer ground beef products. See FSIS Agency History.

1994

Dietary Supplement Health and Education Act establishes specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.

Animal Medicinal Drug Use Clarification Act allows veterinarians to prescribe extra-label use of veterinary drugs for animals under specific circumstances. In addition, the legislation allows licensed veterinarians to prescribe human drugs for use in animals under certain conditions.

Note: "In 1994, a salmonellosis outbreak affecting 224,000 people was blamed on cross-contamination of pasteurized ice cream transported in tanker trailers that had previously hauled non-pasteurized liquid eggs." Excerpt from Keener, L. 2003. Transportation: The Squeaky Wheel of the Food Safety System. Food Safety Magazine.

Note: "USDA issued a rule [in 1994] requiring safe handling labels that address storage, cooking and holding practices for raw meat and poultry products." See The Uses Of Adversity.

1995

Note: "FoodNet [an active surveillance network for foodborne disease] was established in 1995 as a collaborative project of the Centers for Disease Control and Prevention (CDC), USDA, and the Food and Drug Administration (FDA)" See The Uses Of Adversity.

Note: "Also in 1995, PulseNet was born—a computer information system linking Federal and State agencies that has created a growing database of molecular fingerprints of pathogens." See The Uses Of Adversity.

Note: FDA established a system known as Hazard Analysis and Critical Control Point, or HACCP for the seafood industry in December 1995. See HACCP: A State-of-the-Art Approach to Food Safety

Note: "The World Trade Organization came into being in 1995. One of the youngest of the international organizations, the WTO is the successor to the General Agreement on Tariffs and Trade (GATT) established in the wake of the Second World War." See THE WTO IN BRIEF: PART 1.

Note: "At the request of the Codex Executive Committee, and in collaboration with FAO, WHO organized a Consultation on the Application of Risk Analysis to Food Standards Issues." See Application of Risk Analysis to Food Standards Issues.

1996

Federal Tea Tasters Repeal Act repeals the Tea Importation Act of 1897 to eliminate the Board of Tea Experts and user fees for FDA's testing of all imported tea. Tea itself is still regulated by FDA.

Food Quality Protection Act amends the Food, Drug, and Cosmetic Act, eliminating application of the Delaney proviso to pesticides.

The decision to eliminate the 1958 (Delaney) provision reflects advances in scientific technology and its capability to detect ever smaller quantities of carcinogens; without a change in the law, even naturally-occurring carcinogens would be a violation of the 1958 Delaney proviso.

Note: Food Quality Protection Act also mandated that EPA set limits or tolerances for the amount of pesticides that may remain in or on foods. The tolerances are based on a risk assessment and are enforced by the FDA. See Pesticide Tolerances.

Note: FSIS issued the Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) Systems rule. The rule focuses on the prevention and reduction of microbial pathogens on raw products that can cause illness. HACCP clarifies the respective roles of government and industry. Industry [meat and poultry processing plants] is accountable for producing safe food. Government is responsible for setting appropriate food safety standards, maintaining vigorous inspection oversight to ensure those standards are met, and maintaining a strong enforcement program to deal with plants that do not meet regulatory standards. Implementation of HACCP began in January 1997, and completed by 2000. See FSIS Agency History. Also see 9 CFR 416 (SSOP) and 417 (HACCP).

FSIS (USDA) also recognized the impact HACCP may have on producers, the importance of interagency collaboration, and the role of consumer education (see The Impact of Pathogen Reduction/HACCP on Food Animal Production Systems).

“FSIS promotes voluntary adoption of producer quality assurance programs. FSIS is working with FDA to address safe transportation of products. Through the Food Code, FSIS works with local and State authorities to improve wholesale, retail and food service food safety practices. FSIS has helped develop the FIGHT BAC! Consumer education campaign. Provides extensive consumer information and Hotline services.”

1997

Food and Drug Administration Modernization Act … mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to … regulate health claims for foods.

"In 1997, the National Economic Crossroads Transportation Efficiency Act (NEXTEA) included provisions to transfer primary oversight of food transportation safety from the U.S. Department of Transportation (DOT) to the U.S. Food and Drug Administration (FDA)." Excerpt from Keener, L. 2003. Transportation: The Squeaky Wheel of the Food Safety System, Food Safety Magazine, May 25, 2006.

Note: Official agreement between the OIE and the WTO reached in 1998. See Short history of the OIE and Objectives.

USDA FSIS began "implementation of HACCP ... on January 27, 1997, and it was completed by January 25, 2000. The Pathogen Reduction/HACCP rule applied to approximately 6,500 federally-inspected and 2,550 state-inspected meat and poultry (slaughter and processing) plants in the United States." See FSIS Agency History.

2000

Publication of a rule on dietary supplements defines the type of statement that can be labeled regarding the effect of supplements on the structure or function of the body.

2002

In the wake of the events of September 11, 2001, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is designed to improve the country's ability to prevent and respond to public health emergencies, and provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.

Note: an additional set of food safety concerns -- attacks on our food sytem with the intent of injurying consumers.

A strategy for addressing food safety concerns is to have better information about the movement of food products. Accordingly, this 2002 legislation mandates that food businesses "register" with the FDA and that they maintain records of suppliers and buyers of food items to assist in the traceability of a food product. This law does NOT require food establishments to develop and implement security practices, but FDA offers guidance.

Note: FDA imposed HACCP requirements on the juice industry; these took effect in January 2002 for large and medium businesses, January 2003 for small businesses, and January 2004 for very small businesses.

Note: the 2002 farm bill (Farm Security and Rural Investment Act of 2002) requires "country of origin labeling" for beef, lamb, pork, fish, perishable agricultural commodities and peanuts, however, its implementation for most commodities has been delayed to 2008.

2003

To help consumers choose heart-healthy foods, the Department of Health and Human Services announces that FDA will require food labels to include trans fat content, the first substantive change to the nutrition facts panel on foods since the label was changed in 1993.

An obesity working group is established by the Commissioner of Food and Drugs, charged to develop an action plan to deal with the nation's obesity epidemic from the perspective of FDA. In March 2004 the group releases "Calories Count: Report of the Obesity Working Group," which addresses issues connected to the food label, obesity therapeutics, research needs, the role of education, and other topics.

The National Academy of Sciences releases "Scientific Criteria to Ensure Safe Food," a report commissioned by FDA and the Department of Agriculture, which buttresses the value of the Hazard Analysis and Critical Control Point (HACCP) approach to food safety already in place at FDA and invokes the need for continued efforts to make food safety a vital part of our overall public health mission.

The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors, analogous to laws passed for the evaluation of other products FDA regulates, ensuring the safety and effectiveness of drugs for animals and the safety of animals used as foodstuffs.

FAO published "Development of a Framework for Good Agricultural Practices"; see http://www.fao.org/docrep/meeting/006/y8704e.htm. Also see http://www.fao.org/prods/gap/index_en.htm.

2004

Passage of the Food Allergy Labeling and Consumer Protection Act requires the labeling of any food that contains a protein derived from any one of the following foods that, as a group, account for the vast majority of food allergies: peanuts, soybeans, cow's milk, eggs, fish, crustacean shellfish, tree nuts, and wheat.

Deeming such products to present an unreasonable risk of harm, FDA bans dietary supplements containing ephedrine alkaloids based on an increasing number of adverse events linked to these products and the known pharmacology of these alkaloids.

2005

Note: ISO 22000 published; see http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=35466 for a commentary on this standard.

Note: Safe Food Transportation Act (SFTA) of 2005:  after several years and various investigations into food contamination outbreaks that affected both animals and humans, it was determined that DOT did not have the expertise to implement the earlier law passed in 1990.  However, FDA did have the requisite expertise, capability, and mission to regulate food safety-and therefore was determined to have the responsibility for food transportation safety.

2007

FDA offers AN OVERVIEW OF THE CARVER PLUS SHOCK METHOD FOR FOOD SECTOR VULNERABILITY ASSESSMENTS as a method to assess the points in a food business infrastructure that are most vulnerable to an intentional attack.

Note: we are now 100 years since the first U.S. federal food laws were enacted by Congress in 1906 -- what will happen in the next 100 years?

2008

USDA issued an interim final rule for the mandatory country of origin labeling (COOL) program that will become effective on Sept. 30. See http://www.ams.usda.gov/COOL.

2009

Country of Origin Labelling for beef, veal, pork, lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng is fully functional.

2010

The Food Safety Modernization Act was passed in mid-December.  Early indications are that key points of the law include

• More HACCP (??)
• More pro-active approach to food safety, rather than primarily reacting to food safety problems
• More "science-based" approach to food safety concerns
• Authority to mandate product recall (primarily relied on food company voluntarily recalling in the past)
• More inspections; closer oversight of imported food
• Authority to address food safety concerns in the production sector; that is, at the farm level; in the past, FDA's authority focused on the processing sector of the food industry.

This law does NOT amend any USDA authority to oversee meat products.

The next section of SAFE 408/608 discusses the Purpose of Food Law.

Last updated December 27, 2010

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