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Food Safety Regulatory Issues (SAFE 408/608)

Introduction to Food Safety Regulatory Issues
History of US Food Law (sec 1)
Purpose of Food Law (sec 2)
Relevant Agencies and Organizations (sec 3)
Regulatory Strategies (sec 4)
Regulating the Food Processing Sector (sec 5)
Directing Other Sectors of the Industry (sec 6)
Concluding Thoughts (sec 7)
Summary (sec 8)

Relevant Agencies and Organizations (sec 3)

This page overviews several U.S. federal government agencies with primary responsibility for regulating the food industry.  The discussion also introduces the regulatory role of state government and the leadership role of several international organizations.

Visit Selected Legal Concepts for an introduction to the U.S. legal system; topics include 1) the legislative, executive and judicial branches of U.S. government; 2) statutes and regulations; and 3) preemption of federal law over state law.


U.S. Federal Government Agencies

The Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) has extensive responsibility for regulating food businesses. The Center for Food Safety and Applied Nutrition within the FDA has the specific responsibility, but these materials generally refer to the FDA.

FDA has regulatory responsibility and authority over most of the processing sector of the food industry; the major exception in the processing sector of the food industry is the jurisdiction of the USDA Food Safety Inspection Service (FSIS) over meat, poultry and egg processing. The following excerpt introduces the responsibilities of several U.S. federal agencies.

  • “FDA's responsibility in the food area generally covers all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which are under the authority of the U.S. Department of Agriculture (USDA's Food Safety and Inspection Service (FSIS)), the labeling of alcoholic beverages (above 7% alcohol) and tobacco, which are regulated by the U.S. Department of the Treasury's Bureau of Alcohol, Tobacco, and Firearms (ATF), and the U.S. Environmental Protection Agency (EPA), which establishes tolerances for pesticide residues in foods and ensures the safety of drinking water.”
    Excerpt fromCenter for Food Safety and Applied Nutrition – Overview
  • The Center for Food Safety and Applied Nutrition (CFSAN) within the FDA has direct responsibility for regulating the food industry.
  • FDA has jurisdiction over any food that enters interstate commerce – except meat, poultry and egg products.  Any food that moves among states is considered "an interstate movement" and subject to federal regulation.
  • FDA also regulates the safety of imported foods (except those under the jurisdiction of FSIS in USDA).
  • FDA is responsible for overseeing the safety of ingredients used in formulated foods, the safety of ingredients that are generally recognized as safe (GRAS), and the implementation of good manufacturing practices (GMP).
  • FDA is authorized to access a business' records of interstate food shipments, as well as business records pertaining to infant formula, and certain low-acid canned and acidified foods.
  • FDA oversees the packaging and labeling of food products; FDA does not pre-approve labels; instead it focuses on whether the label being used complies with federal requirements.

Many of these points are discussed in more detail in subsequent sections.

Food Safety and Inspection Service (FSIS) in the Department of Agriculture (USDA) is responsible for regulating meat, poultry, and egg processing.

  • FSIS also regulates the safety of imported meat, poultry, and eggs products.
    • FSIS is responsible for assuring that meat, poultry and egg products imported into the US are "safe, wholesome, unadulterated, and properly labeled and packaged."
  • The three primary laws administered by the FSIS are the Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act.
  • FSIS is responsible for 1) inspecting the ongoing operations of plants processing these products, and 2) enforcing labeling and product ingredient requirements.
    • Unlike FDA, FSIS pre-approves product labels and continuously inspects the operations of the processing plants; this different approach to inspection reflects the Congressional requirement that each item of meat and poultry product be inspected.  By comparison, FDA’s is not required to inspect every food item.
  • The "homepage" for the Food Safety and Inspection Service provides links to an extensive set of reference materials about the agency's responsibilities and activities.

As is obvious, there are similarities between FDA and FSIS functions for their respective products; there also are some differences; and in some cases, these two agencies rely on the direction or leadership provided by the other agency.

FDA and FSIS are the two major U.S. federal government agencies addressing food safety regulation.  Distinguishing between their authorities is not always easy; consider the following examples:

  • FDA regulates macaroni and noodle products (21 CFR Part 139) while USDA regulates spaghetti with meatballs and sauce (9 CFR 319.306)
  • FDA regulates Grade A (fluid) milk (21 CFR 131); USDA regulates dairy products such as butter and cheese (7 CFR Part 58); but there is also state involvement (e.g., ND Dept of Ag, Dairy Division)
  • An open-face sandwich (e.g., one slice of bread) with meat or poultry is regulated by USDA; a closed sandwich (e.g., two slices of bread) with meat or poultry is regulated by FDA
  • Soup with more than 2% meat is regulated by USDA; other soup is regulated by FDA
  • Pizza with cheese is regulated by FDA; pizza with meat and cheese is regulated by USDA; but USDA regulates cheese (see previous point), so why would FDA regulate cheese pizza? Explanation -- cheese is only an ingredient in cheese pizza; cheese is not the ultimate product in this case (it is pizza); thus FDA regulates pizza where cheese is an ingredient.
  • Canned beans with more than 2% meat/pork is regulated by USDA; other beans are regulated by FDA.
  • Beef broth is regulated by USDA; dehydrated beef broth is regulated by FDA; dehydrated chicken broth is regulated by USDA; chicken broth is regulated by FDA.

There is an extensive history behind these agencies. Sometimes logic would seem to suggest that their responsibilities should be revised or realigned, but the extensive history is not likely to allow the political process to make those changes.


The Environmental Protection Agency (EPA) participates in food safety by establishing tolerances for pesticide residues.

  • "Under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA establishes tolerances (maximum legally permissible levels) for pesticide residues in food. Tolerances are enforced by the Department of Health and Human Services/Food and Drug Administration (HHS/FDA) for most foods, U.S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) for meat, poultry, and some egg products and the U.S. Department of Agriculture/Office of of Pest Management Policy."
  • See Pesticide Residue on Food -- this EPA web page briefly introduces pesticide residue limits (tolerances) and provides links to associated information.
  • see Food Safety -- this EPA web page introduces the role EPA has in regulating the use of pesticides on food.

    "Although the Food and Drug Administration regulates most aspects of food production and consumption in the United States, the EPA is responsible for regulating the use of pesticides on food. If improperly used, pesticides can cause serious health problems, including birth defects, nerve damage, cancer, and unique health risks to children. The EPA, in cooperation with the states, carefully regulates pesticides to ensure that their use does not compromise food safety. In particular, the Federal pesticide program is designed to ensure that pesticides can be used without posing harm to the most vulnerable members of society, children and infants."

  • Food Quality Protection Act (FQPA) of 1996

    "The 1996 law [establishes] ... a more consistent, protective regulatory scheme, grounded in sound science. It mandates a single, health-based standard for all pesticides in all foods; provides special protections for infants and children; expedites approval of safer pesticides; creates incentives for the development and maintenance of effective crop protection tools for American farmers; and requires periodic re-evaluation of pesticide registrations and tolerances to ensure that the scientific data supporting pesticide registrations will remain up to date in the future. "


Federal Trade Commission (FTC) in the Department of Commerce (DOC)

  • The FTC is responsible for regulating advertising of food products; it primarily focuses on the accuracy of advertising claims.

    "The FTC, FDA, and USDA share jurisdiction over claims made by manufacturers of food products pursuant to a regulatory scheme established by Congress through complementary statutes. Section 5 of the Federal Trade Commission Act ... prohibits "unfair or deceptive acts or practices," and, in the case of food products, Sections 12 and 15 of the FTC Act prohibit "any false advertisement" that is "misleading in a material respect." FDA's authority is embodied in part in Section 403(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) which prohibits "labeling [that] is false or misleading in any particular." Since 1954, the FTC and the FDA have operated under a Memorandum of Understanding, under which the Commission has assumed primary responsibility for regulating food advertising, while FDA has taken primary responsibility for regulating food labeling "

    Excerpt from Enforcement Policy Statement on Food Advertising


Center for Disease Control/Food Safety Office

Animal and Plant Health Inspection Service (APHIS) in USDA

  • "provides leadership in ensuring the health and care of animals and plants."
  • Regulates the health of imported plants and animals.
  • Is involved with the export of plants and animals.
  • Is involved in regulating the research and development of bio-technology.
  • Although not directly involved with food, APHIS is involved with the agricultural commodities that become our food. Accordingly, APHIS has a major role in our food industry.

Center for Veterinary Medicine (CVM) in FDA/HHS

  • Regulate medicines given to livestock, including livestock that will be used for food.
  • "The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived ... "

Food and Nutrition Service (FNS) in USDA

  • "FNS provides children and low-income people access to food, a healthful diet, and nutrition education. "
  • "Food safety and security is an important aspect of the USDA nutrition assistance programs and the Food Safety Unit coordinates food safety and security efforts within all these programs." See Food Safety -- a web page maintained by FNS USDA.

These agencies are not the only US federal agencies with responsibility for assuring the safety of our food, but they have the major responsibilities for this task. The next paragraphs introduce the role of state government in assuring safe food.

State Government Agencies in the United States

In many states, either the health department or agriculture department has primary responsibility for overseeing the food industry.  For example in North Dakota, the primary agency is the Department of Health (Division of Food and Lodging), whereas in Minnesota, the primary agency is the Department of Agriculture (Dairy and Food Inspection Service).  In Wisconsin, the responsibility is divided between the departments of agriculture and health (see Food Processing & Safety by Wisconsin Department of Agriculture, Trade & Consumer Protection and Food Safety & Recreational Licensing by Wisconsin Department of Health & Family Services).

  • See N.D.C.C. 19-02.1 for an example of a state statute that is similar to federal law; e.g., prohibition against adulterated and misbranded foods, definition of adulterated and misbranded, standards of identity, authority to inspect, and enforcement authority.

USDA's web site provides links to many of these state agencies (see State Departments of Public Health). 

Local Government Agencies

Some cities also regulate food businesses within their communities, for example


Relationships among Local, State and Federal Agencies

To accomplish as much as possible with the public resources and to ease the burden on food businesses, these agencies work together.  The relationships are often documented with agreements or memorandums of understanding (MOUs). 

  • The state departments interact with the federal agencies such as FDA, USDA, EPA, etc.
  • Enforcement (especially inspection) often falls upon the states; federal agencies do not have large number of inspectors.
  • Enforcement actions often are based on local findings or the result of inspections by state or local officials.
  • Some state agencies have powers/authorities that federal agencies do not, such as authority to demand the firm's records about manufacturing practices or to impose larger penalties.
  • Memorandum of Understanding (MOU) between the state and the appropriate federal agency is the basis for federally certified state programs.

International Organizations

The expanding role of international trade of food has prompted nations to work more closely on food safety issues. Although some of these discussions were initiated nearly 200 years ago, much of the progress in developing an international understanding of how to assure a safe food supply has evolved during the past 60 years.

  • The first four sections of Understanding The Codex Alimentarius (that is, Preface, The Codex Achievement, Origins of the Codex Alimentarious, and What is the Codex Alimentarious) provide an overview some of the events leading to the current international discussions.

Some of the points in these documents include

    • Different national standards can negatively impact international food trade because exporting businesses must assure that their products comply with the standards of both the exporting nation (where the food was produced) and the importing nation (where the food will be consumed). Complying with two sets of standards can add cost that may impringe on international trade.
      • Nations are encouraged to "harmonize" their standards, to strife for and recognize when their standards are "equivalent" to those of the trading partner, and to make their standards "transparent."
    • There is a recognition that individual circumstances will justify different standards among nations, but it is also recongized that these circumstances can disguise an effort to protect a domestic food industry from competition by exporting nations.
      • Accordingly, food standards are expected to be based on scientific findings and risk assessment.
    • Participation in efforts to harmonize international fodd standards is voluntary; there is no international authority to mandate participation. However, economic reasons usually are the greatest incentives to participate; that is, food businesses often want their national government to do what potential trading partners would like them to do.



    • World Trade Organization (WTO) replaced the General Agreements on Trade and Tariffs (GATT) in 1995 "to ensure that trade flows as smoothly, predictably and freely as possible" (see The WTO...In brief ).
    • WTO is interested in promoting international trade and is concerned that food standards may interfere with trade practices. WTO therefore supports that food standards be based on science, and not used as a disguise for trade barriers (see Standards and safety).
    • WTO recognized the role of Codex in adopting Sanitary and Phytosanitary Standards (SPS); WTO also adopted the concept of equivalency but recongizes a need for stricter standards in regions or nations based on scientific findings.
      • "The SPS Agreement does, however, encourage governments to "harmonize" or base their national measures on the international standards, guidelines and recommendations developed by WTO member governments in other international organizations. These organizations include, for food safety, the joint FAO/WHO Codex Alimentarius Commission; for animal health, the Office of International des Epizooties; and for plant health, the FAO International Plant Protection Convention." Excerpt from Understanding the WTO Agreement on Sanitary and Phytosanitary Measures


    • The International Organization for Standardization's (ISO) is also involved in food safety standards. ISO was organized in 1947 to "to facilitate the international coordination and unification of industrial standards." In September 2005, it published ISO 22000 as "a new International Standard designed to ensure safe food supply chains worldwide."
    • International standards is a dynamic area – watch for future developments. 
      • Some of these efforts extend back nearly 200 years, but much of the international effort has occurred in less than 60 years.  There will continue to be changes as global trade continues to expand.

A Closing Thought

Numerous federal and state government agencies, and international organizations address food safety, but we cannot overlook the many government agencies of nearly all nations with similar responsibilities. The task of refining a global system that still allows local concerns and needs to be addressed apparently will be a challenge for the foreseeable future. Clearly this is an area of career opportunity for interested, trained individuals.


The next section overviews Basic Regulatory Strategies.

Last Updated November 17, 2010

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