The complex challenge of assuring safe food has led to numerous federal and state government agencies having a role in U.S. food safety matters. This page provides an overview of the role of various agencies. The discussion begins by addressing federal agencies.

Resources

• Gateway to Government Food Safety Information (web site with links to numerous U.S. government web pages with information about food safety)

• The Government Agencies (web page with links to U.S. federal and state government agencies involved with food safety concerns)

Who Do These U.S. Agencies Regulate?

• 6,100 meat and poultry processors
• 50,000 food establishments
• more than 1 million food vending locations
• more than 70,000 labeled food products

• FDA describes itself as annually regulating $417 billion worth of domestic food and $49 billion in imported food (this does not include the food regulated by the USDA).
• The U.S. food industry includes more than 136,000 registered domestic food facilities (including more than 44,000 U.S. food manufacturers and processors and approximately 113,000 U.S. food warehouses, including storage tanks and grain elevators).
• The industry also includes more than 2 million farms, roughly 935,000 restaurants and institutional food service establishments, and 114,000 supermarkets, grocery stores, and other food outlets.
• There are approximately 189,000 registered foreign facilities that manufacture, process, pack, or hold food consumed by Americans.
• Source: Food and Drug Administration. "Food Protection Plan -- An integrated strategy for protecting the nation's food supply." Department of Health and Human Services, November 2007.

Much of U.S. food law is based on federal law, even though many states also have addressed issues relating to food safety.  The number of agencies involved in food safety research, regulation and education adds further complexity, but it also illustrates the breadth of issues involved in assuring a safe food supply.

Federal Government Involvement

• All federal agencies are granted their authority from Congress; federal agencies can do no more to regulate food safety than Congress authorizes them to do. Thus food safety issues often take on a political appearance as Congress works to define the role of government in addressing these concerns.

• The basis for federal government involvement in many of food issues lies in the U.S. Constitution, more specifically the "interstate commerce" clause that states Congress has the authority to regulate interstate commerce, that is, business that occurs across state lines.
  • "Section 8. The Congress shall have power to ... regulate commerce ... among the ...states"
  • Business that occurs entirely within a state cannot be regulated by the federal government; those activities are for the states to regulate. However much of our modern economy involves products or services that cross at least one state line sometime during the manufacture and sale of the product. Thus the majority of items in our economy, including most of our food products, involves interstate commerce and is subject to federal authority. Federal statutory law (e.g., 21 U.S.C. §331(a)) explicitly states that it is regulating only those food items that involve interstate commerce; but the reality is that nearly all food involves interstate commerce. As a consequence, the federal government has authority to regulate nearly all food produced or consumed in the United States.

• Federal law preempts state law; again this is based in the U.S. Constitution. If there is a conflict between federal law and state law, the federal law prevails; that is, federal law is supreme.
  • "Article VI. ...This Constitution, and the laws of the United States ... shall be the supreme law of the land"

However, Congress addressing an issue does not prevent a state from also addressing the issue; both Congress and state legislatures can address the same issues. If there is a difference between the two laws, the federal law will prevail or preempt the state law. In some situations,

• Congress recognizes that a state may have a particular issue that requires special attention. In those situations, a common practice is that the federal government sets a minimum standard and then allows states to impose additional standards as necessary to protect the state's special or unique need.
  • Congress sometimes encourages this type of a relationship by providing financial resources to states that take an active role in administering a federal program or direction, e.g. USDA meat inspection program.
• There are situations, however, where Congress will not allow a state to impose additional requirements.

 

Key federal food safety agencies

Food safety concerns frequently focus on the processing sector of the industry; it is primarily since the mid-1990s that discussions about food safety have broaden to encompass "farm to table."  Despite the added breadth, the emphasis for food safety is still on processing and final preparation of food items (but do not overlook the recent (e.g. 2006) surge in concerns about food safety at the commodity production level).  Accordingly, this introduction to agencies involved with food safety begins with an overview of agencies responsible for regulating the processing sector of the industry.

• Food and Drug Administration (FDA) of the Department of Health and Human Services
• FDA primarily (but not entirely) focuses on the processing of food products; that is, post-harvest.
• Overview and History of FDA and the Center for Food Safety and Applied Nutrition
  • FDA's role includes "seeing that products are made right and labeled truthfully."  FDA inspects facilities, collects and analyzes samples of products, and checks product labels.  FDA relies on scientific expertise in fulfilling its mission.
  • "Another major FDA mission is to protect the safety and wholesomeness of food. The agency's scientists test samples to see if any substances, such as pesticide residues, are present in unacceptable amounts. If contaminants are identified, FDA takes corrective action. FDA also sets labeling standards to help consumers know what is in the foods they buy.

  "The nation's food supply is protected in yet another way as FDA sees that medicated feeds and other drugs given to animals raised for food are not threatening to the consumer's health."

  • FDA responds to violations by encouraging firms "to voluntarily correct the problem or to recall a faulty product from the market. A recall is generally the fastest and most effective way to protect the public from an unsafe product.  When a company can't or won't correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. The agency can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors."
• FDA is the primary (lead) agency responsible for regulating food that moves in interstate commerce (except meat, poultry and egg products, those are regulated by USDA); any food that moves among states is considered "an interstate movement" and subject to federal regulation.
• FDA addresses the safety of ingredients used in formulated foods
  • For example, FDA has identified ingredients that are Generally Recognized as Safe (GRAS)
• FDA requires food manufacturers to follow "Good Manufacturing Practices" (GMP)
• FDA is authorized to access the manufacturer's records; e.g., records pertaining to infant formula, certain low-acid canned and acidified food processing records, and interstate shipments.
• FDA regulates food packaging and labeling
• FDA does not preapprove labels for food products; instead it focuses on whether the label in use complies with the legal mandates.
• A Century of Ensuring Safe Foods and Cosmetics
• Center for Food Safety and Applied Nutrition; Food an Drug Administration, Department of Health and Human Services
  • "CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled..."

• A site that may be of interest: Food Protection Plan 2007 by the Department of Health and Human Services
  Food and Drug Administration. November 2007.
  • This plan includes proposal for legislation during the Bush administration. Recognize that an agency's recommendation for legislation is not always enacted by Congress.

• Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture
• "The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged."
• Agency History -- provides an excellent overview, including an overview of the agency's current philosophy.
• Responsible for administering the laws and regulations associated with meat, poultry and eggs
• FSIS Fact Sheets on a range of topics
• FSIS inspects the operations of plants processing meat and poultry products as the plants are being operated; these plants cannot operate without a federal inspector or federally-approved inspector on site.
• FSIS inspects the animal before slaughter and the product after slaughter
• Regulatory programs address labeling, ingredients, and regulatory compliance
  • USDA preapproves labels

Background
FSIS, under its current name since 1981, has been protecting public health since 1906, when the Federal Meat Inspection Act (FMIA) signaled the real beginning of domestic inspection of meat and meat food products in the United States. The Act began a system of continuous, daily organoleptic (sight, smell, touch) inspection in slaughterhouses to detect unsanitary conditions and adulterated products. Poultry inspection began in 1926 on a voluntary basis, and in 1957, Congress passed the Poultry Products Inspection Act (PPIA), which established mandatory, continuous, daily inspection of poultry products.

The 1967 Wholesome Meat Act and the 1968 Wholesome Poultry Products Act amended the FMIA and PPIA, extending Federal requirements to imported products and to state meat and poultry inspection programs. These Acts ensure uniformity in regulation of products shipped interstate, intrastate, and in foreign commerce.

The Egg Products Inspection Act of 1970 required USDA to ensure that egg products are safe, wholesome, and accurately labeled. In 1995, responsibility for egg products inspection was transferred from USDA's Agricultural Marketing Service to FSIS.

The next major change to meat and poultry inspection occurred when FSIS published the landmark Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) Systems rule on July 25, 1996. Implementation of HACCP was phased in and completed in January 2000. Under HACCP, all slaughter and processing plants are required to adopt a system of process controls to prevent food safety hazards.

Also, the HACCP rule clarifies the respective roles of industry and government in ensuring food safety and, therefore, makes better use of government resources in addressing food safety risks. Industry is accountable for producing safe food. Government is responsible for setting appropriate food safety standards, maintaining vigorous inspection to ensure that those standards are met, and maintaining a strong enforcement program to deal with plants that do not meet regulatory standards.

Excerpt from http://www.fsis.usda.gov/factsheets/Biosecurity_&_the_Food_Supply/index.asp

• Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services
  • "The mission of [Centers for Disease Control] CDC's Food Safety Office is to lead CDC's food safety programs to prevent illness, disability and death due to domestic and imported foodborne diseases. We collaborate with and support other CDC organizations with focus on attainment of food safety program plans, goals and objectives. We work in partnership with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), state and local health departments, and other public and private organizations to strengthen regulations and policies for prevention of foodborne diseases."  Taken from CDC's Food Safety Office

• Although not directly regulating food processing businesses, the CDC impacts the food industry through its role of preventing food-borne illnesses and its involvement when a food safety problem arises. For example, the FoodNet project is a collaborative effort among the CDC, ten states, USDA and FDA consisting of "active surveillance for foodborne diseases and related epidemiologic studies designed to help public health officials better understand the epidemiology of foodborne diseases in the United States."

• Environmental Protection Agency (EPA)

The introduction to this section states that concerns about food safety continues to emphasize issues pertaining to food processing and final preparation.  However, this brief overview of the EPA's role in food safety is one example of concerns that ag producers need to address.  It may also be an indication of how the concept of "farm to table" may evolve to include the production sector of the industry.

• Food Safety "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
  • "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."
  • Also visit http://www.epa.gov/pesticides/regulating/laws.htm#fqpa
• Pesticide Residue on Food -- this web site has information about "pesticide residue limits"

Other Federal Agencies Impacting Food Safety

The introduction to the previous section states that food safety concerns still primarily address processing and final preparation.  In this section, other agencies that impact food safety are introduced, including agencies with responsibilities to the production sector of the food industry.  For those agencies, their food safety role is just beginning to evolve and will likely continue to be refined in the future; their mission in the past has not directly focused on food safety concerns.  If (or "as") their food safety responsibilities are revised, their traditional missions are not likely to be eliminated.  Thus an understanding of their traditional role may suggest how food safety concerns could be incorporated into their future missions.

• Other USDA agencies
  • Agriculture Marketing Service (AMS)
    • AMS develops grades and standards for meat, poultry, eggs, dairy products, fruits and vegetables (pre-harvest).
      • Fresh Fruit, Vegetable, Nut and Specialty Crop Grade Standards
      • Livestock and Carcasses Standards
      • Poultry, Rabbit, and Shell Egg Standards
      • Dairy Standardization

      Note that the grades and standards are not regulations, thereby allowing USDA and the industry to update the grades and standars by following a procedure other than promulgating a regulation.

      Most of these standards have existed for many years and address quality characteristics but not the safety of the product.  Although this may change in the future, it may be a slow process.  One example of this possible refinement is the Fresh Produce Audit Verification Program.  Note the reference to FDA, FSIS, "Good Agricultural Practices" and "Good Handling Practices"

  AMS administers the Pesticide  Data  Program.
• "In 1991, the USDA was charged with designing and implementing a program to collect data on pesticide residues in food. Responsibility for this program was given to the USDA AMS which began operating the Pesticide Data Program in May 1991. The data produced by PDP are reported in an annual summary each year." 

"EPA uses PDP data to prepare realistic pesticide dietary exposure assessments as part of its ongoing effort to implement the 1996 Food Quality Protection Act."

"PDP concentrates its efforts in providing better pesticide residue data on foods most consumed by children."

"PDP is a Federal-State partnership. Program operations are carried out with the support of 12 States: California, Colorado, Florida, Maryland, Michigan, Minnesota, Montana, New York, Ohio, Texas, Washington, and Wisconsin."

 

• AMS administers the Microbiological Data Program.
  • "In Fiscal Year 2001, the USDA was charged with implementing a program to collect information regarding the incidence, number, and species of important foodborne pathogens and indicator organisms on domestic and imported fresh fruits and vegetables. USDA's AMS was appointed to undertake the creation and implementation of such a program, currently known as the Microbiological Data Program (MDP).  MDP began collecting and analyzing samples in April 2001." 

"MDP was primarily designed to provide data on microbial presence in order to establish a microbial baseline to assess the risks of contamination, if any, in the domestic food supply."

• AMS purchases surpluses and other foods used in food assistance programs.

• AMS administers the "Country of Origin Labeling" requirement.

"Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) requires country of origin labeling; that is, any retailer engaged in the business of selling beef, lamb, pork, fish, fresh fruits and fresh vegetables, and peanuts at retail (except restaurant, cafeteria, lunch room, food stand, saloon, tavern, bar, lounge, or other similar facility operated as an enterprise engaged in the business of selling food to the public) shall inform consumers, at the final point of sale, of the country of origin of the commodity. This includes muscle cuts of beef, lamb, and pork; ground beef, ground lamb, and ground pork; farm-raised fish; wild fish; fresh fruits and vegetables; and peanuts."

This law has not been without controversy. Its implementation has been delayed but its scope has also been expanded.

USDA Issues Final Rule on Mandatory Country of Origina Labeling; Jan. 12, 2009

7 CFR Parts 60 and 65; Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Chicken, Goat Meat, Wild and Farm-Raised Fish and Shellfish, Perishable Agricultural Commodities, Peanuts, Pecans, Ginseng, and Macadamia Nuts; Final Rule found at Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009

The regulation begins on page 45 of the pdf; the previous pages summarize public comments on the proposed regulation and the agency's response. These pages also include agency explanation of the regulation.

Note that numerous sections of the regulation are "reserved;" this suggestions the regulation will be refined as time passes. Bottom line -- this is not the end of AMS promulgating regulations to implement COOL.

• AMS administers the National Organic Program; 7 CFR Part 205.

"This program establishes national standards for the production and handling of organically produced products, including a National List of substances approved for and prohibited from use in organic production and handling."

"The National Organic Standards require all agricultural products sold, labeled or represented as organic in the United States be certified by a U.S. Department of Agriculture (USDA) accredited certifying agent."

7 CFR § 205.400 General requirements for certification (as an organic producer).
7 CFR § 205.501 General requirements for accreditation (as a certifying agent).

Certifying agents are employed to certify producers because USDA does not have enough staff to certify organic producers.

A North Dakota example of a certifying agent.

In a subsequent discussion on the expanding role of Good Agricultural Practices (GAP), a similarity may become obvious; that is, agricultural producers can decide whether to be certified as following GAP and the certification will be done by private certifying agents, rather than by government.

• "The Federal Grain Inspection Service of USDA's Grain Inspection, Packers and Stockyards Administration provides inspection, weighing, and related services on grains, pulses, oilseeds, and processed and graded commodities." See FGIS overview at http://www.gipsa.usda.gov/GIPSA/webapp?area=home&subject=grpi&topic=landing
  • "GIPSA's Federal Grain Inspection Service (FGIS) establishes the Official Standards for Grain, which are used each and every day by sellers and buyers to communicate the type and quality of grain bought and sold. FGIS also establishes standard testing methodologies to accurately and consistently measure grain quality. Finally, the program provides for the impartial application of these grades and standards through a network of Federal, State, and private inspection agencies known as the official system."
  • Official United States Standards for grain, rice, beans and peas; also see 7 CFR 810
  • The standards were initially intended to protect/inform buyers and sellers; they were not intended to address food safety concerns. However, there is a relationship; for example, a moldy grain may form a toxic that would be present in the baked product and dangerous to for human consumption which would fit the definition of being adulterated. Even though the primary purpose of the law may not be food safety concerns, there is an interaction between grain standards and the safety of the final food product.

   

• Animal and Plant Health Inspection Service (APHIS) - includes: Plant protection and Quarantine; Biotechnology Regulation; (primarily pre-harvest issues)

 

APHIS Plant Protection and Quarantine

"APHIS-PPQ safeguards agriculture and natural resources from the risks associated with the entry, establishment, or spread of animal and plant pests and noxious weeds. Fulfillment of its safeguarding role ensures an abundant, high-quality, and varied food supply, strengthens the marketability of U.S. agriculture in domestic and international commerce, and contributes to the preservation of the global environment."

Example -- Mexican Hass Avocado Imports

Biotechnology Regulatory Services of the APHIS

"APHIS uses the term biotechnology to mean the use of recombinant DNA technology, or genetic engineering (GE) to modify living organisms.  APHIS regulates certain GE organisms that may pose a risk to plant or animal health. In addition, APHIS participates in programs that use biotechnology to identify and control plant and animal pests."

• APHIS regulation of biotechnology is done in coordination with EPA and FDA.
• APHIS exercises its regulatory authority through a system that includes permits, notifications, petitions, and inspections.

• Foreign Agricultural Service (FAS)

• "The Foreign Agricultural Service (FAS) of the U.S. Department of Agriculture (USDA) works to improve foreign market access for U.S. products, build new markets, improve the competitive position of U.S. agriculture in the global marketplace, and provide food aid and technical assistance to foreign countries."

• Agriculture Research Service (ARS)

• Conducts plant and animal research
  • Example:  Red River Valley Agricultural Research Center, Fargo, North Dakota
• Addresses technology and utilization of agricultural products
• Provides technical assistance to other agencies
• Conducts nutrition research, diet data
• ARS Food Safety [research] program

• Food and Nutrition Service (FNS)
  • Administers school lunch and breakfast programs
  • Administers Food Stamp program
  • Administers Women, Infant and Children Program
  • Provides recipes and education materials to improve nutrition
  • Although not directly food safety, the program focuses on nutrition, which relates closely to the purpose of many labeling requirements.

• Other H&HS agencies
  • Center for Veterinary Medicine in the FDA (pre-harvest)

  "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, as well as food additives and drugs for pet (or companion) animals."

  • National Center for Infectious Diseases (Centers for Disease Control and Prevention, Department of Health and Human Services) also provides information about food safety concerns.

   

• Federal Trade Commission

"The FTC acts to ensure that markets operate efficiently to benefit consumers. The FTC's twin missions of competition and consumer protection serve a common aim: to enhance consumer welfare. The Commission's competition mission promotes free and open competitive markets, bringing consumers lower prices, innovation, and choice among products and services. The Commission's consumer protection mission fosters the exchange of accurate, non-deceptive information, allowing consumers to make informed choices in their purchases. Thus, these missions complement each other - accurate information in the marketplace facilitates fair and robust competition - and maximize benefits for consumers.

"Truthful and substantiated health benefit claims in advertising can be an important source of information for consumers. For that reason, combating deceptive health claims, both online and off, continues to be a major focus of the FTC's positive agenda."

Excerpts from A Positive Agenda For Consumers: The FTC Year In Review , April 2003

• Enforcement Policy Statement on Food Advertising (recommended resource)