Who’s Who: Food Safety and Consumer Safety Regulatory Bodies

June 7, 2019

By: Diana E. McMonagle and Avery Nickerson

This article explores the roles, responsibilities, and regulatory powers of the government entities that tasked with overseeing food safety in the United States.

I. FOOD SAFETY

There are five key entities responsible for regulating food safety in the United States: the United States Department of Agriculture (“USDA”), the Department of Health and Human Services (“HHS”), the Centers for Disease Control (“CDC”), the Food Safety and Inspection Service (“FSIS”), and the Food and Drug Administration (“FDA”).

a. The USDA and the HHS: Roles and Divisions

The USDA and the HHS regulate food safety through various subsidiary agencies. The CDC also plays a role in overseeing the nation’s food products.

The USDA is a cabinet-level agency1 that is responsible for meat, poultry, and egg products.2 Created by President Abraham Lincoln in 1862, the USDA has a number of duties and responsibilities, including overseeing the farming industry, inspecting food, and supporting rural communities.3 There are sixteen diverse agencies under the USDA, ranging from the Agricultural Marketing Service, which facilitates the strategic marketing of agricultural products in domestic and international markets, to the Forest Service, which sustains the health, diversity and productivity of the nation’s forests and grasslands.4

The FSIS is the USDA agency chiefly responsible for consumer safety. In 1884, Congress established the Bureau of Animal Industry, which was the predecessor to the Food Safety and Inspection Service.5 The purpose of the Bureau of Animal Industry and, subsequently the FSIS, was to prevent diseased animals from being used in food products. Interestingly, Upton Sinclair’s seminal work, The Jungle, had a remarkable impact on federal regulation of the meat-packing industry and encouraged President Theodore Roosevelt to pass the Food and Drug Act of 1906 and the Meat Inspection Act. 6 These laws empowered the FSIS’s predecessors, and eventually led to the creation of the modern FSIS in 1981.

The central purpose of the FSIS is to protect the public from foodborne illness and to ensure that the nation’s meat, poultry, and egg products are correctly packaged and safe for consumption.7 The agency facilitates inspections of slaughterhouses and meat-processing facilities, enforces correct labeling and packaging, and monitors recalls of tainted meat, poultry, and eggs. The FSIS also works with intelligence and law enforcement agencies to strengthen surveillance systems to detect intentional contamination of meat and poultry products.8

The HHS oversees the FDA, a federal executive department that regulates the majority of other food industries under the authority-granting Federal Food, Drug, and Cosmetic Act on 1938 (“FDCA”).9 The FDA is responsible for ensuring the safety of the nation’s food supply and cosmetics,10 as well as human and veterinary drugs, biological products, and medical devices, among other products.11

For certain products, the FDA shares responsibility with other federal agencies such as the Drug Enforcement Agency, the Federal Bureau of Investigation and U.S. Customs and Border Protection.12 The Food Safety Modernization Act (FSMA) was signed into law by President Obama in January 2011.13 One of the central purposes of FSMA was to steer the FDA’s focus towards preventing food safety problems, rather than reacting to problems after they occur.14

There is some overlap between the FDA and the USDA, which has historically led to confusion over which entity is in charge of what products.15 For example, the FDA regulates shelled eggs, while the USDA is responsible for egg products, including liquid, frozen and dehydrated eggs.16 In the same vein, the FDA regulates the feed chickens eat, but the USDA is responsible for the laying facility. This overlap has interesting consequences for product inspections. While the FSIS conducts daily inspections of facilities and products, FDA inspections have no regular schedule. 17 As one commenter explained:

This inspection imbalance means that pepperoni pizza, because it contains meat, has ingredients that will be inspected three times before the product hits the grocery store freezer: at the slaughterhouse, the packing plant and the pizza factory. A vegetarian pizza produced at the same facility, however, will probably not undergo any inspection.18

Products with less than 2% cooked poultry meat and less than 10% cooked poultry skins, giblets, fat, and poultry meat (limited to less than 2%) in any combination are under FDA jurisdiction. Those poultry products with 2% or more cooked poultry and more than 10% cooked poultry skins, giblets, fat, and poultry meat in any combination are under USDA jurisdiction.19 The fine lines that separate these entities’ responsibilities can make it difficult for the public to discern which foods have been inspected and who is responsible for that inspection.

b. Other Food Safety Entities

The HHS also oversees the CDC, which “monitors the occurrence of illness in the United States attributable to the food supply” and “investigat[es] . . . specific outbreaks of illness[es] when invited to do so by the health department of the state in which the outbreak occurred.”20 The CDC is a federal agency that conducts and supports health promotion, prevention and preparedness activities in the United States.21 The agency collaborates with local, state, and national organizations and institutions to monitor and prevent disease outbreaks, implement disease prevention strategies, and maintain national health statistics. 22

The CDC’s Food Safety Office monitors and works to improve surveillance of foodborne illness and investigation of foodborne disease outbreaks.23 Among other projects, the Food Safety Office coordinated the CDC’s implementation of FSMA, which directs the CDC to “enhance foodborne illness surveillance systems through improved collection, analysis, and reporting of foodborne illness data.”24 The CDC becomes involved in food safety when there is contamination that causes illness; it is not involved in the inspection and regulation of food products, as the USDA and FDA fulfill those roles.

Other agencies involved in food safety are: (1) the Environmental Protection Agency, which coordinates with the USDA and the FDA in regard to regulating tolerances for pesticide residues in food; (2) the Department of Treasury’s Customs Service, which “detain[s] imports based on guidance provided”; (3) the Cooperative State Research, Education, and Extension Service; (4) the Agricultural Marketing Service; (5) the Economic Research Service; (6) the Grain Inspection, Packers and Stockyard Administration; (7) the U.S. Codex Office; and (8) the Department of Commerce’s National Marine Fisheries Service.25 While food safety is generally regulated at the federal level, states individually oversee some localized food safety programs.26

Footnotes

  1. About the U.S. Department of Agriculture, U.S. Dep’t of Agriculture, https://www.usda.gov/our-agency/about-usda (last visited April 12, 2019).
  2. Gretchen Goetz, Who Inspects What? A Food Safety Scramble, Food Safety News (December 16, 2010), https://www.foodsafetynews.com/2010/12/who-inspects-what-a-food-safety-scramble/ (citing Dr. Richard Raymond, former Under Secretary for Food Safety for the Food Safety and Inspection Service).
  3. USDA Celebrates 150 Years, U.S. Dep’t of Agriculture, https://www.usda.gov/our-agency/about-usda/history (last visited April 12, 2019).
  4. Agencies, U.S. Dep’t of Agriculture, https://www.usda.gov/our-agency/agencies (last visited April 11, 2019).
  5. Celebrating 100 Years of FMIA, U.S. Dep’t of Agriculture (February 21, 2014), https://www.fsis.usda.gov/wps/wcm/connect/fsis-content/fsis-questionable-content/celebrating-100-years-of-fmia/overview/ct_index.
  6. Id.
  7. Food Safety and Inspection Service, AllGov, (http://www.allgov.com/departments/department-of-agriculture/food-safety-and-inspection-service?agencyid=7162) (last visited April 13, 2019).
  8. Food Safety and Inspection Service, AllGov, (http://www.allgov.com/departments/department-of-agriculture/food-safety-and-inspection-service?agencyid=7162) (last visited April 13, 2019).
  9. Office for Human Research Protections, Food & Drug Administration, U.S. Dep’t of Health & Human Services (March 18, 2016), https://www.hhs.gov/ohrp/regulations-and-policy/regulations/fda/index.html.
  10. Food and Drug Administration (FDA), AllGov, http://www.allgov.com/departments/department-of-health-and-human-services/food-and-drug-administration-fda?agencyid=7405 (last visited April 13, 2019).
  11. The FDA is also responsible for regulating a number of other products, including tobacco products, as well as advancing public health by facilitating innovations in medical products and providing the public with accurate, science-based information regarding medical products and foods.  See id.
  12. FDA Enforcement Manual, ¶170 FDA AND OTHER FEDERAL AGENCIES, WL 3259306 (2006).
  13. What Government Does, Foodsafety.gov, https://www.foodsafety.gov/keep/government/index.html (last visited April 11, 2019)
  14. Id.
  15. FDA and USDA: Who Regulates What?, Registrar Corp, https://www.registrarcorp.com/resources/fda-usda-food-regulations/ (last visited April 14, 2019).
  16. See, e.g., Gretchen Goetz, Who Inspects What? A Food Safety Scramble, Food Safety News (December 16, 2010), https://www.foodsafetynews.com/2010/12/who-inspects-what-a-food-safety-scramble/; FDA and USDA: Who Regulates What?, Registrar Corp, https://www.registrarcorp.com/resources/fda-usda-food-regulations/ (last visited April 14, 2019).
  17. Gretchen Goetz, Who Inspects What? A Food Safety Scramble, Food Safety News (December 16, 2010), https://www.foodsafetynews.com/2010/12/who-inspects-what-a-food-safety-scramble/.
  18. Id.
  19. FDA and USDA: Who Regulates What?, Registrar Corp, https://www.registrarcorp.com/resources/fda-usda-food-regulations/ (last visited April 14, 2019).
  20. See Centers for Disease Control and Prevention, AllGov, http://www.allgov.com/departments/department-of-health-and-human-services/centers-for-disease-control-and-prevention-cdc?agencyid=7394 (last visited April 15, 2019); Lisa Lovett, Food for Thought: Consistent Protocol Could Strengthen Food Supply Security Measures, 10 Tex. Wesleyan L. Rev. 465, 467–69 (2004).
  21. CDC Organization, Centers for Disease Control and Prevention (April 12, 2019), https://www.cdc.gov/about/organization/cio.htm.
  22. Id.
  23. Food Safety Office, Centers for Disease Control and Prevention (February 16, 2018), https://www.cdc.gov/ncezid/dfwed/food-safety-office/index.html.
  24. Id.
  25. Michael R. Taylor, Preparing America’s Food Safety System for the Twenty-First Century — Who Is Responsible for What When It Comes to Meeting the Food Safety Challenges of the Consumer-Driven Global Economy, 52 Food & Drug L.J. 13, 14 (1997).
  26. Id.