Food Regulation Agencies and Their Roles

Government Regulatory Agencies

Key Agencies

  • USDA: United States Department of Agriculture
  • FDA: U.S. Food & Drug Administration
  • CDC: Centers for Disease Control and Prevention
  • EPA: Environmental Protection Agency

Objectives

  • Recognize agencies involved in regulating food and beverages.
  • Understand the role of each agency.
  • Recognize key regulations that give the agencies the authority to regulate foods.

Federal Agencies Involved in Food Regulation, Inspection, Subsidy and Safety

  • USDA
  • FDA
  • EPA
  • CDC
  • U.S. Department of Commerce
  • FTC
  • Department of the Treasury

Turning Point For Food Inspection

  • 1905 – Upton Sinclair’s "The Jungle":
    • Focused on brutalization and exploitation of workers in a Chicago meatpacking house.
    • Filthy conditions and the threat they posed to consumers caused a public furor.
  • Consumer pressure on President T. Roosevelt to support the presence of federal inspectors in meat-packing houses.
  • Resulted in:
    • Pure Food and Drug Act 1906 (aka Pure Food Law).
    • The Meat Inspection Act 1906.

USDA

  • Enforces:
    • Federal Meat Inspection Act 1906
      • Mandatory inspection for any plant that produces meat that ships across state lines (interstate).
    • Poultry Products Inspection Act 1957
      • Mandatory inspection of all poultry and eggs that ship across state lines.
    • Pathogen Reduction HACCP Final Rule 1996
      • Meat and Poultry plants must implement mandatory (Hazard Analysis and Critical Control Points) HACCP programs.
      • Identify critical points, install controls to prevent, and document the process.

USDA Agencies

  • ARS – Agricultural Research Service
    • In-house research agency.
  • FSIS – Food Safety and Inspection Service
    • Inspects (mandatory) meat, poultry, eggs for safety and quality.
    • Develops HACCP programs required for meat and poultry.
    • These plants must incorporate Sanitation Standard Operating Procedures (SSOPs).
    • Oversight and approval of all meat, poultry, and egg food labels.
  • AMS - Agricultural Marketing Service
    • Grades beef, lamb, chicken, turkey, butter, eggs, fresh and processed fruits and vegetables.
    • National Bioengineered Food Disclosure Mandatory compliance date is 1/1/2022
      • Developed list of bioengineered foods which would require a disclosure.
    • Pesticide Data Program that tests for pesticide residues and reports annually.
  • APHIS - Animal and Plant Health Inspection Service
    • Facilitates safe international trade.
    • Monitors the health of animals presented at the border and regulates the import and export of animals, animal products, and biologicals.
    • Safeguards U.S. agriculture by monitoring the presence of invasive and non-native pests on vegetables at the border.
    • Biotechnology Regulatory Services regulates the introduction of GE organisms and manages compliance of regulations.
  • FNS – Food and Nutrition Service
    • The Farm Bill reviewed every 5 years authorizes the programs.
    • SNAP – Supplemental Nutrition Assistance Program
      • Provides nutrition benefits to supplement the food budget of needy families.
    • Food Help for Disaster Relief - D-SNAP
      • Provides emergency food for shelters and low-income households with food loss due to a natural disaster.
    • TEFAP – The Emergency Food Assistance Program
      • Food supplied through Food Banks.

FDA

  • Main Duties:
    • Inspect facilities and manufacturing processes.
    • Regulate Food Additives.
    • Oversee Food Labeling.
    • Set Food Standards.
    • Conduct research on the safety of food chemicals.
    • Division of the Dept of Health and Human Services (HHS).
  • Enforces:
    • 1938 Federal Food, Drug and Cosmetic Act (FD&C)
      • Rewrote the 1906 Pure Food Law.
      • Provided the FDA the resources to enforce the law.
      • FDA has jurisdiction over all foods passing across state lines, except meat, poultry, eggs.
      • FDA governs products with less than or equal to 3% meat or 2% poultry.
    • Amendments to the 1938 FD&C Act:
      • 1958 Food Additive Amendment
      • 1960 Color Additive Amendment
      • Major Shift of burden of proof of safety to food companies.
      • FDA must approve the use of any additive based upon supplied data by the company.
    • Food Safety Modernization Act (FSMA) 2011:
      • Shift from response to foodborne illness outbreaks to prevention.
  • Sets Standards:
    • Publishes all regulations in the Code of Federal Regulations, CFR title 21 (foods, drugs, and cosmetics).
      • Updated every year on April 1.
      • Throughout the year new rules, proposed rules, and public notices are published in the Federal Register.
    • Includes three content standards
      • Standards of Identity – mayonnaise, butter, and milk, for example.
      • Standards of Minimum Quality
      • Standards of Fill – cans must be filled to 90% of capacity.
    • Publishes the Food Code every 4 years
      • A reference for food safety in restaurants.
  • Monitors Facilities and Products:
    • FDA unannounced inspections
      • Allowed legally due to FD&C Act which prohibits the sale of adulterated products
      • Defective, unsafe, contaminated with filth, produced under unsanitary conditions.
    • Good Manufacturing Practices (GMPs) outlined by FDA are used by plant to be in compliance.
    • FDA has authority to shut down facility.
    • FDA uses product recall system to keep unsafe food from the marketplace
      • Recall levels: Class I (highest risk), Class II, Class III
    • FDA First Mandatory Recall - FSMA
  • Oversees Food Labeling
    • 1966 Fair Packaging and Labeling Act
      • Identity of the product
      • Net quantity of contents
      • Name and place of the manufacturer
      • Ingredient statement in descending order of preponderance
    • 1990 Nutritional Labeling and Education Act (NLEA)
      • 1994 Nutrition Facts Panel is mandatory on foods
    • 1994 Dietary Supplement Health and Education Act (DSHEA)
    • Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004
      • Mandatory labeling of Big 8 food allergens effective 1/1/2006

EPA

  • Enforces:
    • Federal Insecticide, Fungicide, and Rodenticide Act of 1947
      • An exception to the Delaney Clause of 1958
    • Responsible for protecting human health and the environment.
      • Regarding food:
        • Determines the safety of new pesticides
        • Sets tolerance levels for pesticide residues in foods
          • It is illegal for foods to be in excess of these levels
    • FDA enforces levels set by the EPA in raw and processed foods by constantly monitoring levels.
    • EPA works with USDA to publish an annual report on pesticide residue analysis.

CDC

  • Focuses on Preventing and Controlling Food Borne (FB) Disease
    • Tracks foodborne illness outbreaks and aids in determining the cause and preventing recurrence
    • State health officials report to the CDC through NORS (foodborne illness)
    • Manages DNA fingerprinting network (PulseNet)
      • National laboratory network (> or = one per state) that connects foodborne illness cases
    • Monitors antibiotic-resistant infections thru NHSN
    • Targets prevention measures to meet food safety goals
  • Partners with:
    • FDA
    • USDA’s FSIS
    • State and local health departments
    • To ensure all aspects of food safety

U.S. Department of Commerce

  • Responsible for the inspection of fish and fish products.
    • The National Oceanic and Atmospheric Administration (NOAA) oversees fisheries management in the United States.
    • 1946 Agricultural Marketing Act, gave NOAA authority for Seafood Inspection Program
      • Provides voluntary inspection services for fish, shellfish, and fishery products to the industry.
      • Authority within the U.S. Government for issuance of health certificates for fish and fishery products exported to foreign countries.

Federal Trade Commission

  • Truth in Advertising
  • Free and Fair competition
  • No tampering allowed in advertisements
  • Enforces section of Food, Drug, and Cosmetic Act

Department of the Treasury

  • Alcoholic Beverage Regulation
    • IRS – enforces laws because alcohol is subject to federal tax
    • ATF – enforces laws regarding production, distribution, and labeling
    • FDA – governs wines with < 7% alcohol

International Agencies

  • Two agencies part of the United Nations that establish global food standards
    • FAO Food and Agriculture Organization
      • Focused on maintaining statistics on world food production and improving nutrition worldwide
    • WHO World Health Organization
      • Conduct research on nutrition and organize educational campaigns to control disease
    • Jointly create the CODEX Alimentarius Commission
      • Develop international food standards

Key Federal Agencies Involved in Regulation and Safety

  • USDA
    • Inspect meat, poultry, and eggs for interstate sale
  • FDA
    • Food Standards, food labeling, inspections, food additives
  • EPA
    • Regulate the level of pesticides allowed on produce
  • CDC
    • Track and define the source for foodborne illness