Food safety regulation in the United States: An overview of the actors

1. Food safety regulation in the United States: An overview of the actors Prof. Stephanie Tai, Assistant Professor

2. A pictorial overview of the food safety actors Food industry sector: Growers Processors Preparers Often have internal quality-control procedures • Federal Agencies • U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS): meat; poultry; frozen, dried & liquid eggs. • Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN): covers everything else. • Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides and Toxic Substances (OPPTS): pesticides • U.S. Centers for Disease Control and Prevention’s (CDC) Food Safety Office: foodborne infections* Consumers With varying degree of quality control methods. Informed by safety education efforts from all of these sectors. State and local governments Often in charge of on-the-ground inspections, especially of restaurants and food preparation sites Plus a large number more, including FDA’s Center for Veterinary Medicine; Department of Commerce’s National Marine Fisheries Service (NMFS); Department of Treasury’s Customs Service; National Institutes of Health (NIH); USDA’s Animal and Plant Health Inspection Service (APHIS); USDA’s U.S. Codex Office; USDA’s Agricultural Marketing Service (AMS); USDA’s Agricultural Research Service (ARS); USDA’s Cooperative State Research, Education, and Extension Service (CSREES); USDA’s Economic Research Service (ERS); and USDA’s Grain Inspection, Packers and Stockyard Administration (GIPSA).

3. U.S. federal administrative structure:A super-simple view Enacts statutes that give agencies authority to regulate food safety and to enforce those regulations. These statutes are usually fairly particular in the sense of which agencies are accorded authority, but broad(or at least ambiguous) in their grant of authority,. Congress Agencies Promulgate regulations as authorized by statutes; enforces those regulations (and sometimes statutes) • Review challenges to • Statutes • For unconstitutionality • For interpretation • Regulations • For failure to comply with statutes • For failure to apply facts to the considerations required in the statutes • Enforcement actions • For failure to comply with statutes or regulations • For failure to apply facts to the considerations required in the statutes or regulations Courts

4. More on federal responsibilities • Agencies have only the authorities granted to them by Congress • But they have discretion in how they choose to exercise that authority

5. The major federal actors: USDA Food Safety and Inspection Service (FSIS) • Authority • Domestic and imported meat and poultry and related products, like meat-or-poultry containing stews, pizzas, and frozen foods • Processed egg products • Actions • Inspects food animals for disease before and after slaughter • Inspects meat and poultry slaughter and processing plants • Along with USDA Agricultural Marketing Service, monitoring and inspecting processed egg products • Collects and analyzes samples of food products for microbial and chemical contaminants and infectious and toxic agents • Establishes production standards for use of food additives and other ingredients in preparing and (REGULATORY AUTHORITY) • Ensures that foreign meat and poultry processing plants exporting to the United States meet U.S. standards • Seeks voluntary recalls by meat and poultry processors of unsafe products • Can be more “coercive”: forced testing, withdrawal of inspectors • Media and making companies “look bad” • Tracing activities, identifying critical control points • Sponsors research on meat and poultry safety • Educates industry and consumers on safe food-handling practices

6. The major federal actors: Food and Drug Administration (FDA) • Authority • Domestic and imported food sold in interstate commerce, including shell eggs but not meat and poultry • Bottled water • Wine beverages with less than 7 percent alcohol • Actions • Inspects food production establishments and warehouses and collects and analyzes samples for physical, chemical, and microbial contamination • Reviews safety of food and color additives before marketing • Reviews animal drugs for safety • Monitors safety of animal feeds used in food-producing animals • Develops model state codes for regulating restaurants and grocery stores • Establishes good food manufacturing practices (like HACCP) • Works with foreign governments to insure safety of imported food products • Requests recalls of unsafe food products • Takes appropriate enforcement actions • Conducts research • Educates industry and consumers

7. The major federal actors: Environmental Protection Agency (EPA) • Authority • Pesticides • Drinking water • Actions • Determines safety of new pesticides, sets tolerance levels for pesticide residues in foods, and publishes directions on safe use of pesticides • Regulates toxic substances and wastes to prevent their entry into the environment and the food chain • Establishes safe drinking water standards • Assists states in monitoring quality of drinking water and finding ways to prevent contamination of drinking water

8. The major federal actors: Centers for Disease Control and Prevention • Authority • Foodborne infections from all foods • Actions • Investigates sources of food-borne disease outbreaks (in conjunction with local, state, and other federal officials) • Develops and maintains a nationwide system of food-borne disease surveillance • Develops and advocates public health policies to prevent food-borne illnesses • Conducts research to prevent food-borne illnesses • Trains local and state food safety personnel

9. What does this mean for, say, pizza? Taken from Statement of Lawrence J. Dyckman, Director, Food and Agriculture Issues, Resources, Community, and Economic Development Division, U.S. Needs a Single Agency to Administer a Unified, Risk-Based Inspection System, GAO/T-RCED-99-256 http://www.gao.gov/archive/1999/rc99256t.pdf (1999), at 6.

10. So what kinds of food-safety threats are there? Examples… • Biological pathogens • Naturally occurring toxins • Dietary supplements • Pesticide residues • Toxic metals • Decomposition contaminants • Food allergens • Nutrient concerns • Dietary components • Product tampering

11. Technical issues with assuring food safety [drawn from FDA, Food Protection Plan] • Prevention • Diagnosing and outbreak • Finding technologies and production processes that can prevent contamination • Finding technologies that can detect contamination • Finding methods to monitor supply chain • Finding methods to communicate safety information • Developing appropriate acceptable risk levels • Intervention • Finding technologies that can detect contamination • Figuring out source of contamination • Response • Finding methods to avoid or treat contamination • Finding methods to communicate safety information • Source attribution: figuring out the source of an outbreak/contaminant • Responding to new/unknown challenges • Compliance issues with training—making sure people are aware of and actually engaging in good practices • International: Monitoring and communication with foreign suppliers • Even intergovernmental issues from one state to another: uniformity issues & coordination issues • Economic response and communicating safety to the public • Language barriers: (both with other countries and inside the US)

12. FDA Food Protection Plan:Tools that jumped out to you as warranted and/or useful • Increasing corporate responsibility: PR campaign • Through use of preexisting legal mechanisms • Creation of “good actor” list. • Disclosure requirements • Certification systems • Governmental certification (or private): food context, “organic” labelssometimes transitions from private to governmental • Registration • Paying for registration with fees used to support the agency and to increase enforcement efforts • Professional organizations where government and business develop voluntary standards • Ex. ISO, “roundtables” “advisory panels” . Congressional testimony as well.

13. Asserted problems by various consumer groups arising out of the current system (and possible disagreements?) • Trust for America’s Health • Inadequate inspections of manufacturers, • Dearth of scientists who understand emerging new science and technologies, • Inability to speed the development of new therapies, • A broken import system • Food supply risks • Poor information infrastructure • Center for Science in the Public Interest • Concern with split or inconsistent jurisdictions • Inadequate resources for inspections • Works under statutory language like “repeated, serious adverse health consequences or death” that may be insufficient for flexible use of authority • FDA lacks statutory authority to enact traceability standards and impose civil penalties • FDA fails to require food safety plans as well as food security plans • FDA lacks authority to implement and mandate life-cycle approach to food safety • Amazing that anything’s safe: complexity of the food production scheme in general • In some ways, system places more responsibility on individual consumers

14. More on some of the problems • Misaligned Priorities and Resources: much more money spent for USDA programs than FDA programs even though more foodborne illnesses (85% v. 15%) arise in FDA-regulated products • Failure to hold U.S.-based entities legally accountable for ensuring safety of imported goods: Instead, FDA and the U.S. Customs Border and Protection enter data on all U.S. food imports into a database system that electronically screens paperwork on shipments to determine whether their contents might pose a risk to the public’s health. Imported goods that trigger concern can be physically inspected, but due to limited resources, FDA only inspects approximately one percent of shipments. • Outdated laws (requiring outdated practices). Example: mandated visual inspections of chickens even though agricultural practices make this type of inspection obsolete. • Inadequate federal, state, and local collaboration. Standards are voluntary, and are adopted at different intervals.

15. Even more on some of the problems • Inadequate mandate to protect safety of the food supply: statutes provide authority only in particular circumstances • Inadequate resources to protect safety of the food supply: agencies might not have adequate resources to perform the sorts of inspections contemplated by their authorizing statutes • Inadequate legal tools: agencies might lack the ability to inspect, issue fines, mandate adoption of good practices procedures, etc. in certain circumstances • Piecemeal organization/modernization (ex. HACCP voluntary) • Patchwork monitoring system • Few resources within the federal government for monitoring, so much of it is done by the states • Plus also animal ID is voluntary • In smaller areas, tension between what people want to eat and what might still be treated as “unsafe”: tension between food safety concerns and other cultural/food preference concerns difficulties in measuring exposure risk

16. Recommendations • Trust for America’s Health • Farm to fork disease prevention practices (HACCP) • Ability to keep pace with emerging threats • Monitoring foreign imports and international practices • Strengthening FDA and aligning resources with the highest-risk threats • Center for Science in the Public Interest • Coordinating regulatory jurisdiction • Enhancing agency resources • Enhancing agency statutory authority • Requiring more adoption of food safety and life-cycle approaches.

17. A final example: eggs Breeding the hens Producing eggs on farms Cleaning and packing eggs at processing plants Transporting eggs to wholesalers and retailers Handling and preparing eggs at restaurants, institutions, and homes

18. A final example: eggs Cleaning process: Agr. Marketing Service Breeding the hens Producing eggs on farms Cleaning and packing eggs at processing plants USDA: Animal and Plant Health Inspection Service Transporting eggs to wholesalers and retailers Retail outlets: FDA Handling and preparing eggs at restaurants, institutions, and homes State agriculture and health departments

19. A final example: eggs • Imagine various egg products. Jurisdictionally, a number of agencies play different roles in regulation of the product, which means a complex system of coordination. • Or imagine an unknown salmonella outbreak with an unknown egg-related cause. Again, jurisdictionally, a number of agencies would play different roles in regulation of the product, which again would mean a complex system of coordination.