Food safety regulation in the United

States: An overview of the actors

Prof. Stephanie Tai,

Assistant Professor
A pictorial overview of the food
safety actors

Federal Agencies Food industry

sector:
• U.S. Department of Agriculture’s (USDA) Growers
Food Safety and Inspection Service (FSIS): Processors
meat; poultry; frozen, dried & liquid eggs.
Preparers
• Food and Drug Administration’s (FDA)
Center for Food Safety and Applied
Often have internal quality-
control procedures
Consumers
With varying degree of
Nutrition (CFSAN): covers everything else. quality control methods.
• Environmental Protection Agency’s (EPA) Informed by safety
Office of Prevention, Pesticides and Toxic State and local education efforts from
all of these sectors.
Substances (OPPTS): pesticides governments
• U.S. Centers for Disease Control and Often in charge of on-the-
ground inspections,
Prevention’s (CDC) Food Safety Office: especially of restaurants
foodborne infections* 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).
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
Congress
particular in the sense of which agencies are
accorded authority, but broad (or at least
ambiguous) in their grant of authority,.

Promulgate regulations as authorized by statutes;

Agencies enforces those regulations (and sometimes statutes)

Review challenges to
•Statutes
•For unconstitutionality
•For interpretation
Courts •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
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
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
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
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
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
 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.
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
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)
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.
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
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.
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
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.
A final example: eggs

Producing Cleaning and packing

Breeding
eggs on eggs
the hens
farms at processing plants

Transporting eggs to
wholesalers and retailers

Handling and preparing eggs

at restaurants, institutions,
and homes
A final example: eggs
Cleaning process: Agr. Marketing Service

Producing Cleaning and packing Shell Broken

Breeding
eggs on eggs eggs eggs
the hens
farms at processing plants FDA FSIS

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

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.