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
• 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.
Food industry
sector:
Growers
Processors
Preparers
Often have internal qualitycontrol procedures
• Environmental Protection Agency’s (EPA)
Office of Prevention, Pesticides and Toxic
Substances (OPPTS): pesticides
State and local
governments
• U.S. Centers for Disease Control and
Prevention’s (CDC) Food Safety Office:
foodborne infections*
Often in charge of on-theground inspections,
especially of restaurants
and food preparation sites
Consumers
With varying degree of
quality control methods.
Informed by safety
education efforts from
all of these sectors.
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
Congress
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,.
Agencies
Promulgate regulations as authorized by statutes;
enforces those regulations (and sometimes statutes)
Courts
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
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
–
–
–
–
–
–

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
–

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
FDA Food Protection Plan:
Tools that jumped out to you as warranted and/or useful

Increasing corporate responsibility: PR campaign
–
–
–

Certification systems
–

Governmental certification (or private): food context, “organic”
labelssometimes transitions from private to governmental
Registration
–

Through use of preexisting legal mechanisms
Creation of “good actor” list.
Disclosure requirements
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
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
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
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
Shell
eggs
FDA
Broken
eggs
FSIS
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.