Food Safety Actors-1

8/8/2019 Food Safety Actors-1

1/19

Food safety regulation in the UnitedStates: An overview of the actors

Prof. Stephanie Tai,

Assistant Professor


2/19

A pictorial overview of the food

safety actors

Federal Agencies

U.S. Department of Agricultures (USDA)

Food Safety and Inspection Service (FSIS):

meat; poultry; frozen, dried & liquid eggs.

Food and Drug Administrations (FDA)

Center for Food Safety and Applied

Nutrition (CFSAN): covers everything else.

Environmental Protection Agencys (EPA)

Office of Prevention, Pesticides and ToxicSubstances (OPPTS): pesticides

U.S. Centers for Disease Control and

Preventions (CDC) Food Safety Office:

foodborne infections*

Food industry

sector:Growers

Processors

PreparersOften have internal quality-

control procedures

ConsumersWith varying degree of

quality control methods.

Informed by safety

education efforts from

all of these sectors.

Plus a large number more, including FDAs Center for Veterinary Medicine; Department of Commerces NationalMarine Fisheries Service (NMFS); Department of Treasurys Customs Service; National Institutes of Health (NIH);

USDAs Animal and Plant Health Inspection Service (APHIS); USDAs U.S. Codex Office; USDAs Agricultural Marketing Service (AMS); USDAs Agricultural Research Service (ARS); USDAs Cooperative StateResearch, Education, and Extension Service ( CSREES); USDAs Economic Research Service (ERS); and USDAs Grain Inspection, Packers and Stockyard Administration (GIPSA).

State and localgovernments

Often in charge of on-the-

ground inspections,

especially of restaurants

and food preparation sites


3/19

U.S. federal administrative structure:A super-simple view

Congress

Agencies

Courts

Enacts statutes that give agencies authority to

regulate food safety and to enforce those

regulations. These statutes are usually fairly

particularin 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;

enforces those regulations (and sometimes statutes)

Review challenges to

StatutesFor unconstitutionalityFor interpretation

RegulationsFor failure to comply with statutesFor failure to apply facts to the considerations requiredin the statutes

Enforcement actionsFor failure to comply with statutes or regulations

For failure to apply facts to the considerations requiredin the statutes or regulations


4/19

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


5/19

The major federal actors: USDA FoodSafety 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 processedegg products

Collects and analyzes samples of food products for microbial and chemical contaminantsand infectious and toxic agents

Establishes production standards for use of food additives and other ingredients inpreparing and (REGULATORY AUTHORITY)

Ensures that foreign meat and poultry processing plants exporting to the United Statesmeet 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


6/19

The major federal actors: Food andDrug 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


7/19

The major federal actors: EnvironmentalProtection Agency (EPA)

Authority Pesticides

Drinking water Actions

Determines safety of new pesticides, sets tolerance levels for pesticideresidues in foods, and publishes directions on safe use of pesticides

Regulates toxic substances and wastes to prevent their entry into theenvironment and the food chain

Establishes safe drinking water standards

Assists states in monitoring quality of drinking water and finding ways toprevent contamination of drinking water


8/19

The major federal actors: Centers forDisease 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 diseasesurveillance

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


9/19

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 InspectionSystem, GAO/T-RCED-99-256 http://www.gao.gov/archive/1999/rc99256t.pdf(1999), at 6.


10/19

So what kinds of food-safety threatsare there? Examples

Biological pathogens

Naturally occurring toxins Dietary supplements

Pesticide residues

Toxic metals

Decomposition contaminants Food allergens

Nutrient concerns

Dietary components

Product tampering


11/19

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 trainingmaking 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


12/19

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

labelssometimes 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.


13/19

Asserted problems by various consumer groups

arising out of the current system (and possibledisagreements?)

Trust for Americas 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 anythings safe: complexity of the food production scheme in

general


14/19

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

publics 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.


15/19

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


16/19

Recommendations

Trust for Americas 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.


17/19

A final example: eggs

Breeding

the hens

Producing

eggs onfarms

Cleaning and packing

eggsat processing plants

Transporting eggs to

wholesalers and retailers

Handling and preparing eggs

at restaurants, institutions,

and homes


18/19


Breeding

the hens

Producing

eggs onfarms

Cleaning and packing

eggsat processing plants

Transporting eggs to

wholesalers and retailers

Handling and preparing eggs

at restaurants, institutions,

and homes

USDA: Animal and Plant

Health Inspection Service

Shell

eggsFDA

Broken

eggsFSIS

Cleaning process: Agr. Marketing Service

Retail outlets: FDA

State agriculture and health departments


19/19


Imagine various egg products. Jurisdictionally, a

number of agencies play different roles in regulationof 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 inregulation of the product, which again would mean a

complex system of coordination.

Documents

Food Safety Actors-1