President's Council on Food Safety

U.S. Department of Agriculture	Department of Health and Human Services	Environmental Protection Agency	Department of Commerce

Introduction: The Food Safety Initiative (FSI) initially focused on the goal of reducing the number of illnesses caused by microbial contamination of food and water. This past summer when the food safety agencies developed the draft vision statement, it was assumed that the scope of the strategic plan would be broadened beyond the FSI to include chemical hazards in the food supply. The National Academy of Sciences (NAS) report broadly defined food safety as "not only the avoidance of foodborne pathogens, chemical toxicants, and physical hazards, but also issues such as nutrition, food quality, labeling, and education". While the scope of the NAS study included all these components, the report focused primarily on microbial, chemical and physical hazards from "substances that can cause adverse consequences" in domestically-produced and imported foods, including additives, pesticides and animal drug residues.

"Food safety", as used in this paper, includes public health concerns arising in both traditional and novel (e.g., genetic modification) methods of food production, processing, and preparation and covers domestic as well as imported foods. For the Council's purposes in determining the scope of the strategic plan, this paper identifies two categories of activities: "core food safety activities" and "collateral" or related activities. "Core food safety activities" include programs or activities whose mission or purpose is to enhance the safety of the nation's food supply and protect public health by reducing the annual incidence of acute and chronic foodborne illness. Other key considerations in defining "core" activities include: relative public health risks, need for interagency coordination, and public perception.

"Collateral activities" are related to and have implications for food safety but are undertaken to serve another primary purpose or mission, such as the caloric labeling of food. Specific "core" research or regulatory actions may need to be coordinated with these collateral activities, and vice versa, but "collateral activities" will not be included in the strategic plan. Collateral activities will be identified for coordination or integration as the need arises, and, in the future, could be brought within the scope of the strategic plan and the Council's work.

This framework is designed to allow the Council to focus on "core" activities that have a direct impact on food safety. Once developed, the strategic plan should assist the agencies to address the important food safety challenges by identifying priorities and making the best use of limited resources. This paper does not, therefore, determine priorities within the scope for Federal attention and resources, but rather leaves those decisions to the strategic planning process. Further, activities within the scope may not all be addressed in the same depth or at the same time in the plan depending on the assessment of the public health risks and potential benefits of action. The scope of the coordinated annual budgets may be the same or a subset of the strategic plan (or might even include a collateral activity if it was deemed appropriate). The strategic plan will inform the budget deliberations, but it may not be necessary or feasible to develop joint budgets in the first few years that are as broad as the plan.

Recommendation: It is recommended that the Council and the strategic plan focus on "core food safety activities" defined as microbial hazards, chemicals (chemical contaminants and regulated substances with pre-market approval), physical hazards, and hazards from water used in food processing and from water and manures used in production on the farm. Other "collateral activities" that are less directly related to the safety of the food supply will be considered for collaborative efforts or enhanced coordination on a specific, targeted basis as needed. Included in this second category are: the nutrition programs, regulated substances without pre-market approval (e.g., dietary supplements), and certain other waterborne hazards (e.g., drinking water/direct consumption, water for recreation).

Table 1 Food Safety Activities & Recommended Categorization for Scope Purposes
	Core	Collateral
Microbial Hazards	X
Chemical Contaminants	X
Regulated/Pre-Market Approved Substances	X
Regulated/No Pre-Market Approval Substances		X
Physical Hazards	X
Water Used in Food Production & Processing	X
Drinking Water/Direct Consumption & Water For Recreation		X
Nutrition Programs		X

Microbial hazards in food and water, as defined in the FSI, will be addressed by the Council and in the strategic plan. Microbial hazards include not only known and emerging problems due to human pathogens in imported and domestic food (from farm to table) and antibiotic resistance in pathogens, but also some naturally-occurring toxicants (e.g., mycotoxins). The strategic plan will include Federal programs for research, monitoring, surveillance, regulation and prevention (including biosolids, animal manures, irradiation of food, etc.), voluntary and mandatory certification and inspection, and enforcement as well as labeling and education (e.g., "Fight BAC!^TM") that alert consumers to potential hazards (e.g., untreated juice) or encourage use of safe food practices to avoid microbial contamination.

OPTIONS: The remainder of this paper defines and examines options which, separately or in combination, would expand the scope beyond pathogens and make the strategic plan more comprehensive along the lines suggested by NAS. Table 2 (attached) provides information on food safety activities at each agency. The options include:

Option 1: Chemical Substances: Chemicals can get into the food supply in a number of ways as described below. Under this option, FDA, USDA, EPA and CDC chemical-related food safety responsibilities would be considered in the strategic plan. The plan would address chemical/pesticide research (including research on preventive controls and intervention strategies), monitoring/surveillance (food and human diseases), regulation and related voluntary programs, inspection, enforcement, education and outreach.

1. Chemical Contaminants:
   Chemical contaminants may be either intrinsic (e.g., naturally occurring toxic constituents) or added to food (e.g., synthetic chemicals and metals), including approved substances used at unauthorized levels. This category includes environmental contaminants (e.g., methyl mercury in fish, lead in baby food), industrial contamination (e.g., dioxin in chicken feed, polybrominated biphenyls in animal feed), byproducts of manufacturing and process-induced components of foods (e.g., nitrosamines and pyrolysis products), and unauthorized levels of pesticides, food additives, and animal drug residues.

2. Regulated/Pre-market Approved Substances:
   This category includes substances that receive pre-market approval for specific uses in/on food and are either intentionally added (e.g., food additives) or may be present in food at or below legal and "safe" levels (e.g., pesticides). It includes food and feed additives (e.g., coloring agents, preservatives, food packaging waxes), flavors, enzymes, artificial sweeteners, pesticides (both residues in/on food and antimicrobials used to control pathogens), sanitizers, components of packaging materials (e.g., plasticizers, fungicide treated fruit and vegetable wraps), and animal drugs (including residues in meat and/or milk). Because of broad public concern about the risks posed by chemicals in food, they have historically been the subject of Federal attention and regulation.

3. Regulated/No Pre-Market Approval Substances:
   Another type of regulated product, dietary supplements, poses potential health risks. This class of food and ingredients does not undergo pre-market approval to evaluate safety before the products are marketed. Among the substances of concern are naturally-occurring and added substances in dietary supplements (particularly herbals and botanicals, such as ephedrine alkaloids in ma huang and Digitalis lanata in a plantain-containing supplement). Similarly, nutrients present in either low or high levels may pose health risks to vulnerable populations in products specifically designed to meet their needs (e.g., infant formula, medical foods, and foods for special dietary purposes). Also included in this category are certain other food ingredients (e.g., self-determination of GRAS, prior sanctioned additives).

All Chemicals:

• Food safety involves protecting consumers from a wide range of potential hazards including the risks posed by chemicals in the food supply.

• Chemicals are an integral part of food safety, and should be included if we are to create a seamless system.

• The NAS report specifically cited the need to include chemical hazards in any discussion of food safety and called for development of a comprehensive strategic plan for food safety; there would be a significant gap if chemicals were not addressed in the plan.

• The plan will be perceived by the public as deficient if chemicals are left out.

• Including chemicals broadens the Federal programs included in the plan and the stakeholders, and should bring additional opportunities for coordination or integration within the food safety system.

Chemical Contaminants:

• Some resource efficiencies in surveillance and enforcement effortscould likely be achieved by integrating work on microbial and chemical contamination.

• Chemical contaminants of foods have been shown to trigger chronic illnesses, such as cancer, and cause other adverse health effects (e.g., mutagenesis, impaired childhood development).

Regulated/Pre-Market Approved Substances:

• Significant Federal programs/resources at HHS, EPA and USDA are devoted to ensuring public health by regulating chemicals in food; since the mission of these programs includes food safety, they should be part of the food safety strategic plan.

• There is public concern about the safety of pesticide residues, food additives, and other chemicals added to food (including the presence of allergens where not expected).

• There is a direct link between certain regulated chemicals and our ability to control microbial contamination. For example, antimicrobials, pesticides and certain food additives play a role in controlling microbial contamination of food. These areas could benefit from coordination.

• Some of these regulated substances present new and important challenges for the food safety system (e.g., endocrine disruption, effects on vulnerable populations) that should be considered in the strategic plan.

• With respect to pesticides:

  • EPA regulates pesticide residues in/on food under the Federal, Food Drug and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA); EPA's GPRA goal for the pesticides program is "Safe Food".

  • There is a need for improved coordination on pesticides since EPA establishes pesticides residue levels, USDA and FDA monitor for such levels in food, and FDA enforces the standards.

  • The Food Quality Protection Act has focused substantial EPA resources on reassessing pesticide residue levels in/on food to account for cumulative and aggregate exposure from all uses of pesticides as well as drinking water; changes will be needed throughout the Federal system as it is implemented.

  • The NAS report on Pesticides in the Diets of Infants and Children raised food safety concerns about pesticides, especially for a vulnerable subpopulation.

Regulated/No Pre-Market Approval Substances:

• There is growing interest in dietary supplements and dietary ingredients; some supplements, including herbal products, may pose a risk of adverse health effects because they contain a toxic constituent. The Dietary Supplement Health and Education Act exempted dietary supplements from Federal pre-market approval of their safety, so effective post-market approaches are needed.

• Some dietary supplements present new challenges for the food safety system (e.g., impacts on vulnerable populations) that should be considered in the strategic plan.

• Little is known about the risks of some dietary supplements; FDA could benefit from improved coordination and prioritization of research on components of dietary supplements, such as botanicals and trace minerals, that is being done at USDA and NIH.

• The President's Dietary Supplements Commission called for additional research and monitoring; this need is not currently being met, but might be with increased attention by other agencies or through the strategic planning process.

• Dietary supplements have received insufficient Federal attention and has the potential for being a food safety problem in the future.

• The public perception that dietary supplements are not foods and that dietary supplement safety has been reviewed by FDA before marketing needs to be changed; inclusion in the FSI would help to change that public perception.

• Addition of dietary ingredients, such as the botanical St. John's Wort, to conventional foods (e.g., soup) is a growing trend in the food industry that is not anticipated to wane.

• More attention is needed to the potential problems of some food additives, especially those that were grandfathered in under the statute.

There are, however, some reasons to exclude chemicals from the "core".

All Chemicals:

• The urgency of the problem with pathogens warrants a focus on microbial contamination alone.

• There are legal, scientific, regulatory and organizational distinctions that make chemical issues different from microbes; it may be an awkward blend and create challenges in terms of balancing competing priorities.

Chemical Contaminants:

• The potential risks associated with this diverse group of substances varies widely in scope and severity; some believe that including them may broaden the scope beyond what is manageable.

• Some of these substances may not be priorities, and thus may not need to be included initially. For example, there are classes of pesticides (e.g., plant growth regulators with no toxic mode of action) that are addressed differently from those with a toxic mode of action. Similarly, risks posed by regulated food/feed additives are generally well characterized and addressed in terms of science and regulation.

• Pesticide residues are being extensively addressed due to the recent legislation; USDA and EPA are coordinating in various fora, including the Tolerance Reassessment Advisory Committee.

Regulated/No Pre-Market Approval Substances:

• Dietary supplements are mainly an HHS issue; there is less need for coordination in this area than with microbes and the other chemical categories.

• Dietary supplements are a complex, difficult issue which would bring in different constituencies, and thus complicate the strategic planning process.

• There are too many Federal activities included in the plan; some believe that expanding it to include dietary supplements would broaden the scope beyond what is manageable.

Recommendation: Chemical contaminants and regulated/pre-market approved substances should be included within the scope of the Council's efforts and its strategic plan since the mission of these programs is to ensure safe food. Because these chemicals are in the strategic plan does not mean that they all pose public health risks of the same type or magnitude, or that they will all be a priority in the plan or for budget initiatives; however, their inclusion will provide opportunities for better coordination, integration, and resource efficiencies. Further, continued progress on goals and objectives for microbial hazards can be ensured by adding chemical activities slowly on a priority basis to the budget, so that they can be absorbed into the overall FSI work in an orderly fashion (exact timing for budget inclusion to be determined by the Budget Task Force).

Regulated/no pre-market approval substances (e.g., dietary supplements) should be considered "collateral activities" and should not be included within the scope since there is relatively less need for interagency coordination of this work, and inclusion of these substances could increase the complexity of the planning process beyond what is manageable at this time.

Option 2: Physical Hazards This includes a diverse set of "foreign" physical hazards in food that can cause serious harm if consumed, including stones, bones, metal chips or parts, and glass. Included also in this category are insect and rodent infestations (e.g., insects in flour, rat droppings). For purposes of this paper, tampering is categorized here although it is recognized that tampering may include the addition of biological and microbiological agents, as well as chemical or other agents, to foods to intentionally harm the consumer. This category was included in NAS' definition of food safety concerns, but received little attention in the report.

Reasons for inclusion of physical hazards in the "core activities" include the following.

• Some physical hazards can result in significant harm to individuals.

• USDA experiences numerous incidents of metals and other fragments from machinery and other sources in meat which are a risk for the public.

• The public perceives contamination with physical hazards as part of the food safety issue.

• USDA and FDA statutes cover control and prevention of physical hazards, and USDA has resources devoted to inspecting for physical hazards.

• These hazards are relatively easy to detect and may be easy to mitigate with only a little increased Federal attention and without additional resources.

Reasons to not include physical hazards in the "core activities" are as follows.

• The urgency of the problem with pathogens and chemicals warrants a focus on them.

• Food processors and handlers have numerous safeguards in place to protect against physical hazards and tampering in order to avoid liability and other costs as well as the harmful publicity associated with incidents of easily-detected foreign materials in food.

• Partly for the reason cited above and because these hazards generally do not pose as significant a threat to public health as microbes and chemicals, some food safety agencies have paid less attention to physical hazards. Expanding the scope to include them seems unnecessary and would divert Federal resources from more significant public health risks.

• The food safety system for controlling these hazards is perceived bysome to not be broken, with the exception of dealing with tampering and bioterrorism, and thus does not warrant increased attention at this time.

Recommendation: Physical hazards should be included in the "core food safety activities", and addressed in the strategic plan. Preventing these hazards is part of the mission of some food safety agencies and is a problem, especially for meat.

Option 3: Waterborne Hazards Water is an essential component of food production, processing and preparation; food production and processing are also a significant source of contamination to the nation's waters. Public water suppliers provide a majority of the drinking water used for washing and final preparation of food, including use in reconstituted food products available in restaurants and the home. Waterborne hazards include: pathogens in irrigation and other waters used on farms and ranches that can contaminate food -- sometimes as a result of poor farming practices, in particular mismanagement in the application of animal wastes; pathogens and chemicals in surface or groundwater from point and non-point sources that can contaminate food; microbes and chemicals in public and private water supplies used for food processing and preparation; and chemicals and especially pathogens in public drinking water (Cryptosporidium in Milwaukee; E coli in Alpine, Wyoming).

There are several reasons to include waterborne hazards as "core activities" in the strategic plan.

All Water Uses:

• The food safety strategic plan may be perceived by the public as deficient if waterborne hazards are not addressed

• Water, whether for consumption by humans or animals, is considered "food" under FFDCA, and the biomedical community considers water to be a food.

• Some programs to reduce pathogen contamination of water are already included in the FSI, and EPA's research on pathogens to support its drinking water program is in the OSTP research Inventory -- i.e., microbial contamination of water is already in the FSI.

• Several common waterborne pathogens can be transmitted by the foodborne route.

• There is a need to coordinate government research on pathogens to ensure efficiency and non-duplication of Federal research (e.g., the agencies share mutual objectives in the areas of risk assessment, health effects, dose response, and analytical methods for pathogens whether in food or water).

• States will view the strategic plan as deficient if water is not dealt with at least from the standpoint of foodborne illness; the ongoing effort with state and local governments to develop a plan for integration of Federal, state and local food safety activities (which will feed into the strategic plan) is considering water.

Drinking Water/Direct Consumption:

• Drinking water is used in home and restaurant food preparation, and is added to food during manufacturing or packaging (e.g. canning).

• Bottled water, which is regulated by FDA, is considered a food.

Water Used in Food Processing (washing, icing, preparation):

• Inclusion within the scope would provide attention to the important role of processing water in food safety; if food processing water is not add ressed in the strategic plan, it will not cover all of the important challenges that need to be addressed.

• Water is used in most food processing; use of potable water is a fundamental requirement of all regulations and guidance (GMPs, GAP/GMP guidance for produce, HACCP regulations, and recommended codes -- e.g., Pasteurized Grade A milk code).

• Overlaps and gaps exist in the authority of federal agencies (USDA, FDA, and EPA) to assure the safety of water used in food processing.

Water Used in Food Production (on the farm: irrigation, washing food, application of manures):

• Inclusion within the scope would provide attention to the important role of irrigation water in food safety; the plan needs to address the role of water in food production for it to have credibility.

• Irrigation water and animal manures can be a pathway for contamination of food by pathogens; several acute disease outbreaks have occurred from this route (e.g., Cryptosporidium in apple juice), and thus there is a need for coordination of surveillance and inspections.

• Water is used in some food production, and use of potable water is a requirement of FDA guidance (e.g., GAP/GMP guidance for produce).

• EPA is responsible for the quality of shellfish growing waters andprovides guidance, while FDA is responsible for the safety of shellfish meats grown in these waters; these programs could benefit from coordination.

• EPA develops fish advisories for locally-caught fish, while FDA develops action levels for commercial seafood; inconsistencies in the action levels/fish advisories might be addressed through these joint efforts.

• The President's Clean Water Action Plan has brought the impact of non-point sources of pollution on the nation's surface water into sharp focus for EPA, USDA, and the Department of Interior (DOI). However, the impact on the nation's food supply of irrigation and manure application was not fully addressed.

• There are gaps in Federal authority to ensure the safety of water used in food production.

However, there are also reasons why waterborne hazards should not be included in the "core activities".

All Water Uses:

• The main purposes of EPA's water programs are to insure fishable and swimmable surface waters and safe tap water for drinking.

• Inclusion of all water programs in the food safety initiative could divert EPA resources from its primary responsibilities under the Safe Drinking Water Act (SDWA) and the Clean Water Act (CWA), including meeting statutory and judicial deadlines, and may expand the scope beyond what is manageable.

• It will be extremely difficult, if not impossible, to separate EPA's regulation/enforcement water program budget for food safety from the budget for the entire water program.

Drinking Water/Direct Consumption:

• Tap water that is safe for drinking is also safe for food production, processing and consumption. The SDWA regulates all water suppliers who service more than 25 people or have more than 15 connections. The States fill in the gap for systems that service less than 25 people/15 connections.

• There are synergies between the drinking water program and the clean water program that would make it difficult to separate them from each other, and unproductive to include them in the FSI. These synergies include source water protection and clean water activities, and EPA's two revolving loan funds that pay for infrastructure upgrades and sewer systems.

• The distribution system for drinking water is different than for food products, so the kind of response to microbial contamination is different. We know where the drinking water is coming from because of the fixed pipe system. As a result, while drinking water can pose microbial contamination threats, there is little to be gained by integration with food safety risks.

• FDA's bottled water program and the Food Code for retail establishments relies on SDWA standards.

Water Used in Food Processing (washing, icing, preparation):

• EPA does not regulate water in food production, processing, preparation and consumption any differently than it does drinking water; consumer safety from food processing uses of water has not been a primary concern for EPA.

Water Used in Food Production (on the farm: irrigation, washing food, application of manures):

• USDA, DOI, and EPA already coordinate on regulatory issues through the President's Clean Water Action Plan and through the Animal Feeding Operation Strategy.

Recommendation: Waterborne hazards should be considered "core" for those specific activities related to on the farm food production and to food processing. This would include coordination on research and development and on other activities related to:

• Production: Irrigation and other on the farm practices involving water application to crops and application of manures or biosolids (i.e., sewage sludge) to crops; and

• Processing: Water used in food preparation, shipping, and on-site handling, especially with respect to small drinking water systems and unregulated water suppliers.

Assuring the safety of water used for drinking or other direct consumption, and of surface water used for recreation or ecological protection, should be considered a "collateral activity" which is related to food safety but the primary mission of which is not to reduce foodborne illnesses. Collaboration to avoid duplication of research efforts and ensure adequate EPA input into development of FDA and USDA guidelines (e.g., Food Code) is important, but can be accomplished without these other areas of the water category being a part of the strategic plan.

Option 4: Nutrition Programs There are several HHS and USDA programs as well as public-private partnerships designed to define and educate the American people on the benefits of a healthy, nutritious diet. USDA and FDA have developed the food pyramid, which recommends daily consumption of quantities of fruits, vegetables, meat and grains. Both agencies also have labeling programs designed to inform the public on the caloric and nutritional content of food. These programs are important in encouraging the consumption of a healthy, nutritious diet which can help to reduce the incidence of both acute and chronic disease.

Some believe that these nutrition programs are aligned with food safety and should be part of the "core activities" for the following reasons.

• The Federal government cannot ensure a healthy and affordable food supply, as outlined in the draft vision, without consideration of the nutrition programs.

• This would provide an opportunity to develop public health messages about both the nutritional benefits and the infectious/toxicologic hazards associated with various foods.

• Nutrition information could send a positive, constructive message to the American people, making food safety about more than just food contamination and foodborne illness. Food safety could also be about eating a wholesome, balanced diet to reduce the risk of disease, particularly chronic diseases (e.g., some cancers), developmental effects, and malnutrition.

On the other hand, the nutrition programs might not be considered "core activities" for several reasons.

• Inclusion of the nutrition programs could dilute FSI efforts on infectious and toxicologic hazards to the point of ineffectiveness, and the nutrition programs do not need attention or funding.

• The intent of the nutrition programs is to promote healthy eating habits by the American people and reduce the incidence of chronic disease; their primary purpose is not to enhance the safety of the food supply.

Recommendation: Federal programs to define and promote a healthy diet should be considered "collateral activities". They can support and help to implement the vision of a safe, healthy and affordable food supply, but are not designed to ensure food safety. It is recognized that some labeling has specific food safety goals (e.g., warning labels on untreated, raw juices and allergen warnings) and this labeling is included in the "core activities".

TABLE 2 FEDERAL ACTIVITIES RELATING TO FOOD SAFETY
Responsible Federal Agency	Other Agencies Involved	Activity	Type of Activity	Issues Addressed	Core or Collateral Activity
U.S. Department of Agriculture
Food Safety & Inspection Service	FDA EPA CDC	Sets standards for meat, poultry and egg products shipped interstate; inspects domestic and imported meat and poultry and enforces standards; recalls adulterated products.	Regulation, Inspection, Enforcement, & Education	Pathogens Chemical residues Physical hazards Food quality	Core
Agricultural Marketing Service	EPA	Pesticide data program to monitor and collect pesticide residue information for EPA risk assessment; microbial data program surveillance and monitoring; voluntary quality certification program.	Regulatory Support, Monitoring, & Risk assessment	Pesticides Pathogens Food quality	Core
Agricultural Research Service	EPA FDA	Intramural research on elimination, mitigation and detection of hazards.	Research, Regulatory Support, & Education	Pathogens Chemicals	Core
Cooperative State Research, Education & Extension Service	EPA FDA	Extramural research, outreach, and education on elimination, mitigation, and detection of hazards.	Research, Regulatory Support, & Education	Pathogens Chemicals	Core
Animal & Plant Health Inspection Service	EPA FDA	Animal and plant health, regulation of biotechnology and irradiation.	Regulation, Inspection, & Enforcement	Biotechnology Irradiation	Core
Economic Research Service	EPA FDA	Data collection, interpretation and cost-benefit analyses of foodborne illnesses.	Regulatory Support, Guidance, & Risk assessment	Pesticide uses Chemicals Pathogens	Core
National Agricultural Statistical Service	EPA FDA	Data collection and monitoring.	Regulatory Support, & Risk assessment	Pesticides	Core
Grain Inspection, Packers & Stockyards Administration	FDA	Monitors the accuracy of aflatoxin testing services.	Monitoring	Mycotoxins	Core
Office of Risk Assessment & Cost Benefit Analysis	EPA FDA	Data interpretation, guidance, technical assistance and risk assessment.	Regulatory Support, Guidance, & Education	Pathogens Pesticides Chemical hazards	Core
Office of Pest Management Policy	EPA FDA	Data collection, interpretation, guidance, and risk assessment.	Regulatory Support, & Guidance	Pesticides	Core
Food & Drug Administration
Center for Food Safety & Applied Nutrition	USDA EPA CDC DOC HCFA States	Set standards, policy & guidance to ensure minimal levels of microbial & chemical contaminants & physical hazards; monitor foods for those hazards. Evaluate safety & approve use of food ingredients, antimicrobials and certain processing techniques (e.g., irradiation). Enforce tolerances for pesticides in foods (including meat & poultry). Inspect food establishments and imported foods. Conduct risk assessments & risk prioritization. Investigate major foodborne outbreaks, except meat & poultry. Monitor safety of special nutritionals (e.g., dietary supplements). Administer cooperative federal/state programs in milk, shellfish, food service and interstate travel.	Regulation, Research, Risk assessment, Monitoring, Inspection, Enforcement, Guidance, & Education	Pathogens Chemicals hazards Chemical contaminants Pesticide residues Mycotoxins Physical hazards Labeling Nutrition	Core (all programs, except some labeling) Collateral (some labeling)
Center for Veterinary Drugs	USDA CDC	Evaluate safety & approve use of animal drugs & ingredients in animal feeds. Set standards, policy & guidance to ensure minimal levels of microbial & chemical contaminants in animal feeds and minimal occurrence of antibiotic resistant pathogens in food animals and feeds. Conduct risk assessments & risk prioritizations. Conduct research on antimicrobial resistance & methods for analysis for pathogens & contaminants. Monitor occurrence of antibiotic resistance in pathogens in food animals and animal feeds.	Regulation, Research, Risk assessment, Monitoring, Enforcement, & Education	Veterinary drugs Chemical contaminants Regulated substances Pathogens	Core
Centers for Disease Control & Prevention
Centers for Disease Control & Prevention	USDA FDA EPA	Investigates outbreaks of foodborne illness; monitors and collects information on food- and waterborne illnesses; conducts nationwide surveillance for food- and waterborne diseases; designs and implements surveillance systems; does reference identification; performs research on diagnostic and subtyping methods; assesses prevention efficacy; assists state and local health agencies; and training and education.	Surveillance, Monitoring, Outbreak investigation, Research, Technical assistance, Training, & Education	Food- and waterborne pathogens FoodNet & PulseNet Infectious disease outbreaks Chemical hazards	Core
U.S. Environmental Protection Agency
Office of Prevention, Pesticides & Toxic Substances	USDA FDA CDC	Regulation of pesticide uses, residues in/on food and antimicrobials for control of pathogens. Supports investigations of certain chemical contamination incidents and regulates chemicals and metals not covered by FIFRA, FQPA & FFDCA.	Regulation, Guidance, & Risk assessment	Pesticides Chemical contaminants	Core
Office of Water	USDA CDC FDA DOI	Regulates drinking water quality and biosolids; establishes water discharge standards for facilities. Provides criteria for ambient water contamination, watershed controls, and other pathogen elimination/protection authorities.	Regulation, Guidance, Research, & Risk assessment	Pathogens Chemicals Animal wastes Other agricultural wastes	Core (water in food production & processing) Collateral (drinking water/direct consumption, water for recreation)
Office of Research & Development	OSTP USDA FDA	Responsible for research on pathogens in water, pesticide testing methods, chemical monitoring methods development, and risk assessment issues; provides technical and scientific advice on risk assessment, and testing and monitoring methods.	Research, Guidance, & Risk Assessment	Chemicals Pesticides Pathogens	Core (pesticides; pathogens) Collateral (pathogens)
Office of Enforcement & Compliance Assurance	FDA USDA	Ensures that pesticides used on crops/food are registered, are not adulterated, and are used correctly. Ensures that data used to support pesticides registration is not fraudulent. Referrals for possible illegal residues. Collects pesticide production information. Inspects & enforces or oversees State inspection & enforcement of CWA & SDWA requirements.	Inspections, Enforcement, Referrals, Regulation, Risk assessment support, Water discharge standards, & Tap water standards.	Product inspections Use inspections Lab Inspections Pesticide misuse Recalls	Core (pesticides; biosolids) Collateral (drinking water/direct consumption & water for recreation)
Department of Commerce
National Marine Fisheries Service	FDA	Voluntary inspection program for seafood quality.	Inspection	Food quality Toxins Pathogens

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