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MOU 225-85-8400

Memorandum of Understanding

Between
The Food Safety and Inspection Service and Agriculture Marketing Service
United States Department of Agriculture 

and

The Food and Drug Administration
United States Department of Health and Human Services

and

The United States Environmental Protection Agency

 

SUBJECT: MOU with USDA (FSIS and AMS) and EPA regarding regulatory activities concerning residues of drugs, pesticides, and environmental contaminants in foods. (225-85-8400)

 

I. PURPOSE

The purpose of this agreement is to set forth the working relationships among the U.S. Department of Agriculture (USDA), specifically the Food Safety and Inspection Service (FSIS) and the Agriculture Marketing Service (AMS), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA) to promote more effective, efficient, and coordinated Federal regulatory activities concerning residues of drugs, pesticides and environmental contaminants that may adulterate food.

 

This memorandum of understanding (MOU) supersedes an April 1975 MOU between the Animal and Plant Health Inspection Service (APHIS) and FDA, an August 1977 MOU between the Food and Safety and Quality Service (FSQS) and EPA, and a May 1975 MOU between FDA and EPA. By a reorganization dated January 9, 1978, the meat and poultry inspection program was transferred from APHIS to FSQS; and by a reorganization dated September 30, 1981, it was transferred to FSIS.

 

This MOU does not modify any other existing agreements between USDA, FDA, and/or EPA. It supplements an MOU, revised in 1983, defining the authorities and responsibilities of FDA and AMS regarding eggs and egg products.

 

II. BACKGROUND

Food, including meat, poultry, egg products, and animal feed, may become adulterated with residues of drugs, pesticides, or environmental contaminants as a result of drug or pesticide misuse (i.e., unapproved or non-registered use) or because of the presence of pesticides or other chemicals in the environment or other indirect sources of contamination. Regardless of the source of the adulteration, the immediate and primary concern is to assure removal of adulterated food from consumer channels and to prevent further marketing of such adulterated food.

USDA is charged with the enforcement of the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA). Within USDA, FSIS is responsible for the wholesomeness and safety of meat, poultry, and products thereof intended for human consumption. This is accomplished, in part, by inspection at slaughtering and processing establishments and by sampling and analyzing edible tissues derived from livestock and poultry at the time of slaughter or after slaughter at other locations outside the establishment to assure, among other things, that meat and poultry do not contain residues of drugs, pesticides, or environmental contaminants that cause them to be adulterated under the FMIA or PPIA. AMS is responsible for the wholesomeness and safety of egg products. Among other things, it conducts inspection and samples for such residues at plants processing egg products to assure compliance with the EPIA.

 

FDA is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under this act, FDA is responsible for ensuring that human foods and animal feeds are safe and, among other things, do not contain illegal residues of drugs, pesticides, or environmental contaminants. FDA also approves drugs used for food producing animals, establishes tolerances for residues of animal drugs in edible tissues, establishes tolerances (other than for pesticides) and action levels for unavoidable environmental contaminants that may adulterate food, inspects the processing and distribution of human foods and animal feeds, and examines samples of these products to assure compliance with the FFDCA.

EPA is responsible for administering and enforcing the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under this act, EPA has the authority to protect humans and their environment from unreasonable adverse effects of pesticide chemicals by regulating the sale and use of pesticide products. EPA samples chemicals to verify label claims concerning content and safety, and investigates incidents where the misuse of pesticides may have occurred. EPA is responsible under the FFDCA for establishing tolerances and recommending action levels to FSIS and FDA for residues of pesticides in food and has the authority to monitor the effectiveness of surveillance and enforcement. Under the Toxic Substances Control Act (TSCA), EPA also regulates other chemical substances (e.g., industrial chemicals) that can adulterate food.

 

Because FSIS, AMS, FDA, and EPA have common and related objectives in carrying out their respective enforcement responsibilities, it is desirable and in the public interest to set forth in a memorandum of understanding the working arrangements adopted to discharge these responsibilities as effectively as possible.

 

III. SUBSTANCE OF AGREEMENT

A. USDA agrees to:

class="indent1">1. Furnish EPA and FDA headquarters with a list of all federally inspected meat and poultry slaughtering and processing establishments and egg products plants. This shall include periodic updates of changes or additions to the list.

2. Upon request, sample and analyze specific lots of livestock and poultry at slaughtering establishments and egg products at processing plants that FDA or EPA suspects contain residues of drugs, pesticides, or environmental contaminants that exceed tolerances at action levels or otherwise adulterate meat or poultry, or products thereof, or egg products.

3. Notify the appropriate EPA regional office and headquarters of any findings of residues of pesticides or chemical substances in edible tissue samples of meat and poultry, or products thereof, or egg products that may indicate a violation of FIFRA or TSCA. Subsequent relevant information on these findings shall be similarly provided.

4. Notify the appropriate FDA district office and headquarters of any findings of residues of drugs, pesticides, or environmental contaminants in edible tissue samples of meat or poultry, or products thereof, or egg products that exceed tolerances or action levels or otherwise adulterate such food. Subsequent relevant information on these findings shall be similarly provided.

5. Review and investigate as necessary reports from FDA or EPA that meat or poultry, or products thereof, or egg products may be adulterated with residues of drugs, pesticides, or environmental contaminants and notify the referring office of the results.

6. Keep FDA and EPA headquarters informed of all FSIS and AMS sampling and testing programs for residues of drugs, pesticides, and environmental contaminants in meat or poultry, or products thereof, or egg products; and consult periodically with FDA and EPA headquarters on FSIS's National Residue Program through the agencies' Surveillance Advisory Team or other appropriate means.

7. Provide FDA and EPA headquarters with periodic reports listing results of all such residue sampling and testing programs, including, to the extent appropriate, the number and identity of samples tested, the residues for which tests were conducted, the analytical and statistical methodologies used, and other related information.

8. Notify FDA headquarters whenever FSIS plans to seek an action level or tolerance from EPA for a pesticide residue in meat or poultry so that FDA may also consider the need for an action level or tolerance for that pesticide residue in animal feed and animal feed ingredients.

9. Provide FDA with any other information obtained concerning residues of drugs, pesticides, or environmental contaminants that may indicate a violation of the FFDCA; and provide EPA with any such information that may indicate a violation of FIFRA or TSCA.

 

B. FDA agrees to:

1. Notify the appropriate EPA regional office of investigations or findings concerning possible misuse of pesticides or chemical substances that may indicate a violation of FIFRA or TSCA. Subsequent relevant information on these investigations or findings shall be similarly provided.

2. Notify USDA headquarters of findings of illegal residues of drugs, pesticides, or environmental contaminants in human food or animal feed which indicate that the residues also may be present in meat or poultry, or products thereof, or egg products. Subsequent relevant information on these findings shall be similarly provided.

3. Notify the affected FSIS regional office or headquarters, as appropriate, upon obtaining any information that animals that have been or are expected to be offered at any establishment under FSIS inspection may contain residues that would adulterate meat or poultry, or products thereof. Subsequent relevant information on these findings shall be similarly provided.

4. Review and investigate as necessary reports from USDA or EPA that animals or eggs intended for human food or animal feed may contain residues that would adulterate such food or feed and notify the referring office of the results.

5. Keep USDA headquarters informed of all FDA sampling and testing programs for residues of drugs, pesticides, and environmental contaminants in animal feed, dairy products, and eggs and provide USDA headquarters with periodic reports listing results, including, to the extent appropriate, the number and product identity of samples tested, the residues for which tests conducted, the analytical methodology used, and other related information.

6. Keep EPA headquarters informed of all FDA sampling and testing programs for residues of pesticides and chemical substances and notify EPA of any significant new findings from these programs.

7. When requested by USDA, consider the need for establishing tolerances or action levels for environmental contaminants in meat, poultry, or eggs.

8. Notify USDA headquarters whenever it intends to establish or amend a tolerance for an animal drug or a tolerance or action level for an environmental contaminant that may affect USDA's responsibilities under the FMIA, PPIA, or EPIA, and include a summary of the information and evaluation upon which such tolerances or action level is based and a method of analysis to be used to enforce such tolerance or action level. Also notify USDA headquarters whenever it intends to seek an action level recommendation or tolerance from EPA for a pesticide residue in animal feed, feed ingredients, dairy products, or eggs.

9. Provide USDA with any other information obtained concerning residues of drugs, pesticides, or environmental contaminants that may indicate a violation of the FMIA, PPIA, or EPIA; and provide EPA with any such information that may indicate a violation of FIFRA or TSCA.

10. Notify FSIS headquarters when it authorizes to be used for food animals that have been treated with an investigational new animal drug under section 512(j) of the FFDCA and provide relevant information upon which FSIS can authorize slaughter.

 

C. EPA agrees to:

1. Notify the appropriate FDA district office and USDA headquarters, as appropriate, of any pesticide use encountered by EPA that may have resulted in residues that adulterate human food or animal feed, and include relevant safety information on the pesticide(s) involved. Subsequently relevant information shall be similarly provided.

2. Review and investigate as necessary, or refer to the appropriate state enforcement authority for investigation, reports from USDA or FDA of pesticide misuse or other possible violations of FIFRA or TSCA and notify the referring office of the results.

3. Provide USDA and FDA headquarters with information from any monitoring programs, investigations, or other sources involving pesticides or chemical substances that may contaminate human food or animal feed.

4. Notify USDA and FDA headquarters, as appropriate, of regulatory actions under TSCA involving the manufacture, processing, distribution in commerce, use, or disposal of chemical substances when the risk being assessed may include contamination of human food or animal feed.

5. Notify USDA headquarters and FDA headquarters and regional offices, as appropriate, of experimental use permits issued under section 5 and emergency exemptions granted under section 18 of FIFRA that involve uses of pesticides that might affect food; and provide relevant information on the approved non-registered use, including regulatory limits established for residues of the pesticide resulting from such use.

6. Recommend, upon request from and in consultation with FDA and/or FSIS, action levels for pesticide residues in human food or animal feed and consider the need for tolerances.

7. Notify USDA and FDA headquarters, as appropriate, whenever it intends to establish or amend a tolerance, temporary tolerance, or exemption from the requirement for a tolerance for a pesticide residue in food, and include a summary of the information and evaluation upon which the action is based and a method of analysis to be used to enforce such tolerance or temporary tolerance.

 

D. It is jointly agreed that each agency will:

1. Maintain a close working relationship with the others both in headquarters and in the field, with FSIS coordinating the headquarters relationship with USDA.

2. Exchange information with the others relative to analytical methodology it uses to identify and quantify residues of drugs, pesticides, and environmental contaminants in food, and cooperate in the development and implementation of analytical and statistical methodologies to ensure comparability of results in the examination of food and avoid duplication of effort.

3. Advise the other agency or agencies and exchange information whenever it is considering proposing or issuing regulations regarding residue policy or procedures that may affect the other agency or agencies.

4. Advise the other agency or agencies and exchange information whenever it is considering a release of informational materials that may affect the other agency or agencies.

5. When exchanging information, each agency will comply with any relevant restrictions or Federal law concerning trade secrets, confidential commercial or financial information, and personnel, medical, or other similar information constituting a clearly unwarranted invasion of personal privacy. Implementing regulations and procedures shall apply to any agency provided with such materials under this agreement.

6. Coordinate its residue investigations with the others, and with state and other government officials, as appropriate, to avoid duplication of effort.

7. Upon request, make agency personnel available for testimony and make agency documents available to support a regulatory action involving residues of drugs, pesticides, or environmental contaminants.

8. Advise the other agency or agencies whenever engaging in litigation involving issues that affect the duties of the other agency or agencies regarding residues of drugs, pesticides or environmental contaminant that may adulterate food; coordinate litigation that may involve violations of statute(s) enforced by the other agency or agencies, and consolidate such litigation where it appears to be in the interest of the Federal Government; and provide such other agency or agencies with a reasonable opportunity for review prior to entering into any consent judgment or similarly binding legal instrument which may result in a need for regulatory action by or otherwise affect the administrative actions of the other agency or agencies.

9. Assure the effective implementation of this agreement by:

(1) designating as the liaison officer responsible for implementing and being the primary contact for matters concerning this agreement a person whose primary function is managing USDA's, FDA's or EPA's program(s) for residues in foods;

(2) appointing an appropriate senior executive from USDA, FDA, and EPA to an interagency oversight committee that shall be chaired by an executive from a different agency each year and meet at least once each quarter to evaluate and report on the implementation of this agreement and make recommendations to agency heads on its effectiveness;

(3) assigning appropriate personnel to interagency task forces, upon request of affected agency heads, to help coordinate responses to specific residue contamination incidents or other needs, including those related to monitoring, surveillance, analytical methodology, or enforcement; and

(4) issuing and exchanging with the other agencies its instructions implementing this agreement that shall include the identities of the liaison officer, the oversight committee member, and contact points at the field level and shall set forth guidance for field personnel and other appropriate operational procedures.

 

E. Other Agreements

1. This MOU supersedes the 1975 MOU between APHIS and FDA, the 1977 MOU between FSQS and EPA, and the 1975 MOU between FDA and EPA described above. It does not modify any other existing agreements.

2. Nothing in this MOU precludes the agencies from entering into additional, separate agreements with each other as they deem appropriate to achieve the purpose of this MOU.

 

IV. NAME AND ADDRESS OF AGENCIES

 

A. U.S. Department of Agriculture
Food Safety and Inspection Service
and Agricultural Marketing Service
14th Street and Independence Avenue, SW
Washington, DC 20250

 

B. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

 

C. Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460

 

V. PERIOD OF AGREEMENT

This agreement will become effective upon acceptance by all parties and indicated below and will continue indefinitely. It may be modified by unanimous consent or terminated by any party upon a 30-day advance written notice to the other parties.

Approved and Accepted
for the Food Safety and Inspection Service

Signed by: Donald Houston, Administrator

Date: October 12, 1984

Approved and Accepted
for the Agricultural Marketing Service

Signed by: William T. Manley, Acting Administrator

Date: November 5, 1984

Approved and Accepted
for the Environmental Protection Agency

Signed by: Jack Moore, Assistant Administrator for Pesticides and Toxic Substances

Date: November 21, 1984

Approved and Accepted
for the Food and Drug Administration

Signed by: Joseph P. Hile, Associate Commissioner for Regulatory Affairs

Date: December 7, 1984