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MOU 225-96-2006

Memorandum of Understanding

Between
The Food and Drug Administration 

and

The Agricultural Marketing Service
United States Department of Agriculture

I. TITLE
National Laboratory Accreditation Program

 

II. PURPOSE
This agreement between the Food and Drug Administration (FDA) and Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) clarifies and delineates the responsibilities of each agency with respect to the National Laboratory Accreditation Program (NLAP). Each agency has specific responsibilities under the NLAP that are mandated by the 1990 Food, Agriculture, Conservation, and Trade (FACT) Act (7 U.S.C. 138-138i).

 

III. BACKGROUND
The FACT Act of 1990, approved November 28, 1990, authorizes the creation of the NLAP. Under NLAP, laboratories that request accreditation and conduct pesticide residue analysis of agricultural products for human consumption, or that make claims to the public or buyers of agricultural products concerning pesticide residue levels on agricultural products, shall be determined to meet certain minimum quality and reliability standards. The Secretary of Agriculture is charge with administering the NLAP.

 

The FACT Act requires the Secretary of Health and Human Services, after consultation with the Secretary of Agriculture and the Administrator of the Environmental Protection Agency (EPA), to establish, through regulations, standards for the NLAP. The Secretary of Health and Human Services is also required to approve accrediting bodies, and oversee and review the performance of such accrediting bodies, to act on behalf of the Secretary of Agriculture in implementing the certification and quality assurance programs. FDA will carry out these responsibilities under delegation from the Secretary of Health and Human Services. The Secretary of Agriculture is required to issue certificates of accreditation to laboratories who meet the requirements for the accreditation program, provide proficiency test samples to laboratories that apply for accreditation, establish a fee schedule, collect fees from the private laboratories involved in NLAP, and promulgate regulations to carry out the NLAP.

 

IV. SUBSTANCE OF AGREEMENT
It is understood and agreed between the parties as follows:

A. FDA Responsibilities:

1. Promulgate regulations establishing standards for NLAP, after consultation with AMS and EPA (7 U.S.C. 138a(b)), including:

a. standards applicable to laboratories,

b. qualifications of laboratory personnel; and,

c. standards and procedures for quality assurance programs

2. Approve accrediting bodies (7 U.S.C. 138a(c)), which may include:

a. state agencies; and,

b. private non-profit organizations.

3. In making such approvals (7 U.S.C. 138a(c)(1) and (2)) FDA:

a. oversee and review performance of any accrediting body to ensure that the accrediting body is in compliance with requirements of the certification program; and,

b. may obtain all records and materials necessary for the oversight and review in (a) from accrediting bodies and certified laboratories.

B. AMS Responsibilities:

1. Administer the NLAP (7 U.S.C. 138a and 138b):

a. recommend accrediting body(ies);

b. receive laboratory applications;

c. issue certificates of accreditation to qualified laboratories;

d. perform on-site audits;

e. deny or revoke laboratory accreditation; and

f. issue "limited" accreditation to laboratories for specific fields of testing.

2. Provide performance evaluation test samples (7 U.S.C. 138c):

a. to any laboratory that has applied for accreditation;

b. at least twice yearly; and

c. evaluate results.

3. Promulgate regulations to carry out NLAP (7 U.S.C. 138h).

4. Establish a fee schedule for NLAP and collect fees from laboratories (7 U.S.C. 138f).

5. Prepare guidelines for reporting on results of analysis showing pesticide chemicals residues to AMS, FDA, and the owner of the food (7 U.S.C. 138e).

6. Provide results of evaluations of laboratories conducted under NLAP to FDA, and the public, upon request (7 U.S.C. 138g).

7. Prepare a procedural manual for the NLAP.

C. FDA and AMS Cooperative Responsibilities:

1. Prepare written responses from comments received in rulemaking.

2. Receive reports on analyses containing any findings of chemical pesticide residue (7 U.S.C. 138e)

 

V. LIAISON OFFICERS

For AMS:
Chief, Technical Services Branch
Science and Technology Division
Agricultural Marketing Service
United States Department of Agriculture
P.O. Box 96456
Room 3517, South Building
Washington, D.C. 20090-6456

 

For FDA:
Director, Division of Pesticides and Industrial Chemicals
Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 C Street S.W.
Washington, D.C. 20204

 

VI. BASIS OF COOPERATION

This Memorandum of Understanding describes in general terms the basis on which the parties concerned will cooperate, and does not constitute a financial obligation to serve as a basis for expenditures. Any and all expenditures from Federal funds in USDA made in conformity with the plans outlined in the Memorandum of Understanding must be in accord with Department rules and regulations and in each instance based upon appropriate finance papers. Expenditures made by FDA will be in accord with its rules and regulations.

The responsibilities assumed by the cooperating parties under this Memorandum of Understanding are contingent upon funds being available from which expenditures legally may be met.

 

VII. PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties and shall remain in effect indefinitely. This agreement may be modified in writing by mutual consent or terminated in writing by either party upon a sixty (60) day advance notice to the other.

Approved and Accepted
for the Agricultural Marketing Service, USDA

Signed by: Kenneth C. Clayton
Deputy Administrator
Marketing Programs

Date: May 31, 1996

Approved and Accepted
for the Food and Drug Administration

Signed by: Janice F. Oliver for Fred R. Shank, Ph.D.
Director, Center for Food Safety and Applied Nutrition

Date: April 29, 1996