[Federal Register Volume 61, Number 209 (Monday, October 28, 1996)]
[Notices]
[Pages 55646-55647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA 225-96-2006]
Memorandum of Understanding Between the Food and Drug
Administration and the Agricultural Marketing Service, United States
Department of Agriculture
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the Agricultural
Marketing Service, United States Department of Agriculture (USDA). The
purpose of the MOU is to clarify and delineate 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 Act (7 U.S.C. 138-138i).
DATES: The agreement became effective May 31, 1996.
FOR FURTHER INFORMATION CONTACT: Marion G. Clower, Center for Food
Safety and Applied Nutrition (HFS-335), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4036.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and memoranda of understanding
between FDA and others shall be published in the Federal Register, the
agency is publishing notice of this memorandum of understanding.
Memorandum of Understanding Between the Food and Drug Administration
and the Agricultural Marketing Service, USDA
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 charged 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.
[[Page 55647]]
3. In making such approvals (7 U.S.C. 138a(c)(1) and (2)):
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. 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 chemical 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, rm. 3517, South Building,
Washington, DC 20090-6456.
For FDA: Director, Division of Pesticides and Industrial Chemicals,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St., Washington, DC 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.
VIII. Acceptance
Approved and Accepted for the Agricultural Marketing Service,
USDA
By: Kenneth C. Clayton
Title: Deputy Administrator, Marketing Programs
Date: May 31, 1996
Approved and Accepted for the Food and Drug Administration
By: Fred R. Shank,
Title: Director, Center for Food Safety and Applied Nutrition
Date: May 31, 1996
Dated: October 18, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-27592 Filed 10-25-96; 8:45 am]
BILLING CODE 4160-01-F
