[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Notices]
[Pages 12240-12242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5309]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Memorandum of Understanding Between the Food and Drug 
Administration and the Environmental Protection Agency

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA and the Environmental 
Protection Agency (EPA). This action is necessary to establish the 
working arrangements and responsibilities of the two agencies. The 
purpose of the MOU is to establish an FDA liaison to the EPA Gulf of 
Mexico Program Office.

DATES: The agreement became effective September 29, 1994.

FOR FURTHER INFORMATION CONTACT: Juanita Pointer, Center for Food 
Safety and Applied Nutrition (HFS-669), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4098.

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.

    [[Page 12241]] Dated: February 3, 1995,

Ronald G. Chesemore,

Associate Commissioner for Regulatory Affairs.

Memorandum of Understanding Between U.S. Department of Health and Human 
Services, Public Health Service, Food and Drug Administration and 
Environmental Protection Agency, Gulf of Mexico Program

Purpose:

    This Memorandum of Understanding (MOU) is to establish the 
working arrangements and responsibilities of the Food and Drug 
Administration (FDA) and the Environmental Protection Agency (EPA) 
for the purpose of FDA providing a liaison to the EPA Gulf of Mexico 
Program Office.

Background:

     The Gulf of Mexico Program (GMP) was established under the 
leadership of EPA to develop a comprehensive, intergovernmental 
strategy to protect and enhance the environmental quality of the 
Gulf of Mexico. The GMP identified priority issues of environmental 
degradation and concern, established a Gulf-wide committee framework 
and infrastructure to ensure communication and information exchange 
and began implementing a 5-year strategy. The strategy includes:

1. Preparation of environmental characterization reports,

2. Preparation of environmental assessments,

3. Development of an interactive data management system,

4. Preparation of predictive assessments,

5. Development of environmental measurement plans and

6. Development of an environmental monitoring system.

    FDA's Office of Seafood was established to strengthen the 
agency's domestic and imported seafood programs. The Office of 
Seafood coordinates all of FDA's seafood activities, including those 
which assure that seafood does not contain harmful amounts of 
natural or man-made substances, such as toxins, pathogenic 
microorganisms, industrial chemicals or toxic metals. FDA uses 
several strategies to accomplish its public health mission. One 
strategy is to assist EPA in its Gulf of Mexico Program.

A. The Food and Drug Administration agrees to:

    1. Assign one individual to serve as the principal liaison 
between FDA and the Gulf of Mexico Program (GMP) with responsibility 
for managing, coordinating, implementing and evaluating FDA 
activities in support of the GMP. The FDA liaison:
a. Provides program and technical assistance and coordination of FDA 
activities with the GMP Technical Steering Committee, Policy Review 
Committee, technical steering subcommittees and the State, local and 
Federal agencies participating in the GMP.

b. Serves as Federal Co-Chair of the Public Health Subcommittee with 
primary responsibility for developing a Public Health Action Plan for 
the Gulf of Mexico Program and incorporating the recommendations of the 
National Academy of Sciences Report on Seafood Safety. The plan should 
address four major elements, three of which are problems for which FDA 
has the lead:

(1) Illnesses associated with consumption of raw shellfish as a result 
of naturally occurring pathogens and/or pathogens of fecal origin.

(2) Risks associated with consumption of Gulf of Mexico seafood 
contaminated with toxic substances or pesticides.

(3) Effects of naturally occurring marine biotoxins on the public 
health through direct exposure via aerosols and/or exposure via 
contaminated Gulf seafood.

(4) Illness associated with recreational or occupational use of ambient 
waters contaminated with sewage.

c. Coordinates, with other GMP participants, the five major aspects of 
the GMP study: Resource characterization and assessment; problem 
identification and study design; communication and education; 
integration with ongoing programs of the Gulf; and development of 
management, implementation and monitoring strategies.

d. Evaluates technical documents developed by the Technical Steering 
Subcommittees and other agencies as they relate to public health and 
GMP issues and for consistency with FDA policies, programs and 
regulations.

e. Works closely with States to promote cooperation and harmonization 
of their public health programs as they relate to Gulf of Mexico 
issues.

f. Serves as the FDA point of contact with the National Shellfish 
Pollution Indicator Study. Is responsible for keeping the GMP informed 
of developments and providing program needs to the Indicator Study 
directors.

g. Develops appropriate projects to evaluate programs and methods of 
reducing public health risks associated with the use of the waters and 
resources of the Gulf of Mexico.

h. Serves as project officer on extramural projects to conduct 
scientific studies of interest to FDA which relate to the Gulf of 
Mexico Program.

    2. Provide the following administrative support to the assigned 
individual:
a. Salary--The FDA employee will remain on the FDA payroll for the 
entire period of the assignment.
b. Relocation Expenses--The cost of relocating the FDA employee to the 
John C. Stennis Space Center, Mississippi, as provided by policies and 
procedures relating to reporting to a duty station.
c. Travel Expenses--The FDA employee will be provided transportation 
and per diem expenses while in temporary duty status for the entire 
period of the assignment.
d. Equipment--FDA will provide a personal computer for use by the 
employee during the entire period of the agreement.
    3. Provide annual review of the individual's performance for the 
entire period of the assignment.
    4. Administrative Support--Annually provide partial financial 
support to EPA/GMP to defray part of the overall costs to them for 
providing services as stated under this IAG. Amount to be worked out 
between the two agencies.

B. The Environmental Protection Agency-Gulf of Mexico Program 
agrees to:

    1. Provide technical supervision and assign day-to-day tasks to 
the FDA representative to the GMP. The technical and day-to-day 
assignments will be provided by the Director of the Gulf of Mexico 
Program; and he shall serve as the EPA's point of contact and the 
liaison officer for this interagency agreement.
    2. Provide the following administrative support to the assigned 
individual:
a. Space--Space will be provided at the GMP Headquarters at the John C. 
Stennis Space Center; and the space will contain appropriate furniture 
and conveniences.
b. Telecommunication--Telephone service including FTS, Long Distance, 
and Fax will be provided.
c. Secretarial Support--Secretarial support will be provided to 
include: Typing, xeroxing, dictating, filing, printing, duplicating, 
and office supplies.
    3. The Director, GMP, will provide FDA with written comments on 
the individual's performance for the specified rating period. The 
information will be used on the General Workforce Performance 
Appraisal of the FDA liaison.

Period of Agreement:

    It is anticipated that this MOU will be for approximately 5 
years from the date of signature. Modification of the MOU shall be 
by mutual consent of the parties. However, if either party desires 
to terminate this MOU, a written notice to the other party shall be 
forwarded and received 30 days in advance of the desired termination 
date.

Approved and Accepted for the Environmental Protection Agency Gulf of 
Mexico Program

By: Douglas A. Lipka
Title: Acting Director
Date: September 29, 1994

Approved and Accepted for the Food and Drug Administration

By: Fred R. Shank
Title: Director, Center for Food Safety and Applied 
Nutrition [[Page 12242]] 
Dated: September 22, 1994.

[FR Doc. 95-5309 Filed 3-3-95; 8:45 am]
BILLING CODE 4160-01-F