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MOU 225-81-6000

Memorandum of Understanding

Between
The Centers for Disease Control

and

The Food and Drug Administration
for
Radiation Emergency Response Planning
and
Radiation Emergency Response Action

 

PREAMBLE

Over the past year, the Centers for Disease Control ( CDC ) and the Food and Drug Administration ( FDA ) have taken cooperative action to implement the Assistant Secretary for Health's ( ASH ) May 30, 1979, directive designating CDC as the lead agency within the Public Health Service 

( PHS ) for health management of toxic environmental emergencies. This directive facilitates intramural communications and liaison with outside groups and ensures a prompt coordinated Federal response to environmental emergencies that endanger public health and safety. CDC's lead responsibility encompasses emergencies involving potential exposure to radiation, e.g., the accident at Three Mile Island. In September 5, 1979, memorandum to the then acting Commissioner of Food and Drugs, the Assistant Secretary of Health endorsed an active role for the Bureau of Radiological Health ( BRH ) of the FDA in radiation emergencies because of its specialized expertise for radiation emergency response planning.

 

PURPOSE AND SCOPE

The purpose of this memorandum of understanding ( MOU ) is to identify the respective responsibilities of each agency with regard to peacetime radiological emergencies and how emergency planning and action will be coordinated. This document is concerned with radiological accidents which might have an impact on public health and safety. It dose not include the recovery phase of the operation or the non-emergency environmental radiation problems (e.g., foreign atmospheric nuclear testing, dose determination and assessment of Project Smokey and Portsmouth Naval Shipyard).

 

AUTHORITY

FDA and CDC shall continue to act under existing delegations of authority, and no transfer of statutory functions or authority is implied by this MOU.

1. Both CDC and FDA derive authority from the Public Health Service Act, 42 U.S.C., 241 et. seq., which provides authority for the conduct of health studies and the provision of guidance, assistance, and information on both health matters and for health emergencies. The Secretary of HHS is authorized to provide for cooperative planning to cope with problems resulting from disasters, for participation in carrying out such planning, and, at the request of State and local authorities, in meeting health emergencies.

 

2. The FDA is responsible for enforcement of the Federal Food, Drug, and Cosmetic Act ( U.S.C. Title 21, the Radiation Control for Health and Safety Act ( 42 U.S.C. 262b, et. seq.), the Public Health Service Act as it pertains to Regulation of Biological Products ( U.S.C. 262, et. seq.) other sections of the PHS Act, and other laws. In fulfilling its responsibility under these laws, FDA protects the public health and safety by, inter alia, preventing the adulteration of or controlling adulterated products such as foods, drugs, cosmetics, medical devices, animal feeds, and human biological. It also protects the public from the dangers of electronic product radiation.

 

3. On December 7, 1979, the President directed the Federal Emergency Management Agency ( FEMA) to head up all activities associated with the off-site planning and response to all peacetime radiological accidents at nuclear reactor facilities. Because of its leadership role, he further directed FEMA to undertake a series of activities including the development and issuance of updated interagency assignments delineating respective agency capabilities and responsibilities. FEMA outlined such responsibilities a draft Federal Register publication in December 1979.

 

FDA RESPONSIBILITIES

 

1. Response Planning

 FDA will be responsive to CDC's request for representation on task forces and coordinating committees relating to FEMA's Radiological Emergency Response Plan ( RERP).

 FDA will serve as the PHS representative on and participate in the Interagency Radiological Assistance Plan ( IRAP) .

 FDA will coordinate the development of FEMA guidance for HHS responsibilities that clearly fall under FDA's jurisdiction and expertise. Specifically, maintain the responsibility for the following:

 

A. Provide guidance to State and local governments on the use of radioprotective substances ( e.g., thyroid blocking agents) to include dosage and also projected radiation doses at which such drugs should be used.

B. Provide guidance to State and local governments on protective action guides for foods and animal feeds.

 FDA will keep CDC regularly informed, and CDC will be requested to provide, as deemed appropriate, review and comments on the overall PHS perspective on the items mentioned above.

 FDA will in cooperation with CDC work with Regional Advisory Committees to provide appropriate technical review and comment in areas of FDA responsibility for all RERP's.

 FDA will provide technical assistance to CDC in developing and implementing HHS Radiological Emergency Preparedness Training Programs.

 

2. Emergency Response Actions

 When FDA is alerted to a radiation emergency, it will immediately alert CDC.

 In accordance with specific State, regional, or national plans*, this MOU and specific requests by CDC, FDA will:

 

A. As part of the HHS team, participate in the radiological emergency exercises, tests and responses.

B. Establish appropriate emergency response liaison with the on-site CDC designated coordinator and keep CDC headquarters advised.

C. Provide technical support to State, Local, and other Federal Agencies.

 

FDA will implement and coordinate its own Emergency Response Procedures as set forth in Chapter 5-10 of the FDA Regulatory Procedures Manual. Radiological emergency response includes such actions as:

A. Environmental monitoring and sampling of milk, foods, and animal feed following a radiological incident.

B. Analysis and interpretation of food and environmental monitoring data.

* plans as defined in NUREG-0654 "Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants."

C. Taking appropriate compliance actions and implementing protective actions for contaminated food and feed under the statutory authority of the Federal Food, Drug, Cosmetic Act and other Acts administered by FDA.  FDA will provide technical support to CDC for the preparation of HHS news releases, for coordination with other agencies, and for working with public media in informing the public about health significance of a radiological incident.  FDA will give CDC emergency contact telephone numbers for maintaining close liaison in case an emergency response action becomes necessary and for implementing HHS resources.

CDC RESPONSIBILITIES

 

1. Response Planning

 CDC has the lead role within PHS for planning the HHS role in the FEMA national response to radiation emergencies. This includes the following activities:

 

A. CDC is responsible for arranging HHS representation on the Federal Interagency Central Coordinating Committee for RERP and designating HHS lead agency membership on relevant RERP subcommittees ( e.g., FDA to represent HHS on the task force for 1) training and exercises, and 2) off-site instrumentation).

B. CDC arranges for appropriate PHS representation at meetings of all Regional Advisory Committees (RAC).

C. CDC participates in FEMA activities related to planning for radiation emergencies including coordinating the HHS response to review of FEMA documents relating to radiation emergencies.

D. CDC arranges for consultation between appropriate HHS components and State and local agencies and officials to help them plan for radiation emergencies in their jurisdiction.

E. CDC has the lead role for developing specific PHS response plan.

 

2. Emergency Response Actions

CDC has the PHS lead role to coordinate PHS response to radiological emergencies.

When notified of radiological emergency, CDC :

 

A. Obtains sufficient information to allow a determination to be made of whether or not an emergency requiring HHS action exists.

B. Alerts all appropriate HHS agencies

C. Consults with other HHS agencies to determine availability of resources required under the FEMA national contingency plan.

D. Requests mobilizations of resources of PHS agencies.

 

CDC serves as the focal point for communication and coordination of information with in PHS and between PHS and other Federal agencies, including designation of an onsite PHS coordinator at the scene of the emergency. CDC develops and maintains epidemiological surveillance of populations exposed to radiological accidents and emergencies at local, State, and national levels for purpose of disease prevention.

 

As coordinator for the PHS emergency response and liaison with FEMA, CDC consults with other agencies, State and local authorities to:

A. Identify segments of the population which may be at high risk of harm from exposure ( e.g., people with predisposing clinical conditions, children, pregnant women, the elderly).

B. Arrange for collection and analysis of appropriate biological specimens.

C. Consult on recommendations for decontamination and prophylactic procedures.

 

NAMES AND ADDRESSES OF PARTICIPATING AGENCIES:

 

Centers for Disease Control
1600 Clifton Road, N.E.
Atlanta, Georgia 30333

Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857


LIAISON OFFICERS:

 

CDC: Director, Chronic Disease Division
Bureau of Epidemiology

FDA: Senior Health Physics Advisor
Office of Director
Bureau of Radiological Health

Approved and Accepted
for the Centers for Disease Control

Signed by: William C. Watson, Jr.
Deputy Director
Center for Disease Control

Date: November 12, 1980

Approved and Accepted
for the Food and Drug Administration

Signed by: Joseph P. Hile
Associate Commissioner for Regulatory
Food and Drug Administration

Date: November 26, 1980