[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28054-28055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0153]


Accidental Radioactive Contamination of Human Food and Animal 
Feeds; Draft of Recommendations for State and Local Agencies; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Accidental Radioactive 
Contamination of Human Food and Animal Feeds: Recommendations for State 
and Local Agencies.'' This draft guidance would replace the 
``Accidental Contamination of Human Foods and Animal Feeds: 
Recommendations to State and Local Agencies'' issued in 1982 to State 
and local agencies responsible for taking protective actions in the 
event that an incident causes the contamination of

[[Page 28055]]

human food or animal feeds. This draft guidance is intended to assist 
FDA in fulfilling its responsibility to issue guidance on planning 
actions for evaluating and preventing contamination of human food and 
animal feeds and to issue guidance on the control and use of these 
products should they become contaminated. The agency requests comments 
on this draft guidance.

DATES: Written comments by August 20, 1997.

ADDRESSES: Submit written requests for single copies of ``Accidental 
Radioactive Contamination of Human Food and Animal Feeds: 
Recommendations for State and Local Agencies'' to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Send two self-addressed 
adhesive labels to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Dockets Management 
Branch (address above). Requests and comments should be identified with 
the docket number found in brackets in the heading of this document. A 
copy of the draft guidance and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Donald L. Thompson, Center for Devices 
and Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-0012, FAX 301-594-4760.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1982, FDA issued recommendations on accidental radioactive 
contamination of human food and animal feeds. Since 1982, significant 
advancements related to emergency planning have warranted updating the 
guidance document. The draft guidance includes: New scientific 
information and radiation protection philosophy, experience gained 
since 1982, and guidance developed by international organizations. In 
1992, and again in 1994, drafts of the revised document were circulated 
for review by the staff of the principal Federal agencies involved in 
radiological emergency response and by a committee of the Conference of 
Radiation Control Program Directors.
    These recommendations are intended to provide guidance to State and 
local agencies to aid in emergency response planning and execution of 
protective actions associated with production, processing, 
distribution, and use of human food and animal feeds accidentally 
contaminated with radionuclides. Limits, called derived intervention 
levels, are set on the radionuclide activity concentration permitted in 
food, and protective actions for reducing the amount of contamination 
are discussed. The recommendations are applicable to accidents at 
nuclear power plants and many other types of accidents where a 
significant radiation dose could be received as a result of consumption 
of contaminated food. The recommendations do not authorize or apply to 
deliberate releases of radionuclides that could result in 
contamination, nor do they apply to situations of a nonaccidental 
nature. These recommendations would rescind and replace the 1982 FDA 
recommendations.

II. Significance of a Guidance

    A guidance document does not bind FDA or the public, and it does 
not create or confer any rights, privileges, or benefits for, or on, 
any person; however, it does represent the agency's current thinking on 
the subjects discussed therein. The draft guidance announced in this 
document represents the agency's tentative thinking of the subjects 
discussed therein.

III. Request for Comments

    Interested persons may, on or before August 20, 1997, submit to the 
Dockets Management Branch (address above) written comments on the 
``Accidental Radioactive Contamination of Human Food and Animal Feeds: 
Recommendations for State and Local Agencies.'' Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
and received comments may be seen in the Dockets Management Branch 
between 9 a.m and 4 p.m. Monday through Friday.

    Dated: May 12, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-13376 Filed 5-21-97; 8:45 am]
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