[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Notices]
[Pages 43402-43403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21795]



[[Page 43402]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0153]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Accidental Radioactive 
Contamination of Human Food and Animal Feeds: Recommendations to State 
and Local Agencies.'' This guidance will replace the ``Accidental 
Radioactive 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 human food or animal 
feeds. FDA has a responsibility to issue guidance on planning actions 
for evaluating and preventing contamination of human food and animal 
feeds and on the control and use of these products should they become 
contaminated.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Accidental Radioactive 
Contamination of Human Food and Animal Feeds: Recommendation for State 
and Local Agencies'' to the Division of Small Manufacturers Assistance, 
Center for Devices and Radiological Health (HFZ-220), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
on the guidance to the contact person listed below. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    Recommendations on accidental radioactive contamination of human 
food and animal feeds were issued in 1982 by FDA. Since then, there 
have been enough significant advancements related to emergency planning 
to warrant updating the guidance document. New scientific information 
and radiation protection philosophy are incorporated, experience gained 
since 1982 is included, and guidance developed by international 
organizations is taken into account. In 1992, and again in 1994, drafts 
of the revised document were circulated for review by staff of the 
principal Federal agencies involved in radiological emergency response 
and by a committee of the Conference Radiation Control Program 
Directors. In the Federal Register of May 22, 1997 (62 FR 28055), FDA 
published a notice of availability of a draft guidance. Interested 
persons were given until August 20, 1997, to comment on the draft. 
Forty-two comments were received, principally from State and Federal 
agencies. Revision of the draft in response to comments did not involve 
any change in concepts, only clarifications, errata, and definitions.
    The recommendations 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 
nonaccidental nature. These recommendations rescind and replace the 
1982 recommendations.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the Accidental Radioactive Contamination of Human Food and Animal 
Feeds: Recommendations for State and Local Agencies. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the applicable statute, regulations, or both.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive the guidance entitled ``Accidental Radioactive 
Contamination of Human Food and Animal Feeds: Recommendations for State 
and Local Agencies'' via your fax machine, call the CDRH Facts-On-
Demand (FOD) system at 1-800-899-0381 or 301-827-0111 from a touch-tone 
telephone. At the first voice prompt press 1 to access DSMA Facts, at 
second voice prompt press 2, and then enter the document number (1071) 
followed by the pound sign (#). Then follow the remaining voice prompts 
to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the World Wide Web (WWW). The Center for Devices and 
Radiological Health (CDRH) maintains an entry on the WWW for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Web. Updated on a 
regular basis, the CDRH home page includes the guidance ``Accidental 
Radioactive Contamination of Human Food and Animal Feeds: 
Recommendations for State and Local Agencies,'' device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturer's 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
``http://www.fda.gov/cdrh''.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 1-800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for

[[Page 43403]]

general information, or arrow down for specific topics.

IV. Comments

    Interested persons may, at any time, submit to the contact person 
(named above) written comments regarding this guidance. Such comments 
will be considered when determining whether to amend the current 
guidance.

    Dated: August 5, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-21795 Filed 8-12-98; 8:45 am]
BILLING CODE 4160-01-F