[Federal Register: August 13, 1998 (Volume 63, Number 156)] [Notices] [Page 43402-43403] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13au98-78] [[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