[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
