[Federal Register: January 14, 2004 (Volume 69, Number 9)]
[Notices]
[Page 2146-2147]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja04-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Number 2003D-0558]
Draft Compliance Policy Guide, Guidance Levels for Radionuclides
in Domestic and Imported Foods, Availability; and Draft Supporting
Document, Supporting Document for Guidance Levels for Radionuclides in
Domestic and Imported Foods, Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 2147]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft compliance policy guide (CPG) entitled
``Guidance Levels for Radionuclides in Domestic and Imported Foods.''
The draft CPG would rescind and replace the current CPG Sec. 560.750
Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14). The
draft CPG provides updated guidance levels for radionuclide activity
concentration in food offered for import and makes these same guidance
levels for radionuclide activity concentration applicable to food in
domestic interstate commerce for the first time. The draft CPG also
expands the scope of coverage of FDA policy from food accidentally
contaminated with radionuclides to food accidentally or intentionally
contaminated with radionuclides. The agency is also announcing the
availability of a draft supporting document entitled ``Supporting
Document for Guidance Levels for Radionuclides in Domestic and Imported
Foods.''
DATES: Submit written or electronic comments concerning the draft CPG
and/or the draft supporting document by March 15, 2004.
ADDRESSES: Submit written requests for single copies of the draft CPG
entitled ``Guidance Levels for Radionuclides in Domestic and Imported
Foods'' and/or the draft supporting document entitled ``Supporting
Document for Guidance Levels for Radionuclides in Domestic and Imported
Foods'' to Paul South (see FOR FURTHER INFORMATION CONTACT). Send one
self-addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to this document. Submit written comments on the draft CPG and/
or draft supporting document to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Paul South, Center for Food Safety
and Applied Nutrition (HFS-306), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1640, fax: 301-436-
2651, e-mail: psouth@cfsan.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed a draft CPG to rescind and replace CPG Sec.
560.750 Radionuclides in Imported Foods--Levels of Concern (CPG
7119.14) concerning radionuclides in food. While CPG Sec. 560.750
Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14), which
was issued in 1986 following the Chernobyl nuclear accident, only
addresses radionuclides in food offered for import, this draft CPG is
intended to provide clear policy and regulatory guidance to FDA's field
and headquarters staff with regard to radionuclides in both food
offered for import and domestic food in interstate commerce. In
particular, the draft CPG sets forth new guidance levels for
radionuclides, referred to as Derived Intervention Levels (DILs). FDA
would use DILs to help determine whether food in interstate commerce or
food offered for import into the United States presents a safety
concern. The DILs adopted in the draft CPG are not binding on FDA, the
regulated industry, or the courts. In any given case, FDA may decide to
initiate an enforcement action against food with concentrations below
the DILs or decide not to initiate an enforcement action against food
with concentrations that meet or exceed the DILs. The scientific basis
for the DILs established in the draft CPG is presented in the draft
supporting document. The draft CPG also contains information that may
be useful to the regulated industry and to the public.
The agency has adopted good guidance practices (GGPs) that set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (21 CFR Sec. 10.115). The
draft CPG is being issued as a Level 1 draft guidance consistent with
GGPs. The draft CPG represents the agency's current thinking on its
enforcement process concerning the adulteration of foods with
radionuclides. It does not create or confer any rights for or on any
person and does not operate to bind FDA, or the public.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft CPG
and the draft supporting document. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments, the draft CPG, and the draft supporting
document may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft CPG and
the draft supporting document at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora under
``Compliance References.''
Dated: January 7, 2004.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-719 Filed 1-13-04; 8:45 am]
BILLING CODE 4160-01-S