[Federal Register Volume 69, Number 145 (Thursday, July 29, 2004)]
[Notices]
[Pages 45336-45337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17208]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0558]


Compliance Policy Guide, Guidance Levels for Radionuclides in 
Domestic and Imported Foods, Availability; and Supporting Document, 
Supporting Document for Guidance Levels for Radionuclides in Domestic 
and Imported Foods, 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 compliance policy guide (CPG) entitled ``Guidance 
Levels for Radionuclides in Domestic and Imported Foods.'' This 
document is intended to make FDA offices and the industry aware of 
FDA's guidance for enforcement concerning radionuclide activity 
concentration in domestic food in interstate commerce or food offered 
for import. This CPG rescinds and replaces CPG Sec. 560.750 
Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14). The 
agency also is announcing the availability of a final supporting 
document entitled ``Supporting Document for Guidance Levels for 
Radionuclides in Domestic and Imported Foods.''

DATES: Submit written or electronic comments concerning the CPG or the 
final supporting document at any time.

ADDRESSES: Submit written requests for single copies of the CPG 
entitled ``Guidance Levels for Radionuclides in Domestic and Imported 
Foods'' and/or the final supporting document entitled ``Supporting 
Document for Guidance Levels for Radionuclides in Domestic and Imported 
Foods'' to Paul South (see FOR FURTHER INFORMATION CONTACT). Send two 
self-addressed adhesive labels to assist that office in processing your 
request. Submit written comments 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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic access to these documents.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 14, 2004 (69 FR 2146), FDA 
announced the availability of a draft CPG entitled ``Guidance Levels 
for Radionuclides in Domestic and Imported Foods,'' and a draft 
supporting document entitled ``Supporting Document for Guidance Levels 
for Radionuclides in Domestic and Imported Foods.'' After considering 
comments received on these documents, FDA has finalized the CPG and 
supporting document. The CPG rescinds and replaces CPG Sec. 560.750 
Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14).
    FDA received five comments on the draft CPG. The comments 
represented the views of individual consumers, a Federal agency, a 
State health department, and a foreign government. One comment was 
rejected because it was outside the scope of the draft CPG. The 
majority of comments supported the proposed guidance levels while a 
number of comments suggested changes or modification to other aspects 
of the draft CPG. After considering carefully the comments received, 
the agency revised the draft CPG to include a reference to methods for 
radionuclide analysis of foods.
    The CPG is being issued as level 1 guidance consistent with FDA's 
good

[[Page 45337]]

guidance practices regulation (21 CFR 10.115). The CPG represents the 
agency's current thinking on its enforcement process concerning the 
adulteration of food 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 CPG 
entitled ``Guidance Levels for Radionuclides in Domestic and Imported 
Foods,'' and/or the final supporting document entitled ``Supporting 
Document for Guidance Levels for Radionuclides in Domestic and Imported 
Foods.'' 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 the brackets in the heading of this document. A copy of the CPG, the 
final supporting document, and received comments 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 CPG and final 
supporting document may be accessed from the home pages of the Center 
for Food Safety and Applied Nutrition at http://www.cfsan.fda.gov and 
the Office of Regulatory Affairs at http://www.fda.gov/ora/.

    Dated: July 22, 2004.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-17208 Filed 7-28-04; 8:45 am]
BILLING CODE 4160-01-S