[Federal Register Volume 69, Number 9 (Wednesday, January 14, 2004)]
[Notices]
[Pages 2146-2147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-719]


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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://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: [email protected].

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://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