[Federal Register Volume 68, Number 60 (Friday, March 28, 2003)]
[Notices]
[Page 15209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0514]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Irradiation in the Production, Processing, and 
Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the information collection provisions by 
April 28, 2003.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that written comments be electronically mailed 
to [email protected] or faxed to the Office of Information and 
Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA, 
FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Irradiation in the Production, Processing, and Handling of Food--21 CFR 
Part 179 (OMB Control Number 0910-0186)--Extension

    Under sections 201(s) and 409 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is 
subject to regulation under the food additive premarket approval 
provisions of the act. The regulations providing for uses of 
irradiation in the production, processing, and handling of food are 
found in part 179 (21 CFR part 179). To assure safe use of a radiation 
source, Sec.  179.21(b)(1) requires that the label of sources bear 
appropriate and accurate information identifying the source of 
radiation and the maximum energy of radiation emitted by x-ray tube 
sources. Section 179.21(b)(2)(i) requires that the label or 
accompanying labeling bear adequate directions for installation and 
use. Section 179.25(e) requires that food processors who treat food 
with radiation make and retain, for 1 year past the expected shelf life 
of the products up to a maximum of 3 years, specified records relating 
to the irradiation process (e.g., the food treated, lot identification, 
scheduled process, etc.). The records required by Sec.  179.25(e) are 
used by FDA inspectors to assess compliance with the regulation that 
establishes limits within which radiation may be safely used to treat 
food. The agency cannot ensure safe use without a method to assess 
compliance with the dose limits, and there are no practicable methods 
for analyzing most foods to determine whether they have been treated 
with ionizing radiation and are within the limitations set forth in 
part 179. Records inspection is the only way to determine whether firms 
are complying with the regulations for treatment of foods with ionizing 
radiation.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                              Annual Frequency per
            21 CFR Section              No. of Recordkeepers      Recordkeeping     Total Annual Records  Hours per Recordkeeper        Total Hours
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179.25(e)                                        6                   120                   720                      1                     720
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of firms who process food using irradiation is extremely 
limited. FDA estimates that there are two irradiation plants whose 
business is devoted primarily (i.e., approximately 100 percent) to 
irradiation of food and other agricultural products. Four other firms 
also irradiate small quantities of food. FDA estimates that this 
irradiation accounts for no more than 10 percent of the business for 
each of these firms. Therefore, the average estimated burden is based 
on: Two facilities devoting 100 percent of their business (or 600 hours 
for recordkeeping annually) to food irradiation; four facilities 
devoting 10 percent of their business or 120 hours (4 x 30 hours) for 
recordkeeping annually to food irradiation.
    No burden has been estimated for the labeling requirements in 
Sec. Sec.  179.21(b)(2)(i) and (b)(2)(ii) and 179.26(c) because the 
information to be disclosed is information that has been supplied by 
FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public is not a collection of information.

    Dated: March 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-7476 Filed 3-27-03; 8:45 am]
BILLING CODE 4160-01-S