[Federal Register Volume 74, Number 97 (Thursday, May 21, 2009)]
[Notices]
[Pages 23865-23866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11931]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0043]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information 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 collection of information by June 
22, 2009.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0186. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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--(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 ensure 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 (or minimum and maximum) energy of radiation 
emitted by x-ray tube sources. Section 179.21(b)(2) requires that the 
label or accompanying labeling bear adequate directions for 
installation and use and a statement supplied by FDA that indicates 
maximum dose of radiation allowed. Section 179.26(c) requires that the 
label or accompanying labeling bear a logo and a radiation disclosure 
statement. 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.
    In this request for extension of OMB approval, FDA proposes to 
include and consolidate into the subject collection of information (OMB 
control number 0910-0186) the collection of information and associated 
burden hours from OMB control number 0910-0549. This inclusion is 
reflected in the estimated burden reported in table 1 of this document, 
which has increased by the addition of one recordkeeper in the large 
processors line, increasing the number of estimated recordkeepers from 
two to three.
    Description of Respondents: Respondents are businesses engaged in 
the irradiation of food.
    In the Federal Register of February 13, 2009 (74 FR 7236), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

[[Page 23866]]

    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual
21 CFR Section    Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
179.25(e),                      3                   300                900                  1                900
 large
 processors
----------------------------------------------------------------------------------------------------------------
179.25(e),                      4                    30                120                  1                120
 small
 processors
----------------------------------------------------------------------------------------------------------------
Total           .................  ....................  .................  .................              1,020
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate of burden for the recordkeeping provisions 
of Sec.  179.25(e) on the agency's experience regulating the safe use 
of radiation as a direct food additive. The number of firms who process 
food using irradiation is extremely limited. FDA estimates that there 
are 3 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: Three facilities devoting 100 
percent of their business to food irradiation (3 x 300 hours = 900 
hours for recordkeeping annually); four facilities devoting 10 percent 
of their business to food irradiation (4 x 30 hours = 120 hours for 
recordkeeping annually).
    No burden has been estimated for the labeling requirements in Sec.  
179.21(b)(1) and (b)(2) and Sec.  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: May 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.

[FR Doc. E9-11931 Filed 5-20-09; 8:45 am]
BILLING CODE 4160-01-S