[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Pages 43842-43843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18234]



Food and Drug Administration

[Docket No. FDA-2012-N-0473]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 August 
27, 2012.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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 FD&C Act) (21 U.S.C. 321(s) and 348), food 
irradiation is subject to regulation under the food additive premarket 
approval provisions of the FD&C 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

[[Page 43843]]

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 
    In the Federal Register of May 17, 2012 (77 FR 29352), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received outside the scope 
of the four collection of information topics solicited by the notice.
    Description of respondents: Respondents are businesses engaged in 
the irradiation of food.
    FDA estimates the burden of this collection of information as 

                               Table 1--Estimated Annual Recordkeeping Burden \1\
                                                     Number of                        Average
         21 CFR Section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
179.25(e), Large Processors.....               3             300             900               1             900
179.25(e), Small Processors.....               4              30             120               1             120
    Total.......................  ..............  ..............  ..............  ..............           1,020
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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 3 facilities devoting 100 percent 
of their business to food irradiation (3 x 300 hours = 900 hours for 
recordkeeping annually), and 4 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. Sec.  179.21(b)(1), 179.21(b)(2), 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: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18234 Filed 7-25-12; 8:45 am]