
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34681-34682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14886]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 July 
17, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@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 the 
emitted radiation. Section 179.21(b)(2) requires that the label or 
accompanying labeling bear adequate directions for installation and use 
and a statement supplied by us 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 our inspectors to assess compliance with the regulation that 
establishes limits within which radiation may be safely used to treat 
food. We 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 the Federal Register of March 31, 2015 (80 FR 17055), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but did not respond 
to any of the four information collection topics solicited and is 
therefore not addressed by the Agency.
    Description of respondents: Respondents are businesses engaged in 
the irradiation of food.
    We estimate the burden of this collection of information as 
follows:

[[Page 34682]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of                        Average burden
                        21 CFR section                              Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
179.25(e), large processors...................................                 4               300             1,200                 1             1,200
179.25(e), small processors...................................                 4                30               120                 1               120
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................             1,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    We base our estimate of burden for the recordkeeping provisions of 
Sec.  179.25(e) on our experience regulating the safe use of radiation 
as a direct food additive. The number of firms who process food using 
irradiation is extremely limited. We estimate that there are four 
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. We estimate 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 four facilities devoting 100 percent of 
their business to food irradiation (4 x 300 hours = 1200 hours for 
recordkeeping annually), and 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. 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 subject to review by the 
Office of Management and Budget under the Paperwork Reduction Act.

    Dated: June 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14886 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P


