Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food, 22688-22689 [2021-08949]
Agencies
[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22688-22689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08949]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0073]
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.
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[[Page 22689]]
SUMMARY: The Food and Drug Administration (FDA or we) 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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by June 1, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 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 Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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
This information collection supports FDA regulations. Specifically,
under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic
Act (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 used to treat
food, Sec. 179.21(b)(1) (21 CFR 179.21(b)(1)) requires that the label
of the radiation 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) (21 CFR 179.26(c))
requires that the label or accompanying labeling of foods treated by a
source of radiation bear a logo and a radiation disclosure statement.
Section 179.25(e) (21 CFR 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.
Description of Respondents: Respondents to the information
collection are businesses engaged in the irradiation of food.
In the Federal Register of October 16, 2020 (85 FR 65825), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, none
pertained to the information collection topics solicited in the notice
or suggested a change to our burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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179.25(e), large processors..... 4 300 1,200 1 1,200
179.25(e), small processors..... 4 30 120 1 120
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Total....................... .............. .............. .............. .............. 1,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimate of the recordkeeping burden under Sec.
179.25(e) is based 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, and four facilities devoting 10
percent of their business to food irradiation.
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
disclosures are 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 OMB under the PRA.
Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08949 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P
