83 FR 27332 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 113 (June 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 113 (June 12, 2018)
| Page Range | 27332-27333 | |
| FR Document | 2018-12614 |
[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)] [Notices] [Pages 27332-27333] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12614] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. DATES: Fax written comments on the collection of information by July 12, 2018. 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: Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 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 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, 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 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. 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. [[Page 27333]] In the Federal Register of January 26, 2018, (83 FR 3734), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: 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); records for large 4 300 1,200 1 1,200 processors..................... 179.25(e); records for small 4 30 120 1 120 processors..................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,320 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Upon review of the information collection we have retained the currently approved burden estimate. FDA's estimate of the recordkeeping burden under Sec. 179.25(e) is based on 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 = 1,200 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 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 the OMB under the Paperwork Reduction Act of 1995. Dated: June 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12614 Filed 6-11-18; 8:45 am] BILLING CODE 4164-01-P
![27332 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Guidance section FDA form responses per burden per Total hours
respondents responses
respondent response
Section II; Human Food ..................... 3942a 37,134 .5 18,567 .5 (30 minutes) .... 9,284
Section III; Animal Food .................... 3942b 1,120 .5 560 .5 (30 minutes) .... 280
Total ............................................ ........................ ........................ ........................ ........................ .............................. 9,564
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with the estimates found DEPARTMENT OF HEALTH AND Irradiation in the Production,
in our Preventive Controls for Human HUMAN SERVICES Processing, and Handling of Food
Food Rule, we estimate that OMB Control Number 0910–0186—
approximately 37,134 human food Food and Drug Administration
Extension
facilities will each spend approximately
30 minutes (0.5 hour) reporting their [Docket No. FDA–2018–N–0073] This information collection supports
status as a qualified facility to FDA FDA regulations. Specifically, under
every 2 years. Thus, dividing this figure Agency Information Collection sections 201(s) and 409 of the Federal
by two to determine the annual burden, Activities; Submission for Office of Food, Drug, and Cosmetic Act (FD&C
we estimate there will be 18,567 Management and Budget Review; Act) (21 U.S.C. 321(s) and 348), food
Comment Request; Irradiation in the irradiation is subject to regulation under
responses and 9,284 burden hours
Production, Processing, and Handling the food additive premarket approval
associated with this information
of Food provisions of the FD&C Act. The
collection element.
regulations providing for uses of
Similarly, and consistent with the AGENCY: Food and Drug Administration, irradiation in the production,
estimates found in our Preventive HHS. processing, and handling of food are
Controls for Animal Food Rule, we found in part 179 (21 CFR part 179). To
ACTION: Notice.
estimate that approximately 1,120 ensure safe use of a radiation source,
animal food facilities will each spend SUMMARY: The Food and Drug § 179.21(b)(1) requires that the label of
approximately 30 minutes (0.5 hour) Administration (FDA or we) is sources bear appropriate and accurate
reporting their status as a qualified announcing that a proposed collection information identifying the source of
facility to FDA every 2 years. Thus, of information has been submitted to the radiation and the maximum (or
dividing this figure by two to determine Office of Management and Budget minimum and maximum) energy of the
the annual burden, we estimate there (OMB) for review and clearance under emitted radiation. Section 179.21(b)(2)
will be 560 responses and 280 burden the Paperwork Reduction Act of 1995. requires that the label or accompanying
hours associated with this information labeling bear adequate directions for
collection element. DATES: Fax written comments on the installation and use and a statement
collection of information by July 12, supplied by FDA that indicates
The draft guidance also refers to 2018. maximum dose of radiation allowed.
previously approved collections of Section 179.26(c) requires that the label
information found in FDA regulations. ADDRESSES: To ensure that comments on or accompanying labeling bear a logo
The collections of information in 21 the information collection are received, and a radiation disclosure statement.
CFR part 117 have been approved under OMB recommends that written Section 179.25(e) requires that food
OMB control number 0910–0751. The comments be faxed to the Office of processors who treat food with radiation
collections of information in 21 CFR Information and Regulatory Affairs, make and retain, for 1 year past the
part 507 have been approved under OMB, Attn: FDA Desk Officer, Fax: 202– expected shelf life of the products up to
OMB control number 0910–0789. 395–7285, or emailed to oira_ a maximum of 3 years, specified records
submission@omb.eop.gov. All relating to the irradiation process (e.g.,
Dated: June 7, 2018. comments should be identified with the the food treated, lot identification,
Leslie Kux, OMB control number 0910–0186. Also scheduled process, etc.). The records
Associate Commissioner for Policy. include the FDA docket number found required by § 179.25(e) are used by FDA
[FR Doc. 2018–12615 Filed 6–11–18; 8:45 am] in brackets in the heading of this inspectors to assess compliance with the
BILLING CODE 4164–01–P
document. regulation that establishes limits within
FOR FURTHER INFORMATION CONTACT: Ila which radiation may be safely used to
Mizrachi, Office of Operations, Food treat food. We cannot ensure safe use
and Drug Administration, Three White without a method to assess compliance
Flint North, 10A–12M, 11601 with the dose limits, and there are no
Landsdown St., North Bethesda, MD practicable methods for analyzing most
foods to determine whether they have
sradovich on DSK3GMQ082PROD with NOTICES
20852, 301–796–7726, PRAStaff@
fda.hhs.gov. been treated with ionizing radiation and
are within the limitations set forth in
SUPPLEMENTARY INFORMATION: In part 179. Records inspection is the only
compliance with 44 U.S.C. 3507, FDA way to determine whether firms are
has submitted the following proposed complying with the regulations for
collection of information to OMB for treatment of foods with ionizing
review and clearance. radiation.
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![Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 27333
In the Federal Register of January 26, on the proposed collection of FDA estimates the burden of this
2018, (83 FR 3734), FDA published a 60- information. No comments were collection of information as follows:
day notice requesting public comment received.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
179.25(e); records for large processors .............................. 4 300 1,200 1 1,200
179.25(e); records for 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 of information.
Upon review of the information DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
collection we have retained the HUMAN SERVICES https://www.regulations.gov. Follow the
currently approved burden estimate. instructions for submitting comments.
FDA’s estimate of the recordkeeping Food and Drug Administration Comments submitted electronically,
burden under § 179.25(e) is based on [Docket No. FDA–2005–D–0155] including attachments, to https://
experience regulating the safe use of www.regulations.gov will be posted to
radiation as a direct food additive. The General Principles for Evaluating the the docket unchanged. Because your
number of firms who process food using Human Food Safety of New Animal comment will be made public, you are
irradiation is extremely limited. We Drugs Used in Food-Producing solely responsible for ensuring that your
Animals; Guidance for Industry; comment does not include any
estimate that there are four irradiation
Availability confidential information that you or a
plants whose business is devoted
third party may not wish to be posted,
primarily (i.e., approximately 100 AGENCY: Food and Drug Administration, such as medical information, your or
percent) to irradiation of food and other HHS. anyone else’s Social Security number, or
agricultural products. Four other firms ACTION: Notice of availability. confidential business information, such
also irradiate small quantities of food. as a manufacturing process. Please note
We estimate that this irradiation SUMMARY: The Food and Drug
that if you include your name, contact
accounts for no more than 10 percent of Administration (FDA or Agency) is
information, or other information that
the business for each of these firms. announcing the availability of a final
guidance for industry (GFI) #3 entitled identifies you in the body of your
Therefore, the average estimated burden comments, that information will be
‘‘General Principles for Evaluating the
is based on four facilities devoting 100 posted on https://www.regulations.gov.
Human Food Safety of New Animal
percent of their business to food • If you want to submit a comment
Drugs Used in Food-Producing
irradiation (4 × 300 hours = 1,200 hours Animals.’’ This guidance describes the
with confidential information that you
for recordkeeping annually), and four do not wish to be made available to the
type of information that the FDA’s
facilities devoting 10 percent of their public, submit the comment as a
Center for Veterinary Medicine (CVM)
business to food irradiation (4 × 30 recommends sponsors provide to
written/paper submission and in the
hours = 120 hours for recordkeeping address the human food safety of new manner detailed (see ‘‘Written/Paper
annually). No burden has been animal drugs used in food-producing Submissions’’ and ‘‘Instructions’’).
estimated for the labeling requirements animals. The human food safety Written/Paper Submissions
in §§ 179.21(b)(1), 179.21(b)(2), and evaluation of new animal drugs used in Submit written/paper submissions as
179.26(c) because the disclosures are food-producing animals helps ensure follows:
supplied by FDA. Under 5 CFR that food derived from treated animals • Mail/Hand delivery/Courier (for
1320.3(c)(2), the public disclosure of is safe for human consumption. CVM written/paper submissions): Dockets
information originally supplied by the developed this guidance to inform Management Staff (HFA–305), Food and
Federal Government to the recipient for sponsors of the scientific data and/or Drug Administration, 5630 Fishers
the purpose of disclosure to the public information that may provide an Lane, Rm. 1061, Rockville, MD 20852.
is not subject to review by the OMB acceptable basis to determine that the • For written/paper comments
under the Paperwork Reduction Act of residue of a new animal drug in or on submitted to the Dockets Management
1995. food, when consumed, presents a Staff, FDA will post your comment, as
reasonable certainty of no harm to well as any attachments, except for
Dated: June 7, 2018. humans. information submitted, marked and
Leslie Kux, DATES: The announcement of the identified, as confidential, if submitted
Associate Commissioner for Policy. guidance is published in the Federal as detailed in ‘‘Instructions.’’
[FR Doc. 2018–12614 Filed 6–11–18; 8:45 am] Register on June 12, 2018. Instructions: All submissions received
must include the Docket No. FDA–
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P ADDRESSES: You may submit either
electronic or written comments on 2005–D–0155 for ‘‘General Principles
Agency guidances at any time as for Evaluating the Human Food Safety
follows: of New Animal Drugs Used in Food-
Producing Animals.’’ Received
Electronic Submissions comments will be placed in the docket
Submit electronic comments in the and, except for those submitted as
following way: ‘‘Confidential Submissions,’’ publicly
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Document Created: 2018-06-12 00:47:39
Document Modified: 2018-06-12 00:47:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by July 12, 2018. | |
| Contact | Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 27332 |
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