83_FR_27445 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

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)

Page Range27332-27333
FR Document2018-12614

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.

Federal Register, Volume 83 Issue 113 (Tuesday, June 12, 2018)
[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
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                                                                                                                        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–
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                                                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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by July 12, 2018.
ContactIla 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 Citation83 FR 27332 

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