Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food, 65825-65827 [2020-22939]
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
II. Participation
Drug product manufacturers located
in the United States that are interested
in participating in the QMM FDF Pilot
Program should submit a written
request directly to Seongjin (Cindy) Pak
(see FOR FURTHER INFORMATION CONTACT).
Participation in the QMM FDF Pilot
Program is voluntary. Participants in the
Quality Metrics Feedback Program are
encouraged to participate in the QMM
FDF Pilot Program. FDA will select up
to nine participants for the QMM FDF
Pilot Program. Participation in the QMM
FDF Pilot Program is limited to
domestic manufacturing facilities since
FDA’s funding source for this program
is specific to activities related to
domestic manufacturing.
A. Selection Criteria
jbell on DSKJLSW7X2PROD with NOTICES
To be considered for the QMM FDF
Pilot Program, participants must meet
the following selection criteria:
1. Participant is a U.S.-based
manufacturing facility of prescription
and/or OTC drug products.
2. All FDA inspection(s) of the
manufacturing facility conducted within
the 5 years prior to October 1, 2020,
received a final classification of ‘‘No
Action Indicated’’ or ‘‘Voluntary Action
Indicated.’’
3. Participant agrees to:
a. Permit a third-party contractor to
conduct a QMM assessment, whether
the assessment is conducted on-site or
remotely. FDA will identify an external
contractor having the expertise to assess
QMM, and FDA staff will join the
contractor for the assessment.
b. Collect and submit metrics data to
FDA and the contractor by an agreed
upon date, prior to the assessment. As
part of the scoping discussions for the
assessment, FDA will provide the
manufacturer with templates and
additional details about the data
collection.
c. Be available for consultations with
the contractor and FDA prior to and
after the assessment, including
discussions regarding the participant’s
established QMM-related activities and
the contractor’s post-assessment
recommendations regarding these
activities.
During this QMM FDF Pilot Program,
the contractor and FDA staff will be
available to answer questions and
address concerns that arise.
B. Information To Include in the
Request
When submitting a request to
participate in the QMM FDF Pilot
Program, include the information below
to aid in FDA’s selection and planning.
VerDate Sep<11>2014
18:59 Oct 15, 2020
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FDA will not consider requests
submitted without the following
minimal information:
1. A contact person (name and email);
2. manufacturing facility location;
3. facility FDA Establishment
Identifier and Data Universal
Numbering System numbers;
4. a brief description of the
manufacturing operations conducted at
the facility;
5. preferred dates for the assessment;
6. written confirmation that the
facility meets the selection criteria in
section II.A, including agreement to
items 3a–c;
7. written confirmation that the
facility can handle a visit of up to 10
FDA staff and contractors; and
8. a brief description of prior
experiences undergoing an assessment
related to the maturity of the facility’s
quality culture, including the name of
the organization that conducted the
assessment and date of the assessment.
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22976 Filed 10–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0073]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Irradiation in the
Production, Processing, and Handling
of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of our
requirements for food irradiation
processors.
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
65825
Submit either electronic or
written comments on the collection of
information by December 15, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 15,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 15, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–0073 for ‘‘Agency Information
E:\FR\FM\16OCN1.SGM
16OCN1
65826
Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
Collection Activities; Proposed
Collection; Comment Request;
Irradiation in the Production,
Processing, and Handling of Food.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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,
§ 179.21(b)(1) (21 CFR 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) (21
CFR 179.26(c)) requires that the label or
accompanying labeling 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
§ 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.
We estimate the burden of this
collection of information as follows:
jbell on DSKJLSW7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
179.25(e), large processors .................................................
179.25(e), small processors ................................................
VerDate Sep<11>2014
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Frm 00039
Number of
records per
recordkeeper
4
4
Fmt 4703
Sfmt 4703
Total annual
records
300
30
E:\FR\FM\16OCN1.SGM
1,200
120
16OCN1
Average
burden per
recordkeeping
1
1
Total hours
1,200
120
Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
65827
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
21 CFR section
Total ..............................................................................
1 There
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
........................
........................
........................
........................
1,320
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 § 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 §§ 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: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22939 Filed 10–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1216]
Electronic Common Technical
Document; Data Standards; Support
Ends for Electronic Common Technical
Document Module 1 U.S. Regional
Document Type Definition Version 2.01
and Requirement Begins for Electronic
Common Technical Document Module
1 U.S. Regional Document Type
Definition Version 3.3
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
and Center for Biologics Evaluation and
Research are announcing the date that
FDA will no longer support electronic
submissions using the Electronic
Common Technical Document (eCTD)
Backbone Files Specification for Module
1 Version 1.3, Comprehensive Table of
Contents Headings and Hierarchy
Version 1.2.2, U.S. Regional Document
Type Definition (DTD) Version 2.01, and
U.S. Regional Stylesheet Version 1.1,
and will require electronic submissions
to be submitted using eCTD Module 1
U.S. Regional DTD Version 3.3. The
Agency will update the eCTD
Submission Standards document to
reflect these changes.
DATES: The requirement for electronic
submissions to be submitted using eCTD
Module 1 U.S. Regional DTD Version
3.3 will begin on March 1, 2022.
ADDRESSES: You may submit either
electronic or written comments at any
time as follows:
SUMMARY:
Electronic Submissions
jbell on DSKJLSW7X2PROD with NOTICES
Total hours
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
VerDate Sep<11>2014
18:59 Oct 15, 2020
Jkt 253001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1216 for ‘‘Electronic Common
Technical Document; Data Standards;
Support Ends for Electronic Common
Technical Document Module 1 U.S.
Regional Document Type Definition
Version 2.01 and Requirement Begins
for Electronic Common Technical
Document Module 1 U.S. Regional
Document Type Definition Version 3.3.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65825-65827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22939]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0073]
Agency Information Collection Activities; Proposed Collection;
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, we, or Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of our requirements for food irradiation processors.
DATES: Submit either electronic or written comments on the collection
of information by December 15, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 15, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-0073 for ``Agency Information
[[Page 65826]]
Collection Activities; Proposed Collection; Comment Request;
Irradiation in the Production, Processing, and Handling of Food.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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) (21 CFR 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) (21 CFR 179.26(c)) requires that the label
or accompanying labeling 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.
We estimate the burden of this collection of information as
follows:
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..... 4 300 1,200 1 1,200
179.25(e), small processors..... 4 30 120 1 120
-------------------------------------------------------------------------------
[[Page 65827]]
Total....................... .............. .............. .............. .............. 1,320
----------------------------------------------------------------------------------------------------------------
\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: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22939 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P
