Notice2021-26261
Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption
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Published
December 3, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA 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 associated with the standards for the growing, harvesting, packing, and holding of produce for human consumption.
Full Text
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<title>Federal Register, Volume 86 Issue 230 (Friday, December 3, 2021)</title>
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[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Pages 68673-68675]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26261]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0921]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Standards for the Growing, Harvesting, Packaging, and
Holding of Produce for Human Consumption
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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 associated with
the standards for the growing, harvesting, packing, and holding of
produce for human consumption.
DATES: Submit either electronic or written comments on the collection
of information by February 1, 2022.
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 February 1, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 1, 2022. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2011-N-0921 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Standards for the Growing,
Harvesting, Packaging, and Holding of Produce for Human Consumption.''
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
[[Page 68674]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#9dcdcfdccee9fcfbfbddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="69393b283a1d080f0f290f0d084701011a470e061f">[email protected]</span></a>.
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.
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption; 21 CFR Part 112
OMB Control Number 0910-0816--Extension
To minimize the risk of serious adverse health consequences or
death from consumption of contaminated produce, we have established
science-based minimum standards for the safe growing, harvesting,
packing, and holding of produce, meaning fruits and vegetables grown
for human consumption. The standards are codified in part 112 (21 CFR
part 112) and set forth procedures and processes that include
information collection activities such as establishing monitoring and
sampling plans, documenting data and training, and ensuring disclosure
that produce for human consumption meets these requirements. The
regulations also provide for certain exemptions and variances to
qualified respondents. We use the information to verify that the
standards established by the regulations are followed such that produce
entering the marketplace is reasonably unlikely to be associated with
foodborne illness.
In addition to the referenced regulations, we have developed two
draft guidance documents: ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption'' and
``Compliance with and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption for Sprout Operations;'' both are available at
<a href="https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm">https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm</a>. The former was
developed to help covered farms comply with the requirements of the
Produce Safety regulation. This draft guidance, when finalized, will
not create any additional burden not already considered as part of the
Produce Safety regulation.
The latter (the Sprouts draft guidance) was developed to assist
sprout operations also subject to the Produce Safety regulation.
Sprouts represent a special food safety concern because the conditions
under which they are produced (time, temperature, water activity, pH,
and available nutrients) are ideal for the growth of pathogens, if
present. The Sprouts draft guidance, when finalized, will assist sprout
operations subject to the regulations in part 112 in complying with the
sprout-specific requirements in subpart M.
Description of Respondents: Respondents to this information
collection include farms that grow, harvest, pack, or hold produce for
human consumption, meaning fruits and vegetables such as berries, tree
nuts, herbs, and sprouts. Respondents are from the private sector (for-
profit businesses).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper \2\ records
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Exemptions under Sec. 112.7................ 3,285 1 3,285 0.5 (30 minutes)......................... 1,643
Training under Sec. 112.30................. 24,420 1 24,420 7.25..................................... 177,045
Testing requirements for agricultural water 48,361 2.990 144,599 0.825 (~ 50 minutes)..................... 119,294
under Sec. Sec. 112.44 and 112.45.
Records related to agricultural water........ 160,605 2.242 360,076 2.160.................................... 777,765
Testing requirements for sprouts under Sec. 126 245.660 30,953.16 0.825 (~ 50 minutes)..................... 25,536
Sec. 112.144, 112.145, and 112.147.
Records related to sprouts................... 126 62.061 7,819.686 1.412 (~ 85 minutes)..................... 11,041
``Compliance with and Recommendations for 126 233 29,358 1........................................ 29,358
Implementation of the Standards for the
Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout
Operations''.
Documentation supporting compliance with Sec. 4,568 1 4,568 0.079 (~ 5 minutes)...................... 361
112.2.
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Total.................................... 241,617 ................ 605,079 ......................................... 1,142,043
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers rounded to nearest 1/1,000.
[[Page 68675]]
Table 2--Estimated Annual Third-Party Disclosure Burden\1\
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Number of
21 CFR section Number of disclosures per Total Average burden per disclosure Total hours
respondents Respondent disclosures
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Disclosure under Sec. Sec. 112.2, 112.6, 77,165 3.459 266,914 1.422 (~ 85 minutes)..................... 379,551
112.31, 112.33, and 112.142.
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\1\ There are no capital costs or operating or 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.
Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26261 Filed 12-2-21; 8:45 am]
BILLING CODE 4164-01-P
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