[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Pages 68673-68675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26261]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 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

[[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, 
[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.

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 
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
           Activity; 21 CFR section               Number of        records per     Total annual        Average burden per recordkeeping      Total hours
                                                recordkeepers   recordkeeper \2\      records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................          241,617  ................         605,079  .........................................    1,142,043
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                21 CFR section                    Number of      disclosures per       Total            Average burden per disclosure        Total hours
                                                 respondents       Respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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