[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Notices]
[Pages 43273-43274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0921]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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: Submit written comments (including recommendations) on the 
collection of information by August 19, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0816. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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. The information collection continues to 
implement provisions of the FDA Food Safety Modernization Act, while 
certain requirements for covered produce other than sprouts associated 
with pre-harvest agricultural water testing are being amended through 
rulemaking (RIN 0910-AI49). 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).
    In the Federal Register of December 3, 2021 (86 FR 68673), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received and appears to 
pertain to rulemaking that has already concluded, rather than to this 
renewal. Significantly, this comment did not suggest that we revise the 
currently approved estimate. To the extent that the comment relates to 
ongoing rulemaking, we have posted the comment to the docket at FDA-
2021-N-0471 and will ensure it is considered and addressed 
appropriately.
    We estimate the burden of this collection of information as 
follows:

[[Page 43274]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                 Number of
                                                 Number of      records per    Total annual
          Activity; 21 CFR section             recordkeepers   recordkeeper       records          Average burden per recordkeeping         Total hours
                                                                    \2\
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Exemptions under Sec.   112.7...............           3,285               1           3,285  0.5.......................................           1,643
                                                                                              (30 minutes)..............................
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               4,568               1           4,568  0.079 (~ 5 minutes).......................             361
 Sec.   112.2.
                                             -----------------------------------------------------------------------------------------------------------
    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\.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                 Number of
                                                 Number of      disclosures        Total
               21 CFR section                   respondents         per         disclosures          Average burden per disclosure          Total hours
                                                                respondent
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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. As respondents to the collection continue to implement the 
regulatory requirements and compliance schedules continue to be 
realized, we retain our current burden estimates. At the same time, and 
as communicated on our website at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-agricultural-water, we expect 
the burden associated with the testing of certain agricultural water 
for covered produce other than sprouts to be minimal for the period of 
time that FDA intends to exercise enforcement discretion with regard to 
those requirements.

    Dated: July 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15425 Filed 7-19-22; 8:45 am]
BILLING CODE 4164-01-P