[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.
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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\.
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