Rule2024-21840
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
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Published
September 24, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide." We are updating the small entity compliance guide (SECG) to help small entities comply with revised requirements related to agricultural water in the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" regulation.
Full Text
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<title>Federal Register, Volume 89 Issue 185 (Tuesday, September 24, 2024)</title>
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[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Rules and Regulations]
[Pages 77775-77776]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21840]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA-2011-N-0921]
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption: What You Need To Know About the Food and
Drug Administration Regulation; Small Entity Compliance Guide;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption: What You Need to Know About the FDA
Regulation: Small Entity Compliance Guide.'' We are updating the small
entity compliance guide (SECG) to help small entities comply with
revised requirements related to agricultural water in the ``Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' regulation.
DATES: The announcement of the guidance is published in the Federal
Register on September 24, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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 ``What You Need to Know About the FDA Regulation:
[[Page 77776]]
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption--Small Entity Compliance Guide.'' Received
comments 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 Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the SECG to the Office
of Food Safety, Division of Produce Safety (HFS-317), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1636.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 27, 2015 (80 FR 74353), we
issued a final rule entitled ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption'' (produce safety
rule). The produce safety rule, which is codified at part 112 (21 CFR
part 112), established science-based minimum standards for the safe
growing, harvesting, packing, and holding of produce, meaning fruits
and vegetables grown for human consumption. On September 6, 2017 (82 FR
42031) we announced the availability of a guidance for industry
entitled ``Standards for the Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption: What You Need to Know About the FDA
Regulation: Small Entity Compliance Guide'' to help small entities
comply with the produce safety rule.
In the Federal Register of May 6, 2024 (89 FR 37448), we issued a
final rule entitled, ``Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption Relating to Agricultural
Water'' (agricultural water final rule) that revised certain
requirements in subpart E of part 112 (21 CFR 112.40 through 112.50) of
the produce safety rule applicable to pre-harvest agricultural water
for covered produce (other than sprouts). The agricultural water final
rule is effective July 5, 2024. The final rule establishes compliance
dates for the pre-harvest agricultural water provisions for covered
produce (other than sprouts) beginning on April 7, 2025, with date
staggering based on farm size.
We examined the economic implications of the agricultural water
final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-
612) and determined that the final rule might have a significant
economic impact on a substantial number of small entities. In
compliance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-
28), we are making available the SECG to explain the actions that a
small entity must take to comply with the rule.
We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in part 112 have been approved under OMB control number 0910-0816.
III. Electronic Access
Persons with access to the internet may obtain the SECG at either
<a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21840 Filed 9-23-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 24, 2024.
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