[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 [www.gpo.gov]
[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:
     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 ``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 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 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 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. 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