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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 112
Docket No. FDA2021N0471
RIN 0910AI49

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice of proposed rulemaking.

The Food and Drug Administration FDA, the Agency, or we is proposing to amend the agricultural water provisions of the produce safety regulation that covered farms have found complex and challenging to implement. This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce other than sprouts with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections. Additionally, we are proposing to require expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands, in light of findings from several recent produce outbreak investigations. These proposed revisions to the produce safety regulation, if finalized, would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.
DATES: Submit either electronic or written comments on the proposed rule by April 5, 2022. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 5, 2022 see the Paperwork Reduction Act of 1995 section of this document.
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 April 5, 2022.
The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on April 5, 2022. Comments received by mail/hand delivery/courier for written/

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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 elses 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 HFA305, 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
2021N0471 for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. 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 Dockets Management Staff between 9
a.m. and 4 p.m. Eastern Time, Monday through Friday, 2404027500.
Confidential SubmissionsTo submit a comment with confidential information that you do not wish to be
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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 FDAs 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-201509-18/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, 2404027500.
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 to the Office of Management and Budget OMB at https www.reginfo.gov/public/do/
PRAMain. Find this particular information collection by selecting Currently under ReviewOpen for Public Comments or by using the search function. The title of this proposed collection is Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.
FOR FURTHER INFORMATION CONTACT:

Regarding the proposed rule: Samir Assar, Director, Division of Produce Safety, Office of Food Safety, Center for Food Safety and Applied Nutrition HFS317 5001 Campus Dr., College Park, MD 20740, 2404021636, email:
samir.assar@hhs.fda.gov.

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