Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water; Proposed Rule; Public Meetings; Request for Comments

CourtFood And Drug Administration
Citation87 FR 913
Record Number2021-28503
Publication Date07 January 2022
Federal Register, Volume 87 Issue 5 (Friday, January 7, 2022)
[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
                [Proposed Rules]
                [Pages 913-916]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-28503]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                21 CFR Part 112
                [Docket No. FDA-2021-N-0471]
                Standards for the Growing, Harvesting, Packing, and Holding of
                Produce for Human Consumption Relating to Agricultural Water; Proposed
                Rule; Public Meetings; Request for Comments
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notification of public meetings; request for comments.
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                SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
                announcing two virtual public meetings entitled ``Standards for the
                Growing, Harvesting, Packing, and Holding of Produce for Human
                Consumption Relating to Agricultural Water.'' The purpose of the public
                meetings is to discuss the proposed rule entitled ``Standards for the
                Growing, Harvesting, Packing, and Holding of Produce for Human
                Consumption Relating to Agricultural Water,'' which was issued under
                the FDA Food Safety Modernization Act (FSMA). These public meetings are
                intended to facilitate and support the public's evaluation and
                commenting process on the proposed rule.
                DATES: The public meetings will be held virtually on February 14, 2022,
                from 11:45 a.m. Eastern Time to 7:45 p.m. Eastern Time and February 25,
                2022, from 8:45 a.m. Eastern Time to 4:45 p.m. Eastern Time. Submit
                either electronic or written comments on the proposed rule ``Standards
                for the Growing, Harvesting, Packing, and Holding of Produce for Human
                Consumption Relating to Agricultural Water'' by April 5, 2022. See
                ``How to Participate in the Public Meetings'' in the SUPPLEMENTARY
                INFORMATION section of this document for closing dates for advanced
                registration and other information regarding meeting participation.
                ADDRESSES: Due to the impact of the COVID-19 pandemic, these meetings
                will be held virtually to help protect the public and limit the spread
                of the virus.
                 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 at the end of
                [[Page 914]]
                April 5, 2022. Comments received by mail/hand delivery/courier (for
                written/paper submissions) will be considered timely if they are
                postmarked or the delivery service acceptance receipt is on or before
                that date.
                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-2021-N-0471 for the proposed rule ``Standards for the Growing,
                Harvesting, Packing, and Holding of Produce for Human Consumption
                Relating to Agricultural Water.'' Received comments, those filed in a
                timely manner (see ADDRESSES), 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.
                FOR FURTHER INFORMATION CONTACT: For general questions about the public
                meetings or for special accommodations due to a disability, contact
                Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009),
                Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
                240-402-1731, [email protected].
                SUPPLEMENTARY INFORMATION:
                I. Background
                 Congress enacted FSMA (Pub. L. 111-353) in 2011 in response to
                dramatic changes in the global food system and in our understanding of
                foodborne illness. FSMA transformed the nation's food safety system by
                shifting the focus from responding to foodborne illness to preventing
                it.
                 In November 2015, FDA issued the ``Standards for the Growing,
                Harvesting, Packing, and Holding of Produce for Human Consumption''
                rule (80 FR 74354, November 27, 2015) (2015 produce safety final rule)
                (codified at part 112 (21 CFR part 112)), which established science-
                based minimum standards for the safe growing, harvesting, packing, and
                holding of fruits and vegetables grown for human consumption. The
                provisions of the rule focus on addressing major routes of microbial
                contamination--including agricultural water; biological soil
                amendments; domesticated and wild animals; worker health and hygiene;
                and equipment, buildings, and tools.
                 Part 112, subpart E in the 2015 produce safety final rule, which
                outlines standards for agricultural water, includes a general
                requirement that agricultural water must be safe and adequate for its
                intended uses (Sec. 112.41). It also includes microbial water quality
                criteria (Sec. 112.44) and requirements for testing certain water
                sources (Sec. 112.46). The microbial quality criteria are based on the
                intended use of the agricultural water, such as for growing activities
                for covered produce other than sprouts (including irrigation water
                applied using direct water application methods and water used in
                preparing crop sprays) (commonly referred to as ``pre-harvest
                agricultural water''),\1\ and for certain other specified uses,
                including sprout irrigation water and water applications that directly
                contact covered produce during or after harvest.\2\ Since finalizing
                the rule, however, we have received consistent feedback from
                stakeholders expressing concern about the complexity of and
                implementation challenges with certain agricultural water requirements.
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                 \1\ The produce safety regulation refers to pre-harvest
                agricultural water used during sprout production as ``sprout
                irrigation water.''
                 \2\ Because sprouts present a unique safety risk, the produce
                safety regulation establishes sprout-specific requirements on
                multiple topics, including agricultural water.
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                 Accordingly, in the Federal Register of December 6, 2021 (86 FR
                69120), FDA published the proposed rule entitled ``Standards for the
                Growing, Harvesting, Packing, and Holding of Produce for Human
                Consumption Relating to Agricultural Water'' (2021 agricultural water
                proposed rule). This proposed rule would amend the agricultural water
                provisions of the produce safety regulation to replace the microbial
                criteria and testing requirements for pre-harvest agricultural water
                for covered produce (other than sprouts) that
                [[Page 915]]
                covered farms have found to be complex and challenging to implement,
                with provisions for comprehensive assessments of pre-harvest
                agricultural water systems, practices, and on-farm conditions.
                 The proposed agricultural water assessments would provide
                additional flexibility to covered farms, using a systems-based approach
                that would be feasible to implement across the wide variety of pre-
                harvest agricultural water systems, uses, and farm operations and would
                be adaptable as scientific understanding of agricultural water quality
                expands in the future. We also are proposing to require expedited
                mitigation for hazards related to certain activities associated with
                adjacent and nearby land in light of findings from several recent
                produce outbreak investigations.
                 These proposed revisions to the produce safety regulation, if
                finalized, would set forth requirements for comprehensive pre-harvest
                agricultural water assessments and mitigation measures that minimize
                the risk of serious adverse health consequences or death, including
                those reasonably necessary to prevent the introduction of known or
                reasonably foreseeable biological hazards into or onto produce, and to
                provide reasonable assurances that the produce is not adulterated on
                account of these hazards.
                 FDA is announcing two virtual public meetings entitled ``Standards
                for the Growing, Harvesting, Packing, and Holding of Produce for Human
                Consumption Relating to Agricultural Water'' so that stakeholders can
                better understand, evaluate, and comment on the proposed rule. These
                meetings will be held during the formal comment period on the proposed
                rule. The two public meetings will cover the same agenda items and are
                intended to facilitate and support the public's evaluation and
                commenting process.
                II. Purpose and Format of the Public Meetings
                 The purpose of the public meetings is to provide information and
                facilitate public comment on the proposed rule. We invite interested
                parties to provide information and offer comments related to the
                proposed rule. During the public meetings we will provide an overview
                of the current requirements that apply for pre-harvest agricultural
                water for non-sprout covered produce and discuss the proposed
                provisions for systems-based pre-harvest 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. There will be
                an opportunity for questions, as well as an opportunity for open public
                comment.
                III. How to Participate in the Public Meetings
                 There will be a total of two virtual public meetings with different
                timeframes, which will provide persons in different regions an
                opportunity to comment on the proposed rule.
                 Table 1 provides information on participation in the public
                meetings.
                 Table 1--Information on Participating in the Public Meetings and on Submitting Comments to the Proposed Rule
                 Docket
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                 Activity Date Electronic address Other information
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                First public meeting................. February 14, 2022; Webcast information Webcast will have
                 11:45 a.m. to 7:45 will be sent upon closed captioning.
                 p.m. EST. completion of
                 registration.
                Request to make an oral presentation. By February 2, 2022.... https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
                Notice confirming opportunity to make By February 4, 2022.... ....................... An Agency
                 an oral presentation. representative will
                 confirm the
                 opportunity to make an
                 oral presentation and
                 will provide the
                 approximate time on
                 the public meeting
                 agenda to do so.
                Second public meeting................ February 25, 2022; 8:45 Webcast information Webcast will have
                 a.m. to 4:45 p.m. EST. will be sent upon closed captioning.
                 completion of
                 registration.
                Request to make an oral presentation. By February 11, 2022... https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
                Notice confirming opportunity to make By February 15, 2022... ....................... An Agency
                 an oral presentation. representative will
                 confirm the
                 opportunity to make an
                 oral presentation and
                 will provide the
                 approximate time on
                 the public meeting
                 agenda to do so.
                Submitting either electronic or Submit comments by https:// See ADDRESSES for
                 written comments. April 5, 2022. www.regulations.gov. additional information
                 on submitting
                 comments.
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                [[Page 916]]
                IV. Transcripts
                 Please be advised that as soon as a transcript is available, it
                will be accessible at: https://www.regulations.gov. You may also view
                the transcript at the Dockets Management Staff (see ADDRESSES).
                 Dated: December 29, 2021.
                Lauren K. Roth,
                Associate Commissioner for Policy.
                [FR Doc. 2021-28503 Filed 1-6-22; 8:45 am]
                BILLING CODE 4164-01-P
                

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