Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water; Proposed Rule; Public Meetings; Request for Comments, 913-916 [2021-28503]

Download as PDF Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Proposed Rules standard free of charge by contacting Alberta E. Mills, Division of the Secretariat, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: 301–504–7479; email: cpscos@cpsc.gov. shading) defined in section 3, definition 5.01, of ANSI/WCMA A100.1–2018, is a window covering that does not meet the definition of a stock window covering. ■ 3. Amend § 1120.3 by adding paragraphs (e) and (f) to read as follows: XI. Request for Comments The Commission invites interested persons to submit their comments to the Commission on any aspect of the proposed rule. Comments should be submitted as provided in the instructions in the ADDRESSES section at the beginning of this notice. § 1120.3 Products deemed to be substantial product hazards. List of Subjects in 16 CFR Part 1120 Administrative practice and procedure, Clothing, Consumer protection, Cord sets, Extension cords, Household appliances, Lighting, Window coverings, Cords, Infants and children, Imports, Incorporation by reference. For the reasons stated above, and under the authority of 15 U.S.C. 2064(j), 5 U.S.C. 553, and section 3 of Public Law 110–314, 122 Stat. 3016 (August 14, 2008), the Consumer Product Safety Commission proposes to amend 16 CFR part 1120 as follows: PART 1120—SUBSTANTIAL PRODUCT HAZARD LIST 1. The authority citation for part 1120 continues to read as follows: ■ Authority: 15 U.S.C. 2064(j). 2. Amend § 1120.2 by adding paragraphs (f) and (g) to read as follows: * * * * * (e) Stock window coverings that fail to comply with one or more of the following requirements of ANSI/WCMA A100.1–2018: (1) Operating cord requirements in section 4.3.1: section 4.3.1.1 (cordless operating system), 4.3.1.2 (short static or access cord), or 4.3.1.3 (inaccessible operating cord); (2) Inner cord requirements in sections 4.5, 6.3, 6.7, and Appendices C and D; and (3) On-product manufacturer label requirement in section 5.3. (f) Custom window coverings that fail to comply with one or more of the following requirements of ANSI/WCMA A100.1–2018: (1) Inner cord requirements in sections 4.5, 6.3, 6.7, and Appendices C and D; and (2) On-product manufacturer label in section 5.3. ■ 4. Amend § 1120.4 by adding paragraph (d) to read as follows: ■ § 1120.2 Definitions. tkelley on DSK125TN23PROD with PROPOSED RULES * * * * * (f) Stock window covering (also known as a stock blind, shade, or shading) defined in section 3, definition 5.02, of ANSI/WCMA A100.1–2018, is a window covering that is completely or substantially fabricated prior to being distributed in commerce and is a specific stock-keeping unit (SKU). Even when the seller, manufacturer, or distributor modifies a pre-assembled product by adjusting to size, attaching the top rail or bottom rail, or tying cords to secure the bottom rail, the product is still considered stock. Online sales of the product or the size of the order such as multi-family housing do not make the product a non-stock product. These examples are provided in ANSI/WCMA A100.1–2018 to clarify that as long as the product is ‘‘substantially fabricated,’’ subsequent changes to the product do not change its categorization. (g) Custom window covering (also known as a custom blind, shade, or VerDate Sep<11>2014 16:35 Jan 06, 2022 Jkt 256001 § 1120.4 Standards incorporated by reference. * * * * * (d) Window Covering Manufacturers Association, Inc. 355 Lexington Avenue, New York, New York 10017. telephone: 212.297.2122. https://wcmanet.com. (1) ANSI/WCMA A100.1–2018. American National Standard For Safety Of Corded Window Covering Products, IBR approved for §§ 1102.2(f) and (g), and §§ 1120.3 (e) and (f). (2) [Reserved] Alberta E. Mills, Secretary, Consumer Product Safety Commission. [FR Doc. 2021–27897 Filed 1–6–22; 8:45 am] BILLING CODE 6355–01–P PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 913 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. Notification of public meetings; request for comments. ACTION: 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 SUMMARY: E:\FR\FM\07JAP1.SGM 07JAP1 914 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Proposed Rules 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’’). tkelley on DSK125TN23PROD with PROPOSED RULES 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 VerDate Sep<11>2014 16:35 Jan 06, 2022 Jkt 256001 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-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, 240–402–7500. 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, Juanita.Yates@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 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 (§ 112.41). It also includes microbial water quality criteria (§ 112.44) and requirements for testing certain water sources (§ 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. 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 preharvest agricultural water for covered produce (other than sprouts) that 1 The produce safety regulation refers to preharvest agricultural water used during sprout production as ‘‘sprout irrigation water.’’ 2 Because sprouts present a unique safety risk, the produce safety regulation establishes sproutspecific requirements on multiple topics, including agricultural water. E:\FR\FM\07JAP1.SGM 07JAP1 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Proposed Rules 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 915 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 systemsbased 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 Activity Date Electronic address First public meeting February 14, 2022; 11:45 a.m. to 7:45 p.m. EST. By February 2, 2022 ............................. Webcast information will be sent upon completion of registration. https://www.fda.gov/food/news-eventscfsan/workshops-meetings-webinarsfood-and-dietary-supplements. ............................................................... tkelley on DSK125TN23PROD with PROPOSED RULES Request to make an oral presentation. Notice confirming opportunity to make an oral presentation. By February 4, 2022 ............................. Second public meeting. Request to make an oral presentation. Notice confirming opportunity to make an oral presentation. February 25, 2022; 8:45 a.m. to 4:45 p.m. EST. By February 11, 2022 ........................... By February 15, 2022 ........................... Webcast information will be sent upon completion of registration. https://www.fda.gov/food/news-eventscfsan/workshops-meetings-webinarsfood-and-dietary-supplements. ............................................................... Submitting either electronic or written comments. Submit comments by April 5, 2022 ...... https://www.regulations.gov .................. VerDate Sep<11>2014 16:35 Jan 06, 2022 Jkt 256001 PO 00000 Frm 00026 Fmt 4702 Sfmt 9990 E:\FR\FM\07JAP1.SGM Other information Webcast will have closed captioning. An Agency representative will confirm the opportunity to make an oral presentation and will provide the approximate time on the public meeting agenda to do so. Webcast will have closed captioning. An Agency representative will confirm the opportunity to make an oral presentation and will provide the approximate time on the public meeting agenda to do so. See ADDRESSES for additional information on submitting comments. 07JAP1 916 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Proposed Rules Seventh District, Waterways Management Branch (Dpw), U.S. Coast Guard; telephone 305–415–6748, email stephanie.l.miranda@uscg.mil. 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). SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code 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 II. Background, Purpose, and Legal Basis DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2021–0661] RIN 1625–AA11 Regulated Navigation Area; Offshore, Cape Canaveral, Florida Coast Guard, DHS. Supplemental notice of proposed rulemaking. AGENCY: ACTION: On September 17, 2021, the Coast Guard published a notice of proposed rulemaking (NPRM) proposing to replace the existing safety zone in Captain of the Port (COTP) zone Jacksonville, Offshore Cape Canaveral, Florida with a regulated navigation area (RNA). Changes in the type and size of launch vehicles, rocket component recovery methods, and the increased frequency of launches now pose variable risks to marine traffic and require a more flexible regulatory tool. After considering comments received from the public, the Coast Guard is making modifications to the regulated area in the proposed rule. This supplemental notice requests comments on the revised proposal. DATES: Comments and related material must be received by the Coast Guard on or before February 7, 2022. ADDRESSES: You may submit comments identified by docket number USCG– 2021–0661 using the Federal Decision Making Portal at https:// www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. tkelley on DSK125TN23PROD with PROPOSED RULES SUMMARY: If you have questions about this proposed rulemaking, call or email Lieutenant Junior Grade Stephanie Miranda, FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 16:35 Jan 06, 2022 Jkt 256001 The Coast Guard proposes to replace the existing safety zone in 33 CFR 165.775 titled, ‘‘Safety Zone; Captain of the Port Zone Jacksonville; Offshore Cape Canaveral, Florida’’ with a regulated navigation area (RNA). The existing safety zone established in 2009 is composed of four large regulated areas and was established in 2009 with the intent of protecting marine traffic from the hazards associated with the launching of space vehicles, to expedite notification to the public, and to reduce the administrative workload of the Coast Guard. However, since the establishment of the safety zone in § 165.775, changes in the type and size of launch vehicles, rocket component recovery methods, and the increased frequency of launches pose variable risks to marine traffic and require a more flexible regulatory tool. On September 17, 2021, the Coast Guard published a notice of proposed rulemaking entitled, ‘‘Regulated Navigation Area; Offshore, Cape Canaveral, Florida in the Federal Register (86 FR 51845) in order to replace the existing safety zone in § 165.775 with a RNA. During the comment period that ended on October 18, 2021, we received three comments and those comments are addressed in Section III of this SNPRM. The Coast Guard is proposing this SNPRM under authority in 46 U.S.C. 70034. The purpose of this SNPRM is to revise the regulatory text as proposed in the NPRM to expand the zone to include additional missions which are expected to be conducted (including the Transport 2 mission conducted by the U.S Space Launch Delta 45 (SLD 45) and operations by the Blue Origin, LLC), and to include the Captain of the Port’s (COTP) consideration of analysis from (SLD 45) when activating a zone. The revised regulatory text we are proposing in this SNPRM appears at the end of this document. It differs from the text proposed in the NPRM, primarily in that it expands the zone westward to include PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 areas of operation by the SLD 45 and the Blue Origin, LLC. III. Discusion of Comments on the NPRM and Change to the Proposed Rule In response to the NPRM, the Coast Guard received three public comments. Unless we receive recommendations for changes during the SNPRM comment period, we plan to adopt the regulations proposed in the NPRM with revisions to the regulatory text as reflected in this SNPRM. The SNPRM provides an additional comment period to shape the final regulatory action. Concerns received on this SNPRM will be addressed in the final rule. The Coast Guard received a comment addressing the growing effect of commercial space travel in terms of potential for pollution and hazards to land and sea vehicles in the path of flight. The commenter felt the proposed change was valid and important. No changes were made based on this comment. Another comment addressed the growth of the aerospace industry in the region and associated increase in launch activity observed since 2009. The commenter felt that an evaluation of the 2009 rulemaking and the associated changes proposed in the NPRM were warranted and in the interest of preserving the safety of marine interests in the area. No changes were made based on this comment. The Coast Guard received a comment from the Blue Origin Florida, LLC and included a request for an adjustment to the dimensions of the RNA to provide a launch hazard area suitable for potential future launches to Polar Orbits. The change was evaluated and implemented. In response to this comment, the Coast Guard made changes to the regulatory text in this SNPRM by making an adjustment to the southeast launch hazard area to encompass dimensions aligned to a Polar Orbit-mission specific launch exclusion area as provided by the SLD 45. IV. Discussion of Proposed Rule The proposed rule would establish a RNA in the following revised area based on comments received during the NPRM comment period: All waters offshore Cape Canaveral from surface to bottom, encompassed by a line connecting the following points beginning with Point 1 at 28°48′54″ N, 80°28′40″ W; thence southwest to Point 2 at 28°43′20″ N, 80°41′00″ W; thence south along the shoreline to Point 3 at 28°25′18″ N, 80°34′43″ W; thence continuing south offshore to Point 4 at 28°11′00″ N, E:\FR\FM\07JAP1.SGM 07JAP1

Agencies

[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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

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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
----------------------------------------------------------------------------------------------------------------
               Activity                          Date              Electronic address       Other information
----------------------------------------------------------------------------------------------------------------
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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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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