[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]


=======================================================================
-----------------------------------------------------------------------

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

[[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
----------------------------------------------------------------------------------------------------------------
               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.
----------------------------------------------------------------------------------------------------------------


[[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


