Proposed Rule2021-28503
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water; Proposed Rule; Public Meetings; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 7, 2022
Effective
February 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 5 (Friday, January 7, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#d59fa0b4bbbca1b4fb8cb4a1b0a695b3b1b4fbbdbda6fbb2baa3"><span class="__cf_email__" data-cfemail="fdb7889c9394899cd3a49c89988ebd9b999cd395958ed39a928b">[email protected]</span></a>.
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.... <a href="https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements">https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements</a>.
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... <a href="https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements">https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements</a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.