Proposed Rule2022-15134
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
Primary source
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Published
July 19, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is proposing dates for compliance with the pre-harvest agricultural water provisions for covered produce other than sprouts in the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water" proposed rule. We also are specifying the duration of the period during which we intend to exercise enforcement discretion for the harvest and post-harvest agricultural water requirements for covered produce other than sprouts in the produce safety regulation to provide covered farms, regulators, educators, and other stakeholders additional time to facilitate compliance with those provisions. The proposed compliance dates for pre-harvest agricultural water requirements and our exercise of enforcement discretion for the harvest and post-harvest agricultural water provisions are intended to facilitate successful implementation and optimize public health protections. We are reopening the comment period only with respect to the compliance dates for the proposed pre- harvest agricultural water provisions for covered produce other than sprouts.
Full Text
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<title>Federal Register, Volume 87 Issue 137 (Tuesday, July 19, 2022)</title>
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[Federal Register Volume 87, Number 137 (Tuesday, July 19, 2022)]
[Proposed Rules]
[Pages 42973-42979]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15134]
[[Page 42973]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA-2021-N-0471]
RIN 0910-AI49
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption Relating to Agricultural Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; supplemental notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing dates for compliance with the pre-harvest agricultural water
provisions for covered produce other than sprouts in the ``Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water'' proposed rule. We also are
specifying the duration of the period during which we intend to
exercise enforcement discretion for the harvest and post-harvest
agricultural water requirements for covered produce other than sprouts
in the produce safety regulation to provide covered farms, regulators,
educators, and other stakeholders additional time to facilitate
compliance with those provisions. The proposed compliance dates for
pre-harvest agricultural water requirements and our exercise of
enforcement discretion for the harvest and post-harvest agricultural
water provisions are intended to facilitate successful implementation
and optimize public health protections. We are reopening the comment
period only with respect to the compliance dates for the proposed pre-
harvest agricultural water provisions for covered produce other than
sprouts.
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 19, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. 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 September 19, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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 ``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: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1636,
<a href="/cdn-cgi/l/email-protection#b7c4d6dadec599d6c4c4d6c5f7dfdfc499d1d3d699d0d8c1"><span class="__cf_email__" data-cfemail="453624282c376b2436362437052d2d366b2321246b222a33">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Supplemental Notice of Proposed Rulemaking
This supplemental notice of proposed rulemaking proposes compliance
dates for the pre-harvest agricultural water \1\ provisions for covered
produce other than sprouts in the proposed rule, ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to
[[Page 42974]]
Agricultural Water'' (86 FR 69120, December 6, 2021) (2021 agricultural
water proposed rule) and announces our intent to continue the policy of
enforcement discretion for the relevant subpart E requirements in the
produce safety regulation until this rulemaking is completed.
Additionally, we are specifying the duration of our intended
enforcement discretion policy for the harvest and post-harvest
agricultural water \2\ requirements for covered produce other than
sprouts in the produce safety regulation.
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\1\ Agricultural water for produce subject to the requirements
of part 112 (covered produce) other than sprouts, using a direct
application method during growing activities are commonly referred
to as ``pre-harvest agricultural water.'' The produce safety
regulation refers to pre-harvest agricultural water used during
sprout production as ``sprout irrigation water.''
\2\ Agricultural water used during harvesting, packing, and
holding activities are commonly referred to as ``harvest and post-
harvest agricultural water.''
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In light of the revisions we are proposing to certain pre-harvest
agricultural water requirements for covered produce (other than
sprouts) in the 2021 agricultural water proposed rule, we are proposing
to establish dates for compliance with the pre-harvest agricultural
water provisions for covered produce other than sprouts as follows: 2
years and 9 months after the effective date of a final rule for very
small businesses; 1 year and 9 months after the effective date of a
final rule for small businesses; and 9 months after the effective date
of a final rule for all other businesses (see table 3).
We are not proposing a compliance date extension for the harvest
and post-harvest agricultural water requirements for covered produce
other than sprouts because we did not propose to change those
provisions. However, we are specifying the duration of our intended
enforcement discretion policy for the harvest and post-harvest
agricultural water provisions for covered produce other than sprouts in
the produce safety regulation until January 26, 2025, for very small
businesses; January 26, 2024, for small businesses; and January 26,
2023, for all other businesses (see table 3).
B. Summary of the Major Provisions of the Supplemental Notice of
Proposed Rulemaking
The 2021 agricultural water proposed rule, if finalized, would
revise certain provisions in the produce safety regulation applicable
to pre-harvest agricultural water.\3\ The 2021 agricultural water
proposed rule would not substantively alter the standards established
in part 112, subpart E, for agricultural water used for sprouts, for
which the compliance dates have passed, or for harvest and post-harvest
agricultural water, or for treatment of agricultural water.
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\3\ The produce safety regulation refers to pre-harvest
agricultural water used during sprout production as ``sprout
irrigation water.''
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We are reopening the comment period on the 2021 agricultural water
proposed rule to seek public comment on the proposed compliance dates
for the pre-harvest agricultural water provisions for covered produce
other than sprouts. We are proposing to establish dates for compliance
with the pre-harvest agricultural water provisions for covered produce
other than sprouts as follows: 2 years and 9 months after the effective
date of a final rule for very small businesses; 1 year and 9 months
after the effective date of a final rule for small businesses; and 9
months after the effective date of a final rule for all other
businesses. We are proposing these compliance dates in light of the
proposed revisions to certain pre-harvest agricultural water
requirements for covered produce (other than sprouts).
As the 2021 agricultural water proposed rule did not propose to
change the requirements of the produce safety regulation that apply to
harvest and post-harvest agricultural water for covered produce other
than sprouts, we are not proposing a compliance date extension for
those provisions. However, we are specifying the duration of our
intended enforcement discretion policy for the harvest and post-harvest
agricultural water provisions for covered produce other than sprouts in
the produce safety regulation to provide covered farms, regulators,
educators, and other stakeholders additional time to facilitate
compliance with those requirements. (The compliance dates for harvest
and post-harvest requirements are likely to occur before we complete
this rulemaking, in which we have proposed to reorganize and replace
subpart E in its entirety. In this document we refer to those
provisions according to the section numbers in the produce safety
regulation, recognizing that subpart E may be reorganized subsequently
through this rulemaking.) We recognize that prior to the publication of
the 2021 agricultural water proposed rule, stakeholders did not have
clarity on whether additional substantive changes for the harvest and
post-harvest agricultural water provisions would be proposed. In
addition, we recognize that the intended benefits of the harvest and
post-harvest requirements may not be fully realized unless accompanied
by adequate training, technical assistance, and other preparations to
support effective implementation by all parties. Therefore, we intend
to exercise enforcement discretion for the harvest and post-harvest
agricultural water provisions for covered produce other than sprouts in
the produce safety regulation until January 26, 2025, for very small
businesses; January 26, 2024, for small businesses; and January 26,
2023, for all other businesses.
The proposed compliance dates for pre-harvest agricultural water
provisions in the 2021 agricultural water proposed rule and enforcement
discretion policy for the harvest and post-harvest agricultural water
provisions in the produce safety regulation are intended to optimize
public health by allowing for the proper foundation to be established
for successful implementation. Additionally, these dates are informed
by experience, information, and feedback on the inherent implementation
challenges with agricultural water requirements given the scale and
diversity of the produce sector and agricultural water systems and with
a long-term view toward improving public-health outcomes.
At this time, we are not seeking comment on any other provisions of
the previously published proposed rule that are not identified for
public comment in this document. We will complete our review of public
comments received thus far, and take into account comments received on
the proposed compliance dates in response to this document, in issuing
a final rule.
C. Legal Authority
The proposed compliance dates for certain agricultural water
provisions discussed in this document are consistent with our authority
in sections 402, 419, and 701(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 342, 350h, and 371(a)) and sections
311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C.
243, 264, and 271). We discuss our legal authority in greater detail in
the 2021 agricultural water proposed rule (86 FR 69128-69129).
D. Costs and Benefits
We have examined the impacts of this supplemental proposed rule.
Annualized at either 3 percent or 7 percent, our primary estimates for
the costs of this supplemental proposed rule are $ 0.1 million. The
benefit of this supplemental proposed rule is clarity to stakeholders
about the proposed compliance dates for the pre-harvest agricultural
water provisions for covered produce other than sprouts described in
the 2021 agricultural water proposed rule.
[[Page 42975]]
II. Background
This pre-harvest agricultural water compliance dates proposal
concerns one of the seven foundational rules that we have established
as part of our implementation of section 105 of the FDA Food Safety
Modernization Act (FSMA; Pub. L. 111-353): 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 in 21 CFR part 112). FSMA, which was
signed into law on January 4, 2011, is intended to allow FDA to better
protect public health by helping to ensure the safety and security of
the food supply.
In the preamble of the 2015 produce safety final rule, we stated
that the regulation would be effective on January 26, 2016, and
provided for compliance dates of 1 to 6 years from the effective date
depending on farm size, commodity, and provision(s) (see table entitled
``compliance dates'' in the preamble of the 2015 produce safety final
rule, 80 FR 74354 at 74357, as corrected in a technical amendment at 81
FR 26466, May 3, 2016). (Some of the compliance dates identified in the
technical amendment fall on weekends (i.e., January 26, 2019, is a
Saturday and January 26, 2020, is a Sunday) and should therefore be
read as referring to the next business day (i.e., January 28, 2019, and
January 27, 2020, respectively). We use the latter dates throughout
this document.)
For the majority of agricultural water provisions in subpart E (and
for most of the other provisions in the rule), with respect to covered
produce other than sprouts, we provided compliance periods of 4 years
from the effective date of the rule for very small businesses, 3 years
for small businesses, and 2 years for all other businesses.\4\ We
provided an additional 2 years beyond those compliance periods for
certain water quality requirements in Sec. 112.44 and related
provisions in Sec. Sec. 112.45 and 112.46. See table 1.
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\4\ Under the produce safety regulation, a farm is a very small
business if, on a rolling basis, the average annual monetary value
of produce it sold during the previous 3-year period is no more than
$250,000. A farm is a small business if, on a rolling basis, the
average annual monetary value of produce it sold during the previous
3-year period is no more than $500,000, and the farm is not a very
small business. See Sec. 112.3.
Table 1--As Stated in the 2015 Produce Safety Final Rule (80 FR 74461),
Compliance Dates for Requirements in Subpart E (Agricultural Water) for
Covered Activities Involving Covered Produce (Except Sprouts Subject to
Subpart M)
------------------------------------------------------------------------
Extended compliance date of
Compliance dates of 2-4 years additional 2 years beyond the
applicable to the farm based on its compliance date based on size of
size farm
------------------------------------------------------------------------
Sec. 112.41. Sec. 112.44.
Sec. 112.42. Sec. 112.45(a) with respect to
Sec. 112.43. Sec. 112.44(a) criterion.
Sec. 112.45(a) with respect to Sec. 112.45(b).
safe and adequate standard. Sec. 112.46(b)(1) with respect to
Sec. 112.46(a). untreated ground water.
Sec. 112.46(b)(1) with respect to Sec. 112.46(b)(2) and (b)(3).
untreated surface water. Sec. 112.46(c).
Sec. 112.47.
Sec. 112.48.
Sec. 112.49.
Sec. 112.50.
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In a final rule, ``The Food and Drug Administration Food Safety
Modernization Act: Extension and Clarification of Compliance Dates for
Certain Provisions of Four Implementing Rules'' (81 FR 57784, August
24, 2016) we also extended the compliance date for certain ``customer
provisions'' in four of the seven foundational rules that we have
established as part of our implementation of FSMA, including the 2015
produce safety final rule (Sec. 112.2(b)(3)). In that final rule, we
also clarified the compliance dates for certain agricultural water
testing provisions as originally established in the 2015 produce safety
final rule.
In 2017, we issued a proposed rule, ``Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption;
Extension of Compliance Dates for Subpart E'' (82 FR 42963, September
13, 2017) (2017 proposed compliance date extension), in which we
proposed to extend, for covered produce other than sprouts, the dates
for compliance with the pre-harvest, harvest, and post-harvest
agricultural water provisions contained in subpart E of the 2015
produce safety final rule. We proposed to extend the compliance dates,
which we later finalized in a final rule (84 FR 9706, March 18, 2019)
(2019 final compliance date extension), to address questions about the
practical implementation of compliance with certain provisions and to
consider how we might further reduce the regulatory burden or increase
flexibility while continuing to protect public health. In that final
rule we also finalized a uniform compliance date structure such that
all the compliance dates for subpart E provisions as applied to non-
sprout covered produce would occur at the same time, retaining date-
staggering based on farm size. That final rule extended the compliance
dates for the agricultural water requirements in subpart E for non-
sprout covered produce to January 26, 2024, for very small businesses;
January 26, 2023, for small businesses; and January 26, 2022, for all
other businesses. See table 2.
Table 2--As Stated in the Final Rule Extending Compliance Dates for
Subpart E (84 FR 9706), Compliance Dates for Requirements in Subpart E
for Covered Activities Involving Covered Produce (Except Sprouts Subject
to Subpart M)
------------------------------------------------------------------------
Size of covered farm Compliance date
------------------------------------------------------------------------
Very Small Business.................... January 26, 2024.
Small Business......................... January 26, 2023.
[[Page 42976]]
All Other Businesses................... January 26, 2022.
------------------------------------------------------------------------
The 2021 agricultural water proposed rule explains that we intend
to exercise enforcement discretion for these requirements while working
to address compliance dates in a targeted manner through the rulemaking
process, with the goal of completing the rulemaking as quickly as
possible (86 FR 69147). At public meetings to discuss the proposed
rule, we reiterated our commitment to work diligently to address the
agricultural water compliance dates for covered produce other than
sprouts. The comment period for the 2021 agricultural water proposed
rule closed on April 5, 2022.
The proposed pre-harvest agricultural water compliance dates and
enforcement discretion policy for harvest and post-harvest requirements
are intended to optimize public health by allowing for the proper
foundation to be established for successful implementation that will
benefit all stakeholders, as described in sections III and IV. These
dates are informed by experience with produce safety rule
implementation, together with information and stakeholder feedback on
the inherent implementation challenges with agricultural water
requirements given the scale and diversity of the produce sector and
agricultural water systems and with a long-term view toward improving
public-health outcomes. Fully realizing the anticipated benefits to
consumers of the agricultural water requirements (including the pre-
harvest requirements, if finalized) will require a solid foundation for
implementation to ensure that regulators and industry are adequately
trained and understand how to apply the agricultural water requirements
effectively on individual covered farms and, for regulators, also
necessitates ensuring that the requirements are applied consistently.
We note that the compliance dates for provisions of the produce
safety regulation not related to agricultural water have passed, and
all compliance dates for provisions related to sprouts, including for
agricultural water have passed (see table entitled ``Compliance Dates
for the Produce Safety Regulation Under this Final Rule (21 CFR part
112)'' in the 2019 final compliance date extension at 84 FR 9709).
III. Proposed Pre-Harvest Agricultural Water Compliance Dates for
Covered Produce Other Than Sprouts
In the 2021 agricultural water proposed rule, we proposed to revise
certain provisions in the produce safety regulation applicable to pre-
harvest agricultural water for covered produce other than sprouts. In
the proposed rule, we did not propose to revise the requirements
established for harvest and post-harvest agricultural water.
Specifically, the proposed rule would replace the microbial criteria
and testing requirements for pre-harvest agricultural water for covered
produce (other than sprouts) with provisions for systems-based
agricultural water assessments that are designed to be more feasible to
implement across the wide variety of agricultural water systems, uses,
and practices, while also being adaptable to future advancements in
agricultural water quality science, and achieving improved public
health protections. Additionally, we proposed to require expedited
mitigation for hazards related to certain activities associated with
adjacent and nearby lands, in light of findings from several recent
produce outbreak investigations. The proposed revisions in the 2021
agricultural water proposed rule are intended to address stakeholder
concerns about complexity and practical implementation challenges with
certain agricultural water provisions while more comprehensively
addressing a known route of contamination that can lead to preventable
foodborne illness that is a significant public health problem.
We recognize that covered farms will likely need time to prepare
for compliance with the provisions we proposed to revise, if finalized.
We also recognize that regulators, educators, and other stakeholders
may also need time to develop education and outreach, training, and
other tools to facilitate understanding and compliance by covered
farms. FSMA acknowledges the importance of education and outreach in
obtaining compliance with the produce safety rule, which established
the first-of-its-kind Federal produce safety requirements. A key pillar
of FSMA implementation has been to ensure that industry has the
appropriate knowledge and training to effectively comply, making it
important for compliance dates to account for remaining outreach,
education, and training needs.
FSMA further recognizes a critical role for FDA's State regulatory
partners in enforcing the regulation in coordination with FDA. To this
end, FDA has established the FDA-State Produce Safety Implementation
Cooperative Agreement Program \5\ (FDA-State Produce CAP), through
which most states have developed produce safety programs. The FDA-State
CAP has various program objectives--including assessment and planning
to guide the development of produce programs; providing education,
outreach, and technical assistance to produce farms; developing
inspection regulatory programs; and establishing compliance and
enforcement programs--all of which can take significant time,
resources, and planning to successfully administer. Due to the valuable
role of FDA's State regulatory partners in the integrated food safety
system--in particular, their essential participation in produce safety
rule education and enforcement under section 419(b)(2)(A) of the FD&C
Act--we recognize that States need adequate time to fully prepare for
implementation of their program components and that coordination
efforts are taken between state and Federal regulators to ensure
consistent implementation across all regulated industry. Therefore, we
consider it appropriate to propose compliance dates for the proposed
pre-harvest agricultural water requirements for covered produce other
than sprouts and to exercise enforcement discretion for the relevant
pre-harvest requirements in the produce safety regulation until this
rulemaking is completed in order to give covered farms and other
stakeholders adequate time to prepare for compliance.
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\5\ See ``FDA-State Produce Safety Implementation Cooperative
Agreement Program at <a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program</a>.
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This supplemental notice of proposed rulemaking does not address
the underlying requirements in subpart E, and we are reopening the
comment
[[Page 42977]]
period only with respect to the pre-harvest agricultural water
compliance dates identified in this document.
In this supplemental notice of proposed rulemaking, we are
proposing compliance dates for the pre-harvest agricultural water
provisions for covered produce other than sprouts, in the 2021
agricultural water proposed rule. We are not proposing to extend the
compliance dates for the harvest and post-harvest agricultural
provisions that we are not proposing to change, although we intend to
exercise enforcement discretion for those requirements in the produce
safety regulation (see section IV) for covered produce (other than
sprouts). We also propose that any final rule establishing the
compliance dates for the pre-harvest agricultural water requirements
for covered produce (other than sprouts) would become effective 60 days
after the date of publication of the final rule in the Federal
Register.
Specifically, we are proposing compliance dates for the pre-harvest
agricultural water provisions for covered produce other than sprouts
such that the subpart E compliance dates for non-sprout covered produce
would be those in table 3.
Table 3--Compliance Dates for Requirements in Subpart E for Covered
Activities Involving Covered Produce (Except Sprouts Subject to Subpart
M)
------------------------------------------------------------------------
Provisions related Provisions related
to harvest and to pre-harvest
post-harvest agricultural water
Size of covered farm agricultural water -------------------
-------------------- Proposed
Compliance date compliance date
------------------------------------------------------------------------
Very Small Business............. January 26, 2024.. 2 years and 9
months after the
effective date of
a final rule.
Small Business.................. January 26, 2023.. 1 year and 9
months after the
effective date of
a final rule.
All Other Businesses............ January 26, 2022.. 9 months after the
effective date of
a final rule.
------------------------------------------------------------------------
We recognize that stakeholders may benefit from additional clarity
to aid in their understanding of the compliance date structure in table
3. As such, table 4 summarizes the subpart E provisions as stated in
the 2021 agricultural water proposed rule that would apply for
agricultural water used during growing and during harvesting, packing,
or holding for covered produce (other than sprouts). (As discussed
above, the compliance dates for harvest and post-harvest requirements
are likely to occur before we complete this rulemaking, in which we
have proposed to reorganize and replace subpart E in its entirety.
While the discussion regarding our intended exercise of enforcement
discretion for the harvest and post-harvest requirements refers to
those provisions according to section numbers in the produce safety
regulation, table 4 reflects the relevant proposed provision numbers in
the 2021 agricultural water proposed rule.)
Table 4--Summary of the Provisions in Subpart E That Would Apply for Agricultural Water Used During Growing
Activities and During Harvesting, Packing, or Holding Activities for Covered Produce Other Than Sprouts
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
If you use agricultural water Then you must meet these requirements
for this covered activity for
covered produce other than
sprouts
If applicable, you also must meet
these requirements
----------------------------------------------------------------------------------------------------------------
Pre-harvest activities.......... Sec. 112.41..... (quality standard) Sec. 112.43(d).. (testing for
assessment
purposes).
Sec. 112.42..... (inspections and Sec. 112.45..... (measures).
maintenance).
Sec. 112.43..... (agricultural Sec. 112.46..... (treatment).
water assessment).
Sec. 112.50..... (records)......... Sec. 112.47..... (who may test).
Sec. 112.161.... (records review).. Sec. 112.151.... (test methods).
Sec. 112.12..... (alternatives).
Harvest and post-harvest Sec. 112.41..... (quality standard) Sec. 112.44(b).. (testing untreated
activities. ground water).
Sec. 112.42..... (inspections and Sec. 112.45..... (measures).
maintenance).
Sec. 112.44(a).. (microbial quality Sec. 112.46..... (treatment).
criterion).
Sec. 112.44(d).. (additional Sec. 112.47..... (who may test).
management and
monitoring).
Sec. 112.50..... (records)......... Sec. 112.151.... (test methods).
Sec. 112.161.... (records review).. Sec. 112.12..... (alternatives).
----------------------------------------------------------------------------------------------------------------
We acknowledge that some requirements that apply for pre-harvest
agricultural water (for example, Sec. 112.42, which includes
requirements for inspections and maintenance of agricultural water
sources and distribution systems) remain unchanged in the 2021
agricultural water proposed rule. However, we anticipate that
maintaining compliance dates for all pre-harvest agricultural
requirements on the same interval would be important for effective
implementation of the systems-based approach we are proposing for pre-
harvest agricultural water. To bifurcate compliance dates for the pre-
harvest agricultural water requirements based on whether changes have
been proposed would result in a compliance date structure similar to
that originally established in the 2015 produce safety final rule--
i.e., based on specific provisions of subpart E, as opposed to being
based on the covered activity that agricultural water is being used for
(compare table 1 with table 3). In consideration of the feedback
received from stakeholders during rulemaking for the 2019 final
compliance date extension, we do not
[[Page 42978]]
consider that this would be a wise or workable approach to pursue.
Accordingly, we are proposing to maintain compliance dates for all pre-
harvest agricultural water requirements on the same interval,
regardless of whether changes have been proposed.
As the comment period for the 2021 agricultural water proposed rule
closed on April 5, 2022, we are reopening the comment period solely to
request comments on the proposed compliance dates for the proposed pre-
harvest agricultural water provisions for covered produce other than
sprouts. This action does not seek comment on other provisions of the
previously published proposed rule.
Our goal is to complete this rulemaking as quickly as possible, and
in the meantime, we intend to exercise enforcement discretion for the
pre-harvest agricultural water requirements in the produce safety
regulation for covered produce other than sprouts. We note that produce
remains subject to the other applicable provisions of the produce
safety regulation and the applicable provisions of the FD&C Act
notwithstanding this proposed compliance date extension. The Agency
encourages farms to focus their attention on good agricultural
practices to maintain and protect the quality of their water sources.
(See, e.g., FDA's ``Guide to Minimize Microbial Food Safety Hazards for
Fresh Fruits and Vegetables,'' at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables</a>).
IV. Intended Enforcement Discretion for the Harvest and Post-Harvest
Agricultural Water Requirements for Covered Produce Other Than Sprouts
As we are not proposing to change the requirements that apply for
harvest and post-harvest agricultural water through this rulemaking, we
are not proposing a compliance date extension for those provisions for
covered produce other than sprouts. However, we recognize that prior to
the publication of the 2021 agricultural water proposed rule,
stakeholders did not have clarity on whether FDA would be proposing
substantive changes to requirements that apply for agricultural water
used during harvest and post-harvest activities. Because the intended
benefits of the harvest and post-harvest requirements may not be fully
realized unless accompanied by adequate training, technical assistance,
and other preparations to support effective implementation by all
parties, we are specifying the duration of our intended exercise of
enforcement discretion with an understanding that covered farms will
likely need this additional time to prepare for compliance with the
harvest and post-harvest agricultural water provisions, and that
regulators, educators, and other stakeholders may also need time to
develop education and outreach, training, and other tools to facilitate
understanding and compliance by covered farms. Moreover, due to the
valuable role of FDA's State regulatory partners in the integrated food
safety system--in particular, their essential participation in produce
safety rule education and enforcement under section 419(b)(2)(A) of the
FD&C Act--we recognize that States may need the additional time to
prepare for implementation of their program components, and that
coordination efforts are taken between State and Federal regulators to
provide for consistent implementation across all regulated industry.
(See also discussion in section III of this document). We understand
that some of these parties may have been awaiting FDA action before
developing or deploying such training, technical assistance, or other
implementation materials.
Additionally, we recognize that many covered farms may already be
aware of, and have received education and training on, the harvest and
post-harvest agricultural water requirements established in the produce
safety regulation, which we are not proposing to change. (See, for
example, the standardized curriculum developed by the Produce Safety
Alliance, which covers fundamental food safety topics as they relate to
produce and the requirements of the produce safety regulation,
including those for agricultural water used during harvesting, packing,
and holding of covered produce.) However, we understand that even with
education and training on these requirements, covered farms will still
need to apply the knowledge to their operations by taking steps to
implement those requirements on-farm, such that covered farms may need
additional time to come into compliance with those provisions.
In light of these considerations, we intend to exercise enforcement
discretion for the harvest and post-harvest agricultural water
provisions in the produce safety regulation for covered produce other
than sprouts until January 26, 2025, for very small businesses; January
26, 2024, for small businesses; and January 26, 2023, for all other
businesses. In the meantime, covered farms (other than sprout
operations) should focus their attention on good agricultural practices
to maintain and protect the quality of their water source. (See, e.g.,
FDA's ``Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables,'' at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables</a>). We note
that produce remains subject to the other applicable provisions of the
produce safety regulation and the applicable provisions of the FD&C
Act.
V. Preliminary Economic Analysis of Impacts
We have examined the impacts of the supplemental proposed rule to
the 2021 proposed rule, ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption related to
Agricultural Water'' (Docket No. FDA-2021-N-4071; hereafter ``2021
Agricultural Water Proposed Rule'') under Executive Order 12866,
Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct us to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The Office of
Information and Regulatory Affairs in the Office of Management and
Budget determined that the 2021 Agricultural Water Proposed Rule is a
significant regulatory action as defined by Executive Order 12866. This
supplemental NPRM has also been designated as a significant regulatory
action under E.O. 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We previously concluded that the 2021 Agricultural Water
Proposed Rule would not have a significant economic impact on a
substantial number of small entities. Because this supplemental
proposed rule proposes compliance dates without imposing additional
costs to farms (except reading the rule), we anticipate this
supplemental proposed rule will not change that conclusion. If the 2021
Agricultural Water Proposed Rule as amended by this supplement is
finalized, we may, if appropriate, certify that the final rule does not
have a significant impact on a substantial number of small entities.
[[Page 42979]]
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $165 million, using the most current (2021) Implicit
Price Deflator for the Gross Domestic Product. The 2021 Agricultural
Proposed Rule as amended by this supplemental proposed rule would not
result in an expenditure in any year that meets or exceeds this amount.
We have developed a comprehensive Preliminary Economic Analysis of
Impacts (PRIA) that assesses the impacts of the supplemental proposed
rule (Ref. 1). We estimate costs and benefits of the 2021 agricultural
water proposed rule in the ``Standards for the Growing, Harvesting,
Packing and Holding of Produce for Human Consumption Relating to
Agricultural Water; Preliminary Regulatory Impact Analysis'' (2021
agricultural water PRIA) (Ref. 2). This supplemental proposed rule
makes no substantive changes to the provisions in the 2021 Agricultural
Water Proposed Rule. Rather, this supplemental proposed rule proposes
compliance dates for the pre-harvest agricultural water provisions for
covered produce other than sprouts, which are not specified in the 2021
Agricultural Water Proposed Rule. The costs of the supplemental
proposed rule are the costs of reading this rule. Annualized at either
3 percent or 7 percent, our primary estimates of this supplemental
proposed rule are $0.1 million. The benefit of this supplemental
proposed rule is clarity to stakeholders about the proposed compliance
dates for the pre-harvest agricultural water provisions for covered
produce other than sprouts described in the 2021 agricultural water
proposed rule. The full preliminary analysis of economic impacts is
available in the docket for this proposed rule and at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
VI. Analysis of Environmental Impact
The Agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The Agency's finding of
no significant impact, including a supplement to the finding of no
significant impact, and the evidence supporting that finding may be
seen in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and
4 p.m., Monday through Friday (Refs. 3 to 5). Under FDA's regulations
implementing the National Environmental Policy Act (21 CFR part 25), an
action of this type would require an EA under 21 CFR 25.31a(a).
VII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this supplemental notice of proposed
rulemaking contains no collection of information. Therefore, clearance
by the Office of Management and Budget under the Paperwork Reduction
Act of 1995 is not required.
VIII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the proposed rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
IX. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
X. References
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
1. FDA, ``Supplemental Notice of Proposed Rulemaking: Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water; Preliminary Regulatory
Impact Analysis,'' 2022. Available at: <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
2. FDA, ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption Relating to Agricultural
Water; Preliminary Regulatory Impact Analysis,'' 2021. Available at:
<a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
3. FDA, ``Environmental Assessment for the Proposed Rule: Standards
for the Growing, Harvesting, Packing, and Holding of Produce for
Human Consumption Relating to Agricultural Water,'' November 9.
2021.
4. FDA, ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption Relating to Agricultural
Water: Finding of No Significant Impact,'' November 9, 2021.
5. FDA, ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption Relating to Agricultural
Water: Supplement to the Finding of No Significant Impact.''
Dated: July 11, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-15134 Filed 7-18-22; 8:45 am]
BILLING CODE 4164-01-P
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