[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 [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 ``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: 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, 
[email protected].

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

    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 https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program.
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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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables).

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables). 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 https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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 https://www.regulations.gov. 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: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
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: 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
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


