Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, 37448-37519 [2024-09153]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Rules and Regulations]
[Pages 37448-37519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09153]



[[Page 37447]]

Vol. 89

Monday,

No. 88

May 6, 2024

Part III





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 112





 Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption Relating to Agricultural Water; Final Rule

Federal Register / Vol. 89 , No. 88 / Monday, May 6, 2024 / Rules and 
Regulations

[[Page 37448]]


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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: Final rule.

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SUMMARY: The Food and Drug Administration is issuing a final rule to 
amend the agricultural water provisions of the produce safety 
regulation. This rule replaces the microbial criteria and testing 
requirements for pre-harvest agricultural water for covered produce 
(other than sprouts) with a regulatory approach that incorporates 
recent science and Food and Drug Administration outbreak investigation 
findings to achieve improved public health protections as compared to 
the earlier requirements. The rule requires systems-based assessments, 
with required testing in certain circumstances, that focus on key risk 
factors for contamination by pre-harvest agricultural water and will 
enable farms to implement effective preventive measures. The rule 
requires farms to take timely action based on risk and includes a new 
requirement for expedited mitigation for certain hazards. The 
requirements are adaptable to future scientific advancements and 
provide sufficient flexibility to be practicable for all sizes and 
types of farms to implement across the wide variety of agricultural 
water systems, uses, and practices. These revisions to the produce 
safety regulation will more comprehensively address a known route of 
microbial contamination that can lead to preventable foodborne illness 
that is a significant public health problem.

DATES: This rule is effective July 5, 2024.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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: With regard to the final rule: Samir 
Assar, Director, Division of Produce Safety, Office of Food Safety, 
Center for Food Safety and Applied Nutrition (HFS-317) 5001 Campus Dr., 
College Park, MD 20740, 240-402-1636, email: [email protected].
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. FDA Food Safety Modernization Act
    B. 2015 Produce Safety Final Rule
    C. New Information Since Issuance of the 2015 Produce Safety 
Final Rule
    D. 2021 Agricultural Water Proposed Rule
    E. 2022 Supplemental Proposed Rule
    F. Public Comments
    G. General Overview of Changes in the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. General Comments on the Proposed Rule
    C. Definitions (Sec.  112.3)
    D. General Comments Regarding Pre-Harvest Agricultural Water 
Assessments (Sec.  112.43)
    E. Exemptions From Agricultural Water Assessments (Sec.  
112.43(b))
    F. Elements of an Agricultural Water Assessment (Sec.  
112.43(a))
    G. Outcomes (Sec.  112.43(c))
    H. Testing as Part of an Assessment (Sec.  112.43(d))
    I. Reassessment (Sec.  112.43(e))
    J. Corrective and Mitigation Measures (Sec.  112.45)
    K. Treatment of Agricultural Water
    L. Records Relating to Agricultural Water (Sec.  112.50)
VI. Effective and Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Final Rule

    In this final rule, the Food and Drug Administration (FDA, the 
Agency, or we) is amending the ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption'' rule (2015 
produce safety final rule), which was established in accordance with 
the FDA Food Safety Modernization Act (FSMA) and sets forth science-
based minimum standards for the safe growing, harvesting, packing, and 
holding of produce, meaning fruits and vegetables for human 
consumption. This rule revises certain provisions in the 2015 produce 
safety final rule applicable to agricultural water \1\ for covered 
produce other than sprouts, using a direct application method during 
growing activities (commonly referred to as ``pre-harvest agricultural 
water'' \2\). It establishes a regulatory framework of systems-based 
assessments and risk-tiered outcomes through which farms subject to the 
2015 produce safety final rule (covered farms) are required to identify 
known and potential hazards and implement effective preventive measures 
within specific timeframes based on risk.
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    \1\ ``Agricultural water'' is defined at 21 CFR 112.3 as water 
used in covered activities on covered produce where water is 
intended to, or is likely to, contact covered produce or food-
contact surfaces, including water used in growing activities 
(including irrigation water applied using direct water application 
methods, water used for preparing crop sprays, and water used for 
growing sprouts) and in harvesting, packing, and holding activities 
(including water used for washing or cooling harvested produce and 
water used for preventing dehydration of covered produce). Related 
to this definition is our definition of ``direct water application 
method,'' which means agricultural water used in a manner whereby 
the water is intended to, or is likely to, contact covered produce 
or food-contact surfaces during use of the water. If a specific use 
of water does not fit within the definition of agricultural water, 
then the requirements in subpart E do not apply to that specific use 
of water. See 80 FR 74354 at 74429.
    \2\ The 2015 produce safety final rule refers to pre-harvest 
agricultural water used during sprout production as ``sprout 
irrigation water.''
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    The written assessments focus on agricultural water systems, 
including sources, and agricultural water practices that are key 
determinants of contamination risks associated with agricultural water, 
together with crop characteristics and environmental conditions that 
can impact the survival of pathogens. The assessments include a 
requirement to test pre-harvest agricultural water in certain 
circumstances--that is, when doing so would not delay action most 
critical to protect public health and would further inform the farm's 
determination as to whether measures are reasonably necessary. 
Moreover, the assessments are designed for use in diverse circumstances 
and require covered farms to evaluate a broad range of factors that 
impact pre-harvest agricultural water quality, providing results that 
are tailored to address hazards unique to their respective

[[Page 37449]]

operations. This approach will be feasible to implement across the wide 
variety of agricultural water systems, practices, and uses, and it is 
adaptable to future advancements in agricultural water quality science.
    Farms must use the information evaluated to make a written 
determination on the outcomes of their assessments. The outcomes are 
based on risk, and include the actions farms must take within a 
specific timeframe to ensure that their pre-harvest agricultural water 
is safe and is of adequate sanitary quality for the intended use(s). 
Within this framework for risk-tiered outcomes is a new expedited 
mitigation requirement relating to the impacts of certain adjacent and 
nearby land uses on pre-harvest agricultural water.
    These amendments to the 2015 produce safety final rule are 
supported by scientific literature published since FDA promulgated the 
2015 produce safety final rule and findings from FDA's outbreak 
investigations since FDA promulgated the 2015 produce safety final 
rule. These amendments are also supported by information and insights 
shared by an array of stakeholders through a variety of means since FDA 
promulgated the 2015 produce safety final rule (including through 
meetings, educational farm visits, and listening sessions), as well as 
information shared through the notice-and-comment process for this 
rulemaking. Feedback shared by stakeholders included information about 
the complexity of the previous pre-harvest agricultural water testing 
requirements, the practical implementation challenges associated with 
the uniform nature of those requirements, and findings from scientific 
studies demonstrating the need for additional testing in highly 
variable water with previously unaccounted for costs (see section 
III.C.). We have carefully considered the new information as we 
considered revisions to the 2015 produce safety final rule necessary to 
achieve our intended public health goals.
    After considering available information, FDA has concluded this 
final rule will achieve improved public health protections by setting 
forth requirements for comprehensive pre-harvest agricultural water 
assessments. Those assessments will better enable covered farms to 
implement effective measures that minimize the risk of serious adverse 
health consequences or death, including those reasonably necessary to 
prevent the introduction of known or reasonably foreseeable biological 
hazards into or onto produce, and to provide reasonable assurances that 
produce is not adulterated due to those hazards. Moreover, these 
revisions provide sufficient flexibility to be practicable for all 
sizes and types of farms and to account for differences in risk across 
varying agricultural water systems, uses, and practices.

B. Summary of the Major Provisions of the Final Rule

    FDA is amending the 2015 produce safety final rule by revising 
certain provisions relating to pre-harvest agricultural water for 
covered produce other than sprouts, while retaining the existing 
standards applicable to agricultural water for sprouts and for harvest 
and post-harvest activities conducted by covered farms.
    For pre-harvest agricultural water for non-sprout covered produce, 
we are:
     Replacing the microbial quality criteria and uniform 
testing requirements in the 2015 produce safety final rule with new 
provisions for conducting pre-harvest agricultural water assessments 
for hazard identification purposes (including consideration of 
agricultural water sources, distribution systems, and practices, as 
well as adjacent and nearby land uses, and other relevant factors), and 
using the results of the assessments in making risk management 
decisions;
     Including a requirement to test pre-harvest agricultural 
water in certain circumstances (that is, when doing so would not delay 
action most critical to protect public health and would further inform 
the farm's determination as to whether measures are reasonably 
necessary) for generic Escherichia coli (E. coli) (or other appropriate 
indicator organism, index organism, or analyte) to help inform covered 
farms' agricultural water assessments;
     Adding new options for mitigation measures, providing 
covered farms additional flexibility in responding to findings from 
their pre-harvest agricultural water assessments;
     Requiring expedited implementation of mitigation measures 
for known or reasonably foreseeable hazards related to certain adjacent 
and nearby land uses;
     Requiring management review of pre-harvest agricultural 
water assessments; and
     Adding new definitions of ``agricultural water 
assessment'' and ``agricultural water system.''
    We are making additional amendments, such as adding examples and 
making other edits that are designed to provide clarity, such as 
reorganizing subpart E to group provisions of a similar nature. We are 
also making conforming changes elsewhere in the 2015 produce safety 
final rule.

C. Legal Authority

    We are issuing this final rule under FDA's authorities 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 section IV.

D. Costs and Benefits

    Our primary estimates of annualized costs are approximately $17.5 
million at a 3 percent discount rate and approximately $17.7 million at 
a 7 percent discount rate over 10 years.
    Our primary estimates of annualized benefits are approximately 
$10.3 million at a 3 percent discount rate and approximately $10.1 
million at a 7 percent discount rate over 10 years. We discuss non-
quantified benefits of the rule stemming from recalls averted and 
increased flexibility for covered farms to comprehensively evaluate 
their agricultural water systems.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

              Table 1--Table of Abbreviations and Acronyms
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     Abbreviation/acronym                    What it means
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BSAAO........................  Biological Soil Amendment of Animal
                                Origin.
CAFO.........................  Concentrated Animal Feeding Operation.
CAN..........................  California Agricultural Neighbors.
CDC..........................  Centers for Disease Control and
                                Prevention.
CEA..........................  Controlled Environment Agriculture.
CFR..........................  Code of Federal Regulations.
CFU..........................  Colony Forming Units.
CWA..........................  Clean Water Act.

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E. coli......................  Escherichia coli.
EIS..........................  Environmental Impact Statement.
EPA..........................  U.S. Environmental Protection Agency.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FRIA.........................  Final Regulatory Impact Analysis.
FSMA.........................  FDA Food Safety Modernization Act.
GAP..........................  Good Agricultural Practices.
GM...........................  Geometric Mean.
HACCP........................  Hazard Analysis and Critical Control
                                Point.
H-GAP........................  USDA Harmonized Good Agricultural
                                Practices.
HHS..........................  Health and Human Services.
IFSAC........................  Interagency Food Safety Analytics
                                Collaboration.
LGMA.........................  Leafy Greens Marketing Agreement.
L. monocytogenes.............  Listeria monocytogenes.
mL...........................  Milliliters.
MPN..........................  Most Probable Number.
MWQP.........................  Microbial Water Quality Profile.
NASDA........................  National Association of State Departments
                                of Agriculture.
NOP..........................  USDA National Organic Program.
NASS.........................  USDA National Agricultural Statistics
                                Service.
NPDWR........................  U.S. EPA National Primary Drinking Water
                                Regulations.
PCR..........................  Polymerase Chain Reaction.
PHS Act......................  Public Health Service Act.
PRIA.........................  Preliminary Regulatory Impact Analysis.
QAR..........................  Qualitative Assessment of Risk.
RWQC.........................  Recreational Water Quality Criteria.
STV..........................  Statistical Threshold Value.
USDA.........................  U.S. Department of Agriculture.
UV...........................  Ultraviolet.
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III. Background

A. FDA Food Safety Modernization Act

    FSMA (Pub. L. 111-353), signed into law by President Obama 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. 
FSMA transformed the nation's food safety system by shifting the focus 
from responding to foodborne illness to preventing it.
    FSMA enables FDA to establish a prevention-oriented framework that 
focuses effort where food safety hazards are reasonably likely to occur 
and is flexible and practical in light of current scientific knowledge 
and food safety practices. The law also provides enforcement 
authorities for responding to food safety problems when they do occur. 
In addition, FSMA gives FDA important tools to help ensure the safety 
of imported foods and encourages partnerships with State, local, 
Tribal, and territorial authorities, as well as foreign regulatory 
counterparts.
    FDA has issued nine foundational rules that create risk-based 
standards and provide oversight at various points in the supply chain 
for domestic and imported human and animal food. The produce safety 
regulation, established in the 2015 produce safety final rule (80 FR 
74354, November 27, 2015), is one of the nine foundational rules.

B. 2015 Produce Safety Final Rule

    In November 2015, FDA finalized the produce safety regulation, 
which establishes science-based minimum standards for the safe growing, 
harvesting, packing, and holding of fruits and vegetables grown for 
human consumption (codified in the Code of Federal Regulations (CFR) at 
part 112 (21 CFR part 112)). In accordance with section 419 of the FD&C 
Act (21 U.S.C. 350h), the 2015 produce safety final rule sets forth 
procedures, processes, and practices to minimize the risk of serious 
adverse health consequences or death, including those that are 
reasonably necessary to prevent the introduction of known or reasonably 
foreseeable biological hazards into produce and to provide reasonable 
assurances that produce is not adulterated on account of such hazards. 
The regulation focuses on biological hazards (defining a ``known or 
reasonably foreseeable hazard'' as a biological hazard that is known to 
be, or has the potential to be, associated with the farm or the food) 
and major routes of microbial contamination--including agricultural 
water; biological soil amendments; domesticated and wild animals; 
worker health and hygiene; and equipment, buildings, and tools. Farms 
subject to the requirements of part 112 are ``covered farms''; however, 
for purposes of readability, we use the term ``farms'' to mean 
``covered farms'' within the meaning of part 112 in this document.
    Subpart E of the 2015 produce safety final rule includes a general 
requirement that agricultural water must be safe and adequate for its 
intended uses (Sec.  112.41). It also included microbial water quality 
criteria (Sec.  112.44) and requirements for testing certain water 
sources (Sec.  112.46). The microbial quality criteria were based on 
the intended use of the agricultural water--i.e., for growing 
activities for covered produce other than sprouts (including irrigation 
water applied to covered produce, other than sprouts, using a direct 
water application method and water used in preparing crop sprays) 
(commonly referred to as ``pre-harvest agricultural water'') \3\, and 
for certain other specified uses, including sprout irrigation water and 
water applications that directly contact covered produce during or 
after harvest (commonly referred to as ``harvest and post-harvest 
agricultural water'').\4\ For pre-harvest agricultural water for non-
sprout covered produce, the microbial

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water quality criteria consisted of a geometric mean (GM) of 126 or 
less colony forming units (CFU) generic E. coli per 100 milliliters 
(mL), and a statistical threshold value (STV) of 410 or less CFU 
generic E. coli per 100 mL. The 2015 produce safety final rule preamble 
explained that we established the pre-harvest agricultural water 
microbial criteria based on our analysis of the then-current scientific 
information; we also explained that that scientific information relied 
on an underlying dataset that had the necessary scientific rigor and 
described illness rates due to incidental ingestion generalized across 
different bodies of water (see 80 FR 74534 at 74416 and 74441-74442).
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    \3\ The 2015 produce safety final rule refers to pre-harvest 
agricultural water used during sprout production as ``sprout 
irrigation water.''
    \4\ Because sprouts present a unique safety risk, the 2015 
produce safety final rule establishes sprout-specific requirements 
on multiple topics, including agricultural water. Sprouts are not 
the subject of this rulemaking.
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    For untreated surface waters, farms were required to establish an 
initial microbial water quality profile (MWQP) of at least 20 samples 
collected over a 2 to 4-year period, followed by at least 5 annual 
samples thereafter; and for untreated ground water sources, this would 
consist of an initial profile of at least 4 samples collected during 
the growing season or over a period of 1 year, followed by at least 1 
annual sample thereafter (80 FR 74354 at 74452) (Ref. 1).
    In the 2015 produce safety final rule, we explained that the pre-
harvest agricultural water microbial criteria and testing requirements 
were not a direct indicator of the safety of agricultural water for 
immediate use; rather, they were designed as a long-term water quality 
management tool for use in understanding the microbial quality of water 
over time and determining how to appropriately use water from that 
source. 80 FR 74354 at 74430. Moreover, we acknowledged gaps in the 
then-current science related to use of indicator organisms for 
monitoring water quality and predicting pathogen presence and/or fecal 
contamination. 80 FR 74354 at 74427-74428. We discussed that while 
testing water for pathogens has the obvious advantage of directly 
targeting microorganisms in water that are a risk to public health, 
doing so is not without significant challenges. 80 FR 74354 at 74427-
74428. In response to comments received during that earlier rulemaking, 
we considered, and declined, the option to establish a qualitative 
standard alone in lieu of a quantitative microbial quality requirement 
for pre-harvest agricultural water. 80 FR 74354 at 74443. However, 
since 2015, new scientific findings as well as findings from FDA 
outbreak investigations have demonstrated the need for an updated 
systems-based approach.
    Table 2 lists the key FSMA 2015 produce safety final rule documents 
published in the Federal Register. The complete set of Federal Register 
documents associated with the FSMA 2015 produce safety final rule, 
including supporting materials, are available in the docket folders at 
https://www.regulations.gov/docket?D=FDA-2011-N-0921 and https://www.regulations.gov/docket?D=FDA-2021-N-0471.

                 Table 2--List of Key Federal Register 2015 Produce Safety Final Rule Documents
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                 Description                                              Publication
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Notice of proposed rulemaking (2013 proposed   78 FR 3504, January 16, 2013.
 produce safety rule).
Notice of correction for the 2013 proposed     78 FR 17155, March 20, 2013.
 produce safety rule.
Supplemental notice of proposed rulemaking     79 FR 58434, September 29, 2014.
 (2014 supplemental proposed rule).
Final rule (2015 produce safety final rule or  80 FR 74354, November 27, 2015.
 final rule).
Technical amendment to the 2015 produce        81 FR 26466, May 3, 2016.
 safety final rule.
FSMA: Extension and Clarification of           81 FR 57784, August 24, 2016.
 Compliance Dates for Certain Provisions of
 Four Implementing Rules; Final rule.
Extension of Compliance Dates for Subpart E;   82 FR 42963, September 13, 2017.
 Notice of proposed rulemaking (2017 proposed
 compliance date extension).
Extension of Compliance Dates for Subpart E;   84 FR 9706, March 18, 2019.
 Final rule (2019 compliance date extension).
Standards Relating to Agricultural Water;      86 FR 69120, December 6, 2021.
 Notice of proposed rulemaking (2021
 agricultural water proposed rule).
Extension of Compliance Dates for Subpart E;   87 FR 42973, July 18, 2022.
 Supplemental notice of proposed rulemaking
 (2022 supplemental proposed rule).
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C. New Information Since Issuance of the 2015 Produce Safety Final Rule

    In November 2015, FDA began to conduct outreach to educate 
stakeholders about the requirements of the 2015 produce safety final 
rule, including through public meetings, speaking engagements, and 
participation in conferences convened by stakeholders representing a 
broad range of interests. FDA subject matter experts also participated 
in educational farm visits with State partners to observe a range of 
growing conditions and practices in varying regions. Through these 
efforts we heard consistent feedback that the pre-harvest agricultural 
water microbial criteria and testing requirements for non-sprout 
covered produce in the 2015 produce safety final rule were ``one-size-
fits-all'' and did not sufficiently allow for the diversity of farms, 
including a variety of water uses and availabilities. For example, we 
received feedback that the long-term MWQPs required in the 2015 produce 
safety final rule can be difficult, and even impossible, to establish 
for farms that grow rotational crops or crops on leased land, both of 
which are common throughout industry. 86 FR 69120 at 69123-69124. FDA 
also received information and feedback from other stakeholders, 
including water quality specialists and researchers, indicating that 
the 2015 pre-harvest microbial water quality criteria and testing 
requirements did not adequately capture variability that can occur 
within a surface water source, and that sanitary surveys may better 
help inform water management decisions compared to testing.
    In the face of these concerns, including new concerns not 
previously expressed, in March 2017, FDA announced that we were 
considering how we might simplify the microbial quality and testing 
requirements for agricultural water while still protecting public 
health and that we intended to work with stakeholders as these efforts 
progressed (Ref. 2). As part of these efforts, we participated in 
numerous additional meetings, educational farm visits, and listening 
sessions with an array of stakeholders--including produce industry 
members, food industry trade associations, researchers, extension 
educators, consumer groups, and State and Federal partners--to reflect 
various perspectives on managing risks associated with pre-harvest 
agricultural water for non-sprout

[[Page 37452]]

covered produce. See 86 FR 69120 at 69123-69125.
    For example, in October 2017, FDA participated in a collaborative 
forum, sponsored by The Pew Charitable Trusts and the Robert Wood 
Johnson Foundation, where participants representing farms, academia, 
food industry trade associations, consumer groups, and State and other 
Federal partners discussed ideas for how to amend the agricultural 
water requirements within the then-current framework of the rule, as 
well as, and potentially in combination with, ideas for frameworks that 
could improve public health outcomes long-term and allow for the 
incorporation of new scientific knowledge and learnings as they become 
available (Ref. 3). Forum participants identified several possible 
approaches, including: (1) retaining the 2015 pre-harvest microbial 
water quality criteria and testing requirements and issuing companion 
guidance; (2) replacing the 2015 quantitative requirements with a 
qualitative standard and issuing companion guidance; (3) adopting 
private industry standards as a short-term measure while additional 
research continues; and (4) performing a multiyear quantitative 
microbial risk assessment to help fill research gaps. Forum 
participants identified advantages and disadvantages of each approach 
and also identified other areas for further consideration by FDA, 
including qualitative standards, data sharing, and the need for 
additional guidance.
    The pre-harvest agricultural water requirements were also the focus 
of a 2-day Agricultural Water Summit, convened by the Produce Safety 
Alliance at Cornell University, in February 2018 (Ref. 4). The summit 
was attended by academics, produce industry, growers/grower 
associations, State agencies, Federal agencies, and supporting 
industries. During the summit, participants had many questions and 
concerns about reliance on testing as a mechanism for determining pre-
harvest agricultural water quality, including that the 2015 pre-harvest 
agricultural water microbial criteria and testing requirements were not 
supported by scientific evidence sufficient to demonstrate their 
relevance to public health outcomes. Among other things, participants 
questioned the role of water testing, what the information tells farms 
about risks, and how farms would use that information to make water use 
management decisions. Some participants emphasized farms' interest in 
preventing produce contamination while expressing concern that the 
resources that would be required to conduct testing might be better 
used for other approaches with relevance to public health outcomes.
    Many of the discussions at the summit addressed hazards in the 
growing environment, including examples of how risk assessment has been 
conducted in other fields of study, such as for drinking water and 
wastewater management. During the summit, participants identified 
``agricultural water assessments'' as a promising approach for managing 
water quality, suggesting that assessments may provide a more effective 
risk management strategy to farms than a numerical testing standard can 
provide (Ref. 4).
    Moreover, scientific information has become available since the 
2015 produce safety final rule issued that indicates potential 
limitations in basing risk management decisions on the previous pre-
harvest agricultural water testing requirements and that supports a 
shift in regulatory approach away from those requirements. For example, 
various studies since 2015 indicate a high degree of variability in 
generic E. coli levels in surface waters (Refs. 5-10), which can reduce 
the precision of estimation of the GM and STV of a water source (Refs. 
1, 7). Other studies since 2015 have underscored the limitations of 
generic E. coli as an indicator for pathogen presence (Refs. 11-16).
    Further, a scientific evaluation of the 2015 pre-harvest 
agricultural water testing requirements found that the rolling data set 
of five samples per year used to update GM and STV values for untreated 
surface water sources leads to highly uncertain results and delays in 
detecting shifts in water quality (Ref. 7). Specifically, Havelaar et 
al. found that the 20-sample MWQP for untreated surface water was not 
sufficient to reliably characterize the quality of the irrigation water 
with higher variability in generic E. coli levels than was determined 
for the 2015 produce safety final rule (Refs. 1, 7). In simulation 
modeling, the rolling 20-sample MWQP responded ``very slowly'' to 
shifts in water quality. Increases in generic E. coli levels were 
detected only after one to six sample sets, thus delaying signals of 
changes in water quality and (and any needed measures) by 1 to 6 years 
depending on the nature and magnitude of the shift.
    For surface water that had standard deviations up to three times 
higher than accounted for in the 2015 produce safety final rule, 
Havelaar et al. determined that an 180-sample MWQP would be required to 
obtain the same precision of the GM as required by the rule (Ref. 7). 
Havelaar et al. observed that the (nine-fold) increase in sampling 
might address the problem, but it would increase testing costs. We 
acknowledge their findings on the need for substantial testing for 
highly variable pre-harvest agricultural water. Such testing would be 
beyond what is required for pre-harvest surface water testing under the 
2015 produce safety final rule, with an attendant increase in costs. 
Additionally, other recent studies demonstrate a high degree of 
variability in generic E. coli levels in surface waters for pre-harvest 
application (Refs. 5-10), suggesting similar questions about necessary 
additional testing and costs that were not accounted for in the 2015 
produce safety final rule.
    Havelaar et al. also suggested that additional understanding of the 
processes that drive variability in the quality of irrigation water 
sources might inform preventive or rapid corrective actions that have a 
larger impact on produce safety than the 2015 pre-harvest agricultural 
water requirements (Ref. 7). Additionally, for several years, FDA has 
conducted investigations of produce outbreaks to learn what factors may 
have contributed to the outbreaks of foodborne illness or food 
contamination events (Ref. 17). Findings from investigations of several 
outbreaks linked to consumption of produce since 2015--including: (1) 
the spring 2018 E. coli O157:H7 outbreak linked to romaine lettuce from 
the Yuma growing region (Refs. 18 and 19); (2) the fall 2018 E. coli 
O157:H7 outbreak linked to romaine lettuce from California (Ref. 20); 
(3) the fall 2019 E. coli O157:H7 outbreaks linked to romaine lettuce 
(Ref. 21); (4) the fall 2020 E. coli O157:H7 outbreak linked to leafy 
greens (Ref. 22); and (5) the Summer 2020 Salmonella Newport outbreak 
linked to red onions (Ref. 23)--highlight the importance of pre-harvest 
agricultural water quality and the potential impacts of adjacent and 
nearby land uses on agricultural water, which can serve as a route of 
contamination of produce. These outbreak investigations reiterate 
decades of scientific research demonstrating that pre-harvest 
agricultural water is a potential contributing factor in the 
introduction and spread of contamination to produce. See 86 FR 69120 at 
69125-69127. Findings such as these build upon our peer-reviewed ``FDA 
Qualitative Assessment of Risk to Public Health from On-Farm 
Contamination of Produce'' (QAR) (Ref. 17), which provides a scientific 
evaluation of the potential adverse health effects resulting from human 
exposure to microbiological hazards in

[[Page 37453]]

produce to inform FDA's implementation of section 419 of the FD&C Act, 
with a focus on public health risk associated with the on-farm 
contamination of produce, including from agricultural water.

D. 2021 Agricultural Water Proposed Rule

    In light of recent studies and other new information gathered since 
issuance of the 2015 produce safety final rule, including findings from 
FDA produce outbreak investigations as well as feedback on the previous 
pre-harvest agricultural water requirements, on December 6, 2021, FDA 
issued a proposed rule, ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption Relating to 
Agricultural Water,'' (86 FR 69120; hereafter referred to as the ``2021 
agricultural water proposed rule'') that proposed to revise certain 
requirements relating to pre-harvest agricultural water for covered 
produce other than sprouts, while retaining the existing standards 
applicable to agricultural water for sprouts and for harvest and post-
harvest activities. For pre-harvest agricultural water for non-sprout 
covered produce, we proposed to replace the microbial quality criteria 
and uniform testing requirements with provisions for: requiring 
systems-based pre-harvest agricultural water assessments to evaluate 
the key determinants of risk attributable to agricultural water use 
practices, including a requirement to test pre-harvest agricultural 
water when doing so would not delay action most critical to protect 
public health and would further inform the farm's determination as to 
whether measures are reasonably necessary; adding new options for 
mitigation measures; and adding a new requirement for expedited 
implementation of mitigation measures for hazards related to certain 
adjacent and nearby land uses. We also proposed to require management 
review of records related to agricultural water assessments and to add 
new definitions of ``agricultural water assessment'' and ``agricultural 
water system'' to the 2015 produce safety final rule.
    We solicited comments on these proposed amendments. We also 
proposed additional amendments, such as reorganizing subpart E to group 
requirements of a similar nature and ensure that interested parties 
could readily view the proposed pre-harvest agricultural water 
revisions.
    Additionally, in the preamble to the 2021 agricultural water 
proposed rule (86 FR 69120 at 69147) we explained that at that time, 
farms were required to comply with the subpart E pre-harvest, harvest, 
and post-harvest agricultural water requirements for covered produce 
(other than sprouts) beginning on January 26, 2024, for very small 
farms; January 26, 2023, for small farms; and January 26, 2022, for all 
other farms (see also 84 FR 9706). We also explained that we intended 
to exercise enforcement discretion for the subpart E pre-harvest, 
harvest, and post-harvest agricultural water requirements for covered 
produce (other than sprouts) 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.
    The public comment period for the 2021 agricultural water proposed 
rule closed on April 5, 2022.
    In the 2021 agricultural water proposed rule, we indicated that we 
were developing an online tool related to the pre-harvest agricultural 
water assessments described in the proposed rule. In March 2022, FDA 
released v1.0 of an online ``Agricultural Water Assessment Builder'' to 
help farms understand the proposed requirements for an agricultural 
water assessment (Ref. 24). Since then, we have released paper-based 
versions of the Builder in both English and Spanish to make the content 
more accessible to a broader array of users (Ref. 25). We have also 
updated the online version of the Builder to v1.1 to make it more user-
friendly in response to stakeholder feedback. We expect to update the 
Builder to reflect the requirements we are finalizing here.

E. 2022 Supplemental Proposed Rule

    On July 19, 2022, we published a supplemental notice to the 2021 
agricultural water proposed rule (87 FR 42973) (2022 supplemental 
proposed rule) in which we proposed dates for compliance with the pre-
harvest agricultural water requirements for covered produce other than 
sprouts in the 2021 agricultural water proposed rule. In light of the 
revisions we proposed to certain pre-harvest agricultural water 
requirements for non-sprout covered produce, we proposed to establish 
dates for compliance with the pre-harvest agricultural water 
requirements 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 also specified the duration of the period of enforcement 
discretion for the harvest and post-harvest agricultural water 
requirements 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. As 
discussed in the 2022 supplemental proposed rule, we specified the 
duration of our intended period of enforcement discretion to provide 
farms, regulators, educators, and other stakeholders additional time to 
facilitate compliance with those requirements.
    We explained in the 2022 supplemental proposed rule that the 
proposed compliance dates for pre-harvest agricultural water 
requirements and our intent to exercise of enforcement discretion were 
intended to facilitate successful implementation and optimize public 
health protections. We reopened the comment period only with respect to 
the extension of compliance dates for pre-harvest agricultural water 
for non-sprout covered produce. The comment period for the supplemental 
proposed rule closed on September 19, 2022.
    In this document, we use the broad term ``agricultural water 
proposed rule'' to refer to the complete proposed rule, including both 
the 2021 agricultural water proposed rule and the 2022 supplemental 
proposed rule.

F. Public Comments

    After issuing the agricultural water proposed rule, we conducted 
numerous outreach activities. We held two virtual public meetings on 
February 14, 2022, and February 25, 2022, to solicit public comments on 
the proposed rule, inform the public about the rulemaking process 
(including how to submit comments, data, and other information to the 
rulemaking dockets), and respond to questions about the proposed rule. 
The public meetings were attended by domestic and foreign industry 
representatives, academia, State and Federal regulators, retailers, 
third-party certification bodies, laboratories, consumer groups and 
others, and included discussion panels consisting of representatives 
from industry, the States, consumer groups, and retailers. We also held 
a consultation with Federally recognized Indian tribes on February 4, 
2022, to provide an overview of the proposed rule, answer questions, 
and receive feedback.
    Additionally, FDA participated in a webinar hosted by the National 
Association of State Departments of Agriculture (NASDA) on December 15, 
2021, as well as five regional meetings (Southern Region (March 14, 
2022); Western Region (March 11, 2022); Northwestern Region (March 2, 
2022);

[[Page 37454]]

North Central Region (March 2, 2022); and Northeast Region (March 11, 
2022)) that were sponsored by State regulatory partners and attended by 
farms, irrigation districts, educators, environmental groups, and 
others. We also participated in numerous other meetings and speaking 
engagements to discuss the proposed rule, respond to questions, and 
receive feedback.
    We received approximately 180 comment submissions on the 
agricultural water proposed rule by the close of both comment periods, 
each containing one or more comments on one or more issues. We received 
submissions from diverse members of the public, including produce 
farms; coalitions; trade organizations; academia; consumers; consumer 
groups; State and foreign government agencies; and other organizations. 
Some submissions included statements from multiple individuals.
    In sections V and VI of this document we describe these comments, 
respond to them, and explain the changes we made to the agricultural 
water proposed rule, in addition to discussing our consideration of 
alternative approaches, such as requiring all farms to test their water 
as part of their pre-harvest agricultural water assessments. We also 
discuss comments that ask us to clarify the proposed requirements or 
that disagree with, or suggest one or more changes to, the proposed 
requirements. Our responses to the comments include our reasons for 
determining whether to modify any of the proposed requirements. The 
remainder of this document establishes a final rule (``the final 
rule,'' ``this final rule,'' ``the rule,'' or ``this rule'') based on 
the agricultural water proposed rule.

G. General Overview of Changes in the Final Rule

    In response to comments received and on our own initiative, we have 
made several changes to the proposed requirements for pre-harvest 
agricultural water assessments for non-sprout covered produce and for 
mitigation measures to reduce the potential for contamination of 
covered produce and food contact surfaces with known or reasonably 
foreseeable hazards associated with such agricultural water. We have 
provided clarification related to the timing of agricultural water 
assessments and exemptions from the requirement to prepare an 
agricultural water assessment. We have also revised the mitigation 
measures related to a time interval between last direct water 
application and harvest and a time interval between harvest and end of 
storage and/or use of other post-harvest activities to further 
emphasize the flexibility afforded to farms in ways to comply with 
those requirements and provide flexibility as science and post-harvest 
handling practices evolve. Consistent with the changes discussed above, 
we have revised the requirements for certain records that farms are 
required to establish and maintain. This final rule also includes a 
requirement to maintain scientific data or information in support of an 
alternative mitigation measure to align with the agricultural water 
records requirements in the 2015 produce safety final rule.

IV. Legal Authority

    We are issuing this final rule under FDA's authorities in sections 
402, 419, and 701(a) of the FD&C Act and sections 311, 361, and 368 of 
the PHS Act.
    Section 419(a) of the FD&C Act, in relevant part, directs FDA to 
establish science-based minimum standards for the safe production and 
harvesting of those types of fruits and vegetables that are raw 
agricultural commodities for which we have determined such standards 
minimize the risk of serious adverse health consequences or death. 
Section 419(a)(3) of the FD&C Act further requires that these minimum 
standards provide sufficient flexibility and are appropriate to the 
scale and diversity of the production and harvesting of raw 
agricultural commodities. Section 402(a)(3) of the FD&C Act provides 
that a food is adulterated if it consists in whole or in part of any 
filthy, putrid, or decomposed substance, or if it is otherwise unfit 
for food. Section 402(a)(4) of the FD&C Act provides that a food is 
adulterated if it has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health. Additionally, 
section 701(a) of the FD&C Act grants the authority to issue 
regulations for the efficient enforcement of the FD&C Act. This rule 
includes requirements that are necessary to prevent food from being 
adulterated, and a regulation that requires measures to prevent food 
from being held under insanitary conditions whereby either of the 
proscribed results may occur allows for the efficient enforcement of 
the FD&C Act. The amendments we are finalizing to the 2015 produce 
safety final rule thus allow FDA to efficiently enforce sections 402 
and 419 of the FD&C Act.
    In addition to the FD&C Act, FDA's legal authority for the final 
rule derives from sections 311, 361, and 368 of the PHS Act, which 
provides authority for FDA to issue regulations to prevent the spread 
of communicable diseases from one State to another. Specifically, the 
PHS Act authorizes the Secretary of HHS to make and enforce such 
regulations as ``are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the States . . . or from one State . . . into any other State'' 
(section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 
at 42 U.S.C. 202 for transfer of authority from the Surgeon General to 
the Secretary; see Staff Manual Guide 1410.10 at https://www.fda.gov/about-fda/reports-manuals-forms/staff-manual-guides for delegation from 
the Secretary to FDA.) The provisions in this final rule are necessary 
to prevent food from being contaminated with human pathogens such as 
Salmonella, Listeria monocytogenes (L. monocytogenes), and E. coli 
O157, and therefore to prevent the introduction, transmission, or 
spread of communicable disease from foreign countries into the United 
States, or from one state in the United States to another. These 
amendments to the 2015 produce safety final rule will help prevent the 
spread of communicable diseases associated with contaminated produce.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received approximately 180 comment submissions on the proposed 
rule by the close of both comment periods, each containing one or more 
comments on one or more issues. We received submissions from diverse 
members of the public, including produce farms; coalitions; trade 
organizations; academia; consumers; consumer groups; State and foreign 
government agencies; and other organizations. Some submissions included 
statements from multiple individuals.
    In the remainder of this document, we describe the comments that 
are within the scope of this rulemaking, respond to them, and explain 
the revisions we made to the proposed rule. We have grouped similar 
comments together under the same number, and, in some cases, we have 
separated different issues discussed in the same comment and designated 
them as distinct comments for purposes of our responses. The number 
assigned to each comment or comment topic is purely for organizational 
purposes and does not signify the comment's value or importance nor the 
order in which comments were received.

[[Page 37455]]

    We received no comments regarding Sec.  112.40 (``What requirements 
of this subpart apply to my covered farm?'') and are finalizing that 
provision as proposed. We received no comments regarding conforming 
changes in Sec. Sec.  112.12, 112.151, or 112.161(b), or amendments to 
Sec. Sec.  112.42, 112.44, and 112.46 through 112.49 related to 
providing additional clarity and reorganizing subpart E in its entirety 
to group provisions of a similar nature. We are finalizing these 
amendments without changes.
    We received some comments on provisions we did not propose to 
revise and that are outside of the scope of this rulemaking. For 
example, we received comments on the definition of ``agricultural 
water'' (Sec.  112.3); the requirements for general agricultural water 
quality (Sec.  112.41); the requirements for inspections and 
maintenance of agricultural water systems (Sec.  112.42); the 
requirements for harvest and post-harvest agricultural water (Sec.  
112.44); and the requirements for agricultural water treatment (Sec.  
112.46). We do not address out of scope comments in this document.
    We also received some comments that address FDA's plans for 
implementation activities that are outside the scope of this 
rulemaking. As such, we do not address those comments in this document. 
We nonetheless recognize the importance of having educational materials 
and technical assistance and are taking efforts to ensure that 
guidance, training, educational resources, and the FSMA Technical 
Assistance Network are available to help farms as they prepare to 
comply with the requirements in this rule.
    Note that summaries of and responses to comments on the estimated 
costs and benefits of the proposed rule and other topics covered by the 
Preliminary Regulatory Impact Analysis (PRIA) may be found in the Final 
Regulatory Impact Analysis (FRIA) (Ref. 26).

B. General Comments on the Proposed Rule

    Many comments made general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. 
Among comments that were supportive of the proposed rule, some provided 
general feedback suggesting that additional information would help 
clarify the rule. Several comments focused on other topics, such as 
alternative options to the regulatory approach for pre-harvest 
agricultural water and the shift from mandated agricultural water 
testing in the 2015 produce safety final rule to the proposed approach 
for pre-harvest agricultural water assessments. In the following 
paragraphs, we discuss and respond to such general comments.
1. General Comments
    (Comment 1) Many comments support the proposed rule, suggesting 
that the proposed pre-harvest agricultural water assessments are more 
risk-based, flexible, and holistic than the pre-harvest agricultural 
water testing requirements in the 2015 produce safety final rule, which 
commenters characterized variously as complex, prescriptive, and ``one-
size-fits-all.'' Many comments suggest that the proposed approach 
better accommodates the diversity in industry, noting the variety of 
conditions that can exist on farms when it comes to different regions, 
crops, water sources, and water uses. Many of these comments suggest 
that the proposed requirements will help prevent foodborne illness 
outbreaks and lead to improved public health outcomes. Among comments 
supportive of the proposed approach, some suggest that additional 
information on agricultural water assessments would be beneficial to 
further clarify the proposed requirements.
    In contrast, a few comments suggest that the proposed requirements 
for pre-harvest agricultural water assessments are too complicated. 
Some of these comments suggest that quantitative metrics (such as 
criteria derived from testing) would be easier for farms to understand 
and easier for regulators to enforce than agricultural water 
assessments, which are more qualitative in nature. Some of these 
comments suggest that the requirements for agricultural water 
assessments will not be more effective at preventing foodborne illness 
than mandated pre-harvest agricultural water testing.
    (Response 1) We agree with comments received that support the 
proposed rule, including the systems-based assessments that are 
grounded in our QAR (Ref. 17), incorporate recent scientific data and 
other information available to FDA, and are designed to ensure that 
farms have robust and meaningful information about the quality of their 
pre-harvest water for use in risk management decision making. We 
developed this approach to pre-harvest agricultural water by 
considering the public health objectives we aim to achieve through pre-
harvest agricultural water measures for covered produce other than 
sprouts while recognizing that each farm--whether foreign or domestic--
has a unique combination of agricultural water source(s), growing 
practices, current and previous uses of the farmland, and adjacent and 
nearby land uses, among other factors, that may influence the safety of 
its agricultural water.
    The rule establishes assessment factors with sufficient specificity 
to provide farms robust and meaningful information on the quality of 
pre-harvest agricultural water, while also offering adequate 
flexibility to account for the diversity of operations that we are 
required to consider in developing the regulations under 419(a)(3)(A) 
of the FD&C Act.
    The requirements for comprehensive, systems-based pre-harvest 
agricultural water assessments and appropriate corrective and 
mitigation measures as needed will help farms identify potential 
sources of contamination and effectively manage their water. 
Specifically, farms must use the results of assessments to determine 
when, within the framework for risk-based outcomes, they are required 
to take measures to ensure that their pre-harvest agricultural water is 
safe and is of adequate sanitary quality for the intended use(s). The 
combination of assessments and risk-tiered outcomes require farms to 
identify and address sources of potential hazards through 
implementation of effective prevention-oriented mitigation measures 
within specified timeframes. Under the final rule, farms will assess 
hazards at the beginning of the growing season and implement mitigation 
measures for certain hazards earlier than under the 2015 produce safety 
final rule. Further, under the 2015 produce safety final rule, farms 
were required to test pre-harvest agricultural water as close in time 
as practicable to, but prior to harvest, and use those results to 
determine whether to implement mitigation measures without the benefit 
of the written systems-based evaluation of potential sources of 
contamination we are requiring in this final rule.
    We recognize that agricultural water assessments, by their nature, 
will require farms to consider a broader set of factors as part of the 
systems-based approach we are finalizing here, compared to the 
microbial quality criteria and testing requirements for pre-harvest 
agricultural water in the 2015 produce safety final rule. In addition 
to providing the specific factors farms must consider in their pre-
harvest agricultural water assessments in Sec.  112.43(a), we provide 
additional information on the requirements for agricultural water 
assessments throughout the remainder of section V. We reiterate our 
commitment to providing farms education, outreach, and technical 
assistance to facilitate

[[Page 37456]]

compliance with the rule. We intend to pursue various mechanisms, such 
as publishing guidance, holding webinars, and developing other 
educational resources, including work with other stakeholders (such as 
State agencies, educators, and extension agents), to do so. See also 
the response to comment 29.
    Further, the knowledge and experiences gained since 2015 will be 
helpful in supporting successful implementation of the rule, including 
compliance with the requirements for pre-harvest agricultural water 
assessments. For example, we developed the 2015 produce safety final 
rule after considering, in part, that at the time of rulemaking, some 
farms had significant expertise in the area of food safety, and other 
farms had minimal knowledge in the area. We also considered that the 
produce farming community did not have the history of regulatory 
interaction with FDA and the same experience with food safety 
regulations as did the food manufacturing industry. 78 FR 3504 at 3530. 
However, we recognize that since that time, knowledge and awareness of 
food safety, as well as the produce farming community's experience with 
food safety regulations, has evolved. For example, many farms, whether 
for the purposes of required training in accordance with Sec.  
112.22(c) (which we did not propose to change) or for other purposes, 
have since received food safety training, including on topics related 
to potential hazards in the growing environment.
    Additionally, FDA has provided investigation reports for various 
produce-related outbreaks that have occurred since 2015 (e.g., Refs. 
18-23), many of which discuss factors potentially contributing to 
contamination and provide recommendations for farms to consider in 
light of those findings. Moreover, other provisions in the 2015 produce 
safety final rule for which compliance dates have passed, such as those 
in subpart I, ``Domesticated and Wild Animals'' (Sec. Sec.  112.81-
112.83), may provide farms with useful information when evaluating the 
degree of protection of a pre-harvest agricultural water system as part 
of an agricultural water assessment (see response to comment 55).
    For these reasons we have concluded that sufficient support 
exists--including through identification of specific factors that farms 
must consider in Sec.  112.43(a), information provided throughout this 
final rule, and knowledge and experiences gained since 2015 (including 
lessons learned from various produce-related outbreaks)--for farms to 
effectively implement the requirements for agricultural water 
assessments and risk-tiered outcomes that we are finalizing with this 
rule.
    With respect to comments suggesting that the requirements for pre-
harvest agricultural water assessments will be difficult to enforce, we 
disagree. The annual assessments employ a prevention-oriented quality-
systems approach to food safety regulation that FDA has long used and 
successfully enforced across the highly diverse food industry that FDA 
regulates. For example, FDA issued the juice hazard analysis and 
critical control point (HACCP) regulation (that is, the Hazard Analysis 
and Critical Control Point Systems regulation in 21 CFR part 120) and 
the seafood HACCP regulation (that is, the Fish and Fishery Products 
regulation in 21 CFR part 123) more than 20 years ago, which establish 
mandatory frameworks through which industry assesses hazards that are 
reasonably likely to occur and designs tailored controls to prevent or 
eliminate them or reduce them to an acceptable level. More recently, in 
2015, FDA issued the Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Human Food regulation 
(21 CFR part 117), under which food facilities conduct a qualitative 
assessment to identify and evaluate known or reasonably foreseeable 
hazards for each type of food manufactured, processed, packed, or held 
at the facility to determine whether there are any hazards requiring a 
preventive control. These regulations all require the development of a 
food safety plan.
    As discussed in comment 18, we have incorporated many of these 
principles--such as an assessment of risk and the development of a food 
safety plan based on that assessment--into the requirements for pre-
harvest agricultural water assessments in Sec.  112.43. For example, in 
Sec.  112.43(a), we require farms to evaluate and document specific 
factors as part of an assessment, all of which are key determinants of 
contamination risks associated with pre-harvest agricultural water. 
Based on that evaluation, in Sec.  112.43(c), we require farms to make 
written determinations on whether measures under Sec.  112.43(d) are 
reasonably necessary. We further require farms to take necessary and 
timely action in accordance with those determinations. Thus, the 
requirements we are finalizing here share common principles with other 
FDA food safety regulations that have been enforced.
    Thus, based on the specific criteria we have included in Sec.  
112.43 and our experience enforcing other regulations that rely on 
similar food safety principles and approaches to operation-specific 
assessments, we have concluded we can enforce the requirements we are 
finalizing here. For example, the Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food 
regulation includes requirements for hazard identification (see 21 CFR 
117.130), and FDA has enforced that regulation. Additional information 
on inspection, compliance, and enforcement-related information can be 
found on the ``FDA Data Dashboard'' at https://www.fda.gov/about-fda/transparency/fda-data-dashboard.
    To the extent that comments voicing concerns with the proposed rule 
are suggesting that the requirements for pre-harvest agricultural water 
assessments are more than what is necessary for public health purposes, 
we disagree. While we believe that requiring operational assessments 
and food safety plans that address the entirety of a farm's operations 
(including potential sources and routes of contamination addressed in 
other subparts of the 2015 produce safety final rule) would be more 
than a minimum standard and more than what is reasonably necessary for 
us to require to achieve the statutory purposes (80 FR 74354 at 74380), 
given the scientific support for pre-harvest agricultural water 
assessments; the limited scope of the assessments (i.e., the 
requirements only apply for pre-harvest agricultural water for non-
sprout covered produce); and the knowledge and experiences gained since 
2015, we continue to conclude that requiring farms to prepare a pre-
harvest agricultural water assessment for non-sprout covered produce is 
a science-based minimum standard as described in section 419 of the 
FD&C Act. There is significant public health benefit in requiring farms 
to prepare a written assessment that considers various factors that 
affect the safety of their pre-harvest agricultural water and its 
appropriate use during pre-harvest activities for non-sprout covered 
produce. Such written assessments also require farms to identify the 
actions they will take to manage risks associated with their pre-
harvest water. Further, in some instances, the written assessments will 
provide farms with a historical record that will allow them to more 
readily detect changes and react in a timely manner to protect public 
health.
    With respect to comments suggesting that the requirements for 
agricultural water assessments will not be more effective at protecting 
public health than

[[Page 37457]]

the 2015 pre-harvest agricultural water testing requirements, we 
disagree. As discussed further in response to comment 3, there are 
various limitations associated with testing, including that: the 
presence of indicators does not always signal the presence of 
pathogens, and the absence of detection of indicators does not 
guarantee that pathogens are absent (Refs. 27-30) (80 FR 74354 at 
74428). Moreover, since sampling frequency and location relative to the 
source of contamination are reported to affect the performance of 
generic E. coli as an indicator of fecal contamination (Refs. 31 and 
32), non-detection of generic E. coli cannot be considered absolute 
confirmation that fecal contamination has not occurred (80 FR 74354 at 
74428). In light of these challenges, testing may inadvertently provide 
farms with a false sense of security as to the quality of their water, 
potentially resulting in farms not taking action where necessary to 
protect public health. Moreover, as discussed in response to comment 
11, rather than relying on results of a multi-year rolling profile that 
might not always reflect a need for mitigation or elicit a timely 
reaction from farms to address potential hazards (Ref. 7), the approach 
we are finalizing here establishes requirements for measures that are 
directly responsive to the conditions identified as part of an 
assessment and requires that farms implement those measures within 
specific timeframes based on risk.
    As noted in comment 11, our FRIA (Ref. 26) indicates that the 
increase in costs associated with this rule compared to the 2015 pre-
harvest agricultural water testing requirements is largely a result of 
more mitigation occurring in response to findings from pre-harvest 
agricultural water assessments than as a result of the previous testing 
requirements. As also discussed in the FRIA, we estimate likely greater 
benefits under the requirements we are finalizing here, with more 
mitigation occurring in response to assessment findings than in 
response to the testing approach in the 2015 produce safety final rule.
    (Comment 2) Some comments support the proposed requirements for 
pre-harvest agricultural water assessments, and further suggest that 
agricultural water assessments should be required for all agricultural 
water, including treated water, water from public water sources, water 
used for harvest and post-harvest activities, and for sprout irrigation 
water.
    (Response 2) In light of these comments, we considered removing the 
proposed exemptions from the requirement to prepare an agricultural 
water assessment, including for water meeting certain requirements 
applicable to harvest and post-harvest agricultural water (proposed 
Sec.  112.43(b)(1)); water from public water systems or supplies 
meeting certain requirements (proposed Sec.  112.43(b)(2)); and 
agricultural water treated in accordance with Sec.  112.46 (proposed 
Sec.  112.43(b)(3)). However, we ultimately determined that eliminating 
the exceptions was not necessary, for the reasons described below.
    Section 419 of the FD&C Act directs FDA to establish science-based 
minimum standards, including procedures, processes, and practices that 
are reasonably necessary to prevent introduction of hazards and provide 
reasonable assurances produce is not adulterated under section 402 of 
the FD&C Act. Subpart E of the 2015 produce safety final rule 
establishes requirements that are broadly applicable to all 
agricultural water--namely, the requirement in Sec.  112.41 that all 
agricultural water must be safe and of adequate sanitary quality for 
its intended use, and the requirements in Sec.  112.42 related to 
inspections and maintenance of agricultural water systems to identify 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food contact 
surfaces and prevent the systems from being a source of contamination 
to covered produce, food contact surfaces, or areas used for a covered 
activity. We consider applying these requirements to all agricultural 
water (including that used during pre-harvest, harvest, and post-
harvest activities, even if an exemption from other provisions in 
subpart E applies) as commensurate with the risk associated with the 
use of agricultural water for the growing, harvesting, packing and 
holding of covered produce.
    With respect to comments about water from public water supplies, in 
the U.S., Public Water Systems are required under U.S. Environmental 
Protection Agency (EPA) National Primary Drinking Water Regulations 
(NPDWR) in 40 CFR part 141 to provide safe, clean water suitable for 
drinking and thus are at the lowest likelihood for pathogen 
contamination (Ref. 17). Similarly, public water supplies that meet the 
microbial requirement in Sec.  112.44(a) are included in the exemption 
under proposed Sec.  112.43(b)(2) (final Sec.  112.45(b)(1)(ii)) to 
accommodate other public water supplies that are not governed by the 
requirements of the EPA drinking water program, but provide water of a 
quality that meets the microbial requirement of Sec.  112.44(a). See 
also 78 FR 3504 at 3571. Given the nature of Public Water Systems and 
public water supplies meeting these requirements and the low likelihood 
of pathogen contamination of such systems, we consider it appropriate 
to exempt farms using such water sources as pre-harvest agricultural 
water for non-sprout covered produce from the requirement to prepare an 
agricultural water assessment under Sec.  112.43 provided all 
requirements are met (including that the farm have results or 
certificates of compliance demonstrating that relevant requirements are 
met). (See Sec.  112.45(b)(1)(ii) and by reference, Sec.  112.44(c).) 
In light of the nature of these water sources, we have concluded that 
to require farms to prepare an agricultural water assessment for such 
water sources would be more than a science-based minimum standard as 
described in section 419 of the FD&C Act. We also note that the 
exemption for public water systems or public water supplies meeting the 
requirements in Sec.  112.45(b)(1)(ii) is consistent with the exemption 
from the pre-harvest agricultural water testing requirements in the 
2015 produce safety final rule as well as the exemption at Sec.  
112.44(c)(1) and (2) from the requirement to test agricultural water 
used for sprout irrigation and for harvest and post-harvest activities 
for covered produce.
    In consideration of the risks associated with agricultural water 
uses outlined in Sec.  112.44(a) (including harvest and post-harvest 
agricultural water), we have also established requirements in subpart E 
specific to those uses. This includes a stringent microbial quality 
criterion of no detectable generic E. coli per 100 mL of agricultural 
water and a prohibition on the use of untreated surface water (Sec.  
112.44(a)). We established requirements applicable to the water uses 
specified in Sec.  112.44(a) in the recognition that such water uses 
have high potential to serve as a vehicle of fecal contamination 
because if fecal contamination is present (along with the corresponding 
potential for pathogen presence), it is reasonably likely it could be 
transferred directly to covered produce through direct or indirect (via 
food-contact surfaces) contact with the agricultural water. See 80 FR 
74354 at 74440. Moreover, we have established requirements in subpart E 
that are specific to agricultural water treatment. Specifically, Sec.  
112.46 establishes requirements related to treatment efficacy, 
delivery, and monitoring to ensure that treated agricultural water is 
safe and of adequate sanitary quality for its intended use and/or meets 
the relevant microbial quality criterion in

[[Page 37458]]

Sec.  112.44(a), as applicable. We also note that with respect to 
treated agricultural water, an exemption for water treated in 
accordance with Sec.  112.46 is consistent with the exemption from the 
pre-harvest agricultural water testing requirements in the 2015 produce 
safety final rule as well as the exemption at Sec.  112.44(c)(3) from 
the requirement to test agricultural water used for sprout irrigation 
and for harvest and post-harvest activities for covered produce.
    We consider the requirements in subpart E that apply for 
agricultural water treatment, agricultural water used for sprout 
irrigation and harvest and post-harvest activities on covered produce, 
and public water systems and public water supplies meeting the 
requirements in Sec.  112.44(c) to be reasonable and appropriate based 
on the risk associated with such water sources and practices. We do not 
consider it necessary or appropriate to require farms to prepare an 
agricultural water assessment for such water sources and practices, as 
doing so would be more than a science-based minimum standard as 
described in section 419 of the FD&C Act. Thus, we decline the request 
in the comments to broaden the provisions for agricultural water 
assessments in Sec.  112.43 to apply to all agricultural water.
    (Comment 3) While supportive of the general proposed approach for 
pre-harvest agricultural water assessments, some comments suggest that 
all farms should be required to test their pre-harvest agricultural 
water as one part of their agricultural water assessments. Several of 
these comments suggest that mandatory testing with assessments for all 
farms would help with objectivity and provide more certainty for farms 
and regulators. Some comments suggest that if testing is not required 
for all farms as part of an agricultural water assessment, farms may 
avoid testing water, lest the results show a need for treatment or 
other mitigation. Some comments suggest that farms should only be 
exempt from testing as part of an agricultural water assessment if they 
can demonstrate that testing is not necessary for public health 
purposes.
    Conversely, some comments express support for what they consider to 
be a flexible approach to testing in the proposed rule, noting that 
they found the testing requirements in the 2015 produce safety final 
rule to be inflexible, expensive, cumbersome, and not risk-based. Some 
of these comments suggest that testing should not be required for all 
situations, and that mandatory testing for all farms would create 
unnecessary economic hardship for farms.
    (Response 3) In light of these comments, we considered adding a 
requirement for all farms to test their pre-harvest agricultural water 
as one part of their agricultural water assessments. We considered the 
additional burden that would be imposed on farms by such a requirement 
and the impacts on public health that might result. For the reasons 
discussed below, we have concluded that a requirement for all farms to 
test their pre-harvest agricultural water as part of an assessment 
would be more than a minimum standard and more than what is reasonably 
necessary to prevent introduction of hazards and provide reasonable 
assurances produce is not adulterated under section 402 of the FD&C 
Act. Thus, we are retaining the requirements for agricultural water 
assessments and risk-tiered outcomes as proposed, including a 
requirement in Sec.  112.43(c)(4) to test pre-harvest agricultural 
water as part of an assessment in certain circumstances.
    First, a requirement for all farms to test pre-harvest agricultural 
water as one part of an assessment is not necessary given the nature of 
the potential sources of hazards for which immediate action is most 
critical to protect public health. For example, if a farm's 
agricultural water system was impacted by the presence of dead sheep in 
a canal or discharge of untreated sewage into a river, the outcome in 
Sec.  112.43(c)(1), which requires immediate discontinuation of the 
relevant use(s) of the water and corrective measures prior to resuming 
that use, would apply, and agricultural water test results would be 
unlikely to provide information suggesting that those steps would not 
be appropriate or necessary to protect public health.
    Moreover, requiring all farms to test in such circumstances could 
undermine public health protections by inadvertently providing farms 
with a false sense of security as to the quality of their water, 
potentially resulting in farms not taking action where necessary to 
protect public health. For example, throughout rulemaking for the 2015 
produce safety final rule, we discussed the role of water testing when 
it comes to understanding and managing water quality, including various 
challenges with using test results as a direct indicator of the safety 
agricultural water (78 FR 3504 at 3561-3563; 80 FR 74354 at 74427-
74428). Of particular note, we discussed that the presence of 
indicators does not always signal the presence of pathogens, and the 
absence of detection of indicators does not guarantee that pathogens 
are absent (Refs. 27-30). We also discussed that since sampling 
frequency and location relative to the source of contamination are 
reported to affect the performance of generic E. coli as an indicator 
of fecal contamination (Refs. 31 and 32), non-detection cannot be 
considered absolute confirmation that fecal contamination has not 
occurred. 80 FR 74354 at 74428. We emphasized that we viewed the 2015 
requirement outlining the GM and STV criteria as a water management 
tool for use in understanding the microbial quality of water over time 
and determining how to appropriately use water from that source, rather 
than as a direct indicator of the safety or adequacy of the sanitary 
quality of water for its immediate purposes. 80 FR 74354 at 74430. 
Further, we acknowledged that while testing water for pathogens allows 
for direct targeting of microorganisms in water that are a risk to 
public health, it can also present significant challenges, including 
those associated with large sample sizes, high costs, and the wide 
array of potential target pathogens (i.e., the presence or absence of 
one pathogen may not predict for the presence or absence of other 
pathogens). See response to comment 91 and 80 FR 74354 at 74427-74428.
    Indeed, these challenges with using water test results as a direct 
indicator of water safety, particularly when it comes to surface water 
sources, have long been recognized, even before FDA initiated 
rulemaking to establish the 2015 produce safety final rule (see 78 FR 
3504 at 3561-64 and 3567-71 and references cited therein, for example). 
However, despite the historical record of these challenges, comments 
received for the current rulemaking indicate that some farms continue 
to believe that, even under the assessment framework, agricultural 
water test results should alone dictate the level of risk associated 
with a water system and whether action related to the farm's pre-
harvest agricultural water is warranted (see comment 96). As such, we 
are concerned that--particularly in circumstances where quick action is 
most critical to protect public health (i.e., those situations that 
would lead to the outcomes in Sec.  112.43(c)(1) or (2))--a requirement 
for all farms to test their water as part of an assessment would result 
in some farms using test results inappropriately to justify not taking 
action, to the detriment of public health. Further, a requirement for 
all farms to test pre-harvest agricultural water as part of an 
assessment could undermine public health protections by 1) delaying 
discontinuance and necessary corrective action for water that is not 
safe or of

[[Page 37459]]

adequate sanitary quality for the intended use(s) (per Sec.  
112.43(c)(1)), and 2) delaying prompt implementation of mitigation 
measures to address conditions related to animal activity, BSAAOs, or 
the presence of untreated or improperly treated human waste on adjacent 
or nearby lands (per Sec.  112.43(c)(2)).
    Of particular note, when testing agricultural water, it can take 
time to develop a plan, collect samples, test the samples, and analyze 
the results in the context of the other information evaluated as part 
of an assessment--particularly when a farm is collecting samples over 
time to better understand the effects of certain conditions on water 
quality. As a result, if a farm initially identified a potential source 
of hazards as part of its assessment and were then to test the farm's 
agricultural water to better understand that condition, it could delay 
steps the farm takes to protect public health. This would be 
particularly problematic when it comes to conditions for which the 
outcomes in Sec.  112.43(c)(1) and (2) are appropriate. While we 
considered whether to require farms to immediately discontinue the 
relevant use of the water until they have agricultural water test 
results demonstrating safety of the water, we determined that this, 
too, would not be in the best interest of public health due to the 
challenges discussed above with using testing results as a direct 
indicator of the safety of the water and that doing so may result in 
farms inappropriately using test results to justify not implementing 
necessary measures.
    Moreover, we emphasize that for some farms, a requirement to test 
their pre-harvest agricultural water as one part of an assessment would 
impose significant burden without necessarily leading to additional 
public health benefits. For example, in preparing an agricultural water 
assessment, a farm that uses water from a pond as pre-harvest 
agricultural water might find that the pond is at a higher elevation 
than the surrounding land, and that conditions, such as large numbers 
of animals, are not present that would be reasonably likely to 
introduce known or reasonably foreseeable hazards. Depending on the 
circumstances, the farm might determine, along with the other factors 
evaluated under Sec.  112.43(a), that the outcome in Sec.  112.43(c)(3) 
is appropriate and that measures under Sec.  112.45 are not reasonably 
necessary to reduce the potential for contamination of covered produce 
(other than sprouts) or food contact surfaces. Because test results 
would be unlikely to change the farm's determination in this (and 
similar) situations, and because the farm would not be implementing 
measures as a result of its assessment findings, requiring the farm to 
test would impose significant burden on the farm without providing 
added public health benefit.
    In light of the concerns discussed above that a requirement for all 
farms to test their pre-harvest agricultural water as part of an 
assessment would provide farms with a false sense of security as to the 
quality of their pre-harvest agricultural water; delay or preclude 
action most critical to protect public health; and impose significant 
burden on farms without commensurate public health benefits, we have 
concluded that a requirement for all farms to test their pre-harvest 
agricultural water as part of an assessment would be more than a 
minimum standard and more than what is reasonably necessary to prevent 
introduction of hazards and provide reasonable assurances that produce 
is not adulterated under section 402 of the FD&C Act.
    (Comment 4) Some comments suggest that farms should be subject to 
different requirements depending on the risk associated with their 
crop, water source, or water use practices (such as the method and 
timing of water application). For example, several comments suggest 
that farms that grow certain low-risk crops or that use low-risk 
irrigation methods should be exempt from preparing an agricultural 
water assessment and/or from testing their agricultural water. Some 
comments suggest that farms growing low-risk crops and using low-risk 
water sources should be allowed to choose whether to conduct 
agricultural water testing, agricultural water systems inspections 
under Sec.  112.42(a), or a combination of the two, while those growing 
higher-risk covered produce or using higher-risk water should be 
required to conduct both.
    (Response 4) This rule, and the produce safety rule of which it is 
a part, acknowledges and differentiates requirements as appropriate 
based on the varying risks presented by different crops, water sources, 
and water use practices. For example, the requirements for agricultural 
water in subpart E do not apply to water that is not intended to, or 
not likely to, contact covered produce or food-contact surfaces because 
we previously concluded that applying the requirements in subpart E to 
such water is more than what is reasonably necessary for us to require 
to achieve statutory purposes set forth in section 419 of the FD&C Act 
(that is, it is not reasonably necessary to apply the requirements to 
such water to prevent the introduction of known or reasonably 
foreseeable hazards into produce and to provide reasonable assurances 
that produce is not adulterated). 80 FR 74254 at 74429.
    However, we decline to establish differing requirements for pre-
harvest agricultural water based on crop, water source, and/or 
agricultural water use practices alone.\5\ The QAR (Ref. 17) concluded 
that using crop physical characteristics alone seems to be a poor 
indicator of which commodities are at a greater or lesser likelihood of 
contamination that may lead to a foodborne illness outbreak. Rather, 
the specific conditions and practices associated with a produce 
commodity also influence the potential routes of contamination and the 
likelihood that a given route could lead to contamination and illness. 
Additionally, with respect to water sources, the QAR (Ref. 17) 
concluded that the microbial quality of source water is one of the key 
determinants in assessing the relative likelihood of contamination 
attributable to agricultural water. While noting that surface waters 
pose the highest potential for contamination and the greatest 
variability in quality of the agricultural water sources, the QAR also 
concluded that though less likely to be contaminated than surface 
water, ground water continues to pose a public health risk, despite the 
regulation of many U.S. public wells under the Ground Water Regulation. 
Moreover, ground water sources (such as some wells) may contain 
deficiencies which, if left uncorrected, can result in hazards being 
introduced to the water source (Ref. 17).
---------------------------------------------------------------------------

    \5\ We note that because sprouts present a unique safety risk, 
the final 2015 produce safety final rule established sprout-specific 
requirements on multiple topics, including agricultural water. The 
agricultural water requirements for sprouts are different from the 
agricultural water requirements for other produce commodities (for 
example, sprout irrigation water is subject to the microbial 
criterion and testing requirements in Sec.  112.44(a) and (b)).
---------------------------------------------------------------------------

    While we continue to include agricultural water systems, water use 
practices, and crop characteristics as factors that farms must consider 
as part of their pre-harvest agricultural water assessments under Sec.  
112.43, we emphasize that this information must be considered in 
concert with the other factors of the systems-based assessment 
identified in Sec.  112.43(a)(1) through (5). While we have 
incorporated testing agricultural water as part of a pre-harvest 
agricultural water assessment under Sec.  112.43(c)(4), farms must not 
rely on test results alone in making decisions around the safe use of 
their agricultural

[[Page 37460]]

water. Rather, results from pre-harvest agricultural water testing 
serve as an additional source of information for farms to consider 
alongside the other factors evaluated in Sec.  112.43(a)(1) through (5) 
in making a determination as to whether measures under Sec.  112.45 are 
reasonably necessary to reduce the potential for contamination of 
covered produce or food contact surfaces with biological hazards 
associated with agricultural water. See also response to comment 83.
    (Comment 5) Several comments request that FDA modify various 
requirements (such as the requirements for mitigation measures in Sec.  
112.45(b), and the definition of ``agricultural water assessment'' in 
Sec.  112.3) so that farms may consider strategies or other practices 
already being implemented to control hazards with respect to 
agricultural water.
    (Response 5) We agree that strategies or practices a farm is 
already implementing to control potential hazards may affect whether a 
condition is reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food contact 
surfaces. Further, farms must consider such strategies or practices in 
complying with various agricultural water requirements. For example, 
farms must consider the degree of protection of their agricultural 
water system under Sec.  112.43(a)(1); this includes a situation in 
which a farm has a berm established that prevents runoff (which may 
contain hazards) from being introduced to an agricultural water system. 
As another example, farms must consider their agricultural water 
practices under Sec.  112.43(a)(2); this includes a situation in which 
a farm only applies agricultural water from a certain water source to 
non-sprout covered produce early in the growing season. Farms must 
consider the relevant strategy or practice, along with the other 
information evaluated under Sec.  112.43(a)(1) through (5), in 
determining whether measures under Sec.  112.45 are reasonably 
necessary to reduce the potential for contamination of non-sprout 
covered produce or food contact surfaces with known or reasonably 
foreseeable hazards associated with pre-harvest agricultural water. As 
farms must consider such strategies or practices they are currently 
implementing in complying with the requirements for pre-harvest 
agricultural water assessments, we do not consider it necessary to 
revise the requirements related to agricultural water to further 
emphasize the point.
    (Comment 6) Several comments seek clarity on what is expected of 
farms in terms of assessing water that is outside the scope of 
``agricultural water.'' A few comments express concern that in some of 
the outbreaks cited in the 2021 agricultural water proposed rule, the 
water used to grow the produce would not have been subject to the 
requirements in the proposed rule.
    (Response 6) We define agricultural water in Sec.  112.3, in part, 
as ``water used in covered activities on covered produce where water is 
intended to, or is likely to, contact covered produce or food-contact 
surfaces.'' If a specific use of water does not fit within the 
definition of agricultural water, then the requirements in subpart E, 
including those for pre-harvest agricultural water assessments for non-
sprout covered produce, do not apply to that specific use of water. See 
80 FR 74354 at 74429.
    With respect to comments related to the outbreaks referenced in the 
2021 agricultural water proposed rule (86 FR 69120 at 69125-69127) 
(Refs. 18-23), we acknowledge that a definitive source or route of 
contamination of the implicated produce could not always be determined. 
Nevertheless, findings from these outbreaks underscore the potential 
impacts of adjacent and nearby land uses on agricultural water, which 
we designed the requirements for pre-harvest agricultural water 
assessments, in part, to address. See 86 FR 69120 at 69125-69127 and 
responses to comment 16 and comment 56.
    (Comment 7) A few comments state that produce contamination can be 
attributed to more than agricultural water (e.g., airborne transmission 
or long-term persistence in soil) and request that FDA include these 
other methods of pathogen transmission in the proposed rule.
    (Response 7) We agree that produce can become contaminated through 
various routes, including those other than water (Ref. 17). As such, 
the 2015 produce safety final rule focuses on major routes of microbial 
contamination--including agricultural water; biological soil 
amendments; domesticated and wild animals; worker health and hygiene; 
and equipment, buildings, and tools. This rulemaking, however, focuses 
specifically on certain requirements in Subpart E of that regulation 
relating to agricultural water.
    (Comment 8) A few comments argue that the scope of the proposed 
rule is too narrow and FDA should include chemicals and biological 
toxins in the requirements for agricultural water assessments, since, 
the comments suggest, these agents pose a potential toxic disease risk 
to humans. Some comments seek clarity regarding what testing, if any, 
is expected for non-microbial contaminants, such as heavy metals and 
chemicals.
    (Response 8) We disagree with suggestions to expand the scope of 
hazards covered by the rule. Section 419(c)(1)(A) of the FD&C Act 
requires that the 2015 produce safety final rule set forth those 
procedures, processes, and practices that the Secretary determines to 
minimize the risk of serious adverse health consequences or death, 
including procedures, processes, and practices that the Secretary 
determines to be reasonably necessary to prevent the introduction of 
known or reasonably foreseeable biological, chemical, and physical 
hazards and to provide reasonable assurances that the produce is not 
adulterated under section 402 of the FD&C Act. This language provides 
FDA with discretion to determine what procedures, processes, and 
practices are ``reasonably necessary'' for the purposes identified in 
the statute with respect to the identified types of hazards.
    As discussed in the 2015 produce safety final rule, FDA carefully 
considered different types of hazards and determined that the available 
data and information clearly establish that human pathogens constitute 
a biological hazard with the potential to cause serious adverse health 
consequences or death and result in the vast majority of foodborne 
illness known to be associated with produce consumption. On that basis 
we concluded that it was appropriate to establish the 2015 produce 
safety final rule to cover biological hazards and science-based 
standards necessary to minimize the risk of serious adverse health 
consequences or death associated with biological hazards (80 FR 74354 
at 74377). Foodborne illness attribution data reported by the 
Interagency Food Safety Analytics Collaboration (IFSAC) (Refs. 33-35), 
a tri-agency group created by the Centers for Disease Control and 
Prevention (CDC), FDA, and U.S. Department of Agriculture's (USDA) Food 
Safety and Inspection Service, reinforce the significance of biological 
hazards in produce. See also comment 13.
    As further explained in the 2015 final rule, although the potential 
exists for physical or chemical (including radiological) hazards to 
contaminate produce, our analysis led us to conclude that non-
biological hazards associated with produce rarely pose a risk of 
serious adverse health consequences or death for individuals that would 
consume the product. Chemical and physical hazards in produce: (1) 
occur only rarely at levels that can pose a risk of serious adverse 
health consequences

[[Page 37461]]

or death (e.g., radiological contamination as a result of a nuclear 
power plant accident); (2) occur with greater frequency, but rarely at 
levels that can pose a risk of serious adverse health consequences or 
death (e.g., pesticide or mycotoxin residues); or (3) occur 
infrequently and usually do not pose a risk of serious adverse health 
consequences or death (e.g., physical hazards). Moreover, there are 
other programs in place for monitoring and/or controlling physical and 
chemical hazards that may contaminate produce. These programs include 
FDA's routine monitoring of chemical and pesticide residues, other FDA 
efforts (such as Closer to Zero to address environmental contaminants 
in food \6\), EPA's registration of pesticides, and various State and 
industry initiatives. In light of the severity and frequency of 
occurrence of these hazards in produce, and the existing regulatory 
structures that apply to these hazards, we concluded that it was not 
reasonably necessary to establish controls for physical or chemical 
hazards in the 2015 produce safety final rule. See 80 FR 74354 at 
74376-74379.
---------------------------------------------------------------------------

    \6\ See ``Closer to Zero: Reducing Childhood Exposure to 
Contaminants from Foods'' at https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods.
---------------------------------------------------------------------------

    We note that comments on the 2021 agricultural water proposed rule 
did not include data or other information demonstrating a need to 
expand the scope of the pre-harvest agricultural water requirements for 
covered produce other than sprouts to include chemical and physical 
hazards, nor is FDA aware of any such data or information. Therefore, 
we conclude that expanding the scope of the pre-harvest agricultural 
water requirements for covered produce other than sprouts is not 
reasonably necessary.
    (Comment 9) Some comments seek clarity on which requirements of 
Subpart E the proposed rule supersedes or replaces.
    (Response 9) As finalized with this rule, we are reorganizing 
subpart E in its entirety to group similar requirements. We note in 
particular that with this final rule, we are replacing Sec. Sec.  
112.44(b) and 112.46(b) in the 2015 produce safety final rule 
(microbial criteria and testing requirements, respectively, for pre-
harvest agricultural water for covered produce other than sprouts) with 
requirements for written pre-harvest agricultural water assessments. 
While the requirement numbers may have changed for agricultural water 
used for sprouts; agricultural water used during harvesting, packing, 
and holding activities; and for treatment of agricultural water, this 
final rule does not substantively alter those standards as established 
in part 112, subpart E.
    Table 3 summarizes the major changes made to the agricultural water 
provisions in subpart E between the 2015 produce safety final rule and 
this final rule, including the location of the relevant requirements. 
The second column does not reflect technical edits made to provisions 
that were designed to provide added clarity (for example, edits to add 
descriptive headings). While not reflected in the table below, 
conforming changes are also being made to Sec. Sec.  112.12, 112.151, 
and 112.161(b) in light of our revisions to the microbial water quality 
criteria in Sec.  112.44(b), the microbial die-off (calculated log 
reduction) rate in Sec.  112.45(b), and the testing requirements in 
Sec.  112.46(b) as set forth in the 2015 produce safety final rule. As 
discussed in sections V.A., we received no comments on these conforming 
changes and are finalizing them without changes.

  Table 3--Summary of Changes Made to Subpart E Requirements Since the
                     2015 Produce Safety Final Rule
------------------------------------------------------------------------
                                                          Location of
                                                      relevant provision
Subpart E provisions in the 2015   Changes made with    as established
    produce safety final rule       this final rule     with this final
                                                             rule
------------------------------------------------------------------------
Sec.   112.41: All agricultural   None..............  Sec.   112.41.
 water must be safe and of
 adequate sanitary quality for
 its intended use.
Sec.   112.42: Regularly inspect  None..............  Sec.   112.42.
 and maintain all agricultural
 water systems and implement
 measures to reduce potential
 for contact between covered
 produce and pooled water.
Sec.   112.43: If treating        None..............  Sec.   112.46.
 agricultural water, ensure that
 the treatment is effective and
 that treatment is delivered and
 monitored appropriately.
Sec.   112.44(a): Ensure that     None..............  Sec.   112.44(a).
 water used for certain purposes
 (for example, for sprouts and
 for harvest and post-harvest
 uses) contains no detectable
 generic E. coli per 100 mL and
 not use untreated surface water
 for such purposes.
Sec.   112.44(b): Ensure that     Replaced with       Sec.   112.43.
 water used during pre-harvest     provisions for
 activities for covered produce    pre-harvest
 (other than sprouts) meets a GM   agricultural
 of 126 generic E. coli per 100    water assessments
 mL and a STV of 410 generic E.    and risk
 coli per 100 mL.                  management
                                   determinations,
                                   with a
                                   requirement to
                                   test in certain
                                   circumstances.
Sec.   112.45(a): Immediately     None..............  Sec.   112.45(a).
 discontinue use (and take
 corrective measures prior to
 resuming use) if water is not
 safe or is not of adequate
 sanitary quality or if the
 microbial criterion of no
 detectable generic E. coli per
 100 mL is not met for certain
 uses of water.
Sec.   112.45(b): Implement risk- Removed pre-        Sec.   112.45(b).
 reduction measures as soon as     harvest microbial
 practicable but no later than     criteria and
 the following year if the GM      revised to
 and STV microbial criteria in     account for pre-
 Sec.   112.44(b) are not met      harvest
 for pre-harvest water uses for    agricultural
 non-sprout covered produce.       water
                                   assessments;
                                   expanded measures
                                   to include the
                                   flexibility to
                                   change the water
                                   application
                                   method to reduce
                                   the likelihood of
                                   contamination of
                                   covered produce
                                   or to use an
                                   alternative
                                   mitigation
                                   measure; added
                                   expedited timing
                                   for mitigation
                                   related to
                                   certain uses of
                                   adjacent and
                                   nearby lands.
Sec.   112.46(a): There is no     Added similar       Sec.   112.44(c)
 requirement to test if farms      exemptions from     for exemptions
 can demonstrate that water:       the requirements    from testing
 comes from a Public Water         for a written pre-  water for uses
 System that meets Safe Drinking   harvest             specified in Sec.
 Water Act regulations; comes      agricultural          112.44(a); Sec.
 from a public water supply that   water assessment.     112.43(b) for
 meets the microbial criterion                         exemptions from
 in Sec.   112.44(a); or is                            requirements for
 treated in accordance with Sec.                       pre-harvest
   112.43.                                             agricultural
                                                       water
                                                       assessments.

[[Page 37462]]

 
Sec.   112.46(b): For untreated   Replaced with       Sec.   112.43.
 surface water sources used for    provisions for
 pre-harvest applications for      pre-harvest
 non-sprout covered produce,       agricultural
 establish an initial MWQP with    water
 >=20 samples collected over 2-4   assessments, with
 years and update with >=5         a requirement to
 samples per year thereafter;      test in certain
 for untreated ground water        circumstances.
 sources, establish an initial
 MWQP with >=4 samples collected
 over 1 year and update with >=1
 sample per year thereafter.
Sec.   112.46(c): For untreated   None..............  Sec.   112.44(b).
 ground water used for certain
 uses in Sec.   112.44(a),
 initially test >=4 samples over
 the course of 1 year and >=1
 sample per year thereafter.
Sec.   112.47: Ensure that        None..............  Sec.   112.47.
 testing is done by the farm or
 other entity or third-party
 acting on its behalf, and that
 water samples be aseptically
 collected and tested using a
 method set forth in Sec.
 112.151.
Sec.   112.48: For water used     None..............  Sec.   112.44(d).
 during harvest, packing, and
 holding activities, ensure
 that: water is managed as
 necessary (such as by
 establishing and following
 water change schedules); water
 is visually monitored for
 buildup of organic material;
 and an appropriate temperature
 differential between the
 commodity and the water is
 maintained and monitored.
Sec.   112.49: For pre-harvest    Replaced with       Sec.
 water for non-sprout covered      provision           112.45(b)(1)(vi).
 produce, farms may establish      allowing for
 alternative microbial criteria,   alternative
 sampling frequencies for          mitigation
 untreated surface water           measures to those
 sources, or die-off rates         listed in Sec.
 between last direct water         112.45(b)(1)(i)
 application and harvest so long   through (v).
 as certain requirements are met.
Sec.   112.50: Maintain certain   Added               Sec.   112.50.
 records related to the farm's     recordkeeping
 agricultural water, including     requirements
 test results.                     related to pre-
                                   harvest
                                   agricultural
                                   water
                                   assessments;
                                   conforming
                                   changes to remove
                                   records related
                                   to microbial
                                   criteria and
                                   testing for pre-
                                   harvest
                                   agricultural
                                   water.
------------------------------------------------------------------------

2. Scientific and Public Health Support
    (Comment 10) Some comments express concern that FDA lacks 
scientific support for the proposed rule. Of these, some comments raise 
general concerns about the state of the science on pre-harvest 
agricultural water quality as a basis for rulemaking. Other comments 
focus on the science relating to specific requirements, such as the 
assessment of crop characteristics, environmental conditions, and 
potential impacts of cattle operations on adjacent and nearby land, as 
well as the application of a pre-harvest time interval as a mitigation 
measure. These include comments focused on how farms will implement the 
rule with an emphasis on the need for scientific research reflecting 
real-world conditions for farms in various circumstances.
    (Response 10) We disagree with the suggestion that the requirements 
for pre-harvest agricultural water assessments and risk-tiered outcomes 
lack scientific support. We address comments on the scientific support 
for specific provisions in relevant sections of this document. See, for 
example, comment 16 for discussion of comments of the scientific 
evidence on potential risks posed by cattle operations and other animal 
activities on adjacent and nearby lands. We address comments on the 
scientific support for crop characteristics and environmental 
conditions as assessment factors in comment 63 and comment 68, 
respectively. Comment 114 discusses comments on the scientific basis 
for the 4-day pre-harvest time interval as a mitigation measure.
    FDA outlined the history of contamination associated with produce, 
predominantly during growing, harvesting, packing, and holding, during 
the rulemaking to establish the 2015 produce safety final rule in part 
112. See, for example, 78 FR 3504 at 3507 and 80 FR 74354 at 74731. As 
part of that rulemaking, we also developed a peer-reviewed QAR, which 
provides a scientific evaluation of the potential adverse health 
effects resulting from human exposure to microbiological hazards in 
produce, including from contaminated water used in growing, harvesting, 
packing, and holding activities (Ref. 17). With respect to water used 
during growing, harvesting, and post-harvesting activities, the QAR 
concludes in part that agricultural water can be a source of 
contamination of produce and that the microbial quality of source 
waters, method of application, and timing of application are key 
determinants in assessing relative likelihood of contamination 
attributable to agricultural water use practices. The QAR also 
concludes that while different commodities may have different risk 
profiles at different stages of production, all commodities have the 
potential to become contaminated through one or more of the routes 
identified, especially if practices are poor and/or conditions are 
insanitary. See also 86 FR 69120 at 69128.
    Scientific information has also become available since FDA issued 
the 2015 produce safety final rule indicating potential limitations in 
basing risk management decisions on the previous pre-harvest 
agricultural water testing requirements. For example, various studies 
indicate a high degree of variability in generic E. coli levels in 
surface waters (Refs. 5-10), which can reduce the precision of 
estimation of the GM and STV of a water source (Refs. 1, 7). 
Additionally, a scientific evaluation of the 2015 pre-harvest 
agricultural water testing requirements found that the rolling data set 
of five samples per year used to update GM and STV values for untreated 
surface water sources results in highly uncertain results and delays in 
detecting shifts in water quality (Ref. 7). Specifically, Havelaar et 
al. found that the 20-sample MWQP for untreated surface water was not 
sufficient to reliably characterize the quality of the irrigation water 
with higher variability in generic E. coli levels than assumed in the 
2015 produce safety final rule. In simulation modeling, the rolling 20-
sample MWQP responded ``very slowly'' to shifts in water quality. 
Increases in generic E. coli levels were detected only after one to six 
sample sets, thus delaying signals of changes in water quality and (and 
any needed measures) by one to six years depending on the nature and 
magnitude of the shift. Havelaar et al. suggested that additional 
understanding of the processes that drive variability in the

[[Page 37463]]

quality of irrigation water sources might inform preventive or rapid 
corrective actions that have a larger impact on produce safety than the 
2015 pre-harvest agricultural water requirements.
    Moreover, we have extensively discussed other information that has 
become available since 2015, such as findings from several produce-
related outbreak investigations, that support this rulemaking. In 
particular, in the 2021 agricultural water proposed rule, we discussed: 
(1) the spring 2018 E. coli O157:H7 outbreak linked to romaine lettuce 
from the Yuma growing region (Refs. 18 and 19); (2) the fall 2018 E. 
coli O157:H7 outbreak linked to romaine lettuce from California (Ref. 
20); (3) the fall 2019 E. coli O157:H7 outbreaks linked to romaine 
lettuce (Ref. 21); (4) the fall 2020 E. coli O157:H7 outbreak linked to 
leafy greens (Ref. 22); and (5) the summer 2020 Salmonella Newport 
outbreak linked to red onions (Ref. 23); that highlight the importance 
of pre-harvest agricultural water quality and the potential impacts of 
adjacent and nearby land uses on agricultural water. These outbreak 
investigations underscore decades of scientific research demonstrating 
that pre-harvest agricultural water is a potential contributing factor 
in the introduction and spread of contamination to produce. 86 FR 69120 
at 69125-69127. We also discussed foodborne illness attribution data 
reported by IFSAC (Ref. 33), a triagency group created by the CDC, FDA, 
and the USDA Food Safety and Inspection Service, that reinforce the 
significance of biological hazards in produce. 86 FR 69120 at 69127. 
See also comment 13.
    Comments did not indicate what data or information they considered 
to be lacking or provide information that alters FDA's conclusions made 
in light of the information referenced above. As such, we have 
concluded that the scientific information available supports this 
rulemaking and are finalizing the requirements for pre-harvest 
agricultural water assessments for non-sprout covered produce. However, 
we recognize that additional information on the requirements for 
agricultural water in subpart E will help support farms as they work to 
come into compliance. We provide information on the agricultural water 
requirements throughout this final rule, and, to the extent that 
certain requirements are not substantively changing with this 
rulemaking (such as the requirements in Sec.  112.42 for agricultural 
water system inspection and maintenance), in the preamble to the 2015 
produce safety final rule. Additionally, we recognize the need to 
provide farms with education, outreach and technical assistance to 
facilitate compliance with the rule, and we intend to pursue various 
mechanisms, such as publishing guidance, holding webinars, and 
developing other educational resources, including work with other 
stakeholders (such as State agencies, educators, and extension agents), 
to do so.
    (Comment 11) Some comments express concern that FDA changed the 
pre-harvest microbial quality and testing requirements in the 2015 
produce safety final rule in response to industry concerns, rather than 
in an effort to improve public health.
    (Response 11) We are issuing this final rule having determined that 
it will enhance public health protections by setting forth requirements 
for comprehensive, systems-based agricultural water assessments 
evaluating a broad range of factors that may impact the quality of pre-
harvest agricultural water to assist farms in identifying and managing 
risks using appropriate corrective and mitigation measures, including 
expedited mitigation in certain circumstances. As discussed in the 
proposed rule, this comment response, and elsewhere in this rule, these 
revisions to the 2015 produce safety final rule reflect findings of our 
QAR (Ref. 17), new information we have gathered since publication of 
the 2015 produce safety final rule (including findings from several 
produce-related outbreaks), as well as information and feedback from an 
array of stakeholders, including the produce industry, educators, 
researchers, and regulators. As discussed in response to comment 1, we 
continue to conclude that the requirements for systems-based 
agricultural water assessments and risk-management determinations are 
consistent with our mandate to establish science-based minimum 
standards for the safe production and harvesting of produce to minimize 
the risk of serious adverse health consequences or death. As such, we 
disagree with comments suggesting that we are making these revisions to 
the 2015 produce safety final rule in response to industry concerns 
alone, and not in an effort to improve public health.
    As part of rulemaking for the 2015 produce safety final rule, we 
developed a peer-reviewed QAR (Ref. 17), which provides a scientific 
evaluation of the potential adverse health effects resulting from human 
exposure to microbiological hazards in produce, including from 
contaminated water used in growing, harvesting, packing, and holding 
activities (Ref. 17). In part, the QAR discusses that public drinking 
water is generally considered the least likely to serve as a source of 
contamination, followed by ground water, surface water protected from 
runoff, and surface water unprotected from runoff. The QAR also notes 
that where contamination in a water source is known to exist, the 
likelihood of contamination is a function of contact with the commodity 
(example, whether contact is indirect or direct); commodity effects 
(characteristics) (for example, whether the surface is conducive to 
adhesion); and application timing (for example, early or late in crop 
growth). These factors--the water source, method and timing of water 
application, and commodity characteristics--are all reflected in the 
requirements for comprehensive agricultural water assessments under 
Sec.  112.43(a) due to the impact they can have on risk associated with 
pre-harvest agricultural water use.
    Further, findings from investigations of several outbreaks linked 
to consumption of produce that have occurred since 2015 (Refs. 18-23) 
highlight the importance of pre-harvest agricultural water quality and 
the potential impacts of adjacent and nearby land uses on agricultural 
water. These outbreak investigations underscore decades of scientific 
research demonstrating that pre-harvest agricultural water is a 
potential contributing factor in the introduction and spread of 
contamination to produce. 86 FR 69120 at 69125-69127. Findings from our 
investigations into these outbreaks also informed the requirements that 
we are finalizing here--in particular, the requirement in Sec.  
112.43(c)(2) for expedited mitigation for conditions related to animal 
activity, BSAAOs, and untreated or partially treated human waste 
associated with adjacent and nearby lands.
    With respect to feedback from stakeholders in the regulated 
community, as described further in response to comment 14, we designed 
the requirements for pre-harvest agricultural water assessments, in 
part, by taking into account the realities of many agricultural 
operations that resulted in the 2015 pre-harvest agricultural water 
testing requirements being challenging, and in some cases, impossible, 
for farms to implement. For example, while the long-term MWQPs required 
in the 2015 produce safety final rule can be difficult, and even 
impossible, to establish for farms that grow rotational crops or on 
leased land, we have incorporated flexibility in the requirements for 
the once-annual assessments we are finalizing with this rule to allow 
farms to account for these realities, which will assist farms in better 
evaluating and making decisions

[[Page 37464]]

regarding the use of pre-harvest agricultural water as appropriate to 
their unique operations and circumstances.
    However, we emphasize that this rule is reflective of information 
and insights from stakeholders beyond just the regulated industry. For 
example, the pre-harvest agricultural water requirements were the focus 
of a 2-day Agricultural Water Summit, convened by the Produce Safety 
Alliance, in February 2018 (Ref. 4). The summit was attended by 
academics, produce industry, growers/grower associations, State 
agencies, Federal agencies, and supporting industries. During the 
summit, participants had many questions and concerns about water 
testing, what the information tells them about risks, and how to use 
that information to make water use management decisions. Participants 
also had questions about the generic E. coli-based standards in the 
2015 produce safety final rule and suggested that the testing frequency 
required to establish a MWQP for surface or ground water sources lacked 
the necessary science to support its relevance to public health 
outcomes. Many of the discussions at the summit addressed hazards in 
the growing environment, including examples of how risk assessment has 
been conducted in other fields of study, such as for drinking water and 
wastewater management. During the summit, participants identified 
``agricultural water assessments'' as a promising approach for managing 
water quality, suggesting that assessments may provide a more effective 
risk management strategy to farms than a numerical testing standard can 
provide.
    Additionally, information has become available since issuing the 
2015 produce safety final rule indicating potential limitations in 
basing risk management decisions on the previous pre-harvest 
agricultural water testing requirements. For example, various studies 
indicate a high degree of variability in generic E. coli levels in 
surface waters (Refs. 5-10), which can reduce the precision of 
estimation of the GM and STV of a water source (Refs. 1, 7). Other 
studies have further contributed to our knowledge about the limitations 
of generic E. coli as an indicator for pathogen presence (Refs. 11-16). 
Further, a scientific evaluation of the 2015 pre-harvest agricultural 
water testing requirements found that the rolling data set of five 
samples per year used to update GM and STV values for untreated surface 
water sources results in highly uncertain results and delays in 
detecting shifts in water quality (Ref. 7). Havelaar et al. suggested 
that while increasing the number of samples might address these issues, 
doing so would increase costs and would not be an effective or 
efficient way to control the microbial quality of agricultural water 
sources. Rather, they suggested, additional understanding of the 
processes that drive variability in the quality of irrigation water 
sources might inform preventive or rapid corrective actions that have a 
larger impact on produce safety than the 2015 pre-harvest agricultural 
water requirements (Ref. 7).
    While we established the 2015 pre-harvest agricultural water 
testing requirements as a long-term strategy to ensure that farms 
understand the quality of their water, pay attention to changes that 
may affect water quality, and make appropriate decisions about use of 
that water (80 FR 74354 at 74458), we recognize that if farms focus too 
heavily on results of microbial testing and whether quantitative 
metrics are met, they may be left with a false sense of security as to 
the quality of their water, and as a result, not investigate for 
conditions that may warrant further action to protect public health. 
Indeed, rather than relying on results of a multi-year rolling profile 
that might not always reflect a need for mitigation or elicit a timely 
reaction from farms to address potential hazards (Ref. 7), the approach 
we are finalizing here establishes requirements for measures that are 
directly responsive to the conditions identified as part of an 
assessment and requires that farms implement those measures within 
specific timeframes based on risk. Further, as our FRIA indicates (Ref. 
26), the increase in costs associated with this rule compared to the 
2015 pre-harvest agricultural water testing requirements is largely a 
result of more mitigation occurring in response to findings from pre-
harvest agricultural water assessments than as a result of the previous 
testing requirements. As also discussed in the FRIA, we estimate likely 
greater benefits under the requirements we are finalizing here, with 
more mitigation occurring in response to assessment findings than in 
response to the testing approach in the 2015 produce safety final rule.
    In light of the foregoing, we disagree with comments suggesting 
that we are replacing the previous pre-harvest agricultural water 
testing requirements with requirements for agricultural water 
assessments and risk-management determinations in response to industry 
concerns alone, and not in an effort to improve public health. We 
continue to consider it appropriate to pursue an alternative approach 
to the 2015 pre-harvest agricultural water testing requirements that 
protects public health and is adaptable for use in diverse 
circumstances. As such, with this rule, we are replacing the pre-
harvest agricultural water testing requirements in the 2015 produce 
safety rule for covered produce other than sprouts with requirements 
for systems-based agricultural water assessments that are designed to 
achieve improved public health protections, while also being more 
feasible to implement across the wide variety of agricultural water 
systems, uses, and practices, and adaptable to future advancements in 
agricultural water quality science.
3. Options for Regulatory Approach
    (Comment 12) A few comments suggest that issuing guidance would be 
a more appropriate approach to addressing pre-harvest agricultural 
water than rulemaking.
    (Response 12) As discussed in the 2021 agricultural water proposed 
rule, FDA considered various options to address stakeholder concerns 
about complexity and practical implementation challenges with the pre-
harvest agricultural water testing requirements in the 2015 produce 
safety final rule, one of which entailed developing additional guidance 
to support the requirements that were outlined in the 2015 produce 
safety final rule. We concluded that issuing additional guidance alone 
would not adequately address the practical implementation issues 
associated with the pre-harvest agricultural testing requirements in 
the 2015 produce safety final rule. For example, we contemplated 
issuing additional guidance to describe circumstances in which farms 
might satisfy the pre-harvest sampling and testing requirements through 
shared data with other farms. However, there are several limitations 
with this option, including challenges related to establishing data-
sharing arrangements and difficulties in establishing such programs 
given the diversity of agricultural water systems and the 2015 
requirements related to sample collection timing. Moreover, guidance 
alone could not overcome difficulties related to rotational crops or 
growing non-sprout covered produce on leased land, in which a farm may 
not be using (or have access to) the same water source over multiple 
years. See also response to comment 14. Further, while subpart P of the 
2015 produce safety final rule allows requests for variances from one 
or more requirements of part 112, under Sec.  112.171, only States, 
Federally recognized tribes, or countries from which food is imported 
into the

[[Page 37465]]

United States are able to make such a request. See 86 FR 69120 at 
69129.
    Comments received on the 2021 agricultural water proposed rule do 
not provide new information on overcoming these practical 
implementation challenges through the issuance of guidance alone. As 
such, we have concluded that guidance alone would not adequately 
address the practical implementation issues associated with the pre-
harvest agricultural testing requirements in the 2015 produce safety 
final rule.
    (Comment 13) Some comments state that FDA did not directly address 
why the option to conduct a risk assessment and research followed by 
rulemaking was not chosen, suggesting that the Agency moved forward 
with the proposed rule despite lacking sufficient information.
    (Response 13) As discussed in the 2021 agricultural water proposed 
rule, FDA considered whether to conduct another risk assessment, 
followed by a rulemaking to revise the pre-harvest agricultural water 
testing requirements. We also considered whether to issue guidance on 
pre-harvest agricultural water based on industry standards while 
additional research is conducted, followed by rulemaking to revise the 
pre-harvest agricultural water testing requirements. For the reasons 
discussed below, we continue to conclude that it is not necessary for 
additional risk assessment or research to take place before conducting 
or finalizing this rulemaking.
    As part of the rulemaking to establish the 2015 produce safety 
final rule in part 112, we developed a peer-reviewed QAR, which 
provides a scientific evaluation of the potential adverse health 
effects resulting from human exposure to microbiological hazards in 
produce, including from contaminated water used in growing, harvesting, 
packing, and holding activities (Ref. 17). In considering the option to 
conduct a risk assessment or additional research followed by a 
rulemaking to revise the pre-harvest agricultural water testing 
requirements, FDA reviewed the conclusions of the QAR. With respect to 
water used during growing, harvesting, and post-harvesting activities, 
the QAR concludes as follows:
     Agricultural water can be a source of contamination of 
produce.
     Public drinking water systems (domestically regulated by 
the EPA) have the lowest relative likelihood of contamination due to 
existing standards and routine analytical testing.
     Though less likely to be contaminated than surface water, 
ground water continues to pose a public health risk, despite the 
regulation of many U.S. public wells under the Ground Water Regulation.
     There is a significant likelihood that U.S. surface waters 
will contain human pathogens, and surface waters pose the highest 
potential for contamination and the greatest variability in quality of 
the agricultural water sources.
     Susceptibility to runoff significantly increases the 
variability of surface water quality.
     Water that is applied directly to the harvestable portion 
of the plant is more likely to contaminate produce than water applied 
by indirect methods that are not intended to, or not likely to, contact 
produce.
     Proximity of the harvestable portion of produce to water 
is a factor in the likelihood of contamination during indirect 
application.
     Timing of water application in produce production before 
consumption is an important factor in determining likelihood of 
contamination.
     Commodity type (growth characteristics, e.g., near to 
ground) and surface properties (e.g., porosity) affect the probability 
and degree of contamination.
     Microbial quality of source waters, method of application, 
and timing of application are key determinants in assessing relative 
likelihood of contamination attributable to agricultural water use 
practices.
    The QAR (Ref. 17) discusses that potential contributing factors 
cited in produce-associated outbreaks where water was identified as the 
likely source of contamination include runoff from nearby animal 
pastures and feed lots, raw sewage, and surface waters contaminated 
with feces (Ref. 36).
    We have also considered scientific information that has become 
available since issuing the 2015 produce safety final rule indicating 
potential limitations in basing risk management decisions on the 
previous pre-harvest agricultural water testing requirements. For 
example, various studies indicate a high degree of variability in 
generic E. coli levels in surface waters (Refs. 5-10), which can reduce 
the precision of estimation of the GM and STV of a water source (Refs. 
1, 7). Other studies have contributed to our knowledge about the 
limitations of generic E. coli as an indicator for pathogen presence 
(Refs. 11-16). Further, a scientific evaluation of the 2015 pre-harvest 
agricultural water testing requirements found that the rolling data set 
of five samples per year used to update GM and STV values for untreated 
surface water sources results in highly uncertain results and delays in 
detecting shifts in water quality (Ref. 7). Havelaar et al. suggested 
that additional understanding of the processes that drive variability 
in the quality of irrigation water sources might inform preventive or 
rapid corrective actions that have a larger impact on produce safety 
than the 2015 pre-harvest agricultural water requirements.
    In addition to the findings from the QAR and scientific information 
on the previous pre-harvest agricultural water testing requirements 
that has become available since 2015, we considered conclusions from 
the 2019 IFSAC report (Ref. 33), and more recently, the 2020 and 2021 
IFSAC report (Refs. 34 and 35, respectively), which reinforce the 
significance of biological hazards in produce. We also considered FDA's 
experience with investigations of produce-related outbreaks that 
occurred since we issued the 2015 produce safety final rule (Refs. 18-
23), which underscore the importance of pre-harvest agricultural water 
quality and highlight the potential impacts of adjacent and nearby land 
uses on agricultural water, which can serve as a route of contamination 
of produce. 86 FR 69120 at 69125-69127. These sources of information 
helped to inform the requirements we are finalizing here--in 
particular, the requirement for expedited mitigation for known or 
reasonably foreseeable hazards related to certain activities associated 
with adjacent or nearby lands in light of findings from several produce 
outbreak investigations--and further support the conclusions of our QAR 
(Ref. 17). See also response to comment 10.
    Commenters did not indicate what data or information they felt was 
lacking regarding the option to conduct an additional risk assessment, 
nor did they provide information demonstrating that our conclusions in 
the proposed rule regarding that option were inappropriate. Therefore, 
we continue to conclude that it is not necessary for FDA to conduct an 
additional risk assessment or research before conducting rulemaking to 
establish new pre-harvest agricultural water standards. Further, given 
that the requirements for assessments are well-grounded in science, we 
do not consider it necessary to establish interim guidance based on 
industry standards in lieu of the requirements we are finalizing here.
    While we do not consider it necessary to conduct additional risk 
assessment or research in order to establish standards for pre-harvest 
agricultural water, we note that the requirements for agricultural 
water assessments are designed, in part, to be adaptable to scientific 
advancements. To the extent

[[Page 37466]]

that risk assessment and/or additional research related to pre-harvest 
agricultural water may continue to develop in the future, farms may use 
such information as an additional resource to further inform their 
agricultural water assessments under the approach we are finalizing 
here.
    (Comment 14) A few comments express a preference for pre-harvest 
agricultural water testing requirements in the 2015 produce safety 
final rule compared to the proposed pre-harvest agricultural water 
assessments because, the comments suggest, many farms have already 
worked towards compliance with the 2015 testing requirements.
    (Response 14) We understand that not all farms may have faced 
challenges with the pre-harvest microbial quality and testing 
requirements in the 2015 produce safety final rule. However, in light 
of frequent, consistent feedback from industry stakeholders regarding 
challenges associated with the pre-harvest microbial quality and 
testing requirements, as well as information and insights from other 
relevant stakeholders (such as academic researchers), findings of our 
QAR (Ref. 17), and new information gathered since publication of the 
2015 produce safety final rule, we concluded that the most appropriate 
regulatory approach is to undertake rulemaking. See 86 FR 69120 at 
69129-69130. As discussed further in response to comment 10, we 
continue to consider it appropriate to pursue and finalize an 
alternative approach that is adaptable for use in diverse 
circumstances. Thus, we are finalizing requirements for pre-harvest 
agricultural water assessments that are designed to achieve improved 
public health protections, while also being more feasible to implement 
across the wide variety of agricultural water systems, uses, and 
practices, and adaptable to future advancements in agricultural water 
quality science. We designed the requirements for pre-harvest 
agricultural water assessments to be flexible to account for the 
diversity of water systems, commodities, and operations that exist 
across industry, which included, as discussed below, taking into 
account the realities of many agricultural operations that resulted in 
the 2015 pre-harvest agricultural water testing requirements being 
challenging, and in some cases, impossible, for farms to implement.
    For example, feedback on the 2015 pre-harvest agricultural water 
testing requirements indicated that long-term MWQPs can be difficult, 
and even impossible, to establish for farms that grow rotational crops 
or on leased land, both of which are widespread throughout the produce 
industry (Refs. 3 and 4). It has further been suggested that the 
financial investment needed to develop a long-term profile for a water 
source that is only used every few years may not result in commensurate 
food safety benefits (Ref. 4). Conversely, the requirements for once-
annual assessments that we are finalizing here incorporate flexibility 
to allow farms to account for these realities. Such flexibility will 
assist farms in better evaluating and making decisions regarding the 
use of pre-harvest agricultural water as appropriate to their unique 
operations and circumstances, allowing risk-management decisions to be 
made even in the absence of historical knowledge of a water system. See 
also comment 35.
    Farms with multiple water sources, for example, would face 
significant logistical challenges in complying with the 2015 testing 
requirements, since separate MWQPs would be required for each source 
(Ref. 4). These challenges would be particularly difficult to navigate 
for farms that grow multiple types of covered produce using different 
water application timings, given the 2015 requirements for samples to 
be representative of use and collected as close in time as practicable 
to, but prior to, harvest. As discussed further in response to comment 
34, while we acknowledge that farms using multiple agricultural water 
systems during pre-harvest activities for covered produce (other than 
sprouts) will need to conduct an assessment for each system, several of 
the factors evaluated in the assessment might be similar across 
agricultural water systems, thus limiting the amount of information a 
farm needs to collect and consider. Further, the pre-harvest 
agricultural water assessments enable farms to focus on the key 
determinants of contamination risks, without doing so in a way that 
will add significant burden to stakeholders.
    Additionally, while data-sharing is one way that implementation 
challenges associated with 2015 pre-harvest agricultural water testing 
requirements may have been reduced, such data-sharing programs among 
multiple parties could be difficult (or impossible) to establish due to 
the aforementioned 2015 requirements for samples to be representative 
of use and collected close to harvest (Refs. 3 and 4). Conversely, the 
requirements for pre-harvest agricultural water assessments were built 
to be flexible enough for farms to consider and adjust for their unique 
circumstances without having to rely on others' actions in order to 
make use of the inherent flexibility. Moreover, because farms that test 
their water in accordance with Sec.  112.43(c)(4)(ii) will be testing 
to better understand a narrow set of circumstances using an approach 
that incorporates greater flexibility related to sample collection 
requirements, concerns about testing burden associated with the 2015 
pre-harvest agricultural water testing requirements are largely 
addressed with this rule.
    Thus, although we recognize that some farms may not have faced 
practical implementation challenges with the 2015 pre-harvest 
agricultural water testing requirements, we continue to conclude that 
the requirements for pre-harvest agricultural water assessments achieve 
public health protections, while also being more feasible to implement 
across the diversity of farms and their agricultural water systems, 
uses, and practices. To the extent that some farms may be testing their 
pre-harvest agricultural water using the 2015 (or other) approach, we 
emphasize that nothing in this rule precludes them from continuing to 
do so, as long as they also comply with the requirements we are 
finalizing here, as applicable.
4. Responsibility
    (Comment 15) Some comments, while generally supportive of the 
proposed pre-harvest agricultural water assessments, voice concern that 
farms will be required to account for and manage hazards that are 
outside the farm's control (for example, hazards that may be introduced 
by other water users or adjacent and nearby land uses). Some comments 
indicate that the Clean Water Act (CWA) requires State and/or Federal 
governments to hold polluters accountable, suggesting that it is 
therefore unjust to place that responsibility on farms. One comment 
suggests that irrigation districts should not allow livestock to graze 
in open drains, as doing so will introduce risk for downstream users 
who do not have control over that activity.
    (Response 15) We recognize that farms may have little or no control 
over factors such as weather events, other water users, and adjacent 
and nearby lands. However, considering factors such as these, which may 
affect the quality of water source(s) even though they are not 
necessarily under a farm's control, is an important part of evaluating 
whether a farm's water source(s) meets the requirement in Sec.  112.41 
that agricultural water must be safe and of adequate sanitary quality 
for its intended use. Considering these factors under Sec.  112.43(a), 
will help farms determine the appropriate and safe use of the 
agricultural water from their water source(s).

[[Page 37467]]

    Further, we recognize that the CWA (33 U.S.C. 1251 et seq.) 
establishes the basic structure for regulating discharges of pollutants 
into the waters of the United States and regulating quality standards 
for surface waters (Ref. 37). Under the CWA, the EPA has implemented 
pollution control programs and developed national water quality 
criteria recommendations for pollutants in surface waters. We recognize 
that hazards may be introduced into an agricultural water system under 
conditions that may or may not be covered by the CWA and that in many 
instances, this may occur before an agricultural water system comes 
under a farm's control. We emphasize that farms are not required to 
mitigate such hazards at the location where they originate, nor are 
farms expected to take action against other entities that may be 
introducing contaminants into a water system. Rather, farms are 
required to assess potential impacts from activities on nearby and 
adjacent lands and/or other water users on the quality of their 
agricultural water and, as appropriate, implement measures that are 
under the farm's control to reduce the risk associated with that water 
source or system to protect public health. For example, depending on 
the circumstances, this might entail the use of earthen berms on land 
that is under the farm's control to divert runoff from a nearby land 
use from entering the farm's surface water source. See also response to 
comment 105.
    Additionally, we recognize the need to provide farms with outreach 
and education to facilitate compliance with the rule, including in 
those situations where hazards may originate outside of a farm's 
control. We are also aware of efforts underway to bring together 
members of agricultural communities on a large scale to further 
conversations and encourage discussions between land users in 
agricultural areas. For example, the California Agricultural Neighbors 
(CAN) Initiative is designed to provide an opportunity to foster 
collaboration and discuss enhanced neighborly food safety practices 
when various agricultural operations such as leafy green fields, cattle 
ranches, vineyards and compost sites are adjacent to one another (Ref. 
38). Various action items have been identified as part of CAN, one of 
which entails steps that can be taken to foster neighbor-to-neighbor 
interactions and conversations (Ref. 39). See also response to comment 
33. As efforts such as these progress, farms may consider participating 
as an additional means to help address crosscutting food safety issues.
    (Comment 16) Some comments suggest that cattle producers will be 
negatively impacted by the requirement that farms assess the use of 
nearby and adjacent land. These comments suggest that the proposed rule 
implies that adjacent or nearby cattle operations increase food safety 
risks for produce farms without sufficient scientific justification. 
Comments also request clarification that cattle operations are not 
required to change practices in order to assist produce farms in 
complying with the rule.
    (Response 16) As discussed in the 2021 agricultural water proposed 
rule (86 FR 69120 at 69135-69136), it is well established in the 
literature that animal activities on adjacent and nearby lands--
including grazing, livestock operations, and wildlife intrusion--may 
introduce contamination to surface and ground water through runoff and 
through direct access by animals to waterways (Refs. 40-43). Moreover, 
we discussed in the proposed rule various produce related outbreaks 
(Refs. 18-22) in which investigators noted presence of concentrated 
animal feeding operations (CAFOs) or cattle grazing operations as 
potential sources of contamination to agricultural water systems and 
covered produce. See 86 FR 69120 at 69125-69127. In light of this 
information and findings from several produce related outbreaks, we 
consider it important for farms to evaluate animal impacts and 
activities in identifying conditions that are reasonably likely to 
introduce known or reasonably foreseeable hazards into or onto covered 
produce (other than sprouts) or food contact surfaces as part of their 
agricultural water assessments.
    We acknowledge the longstanding colocation of animals and plant 
food production systems in agriculture and note that this rule does not 
prohibit the presence of animals on or near a farm, nor does it 
establish requirements or responsibilities for entities other than 
farms covered by the rule. Rather, the rule requires a farm to conduct 
an agricultural water assessment for hazard identification purposes and 
take any measures that are reasonably necessary to reduce the potential 
for contamination of non-sprout covered produce or food contact 
surfaces with known or reasonably foreseeable hazards associated with 
its pre-harvest agricultural water. This may involve, for example, the 
farm implementing measures that are within its control, such as 
changing the method of water application under Sec.  112.45(b) to 
reduce the likelihood of contamination of the covered produce.
5. Other Food Safety Standards
    (Comment 17) Several comments note that many farms are already 
subject to third-party water quality standards that some produce farms 
follow. Comments seek clarity on whether the proposed rule aligns with 
these standards and, if some third-party standards are more stringent 
than FDA's regulation, whether an audit to those standards could be 
used to meet the rule's requirements.
    (Response 17) We acknowledge the important role third-party 
standards may play in ensuring food safety and questions about 
alignment of FDA's produce safety rule requirements and third-party 
standards. For example, in 2018, FDA and USDA announced the alignment 
of the USDA Harmonized Good Agricultural Practices Audit Program (USDA 
H-GAP) with the requirements in the 2015 produce safety final rule 
(Ref. 44), which preceded both the 2021 agricultural water proposed 
rule and this final rule. In the announcement, we explained that while 
the requirements of both programs are not identical, the relevant 
technical components in the 2015 produce safety final rule are covered 
in the USDA H-GAP Audit Program. We also explained that the alignment 
will help farms by enabling them to assess their food safety practices 
as they prepare to comply with the produce safety rule. However, we 
also noted that USDA audits are not a substitute for FDA or state 
regulatory inspections.
    In October 2023, FDA announced the final results of a voluntary 
pilot program on alignment of private third-party food safety audit 
standards with applicable FDA regulations (Ref. 45). It included a 
third-party primary production standard for non-sprout produce that we 
found to be in alignment with applicable provisions of the produce 
safety regulation--except for the subpart E agricultural water 
requirements that were excluded from the review as they were under 
reconsideration through this rulemaking. Our conclusion from the pilot 
is that FDA currently does not have adequate resources to review and 
evaluate the alignment of third-party food safety standards beyond the 
pilot--notwithstanding the value that such standards may have in 
facilitating industry's implementation of FSMA and the potential of 
these audits to inform risk prioritization. FDA will continue to assess 
future opportunities but is unable to undertake any additional 
alignment reviews at this time, including review of third-party 
standards for pre-harvest

[[Page 37468]]

agricultural water for non-sprout produce.
    Finally, as a general matter, a determination of alignment alone 
does not indicate that a farm audited to that standard is necessarily 
in compliance with the 2015 produce safety final rule. While a 
determination of alignment may help farms as they prepare to comply 
with requirements in the 2015 produce safety final rule, as discussed 
above, audits conducted under third-party standards found to be in 
alignment are not a substitute for FDA or State regulatory inspections.
    (Comment 18) Some comments seek clarity on whether the proposed 
approach for pre-harvest agricultural water assessments is intended to 
be similar to a HACCP approach.
    (Response 18) As discussed in response to comment 1, the annual 
pre-harvest agricultural water assessments employ a prevention-oriented 
quality-systems approach to food safety regulation that FDA has long 
used for the highly diverse food industry that FDA regulates. For 
example, FDA's juice HACCP regulation (21 CFR part 120), seafood HACCP 
regulation (21 CFR part 123), and Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food 
regulation (21 CFR part 117), establish frameworks under which industry 
qualitatively assesses, and as necessary, controls, potential hazards 
as appropriate to their operations. While we believe that a HACCP 
approach--particularly at the level required in parts 120, 123, and 
117--would not necessarily be appropriate at the farm level (80 FR 
74354 at 74379), many of the principles of HACCP can still be applied, 
such as an assessment of risk and the development of a food safety plan 
based on that assessment, and we have incorporated elements such as 
these within the requirements for pre-harvest agricultural water 
assessments in Sec.  112.43.
6. Other Comments
    (Comment 19) A few comments note the phrasing in the proposed rule 
that assessments are designed to be ``adaptable to future advancements 
in agricultural water quality science'' and express concerns that this 
language implies that FDA will make significant implementation 
decisions in the future without public discussion and input. A few 
comments seek clarity on whether and how emerging science or additional 
information relevant to agricultural water assessments will be 
incorporated into trainings.
    (Response 19) We acknowledge that water quality science is expected 
to evolve over time, and we have designed the rule to achieve improved 
public health protections, while also being feasible to implement 
across the wide variety of agricultural water systems, uses, and 
practices, and adaptable to future scientific advancements. For 
example, we discuss in response to comment 115 that as more studies are 
conducted that examine in-field die-off for various circumstances (for 
example, different regions, environmental conditions, commodities, 
pathogens, and crop growth characteristics) (Refs. 46-49), farms may 
use that information to inform a time interval between last direct 
water application and harvest under Sec.  112.45(b)(1)(ii). We 
anticipate that as new information becomes available, it will be shared 
with farms and other interested stakeholders through various 
mechanisms, including guidance in accordance with our good guidance 
practices regulation, 21 CFR 10.115, which generally provides an 
opportunity for public comment before a guidance document is finalized.
    Additionally, new information and scientific advancements will 
likely be incorporated into training programs and other education and 
outreach materials in order to increase awareness by farms. For 
example, we are aware that food safety trainings intended to be 
specific to certain commodities (or commodity groups) have been held, 
which could be a mechanism in the future by which information relevant 
to specific commodities will be shared. We are also aware of research 
organizations and universities that prioritize sharing their findings 
with the produce industry and related stakeholders. We also expect that 
as new science relates to region-specific considerations, local 
extension agents will play an important role in disseminating that 
information to interested parties.
    (Comment 20) A few comments express concerns that the rule will 
result in farms increasing their reliance on ground water sources, 
which could be in conflict with the goals of certain state laws 
designed to help protect ground water resources. For example, some 
comments suggest that the exemption from the requirements to prepare an 
agricultural water assessment in proposed Sec.  112.43(b)(1) related to 
untreated ground water will incentivize farms to make greater use of 
already-stressed resources. Several comments suggest that changing from 
surface water to ground water as a way to reduce risk associated with 
agricultural water may be difficult for some farms due to existing 
conservation laws.
    (Response 20) We are not requiring farms to change their water 
sources, either for the purposes of an exemption from the requirements 
to prepare a pre-harvest agricultural water assessment or as a 
mitigation measure. Rather, we have incorporated flexibility to provide 
farms viable options to reduce the potential for contamination of non-
sprout covered produce or food contact surfaces with known or 
reasonably foreseeable hazards associated with pre-harvest agricultural 
water without needing to alter the source of agricultural water. See 
also response to comment 124.
    In the Environmental Impact Statement (EIS) that was prepared 
during rulemaking for the 2015 produce safety final rule (Ref. 50), we 
discussed that, based on our qualitative analysis, we did not consider 
impacts to water resources to be significant, with the potential 
exception related to ground water withdrawal, where existing 
significant adverse long-term impacts (i.e., water drawdown, potential 
subsidence, and the related continued degradation of water quality) may 
continue to be exacerbated as a result of excessive ground water use.
    We also noted that we did not anticipate that the approach taken 
for pre-harvest agricultural water in the 2015 produce safety final 
rule (i.e., microbial criteria consisting of a GM and STV, with various 
actions a farm may take if the GM and/or STV are exceeded) would result 
in farms on a regional or national scale switching to ground water 
sources. For example, stakeholder feedback indicated that allowing for 
microbial die-off between last irrigation and harvest and/or microbial 
reduction or removal resulting from post-harvest practices provides 
farms viable options to meet the microbial quality criteria without 
needing to, for example, treat water or switch to a ground water source 
(Ref. 50).
    Under this rule, those mitigation measures remain available as 
options. Further, with this rule we are incorporating additional 
mitigation measures beyond those in the 2015 produce safety final rule 
to provide farms with even more flexibility in ways to manage risks 
associated with pre-harvest agricultural water. (Specifically, this 
rule adds mitigation measures for changing the method of water 
application or taking an alternative mitigation measure in accordance 
with Sec.  112.45(b)(1)(iv) and (vi), respectively.). We have provided 
various options for mitigation measures encompassing a range of 
possible costs (see the FRIA (Ref. 26)) to provide farms with

[[Page 37469]]

flexibility in managing risks associated with their agricultural water 
as appropriate to their agricultural water systems, water use 
practices, and unique circumstances. Given the various options farms 
have under this rule, including options that involve more targeted 
changes (such as making necessary repairs to agricultural water 
systems), we do not expect farms to preferentially alter the source of 
their agricultural water as a mitigation measure or for the purposes of 
an exemption from the requirements to prepare a pre-harvest 
agricultural water assessment.
    As discussed in the Agency's finding of no significant impact for 
the current rulemaking and the evidence supporting that finding (Refs. 
51-53), the potential number of farms that could switch to ground 
water, potentially exacerbating drawdown, would be reduced compared 
with the 2015 produce safety final rule with the revisions to the 
subpart E provisions we are finalizing here (Ref. 50). No significant 
adverse environmental impacts have been identified with this rule. See 
also section VIII.
    (Comment 21) FDA received several comments related to conservation 
practices and environmental protection programs, which generally appear 
to be out of scope. Specifically, commenters urge FDA to encourage the 
co-management of food safety, conservation, and environmental 
protection. A few comments request that guidance and training on the 
rule for covered farms and inspectors acknowledge that animals and 
covered farms can co-exist, noting that this is especially important 
when it comes to conservation practices and/or diversified farms. In 
addition, one comment discusses state programs providing incentives for 
farmers to implement climate and environmentally friendly agricultural 
practices, such as use of energy-efficient irrigation systems, healthy 
soil practices (such as compost application), and establishment of 
seasonal and/or permanent vegetation for pollinators and wildlife. The 
comment expresses concern that farms may not participate in such 
environmental stewardship programs if doing so might be in conflict 
with the proposed requirements for pre-harvest agricultural water 
assessments. Further, comments recommend that FDA work with 
stakeholders to develop solutions that will help farmers co-manage such 
environmental sustainability goals with food safety.
    (Response 21) As indicated, FDA considers these comments to 
generally be outside the scope of this rulemaking. However, to the 
extent they are in scope, FDA acknowledges the longstanding co-location 
of animals and plant food production systems in agriculture. 80 FR 
74354 at 74482. As discussed in the 2021 agricultural water proposed 
rule, this rule does not prohibit the presence of animals (such as 
grazing animals or working animals) on a farm, nor does it require the 
destruction of wildlife habitat or the clearing of farm borders. 
Rather, the rule requires farms to evaluate and take measures to 
prevent the introduction of known or reasonably foreseeable hazards 
into or onto non-sprout covered produce or food contact surfaces by 
pre-harvest agricultural water. 86 FR 69120 at 69135.
    Additionally, as discussed in the 2015 produce safety final rule, 
we continue to encourage the co-management of food safety, 
conservation, and environmental protection. We consider it important to 
take into account the environmental practice standards and policies of 
other agencies in the context of food safety. 80 FR 74354 at 74365. We 
believe that the provisions of part 112 are consistent with existing 
conservation and environmental practice standards and policies and are 
not in conflict with Federal or State programs. In addition, Sec.  
112.84, which we did not propose to change, codifies a statement that 
the requirements of part 112 do not require or permit the use of 
practices in violation of the Endangered Species Act (16 U.S.C. 1531-
1544), and that the regulation does not require the use of practices 
that may adversely affect wildlife, such as removal of habitat or wild 
animals from land adjacent to produce fields. 80 FR 74354 at 74365.

C. Definitions (Sec.  112.3)

    We proposed to add two new definitions for ``agricultural water 
assessment'' and ``agricultural water system'' in Sec.  112.3 to 
provide clarity for terminology used in the proposed requirements for 
pre-harvest agricultural water assessments. We received several 
comments on those proposed definitions and respond to comments about 
these definitions in the following paragraphs. We are finalizing the 
definitions for ``agricultural water assessment'' and ``agricultural 
water system'' as proposed, without changes.
1. Agricultural Water Assessment
    (Comment 22) Several comments express support for the definition of 
``agricultural water assessment,'' noting that the assessment, as 
defined, provides broad, science-based flexibility so as to be 
applicable to a wide variety of growing scenarios. One comment suggests 
the definition be revised to include an assessment of the severity of 
illness and injury from the hazard and the probability that the hazard 
will occur. Another comment recommends that FDA clarify in its 
definition of ``Agricultural Water Assessment'' that the assessment 
must be in written form.
    (Response 22) We considered these comments, and as discussed below, 
are finalizing the definition of ``agricultural water assessment'' as 
proposed, without changes. An ``agricultural water assessment'' means 
an evaluation of an agricultural water system, agricultural water 
practices, crop characteristics, environmental conditions, and other 
relevant factors (including test results, where appropriate) related to 
growing activities for covered produce (other than sprouts) to: (1) 
identify any condition(s) that are reasonably likely to introduce known 
or reasonably foreseeable hazards into or onto covered produce or food 
contact surfaces and (2) determine whether measures are reasonably 
necessary to reduce the potential for contamination of covered produce 
or food contact surfaces with such known or reasonably foreseeable 
hazards (Sec.  112.3).
    With respect to comments suggesting the definition be revised to 
capture the severity of illness and injury from the hazard and the 
probability that the hazard will occur, we note that as discussed in 
response to comment 27 and comment 76, the requirements for 
agricultural water assessments provide a mechanism through which farms 
evaluate the risk associated with their pre-harvest agricultural water 
and use that information to determine whether measures are reasonably 
necessary to reduce the potential for contamination of non-sprout 
covered produce or food contact surfaces with known or reasonably 
foreseeable hazards associated with pre-harvest agricultural water. See 
also comment 18, where we discuss comments related to HACCP. As such, 
we do not consider this a necessary change to make. In response to 
comments suggesting that the definition of ``agricultural water 
assessment'' be revised to clarify that the assessment must be in 
written form, we note that Sec.  112.43(a) already specifies that farms 
``must prepare a written agricultural water assessment'' and that Sec.  
112.50(b)(2) requires farms to maintain a record of that agricultural 
water assessment. Therefore, we also do not consider this a necessary 
change to make. As such, we are finalizing the definition of 
``agricultural water assessment'' as proposed, without changes.

[[Page 37470]]

2. Agricultural Water System
    (Comment 23) Several comments support the proposed definition of 
``agricultural water system,'' suggesting that the proposed definition 
helps provide clarity. In reference to farms that draw agricultural 
water from systems that span long distances (such as canals), a few 
comments suggest that the definition of ``agricultural water system'' 
be revised to better account for the point at which the water comes 
under the farm's control.
    (Response 23) We reviewed comments for the proposed definition of 
``agricultural water system'' and agree that it will provide 
stakeholders with additional clarity that will be helpful, for example, 
to farms in determining the scope of where and what to inspect and 
maintain under Sec.  112.42 and for those farms required to conduct a 
pre-harvest agricultural water assessment pursuant to Sec.  112.43.
    With respect to the comment requesting we revise the definition of 
``agricultural water system'' to provide limitations regarding the 
point at which the water comes under a farm's control, we note that 
certain factors over which a farm may have little or no control (such 
as water users upstream of a farm), will likely influence the 
identification or characterization of potential hazards associated with 
the farm's agricultural water system(s). See also comment 15. As such 
factors are important to consider in meeting relevant requirements that 
apply for agricultural water systems (such as those in Sec.  112.42 for 
inspections and maintenance of agricultural water systems and Sec.  
112.43 for pre-harvest agricultural water assessments), we decline to 
revise the definition of ``agricultural water system'' as requested by 
the comment. We also note that Sec.  112.42 requires farms, in part, to 
inspect and maintain agricultural water systems to the extent they are 
under the farm's control (emphasis added) to identify any conditions 
that are reasonably likely to introduce known or reasonably foreseeable 
hazards into or onto covered produce or food contact surfaces and 
prevent the systems from being a source of contamination to covered 
produce, food contact surfaces, or areas used for a covered activity. 
As such, we are finalizing the definition for ``agricultural water 
system'' as proposed, without changes, to mean a source of agricultural 
water, the water distribution system, any building or structure that is 
part of the water distribution system (such as a well house, pump 
station, or shed), and any equipment used for application of 
agricultural water to covered produce during growing, harvesting, 
packing, or holding activities (Sec.  112.3).
    We also anticipate that the configuration of agricultural water 
systems will vary from operation to operation, depending on individual 
water sources, the type of distribution system (including whether a 
building or structure is a component), and the type of equipment used 
to apply agricultural water. Related to our definition of 
``agricultural water system'' is our definition of ``water distribution 
system,'' which means a system to carry water from its primary source 
to its point of use, including pipes, sprinklers, irrigation canals, 
pumps, valves, storage tanks, reservoirs, meters, and fittings (Sec.  
112.3).

D. General Comments Regarding Pre-Harvest Agricultural Water 
Assessments (Sec.  112.43)

    In the 2021 agricultural water proposed rule, we proposed to 
require farms to prepare systems-based agricultural water assessments 
for pre-harvest agricultural water for non-sprout covered produce 
(proposed Sec.  112.43). We proposed that the assessments would be 
conducted annually (and more frequently as needed), documented in 
writing, and used for hazard identification and risk management 
decision-making purposes. We respond to comments of a general nature 
regarding the requirement for farms to prepare an agricultural water 
assessment in the following paragraphs. As discussed below, in response 
to comments received, we are revising Sec.  112.43(a) to clarify that 
agricultural water assessments must be prepared at the beginning of the 
growing season, as appropriate, but at least once annually. Comments on 
exemptions from the requirement to prepare an agricultural water 
assessment, the factors that farms must evaluate as part of an 
agricultural water assessment, and outcomes of an agricultural water 
assessment are discussed in sections V.E., V.F., and V.G., 
respectively.
    (Comment 24) Several comments request greater specificity on when 
farms should conduct their annual agricultural water assessment (for 
example, prior to planting, prior to harvest, between planting and 
harvest, or prior to water use). Some comments request clarity on how 
frequently FDA expects farms to determine the likelihood of any given 
hazard (for example, at least annually). Other comments suggest that 
farms should be required to prepare an agricultural water assessment at 
least annually, with an additional assessment within a week prior to 
harvest.
    (Response 24) We anticipate that preparing an annual agricultural 
water assessment towards the beginning of the growing season may be of 
benefit for farms, as doing so may allow for early identification of 
conditions for which measures under Sec.  112.45 may be reasonably 
necessary. (See, for example, Sec.  112.43(c)(2), which outlines 
circumstances in which mitigation measures must be implemented 
promptly, and not later than the same growing season as the 
assessment.) However, we recognize that flexibility is needed to 
account for certain situations, such as for crops that have year-round 
growing seasons, and for farms that may have multiple crops with year-
round or staggered growing seasons throughout the year. As such, to 
provide additional clarity, we are revising Sec.  112.43(a) to require 
farms to prepare an agricultural water assessment ``at the beginning of 
the growing season, as appropriate, but at least once annually.'' We 
note that this change aligns with the requirement in Sec.  112.42(a) 
for timing of agricultural water system inspections, which we did not 
propose to revise. See 80 FR 74354 at 74433.
    Recognizing that farms may be more likely to prepare their 
agricultural water assessments towards the beginning of their growing 
season in light of this clarification, we also considered whether it 
would be warranted to require farms to conduct a reassessment close to 
harvest to reflect different practices and operations than might exist 
earlier in the growing season (such as during planting). However, we do 
not consider it necessary for farms to prepare an additional assessment 
close to harvest, as farms are already required to account for harvest 
conditions within their initial agricultural water assessments. (For 
example, the requirement in Sec.  112.43(a)(2) for farms to evaluate 
the time interval between the last direct application of agricultural 
water and harvest of the covered produce indicates that farms must 
consider conditions that are close to harvest as part of their 
assessments.) However, we emphasize that a farm must conduct a 
reassessment whenever a significant change occurs in the farm's 
agricultural water system, water use practices, crop characteristics, 
environmental conditions, or other relevant factors that make it 
reasonably likely that a known or reasonably foreseeable hazard will be 
introduced into or onto covered produce (other than sprouts) or food 
contact surfaces. A reassessment conducted under Sec.  112.43(e) due to 
a significant change

[[Page 37471]]

must evaluate any factors and conditions affected by the change.
    (Comment 25) Some comments seek clarity on the relationship between 
inspections, maintenance, and pre-harvest agricultural water 
assessments in proposed Sec. Sec.  112.42(a), 112.42(b), and 112.43, 
respectively. A few comments ask whether conducting an agricultural 
water system inspection would eliminate the need for an agricultural 
water assessment and vice versa. One comment requests clarification as 
to whether the intent is for inspections to inform assessments, which 
in turn, inform maintenance activities such as monitoring--and if so, 
requests that FDA clarify as such by reordering the sequence of those 
requirements to reflect that intent. Another comment suggests that FDA 
limit the scope of the inspection and maintenance requirements to water 
system components that are under the ownership, management, or 
contractual oversight of the operator to help clarify the differences 
in expectations between inspections and maintenance under Sec.  112.42 
and agricultural water assessments under Sec.  112.43, the latter of 
which are intended to be more comprehensive in nature.
    (Response 25) We agree that there are differences between the 
requirements in Sec.  112.42 for inspection and maintenance of 
agricultural water systems used for all covered activities and the 
requirements we are finalizing in Sec.  112.43 for pre-harvest 
agricultural water assessments for covered produce other than sprouts.
    As discussed in the 2021 agricultural water proposed rule (86 FR 
69120 at 69133-69134), the requirements for pre-harvest agricultural 
water assessments in Sec.  112.43 supplement the requirements for 
inspection and maintenance of agricultural water systems in Sec.  
112.42, the latter of which requires a farm to regularly inspect and 
routinely maintain the components of its agricultural water systems, to 
the extent that such components or systems are under its control. While 
Sec.  112.42 entails inspecting and maintaining components of an 
agricultural water system to the extent that they are under the farm's 
control, and applies for all uses of agricultural water (not just water 
used for pre-harvest activities), Sec.  112.43(a) requires farms to 
conduct a more comprehensive assessment of possible sources and routes 
by which known or reasonably foreseeable hazards are reasonably likely 
to be introduced into its pre-harvest agricultural water for non-sprout 
covered produce. Additionally, farms are required to establish records 
of the findings of their inspections under Sec.  112.42 (Sec.  
112.50(b)(1)), whereas they are required to establish more 
comprehensive records of their written agricultural water assessments, 
including the descriptions of factors evaluated and written 
determinations, in accordance with Sec.  112.43 (Sec.  112.50(b)(2)). 
Moreover, unlike the inspection and maintenance requirements in Sec.  
112.42, findings from a farm's agricultural water assessment are 
directly tied to implementation of corrective or mitigation measures, 
as described in Sec.  112.43(c).
    While results of inspections and maintenance under Sec.  112.42 can 
be used to inform an agricultural water assessment under Sec.  
112.43(a) (or the need for a reassessment under Sec.  112.43(e)), 
meeting the requirements in Sec.  112.42 does not eliminate the need 
for a farm to prepare an agricultural water assessment in accordance 
with Sec.  112.43. For discussion related to records of agricultural 
water system inspections and assessments, see response to comment 133.
    With respect to comments requesting that we reorder the provisions 
to clarify that inspections inform assessments, which in turn inform 
maintenance, we decline to make this change. Not only do the 
requirements for inspections and maintenance under Sec.  112.42 have 
different applicability than the requirements for agricultural water 
assessments under Sec.  112.43 as discussed above, but farms are 
required to base their agricultural water assessments, in part, on the 
results of any inspections and maintenance conducted under Sec.  
112.42. We expect that reordering the provisions may result in 
confusion as to their applicability and relationship, and as such, are 
finalizing the order of Sec. Sec.  112.42 and 112.43 without change.
    (Comment 26) A few comments ask FDA to clarify in the final rule 
that the assessment is intended to identify known or reasonably 
foreseeable microbial hazards, specifically.
    (Response 26) As discussed in the 2015 produce safety final rule, 
the regulation focuses on biological hazards related to produce 
growing, harvesting, packing, and holding. We conducted a QAR (Ref. 17) 
and considered the findings of that assessment in finalizing the 2015 
produce safety final rule. While we acknowledged the potential for 
nonbiological (physical or chemical (including radiological)) hazards 
in produce, we explained that we do not address such hazards in the 
produce safety rule. See 80 FR 74354 at 74355 and 74377 and response to 
comment 8. Further, the 2015 produce safety final rule defines ``known 
or reasonably foreseeable hazard'' to mean a biological hazard that is 
known to be, or has the potential to be, associated with the farm or 
the food (Sec.  112.3). We did not propose to change this definition 
from the 2015 final produce safety final rule. As the scope of the 
regulation and definition of ``known or reasonably foreseeable 
hazards'' are specific to biological hazards, we do not consider it 
necessary to revise the requirements for pre-harvest agricultural water 
assessments as suggested by the comments.
    (Comment 27) One comment seeks clarity on how to assess known or 
reasonably foreseeable hazards that are inherent in the environment, 
such as Listeria, for purposes of an agricultural water assessment 
under Sec.  112.43.
    (Response 27) The information considered as part of an agricultural 
water assessment in Sec.  112.43(a) will assist farms in determining 
whether measures under Sec.  112.45 are reasonably necessary in light 
of concerns for the potential presence of environmental pathogens. For 
example, if a farm suspects that adjacent or nearby land that had 
historically been used for a grazing operation may contain pathogens, 
the farm might consider the topography of the land and likelihood of 
whether those hazards may be introduced to the water system. In 
combination with the other factors considered as part of its 
agricultural water assessment (for example, the farm's water use 
practices, crop characteristics, and environmental conditions (such as 
air temperature and UV))--the farm must then consider whether measures 
are reasonably necessary to reduce the potential for contamination of 
covered produce (other than sprouts) or food contact surfaces.
    We also note that the requirements for systems-based agricultural 
water assessments are designed, in part, to be adaptable to future 
advancements in agricultural water quality science. We anticipate that 
this is an area where science will continue to evolve and provide 
stakeholders with an enhanced understanding of the ecology of human 
pathogens in the environment that may cause foodborne illness 
outbreaks. For example, FDA sometimes conducts multiyear environmental 
studies that are designed to elucidate environmental conditions that 
can impact food safety (Ref. 54). Factors that are studied may include, 
but are not limited to, pre-harvest water sources and uses, soil and 
soil amendments, topography of the growing region, areas where animals 
are present (such as wildlife and livestock), wind speed and direction, 
airborne particulates, water runoff, and

[[Page 37472]]

environmental factors (such as temperature, rainfall, fog, and dew). 
Within recent years, FDA, with support from State and local partners, 
has initiated two longitudinal multiyear studies that examine how 
pathogens survive, move through the environment of two different 
regions, and possibly contaminate produce (Refs. 55 and 56). As these 
and similar efforts progress, farms will be able to use similar 
information learned about regions as an additional resource to further 
inform their agricultural water assessments.
    (Comment 28) Many comments suggest that the proposed requirements 
for pre-harvest agricultural water assessments do not sufficiently 
acknowledge that the presence of a hazard does not necessarily 
represent a risk to water or produce that needs to be managed. Some of 
these comments express concerns that, as written, the proposed rule 
would require farms to implement mitigation measures if a hazard is 
present, even if the overall risk associated with the water (for 
example, in light of the other information evaluated as part of an 
assessment) is low.
    (Response 28) We consider that the identification of potential 
sources of known or reasonably foreseeable hazards and consideration of 
the likelihood of those hazards being introduced to an agricultural 
water is an appropriate approach, within a risk-based framework, to 
implement the requirements of section 419 of the FD&C Act to set forth 
procedures, processes, and practices that minimize the risk of serious 
adverse health consequences or death, including those reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable biological hazards into or onto produce and to provide 
reasonable assurances that the produce is not adulterated on account of 
such hazards. The systems-based framework in Sec.  112.43 of evaluating 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards will help a farm determine, alongside the results 
of inspections and maintenance under Sec.  112.42, whether corrective 
or mitigation measures under Sec.  112.45 are reasonably necessary to 
reduce the potential for contamination of non-sprout covered produce or 
food contact surfaces with known or reasonably foreseeable hazards 
associated with pre-harvest agricultural water.
    In particular, we note that agricultural water assessments must 
identify conditions that are reasonably likely (emphasis added) to 
introduce known or reasonably foreseeable hazards into or onto covered 
produce (other than sprouts) or food contact surfaces based on an 
evaluation of all factors identified in Sec.  112.43(a)(1) through (5). 
These factors include: the agricultural water system (including the 
source, water distribution system, and degree of protection from 
possible sources of contamination); agricultural water use practices; 
crop characteristics; environmental conditions; and other relevant 
factors, including test results, where appropriate. (See also comment 
29, where we respond to comments regarding the terms ``reasonably 
likely'' and ``reasonably necessary.'')
    Thus, if a farm identifies a potential source of contamination 
under Sec.  112.43(a)(1), it is not a foregone conclusion that measures 
under Sec.  112.45 are reasonably necessary. Rather, in consideration 
of all of the information evaluated under Sec.  112.43(a)(1) through 
(5), the farm might ultimately determine, for example, that measures 
under Sec.  112.45 are not reasonably necessary to reduce the potential 
for contamination of covered produce (other than sprouts) or food 
contact surfaces with known or reasonably foreseeable hazards 
associated with its agricultural water used in growing covered produce 
(other than sprouts).
    Similarly, while two different farms might identify similar 
potential sources of contamination under Sec.  112.43(a)(1), depending 
on the other information they evaluate in Sec.  112.43(a)(1) through 
(5), their determinations under Sec.  112.43(c) might differ. For 
example, one farm with a surface water source that is regularly subject 
to runoff from lands where animal grazing occurs may determine that 
mitigation measures are reasonably necessary under Sec.  112.45, since 
the farm applies agricultural water from that source to covered produce 
close to harvest, and environmental conditions and crop characteristics 
are not conducive to microbial die-off. However, another farm with 
different crop characteristics, environmental conditions and water use 
practices may determine that mitigation measures are not reasonably 
necessary, even if it uses pre-harvest agricultural water from a 
surface water source with similar runoff conditions.
    As discussed further in comment 29, we have provided various 
examples throughout the proposed rule and this final rule that farms 
should consider in determining whether (and what kind of) measures are 
reasonably necessary. We remain committed to providing education, 
outreach, and training, and intend to pursue various mechanisms for 
disseminating information about the requirements of this rule to farms.
    (Comment 29) Many comments request clarity related to the terms 
``reasonably likely'' and ``reasonably necessary'' as they relate to 
the requirements for agricultural water assessments These comments 
suggest that the terms are subjective and that without a more objective 
benchmark it will be difficult to consistently determine what is 
``reasonably likely'' for a farm.
    (Response 29) Given the diversity that exists across the operations 
of foreign and domestic farms and their agricultural water systems, 
uses, and practices, phrases such as ``reasonably likely to introduce 
known or reasonably foreseeable hazards'' and ``determine whether 
measures are reasonably necessary'' provide flexibility for farms to 
make decisions around the use of agricultural water as appropriate to 
their unique circumstances and operations, taking into account the 
requirement in Sec.  112.41 that all agricultural water must be safe 
and of adequate sanitary quality for its intended use. We note that 
similar language appears in section 419(c)(1)(A) of the FD&C Act,\7\ in 
the agricultural water requirements for harvest-, post-harvest, and 
sprout uses (which we did not propose to change) (e.g., Sec.  
112.44(d)), and in FDA's HACCP regulations (21 CFR part 120 and 21 CFR 
part 123) and FDA's Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Human Food regulation 
(21 CFR part 117). This language is designed to be flexible given the 
diversity of commodities and operations to which these requirements 
apply, and in keeping with the principle that the farm bears the 
responsibility and accountability for establishing and implementing 
food safety systems tailored to its circumstances. We also note that 
such language is flexible to account for future scientific 
advancements, consistent with the requirements for pre-harvest 
agricultural water assessments we are finalizing with this rule.
---------------------------------------------------------------------------

    \7\ Section 419(c)(1)(A) of the FD&C Act requires that the 2015 
produce safety final rule set forth those procedures, processes, and 
practices that the Secretary determines to minimize the risk of 
serious adverse health consequences or death, including procedures, 
processes, and practices that the Secretary determines to be 
reasonably necessary to prevent the introduction of known or 
reasonably foreseeable biological, chemical, and physical hazards 
and to provide reasonable assurances that the produce is not 
adulterated under section 402 of the FD&C Act.
---------------------------------------------------------------------------

    What is considered a known or reasonably foreseeable hazard for one 
farm, in light of the conditions and potential impacts to its 
agricultural water system, may not be known or

[[Page 37473]]

reasonably foreseeable hazard in the light of the conditions and 
potential impacts to the agricultural water system of another farm. For 
example, while a farm in one region might identify wild pigs as a 
potential source of known or reasonably foreseeable hazards to 
agricultural fields and surface waterways (Refs. 57 and 58), wild pigs 
might not be considered a likely source of known or reasonably 
foreseeable hazards in regions where pigs are not prevalent. As another 
example, if runoff is likely to serve as a source of hazards, but the 
farm's agricultural water system is sufficiently protected (e.g., water 
from a well is conveyed through a piped distribution system, and both 
the well and distribution system are properly constructed and 
maintained), then the farm might determine that runoff is not a 
condition that is reasonably likely to introduce known or reasonably 
foreseeable hazards to covered produce (other than sprouts) or food 
contact surfaces.
    Further, farms must use information on the various factors 
evaluated as part of an agricultural water assessment under Sec.  
112.43(a)(1) through (5)--including information related to their 
agricultural water systems; agricultural water use practices; crop 
characteristics; environmental conditions; and other relevant factors, 
such as the results of pre-harvest agricultural water testing, where 
appropriate--to determine whether, given their unique conditions, 
measures under Sec.  112.45 are reasonably necessary to reduce the 
potential for contamination of covered produce (other than sprouts) or 
food contact surfaces with known or reasonably foreseeable hazards 
associated with agricultural water used in growing covered produce 
(other than sprouts). Given the diversity that exists across industry 
in these factors, situations in which measures under Sec.  112.45 are 
reasonably necessary for one farm will not necessarily be the same for 
another. Rather, the unique factors that are relevant to a farm and its 
agricultural water systems will together assist the farm in decision-
making related to its pre-harvest agricultural water as appropriate for 
its relevant conditions, practices, and circumstances. See also 
response to comment 28.
    We have provided various examples throughout the proposed rule and 
this final rule that farms should consider in identifying potential 
sources of hazards, evaluating the likelihood of hazards being 
introduced to covered produce (other than sprouts) or food contact 
surfaces, and determining whether (and what kind of) measures are 
reasonably necessary to reduce the potential for contamination of non-
sprout covered produce or food contact surfaces with known or 
reasonably foreseeable hazards associated with pre-harvest agricultural 
water. See 86 FR 69120 at 69133 and sections V.F., V.G., and V.J. Such 
examples, and consideration for the principles presented in the context 
of each farm's unique conditions, will assist farms in conducting their 
pre-harvest agricultural water assessments under Sec.  112.43. However, 
we also recognize that guidance, educational materials, as well as 
trainings, will help farms understand the requirements of this final 
rule. We remain committed to providing education, outreach and training 
and intend to pursue various mechanisms for disseminating information 
to farms.
    (Comment 30) A few comments suggest that under the proposed rule, 
any surface water source that a farm is preparing an agricultural water 
assessment for will be considered ``hazardous,'' and therefore require 
that the farm conduct mitigation measures.
    (Response 30) The risk associated with agricultural water will vary 
from source to source. For example, ground water obtained from deep 
underground aquifers, with properly designed, located, and constructed 
wells, generally yields higher quality water with little variability 
due to the natural filtering capacity of soils, the depth pathogens 
would have to travel to compromise the source, and because it is not 
expected to be subject to environmental factors such as runoff (Refs. 
17 and 59). By contrast, surface waters, which are exposed to the 
environment, pose a higher potential for becoming contaminated with 
human pathogens due to runoff and greater variability in quality 
because of the potential for external influences (Ref. 17). However, we 
recognize that even within a single type of water source (e.g., surface 
water), the associated risk may vary depending, in part, on the nature 
and likelihood of hazards being introduced. For example, if a farm has 
two different holding ponds--one that is at a higher elevation than 
surrounding lands, and the other that is at a lower elevation--both are 
considered surface water sources. However, the holding pond at the 
higher elevation may be more well-protected from the introduction of 
hazards via runoff than the other holding pond and may therefore 
present less risk when used as pre-harvest agricultural water.
    Additionally, we recognize that the risk associated with 
agricultural water also depends on how and when agricultural water is 
applied to covered produce, characteristics of the covered produce, and 
environmental conditions. As such, we require farms to evaluate these 
various factors under Sec.  112.43(a) as part of their agricultural 
water assessments to assist them in determining whether measures under 
Sec.  112.45 are reasonably necessary to reduce the potential for 
contamination of non-sprout covered produce or food contact surfaces 
with known or reasonably foreseeable hazards associated with pre-
harvest agricultural water. See also response to comment 28. Given the 
variability that exists across industry in water systems, operations, 
and conditions, not every surface water source will require that 
corrective or mitigation measures be implemented under Sec.  112.45.
    (Comment 31) Several comments seek clarity on how to weigh ``low 
risk'' and ``high risk'' elements within an assessment. For instance, 
comments seek clarity on how farmers should weigh a ``low risk'' crop 
irrigated with water from a ``high risk'' source. One comment seeks 
clarity on whether farms can continue using ``low'' or ``medium-risk'' 
practices until ``specific science determines there is a real, 
attributable risk.''
    (Response 31) Throughout the 2021 agricultural water proposed rule, 
this final rule, and supporting materials (such as the QAR (Ref. 17)), 
we have provided principles related to general risk associated with 
conditions and practices related to pre-harvest agricultural water 
sources and uses. For example, table 7 of the QAR (Ref. 17) 
demonstrates that public drinking water is generally considered the 
least likely to serve as a source of contamination, followed by ground 
water, surface water protected from runoff, and surface water 
unprotected from runoff. Further, that table notes that where 
contamination in a water source is known to exist, the likelihood of 
contamination is a function of:
     Contact with the commodity (example, whether contact is 
indirect or direct);
     Commodity effects (for example, whether the surface is 
conducive to adhesion); and
     Application timing (for example, early or late in crop 
growth).
    Given the diversity that exists across the operations of foreign 
and domestic farms and their agricultural water systems, uses, and 
practices, what might be considered ``low'' or ``high'' risk for one 
farm will not necessarily be the same for another.
    As such, in establishing the requirements for pre-harvest 
agricultural water assessments, we have provided flexibility for farms 
to make decisions

[[Page 37474]]

around the use of agricultural water as appropriate to their unique 
circumstances and operations. See also response to comment 29.
    To the extent that comments are voicing concern over the scientific 
basis for the requirements for pre-harvest agricultural water 
assessments in Sec.  112.43, comment 10 addresses those comments.
    (Comment 32) One comment asserts that quantitative microbial risk 
assessment and risk modeling tools may help establish when certain 
``safe harbors,'' such as the use of four days or more between last 
direct water application and harvest as a mitigation measure, may be 
appropriate for farms to use. Specifically, this comment suggests that 
the proposed approach for mitigation measures provides options for 
farms to choose from without caveats or limitations.
    (Response 32) Given the diversity of operations, agricultural water 
sources, and agricultural water uses of domestic and foreign farms, the 
requirements for comprehensive, systems-based pre-harvest agricultural 
water assessments, which require farms to evaluate a broad range of 
factors that may impact the quality of the water they use during pre-
harvest activities, will assist farms in identifying, and managing, 
risks associated with pre-harvest agricultural water as appropriate for 
their relevant agricultural water systems, conditions, and practices. 
While we do not believe that quantitative risk benchmarks are necessary 
in order to establish science-based minimum standards within the 
framework of the comprehensive, systems-based agricultural water 
assessment we are finalizing here, we have included a requirement to 
test pre-harvest agricultural water as part of an assessment when doing 
so would not delay action most critical to protect public health and 
would further inform the farm's determination as to whether measures 
are reasonably necessary. See Sec.  112.43(c)(4).
    We also recognize that additional clarification, such as related to 
the circumstances under which certain mitigations may be appropriate, 
is appropriate. As such, we provide various examples throughout the 
proposed rule and this final rule that farms should consider in 
preparing their agricultural water assessments and taking actions based 
on their assessments. See 86 FR 69120 at 69133 and sections V.F., V.G., 
and V.J. For example, in comment 115, we explain that the use of 
microbial die-off between last direct water application and harvest as 
a mitigation measure under Sec.  112.45(b) can be impacted by a broad 
range of conditions specific to a farm, such as the timing of water its 
water applications and relevant environmental conditions, crop 
characteristics, and pathogen characteristics.
    Further, the QAR (Ref. 17) explains that where contamination of a 
water source is known to exist, the likelihood of contamination is a 
function of various factors, including contact with the commodity, 
commodity effects (characteristics), and application timing. Moreover, 
we discuss in our memos supporting the pre-harvest microbial die-off 
requirements in the 2015 produce safety final rule (Refs. 60 and 61) 
that the reduction of pathogen populations on produce surfaces to the 
point of non-detection is not guaranteed. As such, we disagree that use 
of a time interval between last direct water application and harvest 
alone can serve as a ``safe harbor.''
    We also note that the requirements for agricultural water 
assessments are designed, in part, to be adaptable to scientific 
advancements. To the extent that risk modeling and predictive analytics 
related to pre-harvest agricultural water may continue to develop in 
the future, farms will be able to use such information as an additional 
resource to further inform their agricultural water assessments under 
the approach we are finalizing here.
    (Comment 33) A few comments suggest that evaluating various factors 
(such as the agricultural water source's degree of protection under 
proposed Sec.  112.43(a)(1)) will present a significant challenge to 
many farms and argues that broader collaborations across the 
agricultural sector will need to occur to achieve compliance with this 
requirement. The comment suggests that FDA foster relationships with 
irrigation water districts and engage in conversations with animal 
operations and livestock associations, or other Federal partners such 
as the EPA and USDA's Natural Resources Conservation Service to achieve 
compliance.
    (Response 33) We are aware of efforts underway to bring together 
members of agricultural communities on a large scale, such as through 
the CAN (Ref. 38), which provides a roundtable opportunity to foster 
collaboration and discuss enhanced neighborly food safety practices 
when various agriculture operations such as leafy green fields, cattle 
ranches, vineyards, and compost sites are adjacent to one another. 
Various action items have been identified as part of the CAN 
initiative, including fostering neighbor-to-neighbor interactions and 
conversations, and building a research roadmap to understand key 
landscape processes to guide decision-making both now and into the 
future (Ref. 39).
    Additionally, FDA sometimes conducts multiyear environmental 
studies in collaboration with State and local public health officials, 
academia, and members of the produce industry, that are designed to 
shed light on environmental conditions that can impact food safety 
(Ref. 32). Within recent years, FDA, with support from State and local 
partners such as extension specialists, academic researchers, 
irrigation districts, industry groups, and farms, has initiated two 
longitudinal multiyear studies that examine how pathogens survive, move 
through the environment of two different regions, and possibly 
contaminate produce (Refs. 55 and 56). Information learned through such 
efforts may help inform agricultural water assessments.
    Further, as discussed in section V.K., FDA has collaborated with 
EPA to develop a testing protocol for evaluating the efficacy of 
antimicrobial chemical treatments against certain foodborne pathogens 
in agricultural water sources. We recognize the value of collaborating 
with Federal partners in related disciplines, and will consider 
additional collaborative efforts related to the requirements we are 
finalizing here.
    (Comment 34) Some comments voice concern that it will be difficult 
to prepare agricultural water assessments for farms that use multiple 
sources of water for pre-harvest activities.
    (Response 34) We acknowledge that farms using multiple agricultural 
water systems during pre-harvest activities for covered produce (other 
than sprouts) will need to conduct an assessment for each system unless 
an exemption under Sec.  112.43(b) applies. However, several of the 
factors evaluated in the assessment (for example, agricultural water 
use practices, commodity characteristics, and environmental conditions) 
might be similar across agricultural water systems, thus limiting the 
amount of information a farm needs to collect and consider. We 
emphasize that under Subpart O, ``Records'' of the 2015 produce safety 
final rule, it is not necessary for farms to keep all of the required 
information in only one set of records, nor do farms need to duplicate 
existing records, provided that, taken together, the records satisfy 
all of the applicable requirements. See Sec.  112.163. Therefore, farms 
have flexibility in maintaining records for agricultural water 
assessments as long as all relevant requirements are met.
    (Comment 35) Some comments voice concern that farms who lease land 
for short-term use (for example, one

[[Page 37475]]

growing season) may face challenges in implementing the requirements 
for agricultural water assessments as they lack historical knowledge on 
adjacent lands and water systems available to them. One comment 
suggests that having multiple years of experience using surface water 
to cool strawberries in the field without any history of problems makes 
it difficult to identify risks.
    (Response 35) We recognize that not all farms (including, for 
example, new farms and those growing covered produce on land under 
short-term lease), will have a historic understanding of their 
agricultural water systems, including uses of adjacent and nearby 
lands. While we understand that historical knowledge may be useful in 
preparing an agricultural water assessment, the absence of it does not 
preclude a farm from evaluating the factors in Sec.  112.43(a)(1) 
through (5).
    Moreover, we do not consider a lack of reported issues in the past 
as necessarily being indicative of the risks associated with a farm's 
agricultural water systems and pre-harvest water use. For example, 
between June and October 2020, Federal and State agencies investigated 
a Salmonella Newport foodborne illness outbreak associated with 
consumption of red onions (Ref. 23). We noted that the food vehicle in 
this outbreak, whole red onions, is a raw agricultural commodity that 
had not previously been documented as associated with a foodborne 
illness outbreak. Although a conclusive root cause could not be 
identified, several potential contributing factors were identified, 
including a leading hypothesis that contaminated irrigation water used 
in a growing field may have led to contamination of the onions.
    The QAR (Ref. 17) concluded that, although some types of produce 
have been repeatedly associated with outbreaks, all types of produce 
commodities have the potential to become contaminated through one or 
more of the potential routes of contamination, including water. Use of 
poor agricultural practices can lead to contamination and illness, even 
where the potential for contamination is relatively low. As such, it is 
important for all farms to consider the various factors under Sec.  
112.43(a) as part of their agricultural water assessments, even in the 
absence of any reported history of safety problems associated with 
their covered produce.

E. Exemptions From Agricultural Water Assessments (Sec.  112.43(b))

    In Sec.  112.43(b), we proposed various exemptions from the 
requirement to prepare a pre-harvest agricultural water assessment. We 
tentatively concluded that an agricultural water assessment would not 
be necessary when a farm can demonstrate that its pre-harvest 
agricultural water for non-sprout covered produce:
     Meets the requirements in Sec.  112.44(a), including the 
microbial quality criterion, and, if untreated ground water, also meets 
the testing requirements in Sec. Sec.  112.44(b), 112.47, and 112.151 
(proposed Sec.  112.43(b)(1));
     Meets the requirements in Sec.  112.44(c) for water from a 
Public Water System or public water supply (proposed Sec.  
112.43(b)(2)); or
     Is treated in accordance with Sec.  112.46 (proposed Sec.  
112.43(b)(3)).
    We received numerous comments on the exemptions in proposed Sec.  
112.43(b) and respond to those comments below. As discussed below, we 
are finalizing the exemptions from the requirement to prepare a pre-
harvest agricultural water assessment and clarifying that an exemption 
only applies if it is reasonably likely that the relevant quality of 
water will not change prior to the water being used as agricultural 
water.
    (Comment 36) Some comments voice concern with the proposed 
exemptions in Sec.  112.43(b), noting that while farms may be exempt 
from preparing an agricultural water assessment for water from a 
municipal source or treated water, depending on how the water is used, 
the water quality may change. These comments suggest that exempting 
water in these situations could be a gap in assessing the safety of the 
water.
    (Response 36) We recognize that where the quality of water meeting 
the requirements in proposed Sec.  112.43(b) may change before a farm 
uses it as pre-harvest agricultural water, it would be inappropriate 
for the farm to be eligible for an exemption from the requirement to 
prepare an agricultural water assessment for that water. As such, we 
are revising proposed Sec.  112.43(b) to clarify that a farm is only 
exempt from preparing a written agricultural water assessment if the 
farm can demonstrate that the water meets the requirements in Sec.  
112.43(b)(1)(i), (ii), or (iii) and it is reasonably likely that the 
relevant quality of water will not change prior to the water being used 
as agricultural water (for example, due to the manner in which the 
water is held, stored, or conveyed) (Sec.  112.43(b)(2)).
    For example, if a farm receives water that meets the requirements 
in Sec.  112.44(c) for water from a Public Water System that furnishes 
water meeting the microbial requirements in 40 CFR part 141 and conveys 
that water through a closed distribution system that allows for water 
quality to be maintained, the farm may be eligible for an exemption 
under Sec.  112.43(b), provided all requirements are met (including the 
requirement that the farm have results or certificates of compliance 
demonstrating that relevant requirements are met). However, if a farm 
conveys that water through an open canal system prior to using it as 
pre-harvest agricultural water for non-sprout covered produce and it is 
reasonably likely that the quality of water will change prior to use of 
the water, the farm is not eligible for an exemption from the 
requirement to prepare an agricultural water assessment. The farm must 
consider the nature of the water source as part of their evaluation of 
the agricultural water system under Sec.  112.43(a)(1).
    (Comment 37) Several comments support the exemption in proposed 
Sec.  112.43(b)(1) for water that meets the requirements of proposed 
Sec.  112.44(a), noting that, in some cases, it may make sense for some 
farms to rely on test results rather than conducting annual (or more 
frequent, as appropriate) assessments. Some comments seek clarity about 
whether FDA intends for water tests to be performed each growing season 
for the sole purpose of demonstrating one's exemption from performing 
an agricultural water assessment. Comments also seek clarity as to when 
FDA would expect the testing to be completed (for example, before the 
season starts). Further, some comments question whether historical 
water testing data could be used for the purposes of an exemption from 
preparing an agricultural water assessment. Comments also request 
clarification on whether this exemption could be used for a farm that 
only uses pre-harvest water, but tests to the same standard as post-
harvest water and meets all other relevant requirements.
    (Response 37) We reviewed comments related to the exemption in 
proposed Sec.  112.43(b)(1) and conclude that an agricultural water 
assessment is not necessary when a farm can demonstrate that its pre-
harvest agricultural water for non-sprout covered produce meets the 
requirements in Sec.  112.44(a) (including the stringent microbial 
quality criterion of no detectable generic E. coli) and the testing 
requirements in Sec. Sec.  112.44(b), 112.47, and 112.151 that are 
applicable to agricultural water for sprout irrigation and harvest and 
post-harvest uses. While the provisions referred to in

[[Page 37476]]

Sec.  112.43(b)(1)(i) apply to water that is used for purposes outlined 
in Sec.  112.44(a) (such as water used for harvest and post-harvest 
purposes), we note that a farm that only uses agricultural water for 
pre-harvest activities may still be eligible for this exemption, 
provided all applicable requirements are met.
    For the exemption from the requirement to prepare an agricultural 
water assessment in Sec.  112.43(b)(1)(i), if the water is untreated 
ground water, Sec.  112.44(b) requires that a farm initially test the 
microbial quality of each source of the untreated ground water at least 
four times during the growing season or over a period of 1 year, using 
a minimum total of four samples collected aseptically and 
representative of the intended use(s). If the four initial sample 
results meet the microbial quality criterion under Sec.  112.44(a), the 
farm may test once annually thereafter. As such, in order to be 
eligible for the exemption in Sec.  112.43(b)(1)(i), the farm must test 
the source of untreated ground water each growing season or year.
    Recognizing the diversity that exists in industry as to when and 
how agricultural water is used, the requirement that samples be 
``representative of the intended use(s) of the water'' provides farms 
with flexibility for sample collections under Sec.  112.44(b). While 
one farm may, for example, collect a sample that is representative of 
use at the beginning of the growing season, another farm may, for 
example, collect a sample that is representative of use later in the 
year, or at some other time such as when production occurs year-round.
    Regarding the use of historical data, we note that if a farm 
already possesses sufficient data (consisting of the minimum required 
number of samples) collected in the manner required under Sec.  
112.44(b), the farm is permitted to use that data in support of the 
exemption in Sec.  112.43(b)(1)(i).
    (Comment 38) Several comments address the exemption in proposed 
Sec.  112.43(b)(2) for water that meets the requirements in Sec.  
112.44(c) for water from a Public Water System or public water supply 
that furnishes water that meets the microbial water quality criterion 
on Sec.  112.44(a). Some comments suggest that other water sources, 
such as water from public wastewater treatment systems, should be 
similarly exempt from preparing an agricultural water assessment, even 
if they do not meet the microbial criterion in Sec.  112.44(a). A few 
comments specifically ask that the exemption be revised to apply to 
water from publicly owned systems (including from drinking water 
systems and wastewater treatment systems) that has been treated to meet 
a GM of 126 or less and an STV of 410 or less CFU generic E. coli per 
100 mL, as opposed to expecting such water to meet the microbial 
criterion of no detectable generic E. coli per 100 mL. Some comments 
suggest that use of the GM and STV criteria for such purposes would 
shift the burden of proof to the water supplier, as compared to under 
the 2015 produce safety final rule requirements in which farms would be 
responsible for demonstrating that water meets such criteria.
    (Response 38) In the U.S., Public Water Systems are required under 
NPDWR in 40 CFR part 141 to provide safe, clean water suitable for 
drinking and thus are at the lowest likelihood for pathogen 
contamination (Ref. 17). Similarly, public water supplies that meet the 
microbial requirement in Sec.  112.44(a) are included in the exemption 
under proposed Sec.  112.43(b)(2) to accommodate other public water 
supplies that are not governed by the requirements of the EPA drinking 
water program, but provide water of a quality that meets the microbial 
requirement of Sec.  112.44(a). See 78 FR 3504 at 3571. Where a farm 
can demonstrate that its pre-harvest agricultural water for non-sprout 
covered produce meets microbial EPA drinking water standards or other 
comparable public water supply standards, we have concluded that it is 
not necessary to require farms to prepare a pre-harvest agricultural 
water assessment under Sec.  112.43(a) provided all requirements are 
met (including that the farm have results or certificates of compliance 
demonstrating that relevant requirements are met). See also response to 
comment 2.
    We do not consider it appropriate to broaden the exemption in 
proposed Sec.  112.43(b)(1) to include water from other public water 
supplies, such as wastewater treatment systems, since, as the comments 
note, water from these systems is often not treated to meet or be 
comparable to EPA's drinking water standards and may not similarly be 
at the lowest likelihood for pathogen contamination.
    We also decline to provide an exemption from the requirements to 
prepare an agricultural water assessment for water supplied by a public 
water system that meets a GM of 126 and STV of 410 CFU generic E. coli 
per 100 mL of water, as we do not consider water meeting those criteria 
to provide the same level of confidence in the quality of water 
compared to water from a Public Water System or public water supply 
that meets or is comparable to microbial EPA drinking water standards. 
As such, we are finalizing the exemption in final Sec.  
112.43(b)(1)(ii) to refer to agricultural water that meets the 
requirements in Sec.  112.44(c) for water from a public water system or 
public water supply.
    (Comment 39) One comment notes that the exemption for water from a 
municipal source does not provide guidance on what farms should do in 
the case of potential water main breaks or other failures of the 
system. The comment suggests that FDA account for such circumstances 
and establish requirements for what farms should do when there are 
microbiological risks associated with a municipal source.
    (Response 39) We recognize that water main breaks or other issues 
may occur on occasion that have the potential to affect the quality of 
water coming from public water systems. We emphasize that it is the 
farm's responsibility to ensure that the water the farm uses meets all 
applicable requirements in subpart E, including that all agricultural 
water be safe and of adequate sanitary quality for its intended use 
(Sec.  112.41), even if the farm is eligible for an exemption from the 
requirement to prepare a pre-harvest agricultural water assessment 
under Sec.  112.43(b).
    Nonetheless, as discussed in comments 3 and 37, where a farm can 
demonstrate that its pre-harvest agricultural water for non-sprout 
covered produce meets microbial EPA drinking water standards or other 
comparable public water supply standards, we have concluded that it is 
not necessary to require farms to prepare a pre-harvest agricultural 
water assessment under Sec.  112.43(a) provided all requirements are 
met (including that the farm have results or certificates of compliance 
demonstrating that relevant requirements are met). See Sec.  
112.43(b)(1)(ii) and, by reference, Sec.  112.44(c). In the case of 
issues such as water main breaks or other failures occurring in a 
public water system or public water supply meeting the requirements in 
Sec.  112.44(c), the system authority will oftentimes communicate the 
issue, along with recommendations for whether and how to use the 
impacted water, in an advisory to their affected constituents. Farms 
may find it helpful to consider such information in ensuring that the 
requirement in Sec.  112.41 that all agricultural water be safe and of 
adequate sanitary quality for its intended use is met.
    (Comment 40) Several comments voice concern over how the exemptions 
in proposed Sec.  112.43(b) relate to controlled environment 
agriculture

[[Page 37477]]

(CEA) farms (for example, indoor farms), including hydroponic or 
aquaponic operations. For example, one comment suggests that 
recirculated water used in such operations would be considered 
untreated surface water, and therefore, the exemption in proposed Sec.  
112.43(b)(1) would not apply. Some comments note that while hydroponic 
and aquaponic operations may source their water from a public water 
supply, water in these operations can be recirculated and/or held for 
extended periods of time prior to its use for produce. A few comments 
note that if farms recirculate that water without treatment or other 
controls, they could end up irrigating produce using contaminated 
water. Other comments suggest that chemical treatment for the purposes 
of an exemption in proposed Sec.  112.43(b)(3) may not be applicable in 
hydroponic and aquaponic operations due to concerns over a lack of 
treatment efficacy and that chemical treatment is not currently an 
option for aquaponic operations. For example, one comment notes that 
chlorine and chloramine are toxic to fish at certain concentrations and 
not labeled for use in aquaculture.
    (Response 40) As discussed in comment 36, we are revising proposed 
Sec.  112.43(b) to clarify that a farm is only exempt from preparing a 
written agricultural water assessment if the farm can demonstrate that 
the water meets the requirements in Sec.  112.43(b)(1)(i), (ii), or 
(iii) and it is reasonably likely that the relevant quality of water 
will not change prior to the water being used as agricultural water 
(for example, due to the manner in which the water is held, stored, or 
conveyed) (Sec.  112.43(b)(2)). As such, it is important that each 
farm, including those involved in CEA, consider its unique operations 
in determining whether it is eligible for an exemption from the 
requirement to prepare an agricultural water assessment under Sec.  
112.43(b), including how the farm conveys and/or holds the water; how 
the farm manages the water prior to its point of intended use; and how 
the farm uses pre-harvest agricultural water for non-sprout covered 
produce.
    For example, we are aware that in some CEA operations, such as 
those that employ deep water culture methods, pre-harvest agricultural 
water can be used for extended periods of time to grow multiple batches 
of covered produce in continuous production. For example, some 
operations introduce a new production raft to a growing pond when 
another raft is removed for harvest. Unless there are measures that 
will allow for the quality of water in Sec.  112.43(b)(1)(i), (ii), or 
(iii) to be maintained as new batches of covered produce are added to 
the system, a farm that implements such water use practices is unlikely 
to satisfy the requirements for an exemption in Sec.  112.43(b). 
Examples of measures that may allow for the quality for water to be 
maintained prior to use as agricultural water for sequential batches of 
covered produce include, but are not limited to, ensuring that 
distribution system components and equipment surfaces do not serve as a 
source of contamination to the water and/or using other measures, such 
as adequate treatment, to maintain the quality of water.
    Regardless of whether an exemption from the requirement to prepare 
an agricultural water assessment under Sec.  112.43(b) applies, farms 
remain responsible for meeting all other applicable requirements of 
subpart E, including those related to inspection and maintenance of 
agricultural water systems (Sec.  112.42) and the requirement that all 
agricultural water be safe and of adequate sanitary quality for its 
intended use (Sec.  112.41).
    (Comment 41) A few comments assert that in the 2021 outbreak of 
Salmonella Typhimurium associated with product from a hydroponic leafy 
green facility, the water would have been exempt from the requirement 
to prepare an agricultural water assessment under the proposed rule, as 
the water was from a municipal water source and was treated.
    (Response 41) In response to comment 40, we discuss information 
that CEA farms should consider in determining whether they are eligible 
for an exemption under Sec.  112.43(b). We also explain that regardless 
of whether a farm is eligible for an exemption under Sec.  112.43(b), 
the farm remains responsible for ensuring the safe and adequate 
sanitary quality of the water used to grow covered produce (Sec.  
112.41).
    Regarding the outbreak of Salmonella Typhimurium associated with 
packaged leafy greens produced in a CEA indoor hydroponic operation 
specifically, we note that our investigation did not result in the 
identification of the specific source or route of contamination of the 
leafy greens (Ref. 62). However, we explained in our investigation 
report (Ref. 62) that recovery of Salmonella Liverpool, a strain not 
associated with the outbreak, from a water sample of an indoor 
production pond highlights the importance of minimizing sources of 
microbial contamination as well as operating and maintaining production 
ponds in a manner that does not result in the spread of pathogens to 
produce. For example, while the growing ponds in the operation were 
filled with water sourced from a public water supply that was further 
treated on-site using a sand filtration and ultraviolet (UV) system, as 
our investigation report notes, once water was in the growing ponds, it 
was not routinely disinfected or otherwise treated. Moreover, while the 
operation indicated to investigators that ponds get treated in response 
to sample results revealing the presence of generic E. coli, the 
operation did not have a procedure or systematic approach to ensure 
adequate water treatment. We also noted that a water sample collected 
from a stormwater retention basin located outside of the CEA 
operations' property but approximately 25 feet from the CEA structure 
tested positive for the outbreak strain.
    Although investigators did not observe specific routes of 
contamination to or from areas surrounding the CEA operation, we note 
that the report findings provide further evidence supporting the 
requirements that farms, including those involved in CEA, assess and 
mitigate risks associated with adjacent and nearby land uses that may 
impact operations in both rural and more urbanized settings. While we 
recognize that CEA may provide an additional degree of control compared 
to more traditional outdoor farming operations, we emphasize that it is 
still important for farms that participate in CEA to consider a range 
of potential sources of hazards in ensuring that subpart E requirements 
are met, including those above.
    (Comment 42) A few comments request clarification on the 
documentation farms need to support an exemption from the requirement 
to prepare an agricultural water assessment. For example, one comment 
asks if all farms need to prepare an agricultural water assessment, but 
that for farms eligible for an exemption, doing so would only entail 
maintaining information relevant to the exemption.
    (Response 42) If a farm satisfies the criteria for an exemption 
under Sec.  112.43(b), the farm is not required to prepare a written 
agricultural water assessment. However, the farm is required to 
maintain records applicable to the exemption, such as:
     In support of the exemption in Sec.  112.43(b)(1)(i), 
documentation of test results (Sec.  112.50(b)(5)) and analytical 
methods (if applicable) (Sec.  112.50(b)(12));
     In support of the exemption in Sec.  112.43(b)(1)(ii), 
annual documentation of the results or certificates of compliance from 
a public water system or public water supply demonstrating that the 
water meets the relevant requirements in Sec.  112.44(c) (Sec.  
112.50(b)(6)); and

[[Page 37478]]

     In support of the exemption in Sec.  112.43(b)(1)(iii), 
documentation of scientific data or information the farm relies on to 
support the adequacy of a treatment method (Sec.  112.50(b)(10)) and 
documentation of the results of water treatment monitoring (Sec.  
112.50(b)(11)).
    (Comment 43) Some comments seek clarity on whether the exemptions 
in proposed Sec.  112.43(b) are permanent or temporary.
    (Response 43) Farms are eligible for an exemption from the 
requirement to prepare a written agricultural water assessment under 
Sec.  112.43(b) for as long as the relevant requirements are met. This 
includes maintaining records applicable to the exemption, as discussed 
in response to comment 42.

F. Elements of an Agricultural Water Assessment (Sec.  112.43(a))

    We proposed to require farms that use pre-harvest agricultural 
water for non-sprout covered produce to prepare a written agricultural 
water assessment that would identify conditions that are reasonably 
likely to introduce known or reasonably foreseeable hazards into or 
onto covered produce (other than sprouts) or food contact surfaces, 
based on an evaluation of the farm's agricultural water system; 
agricultural water practices; crop characteristics; environmental 
conditions; and other relevant factors, including, if applicable, 
results of any testing conducted (proposed Sec.  112.43(a)). We respond 
to the comments on proposed Sec.  112.43(a) in the following 
paragraphs. We note that comments on testing conducted under Sec.  
112.43(d) are discussed in section V.H. As discussed in our response to 
comments, we are finalizing Sec.  112.43(a) as proposed, with minor 
edits for clarification.
1. Agricultural Water Systems
    (Comment 44) Several comments contend that the proposed rule does 
not adequately address various types of agricultural water, since only 
ground water and surface water are identified in proposed Sec.  
112.43(a)(1), which would require farms to evaluate each agricultural 
water system (i.e., source and distribution system) used for growing 
activities for covered produce. These comments request that FDA clearly 
define various agricultural water types (including surface water, 
ground water, municipal water, and recycled water) and provide examples 
of when classification may change. For example, one comment requests 
clarity on what requirements in the proposed rule would apply for 
shallow ground water influenced by surface water.
    (Response 44) We recognize that farms may use a variety of water 
sources and distribution systems for their pre-harvest agricultural 
water. As such, we are revising the requirement to clarify that 
considering whether a water source is ground water or surface water is 
just one example of the information farms might consider in evaluating 
the location and nature of the water source (see Sec.  
112.43(a)(1)(i)).
    We do not consider it necessary or practical for us to define types 
of water sources other than ``ground water'' and ``surface water'' in 
Sec.  112.3, as the conditions associated with such other sources are 
expected to vary widely and contain elements addressed within the 
definitions for ground water and surface water, which may result in 
confusion. For example, the term ``recycled water'' in common usage can 
refer to many different things--such as use of water from a canal 
system that is subject to return flows, or use of treated, recycled 
wastewater--such that it would be difficult to define ``recycled 
water'' in a way that is meaningful for hazard identification purposes 
across categories of recycled water. Rather, we intend farms to 
describe the specific conditions and characteristics associated with a 
water source that may affect the likelihood of known or reasonably 
foreseeable hazards being introduced when evaluating the location and 
nature of the source under Sec.  112.43(a)(1)(i), including for 
recycled water. We provide examples of such considerations, including 
situations in which classification of a water source may change, in 
response to comment 30.
    With respect to comments requesting clarity on whether different 
requirements apply based on water source, we note that the requirements 
for agricultural water quality in Sec. Sec.  112.41 and 112.43 apply 
regardless of the source or type of water used as agricultural water. 
Farms must determine the appropriate use of their water sources by 
assessment as required under Sec.  112.43, taking into account the 
standard in Sec.  112.41 that all agricultural water must be safe and 
of adequate sanitary quality for its intended use. As such, we are not 
establishing different requirements for pre-harvest agricultural water 
based on the nature of a farm's water source.
    (Comment 45) A few comments seek clarity on how to classify 
municipal water stored in jugs, enclosed cisterns, food-grade tanker 
trucks, or barrels, and rainwater that is collected prior to use.
    (Response 45) In evaluating each agricultural water system a farm 
uses for pre-harvest agricultural water in Sec.  112.43(a)(1), farms 
are required to evaluate the location and nature of the water source; 
the type of water distribution system; and the degree of protection 
from possible sources of contamination. Considering such information 
will assist farms in evaluating the likelihood of known or reasonably 
foreseeable hazards being introduced to their pre-harvest agricultural 
water, the latter of which may then serve as a source of contamination 
to covered produce or food contact surfaces. For example, if farms hold 
pre-harvest agricultural water in storage vessels such as jugs, 
cisterns, or barrels, the following factors are relevant to consider as 
part of their agricultural water assessment under Sec.  112.43(a)(1):
     Where they sourced the water from (and what they know 
about its quality at that point);
     Whether the storage vessels are structured to protect that 
quality of water (such as whether they are kept closed to prevent entry 
of contaminants, such as from birds or other pests); and
     Whether the storage vessels undergo any regular 
maintenance, cleaning and/or sanitizing to prevent them from serving as 
a source of contamination for the water.
    Such storage vessels are part of the farm's agricultural water 
system as defined in Sec.  112.3, and as such, under Sec.  112.42 the 
farm must inspect and maintain the vessels, to the extent that they are 
under the farm's control, to identify any conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
and prevent the systems from being a source of contamination to covered 
produce, food contact surfaces, or areas used for a covered activity. 
In accordance with Sec.  112.43(a), farms must also consider the 
results of any inspections and maintenance conducted under Sec.  112.42 
in preparing an agricultural water assessment.
    (Comment 46) One comment requests that FDA provide information on 
the scope of water sources that would be considered adjacent and how 
those would be incorporated into agricultural water assessments.
    (Response 46) We recognize that in some instances, known or 
reasonably foreseeable hazards may be introduced into an agricultural 
water system (defined at Sec.  112.3) from a body of water that is not 
otherwise a part of that system. For example, a canal that a farm uses 
for pre-harvest agricultural water may be subject to known or 
reasonably foreseeable hazards from a nearby pond if, when it rains, 
runoff from the pond is introduced into the canal. If there are other 
bodies of water that may introduce

[[Page 37479]]

known or reasonably foreseeable hazards to an agricultural water system 
(as in the above example), farms must consider that information in 
evaluating the degree of protection of the agricultural water system 
from possible sources of contamination under Sec.  112.43(a)(1)(iii). 
For example, a farm might consider the nature of the other body of 
water, the proximity of the other body of water to the farm's 
agricultural water system, and local topography, as these factors might 
affect the likelihood of known or reasonably foreseeable hazards being 
introduced to the agricultural water system from the other body of 
water.
    (Comment 47) Some comments seek clarity as to how the requirements 
to consider the location and nature of the water source in proposed 
Sec.  112.43(a) applies in CEA farms, such as some hydroponic and 
aquaponic operations. Additionally, one comment suggests that indoor 
farms should consider whether the surrounding building and/or other 
infrastructure may impact the quality of pre-harvest agricultural 
water.
    (Response 47) Section Sec.  112.43(a)(1) requires farms to evaluate 
each agricultural water system that they use for growing activities for 
covered produce, including, in part, the location and nature of the 
water source (for example, whether it is ground water or surface water) 
and the degree of protection from possible sources of contamination. 
Although CEA operations may provide an additional degree of control 
over some types of hazards compared to other operations, we emphasize 
that it is still important to consider a range of potential sources of 
hazards that might affect agricultural water used in CEA. For example, 
in our investigation report for the 2021 outbreak of Salmonella 
Typhimurium associated with packaged leafy greens produced in a CEA 
indoor hydroponic facility, we discussed various findings related to 
water use and highlighted the importance of assessing and mitigating 
risks associated with adjacent and nearby land uses that may impact CEA 
operations, in both rural and more urbanized settings (Ref. 62). See 
response to comment 41.
    We also agree that it is important for farms in general (not just 
those participating in CEA) to consider buildings and/or other 
infrastructure that might affect the quality of their pre-harvest 
agricultural water. We note in particular that the definition of 
``agricultural water system'' includes, in part, ``any building or 
structure that is part of the water distribution system (such as a well 
house, pump station, or shed), and any equipment used for application 
of agricultural water to covered produce during growing, harvesting, 
packing, or holding activities'' (Sec.  112.3). As such, to the extent 
that any building, structure, or equipment is a component of a farm's 
agricultural water system, the farm must inspect and maintain those 
components to the extent that they are under the farm's control in 
accordance with Sec.  112.42 and consider those components in 
conducting an agricultural water assessment pursuant to Sec.  112.43. 
For example, in evaluating the degree of protection of an agricultural 
water system from possible sources of contamination under Sec.  
112.43(a)(1)(iii), farms should consider whether buildings or 
structures that are part of its agricultural water system protect other 
components of the agricultural water system from possible sources of 
contamination (such as where a well house or storage shed might protect 
wells and/or water application equipment from debris, trash, 
domesticated animals, or other possible sources of contamination).
1. Degree of Protection of Each Agricultural Water System
a. General
    (Comment 48) A few comments request examples of types of hazards 
beyond animals, biological soil amendments of animal origin (BSAAOs), 
and human waste that should be considered as part of an agricultural 
water assessment. One comment suggests that farms might also consider 
maintenance activities in an irrigation district and whether a farm is 
near an airport subject to nearby chemical intrusion as part of an 
agricultural water assessment.
    (Response 48) Section 112.43(a)(1)(iii) requires that as part of an 
agricultural water assessment, farms evaluate the degree of protection 
of the agricultural water system from possible sources of 
contamination. While other water users, animal impacts, and adjacent 
and nearby land uses related to animal activity, BSAAOs, or presence of 
untreated or improperly treated human waste are provided as examples of 
possible sources of contamination, we note that the list of examples in 
Sec.  112.43(a)(1)(iii) is not exhaustive. For example, if applicable 
to the circumstances, the farm must consider the following potential 
sources of contamination as part of its agricultural water assessment: 
upstream maintenance activity (such as dredging) within a canal system 
that may affect the microbial quality of the water; urban development 
activities from which runoff may introduce hazards to the agricultural 
water system; and human activities (such as recreational vehicle parks) 
that may introduce hazards to the agricultural water system. We note, 
however, that the 2015 produce safety final rule applies to biological 
hazards and not, for example, chemical hazards. See response to comment 
8.
    (Comment 49) Some comments suggest that farms with agricultural 
water systems that span long distances from source to point of delivery 
(such as some irrigation canals) will face challenges when preparing 
agricultural water assessments, as certain portions of the water 
system, such as those that relate to adjacent and nearby lands and/or 
other water users, may not be under the farm's control. A few comments 
suggest that additional clarity on how far upstream farms are required 
to consider impacts on their water systems would help, and request more 
information on what distance upstream farms are responsible for 
considering.
    (Response 49) We recognize that some farms have pre-harvest 
agricultural water systems with water sources and/or distribution 
systems, such as irrigation canals or rivers, that span long distances 
or are impacted by land uses covering a wide area. We further recognize 
that factors that can affect water sources, including those related to 
adjacent and nearby lands and/or other water users, may be outside of a 
farm's control.
    More broadly, due to the variability that exists in agricultural 
water systems and across different growing regions, including in the 
characteristics of water sources and the nature of potential sources of 
hazards, farms' consideration of other agricultural water users and/or 
adjacent or nearby lands will vary widely, include factors that may be 
outside of a farm's control, and will likely depend on each farm's 
unique agricultural water systems and growing operations. For example, 
the QAR (Ref. 17) found that the composition and chemistry of flowing 
waters can be expected to be largely influenced by their course through 
land used for purposes that may lead to their contamination and, 
potentially, to the contamination of produce exposed to those waters. 
As such, we do not consider it appropriate to prescribe a distance for 
which farms must consider factors that have the potential to impact 
their water quality.
    While we are not requiring farms to physically visit areas of an 
agricultural water system that are outside of their control, farms must 
include in their assessments information on sources of hazards (such as 
adjacent and nearby

[[Page 37480]]

land uses and other water users) that have the potential to result in 
contamination of covered produce or food contact surfaces with known or 
reasonably foreseeable hazards associated with agricultural water. We 
note that there are a variety of resources available to farms that may 
provide information as to the presence and nature of impacts that might 
affect the quality of their agricultural water. See response to comment 
51.
    (Comment 50) One comment requests that FDA revise the requirements 
for agricultural water assessments in proposed Sec.  112.43(a) to 
clarify that farms are only required to consider the degree of 
protection and/or adjacent and nearby land uses for surface water 
sources, and that only possible sources of contamination within the 
surface water's drainage basin need to be considered.
    (Response 50) We do not consider it appropriate to limit 
consideration for the degree of protection of an agricultural water 
system and/or adjacent and nearby land uses to surface water sources 
only, as doing so would not sufficiently capture the variety of water 
sources and potential sources of hazards that exist in industry. While 
surface water sources are generally more vulnerable to contamination, 
the potential for contaminants to be introduced to agricultural water 
is not limited to surface water (Ref. 17). For example, if a well is 
not sufficiently protected (for example, due to unprotected cross-
connections or from having an impaired well cap, seals, and/or casing), 
it may increase the likelihood of hazards being introduced to the 
water. Similarly, if the well is situated at a lower elevation than 
adjacent and nearby lands and is subject to runoff from those lands, it 
may be subject to the introduction of hazards. As occurrences such as 
these are important for farms to consider in complying with the 
requirements for pre-harvest agricultural water assessments, we decline 
to make the change suggested by the comment.
    (Comment 51) Some comments state that farms will face difficulties 
in getting information on factors that are outside of their control 
(for example, other users of water and adjacent and nearby lands), such 
as when those areas are not available for farms to access due to 
ownership or geographic barriers. A few comments indicate comfort 
speaking with neighbors about their land use(s), whereas other comments 
state that some farms may face challenges in obtaining information on 
adjacent and nearby lands due to land users either being unwilling to 
share information or providing incomplete or inaccurate information. 
Some of these comments request that farms should be able to assume 
that, in the absence of obvious evidence to the contrary, neighbors are 
following the law. One comment expresses a concern that situations 
could arise in which a neighbor informs a farm that they are 
appropriately controlling hazards but are not doing so, and seeks 
clarity as to whether the farm would be held responsible in this 
situation. While some comments acknowledge that there may be other 
sources of information on adjacent and nearby lands, a few suggest that 
some of these resources (such as visual observation and mapping tools) 
are inadequate because they cannot reveal all specific hazards.
    (Response 51) Farms are responsible for ensuring that all 
applicable requirements of subpart E are met, including the requirement 
in Sec.  112.41 that all agricultural water be safe and of adequate 
sanitary quality for its intended use. While farms are not required to 
physically visit areas of an agricultural water system that are outside 
of their control, in preparing an agricultural water assessment under 
Sec.  112.43, farms must include in their assessments information on 
sources of hazards (such as adjacent and nearby land uses and other 
water users) that have the potential to result in contamination of 
covered produce or food contact surfaces with known or reasonably 
foreseeable hazards associated with agricultural water.
    Although farms may consider working with adjacent and nearby land 
users in evaluating adjacent and nearby land uses under Sec.  
112.43(a), there are a variety of resources available that may provide 
insight as to the presence and nature of impacts that can affect the 
quality of agricultural water. For example, information can be acquired 
through visual observation, from local extension agents and/or industry 
associations, or from online resources such as mapping tools, which may 
provide helpful information on topography and proximity to potential 
sources of hazards. Depending on the water source being used, there may 
also be organizations or water management authorities, such as 
irrigation district managers, that can serve as a source of 
information. We are also aware of efforts underway to bring together 
members of agricultural communities on a large scale, such as through 
the CAN Initiative (Ref. 38), to further conversations and encourage 
discussions between land users in agricultural areas. Various action 
items have been identified as part of CAN, one of which entails steps 
that can be taken to foster neighbor-to-neighbor interactions and 
conversations (Ref. 39). See also response to comment 33. As efforts 
such as these progress, they too may serve as an additional source of 
information for meeting the requirements in Sec.  112.43. In some 
instances, farms may benefit from looking to a variety of resources to 
assist in their understanding of other water users and adjacent and 
nearby land uses to further inform their determinations under Sec.  
112.43(c) as to whether measures under Sec.  112.45 are reasonably 
necessary to reduce the potential for contamination of non-sprout 
covered produce or food contact surfaces with known or reasonably 
foreseeable hazards associated with pre-harvest agricultural water.
    We recognize that even with the variety of resources available to 
farms, farms may still face uncertainty with respect to other water 
users and adjacent and nearby lands that are outside of their control, 
such as if upstream users are not willing to share information. As 
discussed in the 2021 agricultural water proposed rule (86 FR 69120 at 
69137-69138), due to the nature of the risks associated with animal 
activity, BSAAOs, and untreated or partially treated human waste on 
adjacent and nearby lands, in the event of uncertainty, farms should 
consider accounting for the increased likelihood of hazard introduction 
to the water systems. Farms should use that information, particularly 
for surface water unprotected from runoff and in light of other factors 
evaluated under Sec.  112.43(a), in determining whether measures under 
Sec.  112.45 are reasonably necessary. See also response to comment 53.
    (Comment 52) Some comments suggest that when evaluating the degree 
of protection of each agricultural water system, farms may recognize 
riparian buffers and filtrating vegetation for their role in protection 
water from sources of contamination.
    (Response 52) We agree that buffers and filtrating vegetation, in 
addition to walls, earthen berms, ditches, or other barriers, may help 
minimize the influence of runoff on water sources and distribution 
systems. (See 86 FR 69120 at 69134 and 69136.) The comments did not 
request, nor are we requiring, farms to use any of these barriers in 
managing their identified risks. We further agree that there may be 
other mechanisms by which agricultural water systems are protected from 
possible sources of contamination via runoff, the impact of which farms 
may consider when

[[Page 37481]]

conducting their agricultural water assessments.
b. Adjacent and Nearby Land Uses
    (Comment 53) Several comments support the proposed rule's 
requirement for farms to assess adjacent and nearby land uses. 
Conversely, some comments assert that the proposed requirement that 
covered entities must evaluate adjacent and nearby land uses represents 
an unreasonable burden on farms. A few of these comments claim that if 
farms are not able to prove that adjacent or nearby land use does not 
pose a risk, they would be forced to assume risks are present and 
undertake potentially overly conservative or unnecessary mitigations. 
One comment requests that FDA include in the final rule an alternative 
option for achieving the requirement to evaluate adjacent and nearby 
land use, suggesting that a provision for a written explanation for why 
the adjacent and nearby lands cannot be assessed, combined with water 
testing, would suffice. Another comment suggests that adjacent and 
nearby lands should only be evaluated for certain high-risk activities, 
although, the comment notes, what is considered ``high risk'' is also 
dependent on the water source and crop being grown.
    (Response 53) As discussed in the 2021 agricultural water proposed 
rule (80 FR 74354 at 69126-69127), adjacent and nearby land uses have 
been identified as possible contributing factors in several produce 
outbreaks (Refs. 18-23, 58, 63 and 64). FDA's investigations of such 
outbreaks underscore the importance of pre-harvest agricultural water 
quality and the potential impacts of adjacent and nearby land uses on 
agricultural water, which can serve as a route of contamination of 
produce. The requirements we are finalizing with this rule are designed 
to address these concerns by requiring farms to evaluate adjacent and 
nearby land uses in preparing an agricultural water assessment under 
Sec.  112.43(a) and manage use of their pre-harvest agricultural water 
accordingly. As such, we decline to provide an alternative to the 
requirement that adjacent and nearby lands be evaluated under Sec.  
112.43(a) as part of an agricultural water assessment.
    Moreover, we are providing for expedited implementation of 
mitigation measures under Sec.  112.45(b) for known or reasonably 
foreseeable hazards related to certain adjacent and nearby land uses. 
We recognize that activities associated with adjacent or nearby lands 
that introduce known or reasonably foreseeable hazards into a water 
source or distribution system are often not under a farm's control. 
While the farm may not have control over those potential hazards at 
their point of introduction into a water source or system, the 
potential hazards are important for the farm to consider in making 
decisions about the use of agricultural water on covered produce. 
Therefore, for animal activities, BSAAOs, or untreated or partially 
treated human waste associated with adjacent and nearby lands, it is 
important that the farm not only implement mitigation measures that are 
under its control to reduce the risk associated with that water source 
or system, but that it do so on an expedited basis to protect public 
health.
    Many activities on adjacent or nearby lands may create or pose 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food contact 
surfaces, which farms must consider under Sec.  112.43(a) as part of an 
agricultural water assessment if applicable to their operations. 
Examples include other agricultural operations (such as land used for 
growing operations, animal grazing, dairy production, poultry 
production, barnyards, commercial animal feeding operations, and farms 
with working animals); composting sites; lands used for recreational 
activities (such as campgrounds); wastewater treatment facilities (or 
other potential sources of human waste like toilet facilities and 
sewage disposal systems); urban/suburban development activities; and 
lands with significant wildlife intrusion or habitat.
    We recognize that farms may face uncertainty around evaluating 
information related to adjacent and nearby land uses such as these, 
such as if upstream users are not willing to share information. As 
discussed in the 2021 proposed rule (86 FR 69120 at 69137-69138), in 
the event of uncertainty, due to the nature of the risks associated 
with animal activity, BSAAOs, and untreated or partially treated human 
waste on adjacent and nearby lands, farms should consider accounting 
for the increased likelihood of hazard introduction to the water 
systems from adjacent or nearby lands when making decisions around the 
use of their water. However, we disagree that this will ``force'' farms 
to assume risks are present and implement mitigation measures that 
might otherwise not be necessary. Rather, farms should consider the 
increased likelihood of hazard introduction from such adjacent and 
nearby land uses, in addition to other information evaluated in Sec.  
112.43(a)(1) through (5), in determining whether measures under Sec.  
112.45 are reasonably necessary. As a result, farms may find, for 
example, that in light of the information evaluated under Sec.  
112.43(a)(1) through (5), mitigation may not be reasonably necessary to 
address potential hazards from an adjacent or nearby land use.
    (Comment 54) Many comments request that FDA clarify the definition 
of and/or narrowly define ``adjacent and nearby lands'' in terms of 
distance, arguing that absent such a definition, it will be unclear 
what lands farms are responsible for considering. One comment notes 
that other food safety schemes define adjacent land as no CAFOs closer 
than 0.25 miles or 400 feet buffer from hobby farms. Another comment 
expresses concerns that in the Fall 2019 E. coli O157:H7 outbreak 
linked to romaine lettuce referenced in the proposed rule, the outbreak 
strain was found at a point nearly two miles upslope from the impacted 
farms, a distance the comment deems unreasonable for a farm to consider 
in its assessment.
    (Response 54) In the 2021 agricultural water proposed rule (86 FR 
69120 at 69135), we discussed ``adjacent and nearby lands'' with 
respect to agricultural water systems specifically, as adjacent and 
nearby lands may affect the safety of covered produce in ways not 
related to agricultural water, such as through movement of animals, 
equipment and tools, run-off into growing fields, and wind. We 
recognize that this may have led to uncertainty as to the lands that 
farms are required to consider for assessment purposes, and are 
clarifying that for the purposes of subpart E, by ``adjacent'' land we 
are referring to land sharing a common border with the farm's land. By 
``nearby'' land we are referring to a broader category of land, 
including land that does not adjoin the farm's land but has the 
potential to affect the farm's agricultural water systems(s) based on 
the land's location. For example, agricultural water may be affected by 
agricultural practices and runoff from those operations into surface 
water sources or open distribution systems that are used for 
agricultural water even if the operations' lands are not adjacent to a 
farm's land. See also 80 FR 74354 at 74433. Due to the diversity that 
exists in agricultural water systems and across different growing 
regions, what constitutes ``adjacent'' and ``nearby'' land will vary 
between farms and likely depend on each farm's unique agricultural 
water systems. As such, we do not consider it appropriate to prescribe 
an upstream distance for

[[Page 37482]]

which farms must consider uses of adjacent and nearby lands. See also 
response to comment 49.
c. Animal Impacts and Activities
    (Comment 55) Several comments seek clarity on how a farm should 
translate evidence of animal activity (e.g., scat from unidentified 
animals, tracks without scat, or damaged irrigation pipes from an 
unidentified animal) into risk, noting that different animals and 
animal activities represent different levels of risk to water safety. 
One comment expressed a concern that the requirement for farms to 
consider animal activity may lead to the outcome that a farm with any 
animal activity nearby will be expected to implement significant safety 
measures.
    (Response 55) Examples of relevant factors for evaluating the 
degree of protection of agricultural water systems from potential 
sources of contamination associated with animals under Sec.  
112.43(a)(1)(iii) include, but are not limited to, the following:
     The presence and location of any animal activities, such 
as whether there are areas in which animals might be in close proximity 
and/or have direct access to pre-harvest agricultural water systems 
(such as for loafing or drinking). Included in this is consideration 
for any fencing, containment, or other measures that may affect animal 
access to agricultural water systems;
     The presence and location of potential attractants and 
habitats (such as heavy vegetation, wooded areas, water sources, or 
standing water) that may draw animals to agricultural water systems;
     Whether runoff into agricultural water systems from lands 
currently or historically associated with animals is likely to occur, 
including whether there are earthen diversion berms, ditches, or other 
barriers that minimize runoff;
     Whether animals have access to areas relevant to 
agricultural water systems at times when pre-harvest agricultural water 
is being applied to non-sprout covered produce; and
     Whether any systems or structures are in place to handle, 
convey, or store animal waste (such as animal stalls, composting piles, 
pits, manure lagoons, or other waste containment structures or systems) 
that may serve as a possible source of contamination to agricultural 
water systems. Included in this, for example, is whether vehicles 
carrying animal waste follow traffic patterns that may result in the 
introduction of known or reasonably foreseeable hazards from the animal 
waste to agricultural water systems.
    As discussed in the 2021 proposed rule, visual observations by a 
farm for purposes of Sec. Sec.  112.81-112.83 in subpart I, 
``Domesticated and Wild Animals'' of the 2015 produce safety final rule 
may provide useful information for evaluating the degree of protection 
of a pre-harvest agricultural water system under Sec.  
112.43(a)(1)(iii) (86 FR 69120 at 69135). Additionally, a farm may be 
aware of potential animal impacts on agricultural water systems through 
inspections and maintenance performed on agricultural water sources and 
agricultural water systems it controls under Sec.  112.42, which we did 
not propose to change. For example, pooled water in close proximity to 
the crop may serve as an attractant for pests and other animals which 
may in turn introduce hazards into pooled water that may contaminate 
produce. (See 80 FR 74354 at 74434.)
    Given the diversity that exists across industry in water systems, 
operations, and conditions, we do not expect that every animal impact 
or activity will require that corrective or mitigation measures be 
implemented under Sec.  112.45. While farms are required to evaluate 
the degree of protection of an agricultural water system from possible 
sources of contamination including animal impacts and adjacent and 
nearby land uses related to animal activity, they are required to 
consider that information, along with the other factors evaluated under 
Sec.  112.43(a)(1) through (5), in determining whether measures under 
Sec.  112.45 are reasonably necessary.
    (Comment 56) One comment suggests that farms should take the type 
of animal activity into account when evaluating risks as part of an 
agricultural water assessment. For example, the comment asserts that 
management techniques such as prescribed grazing can result in less 
opportunity for contamination of water via runoff compared to CAFOs, 
since fecal matter is dispersed across a larger area of land where 
prescribed grazing occurs. The comment also states that dispersed feces 
in areas used for prescribed grazing are more likely to be inactivated 
by the sun's UV rays versus feces at a CAFO.
    (Response 56) The risk posed by animal activities to a farm's 
agricultural water systems may depend on various factors and are not 
limited only to animal activities with high densities of animals, such 
as CAFOs. Animal activities have the potential to serve as a source of 
human pathogens, and depending on the circumstances, may introduce 
hazards to agricultural water systems (Ref. 17). Animal activities can 
include those related to wildlife (e.g., birds or deer); animal 
intrusion, domesticated companion animals (e.g., dogs, cats); animals 
for protection (e.g., guard dogs); working animals (e.g., horses, 
mules); grazing animals; livestock (including CAFOs); poultry 
production; dairy production; and barnyards.
    For example, as discussed in the 2021 agricultural water proposed 
rule (86 FR 69120 at 69125-69127), in the fall 2018 E. coli O157:H7 
outbreak linked to romaine lettuce from California (Ref. 20), 
investigators noted that extensive wild animal activity in the area and 
animal grazing on nearby land by cattle and horses, among other things, 
may have served as potential sources of hazards. Similarly, in the fall 
2019 E. coli O157:H7 outbreaks linked to romaine lettuce (Ref. 21), 
investigators observed cattle grazing land in the hills above leafy 
greens fields, with numbers of cattle far lower than the volume of what 
is considered a large CAFO. As discussed in the QAR (Ref. 17), exposure 
of produce to hazards from animals may occur, among other means, 
through runoff that enters the growing area and contaminated 
agricultural water. As such, we consider it important for farms to 
consider various animal impacts and activities, not just those related 
to CAFOs, for the potential to serve as sources of known or reasonably 
foreseeable hazards that may be introduced into an agricultural water 
system and contaminate covered produce.
d. BSAAOs
    (Comment 57) One comment requests more information on what FDA 
would consider to be ``high risk'' regarding agricultural water and the 
use of BSAAOs.
    (Response 57) As discussed in response to comment 31, given the 
diversity across farms, ``risk'' related to BSAAOs will vary. For 
example, the QAR (Ref. 17) concluded that composting is less likely 
than controlled chemical or physical treatments to fully eliminate 
human pathogens from animal waste; incompletely treated, or re-
contaminated, BSAAOs may contain human pathogens; and biological soil 
amendments can transmit human pathogens to surface water or ground 
water when stockpiled or applied to fields. The use of BSAAOs both by 
the farm and by users of adjacent and nearby lands are factors to 
consider for purposes of an agricultural water assessment under Sec.  
112.43(a), and in making a risk management determination under Sec.  
112.43. We intend farms to consider information relevant to their 
specific circumstances

[[Page 37483]]

in evaluating the various factors under Sec.  112.43(a).
    Examples of relevant factors for evaluating the degree of 
protection of agricultural water systems from potential sources of 
contamination associated with BSAAOs include, but are not limited to, 
the following:
     The location and proximity of areas where BSAAOs are held 
or applied to land in relation to agricultural water systems;
     Whether runoff or tailwater returns into agricultural 
water systems from areas where BSAAOs are held or applied to land is 
likely to occur, including whether there are earthen diversion berms, 
ditches, or other barriers that minimize runoff;
     Whether the BSAAOs are treated and to what extent;
     Whether BSAAOs are applied to the land during times when 
pre-harvest agricultural water is being applied to non-sprout covered 
produce; and
     Whether any systems or structures are in place to handle, 
convey, and store BSAAOs (such as composting piles, pits, manure 
lagoons, or other waste containment structures or systems) that may 
serve as a possible source of contamination to agricultural water 
systems. Included in this, for example, is whether vehicles carrying 
BSAAOs follow traffic patterns that may result in the introduction of 
known or reasonably foreseeable hazards from the BSAAOs to agricultural 
water systems.
    For farms subject to the 2015 produce safety final rule, we note 
that requirements in subpart F of part 112 (Sec. Sec.  112.51-112.60) 
may apply, including Sec.  112.52(a), which requires that farms handle, 
convey, and store any BSAAO in a manner and location such that it does 
not become a potential source of contamination to water sources and 
water distribution systems.
    (Comment 58) One comment seeks clarity as to whether there are 
``specifications'' for the use of BSAAOs and different types of 
irrigation methods under the proposed rule.
    (Response 58) It is unclear to us what type of ``specification'' 
the commenter is referring to. However, we note that this rule does not 
establish requirements for allowable pre-harvest agricultural water 
application methods based on the source of known or reasonably 
foreseeable hazards to an agricultural water system. Farms remain 
responsible for ensuring that all applicable requirements are met, 
including the requirement in Sec.  112.41 that all agricultural water 
be safe and of adequate sanitary quality for its intended use.
e. Untreated and Improperly Treated Human Waste
    (Comment 59) Some comments address the requirement in Sec.  
112.43(a)(1) to consider the degree of protection from possible sources 
of contamination, including untreated or partially treated human waste. 
One comment pertains to the regulations laid out in 40 CFR part 503 
related to land applied biosolids, and suggest that the applications of 
treated municipal biosolids to land can be safely done. Conversely, 
other comments suggest that application of biosolids from municipal or 
industrial sources requires further evaluation and/or research as it 
relates to impacts on agricultural water and produce safety. One 
comment opposes the land application of municipal wastewater sludge and 
industrial waste (for example, slaughterhouse sludge), suggesting that 
there should be restrictions for the use of such materials on crops and 
that land applications of those materials may serve as a source of 
contamination to water sources.
    (Response 59) As described in the QAR (Ref. 17), human waste may 
contain pathogens in relatively high concentrations. Runoff associated 
with human waste from adjacent and nearby lands may contaminate sources 
or distribution systems for pre-harvest agricultural water for non-
sprout covered produce. As discussed in the 2021 agricultural water 
proposed rule (86 FR 69120 at 69137), an evaluation of hazards 
associated with untreated or improperly treated human waste can include 
consideration of potential sources of contamination such as toilet 
facilities (portable and fixed), sewage systems, sewer overflows, 
septic tanks, and drain fields. 86 FR 69120 at 69137.
    With respect to comments relating to land applications of treated 
sewage sludge (biosolids) and/or industrial waste (such as from 
slaughterhouses), we note that such comments are outside the scope of 
this rulemaking. Rather, as part of a pre-harvest agricultural water 
assessment under Sec.  112.43(a), farms are required to identify 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce (other than sprouts) 
or food contact surfaces based on an evaluation of various factors, 
including the degree of protection of each agricultural water system 
from possible sources of contamination (Sec.  112.43(a)(1)(iii)). As 
part of this evaluation, farms consider the presence of potential 
sources of hazards (such as land applications of such materials); the 
likelihood of those hazards being introduced to their water systems 
(such as through runoff or seepage); and together with the other 
information evaluated in Sec.  112.43(a)(1) through (5), make a 
determination as to whether measures are reasonably necessary to reduce 
the potential for contamination of covered produce or food contact 
surfaces from hazards associated with pre-harvest agricultural water.
    We emphasize that other provisions of the 2015 produce safety final 
rule that we did not propose to change, including the prohibition on 
the use of human waste for growing covered produce (except sewage 
sludge biosolids used in accordance with the requirements of 40 CFR 
part 503, subpart D, or equivalent regulatory requirements) (Sec.  
112.53), continue to apply.
    It is important for farms to consider the increased likelihood of 
hazard introduction to their agricultural water systems for any land 
applications of materials such as treated sewage sludge (biosolids) and 
industrial wastes, because those materials may serve as a source of 
known or reasonably foreseeable hazards that can be introduced into an 
agricultural water system (such as through runoff). Farms should 
consider the increased likelihood of hazard introduction to their 
agricultural water systems, particularly for surface water unprotected 
from runoff and in light of other factors evaluated under Sec.  
112.43(a), in determining whether measures are reasonably necessary 
under Sec.  112.45.
f. Other Water Users
    (Comment 60) Several comments address FDA's request for comment on 
water reuse for pre-harvest agricultural water. Some comments state 
that reused water can be used as safely as other types of water and may 
help farms faced with dwindling water supplies from other sources. A 
few of these comments specifically suggest that wastewater can be 
treated to be ``fit for purpose,'' in which it is treated to a level 
that is safe for a specific use on irrigated food crops. Some comments 
also note that the requirements related to quality and use of pre-
harvest agricultural water in Sec. Sec.  112.41, 112.42, and 112.43 are 
appropriate to apply for all types of water. However, a few comments 
suggest that reused water should be subject to testing before being 
used as pre-harvest water. Another comment requests that FDA clarify in 
the final rule and in subsequent guidance that untreated or improperly 
treated human waste is not present in treated recycled wastewater 
because water recycling includes proper treatment of human

[[Page 37484]]

waste. The comment suggests that without additional guidance from FDA, 
a farm may interpret using a recycled water source as inherently risky 
even when it is not.
    (Response 60) As discussed in the 2021 agricultural water proposed 
rule (86 FR 69120 at 69134-69135), the requirements for agricultural 
water quality in Sec. Sec.  112.41 and 112.43 apply regardless of the 
source or type of water used as agricultural water. Thus, a farm must 
determine the appropriate use of the recycled water in light of the 
conditions and practices on the farm by assessment as required under 
Sec.  112.43, taking into account the standard in Sec.  112.41 that all 
agricultural water must be safe and of adequate sanitary quality for 
its intended use. As comments suggest, farms also need to ensure that 
all other applicable requirements in subpart E are met, including those 
in Sec.  112.42 for inspection and maintenance of agricultural water 
systems to the extent they are under a farm's control, the results of 
which farms will consider in preparing an agricultural water assessment 
under Sec.  112.43(a).
    We are not aware of, and comments did not provide, data or 
information suggesting the need to require that all recycled or reused 
water be tested to adequately complete an agricultural water 
assessment. Therefore, consistent with our mandate to establish 
science-based minimum standards, including procedures, processes, and 
practices that are reasonably necessary to prevent introduction of 
hazards and provide reasonable assurances produce is not adulterated 
under section 402 of the FD&C Act, we are not establishing separate 
requirements related to testing or quantitative thresholds for water 
reuse. Users of such water, if appropriate, may test that water as one 
part of an assessment under Sec.  112.43(d). While we provide examples 
of scientifically valid microbial criteria and sampling frequencies in 
our responses to comment 95 and comment 93, respectively, we expect 
that as the science evolves and more information is learned about 
unique considerations relevant to certain sources of water (such as 
water reuse), such information may be incorporated in future guidance.
    We also recognize that some suppliers of recycled water (for 
example, a public utility), may furnish information on the water's 
microbial quality which can be considered while preparing agricultural 
water assessments and determining whether measures are reasonably 
necessary under Sec.  112.45.
2. Agricultural Water Practices
    (Comment 61) Some comments address the requirement in proposed 
Sec.  112.43(a)(2) that farms assess the time interval between the last 
direct application of agricultural water and harvest of the covered 
produce. These comments suggest that agricultural water used early in 
the production cycle is less risky than water used closer to harvest 
and request that FDA recognize this variation in risk when evaluating 
farms' assessments and records. Other comments note the variability in 
application-to-harvest intervals that exist across industry. For 
example, some comments note that for certain crops, agricultural water 
needs to be applied right up until harvest, whereas for other crops, 
there may be more flexibility as to the timing of the last water 
application. Others cite challenges associated with assessing the 
interval between the last direct application of agricultural water and 
harvest. These comments note that in some instances, the harvest date 
and/or the last water application is established by the shipper, and 
that such decisions may not be made until right before harvest.
    (Response 61) As explained in the QAR (Ref. 17), the timing of 
water application is an important factor in determining the likelihood 
of contamination of produce, because many pathogens die off over time 
on the surface of produce. Generally, bacteria or pathogens in water 
that is applied early in the growing cycle are subject to die-off from 
several environmental forces, such as UV exposure, temperature, 
humidity, and the presence of competitive organisms (Ref. 65). In 
contrast, pathogens present in agricultural water that is applied 
shortly before harvest may not be exposed to the same environmental 
conditions for sufficient time to provide a similar magnitude of die-
off (Ref. 17). We recognize that the time interval between last direct 
application of agricultural water and harvest is likely to vary widely 
across industry, and as such, each farm must capture the practices 
unique to its operation within its agricultural water assessments and 
use that information, alongside the other factors evaluated under Sec.  
112.43(a), in determining whether measures are reasonably necessary to 
reduce the potential for contamination of covered produce (other than 
sprouts) or food contact surfaces with known or reasonably foreseeable 
hazards associated with the farm's pre-harvest agricultural water.
    Further, we recognize that there may be some instances in which 
there is uncertainty as to what the time interval between last 
application of agricultural water and harvest will be. In such 
instances, farms may use their previous experience and knowledge of 
agronomic practices to provide an estimate in their agricultural water 
assessment as to what the expected interval might be. For example, if a 
farm knows that the last water application generally occurs 1 to 2 
weeks before harvest, even though the precise interval may vary and not 
be known until right before harvest, the farm may note that in its 
agricultural water assessment and use that information alongside other 
factors evaluated in Sec.  112.43(a) in making decisions regarding use 
of its pre-harvest agricultural water.
3. Crop Characteristics
    (Comment 62) Many comments address the proposed requirement in 
Sec.  112.43(a)(3) that farms evaluate crop characteristics as part of 
their agricultural water assessments. Several comments seek 
clarification from FDA that characteristics of the crop include aspects 
beyond what is explicitly listed in the preamble of the proposed rule, 
such as whether the crop is grown in a manner that is exposed to pooled 
water or wet soil, whether it supports the growth of foodborne 
pathogens, and whether it has historically been linked to outbreaks 
where pre-harvest water use was a known or suspected route to 
contamination.
    (Response 62) Section Sec.  112.43(a)(3) requires farms to evaluate 
crop characteristics, including the susceptibility of the covered 
produce to surface adhesion or internalization of hazards, as part of 
their agricultural water assessments. Crop characteristics that a farm 
considers may extend beyond those provided as examples in Sec.  
112.43(a)(3), which we are finalizing as proposed, without changes. For 
example, a farm may have information suggesting that characteristics of 
its covered produce support the attachment, survival and/or growth of 
pathogens that may be introduced via agricultural water. We also note 
that contact between covered produce and pooled water is addressed in 
Sec.  112.42(b)(4), which we did not propose to substantively revise. 
Section 112.42(b)(4) requires that farms, as necessary and appropriate, 
implement measures reasonably necessary to reduce the potential for 
contamination of covered produce resulting from contact of covered 
produce with pooled water.
    We emphasize that absence of a history of outbreaks associated with 
a particular commodity should not be

[[Page 37485]]

relied upon as being indicative of that commodity having 
characteristics that inherently make it ``safe''. For example, in our 
investigation of the summer 2020 outbreak of Salmonella Newport linked 
to red onions, we noted that the outbreak was remarkable because the 
food vehicle, whole red onions, is a raw agricultural commodity that 
had not been previously associated with a foodborne illness outbreak 
(Ref. 23). Although a conclusive root cause could not be identified, 
several potential contributing factors were identified, including a 
leading hypothesis that contaminated irrigation water used in a growing 
field may have led to contamination of the onions.
    (Comment 63) Several comments oppose the proposed requirement in 
Sec.  112.43(a)(3) that farms identify and assess crop characteristics 
in their agricultural water assessments and recommend that assessment 
of crop characteristics be included in guidance and/or training 
programs instead, rather than as enforceable requirements in the final 
rule. Some comments request that FDA provide research support and 
scientific information on characteristics that do, or do not, make a 
crop more susceptible to contamination. A few comments note that crop 
characteristics are not a factor in other produce safety programs, such 
as the Leafy Greens Marketing Agreement (LGMA) metrics, noting that 
under the assessment that LGMA requires, leafy greens are treated 
equal, and water should be of adequate quality for its intended use no 
matter what covered produce crop is being grown.
    (Response 63) All agricultural water must be safe and of adequate 
sanitary quality for its intended use (Sec.  112.41), and we consider 
that evaluating crop characteristics, alongside other factors 
identified in Sec.  112.43(a), as part of a farm's agricultural water 
assessment will assist farms in determining whether this standard is 
met.
    While the QAR concluded that using crop physical characteristics 
alone seems to be a poor indicator of which commodities are at a 
greater or lesser likelihood of contamination that may lead to a 
foodborne outbreak, it also explains that where contamination of a 
water source is known to exist, the likelihood of contamination is a 
function of various factors, including contact with the commodity, 
commodity effects (characteristics), and application timing (Ref. 17). 
Moreover, in the 1998 Good Agricultural Practices (GAPs) Guide (Ref. 
59), we explain that produce that has a large surface area (such as 
leafy vegetables) and produce with topographical features (such as 
rough surfaces) that foster attachment or entrapment may be at greater 
risk from pathogens, if they are present, especially if contact with 
agricultural water occurs close to harvest or during post-harvest 
handling. Studies have also shown that the contamination of produce by 
contact with irrigation water is dependent, in part, on the physical 
properties of the plant, such as surface texture (Ref. 66). Moreover, 
survival of pathogens on produce is known to be enhanced if the 
epidermal barrier has been broken by physical damage, such as punctures 
or bruising, or by degradation by plant pathogens or spoilage organisms 
(Refs. 67 and 68).
    In light of the foregoing, we have concluded that there is 
sufficient evidence of the effect of crop characteristics on the safety 
of covered produce to which agricultural water is applied; therefore, 
and we are not removing crop characteristics as one of the factors 
farms are required to evaluate under Sec.  112.43(a). Peer-reviewed 
literature, cooperative extension, and academic or trade organization 
research may serve as additional sources of information on the effect 
of crop characteristics on pre-harvest agricultural water.
    (Comment 64) Several comments assert that the crop characteristics 
listed in the preamble of FDA's proposed rule are not specific to water 
and therefore are outside the scope of the proposed rule. For instance, 
one comment asserts that crop characteristics contribute to risks 
related to cultivation, harvesting, packing, and holding practices as a 
whole and not to agricultural water in particular. The comment 
recommends that if FDA intends to retain crop characteristics as a 
factor in the final rule related to agricultural water, the Agency 
should explicitly state that consideration of crop characteristics is 
limited to how the characteristics relate to potential contamination 
from direct application of agricultural water.
    (Response 64) We disagree that including consideration of crop 
characteristics as part of a farm's agricultural water assessment under 
Sec.  112.43(a) is outside the scope of this rulemaking, as crop 
characteristics have long been identified as a factor influencing the 
potential for water to contaminate produce (see response to comment 
63). However, we recognize that not all crop characteristics may be 
relevant to potential contamination of covered produce by agricultural 
water, and we emphasize that farms are only required to evaluate those 
characteristics that might influence the safety of covered produce in 
light of a farm's pre-harvest agricultural water.
    (Comment 65) Several comments suggest that the inclusion of crop 
characteristics in agricultural water assessments will result in 
confusion, because, the comments claim, crop characteristics are only 
relevant to consider if an agricultural water source is already 
contaminated. For example, comments suggest that crop characteristics 
are only relevant to agricultural water use if the agricultural water 
is not of adequate sanitary quality and, therefore, the farm would 
already need to undertake mitigation measures independent of crop 
characteristics.
    (Response 65) We disagree that crop characteristics are only 
relevant to consider if a farm has already determined that water is not 
safe or not of adequate sanitary quality for its intended use. As 
discussed in the 2013 proposed rule, the principle of ``safe and of 
adequate sanitary quality for its intended use'' contains elements 
related both to the attributes of the source water used and the 
activity, practice, or use of the water. The way in which water is used 
for different commodities and agricultural practices can affect the 
risk of contamination of the produce. 78 FR 3504 at 3563. While the QAR 
concluded that crop physical characteristics alone seems to be a poor 
indicator of which commodities are at a greater or lesser likelihood of 
contamination that may lead to a foodborne outbreak (Ref. 17), 
consideration of various factors that play a role in the safety and 
quality of pre-harvest agricultural water on covered produce, of which 
crop characteristics is only one, will assist farms in making decisions 
around the use of their pre-harvest agricultural water. As such, farms 
are required to consider crop characteristics, in conjunction with each 
other factor in Sec.  112.43(a)(1) through (5), in determining whether 
measures are reasonably necessary under Sec.  112.45.
    (Comment 66) A number of comments note that many farms grow a wide 
variety of crops and suggest that it would be burdensome and time-
intensive for a farm to assess susceptibility for all crops, 
particularly for crops for which limited scientific data on 
susceptibility exists. Some question whether farms need to conduct 
separate assessments for each commodity they grow. One comment notes 
that some farms change what commodities they grow frequently, 
suggesting that requiring the farm to prepare an assessment with each 
change in commodity will be burdensome.
    (Response 66) Farms have the flexibility to evaluate crop 
characteristics in Sec.  112.43(a)(3) as appropriate given their pre-
harvest

[[Page 37486]]

agricultural water uses and growing operations. For example, while we 
recognize that some farms may be growing multiple types of crops using 
the same agricultural water system, in some instances, crops may have 
similar characteristics such that the farm may group them based on 
broad similarities. For example, a farm that grows multiple types of 
leafy greens may assess the characteristics of all types at once, 
noting, for example, the large, rough surface area that may increase 
the likelihood of contaminants being trapped and surviving for extended 
periods of time. Similarly, a farm that grows oranges, mandarins, and 
lemons may assess the characteristics of citrus fruit in general. To 
the extent that a single commodity may have a unique factor that sets 
them apart from the others, the farm may choose to note that unique 
characteristic within its agricultural water assessment, rather than 
establishing a separate evaluation for that one crop. For example, a 
farm might explain whether one type of leafy green is particularly 
susceptible to physical damage that has the potential to result in 
survival and/or growth of pathogens, if introduced.
    Farms that change crops frequently are likely aware of what 
commodities (or types of commodities) it is reasonably likely they may 
grow. This knowledge, along with practices such as grouping crops based 
on similarities in characteristics as discussed above, will assist 
farms in efficiently evaluating crop characteristics as part of their 
assessments. Further, in the instance where a farm does begin growing a 
commodity whose characteristics were not already evaluated as part of 
its agricultural water assessment, we note that reassessments under 
Sec.  112.43[euro] must evaluate any factors and conditions affected by 
the change. As such, a farm's reassessment in light of a new crop may 
be more limited in scope than if a farm were to prepare a completely 
new assessment under Sec.  112.43(a).
    (Comment 67) One comment suggests that for some covered produce 
grown in hydroponic systems (such as green onions and lettuce), human 
pathogens may be internalized via plant roots and translocated 
throughout the plant. The comment also suggests that surface 
characteristics of some crops grown in hydroponic systems, such a 
lettuce, are also applicable to consider as part of an agricultural 
water assessment, as hydroponic lettuce leaves have been shown to be 
suitable for attachment of Listeria.
    (Response 67) We recognize that CEA operations have unique 
considerations compared to more traditional outdoor growing operations. 
We agree that in a CEA operation, crop characteristics may affect the 
safety of the covered produce if contaminants are introduced via 
agricultural water. As such, farms must consider crop characteristics 
as part of their agricultural water assessments under Sec.  112.43(a). 
In response to comment 63, we provide general information on crop 
characteristics relevant to agricultural water assessments for non-
sprout covered produce. We agree that if a farm has information 
reflective of its unique conditions regarding the effect of crop 
characteristics on the safety of covered produce to which agricultural 
water is applied--for example, in the case of hydroponic operations, 
studies demonstrating crop characteristics that are particularly 
relevant to practices used in such operations--then that too is 
relevant to the farm's agricultural water assessment.
4. Environmental Conditions
    (Comment 68) Many comments address the requirement in Sec.  
112.43(a)(4) that an evaluation of environmental conditions be included 
in a farm's agricultural water assessment. A few comments suggest that 
weather conditions can be relatively easily evaluated as part of the 
agricultural water assessment and that basic information regarding 
controlling hazards from weather events is already included in grower 
training courses. In contrast, some comments express concerns, 
suggesting that such a requirement is an unreasonable burden on farms 
that, the comments state, would have to obtain information on years of 
weather history, travel great distances to obtain information from U.S. 
Weather Service-approved stations, or access scientific journals for 
relevant data. Some comments suggest that scientific information on 
environmental impacts on produce safety is limited or nonexistent and 
it is unreasonable, therefore, to expect farms to evaluate it. Several 
comments seek clarity on how FDA will evaluate whether environmental 
factors have been sufficiently considered in the agricultural water 
assessment.
    (Response 68) We considered the comments and are finalizing Sec.  
112.43(a)(4) as proposed, without changes. As described in the QAR 
(Ref. 17), survival of pathogens in the environment is influenced by 
complex physical, chemical, and biological interactions. Generally, 
bacteria or pathogens in water that is applied early in the growing 
cycle are subject to die-off from several environmental forces, such as 
UV exposure, temperature, and humidity (Ref. 65). Changes in 
temperature and seasonality are expected to impact persistence of 
foodborne pathogens in the environment (Ref. 68). Seasonal changes in 
rainfall--particularly heavy rainfall and flooding events--can greatly 
affect surface water quality (Refs. 69 and 70) and may result in 
sediments, which can serve as reservoirs for pathogens, being dispersed 
within the water column (Ref. 71). Airborne transmission may also 
result in contamination of the environment--such as agricultural water 
and growing areas--particularly when dry, windy conditions are present 
(Ref. 72). Moreover, weather events, such as freezing or hail, can 
result in physical damage to the epidermal barrier or produce (e.g., 
punctures or bruising), that may allow for survival of pathogens on 
produce (Refs. 67 and 68). See the 2021 agricultural water proposed 
rule at 86 FR 69120 at 69138-69139.
    In many instances, farms will be able to use their previous 
experience and knowledge of their growing region to assess the 
environmental conditions for their agricultural water assessment. For 
example, many farms already take weather and climatic conditions into 
account when making management decisions for the crops they grow, and 
when and how those plants are planted and harvested. We do not expect 
farms to obtain detailed reports of local conditions, conduct complex 
scientific analyses of weather events, or travel to weather stations in 
order to obtain such information. Rather, knowledge of general trends, 
such as the identification of wet seasons, average monthly 
temperatures, and seasonal trends in sun exposure, will likely provide 
farms with adequate information for their agricultural water 
assessment. If a farm is new to the growing region, the farm can obtain 
relevant information on environmental conditions from internet 
resources (such as average monthly temperatures and rainfall), 
cooperative extension, and other local resources.
    (Comment 69) One comment notes that the weather in their area 
varies significantly by season (e.g., a rainy season and a dry season) 
and seeks clarity on whether FDA expects farms to take different 
measures depending on the season. Several comments suggest that weather 
is unpredictable, for example, due to effects of climate change, and 
request clarity on how this should be accounted for in an agricultural 
water assessment. One comment seeks clarity about whether 1 year of 
historical weather data is enough, and why historical data can be

[[Page 37487]]

used to inform a current plan if weather can be variable year to year. 
Several comments assert that the proposed rule fails to adequately 
define environmental conditions (e.g., ``regular weather'', ``extreme 
weather events'', and ``heavy rain''), making it difficult for farms to 
assess actual risk and for inspectors to consistently evaluate 
compliance. Several comments seek clarity on how a farm should assess 
rare weather events versus routine weather events, and seek guidance on 
what constitutes an unusual weather event and successful strategies for 
managing risks associated with different weather patterns that can 
occur by region.
    (Response 69) We recognize that weather is likely to vary both 
seasonally and year-to-year and expect that farms will take this 
variability into account for their agricultural water assessment and 
determinations under Sec.  112.45. For example, if a farm identifies 
February through May as a rainy season, the farm may determine, 
alongside the other factors evaluated under Sec.  112.43(a), that 
measures are reasonably necessary under Sec.  112.45 during that time 
due to concern over rainfall introducing hazards to its agricultural 
water system via runoff and/or by stirring up sediments. However, the 
farm may determine that measures are not reasonably necessary during 
other times of the year, when rainfall is not as likely to impact its 
agricultural water system(s). Conversely, a farm may determine that its 
rainy season occurs early enough in the growing season that, considered 
alongside the other factors evaluated under Sec.  112.43(a), measures 
may not be reasonably necessary. In the event a farm determines that 
corrective or mitigation measures are reasonably necessary in relation 
to an environmental condition, what measures are appropriate will 
largely depend on the nature of the other factors evaluated under Sec.  
112.43(a). For example, depending on a farm's water use practices and 
crop characteristics, the farm may find it appropriate to change the 
water application method under Sec.  112.43(b)(1)(iv) in response to 
hazards that may be introduced as a result of an environmental 
condition. See response to comment 113 for discussion regarding 
mitigation measures following environmental events.
    In most instances, farms will be able to use their previous 
experience and historical knowledge of their growing region to assess 
not only general ``routine'' trends in environmental conditions (e.g., 
yearly seasonal patterns in sun exposure), but also those conditions 
that might happen on a less frequent basis, but that nonetheless have 
the potential to impact their agricultural water systems or covered 
produce (e.g., hurricanes, heavy winds, or rains that otherwise may 
occur on occasion). By recognizing these events within their 
agricultural water assessments, farms will be able to develop a plan to 
ensure the safety and quality of their pre-harvest agricultural water 
in the instance that such events do occur. However, we recognize that 
farms will not be able to anticipate every environmental condition that 
occurs. If an unanticipated environmental event occurs that is not 
already addressed within a farm's agricultural water assessment, the 
farm must consider whether it results in a significant change that 
necessitates a reassessment under Sec.  112.43(e). For example, an 
earthquake that impairs a farm's piped distribution system, or series 
of atmospheric river events that repeatedly impact a farm's 
agricultural water system over a period of time, may necessitate a 
reassessment under Sec.  112.43(e), depending on the circumstances. See 
also response to comment 100.
    (Comment 70) Some comments suggest that by including the phrase 
``or covered produce'' in proposed Sec.  112.43(a)(4), FDA is requiring 
a farm to evaluate how environmental conditions affect each crop, 
independent of how the environmental conditions impact an agricultural 
water system. These comments contend that any requirement to evaluate 
how environmental conditions affects crops is outside the scope of 
Subpart E. Several comments suggest that environmental considerations 
are better addressed through guidance, training, or education.
    (Response 70) We disagree that an evaluation of environmental 
conditions that may impact covered produce is outside the scope of this 
rulemaking, because some environmental conditions may have a direct 
effect on the susceptibility of the covered produce to surface adhesion 
or internalization of hazards from agricultural water. (See also the 
requirement in Sec.  112.43(a)(3) to consider crop characteristics as 
part of an agricultural water assessment.) For example, if a weather 
event results in physical damage to a crop (such as if hail results in 
punctures or bruising), it may increase the susceptibility to survival 
of pathogens on the produce, if introduced by agricultural water (Ref. 
68). As such, we continue to find it appropriate to require farms to 
consider environmental conditions that impact covered produce as part 
of their agricultural water assessments. However, we recognize that not 
all environmental conditions that affect covered produce may be 
relevant to potential contamination of covered produce by agricultural 
water, and we emphasize that farms are only required to evaluate those 
environmental conditions that may be relevant in light of a farm's pre-
harvest agricultural water use.
    (Comment 71) One comment asserts that weather and climate 
conditions vary by region, and it is unreasonable to expect farmers in 
one area of the country be required to account for potential weather 
events that do not apply to their region.
    (Response 71) We do not expect farms to evaluate environmental 
conditions not relevant to their agricultural water systems and pre-
harvest agricultural water use. As such, a farm in one region is not 
required to consider weather events that occur in another region, if 
the other region's weather is not relevant to the farm.
    (Comment 72) One question seeks clarity on what FDA is looking for 
in terms of air temperatures and sun exposure. Specifically, the 
comment seeks clarity on whether a farm will need to provide separate 
assessments for each field depending on its sun exposure.
    (Response 72) The requirements in Sec.  112.43(a) to prepare an 
agricultural water assessment are specific to each agricultural water 
system that a farm uses for pre-harvest agricultural water. As such, 
farms are not necessarily required to prepare a separate agricultural 
water assessment for each field they use to grow covered produce. 
(However, if, for example, a farm uses different agricultural water 
systems for different fields, the farm is required to prepare an 
agricultural water assessment for each of those systems in accordance 
with Sec.  112.43(a).)
    To the extent that different fields are exposed to varying degrees 
of sun exposure and temperature, the farm may note as much within its 
agricultural water assessment. Farms may find such information 
particularly helpful in considering the appropriateness of relying on 
in-field microbial die-off as a mitigation measure, if they determine 
mitigation measures under Sec.  112.45(b) are reasonably necessary and 
increase the time interval between last direct water application and 
harvest as a result.
    (Comment 73) Some comments seek clarity on how a farm should assess 
heavy rain that occurs several miles upstream.
    (Response 73) Factors to consider in assessing heavy rains as part 
of an agricultural water assessment include,

[[Page 37488]]

but are not limited to, the frequency of such events occurring; whether 
the rain event is reasonably likely to introduce known or reasonably 
foreseeable hazards into the agricultural water system (such as through 
runoff); and whether the farm can expect any other changes to occur by 
the time the water reaches the farm (such as adequate time to allow any 
stirred-up sediments to settle out of the water column). Considering 
this information, alongside the other factors evaluated under Sec.  
112.43(a), will assist farms in determining whether measures are 
reasonably necessary under Sec.  112.45.
    (Comment 74) One comment notes that farms may not irrigate after a 
heavy rain since the crops do not need additional water during that 
time, and requests clarity on how this should be considered under the 
proposed rule.
    (Response 74) We recognize that the various factors identified in 
Sec.  112.43(a) are likely to be interrelated, such as when farms cease 
irrigating their crops following a rain event. If a farm adjusts its 
water use practices based on other elements evaluated within its 
agricultural water assessment, the farm must include that as part of 
its evaluation and use all information considered under Sec.  112.43(a) 
in determining whether measures are reasonably necessary under Sec.  
112.45.
    (Comment 75) One comment suggests that environmental conditions may 
differ for CEA operations compared to outdoor farming, and provides 
various examples of environmental conditions they consider relevant to 
CEA, including condensation and subsequent dripping; use, maintenance, 
and cleaning of heating, ventilation, and cooling equipment; opening or 
closing of vents to the outdoor environment; and local pest 
populations. Moreover, the comment suggests that CEA operations such as 
hydroponic and aquaponic systems have other factors that should be 
considered as part of an agricultural water assessment, such as 
cleaning and sanitizing procedures for food contact surfaces; solids 
management (i.e. the accumulation of organic matter in the water); and 
UV irradiation and ozone treatments for water, which the comment 
suggests may have unknown efficacy in such systems.
    (Response 75) We recognize that CEA operations face a unique set of 
conditions compared to more traditional outdoor growing operations and 
that environmental conditions such as weather events (e.g., rain and 
exposure to sun), may be less relevant to their agricultural water 
systems and covered produce than in open-field systems. We also 
recognize that CEA operations may have other factors that are more 
relevant to their operations than to those growing covered produce in 
an outdoor capacity that nonetheless have the potential to impact their 
agricultural water systems and covered produce. Each farm must capture 
those conditions that are unique to its operation as part of its 
agricultural water assessment.
5. Other Relevant Factors
    Comments regarding other relevant factors, with the exception of 
those related to testing as part of an assessment under Sec.  
112.43(d), are discussed below. Comments on testing conducted under 
Sec.  112.43(d) are discussed in section V.H.
    (Comment 76) Several comments support the language in proposed 
Sec.  112.43(1)(5) that requires consideration of ``other relevant 
factors'' to provide farms with the option to incorporate unique 
circumstances or new scientific data in their agricultural water 
assessments.
    (Response 76) We agree that it will be helpful for farms to capture 
any additional factors that are unique to their operations within their 
agricultural water assessments.
    We also emphasize that there are provisions in other subparts of 
the 2015 produce safety final rule, which we did not propose to change, 
that specify requirements for protecting agricultural water sources and 
distribution systems from potential sources of contamination. For 
example, farms are required to handle, convey and store any biological 
soil amendment of animal origin in a manner and location such that it 
does not become a potential source of contamination to covered produce, 
food contact surfaces, areas used for a covered activity, water 
sources, water distribution systems, and other soil amendments (Sec.  
112.52(a)). Additionally, subpart L of the 2015 produce safety final 
rule specifies requirements for ensuring that toilet facilities (Sec.  
112.129(b)(1)); hand-washing facilities (Sec.  112.130(c)); sewage 
(Sec.  112.131(b) through (d)); trash, litter, and waste (Sec.  
112.132(a)(2)); plumbing (Sec.  112.133(c) through (d)); and 
domesticated animal excreta and litter (Sec.  112.134(a)) do not serve 
as a source of contamination for covered produce, food contact 
surfaces, areas used for a covered activity, agricultural water 
sources, and agricultural water distribution systems.

G. Outcomes (Sec.  112.43(c))

    In Sec.  112.43(c), we proposed for a farm to determine, based on 
the farm's evaluation under proposed Sec.  112.43(a), whether 
corrective or mitigation measures under Sec.  112.45 are reasonably 
necessary to reduce the potential for contamination of covered produce 
(other than sprouts) or food contact surfaces with known or reasonably 
foreseeable hazards associated with its agricultural water used in 
growing covered produce (other than sprouts). We proposed that if a 
farm's pre-harvest agricultural water does not meet certain criteria in 
Sec.  112.43(c), the farm would be required to either implement 
mitigation measures or test the water, consider the test results as 
part of the assessment, and take appropriate action (proposed Sec.  
112.43(c)(4)). We also proposed to require farms to record their 
determination and take appropriate action (proposed Sec.  112.43(c)).
    We received several comments related to outcomes under proposed 
Sec.  112.43(c) and discuss these comments in the following paragraphs. 
We discuss comments related to testing in section V.H. As discussed 
below, we are finalizing Sec.  112.43(c) as proposed, with minimal 
changes.
    (Comment 77) A few comments express concerns with Sec.  
112.43(c)(1) through (3), arguing that the ``tiered approach'' to 
hazard analysis may result in farms expending efforts and resources 
toward strategies for addressing hazards that do not represent the 
biggest risk, while expending less effort and resources to address 
risks that may be more critical. For example, one comment suggests 
there is a lack of framework for determining when a hazard warrants 
immediate action or not, noting in particular that animal activity, 
BSAAOs, or untreated or improperly treated human waste may result in 
water not being safe or of adequate sanitary quality for its intended 
use. This comment also suggests the proposed rule could create 
challenges for farms when deciding which hazards to prioritize 
addressing when most hazards fall within the same tier.
    (Response 77) As discussed in response to comment 28, we consider 
that the requirements for agricultural water assessments, in which 
farms evaluate various factors identified in Sec.  112.43(a)(1) through 
(5), provide a mechanism through which farms evaluate the risk 
associated with their pre-harvest agricultural water and use that 
information to determine if measures are reasonably necessary under 
Sec.  112.45. Further, we have established timeframes for implementing 
corrective or mitigation measures commensurate with the risk associated 
with the relevant condition. For example:

[[Page 37489]]

     Under Sec.  112.43(c)(1), if pre-harvest agricultural 
water is not safe or not of adequate sanitary quality for its intended 
use(s), farms are required to immediately discontinue such use(s) of 
water and take corrective measures under Sec.  112.45(a) prior to 
resuming use. We consider such situations to reflect circumstances 
where it is most necessary to take immediate action in order to protect 
public health;
     Under Sec.  112.43(c)(2), for conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
and are related to animal activity, application of a BSAAOs, or the 
presence of untreated or improperly treated human waste on adjacent or 
nearby lands, the farm must implement mitigation measures under Sec.  
112.45(b) promptly, and no later than the same growing season as the 
agricultural water assessment. Because farms often do not have control 
over those potential hazards at their point of introduction into a 
water source or system, it is important that the farm not only 
implement mitigation measures that are under its control to reduce the 
risk associated with that water source or system, but that it do so on 
an expedited basis to protect public health; and
     Under Sec.  112.43(c)(4)(i), for conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
and are not related to the aforementioned uses of adjacent or nearby 
lands, the farm must implement mitigation measures under Sec.  
112.45(b) as soon as practicable and no later than 1 year after the 
date of the farm's agricultural water assessment or reassessment. We 
note that this timing is consistent with the timing for implementing 
measures in Sec.  112.45(b) of the 2015 produce safety final rule.
    We recognize that one potential source of hazards may be associated 
with various outcomes depending on conditions relevant to the farm. For 
example, animal activity associated with adjacent and nearby lands, 
along with the other information evaluated in Sec.  112.43(a)(1) 
through (5), can result in: the farm immediately discontinuing that use 
of the water and implementing corrective measures prior to resuming use 
(Sec.  112.43(c)(1)); the farm implementing mitigation measures on an 
expedited basis (Sec.  112.43(c)(2)); or there not being any conditions 
for which measures under Sec.  112.45 are reasonably necessary (Sec.  
112.43(c)(3)). Evaluation of the factors identified in Sec.  112.43(a), 
which we discuss in section V.F., will assist farms in determining 
which outcome in Sec.  112.43(c) is appropriate for their 
circumstances.
    With respect to the comment suggesting that some farms have 
multiple sources of hazards that result in the same outcome, we note 
that the requirements for pre-harvest agricultural water assessments 
are designed to provide a holistic evaluation of a farm's agricultural 
water system, water use practices, and other conditions relevant to the 
farm for hazard identification purposes. Consistent with the 
comprehensive nature of agricultural water assessments, the 
requirements for outcomes in Sec.  112.43(c), too, are designed to be 
implemented on a systems-wide basis. To further clarify the systems-
based nature of these requirements, we are revising the requirements 
related to outcomes of agricultural water assessments in Sec.  
112.43(c). (See Sec.  112.43(c)(2), which we have revised to read ``If 
you have identified one or more conditions'' in lieu of ``a 
condition,'' as proposed (emphasis added).) As such, measures that a 
farm implements under Sec.  112.45 may be appropriate in light of the 
totality of information evaluated under Sec.  112.43(a), such as where 
changing the water application method to reduce the potential for 
contamination of covered produce may be adequate to address various 
conditions that result in the same outcome under Sec.  112.43(c).
    (Comment 78) Some comments request that FDA provide additional 
clarity on what constitutes a situation where a farm might determine 
the water is not safe or not of adequate sanitary quality for its 
intended uses which would trigger a corrective measure versus 
situations in which mitigation measures would be an appropriate means 
of reducing risk.
    (Response 78) Section 112.45 outlines two different types of 
measures--corrective measures and mitigations measures--that are 
required under Sec.  112.43(c) if certain conditions exist. For pre-
harvest agricultural water, ``corrective measures'' refer to those that 
farms must implement under Sec.  112.45(a) if the water is not safe or 
is not of adequate sanitary quality for its intended use. Corrective 
measures are used in circumstances where it is necessary to take 
immediate action to protect public health, in that farms are required 
to immediately discontinue use of the water and implement corrective 
measures prior to resuming that use. Conversely, ``mitigation 
measures'' in Sec.  112.45(b) provide more flexibility in the timing of 
decisions as compared to the immediate action required under Sec.  
112.45(a), in that the mitigation measures must be implemented as soon 
as practicable and no later than 1 year after the date of the farm's 
agricultural water assessment or reassessment (as required by Sec.  
112.43), except that mitigation measures in response to known or 
reasonably foreseeable hazards related to animal activity, BSAAOs, or 
the presence of untreated or improperly treated human waste on adjacent 
or nearby lands must be implemented promptly, and no later than the 
same growing season as such assessment or reassessment.
    Given the diversity that exists across industry, and that risk 
associated with pre-harvest agricultural water is a function of the 
various factors evaluated as part of an assessment under Sec.  
112.43(a), we do not expect that situations in which measures under 
Sec.  112.45 are reasonably necessary for one farm will necessarily be 
the same for another. However, there are some conditions that, absent 
information or circumstances indicating otherwise (such as if the farm 
is not using pre-harvest agricultural water during the time period of 
interest), are likely to result in the outcome in Sec.  112.43(c)(1), 
in which the water is not safe or is not of adequate sanitary quality 
for its intended use(s) and the farm is required to immediately 
discontinue use of the water and take corrective measures under Sec.  
112.45(a) before resuming such use. For example:
     Incidents in which raw sewage is introduced to an 
agricultural water system (for example, leakage of sewage from a 
ruptured pipe or improper release of sewage from a sewage treatment 
facility into an agricultural water system);
     Situations where a significant amount of animal waste is 
introduced to an agricultural water system (such as might result from a 
manure lagoon overflowing into an agricultural water system); and
     The presence of dead and decaying animals in an 
agricultural water system (for example, a well in which an animal has 
died, or a canal in which sheep have entered and drowned).
    We emphasize that these examples are not the only circumstances in 
which the outcome under Sec.  112.43(c)(1) will apply, nor do 
circumstances need to be as clear-cut as these in order for Sec.  
112.43(c)(1) to be appropriate. For example, due to the nature of the 
above examples and the high likelihood for those conditions to 
introduce human pathogens to pre-harvest agricultural water, such 
conditions are likely to result in the outcome under Sec.  112.43(c)(1) 
regardless of the agricultural water practices, crop characteristics, 
and environmental conditions evaluated under Sec.  112.43(a) (e.g., 
even if affected water is only

[[Page 37490]]

applied early in the growing season, a determination under Sec.  
112.43(c)(1) is likely appropriate). However, there may be other 
conditions (such as runoff from certain uses of adjacent and nearby 
lands), for which the factors evaluated under Sec.  112.43(a) play a 
larger role as to whether a determination under Sec.  112.43(c)(1) is 
appropriate. Considering the diversity that exists across industry, the 
requirement for farms to evaluate a broad range of factors as part of 
their pre-harvest agricultural water assessments will assist them in 
identifying and managing risks associated with pre-harvest agricultural 
water as appropriate for their agricultural water systems, conditions, 
and practices.
    (Comment 79) One comment notes that Sec.  112.43(c) references an 
``evaluation'' required in Sec.  112.43(a). However, the comment 
suggests, Sec.  112.43(a) does not require an ``evaluation'', it 
requires an ``assessment,'' and as such, requests FDA to revise the 
phrasing in Sec. Sec.  112.43(a) and (c) to avoid potential confusion.
    (Response 79) Proposed Sec.  112.43(a), which we are finalizing 
here, requires that an agricultural water assessment identify 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce (other than sprouts) 
or food contact surfaces, based on an evaluation of the factors 
identified in Sec.  112.43(a)(1) through (5) (emphasis added). As this 
is consistent with use of the term ``evaluation'' in Sec.  112.43(c), 
we decline to make the change requested by the comment.
    (Comment 80) One comment recommends changes to the text of the 
codified to improve clarity, noting that, as written, Sec.  
112.43(c)(1) through (4) use both positive and negative criteria, which 
could lead to confusion.
    (Response 80) We have considered the comment. To improve clarity, 
we are revising Sec.  112.43(c)(3), which in the proposed rule read, 
``If you have identified no conditions . . . ,'' to instead say ``If 
you have not identified any conditions . . .''. We also note that we 
have provided a plain language summary of the outcomes in Sec.  
112.43(c) in table 4 to aid in understanding of the requirements. See 
comment 81.
    (Comment 81) One comment suggests that the third scenario described 
in table 4 of the 2021 agricultural water proposed rule (describing 
what must occur if there is one or more known or reasonably foreseeable 
hazards not related to animal activity, BSAAOs, or untreated or 
improperly treated human waste for which mitigation is reasonably 
necessary) is missing from Sec.  112.43(c), and is therefore not 
enforceable.
    (Response 81) In the preamble language accompanying the table 
referenced by the comment (86 FR 69120 at 69140), we explained that if 
a farm determines that mitigation measures are reasonably necessary to 
reduce the potential for contamination of such produce or food contact 
surfaces with a known or reasonably foreseeable hazard that is not 
related to animal activity, a biological soil amendment of animal 
origin, or untreated or improperly treated human waste on adjacent or 
nearby lands, the farm would be required to either: implement 
mitigation measures under Sec.  112.45(b) as soon as practicable and no 
later than the following year; or test the water pursuant to Sec.  
112.43(d), consider the results as part of their assessment in making a 
determination under Sec.  112.43(c), and implement measures as needed 
under Sec.  112.45. This outcome corresponds to Sec.  112.43(c)(4), 
which we are finalizing as proposed, without changes. However, we 
recognize that the phrasing used in the table may have resulted in 
uncertainty, and as such, we are revising the table to clarify the role 
that adjacent and nearby lands play in the outcomes under Sec.  
112.43(c). See table 4.

    Table 4--Summary of Outcomes of a Pre-Harvest Agricultural Water
           Assessment for Covered Produce (Other Than Sprouts)
                           [Sec.   112.43(c)]
------------------------------------------------------------------------
         If you determine . . .                Then you must . . .
------------------------------------------------------------------------
that your agricultural water is not      immediately discontinue use(s)
 safe or is not of adequate sanitary      AND take corrective measures
 quality for intended use(s).             before resuming use of the
                                          water for pre-harvest
                                          activities.
there is one or more known or            implement mitigation measures
 reasonably foreseeable hazards related   promptly, and no later than
 to animal activity, BSAAOs, or           the same growing season.
 untreated or improperly treated human
 waste on adjacent or nearby land for
 which mitigation is reasonably
 necessary.
there is one or more known or            implement mitigation measures
 reasonably foreseeable hazards not       as soon as practicable and no
 related to animal activity, BSAAOs, or   later than the following year
 untreated or improperly treated human    OR test water as part of the
 waste on adjacent or nearby land, for    assessment and implement
 which mitigation is reasonably           measures, as needed, based on
 necessary.                               the outcome of the assessment.
there are not any known or reasonably    regularly (at least once each
 foreseeable hazards for which            year) inspect and adequately
 mitigation is reasonably necessary.      maintain the water system(s).
------------------------------------------------------------------------


[[Page 37491]]

H. Testing as Part of an Assessment (Sec.  112.43(d))

    For farms that test agricultural water as one part of an 
assessment, we proposed that such testing must use scientifically valid 
collection and testing methods and procedures (proposed Sec.  
112.43(d)). We proposed to require that samples of pre-harvest 
agricultural water be collected aseptically immediately prior to or 
during the growing season and be representative of the water used in 
growing non-sprout covered produce (proposed Sec.  112.43(d)). We 
proposed to require that samples be tested for generic E. coli as an 
indicator of fecal contamination, or for another scientifically valid 
organism, index organism, or other analyte (proposed Sec.  
112.43(d)(2)). Additionally, we proposed to require that the frequency 
of testing and any microbial criteria applied be scientifically valid 
and appropriate to assist in determining, in conjunction with other 
data and information evaluated under paragraph Sec.  112.43(a), whether 
measures under Sec.  112.45 are reasonably necessary to reduce the 
potential for contamination of non-sprout covered produce or food 
contact surfaces with known or reasonably foreseeable hazards 
associated with pre-harvest agricultural water (proposed Sec.  
112.43(d)(3)). We are finalizing the requirements as proposed, with 
minimal changes, and respond to the comments we received on testing as 
part of an assessment below.
1. General
    (Comment 82) Some comments suggest that proposed Sec.  112.43(d) 
should specify that when testing pre-harvest agricultural water as one 
part of an assessment, sample collection should occur at specific 
times, such as ``as close to harvest as reasonably possible,'' to 
reduce the opportunity for farms to ``cherry-pick'' collecting samples 
at times when water quality is expected to be good.
    (Response 82) We do not consider it necessary to require farms that 
test pre-harvest agricultural water under Sec.  112.43(c)(4) to collect 
samples at specific times (for example, as close to harvest as 
possible), as doing so may limit the usefulness of test results in 
further informing the farm's agricultural water assessment. For 
example, if a farm identifies a condition that may allow for the 
introduction of hazards to its agricultural water early in the growing 
season (e.g., a well head that needs repairing) and tests pre-harvest 
agricultural water under Sec.  112.43(c)(4), requiring that water 
samples be collected close to harvest would not provide the farm with 
information as to whether water quality was degraded and/or if repairs 
made to the well head were effective in as timely a manner as testing 
early in the growing season. As such, we decline to make this change.
    (Comment 83) Several comments supportive of the general proposed 
approach for pre-harvest agricultural water assessments note that 
agricultural water testing only provides a ``snapshot in time'' of 
water quality. These comments suggest that because of this, water 
testing alone may be of limited effectiveness in ensuring produce 
safety.
    (Response 83) While we have included a requirement in Sec.  
112.43(c)(4)(ii) for farms to test their pre-harvest agricultural water 
as part of an assessment in certain circumstances, it does not mean 
that farms can rely on test results alone in making decisions around 
the use of their water. Rather, results from pre-harvest agricultural 
water testing serve as an additional source of information that farms 
may use to further inform their agricultural water assessments. 
Specifically, farms that test their pre-harvest agricultural water as 
part of their assessment must consider the test results in concert with 
the other factors evaluated under Sec.  112.43(a) and use information 
in making determinations under Sec.  112.43(c) as to whether measures 
are reasonably necessary to reduce the potential for contamination of 
covered produce or food contact surfaces due to hazards associated with 
pre-harvest agricultural water.
    (Comment 84) Some comments express a concern that because farms are 
not required to test pre-harvest agricultural water under the proposed 
rule, inspectors and farms may come to different conclusions about 
situations in which testing should occur.
    (Response 84) As discussed in response to comment 3, we are not 
requiring all farms to test their pre-harvest agricultural water. 
Rather, Sec.  112.43(c)(4) requires that farms either test the water, 
consider the results as part of the assessment, and take appropriate 
action; or implement mitigations measures as soon as practicable and no 
later than 1 year after the date of the assessment. Whether or not to 
test pre-harvest agricultural water or to implement mitigation measures 
under Sec.  112.43(c)(4) is up to the discretion of the farm.
    (Comment 85) Some comments voice opposition to mandatory product 
testing as a follow-up activity when water test results reveal 
unacceptable results.
    (Response 85) Farms are not required to conduct product testing as 
a follow-up to results of pre-harvest agricultural water testing under 
Sec.  112.43(c)(4).
    (Comment 86) Some comments seek clarity on testing requirements 
that would apply for rainwater that is collected and stored.
    (Response 86) If a farm that collects rainwater to use for pre-
harvest agricultural water tests the water as one part of its 
assessment, the requirements in Sec.  112.43(d) apply.
    (Comment 87) Some comments address testing of agricultural water 
used in CEA farms, such as hydroponic and aquaponic operations. Some 
comments suggest that water used in hydroponic of aquaponic systems 
should be performed on a risk- and science-driven basis (e.g., as 
applicable to each individual farm's unique food safety hazards) to 
support requirements in the proposed rule. Other comments state that if 
a hydroponic or aquaponic farm test its pre-harvest agricultural water 
as part of an assessment, a sampling frequency of 20 samples over a 2 
to 4 year period would likely not be adequate for detection of hazards 
due to the nature of such systems and the use of recirculating water.
    (Response 87) As discussed in response to comment 93, we are not 
establishing a specific testing frequency that farms are required to 
follow if testing their pre-harvest agricultural water as one part of 
an assessment. Rather, Sec.  112.43(d)(3) provides flexibility for 
farms to use a sampling frequency that is scientifically valid and 
appropriate. This enables farms that test their pre-harvest 
agricultural water as part of an assessment under Sec.  
112.43(c)(4)(ii) to take into account conditions that are unique to 
their operations and practices when establishing appropriate sampling 
frequencies under Sec.  112.43(d)(3). We discuss conditions that may be 
relevant to some CEA farms in response to comments 39, 40 and 46, which 
farms may consider in establishing an appropriate sampling frequency 
under Sec.  112.43(d)(3).
    (Comment 88) Several comments express concerns about the 
availability and/or cost of laboratories that can perform testing for 
agricultural water.
    (Response 88) Farms that test their pre-harvest agricultural water 
as one part of an assessment under Sec.  112.43(c)(4)(ii) are not 
required to use a third-party laboratory to analyze test samples. See 
Sec.  112.47, which we did not propose to change, which specifies that 
farms may meet the requirements related to agricultural water testing 
in Sec.  112.43(c)(4)(ii) using results performed by the farm or by a 
person or entity acting on the farm's behalf, or data

[[Page 37492]]

collected by a third-party (or parties), provided applicable 
requirements are met. Additionally, we have provided flexibility in 
analytes, sampling frequency, and microbial quality criteria farms may 
use (Sec.  112.43(d)). The approach taken for testing as part of an 
assessment, which provides for flexibility as science evolves, will 
allow farms to make decisions around pre-harvest agricultural water 
testing as applicable to their given operations and the nature of 
current science. See also response to comment 98, where we discuss test 
methods that may be used if testing agricultural water for generic E. 
coli.
    (Comment 89) Many comments request real-world examples of what 
acceptable testing approaches may look like given the variety in 
commodity production practices, seasonal lengths, and growing 
environments. Some comments note that development of technical tools, 
such as statistical toolkits, would be of benefit to farms. These 
comments suggest that FDA work with industry organizations and other 
partners to develop such resources.
    (Response 89) We provide information on analytes, sampling 
frequencies, and microbial criterion (or criteria) that may be used in 
accordance with the requirements in Sec.  112.43(d) throughout the 
remainder of this section. While we have provided examples of analytes, 
sampling frequencies, and microbial water quality criteria that farms 
may choose to use (see, e.g., comments 90, 93 and 95, respectively), we 
recognize that there is interest in the development of testing 
frameworks that are specific to various circumstances, such as those 
based on hazards, commodity(ies) grown, and regional considerations. We 
encourage collaborations across various groups in the agricultural 
community (for example, produce farms, State and Federal Government 
agencies, academic researchers, and extension specialists) as they 
relate to pre-harvest agricultural water assessments, including 
frameworks for testing agricultural water that are reflective of the 
variety of water systems and practices that exist across industry. We 
remain committed to working with stakeholders to advance critical work 
in the realm of agricultural water quality science.
2. Generic E. coli and Other Analytes
    (Comment 90) Some comments seek clarification on the extent of 
flexibility offered to a farm in using an appropriate analyte (i.e., 
different than generic E. coli) in their testing protocol. A few 
comments ask if farms must determine that generic E. coli is an 
appropriate fecal indicator bacteria to test for, and how a farm may 
determine if a different fecal indicator bacteria is more appropriate. 
Some of these comments request clarity on whether farms using an 
alternate analyte still have to test for generic E. coli. A number of 
comments assert that farms should be able to select the most 
appropriate analyte for their circumstances. Some comments address 
water testing for hydroponic and aquaponic systems, noting that generic 
E. coli may not be the most relevant indicator of water quality in 
these systems.
    (Response 90) Final Sec.  112.43(d)(2) provides farms that test 
their pre-harvest agricultural water as one part of an assessment the 
flexibility to test for generic E. coli or for any other scientifically 
valid indicator organism, index organism, or other analyte. As such, if 
testing for any other scientifically valid indicator organism, index 
organism, or other analyte, a farm does not also have to test for 
generic E. coli.
    While generic E. coli has an extensive history of use as an 
indicator of fecal contamination and is considered the best indicator 
for monitoring water quality (Ref. 73) (78 FR 3504 at 3562), the 
potential use of other indicator organisms, index organisms, or other 
analytes for monitoring water quality continues to be of interest for 
agricultural water, as well as related disciplines. For example, in its 
2012 Recreational Water Quality Criteria (RWQC) EPA provided various 
examples of possible alternate indicators, including Bacteroidales, 
Clostridium perfringens, human enteric viruses, and coliphages (Ref. 
74). We anticipate that as science evolves and more information about 
other indicator or index organisms is learned, testing for organisms 
other than generic E. coli may be used to inform pre-harvest 
agricultural water assessments by farms.
    We note that we are not requiring farms to notify or seek approval 
from FDA as to the analytes, sampling frequencies, and microbial 
criterion (or criteria) the farm uses when testing agricultural water 
as part of an assessment. However, if a farm uses a scientifically 
valid indicator organism, index organism, or analyte other than E. 
coli, the farm is required to maintain records of scientific data or 
information it relies on to support the use of that organism or analyte 
in accordance with Sec.  112.50(b)(3). (Farms are not required to keep 
such documentation if testing their agricultural water for generic E. 
coli.) We discuss the term ``scientifically valid'' in the 2015 produce 
safety final rule to mean an approach that is based on scientific 
information, data, or results published in, for example, scientific 
journals, references, text books, or proprietary research (see 80 FR 
74354 at 74371).
    (Comment 91) Some comments seek clarity on whether farms will be 
expected to test for pathogenic microorganisms in their water, with 
some suggesting that doing so would not be of benefit to farms.
    (Response 91) Farms are not required to test their pre-harvest 
agricultural water for human pathogens. As discussed in the 2015 
produce safety final rule, we acknowledge that testing for pathogens 
allows for direct targeting of microorganisms in water that are a risk 
to public health; however, we continue to believe sampling water for 
pathogens presents challenges compared to sampling water for indicator 
organisms. For example, challenges associated with pathogen testing 
include those related to larger sample sizes; inherently higher costs; 
and the wide array of potential target pathogens (i.e., the presence or 
absence of one pathogen may not predict for the presence or absence of 
other pathogens). See 80 FR 74354 at 74427-74428. As discussed in 
section I.A., we believe that this rule will enhance public health 
protections by setting forth procedures for comprehensive pre-harvest 
agricultural water assessments and corrective and mitigation measures 
that minimize the risk of serious adverse health consequences or death, 
including those reasonably necessary to prevent the introduction of 
known or reasonably foreseeable biological hazards into or onto 
produce, and to provide reasonable assurances that produce is not 
adulterated on account of those hazards.
    (Comment 92) Some comments note that the bacteria detected in their 
water is often different than the bacteria found on their crops, and 
that water quality seems to change as it goes through their water 
distribution system. These comments seek clarity on how the rule would 
address such a situation.
    (Response 92) In this scenario, if the farm tests its water under 
Sec.  112.43, the farm must consider both its water test results as 
well as information about its water distribution system (in addition to 
the other factors evaluated under Sec.  112.43(a)) in determining 
whether measures are reasonably necessary under Sec.  112.45. For 
example, in preparing an agricultural water assessment under Sec.  
112.43(a), a farm finds that large flocks of birds rest in its open 
water distribution system, and that test results for samples collected 
upstream and downstream of the birds indicate that the birds are 
causing water

[[Page 37493]]

quality to degrade. In light of these findings, and depending on the 
other factors evaluated under Sec.  112.43(a), the farm may determine 
that measures under Sec.  112.45 are reasonably necessary to reduce the 
potential for contamination of covered produce (other than sprouts) or 
food contact surfaces with known or reasonably foreseeable hazards 
associated with the farm's pre-harvest agricultural water for non-
sprout covered produce.
3. Frequency of Sampling
    (Comment 93) Some comments interpret the rule as requiring a 
specific number of testing samples per year and oppose this 
requirement. Some comments seek clarity about whether the minimum 
frequency of testing for pre-harvest agricultural water changed from 20 
samples within 2 to 4 years per the 2015 produce safety final rule, to 
four times during the growing season or over a period of 1 year per 
Sec.  112.44(b)(1) of the proposed rule. Other comments request clarity 
as to whether testing may be conducted at a lower frequency than that 
established in the 2015 produce safety final rule. A few comments 
suggest that one test per season prior to use would likely be 
sufficient for deep wells. Some comments request that FDA support 
research and education to help farms understand what sampling frequency 
is adequate.
    (Response 93) Section 112.43(d)(3) requires that for farms that 
test their pre-harvest agricultural water as one part of an assessment, 
the frequency of testing samples must be scientifically valid and 
appropriate to assist in determining, in conjunction with other factors 
evaluated under Sec.  112.43(a), whether measures under Sec.  112.45 
are reasonably necessary to reduce the potential for contamination of 
covered produce (other than sprouts) or food contact surfaces with 
known or reasonably foreseeable hazards associated with their 
agricultural water used in growing covered produce (other than 
sprouts).
    Farms have the flexibility to use any sampling frequency, as long 
as the requirements in Sec.  112.43(d)(3) are met. For example, this 
could include sampling frequencies a farm establishes based on its 
historical data and/or knowledge of water quality variability within 
its source. Sampling approaches that take into consideration other 
site- or region-specific data or information may also be appropriate. 
We recognize that agricultural water quality science is likely to 
continue to evolve and may inform sampling frequencies appropriate for 
use when testing pre-harvest agricultural water as part of an 
assessment. As agricultural water quality science continues to develop, 
and as farms learn more about water quality relevant to their sources, 
systems, and operations--for example, through an evaluation of data 
shared between farms, within water systems, and/or within regions--such 
information can, and should, be used to establish sampling frequencies 
that are appropriate to farms' specific circumstances and conditions.
    While the sampling frequencies for untreated surface water and 
untreated ground water used for pre-harvest agricultural water in the 
2015 produce safety final rule are examples of approaches that farms 
may choose to use to comply with Sec.  112.43(d)(3) if testing their 
water for generic E. coli, they are not required to do so. Further, if 
a farm tests its water for generic E. coli and has scientifically valid 
data or information to support use of a sampling frequency that is more 
reflective of its unique conditions than that used in the 2015 produce 
safety final rule, the farm must use that information in establishing 
an appropriate sampling frequency under Sec.  112.43(d)(3). Moreover, 
because the sampling frequencies in the 2015 produce safety final rule 
were developed for farms that test their pre-harvest agricultural water 
for generic E. coli, a farm that tests for any other scientifically 
valid indicator organism, index organism, or other analyte in 
accordance with Sec.  112.43(d)(2) may not use those sampling 
frequencies unless it has scientific data or information supporting use 
of those frequencies for the relevant organism or analyte.
    We note that farms are required to maintain records of scientific 
data or information they rely on to support the use of a sampling 
frequency in accordance with Sec.  112.50(b)(4). As discussed in the 
2021 agricultural water proposed rule (86 FR 69120 at 69143), if a farm 
tests its water under Sec.  112.43(d) for generic E. coli using the 
sampling frequencies and pre-harvest microbial water quality criteria 
outlined in the 2015 produce safety final rule, the farm can document 
its use of such sampling frequencies and microbial criteria in meeting 
the requirements of Sec.  112.50(b)(4), as we have already determined 
these sampling frequencies and microbial criteria to be scientifically 
valid and appropriate for purposes of Sec.  112.43(d). See also 
response to comment 95 regarding the use of the pre-harvest microbial 
water quality criteria from the 2015 produce safety final rule.
    We would also like to clarify that the sampling frequency in Sec.  
112.44(b)(1) referenced by comments is specific to untreated ground 
water when used for any of the purposes specified in Sec.  112.44(a) 
(e.g., water used during or after harvest activities in a manner that 
directly contacts covered produce). This requirement does not apply for 
farms that test their pre-harvest agricultural water for non-sprout 
covered produce as part of an assessment under Sec.  112.43(c)(4).
    (Comment 94) Some comments seek clarity around whether historical 
test results can be used to justify the safety of their agricultural 
water. Several comments encourage flexibility with regard to sampling 
frequency requirements by allowing inclusion of historic testing data 
in an assessment that may not have been conducted at the same level of 
frequency as discussed in the proposed rule.
    (Response 94) We recognize the value in utilizing historical test 
results, particularly when it comes to analyzing trends in water 
quality over time, which may help to further inform a farm's 
agricultural water assessment. Historical data may be particularly 
useful in situations in which potential hazards are introduced into a 
water system intermittently, such that a farm is able to compare data 
over time to further inform its conclusions of whether measures are 
reasonably necessary under Sec.  112.45. For example, if a farm is 
concerned that the quality of its water may be affected by rain due to 
runoff into a water source and/or stirring up of sediments, the farm 
may use water quality data collected over time to determine if water 
quality is degraded following rain events compared to baseline (i.e., 
limited or no rain) conditions.
    As discussed in response to comment 93, we are not establishing a 
specific testing frequency that farms are required to follow if testing 
their pre-harvest agricultural water as one part of an assessment. 
Rather, if a farm tests its pre-harvest agricultural water as part of 
an assessment under Sec.  112.43(c)(4)(ii), Sec.  112.43(d)(3) provides 
flexibility regarding the frequency of sample collection. As also 
discussed in response to comment 93, farms can use historical data and/
or knowledge of water quality variability within relevant water sources 
to inform sampling frequencies under Sec.  112.43(d)(3) that are 
scientifically valid.
4. Microbial Water Quality Criteria
    (Comment 95) Many comments support the additional flexibility in 
proposed Sec.  112.43(d) for farms to apply any microbial criterion or 
criteria that would be scientifically valid and appropriate. Some 
comments support

[[Page 37494]]

inclusion of a GM of 126 or less CFU generic E. coli per 100 mL and an 
STV of 410 or less CFU generic E. coli per 100 mL in the preamble as a 
standard for agricultural water. In contrast, several comments oppose 
inclusion of these in the preamble, and suggest that because these 
standards were developed for recreational water, they are not suitable 
for agricultural water since agricultural water is not directly 
ingested by humans. Some of these comments request clarification on 
whether any studies have been conducted to determine thresholds of 
fecal indicator bacteria in agricultural water to levels of risk to 
human health. Some comments request FDA remove reference to the GM and 
STV in the preamble because, the comments state, use of those criteria, 
even if not included in the codified requirements, will result in the 
criteria continuing to be used as a benchmark even as new metrics are 
developed. Other comments suggest that FDA retain proposed Sec.  
112.43(d) as written and further clarify in the preamble that the 2015 
microbial standards are not required in order to reduce confusion.
    (Response 95) The microbial water quality criteria in the 2015 
produce safety final rule for pre-harvest agricultural water consist of 
a GM of 126 or less CFU generic E. coli per 100 mL, and an STV of 410 
or less CFU generic E. coli per 100 mL. We established these pre-
harvest microbial water quality criteria using the science underlying 
EPA's 2012 RWQC (Ref. 74). We described the rationale for our use of 
the science underlying the RWQC and our thinking on its relevance to 
agricultural water in a reference memorandum that accompanied the 2014 
supplemental proposed rule (Ref. 75). We are not aware of, and comments 
did not suggest, an alternative standard that is applicable across the 
diversity of operations, agricultural water sources, and agricultural 
water uses. However, we recognize that use of the GM and STV criteria 
for pre-harvest agricultural water for non-sprout covered produce is 
not without its challenges, particularly in light of information that 
has become available since 2015 indicating potential limitations in 
basing risk-management decisions on the 2015 pre-harvest agricultural 
water testing requirements.
    Of particular note, a scientific evaluation of the 2015 pre-harvest 
agricultural water testing requirements found that the rolling data set 
of five samples per year used to update GM and STV values for untreated 
surface water sources results in highly uncertain results and delays in 
detecting shifts in water quality (Ref. 7). Additionally, various 
studies indicate a high degree of variability in generic E. coli levels 
in surface waters (Refs. 5-10), which can reduce the precision of 
estimation of the GM and STV of a water source (Refs. 1, 7). In 
recognition of such limitations associated with the previous pre-
harvest testing requirements, findings from our QAR (Ref. 17), other 
information we have gathered since 2015 (including findings from 
several produce-related outbreaks), as well as information and feedback 
from an array of stakeholders, we are replacing the pre-harvest water 
quality criteria and uniform testing requirements in the 2015 produce 
safety final rule with requirements for systems-based agricultural 
water assessments that include testing in certain circumstances. See 
comment 11.
    Further, we acknowledge that science around agricultural water 
quality and related disciplines is likely to continue to evolve. For 
example, in EPA's second 5-year review of the 2012 RWQC (Refs. 76 and 
77), EPA notes plans to develop new quantitative polymerase chain 
reaction (PCR)-based RWQC that better protect certain sensitive 
populations; expand its recommended RWQC to protect people from 
exposure to viruses; and explore new methods to determine whether a 
waterbody is contaminated with human feces.
    Thus, to allow for scientific advancements, we have incorporated 
flexibility into Sec.  112.43(d)(3) so that farms that test their pre-
harvest agricultural water as part of an assessment can use any 
microbial criteria (or criterion) provided certain requirements are 
met. A farm can rely on a microbial criterion or criteria available in 
the scientific literature or made available by a third party (such as a 
trade association, commodity board, academia, or cooperative extension 
services) provided that the microbial criterion or criteria is 
scientifically valid and appropriate based on the circumstances. (We 
discuss the term ``scientifically valid'' in the 2015 produce safety 
final rule (see 80 FR 74354 at 74371).)
    We recognize that agricultural water quality science is likely to 
continue to evolve and may inform standards appropriate for use when 
testing pre-harvest agricultural water as part of an assessment. While 
farms that test their pre-harvest agricultural water as one part of an 
assessment may choose to use the criteria established in the 2015 
produce safety final rule to meet the requirements in Sec.  
112.43(d)(3), they are not required to do so. Further, if a farm has 
scientifically valid data or information to support use of a microbial 
criterion or criteria that is more reflective of its unique conditions, 
the farm must use that information in establishing an appropriate 
microbial criterion or criteria under Sec.  112.43(d)(3).
    As discussed in response to comment 83, we emphasize that farms 
must not rely on test results alone in making decisions around the use 
of their water; rather, results from pre-harvest agricultural water 
testing serve as an additional source of information that farms may use 
to further inform their agricultural water assessments.
    We intend to issue guidance on the requirements in Sec.  
112.43(d)(3), as appropriate.
    (Comment 96) Some comments suggest that farms should be required to 
take action based on an individual test result, as doing so would 
emphasize the short temporal nature of many microbial hazards. Some 
comments seek clarity as to whether water that meets the EPA 
recreational water standards should be considered low, medium, or high 
risk. A few comments ask whether farms could choose to comply with the 
new rule through the previous rule's testing thresholds (including the 
GM and STV) rather than through preparing an agricultural water 
assessment. Some comments request FDA clarify that if a farm is 
conducting surface water testing and finds that the water has a MWQP 
with a GM of 126 or less CFU generic E. coli/100 mL water and an STV of 
410 or less CFU generic E. coli/100 mL water, then no further 
mitigation measures should be required to use that water for pre-
harvest activities. Conversely, some comments suggest that it is 
inappropriate to assume that water above or below this benchmark is 
always going to be higher or lower risk, and other factors (such as how 
the water is used, crop characteristics, etc.) should be considered, 
rather than strict adherence to quantitative water quality criteria.
    (Response 96) We agree with comments suggesting that water below or 
above a certain microbial water quality criterion (or criteria) based 
on indicator organisms does not guarantee the absence of pathogens that 
can contaminate covered produce as a result of pre-harvest agricultural 
water. See 80 FR 74354 at 74428. We are not aware of, and comments did 
not provide, information suggesting that this conclusion is incorrect. 
As such, whether or not agricultural water meets a microbial criterion 
(or criteria) established in accordance with Sec.  112.43(d) is not the 
sole determinant of whether corrective or mitigation measures are 
reasonably necessary

[[Page 37495]]

under Sec.  112.45. See also response to comment 83.
    For example, if a farm tests its water as one part of an assessment 
per Sec.  112.43(c)(4), in addition to determining whether the water 
meets the criterion (or criteria) established in accordance with Sec.  
112.43(c)(3), the farm can, for example, look at test results collected 
over time for potential insight into changes in water quality that 
might indicate hazards being introduced into the water system. Even if 
the water does not exceed the criterion (or criteria) the farm 
establishes, the farm may find, for example, that migratory birds are 
causing water quality to degrade when present in the area. As another 
example, the farm may find when looking at historical data that test 
results had at one time consistently shown lower levels of generic E. 
coli than more recent data, potentially indicating that a change 
occurred that is affecting the farm's water system.
    In such circumstances, even if the water does not exceed the 
criterion (or criteria) the farm establishes, the trends in water 
quality changes over time show a potential source(s) of contamination 
to a farm's agricultural water. A farm must consider this information, 
along with other factors, in conducting its agricultural water 
assessment (Sec.  112.43(c)(4)(ii)). As discussed in response to 
comment 95, while farms that test their pre-harvest agricultural water 
as part of an assessment may choose to use the GM and STV criteria 
established in the 2015 produce safety final rule to meet the 
requirements in Sec.  112.43(d)(3), they are not required to do so.
    (Comment 97) Some comments suggest that FDA mandate presence/
absence indicator testing for pre-harvest agricultural water to make 
testing more simplified than the 2015 produce safety final rule while 
still providing insight into whether and which mitigation and 
corrective actions are required.
    (Response 97) We disagree with comments suggesting that it would be 
appropriate to require presence/absence testing for indicator organisms 
for pre-harvest agricultural water. We consider that the flexibility in 
Sec.  112.43(d)(3) is appropriate to maintain due to the diversity in 
agricultural water systems and practices that exists across industry. 
For example, a farm that uses pre-harvest agricultural water from a 
ground water source such as a well may determine that presence/absence 
testing is appropriate to use, as ground water sources generally 
provide high quality water and show little variability due to the 
natural filtering capacity of soils (Ref. 17). However, another farm 
that uses agricultural water from a surface water source may determine 
that quantification methods are appropriate to use, as surface water 
sources are subject to the influence of various environmental factors 
that can impact and change the system continually (Ref. 17).
    (Comment 98) Some comments ask FDA to identify a unit of 
measurement for analytes to be ``organism'' or ``counts'' per 100 mL 
instead of CFU, because in some methods of analysis, results are 
provided as a most probable number (MPN). The comment asserts that use 
of CFU limits allowable testing methods.
    (Response 98) We do not consider this necessary to do, as we do not 
specify microbial water quality criteria in CFU when testing pre-
harvest agricultural water as part of an assessment. See, for example, 
Sec.  112.43(d)(3), which requires that ``. . . any microbial criteria 
applied must be scientifically valid and appropriate to assist in 
determining, in conjunction with other data and information evaluated 
under paragraph (a) of this section, whether measures under Sec.  
112.45 are reasonably necessary to reduce the potential for 
contamination of covered produce (other than sprouts) or food contact 
surfaces with known or reasonably foreseeable hazards associated with 
your agricultural water used in growing covered produce (other than 
sprouts).''
    Further, while the method of analysis in Sec.  112.151(a) (EPA 
Method 1603) provides results for generic E. coli testing in terms of 
CFU, if a farm tests pre-harvest agricultural water for generic E. coli 
under Sec.  112.43(d)(2), the farm may use a scientifically valid 
method that is at least equivalent to EPA Method 1603 in accuracy, 
precision, and sensitivity (Sec.  112.151(b)(1)). We have provided a 
list of testing methodologies that meet the requirements in Sec.  
112.151(b)(1) (Ref. 78). Included in this list are methods that report 
results in CFU and methods that report results as MPN, which farms may 
use when testing their agricultural water for generic E. coli.

I. Reassessment (Sec.  112.43(e))

    In Sec.  112.43(e)(1), we proposed that a farm must conduct an 
agricultural water assessment, at a minimum, each year that the farm 
applies pre-harvest agricultural water to non-sprout covered produce. 
In Sec.  112.43(e)(2), we proposed that a farm must conduct a 
reassessment whenever a significant change occurs in its agricultural 
water system(s), agricultural water practices, crop characteristics, 
environmental conditions, or other relevant factors that would impact 
hazard identification or a risk management determination, as described 
in proposed Sec.  112.43(c). For the reassessment in proposed Sec.  
112.43(e)(2), we proposed that a farm must evaluate the impacts of 
those changes on the factors in proposed Sec.  112.43(a)(1) through 
(5), any new hazards identified, and the outcome and determination 
under proposed Sec.  112.43(c). We received several comments seeking 
clarification on the proposed reassessments and respond to the comments 
in the paragraphs below. We are finalizing the requirements for 
reassessments in Sec.  112.43(c) as proposed, without change.
    (Comment 99) Several comments seek clarity on what situations would 
be considered a ``significant change'' in an agricultural water system 
that would warrant a reassessment.
    (Response 99) In the 2021 agricultural water proposed rule, we 
tentatively concluded that it would be reasonable and appropriate to 
require farms to conduct a written pre-harvest agricultural water 
assessment annually, and whenever a significant change would impact the 
hazard identification or risk management determination relating to pre-
harvest agricultural water for non-sprout covered produce. We are not 
aware of, and comments did not provide, information suggesting that 
this conclusion is incorrect. However, we recognize that additional 
information on the requirements in Sec.  112.43(e) will help support 
farms as they work to come into compliance.
    Section 112.43(e) requires, in part, that a farm conduct a 
reassessment whenever a significant change occurs in its agricultural 
water system(s), agricultural water practices, crop characteristics, 
environmental conditions, or other relevant factors that impacts hazard 
identification or a risk management determination as described in Sec.  
112.43(c). For example, as discussed in the 2021 agricultural water 
proposed rule (86 FR 69120 at 69138), a change from an untreated ground 
water source to an untreated surface water source, or the installation 
and use of a new water distribution system, is a significant change 
that requires a reassessment under Sec.  112.43(e), as the degree of 
protection and likelihood of hazards being introduced are likely to 
differ and may impact risk management determinations. As another 
example, some changes in the use of adjacent or nearby land--such as if 
adjacent or nearby land is used for a new dairy production operation--
are significant changes, as the new use of that land may differ in its 
potential to introduce

[[Page 37496]]

hazards into the agricultural water system.
    Changes in agricultural water practices, including the method or 
timing of water application, also are significant changes that require 
a reassessment, as different practices present different risks to the 
crop. For example, overhead sprinkler irrigation may increase the risk 
of contamination as compared with furrow and subsurface drip irrigation 
(Ref. 79). Furthermore, bacteria or pathogens in water that is applied 
early in the growing cycle are subject to greater die-off from several 
environmental forces, such as UV exposure, temperature, humidity, and 
the presence of competitive organisms compared to bacteria or pathogens 
in water that is applied late in the growing cycle (Ref. 65). See 86 FR 
69120 at 69138. Similarly, growing a different type of covered produce 
than previously grown is a significant change, as the unique 
characteristics associated with the crop might affect whether it is 
vulnerable to contamination from agricultural water. See 86 FR 69120 at 
69138. As discussed further in response to comment 100, various 
environmental conditions, such as unexpected flooding that may 
introduce new hazards into an agricultural water system, are also 
significant changes that require a farm to conduct a reassessment.
    Other sources of information may also indicate that a significant 
change has occurred for which a reassessment is required, such as, for 
example, if information suggests that a pathogen may be present in a 
farm's pre-harvest agricultural water (which the farm may be aware of 
through voluntary testing, knowledge or experience, or other means), or 
if an outbreak investigation or other findings indicate a potential 
role for pre-harvest agricultural water in serving as a source or route 
of contamination to covered produce.
    In instances where there is a significant change for which a farm 
is required to conduct a reassessment, the farm must evaluate the 
impacts of those changes on the factors in Sec.  112.43(a)(1) through 
(5), any new hazards identified, and the outcome and determination 
under Sec.  112.43(c).
    (Comment 100) Several comments seek clarity as to whether a 
reassessment is necessary in response to extreme weather events if 
those events are normal, expected, and included in a farm's initial 
assessment. Some comments question whether a farm can amend an 
assessment following such an extreme weather event rather than 
conducting an entirely new one.
    (Response 100) The requirement to consider environmental conditions 
as part of an agricultural water assessment in Sec.  112.43(a)(4) 
includes not only general ``routine'' trends in environmental 
conditions (e.g., yearly seasonal patterns in rainfall), but also those 
conditions that, based on knowledge, history or experience, are 
reasonably likely to happen on a less frequent basis, but that 
nonetheless have the potential to impact agricultural water systems or 
covered produce (e.g., heavy rains that occur on occasion). This 
includes, if applicable, any extreme weather events that have the 
potential to affect the farm's agricultural water systems or 
operations. Thus, if a farm evaluated relevant extreme weather events 
as part of its agricultural water assessment under Sec.  112.43(a), the 
farm is not required to conduct a reassessment each time such an event 
occurs. See also response to comment 69.
    However, we also recognize that not all weather events can be 
anticipated. Unanticipated weather events or weather changes that go 
beyond what was considered as part of a farm's assessment (such as 
unexpected flooding that may introduce new hazards into a surface or 
ground water source, or an earthquake, which may affect a farm's piped 
distribution system) are significant changes that warrant a 
reassessment under Sec.  112.43(e)(2). The reassessment must evaluate 
any factors and conditions that are affected by such change, including 
the factors in Sec.  112.43(a)(1) through (5), any new hazards 
identified, and the outcome and determination under Sec.  112.43(c).
    (Comment 101) Some comments note that what may be considered a 
``significant change'' for one farm would not be considered a 
significant change for another. For example, the comment notes that 
switching water sources is a common practice in some areas and may not 
be perceived by farms as significant.
    (Response 101) We recognize that some farms may make changes to 
their pre-harvest agricultural water systems and practices as a routine 
matter, such as farms that routinely use one water source early in the 
growing season and switch to another water source after plants become 
established; or those that change water sources throughout the season 
as weather and water availability changes. Farms that make routine 
changes to their systems or operations may account for such activities 
in their annual assessment, rather than conducting a reassessment each 
time a change is made, provided they conduct and document an assessment 
that accurately describes and evaluates each of their agricultural 
water systems, the water use practices associated with each of their 
agricultural water systems, and other factors required by Sec.  
112.43(a).
    (Comment 102) Noting that farms may not become immediately aware of 
changes to certain factors that are outside of their control (such as 
uses of adjacent and nearby lands), a few comments suggest that 
proposed Sec.  112.43(e) be revised to clarify that a farm is only 
responsible for conducting a reassessment if the farm is aware of there 
being a significant change (emphasis added).
    (Response 102) Farms are responsible for ensuring that all 
applicable requirements of subpart E are met, including the requirement 
in Sec.  112.41 that all agricultural water be safe and of adequate 
sanitary quality for its intended use.
    We recognize that farms may not always be made immediately aware of 
changes to factors that are outside of their control (such as adjacent 
and nearby land uses and other water users) that might affect their 
agricultural water systems. As discussed in response to comment 51, 
farms must include in their assessments information on sources of 
hazards that have the potential to result in contamination of covered 
produce or food contact surfaces with known or reasonably foreseeable 
hazards associated with agricultural water. Information as to the 
presence and nature of impacts that might affect the quality of their 
agricultural water can be acquired through a variety of resources, 
including from visual observation; local extension agents, industry 
associations, or local water management authorities; and online 
resources such as mapping tools, which may provide helpful information 
on topography and proximity to potential sources of hazards.
    Further, Sec.  112.42(b) requires farms to regularly monitor each 
system, to the extent that it is under the farm's control, to identify 
any conditions that are reasonably likely to introduce known or 
reasonably foreseeable hazards into or onto covered produce or food 
contact surfaces. If during such monitoring a farm identifies a 
condition that that is considered a ``significant change,'' the farm 
must conduct a reassessment under Sec.  112.43(e). See also response to 
comment 25, in which we discuss the relationship between inspections, 
maintenance, and pre-harvest agricultural water assessments.
    Given the various resources available to farms that can provide 
information regarding factors that might otherwise be outside a farm's 
control (see

[[Page 37497]]

comment 51), we do not believe it is necessary to modify the language 
regarding significant changes that require a reassessment under Sec.  
112.43(e).

J. Corrective and Mitigation Measures (Sec.  112.45)

    We proposed requirements for implementing corrective and mitigation 
measures for pre-harvest agricultural water that are reasonably 
necessary to reduce the potential for contamination of non-sprout 
covered produce or food contact surfaces with known or reasonably 
foreseeable hazards associated with agricultural water for covered 
produce (Sec.  112.45). We did not propose to change the requirement 
from Sec.  112.45(a) of the 2015 produce safety final rule that if 
agricultural water is not safe or not of adequate sanitary quality for 
its intended use(s) as required under Sec.  112.41, and/or if a farm's 
agricultural water used as sprout irrigation water or for harvesting, 
packing, or holding activities does not meet the requirements in Sec.  
112.44(a) (including the microbial quality criterion), the farm must 
immediately discontinue such use(s) and implement corrective measures 
prior to resuming such use. In Sec.  112.45(b), we proposed various 
mitigation measures for pre-harvest agricultural water that farms would 
implement to reduce the potential for contamination of covered produce 
(other than sprouts) or food contact surfaces with known or reasonably 
foreseeable hazards associated with the water.
    We discuss comments received on proposed Sec.  112.45 below. Note 
that in this section, we include comments specific to use of treatment 
as a corrective or mitigation measure; we discuss general comments 
related to agricultural water treatment and the pre-harvest 
agricultural water treatment efficacy testing protocol in section V.K.
1. General
    (Comment 103) Several comments express general support for the 
range of options FDA has outlined as possible measures to reduce the 
potential for contamination of covered produce or food contact surfaces 
with known or reasonably foreseeable hazards. In contrast, many 
comments suggest the rule lacks sufficient criteria on when measures 
are necessary or which measures are effective in various scenarios. 
Some comments express a concern that the proposed rule places too much 
responsibility on farms to make decisions about mitigation measures 
without sufficient guidance or input from FDA. The comments request 
that FDA consider delineating specific requirements regarding necessary 
measures for the highest risk situations.
    (Response 103) The provisions for pre-harvest agricultural water 
assessments are designed to be flexible to account for the diversity of 
operations, practices, and conditions that may impact the pre-harvest 
agricultural water used by foreign and domestic farms for non-sprout 
covered produce. Given the diversity that exists across industry, we 
recognize that measures implemented under Sec.  112.45 will vary by 
farm.
    By providing a range of possible measures, farms will be able to 
make decisions around their agricultural water as appropriate to their 
agricultural water systems, water use practices, operations, and local 
conditions. However, we recognize the need for clarity, and we have 
provided general principles throughout the preamble to assist farms in 
determining whether (and what kind of) measures may be appropriate for 
their given circumstances. For example, in our response to comment 105, 
we discuss that measures under Sec.  112.45(b)(1)(i), which entails 
making necessary changes (for example, repairs), generally are more 
relevant when the farm has some control over the potential source of 
known or reasonably foreseeable hazards. However, that may not always 
be the case, such as if a farm builds a berm to reduce runoff from a 
source of hazards into an agricultural water system. As another 
example, in response to comment 123, we explain that changing the water 
application method under Sec.  112.45(b)(1)(iv) for root crops may not 
be an appropriate mitigation measure, as it may be difficult to 
effectively minimize contact between agricultural water and the 
harvestable portion of the crop. For additional examples and 
information, see section V.G. for comments related to outcomes, and the 
remainder of this section for comments related to corrective and 
mitigation measures.
    Further, we recognize the need to provide farms with education, 
outreach and technical assistance to facilitate compliance with the 
rule, and we intend to pursue various mechanisms, such as publishing 
guidance, holding webinars, and developing other educational resources, 
including working with other stakeholders (such as State agencies, 
educators, and extension agents), to do so.
    (Comment 104) Some comments express concerns that the corrective 
and mitigation measures included in the proposed rule are not feasible 
for many farms due to challenges associated with increased costs, water 
scarcity, environmental conditions, farm setup/infrastructure, labor 
shortages, and the need to use water for pest management practices. 
Some of these comments suggest that measures like water treatment, 
which comments note can be costly and complex to implement, calibrate, 
and operate, may be particularly challenging for small farms. Many 
comments request that FDA explicitly allow for other mitigation 
measures beyond those specifically listed in the codified.
    (Response 104) Given the diversity that exists across industry, we 
recognize the importance of flexibility in Sec.  112.45, which we have 
included by providing a range of possible measures, including the 
option in Sec.  112.45(b) to use an alternative mitigation measure that 
meets the requirements in Sec.  112.12.
    With respect to comments about small farms, we note that we are 
finalizing staggered compliance dates for the pre-harvest agricultural 
water requirements for non-sprout covered produce based on farm size 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 also section VI for 
a discussion of comments about compliance dates. We expect that the 
flexibility in Sec.  112.45, along with the extended compliance dates, 
will provide sufficient time and flexibility for small and very small 
farms to receive education and adjust their practices (if needed) to 
comply in a cost-effective manner with the requirements in subpart E.
    Also with respect to comments about costs, we estimate costs of 
measures in our FRIA (Ref. 26).
    (Comment 105) Some comments assert that the proposed rule lacks 
clarity on corrective or mitigation measures for farms to effectively 
control hazards from adjacent or nearby cattle operations and requests 
that FDA establish educational resources that define effective 
strategies, based on science and research. Some comments suggest that 
the farm's responsibility over the quality of water (including steps 
the farm takes to implement mitigation measures) should be based on the 
degree of control the farm has over the water, and that the farm should 
not be responsible for activities on adjacent or nearby lands or 
upstream water users that are not under the farm's control.
    (Response 105) We recognize that farms may have little or no 
control over adjacent and nearby land uses and other

[[Page 37498]]

water users, and do not require farms to access areas that are not 
under their control to meet relevant requirements in subpart E. 
However, while farms may have little or no control of such uses of land 
and other water users, the requirement to consider these potential 
sources of hazards as part of an agricultural water assessment will 
help farms determine the appropriate and safe use of their water 
source(s). See also response to comment 15. While it is generally 
preferred that sources of known or reasonably foreseeable hazards be 
addressed at the point where potential hazards are introduced to an 
agricultural water system, we recognize that this may not always be 
feasible for farms (such as where hazards may originate from adjacent 
or nearby land uses or from other water users), nor are we suggesting 
that farms gain access to such lands or other water uses to do so.
    Taking measures under Sec.  112.45(a)(1) (which includes, but is 
not limited to, re-inspecting the affected agricultural water system 
and making necessary changes) and Sec.  112.45(b)(1)(i) (which entails 
making necessary changes (for example, repairs)) generally are more 
relevant when the farm has some control over the potential source of 
known or reasonably foreseeable hazards. However, this may not always 
be the case. For example, even if a source of hazards is outside of a 
farm's control, depending on the circumstances, measures such as 
building a berm to reduce runoff, installing a windbreak, or making 
repairs to a well-head may be appropriate to reduce the potential for 
known or reasonably foreseeable hazards being introduced into its 
agricultural water system.
    We have incorporated a range of options for measures in Sec.  
112.45 in the recognition that not every measure will be an appropriate 
or viable option for every farm. See also response to comment 103. We 
note in particular that the mitigation measures identified in Sec.  
112.45(b) include those that a farm can implement whether or not the 
farm has control over the potential source of known or reasonably 
foreseeable hazards at the point where hazards may be introduced to an 
agricultural water system. For example, while a farm may have little or 
no control over adjacent and nearby land uses, if the farm determines 
that mitigation measures are reasonably necessary under Sec.  
112.45(b), depending on the circumstances, the farm might determine 
that changing the water application method is appropriate to reduce the 
likelihood of contamination of the covered produce.
    (Comment 106) While supportive of the proposed rule, some comments 
request that water testing be required as a way to verify that 
corrective or mitigation measures were effective. These comments seek 
clarity on how, without test results, farms might demonstrate that 
their water is safe and of adequate sanitary quality. One comment notes 
that the proposed rule differs from LGMA metrics in its omission of a 
retesting requirement for agricultural water that fails to meet a 
specified standard for generic E. coli and requests that FDA include 
such a retesting requirement, suggesting that retesting is essential to 
determine whether mitigation measures were effective.
    (Response 106) We disagree that testing is essential to determine 
if corrective or mitigation measures were effective, as there are other 
actions farms may take to verify the effectiveness of such measures. 
For example, if a farm makes necessary changes as a mitigation measure 
under Sec.  112.45(b)(1)(i), such as repairing a leak within the farm's 
piped distribution system in order to protect it from possible sources 
of contamination, re-inspection of the agricultural water system to 
visually confirm that the repair was successful may be sufficient. As 
another example, if a farm changes the method of water application to 
reduce the likelihood of contamination of covered produce as a 
mitigation measure under Sec.  112.45(b)(1)(iv), the farm might 
regularly monitor the system while the covered produce is being 
irrigated to confirm that the water application method is limiting 
contact with the produce as intended. In yet other instances, such as 
when treating agricultural water as a mitigation measure (Sec.  
112.45(b)(1)(v)); applying a time interval between last direct water 
application and harvest to allow for microbial die-off (Sec.  
112.45(b)(1)(ii)); or applying a time interval between harvest and end 
of storage and/or using other activities during or after harvest to 
allow for microbial die-off and/or removal (Sec.  112.45(b)(1)(iii)), 
the farm is required to maintain scientifically valid data or 
information to support use of those measures (see Sec.  112.50(b)(8) 
and (10)). While farms may choose to test their water to assist them in 
evaluating the efficacy of corrective or mitigation measures that they 
implement, we emphasize that as discussed in comment 83, farms must not 
rely on test results alone in making decisions around the safe use of 
their agricultural water.
    If a farm determines that its mitigation measures are not effective 
to reduce the potential for contamination of the covered produce or 
food contact surfaces with known or reasonably foreseeable hazards, it 
must discontinue use of the agricultural water until it has implemented 
mitigation measures adequate to reduce the potential for such 
contamination, consistent with Sec.  112.41 (Sec.  112.45(b)(2)).
    (Comment 107) Some comments request that FDA provide specifics 
around when pre-harvest water must be treated as a corrective or 
mitigation measure. A few comments suggest FDA specify ``high-risk'' 
situations in which water must be treated, such as requiring that all 
surface water must be treated unless the farm has data demonstrating 
that pathogens are not present in the water. These comments note that 
farms participating in LGMA are not permitted to use untreated surface 
water in overhead irrigation systems in the 3 weeks leading up to 
harvest, and suggest that FDA could similarly specify uses for which 
untreated surface water is prohibited. Some comments suggest that 
treatment would be the only viable mitigation measure for some 
operations. A few comments suggest the rule state that if other 
effective options for mitigation are not available, then farms would be 
required to treat their water.
    (Response 107) Recognizing the wide degree of diversity that exists 
in industry--including in potential sources of known or reasonably 
foreseeable hazards, agricultural water systems, growing operations, 
water use practices, crop characteristics, and environmental 
conditions--what might be considered ``low'' or ``high'' risk for one 
farm may not necessarily be the same for another. See comment 31. 
Moreover, given the diversity that exists in industry, we recognize 
that not every mitigation measure will be appropriate for every farm to 
use. As such, we do not consider it appropriate to specify situations 
in which farms are required to implement mitigation measures, or more 
specifically, treat their pre-harvest agricultural water.
    With respect to commenters' suggestion to specify that if other 
mitigation measures identified in Sec.  112.45(b) are not available to 
a farm that the farm would be required to treat the water, we note that 
Sec.  112.45(b)(2) requires that if a farm fails to implement 
appropriate mitigation measures, or if the farm determines that the 
measures were not effective, the farm must discontinue use of the pre-
harvest agricultural water until adequate mitigation measures have been 
implemented. As such, it is likely that farms will implement any of the 
measures available to them and

[[Page 37499]]

appropriate to their conditions, including treatment, to avoid being 
required to cease that use of pre-harvest agricultural water. As such, 
we consider the change requested in the comments to be unnecessary.
    We also disagree with commenters' suggestion to require treatment 
of agricultural water unless the farm has data indicating that 
pathogens are not present in the agricultural water system. In the 2015 
produce safety final rule, we discuss various challenges associated 
with sampling water for pathogens. These include challenges related to 
larger sample sizes; inherently higher costs, and the wide array of 
potential target pathogens (i.e., the presence or absence of one 
pathogen may not predict for the presence or absence of other 
pathogens). See 80 FR 74354 at 74427-74428. We are not aware of, and 
comments did not provide, information to suggest otherwise. See also 
comment 91. As such, we decline this suggestion.
    (Comment 108) A few comments ask for clarity regarding whether pre-
harvest water treatment must be done during the entire growing season, 
or only a certain amount of time before harvest.
    (Response 108) If a farm treats its pre-harvest agricultural water 
based on its agricultural water assessment, the necessary timing for 
implementing agricultural water treatment will depend on the specific 
conditions at the farm. For example, if the farm treats its pre-harvest 
agricultural water in response to a condition in which there may be 
ongoing introduction of known or reasonably foreseeable hazards into 
the agricultural water system, it may be an appropriate response for 
the farm to treat that water each time it is used as pre-harvest 
agricultural water. For example, in situations where runoff introduces 
known or reasonably foreseeable hazards into the agricultural water 
system, and the farm is not able to prevent such events from occurring, 
it may be appropriate for the farm to treat the water each time it is 
used. Or, depending on the nature of the potential source of hazards as 
well as other information evaluated under Sec.  112.43(a), treatment of 
agricultural water only during certain times of the growing season may 
be sufficient to reduce the potential for contamination of covered 
produce. For example, depending on the circumstances, the farm might 
determine that treatment is only necessary when agricultural water is 
applied close to harvest.
    Conversely, if a farm determines that the introduction of known or 
reasonably foreseeable hazards is not on-going, it may be appropriate 
to treat the water as an isolated event. For example, if the farm is 
able to prevent additional runoff from being introduced to the 
agricultural water system, it may be appropriate to treat contaminated 
water still residing in the water distribution system as a one-time 
event, rather than treating the water as a regular practice.
    If a farm treats its pre-harvest agricultural water, it is required 
to comply with the requirements in Sec.  112.46, which we did not 
propose to substantively revise, including that the treatment be 
effective to make the water safe and of adequate sanitary quality for 
its intended use, and be delivered and monitored in a manner and with a 
frequency adequate to ensure that the treated water is consistently 
safe and of adequate sanitary quality for its intended use.
2. Corrective Measures
    (Comment 109) A few comments request clarity on what corrective 
measures would be appropriate for the example provided in the proposed 
rule in which a dead and decaying sheep results in water being not safe 
or not of adequate sanitary quality for its intended use.
    (Response 109) In the 2021 agricultural water proposed rule, we 
provided the example that, if in performing the agricultural water 
assessment a farm finds that there is a dead and decaying sheep in the 
canal upstream and at a close distance to where it draws water, the 
farm would have reason to believe that the agricultural water is not 
safe or not of adequate sanitary quality for its intended use because 
the water is reasonably likely to contain human pathogens transferred 
by the dead and decaying sheep. Therefore, the farm would have to 
immediately discontinue that use of the water and take corrective 
measures under Sec.  112.45(a) before resuming such use(s). 86 FR 69120 
at 69141.
    In this scenario, one appropriate response is for the farm to re-
inspect the entire affected agricultural water system to the extent it 
is under the farm's control, identify any conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
into or onto covered produce or food-contact surfaces, make necessary 
changes, and take adequate measures to determine if the changes were 
effective (Sec.  112.45(a)(1)). Steps the farm takes to meet the 
requirements in Sec.  112.45(a)(1) include, at a minimum:
     Re-inspecting the entire water system potentially affected 
by the dead sheep to the extent it is under the farm's control to 
identify any relevant conditions (such as additional dead sheep, 
including carcass materials that may have contaminated the farm's water 
distribution system if applicable);
     Removing the dead sheep and any related hazards identified 
during the re-inspection and allowing time for contaminants to clear 
the canal and bypass the point at which the farm draws water from the 
canal;
     Cleaning any necessary equipment that may have been 
contaminated (such as the water distribution system impacted by the 
sheep); and
     Visually verifying that all carcass materials have been 
removed.
    Once the farm has taken all of the appropriate steps in light of 
its specific circumstances, it may resume using the water for direct 
water application irrigation of its covered produce.
    (Comment 110) With respect to the requirements in proposed Sec.  
112.45(a)(1), some comments seek clarity as to whether pre-harvest 
agricultural water for produce commodities other than sprouts needs to 
meet the water microbial quality criterion in Sec.  112.44(a).
    (Response 110) The requirements in Sec.  112.44(a), including the 
microbial criterion of no detectable generic E. coli per 100 mL of 
agricultural water, do not apply to pre-harvest agricultural water for 
non-sprout covered produce (see Sec.  112.40), and as such, the 
reference to Sec.  112.44(a) within Sec.  112.45(a)(1) also does not 
apply to pre-harvest agricultural water for non-sprout covered produce.
3. Mitigation Measures
    In Sec.  112.45(b), we proposed various mitigation measures for 
pre-harvest agricultural water that farms would implement to reduce the 
potential for contamination of covered produce (other than sprouts) or 
food contact surfaces with known or reasonably foreseeable hazards 
associated with the water. We received various comments requesting 
clarification on the proposed mitigation measures and respond to such 
comments below.
    Consistent with the requirements for pre-harvest agricultural water 
assessments that are designed to be adaptable to future advancements in 
agricultural water quality science, we are revising Sec.  
112.45(b)(1)(ii) regarding use of a time interval between last direct 
application or agricultural water and harvest to remove reference to a 
``minimum interval of 4 days.'' We are also removing commercial washing 
as an example of a post-harvest activity in Sec.  112.45(b)(1)(iii) to 
further emphasize that other post-harvest activities may be used as 
mitigation measures.

[[Page 37500]]

    We did not receive comments on the proposed mitigation measure in 
Sec.  112.45(b)(1)(i), in which farms would make necessary changes 
(such as repairs) to address any conditions that are reasonably likely 
to introduce known or reasonably foreseeable hazards into or onto 
covered produce or food contact surfaces, and are finalizing that 
provision as proposed, without change. As noted above, we discuss 
general comments related to agricultural water treatment and the pre-
harvest agricultural water efficacy testing protocol in section V.K.
a. General
    (Comment 111) Several comments urge FDA to allow more time for 
farms to undertake mitigation measures, citing supply chain 
constraints. A few comments suggest that it may not be practical to 
implement mitigation measures (such as those requiring construction) 
mid-season. In contrast, several other comments express concern that 
the rule, as proposed, gives farms too much time to implement 
mitigation measures. Some comments are particularly concerned that the 
rule appears to allow farms up to 1 year to undertake mitigation 
measures for hazards not related to animal activity, BSAAOs, or 
untreated or improperly treated human waste on adjacent or nearby lands 
and question whether that timing adequately protects public health. 
Similarly, some comments question whether making mitigations for 
hazards related to animal activity, BSAAOs, or human waste on adjacent 
or nearby lands within the growing season is sufficiently protective of 
public health, particularly since growing seasons can span many months 
and include the growth of multiple covered crops. The comments seek 
clarity on the meaning of ``growing season'' within the rule.
    (Response 111) The mitigation measures listed in Sec.  112.45(b) 
provide greater flexibility in the timing of decisions as compared to 
the immediate action required under Sec.  112.45(a), in that the 
mitigation measures must be implemented as soon as practicable and no 
later than 1 year after the date of the farm's agricultural water 
assessment or reassessment (as required by Sec.  112.43), except that 
mitigation measures for known or reasonably foreseeable hazards related 
to animal activity, the application of BSAAOs or the presence of 
untreated or improperly treated human waste on adjacent or nearby lands 
must be implemented promptly, and no later than the same growing season 
as such assessment or reassessment. While the requirement that 
mitigation measures be implemented as soon as practicable and no later 
than 1 year after the date of the farm's agricultural water assessment 
or reassessment is consistent with the timing for implementing measures 
in Sec.  112.45(b) of the 2015 produce safety final rule, as discussed 
in the 2021 agricultural water proposed rule, we have incorporated 
expedited mitigation measures for hazards related to certain activities 
associated with adjacent and nearby lands in light of several produce-
related outbreaks that occurred since we issued the 2015 produce safety 
final rule. See 86 FR 69120 at 69145.
    We have incorporated this flexibility to allow sufficient time to 
make any necessary adjustments to farms' current practices. For 
example, we recognize that some mitigation measures identified in Sec.  
112.45(b)(1), such as making necessary changes (for example, repairs) 
or changing the method of water application, may take time to 
implement, as they might entail changes to current, or adoption of new, 
infrastructure and equipment on the farm. Conversely, other mitigation 
measures, such as increasing the time interval between last direct 
water application and harvest to allow for microbial die-off, may be 
relatively easily adopted by farms without need for significant advance 
preparation or changes to the farm's infrastructure or operations.
    The allowable timeframes for implementing mitigation measures in 
Sec. Sec.  112.43(c)(4)(i) and 112.43(c)(2) (i.e., ``no later than one 
year after the date of the agricultural water assessment'' and ``no 
later than the same growing season as the assessment,'' respectively) 
are included in the recognition that, as discussed above, farms may not 
be able to immediately implement mitigation measures in every 
circumstance. Moreover, these end points are important in that they 
provide a basis after which, if a farm does not implement mitigation 
measures, the farm is required to discontinue such use of the water 
until the farm has implemented adequate mitigation measures in 
accordance with Sec.  112.45(b)(2). However, inclusion of these end 
points in Sec.  112.43(c)(4)(i) and 112.43(c)(2) does not permit farms 
to wait until the end of the year after the date of the assessment or 
the end of the same growing season as the assessment (as applicable) to 
implement mitigation measures under Sec.  112.45(b). Rather, farms must 
implement mitigation measures ``as soon as practicable'' or 
``promptly,'' respectively, as applicable to their circumstances.
    For example, if a farm determines that mitigation measures are 
reasonably necessary under Sec.  112.45 in accordance with Sec.  
112.43(c)(4)(i), the farm must implement mitigation measures ``as soon 
as practicable.'' Various timeframes may be ``practicable,'' depending 
on circumstances relevant to the farm. For example, it may be 
practicable for the farm to make modifications for the crop in the 
field at the time the farm makes the determination; during the next 
harvest if the farm has multiple harvests of a crop; or during the next 
growing season if the farm has multiple growing seasons within a year. 
If none of these timeframes are practicable or applicable to the farm's 
operation, it must make the modifications to its water use practices no 
later than 1 year after the date of the agricultural water assessment. 
For this reason, too, we disagree with comments suggesting it would be 
appropriate to provide additional time to implement mitigation 
measures, and we are finalizing the timing for implementing mitigation 
measures as proposed, without change.
    (Comment 112) Some comments seek clarification about whether crop 
characteristics should influence mitigation measures and, if so, 
request that FDA provide examples.
    (Response 112) We recognize that appropriate mitigation measures in 
Sec.  112.45(b) are likely to depend, in part, on the characteristics 
of the commodity being grown. For example, the effectiveness of 
microbial die-off (such as might occur prior to harvest and/or during 
post-harvest storage) and changing the water application method in 
reducing the risk associated with covered produce as a result of 
agricultural water are all likely to depend, in part, on the 
characteristics of the commodity. We discuss these measures further in 
comments 115, 121 and 123.
    (Comment 113) Some comments seek guidance on when and how to 
mitigate hazards after a weather event, such as heavy rain, has 
occurred.
    (Response 113) If a farm determines that mitigation measures under 
Sec.  112.45(b) are reasonably necessary to reduce the potential for 
contamination of non-sprout covered produce or food contact surfaces 
with known or reasonably foreseeable hazards associated with pre-
harvest agricultural water, the nature of the mitigation measure and 
timing for implementation will depend on the specific circumstances 
relevant to the farm, including the nature of the other information 
evaluated under Sec.  112.43(a).

[[Page 37501]]

    For example, if rain events are expected to increase runoff from 
adjacent or nearby lands used to graze sheep, a farm might determine, 
after also considering the other factors required to be evaluated in 
Sec.  112.43(a)(1) through (5), that mitigation measures are reasonably 
necessary under Sec.  112.45(b). Depending on the circumstances, the 
farm might increase the time interval between last direct application 
of water and harvest based on scientifically valid data and 
information, which the farm is required to do promptly, and no later 
than the same growing season as the assessment in accordance with Sec.  
112.43(c)(2). Or, if appropriate to the covered produce being grown, 
the farm might change the water application method to reduce the 
likelihood of contamination of the covered produce.
    As another example, if a farm experiences an earthquake and 
observes seepage on the soil surface above an underground pipe that 
carries spent wash water, it might indicate that the pipe ruptured. If 
the seepage is in proximity to a well used as pre-harvest agricultural 
water, depending on the information evaluated under Sec.  112.43(a), 
the farm might determine that mitigation measures under Sec.  112.45(b) 
are reasonably necessary. In this scenario, the farm might decide that 
making necessary changes (for example, repairs) to the piping system, 
as well as making any necessary repairs to protect the well from 
contamination, together is an effective mitigation measure, which the 
farm is required to do as soon as practicable, and no later than 1 year 
after the date of the farm's agricultural water assessment in 
accordance with Sec.  112.43(c)(4)(i).
b. Time Interval Between Last Application and Harvest
    (Comment 114) Several comments support the ability to increase the 
time interval between last water application and harvest to a minimum 
of 4 days as a mitigation measure under proposed Sec.  
112.45(b)(1)(ii). These comments suggest that this option is effective, 
adds flexibility, and does not require a farm to have extensive 
knowledge of mathematics or microbial science. In contrast, some 
comments voice concern over the use of a 4-day interval. Some of these 
comments suggest that by including a time interval of 4 days, it places 
a burden on regulators to develop evidence justifying why longer die-
off may be necessary in some circumstances. Other comments oppose 
inclusion of a 4-day time interval because, comments state, it 
effectively creates a scientifically unsupported ``safe harbor'' for 
farms, with limited parameters on the conditions in which application 
of such a time interval may not be warranted. Several comments ask that 
FDA remove the 4-day time interval from codified and instead include it 
in subsequent guidance which can be more easily updated as science 
evolves.
    (Response 114) Consistent with the requirements for pre-harvest 
agricultural water assessments that are designed to be adaptable to 
future advancements in agricultural water quality science, we are 
revising Sec.  112.45(b)(1)(ii) to remove reference to a ``minimum 
interval of 4 days.'' Instead, final Sec.  112.45(b)(1)(ii) entails 
farms ``increasing the time interval between last direct application of 
agricultural water and harvest of the covered produce to allow for 
microbial die-off, provided [the farm has] scientifically valid 
supporting data and information.'' We expect this change will further 
reinforce that farms may consider and adopt scientifically valid 
approaches other than that established for the 2015 produce safety 
final rule, both now and as agricultural water quality science 
continues to evolve. Further, recognizing that survival of pathogens 
and other microorganisms on produce commodities prior to harvest is 
dependent upon various factors (see response to comment 115), such a 
change will reinforce that farms may utilize scientifically valid time 
intervals as appropriate to their unique conditions.
    While we are removing reference to a ``minimum interval of 4 days'' 
from Sec.  112.45(b)(1)(ii), we continue to believe it is appropriate 
for farms to use a time interval between last direct water application 
and harvest based on that used in the 2015 produce safety final rule. 
As such, if a farm does not test its pre-harvest agricultural water but 
increases the time interval between last direct application of water 
and harvest as an appropriate mitigation measure, the farm may choose 
to increase its time interval to a minimum of 4 days, based on the data 
used to support the approach in the 2015 produce safety final rule. 
(See also response to comment 117, in which we discuss ``maximum'' vs. 
``minimum'' intervals.) If a farm tests its pre-harvest agricultural 
water and increases the time interval between last direct application 
of water and harvest as a mitigation measure, in light of the approach 
established for the 2015 produce safety final rule, the farm may choose 
to use a microbial die-off rate of 0.5 log per day, for potentially 
less than 4 days between last direct water application and harvest, to 
achieve a calculated log reduction to meet the criteria the farm 
establishes in accordance with Sec.  112.43(d)(3).
    We consider the scientific data and information used to support the 
approach to a pre-harvest time interval established for the 2015 
produce safety final rule as an example of adequate supporting 
scientific data and information farms may use in accordance with Sec.  
112.45(b)(1)(ii) (Refs. 60 and 61). See also 80 FR 74354 at 74444-
74445. As such, a farm may use one of the approaches described 
immediately above for implementing a pre-harvest time interval as a 
mitigation measure under Sec.  112.45(b) without having to develop and 
maintain additional supporting scientific data and information. Prior 
to using one of these approaches, however, the farm should consider 
whether the studies evaluated in support of pre-harvest microbial die-
off in the 2015 produce safety final rule are reflective of conditions 
relevant to the farm. If a farm has scientifically valid data or 
information to support use of an increased time interval that is more 
reflective of its unique conditions, the farm must use that information 
in establishing an appropriate time interval under Sec.  
112.45(b)(1)(ii). See also comment 115.
    (Comment 115) Several comments note that it may be difficult for a 
farm to make decisions regarding sufficient time intervals for 
microbial die-off due to lack of scientific information or expertise, 
and seek further guidance from FDA. Some of these comments contend that 
the effectiveness of microbial die-off as a mitigation method depends 
on various factors that are not listed in the proposed rule (e.g., 
climate and environmental conditions, differences between pathogens, 
and crop characteristics that could impact bacterial survival). Some 
comments request that FDA clarify how pathogens capable of longer-term 
survival (e.g., Listeria) are to be considered in determining time 
intervals between last water application and harvest. Several comments 
ask FDA to provide scientific data for microbial die-off in response to 
UV rays and for specific pathogens and commodities. Some comments 
request that farms be required to ensure that any die-off period used 
is validated for the conditions of their operation and specific hazards 
being targeted.
    (Response 115) We agree that microbial die-off between last direct 
water application and harvest can be impacted by a broad range of 
conditions, such as timing of water application, environmental 
conditions, crop characteristics, and pathogen characteristics. As 
discussed in

[[Page 37502]]

response to comment 114, we are revising Sec.  112.45(b)(1)(ii) to 
remove reference to a ``minimum interval of 4 days.'' Instead, final 
Sec.  112.45(b)(1)(ii) provides farms the opportunity to increase the 
time interval between last direct application of agricultural water and 
harvest of the covered produce to allow for microbial die-off, provided 
the farm has scientifically valid supporting data and information. We 
expect that such a change will further reinforce that farms may utilize 
scientifically valid time intervals as appropriate to their unique 
conditions.
    As discussed in response to comment 114, we consider the scientific 
data used to support the approach to a time interval between last 
direct water application and harvest in the 2015 produce safety final 
rule to be one example of scientifically valid data and information 
(Refs. 60 and 61) (80 FR 74354 at 74444-74445). Further, we recognize 
that as science continues to evolve, time intervals that are more 
appropriate for a farm to use may become increasingly available.
    For example, the studies we reviewed in determining an appropriate 
time interval for the 2015 produce safety final rule included those 
that looked at various types of leafy greens, carrots, and grass (the 
latter of which we considered a useful surrogate for at least some 
produce commodities with regard to leaf structure, and noted that 
particulates are just as likely to occur in grass irrigation water as 
in irrigation water used on produce crops) (Refs. 60 and 61). However, 
we recognize that microbial die-off on produce surfaces prior to 
harvest may differ for other commodities. Moreover, the studies 
evaluated included five field trials for E. coli O157:H7 (including 
surrogates), one field trial and one greenhouse study examining 
Salmonella, and three trials examining viral decay. While the studies 
evaluated reflect a few different growing conditions, we recognize that 
some farms may face different environmental conditions, which could 
affect the microbial die-off that occurs between last water application 
and harvest. Similarly, we recognize that not all pathogens or other 
microbial organisms will necessarily follow the same die-off kinetics 
as those assessed in studies evaluated for the 2015 produce safety 
final rule.
    As more studies are conducted that examine in-field die-off for 
various circumstances (for example, different regions, environmental 
conditions, commodities, pathogens, and crop growth characteristics) 
(Refs. 46-49), it is likely that the science will continue to evolve. 
As we learn more about microbial die-off on produce surfaces prior to 
harvest, those findings can, and should, be accounted for if a farm 
increases the time interval between last direct application of 
agricultural water and harvest as a mitigation measure under Sec.  
112.45(b).
    Scientific data and information used in support must be relevant to 
the farm's conditions (such as the region, crop, and environment), and 
be characterized in a manner that addresses the likely biphasic nature 
of microbial die-off (i.e., rapid short-term die-off and a gradual 
long-term die-off) under Sec.  112.45(b)(1)(ii). Evaluating various 
factors under Sec.  112.43(a), such as the timing of water 
applications, environmental conditions, and crop characteristics, will 
help farms identify conditions relevant to establishing an increased 
time interval between last direct water application and harvest in 
accordance with Sec.  112.45(b)(1)(ii). We intend to issue guidance on 
this topic, as appropriate.
    (Comment 116) Several comments assert that a time interval for in-
field microbial die-off only makes sense if preceded by microbial water 
testing, which would allow farms to calculate an acceptable die-off 
interval rate that may differ from 4 days. These comments note that the 
2015 final rule indicated the importance of sampling water sources when 
a die-off period is used as a mitigation measure, whereas the 2021 
proposed rule did not propose to require sampling to establish a 
baseline understanding of the microbial presence in the water.
    (Response 116) While we recognize that pre-harvest agricultural 
water testing may provide information for farms to consider in 
implementing an increased time interval between last direct water 
application and harvest under Sec.  112.45(b)(1)(ii), we disagree that 
farms should be required to test their pre-harvest agricultural water 
to do so. For example, if a farm increases the time interval between 
last direct water application and harvest as a mitigation measure, and 
in doing so, decides to only apply water from that agricultural water 
system early in the growing season (which could be, for example, weeks 
to months prior to harvest), calculations based on test results may not 
be needed in order to justify use of that time interval as a mitigation 
measure. Rather, the farm must implement that increased time interval 
as supported by scientifically valid data and information in accordance 
with Sec.  112.45(b)(1)(ii). See also comment 115.
    (Comment 117) A few comments note perceived inconsistencies as to 
whether the 4 days referenced in proposed Sec.  112.45(b)(1)(ii) is 
intended to be a minimum interval between last direct application of 
agricultural water and harvest or a maximum interval. For example, 
these comments note that the 2015 final rule references research to 
determine that a maximum die-off period of four days is appropriate, 
but suggest that FDA now uses the same research in the 2021 proposed 
rule to say a minimum of 4 days for die-off is appropriate.
    (Response 117) The mitigation measure involving an increased time 
interval between last direct application of agricultural water and 
harvest in the 2015 produce safety final rule consisted, in part, of 
using a microbial die-off rate of 0.5 log per day to achieve a 
(calculated) log reduction of the farm's GM and STV to meet the 
microbial water quality criteria in previous Sec.  112.44(b), for no 
greater than 4 consecutive days (see Sec.  112.45(b)(1)(i)(A) in the 
2015 produce safety final rule). In light of our proposal to remove the 
quantitative pre-harvest microbial quality criteria in the 2015 produce 
safety final rule, we revised our approach to the mitigation measure 
involving an increased time interval between last direct application of 
agricultural water and harvest to better reflect the proposed 
requirements for systems-based pre-harvest agricultural water 
assessments.
    As discussed in the 2015 produce safety final rule, a 4-day 
interval corresponds to the general mid-point in time representing 
neither end of the range where microbial die-off can be expected to 
occur (Refs. 60 and 61) (80 FR 74354 at 74445). In the proposed rule, 
we stipulated a minimum (as opposed to a maximum) time interval of 4 
days in the recognition that not all farms will have the benefit of 
quantitative test data to support a time interval of fewer than 4 days, 
and that additional die-off is likely to occur beyond 4 days, even if 
not at the same rate.
    However, as discussed in response to comment 114, we are removing 
reference to ``4 days'' from the codified provision at Sec.  
112.45(b)(1)(ii) to further reinforce that farms may use approaches 
based on scientific data and information other than that used to 
establish the 2015 produce safety final rule, both now and as 
agricultural water quality science continues to evolve. While farms may 
use an approach to a time interval between last direct water 
application and harvest based on that established for the 2015 produce 
safety final rule (see comment 114), the farm should first consider 
whether the studies evaluated in support of pre-harvest microbial die-

[[Page 37503]]

off in the 2015 produce safety final rule are reflective of conditions 
relevant to the farm (Refs. 60 and 61). See also 80 FR 74354 at 74444-
74445 and response to comment 115.
    (Comment 118) Many comments assert that a 4-day time interval 
between water application and harvest, or between harvest and the end 
of storage, is not feasible in some environments or for some crops. For 
example, some of these comments note that shippers sometimes request 
application of water to ``freshen'' crops before shipping, and that 
farms are unable to prevent this practice, which presents a challenge 
for using a 4-day time interval as a mitigation. Other comments suggest 
that a pre-harvest time interval may not be feasible for crops (such as 
strawberries, cabbages, and peas) that require frequent water 
applications to support crop viability (for example, due to soils being 
sandy, to reduce heat stress on crops, or as part of the farm's pest 
management strategy). A few comments note that some farms, for example, 
hydroponic and aquaponic operations, irrigate their produce 
continuously and that therefore, there is no interval between water 
application and harvest that would be applicable to their practices.
    (Response 118) As discussed in comment 114, we are revising Sec.  
112.45(b)(1)(ii) to remove reference to a minimum interval of 4 days, 
as we expect this will further reinforce that farms may consider and 
adopt scientifically valid approaches other than that established in 
the 2015 produce safety final rule, both now and as agricultural water 
quality science continues to evolve. However, we recognize that even 
with this change, an increased time interval between last direct water 
application and harvest may not be appropriate for every farm to use as 
a mitigation measure. We expect that providing a range of possible 
measures, of which a time interval between last direct water 
application and harvest is only one, will assist farms in making 
decisions about their agricultural water use that reflects their 
agricultural water systems, operations, and conditions.
    We would also like to clarify that the 4-day time interval 
referenced in the 2021 agricultural water proposed rule was specific to 
the time interval between last direct water application and harvest 
(proposed Sec.  112.45(b)(1)(ii)), and not the time interval between 
harvest and end of storage (proposed Sec.  112.45(b)(1)(iii)), for 
which we are not establishing a specific, broadly applicable, microbial 
die-off rate or time interval. See also comment 121.
    (Comment 119) Some comments seek clarity on whether a farm can use 
the sampling framework in the 2015 final rule to define a time interval 
between last application of agricultural water and harvest of fewer 
than 4 days. Several comments ask whether FDA recognizes the MWQP 
calculator by University of California, Davis as ``other scientifically 
valid data'' and, if so, request clarification on whether a 1-day 
interval would be acceptable if justified by the calculator.
    (Response 119) In comments 93, 95 and 114, we explain that the 
sampling frequency, microbial quality criteria, and approach to a time 
interval between last direct water application and harvest established 
for the 2015 produce safety final rule are examples of approaches 
supported by scientifically valid data or information that fulfill 
applicable requirements under Sec. Sec.  112.43(d)(3) and 
112.45(b)(1)(ii). (We discuss the term ``scientifically valid'' in the 
2015 produce safety final rule (see 80 FR 74354 at 74371).) As such, 
farms that test pre-harvest agricultural water as one part of an 
assessment and increase the time interval between last direct 
application of water and harvest as a mitigation measure can choose to 
use those methods and approaches. However, as discussed in response to 
comment 114, if a farm considers using an approach to a pre-harvest 
time interval based on that established for the 2015 produce safety 
final rule, the farm should first consider whether the studies 
evaluated in support of pre-harvest microbial die-off in the 2015 
produce safety final rule are reflective of conditions relevant to the 
farm (Refs. 60 and 61). See 80 FR 74354 at 74444-74445 and response to 
comment 115. To the extent that a farm uses a calculator or other tool 
to provide decision-making support, the farm remains responsible for 
ensuring that all applicable requirements are met, including that any 
microbial criteria (or criterion), sampling frequencies, pre- or post-
harvest time intervals, or other activities (as applicable) be 
supported by scientifically valid data or information.
c. Time Interval Between Harvest and End of Storage and/or Conducting 
Other Activities
    (Comment 120) A few comments request that increasing the time 
interval between harvest and the end of storage be removed as a 
mitigation measure in the final rule, since, the comments suggest, the 
factors associated with microbial die-off during storage are complex 
and may make it difficult to determine the adequacy of a post-harvest 
time interval. Other comments suggest that commercial washing 
specifically should be removed as an allowable mitigation, as including 
it reinforces an inaccurate perception that commercial washing always 
reduces pathogens on produce surfaces. A few comments note that 
commercial washing with an antimicrobial is designed to prevent the 
spread of pathogens from contaminated produce to other, uncontaminated 
produce, and not to remove microorganisms from contaminated produce. 
Some comments note that farms are not required to use an antimicrobial 
in their post-harvest wash water and suggest that including commercial 
washing as a mitigation measure may ultimately increase risk if water 
is not managed properly.
    (Response 120) We recognize that microbial die-off and/or removal 
during post-harvest storage and as a result of other post-harvest 
activities is likely dependent on a variety of factors, such as 
commodity characteristics, storage time and conditions, and relevant 
production practices. Farms are not required to treat their post-
harvest agricultural water, and post-harvest agricultural water, if not 
adequately managed, has the potential to serve as a source or route of 
contamination. However, if properly performed and scientifically valid 
given a farm's production practices, commercial washing has the 
potential to result in microbial die-off or removal from produce 
surfaces. For example, the World Health Organization has attributed a 
1-log reduction in microbial load to washing (Ref. 65). See also 79 FR 
58434 at 58446. As such, we are not removing Sec.  112.45(b)(1)(iii) as 
an allowable mitigation measure.
    However, we recognize there may be post-harvest activities other 
than commercial washing that have the potential to result in microbial 
die-off or removal on covered produce. See, for example, 80 FR 74354 at 
74370, where we provide controlled atmosphere storage as another 
example of a post-harvest activity that may be appropriate for use as a 
mitigation measure with adequate supporting data and documentation. As 
such, we are removing commercial washing as an example of a post-
harvest activity in Sec.  112.45(b)(1)(iii) to further reinforce that 
farms may use other activities during or after harvest as a mitigation 
measure, provided the farm has adequate supporting data and 
documentation. This revision will further encourage farms to consider 
other post-harvest activities that may result in microbial die-off or 
removal from produce surfaces both now, and in the future as potential 
advancements in

[[Page 37504]]

post-harvest handling practices occur (Refs. 80 and 81). In light of 
our removal of the pre-harvest agricultural water microbial quality and 
testing requirements in the 2015 produce safety final rule, we are also 
revising Sec.  112.45(b)(1)(iii) to remove reference to microbial die-
off ``rates'' and microbial removal ``rates,'' specifically.
    (Comment 121) A number of comments request that FDA provide further 
guidance, scientific information, and examples on how farms may use a 
time interval between harvest and end of storage or commercial washing 
as mitigation measures under proposed Sec.  112.45(b)(1)(iii). For 
example, a few comments request additional guidance, noting that the 
factors associated with microbial die-off during post-harvest storage 
and handling are complex and may depend, for example, on crop 
characteristics. Some comments request clarity on what type of 
organisms should be studied in order to justify the use of post-harvest 
storage or handling as a mitigation measure, noting that if producers 
attempt to develop data in-house, they will not be able to use 
pathogens to conduct in-house studies.
    (Response 121) As discussed in the 2014 supplemental proposed rule 
and the 2015 produce safety final rule, we do not have sufficient 
information to support the derivation of appropriate, broadly 
applicable microbial die-off or removal rates between harvest and end 
of storage or during post-harvest activities such as commercial 
washing. See 79 FR 58434 at 58446 and 80 FR 74354 at 74444. We have not 
been provided with and are not aware of information that changes our 
position. Rather, farms that increase the time interval between harvest 
and the end of storage and/or conduct other post-harvest activities as 
a mitigation measure in accordance with Sec.  112.45(b)(1)(iii) must 
establish parameters for such practices as appropriate to their 
circumstances (for example, in consideration of commodity 
characteristics, storage time and conditions, and/or other relevant 
production practices), as supported by scientifically valid data and 
information.
    For example, a farm that uses commercial washing as a mitigation 
measure under Sec.  112.45(b)(1)(iii) must do so as appropriate to its 
circumstances. The appropriateness of using commercial washing as a 
mitigation measure may be affected by, for example, the characteristics 
of the covered produce being washed (such as where commodity 
characteristics may protect potential contaminants from removal); the 
method of commercial washing (such as through a single-pass system vs. 
one that uses recirculated water); and any monitoring or management 
practices the farm has in place to reduce the potential for the 
agricultural water to serve as a source or route of contamination to 
covered produce (for example, the practices specified in Sec.  
112.44(d)).
    We are not requiring farms to conduct ``in-house'' studies in order 
to support use of a mitigation measure under Sec.  112.45(b)(1)(iii), 
nor are we establishing parameters on what studies conducted to support 
such practices should entail. Rather, we require that any increased 
time interval between harvest and the end of storage and/or other post-
harvest activities used in accordance with Sec.  112.45(b)(1)(iii) be 
supported by scientifically valid data or information. See 80 FR 74354 
at 74371.
    (Comment 122) Some comments seek clarity around the term 
``commercial washing'' in proposed Sec.  112.45(b)(1)(iii), such as 
whether it would include processes that use water for cooling purposes 
(for example, hydrocooling, dump tank, spray bar, and ice-injection 
processes), and whether it is an available mitigation measure for all 
covered produce, or just select commodities.
    (Response 122) As discussed in response to comment 120, we are 
removing commercial washing as an example of a post-harvest activity in 
Sec.  112.45(b)(1)(iii) to reinforce that farms may use other 
activities during or after harvest that result in microbial die-off or 
removal, provided the farm has adequate supporting data and 
documentation. While post-harvest activities conducted under Sec.  
112.45(b)(1)(iii) could involve the use of agricultural water, it is 
not required, such as where controlled atmosphere storage may result in 
microbial die-off or removal (as supported by scientifically valid data 
and information). (See 80 FR 74354 at 74371).
    Additionally, we note that activities allowed as mitigation 
measures under Sec.  112.45(b)(1)(iii) are not limited to any 
commodities in particular. However, as discussed in response to comment 
121, farms must establish parameters for any post-harvest activities 
used in accordance with Sec.  112.45(b)(1)(iii) as appropriate to their 
circumstances (e.g., in consideration of commodity characteristics, 
storage conditions, and/or other relevant production practices) and as 
supported by scientifically valid data and information.
d. Changing the Method of Water Application
    (Comment 123) Some comments request that FDA identify use of drip 
and seepage irrigation as effective strategies for reducing risk 
because in such systems, the water distribution occurs below the soil 
surface (never touching any above-ground portion of the plant) and the 
soil naturally filters out any potential microbial hazards.
    (Response 123) It is unclear to us whether comments are requesting 
that we identify drip and seepage irrigation as methods that do not 
result in contact between agricultural water and the crop, or that we 
identify use of drip and seepage irrigation as water application 
methods that could be broadly applied as mitigation measures under 
Sec.  112.43(b)(1)(iv).
    To the extent that comments are requesting we identify drip and 
seepage irrigation as broadly applicable mitigation measures in Sec.  
112.43(b)(1)(iv), we decline to do so, as the effectiveness of using 
those application methods as a mitigation measure is a function of 
multiple factors, including the water application method, 
characteristics of the crop (such as whether the harvestable portion 
grows near, on, or in the ground), and any relevant practices the farm 
may have in place. For example, changing the water application method 
for root crops may not be an appropriate mitigation measure, as it may 
be difficult to effectively minimize contact between agricultural water 
and the harvestable portion of the crop while allowing the crop access 
to water needed to survive and grow. However, for non-root crops, 
changing the water application method may be effective as a mitigation 
measure under Sec.  112.45(b), if making the change minimizes the water 
that is in direct contact with the harvestable portion of the crop. For 
example, changing from overhead to microjet irrigation for some tree 
fruit (such as citrus) or from microjet to drip irrigation for some 
covered produce that grows near the ground (such as bell peppers) may 
reduce the likelihood of contamination of the covered produce in 
accordance with Sec.  112.45(b)(1)(iv). Additionally, there may be 
instances where multiple practices--such as the use of plastic mulch 
along with changes in water application methods--together serve as 
effective mitigation measures under Sec.  112.45(b)(1)(iv).
e. Alternative Mitigation Measure
    (Comment 124) Several comments suggest that changing water sources 
(from surface water to ground water, for

[[Page 37505]]

instance) might be considered a possible alternative mitigation 
measure.
    (Response 124) We have incorporated flexibility in Sec.  112.45 to 
provide farms viable options to reduce the potential for contamination 
of non-sprout covered produce or food contact surfaces with known or 
reasonably foreseeable hazards associated with pre-harvest agricultural 
water without needing to alter the source of agricultural water, such 
as making necessary changes (for example, repairs) or changing the 
method of water application to reduce the potential for contamination 
of covered produce. However, if a farm changes the water source it uses 
for pre-harvest agricultural water, it is a significant change, and a 
reassessment under Sec.  112.43(e) is required. The reassessment must 
evaluate the impacts of the change on the factors in Sec.  112.43(a)(1) 
through (5), any new hazards identified, and the outcome and 
determination under Sec.  112.43(c). See also section V.I.
    We believe that providing a range of mitigation measures for farms 
to use in Sec.  112.45(b), including the ability to use an alternative 
mitigation measure provided the requirements in Sec.  112.12 are met, 
provides farms with an appropriate level of flexibility in selecting 
mitigation measures that are reasonably necessary to reduce the 
potential for covered produce or food contact surfaces with known or 
reasonably foreseeable hazards associated with pre-harvest agricultural 
water.

K. Treatment of Agricultural Water

    The proposed rule contained edits designed to provide clarity, such 
as reorganizing subpart E to group provisions of a similar nature, 
which included moving the provisions related to agricultural water 
treatment to Sec.  112.46. Additionally, as discussed in the 2021 
agricultural water proposed rule, although we are not requiring farms 
to treat their agricultural water, scientists from FDA's Center for 
Food Safety and Applied Nutrition, in collaboration with EPA, developed 
a testing protocol for evaluating the efficacy of antimicrobial 
chemical treatments against certain foodborne pathogens in agricultural 
water sources (Ref. 82). Since the efficacy protocol was approved by 
EPA on April 29, 2020, we have worked with EPA to provide various 
updates to enhance flexibility (where appropriate) and meet the current 
needs scientifically and practically (Ref. 83).
    We received various comments on agricultural water treatment in 
general, as well as the pre-harvest agricultural water efficacy testing 
protocol, which we discuss below. For comments regarding treatment as a 
corrective or mitigation measure, see section V.J.
    As discussed in section V.A., we did not propose to substantively 
revise the requirements for agricultural water treatment in Sec.  
112.46; therefore, comments on Sec.  112.46 are outside the scope of 
this rule. However, we intend to issue guidance on these requirements 
in the future.
    (Comment 125) Many comments note that there are currently no 
chemical treatment options approved by EPA for use in pre-harvest 
agricultural water against human pathogens, and express concerns that 
this may prohibit the use of water treatment as a corrective or 
mitigation measure until such products are approved. Some comments 
suggest that the lack of available chemical treatments may result in 
some farms using pesticides in an unapproved manner in order to comply 
with the proposed rule.
    (Response 125) Farms are not required to treat their agricultural 
water. Rather, farms have a range of options, and treatment of water is 
one such option. Additionally, if a farm treats agricultural water, 
Sec.  112.46 allows for non-chemical suitable methods of treatment. See 
80 FR 74354 at 74436-74437. Further, as discussed in the 2015 produce 
safety final rule, like all registered pesticide products, 
registrations for antimicrobial products are specific to the use that 
was considered as part of the registration process, and thus the 
products may be legally used for the specified registered use only. See 
80 FR 74354 at 74436.
    (Comment 126) Some comments voice concern that farms are not 
required to test the quality of their water prior to treating it. These 
comments suggest that the chemicals approved using the treatment 
efficacy protocol have limited usefulness in ensuring that treated pre-
harvest water contains no detectable generic E. coli per 100 mL of 
water, as a farm would be unable to document that an EPA-labeled 
treatment that achieves 3-log removal is expected to result in pre-
harvest water containing no detectable generic E. coli per 100 mL of 
water unless the farm knows that the starting concentration of generic 
E. coli is less than 1,000 CFU per 100 mL.
    (Response 126) We understand commenters to be referring to language 
in the pre-harvest agricultural water treatment efficacy protocol 
specifying that results of testing should demonstrate a minimum of 3-
log reduction of each of the test organisms as compared to the control 
count (Ref. 82). We understand that a 3-log reduction is the minimum 
level of reduction of pathogens the EPA will consider when registering 
an antimicrobial treatment that includes a public health claim. While 
the requirements for agricultural water treatment in Sec.  112.46 refer 
in part to Sec.  112.44(a) (which includes a microbial criterion of no 
detectable generic E. coli per 100 mL of water), we note that the 
requirements in Sec.  112.44(a) do not apply to pre-harvest 
agricultural water for non-sprout covered produce (see Sec.  112.40).
    We did not propose to substantively revise Sec.  112.46, which 
includes requirements related to treatment efficacy.
    (Comment 127) Some comments request that FDA remove chemical 
treatment of irrigation water as an allowable mitigation strategy in 
the proposed rule so as to avoid potential effects on the environment.
    (Response 127) As discussed in response to comment 125, farms are 
not required to treat their agricultural water. Rather, farms have a 
range of options, and treatment of water (such as with physical 
treatment, chemical treatment, or other suitable method) is one such 
option. With respect to environmental concerns related to chemical 
treatment of agricultural water, we note that environmental and health-
related risk assessments of pesticide products are conducted by EPA 
prior to their registration and use. See 80 FR 74354 at 74434-74435.
    However, we recognize that improper use, management, or disposal 
associated with chemical treatment of agricultural water can create 
adverse environmental impacts. During rulemaking for the 2015 produce 
safety final rule, and in accordance with the National Environmental 
Policy Act and its implementing FDA regulations, we evaluated the 
potential effects of the 2015 produce safety final rule on the human 
environment in the United States in an EIS (Ref. 50). That document has 
a detailed discussion of the potential impacts such as those related to 
pesticide use, chemical treatment of agricultural water, and changes in 
ground water demand. See also 80 FR 74354 at 74434-74435. At the time 
of this rulemaking, as was also the case at the time of preparation of 
the Agency's finding of no significant impact and environmental 
assessment for the 2021 agricultural water proposed rule (Refs. 51 and 
52), there are no pesticide products which have been registered by EPA 
for treatment of agricultural water during pre-harvest activities. No 
significant adverse environmental impacts have been identified with 
this final rule (Ref. 53).

[[Page 37506]]

We are not aware of, and comments did not provide, data or information 
suggesting these findings are incorrect. Therefore, further analysis of 
potential impacts would be speculative.
    (Comment 128) Several comments agree with FDA's tentative 
conclusion that the proposed rule does not conflict with or duplicate 
the requirements of organic certification under USDA's National Organic 
Program (NOP) standards (7 CFR part 205). However, a few comments 
express concern that chemical products approved by the EPA for use on 
pre-harvest water in the future (such as chlorine compounds) may not be 
allowed for use under the NOP.
    (Response 128) As discussed in the 2015 produce safety final rule 
(80 FR 74354 at 74439-74440), compliance with the provisions of the 
2015 produce safety final rule, including the provisions related to 
agricultural water in subpart E, does not preclude compliance with the 
requirements for organic certification in 7 CFR part 205. We continue 
to conclude that in accordance with section 419(a)(3)(E) of the FD&C 
Act, this rule does not include any requirements that conflict with or 
duplicate the requirements of the NOP established under the Organic 
Foods Production Act of 1990. See also 86 FR 69120 at 69132.
    If a farm treats its agricultural water, non-chemical water 
treatment options (including pesticide devices such as filter units, UV 
light units, and ozonator units) may be also used in compliance with 
Sec.  112.46, which we did not propose to substantively revise. Thus, 
this rule does not require organic farms to use a substance that is 
prohibited in organic production. We also note that the provisions for 
treatment of agricultural water in Sec.  112.46 are not in conflict 
with or duplicative of NOP regulations which permit the use of chlorine 
materials in organic production and handling in accordance with certain 
limitations (see 7 CFR 205.601(a) and 205.605(b)). Additionally, NOP 
guidance, ``The Use of Chlorine Materials in Organic Production and 
Handling'' (Ref. 84), provides information about compliant use of 
chlorine under the organic regulations. See 86 FR 69120 at 69131.
    (Comment 129) Some comments suggest that treatments that are 
effective against the bacterial pathogens identified in the efficacy 
protocol cannot necessarily be expected to have the same level of 
effectiveness against viral and protozoan pathogens, such as Cyclospora 
cayatanensis. Moreover, comments claim that in many situations, a farm 
may not know what specific microbial hazards may be present in an 
agricultural water and request that FDA clarify whether all known or 
reasonably foreseeable hazards must be considered when selecting a 
treatment.
    (Response 129) We recognize that pathogens present in agricultural 
water systems may vary, and that not every treatment will be effective 
against every possible pathogen. While farms are required to consider 
the conditions that are reasonably likely to introduce known or 
reasonably foreseeable hazards as part of their pre-harvest 
agricultural water assessments (emphasis added), we do not necessarily 
expect farms to identify the specific microbial hazards associated with 
each condition in order to treat their water as a corrective or 
mitigation measure. Nonetheless, if a pathogen is known to be, or is 
likely to be, associated with a farm's pre-harvest agricultural water 
(which the farm may be aware of through voluntary testing, knowledge or 
experience, or other means) and the farm treats the water, the farm 
must consider the presence of that pathogen in selecting an appropriate 
method of treatment.
    For example, the efficacy protocol for the development and 
registration of antimicrobial treatments for pre-harvest agricultural 
water, as updated in January 2023 (Ref. 82), specifies Shiga-toxin 
producing E. coli and Salmonella enterica as test organisms. As such, 
any chemistries approved using this protocol will specify those 
organisms on their labels. (While the protocol originally included L. 
monocytogenes, in a January 2023 update (Ref. 83), we explained that we 
were removing L. monocytogenes from the protocol at that time.) We 
emphasize that a variety of measures are available for farms to use in 
Sec.  112.45, not just those related to chemical treatment of 
agricultural water. As we continue to learn more about the known or 
reasonably foreseeable hazards present in pre-harvest agricultural 
water sources and systems, we will consider working with EPA to account 
for other pathogens in efficacy protocols to support registration of 
chemical treatments.
    (Comment 130) Some comments disagree with what they suggest is a 
requirement under the proposed rule for farms to treat their water with 
products labeled for specific pathogens. A few comments request that 
FDA provide flexibility related to the treatment efficacy protocol and 
requirements that chemical treatments be validated for efficacy against 
specific test organisms.
    (Response 130) As discussed in the 2015 produce safety final rule, 
although some antimicrobial substances are regulated by FDA, most 
antimicrobial substances that might be used by farms in agricultural 
water are regulated by the EPA (Ref. 85) (80 FR 74354 at 74439). We 
anticipate that the treatment efficacy protocol (Ref. 82), which EPA 
approved, will facilitate the registration of chemical treatments and 
increase the options for corrective and mitigation measures available 
to farms. We anticipate that having several chemical treatment options 
available encompassing a range of chemistries and applications will 
help ensure coverage over an industry with such variable practices and 
conditions.

L. Records Relating to Agricultural Water (Sec.  112.50)

    We proposed to add new requirements in Sec.  112.50 for records 
relating to pre-harvest agricultural water assessments. We also made 
revisions to conform with the proposed changes to the subpart E 
provisions, including to revise the requirements of Sec.  112.161(b) to 
require supervisory review of records of pre-harvest agricultural water 
assessments and determinations.
    We received various comments on the recordkeeping requirements in 
Sec.  112.50 and respond to those comments in the following paragraphs. 
As discussed below, we are revising Sec.  112.50(b)(7) to further 
reinforce flexibility afforded to farms in establishing records related 
to certain actions taken under Sec.  112.45. We are also revising Sec.  
112.50(b)(8) to reflect the changes we are making to Sec.  
112.45(b)(1)(ii) and (iii) (see section V.J.). Additionally, consistent 
with Sec.  112.50(b)(8) in the 2015 produce safety final rule, we are 
adding the following record requirement: for farms using an alternative 
mitigation measure in accordance with Sec.  112.45(b)(1)(vi), records 
of scientific data or information the farm relies on to support that 
measure (Sec.  112.50(b)(9)). We have renumbered the subsequent 
recordkeeping provisions accordingly. We received no comments on the 
conforming revisions to Sec.  112.161(b) and are finalizing it without 
change.
    (Comment 131) Some comments seek clarity on what standards of 
Subpart O, ``Records,'' apply for pre-harvest agricultural water 
assessments. A few comments request that FDA clarify which records, 
including those for agricultural water reassessments, are required to 
be in writing. A few comments request that FDA provide templates for 
records, with a few of those comments seeking clarity on whether a 
printed copy of the Agricultural Water Assessment Builder tool would 
satisfy the records

[[Page 37507]]

requirements in Sec.  112.50. Others request that FDA provide 
sufficient education and outreach to assist farms in complying with the 
recordkeeping requirements.
    (Response 131) Subpart O of the 2015 produce safety final rule 
established the general requirements applicable to documentation and 
records that farms must establish and maintain under part 112, 
including records related to agricultural water. We discuss the 
requirements in subpart O in the 2015 produce safety final rule. See 80 
FR 74354 at 74510-74514.
    Section 112.43(a) requires that farms, in part, prepare a written 
agricultural water assessment (emphasis added). The requirement that 
agricultural water assessments be in writing also applies for any 
reassessments conducted under Sec.  112.43(e).
    As referenced by the comments, we have made an Agricultural Water 
Assessment Builder (Ref. 24) available to help stakeholders understand 
the requirements in the 2021 agricultural water proposed rule for pre-
harvest agricultural water assessments. While we expect to update the 
Builder to reflect this final rule, use of the Builder does not mean 
that farms are in compliance with the relevant requirements.
    (Comment 132) A few questions seek clarity on whether agricultural 
water assessments prepared by farms will be accessible to outside 
parties.
    (Response 132) Records obtained by FDA in accordance with part 112, 
including agricultural water assessments, are subject to the disclosure 
requirements under 21 CFR part 20 (Sec.  112.167). Our disclosure of 
information is subject to the Freedom of Information Act (5 U.S.C. 
552), the Trade Secrets Act (18 U.S.C. 1905), the FD&C Act, and our 
implementing regulations under 21 CFR part 20, which include protection 
for confidential commercial information and trade secrets. See 80 FR 
74354 at 74514.
    (Comment 133) Several comments request that FDA clarify which 
records can satisfy multiple requirements both for subpart E and for 
other sections of the rule that may be related (for example, subparts I 
and F). Many comments ask whether records used for water system 
inspections can also be used to satisfy the agricultural water 
assessment recordkeeping requirements.
    (Response 133) Under Sec.  112.163(a), farms are not required to 
duplicate any existing records, including those for agricultural water 
assessments, if those records contain all of the required information 
and satisfy the relevant requirements. Similarly, if a farm has records 
containing some but not all of the required information, Sec.  
112.163(b) provides the flexibility to keep any additional information 
required either separately or combined with existing records.
    With respect to comments asking about records for agricultural 
water system inspections and agricultural water assessments, we note 
that records of a farm's agricultural water system inspection in Sec.  
112.50(b)(1) may not be appropriate to fulfill, in full, the 
requirement to maintain records of written agricultural water 
assessments in Sec.  112.50(b)(2), as the requirements in Sec.  112.43 
for agricultural water assessments require consideration of a broader 
range of factors than those considered for water system inspections 
under Sec.  112.42(a). See also response to comment 25.
    (Comment 134) Some comments request that FDA simplify the 
recordkeeping requirements for farms that choose to wait at least 4 
days between the last direct water application and harvest by allowing 
farms to document practices in written standard operating procedures 
instead of requiring farms keep records documenting each individual 
time they use the 4-day interval on each crop.
    (Response 134) We agree that flexibility with respect to records of 
certain mitigation measures is warranted and are revising proposed 
Sec.  112.50(b)(7) to remove specific reference to Sec.  
112.45(b)(1)(ii) and (iii) (regarding a time interval between last 
water application and harvest, and a time interval between harvest and 
end of storage (and/or conducting other post-harvest activities), 
respectively). For example, if a farm implements an increased time 
interval between last direct water application and harvest as a 
mitigation measure under Sec.  112.45(b)(1)(ii) and adopts that 
increased time interval as a routine practice, capturing that practice 
in a single record suffices such that maintaining a record of each 
individual instance the time interval is applied is not necessary. 
This, too, applies to any increased time intervals between harvest and 
end of storage and/or other post-harvest activities that a farm 
implements as a mitigation measure under Sec.  112.45(b)(1)(iii), if 
the farm adopts the relevant practice(s) as a routine activity.
    (Comment 135) One comment notes that proposed Sec.  112.45(b) 
requires the implementation of certain ``mitigation measures'' under 
specified conditions, yet the associated records requirement in Sec.  
112.50(b)(7) requires ``documentation of actions you take in accordance 
with Sec.  112.45.'' The comment requests that Sec.  112.50(b)(7) be 
modified to read, ``Written documentation of mitigation measures you 
take in accordance with Sec.  112.45.''
    (Response 135) We decline to make this change, as Sec.  112.45 
includes required actions beyond the mitigation measures specified in 
Sec.  112.45(b). See Sec.  112.45(a), which requires, in certain 
circumstances, that a farm immediately discontinue use of agricultural 
water and, before resuming use of the water, implement corrective 
measures in Sec.  112.45(a)(1) or (2).

VI. Effective and Compliance Dates

    In the 2021 agricultural water proposed rule, we proposed to 
establish an effective date 60 days after the date of publication of 
the final rule. In the 2022 supplemental proposed rule, we proposed 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 also specified the duration of 
the period of enforcement discretion for the harvest and post-harvest 
agricultural water requirements 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.
    We received several comments in response to the 2021 proposed rule 
as well as the 2022 supplemental proposed rule regarding the proposed 
effective date for a final rule as well as the proposed compliance 
dates for the requirements that apply for pre-harvest agricultural 
water for non-sprout covered produce. We respond to these comments 
here. While in the 2022 supplemental proposed rule we noted that we 
were 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, we received some comments related 
to the end of our intended period of enforcement discretion for the 
harvest and post-harvest agricultural water requirements for non-sprout 
covered produce.
    After considering comments, we are finalizing the effective date as 
proposed, i.e., 60 days after publication of this rule. We are also 
finalizing compliance dates as proposed, such that compliance dates are 
those shown in table 5.

[[Page 37508]]



   Table 5--Compliance Dates for Requirements in Subpart E for Covered
                  Activities Involving Covered Produce
                  [Except sprouts subject to subpart M]
------------------------------------------------------------------------
                                    Provisions     Provisions related to
                                    related to          pre-harvest
                                harvest and  post-   agricultural water
                                     harvest      ----------------------
     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 this rule.
Small Business................  January 26, 2023.  1 year and 9 months
                                                    after the effective
                                                    date of this rule.
All Other Businesses..........  January 26, 2022.  9 months after the
                                                    effective date of
                                                    this rule.
------------------------------------------------------------------------

    (Comment 136) Several comments support FDA's proposed compliance 
dates for pre-harvest agricultural water requirements, suggesting that 
the proposed compliance dates allow sufficient time for farms to 
understand and comply with the requirements. In contrast, other 
comments express a concern that the proposed compliance dates for pre-
harvest agricultural water requirements do not allow sufficient time 
for on-farm preparedness and development of educational and training 
materials to support successful implementation. A few comments suggest 
specific compliance dates from 1 to 3 years after the final rule 
publishes based on farm size would be appropriate, whereas others 
suggest that a single compliance date for all agricultural water 
provisions 2 years after publication of the final rule would be more 
appropriate.
    (Response 136) In light of the extensive outreach we conducted 
following issuance of the proposed rule and anticipated education, 
outreach and training on this final rule, we decline commenters' 
request to provide additional time for farms to come into compliance 
with the pre-harvest agricultural water requirements for non-sprout 
covered produce and are finalizing compliance dates for those 
provisions as proposed, without change. To the extent that comments are 
suggesting we establish a single set of compliance dates for all uses 
of agricultural water (pre-harvest, harvest, and post-harvest) and/or 
establish a single compliance date that applies for farms of all sizes, 
we discuss such feedback in response to comments 141 and 137, 
respectively.
    Regarding outreach conducted following issuance of the 2021 
proposed rule, as discussed in further detail in section III.F., we 
conducted numerous outreach activities following issuance of the 
agricultural water proposed rule. These included participation in 
various webinars; consultations, two virtual public meetings; regional 
meetings sponsored by State regulatory partners; and numerous other 
meetings and speaking engagements to discuss the proposed rule, respond 
to questions, and receive feedback. Further, we are exploring other 
mechanisms, such as webinars, updated training programs, workshops, and 
educational resources, to provide industry with information to 
facilitate compliance the requirements we are finalizing here. We also 
anticipate updating our Agricultural Water Assessment Builder, 
including both the online and paper-based versions, to reflect the pre-
harvest agricultural water requirements we are finalizing here.
    Additionally, we note that although the compliance dates we are 
finalizing here apply for all requirements for pre-harvest agricultural 
water for non-sprout covered produce, many of these requirements have 
not changed since publication of the 2015 produce safety final rule. 
See Sec.  112.40 and response to comment 9. For example, other than 
technical amendments to provide additional clarity (such as adding 
descriptive headings and consolidating certain requirements), the 
requirements in Sec.  112.42 for agricultural water system inspections 
and maintenance remain the same as when the 2015 produce safety final 
rule published. As such, we expect that many farms may already be aware 
of, and have received education and training on, some of the 
requirements that apply for pre-harvest agricultural water that are not 
changing with this final rule. While we recognize the value of outreach 
and training regarding the requirements in Sec.  112.43 for pre-harvest 
agricultural water assessments and outcomes, we disagree that farms 
will need more than the established compliance periods to adapt their 
programs to the specific requirements of this rule.
    (Comment 137) Many comments support staggered compliance dates for 
the pre-harvest agricultural water provisions based on farm size. Some 
comments note that extended compliance dates are especially important 
in order to provide enough time for training, technical assistance, and 
updates to practices, infrastructure, and equipment to occur. 
Conversely, some comments do not support staggered compliance dates 
based on farm size, contending that staggered compliance dates create 
unnecessary complexity for organizations that conduct training since 
they will first have to target only large farms, and then conduct 
training for small farms as the different compliance dates grow near.
    (Response 137) We disagree that we should establish a uniform 
compliance period for the pre-harvest agricultural water requirements 
for non-sprout covered produce across all farm sizes. The purpose of 
staggered compliance dates is to give businesses of various sizes time 
to come into compliance with the rule technically, financially, and 
operationally. In light of practical considerations for small and very 
small businesses, we consider that additional time for small and very 
small farms to come into compliance is warranted. Moreover, we note 
that staggered compliance dates based on farm size is consistent with 
compliance dates for requirements in the 2015 produce safety final rule 
that we did not propose to change, and is consistent with the statutory 
provisions in section 419(a)(3)(A) and (c)(1)(B) of the FD&C Act, which 
direct us to provide sufficient flexibility to be practicable for all 
sizes and types of businesses, including small businesses.
    (Comment 138) Some comments urge FDA to set pre-harvest compliance 
dates only after sufficient research is conducted regarding the impact 
of farming practices on pre-harvest agricultural water quality and 
safety, and mitigation measures that are appropriate to address various 
conditions. Several comments suggest that ``proven'' mitigation 
measures need to be made available before farms should be expected to 
implement the requirements for agricultural water assessments.
    (Response 138) We disagree with these comments. While we have 
designed the rule to be adaptable to future scientific advancements, we 
note that there is long-standing scientific

[[Page 37509]]

support for the mitigation measures identified in Sec.  112.45(b). See, 
for example, the GAPs Guide (Ref. 59) and the QAR (Ref. 17). We also 
discuss the scientific reasoning behind the proposed requirements for 
agricultural water assessments (including mitigation measures) 
throughout the 2021 agricultural water proposed rule and in section V 
of this final rule. To the extent that science related to pre-harvest 
agricultural water quality continues to evolve, farms will be able to 
use such information to further inform covered their pre-harvest 
agricultural water assessments. We anticipate that as new information 
becomes available, it will be shared with covered entities through 
various means. See response to comment 19.
    (Comment 139) A few comments suggest that FDA and States will need 
time to make progress on partnerships related to the pre-harvest 
agricultural water provisions. These comments suggest that partnerships 
should be in place before compliance with the pre-harvest requirements 
is required.
    (Response 139) FSMA recognizes a critical role for FDA's State 
regulatory partners. To this end, FDA has established the FDA-State 
Produce Safety Implementation Cooperative Agreement Program,\8\ through 
which most states have developed produce safety programs (Ref. 86).
---------------------------------------------------------------------------

    \8\ 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.
---------------------------------------------------------------------------

    (Comment 140) Several comments disagree with the proposed effective 
date of 60 days after publication of the final rule, arguing that 60 
days is not enough time for farms to implement necessary changes in 
order to come into compliance with the proposed requirements.
    (Response 140) ``Effective date'' and ``compliance date'' do not 
mean the same thing. The effective date is the date that requirements 
amend the current CFR; and for this rule, the compliance date is the 
date at which a farm is required to be in compliance with the pre-
harvest agricultural water requirements for non-sprout covered produce.
    We proposed that the effective date of this rule would be 60 days 
after the date of publication of the final rule in the Federal 
Register. However, we proposed to provide for a longer timeline for 
farms to come into compliance with the pre-harvest agricultural water 
provisions depending on the size of the farm--i.e., 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 also table 5. As discussed 
throughout this section, we are finalizing the effective and compliance 
dates as proposed.
    (Comment 141) We also received various comments on FDA's intention 
to exercise enforcement discretion for harvest and post-harvest 
agricultural water. One comment notes that most farms have already 
begun complying with the harvest and post-harvest agricultural water 
requirements, and voices support for FDA's intent to exercise 
enforcement discretion for those requirements as described in the 2022 
supplemental proposed rule. In contrast, some comments request that FDA 
provide more time for training and other outreach. A few of these 
comments note that even though FDA did not propose changes to the 
requirements for harvest and post-harvest agricultural water, some of 
the provision numbers for those requirements may change with a final 
rule, which could result in confusion. A few comments assert that 
bifurcated compliance dates will be confusing, and create unnecessary 
complexity by, for instance, requiring educators to conduct separate 
trainings for the harvest/post-harvest and pre-harvest agricultural 
water requirements.
    (Response 141) As discussed in the 2022 supplemental proposed rule, 
we reopened the comment period on the 2021 proposed rule solely to 
request public comment on the proposed compliance dates for the 
proposed pre-harvest agricultural water provisions for covered produce 
other than sprouts. As we did not propose to change the requirements 
that apply for harvest and post-harvest agricultural water, we did not 
propose a compliance date extension for those provisions for covered 
produce other than sprouts. However, we stated our intent to exercise 
enforcement discretion for the harvest and post-harvest agricultural 
water requirements for non-sprout covered produce until specific dates, 
which were staggered according to the size of the farm, to provide 
farms, regulators, educators, and other stakeholders additional time to 
facilitate compliance with those provisions.
    With respect to comments suggesting there will be confusion due to 
the renumbering of various provisions that apply for harvest and post-
harvest agricultural water, we note that Sec.  112.40 specifies which 
provisions in subpart E are applicable to harvest and post-harvest 
agricultural water. Additionally, our response to comment 9 summarizes 
the major changes being made to the agricultural water provisions in 
subpart E between the 2015 produce safety final rule and this final 
rule, including the location of the relevant requirements. We expect 
this information, along with training, technical assistance, 
educational visits, and on-farm readiness reviews, will reduce 
potential confusion associated with reorganizing the provisions of 
subpart E.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review 
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, 
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers 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). Rules are ``significant'' under Executive Order 12866 
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' OIRA has determined that this final rule is not a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    Because this rule is not likely to result in an annual effect on 
the economy of $100 million or more or meets other criteria specified 
in the Congressional Review Act/Small Business Regulatory Enforcement 
Fairness Act, OIRA has determined that this rule does not fall within 
the scope of 5 U.S.C. 804(2).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because some small entities may incur costs larger than 3 
percent of annual revenues, we cannot certify that the final rule will 
not have a significant

[[Page 37510]]

economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes estimates of 
anticipated impacts, before issuing ``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 $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    We estimate costs of the rule resulting from reading the rule, 
conducting pre-harvest agricultural water assessments, conducting 
mitigation measures when reasonably necessary based on the outcomes of 
the pre-harvest agricultural water assessments, and recordkeeping as a 
result of the pre-harvest agricultural water assessments. Our primary 
estimates of annualized costs are approximately $17.5 million at a 3 
percent discount rate and approximately $17.7 million at a 7 percent 
discount rate over 10 years.
    We estimate benefits of this rule resulting from the dollar burden 
of foodborne illnesses averted, and we estimate forgone benefits of 
this rule resulting from foodborne illnesses not averted due to the 
pre-harvest agricultural water microbial quality criteria and testing 
provisions in the 2015 produce safety final rule. Our primary estimates 
of annualized benefits are approximately $10.3 million at a 3 percent 
discount rate and approximately $10.1 million at a 7 percent discount 
rate over 10 years. In the FRIA, we discuss non-quantified benefits of 
the rule stemming from avoiding overly broad recalls of products that 
would have occurred absent the rule. We also discuss non-quantified 
benefits relating to increased flexibility for covered farms to 
comprehensively evaluate their agricultural water systems, in light of 
the requirements for pre-harvest agricultural water assessments being 
designed to accommodate a wide range of agricultural water sources, 
uses, and practices.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 26) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. 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. We have considered the 
changes made between the 2021 proposed rule and this final rule and 
have concluded that the Agency's finding of no significant impact for 
the proposed rule, and the evidence supporting that finding, contained 
in an environmental assessment, continue to apply (Refs. 51-53 and 87). 
The Agency's 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.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description section 
with an estimate of the annual recordkeeping burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    Title: Standards for the Growing, Harvesting, Packing, and Holding 
of Produce; Recordkeeping--OMB Control Number 0910-0816--Revision.
    Description: This rule replaces recordkeeping requirements (found 
in part 112, subpart E) associated with sampling and testing of pre-
harvest agricultural water for non-sprout covered produce with 
requirements to prepare and maintain documentation of written pre-
harvest agricultural water assessments for non-sprout covered produce.
    Description of Respondents: Farms subject to the regulation in part 
112.
    In the following paragraphs, we describe and respond to the 
comments pertaining to the proposed information collection.
    (Comment 142) One comment seeks clarity on how this rule adds to 
the paperwork burden of the produce safety rule in terms of hours and 
numbers of records. This comment also requests clarification as to 
whether the calculated time burden in the 2021 agricultural water 
proposed rule includes reassessments and maintenance activities, and 
expresses a view that FDA may have underestimated the time burden of 
this rule if such activities were not included in the calculations.
    (Response 142) Our estimates of the burden of the information 
collection in the 2021 agricultural water proposed rule and this final 
rule reflect only the requirements that we are finalizing here for pre-
harvest agricultural water assessments for non-sprout covered produce. 
This includes the requirement in Sec.  112.43(e) for farms to conduct a 
reassessment at least once annually, and whenever a significant change 
occurs in their agricultural water system that make it reasonably 
likely that a known or reasonably foreseeable hazard will be introduced 
into or onto covered produce (other than sprouts) or food contact 
surfaces through direct application of agricultural water during 
growing activities. See the third column in table 6 below, in which we 
assume 1.1 agricultural water assessments per year in light of this 
requirement, consistent with our FRIA (Ref. 26). Comments did not 
provide information to suggest that revisions to this approach are 
necessary or appropriate. As such, we use the same approach to 
estimating the burden of information collection in this final rule as 
we did in the 2021 agricultural water proposed rule, with the only 
change being to update farm counts based on more recent data sources 
used in the FRIA compared to that used in the PRIA. For discussion 
related to the estimated time to conduct recordkeeping specifically, 
see comment 143.
    (Comment 143) A few comments suggest that the estimates in the 
proposed rule for time to conduct recordkeeping for pre-harvest 
agricultural water assessments, which ranged from 4-9 hours depending 
on farm size, is too low in light of challenges that some farms may 
face. For example, a few comments suggest that some farms may face 
challenges in conducting agricultural water assessments, such as the 
following: having multiple water sources; having long growing seasons; 
having water sources than span long distances; lacking historical 
knowledge of water systems and adjacent lands; lacking technical 
background; having limited personnel and/or financial resources; and 
not speaking or reading English.
    (Response 143) We recognize that the time it takes farms to conduct 
recordkeeping for pre-harvest agricultural water assessments is likely 
to range for a variety of reasons, including those referenced in the 
comments. To account for a range in the amount of time recordkeeping 
for

[[Page 37511]]

agricultural water assessments may take, in the FRIA (Ref. 26), we 
provide low, most likely, and high estimates based on farm size (see 
tables 31-33 in that document). To estimate the burden of information 
collection associated with the requirements for pre-harvest 
agricultural water assessments, we use the ``most likely'' values in 
the FRIA for each farm size. We are not aware of, and comments did not 
provide, data or information suggesting estimates that are more 
applicable across the diversity that exists in industry in agricultural 
water systems, operations, and conditions. As such, we use the same 
estimates for the time to conduct pre-harvest agricultural water 
assessments when estimating the burden of information collection in 
this final rule as we did in the 2021 agricultural water proposed rule, 
consistent with estimates in the PRIA (Ref. 88) and FRIA (Ref. 26).
    Burden Table: Upon consideration of these comments and in light of 
updated farm count data in the FRIA compared to the PRIA, we estimate 
the burden of the information collection as follows:

                      Table 6--Cumulative Average Annual Burden, Covered Farms of All Sizes
----------------------------------------------------------------------------------------------------------------
                                                                                          Average
 21 CFR part 112, subpart E: requirements     Number of       Number of       Total     burden  per     Total
       that apply regarding records          respondents     records per      annual     farm  (in      hours
                                                             respondent      records       hours)
----------------------------------------------------------------------------------------------------------------
Agricultural Water Assessment and Records           9,911             1.1       10,902            4       43,608
 Maintenance--Very small covered farms
 (Sec.   112.50(b)(2))...................
Agricultural Water Assessment and Records           2,057             1.1        2,263            8       18,102
 Maintenance--Small covered farms
 (proposed Sec.   112.50(b)(2))..........
Agricultural Water Assessment and Records           5,392             1.1        5,931            9       53,381
 Maintenance--All other (Large) Covered
 Farms (proposed Sec.   112.50(b)(2))....
Cumulative totals for covered farms of             17,360  ..............       19,096            7      11,5091
 all sizes...............................
----------------------------------------------------------------------------------------------------------------
                          Cumulative average 7 burden hours per covered farm annually.
----------------------------------------------------------------------------------------------------------------

    Farms using pre-harvest agricultural water for non-sprout covered 
produce are required to prepare and maintain records of their 
agricultural water assessments unless exempt under Sec.  112.43(b). We 
estimate that a total of 17,360 farms (9,911 very small farms, 2,057 
small farms, and 5,392 other (large) farms) will be subject to 
information collection requirements under this rule, consistent with 
figures in our FRIA (Ref. 26) for this final rule and informed by a 
2018 USDA survey of farms' irrigation practices (Ref. 89). The change 
in these numbers compared to estimates provided in the 2021 
agricultural water proposed rule are a result of updates to farm counts 
between the PRIA for the 2021 agricultural water proposed rule (Ref. 
88) and the FRIA for this final rule (Ref. 26). The PRIA relied on farm 
counts from the FRIA for the 2015 produce safety final rule (based on 
2012 National Agricultural Statistics Service (NASS) Census of 
Agriculture data), whereas the FRIA relies on 2017 NASS Census of 
Agriculture data (the most recent available).
    We assume affected farms will conduct approximately 1.1 assessments 
annually, in accordance with the requirement to conduct assessments 
annually and whenever a significant change occurs that increases the 
likelihood that a known or reasonably foreseeable hazard will be 
introduced into or onto covered produce or food contact surfaces (Ref. 
26). We are assuming a range of burden: 4 hours of burden for very 
small farms, 8 hours of burden for small farms, and 9 hours for other 
(large) farms, based on estimates of the amount of time in hours to 
conduct recordkeeping for pre-harvest agricultural water assessments 
(Ref. 26). These numbers are consistent with that used in the 2021 
agricultural water proposed rule as well as the PRIA (Ref. 88) and the 
FRIA for this final rule (Ref. 26).
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the 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 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.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. Although FDA verified the website addresses 
in this document, please note that websites are subject to change over 
time.


[[Page 37512]]


*1. Bowers, J., ``Memorandum to the File--Minimum Sample Size for 
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*3. Collaborative Food Safety Forum, ``Agricultural Water Standards 
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7. Havelaar, A.H., K.M. Vazquez, Z. Topalcengiz, et al., 
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8. Lothrop, N., K.R. Bright, J. Sexton, et al., ``Optimal strategies 
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*13. Topalcengiz, Z., L.K. Strawn, and M.D. Danyluk, ``Microbial 
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*15. Truitt, L.N., K.M. Vazquez, R.C. Pfuntner, et al., ``Microbial 
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16. Lee, D., Tertuliano, M., G. Vellidis, et al., ``Evaluation of 
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*18. FDA, ``Environmental Assessment of Factors Potentially 
Contributing to the Contamination of Romaine Lettuce Implicated in a 
Multi-State Outbreak of E. coli O157:H7,'' November 1, 2018. 
Available at: https://www.fda.gov/food/outbreaks-foodborne-illness/environmental-assessment-factors-potentially-contributing-contamination-romaine-lettuce-implicated.
*19. Gerrity, K., ``Memorandum to the File on the Environmental 
Assessment; Yuma 2018 E. coli O157:H7 Outbreak Associated with 
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Water, Final Regulatory Impact Analysis, Final Regulatory 
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[[Page 37513]]

*33. Interagency Food Safety Analytics Collaboration, ``Foodborne 
Illness Source Attribution Estimates for 2019 for Salmonella, 
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*34. Interagency Food Safety Analytics Collaboration, ``Foodborne 
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*46. Chhetri, V.S., K. Fontenot, R. Strahan, et al., ``Effect of 
Surrounding Vegetation on Microbial Survival or Die-Off on 
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*49. Belias, A.M., A. Sbodio, P. Truchado, et al., ``Effect of 
Weather on the Die-Off of Escherichia coli and Attenuated Salmonella 
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*50. FDA, ``Final Environmental Impact Statement for the Proposed 
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Produce for Human Consumption,'' October 2015. Available at: https://www.fda.gov/food/food-safety-modernization-act-fsma/environmental-impact-statement-eis-fsma-final-rule-produce-safety.
*51. 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.
*52. 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.
*53. 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,'' April 
22, 2024.
*54. FDA, ``Environmental Studies,'' August 24, 2023. Available at: 
https://www.fda.gov/food/science-research-food/environmental-studies.
*55. FDA, ``FDA Partners with the University of Arizona, Wellton-
Mohawk Irrigation and Drainage District, and Yuma Area Leafy Greens 
Stakeholders to Enhance Food Safety,'' September 23, 2019. Available 
at: https://www.fda.gov/food/cfsan-constituent-updates/fda-partners-university-arizona-wellton-mohawk-irrigation-and-drainage-district-and-yuma-area-leafy.
*56. FDA, ``FDA Partners with the California Department of Food and 
Agriculture, Western Center for Food Safety, and California 
Agricultural Stakeholders to Enhance Food Safety,'' November 19, 
2020. Available at: https://www.fda.gov/food/cfsan-constituent-updates/fda-partners-california-department-food-and-agriculture-western-center-food-safety-and-california.
*57. California Food Emergency Response Team, ``Investigation of an 
Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged 
Spinach,'' March 21, 2007. Available at: https://www.marlerblog.com/files/2013/02/2006_Spinach_Report_Final_01.pdf.
*58. Jay, M.T., M. Cooley, D. Carychao, et al., ``Escherichia coli 
O157:H7 in Feral Swine Near Spinach Fields and Cattle, Central 
California Coast.'' Emerging Infectious Diseases 13, no. 12 (2007): 
1908-1911.
*59. FDA, ``Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards for Fresh Fruits and Vegetables,'' October 1998. 
Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-guide-minimize-microbial-food-safety-hazards-fresh-fruits-and-vegetables.
*60. Snellman, E.A., M. Fatica, K. Ravaliya, et al., ``Memorandum to 
the File--Review of Microbial Decay Constants Reported in Field 
Trials of Contaminated Produce.'' September 16, 2014. FDA.
*61. Assar, S., et al., ``Memorandum to the File--Addendum to the 
September 16, 2014 Memo on the Review of Microbial Decay Constants 
Reported in Field Trials of Contaminated Produce.'' October 30, 
2015. FDA.
*62. FDA, ``Investigation Report: Factors Potentially Contributing 
to the Contamination of Packaged Leafy Greens Implicated in the 
Outbreak of Salmonella Typhimurium During the Summer of 2021,'' 
2022. Available at: https://www.fda.gov/food/outbreaks-foodborne-illness/factors-potentially-contributing-contamination-packaged-leafy-greens-implicated-outbreak-salmonella.
*63. FDA, ``Lettuce: FDA Investigation Summary--Multistate Outbreak 
of E. coli O157:H7 Illnesses Linked to Ready-to-Eat Salads,'' 
December 11, 2013. Available at: https://wayback.archive-it.org/7993/20171114154923/https:/www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm374327.htm.
*64. Crawford, W., M. Baloch, and K. Gerrity, ``Environmental 
Assessment: Non-O157 Shiga Toxin-Producing E. coli (STEC): Findings 
and Potential Preventive Control Strategies,'' December 2010.

[[Page 37514]]

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67. Barak J.D. and B.K. Schroeder, ``Interrelationships of Food 
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68. Uyttendaele, M., L.-A. Jaykus, P. Amoah, et al., ``Microbial 
Hazards in Irrigation Water: Standards, Norms, and Testing to Manage 
Use of Water in Fresh Produce Primary Production.'' Comprehensive 
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Niemira C.J. Doona, F.E. Feeherry, and R.B. Gravani, pp. 129-142. 
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*70. Codex Alimentarius Commission, ``Code of Hygienic Practice for 
Fresh Fruits and Vegetables, CXC 53-2003,'' 2017. Available at: 
https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B53-2003%252FCXC_053e.pdf.
71. Muirhead, R.W., R.J. Davies-Colley, A.M. Donnison, et al., 
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72. Bach, S. and P. Delaquis, ``The Origin and Spread of Human 
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and R.B. Gravani, pp. 43-53. Ames, IA: Wiley-Blackwell, 2009.
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Indicators of Faecal Contamination in Water: A Current 
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*74. EPA, ``Recreational Water Quality Criteria,'' 2012. Available 
at: https://www.epa.gov/sites/production/files/2015-10/documents/rwqc2012.pdf.
*75. Ravaliya, K., M. Fatica, E. Snellman, et al., ``Memorandum to 
the File--Review of Water Quality Standards in Development of 
Proposed Microbial Standard in Sec.  112.44(c) of the Proposed 
Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption.'' September 16, 2014. FDA.
*76. EPA, ``Report on the 2nd Five-Year Review of EPA's Recreational 
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*77. EPA, ``Fact Sheet: Report on the Second Five-Year Review of 
EPA's Recreational Water Quality Criteria,'' May 2023. Available at: 
https://www.epa.gov/system/files/documents/2023-05/2023-5year-review-rwqc-factsheet.pdf.
*78. FDA, ``Equivalent Testing Methodology for Agricultural Water,'' 
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Microbial Safety of Fresh Produce: A Review.'' Food Microbiology 32 
(2012): 1-19.
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No. 94151PA7; DP Barcode: 455973; Submission #: 1044629.'' April 29, 
2020. EPA. Available at: https://www.fda.gov/media/140640/download.
*83. FDA, ``FDA Updates Protocol for the Development and 
Registration of Treatments for Preharvest Agricultural Water,'' 
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Materials in Organic Production and Handling,'' July 22, 2011. 
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*85. FDA, ``Determining Regulatory Authority for Antimicrobial 
Substances,'' December 14, 2017. Available at: https://www.fda.gov/food/packaging-food-contact-substances-fcs/determining-regulatory-authority-antimicrobial-substances.
*86. FDA, ``FDA-State Produce Safety Implementation Cooperative 
Agreement Program,'' November 9, 2023. Available 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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Holding of Produce for Human Consumption Relating to Agricultural 
Water: Supplement to the Finding of No Significant Impact,'' July 1, 
2022.
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Flexibility Analysis, Unfunded Mandates Reform Act Analysis,'' 2021. 
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A Survey of U.S. Produce Growers,'' 2018. Available at: https://www.ers.usda.gov/publications/pub-details/?pubid=89720.

List of Subjects in 21 CFR Part 112

    Administrative practice and procedure, Agriculture, Animals, Food 
grades and standards, Foods, Fruits, Packaging and containers, 
Reporting and recordkeeping requirements, Safety, Vegetables, Waste 
treatment and disposal.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 112 is amended as follows:

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND 
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
1. The authority citation for part 112 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 
264, 271.


0
2. Amend Sec.  112.3 by adding in alphabetical order the definitions 
for ``Agricultural water assessment'' and ``Agricultural water system'' 
to read as follows:


Sec.  112.3  What definitions apply to this part?

* * * * *
    Agricultural water assessment means an evaluation of an 
agricultural water system, agricultural water practices, crop 
characteristics, environmental conditions, and other relevant factors 
(including test results, where appropriate) related to growing 
activities for covered produce (other than sprouts) to:
    (1) Identify any condition(s) that are reasonably likely to 
introduce known or reasonably foreseeable hazards into or onto covered 
produce or food contact surfaces; and
    (2) Determine whether measures are reasonably necessary to reduce 
the potential for contamination of covered produce or food contact 
surfaces with such known or reasonably foreseeable hazards.
    Agricultural water system means a source of agricultural water, the 
water distribution system, any building or structure that is part of 
the water

[[Page 37515]]

distribution system (such as a well house, pump station, or shed), and 
any equipment used for application of agricultural water to covered 
produce during growing, harvesting, packing, or holding activities.
* * * * *

0
3. In Sec.  112.12, revise paragraph (a) to read as follows:


Sec.  112.12  Are there any alternatives to the requirements 
established in this part?

    (a) You may establish alternatives to certain specific requirements 
of subpart E of this part, as specified in Sec.  112.45(b), provided 
that you satisfy the requirements of paragraphs (b) and (c) of this 
section.
* * * * *

0
4. Revise subpart E to read as follows:
Subpart E--Agricultural Water
Sec.
112.40 What requirements of this subpart apply to my covered farm?
112.41 What requirements apply to the quality of my agricultural 
water?
112.42 What requirements apply to inspecting and maintaining my 
agricultural water systems?
112.43 What requirements apply to assessing agricultural water used 
in growing covered produce (other than sprouts)?
112.44 What requirements apply to agricultural water used as sprout 
irrigation water and in harvesting, packing, and holding covered 
produce?
112.45 What measures must I take for agricultural water to reduce 
the potential for contamination of covered produce or food contact 
surfaces with known or reasonably foreseeable hazards?
112.46 What requirements apply to treating agricultural water?
112.47 Who must perform the tests required under this subpart?
112.48-112.49 [Reserved]
112.50 Under this subpart, what requirements apply regarding 
records?

Subpart E--Agricultural Water


Sec.  112.40  What requirements of this subpart apply to my covered 
farm?

    This subpart applies to agricultural water used for, or intended 
for use in, growing, harvesting, packing, or holding covered produce. 
If you are using agricultural water for a covered activity listed in 
the first column, then you must meet the requirements in the second 
column. You also must meet the requirements in the third column, if 
applicable.

                                            Table 1 to Sec.   112.40
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
If you use agricultural water     Then you must meet these requirements
 for this covered activity
                                 If applicable, you also must meet these
                                               requirements
----------------------------------------------------------------------------------------------------------------
(a) Growing covered produce      Sec.   112.41......  (quality standard)  Sec.   112.45......  (measures).
 (other than sprouts).
                                 Sec.   112.42......  (inspections and    Sec.   112.46......  (treatment).
                                                       maintenance).
                                 Sec.   112.43......  (agricultural       Sec.   112.47......  (who may test).
                                                       water assessment).
                                 Sec.   112.50......  (records).........  Sec.   112.151.....  (test methods).
(b) Sprout irrigation water....  Sec.   112.41......  (quality standard)  Sec.   112.44(b)...  (testing
                                                                                                untreated ground
                                                                                                water).
                                 Sec.   112.42......  (inspections and    Sec.   112.45......  (measures).
                                                       maintenance).
                                 Sec.   112.44(a)...  (microbial quality  Sec.   112.46......  (treatment).
                                                       criterion).
                                 Sec.   112.50......  (records).........  Sec.   112.47......  (who may test).
                                 ...................  ..................  Sec.   112.151.....  (test methods).
(c) Harvesting, packing, or      Sec.   112.41......  (quality standard)  Sec.   112.44(b)...  (testing
 holding covered produce.                                                                       untreated 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.  112.41  What requirements apply to the quality of my agricultural 
water?

    All agricultural water must be safe and of adequate sanitary 
quality for its intended use.


Sec.  112.42  What requirements apply to inspecting and maintaining my 
agricultural water systems?

    (a) Inspection of your agricultural water systems. At the beginning 
of a growing season, as appropriate, but at least once annually, you 
must inspect all of your agricultural water systems, to the extent they 
are under your control, to identify any conditions that are reasonably 
likely to introduce known or reasonably foreseeable hazards into or 
onto covered produce or food contact surfaces, including consideration 
of the following:
    (1) The nature of each agricultural water source (for example, 
whether it is ground water or surface water);
    (2) The extent of your control over each agricultural water source;
    (3) The degree of protection of each agricultural water source;
    (4) Use of adjacent and nearby land; and
    (5) The likelihood of introduction of known or reasonably 
foreseeable hazards to agricultural water by another user of 
agricultural water before the water reaches your covered farm.
    (b) Maintenance of your agricultural water systems. You must 
adequately maintain all agricultural water systems, to the extent they 
are under your control, as necessary and appropriate to prevent the 
systems from being a source of contamination to covered produce, food 
contact surfaces, or areas used for a covered activity. Such 
maintenance includes:
    (1) Regularly monitoring each system to identify any conditions 
that are reasonably likely to introduce known or reasonably foreseeable 
hazards into or onto covered produce or food contact surfaces;
    (2) Correcting any significant deficiencies (such as control of 
cross-connections and repairs to well caps, well casings, sanitary 
seals, piping tanks, and treatment equipment);

[[Page 37516]]

    (3) Properly storing equipment and keeping the source and 
distribution system free of debris, trash, domesticated animals, and 
other possible sources of contamination of covered produce to the 
extent practicable and appropriate under the circumstances; and
    (4) As necessary and appropriate, implementing measures reasonably 
necessary to reduce the potential for contamination of covered produce 
with known or reasonably foreseeable hazards resulting from contact of 
covered produce with pooled water (for example, through use of 
protective barriers or through equipment adjustments).


Sec.  112.43  What requirements apply to assessing agricultural water 
used in growing covered produce (other than sprouts)?

    (a) Elements of an agricultural water assessment. Based in part on 
the results of any inspections and maintenance you conducted under 
Sec.  112.42, at the beginning of the growing season, as appropriate, 
but at least once annually, you must prepare a written agricultural 
water assessment for water that you apply to covered produce (other 
than sprouts) using a direct application method during growing 
activities. The agricultural water assessment must identify conditions 
that are reasonably likely to introduce known or reasonably foreseeable 
hazards into or onto covered produce (other than sprouts) or food 
contact surfaces, based on an evaluation of the following factors:
    (1) Each agricultural water system you use for growing activities 
for the covered produce, including:
    (i) The location and nature of the water source (for example, 
whether it is ground water or surface water);
    (ii) The type of water distribution system (for example, open or 
closed conveyance); and
    (iii) The degree of protection from possible sources of 
contamination, including by other water users; animal impacts; and 
adjacent and nearby land uses related to animal activity (for example, 
grazing or commercial animal feeding operations of any size), 
application of biological soil amendment(s) of animal origin, or 
presence of untreated or improperly treated human waste;
    (2) Agricultural water practices associated with each agricultural 
water system, including the type of direct application method (such as 
foliar spray or drip irrigation of covered produce growing underground) 
and the time interval between the last direct application of 
agricultural water and harvest of the covered produce;
    (3) Crop characteristics, including the susceptibility of the 
covered produce to surface adhesion or internalization of hazards;
    (4) Environmental conditions, including the frequency of heavy rain 
or extreme weather events that may impact the agricultural water system 
(such as by stirring sediments) or covered produce (such as damage to 
edible leaves) during growing activities, air temperatures, and sun 
exposure; and
    (5) Other relevant factors, including, if applicable, the results 
of any testing conducted pursuant to paragraph (d) of this section.
    (b) Exemptions. You do not need to prepare a written agricultural 
water assessment for water that you directly apply during growing 
activities for covered produce (other than sprouts), if your water 
meets the criteria in paragraphs (b)(1) and (2) of this section.
    (1) You can demonstrate that the water:
    (i) Meets the requirements in Sec.  112.44(a), including the 
microbial quality criterion and the prohibition on the use of untreated 
surface water, and if untreated ground water, also meets the testing 
requirements in Sec. Sec.  112.44(b), 112.47, and 112.151;
    (ii) Meets the requirements in Sec.  112.44(c) for water from a 
public water system or public water supply; or
    (iii) Is treated in accordance with Sec.  112.46.
    (2) It is reasonably likely that the quality of water in paragraph 
(b)(1)(i), (ii), or (iii) of this section will not change prior to the 
water being used as agricultural water (for example, due to the manner 
in which the water is held, stored, or conveyed).
    (c) Outcomes. Based on your evaluation under paragraph (a) of this 
section, you must determine whether measures under Sec.  112.45 are 
reasonably necessary to reduce the potential for contamination of 
covered produce (other than sprouts) or food contact surfaces with 
known or reasonably foreseeable hazards associated with your 
agricultural water used in growing covered produce (other than 
sprouts). You must record your determination in the assessment, and you 
must take necessary and appropriate action, as follows:
    (1) If your agricultural water is not safe or is not of adequate 
sanitary quality for its intended use(s), as required under Sec.  
112.41, you must immediately discontinue use of the water and take 
corrective measures under Sec.  112.45(a) before resuming such use(s);
    (2) If you have identified one or more conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
and are related to animal activity, application of a biological soil 
amendment of animal origin, or the presence of untreated or improperly 
treated human waste on adjacent or nearby lands, you must implement any 
mitigation measures under Sec.  112.45(b) promptly, and no later than 
the same growing season as the agricultural water assessment;
    (3) If you have not identified any conditions that are reasonably 
likely to introduce a known or reasonably foreseeable hazard for which 
measures under Sec.  112.45 are reasonably necessary to reduce the 
potential for contamination of covered produce (other than sprouts) or 
food contact surfaces, you must:
    (i) Regularly inspect and adequately maintain your agricultural 
water system(s) under Sec.  112.42; and
    (ii) Reassess your agricultural water annually and whenever a 
significant change occurs (such as a change in the manner or timing of 
water application) that increases the likelihood that a known or 
reasonably foreseeable hazard will be introduced into or onto covered 
produce or food contact surfaces; and
    (4) If your agricultural water does not meet the criteria in 
paragraphs (c)(1), (2), or (3) of this section, you must either:
    (i) Implement mitigation measures under Sec.  112.45(b) as soon as 
practicable and no later than 1 year after the date of the agricultural 
water assessment (as required by this section); or
    (ii) Test the water pursuant to paragraph (d) of this section, 
consider the results as part of your assessment, and take appropriate 
action under paragraphs (c)(1), (2), or (3), or (c)(4)(i) of this 
section.
    (d) Testing as part of an assessment. In conducting testing to be 
used as part of your assessment under paragraph (a)(5) of this section, 
you must use scientifically valid collection and testing methods and 
procedures, including:
    (1) Any sampling conducted for purposes of paragraph (c)(4)(ii) of 
this section must be collected aseptically immediately prior to or 
during the growing season and must be representative of the water you 
use in growing covered produce (other than sprouts).
    (2) The sample(s) must be tested for generic Escherichia coli (E. 
coli) as an indicator of fecal contamination (or for another 
scientifically valid indicator organism, index organism, or other 
analyte).

[[Page 37517]]

    (3) The frequency of testing samples and any microbial criterion 
(or criteria) applied must be scientifically valid and appropriate to 
assist in determining, in conjunction with other data and information 
evaluated under paragraph (a) of this section, whether measures under 
Sec.  112.45 are reasonably necessary to reduce the potential for 
contamination of covered produce (other than sprouts) or food contact 
surfaces with known or reasonably foreseeable hazards associated with 
your agricultural water used in growing covered produce (other than 
sprouts).
    (e) Reassessment. You must conduct an agricultural water assessment 
and take appropriate action under paragraph (c) of this section:
    (1) At least once annually when you apply agricultural water to 
covered produce (other than sprouts) during growing activities; and
    (2) Whenever a significant change occurs in your agricultural water 
system(s) (including changes relating to animal activity, the 
application of biological soil amendments of animal origin, or the 
presence of untreated or improperly treated human waste associated with 
adjacent or nearby land uses), agricultural water practices, crop 
characteristics, environmental conditions, or other relevant factors 
that make it reasonably likely that a known or reasonably foreseeable 
hazard will be introduced into or onto covered produce (other than 
sprouts) or food contact surfaces through direct application of 
agricultural water during growing activities. Your reassessment must 
evaluate any factors and conditions that are affected by such change.


Sec.  112.44  What requirements apply to agricultural water used as 
sprout irrigation water and in harvesting, packing, and holding covered 
produce?

    (a) Microbial quality criterion. When you use agricultural water 
for any one or more of the following purposes, you must ensure there is 
no detectable generic Escherichia coli (E. coli) in 100 milliliters 
(mL) of agricultural water, and you must not use untreated surface 
water for any of these purposes:
    (1) Used as sprout irrigation water;
    (2) Used during or after harvest activities in a manner that 
directly contacts covered produce (for example, water that is applied 
to covered produce for washing or cooling activities, water that is 
applied to harvested crops to prevent dehydration before cooling, and 
water that is used to make ice that directly contacts covered produce 
during or after harvest activities);
    (3) Used to contact food contact surfaces or to make ice that will 
contact food contact surfaces; and
    (4) Used for washing hands during and after harvest activities.
    (b) Untreated ground water. You must test any untreated ground 
water used as sprout irrigation water or for harvesting, packing, or 
holding covered produce to determine if it meets the microbial quality 
criterion in paragraph (a) of this section, as follows:
    (1) You must initially test the microbial quality of each source of 
the untreated ground water at least four times during the growing 
season or over a period of 1 year, using a minimum total of four 
samples collected aseptically and representative of the intended 
use(s). Based on these results, you must determine whether the water 
can be used for the intended purpose(s), in accordance with Sec.  
112.45(a).
    (2) If your four initial sample results meet the microbial quality 
criterion, you may test once annually thereafter, using a minimum of 
one sample collected aseptically and representative of the intended 
use(s).
    (3) If any annual test fails to meet the microbial quality 
criterion, you must:
    (i) Immediately discontinue the use(s) and meet the requirements of 
Sec.  112.45(a) before resuming such use(s); and
    (ii) Resume testing at least four times per growing season or year, 
as required under paragraph (b)(1) of this section, until all of the 
survey results collected in a year meet the microbial quality 
criterion.
    (4) You may meet these testing requirements using test results or 
data collected by a third party, as provided in Sec.  112.47.
    (c) Exemptions. There is no requirement to test agricultural water 
that is used as sprout irrigation water or for harvesting, packing, or 
holding covered produce when:
    (1) You receive the water from a public water system, as defined 
under the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, 
that furnishes water that meets the microbial requirements under those 
regulations or under the regulations of a State (as defined in 40 CFR 
141.2) approved to administer the SDWA public water supply program, and 
you have public water system results or certificates of compliance that 
demonstrate that the water meets those microbial requirements;
    (2) You receive the water from a public water supply that furnishes 
water that meets the microbial quality criterion in paragraph (a) of 
this section, and you have public water system results or certificates 
of compliance that demonstrate that the water meets that requirement; 
or
    (3) You treat water in accordance with the requirements of Sec.  
112.46.
    (d) Additional management and monitoring practices. (1) You must 
manage water used in harvesting, packing, and holding covered produce 
as necessary, including by establishing and following water change 
schedules for non-single-pass water (including recirculated water or 
reused water) to maintain its safe and adequate sanitary quality and 
minimize the potential for contamination of covered produce and food 
contact surfaces with known or reasonably foreseeable hazards (for 
example, hazards that may be introduced into the water from soil 
adhering to the covered produce).
    (2) You must visually monitor the quality of water that you use 
during harvesting, packing, and holding activities for covered produce 
(for example, water used for washing covered produce in dump tanks, 
flumes, or wash tanks; and water used for cooling covered produce in 
hydrocoolers) for buildup of organic material (such as soil and plant 
debris).
    (3) You must maintain and monitor the temperature of water that you 
use during harvesting, packing, and holding activities for covered 
produce at a temperature that is appropriate for the commodity and 
operation (considering the time and depth of submersion) and that is 
adequate to minimize the potential for infiltration of microorganisms 
of public health significance into covered produce.


Sec.  112.45  What measures must I take for agricultural water to 
reduce the potential for contamination of covered produce or food 
contact surfaces with known or reasonably foreseeable hazards?

    (a) Discontinue use(s). If you have determined or have reason to 
believe that your agricultural water is not safe or of adequate 
sanitary quality for its intended use(s) in growing, harvesting, 
packing, or holding covered produce as required under Sec.  112.41, 
and/or if your agricultural water used as sprout irrigation water or 
for harvesting, packing, or holding activities does not meet the 
requirements in Sec.  112.44(a) (including the microbial quality 
criterion), you must immediately discontinue such use(s). Before you 
may use the water source and/or distribution system again for the 
intended use(s), you must either:
    (1) Re-inspect the entire affected agricultural water system to the 
extent it is under your control, identify any conditions that are 
reasonably likely to introduce known or reasonably

[[Page 37518]]

foreseeable hazards into or onto covered produce or food contact 
surfaces, make necessary changes, and take adequate measures to 
determine if your changes were effective, and as applicable, adequately 
ensure that your agricultural water meets the microbial quality 
criterion in Sec.  112.44(a); or
    (2) Treat the water in accordance with the requirements of Sec.  
112.46.
    (b) Implement mitigation measures. (1) You must implement any 
mitigation measures that are reasonably necessary to reduce the 
potential for contamination of covered produce (other than sprouts) or 
food contact surfaces with known or reasonably foreseeable hazards 
associated with your agricultural water. Such measures must be 
implemented as soon as practicable and no later than 1 year after the 
date of your agricultural water assessment or reassessment (as required 
by Sec.  112.43), except that mitigation measures for known or 
reasonably foreseeable hazards related to animal activity, the 
application of biological soil amendments of animal origin, or the 
presence of untreated or improperly treated human waste on adjacent or 
nearby lands must be implemented promptly, and no later than the same 
growing season as such assessment or reassessment. Mitigation measures 
include:
    (i) Making necessary changes (for example, repairs) to address any 
conditions that are reasonably likely to introduce such known or 
reasonably foreseeable hazards into or onto the covered produce or food 
contact surfaces;
    (ii) Increasing the time interval between the last direct 
application of agricultural water and harvest of the covered produce to 
allow for microbial die-off, provided you have scientifically valid 
supporting data and information;
    (iii) Increasing the time interval between harvest and the end of 
storage to allow for microbial die-off, and/or conducting other 
activities during or after harvest to allow for microbial die-off or 
removal, provided you have scientifically valid supporting data and 
information;
    (iv) Changing the method of water application to reduce the 
likelihood of contamination of the covered produce (such as by changing 
from overhead spray to subsurface drip irrigation of certain crops);
    (v) Treating the water in accordance with Sec.  112.46; and
    (vi) Taking an alternative mitigation measure, provided that you 
satisfy the requirements of Sec.  112.12.
    (2) If you fail to implement appropriate mitigation measures in 
accordance with paragraph (b)(1) of this section, or if you determine 
that your mitigation measures were not effective to reduce the 
potential for contamination of the covered produce or food contact 
surfaces with known or reasonably foreseeable hazards, you must 
discontinue use of the agricultural water until you have implemented 
mitigation measures adequate to reduce the potential for such 
contamination, consistent with Sec.  112.41.


Sec.  112.46  What requirements apply to treating agricultural water?

    (a) Any method you use to treat agricultural water (such as with 
physical treatment, including using a pesticide device as defined by 
the U.S. Environmental Protection Agency (EPA); EPA-registered 
antimicrobial pesticide product; or other suitable method) must be 
effective to make the water safe and of adequate sanitary quality for 
its intended use(s) and/or meet the microbial quality criterion in 
Sec.  112.44(a), as applicable;
    (b) You must deliver any treatment of agricultural water in a 
manner to ensure that the treated water is consistently safe and of 
adequate sanitary quality for its intended use(s) and, if applicable, 
also meets the microbial quality criterion in Sec.  112.44(a); and
    (c) You must monitor any treatment of agricultural water using an 
adequate method and frequency to ensure that the treated water is 
consistently safe and of adequate sanitary quality for its intended 
use(s) and, if applicable, also meets the microbial quality criterion 
in Sec.  112.44(a).
    (d) Treatment may be conducted by you or by a person or entity 
acting on your behalf.


Sec.  112.47  Who must perform the tests required under this subpart?

    (a) You may meet the requirements related to agricultural water 
testing required under Sec. Sec.  112.43(c)(4)(ii) and 112.44 using:
    (1) Results from agricultural water testing performed by you or by 
a person or entity acting on your behalf; or
    (2) Data collected by a third party or parties, provided the water 
sampled by the third party or parties adequately represents your 
agricultural water source(s) and all other applicable requirements of 
this part are met.
    (b) Agricultural water samples must be aseptically collected and 
tested using methods as set forth in Sec.  112.151, as applicable.


Sec.  Sec.  112.48-112.49  [Reserved]


Sec.  112.50  Under this subpart, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records, as 
applicable:
    (1) The findings of inspections of your agricultural water systems 
in accordance with the requirements of Sec.  112.42(a);
    (2) Your written agricultural water assessments, including 
descriptions of factors evaluated and written determinations, in 
accordance with Sec.  112.43;
    (3) Scientific data or information that you rely on to support the 
use of an index organism, indicator organism, or other analyte, other 
than testing for generic E.coli for purposes of Sec.  112.43(c)(4)(ii);
    (4) Scientific data or information that you rely on to support the 
frequency of testing and any microbial criterion (or criteria) you 
applied for purposes of Sec.  112.43(c)(4)(ii), if applicable;
    (5) Documentation of the results of all analytical tests for 
purposes of compliance with this subpart, including any testing 
conducted under Sec. Sec.  112.43 and 112.44;
    (6) Annual documentation of the results or certificates of 
compliance from a public water system required under Sec.  112.44(c)(1) 
or (2), if applicable;
    (7) Documentation of actions you take in accordance with Sec.  
112.45;
    (8) Scientific data or information you rely on to support the time 
interval between last direct application of agricultural water and 
harvest in Sec.  112.45(b)(1)(ii), and/or the time interval between 
harvest and end of storage and/or use of other activities during or 
after harvest in Sec.  112.45(b)(1)(iii);
    (9) Scientific data or information you rely on to support an 
alternative mitigation measure that you establish and use in accordance 
with Sec.  112.45(b)(1)(vi).
    (10) Scientific data or information you rely on to support the 
adequacy of a treatment method used to satisfy the requirements of 
Sec.  112.46(a) and (b);
    (11) Documentation of the results of water treatment monitoring 
under Sec.  112.46(c); and
    (12) Any analytical methods you use in lieu of the method that is 
incorporated by reference in Sec.  112.151(a).

0
5. In Sec.  112.151, revise the section heading and paragraph (b)(2) to 
read as follows:

[[Page 37519]]

Sec.  112.151  What methods must I use to test the quality of water to 
satisfy the requirements of subpart E of this part?

* * * * *
    (b) * * *
    (2) For any other indicator of fecal contamination, index organism, 
or other analyte you may test for pursuant to Sec.  112.43(d), a 
scientifically valid method.

0
6. In Sec.  112.161, revise paragraph (b) to read as follows:


Sec.  112.161  What general requirements apply to records required 
under this part?

* * * * *
    (b) Records required under Sec. Sec.  112.7(b); 112.30(b); 
112.50(b)(2), (5), (7), and (11); 112.60(b)(2); 112.140(b)(1) and (2); 
and 112.150(b)(1), (4), and (6) must be reviewed, dated, and signed, 
within a reasonable time after the records are made, by a supervisor or 
responsible party.

    Dated: April 24, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-09153 Filed 5-2-24; 11:15 am]
 BILLING CODE 4164-01-P