Rule2024-09153
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 6, 2024
Effective
July 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 88 (Monday, May 6, 2024)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09153]
[[Page 37447]]
Vol. 89
Monday,
No. 88
May 6, 2024
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#f58694989c87db9486869487b59d9d86db939194db929a83"><span class="__cf_email__" data-cfemail="3241535f5b401c5341415340725a5a411c5456531c555d44">[email protected]</span></a>.
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,
<a href="/cdn-cgi/l/email-protection#104042514364717676507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="d181839082a5b0b7b791b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.
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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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:
<bullet> 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;
<bullet> 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;
<bullet> Adding new options for mitigation measures, providing
covered farms additional flexibility in responding to findings from
their pre-harvest agricultural water assessments;
<bullet> Requiring expedited implementation of mitigation measures
for known or reasonably foreseeable hazards related to certain adjacent
and nearby land uses;
<bullet> Requiring management review of pre-harvest agricultural
water assessments; and
<bullet> 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
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
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.
[[Page 37450]]
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.
------------------------------------------------------------------------
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
[[Page 37451]]
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
<a href="https://www.regulations.gov/docket?D=FDA-2011-N-0921">https://www.regulations.gov/docket?D=FDA-2011-N-0921</a> and <a href="https://www.regulations.gov/docket?D=FDA-2021-N-0471">https://www.regulations.gov/docket?D=FDA-2021-N-0471</a>.
Table 2--List of Key Federal Register 2015 Produce Safety Final Rule Documents
----------------------------------------------------------------------------------------------------------------
Description Publication
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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 <a href="https://www.fda.gov/about-fda/reports-manuals-forms/staff-manual-guides">https://www.fda.gov/about-fda/reports-manuals-forms/staff-manual-guides</a> 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 <a href="https://www.fda.gov/about-fda/transparency/fda-data-dashboard">https://www.fda.gov/about-fda/transparency/fda-data-dashboard</a>.
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 <a href="https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods">https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods</a>.
---------------------------------------------------------------------------
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:
<bullet> Agricultural water can be a source of contamination of
produce.
<bullet> Public drinking water systems (domestically regulated by
the EPA) have the lowest relative likelihood of contamination due to
existing standards and routine analytical testing.
<bullet> 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.
<bullet> 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.
<bullet> Susceptibility to runoff significantly increases the
variability of surface water quality.
<bullet> 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.
<bullet> Proximity of the harvestable portion of produce to water
is a factor in the likelihood of contamination during indirect
application.
<bullet> Timing of water application in produce production before
consumption is an important factor in determining likelihood of
contamination.
<bullet> Commodity type (growth characteristics, e.g., near to
ground) and surface properties (e.g., porosity) affect the probability
and degree of contamination.
<bullet> 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:
<bullet> Contact with the commodity (example, whether contact is
indirect or direct);
<bullet> Commodity effects (for example, whether the surface is
conducive to adhesion); and
<bullet> 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 fle
[…truncated; see source link]Indexed from Federal Register on May 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.