Proposed Rule2021-26127
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
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Published
December 6, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the agricultural water provisions of the produce safety regulation that covered farms have found complex and challenging to implement. This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections. Additionally, we are proposing to require expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands, in light of findings from several recent produce outbreak investigations. These proposed revisions to the produce safety regulation, if finalized, would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.
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[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Proposed Rules]
[Pages 69120-69155]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26127]
[[Page 69119]]
Vol. 86
Monday,
No. 231
December 6, 2021
Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 112
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption Relating to Agricultural Water; Proposed Rule
Federal Register / Vol. 86 , No. 231 / Monday, December 6, 2021 /
Proposed Rules
[[Page 69120]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA-2021-N-0471]
RIN 0910-AI49
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption Relating to Agricultural Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend the agricultural water provisions of the produce
safety regulation that covered farms have found complex and challenging
to implement. This proposal would replace the microbial criteria and
testing requirements for pre-harvest agricultural water for covered
produce (other than sprouts) with provisions for systems-based
agricultural water assessments that are designed to be more feasible to
implement across the wide variety of agricultural water systems, uses,
and practices, while also being adaptable to future advancements in
agricultural water quality science and achieving improved public health
protections. Additionally, we are proposing to require expedited
mitigation for hazards related to certain activities associated with
adjacent and nearby lands, in light of findings from several recent
produce outbreak investigations. These proposed revisions to the
produce safety regulation, if finalized, would more comprehensively
address a known route of microbial contamination that can lead to
preventable foodborne illness that is a significant public health
problem.
DATES: Submit either electronic or written comments on the proposed
rule by April 5, 2022. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by April 5, 2022 (see the
``Paperwork Reduction Act of 1995'' section of this document).
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 5, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time on April 5, 2022. Comments received by mail/
hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0471 for ``Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption Relating to Agricultural
Water.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at Dockets Management Staff between 9
a.m. and 4 p.m. Eastern Time, Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 to the Office of Management and Budget
(OMB) at <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this
particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function. The
title of this proposed collection is ``Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption
Relating to Agricultural Water.''
FOR FURTHER INFORMATION CONTACT:
Regarding the proposed 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#8ffceee2e6fda1eefcfceefdcfe7e7fca1e9ebeea1e8e0f9"><span class="__cf_email__" data-cfemail="fc8f9d91958ed29d8f8f9d8ebc94948fd29a989dd29b938a">[email protected]</span></a>.
[[Page 69121]]
Regarding 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#5a0a081b092e3b3c3c1a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="653537243611040303250301044b0d0d164b020a13">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose and Coverage of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations and Commonly Used Acronyms in This
Document
III. Background
A. FDA Food Safety Modernization Act
B. Produce Safety Regulation
C. Stakeholder Concerns Regarding Certain Pre-Harvest
Agricultural Water Requirements
D. Recent Outbreaks
E. Recent Information on Relative Food Safety Risks of Produce
IV. Legal Authority
V. Need for Regulatory Action and Proposed Regulatory Approach
A. Option A: Additional Guidance on Subpart E
B. Option B: Risk Assessment/Research Followed by Rulemaking
C. Option C: Retaining the Pre-Harvest Agricultural Water
Requirements for Covered Produce Other Than Sprouts
D. Option D: Rulemaking To Revise Certain Provisions of the
Produce Safety Regulation
VI. Description of the Proposed Rule
A. Scope of the Rulemaking
B. Consistency With National Organic Program
C. Definitions (Proposed Sec. 112.3)
D. Applicability (Proposed Sec. 112.40)
E. Pre-Harvest Agricultural Water Assessments (Proposed Sec.
112.43)
F. Mitigation Measures (Proposed Sec. 112.45)
G. Records Requirements for Pre-Harvest Agricultural Water
Assessments (Proposed Sec. 112.50)
H. Conforming Changes (Proposed Sec. Sec. 112.12, 112.151, and
112.161)
I. Other Amendments (Proposed Sec. Sec. 112.42, 112.44, and
112.46-112.49)
VII. Online Tool
VIII. Proposed Effective and Compliance Dates
IX. Preliminary Economic Analysis of Impacts
X. Analysis of Environmental Impact
XI. Paperwork Reduction Act of 1995
XII. Federalism
XIII. Consultation and Coordination With Tribal Governments
XIV. References
I. Executive Summary
A. Purpose and Coverage of the Proposed Rule
FDA is proposing to amend the ``Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption''
rule (80 FR 74354, November 27, 2015) (2015 produce safety final rule),
which implemented section 105 of the FDA Food Safety Modernization Act
(FSMA) (Pub. L. 111-353) and established science-based minimum
standards for the safe production and harvesting of fruits and
vegetables for human consumption (codified at part 112 (21 CFR part
112)). This proposed rule would revise certain provisions in the
produce safety regulation applicable to agricultural water for produce
subject to the requirements of part 112 (covered produce) other than
sprouts, using a direct application method during growing activities
(commonly referred to as ``pre-harvest agricultural water'').\1\ The
proposed revisions are intended to address stakeholder concerns about
complexity and practical implementation challenges (described more
fully in section III.C.) by replacing certain pre-harvest agricultural
water testing requirements with provisions for comprehensive pre-
harvest agricultural water assessments that would help farms identify
potential sources of contamination and effectively manage their water.
The proposed agricultural water assessments would offer flexibility for
farms subject to the requirements of 21 CFR part 112 (covered farms) to
evaluate a broad range of factors that impact pre-harvest agricultural
water quality, using a systems-based approach that would be feasible to
implement across the wide variety of agricultural water systems,
practices, and uses and would be adaptable to future advancements in
agricultural water quality science. The proposed expedited mitigation
requirements are designed to help address recent outbreak investigation
findings relating to the impacts of certain adjacent and nearby land
uses on pre-harvest agricultural water for (covered produce) other than
sprouts.
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\1\ The produce safety regulation refers to pre-harvest
agricultural water used during sprout production as ``sprout
irrigation water.''
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In light of the identified implementation challenges with the
current pre-harvest agricultural water testing requirements, the
proposed rule, if finalized, would enhance public health protections by
setting forth procedures for comprehensive pre-harvest agricultural
water assessments and mitigation measures that minimize the risk of
serious adverse health consequences or death, including those
reasonably necessary to prevent the introduction of known or reasonably
foreseeable biological hazards into or onto produce, and to provide
reasonable assurances that produce is not adulterated on account of
those hazards.
B. Summary of Major Provisions of the Proposed Rule
FDA is proposing to amend the produce safety regulation 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 proposing to:
<bullet> Replace the microbial quality criteria and testing
requirements Sec. Sec. 112.44(b) and 112.46(b) with new provisions for
conducting pre-harvest agricultural water assessments (proposed Sec.
112.43) 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 risk management decision
making;
<bullet> Include a testing option for certain covered farms that
elect to test their pre-harvest agricultural water for generic
Escherichia coli (E. coli) (or other appropriate indicator organism,
index organism, or analyte) to help inform their agricultural water
assessments;
<bullet> Add new options for mitigation measures in Sec.
112.45(b), providing covered farms additional flexibility in responding
to findings from their pre-harvest agricultural water assessments;
<bullet> Expedite implementation of mitigation measures under Sec.
112.45(b) for known or reasonably foreseeable hazards related to
certain adjacent and nearby land uses;
<bullet> Require management review under Sec. 112.161 of pre-
harvest agricultural water assessments; and
<bullet> Add new definitions of ``agricultural water assessment''
and ``agricultural water system'' to Sec. 112.3 (subpart A) and make
conforming changes in Sec. 112.12 (subpart B), Sec. 112.151 (subpart
N), and Sec. 112.161 (subpart O).
We solicit comments on these proposed amendments, which are
described more fully in section VI.C. through H. We are proposing
additional amendments, such as adding examples and reorganizing some
provisions, which are described in section VI.I.
C. Legal Authority
FDA is proposing to amend certain requirements in the produce
safety
[[Page 69122]]
regulation 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. These changes are
consistent with our authority in sections 402, 419, and 701(a) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342, 350h,
and 371(a)) and sections 311, 361, and 368 of the Public Health Service
Act (PHS Act) (42 U.S.C. 243, 264, and 271). We discuss our legal
authority in greater detail in section IV.
D. Costs and Benefits
We estimate costs of this proposed rule, if finalized. Our primary
estimates of annualized costs are approximately $11.3 million at a 3
percent discount rate and approximately $11.2 million at a 7 percent
discount rate over 10 years.
We estimate benefits of this proposed rule, if finalized. Our
primary estimates of annualized benefits are approximately $9.9 million
at a 3 percent discount rate and approximately $9.6 million at a 7
percent discount rate over 10 years. If finalized, the qualitative
benefits of the rule would stem from increased flexibility for covered
farms to comprehensively evaluate their pre-harvest agricultural water
systems for non-sprout covered produce. These changes are being
proposed, in part, to address practical implementation challenges of
the current pre-harvest agricultural water testing requirements.
II. Table of Abbreviations and Acronyms Commonly Used in This Document
Table 1--Table of Abbreviations and Acronyms
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Abbreviation or acronym What it means
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AMS............................... Agricultural Marketing Service
BSAAO............................. Biological Soil Amendment of Animal
Origin
CAFO.............................. Concentrated Animal Feeding
Operation
CDC............................... Centers for Disease Control and
Prevention
CFU............................... Colony-Forming Units
Codex............................. Codex Alimentarius Commission
EA................................ Environmental Assessment
E. coli........................... Escherichia coli
EPA............................... Environmental Protection Agency
E.O............................... Executive Order
FD&C Act.......................... Federal Food, Drug, and Cosmetic Act
FSMA.............................. FDA Food Safety Modernization Act
GAP............................... Good Agricultural Practices
GM................................ Geometric Mean
IFSAC............................. Interagency Food Safety Analytics
Collaboration
LGMA.............................. Leafy Greens Marketing Agreement
mL................................ Milliliters
MWQP.............................. Microbial Water Quality Profile
PRIA.............................. Preliminary Economic Analysis of
Impacts
NPRM.............................. Notice of Proposed Rulemaking
QAR............................... Qualitative Assessment of Risk
RV................................ Recreational Vehicle
RWQC.............................. Recreational Water Quality Criteria
SDWA.............................. Safe Drinking Water Act
STEC.............................. Shiga toxin-producing E. coli
STV............................... Statistical Threshold Value
USDA.............................. U.S. Department of Agriculture
UV................................ Ultraviolet
WGS............................... Whole genome sequencing
WHO............................... World Health Organization
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III. Background
A. FDA Food Safety Modernization Act
The 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 seven 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 is one of the seven foundational rules.
B. Produce Safety Regulation
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. In accordance with section 419 of the FD&C Act, the
produce safety regulation 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.
The regulation established requirements for ``covered produce,''
defined in Sec. 112.3 as produce that is subject to the requirements
of this part in accordance with Sec. Sec. 112.1 and 112.2. It includes
a produce RAC that is grown domestically and a produce RAC that will be
imported or offered for import in any State or territory of the United
States, the District of Columbia, or the Commonwealth of Puerto Rico
(Sec. 112.1). Covered produce refers to the harvestable or harvested
portion of the crop. (Sec. 112.3). Farms subject to the requirements
are described in Sec. 112.4.
Subpart E of the produce safety regulation includes a general
requirement that agricultural water must be safe and adequate for its
intended uses (Sec. 112.41). It also includes microbial water quality
criteria (Sec. 112.44) and requirements for testing certain water
sources (Sec. 112.46). The microbial quality criteria are based on the
intended use of the agricultural water--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), and for
certain other specified uses, including sprout irrigation water and
water applications that directly contact covered produce during or
after harvest.\2\
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\2\ Because sprouts present a unique safety risk, the produce
safety regulation establishes sprout-specific requirements on
multiple topics, including agricultural water. Sprouts are not
subject to the Subpart E compliance date extension that applies to
other covered produce.
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Covered farms must establish a microbial water quality profile
(Sec. 112.46(b)) for certain pre-harvest agricultural water for non-
sprout covered produce, by calculating two numerical values of generic
E. coli in their water samples: A geometric mean (GM) (a measure of
central tendency of a water quality distribution) and a statistical
threshold value (STV) (a measure of variability of a water quality
distribution, derived as a model-based
[[Page 69123]]
calculation approximating the 90th percentile using the lognormal
distribution). The GM and STV values are initially derived based on an
initial survey data set that consists of a minimum total of 20 samples
for untreated surface water sources (taken over at least 2 years and no
more than 4 years) and 4 samples for untreated ground water sources
(taken during the growing season or over a period of 1 year).
Following the initial survey, covered farms revise the GM and STV
values based on annual survey data, which consists of at least 5 new
samples per year for untreated surface water sources and at least one
new sample per year for untreated ground water sources. The new samples
are then combined with the most recent data from within the previous 4
years, to make up a rolling dataset of 20 samples for untreated surface
water and 4 samples for untreated ground water. The GM and STV values
are recalculated using this updated data set to update the microbial
water quality profile for certain pre-harvest agricultural water for
covered produce, other than sprouts (Sec. 112.46(b)). When testing
untreated surface water or untreated ground water sources used during
growing activities using a direct water application method, the initial
and annual survey samples must be representative of covered farms' use
of the water and must be collected as close in time as practicable to,
but prior to, harvest.
In the produce safety final rule, FDA committed to implementing the
final rule though a broad, collaborative effort to foster awareness and
compliance with guidance, education, and technical assistance, coupled
with accountability for compliance (80 FR 74354 at 74519). This
proposal continues that commitment.
Table 2 lists the key FSMA produce safety regulation documents
published in the Federal Register. The complete set of Federal Register
documents associated with the FSMA produce safety regulation, including
supporting materials, are available in the docket folder at <a href="https://www.regulations.gov/docket?D=FDA-2011-N-0921">https://www.regulations.gov/docket?D=FDA-2011-N-0921</a>.
Table 2--List of Key Federal Register Produce Safety Regulation Documents
----------------------------------------------------------------------------------------------------------------
Description Publication
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Notice of proposed rulemaking (2013 proposed produce 78 FR 3504, January 16, 2013.
safety rule).
Notice of correction for the 2013 proposed produce 78 FR 17155, March 20, 2013.
safety rule.
Supplemental notice of proposed rulemaking 79 FR 58434, September 29, 2014.
(supplemental notice).
Final rule (2015 produce safety final rule or final 80 FR 74354, November 27, 2015.
rule).
Technical amendment to the 2015 produce safety final 81 FR 26466, May 3, 2016.
rule.
FSMA: Extension and Clarification of Compliance 81 FR 57784, August 24, 2016.
Dates for Certain Provisions of Four Implementing
Rules; Final rule.
Extension of Compliance Dates for Subpart E; Notice 82 FR 42963, September 13, 2017.
of proposed rulemaking.
Extension of Compliance Dates for Subpart E; Final 84 FR 9706, March 18, 2019.
rule (subpart E compliance date extension or
compliance date extension).
----------------------------------------------------------------------------------------------------------------
C. Stakeholder Concerns Regarding Certain Pre-Harvest Agricultural
Water Requirements
In November 2015, FDA began to conduct outreach to educate
stakeholders about the new requirements of the produce safety rule and
share the Agency's implementation plans, in keeping with our commitment
to a broad, collaborative effort to foster awareness about, and
compliance with, the rule.
Upon release of the produce safety final rule in November 2015, FDA
conducted a webinar with nearly 400 participants, in which FDA subject
matter experts discussed the significant provisions of the rule and
answered questions. Beginning in December 2015, subject matter experts
discussed the produce safety regulation at a series of public meetings
held in the United States and abroad. This included four regional
meetings in Oregon (December 1, 2015); Vermont (December 15, 2015);
Florida (January 27, 2016); and North Carolina (February 4, 2016), that
were attended by growers and other interested stakeholders and
sponsored by State regulatory partners. Also in December 2015, FDA
officials and subject matter experts discussed the requirements of the
produce safety rule and other foundational FSMA rules at a public
meeting convened by the European Commission. Later that month, FDA
subject matter experts briefed U.S.-based embassy personnel on the
contents of the FSMA rules, including the produce safety rule.
In 2016 and 2017, FDA continued outreach and education efforts to
inform stakeholders, including industry, consumers, academia, and
regulatory partners, about the produce safety rule requirements and
FDA's implementation plans through 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 the range of
growing conditions and practices across the United States (e.g.,
Alaska, Arizona, California, Colorado, Georgia, Maine, Maryland,
Nevada, New Mexico, Oregon, Texas, Vermont, Washington, and Wisconsin).
Through these farm visits, together with speaking engagements,
conferences, coalition meetings, and questions about the rule submitted
to the FSMA Technical Assistance Network, FDA gained an understanding
that numerous industry stakeholders found certain provisions of subpart
E to be the difficult to understand, translate, and implement in their
operations--in particular, the pre-harvest microbial quality criteria
and testing requirements that required farms to establish a Microbial
Water Quality Profile (MWQP) for each water source used for non-sprout
covered produce. For example, FDA repeatedly heard from covered farms
and produce industry associations that the pre-harvest agricultural
water microbial quality criteria (Sec. 112.44(b)) and testing
requirements (Sec. 112.46(b)) are too complicated to understand, and
that questions remain about how to implement them in a practical
manner. We also heard consistent feedback from covered farms and
produce industry associations that these requirements do not
sufficiently allow for a variety of water uses and availabilities.
Specifically, this feedback centered on the following issues:
<bullet> A number of these stakeholders stated that they have large
numbers of water sources--in some cases, dozens of surface water
sources, or upwards of one hundred ground water sources--for which they
would have to establish individual MWQPs under the final rule.
[[Page 69124]]
<bullet> These stakeholders indicated that they find the
alternatives in the final rule for the use of a different microbial
water quality criterion (or criteria) and/or testing frequency for
untreated surface water sources to be unworkable.
<bullet> While data sharing is one way that implementation
challenges associated with sampling could be reduced, some stakeholders
noted that it may be difficult to implement due to the requirements
that water samples be representative of the particular use of the water
and collected as close in time as practicable, but prior to, harvest.
<bullet> Some stakeholders noted implementation challenges with
establishing long-term MWQPs for farms that grow rotational crops or on
leased land, as they may not be using (or have access to) the same
water source over multiple years.
Based on stakeholder feedback received as of March 2017, FDA
publicly 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. 1).
As FDA subject matter experts continued stakeholder engagement
activities, they gained additional feedback that was consistent with
earlier messages that the pre-harvest requirements in subpart E were
complex and challenging to implement, as they were:
<bullet> Inflexible, by imposing a ``one-size-fits-all'' approach
that is difficult to implement across the wide variety of sources,
uses, and practices covered by the rule;
<bullet> Too complicated to understand and implement, such as the
calculation of the GM and STV; and
<bullet> Difficult to implement because covered farms with multiple
pre-harvest agricultural water sources are required to establish
individual microbial quality profiles for each agricultural water
source.
After receiving consistent feedback from numerous stakeholders
expressing concern about complexity and challenges with implementation
of certain agricultural water requirements, in the Federal Register of
September 13, 2017 (82 FR 42963), FDA proposed to extend the compliance
dates for subpart E for covered produce other than sprouts. FDA took
that action based on feedback we received from numerous stakeholders
raising issues regarding the practicality of some of these provisions
(in particular the testing requirements for pre-harvest agricultural
water). The additional time allotted by extending the Subpart E
compliance dates for covered produce other than sprouts was intended to
allow consideration of approaches to address these issues, as well as
to identify opportunities to enhance the flexibility of these
requirements beyond those reflected in the final rule.
As part of the continuing stakeholder engagement on agricultural
water, in October 2017, FDA participated in a collaborative forum,
sponsored by The Pew Charitable Trusts and the Robert Wood Johnson
Foundation, where participants discussed ideas for how to amend the
agricultural water requirements within the rule's current framework to
address near-term challenges, 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. At the invitation of
the sponsor, farms, academia, food industry trade associations,
consumer groups, and other State and Federal partners also attended.
Forum participants identified several possible alternatives for
pre-harvest agricultural water, including: (1) Retaining the microbial
water quality criteria and testing requirements for agricultural water
used during growing activities and issuing companion guidance to
recommend alternative approaches that would satisfy the regulation; (2)
replacing the existing quantitative requirements with a qualitative
standard and issuing companion guidance to recommend alternative
approaches that would satisfy the regulation; (3) adopting private
industry standards in guidance as a short term measure while research
continues on analyte(s) and appropriate numerical thresholds; and (4)
performing a multiyear quantitative microbial risk assessment to
identify index and/or indicator organisms that can be used to
characterize risk associated with agricultural water across a variety
of conditions. Forum participants identified advantages and
disadvantages of each proposed approach and also identified other areas
for further consideration by FDA, including qualitative standards, data
sharing, and the need for additional guidance (Ref. 2).
Implementation challenges with the agricultural water requirements
in subpart E were also the focus of a 2-day Agricultural Water Summit,
convened by the Produce Safety Alliance in February 2018, to discuss
implementation challenges and explore possible approaches that would be
practical to implement while protecting public health (Ref. 3). FDA
subject matter experts joined more than 350 other participants at the
summit, including farmers and other produce industry members,
researchers, extension educators, and State and Federal regulators.
Additionally, approximately 200 people from eight different countries
viewed the summit proceedings via webcast and had the opportunity to
provide comments. The meeting was open to registration by the general
public.
The summit included presentations and discussions on addressing
food safety hazards in the growing environment. Participants discussed
the complexities associated with farm environments. For example,
participants noted that difficulties can arise due to variability in
the following factors: (1) Agricultural water source quality, including
how it arrives and moves throughout the farm; (2) the methods of water
application to the crop; (3) commodity characteristics that influence
vulnerability to contamination; and (4) regional climatic effects.
Participants identified ``agricultural water assessments'' as a
promising approach for science-based management decisions that could
take those factors into account. Participants also recognized that
farmers would need additional educational tools to conduct this type of
assessment (Ref. 3).
FDA produce safety experts continued farm visits into 2018 to
gather additional feedback and perspectives from stakeholders, in
addition to the information and insights from the Agricultural Water
Summit and the Collaborative Forum. Joined on these visits by
representatives from the produce industry, academia, and government
agencies, FDA visited nearly 100 farms in 2018, during which we
observed a wide variety of water sources, distribution systems, and
practices among farms of all sizes. As part of the farm visits, FDA
often participated in listening sessions with farmers to learn about
their water use practices, how they currently manage water quality, and
their perspectives on how best to achieve public health protections
related to agricultural water in a way that would be practicable and
workable across a variety of operations (Ref. 4).
Throughout the produce safety rule outreach and education efforts,
FDA also continued to engage with a broad range of stakeholders,
including consumer protection groups, through coalition meetings, while
also collaborating with State regulatory
[[Page 69125]]
partners to prepare for produce safety rule implementation. FDA heard
frequent and consistent concerns from covered farms and produce
industry trade associations about the complexity and implementation
challenges of certain subpart E requirements, which was reinforced in
their comment submissions. In the face of widespread and steady
concerns, including new concerns that were not expressed in response to
the produce safety proposed rule, FDA concluded that it was in the
public's interest to institute a delay to allow for further
collaboration with an array of stakeholders and pursuit of solutions to
achieve the shared goal of improved produce safety in a way that is
more workable for covered farms.
Accordingly, in the Federal Register of March 18, 2019 (84 FR
9706), FDA extended the compliance dates for subpart E for non-sprout
covered produce, as follows: January 26, 2024, for very small farms;
January 26, 2023, for small farms; and January 26, 2022, for all other
farms covered by the produce safety regulation. FDA noted that ignoring
the widespread concerns raised about complexity and serious questions
about how the requirements can be implemented in practical ways on
farms would be likely to reduce the estimated public health benefits of
the agricultural water provision of the 2015 final rule (84 FR 9706 at
9710). We recognized that farms that cannot understand the requirements
and determine how to implement the requirements are not likely to be
realizing full food safety measures, which led us to conclude that
further collaboration with stakeholders was necessary to understand the
source of the complexity and develop a more workable solution for pre-
harvest agricultural water that would increase produce safety.
In the compliance date extension final rule (84 FR 9706 at 9710),
we also reiterated our commitment to ensuring that the produce safety
rule addresses the risks associated with agricultural water and
emphasized that produce remains subject to the other applicable
provisions of the produce safety regulation and the FD&C Act
notwithstanding the extension. We recommended that farms should
continue to use good agricultural practices to help maintain and
protect the quality of their water sources.
Stakeholders (including covered farms, consumer protection groups,
and state governments) submitted various comments addressing the
underlying subpart E requirements applicable to non-sprout covered
produce in response to the compliance date extension proposed rule. FDA
responded to comments on in the compliance date extension final rule
(84 FR 9706). While substantive issues were outside the narrow scope of
the compliance date extension rulemaking, we considered those comments
in developing this proposed rule. Stakeholders also submitted comments
on the underlying subpart E requirements to Docket No. FDA-2017-N-5094,
``Review of Existing Center for Food Safety and Applied Nutrition
Regulatory and Information Collection Requirements'' (82 FR 42503
(September 8, 2017)). Although this docket was established as part of
the implementation of two Executive Orders (E.O.) that have since been
revoked (see E.O. 13992 (``Revocation of Certain Executive Orders
Concerning Federal Regulation'')), we consider the comments submitted
to this docket on the underlying requirements of subpart E (Refs. 5-10)
as relevant to the purposes of this rulemaking.
Some comments indicate that stakeholder concerns on the
agricultural water requirements were already addressed during
rulemaking for the produce safety rule and argue that further action to
consider stakeholder concerns is therefore unnecessary. These comments
note that stakeholders were given the opportunity to provide comment on
pre-harvest agricultural water testing requirements when the notice of
proposed rulemaking (NPRM) issued in 2013, and again when the
supplemental NPRM issued in 2014. However, the feedback we received
after the 2015 produce safety final rule was published about the
complexity and the implementation challenges posed by the pre-harvest
testing requirements was new and in addition to the comments on the
proposed rule (84 FR 9706 at 9710). Some comments encouraged FDA to
withdraw the proposed compliance date extension and focus on
implementation, noting the public health benefits of the produce safety
regulation and concluding that an extension would harm consumers more
than it would help. As previously indicated, FDA decided to pursue a
rigorous stakeholder engagement plan to consider the practical
implementation of the agricultural water requirements and how to best
achieve the important public health objectives of the rule.
Other comments indicate that certain agricultural water
requirements in the 2015 produce safety final rule are too complex,
overly prescriptive, and not practical to implement, urging FDA to
reconsider the ``one-size-fits-all'' approach of the produce safety
regulations that they state is not risk-based or adaptable based on
future research. Some comments suggest that the pre-harvest
agricultural water testing requirements in subpart E should be reduced
to one annual test per source to be consistent with industry practice
and some State requirements. Some comments cite concerns related to
allowable testing methods, use of historical data and data sharing, the
applicability of recreational water quality criteria to pre-harvest
agricultural water, and considerations about crop rotations and short
growing seasons. Some comments point out that certain areas where
produce is grown lack nearby laboratories capable of testing water
samples. Other comments assert that the produce safety regulation
requires covered farms to hire a consultant or third party to test
their water. Still other comments cite concerns about how the standards
relate to foreign farms, in particular for covered farms located in
foreign countries with a systems recognition arrangement with FDA.
Various comments indicate that a more flexible approach that
incorporates region-, commodity-, and practice-specific information
would be useful in addressing the diversity of agricultural water
sources. These comments recommend taking into account practices and
lessons learned under third-party auditing standards. Other comments
assert that FDA should recognize the risk-based approaches that
different commodity groups and different industry sectors are already
using. Some comments suggest that FDA perform a multiyear quantitative
microbial risk assessment for agricultural water to better understand
the associated risks, while other comments propose building additional
flexibility into the testing requirements to allow for future
scientific advancements, such as the use of metagenomics. Still others
cite a need for ongoing education, training, outreach, and guidance on
a variety of agricultural water-related issues and recommend that FDA
involve a variety of stakeholders, including the States, in any
outreach and guidance efforts. We considered these comments in
developing this proposed rule.
D. Recent Outbreaks
For more than a decade, FDA has conducted investigations of produce
outbreaks to learn what factors may have contributed to the outbreaks
of foodborne illness or food contamination events. These investigations
(also known as environmental assessments, or EAs) are performed in
collaboration with regulatory partners following initial outbreak
response activities and
[[Page 69126]]
focus on identifying possible causes, contributing factors, and
measures to prevent reoccurrence of a similar event. We assess
potential sources of microbial hazards not only in growing fields
identified through traceback investigation of contaminated product but
also potential sources in the larger growing area within the geographic
area of interest. This commonly includes assessment of water sources
and distribution systems used by growers during growing, harvesting, or
post-harvesting activities. These investigations allow us to consider
how a pathogen may be transported from a source in the surrounding area
to the field and ultimately the product. FDA's investigations
underscore decades of scientific research that pre-harvest agricultural
water is a potential contributing factor in the introduction and spread
of contamination to produce. See, e.g., the QAR (Ref. 11), 2013
proposed rule 78 FR 3504 at 3559-3563, 2015 final rule 80 FR at 74354
at 74441-74446, and the discussion in section III.E. The proposed rule
reflects new information and findings on the potential routes of
microbial contamination of pre-harvest agricultural water from
investigations of several recent outbreaks linked to consumption of
produce.
1. Spring 2018 E. Coli O157:H7 Outbreak Linked to Romaine Lettuce From
the Yuma Growing Region
In collaboration with the Centers for Disease Control and
Prevention (CDC) and State partners, FDA led an EA of the Yuma growing
region associated with the spring 2018 E. coli O157:H7 outbreak linked
to consumption of romaine lettuce. Investigators found the outbreak
strain in water samples from three locations along a 3.5-mile stretch
of an open irrigation canal adjacent to a Concentrated Animal Feeding
Operation (CAFO) (Ref. 12). One of these samples was collected
immediately downstream from where shallow ground water is pumped into
the irrigation canal (Ref. 13). The EA investigators also found an area
where ground water may have been seeping directly into unlined sections
of the canal within the 3.5-mile stretch where the outbreak strain was
detected. Although no obvious route of contamination was determined,
the investigators identified onsite wells at the CAFO as a potential
route of ground water contamination from the CAFO (Ref. 13).
The EA team also found Salmonella spp. and other Shiga toxin-
producing E. coli (STEC) strains in water samples collected during the
investigation of the Yuma growing region, including Salmonella Agona,
S. Typhimurium, and E. coli O178:H19, O6:H34, O181:H49, O153:H25, and
O157:H7 (which did not match the outbreak strain) (Ref. 13).
The findings of the Yuma EA led FDA to issue a letter to State
partners and the leafy greens industry that highlighted, in part, the
importance of assessing and mitigating risks related to land uses near
or adjacent to growing fields that may contaminate agricultural water
or leafy greens crops directly (such as nearby cattle operations, dairy
farms, manure, and composting facilities) (Ref. 14).
2. Fall 2018 E. Coli O157:H7 Outbreak Linked to Romaine Lettuce From
California
Following a romaine lettuce outbreak in Fall 2018, FDA led an EA,
in collaboration with CDC and the States, that found the outbreak
strain in the sediment of an on-farm water reservoir in Santa Barbara
County, CA (Ref. 15). We concluded that the water from the on-farm
water reservoir where the outbreak strain was found most likely led to
contamination of some romaine lettuce consumed during this outbreak.
Investigators noted extensive wild animal activity in the area;
adjacent land use, including the use of soil amendments; and animal
grazing on nearby land by cattle and horses. They were unable to
determine, though, how the outbreak strain of E. coli O157:H7 was
introduced into this on-farm water reservoir.
3. Fall 2019 E. Coli O157:H7 Outbreaks Linked to Romaine Lettuce
From late 2019 to early 2020, FDA and state and federal partners
conducted multiple on-farm investigations of contamination of romaine
lettuce with several strains of E. coli O157:H7 that resulted in three
outbreaks of foodborne illness beginning in September and ending in
December 2019 (Ref. 16). These outbreaks, which were all traced back to
farms located in the Salinas, CA, growing region, collectively resulted
in 188 people falling ill. As a result of sampling during the
investigations, one of the outbreak strains of E. coli O157:H7 was
detected in a fecal-soil composite sample taken from a cattle grate on
public land less than 2 miles upslope from a farm with multiple fields
tied to the outbreaks by traceback investigations. Other STEC strains,
while not linked to the 2019 outbreaks, were found in closer proximity
to where romaine lettuce crops were grown, including two samples from a
border area of a farm immediately next to cattle grazing land in the
hills above leafy greens fields and two samples from on-farm water
drainage basins. Of note, the number of cattle we observed on nearby
lands during the 2019 investigations was far lower than the volume of
what is considered a large concentrated animal feeding operation.
4. Fall 2020 E. Coli O157:H7 Outbreak Linked to Leafy Greens
From August to December 2020, FDA and multiple state and federal
partners investigated a multi-state E. coli O157:H7 outbreak associated
with the consumption of leafy greens (Ref. 17). The outbreak, which
caused 40 reported illnesses in the U.S., was linked via genetic
sequencing and geography to the 2019 outbreak (Ref. 16) and the 2018
leafy greens outbreak (in which the outbreak strain was detected in the
sediment of an on-farm water reservoir) (Ref. 15). The investigation
identified the outbreak strain in a cattle feces composite sample taken
alongside a road approximately 1.3 miles upslope from a produce farm
with multiple fields tied to the outbreaks by the traceback
investigations. Three water samples tested positive for other STEC
strains not linked to the outbreak (Ref. 17).
5. Summer 2020 Salmonella Newport Outbreak Linked to Red Onions
From June to October 2020, federal and state agencies investigated
a Salmonella Newport foodborne illness outbreak associated with
consumption of red onions from the Southern San Joaquin Valley and
Imperial Valley in California (Ref. 18). The outbreak, which caused
1,127 reported domestic illnesses and 515 reported Canadian cases, was
the largest Salmonella outbreak in over a decade. The FDA, alongside
state and federal partners, investigated the outbreak to identify
potential contributing factors that may have led to red onion
contamination with Salmonella Newport. While the outbreak strain
(specific whole genome sequence (WGS)) was not identified in any of the
nearly 2,000 subsamples tested, a total of 11 subsamples (10 water and
1 sediment) collected near one of the growing fields identified in the
traceback were positive for Salmonella Newport, representing a total of
three different genotypical strains (unique WGS patterns). Although a
conclusive root cause could not be identified, several potential
contributing factors to the 2020 red onion outbreak were identified,
including a leading hypothesis that contaminated irrigation water used
in a growing field in Holtville, California,
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may have led to contamination of the onions.
While our investigation did not occur during any harvesting
activities, visual observations of the implicated red onion growing
fields suggested several plausible opportunities for contamination
including irrigation water, sheep grazing on adjacent land, as well as
signs of animal intrusion, such as scat and large flocks of birds which
may spread contamination. Similarly, the investigation did not occur
while packing activities were ongoing. However, visual observations and
records review of packing house practices confirmed numerous
opportunities for spread of foodborne pathogens such as Salmonella,
including signs of animal and pest intrusion as well as food contact
surfaces which had not been inspected, maintained, cleaned, or
sanitized as frequently as necessary to protect against the
contamination of produce.
While these outbreaks serve as recent examples of the role that
water quality may play in produce safety, the potential for water to
serve as a source or route of contamination in produce outbreaks has
been a longstanding concern. For example, investigators identified
several risk factors potentially related to a 2006 outbreak of E. coli
O157:H7 associated with pre-packaged spinach, including the proximity
of irrigation wells to surface water exposed to cattle and wildlife
feces (Ref. 19). The outbreak strain was detected in river water,
cattle feces, wild pig feces, and soil samples collected from one of
the investigated farms. The outbreak strain also was detected in two
surface water samples analyzed as part of a separate study (Ref. 20).
(See also section VI.E.)
During investigation of a 2006 outbreak of E. coli O157:H7
associated with iceberg lettuce, the outbreak strain was detected in
water samples collected close to a suspect growing field and from a
nearby dairy (Ref. 20). Investigators found that the dairy wastewater
blending and distribution system used by the farm had inadequate
backflow protection and presented a possible route for conveyance of
contaminated water to fields adjacent to the suspect lettuce growing
fields, as described more fully in section VI.E. Investigators also
found the outbreak strain of Salmonella Saintpaul in agricultural water
during investigation of a 2008 produce outbreak (Ref. 22).
Persistent pathogens in agricultural water may serve as a recurring
source of contamination. For example, two multistate outbreaks linked
to tomatoes in 2002 and 2005 were caused by the same strain of
Salmonella Newport, which was also detected in ponds used to irrigate
tomato growing fields. (Ref. 23). On at least one of the farms
investigated, pond water was used to dilute pesticides sprayed on
tomato plants. Investigators isolated the outbreak strain in irrigation
ponds through sampling conducted 2 years apart, suggesting persistent
contamination (Ref. 23).
FDA outbreak investigations underscore the importance of pre-
harvest agricultural water quality and the potential impacts of
adjacent and nearby land uses on agricultural water, which can serve as
a route of contamination of produce. This NPRM is designed to address
those concerns by proposing to require covered farms to conduct
comprehensive pre-harvest agricultural water assessments and implement
mitigation measures that minimize the risk of serious adverse health
consequences or death, including those reasonably necessary to prevent
the introduction of known or reasonably foreseeable biological hazards
into or onto produce, and provide reasonable assurances that the
produce is not adulterated on account of those hazards.
E. Recent Information on Relative Food Safety Risks of Produce
FDA outlined the history of contamination associated with produce,
predominantly during growing, harvesting, packing, and holding, during
the rulemaking to establish the produce safety regulations in part 112.
See. e.g., 78 FR 3504 at 3507, 80 FR 74354 at 74731.
Recent estimates by the Interagency Food Safety Analytics
Collaboration (IFSAC) indicate that many foodborne illnesses are
attributed to contaminated produce. A tri-agency group created by the
CDC, FDA, and the U.S. Department of Agriculture's (USDA) Food Safety
and Inspection Service, IFSAC developed a method to estimate the
sources of foodborne illness using outbreak data for four priority
pathogens: Salmonella, E. coli O157, Listeria monocytogenes, and
Campylobacter (Ref. 24).
In its 2019 Report (Ref. 25), IFSAC estimated that produce
commodities cause 65 percent of foodborne E. coli O157 illnesses and
over 40 percent of foodborne Salmonella illnesses. IFSAC attributed
approximately 56 percent of E. coli O157 illnesses to vegetable row
crops (such as leafy greens) and approximately 9 percent to fruits and
other types of produce. IFSAC concluded that Salmonella illnesses came
from a broad variety of foods, including more than 13 percent from
fruits and more than 12 percent from seeded vegetables (such as
tomatoes and cucumbers) (Ref. 25).
IFSAC derived estimates for 2018, its most recent reporting year,
based on outbreaks that occurred from 1998 through 2018, relying most
heavily on the most recent 5 years of outbreak data (Ref. 25). The
analysis included 1,459 foodborne disease outbreaks, for which each
confirmed or suspected implicated food fell into a single food
category. Foods were categorized using a scheme IFSAC created to
classify foods into 17 categories that closely align with the U.S. food
regulatory agencies' classification needs (Ref. 26).
More recently, FDA tentatively identified certain FDA-regulated
foods (including certain produce commodities) for inclusion on a Food
Traceability List (Ref. 27) for which additional traceability
recordkeeping requirements will be required, in accordance with FSMA
section 204(d)(2)(A).\3\
---------------------------------------------------------------------------
\3\ In the Federal Register of September 23, 2020 (85 FR 59984),
FDA published a proposed rule to establish additional traceability
recordkeeping requirements for entities that manufacture, process,
pack, or hold foods the Agency has designated as high risk in
accordance with FSMA section 204(d)(2)(A).
---------------------------------------------------------------------------
To determine which foods should be included on the Food
Traceability List (Ref. 27), FDA developed a risk-ranking model for
food tracing (``the Model''), based on the following factors that
Congress identified in the statute:
<bullet> Known safety risks of a particular food, including the
history and severity of foodborne illness outbreaks attributed to such
food, taking into consideration foodborne illness data collected by the
CDC;
<bullet> Likelihood that a particular food has a high potential
risk for microbiological or chemical contamination or would support the
growth of pathogenic microorganisms due to the nature of the food or
the processes used to produce the food;
<bullet> Point in the manufacturing process of the food where
contamination is most likely to occur;
<bullet> Likelihood of contamination and steps taken during the
manufacturing process to reduce the possibility of contamination;
<bullet> Likelihood that consuming a particular food will result in
a foodborne illness due to contamination of the food; and
<bullet> Likely or known severity, including health and economic
impacts, of a foodborne illness attributed to a particular food.
The Model was designed to be flexible and to consider a wide range
of contaminants in FDA-regulated human
[[Page 69128]]
foods (Ref. 28). To identify commodities for the Food Traceability
List, the commodities and associated commodity-hazard pairs produced by
the Model were ranked. Commodities with associated commodity-hazard
pairs with criteria scores in the moderate to strong range were
considered for inclusion on the list.
Based on data in the Model, we tentatively identified foods for
inclusion on the Food Traceability List (Ref. 27), which was announced
in conjunction with issuance of the Food Traceability proposed rule (85
FR 59984, September 23, 2020). When the FDA issues a final rule, we
will also publish the Food Traceability List.
The proposed Food Traceability List (Ref. 27) includes the
following types of produce:
<bullet> Cucumbers (fresh), includes all varieties of cucumbers;
<bullet> Herbs (fresh), includes all types of herbs, such as
parsley, cilantro, basil;
<bullet> Leafy greens (fresh), includes all types of leafy greens,
such as lettuce, (e.g., iceberg, leaf and romaine lettuces), kale,
chicory, watercress, chard, arugula, spinach, pak choi, sorrel, and
endive;
<bullet> Melons (fresh), includes all types of melons, such as
cantaloupe, honeydew, and watermelon;
<bullet> Peppers (fresh), includes all varieties of peppers;
<bullet> Sprouts (fresh), includes all varieties of sprouts;
<bullet> Tomatoes (fresh), includes all varieties of tomatoes; and
<bullet> Tropical tree fruits (fresh), includes all types of
tropical tree fruit, such as mango, papaya, mamey, guava, lychee,
jackfruit, and starfruit.
On-farm contamination of produce is well documented in the
literature. The peer-reviewed ``FDA Qualitative Assessment of Risk to
Public Health from On-Farm Contamination of Produce'' (QAR) (Ref. 11)
provides a scientific evaluation of the potential adverse health
effects resulting from human exposure to microbiological hazards in
produce, with a focus on public health risk associated with the on-farm
contamination of produce. 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 Environmental Protection Agency (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,
groundwater 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. 11) 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.
Based on the foregoing, we continue to conclude that there is an
ample history of microbiological contamination of produce on farms to
justify requirements for pre-harvest agricultural water in part 112 to
help prevent contamination and illness.
IV. Legal Authority
We are issuing this proposed 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 (21 U.S.C. 350h(a)), 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) (21 U.S.C. 350h(a)(3)) 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 (21
U.S.C. 342(a)(3)) 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 (21 U.S.C.
371(a)) grants the authority to issue regulations for the efficient
enforcement of the FD&C Act. This proposed 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 proposing to the produce safety regulation thus would
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 proposed
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 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 21
CFR 5.10(a)(4) for delegation from the Secretary to FDA.) The
provisions in the proposed rule are necessary to prevent food from
being contaminated with human pathogens such as Salmonella, 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. We expect that the proposed
[[Page 69129]]
amendments to the produce safety regulation, if finalized, will help
prevent the spread of communicable diseases associated with
contaminated produce.
V. Need for Regulatory Action and Proposed Regulatory Approach
We are proposing to amend subpart E of the produce safety
regulation based on stakeholder feedback, new information we have
gathered since issuance of the 2015 final rule, and findings from FDA
investigations of produce-related outbreaks.
As described in section III.C., numerous stakeholders have provided
feedback to FDA about the complexity and challenges of implementing the
pre-harvest microbial quality criteria and testing requirements in
subpart E for pre-harvest agricultural water for covered produce other
than sprouts. Stakeholders shared their input and concerns during FDA's
outreach and education efforts on the 2015 produce safety final rule,
at the 2018 Agricultural Water Summit, and at meetings convened by
others. Stakeholders also expressed concerns about these pre-harvest
agricultural water testing requirements in comments submitted to other
dockets, including for the compliance date extension rulemaking (84 FR
9706). (See section III.C. of this document.) The feedback has been
consistent in its message about the implementation challenges of the
pre-harvest agricultural water testing requirements and has come from
individual growers and industry organizations that encompass various
growing regions, farm sizes, and commodities.
FDA investigations of recent produce-related outbreaks have
highlighted the role of pre-harvest agricultural water as a potential
contributing factor in the introduction and spread of contamination to
produce. Section III.D. discusses new information and findings from
several recent investigations of the potential routes of contamination
of pre-harvest agricultural water associated with activities conducted
on lands adjacent and nearby to farms identified during traceback
investigations and the agricultural water systems used by those farms.
This proposed rule would amend the agricultural water provisions of
the produce safety regulation to replace the microbial criteria and
testing requirements for pre-harvest agricultural water for covered
produce (other than sprouts) that covered farms have found to be
complex and challenging to implement, with provisions for comprehensive
assessments of pre-harvest agricultural water systems, practices, and
on-farm conditions. The proposed agricultural water assessments would
provide additional flexibility to covered farms, using a systems-based
approach that would be feasible to implement across the wide variety of
pre-harvest agricultural water systems, uses, and farm operations and
would be adaptable as scientific understanding of agricultural water
quality expands in the future. We also are proposing to require
expedited mitigation for hazards related to certain activities
associated with adjacent and nearby lands in light of findings from
several recent produce outbreak investigations. These proposed
revisions to the produce safety regulation, if finalized, would set
forth requirements for comprehensive pre-harvest agricultural water
assessments and mitigation measures that minimize the risk of serious
adverse health consequences or death, including those reasonably
necessary to prevent the introduction of known or reasonably
foreseeable biological hazards into or onto produce, and to provide
reasonable assurances that the produce is not adulterated on account of
these hazards.
We developed this approach to pre-harvest agricultural water by
considering public health objectives while recognizing that each
covered 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. Cognizant of the practical implementation challenges we
identified, we sought to identify an approach that: (1) Is workable for
covered farms of all sizes, both foreign and domestic; (2) provides
sufficient specificity, while offering adequate flexibility, so that
covered farms can understand what requirements apply and how to
implement them to prevent produce contamination; (3) meets the public
health objectives of the Agency and the relevant requirements set forth
in the FD&C Act; and (4) enables FDA to verify compliance.
After evaluating relevant information gathered since publication of
the final rule, and based on FDA's expertise and experience, we
considered four options.
A. Option A: Additional Guidance on Subpart E
We considered the option of issuing additional guidance with more
reference material, examples, and explanations for covered farms, while
maintaining the existing pre-harvest agricultural water testing
requirements in the produce safety regulation.
In particular, we contemplated issuing additional guidance to
describe circumstances in which covered farms might satisfy the pre-
harvest sampling and testing requirements through shared data with
other covered farms. Discussions at a collaborative forum (Ref. 2) and
the Agricultural Water Summit (Ref. 3), stakeholder comments and
information gathered from farm visits and other stakeholder outreach
(described in section III.C.) revealed several limitations with this
option. There are currently few (if any) agricultural water data-
sharing arrangements between covered farms, and such arrangements
likely would be time-intensive and impractical to establish. For
example, the diversity of agricultural water sources, distribution
systems, and possible impacts from lands adjacent to and nearby each
covered farm would make it difficult for many covered farms to rely on
shared data to satisfy the requirement for samples adequately
representative of their agricultural water at the time of application.
Moreover, some stakeholders indicated that guidance alone could not
overcome difficulties with using alternative microbial quality criteria
(or criterion) or alternative sampling frequency provisions of the
produce safety regulation. Other stakeholders pointed out that, under
Sec. 112.171, the produce safety regulation only allows States,
Federally recognized tribes, or countries from which food is imported
into the United States to request a variance from FDA to use an
alternative approach to the requirements set forth in the produce
safety regulation.
In light of the foregoing, we concluded that issuing additional
guidance as described above would not adequately address the practical
implementation issues associated with the pre-harvest agricultural
testing requirements in the produce safety regulation.
B. Option B: Risk Assessment/Research Followed by Rulemaking
Based on comments and dialogue at collaborative fora and other
stakeholder engagement activities, as described in section III.C., we
considered whether to conduct another risk assessment, followed by a
rulemaking to revise the pre-harvest agricultural water testing
requirements. For example, we could perform a multiyear quantitative
microbial risk assessment to identify index and/or indicator organisms
to characterize risk associated with agricultural water across a
variety of conditions, followed by rulemaking on pre-harvest
agricultural water testing.
[[Page 69130]]
Alternatively, we could issue guidance on pre-harvest agricultural
water based on industry standards while research is conducted to
develop sufficient scientific information on other analyte(s) and
appropriate numerical thresholds, followed by rulemaking to revise the
pre-harvest agricultural water testing requirements. (This is different
than Option A, which would involve additional guidance on the 2015
produce safety final rule testing requirements.)
Having reviewed the conclusions of the QAR (Ref. 11) and the 2019
IFSAC report (Ref. 25), and considered FDA's experience with
investigations of produce-related outbreaks, we concluded that it is
not necessary for FDA to conduct an additional risk assessment (or
issue guidance based on industry standards) before conducting
rulemaking to establish new pre-harvest agricultural water standards to
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 provide reasonable assurances that the produce is not
adulterated on account of those hazards.
C. Option C: Retaining the Pre-Harvest Agricultural Water Requirements
for Covered Produce Other Than Sprouts
Another option would be to allow the existing testing requirements
for pre-harvest agricultural water for non-sprout covered produce to go
into effect after expiration of the compliance date extension (84 FR
9706).
When contemplating this option, we considered repeated stakeholder
feedback that the testing requirements for pre-harvest agricultural
water for non-sprout covered produce are difficult to understand and
challenging to implement in a workable manner given the diversity of
uses and sources of such water. We also considered additional
information, gathered during recent outbreak investigations, on the
variety of factors that impact on pre-harvest agricultural water for
non-sprout covered produce.
Although we continue to believe that the existing rule with
mandated testing frequency and water standards would, if implemented,
result in overall improved agricultural water quality and improved
public health, we understand that if confusion and infeasibility
undermine successful implementation of the pre-harvest agricultural
water requirements for non-sprout covered produce, then the desired
public health improvements are not likely to result. Thus, we have
sought an alternative means to achieve improved public health
protections in this area.
In light of the foregoing, we concluded that retention of the
subpart E pre-harvest requirements, as applicable to non-sprout covered
produce, would not adequately address these issues in a timely manner.
D. Option D: Rulemaking To Revise Certain Provisions of the Produce
Safety Regulation
As another option, we considered whether to engage in rulemaking to
revise the pre-harvest agricultural water testing requirements for non-
sprout covered produce.
In evaluating this option, we considered proceedings of the
Agricultural Water Summit (Ref. 3), which included discussions and
presentations on addressing hazards in the growing environment. In
addition to discussing the feasibility of implementing the pre-harvest
water quality profile and testing requirements of the produce safety
regulation, Summit participants discussed the utility of pre-harvest
agricultural water assessments given the diverse farm environments.
Summit participants identified several complex factors associated
with agricultural water, including the variability in water source
quality (such as how it arrives and moves throughout the farm); the
method of water application to the crop; commodity characteristics that
influence vulnerability to contamination; and regional climatic
effects. After several presentations and lengthy discussions of issues,
Summit participants identified agricultural water assessments as a
promising approach for science-based management decisions that could
take the complexities of each farm into account. Similar themes emerged
during discussions at the Collaborative Food Safety Forum (Ref. 2) and
in stakeholder feedback on the final rule, as described in section
III.C.
In light of the findings of our QAR (Ref. 11), stakeholder
feedback, and new findings and information we have gathered since
publication of the 2015 produce safety regulation (as described in
section III.), we have concluded that the most appropriate regulatory
approach is to undertake rulemaking. We acknowledge that the identified
implementation challenges of the pre-harvest agricultural water testing
requirements for non-sprout covered produce could prevent full
realization of our intended public health objectives.
The proposed rule provides for comprehensive assessments of pre-
harvest agricultural water for non-sprout covered produce that would be
feasible to implement across a wide variety of pre-harvest agricultural
water systems, uses, and farm operations and are adaptable as our
scientific understanding of agricultural water quality expands over
time. The proposed rule also would provide for expedited mitigation for
certain hazards related to animal activity and other activities on
adjacent and nearby lands in light of findings of FDA investigations.
The proposal sets forth procedures, processes, and practices to
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 those hazards. If finalized, the proposed
rule would more comprehensively address the potential for pre-harvest
agricultural water to serve as a route of contamination of non-sprout
covered produce, by using a systems-based, preventive approach that is
sufficiently flexible to accommodate a wide range of agricultural water
sources, uses, and practices and would be adaptable to future
advancements in agricultural water quality science.
VI. Description of the Proposed Rule
We are proposing to amend the produce safety regulation to address
concerns about the practical challenges of implementing the pre-harvest
agricultural water microbial water quality criteria and testing
requirements by providing additional flexibility while continuing to
protect the public health.
If finalized, the proposed rule would replace those pre-harvest
agricultural water microbial criteria and testing requirements for non-
sprout covered produce with requirements for pre-harvest agricultural
water assessments that covered farms would use to determine appropriate
measures for ensuring that their pre-harvest agricultural water is safe
and of adequate sanitary quality under Sec. 112.41. We also are
proposing to enhance risk-based mitigation measures for pre-harvest
agricultural water, including expedited mitigation measures to address
known or reasonably foreseeable hazards in agricultural water systems
due to animal activity, biological soil amendments of animal origin
(BSAAOs), or human waste related to adjacent or nearby land uses. This
proposed rule would add relevant definitions in subpart A and a
requirement in subpart O for
[[Page 69131]]
supervisory review of records of pre-harvest agricultural water
assessments, as well as conforming changes in subparts B and N for the
proposed revisions to pre-harvest agricultural water requirements.
To ensure that interested parties can readily view the proposed
pre-harvest agricultural water revisions, we are proposing to
reorganize and replace subpart E in its entirety. Of note, this
proposed rule would not substantively alter the standards established
in part 112, subpart E, for agricultural water used for sprouts, for
which the compliance dates have passed, or for agricultural water used
during harvesting, packing, and holding activities, or for treatment of
agricultural water.
Sections VI.C. through VI.H. describe our proposed revisions to the
pre-harvest agricultural water requirements in subpart E of the produce
safety regulation and conforming changes to align four additional
provisions (in subparts A, B, N, and O) relating to the subpart E pre-
harvest agricultural water testing requirements that we are proposing
to revise. We seek comment on our proposal to replace the pre-harvest
agricultural water quality criteria and testing requirements with
requirements for agricultural water assessments and enhanced mitigation
measures for pre-harvest agricultural water for non-sprout covered
produce, including expedited mitigation in certain circumstances.
The proposed rule also contains other edits that are designed to
provide clarity, such as reorganizing subpart E to group provisions of
a similar nature, as follows:
<bullet> General provisions for agricultural water for all uses
(proposed Sec. Sec. 112.40 through 112.42);
<bullet> Agricultural water assessments for pre-harvest
agricultural water for covered produce other than sprouts (proposed
Sec. 112.43);
<bullet> Microbial water quality criterion and testing requirements
for agricultural water for irrigation of sprouts and for harvest and
post-harvest uses (proposed Sec. 112.44);
<bullet> Corrective and mitigation measures for agricultural water
for all uses (proposed Sec. 112.45);
<bullet> Requirements relating to treatment methods for
agricultural water for all uses (proposed Sec. 112.46);
<bullet> Who conducts testing for agricultural water (proposed
Sec. 112.47);
<bullet> Reserved (proposed Sec. 112.48 through 112.49); and
<bullet> Records relating to agricultural water for all uses
(proposed Sec. 112.50).
Each of the proposed technical edits is described in the relevant
subsections below.
A. Scope of the Rulemaking
This proposed rule is narrow in scope. We are not proposing to
amend the requirements of the produce safety regulation relating to
Personnel Qualifications and Training (subpart C); Health and Hygiene
(subpart D); Biological Soil Amendments of Animal Origin and Human
Waste (subpart F); Domesticated and Wild Animals (subpart I); Growing,
Harvesting, Packing and Holding Activities (subpart K); Equipment,
Tools, Buildings, and Sanitation (subpart L); Sprouts (subpart M);
Variances (subpart P); Compliance and Enforcement (subpart Q); and
Withdrawal of Qualified Exemption (subpart R), which are in effect for
covered farms of all sizes \4\ (Ref. 29).
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\4\ FDA announced its intent to exercise enforcement discretion
for specific requirements related to written assurances in ``Policy
Regarding Certain Entities Subject to the Current Good Manufacturing
Practice and Preventive Controls, Produce Safety, and/or Foreign
Supplier Verification Programs: Guidance for Industry,'' <a href="https://www.fda.gov/media/110023/download">https://www.fda.gov/media/110023/download</a> (last accessed May 13, 2020).
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Further, this proposed rule would not amend the requirements of the
produce safety regulation in General Provisions (subpart A), other than
the definitions we propose to add to Sec. 112.3; General Requirements
(subpart B), other than the proposed conforming change to Sec. 112.12;
Analytical Methods (subpart N), other than the proposed conforming
change to Sec. 112.151; or Records (subpart O), other than the
proposed revisions to Sec. 112.161(b). Therefore, we are not
soliciting comment on subparts A through B and N through O of the
produce safety regulation (with limited exceptions for the proposed
changes to Sec. Sec. 112.3, 112.12, 112.151, and 112.161), as those
subparts are outside the scope of this rulemaking. We also are not
soliciting comment on subparts C, D, F, I, K through M, and P through R
of the produce safety regulation, as those requirements are outside the
scope of this rulemaking, as discussed above.
B. Consistency With National Organic Program
In accordance with section 419(a)(3)(E) of the FD&C Act, this
proposed rule does not include any requirements that conflict with or
duplicate the requirements of the National Organic Program established
under the Organic Foods Production Act of 1990. Compliance with the
provisions of this proposed rule would not preclude compliance with the
requirements for organic certification in 7 CFR part 205. Moreover,
where this proposed rule and the National Organic Program would include
similar or related requirements, our proposed requirements may be
satisfied concurrently with those of the National Organic Program
(i.e., to the extent the requirements are the same, compliance with
this proposed rule could be achieved without duplication).
For example, proposed Sec. 112.43(a)(1) would require a covered
farm to evaluate the likelihood that adjacent and nearby land uses
involving animal activity, the application of BSAAOs, or the presence
of untreated or improperly treated human waste may contaminate pre-
harvest agricultural water for covered produce (other than sprouts).
This provision would not conflict with or duplicate National Organic
Program requirements to manage plant and animal materials, soil
fertility, and manure in a manner so that they do not contribute to
contamination of water by pathogenic organisms (7 CFR 205.203(c)-(d),
205.239(e)) and manage livestock operations to prevent runoff of wastes
and contaminated waters to adjoining or nearby surface water and across
property boundaries (7 CFR 205.239(a)(5)).
Further, we note that the provisions for treatment of agricultural
water in proposed Sec. 112.46 are not in conflict with or duplicative
of the National Organic Program guidance, ``The Use of Chlorine
Materials in Organic Production and Handling'' (Ref. 30), which
provides that residual chlorine levels in pre-harvest water
agricultural water should not exceed the maximum residual disinfectant
limit under the Safe Drinking Water Act (40 CFR part 141), and post-
harvest agricultural water is permitted to contain chlorine materials
at levels approved by the FDA or the EPA for such purpose. Certified
organic farms would be able to comply with the provisions of this
proposed rule with respect to corrective or mitigation measures that
would be reasonably necessary to implement under proposed Sec. 112.45.
We seek comment on the tentative conclusion that this proposed rule
does not conflict with or duplicate the requirements of the National
Organic Program, while providing the same level of public health
protection as required under FSMA.
C. Definitions (Proposed Sec. 112.3)
We propose to add two new definitions in Sec. 112.3 to provide
clarity for terminology used in the proposed requirements for pre-
harvest agricultural water assessments.
[[Page 69132]]
1. Agricultural Water Assessment
We propose to add a new definition of ``agricultural water
assessment.'' As proposed, the term agricultural water assessment would
be defined to mean an evaluation, conducted by a covered farm, of its
agricultural water system used during growing activities for non-sprout
covered produce, its agricultural water practices for such pre-harvest
water, crop characteristics, environmental conditions, and other
relevant factors (including test results, where appropriate) 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 corrective or mitigation
measures for pre-harvest agricultural water are necessary to reduce the
potential for contamination with such known or reasonably foreseeable
hazards.
A definition of ``agricultural water assessment'' is needed to
provide clarity, particularly in light of widespread use of similar
terms that may have different meanings than the definition in this
proposal. For example, the definition of agricultural water assessment
we are proposing includes crop characteristics. By contrast, an ``ag
water system assessment,'' as described by Western Growers (Ref. 31),
or a ``sanitary survey,'' as described by some stakeholders (Ref. 3) do
not consider this factor.
Crop characteristics also are a factor mentioned in the QAR (Ref.
11). Crop characteristics have long been identified as a factor
influencing the potential for water to contaminate produce. In the 1998
FDA Good Agricultural Practices Guide, for example, we explained that
produce that has a large surface area (such as leafy vegetables) and
produce with topographical features (such as rough surfaces) that
foster attachment or entrapment may be at greater risk from pathogens,
if they are present, especially if contact with agricultural water
occurs close to harvest or during post-harvest handling (Ref. 32). In
light of the role that crop characteristics may play in contamination
of produce, this would be an important component of an ``agricultural
water assessment'' under this proposed rule.
2. Agricultural Water System
We are proposing to define the term ``agricultural water system''
to provide greater clarity and increase consistency in the
interpretation of what comprises an agricultural water system that a
covered farm must inspect under Sec. 112.42(a), to the extent that the
system is under the farm's control. In this proposed rule, an
``agricultural water system'' means 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.
We developed the proposed definition of ``agricultural water
system'' based on elements listed in Sec. 112.42(a) of the produce
safety regulation, which provides that an agricultural water system
includes water sources, water distribution systems, facilities, and
equipment. We also incorporated language from the definition of ``water
distribution system'' in Sec. 112.3 of the produce safety regulation,
which describes a system for carrying water from its source to its
point of use. Additionally, we added examples of buildings or
structures that may be part of a water distribution system--for
example, a well house, pump station, or shed--to clarify the meaning of
``facilities'' as a component of an agricultural water system. We
expect that adding a definition that clearly describes the scope of
``agricultural water system'' will help covered farms ensure that
inspections and maintenance activities under proposed Sec. 112.42
would be of adequate scope and rigor.
We are seeking comment on the definitions of ``agricultural water
assessment'' and ``agricultural water system'' in proposed Sec. 112.3.
D. Applicability (Proposed Sec. 112.40)
We are proposing to add new Sec. 112.40 to summarize the
requirements that would apply to a covered farm. The provision would
include an explanatory table presenting the following:
If you are a covered farm using pre-harvest agricultural water in
growing covered produce, other than sprouts:
<bullet> You must meet the requirements of Sec. Sec. 112.41 (water
quality standard), 112.42 (inspections and maintenance of agricultural
water systems), 112.43 (agricultural water assessment), and 112.50
(records) and
<bullet> As applicable, you must meet the requirements of
Sec. Sec. 112.45 (measures), 112.47 (who may test), and 112.151
(methods). Any water treatment must be in accordance with Sec. 112.46.
If you are a covered farm using agricultural water for sprout
irrigation:
<bullet> You must meet the requirements of Sec. Sec. 112.41 (water
quality standard), 112.42 (inspections and maintenance of agricultural
water systems), 112.44(a) (microbial quality criterion), unless
excepted under 112.44(c), and 112.50 (records) and
<bullet> As applicable, you also must meet the requirements of
Sec. Sec. 112.44(b) (untreated ground water testing), 112.44(c)
(exceptions from testing requirement), 112.45 (measures), 112.47 (who
may test), and 112.151 (test methods). Any water treatment must be in
accordance with Sec. 112.46.
If you are a covered farm using agricultural water for harvesting,
packing, or holding covered produce:
<bullet> You must meet the requirements of Sec. Sec. 112.41 (water
quality standard), 112.42 (inspections and maintenance of agricultural
water systems), 112.44(a) (microbial quality criterion), unless
excepted under 112.44(c), 112.44(e) (additional management and
monitoring practices), and 112.50 (records) and
<bullet> As applicable, you also must meet the requirements of
Sec. Sec. 112.44(b) (testing untreated ground water), 112.44(c)
(exceptions from testing requirement), 112.45 (measures), 112.47 (who
may test), and 112.151 (test methods). Any water treatment must be in
accordance with Sec. 112.46.
E. Pre-Harvest Agricultural Water Assessments (Proposed Sec. 112.43)
Proposed Sec. 112.43 would require covered farms to conduct
agricultural water assessments for the pre-harvest agricultural water
for non-sprout covered produce. The proposed assessments would be
conducted annually (and more frequently as needed), documented in
writing, and used for hazard identification and risk management
decision-making purposes in lieu of the pre-harvest microbial water
quality criteria and testing requirements in Sec. Sec. 112.44(b) and
112.46(b) of the produce safety regulation.
Covered farms would be exempt from the proposed agricultural water
assessment requirement if they can demonstrate that their pre-harvest
agricultural water for non-sprout covered produce:
<bullet> Meets the requirements for harvest and post-harvest
agricultural water (proposed Sec. 112.44(a) and, as applicable,
Sec. Sec. 112.44(b), 112.47, and 112.151);
<bullet> Meets the requirements for water from a Public Water
System or public water supply (proposed Sec. 112.44(c)); or
<bullet> Is treated in accordance with Sec. 112.46.
Unless exempt (as described above), covered farms using pre-harvest
agricultural water for non-sprout covered produce would evaluate their
pre-harvest agricultural water system(s), agricultural water practices,
crop
[[Page 69133]]
characteristics, environmental conditions, and other relevant factors
to identify any conditions that would be reasonably likely to introduce
known or reasonably foreseeable hazards into or onto covered produce or
food contact surfaces. Certain covered farms also may opt to conduct
testing to help inform their assessments.
Covered farms would use the results of their agricultural water
assessments in determining whether corrective or mitigation measures
for their pre-harvest agricultural water for non-sprout covered produce
would be reasonably necessary to reduce the potential for
contamination, or whether routine inspections and maintenance of their
agricultural water systems would be adequate to ensure that their pre-
harvest agricultural water is safe and of adequate sanitary quality for
its intended use under Sec. 112.41.
To assist readers, Table 3 outlines the discussion of proposed
Sec. 112.43.
Table 3--Discussion of Proposed Sec. 112.43
1. Proposed Sec. 112.43(a)--Elements of an Agricultural Water
Assessment
2. Factors
3. Agricultural Water System
4. Location and nature of each water source
5. Type of water distribution system
6. Degree of protection of each agricultural water system
7. Degree of protection from contamination by other users
a. Animal impacts
b. Adjacent and nearby land uses
c. Animal activities as possible contributing factors in outbreaks
d. Endangered Species Act
e. BSAAOs
f. Untreated or improperly treated waste
8. Agricultural water practices
a. Time to harvest
b. Method of application
9. Crop characteristics
10. Environmental conditions
11. Other relevant factors
12. Written annual assessments
13. Proposed Sec. 112.43(b)--Exemptions
14. Proposed Sec. 112.43(c)--Outcomes
15. Proposed Sec. 112.43(d)--Testing for Assessment Purposes
a. Generic E. coli
b. Frequency of testing
c. Microbial water quality criteria
d. Records relating to analytes, sampling frequencies, and pre-harvest
water quality criteria
16. Proposed Sec. 112.43(e)--Reassessment
1. Proposed Sec. 112.43(a)--Elements of an Agricultural Water
Assessment
Unless exempt under proposed Sec. 112.43(b), covered farms using
pre-harvest agricultural water for non-sprout covered produce would
prepare a written assessment of their pre-harvest agricultural water,
at least once each year, to identify any conditions that would be
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto non-sprout covered produce or food contact surfaces.
2. Factors
In light of the diversity of operations, practices, and conditions
that may impact the pre-harvest agricultural water used by foreign and
domestic covered farms for non-sprout covered produce, we propose to
require a covered farm to assess the following factors (further
described in paragraphs 3-11, below) for hazard identification
purposes, under proposed Sec. 112.43(a):
<bullet> Each agricultural water system (defined as proposed in
Sec. 112.3) used for pre-harvest agricultural water for non-sprout
covered produce, including:
[cir] The location and nature of the water source (that is, whether
the source meets the definition of ground water or surface water);
[cir] the type of water distribution system, such as whether the
conveyance is open to the environment (for example, an open irrigation
canal) or is closed to the environment (for example, a closed piping
system);
[cir] the degree to which the agricultural water system(s) are
protected from possible sources of contamination, including possible
contamination by other users of the same agricultural water system and
animal impacts (including by grazing animals, working animals, and
animal intrusion on the covered farm); and
[cir] the degree to which the agricultural water system(s) are
protected from possible sources of contamination, including by adjacent
and nearby land uses--particularly any animal activity (for example
grazing, or commercial animal feeding operations of any size), the
application of BSAAOs, or the presence of untreated or improperly
treated human waste;
<bullet> Agricultural water practices associated with each
agricultural water system used for pre-harvest water for non-sprout
covered produce, including:
[cir] The type of direct application method used (such as foliar
spray or drip irrigation of covered produce growing underground); and
[cir] the time interval between the last direct application of
agricultural water and harvest of the non-sprout covered produce;
<bullet> Crop characteristics, including the susceptibility of the
covered produce to surface adhesion or internalization of hazards;
<bullet> Environmental conditions, such as:
[cir] The frequency of heavy rain or extreme weather events that
may impact the agricultural water system(s) (such as by stirring
sediments) or that may impact covered produce (such as damage to edible
leaves) during growing activities;
[cir] air temperatures; and
[cir] sun (ultraviolet (UV)) exposure; and
<bullet> Other relevant factors, including, if applicable, the
results of any testing conducted to inform the assessment.
3. Agricultural Water Systems
Proposed Sec. 112.43 is intended to supplement the requirements of
proposed Sec. 112.42,\5\ which would require a covered 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 proposed Sec. 112.42 is focused
on agricultural water system components under the covered farm's
control, proposed Sec. 112.43(a) would require covered 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 preharvest agricultural water for non-sprout
covered produce. While the covered farm may not have control over the
factors assessed under proposed Sec. 112.43(a), they are no less
important for the farm to consider when determining the safe use of
agricultural water on covered produce.
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\5\ As described in section VI.I., we are proposing to minor
revisions to Sec. 112.42, which applies to agricultural water for
pre-harvest, harvest, and post-harvest application to covered
produce.
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When conducting pre-harvest agricultural water assessments, covered
farms would use the results of inspections and maintenance they
performed under proposed Sec. 112.42 for agricultural water systems
under their control. For example, a covered farm using an on-farm pond
as a pre-harvest agricultural water source would consider the results
of any inspections and maintenance performed (including inspection
findings documented in records under proposed Sec. 112.50(b)(2)) as
part of its pre-harvest agricultural water assessment (proposed Sec.
112.43).
For hazard identification purposes, under proposed Sec. 112.43, a
covered farm would assess each pre-harvest agricultural water system it
uses for non-sprout covered produce from water source to point of
application. A covered farm could not satisfy the agricultural water
assessment requirements in proposed Sec. 112.43 solely based on
inspection activities conducted under proposed Sec. 112.42, for
example, because the agricultural water
[[Page 69134]]
assessment requires consideration of a broader range of factors,
including agricultural water practices, crop characteristics, and other
relevant factors.
For each agricultural water system used for pre-harvest
agricultural water for non-sprout covered produce, a covered farm would
consider:
4. Location and Nature of Each Water Source
Proposed Sec. 112.43(a)(1) would require covered farms to evaluate
the location and nature of each agricultural water source used during
growing activities for non-sprout covered produce. The covered farm
would need to identify whether the water source was ground water or
surface water as a starting point for its agricultural water
assessment.
The QAR (Ref. 11) 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. For
example, groundwater 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. 11 and 32).
By contrast, surface waters, which are exposed to the environment,
pose a higher potential for contamination due to runoff and greater
variability in quality because of the potential for external inputs
(Ref. 11). Runoff has the potential to carry pathogens and is known to
mobilize pathogens from sediment reservoirs to the water column (Refs.
33-36). Runoff also carries pathogens to the surface water system from
sources such as failing septic systems and deposited animal feces
(Refs. 36 and 37).
5. Type of Water Distribution System
Under proposed Sec. 112.42(a)(1), a covered farm also would
identify the type of water distribution systems used to convey pre-
harvest agricultural water for non-sprout covered produce.
As the QAR (Ref. 11) notes, pathogens can potentially enter a water
system anywhere along the path from source to distribution and use,
potentially introducing hazards onto produce. Some water used for
growing activities is conveyed through open systems of canals and
laterals that can be subject to the introduction of hazards such as via
runoff, animal intrusion, direct discharge, or seepage. For example, in
the investigation of the Spring 2018 E. coli O157:H7 outbreak,
investigators conducted a ground water assessment of the area near the
3.5-mile section of irrigation canal where the outbreak strain was
detected in three samples. (Refs. 12 and 13). Investigators noted that
one of those positive samples was collected immediately downstream from
a shallow ground water discharge into the irrigation canal.
Investigators also found an area where ground water may have been
seeping directly into unlined sections of the canal within the 3.5-mile
stretch where the outbreak strain was detected.
Other water is distributed through closed distribution systems,
such as through piping that conveys water from the source to the field.
If intact, properly constructed, and properly functioning, piped
systems can help protect the water from the potential introduction of
hazards during conveyance.
However, hazards may be introduced into closed piping systems, such
as where interconnected with other systems without adequate backflow
protection. For example, an environmental investigation of a 2006 E.
coli O157:H7 linked to iceberg lettuce led investigators to a farm with
an irrigation system that blended irrigation water from the local water
district and dairy wastewater, and routed the blended water to fields
(Ref. 21). Investigators reported that the irrigation and dairy
effluent conveyance systems appeared to be combined into a complex
piping network, which raised concerns about the potential of microbial
cross-contamination between the growing fields of lettuce and nearby
dairies. Six samples (water, soil, and environmental swabs) matching
the outbreak strain by pulsed-field gel electrophoresis came from areas
where the blended water was routed. Investigators concluded: ``Because
this system has been found to have inadequate backflow prevention
devices, it presented a possible route of conveyance of contaminated
water to fields adjacent to suspect lettuce growing fields associated
with this outbreak.'' (Ref. 38).
Covered farms with open and closed components in their agricultural
water distribution systems would consider the individual properties and
characteristics of each component when conducting a pre-harvest
agricultural water assessment under proposed Sec. 112.43(a)(1).
6. Degree of Protection of Each Agricultural Water System
In evaluating each agricultural water system used for pre-harvest
water for non-sprout covered produce under proposed Sec. 112.43(a)(1),
a covered farm would consider the likelihood that various external
conditions (including those described in paragraphs 7, 11, and 12
below) could introduce known or reasonably foreseeable hazards to pre-
harvest agricultural water, such as from:
<bullet> Other users of the agricultural water system;
<bullet> Animal impacts, including grazing animals, working
animals, and animal intrusion on the covered farm; and
<bullet> Adjacent and nearby land uses involving animal activity,
application of BSAAOs, or presence of untreated or improperly treated
human waste.
Under proposed Sec. 112.43(a)(1), a covered farm would evaluate
whether there are measures in place to contain possible sources of
contamination (such as discharges or runoff) away from the agricultural
water system, including any measures implemented by the farm itself or
by another entity (proposed Sec. 112.43(a)(1)). For example, the QAR
(Ref. 11) indicates that farms may be able to minimize the influence of
discharge or runoff into on-farm surface water held in impoundments,
catches, and ponds, such as through walls or earthen berms. Other farms
may have little to no control over upstream runoff into a larger,
shared body of water, such as a river. While flowing waters generally
may be exposed to the same types of factors as on-farm ponds,
reservoirs, and water containment structures, their composition and
chemistry can be expected to be largely influenced by their course
through land used for purposes that may lead to their contamination
and, potentially, to the contamination of produce exposed to those
waters.
7. Degree of Protection From Contamination by Other Users
In assessing the degree of protection of the agricultural water
system(s) under proposed Sec. 112.43(a)(1), a covered farm would
consider the potential for known or reasonably foreseeable hazards to
be introduced by other users of any pre-harvest agricultural water
source or distribution system used for non-sprout covered produce. For
example, a covered farm that draws water for crop protection sprays
from a pond that is also used for recreational swimming would need to
consider whether that use of the source for recreational swimming would
be reasonably likely to introduce known or reasonably foreseeable
hazards into the agricultural water system, such as through
introduction of human waste.
Under proposed Sec. 112.43(a)(1), covered farms that reuse (or
recycle) water as a source for pre-harvest
[[Page 69135]]
agricultural water would need to consider the potential for known or
reasonably foreseeable hazards to be introduced by the prior use of the
water. This would include consideration of impacts relating to the
nature of the prior use. We note that the requirements for agricultural
water quality in proposed Sec. Sec. 112.41 and 112.43 apply regardless
of the source or type of water used as agricultural water. If
finalized, a covered farm would determine the appropriate use of the
recycled water in light of the conditions and practices on the farm by
assessment as required under Sec. 112.43, taking into account the
standard in Sec. 112.41 that all agricultural water must be safe and
of adequate sanitary quality for its intended use.
We anticipate that some covered farms would treat the recycled
water themselves (or through a third party acting on their behalf) in
accordance with the proposed treatment requirements. Proposed Sec.
112.46 would require the treatment method to be effective and delivered
in a manner to ensure that the treated water is consistently safe and
of adequate sanitary quality for its intended use(s). If finalized as
proposed, the treated water would be monitored using an adequate method
and frequency to ensure that it is consistently safe and of adequate
sanitary quality for its intended use(s).
We seek comment on the types of water reuse that covered farms
might use for pre-harvest agricultural water. We also seek comment from
interested parties on providing greater specificity on testing for
water reuse, such as by setting quantitative thresholds in the final
rule, or by providing testing recommendations in guidance, for recycled
water applied during growing activities for covered produce (other than
sprouts), consistent with our mandate to establish science-based
minimum standards for agricultural water that are reasonably necessary
to minimize the risk of serious adverse health consequences or death
from the use of, or exposure to, covered produce, including those
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into covered produce, and to provide reasonable
assurances that the produce is not adulterated under section 402 of the
FD&C Act.
a. Animal impacts. Under proposed Sec. 112.43(a)(1), a covered
farm would consider the potential for hazards to be introduced into its
pre-harvest agricultural water sources or distribution systems from
animals, including grazing animals, working animals, and wild animal
intrusion on the farm.
As discussed in the QAR (Ref. 11), both wild and domesticated
animals may be a source of human pathogens, including animals that only
sporadically show symptoms (Ref. 39) or that may be asymptomatic
shedders (Refs. 40 and 41). Animal waste has been shown to harbor many
bacterial pathogens--for example, the predominant source of E. coli
O157:H7 in animal feces is cattle, and the predominant source of
Salmonella in animal feces is poultry (Ref. 11). The QAR (Ref. 11)
identifies other domesticated animals (including sheep, goats, and
swine) and wild animals can carry human pathogens as well, such as
pathogenic E. coli in deer, feral swine, pigeons, and seagulls, and
Salmonella in rodents and wild birds.
FDA acknowledges the longstanding co-location of animals and plant
food production systems in agriculture. This proposed rule would not
prohibit the presence of animals (such as grazing animals or working
animals) on a covered farm, nor would it require the destruction of
wildlife habitat or the clearing of farm borders. Rather, the proposed
rule would require a covered farm 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.
Proposed Sec. 112.43(a)(1) is intended to provide a covered farm
with information about animal impacts on its pre-harvest agricultural
water system(s) and to facilitate measures as needed under proposed
Sec. 112.45. Some covered farms will be aware of potential animal
impacts from grazing animals, working animals, or animal intrusion
through assessments done under subpart I (Sec. Sec. 112.81-112.84) of
the produce safety regulation--which, under certain circumstances,
requires a covered farm to assess the relevant areas used for a covered
activity for evidence of potential contamination of covered produce
(such as observation of significant quantities of animals, significant
amounts of animal excreta, or significant crop destruction). (See 80 FR
74354 at 74478-74485.) When determining the probability that animals
will contaminate its covered produce under subpart I of the produce
safety regulation, a covered farm may consider the presence of animal
attractants such as water sources or standing water on or near the farm
(Ref. 42). Visual observations by a covered farm for purposes of
Sec. Sec. 112.81-112.83 could provide useful information for
evaluating the degree of protection of a pre-harvest agricultural water
system under proposed Sec. 112.43(a)(1). For example, if a covered
farm determines that there is a reasonable probability that wild
animals will contaminate their crop, the covered farm must assess the
relevant growing area for evidence of potential contamination in
accordance with Sec. 112.83(b)(1) of the produce safety regulation.
The covered farm could consider findings from this assessment--for
example, whether significant amounts of animal excreta are observed--
when evaluating the likelihood of hazards being introduced into their
pre-harvest agricultural water sources.
Additionally, a covered farm would be aware of potential animal
impacts on agricultural water systems through inspections and
maintenance performed on agricultural water sources and agricultural
water systems it controls under proposed Sec. 112.42. For example,
pooled water in close proximity to the crop may serve as an attractant
for pests and other animals which may in turn introduce hazards into
pooled water that may contaminate produce. (See 80 FR 74354 at 74434.)
b. Adjacent and nearby land uses. Proposed Sec. 112.43(a)(1) would
require a covered farm to consider whether it is reasonably likely that
known or reasonably foreseeable hazards would be introduced into
agricultural water systems by activities conducted on lands adjacent to
or nearby its sources or distribution systems for pre-harvest
agricultural water for non-sprout covered produce.
By ``adjacent'' land, we are referring to land sharing a common
border with the water source or distribution system. By ``nearby''
land, we are referring to a broader category of land, including land
that does not adjoin the water source or distribution system but has
the potential to affect the covered farm's agricultural water source or
distribution system based on the land's location (80 FR 74354 at
74433).
Under proposed Sec. 112.43(a)(1), covered farms would be required
to consider the likelihood of introduction of known or reasonably
foreseeable hazards related to animal activity on adjacent and nearby
lands, for example:
<bullet> Grazing on public or private lands;
<bullet> Commercial animal feeding operations of any size; and
<bullet> Other animal activity, such as dairy production, poultry
production, barnyards, and significant wildlife intrusion or habitat.
Animal activities on adjacent and nearby lands--including grazing,
livestock operations, and wildlife intrusion--may introduce
[[Page 69136]]
contamination to surface and ground water through runoff and through
direct access by animals to waterways (Refs. 43-46). Strong
associations have been reported with E. coli O157:H7 originating from
upstream pastures with unrestricted access to waterways (Ref. 47).
Indicators of fecal contamination in water systems have been reported
to be related to various types of livestock operations--for swine (Ref.
48), poultry (Ref. 49), and cattle (Ref. 50). Animals from densely
populated farms or farms with a high population of immature animals
have an increased likelihood of harboring various pathogens (Ref. 51).
Runoff has the potential to increase the number of pathogens in the
water column if its origins include human, livestock or wildlife feces,
because it has the potential to increase the amount of suspended
sediments which are likely to harbor pathogens (Ref. 43).
c. Animal activities as possible contributing factors in outbreaks.
FDA investigators have identified animal operations of various sizes as
possible contributing factors in several produce outbreaks.\6\ In
particular, animal operations in proximity to, or upstream of, an
agricultural water source or distribution system may pose a significant
risk in some circumstances. Topography is another important factor to
consider in evaluating whether adjacent or nearby lands may serve as a
source of contamination. For example, animal grazing was identified as
a possible contributing factor in investigations of three 2019 E. coli
O157:H7 outbreaks linked to romaine lettuce, in which one of the
outbreak strains was detected in a fecal-soil composite sample taken
from a cattle grate on public land less than 2 miles upslope from a
farm with multiple fields tied to the outbreaks by traceback
investigations (Ref. 16). Additional STEC strains were found in two
samples collected from cattle grazing land in the hills above leafy
greens fields identified by traceback evidence, though neither of the
strains were linked to human illness. During collection of these
samples, investigators observed cattle grazing on hills above the
identified leafy greens fields, but far fewer than would be present on
a large CAFO. Investigators estimated that each of these adjacent
grazing lands had between 50 and 150 head of cattle.
---------------------------------------------------------------------------
\6\ In many instances, these operations did not meet the EPA's
definition of large CAFO. Under 40 CFR 122.23(b), a CAFO is a lot or
facility (other than an aquatic animal production facility) where
animals have been, are, or will be stabled or confined and fed or
maintained for a total of 45 days or more in any 12-month period;
and crops, vegetation, forage growth, or post-harvest residues are
not sustained in the normal growing season over any portion of the
lot or facility. A large CAFO stables or confines 1,000 or more
cattle (other than mature dairy cows or veal calves); 700 dairy
cows; or 500 horses, for example.
---------------------------------------------------------------------------
Cattle and horse grazing on adjacent lands were identified as
potential contributing factors in an investigation of a Fall 2018 E.
coli O157:H7 outbreak linked to romaine lettuce, in which the outbreak
strain was detected in a sediment sample from an on-farm water
reservoir (Ref. 15). Although investigators were not able to determine
how the contamination was introduced into the water reservoir, they
identified several risk factors, including between 250 and 500 cattle
grazing on land adjacent to romaine lettuce production on a farm
identified by traceback investigation. This was a notable observation
given that FDA's outbreak investigations have repeatedly demonstrated
the heightened risk of contamination associated with grazing activities
near produce growing areas and agricultural water sources, unless
appropriate measures are taken to mitigate the risks.
In the investigation of the Spring 2018 E. coli O157:H7 outbreak, a
large cattle CAFO was located adjacent to the 3.5-mile stretch of
irrigation canal where the outbreak strain was found (Ref. 12). One of
these samples was collected immediately downstream from where shallow
ground water is pumped into the irrigation canal. The EA investigators
also found an area where ground water may have been seeping directly
into unlined sections of the canal within the 3.5-mile stretch where
the outbreak strain was detected. Investigators identified on-farm
wells at the CAFO as a possible route of ground water contamination
(Ref. 13).
Nearby cattle feeding operations also were identified as a possible
source of contamination during an investigation of a 2013 E. coli
O157:H7 outbreak, with 33 reported illnesses, linked to ready-to-eat
salads (Ref. 52). Based on traceback information, investigators
conducted on-farm sampling and investigation. Of the ten soil and water
samples collected, five were positive for E. coli O157:H7 but not the
outbreak strain.
Feral swine and cattle were identified as possible vectors for
surface water contamination in an investigation of a 2006 E. coli
O157:H7 outbreak traced to bagged spinach (Ref. 20) The outbreak strain
was detected in feral swine feces, cattle feces, surface water, and
river sediment samples collected from a ranch with cattle pastures
located adjacent to a leased field where spinach implicated by
traceback was grown. Samples were matched by pulsed-field gel
electrophoresis and multilocus variable number tandem repeat analysis
(Ref. 20). Although investigators made no definitive determination on
the route of contamination, they concluded that fecal loading of
surface waterways by livestock and wildlife with subsequent
contamination of wells used for irrigation was one possible route of
transmission to plants in the field (Ref. 20).
Under proposed Sec. 112.43(a)(1), a covered farm would evaluate
animal activity on adjacent and nearby lands, such as grazing or
commercial animal operations of any size, to identify any condition(s)
that may introduce a known or reasonably foreseeable hazard into a
source or distribution system used for pre-harvest agricultural water
for non-sprout covered produce. Animal activities that may introduce
contamination into sources or distribution systems include, but are not
limited to, livestock feeding operations of any size, dairy production,
poultry production, barnyards, or significant wildlife intrusion or
wildlife habitat. In evaluating adjacent and nearby land uses under
proposed Sec. 112.43(a)(1), a covered farm could, for example,
consider the effects of any fencing, containment, or other measures
employed to prevent animal access to water sources or distribution
systems, or earthen diversion berms, ditches, or other barriers to help
minimize the influence of runoff on sources and distribution systems.
Information on adjacent or nearby land uses could be acquired through
visual observations, discussions with local extension agents or
associations, online resources such as mapping tools, or other means
that are appropriate to the circumstances.
The factors a covered farm might consider in evaluating the
likelihood of hazards being introduced from adjacent or nearby lands
may depend on the specific animal activity in question. For example, if
a covered farm draws water from a stream with upstream grazing and
pasturing of animals, the covered farm might consider the proximity of
the grazing and pasture areas to the stream, whether the animals have
direct access to the stream for loafing and drinking, and whether
runoff from the grazed and pastured lands is likely to be introduced
into the stream.
While a covered farm might consider similar factors to these if it
draws water from a canal with an upstream dairy operation, there may be
additional factors to consider when evaluating the likelihood of
introduction of hazards, such as whether the operation has any best
management practices in place (such as to prevent overflow of manure
lagoons), the locations of waste storage
[[Page 69137]]
or composting operations relative to the canal, and animal and traffic
patterns throughout the dairy that have the potential to spread
contaminants.
We recognize that farms may face uncertainty around evaluating
factors like these where they are unable to obtain the relevant
information, such as if adjacent or nearby land users are not willing
to share information. Due to the nature of the risks associated with
animal activity, in these instances, farms should consider accounting
for the increased likelihood of hazard introduction to the water
systems from adjacent or nearby lands when making decisions around the
safe use of their water.
d. Endangered Species Act. Section 112.84 of the produce safety
regulation clarifies that the regulation does not authorize or require
covered farms to take actions that would constitute the ``taking'' of
threatened or endangered species in violation of the Endangered Species
Act (16 U.S.C. 1531-1544), or require covered farms to take measures to
exclude animals from outdoor growing areas, or destroy animal habitat
or otherwise clear farm borders around outdoor growing areas or
drainages.
We note that nothing in proposed subpart E would require covered
farms to take measures to exclude animals from covered farms or from
adjacent or nearby lands, or to destroy animal habitat or otherwise
clear farm borders.
e. BSAAOs. Proposed Sec. 112.43(a)(1) also would require covered
farms to evaluate the presence of BSAAOs on adjacent and nearby lands
that may introduce known or reasonably foreseeable hazards into sources
and distribution systems for pre-harvest agricultural water for non-
sprout covered produce, such as through runoff.
Section 112.3 of the produce safety regulation defines BSAAO to
mean ``any biological soil amendment which consists, in whole or in
part, of materials of animal origin, such as manure or non-fecal animal
byproducts including animal mortalities, or table waste, alone or in
combination. The term biological soil amendment of animal origin does
not include any form of human waste.''
The QAR (Ref. 11) concluded that biological soil amendments can
transmit human pathogens to surface water or ground water when
stockpiled or applied to fields. Composting is less likely than
controlled chemical or physical treatments to fully eliminate human
pathogens from animal waste. Incompletely treated, or re-contaminated,
BSAAOs may contain human pathogens. (See also 80 FR 74534 at 74461-
74478.)
Soil amendments have been identified as possible sources of
pathogens in produce outbreak investigations (Ref. 11). For example,
investigators identified soil amendments on adjacent lands as a
possible source of contamination in the 2018 romaine lettuce outbreak
in which the outbreak strain of E. coli O157:H7 was introduced into the
on-farm water reservoir (Ref. 15).
In evaluating whether the application of BSAAOs on adjacent and
nearby lands may introduce contamination into sources or distribution
systems for pre-harvest agricultural water for non-sprout covered
produce, a covered farm would consider whether the BSAAO is treated or
applied to the land in accordance with the produce safety regulation
(such as where adjacent or nearby lands are covered farms subject to
the produce safety regulation) or any other Federal, State, or
international regulations, recommendations, or guidelines for soil
amendments. Covered farms would consider whether any BSAAOs on adjacent
and nearby lands are handled, conveyed, and stored in a manner and
location so that they do not become a potential source of contamination
to water sources and water distribution systems for pre-harvest
agricultural water for non-sprout covered produce (proposed Sec.
112.43(a)(1)).
Factors to consider when evaluating the likelihood of potential
hazards being introduced into a water system include, for example: (1)
The distance between the fields and the water source; (2) the measures,
if any, an upstream farm uses to control runoff; (3) whether the BSAAOs
are treated and to what extent; (4) how BSAAOs are handled, conveyed,
and stored on the land; and (5) whether runoff is likely to occur. In
the event of uncertainty about use of BSAAO on adjacent and nearby
lands, such as where the upstream farm does not provide information,
farms should consider accounting for the increased likelihood of hazard
introduction to the water systems from such BSAAO uses when making
decisions around the safe use of their pre-harvest agricultural water.
f. Untreated or improperly treated human waste. Proposed Sec.
112.43(a)(1) also would require covered farms to consider adjacent and
nearby land uses related to untreated or improperly treated human
waste.
As described in the QAR (Ref. 11), human waste may contain
pathogens in relatively high concentrations. Runoff associated with
human waste from adjacent and nearby lands may contaminate sources or
distribution systems for pre-harvest agricultural water for non-sprout
covered produce--such as where untreated or improperly treated human
waste is applied as a soil amendment or where human waste systems are
not properly constructed and maintained. Covered farms also should
consider whether any portable toilet facilities on adjacent and nearby
lands are appropriately located away from water sources and
distribution systems in the event of malfunctioning, flooding, or high
winds. Fixed human waste systems also may introduce contamination to
water sources or water distribution systems. For example, investigators
identified a recreational vehicle (RV) park as a potential source of
contamination in a 2010 STEC O145 outbreak associated with romaine
lettuce (Ref. 53). Investigators found that the RV park property had
multiple septic leach systems with subterranean moisture in the area
that drains into an irrigation canal.
When evaluating proposed Sec. 112.43(a)(2)-(4), the covered farm
would consider the likelihood that any hazards, if present in its
agricultural water system, would be reasonably likely to introduce
hazards into or onto non-sprout covered produce, due to the
agricultural water practices employed by the farm, the characteristics
of the crop(s) to which the pre-harvest agricultural water is applied,
and the environmental conditions that may impact the introduction and/
or persistence of hazards. An evaluation of the hazards associated with
untreated or improperly treated human waste from adjacent or nearby
lands could include consideration of potential sources of
contamination, such as wastewater treatment plants, toilet facilities
(portable and fixed), sewage systems, septic tanks, and drain fields.
In considering whether hazards associated with human waste from
adjacent or nearby lands might be introduced to water systems, covered
farms might consider: (1) Whether and how the human waste is treated;
(2) whether the source of human waste is discharged directly into the
water system; (3) the proximity of the potential source to the water
system; (3) the topography between the potential source of human waste
and the water system; and (4) whether there are any physical measures
in place between the potential source of human waste and water system
that would reduce the likelihood of hazards being introduced. In the
event of uncertainty about adjacent and nearby land uses related to
untreated or improperly treated human waste, such
[[Page 69138]]
as if adjacent and nearby land users are not willing to share
information, farms should consider accounting for the increased
likelihood of hazard introduction to the water systems from such land
uses when making decisions around the safe use of their pre-harvest
agricultural water.
We note that in the United States, the use and disposal of treated
sewage sludge (biosolids), including domestic septage, are regulated
under 40 CFR part 503. Subpart D of the Part 503 regulation protects
public health and the environment through requirements designed to
reduce the potential for contact with the disease-bearing
microorganisms (pathogens) in sewage sludge and domestic septage
applied to the land or placed on a surface disposal site (Ref. 54).
8. Agricultural Water Practices
a. Time to harvest. In evaluating any conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce (other than sprouts) or food contact
surfaces under proposed Sec. 112.43(a)(2), a covered farm would
consider the interval between the last time pre-harvest agricultural
water was applied to the covered produce and the date of harvest. For
example, a covered farm that uses furrow irrigation and crop protection
sprays for its non-sprout covered produce would consider the timing of
both types of applications.
As explained in the QAR (Ref. 11), the timing of water application
is an important factor in determining the likelihood of contamination,
because pathogens die off over time on the surface of produce.
Generally, bacteria or pathogens in water that is applied early in the
growing cycle are subject to die-off from several environmental forces,
such as UV exposure, temperature, humidity, and the presence of
competitive organisms (Ref. 55). In contrast, pathogens present in
agricultural water that is applied shortly before harvest may not be
exposed to the same environmental conditions for sufficient time to
provide a similar magnitude of die-off (Ref. 11). For more discussion
of microbial die off rates, see section VI.F.
b. Method of application. Proposed Sec. 112.43(a)(2) also would
require a covered farm to evaluate the method(s) by which pre-harvest
agricultural water is applied to non-sprout covered produce during
growing activities.
The most frequently used irrigation methods include overhead
sprinkler (or spray), surface and subsurface drip, furrow, flood, and
seep irrigation (Ref. 56). The QAR (Ref. 11) explains that different
irrigation methods present different risks based on the extent to which
the irrigation water is directly applied to the harvestable portion of
the crop.\7\ Overhead sprinkler irrigation increases the risk of
contamination as compared with furrow and subsurface drip irrigation
(Ref. 57). The location of the harvestable portion of a plant in
relation to irrigation water plays a significant role in contamination
in studies of lettuce, cantaloupe, and bell pepper (Ref. 58). The
likelihood of produce contamination may be reduced if irrigation water
is delivered by subsurface drip irrigation as compared to using the
same water to irrigate by overhead spray (Refs. 33 and 59).
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\7\ Irrigation water as described in the QAR is broader than the
definition of agricultural water in Sec. 112.3 of the produce
safety regulations that would apply under this proposed rule.
---------------------------------------------------------------------------
Pathogenic E. coli has been recovered from lettuce tissue after
surface irrigation and spray irrigation with suspensions of E. coli
O157:H7; the level of contamination was lower from drip than from
sprinkler irrigation (Ref. 60). The lettuce leaves remained
contaminated with E. coli O157:H7 even after washing, indicating that
surface and spray irrigation of food crops with water of unknown
microbiological quality may introduce risk.
9. Crop Characteristics
Under proposed Sec. 112.43(a)(3), a covered farm would be required
to evaluate whether the covered produce has any characteristics that
make it vulnerable to contamination, such as whether it is susceptible
to surface adhesion of bacteria or internalization of microbial
hazards. This includes increased susceptibility to internalization of
hazards due to physical damage from weather events (such as freezing of
an epidermal peel and hail damage) or biological damage (such as
phytopathogens).
The QAR (Ref. 11) concluded that:
<bullet> The physical characteristics of the crop is one of the
likely factors contributing to the likelihood of contamination,
exposure, and illness.
<bullet> In particular, the growth characteristics (e.g., near to
the ground) and surface properties (e.g., porosity) affect the
probability and degree of contamination.
<bullet> No physical characteristics were identified that would be
protective against contamination.
As discussed in the QAR (Ref. 11), although some physical
characteristics of produce commodities (e.g., netted rind of cantaloupe
or large, rough surface area of some leafy greens) may increase the
likelihood of contaminants being trapped and surviving long enough to
cause illness, physical characteristics that could alter the potential
for contamination (e.g., smooth surfaces) do not always appear to do
so. For example, while honeydew melon has a smooth rind, seemingly
making it less likely to harbor pathogens, it has been associated with
outbreaks. Some crops are more susceptible to the persistence and
growth of human pathogens, including co-infections with plant pathogens
(Ref. 61). (See also, the Codex Alimentarius Commission, Code of
Hygienic Practice for Fresh Fruits and Vegetables (CXC 53-2003) (the
Codex Code) section 3.2.1.1.1 (Ref. 62). We anticipate that as more
information is learned about how commodity characteristics can impact
produce safety, covered farms would use this information to further
inform their pre-harvest agricultural water assessments.
10. Environmental Conditions
Proposed Sec. 112.43(a)(4) would require a covered farm to
evaluate the potential impacts of weather conditions, including
seasonal rainfall patterns, the frequency of extreme weather events
(such as heavy winds or rain), and other relevant agro-ecological
conditions (such as temperature, sunlight (UV exposure)). As described
in the QAR (Ref. 11), survival of pathogens in the environment is
influenced by complex physical, chemical, and biological interactions.
Some pathogens are widely distributed and naturally capable of long-
term survival under a wide range of natural conditions (e.g., Listeria
monocytogenes) while the distribution of others (e.g., Salmonella, E.
coli H7:O157) may be more narrowly defined by temperature, sunlight (UV
exposure), moisture level, pH, available nutrients and related factors,
each of which may limit survival to some degree.
Changes in temperature and seasonality are expected to impact
persistence of foodborne pathogens in the environment (Ref. 56). In
general, the survival of pathogens in water sources decreases with
increasing temperatures (Ref. 56). For example, in mid-latitude areas,
it is thought that the overall survival of foodborne pathogens in
soils, manure-amended soils and surface waters is likely to decrease
with increasing temperatures (Ref. 63). However, exceptions may be
observed in certain geographic areas and/or on certain farm
environments due to factors that confound the effects of temperature,
such as nutrient levels and humidity (Refs. 63 and 64).
[[Page 69139]]
Airborne transmission may also result in contamination of the
environment--such as agricultural water and growing areas--particularly
when dry, windy conditions are present (Ref. 65). One study (Ref. 66)
found that E. coli was present in air samples from the edge of a beef
cattle feedlot, indicating that airborne transfer of microorganisms can
occur. Another study (Ref. 67) found that E. coli was recovered from 20
percent of air samples from an almond orchard downwind from a poultry
operation and from 0.48 percent of air samples from an almond orchard
not located near an animal operation. Increased levels of global dust
activity due to desertification as well as increased wind speeds
associated with storm systems may promote the dispersal and persistence
of some microbial hazards in the environment, especially those that
demonstrate higher levels of resistance to environmental conditions,
such as spore-formers (Ref. 63).
Precipitation and its effects (e.g., discharge and flow rate),
along with temperature, are common factors reported to affect the
microbial quality of watersheds with agricultural land inputs. Seasonal
changes in rainfall--particularly heavy rainfall and flooding events--
can greatly affect surface water quality (Refs. 33 and 62) and may
result in sediments, which can serve as reservoirs for pathogens, being
dispersed within the water column (Ref. 68). One study (Ref. 48) found
that that as rainfall increases, populations of various indicators
(fecal coliforms, generic E. coli, Enterococcus) increased; moreover,
swine-specific markers were detected more frequently in water samples
in the 48 hours following a rainfall event greater than the mean.
Rainfall events are reported to result in enhanced loading of fecal
pollutants from adjacent lands into water systems (Ref. 63) and
increased transport of pathogens onto growing fields (Ref. 63).
Alternately, rainfall may also have a dilution effect on pathogens or
indicator organisms that are already present in growing areas (Ref.
63). Although more research is needed, the possibility of splash
dispersal and internalization of pathogens may also become problematic
during periods of rainfall (Refs. 62 and 69), especially when increased
levels of pathogens are transported to growing areas.
11. Other Relevant Factors
Under proposed Sec. 112.43(a)(5), covered farms would consider any
other factors relevant to identifying any conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce (other than sprouts) or food contact
surfaces. Those relevant factors may include, for example, whether the
covered farm elected to conduct testing under Sec. 112.43(d) to help
inform its agricultural water assessment, as discussed below.
12. Written Annual Assessments
Under proposed Sec. 112.43(a), covered farms using pre-harvest
agricultural water for non-sprout covered produce would prepare a
written assessment of their pre-harvest agricultural water, at least
once each year, to identify any conditions that would be reasonably
likely to introduce known or reasonably foreseeable hazards into or
onto non-sprout covered produce or food contact surfaces, unless the
farm is exempt under proposed Sec. 112.43(b).
A written agricultural water assessment would help FDA to verify
that covered farms conducted comprehensive assessments that included
all of the elements required by proposed Sec. 112.43(a) and made a
written determination as required by proposed Sec. 112.43(c). A
written agricultural water assessment also would allow covered farms
using pre-harvest water for non-sprout produce to more effectively
manage their agricultural water (such as in evaluating the
effectiveness of any mitigation measures), identify trends and changes
impacting their agricultural water systems (such as a change in nearby
land use that might introduce known or reasonably foreseeable hazards),
and help identify potential sources of contamination of the water
system and covered produce. Records of annual agricultural water
assessments also would help covered farms in determining whether
changed conditions would require covered farms to conduct a
reassessment under proposed Sec. 112.43(f)(2), prior to an annual
reassessment.
The proposed requirement for an annual, written agricultural water
assessment for pre-harvest agricultural water, with the elements
described in paragraphs (a)(1)-(5), aligns with the Codex Code Section
3.2.1.1 (Ref. 63), which recommends the assessment of agricultural
water for suitability for use, and the USDA Harmonized GAP Plus+
Standard, section F-4.1 (Ref. 70).
13. Proposed Sec. 112.43(b)--Exemptions
Proposed Sec. 112.43(b) would create various exemptions from the
requirement to conduct an assessment of pre-harvest agricultural water
for application to non-sprout covered produce.
Under proposed Sec. 112.43(b)(1), a covered farm would be exempt
from the requirement to conduct an assessment for pre-harvest
agricultural water if the farm can demonstrate that the agricultural
water meets the requirements of proposed Sec. 112.44(a), which is
applicable to agricultural water used for sprout irrigation or for
harvest or post-harvest uses--i.e., untreated ground water that meets
the microbial water quality criterion of no detectable generic E. coli,
based on testing requirements in proposed Sec. Sec. 112.44(b), 112.47,
and 112.151. The exclusion in proposed Sec. 112.43(b)(1) does not
apply to untreated surface water, because proposed Sec. 112.44(a)
prohibits the use of untreated surface water for sprout irrigation or
harvest or post-harvest application on covered produce.
For example, if a covered farm uses the same untreated ground water
source for pre-harvest and harvest application to non-sprout covered
produce, the farm would be exempt from conducting an agricultural water
assessment for the untreated ground water provided that the farm could
demonstrate, through results of testing as required by proposed
Sec. Sec. 112.44(b), 112.47, and 112.151, that its agricultural water
meets microbial water quality criterion in proposed Sec. 112.44(a).
Ground water obtained from deep underground aquifers with properly
designed, located, and constructed wells, is not subject to the impacts
of runoff from adjacent and nearby lands and similar conditions
evaluated as part of an agricultural water assessment. As explained in
the 2015 produce safety final rule (80 FR 74354 at 74430), the
microbial quality requirement of no detectable generic E. coli in Sec.
112.44(a) in untreated ground water is intended to address the known or
reasonably foreseeable hazards associated with fecal contamination of
agricultural water. The stringency of the requirements in proposed
Sec. 112.44(a) is commensurate with the risks associated with using
contaminated water for sprout irrigation and for harvest and post-
harvest uses.
Proposed Sec. 112.43(b)(2) would exempt a covered farm from the
requirement to conduct an agricultural water assessment for pre-harvest
agricultural water for non-sprout covered produce that a covered farm
receives from a public water system that the covered farm can
demonstrate:
<bullet> Meets the microbial requirements of EPA Safe Drinking
Water Act (SDWA) regulations in 40 CFR part 141 (or the regulations of
a State approved to administer the SDWA program) through
[[Page 69140]]
public water system results or certificates of compliance or
<bullet> Meets the microbial quality criterion in Sec. 112.44(a)
through public water system results or certificates of compliance.
Proposed Sec. 112.43(b)(3) would exempt a covered farm from the
requirement to conduct an agricultural water assessment for pre-harvest
agricultural water for non-sprout covered produce that is treated in
accordance with proposed Sec. 112.46 (such as through application of
an EPA-registered antimicrobial pesticide product).
Although we are not proposing to require covered farms to treat
their agricultural water to meet applicable requirements, we note that
scientists from FDA's Center for Food Safety and Applied Nutrition have
developed a test protocol for evaluating the efficacy of antimicrobial
chemical treatments against public health organisms in agricultural
water sources and submitted it to EPA. On April 29, 2020, EPA approved
FDA's testing protocol, which potential chemical registrants can now
use to develop data to support registration of their pesticide products
for treatment of agricultural water used during growing activities
(Ref. 71).
We tentatively conclude that an agricultural water assessment would
not be necessary when a covered farm can demonstrate that it its pre-
harvest agricultural water for non-sprout covered produce meets the
microbial quality criterion of no detectable generic E. coli and
testing requirements that would be applicable to agricultural water for
sprout irrigation and harvest and post-harvest uses; EPA drinking water
standards or other public water supply standards; or the treatment
requirements in proposed Sec. 112.46. We seek comment on this
tentative conclusion.
14. Proposed Sec. 112.43(c)--Outcomes
Under proposed Sec. 112.43(c), a covered farm would use the
information gathered through inspection and maintenance of its
agricultural water system and evaluation of its agricultural water
practices, the crop characteristics, environmental conditions, and
other relevant factors for hazard identification purposes, as described
in Sec. 112.43(a). The covered farm also would make a written
determination of any corrective or mitigation measures to implement
based on:
<bullet> The farm's evaluation of factors described in proposed
Sec. 112.43(a)(1) through (5);
<bullet> Any conditions the farm identified that would be
reasonably likely to introduce known or reasonably foreseeable hazards
(specifically, biological hazards, as explained in section III.B.) into
or onto covered produce or food contact surfaces; and
<bullet> The results of any inspections and maintenance conducted
by the farm, pursuant to proposed Sec. 112.42, of any agricultural
water systems used during growing activities for non-sprout covered
produce.
Proposed Sec. 112.43(c) would require a covered farm to record the
determination in the written agricultural water assessment and take
appropriate action, as described in table 4:
Table 4--Summary of Outcomes of a Pre-Harvest Agricultural Water
Assessment for Covered Produce (Other Than Sprouts)
[Proposed Sec. 112.43(c)]
------------------------------------------------------------------------
If you determine . . . Then you must . . .
------------------------------------------------------------------------
that your agricultural water is not <bullet> Immediately
safe or is not of adequate sanitary discontinue use(s)
quality for intended use(s). And
<bullet> Take corrective
measures before resuming use
of the water for pre-harvest
activities
there is one or more known or <bullet> Implement mitigation
reasonably foreseeable hazards related measures promptly, and no
to animal activity, BSAAOs, or later than the same growing
untreated or improperly treated human season,
waste for which mitigation is
reasonably necessary.
there is one or more known or <bullet> Implement mitigation
reasonably foreseeable hazards not measures as soon as
related to animal activity, BSAAOs, or practicable and no later than
untreated or improperly treated human the following year
waste, for which mitigation is Or
reasonably necessary. <bullet> Test water as part of
the assessment and implement
measures, as needed, based on
the outcome of the assessment
that there are no known or reasonably <bullet> Regularly (at least
foreseeable hazards for which once each year) inspect and
mitigation is reasonably necessary. adequately maintain the water
system(s)
------------------------------------------------------------------------
With respect to pre-harvest agricultural water for non-sprout
covered produce, under proposed Sec. 112.43(c):
<bullet> If the covered farm determines the agricultural water is
not safe or is not of adequate sanitary quality for its intended
use(s), the farm would be required to immediately discontinue use of
the water and take corrective measures under proposed Sec. 112.45(a)
before resuming such use(s);
<bullet> If the covered farm determines that mitigation measures
are reasonably necessary to reduce the potential for contamination of
such produce or food contact surfaces with a known or reasonably
foreseeable hazard that is related to animal activity, a biological
soil amendment of animal origin, or untreated or improperly treated
human waste on an adjacent or nearby land, the farm would be required
to implement the mitigation measures within the same growing season as
the assessment.
<bullet> If the covered farm determines that mitigation measures
are reasonably necessary to reduce the potential for contamination of
such produce or food contact surfaces with a known or reasonably
foreseeable hazard that is not related to animal activity, a biological
soil amendment of animal origin, or untreated or improperly treated
human waste on adjacent or nearby lands, the farm would be required to
either:
[cir] Implement mitigation measures under proposed Sec. 112.45(b)
as soon as practicable and no later than the following year; or
[cir] test the water, pursuant to proposed Sec. 112.43(d),
consider the results as part of the assessment in making a
determination under Sec. 112.43(c), and implement measures as needed
under proposed Sec. 112.45;
<bullet> If the covered farm determined that no corrective or
mitigation measures under proposed Sec. 112.45 were reasonably
necessary to reduce the potential for contamination of such produce or
food contact surfaces, the farm would be required to regularly inspect
and adequately maintain the
[[Page 69141]]
agricultural water system(s) under proposed Sec. 112.42, and conduct a
written agricultural water assessment annually and whenever a
significant change occurs (such as a change in the manner or timing of
water application) that would increase the likelihood that a known or
reasonably foreseeable hazard would be introduced into or onto covered
produce or food contact surface.
We are maintaining the requirements for corrective measures in
Sec. 112.45(a), as explained and supported by the 2015 produce safety
final rule (80 FR 74354 at 74429-74431, 74440-74441), including the
requirement that if a covered farm determines or has reason to believe
that the agricultural water is not safe or of adequate sanitary quality
for its intended use, then the farm must immediately discontinue such
use. For example, if in performing the agricultural water assessment a
covered farm finds that there is a dead and decaying sheep in the canal
upstream and at a close distance from where it draws water, the farm
would have reason to believe that the agricultural water is not safe or
of adequate sanitary quality for its intended use because the water is
reasonably likely to contain human pathogens transferred by the dead
and decaying sheep. Therefore, the farm would have to immediately
discontinue that use of the water and take corrective measures under
proposed Sec. 112.45(a) before resuming such use(s).
We also are maintaining the requirements to mitigate other risks as
soon as practicable and no later than the following year, also
supported by the produce safety final rule (80 FR 74354 at 74441-
74446), except that a covered farm would be required to implement
mitigation measures under proposed Sec. 112.45(b) for known or
reasonably foreseeable hazards related to animal activity, the
application of BSAAOs, or the presence of untreated or improperly
treated human waste on adjacent or nearby lands promptly, and no later
than the same growing season as the agricultural water assessment. For
example, if in performing their agricultural water assessment, a
covered farm identifies upstream lands used for animal grazing from
which runoff is likely to introduce known or reasonably foreseeable
hazards into the water source based on the topography of the land, the
farm would be required to implement mitigation measures promptly, and
no later than the same growing season as the agricultural water
assessment. (We note that proposed Sec. 112.43(c)(2) is not intended
to include those situations in which animal or human waste impacts
result in water no longer being safe or of adequate sanitary quality
for its intended use under Sec. 112.41. In those instances, a covered
farm would be required under Sec. 112.43(c)(1) to immediately
discontinue that use of the water and take corrective measures under
Sec. 112.45(a) before resuming such use.)
Animal activity, BSAAOs, and untreated or improperly treated human
waste have been identified as possible causal or contributing factors
in several large produce outbreaks in recent years. The pathogens
associated with animal and human waste are well established, as are the
risks associated with introduction of animal or human waste into
agricultural water used in growing covered produce (Ref. 11).
Subparts B, F, I, and L of the produce safety regulation require
covered farms to take appropriate measures to minimize the risk of
serious adverse health consequences or death from the use of, or
exposure to, covered produce, including those measures reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards associated with animal activity, BSAAOs, and
untreated and improperly treated human waste on the covered farm.
In considering how best to achieve public health protections under
this proposed approach, we determined that animal activity, BSAAOs, or
human waste impacts on water sources and systems related to adjacent or
nearby lands should elicit an expedited timeline for implementation of
mitigation measures. We recognize that activities associated with
adjacent or nearby lands that introduce contaminants into a water
source or distribution system are often not under a covered farm's
control. While the covered farm may not have control over potential
hazards at their point of introduction into a water source or system,
the potential hazards are no less important for the farm to consider
when determining the safe use of agricultural water on covered produce.
Therefore, it is important that the covered farm not only implement
mitigation measures that are under its control to reduce the risk
associated with that water source or system, but that it do so on an
expedited basis to protect public health.
15. Proposed Sec. 112.43(d)--Testing for Assessment Purposes
Proposed Sec. 112.43(d) would establish the requirements
applicable to testing that a covered farm chooses to conduct to provide
additional information for its agricultural water assessment. The
testing option for pre-harvest agricultural water for non-sprout
covered produce under proposed Sec. 112.43(d) is science-based and
also provides for flexibility as science evolves. For example, a
covered farm that opts to test pre-harvest agricultural water under
this provision would be required to test its agricultural water for
generic E. coli as an indicator of fecal contamination, but also may
test for another scientifically valid indicator organism, index
organism, or other analyte.
Proposed Sec. 112.43(d) also would require that samples of pre-
harvest agricultural water tested as part of an agricultural water
assessment be collected aseptically immediately prior to or during the
growing season, representative of the water used in growing non-sprout
covered produce, and tested using a scientifically valid method.
Additionally, proposed Sec. 112.43(d) would require that the
frequency of testing and any microbial criteria applied be
scientifically valid and appropriate to assist in determining, in
conjunction with other data and information evaluated under paragraph
Sec. 112.43(a), whether measures under Sec. 112.45 are reasonably
necessary to reduce the potential for contamination of non-sprout
covered produce or food contact surfaces with known or reasonably
foreseeable hazards associated with pre-harvest agricultural water.
a. Generic E. coli. Generic E. coli remains a commonly used analyte
used as an indicator of fecal contamination and currently is the
preferred indicator for monitoring water quality (80 FR 74354 at
74428). However, the potential use of other indicator organisms, index
organisms, or other analytes for monitoring water quality continues to
be of interest for agricultural water, as well as related disciplines.
For example, in its 2012 Recreational Water Quality Criteria (RWQC) EPA
provided various examples of possible alternate indicators, including
Bacteroidales, Clostridium perfringens, human enteric viruses, and
coliphages (Ref. 72). Additionally, as part of the 2017 5-year review
of the 2012 RWQC, EPA evaluated the science related to the recreational
waters and public health to determine if revisions to the criteria
(which specify densities for enterococci and generic E. coli) were
appropriate (Ref. 73). While it did not ultimately revise the 2012 RWQC
during the 2017 review cycle, EPA emphasized that further scientific
research and analysis is likely to contribute to future reviews of the
2012 RWQC. EPA noted, in part, that with further scientific
development, the use of viral indicators such as
[[Page 69142]]
coliphages may help to further advance public health protections. FDA
anticipates that as science evolves and more information about other
indicator or index organisms is learned, testing for other organisms
may be used to inform pre-harvest agricultural water assessments by
covered farms, if finalized as proposed.
b. Frequency of sampling. The 2015 produce safety final rule
established sampling frequencies for covered farms to use in developing
microbial water quality profiles for pre-harvest agricultural water for
non-sprout covered produce. For untreated surface waters, this consists
of an initial profile of at least 20 samples collected over a 2-4-year
period, followed by at least 5 annual samples thereafter; for untreated
ground water sources, this consists of an initial profile of at least 4
samples collected during the growing season or over a period of one
year, followed by at least 1 annual sample thereafter (80 FR 74354 at
74452) (Ref. 74).
During outreach activities, some stakeholders, including covered
farms and some State regulators, indicated that they found the pre-
harvest microbial water quality criteria and testing requirements in
the 2015 produce safety final rule to be overly complex. (See section
III.B. through III.C.) Some farms anticipated that it would be
infeasible to implement the pre-harvest agricultural water testing
requirements in their operations and asked for additional flexibility--
in addition to the alternatives and variances already allowed by the
produce safety regulation. Moreover, various stakeholders shared the
opinion that, as new science continues to become available in the realm
of water quality monitoring, farms should have the flexibility to take
those findings into account when establishing or updating their
sampling programs (Refs. 3 and 75).
We continue to believe that the information used to support the
sampling frequencies in the 2015 produce safety final rule for pre-
harvest agricultural water for non-sprout covered produce is well-
grounded, broadly-applicable science. Therefore, for purposes of
proposed Sec. 112.43(d), covered farms that opt to test their
untreated surface water for purposes of proposed Sec. 112.43(d) may
initially collect at least 20 samples over a 2-4-year period, with at
least 5 samples collected annually thereafter; covered farms that opt
to test their untreated ground water may initially collect at least 4
samples over a growing season or year, with at least 1 sample collected
annually thereafter. Depending on the conditions that may affect their
pre-harvest agricultural water, covered farms may consider collecting
additional samples as needed to better understand whether measures are
reasonably necessary to reduce the potential for contamination of
covered produce (other than sprouts) or food contact surfaces with
known or reasonably foreseeable hazards associated with their pre-
harvest agricultural water for non-sprout covered produce.
We recognize that there are circumstances--for example, when access
to a body of water varies from year to year--in which some covered
farms may not be able to collect samples spanning multiple years. In
situations such as these, covered farms may consider collecting at
least 5 samples per year for untreated surface water sources, or at
least 4 samples per year for untreated ground water sources used for
pre-harvest application to non-sprout covered produce.
However, we are also providing flexibility in proposed Sec.
112.43(d)(3) for covered farms to use any sampling frequency when
testing under proposed Sec. 112.43(d)(3), provided that it is adequate
to assist in determining, in conjunction with other data and
information evaluated under Sec. 112.43(a), whether measures under
Sec. 112.45 are reasonably necessary to reduce the potential for
contamination of non-sprout covered produce or food contact surfaces
with known or reasonably foreseeable hazards associated with pre-
harvest agricultural water for non-sprout covered produce. For example,
other options could include sampling frequencies a covered farm
establishes based on its historical data and/or knowledge of water
quality variability within its source. A covered farm also could, for
example, include consideration for other site- or region-specific data
or information indicating that a certain sampling frequency is
appropriate. We expect that as covered farms learn more about water
quality relevant to their sources, systems, and operations--for
example, through an evaluation of data shared between farms, within
water systems, and/or within regions--that such information may be used
to establish sampling frequencies that are appropriate to their
specific circumstances and conditions.
c. Microbial water quality criteria. The microbial water quality
criteria established by the 2015 produce safety final rule for pre-
harvest agricultural water consist of a GM of 126 colony forming units
(CFU) generic E. coli per 100 milliliters (mL), and an STV of 410 CFU
generic E. coli per 100 mL--using the science underlying EPA's RWQC (80
FR 74354 at 74441-74442).
The information used to support the pre-harvest agricultural water
quality criteria in the 2015 produce safety final rule is the best
science currently available that is broadly applicable to the range of
conditions that exist across the diversity of operations, agricultural
water sources, and agricultural water uses of domestic and foreign
covered farms. Therefore, if a covered farm decides to test its pre-
harvest agricultural water for generic E. coli under proposed Sec.
112.43(d) to inform its agricultural water assessment, the farm may use
a GM of 126 or less CFU generic E. coli per 100 mL and an STV of 410 or
less CFU generic E. coli per 100 mL as microbial criteria.
However, we acknowledge stakeholder concerns and recognize that the
science around agricultural water quality criteria continues to evolve
(Ref. 3). We recognize that there may be other options for microbial
water quality criteria (for example, alternative criteria relevant to
an indicator organism other than generic E. coli).
Proposed Sec. 112.43(d) would offer additional flexibility to
apply any microbial criterion or criteria that would be scientifically
valid and appropriate to assist in determining, in conjunction with
other data and information evaluated under proposed Sec. 112.43(a),
whether measures under Sec. 112.45 are reasonably necessary to reduce
the potential for contamination of non-sprout covered produce or food
contact surfaces with known or reasonably foreseeable hazards
associated with pre-harvest agricultural water. We are not proposing to
require that covered farms notify or seek approval from FDA prior to
applying a microbial criterion or criteria when electing to test their
pre-harvest agricultural water. Rather, we would provide flexibility
for a covered farm to determine which microbial criterion or criteria
to apply, when supported by scientific data or information
demonstrating scientific validity and appropriateness under proposed
Sec. 112.43(d). For example, a covered farm could rely on microbial
criterion or criteria available in the scientific literature or made
available by a third party, such as a trade association, provided that
the microbial criterion or criteria would be scientifically valid and
appropriate based on the circumstances.
When possible, covered farms may continue to collect water quality
data over time--whether historical data, new data, or both--that can
assist in analyzing trends. For example, this approach may be useful in
situations in
[[Page 69143]]
which potential hazards are introduced into a water system
intermittently, such that a covered farm is able to compare data to
further refine its assessments of 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.
d. Records relating to analytes, sampling frequencies, and pre-
harvest water quality criteria. If a covered farm tests its water under
Sec. 112.43(d) for generic E. coli using the sampling frequencies and
pre-harvest microbial water quality criteria outlined in the 2015
produce safety final rule, the covered farm could document its use of
such sampling frequencies and microbial criteria in meeting the
requirements of proposed Sec. 112.50(b)(4), as we have already
determined these sampling frequencies and microbial criteria to be
scientifically valid and appropriate for purposes of proposed Sec.
112.45(b).
Under proposed Sec. 112.50(b)(3)-(4), a covered farm that tests
its pre-harvest agricultural water using a scientifically valid
indicator organism other than generic E. coli, or an index organism or
other analyte would be required to maintain records under proposed
Sec. 112.50 of the scientific data or information used to support its
selection of other indicator organism, index organism, or other
analyte, as well scientifically valid and appropriate sampling
frequency and microbial criterion (or criteria) being applied. (See
also section VI.G. regarding proposed records requirements.)
Such data and information could be developed by the covered farm,
available in the scientific literature, or available to the farm
through a third party. Such scientific support could be derived from
the science underlying commodity-specific or other guidance or
recommendations, including those developed by industry, academia, trade
associations, or other stakeholders.
16. Proposed Sec. 112.43(e)--Reassessment
Under proposed Sec. 112.43(e), a covered farm would conduct an
agricultural water assessment, at a minimum, each year that the farm
applies pre-harvest agricultural water to non-sprout covered produce. A
covered farm also would conduct a reassessment whenever a significant
change occurs in its agricultural water system(s), agricultural water
practices, crop characteristics, environmental conditions, or other
relevant factors that would impact hazard identification or a risk
management determination as described in Sec. 112.43(c). For example,
a change from an untreated ground water source to an untreated surface
water source would be a significant change that would require a
reassessment under proposed Sec. 112.43(e). The reassessment would
evaluate the impacts of those changes on the factors in proposed Sec.
112.43(a)(1) through (5), any new hazards identified, and the outcome
and determination under proposed Sec. 112.43(c).
Agricultural water assessments are the primary tool that covered
farms would use under this proposed rule for hazard identification and
risk management for their pre-harvest agricultural water used for non-
sprout covered produce. Specifically, covered farms would use the
outcomes of their pre-harvest agricultural water assessments (proposed
Sec. 112.43), together with the results of any inspections and
maintenance performed (proposed Sec. 112.42), in determining whether
measures (proposed 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 pre-harvest agricultural water.
The proposed requirements for an agricultural water assessment
align with domestic produce safety standards, such as the USDA
Harmonized GAP Plus+ Standard, section F-4.1 (Ref. 70), and
international standards, such as the Codex Code Section 3.2.1.1 (Ref.
62), which recommends the periodic assessment of agricultural water for
suitability for use.
For the foregoing reasons, we have tentatively concluded that it
would be reasonable and appropriate to require covered farms to conduct
a written pre-harvest agricultural water assessments annually, and
whenever significant changes would impact the hazard identification or
risk management determination relating to pre-harvest agricultural
water for non-sprout covered produce.
F. Mitigation Measures (Proposed Sec. 112.45)
Proposed Sec. 112.45 would establish requirements for implementing
corrective and mitigation measures for pre-harvest, harvest, and post-
harvest agricultural water that are reasonably necessary to reduce the
potential for contamination of non-sprout covered produce or food
contact surfaces with known or reasonably foreseeable hazards
associated with agricultural water for covered produce. This provision
is supplemented by proposed Sec. 112.42, which would require covered
farms to conduct routine maintenance of agricultural water systems to
the extent of their control including, for example, taking steps to
prevent pooled water from contaminating covered produce.
We are proposing to retain the requirement from Sec. 112.45(a) of
the produce safety regulation to immediately discontinue use of any
agricultural water that is not safe or not of adequate sanitary quality
for its intended use(s), until the covered farm implements effective
corrective measures and the agricultural water meets the requirements
of Sec. 112.41. We also propose to retain the requirement, from Sec.
112.45(a) of the produce safety regulation, to discontinue use of
harvest or post-harvest water that does not meet the microbial water
quality criterion in Sec. 112.44(a) until effective corrective
measures are implemented.
Under this proposed rule, a covered farm would make a determination
under Sec. 112.43(c), based on the outcome of its agricultural water
assessment, as to whether mitigation measures would be 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 pre-harvest agricultural water.
A covered farm would be required to implement mitigation measures under
proposed Sec. 112.45(b) as soon as practicable and no later than one
year after the date of the agricultural water assessment or
reassessment (as required by proposed Sec. 112.43), except that
mitigation measures for known or reasonably foreseeable hazards related
to animal activity, the application of biological soil amendments of
animal origin, or the presence of untreated or improperly treated human
waste on adjacent or nearby lands must be implemented promptly, and no
later than the same growing season as its assessment. (See the
discussions of adjacent and nearby land uses and outcomes in section
VI.E.)
Under proposed Sec. 112.45(b), mitigation measures include:
<bullet> Making necessary changes (such as repairs) to address any
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food contact
surfaces;
<bullet> Increasing the time interval between the last direct
application of agricultural water and harvest of the covered produce to
allow for microbial die-off (with a minimum interval of 4 days between
application and harvest, except as supported by test results
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conducted under proposed Sec. 112.43(d), or other scientifically valid
data or information in accordance with proposed Sec. 112.12);
<bullet> Increasing the time interval between harvest and the end
of storage using an appropriate microbial die-off rate, and/or
conducting other activities, such as commercial washing, to reduce
pathogens using appropriate microbial removal rates, except as
supported by scientifically valid data and information;
<bullet> Changing the method of water application to reduce the
likelihood of produce contamination (such as by changing from overhead
spray to subsurface drip irrigation of certain crops);
<bullet> Treating the water in accordance with proposed Sec.
112.46; and
<bullet> An alternative mitigation measure, in accordance with
proposed Sec. 112.12.
We are revising our approach to mitigation measures involving
microbial die-off and/or removal in proposed Sec. 112.45(b)(1) to
reflect our proposal to remove the pre-harvest microbial quality
criteria and testing requirements from the produce safety rule. These
changes also reflect feedback we have received throughout stakeholder
engagement activities.
Proposed Sec. 112.45(b)(1)(i) would provide for an established
time interval between last direct application of agricultural water and
harvest of the covered produce to allow for microbial die-off, with a
minimum interval of 4 days between application and harvest, except as
supported by test results conducted under Sec. 112.43(d), or other
scientifically valid data or information in accordance with Sec.
112.12.
Survival of pathogens and other microorganisms on produce
commodities prior to harvest is dependent upon several environmental
factors, including sunlight (UV) intensity, moisture level,
temperature, pH, the presence of competitive microbes, and suitable
plant substrate (Ref. 55). Generally, pathogens and other microbes die-
off or are inactivated relatively rapidly under hot, dry, and sunny
conditions compared to inactivation rates observed under cloudy, cool
and wet conditions. The impact of these variables results in a range of
microbial die-off rates of 0.5 to 2.0 log per day, as explained in the
2015 produce safety final rule (80 FR 74534, 74443-74446).
In general, high initial rates of die-off during the period
immediately following contamination suggests field conditions through
the first few days are critical in reducing microbial populations on
produce compared to weeks after the event. (80 FR 74354 at 74445.) In
studies reporting decay constant(s) measured over time (e.g., 0 hours
to 14 days or more), pathogen die-off rates were found to be highest
immediately following contamination (inoculation) and to slow over
time; this phenomenon is known as ``tailing'' and suggests that
pathogen die-off curves are biphasic (80 FR 74354 at 74445).
A die-off rate of 0.5 log per day provides a reasonable estimate of
die-off under a broad range of variables including pathogen
characteristics, environmental conditions, crop type, and watering
frequency (80 FR 74354 at 74416). We derived this die-off rate based on
a review of currently available scientific literature and recognize
that microbial die-off rates are dependent on various environmental
factors, including sunlight intensity, moisture level, temperature, pH,
the presence of competitive microbes, and suitable plant substrate.
We reviewed available literature for a time interval that is
appropriate when applying a microbial die-off rate of 0.5 log per day.
(See 80 FR 74354 at 74444-74445.) The studies we reviewed indicate that
greater microbial die-off or decay rates occur during the early
timeframe post-contamination, and although the die-off rate in these
studies was established from survival data or decay rates for bacterial
studies ranging from 2-7 days, the specific timeframe for the biphasic
shift in die-off was not identified. Within this range identified in
the literature, we determined that a time interval of 4 days is
reasonable because it serves as a general mid-point in time
representing neither end of the range where microbial die-off was
observed in these studies.
Based on this information, in Sec. 112.45(b)(1)(i)(A) of the
produce safety final rule, we allowed covered farms to apply a time
interval between last irrigation and harvest using a microbial die-off
rate of 0.5 log per day, for no greater than 4 days, if their water
quality exceeded the pre-harvest microbial water quality criteria (80
FR 74354 at 74443). We consider the scientific data used to support
this approach as one example of adequate supporting scientific data and
information on which a time interval between last direct application
and harvest could be established under proposed Sec. 112.45(b).
Therefore, we have tentatively concluded that it would be appropriate
to allow covered farms to use the following approaches for implementing
a pre-harvest time interval as a mitigation measure under proposed
Sec. 112.45(b), without having to develop and maintain additional
supporting scientific data and information. We seek comment on this
tentative conclusion.
1. Time Interval Without Testing Data
If a covered farm does not test its pre-harvest agricultural water
as part of an agricultural water assessment under proposed Sec.
112.43(d) but determines that the application of a time interval prior
to harvest would be an appropriate mitigation measure, the farm could
use a time interval between last direct application of agricultural
water and harvest of at least 4 days. This would correspond to the
broadly-applicable time frame identified in the 2015 produce safety
final rule that corresponds to the amount of time associated with the
first phase of die-off, when bacterial reduction rates are greatest on
produce surfaces and before ``tailing'' of bacterial populations
occurs. Lacking quantitative test data, the covered farm could not use
less than 4 days as a time interval between last direct application and
harvest under proposed Sec. 112.45(b)(1)(ii), unless the farm had
scientifically valid data or information to support use of a die-off
rate of 0.5 log per day for less than 4 days in accordance with
proposed Sec. 112.12.
2. Time Interval With Testing Data
If a covered farm tests its pre-harvest agricultural water as part
of an agricultural water assessment under proposed Sec. 112.43(d) and
determines that the application of a time interval prior to harvest is
an appropriate mitigation measure, the farm could choose to use a
microbial die-off rate of 0.5 log per day, for potentially less than 4
days between last direct water application and harvest, to achieve a
(calculated) log reduction to meet the criteria the farm would
establish per proposed Sec. 112.43(d)(3). (Alternately, the covered
farm could choose to use a different time interval (and accompanying
die-off rate) if the farm has scientifically valid data or information
in accordance with proposed Sec. 112.12.)
While we consider the information used to support the use of a die-
off rate of 0.5 log per day with a maximum time interval of 4 days as
being one example of adequate supporting scientific data and
information on which a time interval between last direct application
and harvest could be established under proposed Sec. 112.45(b), we
recognize that covered farms may have additional information on in-
field die-off that is applicable to their unique circumstances. For
example, we acknowledged in both the 2014 supplemental produce safety
notice and
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the 2015 produce safety final rule that practices and conditions on a
covered farm and circumstances unique to a specific commodity could
result in higher die-off rates between last irrigation and harvest,
especially with little or no precipitation, coupled with high
ultraviolet radiation, high temperature exposures, or low humidity.
Moreover, during outreach activities related to agricultural water
(as described in section III.C), stakeholders described the diversity
of pathogens, commodities, and climates that may be associated with
different microbial die-off rates and/or time intervals. We also are
aware that further research on the various conditions that exist is
likely to impact the appropriate use of a pre-harvest application
interval (Ref. 3). As more studies are conducted that examine in-field
die-off in various circumstances (Refs. 76-78), we expect that this is
an area where science will continue to evolve.
Therefore, to provide additional flexibility to allow for future
science while continuing to protect public health, we are proposing to
allow covered farms to use a time interval other than the minimum 4
days between last direct water application and harvest as a mitigation
measure, if they have adequate supporting scientific data and
information. We expect that any microbial die-off rate and accompanying
maximum time interval that a covered farm establishes and uses would be
supported by an equally robust and rigorous scientific analysis to that
described above for the 0.5 log per day die-off rate with accompanying
4-day time interval. We expect that scientific data and information
used to support a pre-harvest time interval would be relevant to
conditions on the covered farm (such as the region, crop, and
environment), and be similarly characterized in a manner that addresses
the likely biphasic nature of microbial die-off (i.e., the two
different decay constants of a rapid short-term die-off and a gradual
long-term die-off). We also expect that the scientific approach would
not increase the likelihood that the covered produce will be
adulterated compared to the microbial die-off rate standard in Sec.
112.45(b)(1)(i)(A) of the produce safety regulation.
Consistent with Sec. 112.45(b)(1)(ii) of the produce safety
regulation, we are proposing to allow covered farms to increase the
time interval between harvest and the end of storage to allow for
microbial die-off, and/or adopt activities such as commercial washing
that result in microbial removal as a mitigation measure. This proposed
revision reflects our proposal to remove the pre-harvest microbial
quality criteria and testing requirements from the produce safety
regulation and would allow a covered farm to use microbial die-off or
removal post-harvest (i.e., between harvest and end of storage, and
during activities such as commercial washing) as a mitigation measure,
provided the covered farm has adequate supporting scientific data and
information.
We are not proposing to establish a specific microbial die-off
rate(s) between harvest and end of storage or specific microbial
removal rate(s) during postharvest activities such as commercial
washing. The World Health Organization has attributed a 1-log reduction
in microbial load to washing (Ref. 55). (See also 79 FR 58434 at
58446.) As discussed in the produce safety supplemental notice and
final rule, we do not have sufficient information to support the
derivation of appropriate, broadly-applicable microbial die-off or
removal rate(s) for this purpose. While it is reasonable to expect some
die-off during post-harvest storage, the rate and accompanying time
interval would be highly dependent upon the conditions of storage.
Covered farms would be able to more narrowly define die-off and/or
removal rates associated with their specific production practices, and
apply an appropriate time interval between harvest and end of storage
and/or adopt activities such as commercial washing that result in
microbial removal, as applicable to their circumstances. We are
proposing to provide this option so that a covered farm may account for
microbial die-off or removal during post-harvest activities (i.e.,
between harvest and end of storage, and during activities such as
commercial washing), provided the farm has adequate scientific data or
information to support the conclusions in accordance with proposed
Sec. 112.12.
In light of recent produce outbreaks (including the outbreaks
described in section III.D.), we are proposing in Sec. 112.45(b)(1) to
require expedited mitigation for known or reasonably foreseeable
hazards from animal activity, BSAAOs, or untreated or improperly
treated human waste associated with adjacent or nearby lands.
For any other identified hazards, proposed Sec. 112.45(b)(1) would
require covered farms to implement mitigation measures as soon as
practicable and no later than one year after the date of the
agricultural water assessment (as required by proposed Sec. 112.43).
This requirement aligns with Sec. 112.45(b) of the produce safety
regulation, which requires mitigation measures to be implemented as
soon as practicable and no later than the following year.
Proposed Sec. 112.45(b)(2) would provide that if a covered farm
failed to implement appropriate mitigation measures, or if the farm
determined that the measures were not effective to reduce the potential
for contamination of non-sprout covered produce or food contact
surfaces with any known or reasonably foreseeable hazards, the farm
must discontinue use of the pre-harvest agricultural water until it has
implemented mitigation measures adequate to reduce the potential for
such contamination, consistent with Sec. 112.41.
We note that while not considered agricultural water for purposes
of subpart E, indirect water application methods, such as the use of
drip tape in a manner that water is not likely to contact the
harvestable portion of the crop, remain subject to section 402 of the
FD&C Act. That is, indirect water application may adulterate produce
if, considering the water quality and the manner of its application,
the use of the water causes produce to be prepared, packed, or held
under insanitary conditions whereby it may have been contaminated with
filth or rendered injurious to health under section 402(a)(4) of the
FD&C Act. For example, if a farm uses drip tape in a way that water
does not normally contact the harvestable portion of the crop,
unintentional contact may still occur if the drip tape begins to leak
sprays water on the crop. Although not considered agricultural water
for purposes of subpart E, the farm should consider whether the source
of water may have caused the produce to become adulterated under
section 402 of the FD&C Act (for example, the farm may consider the
conditions described in proposed Sec. 112.43(a)(1)) and, if so,
dispose of the product appropriately.
G. Records Requirements for Pre-Harvest Agricultural Water Assessments
(Proposed Sec. 112.50)
We propose to amend the records requirements in Sec. 112.50 of the
produce safety regulation to conform with proposed subpart E and to add
new requirements for records relating to pre-harvest agricultural water
assessments and the optional testing that certain covered farms may
elect to conduct under proposed Sec. 112.43.
[[Page 69146]]
1. Records of Pre-Harvest Agricultural Water Assessments
Proposed Sec. 112.50(b)(2) would require covered farms to maintain
records of their agricultural water assessments, including written
determinations on whether mitigation measures under proposed Sec.
112.45(b) would be reasonably necessary
[…truncated; see source link]Indexed from Federal Register on December 6, 2021.
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