[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 [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0471 for ``Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption Relating to Agricultural 
Water.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at Dockets Management Staff between 9 
a.m. and 4 p.m. Eastern Time, Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 to the Office of Management and Budget 
(OMB) at https://www.reginfo.gov/public/do/PRAMain. 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: [email protected].

[[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, 
[email protected].

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:
     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;
     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;
     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;
     Expedite implementation of mitigation measures under Sec.  
112.45(b) for known or reasonably foreseeable hazards related to 
certain adjacent and nearby land uses;
     Require management review under Sec.  112.161 of pre-
harvest agricultural water assessments; and
     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
------------------------------------------------------------------------
      Abbreviation or acronym                   What it means
------------------------------------------------------------------------
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 https://www.regulations.gov/docket?D=FDA-2011-N-0921.

                    Table 2--List of Key Federal Register Produce Safety Regulation Documents
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                     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).
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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:
     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]]

     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.
     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.
     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:
     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;
     Too complicated to understand and implement, such as the 
calculation of the GM and STV; and
     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,

[[Page 69127]]

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:
     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;
     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;
     Point in the manufacturing process of the food where 
contamination is most likely to occur;
     Likelihood of contamination and steps taken during the 
manufacturing process to reduce the possibility of contamination;
     Likelihood that consuming a particular food will result in 
a foodborne illness due to contamination of the food; and
     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:
     Cucumbers (fresh), includes all varieties of cucumbers;
     Herbs (fresh), includes all types of herbs, such as 
parsley, cilantro, basil;
     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;
     Melons (fresh), includes all types of melons, such as 
cantaloupe, honeydew, and watermelon;
     Peppers (fresh), includes all varieties of peppers;
     Sprouts (fresh), includes all varieties of sprouts;
     Tomatoes (fresh), includes all varieties of tomatoes; and
     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:
     Agricultural water can be a source of contamination of 
produce.
     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.
     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.
     There is a significant likelihood that U.S. surface waters 
will contain human pathogens, and surface waters pose the highest 
potential for contamination and the greatest variability in quality of 
the agricultural water sources.
     Susceptibility to runoff significantly increases the 
variability of surface water quality.
     Water that is applied directly to the harvestable portion 
of the plant is more likely to contaminate produce than water applied 
by indirect methods that are not intended to, or not likely to, contact 
produce.
     Proximity of the harvestable portion of produce to water 
is a factor in the likelihood of contamination during indirect 
application.
     Timing of water application in produce production before 
consumption is an important factor in determining likelihood of 
contamination.
     Commodity type (growth characteristics, e.g., near to 
ground) and surface properties (e.g., porosity) affect the probability 
and degree of contamination.
     Microbial quality of source waters, method of application, 
and timing of application are key determinants in assessing relative 
likelihood of contamination attributable to agricultural water use 
practices.
    The QAR (Ref. 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:
     General provisions for agricultural water for all uses 
(proposed Sec. Sec.  112.40 through 112.42);
     Agricultural water assessments for pre-harvest 
agricultural water for covered produce other than sprouts (proposed 
Sec.  112.43);
     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);
     Corrective and mitigation measures for agricultural water 
for all uses (proposed Sec.  112.45);
     Requirements relating to treatment methods for 
agricultural water for all uses (proposed Sec.  112.46);
     Who conducts testing for agricultural water (proposed 
Sec.  112.47);
     Reserved (proposed Sec.  112.48 through 112.49); and
     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).
---------------------------------------------------------------------------

    \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,'' https://www.fda.gov/media/110023/download (last accessed May 13, 2020).
---------------------------------------------------------------------------

    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:
     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
     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:
     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
     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:
     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
     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:
     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);
     Meets the requirements for water from a Public Water 
System or public water supply (proposed Sec.  112.44(c)); or
     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):
     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;
     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;
     Crop characteristics, including the susceptibility of the 
covered produce to surface adhesion or internalization of hazards;
     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
     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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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:
     Other users of the agricultural water system;
     Animal impacts, including grazing animals, working 
animals, and animal intrusion on the covered farm; and
     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:
     Grazing on public or private lands;
     Commercial animal feeding operations of any size; and
     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).
---------------------------------------------------------------------------

    \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:
     The physical characteristics of the crop is one of the 
likely factors contributing to the likelihood of contamination, 
exposure, and illness.
     In particular, the growth characteristics (e.g., near to 
the ground) and surface properties (e.g., porosity) affect the 
probability and degree of contamination.
     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:
     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
     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:
     The farm's evaluation of factors described in proposed 
Sec.  112.43(a)(1) through (5);
     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
     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       Immediately
 safe or is not of adequate sanitary      discontinue use(s)
 quality for intended use(s).            And
                                          Take corrective
                                          measures before resuming use
                                          of the water for pre-harvest
                                          activities
there is one or more known or             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             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.                    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     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):
     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);
     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.
     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;
     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:
     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;
     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

[[Page 69144]]

conducted under proposed Sec.  112.43(d), or other scientifically valid 
data or information in accordance with proposed Sec.  112.12);
     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;
     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);
     Treating the water in accordance with proposed Sec.  
112.46; and
     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

[[Page 69145]]

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 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.
    Effective water management includes records necessary to confirm 
that agricultural water is safe and of adequate sanitary quality for 
its intended use(s). Records of pre-harvest agricultural water 
assessments would be critical for a covered farm to maintain to ensure 
its own compliance with the requirements of proposed Sec.  112.43. For 
example, records of agricultural water assessments would be helpful to 
a covered farm in determining whether changed conditions were 
sufficient to trigger the requirement to conduct a reassessment under 
proposed Sec.  112.43(f)(2), prior to an annual reassessment.
    Such records also are important for FDA to verify, for example, 
that the covered farm evaluated all the required elements of an 
assessment listed in proposed Sec.  112.43(a), in support of a written 
determination, under proposed Sec.  112.43(c), regarding whether 
mitigation 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 agricultural water used in growing non-sprout covered 
produce.
2. Records Relating to Testing Pre-Harvest Agricultural Water for 
Analytes Other Than Generic E. coli
    Under proposed Sec.  112.50(b)(3), a covered farm that tests its 
pre-harvest agricultural water to inform its agricultural water 
assessment and uses an indicator of fecal contamination, index 
organism, or other analyte other than generic E. coli, would be 
required to retain records of the scientific data or information the 
farm relies on to support the use of such analyte. These records would 
be necessary for a covered farm to ensure, and for FDA to verify, that 
appropriate scientific methods are being used when the farm elects to 
test its pre-harvest agricultural water under proposed Sec.  112.43(d) 
to inform its agricultural water assessment.
3. Records Relating to the Sampling and Microbial Criterion (or 
Criteria) Applied for Pre-Harvest Agricultural Water
    Under proposed Sec.  112.50(b)(4), a covered farm that tests its 
pre-harvest agricultural water would be required to maintain records of 
the scientific data or information it relied on to support the sampling 
and testing methods and the microbial criterion (or criteria) it 
applied. Records of sampling protocols, testing methods, and microbial 
criterion (or criteria) would be necessary for a covered farm that uses 
testing to ensure that the frequency of testing samples and microbial 
criteria applied are adequate to assist in determining, in conjunction 
with other data and information from their assessment, whether 
mitigation measures are reasonably necessary. Such records would allow 
FDA to help verify a covered farm's compliance with proposed Sec.  
112.43(d).
    Additionally, we would amend Sec.  112.50(b) of the produce safety 
regulation to:
     Move paragraph (b)(2) to proposed Sec.  112.50(b)(5), and 
as a clarifying edit add the phrase, ``including any testing conducted 
for purposes of Sec. Sec.  112.43 and 112.44'';
     Move paragraphs (b)(3) through (b)(4) to proposed Sec.  
112.50(b)(9) through (b)(10);
     Move paragraph (b)(5) to proposed Sec.  112.50(b)(8) and 
remove the phrase ``, in accordance with Sec.  112.45(b)(1)(ii)'';
     Move paragraph (b)(6) to proposed Sec.  112.50(b)(7) and 
remove the phrase ``in accordance with Sec.  112.45(b)(1)(ii) and/or 
(b)(1)(iii)'';
     Move paragraph (b)(7) to proposed Sec.  112.50(b)(6) and 
replace ``Sec.  112.46(a)(1) or (2)'' with ``Sec.  112.44(c)(1) or 
(c)(2)'';
     Remove paragraph (b)(8); and
     Move paragraph (b)(9) to proposed Sec.  112.50(b)(11).

H. Conforming Changes (Proposed Sec. Sec.  112.12, 112.151, and 
112.161)

    As conforming changes in light of our proposal to remove the 
microbial water quality criteria in Sec.  112.44(b), the microbial die-
off (calculated log reduction) rate in Sec.  112.45(b), and the testing 
requirements in Sec.  112.46(b) of the produce safety regulation, we 
would:
     Amend Sec.  112.12 to replace ``Sec.  112.49'' with 
``Sec.  112.45(b)'';
     Amend the section heading of Sec.  112.151 to replace 
``Sec.  112.46'' with ``subpart E''; and
     Amend Sec.  112.151(b)(2) to replace ``Sec.  112.49(a)'' 
with ``Sec.  112.43(d)''.
    As an additional conforming change, we propose to revise the 
requirements of Sec.  112.161(b) of the produce safety regulation to 
require supervisory review of records of pre-harvest agricultural water 
assessments and determinations, given the essential role of such 
records in establishing compliance with the requirements of proposed 
Sec.  112.43 and in confirming that pre-harvest agricultural water is 
safe and of adequate sanitary quality for its intended use(s). 
Therefore, in Sec.  112.161 of the produce safety regulation, we would 
replace ``(b)(4), and (b)(6)'' with ``(b)(7), and (b)(10)''.

I. Other Amendments (Proposed Sec. Sec.  112.42, 112.44, and 112.46-
112.49)

1. Proposed Sec.  112.42
    To provide additional clarity around certain language, based on 
stakeholder feedback and questions, we would:
     Add descriptive headings to paragraphs (a) and (b);
     Consolidate the requirements for maintenance of 
agricultural water systems in Sec.  112.43(b), (c), and (d) into Sec.  
112.42(b)(1)-(4); and
     Clarify the descriptions of possible maintenance measures 
for pooled water in Sec.  112.42(b)(4).
2. Proposed Sec.  112.44
    As part of the proposed reorganization of subpart E to group 
provisions of a similar nature (i.e., requirements specific to pre-
harvest agricultural water, sprout irrigation water, and harvest/post-
harvest agricultural water), we would:
     Revise the section heading of Sec.  112.44 of the produce 
safety regulation by adding ``and testing requirements'' after 
``criteria'' and by replacing ``certain intended uses'' with ``sprout 
irrigation and for harvesting, packing, and holding covered produce'';
     Move Sec.  112.46(c) of the produce safety regulation to 
proposed Sec.  112.44(b), add a paragraph heading, ``Untreated ground 
water.'', and replace ``Sec.  112.44(a)'' with ``paragraph (a)'' 
wherever it appears;
     Move Sec.  112.46(a) of the produce safety regulation to 
proposed Sec.  112.44(c) and add a paragraph heading, ``Exemptions.'' 
and replace ``Sec.  112.43'' with ``Sec.  112.46''; and
     Move the text of Sec.  112.48 of the produce safety 
regulation to proposed Sec.  112.44(d) and add a paragraph heading, 
``Additional management and monitoring practices.''
3. Proposed Sec.  112.46
    As part of our reorganization of subpart E for clarifying purposes, 
we are proposing to move the treatment provision from Sec.  112.43 of 
the produce safety regulation to Sec.  112.46.

[[Page 69147]]

4. Proposed Sec.  112.47
    As clarifying edits, we would:
     In Sec.  112.47(a) of the produce safety regulation, 
replace ``Sec.  112.46'' with ``Sec. Sec.  112.43(c)(4)(ii) and 
``112.44'' and
     In Sec.  112.47(b) of the produce safety regulation, 
replace ``method as set forth in Sec.  112.151'' with ``method set 
forth in Sec.  112.151, as applicable''.
5. Proposed Sec.  112.48
    As part of our reorganization of subpart E, we would move the 
requirements in Sec.  112.48 of the produce safety regulation to 
proposed Sec.  112.44(d), which would contain other requirements 
applicable to harvest and post-harvest uses of agricultural water, and 
reserve Sec.  112.48.
6. Proposed Sec.  112.49
    As part of our reorganization of subpart E, we would remove and 
reserve Sec.  112.49 of the produce safety regulation that allows for 
various alternatives based on the pre-harvest agricultural water 
quality profile and testing requirements that we propose to remove from 
subpart E.

VII. Online Tool

    We recognize that covered farms would likely benefit from resources 
to assist them in complying with the proposed requirements, if 
finalized. As such, we are developing an online tool that would assist 
farms in developing the pre-harvest agricultural water assessments 
described in this proposed rule. We plan to provide additional 
information about this online tool in the near future.

VIII. Proposed Effective and Compliance Dates

    We are proposing that a final rule based on this proposed rule be 
effective 60 days after the date of publication of the final rule.
    Covered farms currently are required to comply with the subpart E 
pre-harvest, harvest, and post-harvest agricultural water requirements 
for covered produce (other than sprouts) beginning on January 26, 2024, 
for very small farms; January 26, 2023, for small farms; and January 
26, 2022, for all other covered farms (84 FR 9706). We intend to 
exercise enforcement discretion for these subpart E requirements while 
pursuing a targeted compliance date rulemaking, with the goal of 
completing the rulemaking as quickly as possible.
    In the meantime, covered farms (other than sprout operations, for 
which compliance dates have already passed) should focus their 
attention good agricultural practices to maintain and protect the 
quality of their water sources (Ref. 32). We note that produce remains 
subject to the other applicable provisions of the produce safety 
regulation and the applicable provisions of the FD&C Act.

IX. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866, 
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). This proposed rule has 
been designated a significant regulatory action as defined by E.O. 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because we estimate that annualized costs will not be larger 
than 3 percent of revenue for any covered farms, we anticipate that the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities. If the proposed rule is 
finalized, we may, if appropriate, certify that the final rule does not 
have a significant impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts (PRIA) that assesses the impacts of the proposed rule (Ref. 
79). We estimate costs of the proposed rule resulting from reading the 
rule, conducting pre-harvest agricultural water assessments, conducting 
mitigation measures when reasonably necessary based on the outcomes of 
the pre-harvest agricultural water assessments, and recordkeeping as a 
result of the pre-harvest agricultural water assessments. We estimate 
cost savings of the proposed rule resulting from pre-harvest 
agricultural water testing and corrective measure provisions in the 
2015 final rule that would be replaced by the proposed provisions for 
pre-harvest agricultural water assessments and mitigation measures. Our 
primary estimates of annualized net costs are approximately $11.3 
million at a 3 percent discount rate over 10 years and approximately 
$11.2 million at a 7 percent discount rate over 10 years.
    We estimate benefits of the proposed rule resulting from the dollar 
burden of foodborne illnesses averted, and we estimate forgone benefits 
of the proposed rule resulting from foodborne illnesses not averted due 
to the current pre-harvest agricultural water testing provisions. Our 
primary estimates of annualized net benefits are approximately $9.9 
million at a 3 percent discount rate and approximately $9.6 million at 
a 7 percent discount rate. We discuss qualitative benefits of the 
proposed rule stemming from increased flexibility for covered farms to 
comprehensively evaluate their agricultural water systems. These 
changes to pre-harvest agricultural water provisions are being 
proposed, in part, to address practical implementation challenges of 
the current pre-harvest agricultural water testing requirements.
    The full preliminary analysis of economic impacts is available in 
the docket for this proposed rule and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

X. Analysis of Environmental Impact

    The Agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The Agency's finding of 
no significant impact and the evidence supporting that finding may be 
seen in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 
4 p.m., Monday through Friday (Refs. 80-81). Under FDA's regulations 
implementing the National Environmental Policy Act (21 CFR part 25), an 
action of this type would require an EA under 21 CFR 25.31a(a) (an 
abbreviated EA under 21 CFR 25.31a(b)).

[[Page 69148]]

XI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description section 
with an estimate of the annual recordkeeping burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Standards for the Growing, Harvesting, Packing, and Holding 
of Produce; Recordkeeping--OMB Control Number 0910-0816--Revision.
    Description: The proposed rule would replace current recordkeeping 
requirements (found in 21 CFR part 112, subpart E) associated with 
sampling and testing of pre-harvest agricultural water for non-sprout 
covered produce with revised requirements to prepare and maintain 
documentation of written agricultural water assessments for certain 
pre-harvest agricultural water.
    Description of Respondents: Farms subject to the regulation in part 
112.
    We estimate the burden of the information collection as follows:

                      Table 5--Cumulative Average Annual Burden, Covered Farms of All Sizes
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
   21 CFR part 112, subpart E:     Total number      Number of     Total annual     burden per
     Requirements that apply      of respondents    records per       records        farm  (in      Total hours
        regarding records                           respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Agricultural Water Assessment              8,218             1.1           9,040               4          36,160
 and Records Maintenance--Very
 small covered farms (proposed
 Sec.   112.50(b)(2))...........
Agricultural Water Assessment              1,613             1.1           1,774               8          14,192
 and Records Maintenance--Small
 covered farms (proposed Sec.
 112.50(b)(2))..................
Agricultural Water Assessment              4,283             1.1           4,711               9          42,399
 and Records Maintenance--All
 other (Large) Covered Farms
 (proposed Sec.   112.50(b)(2)).
----------------------------------------------------------------------------------------------------------------
    Cumulative totals for                 14,114             3.3          15,525             7.0          92,751
     covered farms of all sizes.
----------------------------------------------------------------------------------------------------------------
    Cumulative average 7.0 burden hours per covered farm annually...............................................
----------------------------------------------------------------------------------------------------------------

    Covered farms using pre-harvest agricultural water for non-sprout 
covered produce would prepare and maintain records of their 
agricultural water assessments unless excluded under proposed Sec.  
112.43(b). We estimate that a total of 14,114 covered farms (8,218 very 
small farms, 1,613 small farms, and 4,283 other (large) covered farms) 
would be subject to information collection requirements under the 
proposed rule, consistent with figures in our current approval and our 
PRIA (Ref. 79) for this proposed rule and informed by a 2018 USDA 
survey of covered farms' irrigation practices (Ref. 82). We are 
estimating a range of burden: 4 hours of burden for very small farms, 8 
hours of burden for small farms, and 9 hours for other (large) farms, 
based on estimates of the amount of time in hours to conduct 
recordkeeping for pre-harvest agricultural water assessments.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be submitted through reginfo.gov (see 
ADDRESSES). All comments should be identified with the title of the 
information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. These information collection 
requirements will not be effective until FDA publishes a final rule, 
OMB approves the information collection requirements, and the rule goes 
into effect. FDA will announce OMB approval of these requirements in 
the Federal Register.

XII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. We have determined that the 
proposed rule does not contain policies that have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

XIII. Consultation and Coordination With Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have tentatively determined that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian Tribes, on the relationship between the 
Federal Government and Indian Tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian Tribes. 
We invite comments from tribal officials on any potential impact on 
Indian Tribes from this proposed action.

XIV. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://

[[Page 69149]]

www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. * FDA, ``FDA Considering Simplifying Agricultural Water 
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5. * Comment from California Walnut Commission, posted December 5, 
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6. * Comment from Western Agricultural Processors Association, dated 
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7. * Comment from California Farm Bureau Federation, dated December 
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8. * Comment from Western Agricultural Processors Association, dated 
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9. * Comment from Produce Marketing Association et al., dated 
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Safety Hazards

[[Page 69150]]

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42. * FDA, ``Standards for the Growing, Harvesting, Packing, and 
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50. Lee, D.-Y., H. Lee, J.T. Trevors, et al., ``Characterization of 
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at: https://www.epa.gov/sites/production/files/2015-04/documents/control_of_pathogens_and_vector_attraction_in_sewage_sludge_july_2003.pdf.
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Holding of Produce for Human Consumption Relating to Agricultural 
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November 9. 2021.
81. * FDA, ``Standards for the Growing, Harvesting, Packing, and 
Holding of Produce for Human Consumption Relating to Agricultural 
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82. * Astill, G., T. Minor, L. Calvin, et al., ``Before 
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List of Subjects in 21 CFR Part 112

    Dietary foods, Food grades and standards, Foods, Fruits, 
Incorporation by reference, Packaging and containers, Reporting and 
recordkeeping requirements, Safety, Vegetables.

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

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

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

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

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


Sec.  112.3   What definitions apply to this part?

* * * * *
    Agricultural water assessment means an evaluation of an 
agricultural water system, agricultural water practices, crop 
characteristics, environmental conditions, and other relevant factors 
(including test results, where appropriate) related to growing 
activities for covered produce (other than sprouts) to:
    (1) Identify any condition(s) that are reasonably likely to 
introduce known or reasonably foreseeable hazards into or onto covered 
produce or food contact surfaces; and
    (2) Determine whether measures are reasonably necessary to reduce 
the potential for contamination of covered produce or food contact 
surfaces with such known or reasonably foreseeable hazards.
    Agricultural water system means a source of agricultural water, the 
water distribution system, any building or structure that is part of 
the water distribution system (such as a well house, pump station, or 
shed), and any equipment used for application of agricultural water to 
covered produce during growing, harvesting, packing, or holding 
activities.
* * * * *
0
3. In Sec.  112.12, revise paragraph (a) to read as follows:


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

    (a) You may establish alternatives to certain specific requirements 
of subpart E of this part, as specified in Sec.  112.45(b), provided 
that you satisfy the requirements of paragraphs (b) and (c) of this 
section.
* * * * *
0
4. Revise subpart E to read as follows:

Subpart E--Agricultural Water

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

Subpart E--Agricultural Water


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

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

[[Page 69152]]

requirements in the third column, if applicable.

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

Sec.  112.41  What requirements apply to the quality of my agricultural 
water?

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


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

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


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

    (a) Elements of an agricultural water assessment. Based in part on 
the results of any inspections and maintenance you conducted under 
Sec.  112.42, at least once annually you must prepare a written 
agricultural water assessment for water that you apply to covered 
produce (other than sprouts) using a direct application method during 
growing activities. The agricultural water assessment must identify 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce (other than sprouts) 
or food contact surfaces, based on an evaluation of the following 
factors:
    (1) Each agricultural water system you use for growing activities 
for the covered produce, including the location and nature of the water 
source (whether it is ground water or surface water), the type of water 
distribution system (for example, open or closed conveyance), and the 
degree of protection from possible sources of contamination (including 
by other water users; animal impacts; and adjacent and nearby land uses 
related to animal activity (for example, grazing or commercial animal 
feeding operations of any size), application of biological soil 
amendment(s) of animal origin, or presence of untreated or improperly 
treated human waste);
    (2) Agricultural water practices associated with each agricultural 
water system, including the type of direct application method (such as 
foliar spray or drip irrigation of covered produce growing underground) 
and the time interval between the last direct application of 
agricultural water and harvest of the covered produce;
    (3) Crop characteristics, including the susceptibility of the 
covered produce to surface adhesion or internalization of hazards;
    (4) Environmental conditions, including the frequency of heavy rain 
or extreme weather events that may impact the agricultural water system 
(such as by stirring sediments) or covered produce (such as damage to 
edible leaves) during growing activities, air temperatures, and sun 
exposure; and

[[Page 69153]]

    (5) Other relevant factors, including, if applicable, the results 
of any testing conducted pursuant to paragraph (d) of this section.
    (b) Exemptions. You do not need to prepare a written agricultural 
water assessment for water that you directly apply during growing 
activities for covered produce (other than sprouts), if you can 
demonstrate that the water:
    (1) Meets the requirements in Sec.  112.44(a), including the 
microbial quality criterion, and if untreated ground water, also meets 
the testing requirements in Sec. Sec.  112.44(b), 112.47, and 112.151;
    (2) Meets the requirements in Sec.  112.44(c) for water from a 
Public Water System or public water supply; or
    (3) Is treated in accordance with Sec.  112.46.
    (c) Outcomes. Based on your evaluation under paragraph (a) of this 
section, you must determine whether measures under Sec.  112.45 are 
reasonably necessary to reduce the potential for contamination of 
covered produce (other than sprouts) or food contact surfaces with 
known or reasonably foreseeable hazards associated with your 
agricultural water used in growing covered produce (other than 
sprouts). You must record your determination in the assessment, and you 
must take necessary and appropriate action, as follows:
    (1) If your agricultural water is not safe or is not of adequate 
sanitary quality for its intended use(s), as required under Sec.  
112.41, you must discontinue use of the water and take corrective 
measures under Sec.  112.45(a) before resuming such use(s);
    (2) If you have identified a condition that is reasonably likely to 
introduce a known or reasonably foreseeable hazard and is related to 
animal activity, application of a biological soil amendment of animal 
origin, or the presence of untreated or improperly treated human waste 
on adjacent or nearby lands, you must implement any mitigation measures 
under Sec.  112.45(b) promptly, and no later than the same growing 
season as the assessment;
    (3) If you have identified no conditions that are reasonably likely 
to introduce a known or reasonably foreseeable hazard for which 
measures under Sec.  112.45 are reasonably necessary to reduce the 
potential for contamination of covered produce (other than sprouts) or 
food contact surfaces, you must:
    (i) Regularly inspect and adequately maintain your agricultural 
water system(s) under Sec.  112.42; and
    (ii) Reassess your agricultural water annually and whenever a 
significant change occurs (such as a change in the manner or timing of 
water application) that increases the likelihood that a known or 
reasonably foreseeable hazard will be introduced into or onto covered 
produce or food contact surfaces; and
    (4) If your agricultural water does not meet the criteria in 
paragraph (c)(1), (2), or (3) of this section, you must either:
    (i) Implement mitigation measures under Sec.  112.45(b) as soon as 
practicable and no later than 1 year after the date of the agricultural 
water assessment (as required by this section); or
    (ii) Test the water pursuant to paragraph (d) of this section, 
consider the results as part of your assessment, and take appropriate 
action under paragraph (c)(1), (2), or (3), or (c)(4)(i) of this 
section.
    (d) Testing for assessment purposes. In conducting testing to be 
used as part of your assessment under paragraph (a)(5) of this section, 
you must use scientifically valid collection and testing methods and 
procedures, including:
    (1) Any sampling conducted for purposes of paragraph (c)(4)(ii) of 
this section must be collected aseptically immediately prior to or 
during the growing season and must be representative of the water you 
use in growing covered produce (other than sprouts).
    (2) The sample(s) must be tested for generic Escherichia coli (E. 
coli) as an indicator of fecal contamination (or for another 
scientifically valid indicator organism, index organism, or other 
analyte).
    (3) The frequency of testing samples and any microbial criteria 
applied must be scientifically valid and appropriate to assist in 
determining, in conjunction with other data and information evaluated 
under paragraph (a) of this section, whether measures under Sec.  
112.45 are reasonably necessary to reduce the potential for 
contamination of covered produce (other than sprouts) or food contact 
surfaces with known or reasonably foreseeable hazards associated with 
your agricultural water used in growing covered produce (other than 
sprouts).
    (e) Reassessment. You must conduct an agricultural water assessment 
and take appropriate action under paragraph (c) of this section:
    (1) At least once annually when you apply agricultural water to 
covered produce (other than sprouts) during growing activities; and
    (2) Whenever a significant change occurs in your agricultural water 
system(s) (including changes relating to animal activity, the 
application of biological soil amendments of animal origin, or the 
presence of untreated or improperly treated human waste associated with 
adjacent or nearby land uses), agricultural water practices, crop 
characteristics, environmental conditions, or other relevant factors 
that make it reasonably likely that a known or reasonably foreseeable 
hazard will be introduced into or onto covered produce (other than 
sprouts) or food contact surfaces through direct application of 
agricultural water during growing activities. Your reassessment must 
evaluate any factors and conditions that are affected by such change.


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

    (a) Microbial quality criterion. When you use agricultural water 
for any one or more of the following purposes, you must ensure there is 
no detectable generic Escherichia coli (E. coli) in 100 milliliters 
(mL) of agricultural water, and you must not use untreated surface 
water for any of these purposes:
    (1) Used as sprout irrigation water;
    (2) Used during or after harvest activities in a manner that 
directly contacts covered produce (for example, water that is applied 
to covered produce for washing or cooling activities, water that is 
applied to harvested crops to prevent dehydration before cooling, and 
water that is used to make ice that directly contacts covered produce 
during or after harvest activities);
    (3) Used to contact food contact surfaces, or to make ice that will 
contact food contact surfaces; and
    (4) Used for washing hands during and after harvest activities.
    (b) Untreated ground water. You must test any untreated ground 
water used as sprout irrigation water or for harvesting, packing, 
holding covered produce to determine if it meets the microbial quality 
criterion in paragraph (a) of this section, as follows:
    (1) You must initially test the microbial quality of each source of 
the untreated ground water at least four times during the growing 
season or over a period of 1 year, using a minimum total of four 
samples collected aseptically and representative of the intended 
use(s). Based on these results, you must determine whether the water 
can be used for the intended purpose(s), in accordance with Sec.  
112.45(a).
    (2) If your four initial sample results meet the microbial quality 
criterion, you may test once annually thereafter, using a minimum of 
one sample collected aseptically and representative of the intended 
use(s).
    (3) If any annual test fails to meet the microbial quality 
criterion, you must:

[[Page 69154]]

    (i) Immediately discontinue the use(s) and meet the requirements of 
Sec.  112.45(a) before resuming such use(s); and
    (ii) Resume testing at least four times per growing season or year, 
as required under paragraph (b)(1) of this section, until all of the 
survey results collected in a year meet the microbial quality 
criterion.
    (4) You may meet these testing requirements using test results or 
data collected by a third party, as provided in Sec.  112.47.
    (c) Exemptions. There is no requirement to test agricultural water 
that is used as sprout irrigation water or for harvesting, packing, or 
holding covered produce when:
    (1) You receive the water from a Public Water System, as defined 
under the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, 
that furnishes water that meets the microbial requirements under those 
regulations or under the regulations of a State (as defined in 40 CFR 
141.2) approved to administer the SDWA public water supply program, and 
you have Public Water System results or certificates of compliance that 
demonstrate that the water meets those microbial requirements;
    (2) You receive the water from a public water supply that furnishes 
water that meets the microbial quality criterion in paragraph (a) of 
this section, and you have public water system results or certificates 
of compliance that demonstrate that the water meets that requirement; 
or
    (3) You treat water in accordance with the requirements of Sec.  
112.46.
    (d) Additional management and monitoring practices. (1) You must 
manage water used in harvesting, packing, and holding covered produce 
as necessary, including by establishing and following water-change 
schedules for non-single-pass water (including recirculated water or 
reused water) to maintain its safe and adequate sanitary quality and 
minimize the potential for contamination of covered produce and food 
contact surfaces with known or reasonably foreseeable hazards (for 
example, hazards that may be introduced into the water from soil 
adhering to the covered produce).
    (2) You must visually monitor the quality of water that you use 
during harvesting, packing, and holding activities for covered produce 
(for example, water used for washing covered produce in dump tanks, 
flumes, or wash tanks, and water used for cooling covered produce in 
hydrocoolers) for buildup of organic material (such as soil and plant 
debris).
    (3) You must maintain and monitor the temperature of water at a 
temperature that is appropriate for the commodity and operation 
(considering the time and depth of submersion) and that is adequate to 
minimize the potential for infiltration of microorganisms of public 
health significance into covered produce.


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

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


Sec.  112.46  What requirements apply to treating agricultural water?

    (a) Any method you use to treat agricultural water (such as with 
physical treatment, including using a pesticide device as defined by 
the U.S. Environmental Protection Agency (EPA); EPA-registered 
antimicrobial pesticide product; or other suitable method) must be 
effective to make the water safe and of adequate sanitary quality for 
its intended use(s) and/or meet the microbial quality criterion in 
Sec.  112.44, as applicable;

[[Page 69155]]

    (b) You must deliver any treatment of agricultural water in a 
manner to ensure that the treated water is consistently safe and of 
adequate sanitary quality for its intended use(s) and, if applicable, 
also meets the microbial quality criterion in Sec.  112.44; and
    (c) You must monitor any treatment of agricultural water using an 
adequate method and frequency to ensure that the treated water is 
consistently safe and of adequate sanitary quality for its intended 
use(s) and, if applicable, also meets the microbial quality criterion 
in Sec.  112.44.
    (d) Treatment may be conducted by you or by a person or entity 
acting on your behalf.


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

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


Sec.  112.48-112.49  [Reserved]


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

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


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

* * * * *
    (b) * * *
    (2) For any other indicator of fecal contamination, index organism, 
or other analyte you may test for pursuant to Sec.  112.43(d), a 
scientifically valid method.
0
6. In Sec.  112.161, revise paragraph (b) to read as follows:


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

* * * * *
    (b) Records required under Sec. Sec.  112.7(b), 112.30(b), 
112.50(b)(2), (5), (7), and (10), 112.60(b)(2), 112.140(b)(1) and (2), 
and 112.150(b)(1), (4), and (6) must be reviewed, dated, and signed, 
within a reasonable time after the records are made, by a supervisor or 
responsible party.

    Dated: November 24, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-26127 Filed 12-2-21; 11:15 am]
BILLING CODE 4164-01-P


