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

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.

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:

samir.assar@hhs.fda.gov.

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,

PRAStaff@fda.hhs.gov.

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 § 112.3)

D. Applicability (Proposed § 112.40)

E. Pre-Harvest Agricultural Water Assessments (Proposed § 112.43)

F. Mitigation Measures (Proposed § 112.45)

G. Records Requirements for Pre-Harvest Agricultural Water Assessments (Proposed § 112.50)

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

I. Other Amendments (Proposed §§ 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.

1

The produce safety regulation refers to pre-harvest agricultural water used during sprout production as “sprout irrigation water.”

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 §§ 112.44(b) and 112.46(b) with new provisions for conducting pre-harvest agricultural water assessments (proposed § 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 § 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 § 112.45(b) for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses;

• Require management review under § 112.161 of pre-harvest agricultural water assessments; and

• Add new definitions of “agricultural water assessment” and “agricultural water system” to § 112.3 (subpart A) and make conforming changes in § 112.12 (subpart B), § 112.151 (subpart N), and § 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

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

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 § 112.3 as produce that is subject to the requirements of this part in accordance with §§ 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 (§ 112.1). Covered produce refers to the harvestable or harvested portion of the crop. (§ 112.3). Farms subject to the requirements are described in § 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 (§ 112.41). It also includes microbial water quality criteria (§ 112.44) and requirements for testing certain water sources (§ 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

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.

Covered farms must establish a microbial water quality profile (§ 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

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 (§ 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

Description

Publication

Notice of proposed rulemaking (2013 proposed produce safety rule)

78 FR 3504, January 16, 2013.

Notice of correction for the 2013 proposed produce safety rule

78 FR 17155, March 20, 2013.

Supplemental notice of proposed rulemaking (supplemental notice)

79 FR 58434, September 29, 2014.

Final rule (2015 produce safety final rule or final rule)

80 FR 74354, November 27, 2015.

Technical amendment to the 2015 produce safety final rule

81 FR 26466, May 3, 2016.

FSMA: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules; Final rule

81 FR 57784, August 24, 2016.

Extension of Compliance Dates for Subpart E; Notice of proposed rulemaking

82 FR 42963, September 13, 2017.

Extension of Compliance Dates for Subpart E; Final rule (subpart E compliance date extension or compliance date extension)

84 FR 9706, March 18, 2019.

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 (§ 112.44(b)) and testing requirements (§ 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.

• 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

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

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,

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

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

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 § 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.

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 § 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

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 §§ 112.40 through 112.42);

• Agricultural water assessments for pre-harvest agricultural water for covered produce other than sprouts (proposed § 112.43);

• Microbial water quality criterion and testing requirements for agricultural water for irrigation of sprouts and for harvest and post-harvest uses (proposed § 112.44);

• Corrective and mitigation measures for agricultural water for all uses (proposed § 112.45);

• Requirements relating to treatment methods for agricultural water for all uses (proposed § 112.46);

• Who conducts testing for agricultural water (proposed § 112.47);

• Reserved (proposed § 112.48 through 112.49); and

• Records relating to agricultural water for all uses (proposed § 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 § 112.3; General Requirements (subpart B), other than the proposed conforming change to § 112.12; Analytical Methods (subpart N), other than the proposed conforming change to § 112.151; or Records (subpart O), other than the proposed revisions to § 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 §§ 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 § 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 § 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 § 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 § 112.3)

We propose to add two new definitions in § 112.3 to provide clarity for terminology used in the proposed requirements for pre-harvest agricultural water assessments.

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 § 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 § 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 § 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 § 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 § 112.3.

D. Applicability (Proposed § 112.40)

We are proposing to add new § 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 §§ 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 §§ 112.45 (measures), 112.47 (who may test), and 112.151 (methods). Any water treatment must be in accordance with § 112.46.

If you are a covered farm using agricultural water for sprout irrigation:

• You must meet the requirements of §§ 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 §§ 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 § 112.46.

If you are a covered farm using agricultural water for harvesting, packing, or holding covered produce:

• You must meet the requirements of §§ 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 §§ 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 § 112.46.

E. Pre-Harvest Agricultural Water Assessments (Proposed § 112.43)

Proposed § 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 §§ 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 § 112.44(a) and, as applicable, §§ 112.44(b), 112.47, and 112.151);

• Meets the requirements for water from a Public Water System or public water supply (proposed § 112.44(c)); or

• Is treated in accordance with § 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

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 § 112.41.

To assist readers, Table 3 outlines the discussion of proposed § 112.43.

Table 3—Discussion of Proposed § 112.43

1. Proposed § 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 § 112.43(b)—Exemptions

14. Proposed § 112.43(c)—Outcomes

15. Proposed § 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 § 112.43(e)—Reassessment

1. Proposed § 112.43(a)—Elements of an Agricultural Water Assessment

Unless exempt under proposed § 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 § 112.43(a):

• Each agricultural water system (defined as proposed in § 112.3) used for pre-harvest agricultural water for non-sprout covered produce, including:

○ The location and nature of the water source (that is, whether the source meets the definition of ground water or surface water);

○ 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);

○ 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

○ 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:

○ The type of direct application method used (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 non-sprout covered produce;

• Crop characteristics, including the susceptibility of the covered produce to surface adhesion or internalization of hazards;

• Environmental conditions, such as:

○ 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;

○ air temperatures; and

○ 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 § 112.43 is intended to supplement the requirements of proposed § 112.42,

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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 § 112.42 is focused on agricultural water system components under the covered farm's control, proposed § 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 § 112.43(a), they are no less important for the farm to consider when determining the safe use of agricultural water on covered produce.

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As described in section VI.I., we are proposing to minor revisions to § 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 § 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 § 112.50(b)(2)) as part of its pre-harvest agricultural water assessment (proposed § 112.43).

For hazard identification purposes, under proposed § 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 § 112.43 solely based on inspection activities conducted under proposed § 112.42, for example, because the agricultural water

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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 112.43(a)(1), covered farms that reuse (or recycle) water as a source for pre-harvest

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 §§ 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 § 112.43, taking into account the standard in § 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 § 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 § 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 § 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 § 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 (§§ 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 §§ 112.81-112.83 could provide useful information for evaluating the degree of protection of a pre-harvest agricultural water system under proposed § 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 § 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 § 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 § 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 § 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

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.

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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.

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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 § 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 § 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

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 § 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 § 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 § 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 § 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

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 § 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 § 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.

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Overhead sprinkler irrigation increases the risk of contamination as compared with furrow and subsurface drip irrigation (Ref. 57). The location of the harvestable portion of a plant in relation to irrigation water plays a significant role in contamination in studies of lettuce, cantaloupe, and bell pepper (Ref. 58). The likelihood of produce contamination may be reduced if irrigation water is delivered by subsurface drip irrigation as compared to using the same water to irrigate by overhead spray (Refs. 33 and 59).

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Irrigation water as described in the QAR is broader than the definition of agricultural water in § 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 § 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 § 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).

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 § 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 § 112.43(d) to help inform its agricultural water assessment, as discussed below.

12. Written Annual Assessments

Under proposed § 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 § 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 § 112.43(a) and made a written determination as required by proposed § 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 § 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 § 112.43(b)—Exemptions

Proposed § 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 § 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 § 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 §§ 112.44(b), 112.47, and 112.151. The exclusion in proposed § 112.43(b)(1) does not apply to untreated surface water, because proposed § 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 §§ 112.44(b), 112.47, and 112.151, that its agricultural water meets microbial water quality criterion in proposed § 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 § 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 § 112.44(a) is commensurate with the risks associated with using contaminated water for sprout irrigation and for harvest and post-harvest uses.

Proposed § 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

public water system results or certificates of compliance or

• Meets the microbial quality criterion in § 112.44(a) through public water system results or certificates of compliance.

Proposed § 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 § 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 § 112.46. We seek comment on this tentative conclusion.

14. Proposed § 112.43(c)—Outcomes

Under proposed § 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 § 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 § 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 § 112.42, of any agricultural water systems used during growing activities for non-sprout covered produce.

Proposed § 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 § 112.43(c)]

If you determine . . .

Then you must . . .

that your agricultural water is not safe or is not of adequate sanitary quality for intended use(s)

• Immediately discontinue use(s)

And

• Take corrective measures before resuming use of the water for pre-harvest activities

there is one or more known or reasonably foreseeable hazards related to animal activity, BSAAOs, or untreated or improperly treated human waste for which mitigation is reasonably necessary

• Implement mitigation measures promptly, and no later than the same growing season,

there is one or more known or reasonably foreseeable hazards not related to animal activity, BSAAOs, or untreated or improperly treated human waste, for which mitigation is reasonably necessary

• Implement mitigation measures as soon as practicable and no later than the following year

Or

• 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 foreseeable hazards for which mitigation is reasonably necessary

• Regularly (at least once each year) inspect and adequately maintain the water system(s)

With respect to pre-harvest agricultural water for non-sprout covered produce, under proposed § 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 § 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:

○ Implement mitigation measures under proposed § 112.45(b) as soon as practicable and no later than the following year; or

○ test the water, pursuant to proposed § 112.43(d), consider the results as part of the assessment in making a determination under § 112.43(c), and implement measures as needed under proposed § 112.45;

• If the covered farm determined that no corrective or mitigation measures under proposed § 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

agricultural water system(s) under proposed § 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 § 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 § 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 § 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 § 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 § 112.41. In those instances, a covered farm would be required under § 112.43(c)(1) to immediately discontinue that use of the water and take corrective measures under § 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 § 112.43(d)—Testing for Assessment Purposes

Proposed § 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 § 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 § 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 § 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 § 112.43(a), whether measures under § 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

coliphages may help to further advance public health protections. FDA anticipates that as science evolves and more information about other indicator or index organi

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