Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
Federal RegisterMay 6, 2024
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA-2021-N-0471]
RIN 0910-AI49
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration is issuing a final rule to amend the agricultural water provisions of the produce safety regulation. This rule replaces the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with a regulatory approach that incorporates recent science and Food and Drug Administration outbreak investigation findings to achieve improved public health protections as compared to the earlier requirements. The rule requires systems-based assessments, with required testing in certain circumstances, that focus on key risk factors for contamination by pre-harvest agricultural water and will enable farms to implement effective preventive measures. The rule requires farms to take timely action based on risk and includes a new requirement for expedited mitigation for certain hazards. The requirements are adaptable to future scientific advancements and provide sufficient flexibility to be practicable for all sizes and types of farms to implement across the wide variety of agricultural water systems, uses, and practices. These revisions to the produce safety regulation will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.
DATES:
This rule is effective July 5, 2024.
ADDRESSES:
For access to the docket to read background documents or comments received, go to
https://www.regulations.gov
and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule:
Samir Assar, Director, Division of Produce Safety, Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-317) 5001 Campus Dr., College Park, MD 20740, 240-402-1636, email:
samir.assar@hhs.fda.gov
.
With regard to the information collection:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov
.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose and Coverage of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. FDA Food Safety Modernization Act
B. 2015 Produce Safety Final Rule
C. New Information Since Issuance of the 2015 Produce Safety Final Rule
D. 2021 Agricultural Water Proposed Rule
E. 2022 Supplemental Proposed Rule
F. Public Comments
G. General Overview of Changes in the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
A. Introduction
B. General Comments on the Proposed Rule
C. Definitions (§ 112.3)
D. General Comments Regarding Pre-Harvest Agricultural Water Assessments (§ 112.43)
E. Exemptions From Agricultural Water Assessments (§ 112.43(b))
F. Elements of an Agricultural Water Assessment (§ 112.43(a))
G. Outcomes (§ 112.43(c))
H. Testing as Part of an Assessment (§ 112.43(d))
I. Reassessment (§ 112.43(e))
J. Corrective and Mitigation Measures (§ 112.45)
K. Treatment of Agricultural Water
L. Records Relating to Agricultural Water (§ 112.50)
VI. Effective and Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose and Coverage of the Final Rule
In this final rule, the Food and Drug Administration (FDA, the Agency, or we) is amending the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule (2015 produce safety final rule), which was established in accordance with the FDA Food Safety Modernization Act (FSMA) and sets forth science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables for human consumption. This rule revises certain provisions in the 2015 produce safety final rule applicable to agricultural water
1
for covered produce other than sprouts, using a direct application method during growing activities (commonly referred to as “pre-harvest agricultural water”
2
). It establishes a regulatory framework of systems-based assessments and risk-tiered outcomes through which farms subject to the 2015 produce safety final rule (covered farms) are required to identify known and potential hazards and implement effective preventive measures within specific timeframes based on risk.
1
“Agricultural water” is defined at 21 CFR 112.3 as water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food-contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce). Related to this definition is our definition of “direct water application method,” which means agricultural water used in a manner whereby the water is intended to, or is likely to, contact covered produce or food-contact surfaces during use of the water. If a specific use of water does not fit within the definition of agricultural water, then the requirements in subpart E do not apply to that specific use of water. See 80 FR 74354 at 74429.
2
The 2015 produce safety final rule refers to pre-harvest agricultural water used during sprout production as “sprout irrigation water.”
The written assessments focus on agricultural water systems, including sources, and agricultural water practices that are key determinants of contamination risks associated with agricultural water, together with crop characteristics and environmental conditions that can impact the survival of pathogens. The assessments include a requirement to test pre-harvest agricultural water in certain circumstances—that is, when doing so would not delay action most critical to protect public health and would further inform the farm's determination as to whether measures are reasonably necessary. Moreover, the assessments are designed for use in diverse circumstances and require covered farms to evaluate a broad range of factors that impact pre-harvest agricultural water quality, providing results that are tailored to address hazards unique to their respective
operations. This approach will be feasible to implement across the wide variety of agricultural water systems, practices, and uses, and it is adaptable to future advancements in agricultural water quality science.
Farms must use the information evaluated to make a written determination on the outcomes of their assessments. The outcomes are based on risk, and include the actions farms must take within a specific timeframe to ensure that their pre-harvest agricultural water is safe and is of adequate sanitary quality for the intended use(s). Within this framework for risk-tiered outcomes is a new expedited mitigation requirement relating to the impacts of certain adjacent and nearby land uses on pre-harvest agricultural water.
These amendments to the 2015 produce safety final rule are supported by scientific literature published since FDA promulgated the 2015 produce safety final rule and findings from FDA's outbreak investigations since FDA promulgated the 2015 produce safety final rule. These amendments are also supported by information and insights shared by an array of stakeholders through a variety of means since FDA promulgated the 2015 produce safety final rule (including through meetings, educational farm visits, and listening sessions), as well as information shared through the notice-and-comment process for this rulemaking. Feedback shared by stakeholders included information about the complexity of the previous pre-harvest agricultural water testing requirements, the practical implementation challenges associated with the uniform nature of those requirements, and findings from scientific studies demonstrating the need for additional testing in highly variable water with previously unaccounted for costs (see section III.C.). We have carefully considered the new information as we considered revisions to the 2015 produce safety final rule necessary to achieve our intended public health goals.
After considering available information, FDA has concluded this final rule will achieve improved public health protections by setting forth requirements for comprehensive pre-harvest agricultural water assessments. Those assessments will better enable covered farms to implement effective measures that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce, and to provide reasonable assurances that produce is not adulterated due to those hazards. Moreover, these revisions provide sufficient flexibility to be practicable for all sizes and types of farms and to account for differences in risk across varying agricultural water systems, uses, and practices.
B. Summary of the Major Provisions of the Final Rule
FDA is amending the 2015 produce safety final rule by revising certain provisions relating to pre-harvest agricultural water for covered produce other than sprouts, while retaining the existing standards applicable to agricultural water for sprouts and for harvest and post-harvest activities conducted by covered farms.
For pre-harvest agricultural water for non-sprout covered produce, we are:
• Replacing the microbial quality criteria and uniform testing requirements in the 2015 produce safety final rule with new provisions for conducting pre-harvest agricultural water assessments for hazard identification purposes (including consideration of agricultural water sources, distribution systems, and practices, as well as adjacent and nearby land uses, and other relevant factors), and using the results of the assessments in making risk management decisions;
• Including a requirement to test pre-harvest agricultural water in certain circumstances (that is, when doing so would not delay action most critical to protect public health and would further inform the farm's determination as to whether measures are reasonably necessary) for generic
Escherichia coli
(
E. coli
) (or other appropriate indicator organism, index organism, or analyte) to help inform covered farms' agricultural water assessments;
• Adding new options for mitigation measures, providing covered farms additional flexibility in responding to findings from their pre-harvest agricultural water assessments;
• Requiring expedited implementation of mitigation measures for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses;
• Requiring management review of pre-harvest agricultural water assessments; and
• Adding new definitions of “agricultural water assessment” and “agricultural water system.”
We are making additional amendments, such as adding examples and making other edits that are designed to provide clarity, such as reorganizing subpart E to group provisions of a similar nature. We are also making conforming changes elsewhere in the 2015 produce safety final rule.
C. Legal Authority
We are issuing this final rule under FDA's authorities in sections 402, 419, and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342, 350h, and 371(a)) and sections 311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C. 243, 264, and 271). We discuss our legal authority in greater detail in section IV.
D. Costs and Benefits
Our primary estimates of annualized costs are approximately $17.5 million at a 3 percent discount rate and approximately $17.7 million at a 7 percent discount rate over 10 years.
Our primary estimates of annualized benefits are approximately $10.3 million at a 3 percent discount rate and approximately $10.1 million at a 7 percent discount rate over 10 years. We discuss non-quantified benefits of the rule stemming from recalls averted and increased flexibility for covered farms to comprehensively evaluate their agricultural water systems.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
Table 1—Table of Abbreviations and Acronyms
Abbreviation/acronym
What it means
BSAAO
Biological Soil Amendment of Animal Origin.
CAFO
Concentrated Animal Feeding Operation.
CAN
California Agricultural Neighbors.
CDC
Centers for Disease Control and Prevention.
CEA
Controlled Environment Agriculture.
CFR
Code of Federal Regulations.
CFU
Colony Forming Units.
CWA
Clean Water Act.
E. coli
Escherichia coli.
EIS
Environmental Impact Statement.
EPA
U.S. Environmental Protection Agency.
FD&C Act
Federal Food, Drug, and Cosmetic Act.
FRIA
Final Regulatory Impact Analysis.
FSMA
FDA Food Safety Modernization Act.
GAP
Good Agricultural Practices.
GM
Geometric Mean.
HACCP
Hazard Analysis and Critical Control Point.
H-GAP
USDA Harmonized Good Agricultural Practices.
HHS
Health and Human Services.
IFSAC
Interagency Food Safety Analytics Collaboration.
LGMA
Leafy Greens Marketing Agreement.
L. monocytogenes
Listeria monocytogenes.
mL
Milliliters.
MPN
Most Probable Number.
MWQP
Microbial Water Quality Profile.
NASDA
National Association of State Departments of Agriculture.
NOP
USDA National Organic Program.
NASS
USDA National Agricultural Statistics Service.
NPDWR
U.S. EPA National Primary Drinking Water Regulations.
PCR
Polymerase Chain Reaction.
PHS Act
Public Health Service Act.
PRIA
Preliminary Regulatory Impact Analysis.
QAR
Qualitative Assessment of Risk.
RWQC
Recreational Water Quality Criteria.
STV
Statistical Threshold Value.
USDA
U.S. Department of Agriculture.
UV
Ultraviolet.
III. Background
A. FDA Food Safety Modernization Act
FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA transformed the nation's food safety system by shifting the focus from responding to foodborne illness to preventing it.
FSMA enables FDA to establish a prevention-oriented framework that focuses effort where food safety hazards are reasonably likely to occur and is flexible and practical in light of current scientific knowledge and food safety practices. The law also provides enforcement authorities for responding to food safety problems when they do occur. In addition, FSMA gives FDA important tools to help ensure the safety of imported foods and encourages partnerships with State, local, Tribal, and territorial authorities, as well as foreign regulatory counterparts.
FDA has issued nine foundational rules that create risk-based standards and provide oversight at various points in the supply chain for domestic and imported human and animal food. The produce safety regulation, established in the 2015 produce safety final rule (80 FR 74354, November 27, 2015), is one of the nine foundational rules.
B. 2015 Produce Safety Final Rule
In November 2015, FDA finalized the produce safety regulation, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption (codified in the Code of Federal Regulations (CFR) at part 112 (21 CFR part 112)). In accordance with section 419 of the FD&C Act (21 U.S.C. 350h), the 2015 produce safety final rule sets forth procedures, processes, and practices to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into produce and to provide reasonable assurances that produce is not adulterated on account of such hazards. The regulation focuses on biological hazards (defining a “known or reasonably foreseeable hazard” as a biological hazard that is known to be, or has the potential to be, associated with the farm or the food) and major routes of microbial contamination—including agricultural water; biological soil amendments; domesticated and wild animals; worker health and hygiene; and equipment, buildings, and tools. Farms subject to the requirements of part 112 are “covered farms”; however, for purposes of readability, we use the term “farms” to mean “covered farms” within the meaning of part 112 in this document.
Subpart E of the 2015 produce safety final rule includes a general requirement that agricultural water must be safe and adequate for its intended uses (§ 112.41). It also included microbial water quality criteria (§ 112.44) and requirements for testing certain water sources (§ 112.46). The microbial quality criteria were based on the intended use of the agricultural water—
i.e.,
for growing activities for covered produce other than sprouts (including irrigation water applied to covered produce, other than sprouts, using a direct water application method and water used in preparing crop sprays) (commonly referred to as “pre-harvest agricultural water”)
3
, and for certain other specified uses, including sprout irrigation water and water applications that directly contact covered produce during or after harvest (commonly referred to as “harvest and post-harvest agricultural water”).
4
For pre-harvest agricultural water for non-sprout covered produce, the microbial
water quality criteria consisted of a geometric mean (GM) of 126 or less colony forming units (CFU) generic
E. coli
per 100 milliliters (mL), and a statistical threshold value (STV) of 410 or less CFU generic
E. coli
per 100 mL. The 2015 produce safety final rule preamble explained that we established the pre-harvest agricultural water microbial criteria based on our analysis of the then-current scientific information; we also explained that that scientific information relied on an underlying dataset that had the necessary scientific rigor and described illness rates due to incidental ingestion generalized across different bodies of water (see 80 FR 74534 at 74416 and 74441-74442).
3
The 2015 produce safety final rule refers to pre-harvest agricultural water used during sprout production as “sprout irrigation water.”
4
Because sprouts present a unique safety risk, the 2015 produce safety final rule establishes sprout-specific requirements on multiple topics, including agricultural water. Sprouts are not the subject of this rulemaking.
For untreated surface waters, farms were required to establish an initial microbial water quality profile (MWQP) of at least 20 samples collected over a 2 to 4-year period, followed by at least 5 annual samples thereafter; and for untreated ground water sources, this would consist of an initial profile of at least 4 samples collected during the growing season or over a period of 1 year, followed by at least 1 annual sample thereafter (80 FR 74354 at 74452) (Ref. 1).
In the 2015 produce safety final rule, we explained that the pre-harvest agricultural water microbial criteria and testing requirements were not a direct indicator of the safety of agricultural water for immediate use; rather, they were designed as a long-term water quality management tool for use in understanding the microbial quality of water over time and determining how to appropriately use water from that source. 80 FR 74354 at 74430. Moreover, we acknowledged gaps in the then-current science related to use of indicator organisms for monitoring water quality and predicting pathogen presence and/or fecal contamination. 80 FR 74354 at 74427-74428. We discussed that while testing water for pathogens has the obvious advantage of directly targeting microorganisms in water that are a risk to public health, doing so is not without significant challenges. 80 FR 74354 at 74427-74428. In response to comments received during that earlier rulemaking, we considered, and declined, the option to establish a qualitative standard alone in lieu of a quantitative microbial quality requirement for pre-harvest agricultural water. 80 FR 74354 at 74443. However, since 2015, new scientific findings as well as findings from FDA outbreak investigations have demonstrated the need for an updated systems-based approach.
Table 2 lists the key FSMA 2015 produce safety final rule documents published in the
Federal Register
. The complete set of
Federal Register
documents associated with the FSMA 2015 produce safety final rule, including supporting materials, are available in the docket folders at
https://www.regulations.gov/docket?D=FDA-2011-N-0921
and
https://www.regulations.gov/docket?D=FDA-2021-N-0471.
Table 2—List of Key
Federal Register
2015 Produce Safety Final Rule Documents
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 (2014 supplemental proposed rule)
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 (2017 proposed compliance date extension)
82 FR 42963, September 13, 2017.
Extension of Compliance Dates for Subpart E; Final rule (2019 compliance date extension)
84 FR 9706, March 18, 2019.
Standards Relating to Agricultural Water; Notice of proposed rulemaking (2021 agricultural water proposed rule)
86 FR 69120, December 6, 2021.
Extension of Compliance Dates for Subpart E; Supplemental notice of proposed rulemaking (2022 supplemental proposed rule)
87 FR 42973, July 18, 2022.
C. New Information Since Issuance of the 2015 Produce Safety Final Rule
In November 2015, FDA began to conduct outreach to educate stakeholders about the requirements of the 2015 produce safety final rule, including through public meetings, speaking engagements, and participation in conferences convened by stakeholders representing a broad range of interests. FDA subject matter experts also participated in educational farm visits with State partners to observe a range of growing conditions and practices in varying regions. Through these efforts we heard consistent feedback that the pre-harvest agricultural water microbial criteria and testing requirements for non-sprout covered produce in the 2015 produce safety final rule were “one-size-fits-all” and did not sufficiently allow for the diversity of farms, including a variety of water uses and availabilities. For example, we received feedback that the long-term MWQPs required in the 2015 produce safety final rule can be difficult, and even impossible, to establish for farms that grow rotational crops or crops on leased land, both of which are common throughout industry. 86 FR 69120 at 69123-69124. FDA also received information and feedback from other stakeholders, including water quality specialists and researchers, indicating that the 2015 pre-harvest microbial water quality criteria and testing requirements did not adequately capture variability that can occur within a surface water source, and that sanitary surveys may better help inform water management decisions compared to testing.
In the face of these concerns, including new concerns not previously expressed, in March 2017, FDA announced that we were considering how we might simplify the microbial quality and testing requirements for agricultural water while still protecting public health and that we intended to work with stakeholders as these efforts progressed (Ref. 2). As part of these efforts, we participated in numerous additional meetings, educational farm visits, and listening sessions with an array of stakeholders—including produce industry members, food industry trade associations, researchers, extension educators, consumer groups, and State and Federal partners—to reflect various perspectives on managing risks associated with pre-harvest agricultural water for non-sprout
covered produce. See 86 FR 69120 at 69123-69125.
For example, in October 2017, FDA participated in a collaborative forum, sponsored by The Pew Charitable Trusts and the Robert Wood Johnson Foundation, where participants representing farms, academia, food industry trade associations, consumer groups, and State and other Federal partners discussed ideas for how to amend the agricultural water requirements within the then-current framework of the rule, as well as, and potentially in combination with, ideas for frameworks that could improve public health outcomes long-term and allow for the incorporation of new scientific knowledge and learnings as they become available (Ref. 3). Forum participants identified several possible approaches, including: (1) retaining the 2015 pre-harvest microbial water quality criteria and testing requirements and issuing companion guidance; (2) replacing the 2015 quantitative requirements with a qualitative standard and issuing companion guidance; (3) adopting private industry standards as a short-term measure while additional research continues; and (4) performing a multiyear quantitative microbial risk assessment to help fill research gaps. Forum participants identified advantages and disadvantages of each approach and also identified other areas for further consideration by FDA, including qualitative standards, data sharing, and the need for additional guidance.
The pre-harvest agricultural water requirements were also the focus of a 2-day Agricultural Water Summit, convened by the Produce Safety Alliance at Cornell University, in February 2018 (Ref. 4). The summit was attended by academics, produce industry, growers/grower associations, State agencies, Federal agencies, and supporting industries. During the summit, participants had many questions and concerns about reliance on testing as a mechanism for determining pre-harvest agricultural water quality, including that the 2015 pre-harvest agricultural water microbial criteria and testing requirements were not supported by scientific evidence sufficient to demonstrate their relevance to public health outcomes. Among other things, participants questioned the role of water testing, what the information tells farms about risks, and how farms would use that information to make water use management decisions. Some participants emphasized farms' interest in preventing produce contamination while expressing concern that the resources that would be required to conduct testing might be better used for other approaches with relevance to public health outcomes.
Many of the discussions at the summit addressed hazards in the growing environment, including examples of how risk assessment has been conducted in other fields of study, such as for drinking water and wastewater management. During the summit, participants identified “agricultural water assessments” as a promising approach for managing water quality, suggesting that assessments may provide a more effective risk management strategy to farms than a numerical testing standard can provide (Ref. 4).
Moreover, scientific information has become available since the 2015 produce safety final rule issued that indicates potential limitations in basing risk management decisions on the previous pre-harvest agricultural water testing requirements and that supports a shift in regulatory approach away from those requirements. For example, various studies since 2015 indicate a high degree of variability in generic
E. coli
levels in surface waters (Refs. 5-10), which can reduce the precision of estimation of the GM and STV of a water source (Refs. 1, 7). Other studies since 2015 have underscored the limitations of generic
E. coli
as an indicator for pathogen presence (Refs. 11-16).
Further, a scientific evaluation of the 2015 pre-harvest agricultural water testing requirements found that the rolling data set of five samples per year used to update GM and STV values for untreated surface water sources leads to highly uncertain results and delays in detecting shifts in water quality (Ref. 7). Specifically, Havelaar et al. found that the 20-sample MWQP for untreated surface water was not sufficient to reliably characterize the quality of the irrigation water with higher variability in generic
E. coli
levels than was determined for the 2015 produce safety final rule (Refs. 1, 7). In simulation modeling, the rolling 20-sample MWQP responded “very slowly” to shifts in water quality. Increases in generic
E. coli
levels were detected only after one to six sample sets, thus delaying signals of changes in water quality and (and any needed measures) by 1 to 6 years depending on the nature and magnitude of the shift.
For surface water that had standard deviations up to three times higher than accounted for in the 2015 produce safety final rule, Havelaar et al. determined that an 180-sample MWQP would be required to obtain the same precision of the GM as required by the rule (Ref. 7). Havelaar et al. observed that the (nine-fold) increase in sampling might address the problem, but it would increase testing costs. We acknowledge their findings on the need for substantial testing for highly variable pre-harvest agricultural water. Such testing would be beyond what is required for pre-harvest surface water testing under the 2015 produce safety final rule, with an attendant increase in costs. Additionally, other recent studies demonstrate a high degree of variability in generic
E. coli
levels in surface waters for pre-harvest application (Refs. 5-10), suggesting similar questions about necessary additional testing and costs that were not accounted for in the 2015 produce safety final rule.
Havelaar et al. also suggested that additional understanding of the processes that drive variability in the quality of irrigation water sources might inform preventive or rapid corrective actions that have a larger impact on produce safety than the 2015 pre-harvest agricultural water requirements (Ref. 7). Additionally, for several years, FDA has conducted investigations of produce outbreaks to learn what factors may have contributed to the outbreaks of foodborne illness or food contamination events (Ref. 17). Findings from investigations of several outbreaks linked to consumption of produce since 2015—including: (1) the spring 2018
E. coli
O157:H7 outbreak linked to romaine lettuce from the Yuma growing region (Refs. 18 and 19); (2) the fall 2018
E. coli
O157:H7 outbreak linked to romaine lettuce from California (Ref. 20); (3) the fall 2019
E. coli
O157:H7 outbreaks linked to romaine lettuce (Ref. 21); (4) the fall 2020
E. coli
O157:H7 outbreak linked to leafy greens (Ref. 22); and (5) the Summer 2020
Salmonella
Newport outbreak linked to red onions (Ref. 23)—highlight the importance of pre-harvest agricultural water quality and the potential impacts of adjacent and nearby land uses on agricultural water, which can serve as a route of contamination of produce. These outbreak investigations reiterate decades of scientific research demonstrating that pre-harvest agricultural water is a potential contributing factor in the introduction and spread of contamination to produce. See 86 FR 69120 at 69125-69127. Findings such as these build upon our peer-reviewed “FDA Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce” (QAR) (Ref. 17), which provides a scientific evaluation of the potential adverse health effects resulting from human exposure to microbiological hazards in
produce to inform FDA's implementation of section 419 of the FD&C Act, with a focus on public health risk associated with the on-farm contamination of produce, including from agricultural water.
D. 2021 Agricultural Water Proposed Rule
In light of recent studies and other new information gathered since issuance of the 2015 produce safety final rule, including findings from FDA produce outbreak investigations as well as feedback on the previous pre-harvest agricultural water requirements, on December 6, 2021, FDA issued a proposed rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water,” (86 FR 69120; hereafter referred to as the “2021 agricultural water proposed rule”) that proposed to revise certain requirements relating to pre-harvest agricultural water for covered produce other than sprouts, while retaining the existing standards applicable to agricultural water for sprouts and for harvest and post-harvest activities. For pre-harvest agricultural water for non-sprout covered produce, we proposed to replace the microbial quality criteria and uniform testing requirements with provisions for: requiring systems-based pre-harvest agricultural water assessments to evaluate the key determinants of risk attributable to agricultural water use practices, including a requirement to test pre-harvest agricultural water when doing so would not delay action most critical to protect public health and would further inform the farm's determination as to whether measures are reasonably necessary; adding new options for mitigation measures; and adding a new requirement for expedited implementation of mitigation measures for hazards related to certain adjacent and nearby land uses. We also proposed to require management review of records related to agricultural water assessments and to add new definitions of “agricultural water assessment” and “agricultural water system” to the 2015 produce safety final rule.
We solicited comments on these proposed amendments. We also proposed additional amendments, such as reorganizing subpart E to group requirements of a similar nature and ensure that interested parties could readily view the proposed pre-harvest agricultural water revisions.
Additionally, in the preamble to the 2021 agricultural water proposed rule (86 FR 69120 at 69147) we explained that at that time, farms were required to comply with the subpart E pre-harvest, harvest, and post-harvest agricultural water requirements for covered produce (other than sprouts) beginning on January 26, 2024, for very small farms; January 26, 2023, for small farms; and January 26, 2022, for all other farms (see also 84 FR 9706). We also explained that we intended to exercise enforcement discretion for the subpart E pre-harvest, harvest, and post-harvest agricultural water requirements for covered produce (other than sprouts) while working to address compliance dates in a targeted manner through the rulemaking process, with the goal of completing the rulemaking as quickly as possible.
The public comment period for the 2021 agricultural water proposed rule closed on April 5, 2022.
In the 2021 agricultural water proposed rule, we indicated that we were developing an online tool related to the pre-harvest agricultural water assessments described in the proposed rule. In March 2022, FDA released v1.0 of an online “Agricultural Water Assessment Builder” to help farms understand the proposed requirements for an agricultural water assessment (Ref. 24). Since then, we have released paper-based versions of the Builder in both English and Spanish to make the content more accessible to a broader array of users (Ref. 25). We have also updated the online version of the Builder to v1.1 to make it more user-friendly in response to stakeholder feedback. We expect to update the Builder to reflect the requirements we are finalizing here.
E. 2022 Supplemental Proposed Rule
On July 19, 2022, we published a supplemental notice to the 2021 agricultural water proposed rule (87 FR 42973) (2022 supplemental proposed rule) in which we proposed dates for compliance with the pre-harvest agricultural water requirements for covered produce other than sprouts in the 2021 agricultural water proposed rule. In light of the revisions we proposed to certain pre-harvest agricultural water requirements for non-sprout covered produce, we proposed to establish dates for compliance with the pre-harvest agricultural water requirements for covered produce other than sprouts as follows: 2 years and 9 months after the effective date of a final rule for very small businesses; 1 year and 9 months after the effective date of a final rule for small businesses; and 9 months after the effective date of a final rule for all other businesses.
We also specified the duration of the period of enforcement discretion for the harvest and post-harvest agricultural water requirements for covered produce other than sprouts until January 26, 2025, for very small businesses; January 26, 2024, for small businesses; and January 26, 2023, for all other businesses. As discussed in the 2022 supplemental proposed rule, we specified the duration of our intended period of enforcement discretion to provide farms, regulators, educators, and other stakeholders additional time to facilitate compliance with those requirements.
We explained in the 2022 supplemental proposed rule that the proposed compliance dates for pre-harvest agricultural water requirements and our intent to exercise of enforcement discretion were intended to facilitate successful implementation and optimize public health protections. We reopened the comment period only with respect to the extension of compliance dates for pre-harvest agricultural water for non-sprout covered produce. The comment period for the supplemental proposed rule closed on September 19, 2022.
In this document, we use the broad term “agricultural water proposed rule” to refer to the complete proposed rule, including both the 2021 agricultural water proposed rule and the 2022 supplemental proposed rule.
F. Public Comments
After issuing the agricultural water proposed rule, we conducted numerous outreach activities. We held two virtual public meetings on February 14, 2022, and February 25, 2022, to solicit public comments on the proposed rule, inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and respond to questions about the proposed rule. The public meetings were attended by domestic and foreign industry representatives, academia, State and Federal regulators, retailers, third-party certification bodies, laboratories, consumer groups and others, and included discussion panels consisting of representatives from industry, the States, consumer groups, and retailers. We also held a consultation with Federally recognized Indian tribes on February 4, 2022, to provide an overview of the proposed rule, answer questions, and receive feedback.
Additionally, FDA participated in a webinar hosted by the National Association of State Departments of Agriculture (NASDA) on December 15, 2021, as well as five regional meetings (Southern Region (March 14, 2022); Western Region (March 11, 2022); Northwestern Region (March 2, 2022);
North Central Region (March 2, 2022); and Northeast Region (March 11, 2022)) that were sponsored by State regulatory partners and attended by farms, irrigation districts, educators, environmental groups, and others. We also participated in numerous other meetings and speaking engagements to discuss the proposed rule, respond to questions, and receive feedback.
We received approximately 180 comment submissions on the agricultural water proposed rule by the close of both comment periods, each containing one or more comments on one or more issues. We received submissions from diverse members of the public, including produce farms; coalitions; trade organizations; academia; consumers; consumer groups; State and foreign government agencies; and other organizations. Some submissions included statements from multiple individuals.
In sections V and VI of this document we describe these comments, respond to them, and explain the changes we made to the agricultural water proposed rule, in addition to discussing our consideration of alternative approaches, such as requiring all farms to test their water as part of their pre-harvest agricultural water assessments. We also discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. Our responses to the comments include our reasons for determining whether to modify any of the proposed requirements. The remainder of this document establishes a final rule (“the final rule,” “this final rule,” “the rule,” or “this rule”) based on the agricultural water proposed rule.
G. General Overview of Changes in the Final Rule
In response to comments received and on our own initiative, we have made several changes to the proposed requirements for pre-harvest agricultural water assessments for non-sprout covered produce and for mitigation measures to reduce the potential for contamination of covered produce and food contact surfaces with known or reasonably foreseeable hazards associated with such agricultural water. We have provided clarification related to the timing of agricultural water assessments and exemptions from the requirement to prepare an agricultural water assessment. We have also revised the mitigation measures related to a time interval between last direct water application and harvest and a time interval between harvest and end of storage and/or use of other post-harvest activities to further emphasize the flexibility afforded to farms in ways to comply with those requirements and provide flexibility as science and post-harvest handling practices evolve. Consistent with the changes discussed above, we have revised the requirements for certain records that farms are required to establish and maintain. This final rule also includes a requirement to maintain scientific data or information in support of an alternative mitigation measure to align with the agricultural water records requirements in the 2015 produce safety final rule.
IV. Legal Authority
We are issuing this final rule under FDA's authorities in sections 402, 419, and 701(a) of the FD&C Act and sections 311, 361, and 368 of the PHS Act.
Section 419(a) of the FD&C Act, in relevant part, directs FDA to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which we have determined such standards minimize the risk of serious adverse health consequences or death. Section 419(a)(3) of the FD&C Act further requires that these minimum standards provide sufficient flexibility and are appropriate to the scale and diversity of the production and harvesting of raw agricultural commodities. Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Additionally, section 701(a) of the FD&C Act grants the authority to issue regulations for the efficient enforcement of the FD&C Act. This rule includes requirements that are necessary to prevent food from being adulterated, and a regulation that requires measures to prevent food from being held under insanitary conditions whereby either of the proscribed results may occur allows for the efficient enforcement of the FD&C Act. The amendments we are finalizing to the 2015 produce safety final rule thus allow FDA to efficiently enforce sections 402 and 419 of the FD&C Act.
In addition to the FD&C Act, FDA's legal authority for the final rule derives from sections 311, 361, and 368 of the PHS Act, which provides authority for FDA to issue regulations to prevent the spread of communicable diseases from one State to another. Specifically, the PHS Act authorizes the Secretary of HHS to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States . . . or from one State . . . into any other State” (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary; see Staff Manual Guide 1410.10 at
https://www.fda.gov/about-fda/reports-manuals-forms/staff-manual-guides
for delegation from the Secretary to FDA.) The provisions in this final rule are necessary to prevent food from being contaminated with human pathogens such as
Salmonella, Listeria monocytogenes
(
L. monocytogenes
), and
E. coli
O157, and therefore to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the United States, or from one state in the United States to another. These amendments to the 2015 produce safety final rule will help prevent the spread of communicable diseases associated with contaminated produce.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
We received approximately 180 comment submissions on the proposed rule by the close of both comment periods, each containing one or more comments on one or more issues. We received submissions from diverse members of the public, including produce farms; coalitions; trade organizations; academia; consumers; consumer groups; State and foreign government agencies; and other organizations. Some submissions included statements from multiple individuals.
In the remainder of this document, we describe the comments that are within the scope of this rulemaking, respond to them, and explain the revisions we made to the proposed rule. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received.
We received no comments regarding § 112.40 (“What requirements of this subpart apply to my covered farm?”) and are finalizing that provision as proposed. We received no comments regarding conforming changes in §§ 112.12, 112.151, or 112.161(b), or amendments to §§ 112.42, 112.44, and 112.46 through 112.49 related to providing additional clarity and reorganizing subpart E in its entirety to group provisions of a similar nature. We are finalizing these amendments without changes.
We received some comments on provisions we did not propose to revise and that are outside of the scope of this rulemaking. For example, we received comments on the definition of “agricultural water” (§ 112.3); the requirements for general agricultural water quality (§ 112.41); the requirements for inspections and maintenance of agricultural water systems (§ 112.42); the requirements for harvest and post-harvest agricultural water (§ 112.44); and the requirements for agricultural water treatment (§ 112.46). We do not address out of scope comments in this document.
We also received some comments that address FDA's plans for implementation activities that are outside the scope of this rulemaking. As such, we do not address those comments in this document. We nonetheless recognize the importance of having educational materials and technical assistance and are taking efforts to ensure that guidance, training, educational resources, and the FSMA Technical Assistance Network are available to help farms as they prepare to comply with the requirements in this rule.
Note that summaries of and responses to comments on the estimated costs and benefits of the proposed rule and other topics covered by the Preliminary Regulatory Impact Analysis (PRIA) may be found in the Final Regulatory Impact Analysis (FRIA) (Ref. 26).
B. General Comments on the Proposed Rule
Many comments made general remarks supporting or opposing the proposed rule without focusing on a particular proposed provision. Among comments that were supportive of the proposed rule, some provided general feedback suggesting that additional information would help clarify the rule. Several comments focused on other topics, such as alternative options to the regulatory approach for pre-harvest agricultural water and the shift from mandated agricultural water testing in the 2015 produce safety final rule to the proposed approach for pre-harvest agricultural water assessments. In the following paragraphs, we discuss and respond to such general comments.
1. General Comments
(Comment 1) Many comments support the proposed rule, suggesting that the proposed pre-harvest agricultural water assessments are more risk-based, flexible, and holistic than the pre-harvest agricultural water testing requirements in the 2015 produce safety final rule, which commenters characterized variously as complex, prescriptive, and “one-size-fits-all.” Many comments suggest that the proposed approach better accommodates the diversity in industry, noting the variety of conditions that can exist on farms when it comes to different regions, crops, water sources, and water uses. Many of these comments suggest that the proposed requirements will help prevent foodborne illness outbreaks and lead to improved public health outcomes. Among comments supportive of the proposed approach, some suggest that additional information on agricultural water assessments would be beneficial to further clarify the proposed requirements.
In contrast, a few comments suggest that the proposed requirements for pre-harvest agricultural water assessments are too complicated. Some of these comments suggest that quantitative metrics (such as criteria derived from testing) would be easier for farms to understand and easier for regulators to enforce than agricultural water assessments, which are more qualitative in nature. Some of these comments suggest that the requirements for agricultural water assessments will not be more effective at preventing foodborne illness than mandated pre-harvest agricultural water testing.
(Response 1) We agree with comments received that support the proposed rule, including the systems-based assessments that are grounded in our QAR (Ref. 17), incorporate recent scientific data and other information available to FDA, and are designed to ensure that farms have robust and meaningful information about the quality of their pre-harvest water for use in risk management decision making. We developed this approach to pre-harvest agricultural water by considering the public health objectives we aim to achieve through pre-harvest agricultural water measures for covered produce other than sprouts while recognizing that each farm—whether foreign or domestic—has a unique combination of agricultural water source(s), growing practices, current and previous uses of the farmland, and adjacent and nearby land uses, among other factors, that may influence the safety of its agricultural water.
The rule establishes assessment factors with sufficient specificity to provide farms robust and meaningful information on the quality of pre-harvest agricultural water, while also offering adequate flexibility to account for the diversity of operations that we are required to consider in developing the regulations under 419(a)(3)(A) of the FD&C Act.
The requirements for comprehensive, systems-based pre-harvest agricultural water assessments and appropriate corrective and mitigation measures as needed will help farms identify potential sources of contamination and effectively manage their water. Specifically, farms must use the results of assessments to determine when, within the framework for risk-based outcomes, they are required to take measures to ensure that their pre-harvest agricultural water is safe and is of adequate sanitary quality for the intended use(s). The combination of assessments and risk-tiered outcomes require farms to identify and address sources of potential hazards through implementation of effective prevention-oriented mitigation measures within specified timeframes. Under the final rule, farms will assess hazards at the beginning of the growing season and implement mitigation measures for certain hazards earlier than under the 2015 produce safety final rule. Further, under the 2015 produce safety final rule, farms were required to test pre-harvest agricultural water as close in time as practicable to, but prior to harvest, and use those results to determine whether to implement mitigation measures without the benefit of the written systems-based evaluation of potential sources of contamination we are requiring in this final rule.
We recognize that agricultural water assessments, by their nature, will require farms to consider a broader set of factors as part of the systems-based approach we are finalizing here, compared to the microbial quality criteria and testing requirements for pre-harvest agricultural water in the 2015 produce safety final rule. In addition to providing the specific factors farms must consider in their pre-harvest agricultural water assessments in § 112.43(a), we provide additional information on the requirements for agricultural water assessments throughout the remainder of section V. We reiterate our commitment to providing farms education, outreach, and technical assistance to facilitate
compliance with the rule. We intend to pursue various mechanisms, such as publishing guidance, holding webinars, and developing other educational resources, including work with other stakeholders (such as State agencies, educators, and extension agents), to do so. See also the response to comment 29.
Further, the knowledge and experiences gained since 2015 will be helpful in supporting successful implementation of the rule, including compliance with the requirements for pre-harvest agricultural water assessments. For example, we developed the 2015 produce safety final rule after considering, in part, that at the time of rulemaking, some farms had significant expertise in the area of food safety, and other farms had minimal knowledge in the area. We also considered that the produce farming community did not have the history of regulatory interaction with FDA and the same experience with food safety regulations as did the food manufacturing industry. 78 FR 3504 at 3530. However, we recognize that since that time, knowledge and awareness of food safety, as well as the produce farming community's experience with food safety regulations, has evolved. For example, many farms, whether for the purposes of required training in accordance with § 112.22(c) (which we did not propose to change) or for other purposes, have since received food safety training, including on topics related to potential hazards in the growing environment.
Additionally, FDA has provided investigation reports for various produce-related outbreaks that have occurred since 2015 (
e.g.,
Refs. 18-23), many of which discuss factors potentially contributing to contamination and provide recommendations for farms to consider in light of those findings. Moreover, other provisions in the 2015 produce safety final rule for which compliance dates have passed, such as those in subpart I, “Domesticated and Wild Animals” (§§ 112.81-112.83), may provide farms with useful information when evaluating the degree of protection of a pre-harvest agricultural water system as part of an agricultural water assessment (see response to comment 55).
For these reasons we have concluded that sufficient support exists—including through identification of specific factors that farms must consider in § 112.43(a), information provided throughout this final rule, and knowledge and experiences gained since 2015 (including lessons learned from various produce-related outbreaks)—for farms to effectively implement the requirements for agricultural water assessments and risk-tiered outcomes that we are finalizing with this rule.
With respect to comments suggesting that the requirements for pre-harvest agricultural water assessments will be difficult to enforce, we disagree. The annual assessments employ a prevention-oriented quality-systems approach to food safety regulation that FDA has long used and successfully enforced across the highly diverse food industry that FDA regulates. For example, FDA issued the juice hazard analysis and critical control point (HACCP) regulation (that is, the Hazard Analysis and Critical Control Point Systems regulation in 21 CFR part 120) and the seafood HACCP regulation (that is, the Fish and Fishery Products regulation in 21 CFR part 123) more than 20 years ago, which establish mandatory frameworks through which industry assesses hazards that are reasonably likely to occur and designs tailored controls to prevent or eliminate them or reduce them to an acceptable level. More recently, in 2015, FDA issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), under which food facilities conduct a qualitative assessment to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether there are any hazards requiring a preventive control. These regulations all require the development of a food safety plan.
As discussed in comment 18, we have incorporated many of these principles—such as an assessment of risk and the development of a food safety plan based on that assessment—into the requirements for pre-harvest agricultural water assessments in § 112.43. For example, in § 112.43(a), we require farms to evaluate and document specific factors as part of an assessment, all of which are key determinants of contamination risks associated with pre-harvest agricultural water. Based on that evaluation, in § 112.43(c), we require farms to make written determinations on whether measures under § 112.43(d) are reasonably necessary. We further require farms to take necessary and timely action in accordance with those determinations. Thus, the requirements we are finalizing here share common principles with other FDA food safety regulations that have been enforced.
Thus, based on the specific criteria we have included in § 112.43 and our experience enforcing other regulations that rely on similar food safety principles and approaches to operation-specific assessments, we have concluded we can enforce the requirements we are finalizing here. For example, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation includes requirements for hazard identification (see 21 CFR 117.130), and FDA has enforced that regulation. Additional information on inspection, compliance, and enforcement-related information can be found on the “FDA Data Dashboard” at
https://www.fda.gov/about-fda/transparency/fda-data-dashboard
.
To the extent that comments voicing concerns with the proposed rule are suggesting that the requirements for pre-harvest agricultural water assessments are more than what is necessary for public health purposes, we disagree. While we believe that requiring operational assessments and food safety plans that address the entirety of a farm's operations (including potential sources and routes of contamination addressed in other subparts of the 2015 produce safety final rule) would be more than a minimum standard and more than what is reasonably necessary for us to require to achieve the statutory purposes (80 FR 74354 at 74380), given the scientific support for pre-harvest agricultural water assessments; the limited scope of the assessments (
i.e.,
the requirements only apply for pre-harvest agricultural water for non-sprout covered produce); and the knowledge and experiences gained since 2015, we continue to conclude that requiring farms to prepare a pre-harvest agricultural water assessment for non-sprout covered produce is a science-based minimum standard as described in section 419 of the FD&C Act. There is significant public health benefit in requiring farms to prepare a written assessment that considers various factors that affect the safety of their pre-harvest agricultural water and its appropriate use during pre-harvest activities for non-sprout covered produce. Such written assessments also require farms to identify the actions they will take to manage risks associated with their pre-harvest water. Further, in some instances, the written assessments will provide farms with a historical record that will allow them to more readily detect changes and react in a timely manner to protect public health.
With respect to comments suggesting that the requirements for agricultural water assessments will not be more effective at protecting public health than
the 2015 pre-harvest agricultural water testing requirements, we disagree. As discussed further in response to comment 3, there are various limitations associated with testing, including that: the presence of indicators does not always signal the presence of pathogens, and the absence of detection of indicators does not guarantee that pathogens are absent (Refs. 27-30) (80 FR 74354 at 74428). Moreover, since sampling frequency and location relative to the source of contamination are reported to affect the performance of generic
E. coli
as an indicator of fecal contamination (Refs. 31 and 32), non-detection of generic
E. coli
cannot be considered absolute confirmation that fecal contamination has not occurred (80 FR 74354 at 74428). In light of these challenges, testing may inadvertently provide farms with a false sense of security as to the quality of their water, potentially resulting in farms not taking action where necessary to protect public health. Moreover, as discussed in response to comment 11, rather than relying on results of a multi-year rolling profile that might not always reflect a need for mitigation or elicit a timely reaction from farms to address potential hazards (Ref. 7), the approach we are finalizing here establishes requirements for measures that are directly responsive to the conditions identified as part of an assessment and requires that farms implement those measures within specific timeframes based on risk.
As noted in comment 11, our FRIA (Ref. 26) indicates that the increase in costs associated with this rule compared to the 2015 pre-harvest agricultural water testing requirements is largely a result of more mitigation occurring in response to findings from pre-harvest agricultural water assessments than as a result of the previous testing requirements. As also discussed in the FRIA, we estimate likely greater benefits under the requirements we are finalizing here, with more mitigation occurring in response to assessment findings than in response to the testing approach in the 2015 produce safety final rule.
(Comment 2) Some comments support the proposed requirements for pre-harvest agricultural water assessments, and further suggest that agricultural water assessments should be required for all agricultural water, including treated water, water from public water sources, water used for harvest and post-harvest activities, and for sprout irrigation water.
(Response 2) In light of these comments, we considered removing the proposed exemptions from the requirement to prepare an agricultural water assessment, including for water meeting certain requirements applicable to harvest and post-harvest agricultural water (proposed § 112.43(b)(1)); water from public water systems or supplies meeting certain requirements (proposed § 112.43(b)(2)); and agricultural water treated in accordance with § 112.46 (proposed § 112.43(b)(3)). However, we ultimately determined that eliminating the exceptions was not necessary, for the reasons described below.
Section 419 of the FD&C Act directs FDA to establish science-based minimum standards, including procedures, processes, and practices that are reasonably necessary to prevent introduction of hazards and provide reasonable assurances produce is not adulterated under section 402 of the FD&C Act. Subpart E of the 2015 produce safety final rule establishes requirements that are broadly applicable to all agricultural water—namely, the requirement in § 112.41 that all agricultural water must be safe and of adequate sanitary quality for its intended use, and the requirements in § 112.42 related to inspections and maintenance of agricultural water systems to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces and prevent the systems from being a source of contamination to covered produce, food contact surfaces, or areas used for a covered activity. We consider applying these requirements to all agricultural water (including that used during pre-harvest, harvest, and post-harvest activities, even if an exemption from other provisions in subpart E applies) as commensurate with the risk associated with the use of agricultural water for the growing, harvesting, packing and holding of covered produce.
With respect to comments about water from public water supplies, in the U.S., Public Water Systems are required under U.S. Environmental Protection Agency (EPA) National Primary Drinking Water Regulations (NPDWR) in 40 CFR part 141 to provide safe, clean water suitable for drinking and thus are at the lowest likelihood for pathogen contamination (Ref. 17). Similarly, public water supplies that meet the microbial requirement in § 112.44(a) are included in the exemption under proposed § 112.43(b)(2) (final § 112.45(b)(1)(ii)) to accommodate other public water supplies that are not governed by the requirements of the EPA drinking water program, but provide water of a quality that meets the microbial requirement of § 112.44(a). See also 78 FR 3504 at 3571. Given the nature of Public Water Systems and public water supplies meeting these requirements and the low likelihood of pathogen contamination of such systems, we consider it appropriate to exempt farms using such water sources as pre-harvest agricultural water for non-sprout covered produce from the requirement to prepare an agricultural water assessment under § 112.43 provided all requirements are met (including that the farm have results or certificates of compliance demonstrating that relevant requirements are met). (See § 112.45(b)(1)(ii) and by reference, § 112.44(c).) In light of the nature of these water sources, we have concluded that to require farms to prepare an agricultural water assessment for such water sources would be more than a science-based minimum standard as described in section 419 of the FD&C Act. We also note that the exemption for public water systems or public water supplies meeting the requirements in § 112.45(b)(1)(ii) is consistent with the exemption from the pre-harvest agricultural water testing requirements in the 2015 produce safety final rule as well as the exemption at § 112.44(c)(1) and (2) from the requirement to test agricultural water used for sprout irrigation and for harvest and post-harvest activities for covered produce.
In consideration of the risks associated with agricultural water uses outlined in § 112.44(a) (including harvest and post-harvest agricultural water), we have also established requirements in subpart E specific to those uses. This includes a stringent microbial quality criterion of no detectable generic
E. coli
per 100 mL of agricultural water and a prohibition on the use of untreated surface water (§ 112.44(a)). We established requirements applicable to the water uses specified in § 112.44(a) in the recognition that such water uses have high potential to serve as a vehicle of fecal contamination because if fecal contamination is present (along with the corresponding potential for pathogen presence), it is reasonably likely it could be transferred directly to covered produce through direct or indirect (via food-contact surfaces) contact with the agricultural water. See 80 FR 74354 at 74440. Moreover, we have established requirements in subpart E that are specific to agricultural water treatment. Specifically, § 112.46 establishes requirements related to treatment efficacy, delivery, and monitoring to ensure that treated agricultural water is safe and of adequate sanitary quality for its intended use and/or meets the relevant microbial quality criterion in
§ 112.44(a), as applicable. We also note that with respect to treated agricultural water, an exemption for water treated in accordance with § 112.46 is consistent with the exemption from the pre-harvest agricultural water testing requirements in the 2015 produce safety final rule as well as the exemption at § 112.44(c)(3) from the requirement to test agricultural water used for sprout irrigation and for harvest and post-harvest activities for covered produce.
We consider the requirements in subpart E that apply for agricultural water treatment, agricultural water used for sprout irrigation and harvest and post-harvest activities on covered produce, and public water systems and public water supplies meeting the requirements in § 112.44(c) to be reasonable and appropriate based on the risk associated with such water sources and practices. We do not consider it necessary or appropriate to require farms to prepare an agricultural water assessment for such water sources and practices, as doing so would be more than a science-based minimum standard as described in section 419 of the FD&C Act. Thus, we decline the request in the comments to broaden the provisions for agricultural water assessments in § 112.43 to apply to all agricultural water.
(Comment 3) While supportive of the general proposed approach for pre-harvest agricultural water assessments, some comments suggest that all farms should be required to test their pre-harvest agricultural water as one part of their agricultural water assessments. Several of these comments suggest that mandatory testing with assessments for all farms would help with objectivity and provide more certainty for farms and regulators. Some comments suggest that if testing is not required for all farms as part of an agricultural water assessment, farms may avoid testing water, lest the results show a need for treatment or other mitigation. Some comments suggest that farms should only be exempt from testing as part of an agricultural water assessment if they can demonstrate that testing is not necessary for public health purposes.
Conversely, some comments express support for what they consider to be a flexible approach to testing in the proposed rule, noting that they found the testing requirements in the 2015 produce safety final rule to be inflexible, expensive, cumbersome, and not risk-based. Some of these comments suggest that testing should not be required for all situations, and that mandatory testing for all farms would create unnecessary economic hardship for farms.
(Response 3) In light of these comments, we considered adding a requirement for all farms to test their pre-harvest agricultural water as one part of their agricultural water assessments. We considered the additional burden that would be imposed on farms by such a requirement and the impacts on public health that might result. For the reasons discussed below, we have concluded that a requirement for all farms to test their pre-harvest agricultural water as part of an assessment would be more than a minimum standard and more than what is reasonably necessary to prevent introduction of hazards and provide reasonable assurances produce is not adulterated under section 402 of the FD&C Act. Thus, we are retaining the requirements for agricultural water assessments and risk-tiered outcomes as proposed, including a requirement in § 112.43(c)(4) to test pre-harvest agricultural water as part of an assessment in certain circumstances.
First, a requirement for all farms to test pre-harvest agricultural water as one part of an assessment is not necessary given the nature of the potential sources of hazards for which immediate action is most critical to protect public health. For example, if a farm's agricultural water system was impacted by the presence of dead sheep in a canal or discharge of untreated sewage into a river, the outcome in § 112.43(c)(1), which requires immediate discontinuation of the relevant use(s) of the water and corrective measures prior to resuming that use, would apply, and agricultural water test results would be unlikely to provide information suggesting that those steps would not be appropriate or necessary to protect public health.
Moreover, requiring all farms to test in such circumstances could undermine public health protections by inadvertently providing farms with a false sense of security as to the quality of their water, potentially resulting in farms not taking action where necessary to protect public health. For example, throughout rulemaking for the 2015 produce safety final rule, we discussed the role of water testing when it comes to understanding and managing water quality, including various challenges with using test results as a direct indicator of the safety agricultural water (78 FR 3504 at 3561-3563; 80 FR 74354 at 74427-74428). Of particular note, we discussed that the presence of indicators does not always signal the presence of pathogens, and the absence of detection of indicators does not guarantee that pathogens are absent (Refs. 27-30). We also discussed that since sampling frequency and location relative to the source of contamination are reported to affect the performance of generic
E. coli
as an indicator of fecal contamination (Refs. 31 and 32), non-detection cannot be considered absolute confirmation that fecal contamination has not occurred. 80 FR 74354 at 74428. We emphasized that we viewed the 2015 requirement outlining the GM and STV criteria as a water management tool for use in understanding the microbial quality of water over time and determining how to appropriately use water from that source, rather than as a direct indicator of the safety or adequacy of the sanitary quality of water for its immediate purposes. 80 FR 74354 at 74430. Further, we acknowledged that while testing water for pathogens allows for direct targeting of microorganisms in water that are a risk to public health, it can also present significant challenges, including those associated with large sample sizes, high costs, and the wide array of potential target pathogens (
i.e.,
the presence or absence of one pathogen may not predict for the presence or absence of other pathogens). See response to comment 91 and 80 FR 74354 at 74427-74428.
Indeed, these challenges with using water test results as a direct indicator of water safety, particularly when it comes to surface water sources, have long been recognized, even before FDA initiated rulemaking to establish the 2015 produce safety final rule (see 78 FR 3504 at 3561-64 and 3567-71 and references cited therein, for example). However, despite the historical record of these challenges, comments received for the current rulemaking indicate that some farms continue to believe that, even under the assessment framework, agricultural water test results should alone dictate the level of risk associated with a water system and whether action related to the farm's pre-harvest agricultural water is warranted (see comment 96). As such, we are concerned that—particularly in circumstances where quick action is most critical to protect public health (
i.e.,
those situations that would lead to the outcomes in § 112.43(c)(1) or (2))—a requirement for all farms to test their water as part of an assessment would result in some farms using test results inappropriately to justify not taking action, to the detriment of public health. Further, a requirement for all farms to test pre-harvest agricultural water as part of an assessment could undermine public health protections by 1) delaying discontinuance and necessary corrective action for water that is not safe or of
adequate sanitary quality for the intended use(s) (per § 112.43(c)(1)), and 2) delaying prompt implementation of mitigation measures to address conditions related to animal activity, BSAAOs, or the presence of untreated or improperly treated human waste on adjacent or nearby lands (per § 112.43(c)(2)).
Of particular note, when testing agricultural water, it can take time to develop a plan, collect samples, test the samples, and analyze the results in the context of the other information evaluated as part of an assessment—particularly when a farm is collecting samples over time to better understand the effects of certain conditions on water quality. As a result, if a farm initially identified a potential source of hazards as part of its assessment and were then to test the farm's agricultural water to better understand that condition, it could delay steps the farm takes to protect public health. This would be particularly problematic when it comes to conditions for which the outcomes in § 112.43(c)(1) and (2) are appropriate. While we considered whether to require farms to immediately discontinue the relevant use of the water until they have agricultural water test results demonstrating safety of the water, we determined that this, too, would not be in the best interest of public health due to the challenges discussed above with using testing results as a direct indicator of the safety of the water and that doing so may result in farms inappropriately using test results to justify not implementing necessary measures.
Moreover, we emphasize that for some farms, a requirement to test their pre-harvest agricultural water as one part of an assessment would impose significant burden without necessarily leading to additional public health benefits. For example, in preparing an agricultural water assessment, a farm that uses water from a pond as pre-harvest agricultural water might find that the pond is at a higher elevation than the surrounding land, and that conditions, such as large numbers of animals, are not present that would be reasonably likely to introduce known or reasonably foreseeable hazards. Depending on the circumstances, the farm might determine, along with the other factors evaluated under § 112.43(a), that the outcome in § 112.43(c)(3) is appropriate and that measures under § 112.45 are not reasonably necessary to reduce the potential for contamination of covered produce (other than sprouts) or food contact surfaces. Because test results would be unlikely to change the farm's determination in this (and similar) situations, and because the farm would not be implementing measures as a result of its assessment findings, requiring the farm to test would impose significant burden on the farm without providing added public health benefit.
In light of the concerns discussed above that a requirement for all farms to test their pre-harvest agricultural water as part of an assessment would provide farms with a false sense of security as to the quality of their pre-harvest agricultural water; delay or preclude action most critical to protect public health; and impose significant burden on farms without commensurate public health benefits, we have concluded that a requirement for all farms to test their pre-harvest agricultural water as part of an assessment would be more than a minimum standard and more than what is reasonably necessary to prevent introduction of hazards and provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act.
(Comment 4) Some comments suggest that farms should be subject to different requirements depending on the risk associated with their crop, water source, or water use practices (such as the method and timing of water application). For example, several comments suggest that farms that grow certain low-risk crops or that use low-risk irrigation methods should be exempt from preparing an agricultural water assessment and/or from testing their agricultural water. Some comments suggest that farms growing low-risk crops and using low-risk water sources should be allowed to choose whether to conduct agricultural water testing, agricultural water systems inspections under § 112.42(a), or a combination of the two, while those growing higher-risk covered produce or using higher-risk water should be required to conduct both.
(Response 4) This rule, and the produce safety rule of which it is a part, acknowledges and differentiates requirements as appropriate based on the varying risks presented by different crops, water sources, and water use practices. For example, the requirements for agricultural water in subpart E do not apply to water that is not intended to, or not likely to, contact covered produce or food-contact surfaces because we previously concluded that applying the requirements in subpart E to such water is more than what is reasonably necessary for us to require to achieve statutory purposes set forth in section 419 of the FD&C Act (that is, it is not reasonably necessary to apply the requirements to such water to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated). 80 FR 74254 at 74429.
However, we decline to establish differing requirements for pre-harvest agricultural water based on crop, water source, and/or agricultural water use practices alone.
5
The QAR (Ref. 17) concluded that using crop physical characteristics alone seems to be a poor indicator of which commodities are at a greater or lesser likelihood of contamination that may lead to a foodborne illness outbreak. Rather, the specific conditions and practices associated with a produce commodity also influence the potential routes of contamination and the likelihood that a given route could lead to contamination and illness. Additionally, with respect to water sources, the QAR (Ref. 17) concluded that the microbial quality of source water is one of the key determinants in assessing the relative likelihood of contamination attributable to agricultural water. While noting that surface waters pose the highest potential for contamination and the greatest variability in quality of the agricultural water sources, the QAR also concluded that though less likely to be contaminated than surface water, ground water continues to pose a public health risk, despite the regulation of many U.S. public wells under the Ground Water Regulation. Moreover, ground water sources (such as some wells) may contain deficiencies which, if left uncorrected, can result in hazards being introduced to the water source (Ref. 17).
5
We note that because sprouts present a unique safety risk, the final 2015 produce safety final rule established sprout-specific requirements on multiple topics, including agricultural water. The agricultural water requirements for sprouts are different from the agricultural water requirements for other produce commodities (for example, sprout irrigation water is subject to the microbial criterion and testing requirements in § 112.44(a) and (b)).
While we continue to include agricultural water systems, water use practices, and crop characteristics as factors that farms must consider as part of their pre-harvest agricultural water assessments under § 112.43, we emphasize that this information must be considered in concert with the other factors of the systems-based assessment identified in § 112.43(a)(1) through (5). While we have incorporated testing agricultural water as part of a pre-harvest agricultural water assessment under § 112.43(c)(4), farms must not rely on test results alone in making decisions around the safe use of their agricultural
water. Rather, results from pre-harvest agricultural water testing serve as an additional source of information for farms to consider alongside the other factors evaluated in § 112.43(a)(1) through (5) in making a determination as to whether measures under § 112.45 are reasonably necessary to reduce the potential for contamination of covered produce or food contact surfaces with biological hazards associated with agricultural water. See also response to comment 83.
(Comment 5) Several comments request that FDA modify various requirements (such as the requirements for mitigation measures in § 112.45(b), and the definition of “agricultural water assessment” in § 112.3) so that farms may consider strategies or other practices already being implemented to control hazards with respect to agricultural water.
(Response 5) We agree that strategies or practices a farm is already implementing to control potential hazards may affect whether a condition is reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces. Further, farms must consider such strategies or practices in complying with various agricultural water requirements. For example, farms must consider the degree of protection of their agricultural water system under § 112.43(a)(1); this includes a situation in which a farm has a berm established that prevents runoff (which may contain hazards) from being introduced to an agricultural water system. As another example, farms must consider their agricultural water practices under § 112.43(a)(2); this includes a situation in which a farm only applies agricultural water from a certain water source to non-sprout covered produce early in the growing season. Farms must consider the relevant strategy or practice, along with the other information evaluated under § 112.43(a)(1) through (5), in determining 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. As farms must consider such strategies or practices they are currently implementing in complying with the requirements for pre-harvest agricultural water assessments, we do not consider it necessary to revise the requirements related to agricultural water to further emphasize the point.
(Comment 6) Several comments seek clarity on what is expected of farms in terms of assessing water that is outside the scope of “agricultural water.” A few comments express concern that in some of the outbreaks cited in the 2021 agricultural water proposed rule, the water used to grow the produce would not have been subject to the requirements in the proposed rule.
(Response 6) We define agricultural water in § 112.3, in part, as “water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food-contact surfaces.” If a specific use of water does not fit within the definition of agricultural water, then the requirements in subpart E, including those for pre-harvest agricultural water assessments for non-sprout covered produce, do not apply to that specific use of water. See 80 FR 74354 at 74429.
With respect to comments related to the outbreaks referenced in the 2021 agricultural water proposed rule (86 FR 69120 at 69125-69127) (Refs. 18-23), we acknowledge that a definitive source or route of contamination of the implicated produce could not always be determined. Nevertheless, findings from these outbreaks underscore the potential impacts of adjacent and nearby land uses on agricultural water, which we designed the requirements for pre-harvest agricultural water assessments, in part, to address. See 86 FR 69120 at 69125-69127 and responses to comment 16 and comment 56.
(Comment 7) A few comments state that produce contamination can be attributed to more than agricultural water (
e.g.,
airborne transmission or long-term persistence in soil) and request that FDA include these other methods of pathogen transmission in the proposed rule.
(Response 7) We agree that produce can become contaminated through various routes, including those other than water (Ref. 17). As such, the 2015 produce safety final rule focuses on major routes of microbial contamination—including agricultural water; biological soil amendments; domesticated and wild animals; worker health and hygiene; and equipment, buildings, and tools. This rulemaking, however, focuses specifically on certain requirements in Subpart E of that regulation relating to agricultural water.
(Comment 8) A few comments argue that the scope of the proposed rule is too narrow and FDA should include chemicals and biological toxins in the requirements for agricultural water assessments, since, the comments suggest, these agents pose a potential toxic disease risk to humans. Some comments seek clarity regarding what testing, if any, is expected for non-microbial contaminants, such as heavy metals and chemicals.
(Response 8) We disagree with suggestions to expand the scope of hazards covered by the rule. Section 419(c)(1)(A) of the FD&C Act requires that the 2015 produce safety final rule set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards and to provide reasonable assurances that the produce is not adulterated under section 402 of the FD&C Act. This language provides FDA with discretion to determine what procedures, processes, and practices are “reasonably necessary” for the purposes identified in the statute with respect to the identified types of hazards.
As discussed in the 2015 produce safety final rule, FDA carefully considered different types of hazards and determined that the available data and information clearly establish that human pathogens constitute a biological hazard with the potential to cause serious adverse health consequences or death and result in the vast majority of foodborne illness known to be associated with produce consumption. On that basis we concluded that it was appropriate to establish the 2015 produce safety final rule to cover biological hazards and science-based standards necessary to minimize the risk of serious adverse health consequences or death associated with biological hazards (80 FR 74354 at 74377). Foodborne illness attribution data reported by the Interagency Food Safety Analytics Collaboration (IFSAC) (Refs. 33-35), a tri-agency group created by the Centers for Disease Control and Prevention (CDC), FDA, and U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service, reinforce the significance of biological hazards in produce. See also comment 13.
As further explained in the 2015 final rule, although the potential exists for physical or chemical (including radiological) hazards to contaminate produce, our analysis led us to conclude that non-biological hazards associated with produce rarely pose a risk of serious adverse health consequences or death for individuals that would consume the product. Chemical and physical hazards in produce: (1) occur only rarely at levels that can pose a risk of serious adverse health consequences
or death (
e.g.,
radiological contamination as a result of a nuclear power plant accident); (2) occur with greater frequency, but rarely at levels that can pose a risk of serious adverse health consequences or death (
e.g.,
pesticide or mycotoxin residues); or (3) occur infrequently and usually do not pose a risk of serious adverse health consequences or death (
e.g.,
physical hazards). Moreover, there are other programs in place for monitoring and/or controlling physical and chemical hazards that may contaminate produce. These programs include FDA's routine monitoring of chemical and pesticide residues, other FDA efforts (such as Closer to Zero to address environmental contaminants in food
6
), EPA's registration of pesticides, and various State and industry initiatives. In light of the severity and frequency of occurrence of these hazards in produce, and the existing regulatory structures that apply to these hazards, we concluded that it was not reasonably necessary to establish controls for physical or chemical hazards in the 2015 produce safety final rule. See 80 FR 74354 at 74376-74379.
6
See “Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods” at
https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods
.
We note that comments on the 2021 agricultural water proposed rule did not include data or other information demonstrating a need to expand the scope of the pre-harvest agricultural water requirements for covered produce other than sprouts to include chemical and physical hazards, nor is FDA aware of any such data or information. Therefore, we conclude that expanding the scope of the pre-harvest agricultural water requirements for covered produce other than sprouts is not reasonably necessary.
(Comment 9) Some comments seek clarity on which requirements of Subpart E the proposed rule supersedes or replaces.
(Response 9) As finalized with this rule, we are reorganizing subpart E in its entirety to group similar requirements. We note in particular that with this final rule, we are replacing §§ 112.44(b) and 112.46(b) in the 2015 produce safety final rule (microbial criteria and testing requirements, respectively, for pre-harvest agricultural water for covered produce other than sprouts) with requirements for written pre-harvest agricultural water assessments. While the requirement numbers may have changed for agricultural water used for sprouts; agricultural water used during harvesting, packing, and holding activities; and for treatment of agricultural water, this final rule does not substantively alter those standards as established in part 112, subpart E.
Table 3 summarizes the major changes made to the agricultural water provisions in subpart E between the 2015 produce safety final rule and this final rule, including the location of the relevant requirements. The second column does not reflect technical edits made to provisions that were designed to provide added clarity (for example, edits to add descriptive headings). While not reflected in the table below, conforming changes are also being made to §§ 112.12, 112.151, and 112.161(b) in light of our revisions to the microbial water quality criteria in § 112.44(b), the microbial die-off (calculated log reduction) rate in § 112.45(b), and the testing requirements in § 112.46(b) as set forth in the 2015 produce safety final rule. As discussed in sections V.A., we received no comments on these conforming changes and are finalizing them without changes.
Table 3—Summary of Changes Made to Subpart E Requirements Since the 2015 Produce Safety Final Rule
Subpart E provisions in the 2015 produce safety final rule
Changes made with this final rule
Location of relevant provision as established with this final rule
§ 112.41: All agricultural water must be safe and of adequate sanitary quality for its intended use
None
§ 112.41.
§ 112.42: Regularly inspect and maintain all agricultural water systems and implement measures to reduce potential for contact between covered produce and pooled water
None
§ 112.42.
§ 112.43: If treating agricultural water, ensure that the treatment is effective and that treatment is delivered and monitored appropriately
None
§ 112.46.
§ 112.44(a): Ensure that water used for certain purposes (for example, for sprouts and for harvest and post-harvest uses) contains no detectable generic
E. coli
per 100 mL and not use untreated surface water for such purposes
None
§ 112.44(a).
§ 112.44(b): Ensure that water used during pre-harvest activities for covered produce (other than sprouts) meets a GM of 126 generic
E. coli
per 100 mL and a STV of 410 generic
E. coli
per 100 mL
Replaced with provisions for pre-harvest agricultural water assessments and risk management determinations, with a requirement to test in certain circumstances
§ 112.43.
§ 112.45(a): Immediately discontinue use (and take corrective measures prior to resuming use) if water is not safe or is not of adequate sanitary quality or if the microbial criterion of no detectable generic
E. coli
per 100 mL is not met for certain uses of water
None
§ 112.45(a).
§ 112.45(b): Implement risk-reduction measures as soon as practicable but no later than the following year if the GM and STV microbial criteria in § 112.44(b) are not met for pre-harvest water uses for non-sprout covered produce
Removed pre-harvest microbial criteria and revised to account for pre-harvest agricultural water assessments; expanded measures to include the flexibility to change the water application method to reduce the likelihood of contamination of covered produce or to use an alternative mitigation measure; added expedited timing for mitigation related to certain uses of adjacent and nearby lands
§ 112.45(b).
§ 112.46(a): There is no requirement to test if farms can demonstrate that water: comes from a Public Water System that meets Safe Drinking Water Act regulations; comes from a public water supply that meets the microbial criterion in § 112.44(a); or is treated in accordance with § 112.43
Added similar exemptions from the requirements for a written pre-harvest agricultural water assessment
§ 112.44(c) for exemptions from testing water for uses specified in § 112.44(a); § 112.43(b) for exemptions from requirements for pre-harvest agricultural water assessments.
§ 112.46(b): For untreated surface water sources used for pre-harvest applications for non-sprout covered produce, establish an initial MWQP with ≥20 samples collected over 2-4 years and update with ≥5 samples per year thereafter; for untreated ground water sources, establish an initial MWQP with ≥4 samples collected over 1 year and update with ≥1 sample per year thereafter
Replaced with provisions for pre-harvest agricultural water assessments, with a requirement to test in certain circumstances
§ 112.43.
§ 112.46(c): For untreated ground water used for certain uses in § 112.44(a), initially test ≥4 samples over the course of 1 year and ≥1 sample per year thereafter
None
§ 112.44(b).
§ 112.47: Ensure that testing is done by the farm or other entity or third-party acting on its behalf, and that water samples be aseptically collected and tested using a method set forth in § 112.151
None
§ 112.47.
§ 112.48: For water used during harvest, packing, and holding activities, ensure that: water is managed as necessary (such as by establishing and following water change schedules); water is visually monitored for buildup of organic material; and an appropriate temperature differential between the commodity and the water is maintained and monitored
None
§ 112.44(d).
§ 112.49: For pre-harvest water for non-sprout covered produce, farms may establish alternative microbial criteria, sampling frequencies for untreated surface water sources, or die-off rates between last direct water application and harvest so long as certain requirements are met
Replaced with provision allowing for alternative mitigation measures to those listed in § 112.45(b)(1)(i) through (v)
§ 112.45(b)(1)(vi).
§ 112.50: Maintain certain records related to the farm's agricultural water, including test results
Added recordkeeping requirements related to pre-harvest agricultural water assessments; conforming changes to remove records related to microbial criteria and testing for pre-harvest agricultural water
§ 112.50.
2. Scientific and Public Health Support
(Comment 10) Some comments express concern that FDA lacks scientific support for the proposed rule. Of these, some comments raise general concerns about the state of the science on pre-harvest agricultural water quality as a basis for rulemaking. Other comments focus on the science relating to specific requirements, such as the assessment of crop characteristics, environmental conditions, and potential impacts of cattle operations on adjacent and nearby land, as well as the application of a pre-harvest time interval as a mitigation measure. These include comments focused on how farms will implement the rule with an emphasis on the need for scientific research reflecting real-world conditions for farms in various circumstances.
(Response 10) We disagree with the suggestion that the requirements for pre-harvest agricultural water assessments and risk-tiered outcomes lack scientific support. We address comments on the scientific support for specific provisions in relevant sections of this document. See, for example, comment 16 for discussion of comments of the scientific evidence on potential risks posed by cattle operations and other animal activities on adjacent and nearby lands. We address comments on the scientific support for crop characteristics and environmental conditions as assessment factors in comment 63 and comment 68, respectively. Comment 114 discusses comments on the scientific basis for the 4-day pre-harvest time interval as a mitigation measure.
FDA outlined the history of contamination associated with produce, predominantly during growing, harvesting, packing, and holding, during the rulemaking to establish the 2015 produce safety final rule in part 112. See, for example, 78 FR 3504 at 3507 and 80 FR 74354 at 74731. As part of that rulemaking, we also developed a peer-reviewed QAR, which provides a scientific evaluation of the potential adverse health effects resulting from human exposure to microbiological hazards in produce, including from contaminated water used in growing, harvesting, packing, and holding activities (Ref. 17). With respect to water used during growing, harvesting, and post-harvesting activities, the QAR concludes in part that agricultural water can be a source of contamination of produce and that the microbial quality of source waters, method of application, and timing of application are key determinants in assessing relative likelihood of contamination attributable to agricultural water use practices. The QAR also concludes that while different commodities may have different risk profiles at different stages of production, all commodities have the potential to become contaminated through one or more of the routes identified, especially if practices are poor and/or conditions are insanitary. See also 86 FR 69120 at 69128.
Scientific information has also become available since FDA issued the 2015 produce safety final rule indicating potential limitations in basing risk management decisions on the previous pre-harvest agricultural water testing requirements. For example, various studies indicate a high degree of variability in generic
E. coli
levels in surface waters (Refs. 5-10), which can reduce the precision of estimation of the GM and STV of a water source (Refs. 1, 7). Additionally, a scientific evaluation of the 2015 pre-harvest agricultural water testing requirements found that the rolling data set of five samples per year used to update GM and STV values for untreated surface water sources results in highly uncertain results and delays in detecting shifts in water quality (Ref. 7). Specifically, Havelaar et al. found that the 20-sample MWQP for untreated surface water was not sufficient to reliably characterize the quality of the irrigation water with higher variability in generic
E. coli
levels than assumed in the 2015 produce safety final rule. In simulation modeling, the rolling 20-sample MWQP responded “very slowly” to shifts in water quality. Increases in generic
E. coli
levels were detected only after one to six sample sets, thus delaying signals of changes in water quality and (and any needed measures) by one to six years depending on the nature and magnitude of the shift. Havelaar et al. suggested that additional understanding of the processes that drive variability in the
quality of irrigation water sources might inform preventive or rapid corrective actions that have a larger impact on produce safety than the 2015 pre-harvest agricultural water requirements.
Moreover, we have extensively discussed other information that has become available since 2015, such as findings from several produce-related outbreak investigations, that support this rulemaking. In particular, in the 2021 agricultural water proposed rule, we discussed: (1) the spring 2018
E. coli
O157:H7 outbreak linked to romaine lettuce from the Yuma growing region (Refs. 18 and 19); (2) the fall 2018
E. coli
O157:H7 outbreak linked to romaine lettuce from California (Ref. 20); (3) the fall 2019
E. coli
O157:H7 outbreaks linked to romaine lettuce (Ref. 21); (4) the fall 2020
E. coli
O157:H7 outbreak linked to leafy greens (Ref. 22); and (5) the summer 2020
Salmonella
Newport outbreak linked to red onions (Ref. 23); that highlight the importance of pre-harvest agricultural water quality and the potential impacts of adjacent and nearby land uses on agricultural water. These outbreak investigations underscore decades of scientific research demonstrating that pre-harvest agricultural water is a potential contributing factor in the introduction and spread of contamination to produce. 86 FR 69120 at 69125-69127. We also discussed foodborne illness attribution data reported by IFSAC (Ref. 33), a triagency group created by the CDC, FDA, and the USDA Food Safety and Inspection Service, that reinforce the significance of biological hazards in produce. 86 FR 69120 at 69127. See also comment 13.
Comments did not indicate what data or information they considered to be lacking or provide information that alters FDA's conclusions made in light of the information referenced above. As such, we have concluded that the scientific information available supports this rulemaking and are finalizing the requirements for pre-harvest agricultural water assessments for non-sprout covered produce. However, we recognize that additional information on the requirements for agricultural water in subpart E will help support farms as they work to come into compliance. We provide information on the agricultural water requirements throughout this final rule, and, to the extent that certain requirements are not substantively changing with this rulemaking (such as the requirements in § 112.42 for agricultural water system inspection and maintenance), in the preamble to the 2015 produce safety final rule. Additionally, we recognize the need to provide farms with education, outreach and technical assistance to facilitate compliance with the rule, and we intend to pursue various mechanisms, such as publishing guidance, holding webinars, and developing other educational resources, including work with other stakeholders (such as State agencies, educators, and extension agents), to do so.
(Comment 11) Some comments express concern that FDA changed the pre-harvest microbial quality and testing requirements in the 2015 produce safety final rule in response to industry concerns, rather than in an effort to improve public health.
(Response 11) We are issuing this final rule having determined that it will enhance public health protections by setting forth requirements for comprehensive, systems-based agricultural water assessments evaluating a broad range of factors that may impact the quality of pre-harvest agricultural water to assist farms in identifying and managing risks using appropriate corrective and mitigation measures, including expedited mitigation in certain circumstances. As discussed in the proposed rule, this comment response, and elsewhere in this rule, these revisions to the 2015 produce safety final rule reflect findings of our QAR (Ref. 17), new information we have gathered since publication of the 2015 produce safety final rule (including findings from several produce-related outbreaks), as well as information and feedback from an array of stakeholders, including the produce industry, educators, researchers, and regulators. As discussed in response to comment 1, we continue to conclude that the requirements for systems-based agricultural water assessments and risk-management determinations are consistent with our mandate to establish science-based minimum standards for the safe production and harvesting of produce to minimize the risk of serious adverse health consequences or death. As such, we disagree with comments suggesting that we are making these revisions to the 2015 produce safety final rule in response to industry concerns alone, and not in an effort to improve public health.
As part of rulemaking for the 2015 produce safety final rule, we developed a peer-reviewed QAR (Ref. 17), which provides a scientific evaluation of the potential adverse health effects resulting from human exposure to microbiological hazards in produce, including from contaminated water used in growing, harvesting, packing, and holding activities (Ref. 17). In part, the QAR discusses that public drinking water is generally considered the least likely to serve as a source of contamination, followed by ground water, surface water protected from runoff, and surface water unprotected from runoff. The QAR also notes that where contamination in a water source is known to exist, the likelihood of contamination is a function of contact with the commodity (example, whether contact is indirect or direct); commodity effects (characteristics) (for example, whether the surface is conducive to adhesion); and application timing (for example, early or late in crop growth). These factors—the water source, method and timing of water application, and commodity characteristics—are all reflected in the requirements for comprehensive agricultural water assessments under § 112.43(a) due to the impact they can have on risk associated with pre-harvest agricultural water use.
Further, findings from investigations of several outbreaks linked to consumption of produce that have occurred since 2015 (Refs. 18-23) highlight the importance of pre-harvest agricultural water quality and the potential impacts of adjacent and nearby land uses on agricultural water. These outbreak investigations underscore decades of scientific research demonstrating that pre-harvest agricultural water is a potential contributing factor in the introduction and spread of contamination to produce. 86 FR 69120 at 69125-69127. Findings from our investigations into these outbreaks also informed the requirements that we are finalizing here—in particular, the requirement in § 112.43(c)(2) for expedited mitigation for conditions related to animal activity, BSAAOs, and untreated or partially treated human waste associated with adjacent and nearby lands.
With respect to feedback from stakeholders in the regulated community, as described further in response to comment 14, we designed the requirements for pre-harvest agricultural water assessments, in part, by taking into account the realities of many agricultural operations that resulted in the 2015 pre-harvest agricultural water testing requirements being challenging, and in some cases, impossible, for farms to implement. For example, while the long-term MWQPs required in the 2015 produce safety final rule can be difficult, and even impossible, to establish for farms that grow rotational crops or on leased land, we have incorporated flexibility in the requirements for the once-annual assessments we are finalizing with this rule to allow farms to account for these realities, which will assist farms in better evaluating and making decisions
regarding the use of pre-harvest agricultural water as appropriate to their unique operations and circumstances.
However, we emphasize that this rule is reflective of information and insights from stakeholders beyond just the regulated industry. For example, the pre-harvest agricultural water requirements were the focus of a 2-day Agricultural Water Summit, convened by the Produce Safety Alliance, in February 2018 (Ref. 4). The summit was attended by academics, produce industry, growers/grower associations, State agencies, Federal agencies, and supporting industries. During the summit, participants had many questions and concerns about water testing, what the information tells them about risks, and how to use that information to make water use management decisions. Participants also had questions about the generic
E. coli
-based standards in the 2015 produce safety final rule and suggested that the testing frequency required to establish a MWQP for surface or ground water sources lacked the necessary science to support its relevance to public health outcomes. Many of the discussions at the summit addressed hazards in the growing environment, including examples of how risk assessment has been conducted in other fields of study, such as for drinking water and wastewater management. During the summit, participants identified “agricultural water assessments” as a promising approach for managing water quality, suggesting that assessments may provide a more effective risk management strategy to farms than a numerical testing standard can provide.
Additionally, information has become available since issuing the 2015 produce safety final rule indicating potential limitations in basing risk management decisions on the previous pre-harvest agricultural water testing requirements. For example, various studies indicate a high degree of variability in generic
E. coli
levels in surface waters (Refs. 5-10), which can reduce the precision of estimation of the GM and STV of a water source (Refs. 1, 7). Other studies have further contributed to our knowledge about the limitations of generic
E. coli
as an indicator for pathogen presence (Refs. 11-16). Further, a scientific evaluation of the 2015 pre-harvest agricultural water testing requirements found that the rolling data set of five samples per year used to update GM and STV values for untreated surface water sources results in highly uncertain results and delays in detecting shifts in water quality (Ref. 7). Havelaar et al. suggested that while increasing the number of samples might address these issues, doing so would increase costs and would not be an effective or efficient way to control the microbial quality of agricultural water sources. Rather, they suggested, additional understanding of the processes that drive variability in the quality of irrigation water sources might inform preventive or rapid corrective actions that have a larger impact on produce safety than the 2015 pre-harvest agricultural water requirements (Ref. 7).
While we established the 2015 pre-harvest agricultural water testing requirements as a long-term strategy to ensure that farms understand the quality of their water, pay attention to changes that may affect water quality, and make appropriate decisions about use of that water (80 FR 74354 at 74458), we recognize that if farms focus too heavily on results of microbial testing and whether quantitative metrics are met, they may be left with a false sense of security as to the quality of their water, and as a result, not investigate for conditions that may warrant further action to protect public health. Indeed, rather than relying on results of a multi-year rolling profile that might not always reflect a need for mitigation or elicit a timely reaction from farms to address potential hazards (Ref. 7), the approach we are finalizing here establishes requirements for measures that are directly responsive to the conditions identified as part of an assessment and requires that farms implement those measures within specific timeframes based on risk. Further, as our FRIA indicates (Ref. 26), the increase in costs associated with this rule compared to the 2015 pre-harvest agricultural water testing requirements is largely a result of more mitigation occurring in response to findings from pre-harvest agricultural water assessments than as a result of the previous testing requirements. As also discussed in the FRIA, we estimate likely greater benefits under the requirements we are finalizing here, with more mitigation occurring in response to assessment findings than in response to the testing approach in the 2015 produce safety final rule.
In light of the foregoing, we disagree with comments suggesting that we are replacing the previous pre-harvest agricultural water testing requirements with requirements for agricultural water assessments and risk-management determinations in response to industry concerns alone, and not in an effort to improve public health. We continue to consider it appropriate to pursue an alternative approach to the 2015 pre-harvest agricultural water testing requirements that protects public health and is adaptable for use in diverse circumstances. As such, with this rule, we are replacing the pre-harvest agricultural water testing requirements in the 2015 produce safety rule for covered produce other than sprouts with requirements for systems-based agricultural water assessments that are designed to achieve improved public health protections, while also being more feasible to implement across the wide variety of agricultural water systems, uses, and practices, and adaptable to future advancements in agricultural water quality science.
3. Options for Regulatory Approach
(Comment 12) A few comments suggest that issuing guidance would be a more appropriate approach to addressing pre-harvest agricultural water than rulemaking.
(Response 12) As discussed in the 2021 agricultural water proposed rule, FDA considered various options to address stakeholder concerns about complexity and practical implementation challenges with the pre-harvest agricultural water testing requirements in the 2015 produce safety final rule, one of which entailed developing additional guidance to support the requirements that were outlined in the 2015 produce safety final rule. We concluded that issuing additional guidance alone would not adequately address the practical implementation issues associated with the pre-harvest agricultural testing requirements in the 2015 produce safety final rule. For example, we contemplated issuing additional guidance to describe circumstances in which farms might satisfy the pre-harvest sampling and testing requirements through shared data with other farms. However, there are several limitations with this option, including challenges related to establishing data-sharing arrangements and difficulties in establishing such programs given the diversity of agricultural water systems and the 2015 requirements related to sample collection timing. Moreover, guidance alone could not overcome difficulties related to rotational crops or growing non-sprout covered produce on leased land, in which a farm may not be using (or have access to) the same water source over multiple years. See also response to comment 14. Further, while subpart P of the 2015 produce safety final rule allows requests for variances from one or more requirements of part 112, under § 112.171, only States, Federally recognized tribes, or countries from which food is imported into the
United States are able to make such a request. See 86 FR 69120 at 69129.
Comments received on the 2021 agricultural water proposed rule do not provide new information on overcoming these practical implementation challenges through the issuance of guidance alone. As such, we have concluded that guidance alone would not adequately address the practical implementation issues associated with the pre-harvest agricultural testing requirements in the 2015 produce safety final rule.
(Comment 13) Some comments state that FDA did not directly address why the option to conduct a risk assessment and research followed by rulemaking was not chosen, suggesting that the Agency moved forward with the proposed rule despite lacking sufficient information.
(Response 13) As discussed in the 2021 agricultural water proposed rule, FDA considered whether to conduct another risk assessment, followed by a rulemaking to revise the pre-harvest agricultural water testing requirements. We also considered whether to issue guidance on pre-harvest agricultural water based on industry standards while additional research is conducted, followed by rulemaking to revise the pre-harvest agricultural water testing requirements. For the reasons discussed below, we continue to conclude that it is not necessary for additional risk assessment or research to take place before conducting or finalizing this rulemaking.
As part of the rulemaking to establish the 2015 produce safety final rule in part 112, we developed a peer-reviewed QAR, which provides a scientific evaluation of the potential adverse health effects resulting from human exposure to microbiological hazards in produce, including from contaminated water used in growing, harvesting, packing, and holding activities (Ref. 17). In considering the option to conduct a risk assessment or additional research followed by a rulemaking to revise the pre-harvest agricultural water testing requirements, FDA reviewed the conclusions of the QAR. With respect to water used during growing, harvesting, and post-harvesting activities, the QAR concludes as follows:
• Agricultural water can be a source of contamination of produce.
• Public drinking water systems (domestically regulated by the EPA) have the lowest relative likelihood of contamination due to existing standards and routine analytical testing.
• Though less likely to be contaminated than surface water, ground water continues to pose a public health risk, despite the regulation of many U.S. public wells under the Ground Water Regulation.
• There is a significant likelihood that U.S. surface waters will contain human pathogens, and surface waters pose the highest potential for contamination and the greatest variability in quality of the agricultural water sources.
• Susceptibility to runoff significantly increases the variability of surface water quality.
• Water that is applied directly to the harvestable portion of the plant is more likely to contaminate produce than water applied by indirect methods that are not intended to, or not likely to, contact produce.
• Proximity of the harvestable portion of produce to water is a factor in the likelihood of contamination during indirect application.
• Timing of water application in produce production before consumption is an important factor in determining likelihood of contamination.
• Commodity type (growth characteristics,
e.g.,
near to ground) and surface properties (
e.g.,
porosity) affect the probability and degree of contamination.
• Microbial quality of source waters, method of application, and timing of application are key determinants in assessing relative likelihood of contamination attributable to agricultural water use practices.
The QAR (Ref. 17) discusses that potential contributing factors cited in produce-associated outbreaks where water was identified as the likely source of contamination include runoff from nearby animal pastures and feed lots, raw sewage, and surface waters contaminated with feces (Ref. 36).
We have also considered scientific information that has become available since issuing the 2015 produce safety final rule indicating potential limitations in basing risk management decisions on the previous pre-harvest agricultural water testing requirements. For example, various studies indicate a high degree of variability in generic
E. coli
levels in surface waters (Refs. 5-10), which can reduce the precision of estimation of the GM and STV of a water source (Refs. 1, 7). Other studies have contributed to our knowledge about the limitations of generic
E. coli
as an indicator for pathogen presence (Refs. 11-16). Further, a scientific evaluation of the 2015 pre-harvest agricultural water testing requirements found that the rolling data set of five samples per year used to update GM and STV values for untreated surface water sources results in highly uncertain results and delays in detecting shifts in water quality (Ref. 7). Havelaar et al. suggested that additional understanding of the processes that drive variability in the quality of irrigation water sources might inform preventive or rapid corrective actions that have a larger impact on produce safety than the 2015 pre-harvest agricultural water requirements.
In addition to the findings from the QAR and scientific information on the previous pre-harvest agricultural water testing requirements that has become available since 2015, we considered conclusions from the 2019 IFSAC report (Ref. 33), and more recently, the 2020 and 2021 IFSAC report (Refs. 34 and 35, respectively), which reinforce the significance of biological hazards in produce. We also considered FDA's experience with investigations of produce-related outbreaks that occurred since we issued the 2015 produce safety final rule (Refs. 18-23), which underscore the importance of pre-harvest agricultural water quality and highlight the potential impacts of adjacent and nearby land uses on agricultural water, which can serve as a route of contamination of produce. 86 FR 69120 at 69125-69127. These sources of information helped to inform the requirements we are finalizing here—in particular, the requirement for expedited mitigation for known or reasonably foreseeable hazards related to certain activities associated with adjacent or nearby lands in light of findings from several produce outbreak investigations—and further support the conclusions of our QAR (Ref. 17). See also response to comment 10.
Commenters did not indicate what data or information they felt was lacking regarding the option to conduct an additional risk assessment, nor did they provide information demonstrating that our conclusions in the proposed rule regarding that option were inappropriate. Therefore, we continue to conclude that it is not necessary for FDA to conduct an additional risk assessment or research before conducting rulemaking to establish new pre-harvest agricultural water standards. Further, given that the requirements for assessments are well-grounded in science, we do not consider it necessary to establish interim guidance based on industry standards in lieu of the requirements we are finalizing here.
While we do not consider it necessary to conduct additional risk assessment or research in order to establish standards for pre-harvest agricultural water, we note that the requirements for agricultural water assessments are designed, in part, to be adaptable to scientific advancements. To the extent
that risk assessment and/or additional research related to pre-harvest agricultural water may continue to develop in the future, farms may use such information as an additional resource to further inform their agricultural water assessments under the approach we are finalizing here.
(Comment 14) A few comments express a preference for pre-harvest agricultural water testing requirements in the 2015 produce safety final rule compared to the proposed pre-harvest agricultural water assessments because, the comments suggest, many farms have already worked towards compliance with the 2015 testing requirements.
(Response 14) We understand that not all farms may have faced challenges with the pre-harvest microbial quality and testing requirements in the 2015 produce safety final rule. However, in light of frequent, consistent feedback from industry stakeholders regarding challenges associated with the pre-harvest microbial quality and testing requirements, as well as information and insights from other relevant stakeholders (such as academic researchers), findings of our QAR (Ref. 17), and new information gathered since publication of the 2015 produce safety final rule, we concluded that the most appropriate regulatory approach is to undertake rulemaking. See 86 FR 69120 at 69129-69130. As discussed further in response to comment 10, we continue to consider it appropriate to pursue and finalize an alternative approach that is adaptable for use in diverse circumstances. Thus, we are finalizing requirements for pre-harvest agricultural water assessments that are designed to achieve improved public health protections, while also being more feasible to implement across the wide variety of agricultural water systems, uses, and practices, and adaptable to future advancements in agricultural water quality science. We designed the requirements for pre-harvest agricultural water assessments to be flexible to account for the diversity of water systems, commodities, and operations that exist across industry, which included, as discussed below, taking into account the realities of many agricultural operations that resulted in the 2015 pre-harvest agricultural water testing requirements being challenging, and in some cases, impossible, for farms to implement.
For example, feedback on the 2015 pre-harvest agricultural water testing requirements indicated that long-term MWQPs can be difficult, and even impossible, to establish for farms that grow rotational crops or on leased land, both of which are widespread throughout the produce industry (Refs. 3 and 4). It has further been suggested that the financial investment needed to develop a long-term profile for a water source that is only used every few years may not result in commensurate food safety benefits (Ref. 4). Conversely, the requirements for once-annual assessments that we are finalizing here incorporate flexibility to allow farms to account for these realities. Such flexibility will assist farms in better evaluating and making decisions regarding the use of pre-harvest agricultural water as appropriate to their unique operations and circumstances, allowing risk-management decisions to be made even in the absence of historical knowledge of a water system. See also comment 35.
Farms with multiple water sources, for example, would face significant logistical challenges in complying with the 2015 testing requirements, since separate MWQPs would be required for each source (Ref. 4). These challenges would be particularly difficult to navigate for farms that grow multiple types of covered produce using different water application timings, given the 2015 requirements for samples to be representative of use and collected as close in time as practicable to, but prior to, harvest. As discussed further in response to comment 34, while we acknowledge that farms using multiple agricultural water systems during pre-harvest activities for covered produce (other than sprouts) will need to conduct an assessment for each system, several of the factors evaluated in the assessment might be similar across agricultural water systems, thus limiting the amount of information a farm needs to collect and consider. Further, the pre-harvest agricultural water assessments enable farms to focus on the key determinants of contamination risks, without doing so in a way that will add significant burden to stakeholders.
Additionally, while data-sharing is one way that implementation challenges associated with 2015 pre-harvest agricultural water testing requirements may have been reduced, such data-sharing programs among multiple parties could be difficult (or impossible) to establish due to the aforementioned 2015 requirements for samples to be representative of use and collected close to harvest (Refs. 3 and 4). Conversely, the requirements for pre-harvest agricultural water assessments were built to be flexible enough for farms to consider and adjust for their unique circumstances without having to rely on others' actions in order to make use of the inherent flexibility. Moreover, because farms that test their water in accordance with § 112.43(c)(4)(ii) will be testing to better understand a narrow set of circumstances using an approach that incorporates greater flexibility related to sample collection requirements, concerns about testing burden associated with the 2015 pre-harvest agricultural water testing requirements are largely addressed with this rule.
Thus, although we recognize that some farms may not have faced practical implementation challenges with the 2015 pre-harvest agricultural water testing requirements, we continue to conclude that the requirements for pre-harvest agricultural water assessments achieve public health protections, while also being more feasible to implement across the diversity of farms and their agricultural water systems, uses, and practices. To the extent that some farms may be testing their pre-harvest agricultural water using the 2015 (or other) approach, we emphasize that nothing in this rule precludes them from continuing to do so, as long as they also comply with the requirements we are finalizing here, as applicable.
4. Responsibility
(Comment 15) Some comments, while generally supportive of the proposed pre-harvest agricultural water assessments, voice concern that farms will be required to account for and manage hazards that are outside the farm's control (for example, hazards that may be introduced by other water users or adjacent and nearby land uses). Some comments indicate that the Clean Water Act (CWA) requires State and/or Federal governments to hold polluters accountable, suggesting that it is therefore unjust to place that responsibility on farms. One comment suggests that irrigation districts should not allow livestock to graze in open drains, as doing so will introduce risk for downstream users who do not have control over that activity.
(Response 15) We recognize that farms may have little or no control over factors such as weather events, other water users, and adjacent and nearby lands. However, considering factors such as these, which may affect the quality of water source(s) even though they are not necessarily under a farm's control, is an important part of evaluating whether a farm's water source(s) meets the requirement in § 112.41 that agricultural water must be safe and of adequate sanitary quality for its intended use. Considering these factors under § 112.43(a), will help farms determine the appropriate and safe use of the agricultural water from their water source(s).
Further, we recognize that the CWA (33 U.S.C. 1251
et seq.
) establishes the basic structure for regulating discharges of pollutants into the waters of the United States and regulating quality standards for surface waters (Ref. 37). Under the CWA, the EPA has implemented pollution control programs and developed national water quality criteria recommendations for pollutants in surface waters. We recognize that hazards may be introduced into an agricultural water system under conditions that may or may not be covered by the CWA and that in many instances, this may occur before an agricultural water system comes under a farm's control. We emphasize that farms are not required to mitigate such hazards at the location where they originate, nor are farms expected to take action against other entities that may be introducing contaminants into a water system. Rather, farms are required to assess potential impacts from activities on nearby and adjacent lands and/or other water users on the quality of their agricultural water and, as appropriate, implement measures that are under the farm's control to reduce the risk associated with that water source or system to protect public health. For example, depending on the circumstances, this might entail the use of earthen berms on land that is under the farm's control to divert runoff from a nearby land use from entering the farm's surface water source. See also response to comment 105.
Additionally, we recognize the need to provide farms with outreach and education to facilitate compliance with the rule, including in those situations where hazards may originate outside of a farm's control. We are also aware of efforts underway to bring together members of agricultural communities on a large scale to further conversations and encourage discussions between land users in agricultural areas. For example, the California Agricultural Neighbors (CAN) Initiative is designed to provide an opportunity to foster collaboration and discuss enhanced neighborly food safety practices when various agricultural operations such as leafy green fields, cattle ranches, vineyards and compost sites are adjacent to one another (Ref. 38). Various action items have been identified as part of CAN, one of which entails steps that can be taken to foster neighbor-to-neighbor interactions and conversations (Ref. 39). See also response to comment 33. As efforts such as these progress, farms may consider participating as an additional means to help address crosscutting food safety issues.
(Comment 16) Some comments suggest that cattle producers will be negatively impacted by the requirement that farms assess the use of nearby and adjacent land. These comments suggest that the proposed rule implies that adjacent or nearby cattle operations increase food safety risks for produce farms without sufficient scientific justification. Comments also request clarification that cattle operations are not required to change practices in order to assist produce farms in complying with the rule.
(Response 16) As discussed in the 2021 agricultural water proposed rule (86 FR 69120 at 69135-69136), it is well established in the literature that animal activities on adjacent and nearby lands—including grazing, livestock operations, and wildlife intrusion—may introduce contamination to surface and ground water through runoff and through direct access by animals to waterways (Refs. 40-43). Moreover, we discussed in the proposed rule various produce related outbreaks (Refs. 18-22) in which investigators noted presence of concentrated animal feeding operations (CAFOs) or cattle grazing operations as potential sources of contamination to agricultural water systems and covered produce. See 86 FR 69120 at 69125-69127. In light of this information and findings from several produce related outbreaks, we consider it important for farms to evaluate animal impacts and activities in identifying conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce (other than sprouts) or food contact surfaces as part of their agricultural water assessments.
We acknowledge the longstanding colocation of animals and plant food production systems in agriculture and note that this rule does not prohibit the presence of animals on or near a farm, nor does it establish requirements or responsibilities for entities other than farms covered by the rule. Rather, the rule requires a farm to conduct an agricultural water assessment for hazard identification purposes and take any measures that are reasonably necessary to reduce the potential for contamination of non-sprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with its pre-harvest agricultural water. This may involve, for example, the farm implementing measures that are within its control, such as changing the method of water application under § 112.45(b) to reduce the likelihood of contamination of the covered produce.
5. Other Food Safety Standards
(Comment 17) Several comments note that many farms are already subject to third-party water quality standards that some produce farms follow. Comments seek clarity on whether the proposed rule aligns with these standards and, if some third-party standards are more stringent than FDA's regulation, whether an audit to those standards could be used to meet the rule's requirements.
(Response 17) We acknowledge the important role third-party standards may play in ensuring food safety and questions about alignment of FDA's produce safety rule requirements and third-party standards. For example, in 2018, FDA and USDA announced the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements in the 2015 produce safety final rule (Ref. 44), which preceded both the 2021 agricultural water proposed rule and this final rule. In the announcement, we explained that while the requirements of both programs are not identical, the relevant technical components in the 2015 produce safety final rule are covered in the USDA H-GAP Audit Program. We also explained that the alignment will help farms by enabling them to assess their food safety practices as they prepare to comply with the produce safety rule. However, we also noted that USDA audits are not a substitute for FDA or state regulatory inspections.
In October 2023, FDA announced the final results of a voluntary pilot program on alignment of private third-party food safety audit standards with applicable FDA regulations (Ref. 45). It included a third-party primary production standard for non-sprout produce that we found to be in alignment with applicable provisions of the produce safety regulation—except for the subpart E agricultural water requirements that were excluded from the review as they were under reconsideration through this rulemaking. Our conclusion from the pilot is that FDA currently does not have adequate resources to review and evaluate the alignment of third-party food safety standards beyond the pilot—notwithstanding the value that such standards may have in facilitating industry's implementation of FSMA and the potential of these audits to inform risk prioritization. FDA will continue to assess future opportunities but is unable to undertake any additional alignment reviews at this time, including review of third-party standards for pre-harvest
agricultural water for non-sprout produce.
Finally, as a general matter, a determination of alignment alone does not indicate that a farm audited to that standard is necessarily in compliance with the 2015 produce safety final rule. While a determination of alignment may help farms as they prepare to comply with requirements in the 2015 produce safety final rule, as discussed above, audits conducted under third-party standards found to be in alignment are not a substitute for FDA or State regulatory inspections.
(Comment 18) Some comments seek clarity on whether the proposed approach for pre-harvest agricultural water assessments is intended to be similar to a HACCP approach.
(Response 18) As discussed in response to comment 1, the annual pre-harvest agricultural water assessments employ a prevention-oriented quality-systems approach to food safety regulation that FDA has long used for the highly diverse food industry that FDA regulates. For example, FDA's juice HACCP regulation (21 CFR part 120), seafood HACCP regulation (21 CFR part 123), and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), establish frameworks under which industry qualitatively assesses, and as necessary, controls, potential hazards as appropriate to their operations. While we believe that a HACCP approach—particularly at the level required in parts 120, 123, and 117—would not necessarily be appropriate at the farm level (80 FR 74354 at 74379), many of the principles of HACCP can still be applied, such as an assessment of risk and the development of a food safety plan based on that assessment, and we have incorporated elements such as these within the requirements for pre-harvest agricultural water assessments in § 112.43.
6. Other Comments
(Comment 19) A few comments note the phrasing in the proposed rule that assessments are designed to be “adaptable to future advancements in agricultural water quality science” and express concerns that this language implies that FDA will make significant implementation decisions in the future without public discussion and input. A few comments seek clarity on whether and how emerging science or additional information relevant to agricultural water assessments will be incorporated into trainings.
(Response 19) We acknowledge that water quality science is expected to evolve over time, and we have designed the rule to achieve improved public health protections, while also being feasible to implement across the wide variety of agricultural water systems, uses, and practices, and adaptable to future scientific advancements. For example, we discuss in response to comment 115 that as more studies are conducted that examine in-field die-off for various circumstances (for example, different regions, environmental conditions, commodities, pathogens, and crop growth characteristics) (Refs. 46-49), farms may use that information to inform a time interval between last direct water application and harvest under § 112.45(b)(1)(ii). We anticipate that as new information becomes available, it will be shared with farms and other interested stakeholders through various mechanisms, including guidance in accordance with our good guidance practices regulation, 21 CFR 10.115, which generally provides an opportunity for public comment before a guidance document is finalized.
Additionally, new information and scientific advancements will likely be incorporated into training programs and other education and outreach materials in order to increase awareness by farms. For example, we are aware that food safety trainings intended to be specific to certain commodities (or commodity groups) have been held, which could be a mechanism in the future by which information relevant to specific commodities will be shared. We are also aware of research organizations and universities that prioritize sharing their findings with the produce industry and related stakeholders. We also expect that as new science relates to region-specific considerations, local extension agents will play an important role in disseminating that information to interested parties.
(Comment 20) A few comments express concerns that the rule will result in farms increasing their reliance on ground water sources, which could be in conflict with the goals of certain state laws designed to help protect ground water resources. For example, some comments suggest that the exemption from the requirements to prepare an agricultural water assessment in proposed § 112.43(b)(1) related to untreated ground water will incentivize farms to make greater use of already-stressed resources. Several comments suggest that changing from surface water to ground water as a way to reduce risk associated with agricultural water may be difficult for some farms due to existing conservation laws.
(Response 20) We are not requiring farms to change their water sources, either for the purposes of an exemption from the requirements to prepare a pre-harvest agricultural water assessment or as a mitigation measure. Rather, we have incorporated flexibility to provide farms viable options to reduce the potential for contamination of non-sprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with pre-harvest agricultural water without needing to alter the source of agricultural water. See also response to comment 124.
In the Environmental Impact Statement (EIS) that was prepared during rulemaking for the 2015 produce safety final rule (Ref. 50), we discussed that, based on our qualitative analysis, we did not consider impacts to water resources to be significant, with the potential exception related to ground water withdrawal, where existing significant adverse long-term impacts (
i.e.,
water drawdown, potential subsidence, and the related continued degradation of water quality) may continue to be exacerbated as a result of excessive ground water use.
We also noted that we did not anticipate that the approach taken for pre-harvest agricultural water in the 2015 produce safety final rule (
i.e.,
microbial criteria consisting of a GM and STV, with various actions a farm may take if the GM and/or STV are exceeded) would result in farms on a regional or national scale switching to ground water sources. For example, stakeholder feedback indicated that allowing for microbial die-off between last irrigation and harvest and/or microbial reduction or removal resulting from post-harvest practices provides farms viable options to meet the microbial quality criteria without needing to, for example, treat water or switch to a ground water source (Ref. 50).
Under this rule, those mitigation measures remain available as options. Further, with this rule we are incorporating additional mitigation measures beyond those in the 2015 produce safety final rule to provide farms with even more flexibility in ways to manage risks associated with pre-harvest agricultural water. (Specifically, this rule adds mitigation measures for changing the method of water application or taking an alternative mitigation measure in accordance with § 112.45(b)(1)(iv) and (vi), respectively.). We have provided various options for mitigation measures encompassing a range of possible costs (see the FRIA (Ref. 26)) to provide farms with
flexibility in managing risks associated with their agricultural water as appropriate to their agricultural water systems, water use practices, and unique circumstances. Given the various options farms have under this rule, including options that involve more targeted changes (such as making necessary repairs to agricultural water systems), we do not expect farms to preferentially alter the source of their agricultural water as a mitigation measure or for the purposes of an exemption from the requirements to prepare a pre-harvest agricultural water assessment.
As discussed in the Agency's finding of no significant impact for the current rulemaking and the evidence supporting that finding (Refs. 51-53), the potential number of farms that could switch to ground water, potentially exacerbating drawdown, would be reduced compared with the 2015 produce safety final rule with the revisions to the subpart E provisions we are finalizing here (Ref. 50). No significant adverse environmental impacts have been identified with this rule. See also section VIII.
(Comment 21) FDA received several comments related to conservation practices and environmental protection programs, which generally appear to be out of scope. Specifically, commenters urge FDA to encourage the co-management of food safety, conservation, and environmental protection. A few comments request that guidance and training on the rule for covered farms and inspectors acknowledge that animals and covered farms can co-exist, noting that this is especially important when it comes to conservation practices and/or diversified farms. In addition, one comment discusses state programs providing incentives for farmers to implement climate and environmentally friendly agricultural practices, such as use of energy-efficient irrigation systems, healthy soil practices (such as compost application), and establishment of seasonal and/or permanent vegetation for pollinators and wildlife. The comment expresses concern that farms may not participate in such environmental stewardship programs if doing so might be in conflict with the proposed requirements for pre-harvest agricultural water assessments. Further, comments recommend that FDA work with stakeholders to develop solutions that will help farmers co-manage such environmental sustainability goals with food safety.
(Response 21) As indicated, FDA considers these comments to generally be outside the scope of this rulemaking. However, to the extent they are in scope, FDA acknowledges the longstanding co-location of animals and plant food production systems in agriculture. 80 FR 74354 at 74482. As discussed in the 2021 agricultural water proposed rule, this rule does not prohibit the presence of animals (such as grazing animals or working animals) on a farm, nor does it require the destruction of wildlife habitat or the clearing of farm borders. Rather, the rule requires farms to evaluate and take measures to prevent the introduction of known or reasonably foreseeable hazards into or onto non-sprout covered produce or food contact surfaces by pre-harvest agricultural water. 86 FR 69120 at 69135.
Additionally, as discussed in the 2015 produce safety final rule, we continue to encourage the co-management of food safety, conservation, and environmental protection. We consider it important to take into account the environmental practice standards and policies of other agencies in the context of food safety. 80 FR 74354 at 74365. We believe that the provisions of part 112 are consistent with existing conservation and environmental practice standards and policies and are not in conflict with Federal or State programs. In addition, § 112.84, which we did not propose to change, codifies a statement that the requirements of part 112 do not require or permit the use of practices in violation of the Endangered Species Act (16 U.S.C. 1531-1544), and that the regulation does not require the use of practices that may adversely affect wildlife, such as removal of habitat or wild animals from land adjacent to produce fields. 80 FR 74354 at 74365.
C. Definitions (§ 112.3)
We proposed to add two new definitions for “agricultural water assessment” and “agricultural water system” in § 112.3 to provide clarity for terminology used in the proposed requirements for pre-harvest agricultural water assessments. We received several comments on those proposed definitions and respond to comments about these definitions in the following paragraphs. We are finalizing the definitions for “agricultural water assessment” and “agricultural water system” as proposed, without changes.
1. Agricultural Water Assessment
(Comment 22) Several comments express support for the definition of “agricultural water assessment,” noting that the assessment, as defined, provides broad, science-based flexibility so as to be applicable to a wide variety of growing scenarios. One comment suggests the definition be revised to include an assessment of the severity of illness and injury from the hazard and the probability that the hazard will occur. Another comment recommends that FDA clarify in its definition of “Agricultural Water Assessment” that the assessment must be in written form.
(Response 22) We considered these comments, and as discussed below, are finalizing the definition of “agricultural water assessment” as proposed, without changes. An “agricultural water assessment” means an evaluation of an agricultural water system, agricultural water practices, crop characteristics, environmental conditions, and other relevant factors (including test results, where appropriate) related to growing activities for covered produce (other than sprouts) to: (1) identify any condition(s) that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces and (2) determine whether measures are reasonably necessary to reduce the potential for contamination of covered produce or food contact surfaces with such known or reasonably foreseeable hazards (§ 112.3).
With respect to comments suggesting the definition be revised to capture the severity of illness and injury from the hazard and the probability that the hazard will occur, we note that as discussed in response to comment 27 and comment 76, the requirements for agricultural water assessments provide a mechanism through which farms evaluate the risk associated with their pre-harvest agricultural water and use that information to determine whether measures are reasonably necessary to reduce the potential for contamination of non-sprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with pre-harvest agricultural water. See also comment 18, where we discuss comments related to HACCP. As such, we do not consider this a necessary change to make. In response to comments suggesting that the definition of “agricultural water assessment” be revised to clarify that the assessment must be in written form, we note that § 112.43(a) already specifies that farms “must prepare a written agricultural water assessment” and that § 112.50(b)(2) requires farms to maintain a record of that agricultural water assessment. Therefore, we also do not consider this a necessary change to make. As such, we are finalizing the definition of “agricultural water assessment” as proposed, without changes.
2. Agricultural Water System
(Comment 23) Several comments support the proposed definition of “agricultural water system,” suggesting that the proposed definition helps provide clarity. In reference to farms that draw agricultural water from systems that span long distances (such as canals), a few comments suggest that the definition of “agricultural water system” be revised to better account for the point at which the water comes under the farm's control.
(Response 23) We reviewed comments for the proposed definition of “agricultural water system” and agree that it will provide stakeholders with additional clarity that will be helpful, for example, to farms in determining the scope of where and what to inspect and maintain under § 112.42 and for those farms required to conduct a pre-harvest agricultural water assessment pursuant to § 112.43.
With respect to the comment requesting we revise the definition of “agricultural water system” to provide limitations regarding the point at which the
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