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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
regulation relating to pre-harvest agricultural water for covered produce, other than sprouts, while retaining the existing standards applicable to agricultural water for sprouts and for harvest and post-harvest activities conducted by covered farms. These changes are consistent with our authority in sections 402, 419, and 701a of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C.
342, 350h, and 371a 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.

TABLE 1TABLE OF ABBREVIATIONS
AND ACRONYMSContinued Abbreviation or acronym
What it means
MWQP
PRIA

Microbial Water Quality Profile Preliminary Economic Analysis of Impacts Notice of Proposed Rulemaking Qualitative Assessment of Risk Recreational Vehicle Recreational Water Quality Criteria Safe Drinking Water Act Shiga toxin-producing E. coli Statistical Threshold Value U.S. Department of Agriculture Ultraviolet Whole genome sequencing World Health Organization
NPRM
QAR
RV
RWQC
SDWA
STEC
STV
USDA
UV
WGS
WHO

D. Costs and Benefits We estimate costs of this proposed rule, if finalized. Our primary estimates of annualized costs are approximately $11.3 million at a 3 percent discount rate and approximately $11.2 million at a 7 percent discount rate over 10 years.
We estimate benefits of this proposed rule, if finalized. Our primary estimates of annualized benefits are approximately $9.9 million at a 3
percent discount rate and approximately $9.6 million at a 7 percent discount rate over 10 years. If finalized, the qualitative benefits of the rule would stem from increased flexibility for covered farms to comprehensively evaluate their pre-harvest agricultural water systems for non-sprout covered produce. These changes are being proposed, in part, to address practical implementation challenges of the current pre-harvest agricultural water testing requirements.
II. Table of Abbreviations and Acronyms Commonly Used in This Document
TABLE 1TABLE OF ABBREVIATIONS
AND ACRONYMS
Abbreviation or acronym
What it means
AMS
BSAAO

Agricultural Marketing Service Biological Soil Amendment of Animal Origin Concentrated Animal Feeding Operation Centers for Disease Control and Prevention Colony-Forming Units Codex Alimentarius Commission Environmental Assessment Escherichia coli Environmental Protection Agency Executive Order Federal Food, Drug, and Cosmetic Act FDA Food Safety Modernization Act Good Agricultural Practices Geometric Mean Interagency Food Safety Analytics Collaboration Leafy Greens Marketing Agreement Milliliters
CAFO

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CDC
CFU
Codex
EA
E. coli
EPA
E.O.
FD&C Act
FSMA
GAP
GM
IFSAC
LGMA
mL

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III. Background A. FDA Food Safety Modernization Act The FDA Food Safety Modernization Act FSMA Pub. L. 111353, 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 nations food safety system by shifting the focus from responding to foodborne illness to preventing it.
FSMA enables FDA to establish a prevention-oriented framework that focuses effort where food safety hazards are reasonably likely to occur and is flexible and practical in light of current scientific knowledge and food safety practices. The law also provides enforcement authorities for responding to food safety problems when they do occur. In addition, FSMA gives FDA
important tools to help ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities, as well as foreign regulatory counterparts.
FDA has issued seven foundational rules that create risk-based standards and provide oversight at various points in the supply chain for domestic and imported human and animal food. The produce safety regulation is one of the seven foundational rules.
B. Produce Safety Regulation In November 2015, FDA finalized the produce safety regulation, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. In accordance with section 419 of the FD&C Act, the produce safety regulation sets forth procedures, processes, and practices to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or
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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 contaminationincluding agricultural water; biological soil amendments; domesticated and wild animals; worker health and hygiene;
and equipment, buildings, and tools.
The regulation established requirements for covered produce, defined in 112.3 as produce that is subject to the requirements of this part in accordance with 112.1 and 112.2.
It includes a produce RAC that is grown domestically and a produce RAC that will be imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico 112.1.
Covered produce refers to the harvestable or harvested portion of the crop. 112.3. Farms subject to the requirements are described in 112.4.
Subpart E of the produce safety regulation includes a general requirement that agricultural water must be safe and adequate for its intended uses 112.41. It also includes microbial water quality criteria 112.44 and requirements for testing certain water sources 112.46. The microbial quality criteria are based on the intended use of the agricultural wateri.e., for growing activities for covered produce other than sprouts including irrigation water applied to covered produce, other than sprouts, using a direct water application method and water used in preparing crop sprays, and for certain other specified uses, including sprout irrigation water and water applications that directly contact covered produce during or after harvest.2
Covered farms must establish a microbial water quality profile 112.46b for certain pre-harvest agricultural water for non-sprout covered produce, by calculating two numerical values of generic E. coli in their water samples: A geometric mean GM a measure of central tendency of a water quality distribution and a statistical threshold value STV a measure of variability of a water quality distribution, derived as a model-based 2 Because sprouts present a unique safety risk, the produce safety regulation establishes sproutspecific requirements on multiple topics, including agricultural water. Sprouts are not subject to the Subpart E compliance date extension that applies to other covered produce.

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