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This proposed rulemaking would revise certain requirements for agricultural water in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation for covered produce other than sprouts.

Statement of Need:

Agricultural water can be a major conduit of pathogens that can contaminate produce. Recent produce outbreaks potentially linked to agricultural water have emphasized the importance of ensuring that FDA’s agricultural water standards are workable across the diversity of domestic and foreign farms and account for the variety of factors that impact water sources and uses. FDA plans to amend its produce safety regulation to address concerns about the practical challenges of implementing certain agricultural water requirements, while protecting the public health.

Summary of the Legal Basis:

FDA’s authority for issuing this proposed rule is provided by 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)), as amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), and sections 311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C. 243, 264, and 271). Specifically, this proposed rulemaking would amend certain agricultural water requirements in the produce safety regulation, codified at 21 CFR part 112, and issued under the following authorities: Section 419(a) of the FD&C Act (21 U.S.C. 350h(a)) authorizes 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 such standards minimize the risk of serious adverse health consequences or death. Section 419(a)(3) of the FD&C Act (21 U.S.C. 350h(a)(3)) further requires that these minimum standards provide sufficient flexibility and be appropriate to the scale and diversity of the production and harvesting of such commodities. Section 402(a)(3) of the FD&C Act (21 U.S.C. 342(a)(3)) provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)) provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Additionally, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants the authority to promulgate regulations for the efficient enforcement of the FD&C Act. Sections 311, 361, and 368 of the PHS Act (21 U.S.C. 243, 264, and 271), provide authority for FDA to issue regulations to prevent the spread of communicable diseases from one State to another.

Alternatives:

Alternatives include: (1) issuing additional guidance to assist farmers in complying with the existing agricultural water requirements in the produce safety regulation; (2) conducting another risk assessment (in addition to the risk assessment supporting the 2015 produce safety final rule) or additional research before rulemaking; (3) engaging in rulemaking to address the identified implementation challenges, based on the existing risk assessment and the extensive information gathered since publication of the 2015 produce safety final rule.

Anticipated Costs and Benefits:

FDA anticipates cost savings of the proposed rule resulting from changes to certain agricultural water requirements in the produce safety regulation. Our primary estimates of annualized net costs are approximately $3 million in cost savings at a 7 percent discount rate.

The benefits of this proposed rule, if finalized, would generate unquantified benefits stemming from increasing flexibility and addressing practical implementation challenges associated with certain agricultural water provisions in the produce safety regulation.

Risks:

Produce commodities caused nearly 60% of E. coli O157 illnesses and 40% of Salmonella illnesses in 2017, based on estimates of the Interagency Food Safety Analytics Collaboration. Agricultural water can be a major conduit for produce contamination. This proposed rule is intended to address the practical implementation challenges of certain agricultural water requirements, while protecting public health by setting forth standards to minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce, and provide reasonable assurances that the produce is not adulterated on account of those hazards.