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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules Regarding the information collection:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

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Table of Contents I. Executive Summary A. Purpose and Coverage of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations and Commonly Used Acronyms in This Document III. Background A. FDA Food Safety Modernization Act B. Produce Safety Regulation C. Stakeholder Concerns Regarding Certain Pre-Harvest Agricultural Water Requirements D. Recent Outbreaks E. Recent Information on Relative Food Safety Risks of Produce IV. Legal Authority V. Need for Regulatory Action and Proposed Regulatory Approach A. Option A: Additional Guidance on Subpart E
B. Option B: Risk Assessment/Research Followed by Rulemaking C. Option C: Retaining the Pre-Harvest Agricultural Water Requirements for Covered Produce Other Than Sprouts D. Option D: Rulemaking To Revise Certain Provisions of the Produce Safety Regulation VI. Description of the Proposed Rule A. Scope of the Rulemaking B. Consistency With National Organic Program C. Definitions Proposed 112.3
D. Applicability Proposed 112.40
E. Pre-Harvest Agricultural Water Assessments Proposed 112.43
F. Mitigation Measures Proposed 112.45
G. Records Requirements for Pre-Harvest Agricultural Water Assessments Proposed 112.50
H. Conforming Changes Proposed 112.12, 112.151, and 112.161
I. Other Amendments Proposed 112.42, 112.44, and 112.46112.49
VII. Online Tool VIII. Proposed Effective and Compliance Dates IX. Preliminary Economic Analysis of Impacts X. Analysis of Environmental Impact XI. Paperwork Reduction Act of 1995
XII. Federalism XIII. Consultation and Coordination With Tribal Governments XIV. References
I. Executive Summary A. Purpose and Coverage of the Proposed Rule FDA is proposing to amend the Standards for the Growing, Harvesting,
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Packing, and Holding of Produce for Human Consumption rule 80 FR
74354, November 27, 2015 2015
produce safety final rule, which implemented section 105 of the FDA
Food Safety Modernization Act FSMA
Pub. L. 111353 and established science-based minimum standards for the safe production and harvesting of fruits and vegetables for human consumption codified at part 112 21
CFR part 112. This proposed rule would revise certain provisions in the produce safety regulation applicable to agricultural water for produce subject to the requirements of part 112 covered produce other than sprouts, using a direct application method during growing activities commonly referred to as pre-harvest agricultural water.1
The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges described more fully in section III.C. by replacing certain pre-harvest agricultural water testing requirements with provisions for comprehensive pre-harvest agricultural water assessments that would help farms identify potential sources of contamination and effectively manage their water. The proposed agricultural water assessments would offer flexibility for farms subject to the requirements of 21 CFR part 112
covered farms to evaluate a broad range of factors that impact pre-harvest agricultural water quality, using a systems-based approach that would be feasible to implement across the wide variety of agricultural water systems, practices, and uses and would be adaptable to future advancements in agricultural water quality science. The proposed expedited mitigation requirements are designed to help address recent outbreak investigation findings relating to the impacts of certain adjacent and nearby land uses on pre-harvest agricultural water for covered produce other than sprouts.
In light of the identified implementation challenges with the current pre-harvest agricultural water testing requirements, the proposed rule, if finalized, would enhance public health protections by setting forth procedures for comprehensive preharvest agricultural water assessments and mitigation measures that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or 1 The
produce safety regulation refers to preharvest agricultural water used during sprout production as sprout irrigation water.

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onto produce, and to provide reasonable assurances that produce is not adulterated on account of those hazards.
B. Summary of Major Provisions of the Proposed Rule FDA is proposing to amend the produce safety regulation by revising certain provisions relating to pre-harvest agricultural water for covered produce other than sprouts, while retaining the existing standards applicable to agricultural water for sprouts and for harvest and post-harvest activities conducted by covered farms.
For pre-harvest agricultural water for non-sprout covered produce, we are proposing to:
Replace the microbial quality criteria and testing requirements 112.44b and 112.46b with new provisions for conducting pre-harvest agricultural water assessments proposed 112.43 for hazard identification purposes including consideration of agricultural water sources, distribution systems, and practices, as well as adjacent and nearby land uses, and other relevant factors, and using the results of the assessments in risk management decision making;
Include a testing option for certain covered farms that elect to test their preharvest agricultural water for generic Escherichia coli E. coli or other appropriate indicator organism, index organism, or analyte to help inform their agricultural water assessments;
Add new options for mitigation measures in 112.45b, providing covered farms additional flexibility in responding to findings from their preharvest agricultural water assessments;
Expedite implementation of mitigation measures under 112.45b for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses;
Require management review under 112.161 of pre-harvest agricultural water assessments; and Add new definitions of agricultural water assessment and agricultural water system to 112.3
subpart A and make conforming changes in 112.12 subpart B, 112.151 subpart N, and 112.161
subpart O.
We solicit comments on these proposed amendments, which are described more fully in section VI.C.
through H. We are proposing additional amendments, such as adding examples and reorganizing some provisions, which are described in section VI.I.
C. Legal Authority FDA is proposing to amend certain requirements in the produce safety
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