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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules supervisory review of records of preharvest agricultural water assessments, as well as conforming changes in subparts B and N for the proposed revisions to pre-harvest agricultural water requirements.
To ensure that interested parties can readily view the proposed pre-harvest agricultural water revisions, we are proposing to reorganize and replace subpart E in its entirety. Of note, this proposed rule would not substantively alter the standards established in part 112, subpart E, for agricultural water used for sprouts, for which the compliance dates have passed, or for agricultural water used during harvesting, packing, and holding activities, or for treatment of agricultural water.
Sections VI.C. through VI.H. describe our proposed revisions to the preharvest agricultural water requirements in subpart E of the produce safety regulation and conforming changes to align four additional provisions in subparts A, B, N, and O relating to the subpart E pre-harvest agricultural water testing requirements that we are proposing to revise. We seek comment on our proposal to replace the preharvest agricultural water quality criteria and testing requirements with requirements for agricultural water assessments and enhanced mitigation measures for pre-harvest agricultural water for non-sprout covered produce, including expedited mitigation in certain circumstances.
The proposed rule also contains other edits that are designed to provide clarity, such as reorganizing subpart E to group provisions of a similar nature, as follows:
General provisions for agricultural water for all uses proposed 112.40
through 112.42;
Agricultural water assessments for pre-harvest agricultural water for covered produce other than sprouts proposed 112.43;
Microbial water quality criterion and testing requirements for agricultural water for irrigation of sprouts and for harvest and post-harvest uses proposed 112.44;
Corrective and mitigation measures for agricultural water for all uses proposed 112.45;
Requirements relating to treatment methods for agricultural water for all uses proposed 112.46;
Who conducts testing for agricultural water proposed 112.47;
Reserved proposed 112.48
through 112.49; and Records relating to agricultural water for all uses proposed 112.50.

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Each of the proposed technical edits is described in the relevant subsections below.
A. Scope of the Rulemaking This proposed rule is narrow in scope. We are not proposing to amend the requirements of the produce safety regulation relating to Personnel Qualifications and Training subpart C;
Health and Hygiene subpart D;
Biological Soil Amendments of Animal Origin and Human Waste subpart F;
Domesticated and Wild Animals subpart I; Growing, Harvesting, Packing and Holding Activities subpart K; Equipment, Tools, Buildings, and Sanitation subpart L; Sprouts subpart M; Variances subpart P; Compliance and Enforcement subpart Q; and Withdrawal of Qualified Exemption subpart R, which are in effect for covered farms of all sizes 4 Ref. 29.
Further, this proposed rule would not amend the requirements of the produce safety regulation in General Provisions subpart A, other than the definitions we propose to add to 112.3; General Requirements subpart B, other than the proposed conforming change to 112.12; Analytical Methods subpart N, other than the proposed conforming change to 112.151; or Records subpart O, other than the proposed revisions to 112.161b. Therefore, we are not soliciting comment on subparts A
through B and N through O of the produce safety regulation with limited exceptions for the proposed changes to 112.3, 112.12, 112.151, and 112.161, as those subparts are outside the scope of this rulemaking. We also are not soliciting comment on subparts C, D, F, I, K through M, and P through R of the produce safety regulation, as those requirements are outside the scope of this rulemaking, as discussed above.
B. Consistency With National Organic Program In accordance with section 419a3E of the FD&C Act, this proposed rule does not include any requirements that conflict with or duplicate the requirements of the National Organic Program established under the Organic Foods Production Act of 1990. Compliance with the provisions of this proposed rule would not preclude compliance with the requirements for organic certification in 4 FDA announced its intent to exercise enforcement discretion for specific requirements related to written assurances in Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry, https www.fda.gov/media/110023/download last accessed May 13, 2020.

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7 CFR part 205. Moreover, where this proposed rule and the National Organic Program would include similar or related requirements, our proposed requirements may be satisfied concurrently with those of the National Organic Program i.e., to the extent the requirements are the same, compliance with this proposed rule could be achieved without duplication.
For example, proposed 112.43a1
would require a covered farm to evaluate the likelihood that adjacent and nearby land uses involving animal activity, the application of BSAAOs, or the presence of untreated or improperly treated human waste may contaminate pre-harvest agricultural water for covered produce other than sprouts.
This provision would not conflict with or duplicate National Organic Program requirements to manage plant and animal materials, soil fertility, and manure in a manner so that they do not contribute to contamination of water by pathogenic organisms 7 CFR
205.203cd, 205.239e and manage livestock operations to prevent runoff of wastes and contaminated waters to adjoining or nearby surface water and across property boundaries 7 CFR
205.239a5.
Further, we note that the provisions for treatment of agricultural water in proposed 112.46 are not in conflict with or duplicative of the National Organic Program guidance, The Use of Chlorine Materials in Organic Production and Handling Ref. 30, which provides that residual chlorine levels in pre-harvest water agricultural water should not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act 40 CFR part 141, and post-harvest agricultural water is permitted to contain chlorine materials at levels approved by the FDA
or the EPA for such purpose. Certified organic farms would be able to comply with the provisions of this proposed rule with respect to corrective or mitigation measures that would be reasonably necessary to implement under proposed 112.45.
We seek comment on the tentative conclusion that this proposed rule does not conflict with or duplicate the requirements of the National Organic Program, while providing the same level of public health protection as required under FSMA.
C. Definitions Proposed 112.3
We propose to add two new definitions in 112.3 to provide clarity for terminology used in the proposed requirements for pre-harvest agricultural water assessments.

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