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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
1. Records of Pre-Harvest Agricultural Water Assessments Proposed 112.50b2 would require covered farms to maintain records of their agricultural water assessments, including written determinations on whether mitigation measures under proposed 112.45b would be reasonably necessary to reduce the potential for contamination of nonsprout covered produce or food contact surfaces with known or reasonably foreseeable hazards associated with preharvest agricultural water.
Effective water management includes records necessary to confirm that agricultural water is safe and of adequate sanitary quality for its intended uses. Records of pre-harvest agricultural water assessments would be critical for a covered farm to maintain to ensure its own compliance with the requirements of proposed 112.43. For example, records of agricultural water assessments would be helpful to a covered farm in determining whether changed conditions were sufficient to trigger the requirement to conduct a reassessment under proposed 112.43f2, prior to an annual reassessment.
Such records also are important for FDA to verify, for example, that the covered farm evaluated all the required elements of an assessment listed in proposed 112.43a, in support of a written determination, under proposed 112.43c, regarding whether mitigation measures are reasonably necessary to reduce the potential for contamination of covered produce other than sprouts or food contact surfaces with known or reasonably foreseeable hazards associated with agricultural water used in growing nonsprout covered produce.

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2. Records Relating to Testing PreHarvest Agricultural Water for Analytes Other Than Generic E. coli Under proposed 112.50b3, a covered farm that tests its pre-harvest agricultural water to inform its agricultural water assessment and uses an indicator of fecal contamination, index organism, or other analyte other than generic E. coli, would be required to retain records of the scientific data or information the farm relies on to support the use of such analyte. These records would be necessary for a covered farm to ensure, and for FDA to verify, that appropriate scientific methods are being used when the farm elects to test its pre-harvest agricultural water under proposed 112.43d to inform its agricultural water assessment.

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3. Records Relating to the Sampling and Microbial Criterion or Criteria Applied for Pre-Harvest Agricultural Water Under proposed 112.50b4, a covered farm that tests its pre-harvest agricultural water would be required to maintain records of the scientific data or information it relied on to support the sampling and testing methods and the microbial criterion or criteria it applied. Records of sampling protocols, testing methods, and microbial criterion or criteria would be necessary for a covered farm that uses testing to ensure that the frequency of testing samples and microbial criteria applied are adequate to assist in determining, in conjunction with other data and information from their assessment, whether mitigation measures are reasonably necessary. Such records would allow FDA to help verify a covered farms compliance with proposed 112.43d.
Additionally, we would amend 112.50b of the produce safety regulation to:
Move paragraph b2 to proposed 112.50b5, and as a clarifying edit add the phrase, including any testing conducted for purposes of 112.43 and 112.44;
Move paragraphs b3 through b4 to proposed 112.50b9 through b10;
Move paragraph b5 to proposed 112.50b8 and remove the phrase , in accordance with 112.45b1ii;
Move paragraph b6 to proposed 112.50b7 and remove the phrase in accordance with 112.45b1ii and/or b1iii;
Move paragraph b7 to proposed 112.50b6 and replace 112.46a1 or 2 with 112.44c1 or c2;
Remove paragraph b8; and Move paragraph b9 to proposed 112.50b11.
H. Conforming Changes Proposed 112.12, 112.151, and 112.161
As conforming changes in light of our proposal to remove the microbial water quality criteria in 112.44b, the microbial die-off calculated log reduction rate in 112.45b, and the testing requirements in 112.46b of the produce safety regulation, we would:
Amend 112.12 to replace 112.49 with 112.45b;
Amend the section heading of 112.151 to replace 112.46 with subpart E; and Amend 112.151b2 to replace 112.49a with 112.43d.
As an additional conforming change, we propose to revise the requirements of
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112.161b of the produce safety regulation to require supervisory review of records of pre-harvest agricultural water assessments and determinations, given the essential role of such records in establishing compliance with the requirements of proposed 112.43 and in confirming that pre-harvest agricultural water is safe and of adequate sanitary quality for its intended uses. Therefore, in 112.161
of the produce safety regulation, we would replace b4, and b6 with b7, and b10.
I. Other Amendments Proposed 112.42, 112.44, and 112.46112.49
1. Proposed 112.42
To provide additional clarity around certain language, based on stakeholder feedback and questions, we would:
Add descriptive headings to paragraphs a and b;
Consolidate the requirements for maintenance of agricultural water systems in 112.43b, c, and d into 112.42b14; and Clarify the descriptions of possible maintenance measures for pooled water in 112.42b4.
2. Proposed 112.44
As part of the proposed reorganization of subpart E to group provisions of a similar nature i.e., requirements specific to pre-harvest agricultural water, sprout irrigation water, and harvest/post-harvest agricultural water, we would:
Revise the section heading of 112.44 of the produce safety regulation by adding and testing requirements after criteria and by replacing certain intended uses with sprout irrigation and for harvesting, packing, and holding covered produce;
Move 112.46c of the produce safety regulation to proposed 112.44b, add a paragraph heading, Untreated ground water., and replace 112.44a with paragraph a wherever it appears;
Move 112.46a of the produce safety regulation to proposed 112.44c and add a paragraph heading, Exemptions. and replace 112.43
with 112.46; and Move the text of 112.48 of the produce safety regulation to proposed 112.44d and add a paragraph heading, Additional management and monitoring practices.
3. Proposed 112.46
As part of our reorganization of subpart E for clarifying purposes, we are proposing to move the treatment provision from 112.43 of the produce safety regulation to 112.46.

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