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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules b You must deliver any treatment of agricultural water in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended uses and, if applicable, also meets the microbial quality criterion in 112.44; and c You must monitor any treatment of agricultural water using an adequate method and frequency to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended uses and, if applicable, also meets the microbial quality criterion in 112.44.
d Treatment may be conducted by you or by a person or entity acting on your behalf.
112.47 Who must perform the tests required under this subpart?

a You may meet the requirements related to agricultural water testing required under 112.43c4ii and 112.44 using:
1 Results from agricultural water testing performed by you or by a person or entity acting on your behalf; or 2 Data collected by a third-party or parties, provided the water sampled by the third party or parties adequately represents your agricultural water sources and all other applicable requirements of this part are met.
b Agricultural water samples must be aseptically collected and tested using methods as set forth in 112.151, as applicable.
112.48112.49

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112.50 Under this subpart, what requirements apply regarding records?

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a You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part.
b You must establish and keep the following records, as applicable:

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1 The findings of inspections of your agricultural water systems in accordance with the requirements of 112.42a;
2 Your written agricultural water assessments, including descriptions of factors evaluated and written determinations, in accordance with 112.43;
3 Scientific data or information that you rely on to support the use of an index organism, indicator organism, or other analyte, other than testing for generic Escherichia coli E.coli for purposes of 112.43c4ii;
4 Scientific data or information that you rely on to support the frequency of testing and any microbial criterion or criteria you applied for purposes of 112.43c4ii, if applicable;
5 Documentation of the results of all analytical tests for purposes of compliance with this subpart, including any testing conducted under 112.43
and 112.44;
6 Annual documentation of the results or certificates of compliance from a public water system required under 112.44c1 or 2, if applicable;
7 Documentation of actions you take in accordance with 112.45. With respect to any time interval applied in accordance with 112.45b1ii and/
or iii, such documentation must include the specific time interval or log reduction. if applicable, how the time interval or log reduction was determined, and the dates of corresponding activities such as the dates of last application and harvest, the dates of harvest and end of storage, and/
or the dates of activities such as commercial washing;
8 Scientific data or information you rely on to support the time interval between last direct application of agricultural water and harvest in 112.45b1ii, and/or the time
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interval between harvest and end or storage and/or use of activities such as commercial washing that result in microbial removal in 112.45b1iii;
9 Scientific data or information you rely on to support the adequacy of a treatment method used to satisfy the requirements of 112.46a and b;
10 Documentation of the results of water treatment monitoring under 112.46c; and 11 Any analytical methods you use in lieu of the method that is incorporated by reference in 112.151a.
5. In 112.151, revise the section heading and paragraph b2 to read as follows:
112.151 What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?

b
2 For any other indicator of fecal contamination, index organism, or other analyte you may test for pursuant to 112.43d, a scientifically valid method.
6. In 112.161, revise paragraph b to read as follows:
112.161 What general requirements apply to records required under this part?

b Records required under 112.7b, 112.30b, 112.50b2, 5, 7, and 10, 112.60b2, 112.140b1
and 2, and 112.150b1, 4, and 6
must be reviewed, dated, and signed, within a reasonable time after the records are made, by a supervisor or responsible party.
Dated: November 24, 2021.
Janet Woodcock, Acting Commissioner of Food and Drugs.
FR Doc. 202126127 Filed 12221; 11:15 am BILLING CODE 416401P

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