21 CFR § 112.50 - Under this subpart, what requirements apply regarding records?

(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:

(1) The findings of inspections of your agricultural water systems in accordance with the requirements of § 112.42(a);

(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 E.coli for purposes of § 112.43(c)(4)(ii);

(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 § 112.43(c)(4)(ii), 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 § 112.44(c)(1) or (2), if applicable;

(7) Documentation of actions you take in accordance with § 112.45;

(8) Scientific data or information you rely on to support the time interval between last direct application of agricultural water and harvest in § 112.45(b)(1)(ii), and/or the time interval between harvest and end of storage and/or use of other activities during or after harvest in § 112.45(b)(1)(iii);

(9) Scientific data or information you rely on to support an alternative mitigation measure that you establish and use in accordance with § 112.45(b)(1)(vi).

(10) Scientific data or information you rely on to support the adequacy of a treatment method used to satisfy the requirements of § 112.46(a) and (b);

(11) Documentation of the results of water treatment monitoring under § 112.46(c); and

(12) Any analytical methods you use in lieu of the method that is incorporated by reference in § 112.151(a).