---
kind: "section"
citation: "21 C.F.R. § 112.50"
title: "21"
number: "112.50"
heading: "Under this subpart, what requirements apply regarding records?"
url: "https://uscodex.org/cfr/21/112.50"
---

# §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)](/cfr/21/112.42.md?p=a);
  - (2) Your written agricultural water assessments, including descriptions of factors evaluated and written determinations, in accordance with [§ 112.43](/cfr/21/112.43.md);
  - (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)](/cfr/21/112.43.md?p=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)](/cfr/21/112.43.md?p=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](/cfr/21/112.43.md) and [112.44](/cfr/21/112.44.md);
  - (6) Annual documentation of the results or certificates of compliance from a public water system required under § [112.44(c)(1)](/cfr/21/112.44.md?p=c-1) or [(2)](/cfr/21/112.44.md?p=c-2), if applicable;
  - (7) Documentation of actions you take in accordance with [§ 112.45](/cfr/21/112.45.md);
  - (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)](/cfr/21/112.45.md?p=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)](/cfr/21/112.45.md?p=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)](/cfr/21/112.45.md?p=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)](/cfr/21/112.46.md?p=a) and [(b)](/cfr/21/112.46.md?p=b);
  - (11) Documentation of the results of water treatment monitoring under [§ 112.46(c)](/cfr/21/112.46.md?p=c); and
  - (12) Any analytical methods you use in lieu of the method that is incorporated by reference in [§ 112.151(a)](/cfr/21/112.151.md?p=a).

## Notes

### Source

Source: 89 FR 37515, May 6, 2024, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.