---
kind: "section"
citation: "21 C.F.R. § 112.60"
title: "21"
number: "112.60"
heading: "Under this subpart, what requirements apply regarding records?"
url: "https://uscodex.org/cfr/21/112.60"
---

# §112.60. 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) For any biological soil amendment of animal origin you use, you must establish and keep the following records:
  - (1) For a treated biological soil amendment of animal origin you receive from a third party, documentation (such as a Certificate of Conformance) at least annually that:
    - (i) The process used to treat the biological soil amendment of animal origin is a scientifically valid process that has been carried out with appropriate process monitoring; and
    - (ii) The biological soil amendment of animal origin has been handled, conveyed and stored in a manner and location to minimize the risk of contamination by an untreated or in process biological soil amendment of animal origin; and
  - (2) For a treated biological soil amendment of animal origin you produce for your own covered farm(s), documentation that process controls (for example, time, temperature, and turnings) were achieved.

## Notes

### 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.