21 CFR §112.60

1. (a)You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part.
2. (b)For any biological soil amendment of animal origin you use, you must establish and keep the following records:
   1. (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:
      1. (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
      2. (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. (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.