21 CFR § 112.50 - Under this subpart, what requirements apply regarding records?
(b) You must establish and keep the following records:
(5) Scientific data or information you rely on to support the microbial die-off or removal rate(s) that you used to determine the time interval (in days) between harvest and end of storage, including other activities such as commercial washing, as applicable, used to achieve the calculated log reduction of generic Escherichia coli (E. coli), in accordance with § 112.45(b)(1)(ii);
(6) Documentation of actions you take in accordance with § 112.45. With respect to any time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) and/or (ii), such documentation must include the specific time interval or log reduction applied, how the time interval or log reduction was determined, and the dates of corresponding activities such as the dates of last irrigation and harvest, the dates of harvest and end of storage, and/or the dates of activities such as commercial washing);