RECORD REQUIREMENTS

PSR.29 What are the Produce Safety Rule requirements regarding records?

Except as otherwise specified, all required records must include, as applicable:

  1. The name and location of your farm (21 CFR 112.161(a)(1)(i));
  2. Actual values and observations obtained during monitoring (21 CFR 112.161(a)(1)(ii));
  3. An adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record (21 CFR 112.161(a)(1)(iii));
  4. The location of a growing area (for example, a specific field) or other area (for example, a specific packing shed) applicable to the record (21 CFR 112.161(a)(1)(iv)); and
  5. The date and time of the activity documented (21 CFR 112.161(a)(1)(v)).

Except as otherwise specified, required records must also:

  1. Be created at the time an activity is performed or observed (21 CFR 112.161(a)(2));
  2. Be accurate, legible, and indelible (21 CFR 112.161(a)(3)); and
  3. Be dated and signed or initialed by the person who performed the activity documented (21 CFR 112.161(a)(4)).

Certain required records must be reviewed, dated, and signed by a supervisor or a responsible party within a reasonable time after the records are created (21 CFR 112.161(b)). These records include, as applicable:

  1. Records related to eligibility for the qualified exemption (21 CFR 112.7(b));
  2. Records related to required training of personnel (21 CFR 112.30(b));
  3. Records documenting the results of all analytical tests conducted on agricultural water for purposes of compliance (21 CFR 112.50(b)(2));
  4. Records documenting the results of water treatment monitoring under 21 CFR 112.43(b) (21 CFR 112.50(b)(4));
  5. Records documenting actions you take in accordance with 21 CFR 112.45 (21 CFR 112.50(b)(6);
  6. Records related to process controls for treating biological soil amendments of animal origin you produce for your own covered farm(s) (21 CFR 112.60(b)(2));
  7. Records related to cleaning and sanitizing of equipment (21 CFR 112.140(b)(1) and (2)); and
  8. Records documenting your treatment of seeds or beans to reduce microorganisms of public health significance in the seeds or beans, at your farm; or alternatively, records of documentation (such as a Certificate of Conformance) from your seed supplier that seeds or beans are treated to reduce microorganisms of public health significance and are appropriately handled and packaged following the treatment, in accordance with the requirements of 21 CFR 112.142(e) (21 CFR 112.150(b)(1));
  9. Records documenting the results of all analytical tests conducted for purposes of compliance with Subpart M (21 CFR 112.150(b)(4))
  • Records documenting actions you take in accordance with 21 CFR 112.142(b) and (c), 112.146, and 112.148 (21 CFR 112.150(b)(6)).

RECORD REQUIREMENTS IN DETERMINING A QUALIFIED EXEMPTION

PSR.30 What types of records do I need to keep if my farm is eligible for a qualified exemption from the Produce Safety Rule?

A farm is required to establish and keep adequate records necessary to show that it satisfies the criteria for a qualified exemption that are described in 21 CFR 112.5, including a written record reflecting that an annual review and verification of the farm’s continued eligibility for the qualified exemption was performed (see 21 CFR 112.7(b)).

You must establish and keep records required under 21 CFR 112.7 in accordance with the requirements of subpart O of this part, except that the requirement in 21 CFR 112.161(a)(4) for a signature or initial of the person performing the activity is not required for sales receipts kept in the normal course of business. Such receipts must be dated as required under 21 CFR 112.161(a)(4) (see 21 CFR 112.7(a)).