21 CFR § 112.50 - Under this subpart, what requirements apply regarding records?
---
identifier: "/us/cfr/t21/s112.50"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 112.50 - Under this subpart, what requirements apply regarding records?"
title_number: 21
title_name: "Food and Drugs"
section_number: "112.50"
section_name: "Under this subpart, what requirements apply regarding records?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "112"
part_name: "STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 74547, Nov. 27, 2015, unless otherwise noted."
cfr_part: "112"
---
# 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);
(2) Your written agricultural water assessments, including descriptions of factors evaluated and written determinations, in accordance with § 112.43;
(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);
(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), 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 and 112.44;
(6) Annual documentation of the results or certificates of compliance from a public water system required under § 112.44(c)(1) or (2), if applicable;
(7) Documentation of actions you take in accordance with § 112.45;
(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), 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);
(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).
(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) and (b);
(11) Documentation of the results of water treatment monitoring under § 112.46(c); and
(12) Any analytical methods you use in lieu of the method that is incorporated by reference in § 112.151(a).