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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR112]


Subpart O - Records

Sec. 112.161 What general requirements apply to records required under this part?

(a) Except as otherwise specified, all records required under this part must:

(1) Include, as applicable:

(i) The name and location of your farm;

(ii) Actual values and observations obtained during monitoring;

(iii) 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;

(iv) The location of a growing area (for example, a specific field) or other area (for example, a specific packing shed) applicable to the record; and

(v) The date and time of the activity documented;

(2) Be created at the time an activity is performed or observed;

(3) Be accurate, legible, and indelible; and

(4) Be dated, and signed or initialed by the person who performed the activity documented.

(b) Records required under §§ 112.7(b), 112.30(b), 112.50(b)(2), (4), and (6), 112.60(b)(2), 112.140(b)(1) and (2), and 112.150(b)(1), (4), and (6), must be reviewed, dated, and signed, within a reasonable time after the records are made, by a supervisor or responsible party.

[80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12491, Apr. 2, 2019]

Sec. 112.162 Where must I store records?

(a) Offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review.

(b) Electronic records are considered to be onsite at your farm if they are accessible from an onsite location at your farm.

Sec. 112.163 May I use existing records to satisfy the requirements of this part?

(a) Existing records (e.g., records that are kept to comply with other Federal, State, or local regulations, or for any other reason) do not need to be duplicated if they contain all of the required information and satisfy the requirements of this part. Existing records may be supplemented as necessary to include all of the required information and satisfy the requirements of this part.

(b) The information required by this part does not need to be kept in one set of records. If existing records contain some of the required information, any new information required by this part may be kept either separately or combined with the existing records.

Sec. 112.164 How long must I keep records?

(a)(1) You must keep records required by this part for at least 2 years past the date the record was created.

(2) Records that a farm relies on during the 3-year period preceding the applicable calendar year to satisfy the criteria for a qualified exemption, in accordance with §§ 112.5 and 112.7, must be retained as long as necessary to support the farm's status during the applicable calendar year.

(b) Records that relate to the general adequacy of the equipment or processes or records that relate to analyses, sampling, or action plans being used by a farm, including the results of scientific studies, tests, and evaluations, must be retained at the farm for at least 2 years after the use of such equipment or processes, or records related to analyses, sampling, or action plans, is discontinued.

Sec. 112.165 What formats are acceptable for the records I keep?

You must keep records as:

(a) Original records;

(b) True copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records); or

(c) Electronic records. Records that are established or maintained to satisfy the requirements of this part and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this part, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.

Sec. 112.166 What requirements apply for making records available and accessible to FDA?

(a) You must have all records required under this part readily available and accessible during the retention period for inspection and copying by FDA upon oral or written request, except that you have 24 hours to obtain records you keep offsite and make them available and accessible to FDA for inspection and copying.

(b) If you use electronic techniques to keep records, or to keep true copies of records, or if you use reduction techniques such as microfilm to keep true copies of records, you must provide the records to FDA in a format in which they are accessible and legible.

(c) If your farm is closed for a prolonged period, the records may be transferred to some other reasonably accessible location but must be returned to your farm within 24 hours for official review upon request.

Sec. 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?

Records obtained by FDA in accordance with this part are subject to the disclosure requirements under part 20 of this chapter.

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.