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e-CFR data is current as of September 21, 2020

Title 21Chapter ISubchapter BPart 120Subpart A → §120.12


Title 21: Food and Drugs
PART 120—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
Subpart A—General Provisions


§120.12   Records.

(a) Required records. Each processor shall maintain the following records documenting the processor's Hazard Analysis and Critical Control Point (HACCP) system:

(1) Records documenting the implementation of the sanitation standard operating procedures (SSOP's) (see §120.6);

(2) The written hazard analysis required by §120.7;

(3) The written HACCP plan required by §120.8;

(4) Records documenting the ongoing application of the HACCP plan that include:

(i) Monitoring of critical control points and their critical limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the HACCP plan; and

(ii) Corrective actions, including all actions taken in response to a deviation; and

(5) Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate.

(b) General requirements. All records required by this part shall include:

(1) The name of the processor or importer and the location of the processor or importer, if the processor or importer has more than one location;

(2) The date and time of the activity that the record reflects, except that records required by paragraphs (a)(2), (a)(3), and (a)(5) of this section need not include the time;

(3) The signature or initials of the person performing the operation or creating the record; and

(4) Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring.

(c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3) of this section shall be signed and dated by the most responsible individual onsite at the processing facility or by a higher level official of the processor. These signatures shall signify that these records have been accepted by the firm.

(2) The records in paragraphs (a)(2) and (a)(3) of this section shall be signed and dated:

(i) Upon initial acceptance;

(ii) Upon any modification; and

(iii) Upon verification and validation in accordance with §120.11.

(d) Record retention. (1) All records required by this part shall be retained at the processing facility or at the importer's place of business in the United States for, in the case of perishable or refrigerated juices, at least 1 year after the date that such products were prepared, and for, in the case of frozen, preserved, or shelf stable products, 2 years or the shelf life of the product, whichever is greater, after the date that the products were prepared.

(2) Offsite storage of processing records required by paragraphs (a)(1) and (a)(4) of this section is permitted after 6 months following the date that the monitoring occurred, if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location and comply with paragraph (g) of this section.

(3) If the processing facility is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack but shall be immediately returned to the processing facility for official review upon request.

(e) Official review. All records required by this part shall be available for review and copying at reasonable times.

(f) Public disclosure. (1) All records required by this part are not available for public disclosure unless they have been previously disclosed to the public, as defined in §20.81 of this chapter, or unless they relate to a product or ingredient that has been abandoned and no longer represent a trade secret or confidential commercial or financial information as defined in §20.61 of this chapter.

(2) Records required to be maintained by this part are subject to disclosure to the extent that they are otherwise publicly available, or that disclosure could not reasonably be expected to cause a competitive hardship, such as generic type HACCP plans that reflect standard industry practices.

(g) Records maintained on computers. The maintenance of computerized records, in accordance with part 11 of this chapter, is acceptable.

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