SEC 507.102 General requirements applying to records.
(a) Records must:
(1) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records, which must be kept in accordance with part 11 of this chapter;
(2) Contain the actual values and observations obtained during monitoring;
(3) Be accurate, indelible, and legible;
(4) Be created concurrently with performance of the activity documented; and
(5) Be as detailed as necessary to provide history of work performed.
(b) All records must include:
(1) The name and location of the plant or facility;
(2) The date and time of the activity documented;
(3) The signature or initials of the person performing the activity; and
(4) Where appropriate, the identity of the product and the production code, if any.
SEC 507.106 Additional requirements applying to the food safety plan.
The food safety plan must be signed and dated by the owner, operator, or agent in charge of the facility upon initial completion and upon any modification.
SEC 507.108 Requirements for record retention.
(a) All records required by this part must be retained at the plant or facility for at least 2 years after the date they were prepared.
(b) Records that relate to the general adequacy of the equipment or processes being used by a facility, including the results of scientific studies and evaluations, must be retained at the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food safety plan ( SEC 507.30) or records that document validation of the written food safety plan ( SEC 507.45(a)).
(c) Except for the food safety plan, offsite storage of records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.
(d) If the plant or facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location, but must be returned to the plant or facility within 24 hours for official review upon request.
PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
8. The authority citation for 21 CFR part 579 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371.
9. In SEC 579.12, add the following sentence to the end of the paragraph to read as follows:
SEC 579.12 Incorporation of regulations in part 179.
* * * Any facility that treats animal feed and pet food with ionizing radiation must comply with the requirements of part 507 of this chapter and other applicable regulations.
Note: The following appendix will not appear in the Code of Federal Regulations.
Although the proposed rule that is the subject of this document does not include provisions for environmental monitoring or finished product testing, the Agency believes that these regimes can play a critical role in a modern food safety system. In sections XI.K and XI.L, the Agency requests comment on when and how these types of testing are an appropriate means of implementing the statutory directives set out in section 418 of the FD&C Act. In this Appendix, the Agency provides background material on these testing measures.
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