D. Proposed SEC 507.106--Additional Requirements Applying to the Food Safety Plan
Proposed SEC 507.106 would require that the owner, operator, or agent in charge of a facility sign and date the food safety plan upon initial completion and upon any modification. Such a signature would provide direct evidence of the owner, operator, or agent's acceptance of the plan and commitment to implementation of the plan. Additionally, the signature, along with the date of signing, would serve to minimize potential confusion over the authenticity of any differing versions or editions of the document that might exist.
E. Proposed SEC 507.108--Requirements for Record Retention
Proposed SEC 507.108 contains requirements on the length of time records that would be required under proposed part 507 must be retained and allowances for offsite storage of records under certain circumstances.
1. Proposed SEC 507.108(a) and (b)
Proposed SEC 507.108(a) would require that all records that would be required by proposed part 507 be retained at the plant or facility for at least 2 years after the date they were prepared. Proposed SEC 507.108(b) would require that 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)). Proposed SEC 507.108(a) and (b) implement subsection 418(g) of the FD&C Act, which requires certain records to be maintained for not less than 2 years.
While FDA established shorter records retention requirements for records related to perishable foods in the BT records, seafood HACCP, and juice HACCP regulations, in this case Congress determined and specified in section 418(g) of the FD&C Act that the minimum retention period for the majority of the records required under the implementing regulations for all foods, regardless of perishability, be 2 years. Therefore, FDA tentatively concludes that the same requirement should apply to all records required under this section, regardless of the perishability of the food to which the record relates. This would simplify plants' or facilities' duties in compliance because there would only be one 2-year retention period to apply to any record required under proposed part 507. This 2-year retention period would run either from the date the record was prepared, for day-to-day operational records; or from the date at which use of the record is discontinued, for records relating to the general adequacy or equipment or processes (e.g., the written food safety plan and records that document validation of the written food safety plan). The Agency requests comments on the record keeping requirements for animal food, including whether the Agency should use its authority in section 418(m) of the FD&C Act to modify these requirements with respect to facilities that are solely engaged in the production of food for animals other than man.
2. Proposed SEC 507.108(c)
Proposed SEC 507.108(c) would provide that, except for the food safety plan, use of offsite storage for 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 would be required to remain onsite. FDA realizes that the proposed requirements for recordkeeping could require some plants or facilities to store a significant quantity of records, and that there may not be adequate storage space in the plant or facility for all of these records. Providing for offsite storage of most records after 6 months would enable a facility to comply with the proposed requirements for record retention while reducing the amount of space needed for onsite storage of the records without interfering with the purpose of record retention, because the records will be readily available.
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