Proposed SEC 507.100(c) does not explicitly require a facility to send records to the Agency rather than making the records available for review at a facility's place of business. FDA requests comments on whether proposed SEC 507.100(c) should be modified to explicitly address this circumstance, and if so, whether FDA should require that the records be submitted electronically. Obtaining a facility's food safety plan without going to a facility could be useful to FDA in a number of different circumstances, such as to determine whether a recently identified hazard is being addressed by affected facilities.
Proposed SEC 507.100(d) would establish that the requirements of proposed SEC 507.100 apply only to the written food safety plan and is discussed in more detail in section XII.D.
Proposed SEC 507.100(e) would provide that the requirements of SEC 507.102(a)(2), (a)(4), and (a)(5) and (b) do not apply to the records required by proposed SEC 507.7(e) pertaining to qualified facilities. As discussed in section VIII.D, proposed SEC 507.7(e) would require that a qualified facility maintain records relied upon to support the self-certification that would be required by proposed SEC 507.7(a). Such documentation would be directed to the financial basis (and, when applicable, percentage of sales to qualified end users) as well as to food safety practices at the qualified facility, and could range from invoices to a food safety plan to an operating license issued by a state or local authority. Such records would not be expected to satisfy the provisions of proposed SEC 507.102(a)(2), (a)(4), and (a)(5) and (b) (which are discussed in the next section). To make clear that a qualified facility need not comply with provisions that do not apply to its records, the Agency is proposing to specify that those provisions do not apply to such records.
C. Proposed SEC 507.102--General Requirements Applying to Records
Proposed SEC 507.102 contains general requirements that would apply to records that would be required under proposed part 507, including the format for required records, the recording of actual values and observations obtained during monitoring, when records must be created, and information that must be included in each record.
1. Proposed SEC 507.102(a)
Proposed SEC 507.102(a)(1) would require that the records 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. True copies of records should be of sufficient quality to detect whether the original record was changed or corrected in a manner that obscured the original entry (e.g., through the use of white-out). Proposed SEC 507.102(a)(1) would provide flexibility for mechanisms for keeping records while maintaining the integrity of the recordkeeping system. The proposed requirement allowing true copies provides options that may be compatible with the way records are currently being kept in plants and facilities.
Proposed SEC 507.102(a)(1) also would require that electronic records be kept in accordance with part 11 (21 CFR part 11). Part 11 provides criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. The proposed requirement clarifies and acknowledges that records required by part 507 may be retained electronically, provided that they comply with part 11.
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