Proposed SEC 507.108(c) would also provide that electronic records are considered to be onsite if they are accessible from an onsite location. Computerized systems within corporations can be networked, allowing for the sending and receiving of information in a secure fashion to all of the different food processing facilities of that corporation worldwide. This type of system can be used to provide access at multiple locations to records from multiple plants or facilities.
3. Proposed SEC 507.108(d)
Proposed SEC 507.108(d) would provide that 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. Allowing for transfer of records will give practical storage relief to seasonal operations or those closed for other reasons for prolonged periods.
XIII. FSMA's Rulemaking Provisions
Please see this discussion in section XVI of the document for the proposed rule for preventive controls for human food (78 FR 3646).
XIV. Proposed Conforming Changes
FDA is proposing conforming changes to several applicable sections of the CFR that would add a reference to part 507. The affected sections in title 21 CFR are:
* SEC 225.1 Current good manufacturing practice;
* SEC 500.23 Thermally processed low-acid foods packaged in hermetically sealed containers; and
* SEC 579.12 Incorporation of regulations in part 179.
XV. Legal Authority
FDA is proposing the CGMP regulations under the FD&C Act and the Public Health Service Act. FDA is proposing all other requirements under the FDA Food Safety Modernization Act, the FD&C Act, the Public Health Service Act, and the FDAAA of 2007.
A. Current Good Manufacturing Practice Regulations
FDA is proposing CGMP requirements in proposed subparts A, B, and F. FDA's legal authority to require CGMPs derives from sections 402(a)(3), 402(a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The proposed rule also includes new requirements necessary to prevent food from being adulterated (either because it consists in whole or in part of a filthy, putrid, or decomposed substance, because it is otherwise unfit for food, or because it has been held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health). A regulation that requires measures to prevent food from being held under insanitary conditions whereby either of the proscribed results may occur allows for the efficient enforcement of the FD&C Act. See, e.g., regulations to require HACCP systems for fish and fishery products (part 123) and juice (part 120), regulations to require a safe handling statement on cartons of shell eggs that have not been treated to destroy Salmonella organisms and to require refrigeration of shell eggs held for retail distribution (part 101 and 21 CFR part 115), and regulations for the production, storage, and transportation of shell eggs (21 CFR part 118).
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