Proposed SEC 507.45(e) would implement section 418(f)(5) and (i) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP guidelines, the Codex validation guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry. A discussion on "reanalysis" (or "reassessment of the hazard analysis" as it is called) in HACCP systems can be found in section XII.G.7 of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The requirement in proposed SEC 507.45(e)(1) that the periodic reanalysis of the food safety plan occur at least once every 3 years is explicitly required by section 418(i) of the FD&C Act. The Agency tentatively concludes that, as a practical matter, the proposed requirement for reanalysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard makes it likely that reanalysis would occur more frequently than every 3 years because such changes are likely to occur more frequently than every 3 years.
b. Proposed SEC 507.45(e)(1)(vi)--Reanalysis on the initiative of FDA. Proposed SEC 507.45(e)(1)(vi) establishes that FDA may require a reanalysis of the food safety plan to respond to new hazards and developments in scientific understanding. Proposed SEC 507.45(e)(1)(vi) would implement section 418(i) of the FD&C Act, which provides in relevant part that "[t]he Secretary may require a reanalysis . . . to respond to new hazards and developments in scientific understanding . . . ." As discussed in section X.G.7.a, new hazards can emerge, e.g., as identified through the investigation of outbreaks of foodborne illness by CDC or other public health agencies. In addition, new developments can occur in the scientific understanding of existing or potential hazards, e.g., if scientists and animal food safety regulatory agencies develop a better understanding of the causes of these events. For example, the outbreak from Salmonella Tennessee in peanut butter resulted in a greater understanding of the risks posed by environmental contamination and the importance of control of water in facilities producing low-moisture foods (Refs. 84 and 85. Information submitted to the RFR, which is a relatively recent addition to the regulatory framework for food safety, has the potential to identify new hazards or routes of contamination even before outbreaks occur.
c. Proposed SEC 507.45(e)(2)--Implementation of additional controls. Proposed SEC 507.45(e)(2) would require that the owner, operator, or agent in charge of a facility complete the required reanalysis and implement any additional preventive controls needed to address the hazard identified, if any, before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production. The purpose of the reanalysis is to identify the need for, and implement, preventive controls in light of a reasonable potential for a new hazard, or a significant increase in a previously identified hazard, that is reasonably likely to occur. It follows that the preventive controls must be in place before making the change that creates the potential for a new hazard or a significant increase in a previously identified hazard. As with initial validation in proposed SEC 507.45(a)(1)(i), the Agency is proposing to provide the first 6 weeks of production, when necessary, to implement any additional preventive controls to allow facilities to methodically collect data and information during production to ensure the needed change can be implemented in the facility. The Agency seeks comment on this timeframe. Proposed SEC 507.45(e)(2) would implement section 418(i) of the FD&C Act.
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