* Whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established (proposed SEC 507.45(e)(1)(iv));
* Whenever a preventive control is found to be ineffective (proposed SEC 507.45(e)(1)(v)); and
* Whenever FDA requires a reanalysis in response to newly identified hazards and developments in scientific understanding (proposed SEC 507.45(e)(1)(vi).
For example, if a facility that conducts baking operations for pet treats makes design changes to its oven to increase product throughput, the facility would be required to reanalyze its food safety plan because a design change to equipment that is used to control a hazard that is reasonably likely to occur would be a significant change in the activities conducted at the facility.
The owner, operator or agent in charge of a facility may become aware of a problem due to the finding of a hazard in an animal food as the result of testing by a regulatory agency (Federal, State, tribal, or foreign government) that would require an analysis of the food safety plan to ensure the hazard is significantly minimized or prevented by appropriate preventive controls. In addition, new hazards can emerge, e.g., as identified through the investigation of outbreaks. For example in 2006-2007 there was an outbreak of salmonellosis due to contamination of peanut butter with Salmonella Tennessee (Ref. 83). This was the first outbreak of food borne illness caused by peanut butter consumption in the U.S. and it demonstrated the need for manufacturers to address the hazard of Salmonella spp. in this product and in products into which peanut butter is added, such as pet treats. Information about outbreaks and ensuing product recalls is widely disseminated, including on FDA's Web site, and modern communication tools make it possible for the owner, operator, or agent in charge of a facility to receive such information automatically. For additional discussion related to the proposed requirement that the owner, operator, or agent in charge of a facility conduct a reanalysis whenever such owner, operator or agent becomes aware of new information about potential hazards associated with the food, see the discussion in section X.G.7.b of proposed SEC 507.45(e)(1)(vi), which would provide that FDA may require a reanalysis of the food safety plan to respond to new hazards and developments in scientific understanding.
As noted in section X.F of this preamble, proposed SEC 507.42(b)(4) would require that the owner, operator, or agent in charge of a facility reanalyze the food safety plan in accordance with proposed SEC 507.45(e) to determine whether modification of the food safety plan is required if a preventive control is not properly implemented or is found to be ineffective, and a specific corrective action has not been established. If the owner, operator, or agent in charge of a facility has not identified a specific failure as a foreseeable occurrence, the deviation may be the result of a system-wide problem that is not being properly addressed by the food safety plan (e.g., ineffective preventive controls). Thus, an unforeseen failure for which a corrective action was not identified may indicate an ineffective preventive control, and a reanalysis of the food safety plan is warranted. Similarly, when information arises indicating that the preventive control has not been effective in significantly minimizing or preventing a hazard from occurring, a reanalysis must be conducted to determine if the food safety plan should be modified to ensure that the preventive controls implemented are adequate to significantly minimize or prevent a hazard identified as reasonably likely to occur.
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