3. Proposed SEC 507.42(b)--Corrective Action in the Event of an Unanticipated Problem
Proposed SEC 507.42(b)(1) through (b)(3) would require that if a preventive control is not properly implemented and a specific corrective action has not been established, or a preventive control is found to be ineffective, the owner, operator, or agent in charge of a facility take corrective action to identify and correct the problem, evaluate all affected food for safety, and, as necessary, prevent affected food from entering commerce as would be done following the corrective action procedure under proposed SEC 507.42(a)(3). However, a facility might not anticipate all of the problems that may occur, and a facility may experience an implementation failure for which a corrective action procedure has not been established. Regardless of whether a problem was anticipated and a corrective action procedure was developed in advance, corrective actions to accomplish the steps that would have been included in a corrective action procedure are necessary. Likewise, a facility might determine (e.g., as a verification activity in accordance with proposed SEC 507.45(c), discussed in section X.G of this document), that a preventive control is ineffective. For example, detecting a pathogen in pet food may signal that preventive controls for that pathogen are ineffective. As in the case of an unanticipated implementation failure of a preventive control, corrective actions would be necessary if a preventive control is found to be ineffective.
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 and a specific corrective action has not been established, or if a preventive control is found to be ineffective. (The Agency uses the term "reanalyze" when it refers to a reassessment of the validity of a preventive control or the food safety plan to control a hazard.) Under proposed SEC 507.45(a), the verification required by section 418(f) of the FD&C Act would include validation of the food safety plan, referring to whether it is effectively controlling the hazards or "working correctly." See section X.G of this document for a discussion of proposed requirements for verification (including validation and reanalysis) under section 418(f) of the FD&C Act. Proposed SEC 507.42(b)(4) would apply to unanticipated food safety problems, and the unanticipated nature of the problems is relevant to the reanalysis of the food safety plan. If the owner, operator, or agent in charge of a facility has assessed its procedures, practices, and processed and has not identified a specific failure as a foreseeable occurrence, the owner, operator, or agent in charge must assess whether the problem is simply an implementation failure that could be expected to occur in the normal course of manufacturing, processing, packing or holding the food, or the result of a system-wide problem that is not being properly addressed by the plan (e.g., ineffective preventive controls.) If the problem is simply an implementation failure, and such a failure is now a foreseeable circumstance, reanalysis of the food safety plan would be necessary to determine whether a corrective action procedure should be established for that foreseeable failure. Likewise, if the problem is the result of a system-wide problem that is not being properly addressed by the plan (or is otherwise a result of ineffective preventive controls), reanalysis of the food safety plan would be necessary to identify effective preventive controls. Either way, reanalyzing the food safety plan and modifying it as necessary would be necessary to reduce the risk of recurrence of the problem. Proposed SEC 507.42(b)(4) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry.
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