Proposed SEC 507.42(a) would implement section 418(e) of the FD&C Act (i.e., that the owner, operator, or agent in charge of a facility must establish corrective action procedures) and section 418(h) of the FD&C Act (i.e., that the owner, operator, or agent in charge of a facility must prepare a written plan).
Proposed SEC 507.42(a) would require that corrective action procedures describe the steps to be taken to ensure that:
* Appropriate action is taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur (proposed SEC 507.42(a)(1));
* All affected animal food is evaluated for safety (proposed SEC 507.42(a)(2)); and
* All affected animal food is prevented from entering into commerce, if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act (proposed SEC 507.42(a)(3)).
The hazard analysis and risk-based preventive controls in this proposed rule are designed to identify hazards that are reasonably likely to occur, and to significantly minimize or prevent the occurrence of such hazards and provide assurances that such animal food is not adulterated under section 402 of the FD&C Act. However, a preventive controls system accounts for the possibility of implementation and effectiveness problems and includes procedures for addressing those problems and any affected food.
Proposed SEC 507.42(a) would implement section 418(e)(1) through (e)(3) of the FD&C Act. Section 418(e)(1) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. Section 418(e)(1) and proposed SEC 507.42(a)(1) explicitly require that action be taken to reduce the likelihood of recurrence of the implementation failure. Although not prescribed by proposed SEC 507.42(a)(1), reducing the likelihood of recurrence of an implementation failure is best accomplished by identifying the root cause of failure and then taking action to address that root cause. If the root cause is not identified and corrected, it is more likely that the failure will recur. For example, if the temperature of a heat process cannot be maintained, a corrective action to raise the temperature using the controller may correct the problem short-term. However, if the root cause is a lack of boiler capacity to run multiple heating units at the same time, corrective action should address replacing the boiler to increase capacity.
Proposed SEC 507.42(a)(2) and (a)(3), would require that corrective action procedures include an evaluation of all food affected by a problem and procedures for ensuring that affected food is prevented from entering into commerce if the owner, operator or agent in charge of the facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act. Such an evaluation is implicit in the Agency's HACCP regulations for seafood and juice (SUBSEC 123.7(b) and 120.10(a)) in that these sections do not explicitly require that food affected by the problem be evaluated, but do require that steps be taken to ensure that product that is injurious to health or otherwise adulterated does not enter commerce. Although the Agency's HACCP regulations for seafood and juice do not specify the steps that must be described in a corrective action plan, the regulations require that specific steps be taken when a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation (SUBSEC 123.7(c) and 120.10(b), respectively). Under the seafood and juice HACCP regulations, required steps include segregating and holding affected product, performing or obtaining a review to determine the acceptability of the affected product for distribution and taking corrective action, when necessary, to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation.
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