1. Requirements of Section 418 of the FD&C Act
Section 418(h) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act. Section 418(e) specifies that the owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under section 418(c) of the FD&C Act are not properly implemented or are found to be ineffective:
* Appropriate action is taken to reduce the likelihood of recurrence of the implementation failure (section 418(e)(1) of the FD&C Act);
* All affected food is evaluated for safety (section 418(e)(2) of the FD&C Act); and
* All affected 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 (section 418(e)(3) of the FD&C Act).
Section 418(f)(4) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility verify that the preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards.
2. Proposed SEC 507.42(a)--Corrective Action Procedures
Proposed SEC 507.42(a) would require that the owner, operator, or agent in charge of a facility establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented. Having written procedures in place would enable facilities to act quickly and appropriately when preventive controls are not properly implemented, e.g., when a parameter associated with heat processing exceeds a maximum value or falls below a minimum value. Proposed SEC 507.42(a) would implement section 418(e) of the FD&C Act. A discussion on the use of corrective actions in HACCP can be found in section XII.F.2 of the proposed rule for preventive controls for human food (78 FR 3646). As discussed in section X.C.4, the proposed rule would establish requirements for preventive controls (which may be at critical control points), and proposed SEC 507.36(c)(2) would require that the preventive controls include, as appropriate to the facility and the animal food, the maximum or minimum value, or combination of values, to which any physical, biological, radiological, or chemical parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur. For example, if a parameter associated with heat processing falls below a minimum value, corrective action would be triggered.
The benefits from identifying corrective action procedures in advance of the need to actually take corrective action largely derive from having the procedures in written form. Written corrective action procedures would be essential to the facility's animal food safety team, to auditors, and to inspectors. The facility's animal food safety team will be responsible for ensuring that appropriate corrective actions are taken if preventive controls are not properly implemented. Having access to appropriate, written corrective action procedures determined in advance of the need for such action can ensure that correct and complete actions are taken in a timely fashion without the need for the team to meet and decide on the appropriate action. Having written corrective action procedures available for auditors and for inspectors is essential for them to assess the adequacy of the animal food safety plan; the procedures a facility will use to address implementation failures are essential to the production of safe food, and without them a complete assessment cannot be made. Written corrective action procedures also would be useful for training purposes, so that employees who would need to implement the corrective action procedures will be prepared for what they would need to do.
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