Proposed SEC 507.30(a) would require that the plan be written as is expressly required by section 418(h). A written food safety plan is essential for the facility to implement the plan consistently, train its employees, and periodically reanalyze and update the plan. It is also essential to a facility's food safety team, to auditors, and to inspectors. Proposed SEC 507.30(a) would implement section 418(h) of the FD&C Act. Proposed SEC 507.30(a) would provide flexibility for the owner, operator, or agent in charge of the facility to either prepare the written food safety plan or have that plan prepared, in whole or in part, on its behalf. In addition, proposed SEC 507.30 would provide flexibility for facilities in the development of their food safety plans by allowing facilities to group animal food types or production method types if the hazards, control measures, parameters, and required procedures such as monitoring are essentially identical.
Proposed SEC 507.30(a) would require that the owner, operator, or agent in charge of a facility implement the written food safety plan. Although section 418(h) of the FD&C Act is silent with respect to implementation of the required written plan, other provisions of section 418 address implementation. For example, section 418(c) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility both establish and implement preventive controls (emphasis added). In addition, other provisions of section 418 (e.g., section 418(d) regarding monitoring, section 418(e) regarding corrective actions, and section 418(f) regarding verification) all establish requirements related to the preventive controls required under section 418(c). As discussed later in this section of the document, the written food safety plan would include the hazard analysis required under section 418(b) of the FD&C Act, the preventive controls required under section 418(c) of the FD&C Act, the monitoring procedures required under section 418(d) of the FD&C Act, the corrective action procedures required under section 418(e) of the FD&C Act, the verification procedures required under section 418(f) of the FD&C Act, and the recall plan as authorized by section 418(o)(3)(E) of the FD&C Act. Specific provisions for implementing these sections of the statute would be established throughout proposed subpart C.
3. Proposed SEC 507.30(b)--Preparation of the Food Safety Plan by a Qualified Individual
Proposed SEC 507.30(b) would specify the food safety plan must be prepared by (or its preparation overseen by) a qualified individual. (See the discussion in section X.J regarding the qualifications of a qualified individual as would be established in proposed SEC 507.50(b)). Section 418 of the FD&C Act requires that firms identify and implement preventive controls and that facilities monitor and verify the effectiveness of the preventive controls. A qualified individual must develop the food safety plan in order to ensure the preventive controls are effective. The plan must be designed to identify and to significantly minimize or prevent hazards in order to prevent illness or injury to animals or humans. Designing a plan requires an individual who is knowledgeable in the concepts of preventive controls, the hazards associated with a product and process, the appropriate preventive controls, with associated monitoring and corrective actions for those hazards, and appropriate verification activities for the applicable preventive controls. Such knowledge requires scientific and technical expertise developed through training, experience, or both.
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