Section 418 of the FD&C Act does not address the qualifications of the individual who would prepare the food safety plan. However, proposed SEC 507.30(b) is consistent with the Federal regulations for seafood, juice, and meat and poultry (parts 123 and 120 (21 CFR parts 123 and 120) and 9 CFR part 417 respectively). One way to comply with proposed SEC 507.30(b) could be for a team of individuals (for example, a "HACCP team" or a "food safety team") to develop the food safety plan under the oversight of a qualified individual. Each member of a HACCP or food safety team generally brings specific expertise important in developing the plan. For example, a microbiologist could provide knowledge of microbial hazards, an engineer could establish the critical parameters for delivery of heat treatments, and a maintenance supervisor could identify sources of metal contamination. Proposed SEC 507.30 would not require that all such members of a food safety team satisfy the requirements in proposed SEC 507.30(b) for a qualified individual. However, under proposed SEC 507.30(b), a qualified individual must be responsible for ensuring that all components the food safety plan have been developed, including reviewing all information contained in the food safety plan, thereby verifying the hazard analysis and food safety plan developed by the food safety team.
4. Proposed SEC 507.30(c)--Contents of a Food Safety Plan
Proposed SEC 507.30(c)(1) through (c)(6) would require that the contents of a written food safety plan include:
* The hazard analysis as required by SEC 507.33;
* The preventive controls as required by SEC 507.36;
* The recall plan as required by SEC 507.38;
* The procedures, and the frequency with which these procedures will be performed, for monitoring the implementation of the preventive controls as required by SEC 507.39;
* The corrective action procedures as required by SEC 507.42; and
* The verification procedures and the frequency with which they will be performed as required by SEC 507.45.
Section 418(h) requires that the written plan document and describe the procedures used by the facility to comply with the requirements of section 418, " including analyzing the hazards under [section 418(b) of the FD&C Act] and identifying the preventive controls adopted under [section 418(c) of the FD&C Act] to address those hazards" (emphasis added.) Although section 418(h) of the FD&C Act explicitly references sections 418(b) and (c), the term "including," indicates that the contents of a food safety plan need not be limited to the provisions of sections 418(b) and (c) of the FD&C Act.
FDA interprets the requirement in section 418(h) of the FD&C Act that the written plan document and describe the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act to mean that the written food safety plan would include all procedures required under section 418 of the FD&C Act. As discussed in sections X.E.4.a, X.F.2, X.G.6, and X.D.2, the proposed rule would require written procedures for monitoring the implementation of the preventive controls (proposed SEC 507.39); written corrective action procedures (proposed SEC 507.42); written procedures for some verification activities (proposed SEC 507.45); and a written recall plan (proposed SEC 507.38).
FDA interprets the requirement in section 418(h) that the written plan describe the procedures used by the facility to comply with the requirements of section 418, including analyzing the hazards and identifying the preventive controls adopted to address those hazards, to mean that the contents of the food safety plan must include the hazard analysis conducted by the facility and the preventive controls that a facility must establish for hazards that its hazard analysis identifies as reasonably likely to occur, rather than procedures for analyzing the hazards and procedures for identifying the preventive controls. The general requirement in section 418(a) of the act is directed, in relevant part, to evaluating the hazards that could affect animal food manufactured, processed, packed, or held by a facility, and identifying and implementing preventive controls 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. Review of the evaluation of hazards in the hazard analysis is sufficient to determine the adequacy of the hazard analysis. Written procedures for conducting the hazard analysis are not necessary. Similarly, the preventive controls identified by the facility can be reviewed fully for adequacy without having a separate procedures document.
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