Proposed SEC 507.50(b) also would provide that the qualified individual may be, but is not required to be, an employee of the facility. FDA expects that some facilities may rely on assistance from qualified individuals that are not employees of the facility, such as individuals associated with universities, trade associations, and consulting companies. Proposed SEC 507.50(b) is consistent with HACCP regulations for seafood and juice, which have virtually identical requirements (SUBSEC 123.10 and 120.13(b), respectively). The option in proposed SEC 507.50(b) would provide flexibility to facilities subject to the rule. Such flexibility may be particularly important for those facilities that have limited technical expertise.
Proposed SEC 507.50(c) would require that all applicable training be documented in records, including the date of the training, the type of training, and the person(s) trained. Such records would be a simple mechanism to demonstrate that a person has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as would be required under proposed SEC 507.50(b) should the qualified individual not be otherwise qualified through job experience to develop and apply an animal food safety system.
J. Proposed SEC 507.55--Records Required for Subpart C
1. Requirements of Section 418 of the FD&C Act
Section 418(g) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under section 418(f)(4) of the FD&C Act, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.
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, 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. Section 418(h) of the FD&C Act also specifies that the written plan, together with the documentation described in section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.
2. Proposed SEC 507.5--Records Required for Subpart C
Proposed SEC 507.55(a)(1) through (a)(5) would require that the owner, operator, or agent in charge of a facility establish and maintain the following records:
* The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan;
* Records that document the monitoring of preventive controls;
* Records that document corrective actions;
* Records that document verification, including, as applicable, those related to validation; monitoring; corrective actions; calibration of process monitoring and verification instruments; records review; and reanalysis; and
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