Proposed SEC 507.48(b) would establish that the records that a facility must establish and maintain under proposed SEC 507.48(a)(5) are subject to the requirements of proposed subpart F. Proposed subpart F would establish requirements that would apply to all records that would be required under part 507. FDA describes the requirements of proposed subpart F in section XII. Proposed SEC 507.48(b) is analogous to proposed SEC 507.55(b) in subpart C.
I. Proposed SEC 507.50--Requirements Applicable to a Qualified Individual
Proposed SEC 507.50(a) would require that one or more qualified individuals prepare the food safety plan (proposed SEC 507.30), validate the preventive controls (proposed SEC 507.45(a)), review records for implementation and effectiveness of preventive controls (proposed SEC 507.45(c)), and perform reanalysis of the food safety plan (proposed SEC 507.45(e)). The Agency has discussed the basis for requiring that a trained individual perform or oversee these functions in its discussion of each applicable proposed provision. The Agency is listing the functions that must be performed by a trained individual in SEC 507.50(a) for simplicity and are not imposing any additional requirement through this list. A single individual with appropriate qualifications could perform all of the listed functions, but there would be no requirement for the same individual to perform all the listed functions.
Proposed SEC 507.50(b) would establish the qualification requirements applicable to a qualified individual. To be qualified, an individual must have 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, or be otherwise qualified through job experience to develop and apply a food safety system. Training or job experience is essential to the effective development and implementation of a hazard analysis and risk-based preventive controls. Only a trained individual or individual qualified by job experience is capable of effectively executing certain activities, such as identifying hazards that are reasonably likely to occur; identifying preventive controls that will address those hazards; evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the hazards that are reasonably likely to occur; determining the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur; determining whether monitoring procedures and corrective action procedures are appropriate; and determining whether specific corrective actions have been appropriate and effective. In addition, the products produced by the animal food industry are diverse, and the hazards that are reasonably likely to occur in a particular facility depend on a range of factors that vary from one facility to the next. The Agency requests comment on the scope of the qualifications identified.
FDA will be working with an animal food alliance to develop a standardized curriculum for any final rule establishing requirements for hazard analysis and risk-based preventive controls. Having a standardized curriculum on which facilities, as well as private organizations and academia that conduct training, can base their materials and training would provide a framework to ensure minimum training requirements are met.
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