(a) Cooked beef, roast beef, and cooked corned beef products must be produced using processes ensuring that the products meet the following performance standards:

(1) Lethality. A 6.5-log10 reduction of Salmonella or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product, as well as the reduction of other pathogens and their toxins or toxic metabolites necessary to prevent adulteration, must be demonstrated to be achieved throughout the product. The lethality process must include a cooking step. Controlled intermediate step(s) applied to raw product may form part of the basis for the equivalency.

(2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than 1-log10 multiplication of Clostridium perfringens within the product.

(b) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file and available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to the establishment in order to evaluate and approve the safety and efficacy of each process schedule.

(c) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.