[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.17]

[Page 260]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
                            Subpart A_General
 
Sec. 318.17  Requirements for the production of cooked beef, roast beef, and cooked corned beef products.

    (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 Sec. 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.

[64 FR 744, Jan. 6, 1999]