[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.302]

[Page 276]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
 
                 Subpart G--Canning and Canned Products
 
Sec. 318.302  Thermal processing.

    (a) Process schedules. Prior to the processing of canned product for 
distribution in commerce, an establishment shall have a process schedule 
(as defined in Sec. 318.300(n) of this subpart) for each canned meat 
product to be packed by the establishment.
    (b) Source of process schedules. (1) Process schedules used by an 
establishment shall be developed or determined by a processing 
authority.
    (2) Any change in product formulation, ingredients, or treatments 
that are not already incorporated in a process schedule and that may 
adversely affect either the product heat penetration profile or 
sterilization value requirements shall be evaluated by the 
establishment's processing authority. If it is determined that any such 
change adversely affects the adequacy of the process schedule, the 
processing authority shall amend the process schedule accordingly.
    (3) Complete records concerning all aspects of the development or 
determination of a process schedule, including any associated incubation 
tests, shall be made available by the establishment to the Program 
employee upon request.
    (c) Submittal of process information. (1) Prior to the processing of 
canned product for distribution in commerce, the establishment shall 
provide the inspector at the establishment with a list of the process 
schedules (including alternate schedules) along with any additional 
applicable information, such as the retort come-up operating procedures 
and critical factors.
    (2) Letters or other written communications from a processing 
authority recommending all process schedules shall be maintained on file 
by the establishment. Upon request by Program employees, the 
establishment shall make available such letters or written 
communications (or copies thereof). If critical factors are identified 
in the process schedule, the establishment shall provide the inspector 
with a copy of the procedures for measuring, controlling, and recording 
these factors, along with the frequency of such measurements, to ensure 
that the critical factors remain within the limits used to establish the 
process schedule. Once submitted, the process schedules and associated 
critical factors and the procedures for measuring (including the 
frequency), controlling, and recording of critical factors shall not be 
changed without the prior written submittal of the revised procedures 
(including supporting documentation) to the inspector at the 
establishment.

(Approved by the Office of Management and Budget under control number 
0583-0015)