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 § 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)