1. Thermally Processed, Commercially Sterile Products Paul M. Uhler United States Department of Agriculture Food Safety and Inspection Service Office of Policy, Program Development and Evaluation Technical Analysis Staff

2. Definitions Canned Product: A meat/poultry product with a water activity above 0.85 which receives a thermal process either before or after being packed in a hermetically sealed container. Commercially Sterile (Shelf Stable): The condition achieved by application of heat, sufficient, alone or in combination with other ingredients and/or treatments to render the product free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50°F or 10°F) at which the product is intended to be held during distribution and storage.

3. Current Regulations Subpart G - Canning and Canned Products 318.300 - 311 Meat Products Subpart X - Canning and Canned Products 381.300 - 311 Poultry Products

4. FSIS Agenda for Change: Regulatory Review “Convert requirements for canning and canned products to performance standards....”

5. PR/HACCP Final Rule K“[Establishments] do not have to address the food safety hazards associated with microbiological contamination if the product is produced in accordance with the canning regulations.” 417.2(b)(3) KRecognized that canning regulations are based on HACCP concepts. K“Until changes in the canning regulations are finalized....”

6. Performance Standards For a low-acid product that receives thermal or other sporicidal lethality processing, that processing must be validated to achieve a probability of 10 -9 that there are spores of C. botulinum in a container of the product that are capable of growing, or, a 12-log 10 reduction of C. botulinum, assuming an initial load of  1000 spores per container.

7. Performance Standards For acidified [low-acid] products or products in which pathogen growth is controlled by factors other than thermal or other sporicidal processing, the processing must be validated to prevent multiplication of C. botulinum in the food under the conditions in which the food is stored, distributed, and held.

8. Commercial Sterility The condition achieved by application of heat, irradiation, high-pressure, or other process, alone or in combination with other ingredients or treatments, to render the product free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50°F or 10°F) at which the product is intended to be held during distribution and storage.

9. Commercial Sterility Performance Standard The product must be processed to achieve commercial sterility and the container in which the product is enclosed must be hermetically sealed so as to be airtight and to protect the contents of the container against the entry of microorganisms during and after processing.

10. Questions Should a quantitative standard for the commercial sterility requirement be used, e.g.. 5-log reduction of Clostridium sporogenes or 10 -6 probability of remaining spores?

11. Training All operators of processing systems for commercially sterile meat and poultry products and container closure technicians shall be under the direct supervision of a person who has successfully completed a school of instruction that is generally recognized as adequate for training supervisors of canning operations.

12. Question Whether and in what form should the existing requirements be retained?