# Presentation: 706029

## 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**

## 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.**

## Current Regulations

**Subpart G - Canning and Canned Products** **318.300 - 311  **
**	****Meat Products**
**Subpart X - Canning and Canned Products** **381.300 - 311  **
**	****Poultry Products**

## FSIS Agenda for Change: Regulatory Review

**“****Convert requirements for canning and canned products to performance standards . . . .”**

## PR/HACCP Final Rule

**“****[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)**
**Recognized  that canning regulations are based on HACCP concepts.**** **
**“****Until changes in the canning regulations are finalized . . . .” **

## 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.**

## 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.**

## 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.**

## 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.**

## 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?**

## 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.**

## Question

**Whether and in what form should the existing requirements be retained?**