Thermally Processed, Commercially Sterile Products

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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

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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 50F or 10F) at which the product is
  intended to be held during distribution and
  storage.

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Current Regulations

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

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FSIS Agenda for Change Regulatory Review

• Convert requirements for canning and canned
  products to performance standards . . . .

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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 . . . .

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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-log10 reduction of
  C. botulinum, assuming an initial load of ? 1000
  spores per container.

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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.

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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 50F or 10F)
  at which the product is intended to be held
  during distribution and storage.

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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.

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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?

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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.

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Question

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