Issue View | Council III | 2018 Scribe Packet
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Issue Number: Council III 024
This is a brand new Issue.
Creation of a Committee - Pass/Fail Criteria for a Product Assessment
Issue you would like the Conference to consider
An excerpt from the 2013 FDA Food Code, Annex 3 reads:
"PA [product assessment] means that based on the food's pH and aw and whether it was raw or heat-treated or packaged, it has to be considered TCS until inoculation studies or some other acceptable evidence shows that the food is a TCS food or not."
The Food Code does not provide criteria for qualifying an acceptable inoculation study or other acceptable evidence such as a modeling program. Nor does it provide the organism selection or pass/fail criteria for such studies. This ambiguity causes problems for both retail food operators looking to bring innovative products to the market in a safe, approved manner, as well as retail food safety regulators validating the safety and acceptability of these new products.
Public Health Significance
Providing clear guidance around Product Assessments would allow regulators to quickly assess the food safety risks of proposed products and advise operators on best practices. This would also provide operators with a stationary food safety target and provide them the tools to ensure they are bringing the safest possible products to market.
Recommended Solution: The Conference recommends...
that a Product Assessment Committee be created to investigate inoculation studies and microbiology modeling programs, and charged to:
- Develop criteria for acceptable inoculation studies and microbiological modeling programs, including but not limited to organism selection, testing protocols and parameters, and pass/fail criteria, with the ultimate goal of facilitating the standardization of the review and approval process.
- Report the committee's findings and recommendations back to the Conference at the 2020 Biennial Meeting.