Process Authority and Microbial Risk Assessment

ToxStrategies’ consulting scientists have broad experience in practical application of the requirements of the low-acid canning and acidified foods canning rules (21 CFR 113,114), as well as the Food Safety Modernization Act (FSMA) risk assessment requirements. Our professionals have expertise in the development, implementation, and validation of the required thermal and non-thermal processes required for low-acid and acidified foods, as well as inactivation kinetics and risk assessment of pathogens and spoilage bacteria involved in these processes. Selected examples of our consulting services include the following:

  • Gap assessment of your facility vs. 21 CFR requirements
  • Gap assessment of your modified FSMA requirements vs. 21 CFR requirements
  • Gap assessments can be on-site or desk-top reviews, depending on applicable requirements
  • Process Authority Letter
  • Assistance in filing scheduled processes (2541(a-f))
  • Assistance with process deviations
  • Assistance with thermal processing study design or execution
  • Determination of appropriate thermal and nonthermal processing parameters
  • Assistance with Foreign Supplier Verification Plans if you are importing shelf-stable foods into the US
  • Assistance to foreign suppliers wishing to export shelf-stable product to the US