The food industry continues to be complicated as new food products with unique ingredients are introduced into the marketplace, supply chain interruptions remain a challenge, and the demand for minimally processed foods grows. Ensuring that appropriate food safety parameters are utilized during the manufacture of food products, with the right supporting documentation, is paramount to providing customers with safe and wholesome food.
The Food Safety Modernization Act’s (FSMA’s) Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation requires that preventive controls for food are validated. Per the regulation, validation “…must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards.” Validations for thermal processes are conducted to demonstrate that a specific thermal process can adequately eliminate or reduce the pathogen of concern to a reasonably safe level.
Performance standards are the specific pathogen reduction levels that must be attained during processing to ensure that proper food safety has been achieved. In the case of traditional canning, these limits have been established over decades of scientific testing of canned foods. The 12-D concept, which describes a thermal process that results in a 12-log reduction of Clostridium botulinum spores, has been established for low-acid canned foods as an acceptable performance standard that results in a very low health risk for consumers.
However, in the case of non-canning processing (heat treatment or an alternative), these performance standards can vary depending on the product type. For some non-canned products such as meats, poultry, and nuts, the performance standards have been established by previous scientific testing. For other food products where thermal processes such as baking or blanching are applied, sufficient scientific data is not available or is still in development to establish the proper performance standards for those respective items. Applying previously established high-moisture products’ cook time and temperature parameters to low-moisture products has been proven to be ineffective. Other variables must be considered, such as increased thermal resistance of Salmonella spp. in lower-moisture products, as demonstrated by some recent scientific investigations1 and the effect of impingement cooking on the surfaces of meat products.2,3
Performance standards can be chosen based on available scientific literature, scientific studies performed by the company, or by using risk-based pathogen modeling. In the case where there is no industry-available scientific literature to reference, food companies are expected to provide their own scientific studies and justifications for the safety of their food products.
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