Ready-to-eat (RTE) products are considered safe to consume without further cooking and are produced using controls such as thermal treatments that are validated to ensure that safe products are produced. However, non-ready-to-eat (NRTE) products may contain vegetative pathogens that require further cooking by the consumer to ensure that they are safe to consume. As such, cooking instructions provided by manufacturers should be validated to make sure that the NRTE product being cooked by the consumer provides the necessary lethality treatment to eliminate or reduce pathogen hazards to an acceptable level.
In 2006, FSIS issued notice 75-06 to their inspection program personnel to verify that establishments that produce certain uncooked and raw, breaded, boneless poultry products have adequate validation to support the cooking instructions that they include on the labels that will be applied to these products. FSIS has since provided guidance (FSIS-GD-2017-0017) for validation of cook instructions for these NRTE products. They also provide cook instruction validation guidance for mechanically tenderized beef products (FSIS-GD-2015-0022).
The FDA, unlike FSIS, does not have regulations addressing validation of cook instructions for NRTE products. However, the FDA fully expects NRTE products to be safe and products should contain labeling instructions related to safety (e.g., “keep refrigerated” or cooking instructions). Validation of cooking instructions by the manufacturer is a key step to ensure that products are safe when produced by consumers utilizing manufacturer’s preparation instructions. While guidance from FDA on cook instruction validation is lacking, trade associations such as the Consumer Brands Association (formerly the Grocery Manufacturer’s Association) and the American Frozen Food Institute do provide guidance.
Cook instruction validation begins with determining the appropriate lethality requirements. This can come from safe harbor time/temperature regulatory guidance, published scientific studies, and product-specific microbiological inactivation studies. The validation can then involve proving that the product meets a specific temperature after it is cooked (following the directions on the label) that meets safe harbor parameters. Or the validation may involve a microbial inactivation study, which may be more appropriate for products at greater risk of microbial contamination or those that achieve variable target temperatures
when following the cook instructions.
Factors affecting the validation include product packaging and the cooking device (e.g., microwave, stovetop oven, fryer) that can affect uniform heating of the product. Cold spots should be assessed and the amount of samples should account for variability among lots and be evaluated by a qualified individual. Cooking instructions should be reassessed when changes to ingredients and packaging occur. While validated cook instructions will provide assurance that microbial lethality requirements are met by the consumer, it should be noted that the consumer does not always follow the directions. This has led FSIS to propose declaring Salmonella an adulterant in breaded stuffed raw chicken products. Appropriate labeling or consumer education may be necessary to draw attention to the importance of following the cook instructions as they appear on the label.