Pathogens are most often introduced in LMFs via contaminated ingredients or cross-contamination during processing. Regulatory agencies such as FDA therefore recommends conducting hazard analyses for preventive controls for human food, and manufacturers need to consider the potential for biological, chemical, and physical hazards relating to their raw materials and other ingredients (ingredient-related hazards), processes (process-related hazards), and the food-production environment (facility-related hazards). Regulatory guidelines also recommend good hygienic practices, hygienic design of equipment, proactive maintenance programs, control of incoming materials, and effective ingredient control in the LMF establishment to prevent contamination. The Codex advises that special attention be paid to those products exposed to the processing environment following a pathogen reduction step (such as almonds and pistachios), products that are not subjected to a pathogen reduction step (such as flour and dry mixes), and products for which ingredients are added after a pathogen reduction step (such as herbs and spices).
Beyond Finished Foods: Production Environments
In contrast to the historical focus on testing finished products for pathogens just prior to release with little or no attention given to the processing operation and environment, new guidelines and regulations place more attention on environmental monitoring and entire process operation as means to prevent pathogen contamination.
The FSMA Preventive Controls rule, for example, focuses both on environmental monitoring and finished product testing for human food. In addition to recommending that raw materials, ingredients, and end products be tested, FSMA highly recommends environmental monitoring of pathogens in LMF and ready-to-eat (RTE) food processing environments. According to FSMA, “Foods such as peanut butter, soft cheeses, dried dairy products for use in RTE foods, and roasted nuts are among the products for which manufacturing operations would need to have an environmental monitoring program when such foods are exposed to the environment.”