How FSMA is Continuing to Change the Industry

Although FSMA does not detail standard requirements for pest management, what it does say about pest management is almost identical to Good Manufacturing Practices (GMPs) previously published as FDA guidance — except that the wording has been changed from “should” and “may” to “must” — making GMPs are no longer recommendations; they are now regulation. FSMA also requires that pest management preventive controls be included in the written Food Safety Plan.

A look at FDA’s 483 Inspection Observations (a list of conditions inspectors have deemed to be objectionable and indicating that an FDA-regulated product may violate FDA regulations) also provides an overview of pest management practices the agency sees as critical. Included among the top observations cited in fiscal year 2018 were:

As the highest priority — and severity — Category I pests are those that are potential vectors for foodborne pathogens. Pests that are known to carry pathogens are considered vectors regardless of whether a microbiological hazard is actually detected. In other words, FDA states, “If a pest lives around people, enters buildings, is attracted to and moves back and forth between filth and human food, and is known to carry food-borne pathogens, it is a Category I pest.”

This gains significance with the FSMA changes. Previous FDA standards focused on identifying a contaminant or adulterant in finished product, but FSMA moved that focus up the production line. Now, any evidence that suggests a product may have been adulterated can lead to action against the facility—regardless of whether there is evidence of actual contamination or adulteration in the end product.