How FSMA is Continuing to Change the Industry

Though the Food Safety Modernization Act (FSMA) was passed nearly nine years ago, some aspects are still being rolled out with others requiring regular updates. Do you understand all the changes wrought by the rules – particularly those for pest management?


Published December 12, 2019

Though the Food Safety Modernization Act (FSMA) was passed nearly nine years ago, some aspects are still being rolled out with others requiring regular updates. Do you understand all the changes wrought by the rules – particularly those for pest management?

Enacted to better protect public health by strengthening the food safety system, FSMA focuses on preventing food safety problems rather than relying primarily on reacting to problems after they occur. Applying equally to pest management as to other food facility practices and programs, this focus serves to change the “conventional wisdom” of reaction: If there isn’t a current pest problem, there is no need to add to or change pest management practices, to prevention: Facilities must continually and actively seek to improve pest mitigation—and proactively implement preventive controls even when no pest issues exist.

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:

• 247 citations for lack of exclusion (including lack of effective pest exclusion; lack of screening (or other protection against pests); harborage areas (for pests); animals and pests in facility; and/or odor or other attractant for pests or harborage
• 188 citations for lack of pest prevention/control (including inadequate pest control measures and/or pest contamination in buildings)
• 17 citations for lack of documentation (including written pest control procedures; cleaning/pest control records; and/or rodent and pest control documentation)
 
FDA also has a Pest Control in Food Establishments Course, specifically intended to provide inspectors and food establishment proprietors with basic information on pests. Included in that course is an explanation of pests (including insects, rodents, birds, and bats) that are considered to be significant as potentially adulterating or contaminating human food. FDA sees pests as significant because:
• They may carry food-borne pathogens.
• Their presence may be an indicator of insanitation in the facility.
• They may adulterate food products with foreign substances such as insect eggs, larval skins, frass, rodent hairs, and waste that are at the very least aesthetically objectionable in food.
• They may cause millions of dollars’ worth of damage.
• They are considered filth which, whether or not an actual health hazard, by its mere presence in a product, it will render that product adulterated.
 
Additionally, FDA divides pests common to food establishments into three categories.
• Category I. The most serious as they can potentially transmit diseases to food and cause allergic reactions.
• Category II. Don’t directly carry disease but are indicators of insanitary conditions.
• Category III. Pose no health hazard and are not indicative of insanitation, but their presence in food would be aesthetically unpleasant and unacceptable.
 

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.

In practice, this means that the presence of any pest activity can be enough evidence for a facility to be fined or even shut down. The more stringent focus on preventive measures also means that issues previously considered minor non-conformities by auditors may now be elevated to critical non-conformities.
With FSMA, FDA has expanded authority and resources to enforce food safety regulation — including all those for pest management preventive controls. This not only means more robust investigation into reported issues, it can mean more frequent and more severe action for non-compliance. In short, FSMA requirements have more “teeth” than any previous food safety regulation.
 

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