FDA Expectations for Controlling Listeria monocytogenes
In January 2017, FDA published its document entitled “Control of Listeria monocytogenes in Ready–To–Eat Foods: Guidance for Industry.” Interestingly, it may be that disparity in expectations for food safety controls related to Listeria monocytogenes (LM) have existed in FDA– vs. USDA–regulated ready–to–eat (RTE) and ambient at–risk production systems. It appears that FDA has now taken strides to rectify what appears to be a concern for contamination of food with LM.
For plants that are regulated by FDA, official dates for implementation of 21 CFR §117—Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food (the Final Rule)—have been somewhat confusing. Implementation dates for some components of the regulations were extended last year (e.g., supply–chain program dates were amended “so that a food facility will not be required to comply with the supply–chain program provisions before its supplier is required to comply with the [Final Rule] or the produce safety rule”). Nonetheless, FDA has described plant size classification and general implementation dates as follows:
- Very small businesses (averaging less than $1 million per year [adjusted for inflation] in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Implementation three years, except for records to support its status as a very small business (January 1, 2016), after date that Final Rule was published.
- Small businesses (a business with fewer than 500 full–time equivalent employees): Implementation two years after date that Final Rule was published (i.e., September of 2017).
- All other businesses: Implementation one year after date that Final Rule was published (i.e., September of 2016).
It seems apparent that a large number (all but “Qualified”/very small businesses) of FDA–regulated facilities will need to comply with the Final Rule by September of 2017. Therefore, the risk of NOT also addressing suggested practices for controlling LM in plants that produce RTE products, as suggested in the draft guidance, will be significant.
During an October 2015 FDA Public Meeting in Chicago concerning the Final Rule, Priya Rathnam, a Supervisory Consumer Safety Officer for FDA, stated: “. . . the regulatory strategy that I just wanted to highlight here is really focused on achieving compliance through prompt voluntary corrective action and really minimizing public exposure to hazards. So, again, the emphasis being to achieve and document more corrective actions rather than, for example, counting the number of legal actions. The regulatory strategy would invoke swift action like some of our newer and expanded authorities under FSMA when public health is at risk.” Hence, it appeared—at least at that time—that FDA intends to address food safety issues via voluntary implementation of the regulations and corrective actions following inspections and/or an event rather than via an expectation of significant robust compliance with the Final Rule in advance. There appears to exist a philosophy of outreach and education rather than significant enforcement of the lengthy Final Rule.
So, to put the current scenario in context, consider a company producing RTE products that is required to implement the Preventive Controls Final Rule by this upcoming September (or, worse yet, by last September 2016). In this scenario, let’s imagine that said company does not implement the Final Rule and/or does not conform with suggestions included in the LM Guidance for RTE foods. If it were found that such noncompliance was associated with a recall or, God forbid, an illness or death associated with LM, then significant liabilities could exist that would have previously been unanticipated. These liabilities (with no attempt to presume how laws may be interpreted here) could include regulatory, civil and criminal charges, as accountability appears to have evolved in the legal system.
Although generally more concerned with LM growth rather than its presence on foods, the new FDA Guidance provides good general advice on how plants may begin to address risks associated with LM contamination. Specific examples of types of foods that have led to listeriosis are provided, including foods that support growth of, and that have been found to be contaminated with, LM. That list includes “unpasteurized and pasteurized milk, high fat dairy products, soft unripened cheese (Cottage Cheese, Cream Cheese, Ricotta), cooked ready–to–eat crustaceans (shrimp, crab), smoked seafood, fresh soft cheese (Queso Fresco), semi–soft cheese (Blue, Brick, Monterey), soft–ripened cheese (Brie, Camembert, Feta), deli–type salads, sandwiches, fresh–cut fruits and vegetables, and raw molluscan shellfish.” The draft Guidance also lists ice cream as an example of a RTE food “that does not support growth of LM, but that has been found to be contaminated.”
The document includes background, regulatory framework, and characteristics of LM to help plants understand some of the concerns regarding this organism. In addition, the draft Guidance includes specific recommendations for controls: of personnel hygiene, in–plant bacterial transmission, sanitation, maintenance, plant design and construction, air and airflow, water systems, equipment, raw materials, testing of raw materials. It also addresses formulation of RTE foods to have intrinsic properties that prevent growth of LM, listericidal process controls, and environmental monitoring to verify control of Listeria spp. or LM.
In the end, as they implement the Final Rule for Preventive Controls for Human Food, it will be important for FDA–regulated plants that produce RTE and ambient RTE products to also quickly address potential risks associated with LM contamination. Because of mortality rates associated with listeriosis, liabilities associated with this organism as FDA learns how to enforce the new regulations could be substantial.