A new draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” was published by the US Food and Drug Administration (FDA) on January 13, 2017. Comments for this guidance were due July 26 and many trade associations and food manufacturers have submitted remarks. This draft guidance offers some excellent background information about Listeria control – more than simply using an environmental monitoring program (EMP). It also includes detailed coverage of many of the prerequisite programs (Good Manufacturing Practices) that are integral for Listeria control. In addition, it provides a comprehensive compilation of industry best practices and includes information about the validation of listeriostatic or listeriocidal formulations and processes. Continue Reading

The identification and differentiation of bacteria date back to the late 1800s. Primary interest often focused on microorganisms impacting animal or human health. Salmonella falls under this umbrella, as it was first identified during a hog cholera study in the 1880s. Early work relied on phenotypic (observable) characteristics due to the limitations of the science at the time, but advancements in science led to the initial development of an antigenic schema for Salmonella. Over the ensuing years, the use of phenotypic and antigenic characteristics helped define the taxonomy of Salmonella (>2600 serovars). These characteristics have also been used for decades in public health investigations involving foodborne illnesses. Linking a Salmonella isolate from an ill human to a Salmonella isolate from a food through serotyping played a critical role in these investigations. Continue Reading

Major developments in the Food Safety Modernization Act (FSMA) have given the FDA new authority under the law. If the FDA decides to conduct a swabathon at your facility, you should expect a minimum of 100 to 300 swabs to be taken and a team of several investigators to conduct the swabathon. Based on the type of swabathon, you may also be required to hold production in your facility. This need is based on several factors, but, in particular, the zones that will be tested.

The FDA’s goal is to find pathogen isolates of Salmonella and or Listeria monocytogenes in and around the processing environment. As an outcome, the FDA will subsequently perform Whole Genome Sequencing (WGS) on these Listeria monocytogenes isolates for their database. The FDA is now swabbing Zone 4 specifically for this purpose, with a WGS analysis of Salmonella expected to follow. The FDA’s zone focus will differ based on the environment and the specific pathogen they are seeking out. For Listeria monocytogenes, you can expect the FDA to begin sampling no sooner than 4 hours into production. Continue Reading

Many companies have Environmental Monitoring Programs (EMPs) setup to monitor the processing (and surrounding) environments for transient pathogens such as Listeria monocytogenes and Salmonella. However, it is important to realize that growth niches are likely to occur from these transient guests. If your EMP does not include a “seek and destroy mission,” an event section, (i.e. increasing swab surveillance with roof leaks, construction, etc) or is simply not robust enough, then routine monitoring may be insufficient protection against an FDA swabathon. Additionally, if your site selection is fixed, new sites aren’t being rotated in, a low number of swabs are being taken, you have an infrequent swabbing schedule and corrective actions are not being implemented, the same result will surely occur.
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