A new draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” was published by the US Food and Drug Administration (FDA) on January 13,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 This draft guidance offers some excellent background information about Listeria control – more than simply using an environmental monitoring program (EMP).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

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

Whether they’re sprinkled on top of a salad, mixed into brownie batter or added as the star ingredient in a granola bar; nuts and seeds tend to find their way into many food products. However, it is vital for food manufacturers to ensure the safety of these items in their products. Tree nuts such as almonds, hazelnuts, pine nuts, pistachios, macadamia nuts, pecans, walnuts and peanuts have been identified as a vehicle for foodborne pathogens, including Enterohemorrhagic E. coli (EHEC), Listeria monocytogenes and Salmonella. Moreover, seeds such as sesame seeds, sunflower seeds and pumpkin seeds have been recently linked to bacterial pathogens. For example, in May 2016, almost 100 products were recalled due to Listeria contamination in sunflower seeds. Salmonella also appears to be of concern in nuts, as it has been associated with many outbreaks and recalls in recent years. Continue Reading

Those with lengthy careers or students of food microbiology history may recall the original Listeria Hysteria in the 1980s. While Listeria monocytogenes was responsible for an outbreak associated with fluid milk earlier in the decade, the Jalisco Cheese-related outbreak in 1985 was a major eye opener for the food industry. In the ensuing years, multiple dairy products were found to contain Listeria monocytogenes. A few years after that, the Ready-to-Eat (RTE) meat industry was the center of attention relative to reported incidents of contamination with Listeria monocytogenes. Over the next few years, fruits, vegetables, seafood, deli salads and other products were also found to contain Listeria monocytogenes. Continue Reading

The practice of whole genome sequencing (WGS) has received a great deal of attention in the food industry and among industry trade associations in recent years. Whole genome sequencing is a process that uses laboratory methods to determine or map the complete DNA sequence of an organism’s genome. Each microorganism has a unique genetic fingerprint that can be identified and traced using WGS. Continue Reading

Back in 1999, I started contributing as a developer and instructor for the “Advanced Listeria monocytogenes Intervention and Control Workshop,” presented by the American Meat Institute, which is now called the North American Meat Institute (NAMI). During the first few meetings, I took great interest in learning how each of the major US meat and poultry Ready-to-eat (RTE) manufacturers were conducting their Environmental Monitoring Programs (EMPs). A pledge by industry executives to keep food safety a non-competitive issue enabled open sharing, which brought some intense discussions as we worked towards a consensus of what constituted the true best practices for EMPs. This open forum, combined with a close collaborative interaction with the USDA- FSIS, allowed the US RTE meat and poultry industry to make tremendous strides in reducing the risk of L. monocytogenes.  Continue Reading

If you are subject to the final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule), then you should be aware of FDA’s new recommendations for controlling Listeria monocytogenes in ready-to-eat (RTE) foods. Manufacturers, processors, packers and holders of RTE foods will benefit from an understanding of the strategies and recommendations described within the new draft guidance.

Released this month, the draft guidance sheds light on the agency’s thinking regarding effective strategies for controlling L. monocytogenes in RTE foods, including identifying the risks associated with raw materials and ingredients, listericidal process control, environmental monitoring, product testing, and the analysis of verification data trends. Continue Reading