Would you be prepared if the FDA showed up at your facility unexpectedly to perform a swabathon? The FDA is conducting these elevated inspections by swabbing ready-to-eat (RTE) and high-risk food manufacturing facilities in search of foodborne pathogens. To help prepare manufacturers for these swabathons, our subject matter expert, Tim Freier, Ph.D., sat down to answer some questions posed by food industry professionals following our recent swabathon webinar, which is available to stream on-demand for free. Continue Reading

A new draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” was published by the US Food and Drug Administration (FDA) on January 13,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 This draft guidance offers some excellent background information about Listeria control – more than simply using an environmental monitoring program (EMP).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

Recently,  multiple foodborne outbreaks caused by shiga toxin-producing E. coli (STEC) have been epidemiologically linked to the consumption of wheat flour. This has been a hot topic of discussion with many of our flour milling clients as well as manufacturers and retailers who use flour as an ingredient or sell flour to consumers. Many in the food industry are wondering if they should be changing their hazard analyses, environmental monitoring programs, ingredient testing or finished product testing. 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

Recently, significant changes have been made to how the US Food and Drug Administration (FDA) conducts investigations of food manufacturing facilities. For starters, note that I did not say FDA inspections; they are now investigations. This change in semantics indicates a shift from a superficial “look around” a facility to diving into records and sometimes taking hundreds of environmental pathogen samples. The Food Safety Modernization Act (FSMA) has prompted many of these changes, and has given the FDA increased power and access to records. The FDA is also now much more likely than in the past to involve the Department of Justice if there is any possibility of criminal intent. Along with this significant new regulatory authority, the industry has seen major leaps forward in microbial strain tracking technology, the most important being Next Generation Sequencing and its use for Whole Genome Sequencing (WGS).  Continue Reading