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
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.
The top priority for most food manufacturers is protecting the food consumers eat. Yet, one of the major causes of product recalls in the food industry is product contamination in the processing environment by pathogens such as Salmonella and Listeria monocytogenes. These pathogens take up residence within the structure of food plants and within the processing equipment itself. Once it makes a home there, it can contaminate the food products it comes into contact with as they make their way through the production process. Continue Reading
The Food Safety Modernization Act has introduced many new food safety requirements to the food industry. In particular, FSMA places a focus on performing a hazard analysis and using preventive measures in food manufacturing. The requirement to develop and implement supplier preventive controls for raw materials and ingredients to address hazards has renewed interest in methods for sampling and testing raw materials. In order for sampling and testing to be used to address pathogen concerns identified in the hazard analysis of raw materials, a valid sampling plan must be in place. Continue Reading
With summer vacation season upon us, most people can relate to the angst of the question, “Are we there yet?” In fact, I suspect many food industry professionals have recently pondered this question when reflecting on the regulations of the Food Safety Modernization Act (FSMA), and then wondered what is “coming down the pike?”
Upon enactment of the FSMA law in January 2011, the U.S. Food and Drug Administration (FDA) implemented a few requirements immediately, but the most significant rules require years to develop. The implementation phase of the FSMA regulations officially began two years ago with the beginning of Phase II of the FDA’s operational strategy for FSMA, which included regulator training and targeted risk-based inspection, sampling, testing and data collection activities. Continue Reading
All natural. Gluten free. Low in fat. Organic. Peanut free. The number of claims available for use to describe a food seems endless, so how does a manufacturer or producer know which words they can and cannot use? Taking one quick trip down the grocery aisle bombards a consumer with confusing label call-outs, outrageous marketing promises and countless newly innovative products.
The food and beverage market is a multi-million dollar industry that just keeps growing, providing consumers with access to trendy or niche foods they have never heard of before. The fast-paced world of food research and new product introductions may even leave some consumers questioning how true some of these claims are on new products with their fancy marketing call-outs and implied promises of renewed health and energy. Continue Reading
After a flood of food regulations during President Obama’s administration, the food regulatory environment in the United States could experience a drought in new regulations due to the deregulatory philosophy of the Trump administration and the U.S. Congress.
In April, President Trump signed an executive order with the objective of eliminating unnecessary “regulatory burdens” for the agricultural sector. Earlier this year, the U.S. House passed legislation (H.R. 5), referred to as the “filthy food act” by opponents, which would impede the development of new food regulations. The U.S. Senate is expected to vote on the bill later this month. Continue Reading