A new draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” was published by the US Food and Drug Administration (FDA) on January 13,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 This draft guidance offers some excellent background information about Listeria control – more than simply using an environmental monitoring program (EMP).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

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

The Trump Administration’s Executive Orders requiring federal agencies to eliminate two regulations for every new regulation is adversely impacting the agencies responsible for food safety and nutrition. On July 20th, the federal government released the latest Unified Agenda of federal regulatory activities, which contained a new category for regulations requiring further review or consideration.

Within the Spring 2017 agenda, more than 100 regulatory measures were identified under this new category “inactive,” including significant regulations related to food labeling, organic agriculture and the Food Safety Modernization Act (FSMA). The impactful regulatory measures considered “inactive” in the food industry are detailed below: Continue Reading

Clients often ask me, “If I am certified to the Global Food Safety Initiative (GFSI), will I be ready for the FDA to inspect my operation for compliance with the Food Safety Modernization Act (FSMA) Preventive Controls Rule?” In the past, I have told many clients with certifications such as the Safe Quality Food (SQF) Code and British Retail Consortium (BRC) Standard, that because they went through the steps to become certified, they are well positioned to ensure compliance with the FSMA law requirements. However, there are similarities and differences between the two that must be taken into account. For companies that fall under the FDA regulatory jurisdiction and must become compliant with the FSMA Preventive Controls for Human Food Rule or the Animal Food Rule, taking the journey to become GFSI certified will help them meet the FSMA requirements. It will also change the working culture throughout the organization to prepare for FSMA implementation. Continue Reading

 

I recently attended the annual meeting for the International Association for Food Protection (IAFP) in Tampa, Florida. I always enjoy attending the food safety sessions, as well as seeing old friends from across the food industry. My presence at numerous IAFP meetings over the years has afforded me the chance to seek out new EnviroMap customers, but it has also given me the opportunity to speak with many legacy customers.

EnviroMap was developed several years ago, so our time at IAFP helps us move the product forward and provides insight on its real-world application. We have customers who use it for finished products as well as environmental testing. Some feel that the best feature of EnviroMap is reporting, while others claim it is the control/visibility over their local environmental program as well as their enterprise environmental management. I’m also fairly certain the local plant folks would all agree it has made their lives easier and freed up time to devote to other tasks.  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.
Continue Reading