Our March FSMA Fridays session with Dr. Peyman Fatemi and Randy Porter of The Acheson Group explored questions about the FDA’s current focus on listeria and offered additional insights on FDA guidance and best practices for companies to consider for managing this risk in their facilities.
Latest FSMA Update–Compliance Deadline for The Sanitary Transport Rule, FDA’s Recent Guidance on DUNS for Foreign Supplier Verification, and More!
To kick off the general FSMA discussion, Peyman discussed the April 6th compliance deadline for the Sanitary Transport Rule. He described how while components of it are already in place, the rule is really forcing companies to take a look at the roles and responsibilities of various players within the transport chain, whether those players are shippers, loaders, carriers, or receivers. Because of the rule, companies are looking at the relationships and agreements that they have in place within their supply chain and determining whether they required to do any additional activities. In some cases, the amount of verification work and responsibility that is currently delegated to each entity is sufficient.
Peyman also talked about a recent guidance from the FDA about formally recognizing the DUNS number, the Data Universal Numbering System number, for using as part of the foreign supplier verification activity. He would encourage those that are interested to visit the FDA site and take a look at the guidance.
Other FSMA updates discussed included monitoring what is going on in terms of the budget approvals of the new administration. Peyman summed up the discussion of FSMA updates by stating that so far, what he’s seen is that food safety is more or less left alone: “The budgets haven't been cut and FSMA is, as we expect, going to be alive and well moving forward. How much funding is allocated to the FDA is still up for discussion, but in terms of the regulations at least in place, things are still moving forward.”
Answering Your Questions on Testing for Listeria
The conversation continued in a Q&A format, with Jill Bender, SafetyChain’s VP of Marketing introducing a selection of questions that FSMA Fridays participants asked during the previous Listeria discussion in February. Here are some of the great questions our attendees asked along with answers provided by Peyman and Randy.
Question: If you are testing for listeria species on a food contact surface, what are best practices for holding/shipping product while awaiting lab results?
Peyman responded that if you're conducting any type of testing on a food contact surface and you're not putting the food on hold, you're taking a risk because you might, as part of the follow-up and corrective action for a positive, realize that maybe there is a bigger issue and a lot of that product may have to come back. He went on to describe the increase in complexity that can result if you do let the product go out into the market from the first test you conduct. You have a positive, you conduct corrective actions, and a root cause analysis. Then down the road, you may have another positive, maybe in a fairly-close time point. As a result, you now have to potentially bring back that product that you shipped out after the first test, which puts your company at a bit of a risk.
Peyman’s recommendation is do what essentially folks have always done, “If you're doing food contact surface testing, keep the product on hold until you get the results. That may be the easiest way to manage it. Of course, there's a logistics component of that, there is the management of the warehouse, the production, and everything else that goes with it, but from a brand exposure and regulatory risk standpoint, I think it's probably the most prudent thing to do—just hold on to the product until you get the results.”
Question: Is there an acceptable level of positives for Listeria species, such as zone 3 and 4? Is it zero tolerance overall?
Randy took this question, and answered that while the goal is certainly zero, that's not a reality because Listeria is so ubiquitous in the environment and in facilities, and that if you have a facility that has a product mix, or has a wet environment, or cold storage environment, you're at a much higher risk to have positives that show up in your environmental program.
Randy described the FDA guidance as addressing an understanding of the effectiveness of your program, and if you have all zeroes, you're program likely is not well designed to find them. The goal is to search, to seek, and to destroy. According to Randy, “You should expect to find some occasional positives. Now, having said that, if you have more than the occasional, if you have daily, weekly, multiple hits, that's going to be an issue with the FDA as well. It really comes back to how robust your program is.”
He went on to say, “It's really about how well are you managing the program, how well are you finding occurrences, and then more importantly, how well are you eradicating them from your facility? It's not zero, that's not realistic. I don't believe the FDA expects to see zeroes. In fact, they would probably challenge you that your program is not robust enough if they find no positives whatsoever, especially in a facility with a product mix and an environment that would support Listeria survival and growth.”
Randy summed up his answer by reiterating that while zero is certainly the goal, it is not a completely realistic goal. You will find some positives, and if not, you need to reevaluate your program and see if there are other sites that you should be selecting versus the ones that you are currently selecting. The FDA guidance addresses trending and tracking and obviously taking a very aggressive action once you do find positives to make sure that you can eliminate them from your environment.
Question: When should I reassess my testing program?
Jill asked Randy to elaborate on the reassessment of programs, and to provide advice on a recommended time frame of when a program should be evaluated to determine whether there are gaps or to confirm that the program is performing at the needed level of efficacy. According to Randy, if you have an established program, you would typically reevaluate your program at least annually and you would look to see historically where you have had negatives. You would consider whether you should be looking in additional places and to change out some of those locations where you've never seen anything for two or three years, then start looking for new sites. For example, if you were to get a positive in an area where you haven't had one historically, then you might want to expand that area and start searching for that source, but typically, if you've established a good, robust program, at least conduct an annual review of hot spots, assess whether that has changed from past history, and whether there are areas you are not currently swabbing that you can now include in the program.
And There’s More on Zone 1 Swabbing in Closed Systems, Testing Raw Materials, and In-House Testing Labs!
Access the full session recording to hear more of our presenter’s perspectives, including recommendations for testing in clean-in-place (CIP) systems and how the effective management of your supply chain can also help you manage Listeria risk.
Need Help Ensuring FSMA Compliance?
The TAG team can help you identify gaps and update your food safety and recall plans. For more information visit www.achesongroup.com.
Interested in learning how SafetyChain’s solutions are helping our customers reduce risk, control costs and ensure regulatory, non-regulatory and customer compliance? Learn more about our solutions.
Join Us for Our FSMA Fridays April Session
Be sure to save the date for our next FSMA Friday session, Friday, April 28, when we will talk more about the Sanitary Transport Rule and have additional updates on FSMA. Not part of FSMA Fridays? Sign up for our next FSMA Friday Webinar!
FSMA Fridays LinkedIn Group–Over 100 Members Strong and Growing!
We are delighted to extend the conversation on FSMA beyond our monthly sessions with the FSMA Fridays LinkedIn group, which serves as a forum for series participants for peer discussion, sharing additional FSMA Fridays session content, and facilitating dialogues around the management of FSMA compliance, audits, and more. The group provides great opportunities for our FSMA Fridays community to learn from each other.