“This is a very serious matter for people to really pay attention to. If I was to put one of the top two or three things that keeps me awake at night with food companies, it is environmental contaminants, especially if you’re making a ready-to-eat food. That really is the focus of the listeria guidance from FDA. Irrespective of the reasoning, this is definitely a hot topic.“ —David Acheson, MD
Our February FSMA Fridays session with David Acheson, MD of The Acheson Group offered insights on why FDA is focusing on listeria and explored the suggested approach companies should take with respect to this pathogen.
Latest FSMA Update—New Administration Happenings, Single Food Agency? And More!
To kick off the general FSMA discussion, Acheson discussed the first 100 days of the current administration and described a proposed dismantling of regulations in a recent report by Congressman Mark Meadows. In the report, some of the FSMA regulations were on the list to remove. Two in particular were the intentional adulteration rule and the prevent and control rule for human foods. All other rules remained intact, and weren’t included on Meadows’ list. Acheson didn’t think these FSMA regulations will be going anywhere, but does think we may see a reduction in funding for them and enforcement may be reduced as well. Acheson’s advice to webinar participants was just to continue to build programs, and unless we hear something very concrete, assume that regulations will be in place.
Other FSMA updates discussed included FDA talk about training of inspectors, although the TAG Team is not really hearing a great deal yet about impacts of visits from inspectors around FSMA. Peripheral to FSMA is the latest report from the Government Accountability Office (GAO), which was tasked yet again with recommending whether the country should have a single food safety agency. While the GAO didn’t call for a single food agency, per se, what it did call for was a national food safety strategy—essentially making sure that all the federal agencies are communicating properly, sharing information, and sharing resources. It really didn’t, in Acheson’s opinion, say anything unexpected, and he doesn’t see any of that changing, remarking that, “The bottom line is: Continue to build, plan, and assume if you are a small business that you will have to be online for prevent and control rules by September.”
Dr. Acheson brought up the numerous recent recalls linked to listeria in the environment, listeria in products, and some situations where there have been fairly significant outbreaks and public health risk from listeria in certain foods. He indicated that the Center for Disease Control reports about 2,500 cases a year of listeriosis, which is essentially when the disease actually manifests itself in people, typically the elderly, the immune compromised, or the fetuses of pregnant women, that are particularly susceptible. Contrasting the number of listeriosis cases with salmonella, where the number of cases are at about a million per year, one may wonder why all the focus is on listeria. Acheson explained that if you encounter listeria and you get listeriosis, it is a very serious illness with a very high hospitalization rate and high mortality rate, around 20%. He added, “The focus on listeria, I think, is partly because of its public health consequence, clearly not because of its amount of disease. It’s way less than salmonella.”
Acheson continued, “This is a very serious matter for people to really pay attention to. If I was to put one of the top two or three things that keeps me awake at night with food companies, it is environmental contaminants, especially if you’re making a ready-to-eat food. That really is the focus of the listeria guidance from FDA. Irrespective of the reasoning, this is definitely a hot topic.“
FDA Guidance—Zone One Testing, Plant Mapping, and Whole Genome Sequencing
Acheson described the general message of FDA, which is for companies to figure out where listeria originates in a facility, understand how to control it through multiple methodologies, and then make sure they are controlling it through an environmental monitoring program. He explained that while it would take hours to go through all of the nuances in the guidance, to summarize, the general approach is to look at how to control risks. One remark he made about the guidance document is that it isn’t just about how to establish an environmental monitoring program. It is much broader and provides a practical approach.
The discussion moved into the pros and cons of zone one testing as suggested by FDA, including when to test zone one, implications of finding a positive, and the number of swabs to test per line. Acheson described the implications of a company’s approach, “I think a con is if you’re not testing zone ones, will FDA ding you for it? I don’t know the answer to that. The guidance very clearly says you should be.” He goes on to stress that while guidance is not binding, the decision about zone one testing must be framed around an overall environmental control program that is very thorough: “If you choose to have a sloppy program and you’re not testing zone ones and there’s a problem, I think the consequences could be quite dire.”
What should food companies do? Acheson’s first recommendation is to take environmental controls and monitoring very seriously, and consider all aspects of risk management, including whole genome sequencing, swab-a-thons, and mapping facilities for pathogens. Secondly, he advises to read the guidance document thoroughly and distill from it what you need to address the risks to your operation.
And There’s More on FDA Listeria Guidance and Proposed Rules Changes!
Access the full session recording to hear more of our presenter’s perspectives, including an in-depth discussion of specific approaches to zone one testing and a discussion of how proposed changes to the rules included in the Meadows report may impact new labeling requirements.
Need Help Ensuring FSMA Compliance?
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FSMA Fridays March Session–Continuing Discussion with Even More on Listeria
Be sure to save the date for our next FSMA Friday session, Friday, March 31, when we will continue to explore this top-of-mind topic. Not part of FSMA Fridays? Sign up today at www.FSMAFridays.com.
Join the new FSMA Fridays LinkedIn Group
FSMA Fridays series participation has grown considerably over the past 3+ years and we are delighted to extend the conversation beyond our monthly sessions. The group will serve as a forum for FSMA Fridays participants with the goal of answering FSMA-related questions that were not addressed during the monthly session, posting FSMA questions for peer discussion, sharing FSMA Fridays session content, and facilitating dialogues around the management of FSMA compliance, audits, and more. We look forward to extending our FSMA Fridays community with additional opportunities to learn from each other. We do hope you will join us!