Repeated Recalls with Ready-to-Eat Products: A Major Focus of Regulators
There's no question that this continues to be a major focus of the regulators, especially on the FDA side. According to Dr. Acheson, what is currently being observed is repeated recalls in different situations with ready-to-eat products in which the agency has determined that the company has manufactured/processed in an unsanitary environment. That determination is based on environmental monitoring data that the FDA has.
According to Dr. Acheson, this is an area that requires focus for three very specific reasons.
- There is now a regulatory requirement to have an environmental monitoring program. You've got to make sure that you have got all your boxes checked on that one.
- There is very clearly a risk in terms of a recall. With environmental monitoring going on and the connection through whole genome sequencing, it isn't just about regulatory risk, rather, it is about true, operational risk, and the chances of a recall.
- The reputational risk to the company. When you have a recall, managing the impact on your brand.
While there are new regulatory requirements in this space, environmental control and monitoring, in Dr. Acheson's view, is a major focus of all the areas that FDA is looking at. For the companies that The Acheson Group is working with, this is the area where many of their clients are most nervous. The questions they are asking are, "What do we need to do? How do we stay out in front? How thorough do we have to be and what will happen if we have a problem?"
Dr. Acheson asserts, "It isn't the only focus of the regulators by any means, but to me, it is a huge one and continues to be a huge one. It's really important that we pay attention to this from both a FSMA perspective, as well as just making sure we do this right so that we don't get tangled up in a recall."
What Are the Environmental Monitoring Requirements Dictated by FSMA?
Actual FSMA requirements for environmental monitoring dictate that if you are making a ready-to-eat food, and it is exposed to your manufacturing or processing environment. Dr. Acheson continues, "By that, my interpretation of that is that if it's coming out of some sort of a process. Let's assume it's a cooking process, or a steaming process, or a pasteurization process, and it is exposed. That means that it has not been cooked in a bag, or a can, or a bottle, or anything. If it is exposed to the environment, even if only briefly, then it falls into this category of exposed. At that point, I think it's very critical that the manufacturers do a risk assessment and say, 'All right, it's coming red hot. It's really hot. We're doing a hot fill. It's going right into a container within seconds. Yes, it's exposed, but the risk is really, really small.' Take that into account. I think that's a factor that can help you. If on the other hand it's coming out of a 'cooking environment,' and is then moving down a conveyor belt, and is very obviously exposed, then that's obvious, before it goes in its final packaging."
Dr. Acheson emphasized the following key points to think about:
- Is my product exposed? If it is, then ask yourself whether you've got a risk from a contamination in the environment. The FDA is focused on Listeria monocytogenes and salmonella, very clearly. Those are the two bugs they're focused on in most situations.
- If after exposure, your food is going into a package and does not either receive a further 'kill' step (which means it's cooked, pasteurized, steamed, etc.) — then you need to have an environmental monitoring program. The other criteria, which will get you out of needing to do this, is if that food is formulated in some way in which that, if there has been a contamination while it was exposed, then the formulation would effectively take care of the pathogen.
To simplify, Dr. Acheson offered the following: "Question one: Is my food exposed? Questions two: Is there a risk associated with that, which would trigger the need for an environmental monitoring program? My view of that is unless it's a very, very short gap with hot product, there is a risk, which means you need a monitoring program."
Dr. Acheson summarizes this assessment by reminding session participants to keep in mind that if they are having to put in place a monitoring program based on FSMA, there are a number of details in the rule around which labs you're using, what assays you're using, documenting your site, and documenting your corrective actions. It is important to make sure that you've got all those boxes checked in your food safety plan and your monitoring records.
Join Our Next FSMA Fridays Session: August 25
Save the date for our next session at 9:00 a.m. Friday, August 25, when we will explore another top-of-mind FSMA topic, review current developments pertaining to FDA, and more! Register for our monthly series at www.FSMAFridays.com.
There's More on Environmental Monitoring on the FSMA Fridays LinkedIn Group
After July's session wrapped up, we expanded the discussion on environmental monitoring and controls LinkedIn in the FSMA Fridays group with additional participant questions on FDA inspections and environmental monitoring programs. Our LinkedIn group has grown steadily over the months to include over 150 members. Group participation offers opportunities for peer discussion, access to additional FSMA Fridays session content, and engagement in valuable dialogues around the management of FSMA compliance. Join today!