New “From the Trenches”-Part 1
When the FDA Comes Knocking
By Rob Ralyea

In 15 years as a dairy extension person in New York, I have come to realize that many of us labor in our own little worlds, mostly oblivious to what’s happening around us. I field many calls from people looking for advice, regulatory interpretation, and help with food safety questions. I thought it’d be a worthwhile endeavor to discuss some common issues I see across the State. Part 1 is ‘here comes the Food and Drug Administration (FDA) field staff (or other regulatory authority)’.

Not much strikes as much fear into the hearts of food producers as a visit from the FDA. Now that the Food Safety Modernization Act (FSMA) is in full swing, their powers have been expanded. Further, as microbiological genomic technologies have become more exact, the pressure is even higher for food processors. If your Food Safety Plan (FSP) is in shambles, disarray, or even worse, nonexistent, then the fear is probably justifiable. If you are prepared, all of your documentation is in place, and you are knowledgeable of what is going on in your plant, then you should do just fine. After all, they are not out to ‘get you’, they are just doing their job of protecting public health. The level of angst that you experience is really a result of your preparation for such a visit. Part of the way you can prepare is knowing what to expect from a visit.

If/when an FDA inspector arrives, be cordial and polite. They may demand to see pieces/parts of your FSP which is an “inspectable” document, and is required to be on site. They may observe your procedures and your employees in action. They may also ask questions of employees. They may make observations of what they see during their visit, and they may take environmental swabs of your plant premises. If the FDA inspector takes finished product samples, they should annotate that on a receipt form and you should get reimbursed for those samples. All of these things are legal and perfectly acceptable. The question is, how do you react?

First, show them what they wish to see. If they find something is out of place, do not try to lie about it to ‘minimize the damage’. Accept an issue for what it is and make the correction, at the time if possible. Make sure your FSP is accurate in that it reflects what you are actually doing day-to-day in your facility. In regard to employees, FSMA requires ALL employees be trained for the tasks that they’re asked to do. So, if an employee is running a piece of equipment, there should be a training record on file that indicates they have been shown how to properly run it. Therefore, it would be logical to assume that the employee would be able to correctly answer any questions that the inspector might ask as it relates to the operation of the piece of equipment. We can apply those same principles to GMP training as well (handwashing, hygiene, general cleaning procedures, colored brush program, etc). If they take environmental samples, the question I am often asked is ‘should I take swabs of the same area too’? My response is ‘no’…not unless you have very deep pockets. The one potential advantage of doing side by side swabbing, would be to receive swab results more rapidly, and therefore react more quickly to a swab if it comes back positive. Most of the small plants that I have dealt with are probably less than 5,000 -6,000 square feet in size. I have seen the FDA take anywhere from 80-180 swabs in those environments. So, unless you have the financial assets to send those off for testing, taking ‘side by side’ swabs becomes a moot point. Leaving the financial interest aside, if you get a negative swab for a pathogen and they get a positive swab, it still makes it a positive swab. Conversely, if they get a negative swab and you get a positive swab, you now have to document the positive pathogen discovery and react to it as well. In the end, side by side swabs mean nothing, as the FDA swab is the official swab. If you have sanitation preventive controls in your FSP, you probably should already have an environmental monitoring program in place as well as a corrective actions Standing Operating Procedure that is followed when positive pathogen sites are found.

Now, what happens to those swabs and finished product samples? They will be taken back to the laboratory and tested for specific pathogens, most generally in the dairy industry for Listeria monocytogenes. They will use an approved method and they will enrich for the pathogen of choice, meaning if there is 1 cell there, they want to grow it out so they have millions. They are not trying to enumerate what you might have in your plant, they are trying to detect its presence. It only takes a single cell to indicate presence. If a pathogen is detected and confirmed, it will go for whole genome sequencing (WGS).

This sequence is uploaded into the national database at the National Center for Biotechnology Information (NCBI). The NCBI database includes both FDA (environmental and food isolates) data as well as Center for Disease Control’s (CDC) data. Why is this important? Because the WGS alignments can be done in rapid fashion to identify any common sources. Ultimately, this means that regulatory agencies are able to use WGS to see whether or not your positive sample is a match to other positive hits in the database. This is the least understood and scariest part to deal with from a food processor’s point of view. Many individuals and organizations do not realize that they have access to this database. If you want to have the information at your fingertips, you need an NCBI account, and you need to know what you’re specifically looking for. You also need to understand the terminology associated with the sequence data. If you find yourself in the position of having to deal with this scenario, feel free to reach out to us at Cornell Dairy Extension and we’ll be glad to help you.

Look for Part 2 of our View from the Trenches series in our November Newsletter. ‘What does it mean if my team or a regulatory authority finds a pathogen in my plant?’