By Lisa Lupo
A transient pathogen “pest” can be brought into the food production facility in a number of ways, be detected on a swab, and eliminated through cleaning and sanitation. But a pathogen that finds harborage can quickly become a resident pathogen “pet” — fed and nurtured with every run to grow into a resident food-adulteration risk and, eventually, find its way onto an environmental sample picked up during an FDA Preventive Controls inspection “swab-a-thon.”
Both FDA and facilities that have undergone the new inspections have said that, in its environmental sampling, FDA is taking 150-200 swabs, regardless of the size of facility (thus the expression “swab-a-thon”).
However, the goal of environmental monitoring for pathogen detection should not be simply to prevent FDA detection, but to identify weak points and sources, and develop and implement corrective action. That said, FDA’s extensive testing shows the significance the agency is placing on environmental monitoring and controls for food safety, and the importance you should be placing on it as well. “FDA shouldn’t be finding things you’re not finding,” said Hogan Lovells Partner Joseph Levitt at the GMA Science Forum in April. “If you’re testing, you will find something. And when you find it, be sure your records tie your corrective action to your finding.”
It is because FDA will have access to all your records that you need to tie your corrective actions to your positive environmental findings, Levitt said. “Don’t be afraid of environmental findings; just take corrective action.” In fact, FDA sees extensive environmental testing as so important that it is encouraging the industry to do so by giving, what Levitt terms, a “mulligan” on the first finding, even in zone 1.
FDA recognizes that Listeria spp. will be in the environment; that it is ubiquitous, said FDA Senior Science Advisor Mickey Parish. “We know this and we are instructing our inspectors to look at environmental monitoring records and focus on corrective action you have taken to remove it.” Then, as is written in the guidance, retest during the next three production cycles. It is a “one bite of the apple” approach, Parish said. FSIS has had success with it, so, he added, “we’re willing to take that approach as well.”
The FDA approach is focused on a “find and fix” mentality — giving food facilities the incentive to find Listeria, with the understanding that the agency knows you will find it, but giving you the ability to fix it, Parish explained. “We won’t come in and drop the hammer just because you find Listeria.”
But that do-over is applicable only on the first finding, and anything found in zone 1 will be put into test and hold. If you do have to hold product, industry experts have recommended that you ask FDA to write “voluntary hold” on its report so that results are relayed back to you quickly.
WHOLE GENOMRE SEQUENCING. Besides swabbing to test for pathogens, “FDA is collecting samples from plants for their WGS (whole genome sequencing) data,” said Commercial Food Sanitation President Joe Stout. In fact, because of its ability to link pathogens across time and space, “WGS is more impactful on the industry than FSMA,” he said.
“FDA will put everything positive through WGS,” Levitt said. “It won’t bother you the first time, but the next time ... you’ve got a pet.” That is, if a successive FDA inspection finds that you have not taken sufficient corrective action for a detected pathogen, or if it comes back showing that you have a resident strain, then you will have to face the consequences. Essentially, Levitt said, FDA is saying, “Wake up folks! You’ve got a ‘pet’ and you need to get rid of it.”
Because WGS also can link a pathogen strain in your plant all the way from farm to fork, and forward and back in time, your protection against linkage to a recall is good environmental testing, he said. There also is now a legal requirement to have a well-designed program for prevention and testing.
To ensure your testing detects the hidden pathogen pets, you should be testing several hours into a production run. Not only does this ensure you are not testing just-sanitized surfaces, it gives time for deep-rooted pathogens to work their way to contact surfaces — which is where they are a problem. Additionally, it is when FDA Guidance recommends that testing be done. “The goal is to find it,” said Kraft Heinz Associate Director of Food Safety and Regulatory Affairs Joe Meyer. “Find it so you can fix it.”
While environmental monitoring is not, itself, a control, it is a verification of your controls, he said. However, not finding a pathogen pet or a pest in your testing doesn’t necessarily mean all is well, it may mean you are just not looking hard enough. Conduct your environmental monitoring with a seek-and-destroy mentality, Meyer said. Follow the thinking that: “If I can find it, I can take aggressive action.”
Otherwise, you may be very surprised when a team of FDA investigators shows up at the door with sampling kits in hand ready to review your records and swab everything in your plant to get their own results. “FDA will say, ‘Really? You’re never finding anything? And they’ll take their own samples,” he said. “Don’t let negatives be an excuse for not doing the right thing — testing is not a control.”
RECOMMENDATIONS IN SAMPLING. Other recommendations Meyer made include:
- Read FDA Warning Letters to learn from their findings and mistakes.
- Do data mapping. On a blueprint of your facility highlight where positives were found, then review it for patterns, such as traffic flow, columns and walls that traverse floors, etc.
- Map out your highest risk areas by zones — draw it out so it’s easy to see. Then take samples and make corrective action in zones 2 to 4 before focusing on zone 1.
- Use the data you collect to understand your baseline, so you can understand seasonal and other such variations.
- Pay close attention to cracked floors and other areas that pathogens can get into and harbor. “Once Listeria or Salmonella get into those areas, it’s very difficult to get them out; they may survive in that environment for years.”
“When it comes to environmental monitoring, you need to know your plant better than FDA,” Stout said. So when you swab, “swab with authority. You’re in charge; you could be controlling the destiny of your company.”
Stout compared bacteria to an arriving battalion of soldiers, citing D-Day as an example. What’s the first thing they did when they landed on the beach? They found a foxhole, he asked and answered. Like them, your bacteria will find a foxhole, so you need to reswab every previous “foxhole” harborage each week as a scouting site.
And if you find it? “Every company should have a standard operating practice (SOP) for when you get a positive and what to do.” The SOP should follow FDA guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods”, and increase sanitation and cleaning controls as applicable.
“It’s all about sanitation,” Stout said. “The preventive control for pathogen control is sanitation.” As FDA states in the guidance, “to minimize the potential for contamination of RTE food and FCSs (food contact surfaces) with L. monocytogenes, we recommend that you establish and use a sanitation program that includes written sanitation procedures and a sanitation schedule for areas where RTE foods or FCSs are processed or exposed.”
The author is Editor of QA magazine. She can be reached at email@example.com.