By Bryan Armentrout
We are now firmly in the era of the Food Safety Modernization Act. It’s no longer theoretical, it’s real world, and FDA is auditing and asking questions about what they are seeing.
I think we can all agree on one thing. The way we looked at environmental pathogen testing in the past is out the window. Gone are the days of testing the same 10 sites every few months for generic Listeria and calling it good. Sometimes, you would get a hit and do an investigation, but that was the extent of the excitement.
You now need a robust program that looks at multiple pathogens and takes them all the way out to speciation. Some companies are even going further and developing a “microbiological map” of their processing areas. The technology is overwhelming, but one factor is still critical, and that’s time.
No one has the time to put all their product on hold while waiting for five days to a week for results. Of course, that assumes that nothing comes back as a presumptive positive. If it does, you can wait a few days longer while logistics breathes down your neck, and customers have empty shelves. What to do?
You need a new program to test for your environmental pathogens. But, how do you choose? Instead of evaluating the ever-changing landscape of tests available, it might be more useful to list four rules you need to follow for your decision-making process. This is an expensive decision, so make the right one as you are going to be living with it for a long time.
You need a fast turnaround, and in most cases, that means you are now considering something that wasn’t even possible in the past -testing samples and releasing in-house. The first step is to get out there and see the amazing new micro testing world that is at your fingertips.
- Don’t get sold by a fancy presentation You begin your journey by attending a trade show and marveling at the technology available. You strike up a conversation with a salesperson and after ten minutes, you are convinced that this new whiz-bang machine is the wave of the future. If you place your order today, you can get a huge discount and get one of the few machines that are even available. You can also add in a low monthly payment program. It does everything you want, and more in an hour and costs pennies to operate. It’s amazing, and you are in love. Not so fast, partner. It’s just like when you buy a car. The salesman at the dealership does everything to move you toward a purchase. How? By using your emotions. People buy on emotion and use logic to rationalize their decision after the fact. The thing the salesman wants you to forget is that this is a commodity and another similar model is available just down the street. Remember, any attempt to pressure you into a purchase should be met with a knowing smile. The deal they quote is not a once in a lifetime opportunity, and it will be there once you have time to make a decision in the calm light of rational thought. Be cool, try to find a technical representative of the company to talk with in addition to the sales or marketing staff. Remember it’s a piece of equipment, and one that is equally as good or even better is just around the corner. Add this piece of equipment to your list of possible testing methods and move on down the trade show to the next one.
- Not using a validated methodology This goes with the first point. You need a method and technology that are approved for your application. It needs to be benchmarked back to reference methodologies. Has it been used on your product matrix? Peanut butter will likely react very differently to the test than yogurt. Everything on your list needs to clear these hurdles before you even consider it. Don’t accept “the approval will happen in two weeks” line or something similar. You are in control of the validation and benchmarking process and must have a test and equipment that hold up to regulatory scrutiny. Ask the following questions as you look at the candidates:
- Has it been validated for my product matrix by one of the following?
- A recognized independent organization such as AOAC, AFNOR, MicroVal or
- A US regulatory body (FSIS MLG, FDA BAM or an ISO Method?
- Is the method?
- Fit for the purpose and application
- Performed under validated conditions by a lab that assures the quality of analytical results These questions come from the USDA Food Safety Inspection Service. They have compiled a list of validated methods that you can use as a starting point. It’s forty-six pages long! Cross off any candidates that didn’t make your list, realizing that FDA utilizes the BAM as their reference for acceptable analytical methods.
- Has it been validated for my product matrix by one of the following?
- Not testing in-house before you buy Never, ever buy a new testing method without trying it out first – for a long period of time. Any reputable company will have a loaner machine you can use. If they balk, cross them off the list and move on. Decide if you can test as a group or one at a time. This is a question of resources and how many people can do what. Don’t use the results for actual product release. Keep that the same as you are doing now. Another good idea is to test at the point of use in the plants. Don’t test at the corporate lab. You lose too many variables that need to be accounted for at the plant. Test it with every permutation you can think of. Analyze enough samples so you can make sure the results are repeatable. Find out the limits of detection for your product. What are the false positive and false negative rates? What is the turnaround time for results? See if your technicians can screw up the test. Make your test as foolproof as you can. Also ask yourself: Can you get test supplies in a reasonable period of time? What is the minimum order quantity? What is the breakpoint for discounts? Are your supplies expiring before you can use them? Are there other uses for this equipment? This list is not inclusive by any stretch; its a starting point. Create the list and stick to it. Don’t change it as you go along as it will bias the results toward the newest test. Be consistent. Remember, you may need to defend the test results in court one day. This is the litmus test for acceptance that you must always keep in mind in the age of FSMA. Send back any that don’t make the cut and cross them off the list.
- Not researching the company Great! Your list is down to the top two testing methods. They are both reliable and repeatable, have fast turnaround time, dependability and a decent cost per test. How do you decide now? The test is only as good as the company supporting it. If they are new to the scene, will they be here in five years? Will they come up with a new test and abandon the old one, leaving you with an expensive paperweight? Do they have references you can talk to? Can you talk to references who have had challenges with the test? Are they willing to work with you on price? Can you get other perks such as free service calls? How will they support you and the warranty? Just like the test, you need a huge list of questions to hit them with.
Congratulations! This was a big decision, but you made the right one for you. The method and the test you selected are the cornerstones of your new environmental testing program. You are finding out where pathogens hide in your plant and eradicating them. You have a clear record of identification and correction that any auditor will be happy to review. You sleep easy at night knowing that you made the right decision, and you have the ability to defend it if you need to.
Be proud of your work and welcome to the new age of FSMA!