From the Plant Floor

As professionals in food quality management, we do our best to manage allergens in our plant. We have amazing, complicated, and fully integrated, “allergen Kryponite” programs to ensure that an allergen does not accidentally get into a product that is not supposed to have allergens.

We spend our days following products and people around our plants to assure that everything goes right. We plan time with our colleagues in the warehouse to assure that they are doing their part to identify and segregate allergens, that they are keeping rework separated, and that the lift truck drivers are reading labels and delivering the right materials to production. We assure that scheduling efforts are correct and allergens are run last in the production order-of-run. We plan validation studies to ensure that cleaning removes allergens. We are in tight with the operations teams, because we train them to understand the importance of what they do.

Despite all this, we spend our nights worrying that everything we put in place to keep our products safe won’t be the allergen Kryptonite we want it to be. We worry that someone in the chain of that complicated program will make a mistake, and we will wake up to a product recovery, or worse—a product recall.

Our worries are based, in part, in the knowledge that production looks to us as the experts to help them ensure that allergens don’t get into non-allergen products. They pull samples for our labs to test—samples of CIP rinse waters, of batched WIP, and of finished product.
 

Testing and Validation. To ensure that we use the best possible methods for our needs, we are continually evaluating new tests. New to the market are tests that can detect all allergen proteins, which could allow us to have one test for all allergens in our plant. Could this be the Kryptonite for those of us who have to manage allergen programs?

It just may be—eventually. As of now, however, it can only be used for verification, not validation. As described by our SQF audit company, all validation work must be done with an approved method, and it is my understanding that the rapid all-proteins test is not yet an officially approved method. Be sure to check with your audit company to get their interpretation.

Also new to allergen testing is ever faster results in allergen test kits. One that we have used (Neogen’s Reveal 3-D) is a fast and easy kit that detects at the “recommended levels” of eight different, yet specific, allergens…and it is ready to run right out of the box. Testing time is less than 10 minutes from start to finish. However, due to the small sample size, the test is not recommended for product testing. Instead, it is designed for surface or rinse water testing. The speed of such testing can greatly enhance our allergen programs, as it could allow for operations to have allergen test results prior to starting the lines.

Whenever a plant is seeking to introduce a new test, in-plant validation is needed prior to implementation. I, personally, look for three items when validating a test or test kit: accuracy, speed, and assurance that the test can detect several levels of the allergen.

When discussing testing, we also need to be sure to discuss testing for markets other than the U.S. Canada includes sesame and other allergens in its regulations; the European Union includes foods such as celery and lupin. If you’re producing products destined for these markets, it is important to look for testing to validate your abilities to remove these allergens, as well as the “Big 8” of the U.S.

Certified “Allergen Free.” What else can be considered new? Believe it or not, there are organizations that will certify your products as “allergen free.” This is primarily related to gluten-free certifications. The Gluten Free Certification Organization (GFCO) can help quality managers sleep at night by helping in the selection of a proven (validated) test method that is product specific. For example, GFCO Executive Director Cynthia Kupper has said that some allergen test kits do not detect allergens in products that have been high-heat treated. GFCO has put in the labor to ensure that proper tests are used for these products and to assure that the test is accurate to a specific level. GFCO has even set a threshold level for detectability even though the FDA and USDA have not.

The GFCO should be commended for four things: providing approved test methods, defining sampling and test protocols, defining a threshold level, and consulting with plants to assure the entire program for gluten management is appropriate. It’s also commendable that they have a logo that can be used on the packaging of products for which the program is properly followed. In addition to being of benefit to consumers with gluten allergies or sensitivities, the logo is beneficial in product marketing.

Other organizations that provide some level of certification include a United Kingdom program to allow the use of a cross-grain symbol, and the Celiac Sprue Association’s Seal of Recognition.

Where does all this take us? Do we have our allergen Kryptonite? Is there some new miracle cure to keep all allergens from getting into places and products they’re not supposed to be?

Don’t we wish this were true.

Unfortunately, no allergen Kryptonite is available yet. But there are advances in allergen program elements that will certainly help. We have new tests; we have certification programs; and we have that amazing, complicated, and fully integrated program that we worked so hard to develop and implement.

As for me, I’m sure we quality managers will continue to train and review and test, and our bosses will continue to ask if we’re doing all we can. We can assure those bosses that we are on top of the recent advances, and we will keep improving the allergen program. We might even feel good enough about our programs that we can stop losing sleep at night.