Have you ever played in the sand at the beach? You shove your hand deep in the sand, grabbing a handful and pulling it out to see what is in it. Sometimes you find something, but most of the time you do not. That is what testing of food products is like. Companies probe 50, 100, 500, or 1000-pound containers of an ingredient. They might take finished product from the beginning, middle and end of a 5000 pound run for testing. Sometimes these samples are tested independent of each other or blended together to make a composite sample before being tested. Composite samples are a representative sample of the entire production lot (a specific production run of the product).  

 

Testing is a measurement of a single point in time, a sample of a larger amount of product. It is a snapshot of a larger picture. When determining testing needs manufacturers take into consideration: the raw materials and the possibility of them being cross-contaminated; the process used in production (movement of raw materials, equipment, etc) that could increase cross contamination; cleaning and packaging processes.

 

Further, the manufacturer will evaluate the best methods to be used in their testing procedures, and the frequency of testing needed to assure a level of confidence in the overall process and safety of finished products. They take into account:

 

Like finding something in the sand that you did not expect to find, sometimes when testing products you will find something unexpected. Companies rely on their Good Manufacturing Practices (GMP), Hazard Analysis Critical Control Point (HACCP) programs, and standard operating processes and procedures to determine a corrective action plan. With testing, there are three possible outcomes, each with actions after them. Some of the results and actions more clear than others. 

 

 

3.    A positive… this is when it gets challenging… is this a true positive pervasive and representative of the product batch overall. Or is it a “hot spot” positive neither pervasive nor representative of the product? The only way to determine the answer is further product testing and review of the gluten free program overall.   When positive test results are involved, retesting is a standard part of the corrective action process, often on the same sample previously tested and on additional samples from the same lot or containers of raw ingredients. If the retesting results are negative, it is possible that the testing was initially performed incorrectly; the sample was contaminated, or may represent a "hot spot" in the food (an unexpected contaminate).

 

Hot spots are concentrated areas of contamination of a product or raw material with a substance that is undesirable, such as gluten. Unless food is grown in your own garden in an airtight bubble, it is impossible to guarantee a 100% pure product. Foods and ingredients are not uniform in their makeup. Therefore testing can hit a hot spot that may not be representative of products as a whole. Hot spots may represent a very small amount of contamination or a large level of contamination. The only way to know how pervasive the contamination is, is to do multiple tests of the entire lot. There is no way to know if there are hot spots in a product or raw material until one is discovered with testing. Companies retain samples of the materials they test for use with additional testing if something should require it in the future.

 

As with all testing, gluten free testing is not an exact science. The best assurance in representative gluten free test results involves continual monitoring of processes involved in the prevention of contamination of products. In gluten-free production, comprehensive testing can be an effective means of monitoring contamination. The amount of testing conducted and at what critical points in the process helps to assure 'due diligence' is being followed in order to assure safety of foods and other products. The more testing done at different phases of production the more assurance that the product's safety is maintained.

 

GFCO looks at all of these factors when determining the requirements for a company's certification agreement. GFCO also periodically pulls products from the "point of sale", sending them to various labs for independent testing using r-5 Elisa analysis and other testing as needed.

 

 

 

Periodically testing results by the company or GFCO are unacceptable (greater than 10 ppm gluten). This does not automatically mean the product is bad. However, when this happens, an action plan is required. This generally starts with retesting to assure the testing was valid. An action plan might include recleaning and retesting the equipment, or testing the raw materials or finished product. GFCO encourages companies to retest with the original testing method, the original lab and a second lab, if the original tests continue to be positive. GFCO also will ask a lab to spike a sample. This helps to assure that the test results are valid. At times, GFCO will also request that other specialized testing be done to help evaluate any outstanding questions. GFCO may require raw material and equipment testing, however the GFCO standard of less than 10 ppm is based on testing of the finished product.

 

If a product on multiple testing continues to be out of acceptable range GFCO has a number of possible remedies including holding product, recalling product, destruction of product, public notice, and others. GFCO has held product, recalled product and destroyed product. GFCO works closely with companies in a proactive manner on issues of contamination of products. Because of this relationship, GFCO is able to stop unsafe items from reaching the distribution chain. Actions taken by GFCO are based on the evaluation of all the information gathered in the investigation process, including multiple testing results and consultation with leading experts in testing processes.

 

However, if the test results are mixed, some positive and some negative, than an assessment must be made. Is there a non – pervasive hot spot? If the data suggests a non-pervasive hot spot then there are possible actions related to the product including notifying the public communicating the low but possible risk of gluten. If there is a pervasive/large hot spot then more options open p including notification, recall, change in ingredients an//or processes. In all of these instances, GFCO works with companies to address the specific lot of product in concern. GFCO will also work with the company to evaluate possible improvements to their gluten-free program. 

 

When a consumer complains to GFCO that a certified product made them sick, the following process is implemented:

 

 

Testing is one means of determining the safety of GF products and production processes. Although not foolproof, testing is an effective way to monitor safety. Over the years of assisting and certifying companies with their testing, we have found the following critical truths about testing:

 

1.    Results are only as good as the testing program itself

2.    Good testing programs are comprehensive involving testing throughout the supply chain and production

3.    False positives, false negatives, hot spots results are all a part of the challenges of gluten free testing. Special care must be taken to evaluate and address each test results and the overall effectiveness of a company's gluten free program. 

4.    A point in time test result does not define whether the brand or product is safe overall. Instead, a company's commitment to safe Gluten free production and comprehensive testing does predict a company's success to delivering consistently Gluten free products.   As a leading part of this GFCO certified companies takes the standard of less than 10 ppm very seriously.