Understanding Hot Spots and Testing Results

Gluten Free Certification Organization White Paper

Have you ever played in the sand at the beach? You shove your hand deep in the sand, grabbing a handful of sand and then inspect it out to see what is in it. Sometimes you find something unusual, but most of the time you do not. That is what it is like testing food products. 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 composited (blended together as one 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 processes used in production (movement of raw materials, equipment, etc.) that could increase the risk of cross contamination, and the cleaning and packaging processes. The manufacturer will also 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. In making these decisions the following are taken into account in the decision process:

What is being a tested – raw material, equipment, finished products?
What type of lab technology is available for onsite testing?
What types of raw materials are used and what type of finished product is made?
How frequently will samples be sent to an outside lab for testing?
What risks are associated with these items?

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 possible action plans after them. Some of the results and actions more clear than others.

Possible test results include:

1. A true negative… this is the most likely scenario when a comprehensive testing and a gluten free program are maintained. Action: the product continues into distribution.

2. A false negative… least likely scenario given the science of the testing kits and with a comprehensive test program correctly applied. Action: Product/production put on hold for further testing (in-house or by a 3rd party lab), re-cleaning of equipment followed by re-testing, and determination of safety and disposition of product.

3. A positive… this is when it gets challenging… is this true positive pervasive and representative of the overall product batch? 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. When positive test results are involved, retesting is a standard part of the corrective action process in GFCO, 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 it 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 an airtight controlled enviornment, 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, would be 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 identifying the 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 that is 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 testing 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.

When Testing is out of Acceptable Limits for GFCO Certification

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 re-cleaning and retesting the equipment, 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. At times, GFCO will request that other specialized testing be done to help evaluate any questionable testing. 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, upon multiple testing, continues to be out of acceptable range GFCO has a number of possible remedies valuable to use, including holding product, pulling product back, destruction of product, public notice, and others. GFCO has held product, pulled product and required product be destroyed. GFCO works closely with companies in a proactive manner on issues of contamination. 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. GFCO will also work with the company to evaluate possible improvements to their gluten-free program.

When a Consumer Complains a Product Makes Them Sick?

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

A health care professional will conduct an interview with the consumer to understand the circumstances around the illness.
GFCO requests the consumer send any remaining product to GFCO, in the original package. This is sent to a lab for analysis.
Company testing records are reviewed by GFCO for the period and lot production of that product.
An unannounced audit may be scheduled
Once the actions are reviewed and evaluated, an action plan, if necessary, is put into place with the company.
The product is put on our “hot testing” list and may be tested more frequently.
The consumer is notified of results.

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:

Results are only as good as the proficiency of the person doing the testing, the test method and the testing program itself
Good testing programs are comprehensive involving testing throughout the supply chain and production
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.
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.

GFCO and GFCO certified companies take the standard of less than 10 ppm very seriously.