I work for a flour mill where wheat is the primary ingredient and product. We do manufacture non gluten origin products but we do not nor intend to claim low gluten or gluten free. We are concerned with giving the customer warning of the presence of gluten in our facility/products.Our labels state, "May Contain Wheat". Additionally, "Do Not Eat Raw" is printed on our labels as the kill step is passed to customer. All relevant documents (Specs, COAs, Internal Docs.) state the same and have more detail.
Our facility is a dry facility where only dry cleaning via brushes, vacuums, and purges is conducted. We have a thorough sanitation program, training and documentation. To date we have not validated our sanitation for allergens or pathogens. In my time here I have been advised and consulted on many a warning to beginning the process of testing. Especially pathogens. Something inherent in grain.
Note: the facility has resisted moving forward into any scheme. We are currently only annually inspected for GMP. We do not have an environmental monitoring program.
1. I understand that the FDA does not approve of allergen statements such as ours to be a replacement for sanitation. Our programs and documentation thorough and shows our due diligence. Do we need to test as well?
2. If we do need to test. What would we be accountable for testing? Allergens. Pathogens. Or both? I have my own opinions on testing, but I am a little worried about the possibility of testing for salmonella as it is inherent in grain and I would expect the test to come back positive.
3. If testing for pathogens is done, is there any possible way for a dry facility, processing raw gain to clean or control salmonella, E. coli, etc? Even if dry sanitation lowered the salmonella our facility would have already tested positive. Isn't this bad in itself?
I have conducted some random allergen testing on our flour milling with mixed results. My tests were fallible and unofficial yet they did show levels high above 20 ppm. Again, gluten free is not something we are aiming for, but the high result made me feel that our sanitation appeared or is inadequate. I felt the result should be lower even if above 20 ppm. This of course, is easier to correct than pathogens should it be proven. This has been presented to management.
I have presented my research and opinion to management. There are good and bad arguments on sides to be fair. Sure. My main case is to continue to research and determine our responsibility. This is why I am opening this to you. I need support and direction with my own understanding on the matter.
Management feels that the allergen warning is there, sanitation is being conducted ("our programs and records have been consistently approved by 3rd party auditors") and the kill step is passed to the customer. "What more do we need to do?"
Maybe they are right. I'd feel a lot better if someone ELSE could convince me. Thanks in advance.