We are a dry manufacturing facility with Soy Lecithin as the only allergen that we declare. We adhere to the labeling and storage requirements. What I have struggled with is there is no test capable of detecting protein in soy lecithin.
If we swab the ingredients directly it will not show soy proteins.
I have an expert opinion from University of Nebraska stating that they dont believe special cleaning procedures are needed for shared equipment with ingredients that do contain soy lecithin and those that dont.
How would I implement a comprehensive thought out Allergen program in this scenario. I believe a hazard analysis would drive the requirements for internal controls. But how do i do this if Soy is a known allergen but likelihood of the hazard is low but severity (at least for soy is high)?
Soy lecithin seems to be in the grey area for the FDA and creates ambiguity.
Iam uncertain how to validate that operators running one line with Soy Lecithin at the same time they operate another line without soy Lecithin, shared draining vacuum equipment, and utensils dont need to be controlled for.