My company, which is in the U.S. and re-packs dry ingredients such as pulses, grains, and seeds, has recently purchased a laser color sorter as a way to control for foreign objects in incoming bulk product. We are subject to the Hazard Analysis and Risk-Based Preventive Controls rule (HARPC) - also known as the Preventive Controls for Human Food rule (PCHF) - under FSMA. In our hazard analysis we identified foreign objects (e.g., stones, metal, debris) as a potential food safety hazard for most of our incoming ingredients (it should be said that we do have finished product metal detection in place).
I realize that foreign objects can be seen as a quality issue, but on the conservative side they can also be food safety hazards if big enough, sharp enough or hard enough. If I recall correctly off the top of my head, the FDA will consider food adulterated if it contains foreign objects larger than 7mm. So we have taken the conservative approach and have identified foreign objects as potential food safety hazards.
We are trying to determine if the laser color sorter can be considered a Process Preventive Control to control for foreign objects as potential food safety hazards. If yes, we must also validate that the preventive control is "adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system."
So, my questions are:
1. Has anybody out there identified their optical sorter or laser sorter as a preventive control? Or is it really better classified as a GMP/PRP?
2. How does one validate a color sorter?
3. As a "bonus" question, has anyone used color sorting as a control for mycotoxins (i.e., for culling moldy grains/seeds)? If so, is it possible to validate for this?