FSMA - Optical/Laser Color Sorter as Preventive Control

Hi all,

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?

Thanks much!

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?

 

------------

1. Client uses a combo LED/Optical Laser sorter as a preventative control in a fresh (right off the boat and onto a conveyor that shoots thru the sorter) shrimp processing facility in Mississippi and it kicks out the ones with black spots, discolors (normally meaning that ice was not applied properly in the holding bins onboard the vessels) and damaged shrimp.

2. Interesting enough the manufacturer provided validation studies and wrote the validation for their current GFSI certification.

3. Sorry, bonus does not apply. darn.

Hi all,

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?

 

Thanks much!

GrainGirl,

I can address your #3 bonus question.  The concept of using optical sorters in culling mycotoxin-laden grains/seeds is a good approach in that it’s a real-time solution that has enormous advantages with respect to sampling rate and size.  However, some optical sorters don’t have the resolution or wavelength range to make these kind of chemical assessments with adequate sensitivity.  One method currently being utilized for mycotoxin detection in whole grains is AI-NIR-HSI (Artificial Intelligence-Aided Near Infrared Spectroscopy Hyperspectral Imaging).  This method is currently being reviewed by the Federal Grain Inspection Service (FGIS) of the USDA for detection of Deoxynivalenol (DON) in wheat and corn, and has shown the ability to detect as little as 2ppm DON with an accuracy of >95%.

Hi all,

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. 

 

 

Hi GG,

^^^(red) - You probably need to re-read the full document. I doubt that FDA will agree with yr "recall" in a general sense.

Offhand, how would you react to finding 5mm ball bearings in yr food/mouth ?

In my experience in a rice mill we used optical sorters (color sorters) to pull various colorations based on product running at the time. At our point in the process this functioned for quality purposes and not food safety. I am not sure how accurately this would reject foreign material continuously. It would depend on your flow rate as well as the density of product and typically optical sorters have a channel that sorts a 2nd time before the reject is a "reject". The draw back to this was we had to add compressed air as an input since these sorters used compressed air as the rejection mechanism. The compressed air not only rejected selected grains but it also came in contact with grains that were not rejected. We had to test the compressed air for purity as well have the .01 micron filters at point of use. Great machines but add more lab testing and filters changes that auditors like to look at.