Produce Rule Vs Preventive Rule and FDA Registration

Dear all,

I hope you can help me to answer this question:

I am working in a company that package Hidroponic Lettuce. The previous Manager have implemented a HACCP plan with a CCP metal Detector. Which as my understanding put us as a Preventive Control Rule NOT Produce Rule. Even though we have a packing house not a processing facility.

Since we are definied as a secondary farm activity, we do not actually need to apply for a FDA Registration. However, the CEO wants that becose the company uses as a marketing tool. I am afraid that if we register under the FDA and get elligible for a visit they are going to see that ours is a packing house with a CPP. I am afraid that can bring us some futher problems. Does any one have any advice on this?

Pull the metal detector.
Redesign the HACCP plan.
Tell the owner/president to get GFSI certified (my bias is SQF) and use the certification as a marketing tool.

Hi Glenn,

Thank you for your advice. I am redesing the HACCP plan as you suggested. I have been talking to some people around about their inputs and experience in this topic. I have found one consultant that tells me that I do not need declare the metal detector as a CCP in the HACCP plan. He said do not write the metal detector in your HACCP plan. You can have it as costumer request and not put that on the HACCP and we that you do not need to register with FDA and I can remain in the produce rule. What do you think?

Another consultant said you can write the metal detector as a CP only but with that you have fall onto the Preventive rule.

Another said remove the metal detector completely and problem solve.

Advices?

Do you REALLY need the metal detector??????  Have you EVER found any metal in the lettuce (i would think the risk of this happening would be exceeding low). You can't include a metal detector in your plant and NOT include it in your plan (think sanitation of it etc.) you can however really easily downgrade it from a CCP to a PC (process control)

I agree with Glenn.........your opening a huge can of worms you want zero part of my requiring FDA preventative rule parameters and GFSI are globally recognized