FSMA Food Defense

Hi all,

 

We are doing FSMA Food Defense gap analysis, and the guideline says below:

 

You do not need to evaluate points, steps, and procedures that are not part of your food operation. For example, you would not consider mail handling procedures, human resources procedures, utilities and processing aids that do not come into contact with or that are not incorporated into the food, facility emergency evacuation procedures, and other business processes.

 

It looks like FSMA only cares about Food Defense at processing steps. They want us to use a HACCP approach to analyze each process step, but do not care about the "traditional" facility defense part (visitor control, mail handling etc).

 

Am I misunderstanding it?

I would start by using the FDA food defense plan builder to get a good idea of what they're looking for.

 

https://www.fda.gov/...se-plan-builder

Hello, as per my understanding, those topics (external fence, training, mail box, etc) are the basic Food Defense elements.

Then, the mitigation assessment (vulnerability/accessibility), is your REAL food defense plan, where you describe mitigation measures as a function of your result

ok?

 

best regards,

Leila

The FDA Intentional Adulteration Rule focuses only on potential food defense issues within the production and bulk liquid storage areas. So FDA would only audit food defense measures related to those areas. It is prudent to take additional measures like gates and monitoring mail, but these are outside the scope of the FDA rule.