FSMA 204 Final Rule

Hi everyone!

I am a newer member, and I am currently the QA manager at a seafood processing plant. I wanted to reach out and see what people were planning on doing for the upcoming changes with the FSMA 204 rule. Any advice or suggestions on where to learn more or find templates? Anything would help!

Thank you in advance,

Shrimper

I'm in the cut fruit and veg industry, with a handful of the other items on the list affecting us as well.  It's been on our radar for a little over a year but the compliance date kept getting pushed back (currently January 2026), so it's hard to get the execs to start listening.  Knowing it'll affect retailers, there's a sort of "wait and see" attitude developing in my company as well, as we're sure the major retailers we sell too will develop requirements we'll be forced into and we can then translate these in reverse to our suppliers.  Some of the smaller farms are going to struggle to adapt.

I've been tuning into a number of webinars that discuss, and they so far seem to be focusing on teaching about all the acronyms without any real help deciphering whether there's going to be a required format for presenting information to the FDA (the rule only says things like "sortable spreadsheet within 24 hours upon demand").  I just know the more I read into it, there's a lot of back end data collection we currently aren't equipped to maintain at the plants we operate.

I have just finalised documentation with FDA I can share some if you like, I work with in Finfish, Bivalves, Lobster and crab. 

Effectively the biggest question is whether or not your product is co-mingled! There are three options - Co-mingle exemption- just write a note, supply chain for kill step- which requires a supplier agreement and then the standard KDE's and traceability. 

I have just finalised documentation with FDA I can share some if you like, I work with in Finfish, Bivalves, Lobster and crab. 

 

Effectively the biggest question is whether or not your product is co-mingled! There are three options - Co-mingle exemption- just write a note, supply chain for kill step- which requires a supplier agreement and then the standard KDE's and traceability. 

CSCL that would be amazing if you could share that! I have just started to build our traceability plan, and I have a feeling things are a lot more simple than the vague rule explains. The most confusing part is the traceability lot code and the reference part as well. 

For the part you mentioned about co-mingling product, is there an exemption for co-mingled products??

Hi Shrimper,

I'm also in Seafood Processing. We do imported products from our overseas suppliers, and we have one domestic plant here. We work with Soft Shell Crab, VA Crab Products, VA Shrimp Products, and VA Soft Shell Crabs, and Crab Meat.

My biggest confusion is how to trace our soft-shell crabs, since the crabs are commingled between watermen once we receive them into our plant for grading AND crabs are commingled between harvests out in the shanties while they watermen wait for them to molt. If anyone has any advice I would be very grateful.

As far as resources, the NFI has a lot of resources (though I'm still confused on a lot, they are a lot of help, reach out to them if your company is a subscribing member, they can help answer questions). 

Link for Traceability plan template

Link for Supply Chain Written Agreement (to ask suppliers to sign off and agree that they will help comply with FSMA204

Link for Supply Chain Partner Notification Letter (This would let your downstream partners know you did not perform the killstep, but someone else will)

Link for Traceability Worksheets in PDF and Docx format (These help you figure out if you already keep track of KDEs and where you're getting them from)

Link for FDA Official CTE & KDE guide

Hi Shrimper,

 

I'm also in Seafood Processing. We do imported products from our overseas suppliers, and we have one domestic plant here. We work with Soft Shell Crab, VA Crab Products, VA Shrimp Products, and VA Soft Shell Crabs, and Crab Meat.

 

My biggest confusion is how to trace our soft-shell crabs, since the crabs are commingled between watermen once we receive them into our plant for grading AND crabs are commingled between harvests out in the shanties while they watermen wait for them to molt. If anyone has any advice I would be very grateful.

 

As far as resources, the NFI has a lot of resources (though I'm still confused on a lot, they are a lot of help, reach out to them if your company is a subscribing member, they can help answer questions). 

 

Link for Traceability plan template

Link for Supply Chain Written Agreement (to ask suppliers to sign off and agree that they will help comply with FSMA204

Link for Supply Chain Partner Notification Letter (This would let your downstream partners know you did not perform the killstep, but someone else will)

Link for Traceability Worksheets in PDF and Docx format (These help you figure out if you already keep track of KDEs and where you're getting them from)

Link for FDA Official CTE & KDE guide