FSMA 204 Lot Code Questions for RTE Fish Products
Hi Folks,
Has anyone implemented this new food traceability system? We produce a RTE fish product (imitation crab) and the fish we import is on the FTL. my questions:
1- Do we have to assign a lot code to imported fish other than what manufacturer has printed on packs which is a bbd?
2- Do we have to assign this lot code to fish manufacturer that we import from?
3- for the final product do we have to create a lot code other than bbd that we use for traceability? or does it have to come from customer?
I'm having hard time understand this rule. If anyone can help, it would be great. Thank you.
Hi again from the other thread. We haven't fully developed what we're doing, we're just now getting instructions from our retail customers on how they expect us to send our KDE's to them. I'm not super knowledgeable on seafood, but here's my $.02 cents (which is technically $.029 CAD these days lol)
1- Do we have to assign a lot code to imported fish other than what manufacturer has printed on packs which is a bbd?
Are you the "first land based receiver"? If so, yes, you must apply a lot code. If your supplying manufacturer is the land based receiver, meaning they took it from the fishing vessel, THEY need to apply a Traceability Lot Code
2- Do we have to assign this lot code to fish manufacturer that we import from?
Confused, you don't assign a Traceability Lot Code to a manufacturer. You would apply it to the food IF you are the first land-based receiver. If the actual first land-based receiver applied a lot code already, you DO NOT alter the TLC until you transform the fish (see links below).
3- for the final product do we have to create a lot code other than bbd that we use for traceability? or does it have to come from customer?
Absolutely, yes. From your other thread I pointed out your finished good is exempt from Rule 204 thanks to the kill step. But a finished lot code that can be traced to your CTE transformation of a kill-step is necessary for you to prove to FDA that you applied a validated kill step to that exact lot of fish.
I'm not an expert on this, just a dude who has been reading on this since Summer 2023 for his company. Some of the more helpful links I've found are:
Food Traceability Rule: Critical Tracking Events and Key Data Elements (handy list of all CTE's requiring KDE's)
FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA (main site for all things Rule 204, including a note on TLC's):
"You must assign a traceability lot code to a food on the Food Traceability List (FTL) when you do any of the following: initially pack a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food. If you receive an FTL food from an entity that is exempt from the final rule, you must assign a TLC if one has not already been assigned (unless you are a retail food establishment or restaurant). Otherwise, you must not establish a new TLC when you conduct other activities (e.g., shipping) for a food on the Food Traceability List. "
Frequently Asked Questions: FSMA Food Traceability Rule | FDA (Page of faqs where someone asked if it applies to foreign fish handlers):
"TLBR.1 Are foreign entities responsible for maintaining First Land-Based Receiving Key Data Elements (KDEs) if the destination of the product is unknown when it is caught?
Yes. In the final rule, the entity, whether foreign or domestic that is the first land-based receiver is required to maintain certain information about the food that was caught."
Hi again from the other thread. We haven't fully developed what we're doing, we're just now getting instructions from our retail customers on how they expect us to send our KDE's to them. I'm not super knowledgeable on seafood, but here's my $.02 cents (which is technically $.029 CAD these days lol)
1- Do we have to assign a lot code to imported fish other than what manufacturer has printed on packs which is a bbd?
Are you the "first land based receiver"? If so, yes, you must apply a lot code. If your supplying manufacturer is the land based receiver, meaning they took it from the fishing vessel, THEY need to apply a Traceability Lot Code
2- Do we have to assign this lot code to fish manufacturer that we import from?
Confused, you don't assign a Traceability Lot Code to a manufacturer. You would apply it to the food IF you are the first land-based receiver. If the actual first land-based receiver applied a lot code already, you DO NOT alter the TLC until you transform the fish (see links below).
3- for the final product do we have to create a lot code other than bbd that we use for traceability? or does it have to come from customer?
Absolutely, yes. From your other thread I pointed out your finished good is exempt from Rule 204 thanks to the kill step. But a finished lot code that can be traced to your CTE transformation of a kill-step is necessary for you to prove to FDA that you applied a validated kill step to that exact lot of fish.
I'm not an expert on this, just a dude who has been reading on this since Summer 2023 for his company. Some of the more helpful links I've found are:
Food Traceability Rule: Critical Tracking Events and Key Data Elements (handy list of all CTE's requiring KDE's)
FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA (main site for all things Rule 204, including a note on TLC's):
"You must assign a traceability lot code to a food on the Food Traceability List (FTL) when you do any of the following: initially pack a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food. If you receive an FTL food from an entity that is exempt from the final rule, you must assign a TLC if one has not already been assigned (unless you are a retail food establishment or restaurant). Otherwise, you must not establish a new TLC when you conduct other activities (e.g., shipping) for a food on the Food Traceability List. "
Frequently Asked Questions: FSMA Food Traceability Rule | FDA (Page of faqs where someone asked if it applies to foreign fish handlers):
"TLBR.1 Are foreign entities responsible for maintaining First Land-Based Receiving Key Data Elements (KDEs) if the destination of the product is unknown when it is caught?
Yes. In the final rule, the entity, whether foreign or domestic that is the first land-based receiver is required to maintain certain information about the food that was caught."
Thanks for the reply. no, we are not the first land receiver. we purchase the half processed fish from them, mix it with other ingredients, mold, pack, pasteurize, cool, freeze. so:
1-Do we have to write KDEs for all this Steps even though everything is being held internally?
2-Regarding the mixing step, do we have to write KDE for all other ingredients that are not on the FTL?
3-our current ingredient logs are tracible to bbd of ingredients, is that enough as a TLC? or are they requiring something else? eg. GS1 barcodes from supplier? ( this is the most important part that i dont understand)
Thanks for the reply. no, we are not the first land receiver. we purchase the half processed fish from them, mix it with other ingredients, mold, pack, pasteurize, cool, freeze. so:
1-Do we have to write KDEs for all this Steps even though everything is being held internally?
2-Regarding the mixing step, do we have to write KDE for all other ingredients that are not on the FTL?
3-our current ingredient logs are tracible to bbd of ingredients, is that enough as a TLC? or are they requiring something else? eg. GS1 barcodes from supplier? ( this is the most important part that i dont understand)
I also made this file based on all these guidance docs. i will appreciate if you can comment on that. you have been studing since 2023 on this regulation, so you obviously know much more than me :). thanks,SM
Attached Files
No help on the spreadsheet sadly lol. I'm still trying to decide what I want to create and give out to our plants. Right now we're stuck on meeting our customer requirements given they're asking for implementation early (some starting at end of April), and we still need our execs to start steering how we change the internal processes.
To you other points:
1-Do we have to write KDEs for all this Steps even though everything is being held internally?
My interpretation is yes. Until you kill-step it, you are handling a FTL item and must maintain the required KDE's and link those KDE's to the kill-step for each lot. FDA's goal here is that you've got the KDE's ready to go, so when they pull your item from a retailer they know how to find you, and then you know how to point them directly towards the previous step, so on and so forth.
2-Regarding the mixing step, do we have to write KDE for all other ingredients that are not on the FTL?
I think/believe you only have to record them as part of the transformation. Basically showing all of the inputs for the material that will eventually have your new TLC after you cook.
3-our current ingredient logs are tracible to bbd of ingredients, is that enough as a TLC? or are they requiring something else? eg. GS1 barcodes from supplier? ( this is the most important part that i dont understand)
GS-1's are not required, we have flexibility of how we maintain KDE's (so long as it gets into a sortable spreadsheet within 24 hours of FDA demand). Lots of retailers are requiring unique GS-1's on cases and pallets, but all of that is Greek to me and I'm letting IT sort it out. I do not feel tracking to only a BBD is sufficient because where YOU may have a situation where BBD's are unique, others may have multiple lots of product with identical BBD's. Lots of companies include the BBD in their lot code, but say you have two suppliers who only issue BBD's: how could you differentiate between ingredients between these suppliers when they expire same day?
Keep in mind, "Once a TLC is assigned, it must stay the same as the food moves through the supply chain; it can only be changed if the food is transformed." If your suppliers are trying to stick to BBD only as a lot code, you will need to push them to update product at least as it comes to you because you cannot change the TLC until transformation.
Traceability Lot Code | FDA (lot code examples)
No help on the spreadsheet sadly lol. I'm still trying to decide what I want to create and give out to our plants. Right now we're stuck on meeting our customer requirements given they're asking for implementation early (some starting at end of April), and we still need our execs to start steering how we change the internal processes.
To you other points:
1-Do we have to write KDEs for all this Steps even though everything is being held internally?
My interpretation is yes. Until you kill-step it, you are handling a FTL item and must maintain the required KDE's and link those KDE's to the kill-step for each lot. FDA's goal here is that you've got the KDE's ready to go, so when they pull your item from a retailer they know how to find you, and then you know how to point them directly towards the previous step, so on and so forth.
2-Regarding the mixing step, do we have to write KDE for all other ingredients that are not on the FTL?
I think/believe you only have to record them as part of the transformation. Basically showing all of the inputs for the material that will eventually have your new TLC after you cook.
3-our current ingredient logs are tracible to bbd of ingredients, is that enough as a TLC? or are they requiring something else? eg. GS1 barcodes from supplier? ( this is the most important part that i dont understand)
GS-1's are not required, we have flexibility of how we maintain KDE's (so long as it gets into a sortable spreadsheet within 24 hours of FDA demand). Lots of retailers are requiring unique GS-1's on cases and pallets, but all of that is Greek to me and I'm letting IT sort it out. I do not feel tracking to only a BBD is sufficient because where YOU may have a situation where BBD's are unique, others may have multiple lots of product with identical BBD's. Lots of companies include the BBD in their lot code, but say you have two suppliers who only issue BBD's: how could you differentiate between ingredients between these suppliers when they expire same day?
Keep in mind, "Once a TLC is assigned, it must stay the same as the food moves through the supply chain; it can only be changed if the food is transformed." If your suppliers are trying to stick to BBD only as a lot code, you will need to push them to update product at least as it comes to you because you cannot change the TLC until transformation.
Traceability Lot Code | FDA (lot code examples)
I see, that could be the reason some of our customers have sent us new barcode instructions for the cases.
Yep. Couple of my customers want electronic ASN's with all of the KDE's required for Shipping (and they're adding a few other things, of course). They want GS1 SSCC-18 barcodes on the pallets and GS1-128 barcodes on the cases that all correlate to the ASN. Voodoo, I'm letting IT figure that out.
And keep in mind for Shipping KDE's, you don't have to send the full Transformation nor your Receiving set. You only have to provide info for the finished product under your Shipping KDE's. That part hung me up for quite awhile. You have to maintain your Receiving and Transformation, but only Shipping goes to the customer. So far two of my major customers don't care if the item is 204 exempt or not, they want this Shipping KDE information for all foodstuffs.