12 replies to this topic

[TimG]

This one doesn't affect me currently, but I've been watching it with some interest for a while. There are A LOT of comments on the docket. This affects quite a few of us..

Regulations.gov

 

 

[Tony-C]

Hi Tim

 

Is there somewhere where you can access all comments without having to download them individually?

 

Kind regards,

 

Tony

[LostInTheWoods]

Hi Tim

 

Is there somewhere where you can access all comments without having to download them individually?

 

Kind regards,

 

Tony

From what I've seen, these aren't "comments" in the typical internet sense. It's lobbying organizations and trade groups writing multi-page position papers. So maybe the format does match the comments that they're getting.

[Scampi]

So this doesn't affect me at all, but WTH!   Case level tracking???  What are they thinking!?!?!?!?!?

[TimG]

So this doesn't affect me at all, but WTH!   Case level tracking???  What are they thinking!?!?!?!?!?

Yes, it's going to be a huge deal! And of course, tracegains is pushing hard 'you need us to be compliant to FDA!' I know this has to be hitting some of us here, so I'm interested to see what those affected have to say about it. From what I read it pretty much requires bar code scanning? Even if you can track what you have currently, you still need to buy a system?? (granted I read that 6 months or so ago so maybe it's changed)

 

And no Tony there probably isn't a big list of comments. It's FDA and they still do things the FDA way. All the comments are just the big grocers and other folks (1.23k of them so far) and of the 5 or so I've read, they are all strongly against the change. Some of them obviously got their lawyers to write how strongly against it they are, so I feel this one is going to be a fight.

[MDaleDDF]

Insanity.   Happy to be low risk product.

[jfrey123]

OP's link is referring to the FDA's "Requirements for Additional Traceability Records for Certain Foods", more commonly referred to as Rule 204 which has been loosely discussed on this board.

 

FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA

 

If one of your ingredients is on the list, it affects you.  For receiving, and/or transformation, and/or shipping (shipping unless you have a kill step for your finished good).  I've been trying to scream from the high heavens about this, but since enforcement got pushed back to 2028, it's been back burnered by a lot of people.

Food Traceability List | FDA

 

The list of foods is:

Cheeses (just about all of them)

Shell Eggs

Cucumbers (fresh)

Herbs (fresh)

Leafy Greens (fresh and fresh-cut)

Melons (fresh)

Sprouts (fresh)

Tomatoes (fresh)

Tropical tree fruits (fresh)

Fruits (fresh-cut)

Vegetables other than leavy greens (fresh-cut)

Finfish (fresh, frozen, previously frozen)

Smoked finfish (refrigerated, frozen, previously frozen)

Crustaceans and bivalves (fresh, frozen, previously frozen)

RTE deli salads

 

Go poke around these links.  The rule is an absolute nightmare...  Developing the tools to track the Key Data Elements (KDE's) required for each Critical Tracking Event (CTE): Food Traceability Rule: Critical Tracking Events and Key Data Elements

[Scampi]

it reads like someone doesn't understand supply chains at all--but I will say----should you not be able to get almost all of that information relatively quickly anyway?  (baring the wayfinding coordinates for farm/pond portion)      Wouldn't your batch record say what lot of X/Y/Z you've used of all the ingredients?

 

best of luck to anyone trying to adhere to that--particularly case lot tracking HAHAHAHA  

[Shrimper]

Where do you all see case level tracking? I've been trying to stay ahead of this for a bit now, but like jfrey said it keeps getting put on the back burner. Don't all cases already have a trace code that the processor/supplier should be able to traceback within a reasonable amount of time? 

[Scampi]

I see it in the comments, for example from the meat institute comments

 

The Act states the agency shall “not require – product tracking to the case level.”6 Yet, the lot code traceability requirements will require exactly this behavior in many supply chains. Many companies purchase large quantities of products, which may be from one or more lots, and then sell smaller quantities, down to one case, to the customer, such as a single grocery store or restaurant. By requiring the seller to send lot code information in these supply chains, the agency is requiring case level traceability in practice, regardless of whether that is the original intent. Tracking to the case level is the only way to know the lot of each case on the load received by the seller to accurately send that information to the customer. The agency must abandon its proposed requirements for lot code traceability.

 

 

And then there's this feed back from GMA

This would unnecessarily result in added costs to the food industry with little, if any, added public health benefit. In particular, there is no reason to classify packaged food products that undergo a validated pathogen kill step as high-risk, yet FDA’s proposed model would do just that. FDA should revise its approach to more closely align with the FSMA mandate to effectively identify both high-risk foods and those that are not. When done effectively, FDA and industry will have a system that allows identification of high-risk foods that merit additional recordkeeping requirements for tracing to protect public health.

7. FDA Should Keep in Mind that Tracing Recordkeeping Requirements Do Not Make Food Safe. Tracing records are most useful for identifying the source of a foodborne illness outbreak and they may help locate contaminated product so that it can be removed from the supply chain. Tracing records do not, however, make food safe. When considering which foods should be subject to additional recordkeeping requirements for tracing, FDA must consider the burden and impact of such requirements and whether the public health can be better protected by directing limited Agency and industry resources to steps that prevent contamination in the first place.

Edited by Scampi, 08 July 2026 - 06:19 PM.

[G M]

Where do you all see case level tracking? I've been trying to stay ahead of this for a bit now, but like jfrey said it keeps getting put on the back burner. Don't all cases already have a trace code that the processor/supplier should be able to traceback within a reasonable amount of time? 

 

I think it is coming from the Shipping CTE.  Not really any different than any other 'one-down' trace requirement.  The language seems to allow defining lots pretty broadly most of the time.

[Shrimper]

Thank you both. I see how if you end up shipping one case (or even very few) that needs to be designated as its own "lot" as a CTE. The part that we always got concerned with was the Traceability Lot Code (TLC) source. Essentially you need to say who assigned the TLC. For distributors who don't transform the product, this is basically calling out who you get it from.

 

I've seen that you are allowed to use a Traceability Lot code source reference - a code for who assigned the TLC, but we have not thought of any creative ways to keep this concealed. Thoughts? I saw a post somewhere that corporate officers were allowed to be used as the TLC source if they have multiple facilities, but can we do the same thing if they are not OUR facility? 

[jfrey123]

Thank you both. I see how if you end up shipping one case (or even very few) that needs to be designated as its own "lot" as a CTE. The part that we always got concerned with was the Traceability Lot Code (TLC) source. Essentially you need to say who assigned the TLC. For distributors who don't transform the product, this is basically calling out who you get it from.

 

I've seen that you are allowed to use a Traceability Lot code source reference - a code for who assigned the TLC, but we have not thought of any creative ways to keep this concealed. Thoughts? I saw a post somewhere that corporate officers were allowed to be used as the TLC source if they have multiple facilities, but can we do the same thing if they are not OUR facility? 

 

To your first point:  Each shipment won't have "it's own lot" as you can't alter a lot from the previous transformation/harvesting step, if you're shipping partials then you're only expected to list the number of cases sent for that small order (with full reconciliation possible across multiple shipments/customers per a normal trace).  In fact, the idea of creating new lots for a specific shipment is heavily restricted under Rule 204.  Say a fruit packinghouse needs to fill a 40,000lb order for mangoes: they have three separate lots in stock and decide to pull all three into the order; they're required to carry the farm's TLC data through to their customer instead of listing a combo lot number they create for the shipment.

 

To the second point:  shippers will be required to share the TLC code source reference, which is getting a fair amount of pushback.  Suppliers are required to send/include the instructions for how to decipher the lot code, and many of us would assert this sometimes includes data we want kept confidential.  For distributors, you're required to include your suppliers TLC reference as you have to transmit the original lot data to your customers.  Now, the saving grace is they aren't requiring a specific lot coding format, so your corporate office idea has some merit, but I think you'll instead see that companies will make their lot code tracking more generic.  I know some places I've consulted for include things like a [facility number][shift identifier][processing line][julian day code], so I suspect they'll start modifying the lot codes and merely track the proprietary info internally.