18 replies to this topic

[hglazunov]

Hi everyone, 

 

Is anyone else struggling with the FSMA204 Final Rule regulations? In theory it all seems simple, track your product and the ingredients that make up the FTL (Food Traceability List) at each step. We are struggling with our GDST and syncing it to our current ERP and feels like we're doing it blind. Can anyone share some insight that made it all "click" for them?

 

Thank you in advance,

 

Helen

[jfrey123]

No insights yet, we too are struggling with what it's going to look like for us.  The ability to get it all into a sortable excel file at random FDA demand is also a factor for us.  Enforcement appears to be delayed to 2027 now, so it's hard to get traction to make changes at my company for now.  Knowing that our customers are affected is likely going to be the driving factor for us, once they start asking for it it'll become a rush project lol.  I also forecast we'll have some struggles with our smaller farms and packing houses to sort through whatever hodgepodge they come up with for sending the KDE's to us (I'm in the cut fruit and veg industry just as a heads up).

[hglazunov]

Thank you for sharing, we're in the Seafood industry ourselves. I really struggle to figure out how to get out of the weeds and have some traction to this data while higherups are demanding implementation plans and presentations... we are just not there yet. 

No insights yet, we too are struggling with what it's going to look like for us.  The ability to get it all into a sortable excel file at random FDA demand is also a factor for us.  Enforcement appears to be delayed to 2027 now, so it's hard to get traction to make changes at my company for now.  Knowing that our customers are affected is likely going to be the driving factor for us, once they start asking for it it'll become a rush project lol.  I also forecast we'll have some struggles with our smaller farms and packing houses to sort through whatever hodgepodge they come up with for sending the KDE's to us (I'm in the cut fruit and veg industry just as a heads up).

[TucsonFoods-QA]

We use semi soft cheese in a product that is not cooked. We do freeze it and it's my understanding that if the cheese is frozen or has been previously frozen that it's exempt? Anyone going through this one?

[Shrimper]

Good day hglazunov,

 

I too am in the seafood industry focusing on frozen products, but mostly shrimp. I am interested in your GDST system you have. I would love to hear more about it. My plant is pretty small and all of our work is done on paper, so that makes the transition from paper docs to a "sortable spreadsheet" more difficult. From my understanding, the steps to approach FSMA 204 is to 1) identify the CTE's that apply to you, 2) list out which KDE's you already track, and 3) begin to format a traceability plan. Some further steps that I think area valuable to do are to draft a letter that addresses the requirements for your persons up and down the supply chain. Our biggest worry is regarding the shrimp shed that unload the vessels since they are considered "first land-based receivers." I asked for some advice regarding FSMA 204, and got similar responses to this page, but someone did attach some good links:

 

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.

 

Let me know if you have more questions, FSMA is a topic I would like to discuss more since it seems everyone is sort of confused on the topic. 

 

Best,

Shrimper

[hglazunov]

@Shrimper

 

Thank you for your response! We are using Trace Register's system TR5 but it has not been a smooth process. I have discovered much of the same difficulties you mentioned, and thank you for linking me back! Believe it or not that was actually my post hahaha. I am stepping down from my role, so I do with you the best of luck!

[Lynx42]

We use semi soft cheese in a product that is not cooked. We do freeze it and it's my understanding that if the cheese is frozen or has been previously frozen that it's exempt? Anyone going through this one?

 

I think there is also a comingled or multi-ingredient rule that may exempt it if it's mixed with something.

 

From the FDA frequently asked questions. https://www.fda.gov/...aceability-rule
Ctrl-F will allow you to search for key words so you don't have to read or scan the whole thing.

 

The Food Traceability List (FTL)

TFTL.7 Is frozen cheese used on a frozen pizza, covered by the rule?

Direct Link

No. Frozen cheese is not on the FLT and therefore not covered by the final rule.

2023-01-10

[Esoto728]

struggling with the cheese as well. I am in process of getting clarification, same as your company.

[jfrey123]

I think there is also a comingled or multi-ingredient rule that may exempt it if it's mixed with something.

 

From the FDA frequently asked questions. https://www.fda.gov/...aceability-rule
Ctrl-F will allow you to search for key words so you don't have to read or scan the whole thing.

 

The Food Traceability List (FTL)

TFTL.7 Is frozen cheese used on a frozen pizza, covered by the rule?

Direct Link

No. Frozen cheese is not on the FLT and therefore not covered by the final rule.

2023-01-10

 

 

In this example, the cheese is exempted because it is frozen, not because it's mixed with other ingredients.  My take on all of the FTL items is that adding an ingredient on the list to your finished product makes your product an FTL item moving forward.

 

"The additional recordkeeping requirements apply to the foods specifically listed on the FTL, and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list."

Food Traceability List | FDA

 

To the pizza example:  if you're creating pizzas with refrigerated cheese and then freezing the whole pizza, you're on the hook to have KDE's for the cheese up until your documented freezing of the product, at which point your can claim an exemption.  If you're adding fresh-cut vegetables to your pizza, it too is a traceable item now up until the point it gets frozen (because freezing would change the status of the fresh-cut vegetables to frozen vegetables).

 

Going round and round on this with two of our plants that make products with ingredients on the list: 

First plant:

"We cook the salmon burgers, so we're exempt." 

'The finished product is exempt, yes, but you're getting the fish raw so you need to have the KDE's from the shipper and you need to record them at receiving.  Then we need to document KDE's at the transformation of raw fish into a cooked patty.' 

"But the finished product is exempt!"

'Grumbling noises'

 

Second plant:

"Our jalapeno poppers are to be cooked by the consumer, so they will undergo a kill-step, and they should be exempt."

'No, your jalapeno poppers have peppers, an FTL item from their harvest, which you cut and create a new FTL item (fresh-cut veg), which you stuff with another FTL item (cheese).  These are FTL the whole way."

"But if the bacon we wrap them with is pre-cooked, doesn't that count as a kill-step?"

'How do you...........*eye twitch*..........NO!'

[AtomicDancer]

@jfrey123

 

Your examples highlight just how confusing this requirement can be. Our ingredient isn't on the list, yet, but once the initial implementation is there, I anticipate more and more ingredients being added to the FTL list. :/

[kfromNE]

In this example, the cheese is exempted because it is frozen, not because it's mixed with other ingredients.  My take on all of the FTL items is that adding an ingredient on the list to your finished product makes your product an FTL item moving forward.

 

"The additional recordkeeping requirements apply to the foods specifically listed on the FTL, and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list."

Food Traceability List | FDA

 

To the pizza example:  if you're creating pizzas with refrigerated cheese and then freezing the whole pizza, you're on the hook to have KDE's for the cheese up until your documented freezing of the product, at which point your can claim an exemption.  If you're adding fresh-cut vegetables to your pizza, it too is a traceable item now up until the point it gets frozen (because freezing would change the status of the fresh-cut vegetables to frozen vegetables).

 

Going round and round on this with two of our plants that make products with ingredients on the list: 

First plant:

"We cook the salmon burgers, so we're exempt." 

'The finished product is exempt, yes, but you're getting the fish raw so you need to have the KDE's from the shipper and you need to record them at receiving.  Then we need to document KDE's at the transformation of raw fish into a cooked patty.' 

"But the finished product is exempt!"

'Grumbling noises'

 

Second plant:

"Our jalapeno poppers are to be cooked by the consumer, so they will undergo a kill-step, and they should be exempt."

'No, your jalapeno poppers have peppers, an FTL item from their harvest, which you cut and create a new FTL item (fresh-cut veg), which you stuff with another FTL item (cheese).  These are FTL the whole way."

"But if the bacon we wrap them with is pre-cooked, doesn't that count as a kill-step?"

'How do you...........*eye twitch*..........NO!'

 

Once you turn it into a USDA item by adding bacon to them - the finished product is now exempt 

[jfrey123]

Once you turn it into a USDA item by adding bacon to them - the finished product is now exempt 

 

We've been trying to look into potential USDA exemptions.  The FDA's website is not super helpful in describing this, with some examples on their slide show mentioning that shell eggs processed in a USDA facility are exempted from the rule.  Do you have any hints where I can find good source material for my USDA facilities on other exemptions?

 

Taking jalapeno poppers one of my sites makes as an example, we've got fresh-cut peppers and soft cheese (both FTL ingredients) that they then wrap with bacon (today I learned the bacon is smoked but not RTE, it's RTC).  Since the finished product is NRTE, we can't claim exemption for a kill step applied at our facility, but if I can find this exemption for USDA facility produced goods entirely, that would save them a lot of headaches.

[kfromNE]

We've been trying to look into potential USDA exemptions.  The FDA's website is not super helpful in describing this, with some examples on their slide show mentioning that shell eggs processed in a USDA facility are exempted from the rule.  Do you have any hints where I can find good source material for my USDA facilities on other exemptions?

 

Taking jalapeno poppers one of my sites makes as an example, we've got fresh-cut peppers and soft cheese (both FTL ingredients) that they then wrap with bacon (today I learned the bacon is smoked but not RTE, it's RTC).  Since the finished product is NRTE, we can't claim exemption for a kill step applied at our facility, but if I can find this exemption for USDA facility produced goods entirely, that would save them a lot of headaches.

 

It's been a while since I've looked at it but in my notes for our items I have 'Items on the Traceability List but put into USDA item – we will have to maintain the purchasing records for those items in the plant but once put into a USDA item – exempt.'

 

I'm almost positive I heard it here. 

https://www.fda.gov/...l-rule-12072022

Mentions as an exemption - foods regulated by the USDA. Slide 23 and 33 

[ChristinaK]

I was notified via Shareify that McLane (for Walmart) is requiring all food items meet the requirements, which is throwing us for a real loop. We already supply them with ASN and all paperwork includes best-by dates of the finished product (which is how we establish our "lot code" right now)...so I'm really unsure of whether we need to do more or not. 

The good news is that they did share some useful links, which I'm going to share here in case they can help anyone.

 

Here's the FDA easy decision tree tool to help decide if your product is or is not exempt from requirements.

 

The Produce Traceability Initiative has a lot of resources here, as well. (A lot of resources at this link)

 

FDA walkthrough video for FSMA 204.

[FoodSafetyGuru27]

Hi,

My confusion is with what is listed on the FDA website as exemptions vs what training workshops communicate. For example, I work with nut butters (specifically peanut butter). This is a "raw" ingredient for us going into a finished product. All training sessions or seminars state that this would be exempt, however the FAQ's state something different. Does anyone have better insight into this?

See the FAQ below:

 

TFTL.6 Are foods that contain a Food Traceability List (FTL) food as an ingredient also covered by the final rule?

 

Yes, if the ingredient remains in the form in which it appears on the list. Thus, if a commodity designated as “fresh” is used in its fresh form as part of a multi-ingredient food, then the multi-ingredient food would also be covered under the final rule.  For example, a bagged salad mix with fresh lettuce, a prepared smoothie with fresh cantaloupe, or a sandwich containing fresh tomato slices would be covered. However, a frozen pizza with spinach topping or trail mix with dried papaya would not be covered.

For foods on the FTL that are not designated as “fresh” that are used as ingredients in a multi-ingredient food, if no kill step is applied and the FTL food is not otherwise changed such that it is no longer on the FTL, then the multi-ingredient food would be covered by the final rule.

For example, peanut butter in a sandwich cracker for which no kill step is applied (to either the peanut butter or the peanut butter sandwich cracker) is covered by the rule.

2023-01-10

Edited by FoodSafetyGuru27, 20 November 2024 - 05:13 PM.

[ChristinaK]

Hi,

My confusion is with what is listed on the FDA website as exemptions vs what training workshops communicate. For example, I work with nut butters (specifically peanut butter). This is a "raw" ingredient for us going into a finished product. All training sessions or seminars state that this would be exempt, however the FAQ's state something different. Does anyone have better insight into this?

See the FAQ below:

 

TFTL.6 Are foods that contain a Food Traceability List (FTL) food as an ingredient also covered by the final rule?

 

Yes, if the ingredient remains in the form in which it appears on the list. Thus, if a commodity designated as “fresh” is used in its fresh form as part of a multi-ingredient food, then the multi-ingredient food would also be covered under the final rule.  For example, a bagged salad mix with fresh lettuce, a prepared smoothie with fresh cantaloupe, or a sandwich containing fresh tomato slices would be covered. However, a frozen pizza with spinach topping or trail mix with dried papaya would not be covered.

For foods on the FTL that are not designated as “fresh” that are used as ingredients in a multi-ingredient food, if no kill step is applied and the FTL food is not otherwise changed such that it is no longer on the FTL, then the multi-ingredient food would be covered by the final rule.

For example, peanut butter in a sandwich cracker for which no kill step is applied (to either the peanut butter or the peanut butter sandwich cracker) is covered by the rule.

2023-01-10

 

Are you receiving raw peanuts and processing them into peanut butter? Or do you receive peanut butter as the raw ingredient?

• If it's the first, then there are at least some parts of the requirements you need to follow. Use the flow chart decision tree tool I linked in my previous post to help determine what you need to do. After playing around with it, depending on your answers, it looks like different requirements may apply, depending on what entity is applying the kill step.
• If it's the second, then you are exempt regarding that food. The FTL food (peanuts) has already been "transformed" (processed into pb) by the supplier who applied a kill step or other method to reduce pathogenic microorganisms. However, as best practice, I would seek a statement from your peanut butter supplier that they meet the requirements of FSMA 204. 

[jfrey123]

 

Are you receiving raw peanuts and processing them into peanut butter? Or do you receive peanut butter as the raw ingredient?

• If it's the first, then there are at least some parts of the requirements you need to follow. Use the flow chart decision tree tool I linked in my previous post to help determine what you need to do. After playing around with it, depending on your answers, it looks like different requirements may apply, depending on what entity is applying the kill step.
• If it's the second, then you are exempt regarding that food. The FTL food (peanuts) has already been "transformed" (processed into pb) by the supplier who applied a kill step or other method to reduce pathogenic microorganisms. However, as best practice, I would seek a statement from your peanut butter supplier that they meet the requirements of FSMA 204. 

 

 

 

I think you're thinking that "peanuts" are the FTL item in question with this reply.  It's actually all "nut butters", in all forms.

 

Food Traceability List | FDA

 

Nut butters Includes all types of tree nut and peanut butters. Includes all forms of nut butters, including shelf stable, refrigerated, frozen, and previously frozen products. Examples include, but are not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters. Does not include soy or seed butters.

I think that unless FSG27's process applies a kill step after peanut butter is added, the ingredient makes the whole new transformed food a FTL food.

 

At least that's my logic for one of our plants that produce fully cooked salmon burgers.  They'll have to comply with the rule for receiving and transformation, but as we are cooking with a full kill step, the FTL stops with transformation, and we are exempt through shipping.

[ChristinaK]

I think you're thinking that "peanuts" are the FTL item in question with this reply.  It's actually all "nut butters", in all forms.

 

Ah yep! I don't know how the heck I got so mixed up there. Blood sugar must have been too low before lunch, haha. Lemme just edit that... Ah, I cannot edit that post. JUST IGNORE THAT POST EVERYONE.  

 

You're right. FSG27 would be subject to the food traceability rule unless they meet any of the exemption requirements. They can use the flow chart to see if they're eligible for an exemption, but that seems it's only likely if they apply a kill step to the product after peanut butter has been added (like you said).

Edited by ChristinaK, 20 November 2024 - 10:13 PM.

[Ahead]

Clarification on FTR Compliance for Co-Packed Cheese at a USDA Facility

 

I recently joined my company and was contacted by one of our distribution centers regarding their efforts to comply with the FDA's Food Traceability Rule (FTR). Historically, the company marked itself as exempt due to being a USDA-regulated site. However, upon further investigation, I found that we have cheese co-packed with our Name attached (sliced American and Pepper Jack cheese) and I believe these products fall under the FTR requirements.

 

Does anyone have experience with how the FTR applies to a company like ours, which acts as a middleman in the supply chain? Specifically:

• Are we required to maintain FTR-compliant traceability records for co-packed products?
• How do these requirements differ for Pepper Jack (semi-soft cheese) versus American (processed cheese)?
• What steps should we take to ensure compliance while working as a USDA site?

Any insights or shared experiences would be greatly appreciated!