12 replies to this topic

[FSM4you]

Hello,

 

Just a couple of questions about the 204 rule that seem a little fuzzy to me, and I know you guys can help. 

 

We assemble sandwiches/wraps/salads as one part of business. The way I am understanding it, we would need to keep a record of the previous supplier and who we ship to only, is that correct? We buy from different vendors for each item in the wrap/sandwich/salad.

All we do is assemble them and pack them and sell to a different vendor who sells directly to consumers. 

 

The other part, we make other products too but apply a kill step ourselves, which would put on on the EXEMPT list according to the tool, i think?

 

Any clarification/help/insight is helpful. 

[GMO]

I tried to wrap my head around it.  Not sure if this is helpful but there is a FAQ on the FDA website:

 

Frequently Asked Questions: FSMA Food Traceability Rule | FDA

 

And this might be useful too:

 

Federal Register :: Requirements for Additional Traceability Records for Certain Foods

 

As I understand it the trace rule is about additional requirements up and down the chain not saying that other products don't need tracing but I'm happy to be corrected as I'm not US based.

[jfrey123]

It all starts with The List, and starting at receiving you need to get the KDE's from your supplier for the ingredients on the list.  If you're a sandwich maker, I would venture a guess that cheese and leafy greens are Rule 204 ingredients that apply to you, so those suppliers giving you those ingredients must provide KDE's and you must maintain them and add your info (them as the shipper, you as the receiver).

 

You'll need to maintain the KDE's through the transformation step.  For the product you indicate has a kill step, you'll still need to apply the KDE's to transformation and then you can add evidence of your kill step for each lot produced, then Rule 204 will stop applying after the kill.

 

For the non-exempt products, you'll need a method to forward all KDE's for each lot to your customers.  As we're getting closer, I'm seeing at least two of my customers are demanding we sign up for two separate portals that they want to utilize and start receiving advanced shipping notifications with the KDE's attached.  Joy to the effing world...

[FSM4you]

It all starts with The List, and starting at receiving you need to get the KDE's from your supplier for the ingredients on the list.  If you're a sandwich maker, I would venture a guess that cheese and leafy greens are Rule 204 ingredients that apply to you, so those suppliers giving you those ingredients must provide KDE's and you must maintain them and add your info (them as the shipper, you as the receiver).

 

You'll need to maintain the KDE's through the transformation step.  For the product you indicate has a kill step, you'll still need to apply the KDE's to transformation and then you can add evidence of your kill step for each lot produced, then Rule 204 will stop applying after the kill.

 

For the non-exempt products, you'll need a method to forward all KDE's for each lot to your customers.  As we're getting closer, I'm seeing at least two of my customers are demanding we sign up for two separate portals that they want to utilize and start receiving advanced shipping notifications with the KDE's attached.  Joy to the effing world...

This is exactly what I was thinking also.

 

I guess I will have to have procurement get a list of every ingredient we use and start there. This is kind of a nightmare....

[FSM4you]

One thing I'm not understanding is we already have a traceability system that assigns batch numbers and item numbers to all of our products. 

 

Are we going to need to send each item in a sandwich to them as a KDE, or since we are transforming the item, we assign them as new batch numbers, and send that number like we do currently?

 

So our suppliers will need to send the KDEs to us, we will need to keep track of them, and send the KDE information to our buyers, is that correct?

 

Everyone is ruffled, and I am trying to explain it the best I can with the information available. 

[jfrey123]

My layman understanding:

 

Receiving:  Keep and maintain KDE's for the Rule 204 ingredients (cheese and leafy greens)

 

Transformation:  Document the KDE's, including your NEW lot code for the new food you have created linked to the old lot code.  You need to be able to show exactly what 204 ingredients went into your new 204 item.

 

Shipping:  Go double check the FDA website for Shipping KDE's, but my take is that you only have to provide the information for your new food (sandwich).  It's doubtful the customers you're sending to would have the electronic capability to receive information for each individual ingredient.

 

You don't need to send your receiving KDEs to your customers, but you need to keep and maintain them to put into the electronic sortable spreadsheet within 24 hours upon FDA demand.

[Shrimper]

You don't need to send your receiving KDEs to your customers, but you need to keep and maintain them to put into the electronic sortable spreadsheet within 24 hours upon FDA demand.

jfrey,

 

Are you sure on this? This has been the most confusing part for my company to wrap our heads around. Would this not be how it already is? What makes FSMA 204 different besides the electronic spreadsheet? Thanks! 

[FSM4you]

jfrey,

 

Are you sure on this? This has been the most confusing part for my company to wrap our heads around. Would this not be how it already is? What makes FSMA 204 different besides the electronic spreadsheet? Thanks! 

This is what we are thinking too. We already have a traceability plan, which is required under FDA/USDA/SQF etc. Every item we use to make products are already assigned an item number, and when we combine it, its assigned a new number, with dates, item descriptions, and where it came from, in a program.

[jfrey123]

jfrey,

 

Are you sure on this? This has been the most confusing part for my company to wrap our heads around. Would this not be how it already is? What makes FSMA 204 different besides the electronic spreadsheet? Thanks! 

 

As far as I can read it, I'm confident in what I said.  My take will be [marked in brackets below], but I'm not seeing where I need to furnish any of my Receiving KDE's as part of my Shipping KDE's.  My take is based on each Critical Tracking Event being unique onto itself, meaning the KDE's for each step must be recorded separately (if that makes sense).

 

Shipping KDE's: Food Traceability Rule: Critical Tracking Events and Key Data Elements

KDEs must be linked to the traceability lot for the food

• Traceability lot code for the food

["the food" is the final thing you created, so only traceability lot code you produced is relevant in the Shipping CTE KDE]

 

• Quantity and unit of measure of the food

[bunch of interpretations possible, but how many of our companies just list total cases and lbs on the BOL's?  I think they want you to document 1,000 6oz containers were sent in 50 cases weighing 375lbs]

 

• Product description for the food

[eCFR :: 21 CFR 1.1310 -- What definitions apply to this subpart? Product description now a lot more than just your generic description in your ERP/WMS software]

 

• Location description for the immediate subsequent recipient (other than a transporter) of the food

[basic stuff, but how often does your company list it other than on the BOL?  "Location description" now has a full definition of what must be included eCFR :: 21 CFR 1.1310 -- What definitions apply to this subpart?]

 

• Location description for the location from which you shipped the food

[same as above, how often do we record our own address on our shipping records other than the BOL?]

 

• Date you shipped the food

[basic stuff]

 

• Location description for the traceability lot code source or the traceability lot code source reference

[we're not currently telling our customers how to interpret our lot coding, and now we at least need to tell them where to find the info]

 

• Reference document type and reference document number (maintain only)

[internal only, have a document that describes everything we use to record KDE's, kind of like a roadmap spelling out the documents and their control numbers so FDA can ask "show me all 14 of these records")

 

---------------------------------------------------------------------------------------------------

 

Now separately, some customers are expanding from the above list of bare minimum.  One of my customers for example is going to require the following be sent via electronic ASN for each order:

Data Elements

PO Number

Item Number

Bill of Lading

Ship Date

Ship-From Location, GLN, Address, Phone

Ship-To Location, GLN, Address

GTIN

Product Description

Lot/Batch Number

Traceability Lot Code Source (or) Traceability Lot Code Source Reference

(GLN, FFRN, USDA Est Number)

Country of Origin

Pallet Quantity

Case Quantity

Net Weight, Pounds (variable measure trade item)

Net Weight, Kilograms (variable weight trade item)

Gross Weight, Pounds

Gross Weight, Kilograms

[Shrimper]

jfrey,

 

I 100% agree with everything you said. Thank you for the thorough response, too! The reason I ask is because I feel like I am constantly asked, how is this different than our current processes? What you explained in the end of your response, about customers requiring more is my answer every time. Inital thoughts from people at my company was that some sort of code would have to follow a lot from harvest to plate (which would be crazy). 

 

I've got another question for you and everyone. What is your plan for the TLC source? I don't want to put our vendor's info for our customer to see (and potentially cut us out). I know you are allowed to use a reference, but an FDA number doesn't always work and other options seem difficult to establish for every lot. Suggestions? 

 

Cheers,

Shrimper

[jfrey123]

TLC source for a finished good you create should be your company:

 

Location description** for the traceability lot code source or the traceability lot code source reference

**"Location description means key contact information for the location where a food is handled, specifically the business name, phone number, physical location address (or geographic coordinates), and city, State, and zip code for domestic locations and comparable information for foreign locations, including country."

 

FDA has a whole page dedicated to TLC's as well that probably gets you what you need Shrimper: Traceability Lot Code | FDA

 

 

Diving deeper if Shrimper is still in the shrimp business:  if you're just crossdocking or reselling a food that you didn't perform a transformation step with the FTL food (say you buy and resell shrimp by the case), you are prohibited from removing your supplier's TLC and adding your own.  And in those circumstances, yes, you would have to furnish where the original TLC was created and maintain that original TLC through your system.

 

When must firms assign a traceability lot code? 

Firms must assign a traceability lot code when they:

• 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. 
• Firms must not establish a new traceability lot code when they conduct any other activities (e.g., shipping). However, if you receive a food from a person who is exempt from the rule, you must assign a traceability lot code

And if you are still in the shrimp biz Shrimper, it gets even MORE fun if you are the initial packer from a fishing vessel.

 

Off I go for more coffee... and bourbon.

[Shrimper]

jfrey,

 

Still in the shrimp business! Again with excellent information. There are times where we definitely transform a food, and then there are times we do not touch the product whatsoever. My concern is if I put the TLC source/reference that someone can just find who we buy the food from, and they can then just buy directly from them. The FDA suggests a web address or an FDA number. FDA numbers are commonly shared now a days and can be searched in some cases. A web address does no more than tell you the name of the business. 

 

Interesting that you say that "you are prohibited from removing your supplier's TLC and adding your own." I had a traceability demo where I asked the same questions as above, and I was told to just put my own despite not transforming. 

 

Interested in seeing what you have to say. Maybe I can put some sort of other code on the shipping docs that links to the true source in these circumstances, would that work? 

 

Cheers,

Shrimper

[jfrey123]

Interesting that you say that "you are prohibited from removing your supplier's TLC and adding your own." I had a traceability demo where I asked the same questions as above, and I was told to just put my own despite not transforming. 

 

Interested in seeing what you have to say. Maybe I can put some sort of other code on the shipping docs that links to the true source in these circumstances, would that work? 

 

Cheers,

Shrimper

 

I'm far from a full expert on this topic, but in my previous reply the 4th bullet is direct from FDA's website stating that a firm must not establish new TLC's for any other activity, and they directly call out shipping.

 

I also understand your concern about cluing in your customers to your suppliers.  In your shoes, I'd be researching and considering performing some type of transformation and documenting it in your process.  Could be repacking from a 50lb box to a 40lb box becomes sufficient (as that would allow you to change the description of the food, which I think *technically* makes it a new food in the eyes of 204).