FSMA 204 Regulations

[nancyVigo]

Hello community,

Looking for some clarity on FTL ingredients and kill-step disclosure.

We produce several items that contain FTL ingredients, some of which we apply the kill step and some of which the kill step is applied prior to us receiving the ingredient. I understand that for the items in which we apply the kill step to the ingredient it is our responsibility to record the KDEs up to the point in which the kill step is applied. We would then classify the item as “Not applicable” for the regulatory compliance indicator and then “KILL_STEP_APPLIED” as the reasoning. Are we also required to disclose specifically what the kill still is?

Does this also pertain to items we sell in which the kill step is applied prior to us receiving the item/ingredient? Does it matter how far back in the supply chain the kill step was applied?

Thanks in advance!

[George_C]

Hello, @nancyVigo  thanks for continuing the use of the community. Welcome back.

We are researching your question further and will contact you with more details shortly once we have more information. Thank you for your time and patience.

[nancyVigo]

@George_C, thank you so much for your prompt response!

I will let my team know that the Community is working on getting us some answers so we can take the necessary steps. 🙂

[Scott_Brown]

Nancy,

This is a great question. The answer is yes. The end recipient needs to know that there is no tracking for the item as a kill step was reached. For them it would not matter if the kill step was accomplished by you or three folks before you. 

This helps to ensure they know what to track and what not to track. It also helps with what would not have tracking in the case of an adverse event.

Hope this helps,

S

[nancyVigo]

@Scott_Brown, thanks for the clarification.  As a follow up question: Will we be required to disclose what the Kill Step is to our customers?

Thanks again!

[Scott_Brown · Accepted solution]

Not as part of the master data set. There might be questions over time if an adverse event happens. However, that would be up to the FDA to call out.

[nancyVigo]

@Scott_Brown, thanks again...I will pass this information along to our team! 🙂