The FSMA Intentional Adulteration Rule – what you need to know…

The final FSMA Intentional Adulteration Rule was published at the end of May.  There are no major differences between the proposed rule and the final rule, the FDA have added some clarification, but the requirements have not changed.  Most business (unless you are small or very small) have to comply by July 26, 2019, so we have three years to get this in place.
In this week’s post I’ve picked out the 8 most important points you need to know about, in order for your food defense plan to comply:

Only threats which are intended to cause wide scale public health harm should be included

The assessment must take into account – the impact on public health impact, access to the product, ability of the attacker

The assessment must take into account attackers from outside and also those from within the facility

The vulnerability assessment and food defense plan must be documented and the inspector must be able to understand from reading it, how you came to your decisions and how the mitigation actions add protection

All mitigation actions must be at a set frequency and the completion of these must be recorded so you can prove they’ve been done

Make sure your plan includes pre-agreed corrective actions in case things go wrong and verification (e.g. checks and auditing) to ensure that the plan continues to be effective

Food defense awareness training must be completed at the facility

Those carrying out the assessment must be competent – through training or experience

Extra tip: If you want to know the lingo – the FSMA intentional adulteration rule is being abbreviated to the ‘IA Rule’

As always, if you have any questions please just add them to the comments section below.

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