In a recent FSMA Fridays event, three experts from The Acheson Group – Jennifer Cleveland McEntire, Ph.D., Vice President and Chief Science Officer; <strong”>Anne Sherod, Director of Food Safety; and Valerie Scheidt, Director of Food Safety – talked about preparing for final FSMA rules. Food Safety Tech presents some excerpts:

How close are we to the final rules in terms of how much can things still change, and are we more confident about some rules than others in terms of how much change we might still see?

We anticipate some changes with the proposed Third Party Certification rules especially around the responsibility of auditors to have mandatory reporting to FDA if they find any signification non-conformances. And this covers findings from consultative audits as well, so we feel it may be counterintuitive to do this as companies are aiming for continuous improvement.

We also think they may be some changes with the Food Defense rule. The agency may consider how GFSI views food defense and some of the mitigation strategies that are being proposed.

But for the most part, we think the other proposed rules will pretty much be as is.

What are Top 3 things that companies should be doing NOW to prepare?

First, companies need to figure out who that qualified individual will be especially in manufacturing facilities that have to comply with the preventive controls or foreign supplier verification rule. It’s important that this qualified individual is adequate informed and understands their responsibilities and what they need to do.

Also it’s really important to understand thoroughly the preventive controls rule and how it applies to your facility for instance, to your pre-requisite programs, GMP etc. Analyze how the preventive control rule will go beyond process control, and CCPs.

Another aspect that companies are really struggling with is document management, and realizing how they will be used by FDA.

Adding a fourth to do, companies need to be thorough with Supplier Controls – understand who is in the supply chain, and how they have been approved. FDA will be interested to know if you know their risks and how you are managing them.

In the area of supplier control, FDA made some significant changes in this last round of revisions. Will these hold? If so, what should companies be doing now to prepare?

You will need to have strong supplier controls. Although it looks like a new component, it was always expected. While regulatory compliance is the baseline, what we are seeking in brand protection as an end result. There are two things to get started – get a supplier approval process in place, after assessing supplier risk and making decisions on what can control that risk. You will also need to have monitoring and verification programs, and corrective actions in place.

Step two will be managing all this information. Documentation needs to fully support this system. Companies can do this either manually, or leverage technology that they currently are using, or can look for new technology opportunities. Whatever option they choose, companies must have everything in writing, especially a list of non-negotiable items that they can provide to their suppliers to see what they can do to meet your requirements.

From a scientific standpoint, it looks like companies will need to validate safety processes. Will FDA will be flexible in accepting tried and true operations, or will new studies need to be conducted?

FDA will accept tried and true operations, e.g. if you are doing a cook process, and you are monitoring for end point internal temp of 160 degrees, or if you have pH control of less than 4.6, and if these help in eliminating pathogens, then you have scientific validation for what you are doing. However, if you are doing a new process or a novel product, and have no process that’s scientifically supported, such as cook process, temperature or pH control, you need to have supporting data. In such cases, you will need to reach out to a Qualified Individual, and possibility have to do those studies to to make sure you have scientific justification for validation of your food safety plan.

What are requirements for a qualified individual?

A qualified individual is someone who has the required education, training, and experience to make decisions that are needed. However, that FD training that is required, doesn’t exist yet. So there’s a little bit of ambiguity here. But you look at types of responsibilities and information they need to know, the individual primarily has to be knowledgeable and confident about food safety. Just because that training and curriculum aren’t out yet, it doesn’t mean that you cannot look intuitively, and tell and this is the appropriate person and identify any training they may need.

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