FSMA Fridays: Sanitary Transportation Rule (Part Four Of Four)

View the entire webcast and read Part One, Part Two, and Part Three of this series

In part three of FSMA Fridays: Sanitary Transportation Rule, SafetyChain Software’s VP of sale, Dave Detweiler, was joined by The Acheson Group’s (TAG) Founder and CEO Dr. David Acheson to share insight on FSMA's Sanitary Transportation Rule including waivers and what companies should be doing if they are not ready for the rule. Here, in part four, the duo begins handling questions for the web cast’s live audience.

Dave: The question I think everybody's wondering is, “Okay, so how aggressive — and you mentioned the administration and changes they have coming out — do you think they are going to be enforcing this rule?”

Dr. Acheson: The FDA has signaled that with like a lot of FSMA, they're going to educate and then regulate. That's good to hear. I think they've recognized that there's a lot of education that needs to be done here. I think everybody in the private sector is saying, “Well, it’s just educating us on the private side…” it’s educating inspectors as well.

I think the FDA recognized they have a lot of training to do with their own people. So the message that I'm hearing is the compliance date is here, it was in April. So, this month on the sanitary transport rule, legally from a regulatory perspective, you need to have all this up and running but we recognize that you may not be quite there yet. But be on a good path, a good trajectory, and the FDA is going to be gentle, at least to begin with. This has been echoed in the way they're talking about implementing requirements. The preventive control rule has well been regulated slowly. I think, fundamentally, what I'm hearing here is that if the FDA is showing up to check whether you're compliant with the transport rule, and if you're not, they will they will not be issuing 483s right out of the gate. Now, don't quote me on that because every inspector has a right to do that. But, the message from the agency is that's not what we're going to do; we're not trying to get a high list of “gotchas.” But, and then this is a very important, if they do come in and look at this program and find gaps and holes and they do educate. If, when they come back, however long that is three months, six months, two years, if you have not got there, if you have not filled the gaps that they found you will get a 483.