The FDA is Getting Serious, Are You?

By inpowerUncategorized

Ready for it or not, the FDA is overhauling the food safety system, and companies impacted by the FSMA ruling will be forced to abide by these eventual new regulations.

How soon must shippers, drivers, carriers, and receivers of food products comply?  The answer is clear that vendors will need to get themselves in gear.

On June 26, 2014, Deltatrak’s Peter Norton, Director of Business Development, and Kelly Gullo, Social Media Marketing Manager, spoke with FDA policy analysts from the Food Defense and Emergency Coordination Staff. On the call from the FDA were: Julia Guenther, Ryan Newkirk, PhD, MPH, and Colin Barthel.

The purpose of this call was for DeltaTrak to garner (from a vendor’s perspective) what companies should be doing to prepare for this ruling. Guenther acknowledged that the FDA is limited on what they can say, since the comment period is still open on this public ruling. Guenther and her colleagues’ area of expertise is ‘Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.’

The FDA may seemingly be dragging its feet with regard to the proposed FSMA ruling, since it is immersed in a large undertaking. In spite of the fact that additional time is needed to initiate this enormous ruling, the department is fully intent on enforcing these sanitary and food safety rules in 2015 and early 2016. The FDA is already focusing inspections on companies that deal in food handling, storage, shipping, and sanitation. It will target certain processes within a facility that are most likely to be vulnerable, rather than targeting specific foods or hazards.

Here is what DeltaTrak learned from its discussion with the FDA analysts:

How were the numbers of impacted companies calculated?

The Intentional Adulteration Group was a ‘subset’ of the 14,000 companies impacted, and it was comprised of 4,624 companies. This number was calculated by conducting an impact analysis using economics based upon companies doing more than 10 million annually in sales. The analysis was taken using SIC codes and Dunn and Bradstreet reports.

Norton asked if once this law comes into force, what companies would the FDA see as being priority companies to focus on first.

Julia: “Within the proposed (Intentional Adulteration Group) rule, we’ve outlined a staggered compliance schedule. When we say ‘comply’ that means they (vendors) don’t have to do all the things we’re proposing, they just have to comply with the modified requirements, which is essentially documenting that they are exempt from X, Y, and Z.”

There will be different thresholds for other sections and other rules. So, preventive controls, produce, and transportation will all have a different number.

Colin advised that there is a link to thePreliminary Regulatory Impact Analysis documents on the FDA website which vendors can access for statistics.

“The best way to keep on top of what’s going on is through our FSMA subscription service. That’s where you can get the most up-to-date information.” said Colin.

What are most of these companies doing in the meantime?

Starting May 31, 2015, the FDA will begin a staggered compliance schedule beginning with:

Any businesses doing $10,000,000 and over, with no exemptions, would have to comply one year after the publication of the final rule.

Small businesses employing fewer than 500 persons would have to comply two years after the publication of the final rule.

Peter asked the panel what most companies that fall under this category have been doing to comply with food defense up until now, because the assumption is that many are only going so far as monitoring lot numbers and loads, and getting shipments to the right places.

Julia: “It runs the gambit. We only know what we’ve been told anecdotally, and also through literature reviews. We don’t have hard data on this.” Guenther added, ”We know that some companies are conducting vulnerability assessments, and some have implemented focused mitigation strategies, while for some, this will be their first introduction to food defense.”

How will audit procedures be defined for these companies?

Small businesses will have guidance through online links provided by the FDA. There is no clear decision yet on who will be audited, or how these audits will be conducted, or how they will be separated (by safety, adulteration, or jointly).

In essence, there will be an expectation placed upon every vendor, shipper, supplier, and receiver of foods to comply with these standards. Companies will need to be ready with records to verify they are in compliance. Facilities will sometimes be required to provide this proof within 24 hours. In the context of ‘preventable control,’ the FSMA ruling gives the FDA legal authority to access records, determine reasonable belief the food might be adulterated, and allow 3rd parties to help enforce these rules. The final rule for Intentional Adulteration will be last in implementing, which is due May 31, 2016.

The compelling message from this phone discussion with the FDA is that vendors will need to be ready – whether they like it or not – when this ruling becomes mandatory.

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