Attorney: FSMA delay no reason to bury your head in the sand. Get your house in order now!

By Elaine WATSON

- Last updated on GMT

Related tags Fda Food and drug administration

FDA reinspection fees: “No one knows how many hours/people/travel FDA is going to bill you for.”
FDA reinspection fees: “No one knows how many hours/people/travel FDA is going to bill you for.”
Just because food manufacturers are still waiting for the devil to emerge from the detail of the Food Safety Modernization Act (FSMA) does not mean there is nothing they can do now but wait, according to one legal expert, who says firms can do a huge amount to prepare before detailed rules are published.  

Joe Levitt is a partner at the Washington DC office of law firm Hogan Lovells and a former director of the FDA’s Center for Food Safety and Applied Nutrition.

The statute itself contains many specifics…

While there have been delays in the publication of key FSMA rules covering preventative controls for food and animal feed facilities; a new foreign supplier verification program, and a produce safety rule, Levitt predicted that ”by the end of the year we’ll see something​” and urged manufacturers to get their houses in order now.

He told FoodNavigator-USA: “The statute itself contains many specifics that in the past would have been reserved for regulations, so companies already have a good idea what to expect.”

It’s like being asked by a school teacher to turn in your lecture notes

So what can firms do now to prepare?

“Right now it is critical that companies look again at how they keep records, which might make perfect sense internally but would not make sense to an FDA inspector”, ​he said.

“It’s like being asked by a school teacher to turn in your lecture notes, which are written in your own code. Many food manufacturers’ records are not designed to be read by external parties.

“But under FSMA, all that will change, so your records have to make sense to outsiders. And that’s a huge change for the industry.”

Some companies are worried about providing too much detail about problems that they have corrected, but providing FDA with good records is a way to show the agency that you acted responsibly and did a good job, he added.

“Remember​ [in the FDA’s eyes] if it isn’t documented, it didn’t happen.”

Food safety plans, environmental testing, supplier verification

But what else should companies be doing to prepare?

The top priority, if they haven’t done this already, is forming a steering committee with representatives from regulatory, food safety/quality, legal, operations, procurement and supply chain to address FSMA compliance, he said.

Next, manufacturers need to urgently review/update food safety plans to include a hazard analysis of known or reasonably foreseeable hazards; and designate appropriate preventive controls to minimize or prevent those hazards.

This should designate any critical control points and describe monitoring steps, corrective actions, and verification activities.  

Firms should also re-examine product and environmental testing programs and develop a food defense plan that evaluates hazards that may be intentionally introduced (eg. by acts of terrorism) and describes how these are minimized or prevented.

Finally manufacturers must look again at how they oversee domestic and overseas suppliers and co-manufacturers and describe how this process works in a supplier verification plan the FDA can review upon request, he added.

However, there is still some uncertainty over whether the FDA will accept third party audits of supplier sites as a verification activity, he acknowledged.

Flexibility on testing requirements

Some of the anxiety in the industry about FSMA is due to uncertainty over how much flexibility manufacturers will have over deciding appropriate testing regimes for their products, with some worried that FDA guidance will be too specific, said Levitt.

“Manufacturers would prefer the FDA to be more general so they can explain to inspectors why they do it this way during the inspection.”

Acheson: Don’t bury your head in the sand

Writing in his blog​, former FDA Associate Commissioner of Foods Dr David Acheson, who now heads up the food and import safety division at consultancy Leavitt Partners, agreed that firms should start making preparations for FSMA now.

Obviously having the proposed rules out will be helpful, but… prevention is an area that industry can and should be implementing regardless of such regulation.”

Meanwhile, recent legal action designed to speed up the publication process “will likely have zero impact on either Office of Management and Budget or FDA”, ​he predicted.

“It will waste resources and creates a false impression that proposed rules published today will prevent outbreaks next week…So sit tight and focus on building good preventive controls.”

Re-inspection fees: ‘No one knows how many hours/people/travel FDA is going to bill you for’

As for re-inspection fees, while we know how much the FDA can charge -$221/hour where domestic travel is required or $289/hour where foreign travel is required - the total bill for a re-inspection could be “wildly unpredictable​”, claimed consultancy FDA Imports (click here​ for more details).

“No one knows how many hours/people/travel FDA is going to bill you for.”

Re-inspection involves FDA’s re-examination of a food or facility to determine whether corrective actions have been implemented and compliance achieved.

And the costs could soon add up, points out FDA Imports.

If for example, the FDA inspects a US factory and finds the manufacturer in violation of cGMPs and issues a form 483, the FDA will bill the firm hourly for the time it takes to review its written response to the 483, to prepare for travel, to travel to and from the facility for re-inspection, to conduct the re-inspection, and to prepare any subsequent reports post re-inspection.

“What might the above scenarios cost? 10 hours of FDA’s time? 100? 1000? Nobody knows. The costs might be $2,210, $22,100, or $221,000 accordingly.”


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