FDA promises help, not crackdown, on FSMA rules

06/12/2014 05:53:00 AM
Tom Karst

CHICAGO — The Food and Drug Administration is looking to educate before it enforces new food safety laws.

United Fresh Produce AssociationStressing voluntary compliance of the Food Safety Modernization Act, Roberta Wagner, deputy director for regulatory affairs for the FDA’s Center for Food safety and Applied Nutrition spoke at a June 11 workshop at United Fresh 2014.

All rules for the Food Safety Modernization Act are due from the agency in 2015.

Wagner often referred to an FDA document issued May 2 that outlines the agency’s strategy on the rules.

She said there are three basic steps to enact the FSMA: rulemaking, planning and implementation.

“What we really want is to gain voluntary industry compliance with these new standards so that when we do start inspecting against the standards and find noncompliance, what we want is voluntary industry corrections that are adequate and timely,’ she said.

Culture change

Part of FDA’s challenge is creating a new way of treating inspections. For example, Wagner said that looking at independent third-party audits showed new ways to determine whether a company has a culture of food safety.

“What we’re learning is that there is a line of questioning that helps establish whether there is a food safety culture in a facility or on a given farm and we don’t have that line of questioning,” she said. ”We need to ask different questions to assess if there is a food safety culture in a given facility or in a growing operation.”

Wagner said the FDA also may want to give industry credit for making voluntary corrections. To do that, she said the agency plans to capture more data on voluntary compliance.

“To elicit the culture change, we literally have to start with the way we hire, what we look at in our investigators, how we train our investigators and how we establish compliance strategies,” she said.

As the FDA establishes the FSMA’s produce safety rule, the agency will have produce safety experts to help growers comply.

The agency will also put more emphasis on data analysis and risk factors.

“One-size-fits-all is not the way of the future,” she said.



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R Henry    
LA  |  June, 16, 2014 at 10:19 AM

I am so relieved to hear the FDA is going to be kind the produce industry! I am sure it will be a lovely experience when the next mandatory recall begins...!

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