Source:Tom Johnston, MEATINGPLACE, 9/20/17

The U.S. Food and Drug Administration’s thrust behind the Food Safety Modernization Act and its “war on pathogens” has raised the level of risk for companies that make food products that can make people sick.

Shawn Stevens, a food industry consultant and attorney who represents processors in food safety litigation — and a blogger for Meatingplace — warned attendees here at the Process Expo that, as companies like the Peanut Corporation of America already have discovered, the FDA can hold them criminally liable if consumers get sick from eating their products.

A misdemeanor charge does not require intent like a felony would. That is, a company does not have to know that it has shipped a product that is making people sick. It just has to have been aware of a condition that could result in illness and have had done nothing to prevent the problem. Each count can carry up to a year in prison or up to a $250,000 fine.

So, whereas companies were once only exposed to civil and regulatory penalties, they now also are exposed to criminal penalties.

“The exposures we face as an industry are incredibly high and on a daily basis they’re getting higher,” Stevens said.
For now, it’s the FDA making this push, but Stevens told Meatingplace in an interview after his presentation he predicts that USDA’s Food Safety and Inspection Service (FSIS) eventually will adopt the same approach.

“FSIS has watched with interest the shifts in FDA enforcement policy, and there have been some signals that FSIS, in response, may be intensifying slightly its own policy in that it’s suggested that in cases where a food safety assessment (FSA) or an investigation following an outbreak suggests there may be a basis for criminal liability, it may conduct a more intensive investigation,” Stevens said. “I predict that the more aggressive that FDA becomes, and the less tolerance that FDA shows for outbreaks, USDA will likely, even if slowly, follow suit.”

Among the most important things that Stevens listed for processors to do ahead of an FDA visit was to conduct their own microbiological profiling during production to get a clear picture of problem areas and correct them. He urged them also to get to the root source — not just the root cause — of the contamination by doing comprehensive environmental testing.

“The heart and soul of producing safe product is environmental monitoring,” he said.

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