The Food and Drug Administration Food Safety Modernization Act (FSMA) is a “big deal and is here to stay,” Joseph Levitt, partner, Hogan Lovells LLP, Washington, told soft wheat millers participating in the annual spring conference of the North American Millers’ Association on Marco Island on March 13. Mr. Levitt said FSMA is “the most important change to food safety in our professional lifetimes” and may serve as the foundation for the federal approach to food safety for the next 50 years.
Mr. Levitt, whose career includes 25 years as an attorney with the F.D.A., six of which were as director of the Center for Food Safety and Applied Nutrition, provided five underlying principles he said should be considered when approaching FSMA.
First, implementation of FSMA will go forward.
“It’s here to stay,” Mr. Levitt asserted. “It was a bipartisan bill. There always will be (foodborne illness) outbreaks in the news. Politicians will not want to roll back food safety. The food program at the F.D.A. is not on the chopping block as are other agencies like the Environmental Protection Agency. So, No. 1, you better keep your attention on FSMA because it is going to be around.”
Second, contrary to some of the early messaging about the bill as it was being drafted, it does raise the bar for food safety for all companies, Mr. Levitt said.
“Early messaging was, especially in the case of large companies, ‘Don’t worry, we’re just codifying what you do. You’re going to be in compliance on day one,’” Mr. Levitt said. Congress reasoned the bill would embody HACCP (hazard analysis and critical control point) principles, and many in the industry already had HACCP plans.
“What those drafters forgot was, when you hand a law, even a 300-page law, to a regulatory agency, the agency is going to amplify it,” he said. “When they amplify it, they don’t amplify it down, they amplify it up.”
Turning to a comment made by a previous F.D.A. administrator, Mr. Levitt remarked, “Remember, dogs bark, cows moo, and regulators regulate. That’s what they do.
“If you give the F.D.A. a statute that requires strong preventive controls, strong supplier verification and strong food defense, that’s what you’re going to get. Anyone who thinks this is business as usual is working under a misimpression.”
Third, FSMA is clearly aimed at the entire supply chain. Mr. Levitt said this key feature of FSMA is important to food manufacturers because they are being monitored not only by the F.D.A. but by their customers.
“Your customers are all going to be overseeing you,” he said. “It was intentionally set up that way because both Congress and the F.D.A. knew the F.D.A. couldn’t reach everyone.”
Fourth, FSMA is directed not only at the domestic supply chain but the worldwide supply chain as it pertains to food products and ingredients that are imported for use in the United States.
Finally, Mr. Levitt said while FSMA is all about prevention, from a regulators point of view, it is all about accountability. Congress built accountability into the law in three ways.
No. 1 is records access review.
“The importance of records is that if F.D.A. inspectors go out, they’re not on a field trip,” he said. “They are there to collect evidence. And their evidence is records. It used to be they would go out and tour a plant, and what they saw is what they got. Now, they’re there to see not only what happens that day, but also what happened last week, last month, last year. That’s a whole different story. I can guarantee you that the F.D.A. has always viewed record access as just about the most important part of any new food safety law.”
Mr. Levitt said first, companies must be accountable to themselves through maintaining records. Secondly, companies have accountability in relation to the activities of their suppliers, and, in turn, the companies they supply become accountable for their activities. And third, there is accountability in the enforcement sense.
“FSMA does give the F.D.A. a number of new authorities: mandatory recall, suspension of registration, meaning it can shut your facility down, and others. That again is Congress’s message: ‘We’re not kidding here.’”
Mr. Levitt noted the flurry of executive orders issued by the Trump administration relating to regulations and budget will have some effect on the pace of implementation and enforcement; for instance, the issuance of further guidance documents may be delayed. But a rollback of FSMA itself was not in the cards.