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Taylor Outlines FSMA Implementation Strategies

FDA Has A Lot to Tackle With FDA Food Safety Modernization Act Implementation

It’s no secret in food policy circles, that the U.S. Food and Drug Administration is an agency with its work cut out for it in the coming years. With the stroke of a pen in January, President Obama ushered in what is widely considered the most sweeping update to food law in over seven decades with the FDA Food Safety Modernization Act, and implementing the new law, which essentially shifts the system from reactive to preventive, will be a massive undertaking.

This month, Michael Taylor, Deputy Commissioner for Foods at FDA, laid out a bit of detail about the agency’s strategy for implementing the new law. With finite resources and a whopping mandate, the agency is working to prioritize.

“As you can imagine, this is a huge undertaking,” said Taylor, in a speech before the Food and Drug Law Institute earlier this month. “But it’s a welcome challenge to build a new system of food safety oversight that looks at the food system as a whole and marshals the efforts not only of FDA but of government at all levels and actors throughout the food system to improve food safety. And it is a powerful, positive thing that Congress has told FDA to create this system.”

“We have our work cut out for us,” added Taylor.

Before the Atlantic Food Summit in Washington last week, Taylor emphasized the historic nature of the new law and discussed the need to set priorities.

“We are at a special moment … [the law] really does represent a fundamental paradigm shift: from the primary reliance on reaction to building in prevention measures at each step of the way from farm to process and transport, all the way to retail–and that is historic,” said Taylor, noting that a new comprehensive regulatory system needs to be built in the coming years.

“We’ve been brought up to at least the 20th century, actually the 21st century, with this terrific toolkit that we’ve got,” said Taylor.

When asked about the agency’s priorities–especially considering finite budget resouces–Taylor was quick to admit that FDA has a lot to tackle in the coming years.

“This law has 50 major deliverables: regulation, guidances for industry, over a dozen reports to Congress, all due over the next two or three years, with timelines that are pretty strict,” he explained during a Q&A session with Atlantic food editor Corby Kummer. “I’ve conceded publicly that it is physically impossible to get all of those deliverables to the finish line [within the deadlines]… so we are prioritizing.”

Taylor cited preventative controls standard setting as a top priority, including rules for produce safety and for preventing intentional adulteration.

In his speech before FDLI earlier this month, Taylor described the system FDA is using to tackle implementation.

“We are using a matrix management system that combines FDA staff from across the regulatory, policy and scientific areas into teams,” he said. “This takes production out of the usual organizational structure. It allows problems to be raised early and resolved quickly. The teams have a clear charge, have specific deliverables, are empowered to make decisions, and are working through a streamlined clearance process.”

According to Taylor, there are six implementation teams: Prevention standards, Inspection and compliance, Imports, Federal/state integration, Fees, and Reports and studies.

“We are focusing first on those with the greatest public health benefit, such as preventive controls, inspection and compliance, and the import provisions,” said Taylor at FDLI. “Even with these priorities, some of the deadlines are difficult.”

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