Removing ‘Food’ From FDA

This fragmented nature of the U.S. food safety system “has caused inconsistent oversight, ineffective coordination, and inefficient use of resources,” concludes a recent report by the Government Accountability Office, the investigative arm of Congress. At least 30 laws related to food safety are administered by 15 federal agencies led by FDA and FSIS, but also involving the Environmental Protection Agency (pesticides and crops) and the National Oceanic and Atmospheric Administration (Seafood Inspection Program). While FDA and USDA coordinate some activities, “existing mechanisms focus on specific issues and none provides for broad-based, centralized collaboration,” the report says.

“I think it’s a discussion worth having in terms of how we can best align the different components of government that are involved in food safety and what kind of an organizational structure would be necessary to best support that,” outgoing FDA commissioner Margaret A. Hamburg, MD, told a House Appropriations subcommittee in March. Agriculture Secretary Tom Vilsack said Congress needs to give the Obama administration authority to reorganize the agencies. “This is a new way of thinking. The point of this is to get this [reorganization proposal] on the table so people can have a conversation about it,” Vilsak told reporters at a USDA budget briefing in February.

But Senate Agriculture Committee Chairman Pat Roberts, R-KS, signaled early opposition. “In this tough economy, the last thing producers and consumers need is more red tape,” Roberts said in a statement. Many agricultural and food industry groups have also expressed concern over the administration’s proposal. Western Growers, an association representing half of the U.S. produce industry, believes the reorganization would pose a “major distraction” because key FSMA regulations are still being finalized. Similar sentiments were expressed by the National Milk Producers Federation and the National Cattleman’s Beef Association.

On the other hand, many consumer advocacy groups support the consolidation effort. “Our current food systems are redundant and fragmented,” says National Consumers League executive director Sally Greenberg. The administration’s proposal to consolidate the responsibilities of FSIS and FDA “will ensure cohesive practices and superior response times in the event of an outbreak, ultimately keeping consumers and our food supply safer,” she says.

But other groups think the proposal doesn’t go far enough, and support the creation of an independent agency. HHS is a massive organization, says Christopher Waldrop, director of the Food Policy Institute at Consumer Federation of America. “A new food safety agency would be lost among the other priorities of the department, and would likely not receive the recognition or resources necessary for it to be effective,” Waldrop says. And because FDA is also implementing FSMA, consolidation efforts “would seriously undermine FDA’s implementation activities and hamper efforts to prevent consumers from becoming sick from contaminated food,” he adds, supporting the establishment of a new independent food safety agency.

Along these lines, Democratic lawmakers Rep. Rosa DeLauro of Connecticut and Sen. Richard Durbin of Illinois have reintroduced legislation that would remove the food safety inspections, enforcement, labeling, and research responsibilities from FDA and USDA and merge them into a new independent agency to be called the Food Safety Administration. The lawmakers introduced the Safe Food Act of 2015 in the House (HR-609) and Senate (S-287) in January. The 90-page bill mirrors legislation that DeLauro and Durbin introduced four times previously in 1999, 2004, 2005, and 2007.

The Food Safety Administration would also have authority for mandatory recall of unsafe food; require risk assessments and preventive control plans to reduce adulteration; authorize enforcement actions to strengthen contaminant performance standards; improve foreign food import inspections; and require full food traceability to better identify sources of outbreaks.

As of publication time, the bill has attracted only 11 cosponsors in the House and three in the Senate—all of them Democrats—and is considered unlikely to gain traction this time around. “The bill was not written in a way to allow it to move forward,” Dr. Acheson says. “It includes little detail on how the transfer and consolidation would work. In fact, details are turned over to an administrator to determine within 180 days after enactment. There is just no way this will happen and the resulting product be well thought out and practical,” says Dr. Acheson. DeLauro and Durbin also support the Obama administration’s HHS consolidation approach as being a step in the right direction.

Budget Wrangling Begins

FDA’s overall Fiscal 2016 budget request totals $4.9 billion, a 9 percent increase. “This is the largest FDA request in recent history. [It] will be tough to swallow,” said House Appropriations Committee chairman Rep. Hal Rogers (R-KY) during an FDA budget hearing in March. Dr. Hamburg told him that not getting the requested funding will result in fragmented food safety efforts. “We do need real money to get the job done. If we make this investment, it will benefit all,” she said.