Removing ‘Food’ From FDA

The Obama administration’s recent proposal to remove food safety-related components from FDA and USDA’s Food Safety and Inspection Service (FSIS) and consolidate them into a single new agency is unlikely to gain traction anytime soon, experts say. The proposal is included in FDA’s Fiscal 2016 budget request, which seeks $1.3 billion in appropriated federal funds for food safety activities beginning Oct. 1, 2015 (a 9 percent increase of $109.5 million) and $206.2 million from food industry user fees ($191.8 million of it new). The net food safety increase would come to about $301.2 million, 25 percent more than at present.

The proposed new food safety agency would, like FDA, remain situated within the Department of Health and Human Services (HHS), which also houses the CDC and other public health agencies. (USDA is an independent agency and not part of HHS.) The proposed agency would have primary responsibility for food safety inspections, enforcement, applied research, and outbreak response and mitigation.

“The new agency would be charged with pursuing a modern, science-based food safety regulatory regime drawing on best practices of both agencies,” the White House said in a budget document. It would also serve as the central point for coordinating with state and local agencies and would “rationalize the food safety regulatory regime and allow the federal government to better allocate resources and responsibilities.”

While details have not been revealed, the concept has drawn mixed reactions from food industry experts, trade associations, lawmakers, and consumer groups. Some call it a good idea, but challenging to implement; others think it should be abandoned; and still others applaud the concept, but say it doesn’t go far enough.

“The concept of a single food agency has been wrestled with for decades. People want greater efficiencies and would like to have more clarity in the food inspection process,” says Craig W. Henry, PhD, vice president of business development for the Americas, Decernis LLC. “There are good reasons why a single food agency should happen, but there are a multitude of reasons why it would be very, very difficult to execute,” he tells Food Quality & Safety magazine.

There are, for example, political turf issues at FDA and USDA. Other concerns include possible budget cuts, job losses, and funding reductions to the states. Pending Food Safety Modernization Act (FSMA) regulations will likely need to be addressed because they specify what are likely to become outdated regulatory and inspection processes. “It will be a pain both domestically and for everybody around the world,” Dr. Henry says.

David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods, supports the idea of a single agency. “But you would need a group of people to sit down and figure out what it might look like and how to structure it effectively,” he adds.

Pizza the Poster Child

FDA has the lion’s share of responsibility for food safety, overseeing about 80 percent of the nation’s food products including produce, most seafood, dairy products, and shell eggs. FSIS oversees meat, poultry, processed eggs, and catfish. FSIS inspects manufacturers of packaged open-face meat or poultry sandwiches, while FDA inspects manufacturers of closed-face meat or poultry sandwiches. Manufactured frozen pizza has become the poster child of this fragmentation: A cheese pizza and its ingredients are regulated by FDA, but a pepperoni pizza is regulated by both agencies. The agencies differ in their inspection protocols: USDA inspectors are stationed at nearly every U.S. slaughterhouse, while FDA rarely inspects a facility unless a problem is reported or suspected. At ports of entry, FDA inspectors scrutinize less than 2 percent of shipments due to the sheer volume of imports.