Policy group says FDA needs single food safety chief

Robert Roos

Mar 25, 2009 (CIDRAP News) A public health policy group today urged the government to put one person in charge of all food safety efforts at the Food and Drug Administration (FDA) as a first step toward preventing the kinds of foodborne disease outbreaks that have plagued the nation in recent years.

For one of the next steps, the nonpartisan Trust for America's Health (TFAH) said in a report released today, Congress should put the FDA's food safety programs in a proposed new "Food Safety Administration" (FSA) within the Department of Health and Human Services (HHS), thus splitting the FDA into separate food and drug agencies.

The report also calls for increasing the FDA's food safety funding and giving it greater authority to require food companies to embrace sound prevention systems. In addition, it calls for a closer partnership between the FDA's food safety programs and the food safety epidemiology program at the Centers for Disease Control and Prevention (CDC).

The report, "Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the US Department of Health and Human Services," renews and amplifies recommendations that TFAH made in a report a year ago. (See Apr 30, 2008, CIDRAP News story.) The new report was prepared in collaboration with the Robert Wood Johnson Foundation.

"Our goal with this report is providing a road map for the first steps in reforming the food safety system," TFAH Executive Director Jeffery Levi said at a press teleconference today.

In the wake of recent major foodborne disease outbreaks, including the nationwide Salmonella outbreak tied to peanut products, the time is ripe for food safety policy changes, TFAH officials said.

"I actually think we've reached a tipping point, now that there've been a series of crises and now in the peanut incident a bad actor and therefore a recognition that we need stronger government authority," said Levi. "I think that created the political will for the Congress to act and the administration to move more rapidly."

"With the public scrutiny on the issue, if we're not going to do food safety reform this year, and specifically the first half of this year, it's hard to say when we're going to do it," said Michael R. Taylor, JD, a professor of health policy at George Washington University who worked with TFAH on the report. He is a former deputy commissioner for policy at the FDA.

Seeking a food safety administrator
The report notes that the FDA has several units that deal with food safety, including the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Regulatory Affairs (ORA), and the Office of Food Protection.

"There is no FDA official whose full-time job is food safety and who has line authority over food safety efforts as a whole," said Taylor. Noting that the FDA commissioner is in charge of responsibilities for drugs and medical products as well as food, he added, "The practical result is that no one is really in charge and realistically accountable for the success or failure of FDA food safety programs."

The HHS secretary has "ample authority" to put one administrator in charge of the FDA food programs, the report says. It says the existing structures of CFSAN and CVM could be maintained until the proposed separate food safety agency is set up.

TFAH calls for three other immediate steps, besides appointing a food safety administrator. One is to double the funding for HHS food safety programs over the next 5 years, including both the FDA and CDC programs.

Second, the group says Congress should give the HHS secretary more authority and better legal tools to ensure that food companies use contamination-prevention controls and meet food safety performance standards. Congress should empower HHS to access company food safety records, order food recalls, enact user fees for food facilities to boost safety, set performance standards, and require traceability of food.

Third, states should be "encouraged and incentivized" to adopt and comply with the FDA Food Code and the National Retail Food Regulatory Program.

Setting up a new agency
TFAH proposes the FSA as a "medium-term" step to raise the profile of food safety at HHS. The food agency would be created by separating the FDA's food functions from its medical product functions, with the latter moving to a new "Federal Drug and Device Administration."

"Over time, we want to see taking the 'F' out of FDA and creating a separate Food Safety Administration," said Levi. "This will ensure food safety gets the attention it deserves."

The new food agency would include the functions and resources of CFSAN and CVM as well as the food-related functions of the ORA and the FDA Office of the Commissioner, the report says. It would also incorporate the National Center for Toxicological Research.

The proposed structure would consolidate the scientific divisions of CFSAN and CVM into one unit. Similarly, it would combine the compliance and enforcement elements of CFSAN, CVM, and relevant parts of the ORA in a single entity.

The new agency would have one administrator, but the proposal also calls for creating a Leadership Council to make strategic plans, set agency-wide priorities, and allocate resources, according to the report.

The TFAH plan does not call for the FSA to take over the CDC's food safety functions, but it does envision "an active partnership" with the CDC. In this plan, the CDC would receive FDA funds in return for providing the data and analysis needed by the FSA, the report says.

"This would put more resources into the badly underfunded food safety program at CDC, and it would create a contractual, client-service provider relationship in which FSA's information needs and CDC's accountability for meeting them would be clear," the document states.

TFAH says the oft-mentioned idea of consolidating all federal food safety efforts into one agency should be considered by Congress as a long-term goal. This would mean combining the FDA's food programs, the meat safety programs of the US Department of Agriculture, and food safety activities of the Environmental Protection Agency.

Proposed legislation
Several bills pending in Congress have elements that fit TFAH's recommendations, according to the report.

It says that a bill offered by Rep. Rosa DeLauro, D-Conn., would create a new food safety administration within HHS and would modernize the food safety law that governs the FDA. Another bill, sponsored by Sen. Richard Durbin, D-Ill., and several others, would require more preventive controls and give HHS more authority to regulate food.

In addition, Rep. John Dingell, D-Mich., has introduced a bill that would impose user fees on food facilities, set safety standards for produce, and mandate food traceability, the report notes.

Consumer group supports proposal
The TFAH recommendations, especially the proposals to put food safety under one person and in a separate agency, were welcomed by the Consumer Federation of America (CFA).

CFA spokesman Chris Waldrop said the FDA needs more resources and stronger laws, "but you won't be able to take full advantage of those things if you don't change the structure within HHS and give the food safety function more authority."

He also said such changes could help strengthen food safety efforts at the state and local levels. "This structural reform puts a single person in charge of food safety at HHS, so that person can better deploy resources and create better systems in terms of how the federal government interacts with the states and locals on food safety," he said.