Food safety predominated at the first congressional review of the fiscal 2013 FDA budget proposal Feb. 29 as members of a House Appropriations subcommittee revisited proposals that previously failed – removal of food safety from FDA’s agenda and adding food facility registration fees.

Republicans raised the issues as the Appropriations Agriculture/FDA subcommittee questioned FDA Commissioner Margaret Hamburg about the Obama administration’s $4.5 billion budget request for the agency, including $583 million from user fee programs that still need Congress’ approval and that prompted doubts from some members Also see "Sanofi-Aventis offer" - Pink Sheet, 31 May, 2004..

There was little discussion of actual funding levels. FDA requested only an $11.5 million increase in budget authority – money from the U.S. Treasury and not from user fees. Subcommittee Chairman Jack Kingston, R-Ga., praised the “sensitivity to the budget battle” shown by that request, but voiced concern about FDA attracting the personnel needed to accomplish its tasks.

“We want to make sure you have the best and brightest coming out of America’s universities and staying in terms of a career” and not leaving for more lucrative jobs outside, he told Hamburg.

Focus On Pharma And Devices?

Wyoming Republican Cynthia Lummis also had FDA’s scientific expertise in mind. FDA is responsible for complex drug and medical device products as well as foods and it could be time to allow the agency to focus its scientific abilities where they are most needed, she suggested.

Without the food safety component, FDA “could really concentrate where we need these highly technically skilled physicians and medical engineers to deal with these extraordinarily complex issues related to drugs and medical devices and related components,” Lummis told Hamburg.

Lummis suggested moving FDA’s food safety programs to the Department of Agriculture, which is transitioning already from “something that’s focused on farmers and ranchers to something that’s focused on food safety and the consumption of food and food nutrition programs.”

Ranking Democrat Sam Farr, of California, pointed out that Rep. Rosa DeLauro, D-Conn., a subcommittee member and former chair, failed in previous sessions of Congress to gain approval for separating the medical product and food duties of FDA.

DeLauro’s focus had been on retaining the food safety authority within the Department of Health and Human Services, but in a separate agency. Her most recent proposal failed to make it into the Food Safety and Modernization Act of 2009 due to objections from Rep. Henry Waxman, D-Calif., then chairman of the Energy and Commerce Committee, which writes authorizing legislation for FDA Also see "First Course For Waxman: Fix Food Safety, Hold The Separate Agency Plan" - Pink Sheet, 16 March, 2009..

FDA’s top food safety official, Deputy Commissioner Michael Taylor, also suggested a separate agency in a 2009 report he helped write as a health policy professor at the George Washington University Also see "Would Supplements’ Regulatory Home Change With A Separate Food Agency?" - Pink Sheet, 20 April, 2009..

While dietary supplements are categorized as food and overseen by FDA’s Center for Food Safety and Applied Nutrition, proposals for a separate food agency have not detailed whether regulation of supplement manufacturing and marketing would move out of FDA.

Kingston pointed out that splitting up FDA authorities is not within the jurisdiction of the appropriations panel. But the subcommittee chairman, a proponent of eliminating duplicative programs within and across agencies, commented after the hearing that a model for a split to save money and improve safety would be worth considering.

No Benefit, But Priorities From Fees?

Rep. Tom Latham, R-Iowa, was highly critical of $220.2 million in proposed food facility registration user fees, which would be applied to supplement manufacturers. Latham contends the fees would not benefit the food industry, although FDA sets users fees for industries according to its estimated costs for regulating each one.

He said the proposed fees are for food facilities “existing,” not for the government performing a service. He added that these fees have already been rejected twice by Congress and the agency should have asked for budget authority instead.

FDA currently receives user fees from the pharmaceutical, medical device and supplement and food product industries. However, facility registration fees are not part of the food industry user fees, which were imposed for the first time for fiscal 2012.

The high proportion of the FDA budget that comes from user fees is another sore point with DeLauro, who pointed out that the fees represent 44% of FDA funds in the fiscal 2013 budget proposal, compared to 35% in fiscal 2012.

Relying on user fees is “an abdication of congressional responsibility,” she said. The fees paid by FDA-regulated industries “drive the work that’s being done by the agency because the Congress failed in its responsibility to make the necessary investment,” DeLauro observed.

The food establishment registration fees would help fund activities dictated by the Food Safety Modernization Act, including establishing new food safety standards, increasing the frequency of inspections, launching an integrated food safety system with state and local governments and establishing a program for import safety, among other activities.

In addition to food facility registration, the fiscal 2013 budget request includes $18.7 million from another fee program Congress has not approved – user fees for domestic and foreign manufacturers of cosmetics, including mouthwashes.

FDA also asks Congress to approve a food contact notification fee to provide $4.9 million to continue funding the Food Contact Notification Program, which allows firms to market food packaging and processing equipment 120 days after notifying FDA unless the agency raises objections. The Food, Drug and Cosmetic Act dictates that the program, which has been hailed as a regulatory success, can operate only if adequately funded, FDA says in the justification.

Appropriators Suggest Moving Food Safety Out Of FDA, Question User Fee Proposals

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