FDA again proposes user fees in 2013 budget

02/14/2012 11:38:00 AM
Tom Karst

(UPDATED COVERAGE, Feb. 16) While sketchy on details, the Food and Drug Administration is proposing hefty new industry user fees in fiscal year 2013 to help fund new food safety oversight responsibilities.

In the 2013 White House budget unveiled Feb. 13 — which is subject to Congressional revision — the agency requested a budget of $4.5 billion, up 17% from 2012.

The budget allows $1.5 billion for FDA and Centers for Disease Control for food safety activities, which the agency said is an increase of $271 million from 2012.

“(The) budget proposes an FDA food inspection and food facility registration user fee that will aid in providing resources to FDA to ensure the safety and security of the nation’s food supply,” according to the proposed budget.

The agency projected $220 million in new fees for food facility registration, and $15 million and $12 million from the already-in-place food reinspection fee and food recall fee, respectively.

In a press teleconference Feb. 13, Patrick McGarey, assistant commissioner for budget for the FDA, said those who register their facilities with the FDA would be subject to the user fee.

“The laws defines who should register and that is our starting point with our engagement with stakeholders,” he said in the briefing. “The important thing to understand is that we are open to working with industry to shape a proposal that meets their objectives and our objectives and the public health need for food safety,” McGarey said.

The FDA hasn’t defined the proposed new fee, about which facilities would pay and what amount the fee would be, he said.

According to the FDA, more than 415,000 facilities have registered, , including more than 251,000 foreign facilities. Based on $220 million split equally between all registered facilities, the fee would equal about $530 per facility.

New user fees also were proposed in 2012, but Congress passed an FDA budget without them.

Any fees associated with food safety enforcement should not be an unfunded mandate, said Ray Gilmer, vice president of communications for the United Fresh Produce Association, Washington, D.C..


“This is just the administration’s proposed budget and as we have seen with every budget cycle, it usually doesn’t look much like what the president proposes by the time it finally passes Congress,” Gilmer said.

The Washington, D.C.-based Alliance for a Stronger FDA — with members including Newark, Del.-based Produce Marketing Association, and Washington, D.C.-based Grocery Manufacturers Association — expressed concern that the increase in FDA funding did not come from appropriated general funds.

“We believe that FDA’s funding should be increased to reflect the agency’s vast responsibilities and increased workload,” Margaret Anderson, president of the alliance said in a news release.

Glenn Boyet, senior director of public relations for PMA, said in an email that Congress considered rejected user fees in the Food Safety Modernization Act. “PMA opposes (user fees) and Congress is very unlikely to revisit the issue as it would require statutory change,” Boyet said.

In other budget items, the White House request includes an increase of $17 million above the 2012 budget to support the Centers for Disease Control and Preventions’ role in implementing the Food Safety Modernization Act. The funds will be used to improve detection and tracking of foodborne illnesses, according to the budget document. The CDC also will support five integrated Food Safety Centers of Excellence throughout the country at state health departments, according to a news release.



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