The Hagstrom Report

Agriculture News As It Happens


Hamburg: Slow going on FDA user fees for food companies

Margaret Hamburg, FDA

Margaret Hamburg, FDA
Food and Drug Administration Commissioner Margaret Hamburg signaled today the FDA has not made much progress on writing a proposal for user fees on food companies, but said that if the fees are established they will apply to foreign as well as domestic companies.

Senate Agriculture Appropriations Subcommittee Chairman Herb Kohl, D-Wis., took a dim view of the Obama administration’s proposed budget for fiscal year 2013, which included an increase of only $15 million, bringing total funding to approximately $2.5 billion.

Kohl noted that since 2008, Congress has provided the FDA with budget increases totaling nearly 30 percent and that the agency is expected to implement the new Food Safety Modernization Act but that this year “the only additional funds for food safety are requested in the form of a new user fee.”

Sen. Herb Kohl, D-Wis.

Sen. Herb Kohl, D-Wis.
“My understanding is that negotiations on this user fee are in their earliest stages, and it is highly unlikely to be passed this year,” Kohl said. “This means essentially that food safety activities are flat-funded in this budget, when we all know that the FDA’s workload in this area has certainly not leveled off.”

Hamburg told the committee that she has begun talking to the industry about the proposed $220 million in fees, but “These are difficult, challenging economic times.
We also recognize that.”

Hamburg also said that the agency is “working with other potential partners as we implement the act,” but did not name them.

“We will continue to make progress but we will have to prioritize,” she said, noting that this means “we will not be able to put in place systems that prevent disease and economic burdens. The process may take more time than we would like. We are going to have to make very difficult choices, we won’t be able to do everything.”

As to priorities, Hamburg said the agency needs “to respond to the challenge of globalization” because food is imported from 200 countries. She also said the FDA will work with the state health, regulatory and agriculture agencies.

“We had hoped to have resources to give to states, but that will be less possible,” she said.

Sen. Roy Blunt, R-Mo.

Sen. Roy Blunt, R-Mo.
Under questioning from Senate Agriculture Appropriations Subcommittee ranking member Roy Blunt, R-Mo., Hamburg said that companies in China and other foreign countries would have to pay the fees if they are imposed.

Blunt and Sen. Jerry Moran, R-Kan., quizzed Hamburg about a rule that would implement a provision in the healthcare bill requiring labeling of menus in chain restaurants for caloric content and nutritional information. Both said they had received many questions from constituents about the proposed rule, particularly about whether it will cover food services in grocery stores.

Blunt urged Hamburg to be as flexible as possible in implementing the rule, particularly in facilities that customers don’t enter.

Hamburg said she could not discuss details of the rule because it is already in process, but added that in establishments such as Domino’s Pizza, which receives customer orders by phone, it would make more sense to require calorie information on the Internet and on fliers rather than on menu boards.

Sen. Jerry Moran, R-Kan.

Sen. Jerry Moran, R-Kan.
Moran urged Hamburg to exempt grocery stores from the program, but Hamburg noted that the law said the program should cover restaurants and “restaurant-like” facilities.

Moran said that as co-chair of the Senate Hunger Caucus, he is worried that if grocery stores are required to provide labeling on salad bars they may decide that serving salads and fruit and vegetables is too much work.

Noting that there is concern about food deserts — areas without proper grocery stores — Moran said the burdens FDA places on the stores “may reduce access to quality food.”

After questioning Hamburg about her role in regulating drugs and medical devices, Sen. Sherrod Brown, D-Ohio, said, “I respect you. I’ve watched your career. I am not convinced yet you are aggressive enough.”