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Hamburg Tells Senate Budget Committee FSMA Funding Needed to Fill ‘Significant’ Gaps

Many questions directed at outgoing Food and Drug Administration (FDA) Commissioner Margaret Hamburg during a Senate budget hearing on Thursday concerned funding for the Food Safety Modernization Act (FSMA) and details of the law’s rules.

The agency’s budget proposal for fiscal year 2016 asks for a total of $1.5 billion for food safety and nutrition, including a $109.5-million increase largely dedicated to FSMA implementation.

FDAmoney_406“Significant funding gaps still loom,” Hamburg said. “I cannot overstate the importance of our request to fund continued implementation of FSMA. A shortfall in funding will undermine Congress’ intent to transform our country’s food safety program and will harm all stakeholders. If we invest now, I’m confident we can fulfill FSMA’s vision of a modern, prevention-oriented system.”

The funding is important for modernizing inspections and retraining staff, providing guidance and technical assistance, working with states, and raising the level of oversight overseas, Hamburg said.

Sen. Jon Tester (D-MT) voiced concern about inspectors misinterpreting food regulation.

“One of the reasons I want to give you money is to make sure those inspectors are trained,” he said. “I want you to be able to do your job, but I also want to be able to do it in a way that meets the needs of the consumer and meets the needs of the business community.”

The other senator from Montana, Republican Steve Daines, said that he had been hearing concerns from Montana farmers and ranchers about a proposal in the budget request to consolidate the Department of Agriculture’s Food Safety and Inspection Service (FSIS) and FDA’s food-safety components into a new agency within the Department of Health and Human Services.

“They are concerned that an inevitable result of such a significant consolidation could negatively impact FSMA and result in inspection delays and some logistical challenges,” Daines said. “Why are you removing the USDA from the food inspection process?”

While his question skipped a few steps since no single food safety agency has yet been agreed to, Hamburg responded that she believes the proposal is “laying out the concept of trying to find more integrated ways of addressing a very important problem of food safety.”

“As we implement FSMA, we are trying to do it in coordination with USDA and other important players at the state and the federal level, and we think that it is a process that’s working very well,” she added.

Sen. Jeff Merkley (D-OR) wanted to talk about how FSMA deals with irrigation water, particularly as it affects onion growers in his state.

There has not been a single known case of E. coli contaminating an onion bulb product in this country, he said, and Hamburg replied that this was correct to the best of her knowledge. The onions lie fallow long enough that any possible E. coli there dies, Merkley said, so his constituents appreciated that FDA revised its produce rule to cut back a “substantial” burden on them that holds no public health benefits.

“It is still anticipated that they are still going to be asked to test their irrigation water every week and report,” he said. “If you know in advance your irrigation water is never going to meet that test, and you know in advance that you are going to be exempted from having to meet that test, maybe that’s also an unnecessary burden on the industry and maybe there’s another way to approach it.”

Merkley asked that the agency consider this issue in finalizing the FSMA rule.

Tester was also interested to know exactly how much of FDA’s budget authority would go toward research conducted by the Center for Food Safety and Nutrition.

Research into what “will kill you and what will keep you healthy” is “a very critical component to the FDA’s job,” he said. “I don’t know that you can tell somebody that they can or can’t put an ingredient into food or into cosmetics, or into medicine unless you know what it’s going to do.”

Tester’s press office told Food Safety News that there was no single issue that prompted the question, but that the senator has received general feedback from constituents about wanting consistency in FDA regulation.

Toward the end of her comments, Hamburg said she didn’t think that “while our budget authority request is bigger than you’ve seen before, that it is excessive in terms of what’s needed.”

When FSMA was approved in 2010, the Congressional Budget Office estimated that FDA would need an increase of more than $580 million to fund the expanded food safety activities.

Hamburg said that if Congress grants FDA the $109.5-million increase requested, the funding the agency has received over the years for FSMA will have reached about half of that number.

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