Budget Concerns Rear Head as FDA Implements FSMA

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By Josh Long

WASHINGTON — the U.S. Food and Drug Administration (FDA) faces a bevy of obligations under the Food Safety Modernization Act (FSMA), raising a question that government officials clearly have pondered. Will the agency have sufficient resources to effectively carry out a two-year-old law designed to better protect the nation's food supply?

"FDA is generally underfunded especially if you ask those who are in the FDA-regulated industries," said Cara Welch, vice president of scientific & regulatory affairs with the Natural Products Association.

The health agency is operating in the current fiscal year (2013) with a budget that is roughly the same as in the previous year in spite of a request from the White House for about $253 million in additional food-related funds, including $220 million in so-called user fees that are distinguishable from taxpayer dollars, said Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, a multi-stakeholder advocacy group for increased resources for FDA. Grossman interpreted the request as a message to Congress on the amount of funding the Obama Administration thinks it truly needs for food safety programs and FSMA.

David Plunkett, a senior staff attorney with the Center for Science in the Public Interest, said FDA received approximately $866 million in FY2012 for food safety activities.

During a recent call updating the media on FSMA, FDA's top official Margaret Hamburg acknowledged "resources remain an ongoing concern."

FDA recently proposed rules crafted to make fruits and vegetables safer and decrease the risks that pathogens such as E. coli will taint other foods. When those rules take effect, the agency will need sufficient resources to ensure farmers and food facilities are complying with the requirements.

Shelly Burgess, an FDA spokeswoman, said the agency had been appropriated an additional $100 million over the past several years to implement FSMA.

"We are still working on the FY14 budget and the President's budget and will include any proposals we have for additional FSMA implementation," Burgess said. 

For FY2013, bills in the House and Senate had allocated $866 million and $867 million, respectively, in appropriations for FDA's food program, Plunkett said. Neither bill made it to the floor for a vote. A report accompanying the Senate bill referenced an increase of $12.5 million expressly for implementation of FSMA, he observed.

FDA currently is being funded in FY2013 under a continuing resolution. It has received .022 percent more (roughly $15 million) in appropriated funds over its entire 2012 budget of roughly $2.5 billion (excluding $1.3 billion in user fees), Grossman said.

Funding, however, could soon shrink substantially if a "sequestration" law cutting federal government programs takes effect. Automatic cuts to government programs are scheduled to occur on March 1, 2013 should Congress fail to enact a plan to reduce the deficit by more than $1 trillion over 10 years.  If the sequester occurs,  Grossman said the agency would lose about  $65 million in funding for food programs alone.

That result could undermine FDA's ability to effectively carry out a sweeping law whose obligations include increasing the number of domestic and foreign inspections of food facilities. In FY2011, FDA used $189.5 million in appropriations to inspect (including through an agreement with states) 19,073 domestic food facilities and 995 foreign food facilities, according to a 2012 annual report submitted to Congress over the summer.

The inspections aren't cheap. It cost FDA, on average, $21,100 to inspect a "high-risk" food facility in the U.S. and $24,800 to inspect a high-risk foreign facility, the agency disclosed in the report to Congress. Within one year of enactment, FDA was required to inspect 600 foreign facilities and double those inspections every year for the next five years.

"The biggest cost driver under FSMA is the inspection schedules, the inspection rates," Plunkett said. "It's not an impossible task but it's a big task …That's where the money will be spent."

Grossman agreed, but said inspections are just one component of the food safety regime at an agency that is responsible for protecting 80 percent of the nation's food supply.

"You need money for inspectors, you need money for rules, you need money for prevention, you need money … to convert to the" modern system that FSMA envisions, he said. "FSMA is a whole different approach to food safety: preventing problems before they occur and being more knowledgeable about how to focus on high-risk situations."

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