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FDA Granted One-Time FSMA Funds in Final Budget

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WASHINGTONThe fiscal budget signed on March 26 by President Obama authorizes the U.S. Food and Drug Administration (FDA) to spend roughly $40 million on one-time activities supporting implementation of the Food Safety and Modernization Act (FSMA).

The funds don't have to be spent in 2013 because they were authorized under a section that is distinct from the fiscal year budget that funds FDA through Sept. 30, 2013.

The 2-year-old Food Safety Modernization Act (FSMA) has been hailed as the most comprehensive food-safety law in generations. But the law places a significant onus on FDA to carry out and enforce its provisions.

Over the past several years, the agency has been appropriated an additional $100 million for implementation of FSMA, according to Shelly Burgess, an FDA spokeswoman. However, that's only a fraction of the $1.4 billion the Congressional Budget Office (CBO) estimated (in 2010) FSMA would cost between 2011 and 2015.

FDA could dip into other budgeted monies for FSMA beyond the roughly $40 million in one-time funds. But FDA representatives weren't immediately available today to disclose the total funds the agency intends to use in FY13 to implement the food-safety law.

Under the Consolidated and Further Continuing Appropriations Act, 2013, FDA's Center for Food Safety and Applied Nutrition (CFSAN) received $887.16 million in appropriations. The figure, however, excludes the impacts of the sequesterthe $85 billion in across-the-board budget cuts to government programsand a 2.5% rescission affecting FDA's budget authority, according to the Alliance for a Stronger FDA (a multi-stakeholder group that advocates for increased resources for FDA). The appropriations also include user fees that FDA collects from regulated companies.

Excluding user fees and taking the cuts into account, Steve Grossman with the Alliance for a Stronger FDA reckons CFSAN's FY13 actual budget is around $821 million.

Combined, CFSAN and the Center for Veterinary Medicine (CVM) received $1.004 billion in FY13 taxpayer appropriations, although only $931 million is available following the sequestration and the rescission, according to the Washington, D.C.-based alliance.

Grossman, the alliance's deputy executive director, noted the agency will have roughly $39 million available in one-time activities related to FSMA after the rescission. Assuming these funds are used in the current fiscal year, CFSAN and CVM will have roughly $34 million (3.4%) less to spend than in the previous fiscal year, the alliance stated in an analysis today.

During a call in January updating the media on FSMA, FDA Commissioner Margaret Hamburg acknowledged "resources remain an ongoing concern." Inspections of food facilities constitute the largest expense under the law, according to David Plunkett, a senior staff attorney with the Center for Science in the Public Interest (CSPI).

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