FDA needs increased funding to implement FSMA

By A. G. Kawamura

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WASHINGTON, April 4, 2014 - The FDA needs increased funding in FY 2015 to completely implement rules for the Food Safety Modernization Act (FSMA), FDA Administrator Margaret Hamburg told a Senate panel Thursday.

Hamburg said current FY 2014 funding levels would allow the agency to issue the FSMA regulations, but “without increased funding it will be impossible to implement the rules.”

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Hamburg told a Senate Appropriations subcommittee that the overall FDA budget request includes a “modest” 8 percent increase. The administration is requesting $4.74 billion for the total program level, which is $358 million above the FY 2014 enacted level. Of the total funding, $2.58 billion is in budget authority and $2.16 billion is in user fees. The FY 2015 increase consists of $23 million in budget authority and $335 million in user fees.

Hamburg testified that the growth in user fee funding stems from several new programs, along with increased collection authority for many of FDA's existing programs.

“We are mindful of the larger pressures on the federal budget, and have focused our request on the most urgent needs for FY 2015,” Hamburg said.

The budget proposal includes $1.48 billion for food safety, which is $263 million above the FY 2014 enacted level. Within this amount, FDA is seeking to invest $24 million in budget authority to further advance recent gains in food safety modernization through implementation of FSMA. A majority of the increase would come from new user fees, including $60 million in Food Facility Registration and Inspection fees, and $169 million in Food Import fees.

Hamburg told senators that, with an increase in budget authority, FDA will be able to develop guidance and provide technical assistance for industry, provide technical support for FDA inspectors, and begin to implement training for FDA and state inspectors.

Further, Hamburg testified that if the proposed user fee revenue is authorized and appropriated, the agency will be able to undertake a wider array of activities needed to fulfill the goals of FSMA, including retraining of the federal and state inspection force, training and technical assistance for small and mid-size growers and processors, and building a modern import oversight system mandated by FSMA.

She said the implementation of the broad preventive controls framework mandated in FSMA will reduce instances of foodborne illness seen recently as a result of E. coli contamination of pre-packaged salads, salmonella and listeria contamination of cheese products, and listeria contamination in cantaloupe. This would minimize market disruptions and economic costs inflicted by illness outbreaks and significant contamination incidents, Hamburg said.

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