The U.S. Food and Drug Administration announced that it is requesting an additional $109.5 million for the implementation of the FDA Food Safety Modernization Act (FSMA) as part of President Obama’s FY 2016 budget request, released to Congress Monday.
FSMA, signed into law by President Obama in 2011, required sweeping changes to the nation’s food safety program, including multiple new regulations and a substantial strengthening of the Agency’s food inspection capabilities. FSMA fundamentally changes FDA’s approach to food safety oversight, from primarily reacting to problems to preventing them in the first place.
Since FSMA was enacted, FDA has carried out extensive work to implement the law by publishing key FSMA proposed rules that would provide needed food safety protections for the American public, while at the same time making the proposed rules as flexible as possible and workable across the great diversity of the nation’s food system. These proposed rules were informed by current industry practices and by conducting extensive outreach and dialogue across the country and overseas with farmers, manufacturers, commercial food handlers, consumers, and government partners.
FDA is under court-ordered deadlines to issue key final FSMA rules in the summer and fall of 2015, and in the spring of 2016. FDA said getting the final rules out is a massive task and a significant ramping up is needed in 2016.
The agency said fiscal years 2015 and 2016 are crucial years for doing the upfront work that is needed to implement FSMA, domestically and for imports. “FDA must be equipped to lay the foundation now to ensure smooth and effective implementation in late 2016 and 2017,” the agency said. “Without immediate investment to prepare for the smooth and sound implementation of the key FSMA rules, there is a risk of uneven and delayed implementation to the detriment of public health and the food industry.”
In the current fiscal year, the agency received an additional $27.5 million in budget authority, and the President has proposed additional resources including an increase of $109.5 million of new budget authority in his FY 2016 Budget Request. These funds continue to close the gap between the resources FDA has received and those required for timely, effective FSMA implementation, FDA said.
With a total of $1.3 billion in budget authority, an increase of $109.5 million, requested in the President’s Budget, FDA will continue improvements that began with FY 2015 funds.
Specifically asked for $25 million for inspection modernization and training. For example, FDA will deploy more specialized inspectors, supported by technical experts, to assess the soundness and performance of a facility’s overall food safety system and will use data to guide risk-based inspection priority, frequency, depth, and approach. FDA will also focus on ensuring consistency among inspections conducted by FDA or the states on behalf of FDA.
FDA requested an additional $32 million for a national integrated food safety system to assist in the training of 1,000 state inspectors and equip states with real-time information sharing capacity with FDA and other states, state laboratory accreditation and inspector certification programs.
The request also sought $25.5 million for developing new import safety systems. The Foreign Supplier Verification program mandated by FSMA will require importers to implement supplier vertification plans to ensure food produced overseas meets U.S. food safety standards. The agency said the additional money is needed to train the 400 current FDA investigative and compliance personnel and the addition of new staff (including 50 in 2016) with the audit skills needed to assess importer safety plans.
An additional $11.5 million was required for education and technical assistance, $4 million for technical staffing and guidance development and $4.5 million for risk analytics and evaluation which will fund tools for ranking risks, prioritizing program activities based on opportunities to reduce risk and linking risk-based priorities more clearly with budget formulation and execution.