Dr. Margaret Hamburg, who retired as FDA Commissioner late last month, discussed the agency’s Food Safety Modernization Act (FSMA) budget in her final appearance before a House Appropriations Committee hearing on Capitol Hill, March 4.
Mindful of pressures on the federal budget, the administration focused its budget request for fiscal year 2016 on “the most urgent needs,” she told the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.
The agency’s budget request for FY 2016 seeks an increase of $301 million above the enacted level for FY 2015 for a total of $1.5 billion for food safety. This total includes a $109.5 million increase in budget authority and a $191.8 million increase in user fees. Almost all of the proposed budget authority increase will be dedicated to FSMA implementation, she said.
“With FDA under court order to issue many key FSMA regulations in 2015, FY 2016 is an absolutely crucial year for the investments needed to ensure timely, effective, and non-disruptive implementation,” she said.
As it implements FSMA, the agency will be taking a collaborative approach to inspection and enforcement, focusing on food safety outcomes and encouraging voluntary compliance. The largest single portion of the budget authority will go to states to better integrate, coordinate, and leverage federal and state food safety efforts, Hamburg said.
The agency’s FSMA philosophy of “educate before and while we regulate” calls for investing in guidance, education, and technical assistance for industry to support compliance efforts, especially by smaller scale farmers and manufacturers, she said.
Finally, she said, FDA must make investments in FY 2016 to implement the new import safety system, including the Foreign Supplier Verification Program (FSVP).
“The investments FDA can make with the FY 2016 budget authority request will enable the agency to maintain momentum toward timely and successful implementation of FSMA. Without these investments, implementation will be disrupted and delayed,” she said.
The FDA Center for Food Safety and Applied Nutrition is the only product center that does not receive a substantial portion of its budget from user fees charged to the regulated industries. Of the $4.9 billion requested by the Administration for FDA in 2016, $2.2 billion (45%) comes from user fees, yet the food safety program receives only 1% of its budget from user fees. In early House versions of the FSMA bills, user fees of $1,000 per registered facility were included. This was reduced to $500 per facility in subsequent versions, and eliminated altogether in the final version. With nearly 200,000 registered food facilities, user fees could have generated $200 million per year, increasing the food safety budget by 16%.
I believe the FDA food safety program will never be able to fulfill the promise of FSMA as long as its budget is limited to federal appropriations. Cost recovery user fees would go a long way toward closing the gap, but that opportunity was lost when registration fees were cut from FSMA.
With the first batch of FSMA-implementing regulations on the way this year, it would be prudent for food companies to look ahead and consider budgets for compliance with the new FSMA regulations.