As 2015 unfolds, federal, state, and local governments will be ramping up their oversight of food growers, producers, and processors in the drive to improve the safety and security of the nation’s food supply system. But with financial and other resources lagging or remaining modest at best, this task promises to become more challenging as the global supply chain expands and imports from China and other questionable countries increase.
All this will continue to put pressure on the private sector to take responsibility for food safety. By the latter half of this year, the FDA will publish final regulations to implement five major provisions of the Food Safety and Modernization Act (FSMA). These include final rules for preventive controls for human food and preventive controls for animal food by the end of August, and final rules for produce safety, the Foreign Supplier Verification Program, and third-party accreditation by the end of October. The FDA in September 2014 had issued proposed minor revisions to the first four of these rules, for example, clarifying definitions of small and very small businesses and outlining activities that would re-categorize a traditional farm into a food facility subject to FDA registration and inspection.
Because many of the proposed new changes had been triggered by earlier comments from industry, the final rules are likely to be very similar the second time around. “We don’t expect to see much change in the final rules, particularly as the re-proposals filled in some of the expected gaps in the preventive control rules around environmental monitoring, supply chain controls, and product testing,” says David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods.
“The big challenge in 2015 will be FDA’s obvious lack of resources,” Dr. Acheson says. “What will get expensive for FDA is building the FSMA training programs, the education strategies, and the outreach that the agency needs to do with different countries and industries. Unfortunately those resources will be lacking,” Dr. Acheson tells Food Quality & Safety magazine. “Many small- and medium-sized food companies will be totally clueless about what they need do to comply with FSMA,” he adds. But they will have two to three years to comply with the regulations and thus have some breathing room. Big food companies, on the other hand, have only one year to comply after the final rules are published but because most of them have been preparing, they should be well positioned.
Budget Status Quo
The current fiscal year ends Sept. 30, 2015 and thanks to last December’s enactment of the Consolidated and Further Continuing Appropriations Act, 2015 (HR 83), the Fiscal Year 2015 budgets for FDA, USDA, CDC, and other food-related federal agencies are locked into place. Under the $1.1-trillion “cromnibus” (for “continuing resolution” and “omnibus”) spending bill, FDA’s budget rises to $4.44 billion, a $96.7 million (2.2 percent) increase over Fiscal Year 2014. Of this total, about $2.59 billion comes from public funding, which is $37 million (1.5 percent) more than the agency received last year and $4 million more than the White House had requested. The $1.85 billion balance comes from new and existing industry user fees, imposed mostly on manufacturers of prescription and generic drugs, medical devices, and tobacco products.
FDA’s Center for Food Safety and Applied Nutrition gets $903 million and the Center for Veterinary Medicine receives $147 million. Food safety activities within these and other FDA centers and offices increase by only $27.5 million over the 2014 funding levels (the White House had originally requested an increase of $263 million, the lion’s share of which would have come from user fees). Nevertheless, any increase is vital because the agency estimates it will need $300 million over the next two to three years to fully implement FSMA. Much of this would be used to hire and train more inspectors, improve the agency’s aging IT infrastructure, and partner with and provide cooperative assistance to federal, state, and local government agencies to implement many FSMA regulations.