F.S.M.A. at a crossroads

by Jay Sjerven
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The Food and Drug Administration in a report submitted to Congress on May 23 asserted the agency required $400 million to $450 million in additional funding each year through fiscal year 2017 to fully implement the historic F.D.A. Food Safety Modernization Act. The act was passed with strong bipartisan support in 2010 and signed into law on Jan. 4, 2011. It mandated an overhaul of U.S. food safety programs and a shift toward preventing food safety problems from occurring instead of just reacting to them after they occur.

The report titled “Building domestic capacity to implement the F.D.A. Food Safety Modernization Act (F.S.M.A)” documented the progress the F.D.A. has made during the past two years in building the foundation upon which further progress in F.S.M.A. implementation may be based, and it identified additional programs and practices needed to promote the safety of the U.S. food supply. The report emphasized Congress knew when it passed the act increased funding would be needed to ensure its success and that the increased funding was needed now.

Michael R. Taylor, the F.D.A.’s deputy commissioner for foods and veterinary medicine, said, “The promise of F.S.M.A. to modernize the food safety system in the United States and to significantly reduce the burden of foodborne illness cannot be realized without additional funding. Rules can be written, but they can’t be implemented effectively and efficiently with current funding.”

Mr. Taylor said investments were needed to provide guidance and technical assistance to industry, train federal and state inspectors, modernize and strengthen the inspection program to ensure quality and consistency nationwide, and implement a new import oversight system that will ensure the safety of imported food and create a level playing field for the U.S. food industry.

“The Congressional Budget Office estimated that the first five years of F.S.M.A. implementation would require an increase of $583 million over F.D.A.’s 2010 base budget,” Mr. Taylor said. “In the fiscal year 2011 and 2012 F.D.A. budgets, Congress added a total of $100 million to the base budget. We estimate that F.D.A. will need an additional $400 million to $450 million in funds added to its fiscal year 2012 base to make F.S.M.A. a fully successful initiative.”

The report asserted if the F.D.A. does not have sufficient resources to modernize and reform food safety, the agency will be unable to meet the expectations of Congress, the food industry and the public, and the United States will not move from a “chase problems after they occur” system to one based on good science and prevention of problems before they happen.

The F.D.A., with a headquarters staff of about 900 and a field staff of 2,600 composed of inspectors and other compliance staff, is expected to oversee 80% of the U.S. food supply, including most food imports; a $1.1 trillion food processing industry; more than 100,000 domestic food manufacturing facilities and an even larger number of foreign facilities; more than 150,000 fresh produce growers, and 10 million annual shipments of imported food.

The report noted for most of the F.D.A.’s history, its food program accounted for almost half of the agency’s budget, reflecting the size of the food industry and the diversity of food products the agency was charged with regulating. In recent years, the report added, that percentage of the F.D.A. budget allocated to food programs steadily declined.

The F.D.A.’s food program accounts for only 23% of the agency’s budget, including the increases of $324 million in appropriations for the F.D.A. Congress added in fiscal years 2008, 2009, and 2010, the report said. Additional appropriations increases targeted specifically for food safety in fiscal year 2011 and 2012 allowed the food program to approach its earlier resource levels. (The fiscal year 2013 Continuing Resolution provided the F.D.A. with $40 million in “one-time” funding for food safety that will help offset the effects of sequestration, but only for that year).

“Thus, while the budget provided increases in recent years, they had the effect of only allowing F.D.A.’s food program to begin a return to staffing levels of earlier years,” the report noted. “Meanwhile, various metrics of F.D.A. success in the food safety arena during this time period and prior remained substantially degraded or unimproved.”

In recent years food import inspection rates were below 2%, the F.D.A. said, meaning most imported foods entered the United States with no physical inspection at the border. Inspection rates of foreign food facilities were consistently below 100 per year. Instances of foodborne disease outbreaks climbed since the 1990s involving a range of commodities with some of the outbreaks caused by pathogens new to science and about which little was known. The economic costs of foodborne disease outbreaks to consumers, farmers and food processors were estimated at more than $100 billion per year.

“Against this background of fluctuating and overstretched resources, F.S.M.A. places broad new demands on F.D.A. to build and implement a modern, new food safety system that includes sweeping overhaul of the regulatory framework; new inspection frequency mandates; enhancement of state and local capacity; and the construction of a new import food safety system commensurate with the demands of today’s global food system,” the report asserted. “F.S.M.A. cannot be fully implemented in a timely manner without additional resources.”

When taking into account funds provided in fiscal year 2013, and new resources, including new user fees proposed in President Obama’s fiscal 2014 budget, well more than half of the additional funds needed for implementing F.S.M.A. would be available, the F.D.A. said.

President Obama’s fiscal 2014 budget requested authority for the F.D.A. to generate user fee revenue for food safety in the amount of $225 million, the report said. Indeed, 94% of the increase in spending on food safety the president proposed would be accounted for by new user fees, and the report reviewed models of how such fees might be collected. But heretofore, user fees have not provided significant resources for the food safety program, and it was suggested by many supporting a stronger food program that the principal source of required additional funding should come through the appropriations process.

“The latest F.D.A. report to Congress on F.S.M.A. provides further evidence of the disconnect in Congress when it comes to the F.D.A.,” said Steven Grossman, deputy executive director of the Alliance for a Stronger F.D.A. “The F.S.M.A. is one of several important, public health laws passed by Congress in the last few years, reflecting vital national priorities that F.D.A. must implement. Congress must now step up and provide F.D.A. the money to get the job done.”
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