FDA Funding Shortfall May Hamper FSMA Enforcement
By Melissa Lind, contributing writer
The Food Safety Modernization Act is the largest change to U.S. food-safety laws since the Food, Drug, and Cosmetic Act was passed in 1938. Implementation is estimated to have a total cost of $580 million, but less than half of that has been provided. Could the shortfall prevent the agency from enforcing new regulations?
The U.S. experiences an estimated 48 million cases of food-borne illness each year with nearly 130,000 hospitalizations and about 3,000 deaths. The Department of Agriculture, also involved in food safety control, estimates that treatment for these illnesses and resulting loss of income may cost the U.S. economy over $15 billion each year. Representative and member of the appropriations subcommittee Rosa DeLauro (D-CT) has stated that continuing to shortchange the FDA “will continue to cost us billions of dollars a year to deal with food-borne illnesses.” DeLauro helped to write a portion of the Act and has said that the White House and the Department of Health and Human Services are partially responsible for the shortfall due to attempts to impose user fees on food industry participants.
In the current fiscal year, only $27.5 million was authorized for FSMA, and though $109.5 million has been requested for FY2016, the current economic environment puts a significant damper on hopes that the request will be authorized. Even if the current request is honored, this total represents only about half of the total cost that was projected when FSMA was signed in 2011. With the FDA’s total budget request of $4.9 billion — representing an increase of 9 percent or $425 million over last year’s budget — Representative and Chair of the appropriations subcommittee Harold Rogers (R-KY), who oversees the agency’s funding, has stated the FSMA funding request will be “tough to swallow.”
User fees are used by the FDA in other sectors, such as the pharmaceutical industry, and were included as part of the last five budget requests. If granted, user fees would have covered about half of projected FSMA costs, but Congress has refused to implement the fees.
FSMA has put most of the burden of ensuring food safety squarely on the food industry. Previously, the FDA relied on inspectors to identify and address concerns with the food industry, but the new regulations have required the industry to make moves to prevent food-contamination occurrences. FSMA has also given the power to issue recalls directly to the FDA, which had not been allowed in the past. Though the agency has been able to issue new regulations, funding shortfalls make it difficult to modernize practices and retrain the field of inspectors and staff. The FDA may also face difficulties in providing assistance and guidance to state agencies that are set to overtake some of the new inspections that will be required.
FSMA also calls for additional supervision of food imports — a crucial element, as much more of the domestic food supply comes from outside of the U.S. The foreign food market presents new challenges and the FDA has already fallen far behind its inspection schedule with only 1,323 inspections completed in 2014, rather than the 4,800 mandated by Congress. Despite current challenges, some food safety groups, such as the Center for Food Safety, remain optimistic that Congress will eventually appropriate the money required to enforce the sweeping food safety regulatory changes.