Bumpy Path to Food Safety: The Implementation of FSMA

2012 promises to be a pivotal year for improving the security and safety of the U.S. food supply. By June, the FDA plans to have issued and finalized the regulations by which it will exercise the broad new enforcement powers granted by the Food Safety Modernization Act (PL 111-353), the first major change in food safety legislation in more than seven decades.

Under FSMA, enacted in January 2011, the FDA is responsible for mitigating food safety problems by using science- and risk-based approaches to oversee about 80% of the nation’s domestic and imported food supplies. The plan includes establishing minimum produce safety standards, exercising the authority to order mandatory recalls of suspected food products, conducting a broad range of food facility inspections, establishing a comprehensive product tracing system, holding imported food products to the same safety standards as domestic products, and requiring food growers and facilities to develop and implement hazard prevention control plans.

However, the path to implementing these responsibilities is likely to be bumpy because the FDA lacks the scientific expertise and faces ongoing budgetary challenges. The agency needs $1.4 billion from 2011-2015 to fulfill FSMA requirements. For fiscal year 2012, which began Oct. 1, Congress increased the FDA’s budget by $50 million, $39 million of which is to begin implementing FSMA in January. This is a “small but significant increase that will enable us to work in some critical areas both in food safety and on drug and medical product issues,” said FDA Commissioner Margaret Hamburg at a forum in November.

But budget challenges are far from over. The failure of the congressional Joint Select Committee on Deficit Reduction, known as the Super Committee, to identify at least $1.2 trillion in discretionary spending cuts over 10 years means that automatic across-the-board spending reductions, split between defense and discretionary domestic spending, will kick in starting in 2013. Unless Congess and President Obama agree on an alternative savings approach, the FDA is facing an automatic cut of $150 million to $250 million.

“FDA would be unable to implement recent legislation to improve the food safety system,” wrote Rep. Norm Dicks, D-Wash., ranking Democratic member of the House Appropriations Committee, in a letter to the Super Committee in October.

Even with full funding, the FDA would be hard-pressed to accomplish all its responsibilities. For instance, FSMA requires the FDA to inspect at least 600 foreign food facilities within the next year and double that number each year for the next five. “While the goal may be attainable in the first year, it would be impossible for FDA to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the FDA acknowledged in a June report, “Pathway to Global Product Safety and Quality.”

Further complicating matters, the FDA faces longstanding deficiencies in conducting science-based assessments. According to a November 2007 report by the FDA’s Science Board, the nation’s food supply is at risk because of chronic deficiencies in the FDA’s scientific organizational structure, workforce, and IT capabilities. Sustained additional resources are needed to correct these shortcomings, the board concluded—an unlikely scenario given present fiscal pressures.

But it’s not only the FDA’s budget that’s problematic. The FDA relies on more than 400 state agencies nationwide to conduct field inspections and detect food security and safety problems. Due to state budget cutbacks, there are 44,000 fewer state and local health department employees today than there were a few years ago.

Hazard Prevention, Control

Under FSMA, food manufacturing facilities and importers must take steps to guarantee the security and safety of their products. For producers, these requirements include submitting written food safety plans modeled after the HACCP system methodology, used by the FDA in the past to address the safety of seafood, juices, and shell eggs (see “HACCP Principles: Benchmark for Food Safety,” Food Quality, February/March 2010).

About Ted Agres

Ted Agres covers food safety regulatory and legislative issues from the nation’s capital. He has 40 years of experience in reporting on issues such as health policy, medical technology, and pharmaceutical development. He holds an MBA from Johns Hopkins University and a bachelor’s degree from the University of Chicago. He enjoys playing the piano, amateur radio, and paintball. He lives in Laurel, MD.

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