FDA Cautious in Rolling Out Food Safety Moderization Act Provisions

Slow but steady. That’s the message from the FDA as it navigates bureaucratic, budgetary, and political mazes to implement the Food Safety Modernization Act. The FDA missed its Jan. 4 deadline for issuing draft regulations for several major provisions, including produce safety and hazard analysis and preventive control measures for processors of food and animal feed.

The proposed rules for fresh produce and preventive controls, which reportedly number in the hundreds of pages, have been held up under review by the White House Office of Management and Budget. They were expected during the first quarter of 2012 but, as of this issue of Food Quality, had not yet been released. When the rules are finally published in the Federal Register, a 90-day public comment period will follow, allowing growers and processors to submit feedback. The FDA will evaluate the comments and issue final regulations sometime thereafter.

“Big change is coming in the U.S. food safety system, but it will not happen overnight,” said Michael R. Taylor, FDA deputy commissioner for foods. “This process takes time, but it is crucial to ensuring we get the rules right based on input from all of our stakeholders,” he told a conference in Beijing late last year.

Michael R. Taylor

Michael R. Taylor

FSMA is the first major change in food safety legislation in more than 70 years. It gives the FDA responsibility 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. In addition to establishing minimum produce safety standards and requiring food growers and facilities to implement hazard prevention control plans, the FDA can order mandatory recalls of suspected foods, conduct a broad range of food facility inspections, establish a comprehensive product tracing system, and hold imported food products to the same safety standards as domestic products. The agency is also developing rules for establishing foreign supplier verification and accredited third-party certification.

“Some in the industry may think the new rules will be onerous, others may think they are not aggressive enough,” said Craig Henry, a director at Deloitte & Touche LLP. “Most large companies are already reviewing their records and processes to determine whether they will be amenable to more detailed regulations if they have higher-risk products,” Henry told Food Quality.

Budget Headaches

Federal budgetary challenges will further complicate implementation. The FDA needs $1.4 billion from 2011-2015 to fulfill FSMA requirements, according to the Congressional Budget Office. For the current fiscal year, which began Oct. 1, 2011, Congress gave the FDA $39 million to start implementing FSMA. For fiscal year 2013, beginning Oct. 1, the Obama administration is seeking $253 million for FSMA, with all but $28 million, or nearly 90%, coming from industry user fees for inspections and registrations. Of this, $220 million would come from food inspection and facility fees, and $5 million from food contact notification user fees. Details have not been worked out.

“It’s not inappropriate that industry help share and support these critical services,” FDA Commissioner Margaret A. Hamburg told reporters in February. “These are austere budget times, and the FDA budget request reflects this reality.”

Many industry representatives do not share her perspective. A coalition of more than 30 food groups in January urged the Obama administration not to impose any new fees to implement the FSMA. “We believe imposing new fees on food makers is the wrong option for funding food safety programs,” wrote the coalition, which included the American Frozen Foods Institute, the American Meat Institute, the United Fresh Produce Association, and the Juice Products Association. Overall, 98% of the FDA’s requested $654 million budget increase for fiscal 2013 comes from user fees from regulated industries.

About Ted Agres

Ted Agres is an award-winning writer who 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. Reach him at tedagres@yahoo.com.

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