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From: Food Quality & Safety magazine, April/May 2012

FDA Cautious in Rolling Out Food Safety Moderization Act Provisions

by Ted Agres

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.

Congress has twice rejected FDA user fee proposals, making it uncertain whether the agency will receive significant increases for food safety in the coming year. “This is not a user fee; this is an existence fee,” Rep. Tom Latham, R, Iowa, lectured Hamburg at a House appropriations subcommittee hearing in late February. “Why don’t you just ask for money rather than do something you know is not going to happen?” he asked. Hamburg replied: “Well, if you want to give us the appropriations, we’d be glad to have that.”

The FDA budget request comes on the heels of other austerity measures. In January, the USDA announced it would close 259 offices, labs, and other facilities to save $60 million in the current $145 billion budget. Included were closures of five of the 15 FSIS offices, responsible for meat, poultry, and egg safety, along with 10 agricultural research stations, and the cutting back or ending of data collection and reporting on pesticide use on fruits, vegetables, and livestock pens by the National Agricultural Statistics Service.

The USDA’s fiscal 2013 budget request eliminates the Agricultural Marketing Service’s microbiological data and pesticide recordkeeping programs, for $7 million in savings. While these and earlier cutbacks raised alarms among some consumer groups, Elisabeth Hagen, MD, USDA undersecretary for food safety, promised “there will be no reduction in inspection presence at slaughter and processing facilities and no risk for consumers.” Agriculture Secretary Tom Vilsack said the cost-cutting measures would allow the USDA to invest in other programs. “Over the long haul, we believe farmers and ranchers across the country will be better served by the choices we made,” he said in January.

“Some in the food industry may see such cuts as a good thing, reducing federal and state ability to conduct inspections and thus decreasing the chance of finding problems in a plant,” commented David Acheson, MD, former FDA associate commissioner of foods. “However, when an outbreak starts, the earlier a potential foodborne illness can be found, the more likely it will be able to be contained, and the less potential impact it will have on the food company’s brand and litigation risk,” Dr. Acheson wrote in January on the website of Leavitt Partners, where he advises food clients.

As the FDA implements FSMA, manufacturers should adopt policies and procedures to comply. “Challenges to implementing food safety testing can range from not having a reliable record-keeping system in place and relying on traditional (slower) microbial testing methods to not properly preparing for potential contaminations and the steps you’d take if a contamination event does occur,” said Scott Scdoris, director of food and beverage at Celsis Rapid Detection.

Progress and Pilots

Despite missing deadlines for key regulations, the FDA has met other key FSMA milestones. In its one-year progress report in January, the agency said it had met the mandate for inspecting 600 foreign facilities, issuing guidance on seafood safety hazards, and inspecting more than 20,000 domestic food facilities along with state partners. “At this rate, the agency will most assuredly meet the domestic food inspection frequency mandates,” the FDA said.

In February, the FDA issued an interim final rule that expands its access to records beyond those relating to specific suspect food articles if the agency reasonably believes that other products are likely to be similarly affected. The rule brings agency regulations in line with FSMA. In March, the FDA updated information on how it defines high-risk food facilities, which are subject to earlier and more frequent inspections than non-high-risk facilities under FSMA. According to the FDA, high-risk facilities will be determined primarily by the known safety risks of the food being prepared or processed plus the facility’s compliance history, including food recalls, outbreaks, and safety violations. High-risk facilities must be inspected at least once during the first five years following FSMA enactment and then at least every three years thereafter, compared to seven and five years, respectively, for non-high-risk facilities.

The FDA has also launched pilot projects to explore tracking and tracing. In conjunction with the Institute of Food Technologists, one pilot seeks to demonstrate tracking and tracing of processed food and key ingredients; another deals with selected fresh fruits and/or vegetables. Both pilots seek to identify and evaluate data useful for tracing in cases of foodborne illnesses, establish how to connect points along the supply chain from farms to restaurants and grocery stores, and determine how quickly data can be made available to the FDA. The FDA will use the results when drafting record-keeping regulations for tracing high-risk foods.

Under the FSMA, manufacturing facilities and importers must take steps to guarantee the security and safety of their products. For producers, this includes 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.

To facilitate this goal, the FDA contracted with the Illinois Institute of Technology’s Institute for Food Safety and Health to develop training curricula and supply technical and scientific guidance, especially for small- to midsize companies. The one-year, $1 million Food Safety Preventive Controls Alliance will develop standardized hazard analysis and preventive controls training tools, develop a distance-learning program, and create a technical assistance network for companies in the human and animal food industries.

Agres is based in Laurel, Md. Reach him at



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