FDA Cautious in Rolling Out Food Safety Moderization Act Provisions

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.