Although the FDA has not spelled out specific new priorities for this year, its budget for fiscal year 2010 is revealing. The agency’s $3.2 billion budget is 19 percent higher than its 2009 budget. It has two major initiatives: protecting America’s food supply and ensuring safer medical products. Below are the FDA’s programs relevant to those two areas.
Food supply initiatives
The $259.3 million food supply budget includes $94 million in new user fees to register food facilities, increase food inspections, issue food and feed export certifications and reinspect food facilities that fail to meet FDA safety standards.
Food safety legislation. The FDA’s emphasis on food safety is aided considerably by the President’s Food Safety Working Group, which last summer called for developing tougher standards to protect eggs, poultry, beef, leafy greens, melons and tomatoes; a new national traceback and response system; and improved technology to deliver individual food safety alerts to consumers. The FDA’s stepped-up enforcement and fee authority would come from two bills—The Food Safety Enhancement Act in the House and the Food Safety Modernization Act in the Senate. Impact on retailers: How much of the increased cost for fees and other requirements (record-keeping, audits and traceback) manufacturers and suppliers will pass on to retailers is unclear. But retailers also might benefit from the ability to trace a problematic product to a specific locale or factory. Retailers then might have to pull only products that came from that identified area, not every similar item on the shelf.
Food code. A new food code aimed at the retail food industry, among others, focuses on strategies for training, food handling, hygiene, sanitation, water safety and proper storage and temperature control. “One of the strengths of this new food code is to help achieve uniformity,” says Glenda Lewis, leader of the FDA’s retail food protection team. Impact on retailers: “The importance of the food code is control of pathogens at the retail level,” says Lewis. “For example, how you receive food—if it was supposed to be frozen, did you get it frozen?” To help retailers train employees on the new code guidelines, Lewis says a satellite broadcast is planned for May.
Produce guidance. Samir Assar, director of the produce safety staff in the FDA’s Office of Food Safety, says draft guidances on food safety for melons, tomatoes and leafy greens represent the FDA’s current thinking and recommendations on topics, and the recent draft is a response to increases in outbreaks of food-borne illnesses. Impact on retailers: If growers are asked to pay more or do more in order to document procedures, the updated guidance could overburden smaller natural products companies and farms with limited resources. Samir says the FDA conducted “listening sessions” last fall with small and organic growers in Delaware, North Carolina and Florida specifically to hear “about the challenges they face and their concerns about produce safety. It’s certainly something we’re cognizant of. [The guidance] will certainly be scale-appropriate.”
Product traceability. Sherri McGarry, director of the Division of Public Health and Biostatistics at the Center for Food Safety and Applied Nutrition at the FDA, says the agency held public meetings in December to hear comments on mechanisms to establish more effective and efficient product tracing for all foods. Food supply traceability is geared to speed up the response to outbreaks of food-borne illness and contamination. A recent report commissioned by the FDA makes recommendations on product tracing systems, practices and technology. Impact on retailers: The new guidelines could help retailers identify products that need to be removed from store shelves more quickly, reducing the number of food-borne illnesses.
Medical products initiatives
The FDA has earmarked $166.4 million this year to improve the safety of drugs and other medical products.
Bodybuilding supplement crackdown. The FDA has targeted companies that sell harmful bodybuilding supplements and anabolic steroids under the guise of dietary supplements. “The FDA’s biggest concern in this area, hands down, is supplements containing steroids or any other hormone or drug,” says attorney Susan Brienza. Impact on retailers: Just as they are now, retailers would be expected to weed out such supplements and also ensure that advertising or signage complies with regulations for marketing dietary supplements.