Are You Ready for Food-Safety Reform?

FDA would also inspect food-processing plants once every four years, and those identified as high-risk would be inspected annually. The bill also empowers the agency with mandatory recall authority and the ability to assess fees or civil penalties for noncompliance. FDA would also be required to institute science-based regulatory standards to prevent or mitigate contamination in food production, and to create a national tracing system to detect and resolve contamination events early and quickly.

The companion Senate bill, S. 510, passed in committee in Nov. 2009 and pending full Senate vote, closely mirrors—but is less prescriptive than—its House counterpart in areas such as certification, traceability and circumstances under which civil fines and reinspection and recall fees are assessed. In addition to similar provisions that increase the frequency of food-plant inspections and strengthen FDA’s authority to order recalls and detain unsafe food at ports of entry, S. 510 would require FDA to set new science-based standards for fresh fruits and vegetables and would require the creation of a qualified importer program that expedites entry of goods from foreign suppliers who have achieved food-safety certification.

“Neither bill represents a one-size-fits-all approach,” Hall says. “For example, while both focus on traceability, the House bill would require the development of a regulatory-mandated tracing system, whereas the Senate opts to establish a pilot program to assess how we can improve traceability methods for processed foods while mandating regulation for tracing fresh produce. These kinds of differences will need to be resolved before we will know the real impact on industry in terms of new protocols or systems to be implemented.”

PROACTIVE PREPARATION

Regardless of the specific provisions in the final version of any food-safety legislation, say industry experts, there are some general concepts that the food industry can expect to see mandated in some form. Written food-safety plans will be one of them, says Robert E. Brackett, Ph.D., senior vice president and chief science and regulatory affairs officer, Grocery Manufacturers Association (GMA), Washington, D.C., and former director of FDA’s Center for Food Safety and Applied Nutrition. “Developing and writing a food-safety plan is going to be a new way of thinking for the food companies that don’t have them or may have inadequate plans. These prevention-focused food-safety programs, of which HACCP is best known, will need to spell out the justifications for what companies are doing and why they are doing it to prevent adulterated product from getting out the door in the first place.”