Expert Recall

By Robert G. Hibbert, Partner, K&L Gates LLP

It’s been more than a year since the Food Safety Modernization Act (FSMA) became law, and the U.S. Food and Drug Administration has fallen behind on some important deadlines Congress included in the legislation.

By January 4, the agency was to have initiated the rule-making process for produce safety standards and completed rules for the new foreign supplier verification program. There is no word from FDA on when those rules will be implemented. Under the law, the FDA was also ordered within a year to have published guidance for schools and childcare programs on allergy risks – a step that determines what products falls into the “high-risk foods” category facing stricter record-keeping requirements. By this time it was also supposed to have established five Integrated Food Safety Centers of Excellence at state health departments.

Over the next three years, the law directs the FDA to implement more than 50 new rules, regulations, and programs designed to improve food safety. FDA spokespeople tell us broadly that it will be physically impossible to make good on all of those deadlines but that they are busy prioritizing the tasks. Most consumer and health groups are exercising patience with the delays, pointing out that the FDA has met a number of other deadlines, including the completion of 600 facility inspections in 2011 and revamping its recall website to make it more consumer-friendly.

Food processors, retailers and all of the other links in the chain from farm to table should take no comfort in the delays inherent in FDA rulemaking. Instead, they should be aggressively upgrading their own food-safety systems, recall plans and other related programs on an ongoing basis. Regardless of what is or isn’t happening currently at the federal level, the movement toward a food safety system that is preventative, scientifically based, traceable and global in scope continues to accelerate. It may take a bit of extra time to get all of the government architecture in place, but that day will arrive soon enough and, before it does, expectations within the trade and the general public, not to mention the behavior of the courts as driven by the plaintiff’s bar, will continue to create new opportunities for those who can adjust and serious problems for those who cannot.

What are your thoughts about the FSMA? Is your company prepared for it? Do you consider it a hindrance to your business or an essential way to protect consumers? Please feel free to present your comments below.

Robert G. Hibbert’s practice focuses upon federal regulation of the food and agricultural industries. Areas of particular concern include food safety, food security, animal health, biotechnology, labeling, advertising, and new product development. You may contact him at 202-778-9315, or robert.hibbert@klgates.com.