The FDA submitted drafts of the four of the most critical rules mandated by FSMA to the White House’s Office of Management and Budget for review in December 2011, which is a normal step for economically significant regulations, but stakeholders and consumer advocates have been at a loss for why the rules have been under review for a year. The normal review limit is 90 days.
For the past year, consumer advocates have worried that presidential election politics put the rules on the back burner, so the administration could avoid the optics of “job-killing” regulations — even if they are generally supported by the food industry and a bipartisan coalition. Throughout the review, FDA and OMB have insisted there are substantive issues to work through, but decline to provide details.
Meanwhile, the agency has missed several of the deadlines set by Congress for implementation. The Center for Food Safety and Center for Environmental Health sued FDA over the summer to try to force the agency to put certain provisions in place without waiting for the stalled OMB review.
In a motion filed in the U.S. District Court for the Northern District of California, FDA lawyers argue that the complaint against the agency should be dismissed.
“The enormity and scope of the task given to FDA cannot be overstated,” they say, as the agency is charged with building a new preventative food safety system with rules that have to effectively cover $450 billion worth of domestic and imported foods and hundreds of thousands of food facilities. Because of this complexity, the FDA says, it’s understandable that the rules are taking some time to develop. The agency also asks the court to dismiss the complaint against OMB because the suit does not identify a basis for judicial review.
The agency says it’s devoted “enormous effort and resources to developing the novel and complex regulations.”
The document points out that FDA created an internal organization structure for implementing the new law, prioritized the many requirements the law calls for, and made “substantial progress” in developing the regulations. The four rules under review at OMB would set safety standards for produce safety, require preventive controls for food and animal feed, and set up a foreign supplier verification program. The agency sent a fifth draft rule regarding third party audits to OMB for review last week.
On Friday, the Make Our Food Safe Coalition wrote to President Obama asking that the rules be released. “On behalf of those whose lives have been directly impacted by foodborne illness and others who may be unfortunately impacted in the future, as well as for all of the consumer, public health and victim organizations that worked tirelessly to get FSMA enacted, we are writing to respectfully ask you to release these long-delayed proposals so that the promise of this landmark law can become a reality.”
George Kimbrell, senior attorney for the Center for Food Safety, told Reuters Monday that his group believes FDA is breaking the law and needs to act to protect public health.
“They are not disputing that they missed the deadlines Congress set. They are just arguing those deadlines essentially don’t matter,” said Kimbrell. “In addition to being wrong as a matter of law, FDA’s foot-dragging excuse that ‘it’s too hard’ is misdirected and weak. We didn’t set the deadlines – Congress did.”
The FDA’s lawyers argue that getting the rules right is more important than meeting statutory deadlines: “Although FDA has been unable to meet the aggressive statutory timelines for the seven new rules, there is no indication that Congress believed that strict adherence to those timetables is more important than careful consideration and development of these complex regulations to create an effective and modernized food safety system, provide clear guidance to the industry, and minimize later challenges or revisions to hastily adopted regulations.”
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