FSMA Implementation Requires New Deadlines, Judge Rules

A federal judge in California wants the U.S. Food and Drug Administration (FDA) to settle on new achievable deadlines for implementing regulations set forth in the Food Safety Modernization Act.  U.S. District Judge Phyllis Hamilton used her federal bench in Oakland to chide FDA for “admittedly” failing to comply with the mandatory rule-making schedule contained in the FSMA. In other words, the judge found FDA is violating the very law it is supposed to be implementing to prevent outbreaks of foodborne disease.  Hamilton said the aggressive timelines in the law have turned out to be “unachievable.” She added, “endless delay does not serve the purpose of the FSMA.”  The judge’s decision is at least an academic victory for the Center for Food Safety, which sued FDA Commissioner Margaret Hamburg to help dislodge the FSMA rules from the elite regulatory unit in the White House Office of Management and Budget (OMB).  OMB kept the rules under wraps for the entire 2012 election year, and only after they finally became public earlier this year did it become known that the White House had scaled them back considerably.  FDA has not said whether it will appeal the trial court’s call for a new set of deadlines.