Court rules FDA failed to comply with FSMA rulemaking schedule
FDA delayed promulgating seven new regulations for FSMA, Center for Food Safety, Center for Environmental Health said in complaint
On April 22, a Federal Court sided with two nonprofit organizations when it ruled that the US Food and Drug Administration failed to comply with the Food Safety Modernization Act's mandatory rulemaking schedule.
After failing to meet a July 2012 deadline that required FDA to promulgate seven new regulations covering extensive food safety topics, the Center for Food Safety and the Center for Environmental Health filed a complaint against FDA in the US Federal District Court for Northern California.
In the complaint, the two groups alleged that FDA had unlawfully delayed issuance of the new rules and asked for relief. FDA argued that it has been working diligently on the regulations and broke no law.
However, according to the court's ruling: "FDA is correct that the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress.” Noting that any schedule the Court were to set “will necessarily be arbitrary,” the Court ordered the parties “to meet and confer” and to submit to the Court “a joint written statement setting forth proposed deadlines” by which the regulations will be issued by May 20.
Parties may submit written comments to the proposed rules up to May 16.