FDA Gets More Time to Set Schedule for Food Safety Rules
A U.S. district court judge has granted a request by the Food and Drug Administration for more time to develop a timeframe for promulgating a number of regulatory changes required by the Food Safety Modernization Act. The judge has extended from May 20 to June 10 the date by which the FDA must come up with a schedule acceptable to the Center for Food Safety, which sued the agency last fall after it missed a July 2012 deadline for issuing the new rules.
Earlier this year the FDA issued its first two proposed rules to implement FSMA provisions. The first rule would establish science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The second rule would apply to human food and require domestic and foreign facilities that are required to register under the Federal Food, Drug and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results, and act to correct problems that arise. The FDA has twice extended the public comment period on these rules, most recently to Sept. 16.
Other proposed regulatory changes have yet to be published, including rules on the Foreign Supplier Verification Program, sanitary transportation of food products, accreditation of third-party auditors and protection against intentional adulteration.
The FDA has attributed the delay to the complex nature of the subject matter and the extent of the changes made by FSMA. The agency said in court proceedings that effective implementation of this law is its top priority and that it therefore needs sufficient time to ensure that the regulations are developed properly. Officials have also pointed out that the FDA has made substantial progress implementing the law in other ways, including issuing a list of frequently-asked questions on food facility registration, holding three public meetings on the two proposed rules already issued, amending regulations and revising industry guidance on the administrative detention of food, releasing a plan to help manage international food safety capacity-building programs, and requesting public comments on a pilot project to improve product tracing along the food supply system.
For more information about the contents and potential impact of the FSMA rules, please contact Shelly Garg at (305) 894-1043.