FDA Wont Set Specific FSMA Deadlines Despite Court Order
The order came after CFS sued FDA in August 2012 for missing several statutory deadlines in its implementation of FSMA, the most sweeping update to food safety law in seven decades. The two parties, unable to agree on deadlines as the court ordered, were granted a 20-day extension to June 10 by a U.S. District Court, but ultimately did not submit a joint proposal like they were supposed to. They each submitted their own timelines for the remaining regulations.
FDA’s timeline for each key part of FSMA – including the foreign supplier verification program, preventive controls, produce safety, and other provisions – is longer than CFS’ and it lacks specific dates.
For example, FDA proposed issuing a final rule for produce safety standards by roughly June 2015, but CFS proposed a final deadline of May 1, 2014, which could be extended by up to one year if further analysis is required by the National Environmental Policy Act.
For the foreign supplier verification program, FDA set a deadline for a proposed rule by this summer, without setting a date, while CFS set a deadline of August 31, 2013. For the final rule, FDA set a deadline of summer 2015, while CFS set a deadline of December 31, 2013.
FDA set its own timeline for issuing a proposal for accrediting third party auditors. The agency plans to have a proposed rule out by this summer and a final rule by “roughly” summer 2015. CFS set an August 31, 2013 deadline for a proposed rule and a December 31, 2013 deadline for a final rule.
Consumer advocates said they are dismayed by FDA’s refusal to agree to a shorter timeline for many key food safety rules, many of which are already well passed the statutory deadlines set by Congress.
“The Center for Food Safety’s proposed deadlines are entirely reasonable,” said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest. “FDA needs to get the job done. We’re tired of waiting for regulations and proposals that are long overdue.”
Smith DeWaal said it was “ridiculous,” for example, that FDA was setting a goal of summer 2015 for the foreign supplier verification proposal, especially considering the agency submitted a draft proposal to the White House Office of Management and Budget in November 2011 for review. In FSMA, FDA was directed to write this program no later than one year after the law was enacted in January 2011, so FDA met this requirement and has now been waiting on OMB for nearly a year and a half.
Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America, said that Congress included specific deadlines in the law “for a reason – to ensure timely implementation of the important food safety provisions contained in FSMA.”
“I think CFS’ argument that the implementation period should not be ‘open-ended’ is a valid one,” he said. “Not everything in the process is under FDA’s control, but it is in the best interest of consumers for implementation of FSMA to occur expeditiously. And court-imposed deadlines could help make that happen.”