Advocates Spar with FDA over FSMA Rulemaking Deadlines
The Center for Food Safety and the Food and Drug Administration (FDA) have filed separate proposals to implement a court order requiring the agency to complete its rulemaking under the Food Safety Modernization Act (FSMA) after finding that FDA had violated the law by failing to meet its rulemaking deadlines. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., proposals filed June 10, 2013). Additional information about the court’s order appears in Issue 481 of this Update.
According to plaintiff’s proposal for injunctive relief, FDA “utterly fails to
comply with the Court’s Order and FSMA,” because the agency has insisted on
establishing “a schedule of target timeframes” that the agency “will endeavor
to meet” with caveats that could require new timeframes. The Center
proposes May 1, 2014, as the date on which seven final implementing rules
must be submitted to the Federal Register. It would add an additional year to
the produce safety standards if “FDA alters its view and undertakes further
NEPA [National Environmental Policy Act] analysis.” The plaintiff argues that a
“deadline is a deadline, a firm parameter with meaningful consequences, not
a ‘target timeframe.’” It claims to have consulted with experts and stakeholders
in establishing its proposed deadlines.
Meanwhile, claiming “it is not feasible to predict with anything approaching
certainty when the final FSMA regulations will be ready to be published,”
FDA proposes “a schedule of target timeframes” that could be delayed if the
administrative records require supplementation or one or more regulations
need to be re-opened. The agency notes that its rulemakings generate “a
significant number of substantive comments,” it must revise its economic
analyses each time rules in the development stage are changed, and its
financial and human resources are limited. Accordingly, its “target timeframes”
would roll out the seven proposed rules through the second quarter of 2014
and finalize them anywhere from 15 to 21 months after each comment period
closes.
