DC Circuit Rules that FDA Inaction on Requested BPA Ban Should be Challenged in District Court

By Ricardo Carvajal –

In October 2008, the Natural Resources Defense Council ("NRDC") submitted a citizen petition to FDA asking the agency to repeal regulations that permit food additive uses of BPA, to which FDA tentatively responded with a standard letter stating that “limited availability of resources and other agency priorities” had prevented FDA from rendering a decision on the citizen petition.  When FDA took no further action, NRDC petitioned the DC Circuit Court of Appeals to direct FDA to render a decision.  Among other things, NRDC argued that FDA’s action on the citizen petition would necessitate rulemaking under FDC Act section 409, which vests exclusive jurisdiction in the circuit courts of appeals over any challenge to an order amending or repealing a food additive regulation.

Last week the DC Circuit ruled that it lacks exclusive jurisdiction over the NRDC citizen petition because: (1) NRDC submitted a citizen petition rather than a food additive petition, and “lawsuits involving citizen petitions are regularly heard in the district courts;” (2) agency action under section 409 in response to the NRDC citizen petition is not a foregone conclusion, as FDA can provide a tentative response to the citizen petition or deny it outright – neither of which would require rulemaking under section 409; and (3) 21 CFR Part 10 does not provide for the use of a citizen petition to repeal a food additive regulation. 

NRDC must now decide whether to continue to pursue its case in district court.  FDA action on the citizen petition appears unlikely – particularly in the face of significant cuts to FDA's food safety budget.