FDA Argues Time Frame for Perchlorate Decision is Reasonable

The U.S. Food and Drug Administration (FDA) has filed an opposition
to a petition for a writ of mandamus seeking a response to several
consumer groups’ petition to prohibit perchlorate, an additive currently
approved for limited use in food packaging. Breast Cancer Fund v.
FDA, No. 16-70878 (9th Cir., petition filed July 8, 2016). The groups’
petition urged the Ninth Circuit Court of Appeals to compel FDA to
respond to their December 2014 food additive petition, arguing the
agency was required to respond by June 2015. Details about the petition
for a writ of mandamus filed by the groups—which include the Center
for Environmental Health, Center for Food Safety, Center for Science
in the Public Interest, Environmental Working Group and the Natural
Resources Defense Council—appear in Issue 599 of this Update.

FDA’s response first challenges the group’s standing to sue. “Even if
petitioners could demonstrate that perchlorate poses some risk to them,
the issue with respect to standing is not whether there is a risk that
petitioners may be harmed by perchlorate, but whether there is an actual,
imminent injury caused by the claimed marginal increase in exposure
resulting from the limited uses of perchlorate in food packaging—or,
put differently, whether the alleged injury would be redressed if the
FDA granted the requested administrative relief,” the opposition argues.
The agency also asserts that it has devoted “substantial resources” to
“considering the complex issues raised by the petition,” resulting in a
time frame for response that is “entirely reasonable.”

Issue 611