EPA Pesticide Registration and ESA Compliance

EPA’s Science Advisory Board met on March 7-8, 2013, to review several issues including EPA “Risk Assessments—Use of Computational Toxicology.” EPA hopes to use CompTox in several contexts, including the Agency’s Endocrine Disruptor Screening Program. Given its proposed EDSP use, and the EPA Science Advisory Panel’s continuing review of CompTox, SAB Member Dr. Elaine Faustman pointed out that “[t]he review highlights in several contexts the significance of the early use of the CompTox data for screening dispersants in the Gulf however it is silent of the very large exercise of screening for endocrine disruption that is occurring as a part of the EPA endocrine screening program. Shouldn’t the review applaud EPA’s approach to emphasize the importance of such evaluations of Comp Tox results for current EPA needs?”

On March 7, 2013, at 1:15 p.m., EPA’s Science Advisory Board will review the draft SAB Report “SAB Advice (1/29/13 Draft) on Advancing the Application of CompTox Research for Human Health Risk Assessment.” A copy of this draft report is available here.

This draft report includes several recommendations, one of which is that “EPA should develop data use guidelines for information generated by CompTox, including ExpoCast, for the various purposes to which it is intended.”

On January 29-31, the FIFRA Science Advisory Panel reviewed EPA’s current efforts to prioritize the universe of Endocrine Disruptor Screening Program chemicals using computational toxicology tools. At this SAP meeting, EPA representatives stated that the Agency intends to convene three more SAPs in 2013 to review EDSP issues. According to EPA, these three additional SAPs will

● the first additional SAP will review some “operational aspects” of the current EDSP tier 1 tests;

● the second additional SAP will review the validation status of the EDSP Tier 2 tests that EPA is developing; and

EPA has published a Federal Register notice soliciting public comment on the Agency’s proposed new regulations on the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides. EPA proposes adding specific chemical identifiers that would make it clearer to manufacturers; the public; and Federal, state, and tribal inspectors which ingredients are permitted in minimum risk pesticide products. EPA is also proposing to modify the label requirements in the exemption to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label.  EPA must receive any public comments on these proposals on or before April 1, 2013.

Environmental NGOs are suing EPA, basically asking a California federal district court to take over EPA’s pesticide program because EPA allegedly failed to meet all its ESA consultation obligations under the Endangered Species Act. EPA has filed a motion to dismiss the Plaintiffs’ complaint in the case. The Plaintiffs have filed their opposition to EPA’s motion to dismiss.  The Plaintiffs’ opposition makes the following arguments:

I.  Defendants’ Motions Improperly Elevate FIFRA above the ESA

II. EPA’s Continuing Authority over Pesticide Registrations is Ongoing Agency Action Subject to the ESA’s Consultation Requirement