On January 20, 2011, the Center for Biological Diversity and Pesticides Action Network filed a complaint in the United States District Court for the Northern District of California (San Francisco). EPA is the defendant. The CBD and PAN complaint is attached below. It asks for the following relief:
1. Declare that EPA is violating Section 7(a)(2) of the [Endangered Species Act] by failing to consult with the [United States Fish and Wildlife Service and National Marine Fisheries Service] concerning effects of pesticides on the endangered and threatened species and critical habitats identified herein;
2. Order EPA to begin or reinitiate consultation pursuant to Section 7(a)(2) of the ESA on the effects of pesticides identified herein on the endangered and threatened species and critical habitats identified herein in an expeditious fashion;
3. Order appropriate restrictions on the use of the identified pesticides where they may affect endangered and threatened species and critical habitats until the consultation process has been completed and EPA has brought its pesticide registrations into compliance with Section 7(a)(2) of the ESA;
4. Award Plaintiffs’ costs, including reasonable attorneys’ fees and expert witness fees; and
5. Grant Plaintiffs such additional and further relief as the Court may deem just and appropriate.
EPA’s response to the complaint is due March 25, 2011.
This complaint covers all pesticides and all geographic areas that are not already subject to an ESA consultation court order. It asks a federal district court to take over and run a major portion of the pesticides regulatory program that Congress told EPA to run. There is no justification for this requested usurpation of EPA’s authority. Any court order granting the requested relief would have a significantly adverse impact not only on those who make their living from pesticide manufacture and sale, but also on the growers who need pesticides to raise their crops.
Paragraphs numbered 72, 82, 90-91, 107 in the complaint allege that pesticides cause endocrine disruption in endangered species. The complaint ignores the fact that EPA and the ESA consulting agencies (NMFS and FWS) cannot use environmental endocrine disruption as a regulatory endpoint until they have developed and validated adequate analytical tools in a manner consistent with all applicable statutes, regulations and guidance.
For example, the Information Quality Act’s Objectivity Standard requires EPA to ensure that information it disseminates is “accurate, reliable, and unbiased.” EPA and most other federal agencies have established a government-wide data quality standard that requires proper validation of tests before the test results can be considered accurate, reliable, and unbiased:
Before a new or modified test method is used to generate information to support regulatory decisions, it must a) undergo adequate validation to determine its reliability and accuracy for a specific proposed use, and b) be deemed acceptable by one or more regulatory agencies to fill a specific need. Criteria for validation and regulatory acceptance have been developed by the U.S. Federal government and are described in the report, Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods Prior to the initiation of test method development or validation efforts, sponsors should consider these validation and acceptance criteria.
There are no properly validated tests for environmental endocrine disruption. Consequently, EPA cannot settle or otherwise agree in this case or anywhere else to include environmental endocrine disruption in its ESA pesticide consultations. Further, EPA, NMFS and FWS cannot use or rely on any studies allegedly showing environmental endocrine effects until and unless those studies are demonstrated to contain properly validated tests.
The lack of test validation is just one of many flaws in the Complaint. CRE will post a series of articles discussing these flaws, beginning with a more detailed discussion of the need for test validation.
We encourage readers to respond to these articles, whether you agree with us or not. To respond, please click on the comment link in the upper right corner of this page and follow directions.