July 6, 2015

Biotechnology: White House Announces Effort to Modernize the Regulatory System for Biotechnology Products

In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update...
July 3, 2015

California Superior Court Denies PANNA Petition for Writ of Mandate

On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of the Pesticide Action Network North America, et al. (PANNA) for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA.  The active ingredient in both products at issue, dinotefuran, is a...
July 2, 2015

EPA Releases Guidance Document:  Antimicrobial Pesticide Use Site Index

On July 01, 2015, the U.S. Environmental Protection Agency (EPA) issued a notice announcing the availability of and requesting public comment on a proposed guidance document called the Antimicrobial Pesticide Use Site Index (USI).  In 2014, EPA issued a final rule amending the regulations setting forth the data requirements that support an application to register a pesticide product.  The final rule contains the data requirements specifically applicable to antimicrobial...
July 1, 2015

EPA Releases Endocrine Disruptor Screening Program Tier 1 Assessments

The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant bench-mark in the program since the original List 1 test orders were initially issued in October 2009.  Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants.  The intended purpose of the Tier 1 screening was to identify...
June 26, 2015

Canadian Province Finalizes Neonic Reduction Rule

The Canadian province of Ontario has issued its final regulations under the Ontario Pesticides Act aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides.  These changes have been made as part of its broader strategy to protect pollinators, and aim to reach an 80 percent reduction in the number of hectares planted with neonicotinoid-treated corn and soybean seed by 2017.  The new rules create a new class of pesticides, known as...
June 25, 2015

U.S. District Court Affirms FIFRA Arbitration Award

On June 19, 2015, the United States District Court for the District of Columbia granted a motion for default judgment by the Non-Dietary Exposure Task Force (Task Force) and confirmed an arbitration award against an Indian pesticide manufacturer, Tagros Chemicals India, Ltd. (Tagros) (Non-Dietary Exposure Task Force v. Tagros Chems. India Ltd., 2015 BL 195490, D.D.C., 1:15-cv-00132, 6/19/15).  The Task Force sued Tagros after Tagros refused to sign a $500,000 settlement agreement negotiated...
June 24, 2015

EPA Announces Plans to Modernize Audit Policy

On June 10, 2015, and June 15, 2015, the U.S. Environmental Protection Agency (EPA) held a webinar entitled “eDisclosure:  EPA’s Plan to Modernize the Implementation of the Audit Policy and the Small Business Compliance Policy.”  During the webinar, EPA set forth its plans to release in fall 2015 a centralized online portal called eDisclosure to allow companies to submit self-disclosures electronically under EPA’s Incentives for Self-Policing: ...
June 23, 2015

EPA Announces Plan for Use of New Methods for Endocrine Disruptor Screening

On June 19, 2015, the U.S. Environmental Protection Agency (EPA) announced a plan for incorporating validated high throughput assays and a computational model into the Endocrine Disruptor Screening Program (EDSP) to screen chemicals for their ability to interact with the endocrine system.  These proposed new methods would serve as an alternative for three of the eleven current assays in the EDSP Tier 1 screening battery, specifically the estrogen receptor binding (ER), estrogen...
June 19, 2015

EPA Announces Availability for Comment of OCSPP Harmonized Test Guidelines

On June 17, 2015, the Environmental Protection Agency (EPA) published a notice announcing the availability for comment of three draft revised 810 series test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP).  These test guidelines will provide updated guidance on antimicrobial efficacy testing to the regulated community. EPA states that when these guidelines were published in final in 2012, they drew criticism as confusing and inaccurate.  EPA...
June 19, 2015

District Court Issues Order Allowing Plaintiffs in Case Seeking Review of Neonicotinoid Pesticides under the ESA to Utilize Extra Record Material

On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified administrative record to support their contentions that the U.S. Environmental Protection Agency (EPA) improperly failed to consult the Fish and Wildlife Service (FWS) under Section 7 of the Endangered Species Act (ESA).  The plaintiffs in the Ellis case are...