On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union. The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a “fair,...
January 8, 2016
EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA
On January 6, 2016, a complaint was filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Northern District of California by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners). The Petitioners allege that EPA has allowed “the ongoing sale and use of unregistered pesticide products” because, they claim, EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be...
On January 6, 2016, the U.S. Environmental Protection Agency (EPA), in collaboration with California’s Department of Pesticide Regulation (DPR) announced the release of a preliminary pollinator risk assessment for the neonicotinoid insecticide, imidacloprid (Preliminary Risk Assessment or Assessment). In its assessment, EPA states that imidacloprid potentially poses a risk to hives when the pesticide comes in contact with certain crops that attract pollinators. EPA...
The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28, 2015. The revisions include codifying the inert ingredients list and adding specific chemical identifiers, where available, for all active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption. Labeling...
The U.S. Environmental Protection Agency (EPA) recently launched a new Pesticide Worker Protection Dashboard (Dashboard). EPA states this Dashboard is “focused on the universe of agricultural operations regulated and farm workers and pesticide handlers covered by the Worker Protection Standard.” EPA states that the Dashboard provides charts and graphs presenting certain key enforcement and compliance information related to the Worker Protection Standard (WPS) program...
On December 17, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), the U.S. Environmental Protection Agency (EPA) filed a reply in support of its motion for voluntary vacatur and remand of its decision granting a registration to intervenor DowAgroSciences LLC (DowAgro) for Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). DowAgro responded to the motion by agreeing that remand is appropriate but...
The U.S. Environmental Protection Agency (EPA) recently updated the electronic reporting option for pesticide establishments using the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section Seven Tracking System (SSTS), now referred to as the Enhanced Section Seven Tracking System (eSSTS). On December 17, 21, 22 and 28, EPA will hold four public webinars to explain the Central Data Exchange (CDX) registration process for the eSSTS and demonstrate report submission using...
December 14, 2015
EPA Makes Available Supporting Documents for Endangered Species Biological Evaluations
On December 11, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated: chlorpyrifos, diazinon, and malathion. For each chemical, the following supporting documents are now available: problem formulation; fate and effects characterizations; and related appendices. ...
December 11, 2015
California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims
On December 11, 2015, the California Department of Pesticide Regulation (DPR) issued California Notice 2015-13 that will require each person/company with products made from pesticide impregnated material that are sold into or within California under their own company name to register their product(s) as a pesticide. Examples of pesticide impregnated materials affected by this Notice include apparel (e.g., jackets, shirts, hats, socks, pants, shorts) and non-apparel (e.g.,...
December 10, 2015
DowAgro and Center for Food Safety File Responses to EPA’s Motion for Voluntary Vacatur and Remand
On December 7, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated) Intervenor Dow AgroSciences, LLC (DowAgro) filed a response, and Petitioner the Center for Food Safety, et al. (CFS, et al.) filed joinder in and response to the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur and remand of EPA’s registration of DowAgro’s Enlist Duo herbicide under the Federal Insecticide, Fungicide, and...
December 9, 2015
D.C. Circuit Denies EPA Motion for Summary Affirmance of District Court Order Dismissing ESA Complaint for New Pesticide
On December 7, 2015, in Case Nos. 14-1036 and 15-5168, the U.S. Court of Appeals for the D.C. Circuit issued an order denying the U.S. Environmental Protection Agency’s (EPA) motion for summary affirmance of an order issued by the D.C. District Court dismissing a complaint filed by Plaintiffs-Appellants Center for Biological Diversity, et al. (the Center) for lack of jurisdiction. The Center’s complaint alleged that EPA violated the Endangered Species Act (ESA) and the Administrative...
On November 19, 2015, the USDA published Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational process, and member responsibilities of the AC21; update committee members on relevant regulatory developments, initiatives, and USDA activities; and to outline new tasks for the committee to address. There will also be an opportunity for members of the public to make...
On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-73353, the U.S. Environmental Protection Agency (Respondent; EPA) filed a motion for voluntary vacatur and remand of EPA’s registration, as amended, of Dow AgroSciences LLC’s (Dow) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. This case commenced in October 2014 when the...
In a press release issued on November 22, 2015, the Canadian province of Québec (Quebec) announced its release of Québec Pesticide Strategy 2015-2018. Although the Strategy itself is available only in French, Québec has provided a summary of the Strategy in English, which is available here. Québec’s press release states that the Strategy “sets out the major directions and goals that will guide government action to protect public health, pollinators, and the environment in...
On November 12, 2015, the U.S. Environmental Protection Agency (EPA) issued a final cancellation order for all previously registered pesticide products containing the active ingredient sulfoxaflor, pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1). The registrations for the sulfoxaflor products in question were cancelled effective on November 12, 2015, by an order issued by the U.S. Court of Appeals for the Ninth Circuit that vacated the original...
On November 6, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has a new webpage that compiles information about secondary containers and service containers for pesticides. Secondary and service containers are containers that are used by the pesticide industry as part of the process of applying pesticides, not for further sale or distribution. EPA states that the website combines and replaces information previously found on the Labeling Questions and...
On November 3-5, 2015, the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) on Pesticides, established in 1997 to streamline certain pesticide shipments between Canada (CN), Mexico (MX), and the United States (U.S.), held a meeting hosted by the U.S. Environmental Protection Agency in Durham, North Carolina. NAFTA TWG states that its primary objective “is to develop relevant and cost-effective pesticide regulation and trade among the three countries and meet...
In a November 2, 2015, Federal Register notice, the U.S. Environmental Protection Agency (EPA) issued the final rule revising the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS). EPA previously announced these revisions on September 28, 2015, and stated that it would issue the final rule in the Federal Register within 60 days. The following are important dates: EPA also states that it is “committed to a...
On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos. EPA issued this proposal in response to an August 10, 2015, writ of mandamus by the U.S. Court of Appeals for the Ninth Circuit. The court granted this unusual relief in response to a 2007 administrative petition to cancel chlorpyrifos registrations or to revoke chlorpyrifos tolerances by the...
October 29, 2015
Environmental Groups File Opening Briefs Challenging EPA’s Decision to Register Enlist Duo
On October 23, 2015, in the U.S. Court of Appeals for the Ninth Circuit, the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed separate opening briefs in Case Nos. 14-73353 and 14-73359 (consolidated) arguing that the U.S. Environmental Protection Agency’s (EPA) decision to register Dow AgroScience’s Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on Enlist corn...
October 28, 2015
EPA’s OCSPP Agrees to More Communication, Transparency, and Efficiency When Processing Pesticide Petitions
On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide Petitions in a Transparent and Efficient Manner” (OIG Report). OIG evaluated how EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) tracks the receipt, disposition and resolution of public petitions, focusing on OCSPP’s Office of Pesticide...
October 23, 2015
Public Meeting Announced To Discuss Modernizing the Regulatory System For Biotechnology Products Memorandum
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), announced in the Federal Register a public meeting to be held on October 30, 2015, to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the...
Like so many other regulatory programs in China, pesticide regulations are changing. At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring...
The U.S. Environmental Protection Agency (EPA) has launched a new pesticides website: http://www2.epa.gov/pesticides, and a new biopesticides website: http://www2.epa.gov/pesticides/biopesticides, among others. EPA states that this gradual move to new versions of its content is part of a larger EPA effort to build a more user-friendly website. The updated biopesticides website focuses on providing general information on biopesticides, as well as tools to assist...
On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard. EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective...
On September 22, 2105, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register listing its revised registration service fees applicable to specified pesticide applications and tolerance actions for fiscal year (FY) 2016 that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Pesticide Registration Improvement Act of 2003 (PRIA) established FIFRA Section 33, creating a registration...
September 14, 2015
Ninth Circuit Vacates EPA’s Unconditional Registration for the Neonicotinoid Pesticide Sulfoxaflor Based on Hazard to Bees
In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other...
On September 8, 2015, the Environmental Protection Agency (EPA) announced that it will host a Disinfection Hierarchy Stakeholder Workshop and corresponding webinar on October 7, 2015, from 8:30 a.m. – 5:00 p.m. (EDT). The “disinfection hierarchy” describes the descending order of susceptibility of classes of microorganisms to antimicrobial chemicals. Demonstrated efficacy against a representative organism would support a manufacturer’s claims against more...
On September 2, 2015, the European Chemicals Agency (ECHA) issued an updated list of biocide suppliers as required under Article 95 of the Biocidal Product Regulation (BPR). Although prior versions of the list were released previously, this list has current legal effect since Article 95 provides that, as of September 1, 2015, a biocidal product cannot be made available in European Union (EU) markets unless the active ingredient supplier or product supplier is listed for the...
On September 1, 2015, the U.S. Environmental Protection Agency (EPA) announced the debut of a new electronic system for pesticide applications, the Pesticide Submission Portal. According to EPA, this debut is the first step in a phased approach that ultimately will allow EPA to accept all pesticide applications electronically — a move that will help modernize the pesticide registration process, increase operational efficiencies, and reduce paper waste. EPA will continue to...
August 28, 2015
EPA Issues Draft Guidance on Pesticide Cumulative Risk Assessment: Framework for Screening Analysis
The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015. EPA’s draft framework provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation. EPA proposes using a two-step approach, beginning with the evaluation of available toxicological information and, if necessary,...
On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines,” as follows: These test guidelines are part of a series of test guidelines established by OCSPP for use in developing data on potentially adverse effects of pesticides and...
On August 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposal to revise the Certification of Pesticide Applicators rule. EPA is proposing stricter standards for people certified to use “restricted use” pesticides (certified applicators). Restricted use pesticides are not available for purchase by the general public, require special handling, and may only be applied by a certified applicator or someone working under the direct supervision of a certified...
August 19, 2015
Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review
On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated). Both motions requested that the court stay an October 15, 2014, decision by the U.S....
August 18, 2015
Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos
In an opinion issued on August 10, 2015, the U.S. Court of Appeals for the Ninth Circuit granted a writ of mandamus requested by Pesticide Action Network North America and the Natural Resources Defense Council (Petitioners) to require that the U.S. Environmental Protection Agency (EPA) act in response to a 2007 administrative petition to cancel the registrations of all pesticides containing chlorpyrifos. A writ of mandamus to compel administrative action is an extraordinary remedy and...
On June 24, 2015, in the United States District Court for the Northern District of California, the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (Plaintiffs) sued the U.S. Environmental Protection Agency (EPA) and its Administrator Gina McCarthy regarding a 2014 decision by EPA not to proceed with a rulemaking to require disclosure of hazardous inert ingredients on pesticide product labels under the Federal Insecticide, Fungicide, and Rodenticide...
On July 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice extending the public comment period regarding its proposed Antimicrobial Pesticides Use Site Index (USI) from July 31, 2015 to August 31, 2015. The initial Federal Register notice announcing the availability of EPA’s guidance on the USI was issued on July 1, 2015. By way of background, in 2014, EPA issued a final rule on Data Requirements for Antimicrobial...
July 16, 2015
EPA Gets Closer To Issuing Final Rule On Revisions To Minimum Risk Exemption For Pesticides
On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning the draft final rule entitled ”Pesticides; Revisions to Minimum Risk Exemption.” This notice states that the draft final rule will not be available to the public...
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...
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...
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...
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...
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...
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...
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: ...
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...
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...
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...
June 17, 2015
Court of Appeals Grants Writ of Mandamus Requiring EPA to Take Final Action on Chlorpyrifos Petition
On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the Court is impatient about what it perceives to be the slow...
June 16, 2015
European Court of Justice Dismisses Case Regarding Confidential Treatment of Information Submitted to EFSA
On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential. The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information...