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EPA Issues Draft Guidance on Pesticide Cumulative Risk Assessment: Framework for Screening Analysis
The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015.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: Medaka Extended One Generation Reproduction Test (MEOGRT), OCSPP Test Guideline 890.2200; Larval Amphibian Growth and Development Assay (LAGDA), OCSPP Test...
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. Environmental Protection Agency (EPA) to register Enlist...
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 is...
August 15, 2015
EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds
On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval of Prop 65 warnings on pesticide labels. EPA’s August 7, 2019, letter to glyphosate registrants states that EPA “will no longer approve labeling that includes the Proposition 65 warning statement for glyphosate-containing products.” EPA stated...
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 until after...
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: Discovery,...
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 pace of review by the U.S. Environmental...
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...
On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions. The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and...
June 12, 2015
EFSA Issues Call for Data on the Health and Environmental Effects of Neonicotinoid Pesticides
On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the European Union (EU) from the use of the three neonicotinoid pesticide active substances: clothianidin, imidacloprid, and thiamethoxam (the substances). The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to...
The U.S. Environmental Protection Agency’s (EPA) Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products published in the Federal Register on May 29, 2015, seeks comment on a proposal to adopt mandatory pesticide label restrictions to protect managed bees under contract pollination services from foliar application of pesticides that are acutely toxic to bees on a contact exposure basis, unless the application is made in accordance with a government-declared public...
On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.” This is the second nanosilver registration issued by EPA and reflects the Agency’s growing expertise in addressing, processing, and approving nanopesticide registration applications. According to EPA, the product will be used as a non-food-contact preservative to protect...
May 19, 2015
Pollinator Health Task Force Issues National Strategy to Promote the Health of Honey Bees and Other Pollinators
On May 19 2015, President Obama’s interagency Pollinator Health Task Force -- co-chaired by the Secretary of Agriculture and the Administrator of the U.S. Environmental Protection Agency (EPA) -- issued its long awaited and anticipated “National Strategy to Promote the Health of Honey Bees and Other Pollinators,” as well as its “Pollinator Research Action Plan.” This work was done in response to President Obama’s June 20, 2014, memorandum...
On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations. This challenge was...
On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces. In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial...
On April 20, 2015, the U.S. Environmental Protection Agency (EPA) announced it had reached settlements with three major pesticide registrants, for the actions of a third-party pesticide distributor, Harrell’s LLC (Harrell’s), a Florida-based lawn and turf care business that was distributing the registrants’ respective products. EPA alleged that Harrell’s sold improperly labeled products that contained the pesticides dithiopyr, chlorantra-niliprole, and imidacloprid. Without...
April 27, 2015
DPR Proposal for Right-to-Know Notifications Prior to Soil Fumigant Applications Could Have Far-Reaching Implications
On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field fumigations. The presentations and video from that workshop are now available on DPR’s website. DPR’s presentation at the workshop focused on the background that it believes supports the consideration of a notification requirement, and on current methyl bromide...
On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to...
April 16, 2015
EPA Issues Letter Stating It is “Unlikely” to Approve New Outdoor Neonicotinoid Pesticide Uses
On April 2, 2015, the U.S. Environmental Protection Agency (EPA) sent a letter to all registrants of nitroguanidine neonicotinoid pesticide products stating that “until the data on pollinator health have been received and appropriate risk assessments completed,” EPA is “unlikely to be in a position to determine that such uses would avoid ‘unreasonable adverse effects on the environment’ as required under FFIRA to support further regulatory expansion of these pesticides in...
Recently, the results of a three-year University of Maryland study assessing the potential chronic sublethal effects on whole honey bee colonies of a diet containing imidacloprid, an insecticide that belongs to the neonicotinoid class of chemicals, at 5, 20, and 100 μg/kg over multiple brood cycles have been released. The study, Assessment of Chronic Sublethal Effects of Imidacloprid on Honey Bee Colony Health, funded primarily by a Cooperative Agreement with the U.S. Department of...
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act...
On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides. Specifically, IARC classified the herbicide glyphosate and the insecticides malathion and diazinon as probably carcinogenic to humans (Group 2A), and classified the insecticides tetrachlorvinphos and parathion as possibly carcinogenic to humans (Group 2B)....
The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential information related to substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. EPA and FDA state in the MOU that the sharing of such information will “open[] channels of communication between the agencies” and will “serve to...
March 16, 2015
Supreme Court Confirms That Agency Interpretative Rules Do Not Require Notice and Comment, Even When They Change a Prior Interpretation
In a March 9, 2015, decision in Perez v. Mortgage Bankers Ass'n., the U.S. Supreme Court unanimously held that an interpretative rule issued by an administrative agency does not require notice and opportunity for comment, even if the interpretative rule construes a substantive (or "legislative") rule previously issued by the agency and even if the interpretative rule alters a prior interpretation of the same rule. In the Perez decision, the Court explicitly...
On March 2, 2015, the United States Environmental Protection Agency (EPA) and the American Chemistry Council (ACC) executed a settlement agreement (Agreement) following the ACC’s petition for judicial review of EPA’s antimicrobial pesticide data requirements final rule issued on May 8, 2013 (78 Fed. Reg. 26936). The judicial review proceeding was held in abeyance while settlement discussions were pursued between EPA and ACC for this final rule, entitled “Data Requirements...
On March 2, 2015, European Union (EU) Ministers approved a Directive previously approved by the European Parliament with regard to genetically modified organisms (GMO). EU Directive 2010/0208, entitled Directive of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, will allow individual Member States to determine whether...
On March 1, 2015, the U.S. Environmental Protection Agency (EPA) released the 11th Annual Report on EPA’s implementation of the Pesticide Registration Improvement Extension Act (PRIA 3) that is required under Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This annual report details changes in processes, practices, and policies for Fiscal Year (FY) 2014 that ran from October 1, 2013, through September 30, 2014. The report is divided into different...
The U.S. Environmental Protection Agency (EPA) issued an updated schedule for the Pesticide Registration Review program that sets forth a timetable for opening dockets for the next three years, through end of fiscal year 2017 (September 2017). Through the Pesticide Registration Review program, EPA reviews all registered pesticides at least every 15 years, as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Following the newly issued schedule, all...
REMINDER Border Security: EPA's Increased FIFRA Import Enforcement InitiativeMarch 12, 20152:00 p.m. - 3:00 p.m. (EDT)Register online Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1),...
March 4, 2015
DPR Issues California Notice 2015-3 Regarding Concurrent Application Submissions to DPR and EPA
On February 27, 2015, the California Department of Pesticide Regulation (DPR) released California Notice 2015-3, entitled Concurrent Submission of Pesticide Products to the Department of Pesticide Regulation and the U.S. Environmental Protection Agency. In this Notice, DPR describes the four types of applications that may be submitted concurrently to DPR and to the U.S. Environmental Protection Agency (EPA), the procedure applicants should follow to request concurrent submission, and how...
February 27, 2015
United States Court of Appeals for the 9th Circuit Is Likely to Consider Requests to Stay the Registration of a New Herbicide Despite the Registrant
Center for Food Safety v. EPA is a case in the U.S. Court of Appeals for the 9th Circuit (9th Circuit) that consolidates two petitions for review of a decision by the U.S. Environmental Protection Agency (EPA) to register the new herbicide product Enlist Duo for use in six Midwestern states. A group of non-governmental organizations filed one of the petitions and the Natural Resources Defense Council (NRDC) filed a separate petition. Enlist Duo combines the active ingredients glyphosate and...
The California Department of Pesticide Regulation (DPR) announced on February 26, 2015, a revision to the process for evaluation of the potential for a pesticide to move off-site into surface water when the pesticide is used in an urban area. The former evaluation method followed the U.S. Environmental Protection Agency (EPA) approach with California specific parameters. This revision will continue to use the EPA approach but allow incorporation of a module specific for California urban...
February 26, 2015
European Chemicals Agency Releases Practical Guide on Biocidal Products Regulation
Not a moment too soon, the European Chemicals Agency (ECHA) released a useful and clearly written Practical Guide on Biocidal Products Regulation, ECHA-14-B-19-EN. ECHA is the European Union (EU) agency tasked with implementing the Biocidal Products Regulation (BPR), along with other EU chemical laws and regulations. Adopted in 2012, the BPR revised the Biocidal Products Directive and imposes requirements on producers of active substances and biocidal products. Starting on September 1,...
The California Department of Pesticide Regulation (DPR) recently issued its Progress Report 2012-2014, which highlights DPR’s view of achievements under the leadership of Director Brian Leahy. Among the achievements noted are the following; others are also discussed in the report. • Restricting sales of Second Generation Anticoagulant Rodenticides (SCAR). This action is described as having been “the catalyst for a national change, as the manufacturer agreed with U.S. EPA to phase...
The California Department of Pesticide Regulation (DPR) has extended, from February 27, 2015, to Friday, March 13, 2015, the submission of written comments following DPR’s January 14, 2015, Registration Fee Workshop where DPR discussed the potential increase in registration fees for pesticide products pursuant to Food and Agricultural Code (FAC) § 12812(a). Under the proposal, DPR would increase fees for applications and renewals from $750 to $1,150, decrease fees for certain...
February 17, 2015
EPA Releases For Public Comment Controversial “EPA Framework for PIP Registrants: Proposal to Address Key SAP Recommendations for Corn Rootworm (CRW) IRM”
On January 28, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has made available for public comment its proposal to improve the corn rootworm insect resistance management program currently in place for registrations of plant-incorporated protectants (PIP) derived from Bacillus thuringiensis (Bt) in corn. The EPA framework contains a number of controversial provisions, including the following proposed restriction of soil applied insecticides (SAI): “SAIs must be...