FIFRAblog®

A tentative ruling issued January 26, 2017, in Monsanto Company v. Office of Environmental Health Hazard Assessment, et al., Case No. 16 CE CG 00183, by the Superior Court of California, County of Fresno, granted the Office of Environmental Health Hazard Assessment’s (OEHHA or Defendant) motion for judgment on the pleadings as to Monsanto Company’s (Monsanto) petition and complaint, and sustained the demurrers to Monsanto’s petition and complaint (Sierra Club) and California Citrus’...

The U.S. Environmental Protection Agency (EPA) has scheduled a final rule to be published on on January 26, 2017, which will temporarily delay the effective date of certain regulations until March 21, 2017.  This final rule is being issued in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017.  Among the 30 regulations that meet those criteria is the final rule Pesticides; Certification of Pesticide Applicators, which revises...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA), together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.  82 Fed. Reg. 7151.  The Federal Register publication states that this final rule is intended to “better protect human subjects involved in research,...

On November 23, 2016, the European Court of Justice (ECJ) issued two landmark judgments in Case C-673/13 P (Commission v Stichting Greenpeace Nederland and Pan Europe) and Case C-442/14 (Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden). In Case C-673/13 P, the associations Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN Europe) submitted a request to the European Commission (EC)...

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) which describes methods for addressing acute risks to bees from pesticides.  EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with...

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and...

On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity...

On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final.  This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s...

On November 1, 2016, the U.S. Environmental Protection Agency (EPA) published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816.  The 2016 NPDES Pesticide General Permit (PGP)...

The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments.  EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide,...

The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase...

The following documents have been filed in the Anderson v. McCarthy proceedings in the U.S. District Court for the Northern District of California:  (1) U.S. Environmental Protection Agency’s (EPA) Notice of Motion and Motion for Summary Judgment; (2) Defendant-Intervenors CropLife America, et al.’s Notice of Motion and Motion for Summary Judgment; and (3) Plaintiffs’ Memorandum of Points and Authorities in Support of Motion for Summary Judgment. EPA’s documents are...

On August 23, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) adopted its first decision on a data sharing dispute under the Biocidal Products Regulation (BPR). Thor GmbH (Thor) lodged the appeal in 2015 after ECHA granted permission to a company to cite studies owned by Thor for the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (CIT/MIT).  According to ECHA, Thor had insisted on a technical equivalence assessment of...

The fourth Biocides Stakeholders’ Day took place on September 1, 2016, at the European Chemicals Agency’s (ECHA) headquarters in Helsinki, Finland.  The event provided biocides stakeholders with information on the Biocidal Products Regulation (BPR) and the tools and support available.  The focus was on experiences from companies, ECHA, and the European Commission (EC).  ECHA stated “[t]he objective was to equip companies with information about their roles and obligations to...

On September 19, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report, EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants, the result of OIG’s review of EPA’s Antimicrobial Testing Program (ATP) to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for...

On September 16, 2016, the U.S. Environmental Protection Agency (EPA) announced it settled an enforcement matter with Syngenta Crop Protection, LLC (Syngenta or Respondent) via a Consent Agreement and Final Order (CAFO) concerning EPA’s allegations that Syngenta violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and EPA’s Pesticide Container and Containment Rule (PCCR).  The investigation took place over three years, starting in August 2012 and concluding...

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance).  A draft of this guidance was issued in April 2016 and comments were sought at that time.  More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products....

The threat of the Zika Virus grows every day, and the need for clear information is especially pressing if you are pregnant.  How do you prevent getting infected with the Zika Virus, and what insect repellents are best?  The first question is easy to answer:  public health experts agree that women who are pregnant or who might be pregnant should use insect repellents.  The answer to the second question is not so simple. I am a former senior official at the U.S. Environmental...

On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos.  The court opted instead to afford EPA a three month extension, stating that “this is the final extension, and the court will not grant any further extensions."  EPA sought the six month extension on June 29, 2016, to allow time for EPA...

The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016.  A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor...

The comment deadline of August 15, 2016, is approaching on the June 14, 2016, notice of availability of the draft Pesticide Registration Notice (PRN) 2016-X issued by the U.S. Environmental Protection Agency (EPA), in consultation with the U.S. Department of Agriculture (USDA).  Draft PRN 2016-X proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use.” Federal Insecticide, Fungicide, and...

On July 29, 2016, the Environmental Appeals Board (EAB or Board) issued its Final Decision and Order (Order) upholding the Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and...

On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.”  This SAP was convened to advise...

On July 1, 2016, in an administrative appeal of the June 1, 2016, Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide...

In two recent orders issued in the neonicotinoid seed treatment case Anderson v. McCarthy, the U.S. District Court for the Northern District of California declined to take immediate action in response to a motion by the U.S. Environmental Protection Agency (EPA) requesting that the Court dismiss the case for lack of subject matter jurisdiction.  This case involves allegations by a coalition of beekeepers, farmers, and non-governmental organizations (Petitioners) that EPA has...

On July 18, 2016, the U.S. Environmental Protection Agency (EPA) announced that PuriCore Inc. (PuriCore), paid a $550,000 penalty for the unauthorized distribution of two of its pesticide products, ProduceFresh and FloraFresh, that were used in supermarkets nationwide.  Along with the penalty, EPA issued a stop-sale order to PuriCore prohibiting the sale of ProduceFresh.  PuriCore’s unauthorized distribution and sale of pesticide products violates the Federal Insecticide, Fungicide,...

On July 1, 2016, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register an interim final rule adjusting penalty amounts for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations by more than three times the current level, in some cases.  The rule also adjusts the level of statutory civil monetary penalty amounts for the other statutes that EPA administers.  EPA issued this interim final rule pursuant to 2015 amendments to the...

On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.”  Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y...

On June 29, 2016, the U.S. District Court for the Northern District of California (Court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting the U.S. Environmental Protection Agency’s (EPA) motion for summary judgment.  Background This case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking to...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos.  The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30,...

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...

On June 7, 2016, the U.S. Environmental Protection Agency (EPA) announced that it was making two draft Pesticide Registration Notices (PR Notices) available for public comment:  (1) PR Notice 2016-X:  Draft Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling; and (2) PR Notice 2016-XX:  Draft Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship.  In its news release, EPA states that it has started a...

On June 2, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) and Health Canada’s Pest Management Regulatory Agency (PMRA) released harmonized product chemistry templates for use by registrants when submitting pesticide registration packages.  These templates were developed by EPA and PMRA under the United States -- Canada Regulatory Cooperation Council (RCC) workplan.  EPA stated that the templates are based on the Organization for...

On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct).  HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted...

On Wednesday, June 1, 2016, Administrative Law Judge (ALJ) Susan L. Biro issued an Initial Decision in the matter of Bayer CropScience LP and Nichino America, Inc. (BCS/NAI), U.S. Environmental Protection Agency (EPA) Docket No. FIFRA-HQ-2016-0001. This decision was issued following BCS/NAI’s request for a hearing to contest EPA’s Notice of Intent to Cancel Pesticide Registrations (NOIC).  BCS/NAI challenged EPA’s position that a conditional registration term in the relevant...

On May 11, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Compliance (OC) and Office of Pesticide Programs (OPP) issued a memorandum to its regional Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Division Directors and Branch Chiefs to establish a joint position of OC and OPP “for how regions should respond to requests for EPA-issued Certificates of Establishment (COEs) and Certificates of Origin (COOs).” OC and OPP state that the need for a joint position is...

On May 9, 2016, Jack Housenger, Director of the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP), announced the selection of Anna Lowit for the Senior Science Advisor Position in OPP’s Immediate Office.  Lowit has been a toxicologist in OPP’s Health Effects Division since 1998. Housenger’s announcement of Lowit’s selection notes that she has “provided expert technical advice and guidance to senior management on issues related to toxicity testing, human...

On May 3, 2016, the U.S. Environmental Protection Agency (EPA) issued a final rule that amends current pesticide tolerance crop grouping (Crop Group) regulations.  Crop groupings allow petitioners to request a tolerance for multiple related commodities based on research data for one or more representative crops.  This final rule is the fourth amendment in a series of planned Crop Group updates begun in December 2007 through collaboration by the U.S. Department of Agriculture’s...

On April 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Administrative Law Judge (ALJ) Susan L. Biro issued an order denying Petitioners Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI or Petitioners) motion for accelerated decision and deciding that the abbreviated Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) cancellation hearing, rather than the full Section 6(b) process, was appropriate (Order).  This decision is significant...

In an April 22 memorandum, the Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced its intent to begin preliminary research to assess the EPA’s inspections of, and enforcement against, illegal pesticide imports. OIG states that its objective with this project is to “determine whether the EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) import inspection program is effectively deterring, identifying and confiscating illegal...

In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens.  Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  Many...

On March 28, 2016, a three-judge panel in the U.S. Court of Appeals for the Ninth Circuit, Case Nos. 15-71207, et al. (consolidated) issued an order denying the Petitioners’ March 10, 2016, motion asking the court to adjudicate their challenges to the Environmental Protection Agency’s (EPA) registration of the pesticide Enlist Duo during remand of the registration decision to EPA, as well as their alternative request that the court stay issuance of its mandate and retain...

On March 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) sent a memorandum to Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), announcing that it plans to begin preliminary research to assess EPA’s management and oversight of resistance issues related to herbicide tolerant genetically engineered (GE) crops.  OIG states that its review will include the Office of Pesticide Programs (OPP), as well...

On March 10, 2016, the U.S. Environmental Protection Agency (EPA) filed a motion to dismiss for lack of subject matter jurisdiction and a supporting memorandum of law (Memorandum) in Anderson v. McCarthy, Case No. 3:16-cv-00068 (N.D. Cal. filed Jan. 6, 2016).  In support of its motion, EPA states that the District Court lacks jurisdiction because three of the four claims stated in the complaint “seek review of a guidance document that does not constitute ‘final agency action’...

On March 16, 2016, the European Commission (EC) issued its final report on the sustainable use of biocides.  Article 18 of the European Union’s (EU) biocidal products regulation (BPR) directs the EC to issue a report on how the BPR contributes to the sustainable use of biocidal products, and on whether there is a need to introduce additional measures, in particular for professional users, to reduce the risks posed to human health, animal health, and the environment by...

On March 17, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), announced in an open letter to stakeholders, that it has developed new tools to “enhance the quality of its risk assessments and risk management decisions and better ensure protection of human health and the environment from pesticide use.”  These tools have been developed as part of EPA’s efforts to implement OPP’s Strategic Vision for Adopting 21st Century Science...

On March 8, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register stating that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will hold a three-day meeting scheduled for April 19-21, 2016, from 9:00 a.m. to 5:00 p.m. (EDT) to consider and review Chlorpyrifos:  Analysis of Biomonitoring Data.  The meeting will be held at EPA’s Conference Center, Lobby Level, One...

On May 11, 2016, the U.S. Court of Appeals for the Ninth Circuit issued an unpublished memorandum decision in an environmental justice case, Garcia v. McCarthy, Case No. 14-15494, that many have been watching closely.  The Ninth Circuit affirmed a decision by the U.S. District Court dismissing the Plaintiffs’ Complaint for lack of subject matter jurisdiction.  The District Court case involved an effort by the original complainants (parents of Latino school children) to obtain...

On February 29, 2016, the U.S. Environmental Protection Agency (EPA) released a prepublication copy of a notice of intent to cancel all Bayer CropScience, LP and Nichino America, Inc. (BCS/NAI) flubendiamide products.  The affected products are: EPA Reg. No. 264-1025 -- BELT SC Insecticide; EPA Reg. No. 71711-26 -- FLUBENDIAMIDE Technical; EPA Reg. No. 71711-32 -- VETICA Insecticide; and EPA Reg. No. 71711-33 -- TOURISMO Insecticide. The cancellation notice was issued by EPA, pursuant...