All Knowledge & Insights By Date

On September 19, 2017, the U.S. Environmental Protection Agency (EPA) announced an update to Chapters 15 and 16 of the Office of Pesticide Programs’ (OPP) Label Review Manual.   Updates to Chapter 15: Company Name and Address, include removing non-label related instructions on submitting address change requests and updating the National Pesticide Information Center’s contact information, including new hours of operation.  Updates to Chapter 16: Graphics and Symbols, include...

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments.  EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration...

On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year.  The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically.  The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration.  This new PSP, version 1.4,...

On July 18, 2017, four Senators (Tom Udall (D-NM); Benjamin Cardin (D-MD); Richard Blumenthal (D-CT); and Cory Booker (D-NJ)) submitted a letter to Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI), the Chairman and the Ranking Member of the Senate Committee on Agriculture, Nutrition, and Forestry, regarding reauthorizing the Pesticide Registration Improvement Act (PRIA), worker protections, and the U.S. Environmental Protection Agency’s (EPA) “legal duty to protect the public from...

On August 1, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa (P. aeruginosa) and Staphylococcus aureus (S. aureus): EPA Microbiology Laboratory Branch (MLB) SOP MB-19:  Growing a Biofilm using the CDC Biofilm Reactor; and EPA MLB SOP MB-20:  Single Tube Method for...

On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings.  In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the U.S. Environmental Protection Agency’s (EPA) denial of Petitioners’ petition to revoke all...

In June 2017, the U.S. Environmental Protection Agency (EPA) issued a draft Office of Chemical Safety and Pollution Prevention (OCSPP) National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities.  EPA uses an Annual Commitment System (ACS) to track annual regional performance information and...

On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances.  82 Fed. Reg. 27254.  EPA states that this...

A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document.  These...

On June 22, 2017, a complaint was filed against the U.S. Environmental Protection Agency (EPA) by American Oversight, a nonprofit organization (Plaintiff), in the United States District Court for the District of Columbia.  The complaint asks the court to compel EPA to provide information in response to a Freedom of Information Act (FOIA) request submitted by the Plaintiff on April 11, 2017, “seeking communications between certain individuals at each agency and certain outside entities...

On June 1, 2017, in the People’s Republic of China (China), a newly revised Regulation on Pesticide Administration (RPA) became effective.  The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017 and published as Decree Number 677 of the State Council of China (in Chinese only) (China Decree 677) on April 1, 2017. The first version of the RPA became effective on May 8, 1997, and was revised on November 29,...

On May 31, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of its Food Contact Sanitizing Solutions Model (FCSSM), a pesticide risk assessment model that has been developed to “estimate indirect dietary exposure to components of sanitizing solutions used in commercial settings.”  EPA states that “the model offers guidance for estimating exposure where there may be inadvertent transfer of residue to edible items prepared or transported on surfaces...

On May 25, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of ecological risk assessments for four neonicotinoid active ingredients for public comment as well as the Registration Review Update for Four Neonicotinoid Insecticides (Update).  82 Fed. Reg. 24113.  The ecological risk assessments are: The preliminary aquatic risk assessment for imidacloprid; The combined preliminary bee risk assessment for clothianidin and thiamethoxam; and The draft...

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration.  NRDC v. EPA, No. 15-72308.  The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the...

On May, 24, 2017, the California Department of Pesticide Regulation (DPR) issued guidance regarding its Notice 2015-13 to applicants registering pesticide impregnated materials bearing pesticide claims to be sold and distributed into or within California, per Notice 2015-13, issued December 11, 2015.  Each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017.  The...

On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of The Year in Review 2016:  Environment, Energy, and Resources Law by the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER).  The Year in Review provides an annual summary of developments in environmental, energy, and resources law.  B&C Managing Partner Lynn L. Bergeson and Senior Chemist Richard E. Engler,...

In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina granted in part a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement.  Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274.  The claims at issue...

On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances.  In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances.  Petitioners state that EPA’s response to the...

On March 29, 2017, U.S. Environment Protection Agency (EPA) Administrator Pruitt signed an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos.  This is the latest EPA action in a long and contentious battle concerning chlorpyrifos tolerances and registrations, and is likely not the end of this...

On March 20, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice that it was delaying the effective date of five regulations, including the final rule on the certification of pesticide applicators.  The effective date for this final rule is now May 22, 2017 (original effective date was March 6, 2017).  In the notice, EPA states that it is “taking this action to give recently arrived Agency officials the opportunity to learn more about these...

On February 21, 2017, the Northwest Environmental Advocates (NWEA) filed a Clean Water Act (CWA) lawsuit in the U.S. District Court for the Western District that involves a number of pesticide active ingredients in addition to other chemicals.  The lawsuit seeks to compel the U.S. Environmental Protection Agency’s (EPA) response to NWEA’s 2013 Petition for Rulemaking to Update the Water Quality Criteria for Toxics in the State of the Washington (NWEA v. EPA, No.: 2:17-cv-00263)....

President Trump’s February 28, 2017, Executive Order (E.O.) directing the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) to rescind and replace the Clean Water Rule (CWR) is the latest development in the attempt to resolve the long-standing question of which surface waters and wetlands may be federally regulated and subjected to permitting under the Clean Water Act (CWA).  Critics of the CWR assert that it would have drastically expanded the reach...

On February 22, 2017, the California Department of Pesticide Regulation (DPR) announced it was extending the filing date for applications to register products made from pesticide impregnated materials bearing pesticide claims from March 1, 2017, to July 1, 2017.  Specifically, each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017.  DPR’s California Notice 2015-13 issued...

On February 17, 2017, the U.S. Environmental Protection Agency (EPA) announced that the Centers for Disease Control and Prevention (CDC) issued guidance revising its recommendation regarding controlling Candida auris (C. auris) infections in U.S. healthcare facilities.  The CDC guidance now recommends a “thorough daily and terminal cleaning and disinfection” of patient rooms in which C. auris infection or colonization was present … with the use of an...

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...

In a final rule issued on January 12, 2017, EPA adjusted the level of statutory civil monetary penalty amounts under the statutes EPA administers. 82 Fed. Reg. 3633. The adjustments are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The latter law prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of...

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...

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 Click here for a PDF brochure of the memorandum 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress significantly amended the Toxic Substances Control Act (TSCA). The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing,...

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...

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 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...

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...

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 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 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 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...

On April 22, 2016, the National Toxicology Program (NTP) issued a monograph concluding that cobalt and cobalt compounds that release cobalt ions in vivo are expected to cause human cancer. Specifically, NTP stated that "[t]here is sufficient evidence for the carcinogenicity of cobalt and cobalt compounds that release cobalt ions in vivo (collectively referred to as cobalt) in experimental animals based on increased incidence of malignant and/or a combination of malignant and...