On July 18, 2019, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a Federal Register notice announcing a final order denying the Pesticide Action Network North America’s (PANNA) and the Natural Resources Defense Council’s (NRDC) 2007 Petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos (Order). This Order constitutes final Agency action denying all of the Petitioners’ objections to EPA’s...
July 2, 2019
EPA Extends Deadline to Submit Comments on Proposed Interim Registration Review Decision for Glyphosate
On June 26, 2019, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment deadline on its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms. 84 Fed. Reg. 30112. EPA states that it is extending the comment deadline “after receiving public comments requesting additional time to review the Glyphosate Proposed Interim Registration Review Decision and supporting materials.” The deadline to submit...
On June 14, 2019, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2019-01, “Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room.” Before a pesticide can be registered for use in Canada, PMRA states that it reviews the available scientific test data to determine whether there are concerns for human health or safety, or the environment, when the product is used according to the...
On May 31, 2019, Health Canada’s Pest Management Regulatory Agency (PMRA) issued its Proposed Re-evaluation Decision PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment (Updated Environmental Risk Assessment). PMRA states that this re-evaluation “considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies” and that “Health Canada applies internationally accepted...
June 7, 2019
Ninth Circuit Makes Determination on Scope of Review of EPA Order on Enlist Duo; Requests Briefing
On May 30, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order in National Family Farm Coalition v. EPA, No. 17-70810 (filed Mar. 21, 2017) regarding the scope of its review of a petition challenging a 2017 U.S. Environmental Protection Agency (EPA) Notice of Pesticide Registration. This 2017 order addresses Dow AgroSciences LLC’s Enlist Duo product. The Petitioners include the National Family Farm Coalition and the Natural Resources Defense...
On May 21, 2019, the U.S. Environmental Protection Agency (EPA) announced that “to increase transparency and ensure information is easily accessible,” it has created a new web-based table of the most recent pesticide registration review actions that contains a list of the registration review actions EPA has taken over the current fiscal year, including the chemical name, docket number, and public comment period when applicable. EPA will update the table each time a registration...
May 30, 2019
California DPR Announces Changes to California-like Conditions for Terrestrial Field Dissipation Studies
On May 29, 2019, the California Department of Pesticide Regulation (DPR) released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06). Notice 2018-06, issued in January of 2018, provided to applicants for California registration...
On May 28, 2019, the California Department of Pesticide Regulation (DPR) posted a new presentation identifying the top ten agricultural pesticide use violations of 2018. Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.” The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here. The violations are listed from the least common (number 10) to...
Please check out Bergeson & Campbell, P.C.’s (B&C®) new podcast “Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn” on its All Things Chemical™ webpage. In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP): Alexandra Dapolito Dunn. As Assistant Administrator Dunn has...
On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos. In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health...
On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method). 84 Fed. Reg. 22120. It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide...
On May 15, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is extending the comment period for the Draft Guidance for Plant Regulator Label Claim, Including Plant Biostimulants that was made available on March 27, 2019. 94 Fed. Reg. 21773. The original comment date was May 28, 2019; comments are now due by July 28, 2019, in Docket No. EPA-HQ-OPP-2018-0258. Several trade groups and a number of individual companies had requested an...
On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms. 84 Fed. Reg. 19782. In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential...
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300: Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests. The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel...
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and...
April 29, 2019
Ninth Circuit Issues Order Requiring EPA to Rule on Objections to Denial of Tolerance Revocation for Chlorpyrifos within 90 Days
On April 19, 2019, the U.S. Circuit Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order following an en banc rehearing in League of United Latin Am. Citizens (LULAC) v. Wheeler, No. 17-71636. The February 6, 2019, Ninth Circuit decision to grant a U.S. Environmental Protection Agency (EPA) request for rehearing effectively vacated an August 9, 2018, decision in LULAC that had ordered EPA to revoke all tolerances and cancel all registrations for...
On April 23, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making available its Interpretive Statement addressing whether the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) permit program applies to releases of a pollutant from a point source to groundwater (Interpretive Statement) for comment. 84 Fed. Reg. 16810. EPA is issuing the Interpretative statement to “provide clarity on [EPA’s] interpretation...
On April 19, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 8, 2019, from 9 a.m. to 5 p.m. and May 9, 2019, from 9 a.m. to 12:00 p.m. (EDT) in the first-floor conference center at One Potomac Yard South, 2777 South Crystal Drive in Arlington, Virginia. 84 Fed. Reg. 16486. The Federal Register notice states that the agenda is...
On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket on the draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile. Comments are due by July 8, 2019. The draft profile includes a chapter on glyphosate’s potential for human exposure, which...
March 27, 2019
EPA Releases Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants
On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. Comments on the draft guidance are due by May 28, 2019. EPA states that the draft guidance is intended to “provide guidance on identifying product label...
On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was updating its Residual Time to 25% Bee Mortality (RT25) Data Table with information it has collected since the table was first published in 2014. EPA states that the “RT25 data help farmers and beekeepers know about how long a specific pesticide may remain toxic to bees and other insect pollinators following foliar application to crops,” and the new data “reflect the results of studies...
March 15, 2019
European Court Annuls Prior Judgments to Protect Testing Information Related to Glyphosate Authorization
On March 7, 2019, in the Court of Justice of the European Union (EU), the Eighth Chamber of the General Court issued two judgments in cases regarding access of confidential information related to glyphosate. One of these decisions (Tweedale v. EFSA, Case T-716/14) related to a 2014 request for two toxicity studies that were “key studies” in the determination of glyphosate’s acceptable daily intake (ADI). The second decision (Hautala et al. v. EFSA, Case T-329/17)...
On March 8, 2019, President Trump signed S. 483, the “Pesticide Registration Improvement Extension Act of 2018,” which reauthorizes the Pesticide Registration Improvement Extension Act (PRIA 4) through fiscal year 2023, updates the fee collection provisions and authorities available under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and addresses worker protection matters. The text is available at Congress.gov, which has not yet been updated to confirm...
On February 14, 2019, the Senate approved S. 483 to reauthorize the Pesticide Registration Improvement Extension Act (PRIA 4). The Senate bill did not have the specific categories and timelines of earlier reauthorization language, referring instead to more general legislative language that the Senate approved during the Farm Bill authorization in 2018. Legislation in this new session of Congress was necessary since PRIA was not reauthorized as part of the appropriations language...
February 28, 2019
New All Things Chemical Podcast™ Episode “Pesticides: Navigating New Technologies under FIFRA”
This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides: past, present, and future. In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we...
February 26, 2019
Ninth Circuit Grants Petition for En Banc and Panel Rehearing in Chlorpyrifos Case
On February 6, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting the U.S. Environmental Protection Agency’s (EPA) and Acting EPA Administrator Andrew Wheeler’s (collectively EPA or Respondents) September 24, 2018, petition for an en banc rehearing concerning the Ninth Circuit’s August 9, 2018, decision that vacated an EPA order maintaining chlorpyrifos registrations and remanded the case to EPA with directions to revoke all tolerances...
February 25, 2019
FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Combination Sunscreen-Insect Repellent Products
The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Under the proposed rule, products that...
The Appropriations Bill that is expected to be signed into law on February 15, 2019, provides funding for the rest of Fiscal Year (FY) 2019 and averts another federal government shutdown. It does not, however, include either an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or Reauthorization, widely referred to as PRIA 4. This omission was a surprise to industry and to the U.S. Environmental Protection Agency (EPA). On February 13, 2019,...
As reported in the trade press on February 14, 2019, following budget negotiations late on Wednesday, February 13, several legislative riders did not make it into the conference report for the final fiscal year (FY) 2019 omnibus spending package. This purportedly includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or the long-awaited Reauthorization known as “PRIA 4.” This may be the result of political pressure to avoid another government...
February 12, 2019
Deadline for Filing Annual Pesticide Production Reports — March 1, 2019
The March 1, 2019, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2018 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of...
The short-term continuing resolution (CR) includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) through the duration of the funding measure, February 15, 2019. This was expected, and is welcome news to registrants who have delayed submittal of registration applications due to the shutdown. The status of applications submitted during the shutdown period is uncertain at best. As described in our earlier blog item Registrants Face PRIA and Shutdown...
January 3, 2019
CDPR Issues Notice 2018-26 for Changes to Notice of Decision and Public Report Documentation
On December 28, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-26 changing its Notice of Decision (NOD) and public report documentation for proposed registration decisions to ensure continued compliance with its certified regulatory program obligations under the California Environmental Quality Act (CEQA). The new changes to the NODs and public report documentation will be effective May 1, 2019. These changes are as a result of a 2014...
Due to the government shutdown and to the late notification to applicants, the U.S. Environmental Protection Agency (EPA) has extended the annual maintenance fee submission date for pesticide registrants from January 15, 2019, to February 15, 2019. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A), each registrant of a pesticide must pay an annual fee by January 15 of each year for each registration; the fee for 2019 is $ 3,392. The...
Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down. Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown. According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B)...
December 21, 2018
Appropriations Continuing Resolution Passed by the Senate on December 19, 2018, Extends PRIA through February 8, 2019
On December 19, 2018, the Senate passed a short-term Continuing Resolution (CR) to prevent a government shutdown and continue funding for the government through February 8, 2019. Currently, however, given the uncertainty over border wall funding, it appears likely that there may well be a government shutdown for some period of time. Until the immigration issue is ultimately resolved in an eventual agreement, however, the majority and Democratic staff of the U.S. House of...
December 14, 2018
EPA Proposes Joint Stipulation in Ellis Case Requiring EPA to Issue ESA Effects Determinations for Two Neonicotinoid Pesticides
On December 12, 2018, the U.S. Environmental Protection Agency (EPA) announced a proposed joint stipulation and proposed stipulated notice of dismissal for Ellis v. Keigwin, No. 3:13-CV-1266 (N.D. Cal). 83 Fed. Reg. 63865. The Federal Register notice states that the parties are “proposing to reach a settlement in the form of a joint stipulation” that would, among other provisions “set a June 30, 2022, deadline for EPA to complete ESA [Endangered...
December 12, 2018
European Court Denies Appeal to Disclose Testing Information related to Glyphosate Authorization
On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an...
December 11, 2018
EPA Issues Proposed Rule to Harmonize EPA-specific Regulations in Revised Common Rule
On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149). Specifically, EPA is proposing to amend subparts C,...
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from...
November 9, 2018
EPA Orders Arizona Pool Chemical Company to Stop Sales of Bacteria and Algae Control Product
On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets. The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA. EPA’s...
On October 31, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is extending the registration of dicamba for two years for “over-the-top” use (application to growing plants) to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. EPA states that the registration for these dicamba products will expire on December 20, 2020, unless EPA decides to further extend it. EPA states that the label changes described below...
On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the...
On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on November 1, 2018, from 8:30 a.m. to 12:00 p.m., it will be hosting an informational seminar on biotechnology-pesticide issues for stakeholders. 83 Fed. Reg. 50921. The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777...
October 3, 2018
EPA Requests Public Nominations for FIFRA SAP; Requests Independent Scientific Advice on Health and Safety Issues
On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB). 83 Fed. Reg. 49091. EPA states that “all nominees will be considered for ad...
On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards. Section 18 of the Federal Insecticide, Fungicide, and...
On September 24, 2018, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit), respondents U.S. Environmental Protection Agency (EPA) and Acting EPA Administrator Andrew Wheeler (collectively EPA) petitioned for an en banc and panel rehearing concerning the Ninth Circuit’s August 9, 2018, decision that granted judicial review of EPA’s initial order denying an administrative petition by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense...
September 27, 2018
California DPR Proposes Rule to Designate Chlorpyrifos as a Toxic Air Contaminant
On September 19, 2018, the California Department of Pesticide Regulation (DPR) proposed a regulation to designate chlorpyrifos as a toxic air contaminant (TAC). DPR states that this proposal is being presented “after an extensive period of scientific and public review.” The proposed rule is based on a final evaluation issued in July 2018, in which DPR’s Human Health Assessment (HHA) Branch determined that chlorpyrifos meets the quantitative criteria for designation as...
On September 20, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00 p.m. to 3:30 p.m. (EDT). The announcement states that this webinar is tailored for “growers, pesticide applicators, pest management professionals, and other interested stakeholders who work in crop production.” The webinar will be presented by Dr. Greg Kruger, a weed science and application...
August 22, 2018
EPA Posts New FAQs on Honeybee Toxicity Testing for Registrants and Contract Laboratories
On August 21, 2018, the U.S. Environmental Protection Agency (EPA) announced it was posting new frequently asked questions (FAQ) for registrants and contract laboratories conducting honeybee toxicity testing. EPA states that these FAQs are “made up of responses to inquiries EPA commonly receives about protocols used to generate honeybee toxicity data for submission in support of pesticide registration,” and are “meant to complement the Agency’s existing Pollinator Risk Assessment...
August 10, 2018
Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos
On August 9, 2018, the majority of a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by the U.S. Environmental Protection Agency (EPA) that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back...