The U.S. Environmental Protection Agency (EPA) recently settled two cases involving allegations of non-compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Although the Consent Agreement and Final Orders (CAFO) and Stop Sale, Use or Removal Orders (SSURO) issued in these cases are not yet available online, the penalty amounts at issue -- $200,000 and $1,489,000 -- reflect increased enforcement in targeted areas and EPA’s willingness to seek and obtain heroic...
On October 15, 2019, EPA posted a total of 11 documents to the registration review docket for paraquat dichloride (EPA-HQ-OPP-2011-0855). Of primary interest in the registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are the draft human health and ecological risk assessments. Additional supporting documents posted to the docket include dietary, residential, and occupational exposure assessments; a review of analytical...
On October 31, 2019, as required by the 2018 Farm Bill, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service published its interim rule, “Establishment of a Domestic Hemp Production Program” (Interim Rule). The Interim Rule proposal specifies rules and regulations governing hemp production in the U.S., including: Requirements for state/tribal plans for states pursuing regulatory authority over hemp production; Recordkeeping requirements; Licensing requirements;...
October 30, 2019
EPA Proposes Rule to Update the Worker Protection Standard Pesticide Application Exclusion Zone Requirements
On October 24, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is proposing narrow updates to the Worker Protection Standard’s (WPS) provision on the Application Exclusion Zone (AEZ) requirements. By narrowing updates to the WPS, EPA states that it will “improve the long-term success of the agency’s Application Exclusion Zone requirements” and “would improve enforceability for state regulators and reduce regulatory burdens for farmers.” EPA believes...
On October 17, 2019, the U.S. Environmental Protection Agency (EPA) released the Spanish Translation Guide for Pesticide Labeling resource for use by all, including pesticide registrants that choose to display parts of their pesticide product label in Spanish. The purpose of the guide is to be a resource for the translation of the health and safety sections on pesticide labeling from English to Spanish. EPA states that the “guide is written in a universal form of Spanish...
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) released an updated Aquatic Life Benchmarks Table for registered pesticides. The update includes four newly registered pesticides and their degradants as well as new values for more than 30 previously registered pesticides. The benchmarks inform state and local regulators in their interpretation of water quality monitoring data. Waterbodies where benchmarks are exceeded may be prioritized for further investigation. EPA...
October 8, 2019
EFSA Opens Consultation Period on Two Pilot Assessments on the Risks Caused by Multiple Pesticide Residues in Foods
On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food. EFSA is seeking comments from interested parties on the assessments. The first assessment considers the chronic effects of multiple pesticides on the thyroid system. The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...
On October 2, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and soliciting public comment on, the draft document entitled “Antimicrobial Performance Evaluation Program (APEP) A (Draft) Risk Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants” (draft Strategy). EPA states that “The draft Strategy provides a framework to ensure that registered hospital-level disinfectants...
October 1, 2019
EPA Announces Revised Service Fees for Pesticide Registration Applications Under PRIA 4
On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019. The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019. The revised fees will remain in effect...
On September 24, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines. The guideline, 810.3500 Premise Treatment, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies and wasps in connection with registration of pesticide products for use against public health...
September 11, 2019
EPA Seeks Comment on its Risk Assessment Methodology for Evaluating Potential Synergistic Effects of Pesticides on Non-Target Organisms
On September 9, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) published a notice in the Federal Register announcing the availability of, and an opportunity for comment on, a document describing an “interim process” that OPP’s Environmental Fate and Ecological Effects Division is currently using to evaluate potential synergistic effects of mixtures of pesticide active ingredients on non-target organisms. As part of...
September 6, 2019
Environmental Modeling Public Meeting Announced by EPA Environmental Fate and Effects Division
On September 4, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ Environmental Fate and Effects Division (EFED) announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019. The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory...
On August 28, 2019, the U.S. Environmental Protection Agency (EPA) released the Frequently Asked Questions (FAQ) web resource for the Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines. As of August 28, 2019, efficacy testing should be in compliance with the following Product Performance Test Guidelines published by EPA in February 2018: 810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides, Guide for...
August 28, 2019
NIEHS-Funded Research Finds that Graphene Shield Shows Promise in Blocking Mosquito Bites
On August 26, 2019, the National Institute of Environmental Health Sciences (NIEHS) announced that the results of an NIEHS-funded study show that graphene could provide alternatives to chemicals in insect repellant and protective clothing. The study, “Mosquito Bite Prevention through Graphene Barrier Layers,” was published in the Proceedings of the National Academy of Sciences. According to the abstract, the researchers hypothesized that graphene films may provide mosquito bite...
On August 27, 2019, the U.S. Environmental Protection Agency (EPA) published a proposed rule in the Federal Register that makes several changes to the current “Crop Group 19: Herbs and Spices Group.” This latest proposal, which is the fifth in a series of crop group amendments, was created in response to a petition developed by the International Crop Group Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4...
On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site. The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol...
On August 13, 2019, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a four-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will be held November 19-22, 2019. The meeting location will be announced in the future on the FIFRA SAP website. The title of the SAP meeting is “Approaches for Quantitative Use of Surface Water Monitoring Data in Pesticide...
On August 14, 2019, the California Department of Pesticide Regulation (DPR) issued cancellation notices to thirteen California registrants of pesticide products containing chlorpyrifos, including Dow Agrosciences LLC (now Corteva). Each of these notices is referred to as an "Accusation," and each affected registrant has 15 days to request a hearing concerning the proposed cancellation. DPR's issuance of these notices followed a final decision by the U.S....
On August 7, 2019, the League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, and other petitioners (Petitioners) filed a new petition in the Ninth Circuit Court of Appeals seeking judicial review of United States Environmental Protection Agency (EPA) orders denying their request that EPA revoke all tolerances and cancel all registrations for chlorpyrifos. On August 8, 2019, New York, California, Hawaii, Maryland, Vermont,...
On August 2, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it has decided to reduce the Food Quality Protection Act (FQPA) safety factor for infants and children for pyrethroids from its current value of 3X to a new value of 1X. This decision is based on a July 1, 2019, OPP report entitled “USEPA Office of Pesticide Programs’ Re-evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data...
On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor. EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries. EPA states that...
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 spent just over five...
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 not yet...
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) related to a...
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, the Senate...
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...