FIFRAblog®

The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 reporting year is fast approaching.  Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “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...

Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021.  Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff.  According to the...

On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in response to the request of retailers, states, and industry. Registrants who wish to disclose all inert ingredient can choose to do so in three ways under the new policy: On the product label as part of the full ingredient statement or on the product’s back...

On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos.  85 Fed. Reg. 78849.  EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments.  The PID proposes the following measures: Label amendments limiting application to address potential drinking water risks of...

The January 15, 2021, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires that everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect.  The maintenance fee...

On November 16, 2020, the U.S. Environmental Protection Agency (EPA) announced that it will now provide pesticide registrants with electronic Certificates of Registration, commonly known as “Gold Seal” letters.  A Gold Seal letter from EPA certifies that a product to be exported is registered with EPA and meets all necessary registration requirements.  EPA states that this improved process will allow for the electronic Gold Seal letters to be e-mailed to registrants...

On November 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register that makes several changes to “Crop Group 19:  Herbs and Spices Group.”  85 Fed. Reg. 70976.  The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional...

On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment.  85 Fed. Reg. 70146. EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service,...

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307. The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting...

On October 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.”  According to EPA, the targeted changes improve the enforceability and...

On October 30, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria.  EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as pesticide devices...

On October 28, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report).  85 Fed. Reg. 68327.  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The...

On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses.  This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes...

On October 15, 2020, the U.S. Environmental Protection Agency (EPA) announced a settlement with Electrolux Home Products, Inc. (Electrolux) to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for importing air filter products that contain nanosilver.  Specifically, the settlement resolves EPA’s claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notices of...

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  EPA’s guidance specifies scientific testing requirements for two different types of products:  (1) disinfectants that also provide residual efficacy, and (2)...

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below. This week, I sat down with Lisa Campbell, my Partner here at Bergeson & Campbell (B&C®) and its consulting affiliate, The Acta Group (Acta®), and a well-recognized expert on all things regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  With so much attention...

On October 6, 2020, the California Developmental and Reproductive Toxicant Identification Committee (DARTIC) announced it will be meeting on December 11, 2020, to discuss the possible developmental and reproductive toxicity (DART) of 22 chemical substances and chemical groups, including glyphosate and its salts, and three neonicotinoid pesticides (acetamiprid, clothianidin, and imidacloprid).  DARTIC is composed of scientists who advise California’s Office of Environmental Health...

On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects.  This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by...

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  As most know, EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time,...

Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, wrote to Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos on October 7, 2020, requesting that he launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall...

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below. This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group.  As a former Assistant Administrator in what is now the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim has a...

Innovations in agricultural chemicals have revolutionized and enhanced food production, but with progress come new challenges.  Agricultural chemicals can have widespread impacts on ecosystems and human health, and marginalized communities -- children and farmworkers in particular -- can be especially vulnerable.  Manufacturers, regulatory agencies, public health experts, and nonprofit organizations are working to address these challenges head-on by developing new products and devising robust...

On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days.  EPA states that after carefully reviewing the available data and...

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted from pesticide registration.  One of those conditions is that the active ingredient in the minimum...

On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens.  EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims. ...

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2.  In January 2020, at the...

On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.  This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product...

On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19.  This research is being conducted at EPA’s Office of Research and Development's Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the high...

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below. This week I sat down with James Aidala, B&C’s Senior Government Affairs Consultant, to catch up on what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is up to and to get a sense of what we might expect to develop over the remainder of the year.  As a...

On July 6, 2020, the U.S. Environmental Protection Agency (EPA) announced that it approved amended labels for two products, Lysol Disinfectant Spray (EPA Reg. No. 777-99) and Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127), based on laboratory testing that shows the products are effective against SARS-CoV-2.  These are the first products for which EPA has reviewed laboratory testing data and approved label claims against SARS-CoV-2.  In January 2020, at the beginning of the...

The U.S. Environmental Protection Agency (EPA) announced on July 2, 2020, that it has registered NSPW Nanosilver (a new nanosilver formulation) to suppress odor-causing bacteria and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles.  Textiles that may be treated with NSPW Nanosilver include fabrics, sportswear, footwear, linens, and awnings.  NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH...

On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate.  The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial...

On June 17, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use, or Removal Order (SSURO) to OCCS, Inc. (OCCS) for the sale and distribution of unregistered antimicrobial disinfectants.  EPA Region 9 states in a press release that OCCS, a chemical supply company located in Stanton, California, distributed and sold two unregistered products, Sanitizer/Quat Solution Ready to Use and Quat Solution Ready to Use Cleaner, in violation of the Federal Insecticide,...

On June 11, 2020, the U.S. Environmental Protection Agency (EPA) announced in a press release that it issued stop sale, use, or removal orders (SSURO) to Amazon.com Services LLC (Amazon) and eBay, Inc. (eBay) for selling certain pesticide products that EPA claims are unregistered, misbranded, or restricted-use pesticides, and pesticide devices that EPA asserts make false or misleading claims.  The SSUROs address over 30 products sold on Amazon and over 40...

On June 8, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of an existing stocks order under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1) governing further sale, distribution, and use of existing stocks of three reduced volatility dicamba products (XtendiMax®, EngeniaTM, and FeXapanTM) with conditional registrations that were vacated by the June 3, 2020, decision of the Ninth Circuit Court of Appeals in National Family...

On June 3, 2020, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in National Family Farm Coalition v. EPA, No. 19-70115, vacating the U.S. Environmental Protection Agency’s (EPA) 2018 decisions to extend the conditional registrations for  three reduced volatility dicamba herbicides, Bayer’s XtendiMax, Corteva’s FeXapan, and BASF’s Engenia.  The manufacturers of these dicamba products designed them to facilitate control of glyphosate...

On June 1, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a compliance advisory on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA states that the advisory was issued because it has received tips and complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices.  EPA says it is actively...

From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf.

On May 15, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is issuing its third temporary modification to Pesticide Registration (PR) Notice 98-10 to include food-contact surface sanitizer products containing the active ingredient (AI) isopropyl alcohol.  This new temporary amendment permits all the registration modifications outlined in the March and April modifications, while also expanding the criteria for the types of products that qualify for the provisions of...

The Science Advisory Board (SAB) of the U.S. Environmental Protection Agency (EPA) announced that it will convene the Chartered SAB meeting on May 20, 2020, to review and discuss the draft report prepared by the SAB COVID-19 Review Panel.  The draft report, SAB Technical Review of EPA’s Identification of Research Needs to Address the Environmental and Human Health Impacts of COVID-19, was funded by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.  This...

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19. EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the...

On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment.  The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19. DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor...

On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases including Zika virus.  The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring...

On April 29, 2020, the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the...

On April 24, 2020, the U.S. Environmental Protection Agency (EPA) and U.S. Customs and Border Protection (CBP) announced that the agencies prevented a significant number of shipments of illegal health products from entering the Los Angeles International Airport (LAX) and the San Francisco International Airport (SFO). The products at issue were not registered with EPA, including Virus Shut Out products.  EPA previously announced on March 25, 2020, that EPA and CBP had...

On April 23, 2020, the Supreme Court ruled that pollution traveling indirectly to rivers and streams through groundwater can be covered by the Clean Water Act’s (CWA) permitting requirements.  The case, County of Maui, Hawaii v. Hawaii Wildlife Fund, et al, 590 U.S. (2020), concerned whether pollutants discharged from a point source into groundwater, a non-point source, and then conveyed into navigable waters fall within permitting requirements of the CWA.  In a 6-3 Opinion...

On April 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Wheeler has requested that the Science Advisory Board (SAB) provide feedback on research needs concerning SARS-CoV-2 (the virus that causes COVID-19).  This research is intended to help EPA understand and mitigate the environmental and human health impacts from COVID-19, and identifies EPA research that is already underway as well as new EPA research that has been proposed.  EPA issued...

On April 23, 2020, the U.S. Environmental Protection Agency (EPA) announced it is continuing efforts to provide critical information on surface disinfectant products that can be used against SARS-CoV-2, which causes COVID-19.  EPA states that it now has nearly 400 products that have qualified to be effective against SARS-CoV-2.  EPA also published an overview of its actions and resources related to disinfection against the novel coronavirus. EPA’s Office of Chemical Safety and...

On April 22, 2020, Assistant Administrator Alexandra Dapolito Dunn stated, on prerecorded remarks posted by the American Bar Association, that the U.S. Environmental Protection Agency (EPA), after the coronavirus crisis subsides, will review whether some of the current requirements to submit notifications or label amendments are necessary.  Some of these requirements have been suspended as part of EPA’s efforts to hasten the process for disinfectants approved for use against SARS-CoV-2,...

Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member...