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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 workability of the AEZ requirements, decrease regulatory burdens for farmers, and maintain critical worker protections. EPA also states the revisions made to the AEZ are consistent with the 2018 Pesticide Registration Improvement Extension Act of 2018 (PRIA 4).
The final AEZ requirements will go into effect on December 29, 2020.
EPA initially promulgated the WPS regulation in 1992 under EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorities to protect farm workers from pesticide exposures in production agriculture. According to EPA, “WPS is a uniform set of requirements for workers, handlers, and their employers that are generally applicable to all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its requirements complement the product-specific labeling restrictions and are intended to minimize occupational exposures generally.”
In 2015, EPA issued significant revisions to the 1992 WPS. Of particular significance, 2015 revisions included a new provision requiring agricultural employers to keep workers and all other individuals out of the AEZ during outdoor pesticide applications. The AEZ was set at 25 feet in all directions for ground pesticide applications when sprayed from a height greater than 12 inches, and 100 feet in all directions for outdoor aerial, air blast, air-propelled, fumigant, smoke, mist, and fog pesticide applications. This provision was controversial, however, with state regulators expressing concerns with enforcing the complex AEZ requirements and farm owners expressing concerns with applying and complying with pesticide regulations.
EPA states in the final rule that it clarified and simplified the AEZ requirements based in part on input from state pesticide regulatory agencies and agricultural stakeholders after the adoption of the 2015 WPS rule. Consistent with PRIA 4, EPA is implementing changes related only to the AEZ requirements in the WPS. These targeted changes include:
EPA states that many of the changes proposed in November 2019 were retained in the final rule. Changes that were made include the following:
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 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2018 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before December 28, 2020.
EPA’s completed product reregistration actions totaled 177, short of EPA’s goal of 400 actions. The table below details the actions completed in FY 2018.
Table 1. Product Reregistration Actions Completed in FY 2018 (as of September 30, 2018)
EPA also states that 4,193 products had product reregistration decisions pending at the end of FY 2018, compared to 4,370 products with product reregistration decisions pending at the end of FY 2017, and 4,621 products with product reregistration decisions pending at the end of FY 2016. Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”
The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has been more consistent in recent years, with 2,422, 2,574, and 2,303 in 2016, 2017, and 2018, respectively.
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 COVID-19. While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks, or years after the product is applied.
EPA announced in an October 26, 2020, memorandum that it is seeking feedback from the public on the expedited process, design elements for evaluating residual product claims, and the test methods associated with this initiative.
All comments on the interim guidance must be submitted to Docket Number EPA-HQ-OPP-2020-0529 on or before January 4, 2021.
The interim guidance documents -- Interim Method for Evaluating the Efficacy of Antimicrobial Surface Coatings, Interim Guidance - Expedited Review for Products Adding Residual Efficacy Claims, and Interim Method for the Evaluation of Bacterial Activity of Hard, Non-Porous Copper-Containing Surface Products -- are available in Docket Number EPA-HQ-OPP-2020-0529. More information on the interim guidance is available on our blog.
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 Arrival in violation of FIFRA Section 12(a)(2)(N). As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400. The Consent Agreement and Final Order (CAFO) is available here.
According to EPA, Electrolux imported approximately 420,000 Frigidaire brand dehumidifiers and air conditioners that contained filters incorporating an unregistered nanosilver and that were labeled and marketed with pesticidal claims. With regard to the incorporation of nanosilver, there currently are no nanosilver pesticide products registered with EPA for use in home appliances to disinfect the ambient air or protect the health of the user. The only nanosilver pesticides that are currently registered with EPA are approved solely for incorporation into textiles to protect those articles themselves from antimicrobial pests such as mold and bacteria that can cause deterioration, discoloration, or odors. In those cases, the products (textiles) incorporated with nanosilver can be exempt from FIFRA registration under the “treated article” exemption. With regard to the claims, EPA states that claims it considers pesticidal include “antibacterial filter,” and “helps eliminate bacteria in the air that can make breathing difficult.”
The penalty in this case is significant, and represents a potentially growing trend for penalty amounts substantially higher than past cases. This trend is due at least in part to the inflation adjustments to statutory civil penalty amounts, as discussed further here.
In addition to the civil penalty, the CAFO states that Electrolux has replaced the filters manufactured with nanosilver and removed the online and on-box pesticidal claims for the products it had imported, as well as some additional products already in the United States. The CAFO states:
The CAFO further states that “Respondent offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver within its possession regardless of the date those products were imported.” To date, EPA states that Electrolux has brought over 500,000 air conditioners and dehumidifiers into compliance.
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) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that do not meet EPA’s standards for disinfectants but are intended to be used as a supplement to standard List N disinfectants.
In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings. These laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.
While EPA does not have an approved standard method to support virus claims for these types of products, EPA states that the following information is intended to provide interim guidance on the study design elements necessary to support these types of claims. EPA states that it may consider other methods or studies to support residual efficacy claims, provided they are scientifically sound. Applicants are highly encouraged to consult with EPA prior to submitting. Of significant interest, EPA states that products may make both types of residual claims provided that they are supported by the appropriate data.
Due to lab capacity concerns, EPA plans to consider non-GLP (Good Laboratory Practice) data to support residual claims, provided that the study submission accurately represents how the study differs from the GLP standards in the 40 C.F.R. Section 160.12 statement of non-compliance. Additional details provided in the EPA guidance on how to qualify products for residual disinfectants or supplemental residual antimicrobial products are briefly outlined below.
Residual Disinfectant Claims
Residual disinfectants must clear a higher standard of efficacy than supplemental residual antimicrobial products. Residual disinfectant products must be effective within 10 minutes of a virus or bacteria contacting a treated surface and must remain effective for up to 24 hours. Surfaces treated with residual disinfectants must not require additional cleaning or disinfection during this window. EPA-approved residual disinfectant products are eligible to be added to List N. In addition, long-lasting coating products must satisfy all requirements for standard disinfectant claims (non-residual) to be eligible for residual disinfectant claims and must have undergone testing to support standard disinfectant claims.
To support a claim as a residual bactericidal disinfectant, applicants should use EPA’s Residual Self-Sanitization Protocol with the following modifications:
EPA’s Residual Self-Sanitization Protocol with the modifications below should be used to support residual virucidal claims. Virucidal efficacy should be assessed consistent with the principles of ASTM E1053 (e.g., recovery, cytotoxicity, neutralization, and calculations), the standard virucidal method detailed in OCSPP 810.2200 Product Performance Test Guideline.
Supplemental Residual Antimicrobial Products
Supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years. These products can supplement, but not replace, routine cleaning and disinfection using products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19). Approved supplemental residual antimicrobial products are not eligible for inclusion on List N, but will be added to a separate List N appendix.
Qualifying antimicrobial surface coatings, films, fixed/solid, and paint products should demonstrate efficacy against vegetative bacteria first before virus claims can be supported. These products are not required to meet the efficacy standards for disinfectants and can only be approved for use as supplements to standard disinfection. The duration of residual effectiveness claims that EPA will consider for expedited review depends on the type of product, as outlined below.
For these products, EPA states that EPA’s draft Performance of Antimicrobial Surface Coatings on Hard Non-porous Surfaces for qualifying bacteria should be used. EPA provides the following additional information for products on which virus claims would be added:
EPA states that this new category of antimicrobial products should be labeled as supplemental residual antimicrobial surfaces. EPA provides the following additional information:
EPA states that these products should use EPA’s Draft Copper Surface Protocol for qualifying bacteria. EPA provides the following additional information for products that wish to have virus claims added.
EPA states that these products should be labeled as supplemental residual antimicrobial surfaces. EPA states the following with regard to these products:
EPA intends to require, as a term of registration, that registrants of all supplemental residual antimicrobial products prepare and implement a written stewardship plan designed to support the responsible use of supplemental residual coatings and antimicrobial surface products. Unlike conventional antimicrobial products, EPA believes that these products represent unique challenges that require timely feedback to ensure proper use and compatibility in combination with current infection control practices. EPA expects that plans would be submitted for EPA review and approval during the registration process, or shortly thereafter (e.g., within two months after the registration date). An approvable plan would address the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products. EPA states that plans should include, at a minimum, the following elements:
EPA states further that “if EPA determines at any time following registration that the Plan is not being adequately or timely implemented or does not effectively ensure the product’s safe and effective use, the registration may be cancelled by the Agency.” It is not clear from the statement whether EPA intends such a cancellation to be a term of the registration or whether it would be undertaken pursuant to the standard FIFRA cancellation procedures.
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 focused on registering new products to combat COVID-19, we thought it timely to check in again with the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) and see what it is up to. OPP has been extraordinarily busy since March keeping up with new products to combat the coronavirus and forging new ways of leveraging its resources while maximizing the public health benefits of these new products.
We also discuss the government’s heightened interest in ensuring that marketers of products -- new and existing -- are precluded from placing products on the market that EPA believes are not effective against COVID-19, when they are promoted as effective against the virus. EPA has been quite aggressive in ensuring that products that claim to be effective in fact are effective.
We then update our listeners on a few other OPP developments unrelated to the pandemic, as OPP’s jurisdiction extends far beyond approving new products to address COVID-19.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.
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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 Hazard Assessment (OEHHA) on the prioritization of chemicals for potential Proposition 65 (Prop 65) listing and identification of chemicals that have been shown through scientifically valid testing according to generally accepted principles to cause reproductive toxicity.
Public comments on the 22 substances will be accepted until November 16, 2020, and OEHHA will forward those comments to DARTIC members prior to its meeting.
The full list of chemicals and chemical groups that DARTIC will discuss are:
OEHHA’s document, Prioritization: Chemicals Identified for Consultation with the Developmental and Reproductive Toxicant Identification Committee, presents information on these chemicals or chemical groups for DARTIC’s consideration. Specifically, OEHHA states: “For each, an initial, abbreviated appraisal of the scientific information identified through the screening-level literature search and the preliminary toxicological evaluation is presented.” With regard to glyphosate and its salts, OEHHA provides “a brief overview of the relevant studies published within the last five years and those included in the Toxicological Profile for Glyphosate by ATSDR (ATSDR 2020) that were identified during the preliminary toxicological evaluation.”
No listing decisions will be made by DARTIC at the December meeting. If OEHHA moves forward to propose to list any substances, it will separately issue a notice and seek public comments.
The fact that OEHHA is seeking DARTIC’s review of glyphosate is particularly interesting, as glyphosate is already listed under Prop 65 based on a finding that glyphosate is a chemical known to cause cancer. That listing is in jeopardy, however, based on a June 2020 court decision that prohibits OEHHA from requiring Prop 65 warnings because the basis for the listing, a determination by the International Agency for Research on Cancer (IARC) that the glyphosate is “probably” carcinogenic to humans, is not consistent with the findings of the U.S. Environmental Protection Agency (EPA) and other agencies. Additional information regarding glyphosate’s Prop 65 listing is available here. If OEHHA is not successful in its appeal of the court’s ruling and is successful in listing glyphosate based on its potential to cause developmental and reproductive toxicity effects, the result would be a new basis upon which to impose Prop 65 warning requirements. At the same time, EPA’s registration review of glyphosate encompasses, in EPA’s view, a health risk assessment, which includes a pesticide’s potential risks of developmental and reproductive effects. As a result, it is not clear if EPA’s arguments that its FIFRA labeling authority prohibits Prop 65 warnings also would apply to its registration review of health risks, which includes possible developmental and reproductive effects.
EPA Announces Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products
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, given the broad diversity of contact opportunities and scenarios. Importantly, EPA states that pursuant to Title VII of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, it is providing notice of its intention to expedite reviews for addition of residual (i.e., extended or long-lasting) efficacy claims for currently registered or new product registrations that are on EPA’s Disinfectant List N, that would qualify for List N, or products that can be used as a residual supplement to disinfectants on List N. The guidance specifies scientific testing requirements for two different types of products, supplemental residual antimicrobial products and residual disinfectants. According to EPA, supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years. EPA notes that these products can supplement, but do not replace, routine cleaning and disinfection using products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19). Approved supplemental residual antimicrobial products are not eligible for inclusion on List N, but EPA will add them to a separate List N appendix.
In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings. According to EPA, “[t]hese laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.”
More information will be available in a forthcoming memorandum that will be available on our website.
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 2035.
According to EPA, the draft dermal toxicity guidance would allow applicants to request waivers for acute dermal toxicity studies on single-active ingredients used to develop end-use products. The new draft guidance also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both formulations and technical chemicals in 2017. The draft guidance is in addition to the final guidance for waiving acute dermal toxicity tests published by EPA in November 2016 for pesticide formulations.
In developing the guidance, EPA states that it conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 active ingredients across numerous chemical classes and toxicity categories. Fumigants and rodenticides were excluded from this analysis, based on their physical state and/or anticipated exposures to them. EPA concluded that for 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category. For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category; thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective. For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements. EPA concluded that its requirements for such acute dermal toxicity studies provide little to no added value in regulatory decision making. EPA states that this guidance, when finalized, is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.
EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides. Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale. Once the guidance is issued in final form, EPA states that applicants who wish to pursue waivers for these studies would submit formal waiver requests as part of the registration application through existing processes and cite the guidance as support for the requests. EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.
Comments on the draft guidance are due on or before November 9, 2020, and can be submitted at http://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2016-0093.
EPA also announced the launch of its new webpage that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and work plans tied to the larger Toxicology in the 21st Century Initiative across the federal government. The directive, issued by EPA Administrator Andrew Wheeler in September 2019, calls for EPA to reduce animal testing and to reduce funding 30 percent by 2025 and eliminate it by 2035. EPA states that its actions to date to support these efforts include:
EPA will host its Second Annual Conference on the State of the Science on Development and Use of NAMs for Chemical Safety Testing virtually on October 19 and 20, 2020. Additional information on EPA’s efforts to reduce animal testing is available here.
Pallone and Schakowsky Request Amazon Investigate Safety of Its Product Line and Answer Questions Pertaining to Company’s Product Safety and Recall Practices
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 practices. The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.” According to the press release, many of these products were never recalled and continue to be sold.
In addition to their request that Bezos initiate an investigation into the safety of AmazonBasics products, Pallone and Schakowsky also seek answers to a series of questions, including:
The letter requests a response no later than October 21, 2020.
The letter and request for answers to the questions noted above are another indication of the pressure certain Members in Congress are putting on Amazon to ensure the safety of the products the platform hosts. Amazon is under increasing scrutiny by the U.S. Environmental Protection Agency (EPA) in this regard, as reported in our February 16, 2018, and June 17, 2020, blog items, and this Congressional inquiry seems more of the same. These efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant.