EPA Allegedly Refuses to Address Toxic Pesticide Ingredients

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The Center for Food Safety and other non-profit organizations dedicated to environmental advocacy brought suit against the EPA, claiming that the Agency fails to assess the full environmental and health impacts of pesticides in its approval process. Current EPA regulations require pesticide producers to submit toxicity data on active ingredients as part of the registration process.  However, such data is not required for inert ingredients. Active ingredients are those designed to harm the targeted pests, while inert ingredients, which can also be toxic, are used for other purposes, such as acting as a solvent to help the active ingredient penetrate a plant’s leaf surface, preventing foaming or caking, and extending a product’s shelf life. EPA is required to determine the safety of all active and inert pesticide ingredients. Petitioners argue this isn’t achievable without toxicity data for inert ingredients. This is not the Center for Food Safety’s first plea to the Agency to address this issue; in 2017, it filed a petition with EPA requesting a rulemaking change for pesticide regulations, but the Agency never responded.

EPA Advances Early Pesticides Protections for Endangered Species

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On November 16, 2022, the Environmental Protection Agency (EPA) released an update to its Endangered Species Act (ESA) Workplan that outlines steps to increase protections for wildlife while also providing regulatory certainty for pesticide users. The update, which follows the EPA’s April 2022 ESA Workplan, aims to address the complexity of meeting the Agency’s obligations under the ESA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). When registering or reevaluating a pesticide, EPA has an obligation under FIFRA to determine whether the pesticide presents unreasonable adverse effects on human health or the environment.   EPA is also obligated under the ESA to ensure pesticide registrations do not imperil the continued existence of ESA-listed species or adversely impact their respective critical habitats.

To better fulfill the Agency’s obligations under the ESA, the Workplan update stresses the need for pesticide registration review and other FIFRA actions to provide protections for nontarget species, including endangered and threatened species, earlier in the review process. As well as resulting in better ESA compliance, these changes could provide farmers with more predictable access to pesticides.

  1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
  2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for future conventional and biological pesticide registration and registration review actions to protect non-target species
  3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture..
  4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The FIFRA Interim Ecological Mitigation measures will focus on reducing pesticide spray drift and runoff. and will be applied on a case-by-case basis, depending on the level of risk that a particular pesticide presents to species and the exposure route. This approach is intended to more efficiently protect nontarget species, including listed species, and to standardize protections across similar pesticides, rather than addressing risks on a pesticide or species-specific basis as the EPA has done in the past.

Additionally, the Agency plans to work with registrants of pesticides to add language to pesticide labels that direct users to reference Bulletins Live! Two, a website containing endangered species protection bulletins. These bulletins contain use limitations to protect threatened and endangered species and their designated critical habitat in specific geographic areas. The EPA expects that adding the reference to Bulletins Live! Two, to pesticide labels in advance of consultation with the US Fish and Wildlife Service and the National Marine Fisheries Service, will save time and resources by reducing the number of amendments to labels. It further plans to add language on pesticide incident reporting and advisory language to protect insect pollinators to protect listed and other non-target species better.

Verdant Law’s Irene Hantman Gives Presentation to Chemical Society of Washington on Chemical Commercialization

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Verdant Law is pleased to announce that Irene Hantman gave a presentation, Chemical Commercialization: What to Know about EPA Regulations, before the Chemical Society of Washington. The presentation provided a comprehensive overview of chemical commercialization under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The overview of TSCA detailed the definitions of chemical substances and substances in commerce, background on the TSCA Inventory and the premanufacture notification (PMN) process, and the EPA platforms for reporting and submitting data related to PMNs and active Inventory substances. The overview of FIFRA outlined the definition of pesticides under the law, the pesticide registration process, data requirements, review timelines and fees, and potential tolerance limitations EPA may set on chemicals with food uses. For questions about this presentation, contact Irene Hantman.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

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On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims stating that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their own company websites as well as on Amazon. The product’s labeling contained public health claims that EPA stated differ substantially from statements submitted to the Agency in connection with its pesticide registration; in other words, the companies were committing misbranding under FIFRA, The product’s registration allows only for labeling claims related to effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae. The product is not registered for use as a disinfectant or sanitizer, nor is it registered for any public health purpose. Therefore, it was a violation of the statute to make such claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

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On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their companies’ websites as well as on Amazon. The product’s labeling contained public health claims that EPA found to differ substantially from statements approved by the Agency in its review of the product label. The approved label allows only for statements regarding the product’s effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae.  EPA did not approve the use of the product as a disinfectant or sanitizer or make any public health claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

Amicus Brief on EPA and Sulfoxaflor

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On December 7, 2020, the attorneys general for 11 states filed an amicus brief with the Ninth Circuit Court of Appeals opposing EPA’s remand motion concerning the pesticide sulfoxaflor.  EPA’s motion asked the court to allow revision of its registration for sulfoxaflor without vacating it.  EPA initially registered sulfoxaflor for use in 2013 with limitations on its use due to its toxicity to bees and the potential risk to birds.  In 2019, EPA registered new uses for sulfoxaflor, including application to alfalfa, corn, cacao, grains, pineapple, strawberries.  At issue in the litigation are the following:

  • Approval of sulfoxaflor uses without consideration of its effects on endangered species after 2015 Ninth Circuit Court ruling to vacate the registration.
  • Need for consideration of sulfoxaflor’s effects on endangered species in its registration.
  • Need for consultation with expert agencies.
  • Whether the Endangered Species Act (ESA)-protected species are endangered in violation of EPA’s FIFRA mandate that its pesticide use approvals not result in “unreasonable adverse effects on the environment.”

Granting EPA’s motion would allow sulfoxaflor use for at least seven years.

The amicus brief states EPA’s motion for remand without vacatur is unwarranted because EPA has demonstrated ongoing and systematic failure to consult under the ESA.  The attorneys general noted that Congress ordered EPA to report on its ESA consultation progress in 2014 and 2018.  The brief stressed that the backlog of pesticide chemicals for review is already quite long, and that EPA has admitted that the evaluation of sulfoxaflor on remand would not begin until June 2025, at the earliest.  Concern that without proper foundational review by EPA, the burden of ensuring pesticide safety passes down to the states was emphasized by the brief.  Finally, the brief argues that “proceeding to the merits would most efficiently resolve the issues in this case.”

FIFRA Enforcement Against Electrolux

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An October 6, 2020 Consent Agreement and Final Order (CAFO) between EPA and Electrolux Home Products, Inc. resulted in Electrolux agreeing to pay nearly $7 million.  EPA settled FIFRA violations in relation to the import and distribution of Electrolux dehumidifiers and air conditioners containing a filter manufactured with nanosilver.  Although the products made pesticidal claims, they were not registered with EPA – pesticide products imported into the United States for distribution or sale must be first registered with EPA, unless the product is exempt from FIFRA (e.g., under the treated articles exemption).  Marketing materials for the dehumidifiers and air conditioners included the following pesticidal claims “Antimicrobial Filter Cleans air by removing harmful bacteria” and “Our removable, washable filter reduces bacteria, room odors and other airborne particles for a healthier, more comfortable environment.”  The CAFO notes that “at no time relevant to the allegations herein was the nanosilver that was used to manufacture the filters that were contained in the [dehumidifiers and air conditioners] registered with the EPA”, in violation of Section 12(a)(1)(A) of FIFRA, 7 U.S.C. § 136j(a)(1)(A). 7 U.S.C. § 136l(a)(1).

Key Points of the Agreement are as follows:

  • Electrolux failed to file a Notice of Arrival of Pesticides and Devices for these imports on 141 occasions.
  • Electrolux imported unregistered pesticide products on 573 occasions.
  • EPA issued a Stop Sale, Use or Removal Order.
  • Electrolux offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver.
  • The Civil Penalty to settle the action is $6,991,400.
  • The Civil Penalty includes a 20% reduction in the amount for Electrolux’s good faith efforts to bring their products into compliance with FIFRA.

EPA Updated the Pesticide Label Review Manual

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EPA has substantively updated the General Labeling Requirements, Precautionary Statements, and Net Contents/Net Weight Chapters of the Pesticide Label Review Manual, and made minor editorial changes throughout the rest of the manual. This manual is designed to help industry understand the pesticide labeling process and how labels should be drafted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The latest updates are as follows:

General Labeling Requirements — Chapter 3:

  • Web-distributed labeling section now includes container label language example;
  • Label submission requirements section now includes e-submission option;
  • Final printed labeling section now reflects current practices;
  • Updated mode of action symbol reference from PR Notice 2001-5 to PR Notice 2017-1; and
  • First aid statement location now reflects requirements of EPA’s guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”

Precautionary Statements — Chapter 7:

  • Added dermal sensitization to acute toxicity categories table (Table 1);
  • Reinstated first aid statements per PR Notice 2001-1, and updated location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
  • Added Note to Physician statement for products containing zinc phosphide;
  • Updated National Pesticide Information Center NPIC information in first aid statements example in Table 9;
  •  Changed “Labeling Options” section to “Modified precautionary statements for diluted products (aqueous solutions only)”;
  • Removed redundant section on NPIC and referenced Chapter 15 for details; and
  • Removed “Optional Labeling/Deviations” section and moved directions under their respective sections.

Net Contents/Net Weight — Chapter 17:

  • Updated introduction section to include notes on declaring net contents information on application form 8570-1 and leaving net contents information blank on draft label for refillable containers; and
  • Updated labeling requirements for packages that use Bag on Valve technology to reflect 2018 NIST Handbook 130 regulations for net weight measurements.

EPA is Removing 72 Inert Ingredients Previously Approved for Use in Pesticide Products

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On October 22, 2014, EPA published for comment a proposal to remove from EPA’s list of inert ingredients approved for use in pesticide products 72 chemical substances that are no longer being used as inert ingredients in pesticide products. (79 FR 63120) In response to EPA’s request for comments, no specific information regarding those 72 chemical substances or any products that may include them was provided to EPA, indicating that these chemical substances are not being used in currently approved pesticide product formulations. Therefore, as of December 14, 2016, (81 FR 90356) EPA decided to remove all 72 from the inert ingredient list. A list of the 72 inert ingredients can be found here.

Removal of a chemical substance from the approved inert ingredient listing does not, in and of itself, restrict the use of the chemical substance in a pesticide product, instead it changes the way an application is processed. Once removed, the chemical substance would be considered a “new” inert ingredient. Any inert ingredient that is not on the approved list must be approved by EPA before registration for a formulation containing that chemical substance as an inert ingredient. EPA approval can be obtained by submitting a request, along with relevant data including, among other things, studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity, as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative. Further, adding the chemical substance to the list of approved inert ingredients would also require payment of a fee in accordance with FIFRA Section 33, 7 U.S.C. 136w-8.

EPA releases interim guidance on data requirements for antimicrobial pesticides and food contact surfaces.

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Last week, EPA released interim guidance on the agency’s toxicology data requirements for antimicrobial pesticides on food contact surfaces. The interim guidance clarifies that the 200 parts per billion (ppb) threshold that triggers different data requirements is based on “total estimated daily dietary intake” for an individual and not the total amount of residue on a food item, which interpretation is in line with the policy of the U.S. Food and Drug Administration (FDA). Generally, if pesticide residues from food contact services are found in food at 200 ppb or less, EPA requires the submission of certain toxicology data, and additional data may be required if residues are greater than 200 ppb.

The interim guidance was issued as part of a March 2, 2015 settlement reached between the EPA and the American Chemistry Council (ACC) resolving the trade group’s challenge of EPA’s 2013 Final Rule on “Data Requirements for Antimicrobial Pesticides.” The settlement also requires that EPA propose, by July 2, 2015, a guidance document called the “Antimicrobial Pesticide Use Site Index,” which will be subject to public comment. In addition, by September 2, 2017, the agency must propose a “correction” to 40 C.F.R. § 158.2230(d) clarifying that the 200 ppb level relates to total estimated daily dietary intake, consistent with the FDA policy.