EPA Releases Final Guidance for Pesticide Submissions for New Outdoor Uses that Require ESA Reviews

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EPA has published the document Final Guidance for Pesticide Submissions for New Outdoor Uses that Require Endangered Species Act (“ESA”) Reviews. In October, the Agency requested public comment on the draft version of this document which was due to the Agency by October 16. In its press release regarding the guidance, EPA stated that the document will fulfill the requirements imposed upon it under the Pesticide Registration Improvement Act of 2022 (“PRIA 5”). Under PRIA 5 EPA must develop and issue guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from new outdoor uses of pesticide products on ESA species and designated critical habitats. The draft guidance will apply to the following outdoor uses:

  • new uses of existing conventional pesticides
  • new uses of existing biocides
  • new conventional pesticide active ingredients
  • New uses of biocide active ingredients

The document does not detail any new requirements for applicants. Its purpose is to serve to assist applicants in addressing potential effects on ESA species for the types of new outdoor uses listed above. Many recommended actions include steps that applicants can take voluntarily in developing proposed mitigation efforts. These efforts include:

  • identifying the action area,
  • identifying routes of exposure to potentially affected ESA species,
  • performing initial special overlap analysis to identify where proposed new uses will overlap with critical habitats,
  • identifying mitigation measures (such as decreasing run-off by deploying soil binding agents) and
  • address the risk associated with all active ingredients

The Agency states that “if followed, these recommendations should expedite the review for new outdoor uses of existing conventional pesticides and biopesticide active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and improve the efficiency of the overall ESA-FIFRA process.”

EPA Requests Comment on Petition Requiring Proof of Effectiveness for Systemic Insecticides

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On November 24, 2023, EPA announced that the Agency is seeking public comment on a petition filed by environmental groups requesting that EPA consider efficacy data when evaluating the registration of neonicotinoids and other systemic insecticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Comments will be accepted through January 23, 2024.

In 1980, EPA waived (in most cases) the requirement that registrants provide efficacy data when registering a pesticide under FIFRA (see 40 CFR 158.400(e)(1)).  The petition, filed by the Public Employees for Environmental Responsibility and the American Bird Conservancy, argues that neonicotinoid use is largely ineffective and causes widespread environmental harm.  According to the petition, EPA’s failure to consider neonicotinoids’ lack of efficacy conflicts with the stated purposes of the Agency’s FIFRA registration data requirements to “make regulatory judgments…about the risks and benefits of pesticide products” (40 CFR 158.1(a)) and “ensure that pesticide products will perform as intended” (40 CFR 158.130(c)).

In addition to requiring efficacy data during systemic insecticide registration, the petition asks EPA to mandate that existing systemic insecticide registrants submit efficacy data to EPA within 180 days.  If a proposed or existing systemic insecticide registration “lacks a demonstration that its benefits exceed its environmental and overall costs,” EPA would be required to deny or revoke the registration accordingly.

Systemic insecticides are most commonly used prophylactically to treat plant seeds.  Treated seeds are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) if their use is consistent with the treating pesticide’s label instructions.  However, EPA recently signaled that the Agency may revise this exemption.

Systemic insecticides are designed to be absorbed and transported through the target plant.  Neonicotinoids, a class of systemic insecticides that include the active ingredients imidacloprid, thiamethoxam, and clothianidin, are one of the most widely used types of insecticides in the world.

EPA Releases Strategic Plan for Endocrine Disruptor Screening Program

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EPA has released a notice requesting comment on its strategic plan to meet its obligations under the Federal Food, Drug, and Cosmetic Act (FFDCA) to screen for and protect against endocrine-disrupting effects in humans. Endocrine disruptors are chemicals that mimic, block, or disrupt the normal function of endocrine system hormones and can negatively impact biological processes within the endocrine, immune, and nervous systems. Under the new program, the Agency will assess pesticides more quickly and effectively to evaluate their potential to cause endocrine effects in humans. These assessments will be incorporated into pesticide review efforts made under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).

In the Agency’s press release regarding the program, the Deputy Administrator for Pesticide Programs in the Office of Chemical Safety and Pollution, Jake Li, noted that the program is a major milestone. He also stated that “starting with our highest priority chemicals, EPA will communicate more transparently our endocrine findings for humans.”

EPA review of preliminary data has identified 30 high-priority pesticides that these chemicals affect the endocrine system. The Agency requests additional endocrine data for human health for these chemicals in its request for comment. The Agency intends to fill any remaining data gaps by issuing FIFRA human health data requests for these chemicals in early 2024. These chemicals are identified in EPA’s List of Conventional Registration Review Chemicals, for Which an FFDCA Section 408(p)(6) Determination is Needed, which is available in docket EPA–HQ–OPP–2023–0474 on regulations.gov. FFDCA section 408(p)(6) requires EPA to ‘‘as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health’’ for ‘‘any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans.’’ In addition, in the Federal Register notice, EPA requested that stakeholders submit data on the endocrine effects of these pesticides. Data are requested during the notice’s 60-day comment period. After the assessment of the high-priority pesticides is completed, the Agency will request data on a second group of 126 pesticides.

In the strategic plan, EPA explains that the program will pull from existing data when possible.   and request new data if needed. Existing data has been collected under FIFRA and the FFDCA. EPA has chosen 400 conventional pesticide active ingredients that are being registered for the first time or are undergoing registration review for which, through the implementation of its Strategic Plan, the Agency will assess for endocrine effects and determine if additional protections are needed.

The comment period for this notice began on October 27, 2023, and has been extended to February 26, 2024.

EPA to Consider Revising FIFRA Exemption for Pesticide-Treated Seeds and Paint

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On October 12, 2023, EPA published an advance notice of proposed rulemaking on seeds (“treated seeds”) and paint (“treated paint”) treated with a pesticide that is registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (“treating pesticide”). Treated seeds and treated paints are currently exempted from FIFRA under the “treated articles and substances” exemption at 40 CFR 152.25(a) as long as their use is consistent with the treating pesticide’s label instructions.

EPA’s longstanding position has been that subjecting treated articles to FIFRA requirements would be unnecessary since the treating pesticide would have already been assessed during the pesticide registration process. This position was challenged in 2017 by the Center for Food Safety, which filed a petition requesting that EPA remove the exemption for treated seeds and aggressively enforce FIFRA’s pesticide labeling and registration requirements for seeds treated with systemic insecticide chemicals. EPA denied the petition in 2022 but acknowledged that the use of a treated seed contrary to the treating pesticide’s labeling instructions is generally not enforceable under FIFRA. As a result, EPA noted its intention to issue the current advance notice of proposed rulemaking to collect more information on treated seeds. EPA also included treated paints in the notice because of concerns that painters may be exposed to treated paint without adequate PPE.

The information specifically requested by the notice falls into five main categories:

  1. Effectiveness of instructions on treated seed product labeling to mitigate potential risks. EPA seeks comment on the Agency’s labeling instructions for treated seeds, particularly with regard to whether these instructions are clear, generally achievable, and adequate.
  2. Use, usage, and tracking of treated seed products. EPA seeks comment on the use, usage rates, and volume of imports of treated seeds. EPA also seeks comment on whether tracking treated seed distribution, sale, and/or use would provide any meaningful improvements in the assessments of treating pesticides and whether the treated article exemption should be amended so that manufacturers of treated seeds would be subject to FIFRA section 7 registration and reporting requirements.
  3. Management of spilled or excess treated seed. EPA included additional labeling instructions for the management of spilled and excess treated seed in the registration review proposed interim decisions and interim decisions of several chemicals. EPA seeks comment on whether these instructions are sufficient. EPA also seeks comment on what farmers, distributors, and companies currently do with excess treated seed.
  4. Treated paint. Pesticide labeling requirements for treated paint do not currently exist. EPA seeks comment on whether it should add pesticide labeling requirements and what those requirements should include. EPA also seeks comment on whether it should add specific use instructions or enforceable use requirements for professional painters and whether the treated article exemption should be amended so that manufacturers of treated paints would be subject to FIFRA section 7 registration and reporting requirements.
  5. Administrative action, amendment of the treated article exemption, and/or FIFRA section 3(a) rule. EPA seeks comment on whether action is necessary to prevent unreasonable adverse effects on human health and the environment, considering the concerns raised regarding the enforceability of labeling instructions on treated seeds and paint and whether there are any such examples of the use of treated seed contrary to labeling instructions. If so, EPA requests comments on what the proper action should be and how such an action might impact states.

EPA also requests comments on whether exposure to treated seeds and paint may be an environmental justice concern and comments regarding potential child health concerns. Comments on the notice will be accepted through December 11, 2023.

DOJ Files Lawsuit Against eBay for Environmental Violations

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On behalf of EPA, the Department of Justice (DOJ) has filed a lawsuit against the online retailer eBay for selling and distributing “hundreds of thousands of products” that allegedly violate the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).

DOJ first alleges that eBay violated the CAA by selling or causing the sale of over 343,000 automotive aftermarket defeat devices.  These devices, which are often advertised as vehicle power enhancers, “can cause motor vehicles to emit hundreds to thousands of times more pollution than a motor vehicle with properly functioning emission controls,” the complaint says.  DOJ alleges that each aftermarket defeat device sold, offered for sale, or caused to sell by eBay constitutes a violation of CAA section 203(a)(3)(B), which forbids selling or offering to sell a motor vehicle part that bypasses an emission-related element of design.

Second, the complaint alleges that eBay committed a series of FIFRA violations by selling or distributing a minimum of 23,000 unregistered, misbranded, or restricted use pesticide products.  DOJ also alleges 8,074 violations of a Stop Sale, Use, or Removal Order (SSURO) issued by EPA in 2020 (and amended in 2021), which identified some of these allegedly unlawful pesticide products.  Among the products sold in alleged violation of the SSURO was an insecticide containing dichlorvos, which DOJ characterizes as highly dangerous, and a “disinfection card” claiming to protect users from COVID-19 when worn around their neck.

Finally, eBay is being sued under TSCA for violating a 2019 rule prohibiting the manufacture, processing, and distribution of products containing methylene chloride for consumer paint and coating removal.  The TSCA section 6(a) rule was the result of EPA’s determination that those uses pose an unreasonable risk of injury to health due to methylene chloride’s acute human lethality.  According to the complaint, eBay has distributed over 5,600 items in violation of the rule.

The lawsuit seeks injunctive relief to prevent eBay from further selling products violating the CAA, FIFRA, and TSCA.  The complaint additionally requests civil penalties for each of the CAA violations, which could amount to $5,580 per violation.

EPA Faces Lawsuit for Classifying Water Filtration System as a Pesticide Product

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The U.S. District Court for the Northern District of Texas will be tasked with determining whether EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) enforcement actions against Berkey, a water filters brand, were arbitrary and capricious in the case Shepherd v. Regan.  The case concerns seven Stop Sale, Use and Removal Orders (SSUROs) issued by EPA against third-party distributors and manufacturers of Berkey water filtration products due to their alleged use of silver as an unregistered antimicrobial pesticide.

The complaint does not deny the presence of silver in Berkey products.  However, the plaintiffs say that they are unaware of any instances where a Berkey-authorized entity claimed that the silver in their products was “used for any purpose other than to protect the filter itself.”  This is significant because articles treated with a FIFRA-registered pesticide for the purpose of protecting the article are exempt from FIFRA under the treated articles exemption at 40 CFR 152.25.

The plaintiffs argue that the orders were the result of an unlawful reinterpretation of a 2007 notice, which clarified EPA’s position that equipment that uses electrodes to emit ions for pesticidal purposes is a “pesticide,” rather than a “device,” under FIFRA.  The complaint alleges that EPA reinterpreted this notice without opportunity for public comment to “now apply to the presence of inert silver in water filters.”

In its response, EPA argues that the plaintiffs—which do not represent Berkey itself—lack standing.  The Agency also characterizes the 2007 notice referenced in the complaint as a “straw man” with no bearing on the case.  EPA does not believe there is any ambiguity regarding the distinction between “pesticides” and “devices,” arguing that EPA has excluded water filters containing pesticidal substances from its interpretation of “devices” since 1975.

EPA focuses on claims made by the SSURO recipients, which allegedly advertised that Berkey filters removed viruses and pathogenic bacteria.  The Agency has long held that such public health claims make a product ineligible for the treated article exemption, EPA says.  Combined with knowledge of the presence of silver in the products, and no pesticide registration, EPA argues that it had “reason to believe” (the requirement for issuance of an SSURO) that the substances were sold in violation of FIFRA.

EPA Sued Over Herbicide Registration Renewal

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On June 6, 2023, the Center for Food Safety and two other environmental groups sued EPA over the Agency’s decision to renew registrations for Enlist One and Enlist Duo, two herbicides manufactured by Corteva Agrisciences, LLC.  The case is currently pending before the U.S. District Court for the District of Columbia as Center for Food Safety v. EPA.

The lawsuit alleges that EPA failed to properly evaluate the Enlist products’ risks as required by the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) and the Endangered Species Act (“ESA”) when the Agency renewed the herbicides’ registrations until 2027.  According to the plaintiffs, the herbicides cause numerous adverse environmental effects, including harm to crops growing on neighboring properties and drinking water contamination.  The plaintiffs allege that EPA understated these risks in making its decision, while overstating the herbicides’ effectiveness.  In addition, the plaintiffs argue that EPA’s decision harms the survival, growth, and reproduction of exposed plants and animals, including endangered and threatened species.  The plaintiffs ask the court to vacate EPA’s decision and to stop the sale and use of the Enlist products.

In an EPA memorandum supporting the Agency’s decision, EPA stated that it had “evaluated the benefits and risks to human health and the environment from these products’ uses, including potential risk to non-target organisms, and conducted effects determinations for federally listed endangered and threatened species.”  According to EPA, the results of its evaluations and assessments were sufficient for the Agency to conclude that granting the registration renewal met the requirements of FIFRA and ESA.  These requirements include FIFRA section 3(c)(5), which directs EPA to register a pesticide when the Agency finds that the pesticide will not generally cause unreasonable adverse effects on human health or the environment, among other criteria; ESA section 7(a)(2), which requires EPA to consult with the Fish and Wildlife Service to ensure that actions taken by EPA do not jeopardize endangered and threatened species; and ESA section 7(d), which prevents EPA from taking irreversible action during 7(a)(2) consultation that eliminates the implementation of reasonable alternatives.

Enlist Duo has previously been the subject of litigation.  In National Family Farm Coalition, et al., v. U.S. EPA, et al., 966 F.3d 893 (9th Cir., 2020), petitioners challenged EPA’s decisions to register the herbicide in 2014, 2015, and 2017 on FIFRA and ESA grounds.  The panel rejected the petitioners’ ESA claims and the majority of the petitioners’ FIFRA claims, allowing Enlist Duo registration, but agreed with the petitioners that EPA did not properly assess harm to monarch butterflies due to the herbicide’s effects on milkweed.  The panel remanded the registration decision to EPA so the Agency could assess this concern and determine whether it presented an unreasonable adverse effect under FIFRA.

According to EPA, Enlist One and Enlist Duo are registered for use in 34 states for a variety of uses on corn, cotton, and soybeans.  Both herbicides contain the active ingredient 2,4-dichlorophenoxyacetic acid choline salt.  Enlist Duo also contains the active ingredient glyphosate.

Oral Arguments in Monsanto “Roundup” Case

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On June 13, 2023, the full Eleventh Circuit heard oral arguments in the case Carson v. Monsanto Co.  The case hinges on whether a Georgia law that requires Monsanto to warn consumers about risks the company knows about or has reason to know about is preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The appellant, John D. Carson Sr., alleges that he developed cancer due to regular use of Roundup, a glyphosate-based pesticide manufactured by Monsanto. Carson claims that Monsanto “has known for decades” that Roundup use can cause cancer and failed to label their products in a way that notified consumers of this risk as required by Georgia law.

FIFRA requires pesticide manufacturers to include warning labels on products that adequately protect consumer health, but EPA has concluded that glyphosate is “not likely to be carcinogenic” to humans.  FIFRA prohibits state labelling laws that are “in addition to or different from” FIFRA requirements (7 U.S.C. § 136v(b)). Monsanto argues that this language expressly preempts the Georgia law, while Carson contends that the Georgia law merely “parallels” FIFRA’s provisions. Carson cites Bates v. Dow AgroSciences LLC, interpreting the ruling to mean that claims “equivalent to” or narrower than FIFRA provisions are not preempted (544 U.S. 431, 447 (2005)).

Also at issue in the case is the question of whether EPA’s actions with regard to Roundup constitute “force of law.” Carson asserts that EPA’s registration of Roundup does not have the force of law necessary to preempt Georgia law.  Monsanto argues that no force-of-law analysis is required because “EPA determinations define the scope of preemption as a matter of statutory construction,” but also argues that EPA’s actions constitute force of law even if such an analysis is undertaken.

During oral arguments the court posed questions to Carson’s attorney regarding whether a force-of-law analysis is necessary and questioned the attorney representing Monsanto on whether the grounds for an impossibility preemption were met. In addition, both attorneys were asked whether the appeal was “collusive” due to the type of settlement the parties reached in the case.

Carson’s suit was initially dismissed by a Georgia court, which held that FIFRA expressly preempted the Georgia law. In July 2022, it was reinstated by a three-judge Eleventh Circuit panel which ruled in favor of Carson. The panel reached the same result in a new opinion in October 2022. Last December, the full Eleventh Circuit vacated the opinion, ordering that the case be heard en banc.

EPA Exempts Categories of Genetically Engineered Plant-Incorporated Protectants from Regulatory Requirements

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On May 31, 2023, EPA published a final rule exempting two categories of plant-incorporated protectants (PIPs) created using genetic engineering from certain Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration requirements and from food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA).  In addition to reducing regulatory burden, EPA stated in a press release that the final rule may result in increased research and development in this sector and provide more pest control options for farmers, ultimately reducing the use of conventional pesticides.

PIPs are defined (in part) at 40 CFR 174.3 as “pesticidal substance[s] that [are] intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance.”  In 2001, EPA exempted PIPs derived through conventional plant breeding from FIFRA registration and FFDCA food tolerance requirements, but did not exempt PIPs created using biotechnology.  Because of recent scientific advances, however, EPA writes that PIPs “can now be created through genetic engineering that are virtually indistinguishable from those created through conventional breeding.”  The final rule adds exemptions for the following two categories of genetically engineered PIPs, which EPA states pose no greater risk than PIPs created through conventional breeding:

  1. PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption.
  2. Loss-of-function PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect.  For this category of PIP, biotechnology developers can either make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.

Exempted PIPs are still subject to the adverse effects reporting requirements at 40 CFR 174.71 and recordkeeping requirements.

In the preamble to the final rule, EPA established that the Agency is open to considering additional PIP category exemptions and expanding the categories of PIPs that are allowed to self-determine without EPA confirmation of their eligibility exemption.

EPA Revokes Interim Approval of Glyphosate

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EPA recently withdrew its 2020 Interim Approval of glyphosate, often referred to by its trade name Roundup. Interim approvals are part of a conditional registration process used by the Agency to allow new active ingredients to enter the market for an unspecified period of time while the registrant generates missing data required by the Agency for the formal registration process.  Although the Interim Approval was revoked, EPA maintains that the chemical is not carcinogenic, and the product will remain on the market as the Agency completes its periodic review as required by law. In its registration review of glyphosate, the Agency will attempt to elaborate on its evaluation of the carcinogenic potential of glyphosate. EPA will also consider whether a better explanation is needed for its findings on other aspects of the human health analysis. EPA expects to complete the review of glyphosate in 2026.

The 2020 Interim Approval was challenged in the U.S. Court of Appeals for the Ninth Circuit. Petitioners made two main allegations, first that EPA’s analysis of human health, particularly related to cancer analysis, was faulty. Second, the Agency violated the Endangered Species Act (ESA) which requires the weighing of such risks against the benefits of glyphosate and the interim risk mitigation measures.

In June 2022, the Court vacated the human health portion of the glyphosate interim review decision and held that EPA’s registration review decision under FIFRA triggered ESA obligations. It also granted EPA’s request for voluntary remand, without vacatur, of the ecological portion of the interim registration review decision but imposed a deadline for EPA to issue a new ecological potion.

While the EPA has made this withdrawal decision, it is unable to finalize the new ecological portion in a registration review decision as mandated by the Court decision. The Agency states the delay is necessary to appropriately address the issues EPA sought to remedy in the ecological potion and satisfy the ESA requirements. EPA is currently working on a consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Services. Any proposed decisions will require a 60-day comment period and an assessment of comments received. You can read EPA’s full release on its withdrawal decision here.