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

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

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 Sued Over Herbicide Registration Renewal

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.

Hearing Announced on EPA’s Intent to Cancel Chlorpyrifos Pesticide Registrations

On June 21, 2023, EPA announced that a public hearing will be held in response to objections and hearing requests following EPA’s issuance of a Notice of Intent to Cancel (“NOIC”) pesticide registrations for three products containing chlorpyrifos. The hearing will begin at 9 a.m. on January 8, 2024, and will continue as necessary through January 11, 2024.

The objections and hearing requests following the NOIC came from a collection of grower groups and a producer of chlorpyrifos products. The petitioners are currently challenging EPA’s 2021 final rule, which revoked all tolerances for chlorpyrifos, in the Eighth Circuit case Red River Valley Sugarbeet Growers Association et al. v. Regan. The petitioners argue that EPA should stay or withdraw the NOIC until the pending case is decided.

EPA’s NOIC was the result of over a decade of efforts to ban chlorpyrifos use. In 2007, two non-profit organizations filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos, pointing to studies showing neurotoxic, developmental, endocrinal, and carcinogenic effects in humans and animals as a result of exposure. EPA did not take final action on the petition until it denied the petition in 2017, concluding that the science behind the effects of exposure remained unresolved.  In 2021, the Ninth Circuit vacated EPA’s decision in League of United Latin Am. Citizens v. Regan. The court held that EPA had abdicated its statutory duty under the Federal Food, Drug, and Cosmetic Act by failing to update the tolerances for chlorpyrifos despite its inability to conclude, to the statutory standard of reasonable certainty, that present tolerances caused no harm. The court ordered EPA to grant the 2007 petition and modify or revoke the tolerances accordingly. EPA opted to revoke all tolerances in the final rule.

In the ongoing case, Red River Valley Sugarbeet Growers Association et al. v. Regan, the grower groups and the chlorpyrifos producer argue that the final rule was arbitrary and capricious due to EPA’s disregard for safe chlorpyrifos uses. The petitioners observe that shortly before the final rule was published, EPA completed a human health assessment that found that chlorpyrifos use on eleven crops in select regions was safe. By refusing to act on its own evidence, the petitioners assert that EPA disregarded its statutory mandate to review the safety of tolerances using current science.

According to EPA, chlorpyrifos was registered for use in the U.S. beginning in 1965. At the time of the final rule, chlorpyrifos was registered for use on fruit and nut trees, many types of fruits and vegetables, and grain crops.

Oral Arguments in Monsanto “Roundup” Case

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.

Study Finds Roundup Cancer Risk Isn’t from Active Ingredient Glyphosate

A newly released study has found that glyphosate, the active ingredient in Roundup, may not be directly responsible for the increased risk of cancer that has been associated with the weedkiller. The study was conducted by a team of federal and private sector researchers who tested glyphosate and herbicide mixtures using glyphosate on human B-lymphoblastoid TK6 cells. The researchers concluded that neither glyphosate nor its metabolite forms damaged DNA, causing cancer. Instead, they found that some other ingredient in weedkillers containing glyphosate may be responsible for the DNA damage attributed to glyphosate. This finding contradicts the 2015 World Health Organization (“WHO”) conclusion that glyphosate was “probably carcinogenic to humans” and genotoxic (meaning it damages DNA). WHO’s conclusion has led to numerous lawsuits against Bayer AG and Monsanto Co., as well as lawsuits against the Environmental Protection Agency for concluding that the herbicide would not cause cancer.

Although the study indicates that DNA damage was caused by other components of the formulations, not glyphosate, it did not rule out the possibility that exposure to glyphosate might cause cancer through other mechanisms, according to the National Toxicology Program. Bayer AG has long maintained that glyphosate does not cause cancer and is not genotoxic, and the company released a statement in response to the study, stating that “the extensive body of research on glyphosate-based herbicides and findings of leading health regulators worldwide support the conclusion that glyphosate does not cause cancer and is not genotoxic.”

EPA Revokes Interim Approval of Glyphosate

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.

EPA Advances Early Pesticides Protections for Endangered Species

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.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

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.

EPA Issues Stop Sale, Use, or Removal Orders to Amazon

In February 2021, EPA announced that the Agency issued a “stop sale” order to Amazon in relation to unregistered pesticides and disinfectants.  This is the third stop sale order Amazon has been issued by EPA and brings the list of products in the stop sale order from 30 to 70.  The first stop sale order for unregistered pesticide products was on August 12, 2015.  The second stop sale order for unregistered pesticide products was on January 29, 2016.  For the current stop sale order, a majority of the products at issue make antimicrobial, antibacterial, or antiviral claims.  A few examples include Antimicrobial Pure Copper Therapy Ring, Replaceable Wipes Made of Sterile Non-Woven Fabric, and Antibacterial Sanitizing Disinfecting Alcohol Wipes.  EPA states that consumers wishing to purchase products to kill the coronavirus SARS-CoV-2 (COVID-19) should refer to the Agency’s list of disinfectants, instead of purchasing unregistered pesticides, because unregistered pesticides have not been evaluated for safety and efficacy by EPA.

In its announcement, EPA reminded the public that unregistered pesticides pose health risks to consumers, children, pets, and others who are exposed to the products.  Additionally, EPA advised consumers to dispose of the unregistered pesticides and disinfectants in accordance with local, state, and federal laws.  The announcement noted that pesticides and disinfectants intended for sale in the U.S. must be evaluated by EPA and have approved labeling with an EPA registration number according the requirements of the Federal Insecticide Fungicide and Rodenticide Act.