EPA Proposes New Mitigation Measures for Rodenticides, Including Pilot for Protecting Endangered Species

This original announcement was published by the EPA on November 29, 2022. Click here for more information.

EPA Proposes New Mitigation Measures for Rodenticides, Including Pilot for Protecting Endangered Species

Today, the U.S. Environmental Protection Agency (EPA) proposed new measures to protect human health and the environment for 11 rodenticides, including measures to reduce potential exposures to three federally listed endangered and threatened (“listed”) species and one critical habitat.  

This work furthers the goals outlined in EPA’s April 2022 Endangered Species Act (ESA) Workplan and one of the ESA pilots described in its November 2022 update to provide practical, timely protections for listed species from pesticides. 

Each year, rodents cause significant damage to property, crops, and food supplies across the United States. They may also spread diseases, posing a serious risk to public health. Rodenticides are used in residential, agricultural, and non-agricultural settings to control a variety of pests including house mice, Norway rats, roof rats, moles, voles, pocket gophers, prairie dogs, ground squirrels, feral hogs, and mongooses. 

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires EPA to review registered pesticides every 15 years to ensure that, as the ability to assess risk evolves and as policies and practices change, the pesticides continue to meet the statutory standard of causing no unreasonable adverse effects on human health or the environment. When EPA identifies unreasonable adverse effects to human health or the environment, it proposes amendments to pesticide labels to mitigate these risks. During registration review, the Agency also has obligations under the ESA that may result in additional assessments and mitigations.  

Proposed Risk Mitigation Measures 

In 2008, EPA issued a risk mitigation decision (RMD) for 10 rodenticides that represented the Agency’s final decision on the reregistration eligibility of rodenticide products at that time and constituted the Agency’s final action in response to the remand order in West Harlem Environmental Action and Natural Resources Defense Council v. U.S. Environmental Protection Agency. The 2008 RMD included mitigation measures to reduce risks to human health and non-target organisms. For example, EPA implemented minimum packaging size requirements for products on the consumer market (must be in packages one pound or less), prohibited products intended for general consumers (i.e., homeowners or residential consumers) from containing second-generation anticoagulant rodenticides (SGARs), and required tamper- and weather-resistant bait stations for outdoor, above-ground placements where children, pets, and wildlife may be present.  

The proposed interim decisions (PIDs) released today cover three first-generation anticoagulant rodenticides (FGARs), four SGARs, and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 RMD but is now included as part of EPA’s registration review of the rodenticide group. 

These PIDs build on the earlier protections by proposing additional mitigation measures based on findings in the 2020 draft human health and ecological risk assessments (DRAs) and feedback submitted during the DRAs’ public comment period. These measures are intended to reduce exposure to non-target organisms such as mammals and birds that may inadvertently consume rodenticides through their prey, or animals that may consume the rodenticide directly. Proposed measures include requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained, and requiring users to collect carcasses of rodents that may have consumed rodenticides to prevent further exposures to non-target organisms that could consume the carcasses. In addition, the PIDs propose that all products, excluding those registered solely for use by homeowners, include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product.   

Endangered Species Pilot 

The ESA workplan described how EPA is developing early mitigation for a subset of species where EPA predicts a likelihood of a jeopardy or adverse modification finding for one or more of the registration review pilot pesticides if mitigation is not undertaken. One of these pilots is for rodenticides, which will focus on addressing effects to mammals and birds that consume rodenticide bait (primary consumers) and to birds, mammals and reptiles that consume primary consumers (secondary consumers).  

As part of its registration review ESA pilot for the rodenticides, EPA evaluated their potential effects on individuals and populations of Stephens’ kangaroo rat, Attwater’s prairie chicken, and the California condor and its designated critical habitat. EPA’s draft evaluation determined that rodenticide use is “likely to adversely affect” these three species but predicted the proposed mitigations will protect them from likely “jeopardy” (i.e., potential impacts to the survival of listed species) and “adverse modification” of critical habitat. A “likely to adversely affect” determination means EPA reasonably expects that at least one individual animal of any of the three species may be exposed to one or more of the rodenticides at a sufficient level to have an adverse effect.    

EPA’s draft likelihood of jeopardy and adverse modification predictions examine effects of the rodenticides at the species scale (i.e., the population as opposed to an individual of a species). While EPA has made predictions about the likelihood of jeopardy and adverse modification, the U.S. Fish and Wildlife Service (USFWS) is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so. 

EPA chose these three listed species because they represent species that may be affected by rodenticides through different routes of exposure, like primary consumption, for example, by Stephens’ kangaroo rat and Attwater’s prairie chicken and secondary consumption, for example, by California condor.

To focus the mitigations where they are most needed while retaining options for rodenticide users, the proposed mitigation measures for the three listed species would be targeted in specific geographic areas most relevant to the species. The PIDs include proposed mitigation measures to be included on the Bulletins Live! Two website for the species and the critical habitat of the California Condor. 

The draft evaluation for the three species and one critical habitat and associated mitigation measures are pilots for other listed species that may be similarly exposed and affected by rodenticides. In developing and applying mitigation measures for these species, EPA recognized that not all rodenticides have the same effects.  

Next Steps  

In addition to describing the pilot and the mitigation measures for the selected species, the PIDs also describe EPA’s plans for expanding those mitigation measures to the other approximately 90 listed species potentially affected by rodenticides. This plan, when finalized, will be known as the Rodenticide Strategy the Agency described in its November 2022 update to its ESA Workplan.  

EPA also intends to make effects determinations for all listed species available in a draft biological evaluation (BE), which the Agency anticipates making available for public comment in November 2023. The BEs will contain EPA’s draft analysis of the potential effects of the rodenticides on listed species and their designated critical habitats and will identify mitigation measures for these species and critical habitats to avoid or minimize exposure from the rodenticides (Rodenticide Strategy). EPA expects to complete the final BE for the rodenticides in November 2024.  

If EPA’s final BE continues to find that rodenticide use is likely to adversely affect listed species or adversely modify their critical habitats, then EPA will initiate formal consultation and share its findings with USFWS, which will use the information in EPA’s BE to inform its biological opinions. If the USFWS determines in its final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination, or to address any incidental take, then EPA will work to ensure that any necessary registration or labeling changes are made.   

The PIDs are now available for public comment in their respective pesticide registration review dockets at www.regulations.gov for 75 days. See the Federal Register notice for more information. After the PIDs, the next step in the registration review process is issuing an interim decision. 

For more information, visit EPA’s rodent control pesticide safety review webpage.

EPA Approves Stronger Plans for Certification of Pesticide Applicators

This original announcement was published by EPA on November 22, 2022. Click here for more information!

The U.S. Environmental Protection Agency (EPA) has approved 13 state and federal agency certification plans that comply with the improved federal standards to enhance worker safety under the 2017 Certification of Pesticide Applicators (CPA) rule.

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires authorities to have an EPA-approved plan to certify applicators of restricted use pesticides (RUPs). To date, of the nation’s 68 certification programs, EPA has reviewed all proposed modified plans and has approved eight plans from states and territories and five from federal agencies, of which all are now starting to be implemented.

In 2017, EPA updated the CPA regulations, setting stronger standards for people who apply RUPs. Improvements include enhancing applicator competency standards to ensure RUPs are used safely, establishing a nationwide minimum age for certified applicators and persons working under their direct supervision, and protection for noncertified applicators by requiring training before they can use RUPs (under the direct supervision of a certified applicator), among others.

The implementation of revised certification programs is crucial to reducing potential RUP exposures to certified applicators and those working under their direct supervision, other workers, the public, and the environment.

The following approved state and territory certification plans meet or exceed the standards mandated in the 2017 CPA rule:

  • Alaska (Alaska Department of Environmental Conservation)
  • California (California Department of Pesticide Regulation)
  • Nebraska (Nebraska Department of Agriculture)
  • New York (New York State Department of Environmental Conservation)
  • Oregon (Oregon Department of Agriculture)
  • Puerto Rico (Puerto Rico Department of Agriculture)
  • Vermont (Vermont Agency of Agriculture, Food and Markets)
  • U.S. Virgin Islands (U.S. Virgin Islands Department of Planning and Natural Resources)

In addition, the following federal agency certification plans meet or exceed the standards mandated in the 2017 CPA rule:

  • U.S. Department of Agriculture, Animal and Plant Health Inspection Services, Plant Protection and Quarantine
  • U.S. Department of Agriculture, Forest Service
  • U.S. Department of Defense
  • U.S. Department of Energy; Bonneville Power Administration
  • U.S. Department of the Interior, Bureau of Land Management

State, territory and tribal authorities with existing plans can continue using those plans until November 4, 2023, consistent with EPA’s recently issued extension (87 FR 50953, August 19, 2022). EPA is working closely with authorities to address challenges in revising their plans and will continue to approve plans on a rolling basis. After November 4, 2023, only authorities with EPA-approved modified certification plans can continue to certify applicators of RUPs.

EPA makes these certification plans available to the public by:

  • Tracking the progress of certification plan reviews and approvals here.
  • Approving certification plans as they are ready and announcing the approvals in batched Federal Register Notices (approximately quarterly).
  • Making all pre-2017 and newly approved certification plans publicly available in EPA’s Certification Plan and Reporting Database (CPARD) here.

Upon publication, the Federal Register Notice will be available in docket EPA-HQ-OPP-2022-0509 at www.regulations.gov.

EPA Advances Early Pesticides Protections for Endangered Species, Increases Regulatory Certainty for Agriculture

This original announcement was published by the EPA on November 16, 2022. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) released an Endangered Species Act (ESA) Workplan Update that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) actions. These early protections will help EPA comply with the ESA, thus reducing the Agency’s legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle. 

This update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. Among other things, the ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.  

When EPA registers a pesticide or reevaluates it in registration review, it has a responsibility under FIFRA to determine whether the pesticide presents unreasonable adverse effects to human health or the environment. EPA conducts human health and ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use(s) or proposed use(s) are necessary to protect human health or the environment. In 2007, an amendment to FIFRA formalized a requirement that EPA review each registered pesticide every 15 years. This amendment set the registration review deadline for pesticides registered before Oct. 1, 2007, as Oct. 1, 2022. EPA shared an update on its registration review work in Sept. 2022. 

EPA also has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. In the past few decades, EPA has seen an increase in litigation due to the Agency’s failures to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides—the most the Agency estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the Agency’s ESA workload well beyond 2030. If EPA’s ESA efforts continue at this pace, a future court may decide to drastically curtail pesticide use until EPA meets its obligations. This unsustainable and legally tenuous situation not only provides inadequate protection for listed species but also creates regulatory uncertainty for farmers and other pesticide users.  

ESA Workplan Update  

Today’s document is EPA’s first update to the ESA Workplan and covers four main goals:  

  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 many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.   
  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. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.  
  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.   

On Nov. 17, EPA is hosting a webinar to discuss these efforts and answer questions (register here). EPA will continue to share progress on existing and future ESA initiatives with stakeholders through updates to its website and other public forums. 

FIFRA Interim Ecological Mitigation measures to protect nontarget species 

The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” As part of its work to execute this strategy, EPA has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.  

The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route. 

In contrast to identifying mitigation measures pesticide-by-pesticide or species-by-species as EPA has typically done in the past, EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides.  

Endangered species protection bulletins and other label language 

To better protect listed and other nontarget species, EPA will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two 

Bulletins Live! Two is a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.  

EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.  

EPA also expects that working with registrants to proactively add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save the Agency, state partners, and registrants time and resources by minimizing the number of amendments to labels.  

Improving the pesticide consultation process and new approaches to identifying mitigation for multiple species and pesticides 

The ESA Workplan Update also describes initiatives that will help EPA and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations. 

EPA is accepting public comment on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix for 75 days in docket EPA-HQ-OPP-2022-0908 at regulations.gov. 

EPA Adds Chitosan to the List of Active Ingredients Eligible for Minimum Risk Pesticide Exemption

This original announcement was published by the EPA on November 9, 2022. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) finalized a rule adding chitosan (Poly-D-Glucosamine), a naturally occurring substance found in the cell walls of all crustaceans, most fungi, and the exoskeletons of most insects, to its minimum risk pesticide exemption list. In doing so, EPA is specifying that the listing also includes those chitosan salts that can be formed when chitosan is mixed with the acids that are listed as active or inert ingredients eligible for use in minimum risk pesticide products.  

The purpose of the exemption list is to eliminate the need for the Agency to expend significant resources to regulate products deemed to be of minimum risk to human health and the environment. Products that contain only those active and inert ingredients allowed by the exemption and meet certain Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requirements are exempt from the normal FIFRA registration requirements. Approximately a decade has passed since a substance was added to the list of ingredients eligible for the minimum risk pesticide exemption. 

Chitosan is currently registered with EPA under FIFRA as a fungicide, antimicrobial agent, and plant growth regulator that boosts the ability of plants to defend against fungal infections. Chitosan is currently widely available to the public for non-pesticidal uses, and has established applications in various industries including textiles, cosmetics, beverage processing, and water treatment.  

On October 10, 2018, EPA received a petition from Tidal Vision Products, LLC requesting that chitosan be added to the list of active ingredients allowed in exempted minimum risk pesticide products. In November 2020, EPA requested comments from the public on a proposed rule to add chitosan to the list of active ingredients eligible for the exemption. In November 2021, EPA requested additional information from the petitioner on chitosan salts and their potential effect on the environment. In response, received two aquatic toxicity reports which were made available for public comment via a Notice of Data Availability in May 2022. 

After reviewing the latest available science, reviewing comments on the proposed rule and on the Notice of Data Availability, EPA is now adding chitosan to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption. The Agency’s analysis of the available data suggests that chitosan and chitosan salts are of low toxicity to humans and no environmental risks of concern have been identified. As a result of this final rule, chitosan products will no longer need to be registered under FIFRA. EPA estimates this action will result in cost savings of up to $116,000 initially and about $3,400 per year thereafter for registrants and manufacturers of chitosan-containing pesticide products. 

The final rule is available in docket EPA-HQ-OPP-2019-0701 at www.regulations.gov.