EPA Releases Draft Biological Evaluations of Three Neonicotinoids for Public Comment

This original announcement was published by the EPA on August 26, 2021. Click here for more information.


EPA is releasing its draft biological evaluations (BEs) for clothianidin, imidacloprid and thiamethoxam, which are part of a group of insecticides known as the neonicotinoids, for public review and comment. These neonicotinoids are used on a variety of crops, turf, and ornamentals, among other residential and commercial indoor and outdoor uses.

EPA evaluated clothianidin, imidacloprid and thiamethoxam to determine whether they may affect one or more species listed under the Endangered Species Act (ESA) or their designated critical habitats. The draft BEs find that each of these chemicals is likely to adversely affect certain listed species or their designated critical habitats.

The “likely to adversely affect” (LAA) determination means that EPA reasonably expects that at least one individual animal or plant, among a variety of listed species, may be exposed to the pesticide at a sufficient level to have an effect, which will be adverse. The LAA threshold for a BE is very sensitive because the likely “take” of even one individual of a species, which includes unintentional harm or death, triggers an LAA determination. This is the case even if a species is almost recovered to a point where it no longer needs to be listed. As a result, there are often a high number of “may effect” and LAA determinations in a BE. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy. Jeopardy determinations are made by the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively “the Services”) in the course of a formal consultation that evaluates any effects of the pesticides on entire species.

A BE is a document that contains EPA’s analysis of the effects of a pesticide on federally threatened or endangered species and their designated critical habitat, and any conclusions that the pesticide may affect, and is likely to adversely affect, any of these species or habitats. The BE is used to initiate consultation with the Services, if needed. This evaluation encompasses all registered uses and approved product labels for pesticide products containing these chemicals.

When formal consultation is necessary, the Services use the information in EPA’s final BE to develop their biological opinions (BiOps). In their BiOp, the Services document their determination of whether a pesticide jeopardizes the continued existence of the species and whether there will be adverse modification to its designated critical habitat. If jeopardy or adverse modification is determined, the Services, with input from EPA, will propose additional protections.

The draft BEs released today were developed after the release of EPA’s proposed interim decisions (PIDs) for the neonicotinoid pesticides in January 2020. As part of the PIDs, EPA has begun the process of proposing mitigation measures, such as annual application rate reductions and application timing restrictions under the Federal Insecticide, Fungicide, and Rodenticide Act, which will be finalized after the completion of the final BEs. Additional mitigation measures may be developed through formal consultation on the neonicotinoid pesticides. EPA is interested in finding ways, through discussions with stakeholders, to implement mitigation measures that further protect endangered and threatened species earlier in the ESA consultation process.

Read the draft biological evaluations for clothianidinimidacloprid and thiamethoxam on our webpage. To learn more about these BEs, see the Frequently Asked Questions. EPA is accepting public comments for 60 days upon publication via docket EPA-HQ-OPP-2021-0575 at www.regulations.gov, and will finalize the BEs after reviewing the comments.

EPA Announces Plan for Pet Incident Reporting and Releases Proposed Interim Decisions for Four Pesticides

This original announcement was published by the EPA on August 3, 2021. Click here for more information.


The U.S Environmental Protection Agency (EPA) is announcing its plan collect pet incident data on four pesticides used in a variety of agricultural and non-agricultural settings, including in residential pet products. These pesticides are MGK-264, piperonyl butoxide (PBO), pyrethrins, and amitraz.

In its overall efforts to protect pets under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA intends to request enhanced incident reporting and sales data for these pet products to align with what is already submitted for spot-on products. These data would allow the agency to conduct a comparative assessment of pet incidents across registered pet products based on sales data to better determine whether any changes to the pet product registrations and labels are necessary. EPA is interested in feedback from stakeholders on the most efficient way these data can be provided to the agency and types of analyses that could be submitted to expedite the agency’s assessment. EPA is also considering additional measures that could enhance its oversight of pet products, such as additional targeted studies and monitoring, and welcomes public comments on these and other potential measures.

Additionally, EPA is releasing proposed interim decisions (PIDs) for MGK-264, PBO, and pyrethrins to address potential human health and ecological risks. EPA is also releasing the PID for amitraz. FIFRA requires the agency to periodically re-evaluate pesticides through registration review to ensure that risk assessments and pesticide decisions reflect the best available science. Registration review is a multi-step process to identify risks as well as actions that can mitigate risks.

Based on the findings in the draft human health and ecological risk assessments and feedback submitted during the public comment periods, EPA is proposing the following mitigation measures for MGK-264, PBO, and pyrethrins:

  • Additional personal protection equipment for several occupational handler scenarios;
  • Prohibiting certain applications via indoor dusters, shakers, aerosol space sprays, handheld/portable misters and foggers, and liquid spray applications;
  • Adding mandatory spray drift management label language (PBO and pyrethrins only); and
  • Cancelling multiple products/uses for certain residential, commercial (e.g. food handling establishments, warehouses) and indoor agricultural use (e.g., poultry houses, animal quarters).

For amitraz, the agency did not identify any human health risks of concern. Additionally, the agency has concluded that, although the potential ecological risks are limited only to honey bees in hives treated with amitraz, the risks are low and has, therefore, made a “no effect” determination for species groups for amitraz products under the Endangered Species Act. EPA is not proposing any risk mitigation for amitraz.

Upon publication of Federal Register notice, public comments will be accepted for 60 days in the registration review dockets, EPA-HQ-OPP-2012-0415 (MGK-264), EPA-HQ-OPP-2010-0498 (PBO), EPA-HQ-OPP-2011-0885 (pyrethrins) and EPA-HQ-OPP-2009-1015 (amitraz) at www.regulations.gov.

After a thorough review of the science and carefully considering scientific peer review and public comments, EPA will proceed with the registration review process for MGK-264, PBO, pyrethrins, and amitraz. The next step in the FIFRA registration review process is the interim decision, which imposes risk mitigation measures necessary to protect human health and the environment.

Background on Pesticide Uses

Pyrethrins are a mix of six compounds used as insecticides to target a wide range of pests in agricultural and non-agricultural settings. Pyrethrins are also registered for use in residential pet products, such as pet shampoos, pet spot-ons, and pet dusts.

MGK-264 and PBO are insecticide synergists used in combination with a variety of insecticides such as the pyrethrins and pyrethroids. Synergists are chemicals that, while lacking pesticidal properties of their own, enhance the pesticidal properties of other active ingredients. The use patterns for PBO are similar to the pyrethrins. MGK-264 has similar indoor commercial and indoor residential uses, but has no agricultural crop uses. Outdoor uses of MGK-264 are limited to building surface treatments. Both MGK-264 and PBO are registered for use in residential pet products, such as pet shampoos, pet spot-ons, and pet dusts.

Amitraz is an insecticide/acaricide currently registered for use in pet collars for control of ticks on dogs and in impregnated strips for control of Varroa mites in beehives.

EPA Finalizes New, Stronger Safety Measures for Pesticide Paraquat

This original announcement was published by the EPA on August 2, 2021. Click here for more information.


The U.S. Environmental Protection Agency (EPA) is releasing the interim decision (ID) for the pesticide paraquat dichloride (paraquat) finalizing new, stronger safety measures to reduce exposure. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires the agency to periodically re-evaluate pesticides through registration review to ensure that risk assessments and pesticide decisions reflect the best available science. The ID is part of the legally required registration review process to identify risks as well as actions that can mitigate risks.

Paraquat is an herbicide applied annually to control invasive weeds and grasses in crops including cotton, corn, and soybeans. No direct one-to-one alternatives to paraquat are available. All paraquat products are Restricted Use Products and may only be used by certified pesticide applicators.

The agency has taken proactive steps to ensure paraquat is used in a manner that will not cause unreasonable adverse effects to human health or the environment and is consistent with the label directions. EPA’s 2016 Paraquat Human Health Mitigation Decision included a safety awareness campaign, targeted training for paraquat applicators, and changes to labels and product packaging to help prevent illness, injury, or death resulting from improper use.

The ID released today builds upon this previous work and includes the following enforceable mitigation measures that specify parameters for application and institute restrictions to further protect individuals from exposure. EPA has determined that these mitigation measures are necessary to address the risks identified from paraquat exposure while allowing for the continued use of this important agricultural tool.

  • Limiting aerial applications and requiring residential buffers.
  • Prohibiting pressurized handgun and backpack sprayer applications.
  • Requiring enclosed cabs or respirators for groundboom applications.
  • Increasing the Restricted Entry Interval (REI) for several crops.

Additionally, EPA evaluated hundreds of studies, including published toxicity and epidemiology literature on paraquat exposure and adverse health outcomes, including Parkinson’s Disease. There are many studies on paraquat and Parkinson’s Disease that range in quality and provide conflicting results. Following EPA’s 2019 literature review, an updated study of the Agricultural Health Study cohort was published in 2020 that reported no association between paraquat exposure and Parkinson’s Disease. Notably, this updated study did not replicate earlier 2011 findings from AHS that were considered by EPA and suggested a potential association may exist. After a thorough review of the best available science, as required under FIFRA, EPA has not found a clear link between paraquat exposure from labeled uses and adverse health outcomes such as Parkinson’s disease and cancer.

The new safety measures announced today will significantly reduce potential human health risks and are protective of all potential human health outcomes, including Parkinson’s disease.

More information about paraquat and the interim decision is available on EPA’s website.