EPA Releases Final Biological Evaluation for Effects of Inpyrfluxam on Endangered Species

Released on June 21, 2023

The U.S. Environmental Protection Agency (EPA) has released its final biological evaluation (BE) and its response to comments received on the draft BE for the potential effects of inpyrfluxam on federally listed endangered and threatened species and designated critical habitats. Inpyrfluxam is a fungicide used to protect a variety of crops against fungal pests, such as Rhizoctonia fungi, that cause seed decay, seedling damping‐off, and root rot. This final BE is part of EPA’s efforts to meet its obligations under the Endangered Species Act (ESA), which are discussed in EPA’s workplan Balancing Wildlife Protection and Responsible Pesticide Use.

As proposed in the draft BE, EPA’s final BE does not predict a likelihood of jeopardy or adverse modification to listed species from the proposed or registered uses of inpyrfluxam. That is, EPA predicts that inpyrfluxam is not likely to jeopardize the continued existence of any listed species or destroy or adversely modify critical habitat that has been designated for those species. However, EPA determined that inpyrfluxam is likely to adversely affect (LAA) certain listed species and critical habitats. An 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 adverse effect.

When EPA determines in a final BE that a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) action may affect listed species or critical habitats, the Agency must initiate consultation with the U.S. Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (known collectively as the Services). Because EPA’s final BE of inpyrfluxam made LAA determinations for species under both Services' jurisdiction, EPA will initiate formal consultation with both Services.

After reviewing public comments on the draft BE, EPA revised its evaluation of inpyrfluxam, including using updated species range and critical habitat maps to determine the potential effects on listed species and their critical habitats. The Agency also made predictions of whether inpyrfluxam is likely to jeopardize listed species or adversely modify critical habitats. EPA’s final BE finds that inpyrfluxam:

• Will have no effect on 36 percent of species and 33 percent of critical habitats (as compared to 35 percent and 33 percent, respectively, from the draft BE);
• May affect but is not likely to adversely affect 56 percent of species and 57 percent of critical habitats (as compared to 56 percent and 58 percent, respectively, from the draft BE); and
• Is likely to adversely affect 8 percent of listed species and 10 percent of critical habitats (as compared to 9 percent and 8 percent, respectively, from the draft BE).

Additionally, in its final BE, EPA does not predict a likelihood of jeopardy or adverse modification from the approved and proposed uses of inpyrfluxam. While EPA has made predictions about the likelihood of jeopardy and adverse modification as part of its effects determinations consistent with the ESA, the Services are responsible for making the actual jeopardy/adverse modification findings and have the sole authority to do so.

A “may affect but is not likely to adversely affect” determination is made when effects on a listed species or critical habitat are expected to be discountable (for example, effects that are extremely unlikely to occur), insignificant, or beneficial. An LAA determination means EPA reasonably expects at least one individual animal or plant, among a variety of listed species, may be exposed to inpyrfluxam at a sufficient level to have an adverse effect. This is the case even if a listed species is almost recovered to a point where it may no longer need to be listed. The likely “take,” which includes unintentional harm or death, of even one individual of an animal species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations in a BE. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

Subsequent to the draft BE, the registrant submitted a commitment letter that included additional mitigation measures to be added to the pesticide label to minimize the potential for incidental take for the LAA determinations in the final BE. These include mitigations for reducing spray drift and runoff exposure to aquatic environments and additional label language for seed treatments.

During formal consultation, the Services use EPA’s effects determinations to inform their biological opinions. If the Services determine in their final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determinations (that the Services may make) or to address any incidental take beyond those mitigations agreed to by the registrant in a commitment letter dated June 1, 2023, then EPA will work to ensure that any necessary registration or labeling changes are made.

The final BE and the response to comments are available in docket EPA-HQ-OPP-2018-0038 on regulations.gov.

Background on inpyrfluxam 

Inpyrfluxam was first registered in 2020. The proposed and currently approved product labels include some mitigation measures to reduce effects to plants and animals based on FIFRA ecological risk assessments that EPA conducted before registering products containing inpyrfluxam.

After EPA registered several products containing inpyrfluxam, some organizations challenged the registrations because the Agency had not met its ESA obligations before issuing the registrations. Under the ESA, EPA must assess the effects of inpyrfluxam on listed species and critical habitats and, if necessary, initiate consultation with FWS and/or NMFS. In July 2022, the Ninth Circuit Court of Appeals ruled in Center for Biological Diversity v. EPA (No. 20-73146) that EPA was required to complete a final effects determination (which EPA has included in its final inpyrfluxam BE) by June 22, 2023.