U.S. EPA issues revised proposed registration decision of fluazaindolizine

The U.S. Environmental Protection Agency (EPA) is revising its proposed registration decision for fluazaindolizine, a new pesticide active ingredient for agricultural use, to include EPA’s new analysis of the pesticide’s potential effects to federally endangered and threatened (listed) species and their designated critical habitats. This analysis, known as the draft effects determination, was completed as part of EPA’s efforts to meet its obligations under the Endangered Species Act (ESA) and furthers the goals outlined in EPA’s April 2022 ESA Workplan to provide practical protections from pesticides for listed species. Additionally, EPA expects fluazaindolizine will play a role in resistance management and integrated pest management programs to help delay the further development of nematicide resistance.

Background on Fluazaindolizine

Fluazaindolizine, which was first proposed for registration in July 2021, is a pesticide that would be used to control nematodes on vegetables such as carrots, squash, tomatoes, eggplant, potatoes and taro, and on some fruits, including oranges, peaches, almonds, and grapes.

As part of the initial proposed registration decision, EPA assessed whether exposures to these products would cause unreasonable adverse effects to human health and the environment, as required by the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA). Based on EPA’s human health risk assessment, there are no human health risk concerns from the proposed uses of fluazaindolizine. However, EPA’s ecological risk assessment identified risks of concern for mammals and honeybees near use sites. These risks would be mitigated with measures EPA previously proposed, including soil incorporation (mixing the pesticide into the soil) and restrictions that limit pesticide spray drift.

When EPA first proposed to register fluazaindolizine, the Agency used an interim approach to evaluate potential effects to listed species and critical habitats while EPA continued to work towards a long-term approach for assessing how new active ingredients may affect listed species or critical habitats. Since then, the Agency finalized its approach and released the 2022 ESA Workplan, which provides a strategy for how EPA will provide practical protection from pesticides for listed species. For new active ingredients such as this action, EPA will not issue new registrations without first making ESA assessments (effects determinations and predicting the likelihood of jeopardy and adverse modification), implementing needed mitigation, and initiating consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary.

EPA’s Draft Effects Determination

EPA’s draft effects determination finds that fluazaindolizine:

• Will have no effect on 1,566 listed species and 782 critical habitats;

• May affect but is not likely to adversely affect 125 listed species and 18 critical habitats; and

• Is likely to adversely affect (LAA) 18 listed species and three 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 fluazaindolizine 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 a species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

EPA further refined its analysis for the species and critical habitats where it made LAA determinations to predict the likelihood that fluazaindolizine use could lead to a future jeopardy finding for certain listed species or adverse modification finding for critical habitats. These predictions examine effects of fluazaindolizine at the species scale (as opposed to one individual of a species). EPA predicts the originally proposed uses of fluazaindolizine would present a likelihood of jeopardy for one listed plant species (Kern Mallow) and no likelihood of adverse modification for any critical habitats. EPA has therefore determined that additional mitigations are necessary to address effects to this listed species.

Additional Mitigation to Protect the Kern Mallow Plant

In accordance with the ESA Workplan, EPA is proposing geographically specific pesticide use limitations for the protection of the Kern Mallow plant. In areas where Kern Mallow is known to be present, users would not be allowed to use micro-sprinklers to apply the pesticide on certain orchard trees.

Users must check the Bulletins Live Two! Website to identify whether these restrictions apply to their geographic area. With these proposed mitigations in place, EPA predicts that approving the use of fluazaindolizine would not present a likelihood of jeopardy to the Kern Mallow species.

Next Steps

After considering public comments on the proposed registration and the draft effects determination, EPA will determine whether the registration action meets the FIFRA standard and ESA obligations. If EPA determines that the registration action can be granted, EPA will finalize the effects determination. If the final effects determination continues to find that fluazaindolizine is likely to adversely affect listed species and/or their critical habitats, then EPA will initiate formal consultation and share its findings with the Services, as appropriate.

During formal consultation, the Services use the information in EPA’s final effects determination to inform their biological opinions. While EPA has made predictions about the likelihood of jeopardy and adverse modification as part of its effects determinations, the Services are responsible for making the actual jeopardy/adverse modification findings and have the sole authority to do so. If the Services determine in their 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 revised proposed registration decision, including the draft effects determination, will be available for comment for 30 days in docket EPA-HQ-OPP-2020-0065 at www.regulations.gov.