US EPA proposes streamlined registration review process for several low risk biopesticides

On December 10, 2024, the U.S. Environmental Protection Agency (EPA) announced streamlined proposed registration review decisions for several biopesticides used in a variety of agricultural, commercial, and residential applications. These biopesticides present very low toxicity, exposure, and risks to human health and the environment, and there have been no human health or environmental incidents reported or new information that would necessitate additional assessment or reconsideration of EPA’s prior decision. The Agency is proposing that no further registration review is necessary for these biopesticides at this time. This streamlined approach allows EPA’s Office of Pesticide Programs to be more flexible and efficient with its limited resources.

Through the registration review program, EPA reevaluates each pesticide’s registration based on current scientific and other knowledge about the pesticide, including its effects on human health and the environment, taking into consideration any changes in law, regulations, or policy since the last review.

Pesticides go through a registration review process that can take years to complete. The provision in EPA’s regulations at 40 CFR 155.46 allow the Agency to determine that there is no need to reconsider a previous decision that a pesticide meets the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration. This provision would not be appropriate for higher risk pesticides, pesticides about which adverse incidents have been reported, or those that have new scientific or information that would necessitate that the Agency conduct additional assessment and possibly change the Agency’s prior risk determination or required mitigations.

Biopesticides—which include naturally-occurring substances—are commonly less harmful compared to traditional pesticides. The biopesticides being considered in this streamlined approach to registration review are:

• Alpha methyl mannoside (improves the growth of a range of crops);

• Duddingtonia flagrans strain IAH 1297 (breaks the cycle of parasitic nematode infections in grazing animals);

• Pepino mosaic virus, strain CH2, isolate 1906 (protects greenhouse tomatoes from other viruses);and

• Sheep fat (repels animals like deer from ornamentals, trees, shrubs, and other plants).

Each of the listed biopesticides underwent a comprehensive review during registration, wherein EPA concluded that they met the FIFRA standard of reasonable certainty of no harm. Given the low risk presented by these biopesticides, the Agency determined that no additional review, or reconsideration of the prior decision were needed. For higher risk pesticides, EPA would follow the standard registration review process to ensure they still meet the FIFRA standards to support the prior decision.

If the proposed decisions are made final, EPA would be making the determination that these biopesticides continue to meet the FIFRA standard. Under the Endangered Species Act alpha methyl mannoside has been determined to ‘Not likely to Adversely Affect’ listed species and their critical habitats. Duddingtonia flagrans strain IAH 1297, pepino mosaic virus, strain CH2, isolate 1906 and sheep fat have been determined to have ‘No Effect’ on listed species and their critical habitats.

The proposed registration review decisions are available for public comment in docket EPA-HQ-OPP-2024-0520 at www.regulations.gov.