EPA Issues First Voucher to Incentivize the Development of Novel Mosquito Control Products
Released on December 5, 2024
The U.S. Environmental Protection Agency (EPA) has issued its first voucher under its Vector Expedited Review Voucher (VERV) Program as a result of a recent approval by EPA of a new active ingredient - Wolbachia wAlbB strain. The VERV Program, which is required by the Pesticide Registration Improvement Act of 2022 (known as “PRIA 5”) and announced in December 2023, aims to incentivize companies to develop novel or unique mosquito control products to help prevent the spread of mosquito-borne diseases like malaria, dengue, and Zika.
Mosquito-borne diseases are among the world's leading causes of illness and death and pose a significant risk to people in the United States. Controlling mosquitoes is challenging, especially because many are developing resistance to currently registered insecticides. The pesticide product associated with this new active ingredient, WB1 Males, was registered by EPA in April 2024 for commercial use as a population suppression tool for Aedes aegypti mosquitoes which are a known vector of several serious illnesses including dengue, chikungunya, and Zika. WB1 Males prevents population growth by reducing reproductive success in areas where the product is continually released over time. The use of this particular Wolbachia bacteria strain within the WB1 Males is a novel mode of action for the Aedes aegypti species, which has had reported resistance to a range of mosquito insecticides.
Under the VERV program, EPA may issue a voucher to the registrant of a new, qualifying pesticide product for mosquito control after it is successfully registered. Vouchers may be sold or transferred to other registrants. An applicant may then redeem this voucher when submitting a future application for a different product under one of the specified PRIA codes. EPA will then expedite its review of the new application, potentially providing a shorter time to market for the product involved. The EPA’s issuance of a voucher is in no way to be construed as an endorsement or recommendation of this product.
After reviewing all submitted data, EPA determined that WB1 Males meets the required criteria for VERV Program eligibility:
- Proven Efficacy: After different trials showed population reductions of 68 - 95%, the EPA concluded that the product can be expected to provide population suppression over a minimum of a 20-acre contiguous area.
- Novel Mode of Action: The use of Wolbachia with the WB1 Males product is novel for the species, Ae. aegypti.
- Targets Mosquitoes Capable of Spreading Diseases: The target pest, Ae. aegypti, is a vector of a number of human diseases, including yellow fever, chikungunya, dengue, and Zika viruses.
- Accessibility and Global Access Plan: The registrant submitted a plan addressing the manufacture, distribution, procurement, and pricing processes for foreign vector control programs for the use of WB1 Males.
- Broadens Integrated Pest Management Strategies: The label for WB1 Males indicates that the product is intended to be used as part of a mosquito control program.
- New Product Containing a New Active Ingredient: No products containing the active ingredient, Wolbachia wAlbB strain, have been previously registered by the EPA for use against Ae. aegypti.
For more information about the VERV Program, visit EPA’s webpage. The final registration decision and supporting documents for WB1 Males are available at docket ID EPA-HQ-OPP-2020-0028 on www.regulations.gov.