Vector Expedited Review Voucher (VERV) Program
Under the Vector Expedited Review Voucher (VERV) Program, a pesticide applicant may request a voucher when applying to EPA for registration of a new mosquito control product that controls pyrethroid- or other insecticide-resistant mosquitoes. If granted, the voucher may be redeemed to shorten the decision review time for a future pesticide application falling under certain specified PRIA categories (see table below). This program incentivizes companies to develop novel or unique mosquito control products to help prevent the spread of mosquito-borne diseases like malaria, dengue, and Zika. The VERV program is mandated by law under the Pesticide Registration and Improvement Act of 2022 (PRIA 5).
On this page:
- Voucher Eligibility Requirements
- Determinations on Novel or Unique Mode of Action
- Requesting a Waiver to Allow Repurposing of an Existing Agricultural Pesticide
- How to Apply for a Voucher
- How to Redeem a Voucher
- Vouchers Issued by EPA
- For More Information
Voucher Eligibility Requirements
To qualify for a voucher under the VERV Program, application for a new active ingredient must show that the ingredient:
- Demonstrates a proven efficacy (performance) against pyrethroid or other insecticide-resistant mosquitoes. Efficacy studies along with resistant ratio determinations of the resistant mosquito strain must be submitted to fulfill product performance requirements. On a case-by-case basis, EPA may accept a rationale for efficacy based on the active ingredient’s novel mode of action to demonstrate control of insecticide-resistant mosquitoes. EPA will evaluate these studies and ensure efficacy data meet the same requirements required for other products intended for mosquito control.
- Prevents, kills, mitigates, or repels pyrethroid- or other insecticide-resistant mosquitoes, with a novel or unique mechanism different from other insecticides already registered by the Agency for mosquito control. Requirement may be waived if the Agency determines there is a significant public health benefit. Waiver requests must be submitted with the application and decisions will be made on a case-by-case basis.
- Targets mosquitoes capable of spreading such diseases as malaria, dengue, Zika, chikungunya, St. Louis encephalitis, eastern equine encephalitis, western equine encephalitis, West Nile encephalitis, Cache Valley encephalitis, La Crosse encephalitis, and yellow fever.
- Is made accessible for use in the United States, including territories or possessions of the United States, and countries where mosquito-borne diseases, such as malaria, are prevalent.
- Broadens the adoption of integrated pest management strategies, such as insecticide resistance management, or makes those strategies more effective.
- Is not contained in any pesticide product registered by the Agency as of the date of the enactment of the Pesticide Registration Improvement Act of 2022 or does not contain an active ingredient approved in the 2-year period preceding the date of registration by any global stringent regulatory authority for the same uses, vectors, and applications. Requirement may be waived if the Agency determines there is a significant public health benefit. Waiver requests must be submitted with the application and decisions will be made on a case-by-case basis.
The application must also include a global access plan that will be made publicly available for the active ingredient and that addresses: a) manufacturing locations, including any licensed third-party manufacturers; b) distribution and procurement processes for malaria vector control programs in selected countries (when the product targets Anopheles mosquitoes); and c) the prices for common quantities of the product.
Determinations on Novel or Unique Mode of Action
EPA will determine whether or not an application has a unique or novel mode of action on a case-by-case basis. In making this determination, the agency will look for factors such as whether:
- The mechanism targets new or different receptors
- The pesticide is in a new or different chemical class (including classification by the Insecticide Resistance Action Committee)
- The mechanism uses special approach such as interrupting behavior, targeting different life stages, or prohibiting reproduction
- Live release control techniques should target a specific species not controlled by another live-release product.
Requesting a Waiver to Allow Repurposing of an Existing Agricultural Pesticide
The requirement(s) that a product’s active ingredient must not be contained in any previously-registered product and for a novel mechanism action may be waived if the Agency determines there is a significant public health benefit. Waiver requests must be submitted with the application and decisions will be made on a case-by-case basis.
How to Apply for a Voucher
To apply for a voucher, pesticide registrants must indicate their intent on EPA Form 8570-1: Application for Pesticide Registration/Amendment, which can be submitted through the electronic portal. Registrants must supply all supplemental information necessary for EPA to process a request for a voucher with the application, including a global access plan that will be made publicly available for the active ingredient and that addresses: a) manufacturing locations, including any licensed third-party manufacturers; b) distribution and procurement processes for malaria vector control programs in selected countries (when the product targets Anopheles mosquitoes); and c) the prices for common quantities of the product.
Electronic copies of the form are available on EPA’s website.
Completed forms can be sent electronically through the Pesticide Submission Portal (PSP) which is accessed through the EPA’s Central Data Exchange (CDX) Network.
How to Redeem a Voucher
Prior to redeeming a voucher, an applicant must notify EPA of their intent at least 90 days prior to submitting the application to be eligible for the expedited review process. Applicable registration service fees are still required. EPA will expedite decisions only for the following PRIA categories and timeframes:
PRIA Category | Expedited Decision Review Times (compared to standard times) |
---|---|
R010, New Active Ingredient, Food use | 30 months (6 months shorter than 36 months) |
R020, New Active Ingredient, Food use; reduced risk | 21 months (6 months shorter than 27 months) |
R060, New Active Ingredient, Non-food use; outdoor | 24 months (6 months shorter than 30 months) |
R110, New Active Ingredient, Non-food use; indoor | 14 months (6 months shorter than 20 months) |
R070, New Active Ingredient, Non-food use; outdoor; reduced risk | 20 months (4 months than 24 months) |
R120, New Active Ingredient, Non-food use; indoor; reduced risk | 12 months (2 months shorter than 14 months) |
As with any pesticide application, the quality of the application for which a voucher is redeemed can impact EPA’s ability to complete its review within the specified deadline. Other issues such as scientific or use complexity, incomplete or insufficient data sets, or endangered species considerations, may also impact deadlines. For these reasons and others, there may be challenges to EPA’s ability being able to meet an expedited timeframe for an application submitted under the proposed expedited voucher program.
Before EPA registers any new conventional active ingredient, the Agency will first evaluate the potential effects of the active ingredient on federally threatened or endangered (listed) species and their designated critical habitats, require registrants to implement ESA mitigation measures if needed, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service where appropriate. This requires significant resources and time when evaluating new pesticides. EPA is currently evaluating approaches to streamline the associated steps, since the Agency has experienced challenges in meeting deadlines when considering impacts to listed species.
Once a voucher has been redeemed and the application has cleared the 21-day content screen (FIFRA Section 33(f)(4)(B)(i)(I)), it cannot be submitted with or transferred to another application.
Vouchers Issued by EPA
As of this writing, the Agency has not yet issued any voucher. The agency will notify the registrant of the voucher decision and registration decision at the same time. Applicable information will be listed in the table below.
Voucher Identification Number | Issued for Registration Number | Date Voucher Issued | Voucher Issued to |
---|---|---|---|
TBD | TBD | TBD | |
For More Information