Genetically Engineered Mosquitoes Research Authorization Application

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On March 10, 2022, The California Department of Pesticide Regulation (DPR) received Oxitec, Ltd’s application for a research authorization to release and study the use of genetically engineered Aedes aegypti mosquitoes to reduce the current Aedes aegyptis mosquito population in Tulare County, California. Oxitec submitted its application to DPR following US EPA’s approval of its related application for an Experimental Use Permit. A research authorization from DPR is required for Oxitec to conduct the study in Tulare County.

DPR’s review of the research authorization application will entail a rigorous scientific evaluation, consultation with government agencies including the California Department of Public Health, the Tulare County Agricultural Commissioner’s Office, and the Delta Mosquito and Vector Control District, and consideration of public comments and input.

The department will open a 15-day public comment period beginning April 5 and ending on April 19 at 5 p.m. to collect information and feedback from the public to be considered as part of the review and evaluation of the application. Comments can be submitted via email to mosquito.ra@cdpr.ca.gov.

DPR will provide updates on its review of the research authorization application on this website page.

This webpage was last updated on April 5, 2022.

What is the status of DPR’s review of Oxitec’s research application to release and study the use of genetically engineered mosquitoes to reduce mosquito populations?

On March 10, 2022, the department received an application for a research authorization from Oxitec, Ltd to release and study the use of genetically engineered Aedes aegypti mosquitoes to reduce the Aedes aegypti mosquito population in Tulare County, California. This application is currently under review and evaluation by DPR; the department has not approved any release of genetically engineered mosquitoes.

DPR must approve a research authorization application before an unregistered pesticide can be field tested in the state. DPR’s application process for a research authorization includes a rigorous scientific review and risk evaluation process. Research authorizations are approved or refused based on an evaluation of whether that research may involve a hazard to handlers or field workers, public health, or the environment. Research authorizations may limit the amount of a pesticide used and the area and the time-period that the product may be tested, are subject to monitoring and reporting requirements, and may include additional requirements and limitations.

What is DPR’s review process for Oxitec’s research authorization application?

DPR toxicologists, entomologists, microbiologists, ecotoxicologists, and other department scientists will review the application, research design, scientific studies, and additional information to evaluate whether the research may involve a hazard to handlers or field workers, public health, or the environment. This evaluation will include:

  • Research Authorization Review:
    • Evaluation of submitted materials, including a review of the map of proposed research sites and potential tetracycline sources in surrounding region.
  • Pest and Disease Protection Review:
    • Evaluation of the submitted research protocols to determine whether the proposed research is adequately designed to evaluate efficacy of the product.
    • Assessment of mosquito sampling and monitoring protocols.
  • Ecotoxicology Review:
    • Evaluation of any potential hazards associated with the release of genetically engineered mosquitoes to non-target organisms, including threatened and endangered species.
    • Assess the potential for introgression of genes into the local mosquito population (hybrid vigor).
  • Microbiology Review:
    • Evaluation of the manufacturing process and information characterizing the genetically engineered mosquitoes.
  • Human Health Assessment Review:
    • Evaluation of any potential hazards associated with the release of genetically engineered mosquitoes on public health, including toxicity and allergenicity.

The department’s review will include consultation with the California Department of Public Health, the County Agricultural Commissioner’s Office, the Delta Mosquito and Vector Control District and other appropriate government agencies to assess human health and ecological risks. The review will also consider public comments.

What is the timeline for DPR’s review of Oxitec’s research authorization application?

The department is currently evaluating the application and anticipates that the review will take at least several months.

What research is Oxitec requesting to conduct with genetically engineered mosquitoes?

Oxitec is requesting to conduct four trials to study the effectiveness of genetically engineered Aedes aegypti mosquitoes to reduce the Aedes aegypti mosquito population. The proposed trials include:

  1. Release of mosquitoes from a single point with monitoring extending out in concentric rings from the initial release.
  2. Release of mosquitoes from multiple points within a set area at different doses.
  3. Release of mosquitoes from a single point at different doses.
  4. Release of marked mosquitoes from a single point with monitoring extending out in concentric rings from the initial release.

Where is Oxitec requesting to release and study genetically engineered mosquitoes?

Oxitec proposes field testing in Tulare County. The company has not yet identified proposed testing sites. The location of the release sites, how many sites are necessary to conduct the requested research, and the number of mosquitoes released per each site will be evaluated by DPR as part of its review of the application.

What is the geographic scope of approved research authorizations?

Approved research authorizations can only be conducted under the conditions of the approved application, including limited geographic locations, restricted acres for treatment, length of time the research can be conducted, and other limitations as required by DPR. The application received by Oxitec requests research authorization in Tulare County, California.

Before a pesticide may be used for purposes other than the defined scope of a research authorization, it is subject to DPR’s separate, comprehensive registration evaluation and review process, which is required before a pesticide is sold or used in California.

How many genetically engineered mosquitoes does Oxitec propose to release as part of its research request?

Oxitec proposes to release 5,000-30,000 mosquitoes per week at each site. The location of the release sites, how many sites are necessary to conduct the requested research, the proposed monitoring and containment tracking of the mosquitoes and the number of mosquitoes released per each site will be evaluated by DPR as part of its review of the application.

How many locations in Tulare County does Oxitec propose to release genetically engineered mosquitoes?

The location of the release sites, how many sites are necessary to conduct the requested research and the number of mosquitoes released per each site will be evaluated by DPR as part of its review of the application.

Oxitec’s application proposes up to 48 release sites to conduct studies on the use of genetically engineered mosquitoes to reduce mosquito populations. Release sites have not yet been identified by Oxitec. Identification of those sites is required by DPR for its review and evaluation of the research authorization application.

How long does Oxitec propose to monitor locations where they are requesting to release genetically engineered mosquitoes?

The federal Experimental Use Permit issued by the US EPA is effective through April 30, 2024. Oxitec’s research authorization application proposes four different studies conducted at multiple sites, each with varied structures and timelines for monitoring.

The location of the release sites, how many sites are necessary to conduct the requested research, how the sites are monitored post-study and the number of mosquitoes released per each site will be evaluated by DPR as part of its review of the application.

Where can I review Oxitec’s submitted research authorization application received by DPR?

The department has posted on its website the following documents related to Oxitec’s research authorization application:

How do I submit comments regarding Oxitec’s research authorization application?

The department is opening a 15-day public comment period beginning April 5 and ending on April 19 at 5 p.m. to collect information and feedback from the public to be considered as part of the review and evaluation of the application. Comments can be submitted via email to Mosquito.RA@cdpr.ca.gov. Comments will be reviewed by department staff and scientists as part of the review and evaluation process for this research authorization application.

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