Unanimous Decisions by U.S. EPA, State of Florida Approve Environmentally Sustainable Oxitec Friendly Mosquitoes for Pilot Project

• Following federal approval in May by the U.S. EPA, Oxitec’s permit to deploy safe mosquito control technology, an alternative to the use of chemical pesticides, received unanimous approval by seven State of Florida departments and agencies, including the Florida Department of Agriculture and Consumer Services (FDACS), the Florida Department of Health, the Florida Fish and Wildlife Conservation Commission and the Florida Department of Environmental Protection.

• Oxitec’s Friendly™ mosquitoes are the result of 18 years of public-private collaboration with leading universities, governments, global foundations, scientific research institutes, and over 200 scientists from more than 20 countries.
  

• Federal and state regulators carried out exhaustive scientific reviews to confirm that Friendly™ mosquitoes pose no risks to human health or the environment, including fish and other aquatic life, birds, bats, plants, invertebrates, or endangered species.

Washington, DC - Oxitec, a US-owned company developing safe, sustainable biological control tools, is pleased to announce the State of Florida yesterday issued its approval for an Experimental Use Permit (EUP), paving the way for a pilot project of Oxitec’s Friendly™ Aedes aegypti mosquito technology (“OX5034”) in the Florida Keys.

Oxitec’s technology received unanimous approval from the following agencies:

• U.S. EPA, with scientific endorsement from U.S. Centers for Disease Control (CDC).
• Florida Department of Agriculture and Consumer Services.
• Florida Bureau of Chemical Residue Laboratories (BCRL).
• In 2016, the U.S. FDA issued its findings that Oxitec’s technology would have no negative impacts on human, environmental or animal health.

• Florida Department of Environmental Protection (FDEP).
• Florida Fish and Wildlife Conservation Commission (FWC).
• Florida Department of Health (DOH).
• Florida Bureau of Inspection and Incident Response (BIIR).
• Florida Bureau of Scientific Evaluation and Technical Assistance.
• Florida Bureau of Agricultural Environmental Laboratories (BAEL).

Oxitec’s Friendly™ Aedes aegypti mosquito is a major advancement in safe, targeted vector control technology to combat the mosquito that transmits dengue, Zika and yellow fever. It is an insect-based solution built specifically to provide targeted suppression with simplicity, scalability, and economic and environmental sustainability, further unlocking the benefits of biological public health solutions for governments, communities and other end-users of all types. This pilot project will help demonstrate the technology’s biosafety and ability to control this disease-transmitting mosquito in the U.S.

The U.S. EPA and Florida’s Department of Agriculture and Consumer Services (FDACS) commissioned a range of scientific experts to study Oxitec’s technology. The EPA published its complete risk assessment, its reviews of the planned pilot program, and its 150-page response to all substantive public comments, on its website and available here. At the end of this comprehensive review, the EPA concluded that Oxitec’s Friendly™ Aedes aegypti mosquito carries no risk to human health or to the environment, including endangered species.

Alongside these approvals and endorsements from governments and scientific institutions around the world, Oxitec’s technology has been reviewed exhaustively in more than 100 scientific publications. Oxitec has been working with the local mosquito control district in Florida for over a decade in designing and preparing for a pilot project. In 2016, a public referendum on Oxitec’s mosquito technology received support in 31 out of 33 precincts and the local mosquito control district approved the field trial. The trial was delayed due to a transfer of jurisdiction from FDA to the EPA, after which Oxitec reapplied with its next generation Friendly™ mosquito, OX5034.

“There is broad consensus amongst public health officials in the U.S. that a new generation of safe, targeted and cost-effective vector control tools are needed urgently to combat the growing threat posed by Aedes aegypti without impacting the ecosystem. We’re pleased that the EPA and Florida state regulators have, after extensive scientific reviews, approved our demonstration trials and we look forward to continuing the collaboration with our local partners as they take up the matter,” said Grey Frandsen, CEO of Oxitec.

About Oxitec

Oxitec is a pioneer in biological solutions to safely and sustainably control insect pests that spread disease and damage crops. Oxitec was founded in 2002 as a spinout from the University of Oxford (UK) and is made up of a passionate and diverse team comprised of 15 nationalities.

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Oxitec Press inquiries:

Meredith Fensom and Joshua Van Raalte

Email: press@oxitec.com

UK & international: +44(0) 20 7785 7383

US: 1-781-519-9981

Key Facts and Resources:

• U.S. EPA approval;
• FDACS approval;
• List of 100+ scientific publications relating to Oxitec’s technology;
• Information about OX5034 performance in Brazil;
• 2016 referendum result;
• 2016 local mosquito control authority approval of field trials.

EUP Documents Issued by the EPA:

• Office of Pesticide Programs (OPP) Update: https://content.govdelivery.com/accounts/USAEPAOPPT/bulletins/2896a76

• Permit Issuance Letter: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0353

• Human Health and Ecological Risk Assessment: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0359

• Draft Label: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0357

• Response to Comments: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0354 (Explanatory Memorandum) and https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0355 (Response to Comments)

• Section G Field Protocol: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0358

• Reviews of Section G Field Protocol: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0356 (26 Mar 2020) and

https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0352 (Addendum 30 Apr 2020)

• Joint Memorandum with CDC on Introgression and Vectorial Capacity: https://www.regulations.gov/document?D=EPA-HQ-OPP-2019-0274-0351