March 10, 2018

EPA opens public comment period for Oxitec’s Experimental Use Permit application for Friendly™ Mosquitoes in Florida Keys

Oxitec

MARATHON, Florida, March, 9th, 2018 – Today, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice of receipt of an application for an Experimental Use Permit (EUP) for the release of Oxitec’s OX513A Friendly™ Mosquitoes in Monroe County, Florida. This marks the opening of a 30-day public comment period, after which the EPA will review the comments as part of their evaluation of Oxitec’s EUP application.

“We’re thrilled to be partnering with FKMCD on this important pilot project. Our Friendly Mosquitoes have been highly successful in projects around the world and we’re now looking forward to deploying right here in the US.” – Grey Frandsen, General Manager Oxitec Ltd.

Following guidance issued by the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM), regulatory jurisdiction for self-limiting Aedes aegypti Friendly™ Mosquitoes in the United States was transferred to the EPA as a pesticide product in October 2017.

While under FDA jurisdiction, the FDA published a final Finding of No Significant Impact (FONSI) and final Environmental Assessment (EA) on self-limiting Friendly™ Mosquitoes for an investigational trial in the Florida Keys. The finding concluded that a field trial of the genetically engineered (GE) Friendly™ Mosquitoes in Key Haven, Florida, will not result in a negative impact on the environment or human or animal health. This assessment was carried out by an FDA-led team and included experts from the FDA-CVM, the Centers for Disease Control and Prevention (CDC) and the EPA.

The purpose of Oxitec’s experimental use program is to determine the efficacy of Oxitec’s self-limiting Aedes aegypti Friendly™ Mosquitoes as a control method for the wild pest Aedes aegypti population.

“We are focused on reducing the population of wild Aedes aegypti mosquitoes without any impacts to other insects or animals. Friendly™ Mosquitoes are a precise, species-specific and environmentally-responsible vector-control solution with a proven record of success.” – Derric Nimmo, Principal Scientist Oxitec Ltd.

The Federal Register publication is available at:
https://www.federalregister.gov/documents/2018/03/09/2018-04705/pesticide-experimental-use-permit-receipt-of-application-comment-request

Comments may be submitted at:
https://www.regulations.gov/document?D=EPA_FRDOC_0001-22013

How Friendly™ Mosquitoes work
Oxitec has been working in Aedes aegypti control for over a decade and pioneered the use of a biological method to suppress wild populations of this dangerous mosquito species through the release of Friendly™ Mosquitoes, which do not bite and do not transmit diseases. When released, these males search for wild females to mate, and their offspring inherit a self-limiting gene that causes them to die before reaching adulthood.  Friendly™ Mosquitoes offspring also inherit a fluorescent marker that allows tracking and monitoring, making the assessment of effectiveness accurate throughout the  Friendly™ Mosquitoes deployment program. Unlike other approaches, Friendly™ Mosquitoes die along with their offspring, and therefore do not persist in the environment or leave any ecological footprint.

About Oxitec
Oxitec is a pioneer in using genetic engineering to control insect pests that spread disease and damage crops, and was founded in 2002 as a spinout from Oxford University (U.K.). Oxitec is a subsidiary of Intrexon Corporation (NYSE: XON), which engineers biology to help solve some of the world’s biggest problems.  Follow us on Twitter at @Oxitec, on Facebook, and LinkedIn.

About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is Powering the Bioindustrial Revolution with Better DNA™ to create biologically-based products that improve the quality of life and the health of the planet.  The company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells.  We call our synthetic biology approach Better DNA®, and we invite you to discover more at www.dna.com or follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements.  These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business.  Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

Oxitec Contact UK:
Sarah Hoey, PhD
Communications Manager
Tel: +44 (0) 1235 832 393
info@oxitec.com

Source: http://www.oxitec.com/epa-opens-public-comment-period-oxitecs-experimental-use-permit-application-friendly-mosquitoes-florida-keys/

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