OXFORD, United Kingdom -- The US Food and Drug Administration's
Center for Veterinary Medicine (FDA-CVM) today published a final finding
of no significant impact (FONSI) and final environmental assessment
(EA) on Oxitec's self-limiting OX513A
Aedes aegypti mosquito for
an investigational trial in the Florida Keys. The finding concludes
that a field trial of the Company's genetically engineered (GE) OX513A
mosquitoes in Key Haven, Florida, will not result in a significant
impact on the environment.
The publication of the final FONSI and EA follows an FDA-led
evaluation of potential impacts on health and the environment of the
proposed trial. This culminated in the publication of a preliminary
FONSI in March 2016, after which there was a period of public comment.
These public comments were reviewed by the FDA-led team before the final
documents were published today.
Oxitec's Chief Executive Officer Hadyn Parry said, "We've
been developing this approach for many years, and from these results we
are convinced that our solution is both highly effective and has sound
environmental credentials. We're delighted with the announcement today
that the FDA, after their extensive review of our dossier and thousands
of public comments for a trial in the Florida Keys, have published their
final view that this will not have a significant impact on the
environment. We are now looking forward to working with the community in
the Florida Keys moving forward."
The purpose of the proposed trial is to determine the
efficacy of Oxitec's self-limiting mosquitoes for the control of the
local population of
Aedes aegypti in Key Haven, Monroe County, Florida.
Oxitec's self-limiting mosquitoes have been genetically
engineered so that their offspring die before reaching adulthood. Male
Oxitec mosquitoes, which do not bite or spread disease, are released to
mate with wild female
Aedes aegypti so that their offspring die,
reducing the population. Efficacy trials in Brazil, Panama, and the
Cayman Islands have tested this approach, and in each of these trials
the population of
Aedes aegypti was reduced by more than 90% – an exceptional level of control compared to conventional methods, such as insecticides.
The FDA review team consisted of experts from the Center for
Veterinary Medicine (CVM), the Centers for Disease Control and
Prevention (CDC), and the Environmental Protection Agency (EPA). The FDA
led an extensive review of evidence from trials in urban environments
performed in Brazil and the Cayman Islands since 2009, and data from
numerous safety studies, site inspections and independent experts.
For more information:
Oxitec Florida Keys Project FAQ: http://www.oxitec.com/health/
florida-keys-project/
Florida Keys Mosquito Control District: http://keysmosquito.org/
latest-gm-information/
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 (UK). Oxitec is a subsidiary
of Intrexon Corporation(NYSE: XON), which engineers biology to help solve some of the world's biggest problems.