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EPA now the regulator for Oxitec's engineered mosquitoes; parent Intrexon up 1%

Oct. 04, 2017 3:18 PM ETPrecigen, Inc. (PGEN) StockPGENBy: Douglas W. House, SA News Editor44 Comments
  • The FDA's Center for Veterinary Medicine issues new guidance that transfers regulatory jurisdiction for Intrexon (XON +1.3%) unit Oxitec's Friendly Aedes mosquito (OX513A) to the Environmental Protection Agency (EPA) since it is considered a pesticide product.
  • FDA-CVM guidance clarifies "that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes, and that are not intended to cure, mitigate, treat or prevent a disease (including by an intent to reduce the level, replication or transmissibility of a pathogen in mosquitoes), are not "drugs" under the Federal Food, Drug, & Cosmetic Act, and will be regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide ActWith the issuance of final guidance #236, Oxitec Ltd's genetically engineered mosquito, with its proposed claim to control the population of wild-type Aedes aegypti mosquitoes, now falls under EPA's regulatory authority and all related regulatory questions should be directed to the EPA."
  • Oxitec says once EPA registration is completed it will work with state and local authorities on the coordinated release of OX513A.

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