aportes a la gestión necesaria para la sustentabilidad de la SALUD PÚBLICA como figura esencial de los servicios sociales básicos para la sociedad humana, para la familia y para la persona como individuo que participa de la vida ciudadana.
domingo, 14 de agosto de 2016
CVM Updates > FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito
FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito
August 5, 2016
The FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, the FDA has published a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.
FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.
May 16, 2016
The public comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes was extended for 30 days and closed on May 13, 2016. The FDA is thoroughly reviewing all public comments and information submitted before determining its next steps. Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA and determined whether it will finalize the EA and FONSI or prepare an Environmental Impact Statement.
March 11, 2016
The FDA is releasing for public comment a draft environmental assessment (EA) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya.
The National Environmental Policy Act (NEPA) requires federal agencies to assess the environmental impacts of certain actions. Pursuant to FDA regulations, sponsors opening an Investigational New Animal Drug (INAD) file must submit either a draft EA or a claim of categorical exclusion from the EA requirement.
The FDA is also releasing a preliminary finding of no significant impact (FONSI) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment.
Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA, and subsequently has issued either a final EA and FONSI or an environmental impact statement.
The FDA is accepting public comments on the draft EA and preliminary FONSI for 30 days from the date of publication in the Federal Register. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2014-N-2235 in the search box. While comments are welcome at any time, you should submit them by the closing date to ensure FDA considers your comments.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-2235 on each page of your written comments.
The Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
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