Oxitec and MosquitoMate in the United States: lessons for the future of gene drive mosquito control

Figures & data

Figure 1. Timeline summarizing .Table 1

Table 1. Identified events in the development and regulation of Oxitec and MosquitoMate products

MosquitoMate		Oxitec
--		Prior to 2010	Jan 2003 Oxitec Company founded
			Jan 2009 Draft Guidance #187 – FDA to have jurisdiction over GE animals
			Nov 2009 Grand Cayman Trial
			Mar 2010 USDA Application: Assessment of OX513A field trials
Jan	Patent filed for “Transfected Mosquito Vectors”	2011	Nov FDA Application: Assessment of OX513A field trials
May	EPA Application: EUP for ZAP males trial in American Samoa (4 comments)	2012	Jan Publication Critical of Regulatory oversight in Cayman Trial (Reeves et al)
Jun	EPA Application Amendment: EUP, add CA, FL, and NY		Mar FKMCD hosts 1^st Town Hall Meeting
Jul	EPA EUP granted for American Samoa trial		Apr News coverage of controversy in FL
Sep	EPA EUP granted for CA, FL, and NY		Nov FDA receives petition to deny permission for field trial in Key West
Nov	EPA Application Amendment: addition of San Gabriel Valley, CA to EUP
May	EPA Application: EUP for ZAP males trial in Lexington, KY; Public Comment Period (3 comments)	2013	--
Apr	EPA Request: Date extensions for EUPs	2014	Dec FKMCD hosts 2^nd Town Hall Meeting
Aug	“MosquitoMate” trademarked
Aug	EPA grants extensions
--		2015	Aug Oxitec Acquired by Intrexon
Mar	Field trials in Clovis CA	2016	Jan Brazil Trial Reported as Success
Apr	EPA Application: Federal Pesticide Product Registration for ZAP Males; Public Comment Period (10 comments)		Feb Zika in Brazil; Concerns for US
Sep	EPA EUP extended to more CA counties and Monroe County, FL		Mar FDA Posts Draft Environmental Assessment and FONSI; opens comment period (extended through May 13; 2640 comments)
			Apr Referendum in FL announced
			Aug Final FDA FONSI
			Nov Election and Referendum: Split, No GE Mosquitoes in Key Haven
			Nov FKMCD Board postpones, moves trial
Apr	Trial begins in West Keys, FL	2017	Jan New Draft Guidance (#236), “Regulation of Mosquito-Related Products” moves jurisdiction to EPA
Jul	Begin Debug Fresno Trial in Fresno, CA; partner with Verily
Sep	EPA Registration Decision: Public Comment Period (10 comments)
Nov	EPA Final Registration: ZAP males approved for use in 20 states and Washington D.C.
--		2018	Mar EPA Application: OX513A EUP, Public Comment (564 comments)
			Nov Oxitec announces phase out of OX513A mosquito to be replaced with OX5034 mosquito; withdrawal of EPA application for OX513A
--		2019	Sep Publication demonstrating gene transfer from OX513A to wild population in Brazil (Evans et al)
			Sep EPA Application: EUP for OX5034 (343 comments)
Apr	Debug Fresno results published	2020	Jun EPA Grants EUP for OX5034
			Aug Field test of OX5034 approved in FL for summer 2021