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| Jan 2009 Draft Guidance #187 – FDA to have jurisdiction over GE animals |
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| Nov 2009 Grand Cayman Trial | |||
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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 1st 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 |
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| Nov |
EPA Application Amendment: addition of San Gabriel Valley, CA to EUP |
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| 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 2nd Town Hall Meeting |
| Aug | “MosquitoMate” trademarked | ||
| Aug |
EPA grants extensions |
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| -- |
|
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) |
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| Apr Referendum in FL announced | |||
| Aug Final FDA FONSI | |||
| Nov Election and Referendum: Split, No GE Mosquitoes in Key Haven |
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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| Apr | Trial begins in West Keys, FL | 2017 | Jan New Draft Guidance (#236), “Regulation of Mosquito-Related Products” moves jurisdiction to EPA |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. |
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| -- | 2018 | Mar EPA Application: OX513A EUP, Public Comment (564 comments) |
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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) |
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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 |
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