On September 6, 2016, 61 members of the Florida House of Representatives issued a letter to the U.S. Department of Health and Human Services (HHS) and to the U.S. Food and Drug Administration (FDA) to urge them to: (1) declare a public health emergency for the Zika virus; (2) grant Florida’s state and local governments access to Oxitec Ltd.’s (Oxitec) genetically engineered (GE) mosquitoes that can suppress the local Aedes aegypti mosquito population; and (3) grant an Emergency Use Authorization under Section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to make Oxitec’s GE mosquitos immediately available in any Florida area “where Zika is being transmitted or is likely to be transmitted.”
FDA completed and issued the final environmental review for a proposed field trial to determine whether the release of Oxitec’s GE mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida on August 5, 2016. FDA's final issuance of an Environmental Assessment (EA) and its Finding of No Significant Impact (FONSI) does not mean that Oxitec's GE mosquitoes are approved for commercial use, however, as Oxitec is still 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, determining whether and when to begin the proposed field trial in Key Haven, Florida.
More information on Oxitec’s GE mosquitos is available in the Oxitec Case Study section of a report authored by the legal experts, scientists, and policy specialists of Bergeson & Campbell, P.C. (B&C®) and released through the Wilson Center's Synthetic Biology Project, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?" (October 2015).