Florida health officials reported one additional travel-associated Zika virus case in Miami-Dade County today, bringing the state total to 60.

Aedes aegypti/CDC
Aedes aegypti/CDC

In addition, the Food and Drug Administration (FDA) released their preliminary finding on the use genetically engineered (GE) male Aedes aegypti mosquitoes,  strain OX513A, from Oxitec, giving it a Preliminary Finding of No Significant Impact (FONSI).

The proposed investigational field trial would be carried out in Key Haven, Monroe County, Florida under Oxitec’s supervision in conjunction with the Florida Keys Mosquito Control District (FKMCD). Ae. aegypti is a known vector for human diseases including dengue fever and chikungunya.

Some of the findings concerning risks to humans and animals are listed below:

FDA found that the probability that the release of OX513A male mosquitoes would result in toxic or allergenic effects in humans or other animals is negligible based on the sponsor’s draft environmental assessment (EA). Almost all of the OX513A mosquitoes released for the investigational field trial will be male, and male mosquitoes do not bite humans or other animals. They are therefore not expected to have any direct impacts on human or animal health.

FDA concluded that that the immunological response in humans and animals to OX513A female mosquito bites is not expected to be different from the immunological response to bites by wild type Ae. aegypti mosquitoes.

It is also highly unlikely that the #OX513 rDNA construct itself would have any adverse impacts on humans or any other animals.

FDA found that it is highly unlikely that release of OX513A male mosquitoes would contribute to the increase in transmission of dengue or other diseases transmitted by mosquitoes. Male mosquitoes do not bite humans or other animals and therefore do not transmit diseases. Further, their environmental lifetimes are short (~2 days), limiting their ability to interact with humans.

FDA found that the probability that the release or rearing of OX513A Ae. aegypti would have adverse impacts on the ecosystem is largely negligible; a finding of low risk was found for the potential for tetracycline in the environment to kill bacteria involved in environmental processes.

On Friday, the FDA announced a comment period for the public on the draft EA and preliminary FONSI.