THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
FDA’s Review of GE Mosquito Release in Florida Comes Under Public Critique
Biotech company, Oxitec (UK) is urging the US Food and Drug Administration (FDA) to speed up the approval of a trial involving widespread release of genetically engineered (GE) mosquitoes in the Florida community of Key Haven.
More than 270,000 people have, however, submitted comments to criticize the FDA’s review of Oxitec’s planned release. Local community members are particularly concerned about not having a voice in the issue. Public health, food safety and environmental groups including Center for Food Safety (CFS) are calling on the FDA to conduct a new and more thorough review of the risks associated with the release (Item 1).
The CFS points out that the FDA’s formal review of the company’s application and environmental assessment fails to evaluate key issues surrounding the releases, including safety to human health, potential for the experimental mosquitoes to move out of testing areas, and whether or not large numbers of the GE mosquitoes will actually reduce the spread of diseases like West Nile, Dengue or Zika.
The FDA released a Finding of No Significant Impact (FONSI) Concerning the Investigational Use of Oxitec OX513A Mosquitoes. which GeneWatch UK has responded to (Item 2). While the FONSI states that "the status of the environment is restored when releases are stopped”, GeneWatch refutes this claim. Potential changes to the environment include: dispersal of non-native traits (potentially including insecticide resistance or enhanced disease transmission properties) via introgression into the native wild mosquito population and/or further afield; ecosystem changes that may not be reversible e.g. increase in competitor mosquito species; potential for dispersal of antibiotic resistant bacteria into the environment via the releases of adult mosquitoes or disposal of the rearing water; and direct adverse effects that may not be reversible (but which may occur due to lack of adequate safety testing) e.g. harm to humans or animals through ingestion. In addition, there is a need for clarity over who will be liable if adverse impacts do arise and how such impacts would be identified.
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Third World Network
131 Jalan Macalister
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Website: https://biosafety-info.net/ and http://www.twn.my/
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Item 1
FDA ASSESSMENT OF PLAN TO RELEASE GENETICALLY ENGINEERED MOSQUITOES IN FLORIDA KEYS INADEQUATE
Center for Food Safety
http://www.centerforfoodsafety.org/press-releases/4368/groups-slam-feds-for-weak-review-of-gmo-mosquito-risks
WASHINGTON—Public health, food safety and environmental groups including Center for Food Safety, Food & Water Watch, Friends of the Earth and the Florida Keys Environmental Coalition are calling on the Food and Drug Administration (FDA) to conduct a new and more thorough review of the risks associated with releasing genetically engineered (GE) mosquitoes. Biotech and pest control company Oxitec is urging the FDA to speed approval of a trial involving widespread release of GE mosquitoes in the Florida community of Key Haven. Oxitec’s application to the FDA does not claim that the release of the GE mosquitoes would cause the reduction of diseases such as Dengue or Zika. More than 270,000 people submitted comments to criticize the FDA’s review of Oxitec’s planned release of the GE mosquitoes in Key Haven.
In its formal review of the company’s application and environmental assessment, the FDA fails to evaluate key issues surrounding the releases, including safety to human health, potential for the experimental mosquitos to move out of testing areas, and whether or not large numbers of the GE mosquitoes will actually reduce the spread of diseases like West Nile, Dengue or Zika.
“Allowing the widespread release of potentially harmful genetically engineered insects before seeing the hard science is sheer negligence, especially when we’re talking about accidental ingestion,” said Jaydee Hanson, senior policy analyst at Center for Food Safety.
Several national, state and local groups have submitted comments to FDA, specifically calling into question the lack of safety testing for human consumption of the mosquitoes. In many areas where the company has already released the GE mosquitoes, so many mosquitoes were released that people could not avoid breathing in and swallowing mosquitoes.
“The FDA really missed the mark on this one,” said Wenonah Hauter, executive director of Food & Water Watch. “The agency seems so eager to speed the process along that they have failed to do a real review of the potential risks, and are ignoring widespread concern in the community where the release will happen.”
The groups also flag the inadequacy of testing done to see how the modified mosquitoes will spread through the environment and what impact that will have on both local and regional ecosystems.
“FDA’s assessment is inadequate. GE mosquitoes would be virtually unregulated, and we don’t know how they would thrive in the wild and what the unintended consequences could be. They could cause more problems than solve,” said Dana Perls, senior food and technology campaigner with Friends of the Earth, U.S.
Local community members are particularly concerned about not having a voice in the issue.
“People here in Florida do not consent to the GE mosquitos or to being guinea pigs in a living lab for an experiment that hasn’t been properly vetted by the government. We are demanding sound science, not marketing hype. It is critical to prioritize the less risky, more environmentally sustainable, lower cost and natural alternatives,” said Barry Wray, Executive Director of the Florida Keys Environmental Coalition.
Item 2
GENEWATCH UK COMMENTS ON FDA DOCKET FDA-2014-N-2235: DRAFT ENVIRONMENTAL ASSESSMENT AND PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT CONCERNING INVESTIGATIONAL USE OF OXITEC OX513A MOSQUITOES
http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/FDA_Oxitec_GWresponse_fin2.pdf
Summary of concerns regarding the draft FONSI (Excerpted)
In summary, it is premature to issue a Finding of No Significant Impact (FONSI) in the absence of further information, including:
- Further laboratory safety tests, including feeding trials for relevant wild species and laboratory rats to better establish the claim of no harmful effects of ingestion.
- Estimates of the numbers of GM biting female mosquitoes that may be released during the proposed experiments, or that may survive from subsequent generations, taking into account the potential to encounter tetracycline in the environment or evolve resistance to the killing mechanism during mass breeding.
- A protocol for testing the GM mosquitoes for pathogenic agents prior to release.
- Identification of relevant septic tanks and cess pits where mosquitoes may breed and testing of tetracycline levels in them.
- Identification of potential sites where GM mosquitoes could encounter industrially farmed meat (e.g. discarded takeaways, pet food) and testing of tetracycline levels at these sites.
- Laboratory studies of the potential for antibiotic resistant bacteria to be spread into the environment via adult mosquito releases or disposal of larval rearing water from the mosquito production facility.
- Information about which existing control methods will continue to be applied during the proposed releases.
- Published criteria for assessing the impact of existing control measures and the proposed releases on the risk of all the relevant diseases.
- Full independent testing of the non-native strain proposed for release for disease transmission traits for all relevant diseases and insecticide resistance for all relevant insecticides.
- More in-depth consideration of the risk of increasing other mosquito vectors, including: laboratory and caged trials on the impacts of interspecies competition; thorough baseline studies of mosquito populations; studies on the disease transmission properties of other vectors for all relevant diseases; and consideration of the possibility that viruses will evolve in response to ecosystem changes.
- Confirmation that Aedes aegypti is the main vector causing the outbreak of zika in Brazil and that other species do not also play a role.
- Further consideration of the dynamic changes in local ecosystems as a result of the proposed releases, including the impacts of a large (several orders of magnitude) increase in the number of adult mosquitoes in the target area during the releases.
- Independent replication of Oxitec laboratory results, including studies of proteins in saliva and larval survival rates in the presence of tetracycline contamination.
- A full, published investigation into the unexpected survival of female mosquitoes in Oxitec’s experiments in Mexico.
- In addition, there is a need for further clarity over who will be liable if adverse impacts do arise and how such impacts would be identified.