Abstract
Experimental releases of genetically modified (GM) insects are reportedly being evaluated in various countries, including Brazil, the Cayman Islands (United Kingdom), France, Guatemala, India, Malaysia, Mexico, Panama, Philippines, Singapore, Thailand, the United States of America, and Vietnam. GM mosquitoes (Aedes aegypti) have already been released for field trials into inhabited areas in the Cayman Islands (2009–?), Malaysia (2010–2011), and Brazil (2011–2012). Here, we assess the regulatory process in the first three countries permitting releases (Malaysia, US, and the Cayman Islands) in terms of pre-release transparency and scientific quality. We find that, despite 14 US government–funded field trials over the last 9 years (on a moth pest of cotton), there has been no scientific publication of experimental data, and in only two instances have permit applications been published. The world's first environmental impact statement (EIS) on GM insects, produced by US authorities in 2008, is found to be scientifically deficient on the basis that (1) most consideration of environmental risk is too generic to be scientifically meaningful; (2) it relies on unpublished data to establish central scientific points; and (3) of the approximately 170 scientific publications cited, the endorsement of the majority of novel transgenic approaches is based on just two laboratory studies in only one of the four species covered by the document. We find that it is not possible to determine from documents publically available prior to the start of releases if obvious hazards of the particular GM mosquitoes released in Malaysia, the Cayman Islands, and Brazil received expert examination. Simple regulatory measures are proposed that would build public confidence and stimulate the independent experimental studies that environmental risk assessments require. Finally, a checklist is provided to assist the general public, journalists, and lawmakers in determining, from documents issued by regulators prior to the start of releases, whether permit approval is likely to have a scientifically high quality basis
Highlights
Over the last 2 years there has been a dramatic increase in activities relating to the experimental release of Genetically Modified (GM) insects into the environment
It is reported that commercially generated male GM mosquitoes were experimentally released into populated areas in the Cayman Islands starting in November 2009 [1,2]
In September 2010, the European Food Safety Authority (EFSA) published a document entitled Defining Environmental Risk Assessment Criteria for Genetically Modified (GM) Insects to Be Placed on the European Union (EU) Market, further illustrating the global extent of interest in releasing GM insects [12]
Summary
The US has approved 14 field trials since 2001 with pink bollworm (Pectinophora gossypiella), a moth that is an agricultural pest of the cotton plant. The degree of specificity necessary for meaningful EIAs is explicitly addressed in the 2007 North American Plant Protection Organization (NAPPO) guidelines on confined field releases of transgenic arthropods [75] and the 2006 Food and Agriculture Organization and International Atomic Energy Agency/(FAO/IAEA) report entitled Status and Risk Assessment of the Use of Transgenic Arthropods in Plant Protection (section 5.3.4.2, pages 22–24 [21]) Both of these documents are cited in the 2008-EIS [42]. This striking omission appears to be justified in the last section of the document, which is reproduced below
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