Abstract
Experimental releases of genetically modified (GM) insects are reportedly being evaluated in various countries including Brazil, the Cayman Islands (UK), France, Guatemala, India, Malaysia, Mexico, Panama, Philippines, Singapore, Thailand, the USA 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, USA, and 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 2 instances have permit applications been published. The world’s first environmental impact statement 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that: (1) most consideration of environmental risk is too generic to be scientifically meaningful; (2) it relies on unpublished data to establish central scientific points; (3) of the approximately 170 scientific publications cited, the endorsement of the majority of novel transgenic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.

The Table of Contents is as follows:

Introduction

A Short History of US GM Insect Regulation 2001–2010

The 2008-EIS as a Regulatory Document of Global Scientific Value

What Constitutes a ‘‘Substantial Body of Scientific Evidence’’ in the 2008-EIS?

The Use of Unpublished Evidence in Regulatory Documents around the World

Do Restrictions to Public Scrutiny of Regulatory Documents Facilitate Practices that Undermine Public Confidence?

Established Precedents in US Regulation of GM Insects and Their Global Impact on Building Confidence in GM Insect Regulation

When Considering the Potential Environmental Impacts of Complex Biotechnological Approaches, How Useful Are Highly Generic Discussions?

Generic Considerations of GM Insects Are Often of Limited Scientific Value

The Release of GM Mosquitoes in the Cayman Islands and Malaysia (2009–2011)

Summaries of EIAs Can Be of Limited Scientific Value and May Not Build Public Confidence

Credible Risk Assessments of GM Insects Require a Documented, Multi- Disciplinary Approach

A Checklist for Assessing the Probable Scientific Quality of Regulatory Release Approvals, Based on Publically Available Pre-Release Documents

Conclusions