Bt Brinjal The scope and adequacy of the GEAC environmental risk assessment

8 Bt Brinjal: The GEAC environmental risk assessmentContext and NeedEnvironmental risk assessment (ERA) has changed substantially since it was initiated about 50 years ago to address pointsourcepollution, environmental siting decisions, and pesticide regulation. Since that time, its scope has expanded to addresssuch diverse activities as global climate change, invasive species, non-point source pollution, comparative and cumulativeenvironmental risk, and the subject of this report, transgenic organisms.As the scope of ERA expanded, the original methodologies were pulled, stretched, and cut to fit the topic, much like aProcrustean bed. In the process the whole purpose of ERA became obscured and was sometimes lost as people sought to adaptold means to new ends. Indeed, the scope and adequacy of the US regulatory structure for transgenic organisms came underconsiderable criticism in a series of reports from the US National Academy of Sciences (NRC 2000, 2002, 2004).These considerations lead to the following problematic, which has not been adequately addressed by the GEAC in India.An ERA may fulfil the regulatory requirements of a country and be deemed acceptable relative to those requirements, but atthe same time, it may not assess any substantive environmental risks because the regulatory structure is too slow to change andrelies more on procedural standards than on outcome-based standards. For example, a common way for an applicant to meetregulatory requirements is to complete whatever study is requested by the regulator. Whether that study actually tells anyoneanything about an outcome about environmental risks can be forgotten in the frenzy to set and meet regulatory standards.In other words, an ERA that is “good” according to certain regulatory standards may not be the ERA that ought to havebeen done to assess actual potential environmental risks. No matter how “good” it may be relative to this narrow regulatorystandard, it may be no good for the environment.For transgenic organisms, including Bt brinjal, an ERA ought to identify thepossible concerns that the transgenic organism could affect in the environmentin concrete terms.It should then proceed to determine if any of these concrete concerns are so small as to not matter, are so large that we must beconcerned, or somewhere in the middle that we have to figure out what to do about them. A concrete concern must identifyan environmental value at risk (e.g., the endangerment of a species, the loss of the economic security of a farmer, a reduction inproductive capacity of the soil, etc.), identify an ecological entity through which the value is reduced (e.g., a particular endangeredspecies, the security of small-scale resource-poor brinjal farmers in India, the nutrient or micronutrient content of the soil, etc.),and specify all of the means by which the transgenic organism could affect the identified ecological entity. At this point, but notbefore, it is possible to assess the significance of the potential environmental risk.This report holds the EC-II ERA to the standard of assessing outcomes about concrete environmental risks, and does notdwell much on the more narrow concern of whether the EC-II ERA meets the regulatory standards of the GEAC. By doingso, this report points out where the scope of the EC-II ERA is too narrow and challenges the adequacy of the ERA frameworkestablished by GEAC and under which Bt brinjal has been assessed by EC-II. At many points in this report, the EC-II iscriticised not for whether it has accomplished what it set out to do, but whether it set out to do the right thing in the first place.The main thesis of the report is that the GEAC set too narrow a scope for ERA, and it is because of this overly narrow scopethat the EC-II is not an adequate ERA.The report first describes the context into which Bt brinjal is meant to be introduced in India. The described context ismore nuanced than that provided by EC-II and contradicts EC-II in many significant ways. The report next addresses the scopeand adequacy of the characterisation of the transgene, EE-1, that is incorporated into Bt brinjal. The focus is on what must becharacterised to enable an effective ERA. It does not address how to characterise a transgene so that risks to human and animalhealth can be assessed. Within this topic, the genetic and phenotypic characterisation of the transgene is addressed, followedby an evaluation of the quality of the EE-1 transgene, and a scientific opinion on compliance of the EC-II ERA to international