Brief & Press Release including comments by Aruna Rodrigues

Bt Brinjal Event EE1: The scope and adequacy of the GEAC environmental risk assessment

“The GEAC set too narrow a scope for environmental risk assessment (ERA) of hybrid Bt brinjal, and it is because of this overly narrow scope that the EC-II is not an adequate ERA” ... “ most of the possible environmental risks of Bt brinjal have not been adequately evaluated; this includes risks to local varieties of brinjal and wild relatives, risks to biological diversity, and risk of resistance evolution in BFSB”. – Prof David Andow

David Andow is an acknowledged international expert on the environmental risks of GM crop plants. This 80 page comprehensive critique of Monsanto's Dossier and the Bt brinjal Expert Committee II Report (EC II), is an authoritative and meticulous scrutiny of the raw data of the Dossier. Andow lists some 37 studies of which perhaps 1 has been conducted and reported to a satisfactory level by Monsanto: “Briefly, EC-II relied on dubious scientific assumptions, did not focus on realistic environmental concerns, inadequately evaluated some important environmental concerns, and ignored other real environmental concerns”. I pick out the following critical points from his definitive environmental appraisal of Bt brinjal:

• India is the centre of the world's biological diversity in brinjal with over 2500 varieties grown in the country and as many as 29 wild species. Some local varieties have significant religious and cultural value.
• The EE-1 transgene may be a second-rate Bt brinjal product. Efficacy of EE-1 is low. It provides only 73% control of BFSB in the MST (multi-site trials) field trials (Dossier vol. 6). Given these considerations, it seems clear that the applicant has invested little in the development of a useful Bt brinjal product for India. Indeed, an inflammatory characterisation of the process so far would be a case of “transgene dumping.”
• Nearly all brinjal farmers in India are small-scale resource-poor farmers, who farm <1ha for all of their crops (DES 2008). They grow brinjal in small (~65 m2) plots, and sell to local village and town markets. For these farmers, brinjal production is essential for their overall economic security and well-being (APEDA 2009).
• Brinjal fruit and shoot borer (BFSB) causes significant economic damage to brinjal throughout India for all farmers –averaging about 30% yield loss (a comparison of yield with pest management versus no pest management). Farmers are prone to overestimate the loss to BFSB, precipitating an over-use of insecticides significantly beyond that justified by the actual economic significance of BFSB. Real losses from BFSB are higher for large-scale commercial producers than for small-scale resource-poor producers because of the way damaged fruit can be used by the small-scale resource-poor farmers. EC-II vastly over-estimated losses to BFSB.
• Insecticide use can be reduced substantially using integrated pest management (IPM). Useful alternative production systems for control of BFSB are being tested, actively used, and promoted in India: IPM, traditional pest management, organic production and other locally-derived methods that reduce costs associated with external inputs.
• Many of the experiments submitted by Mahyco in the Dossier provide little relevant information about the potential impact of Bt brinjal on species in India and do not assess any real concern in India. The soil studies were not designed to evaluating effects on soil health, brinjal productivity, or the productivity of other crops grown by brinjal farmers, which are the real concerns for Indian farmers. Instead, they measure microbial populations, which have little relevance for assessing these real concerns.
• Resistance: Any major pest control practice will select for resistant individuals in the target pest population. If enough individuals become resistant, the control fails, the pest becomes abundant and crop yields decline. The evolution of resistance to Bt crops is a real risk and is treated as such throughout the world and the evolution of resistance in BFSB to overcome Bt brinjal is a real risk that must be managed. EC-II does not acknowledge this risk and the Dossier does not propose effective means to manage it.
  • Event EE-1 Bt brinjal poses several unique challenges because the likelihood of resistance evolving quickly is high. Without any management of resistance evolution, Bt brinjal is projected to fail in 4-12 years.
• EE-1 Bt brinjal is proposed as a hybrid, and is unlikely to fit well in the small-scale production systems relying on open-pollinated varieties (OPVs) of brinjal. For small-scale resource-poor farmers brinjal is critical for creating economic security. Farmers are expected to retain only 10% of the increase in profitability from Bt brinjal,but are expected to retain 63% of the increase from brinjal IPM.
• The assessment does not comply with CODEX: the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (Codex, 2003, CAC/GL 45-2003). The lack of compliance of EC-II to Codex highlights a serious deficiency in the EC-II assessment.

Comments by Aruna Rodrigues:

1. This risk assessment raises the key Q: on what basis did the EC II recommend Bt brinjal and the GEAC uphold that recommendation and approve it on 14 Oct. 2009? Either our regulatory bodies (GEAC/RCGM) did not bother to look at the raw data of the dossier, or are incapable of analysing such data. Either way, the Regulators and the ‘Rules’ governing GMOs pose an unacceptable risk to India’s bio-safety on the many dimensions of the irreversible risks of GM crops and in this specific case, the risks from Bt brinjal
2. Beyond this, it is clear that the conflict of interest favouring GM crops, at the level of the STATE, not merely the proven case within the regulatory bodies, has allowed a situation where the only bio-safety dossier produced for any crop, viz. Monsanto’s Bt brinjal, is quite simply fraudulent. Much more serious is the Government Regulators' role in upholding that dossier.
3. Can it get worse? Yes, because the claim was that the dossier complied with the ICMR guidelines for the risk assessment of GM crops, which were supposedly in compliance with the spirit and letter of our international obligations under Cartagena and the Codex. Both are false and manifestly so.
4. What we need are 'Rules' for GMOs which DO THE CORRECT THING BY INDIA, not merely regulate this technology to the substandard ICMR guidelines, but approach it with the required sceptical analyses, an absolute requirement for risk assessment protocols for this lab-based technology which presents unique risks.
5. Can it get even worse? Yes it can. According to Andow’s research, Brinjal farmers in India have a quite low suicide rate, because brinjal helps cash flow and buffers income variation in other crops. Yet, what will happen to these farmers with the advent of Bt brinjal, when we have crop failures projected to occur in 4-12 years because there is no recognition of ‘resistance’ of the BFSB? (In the Supreme Court, the risks for farmers, arising from ‘resistance’ has been the focus of the Petitioners for over 3 years. The Apex Regulator has actively denied the fact of resistance – a thoroughly unscientific and untenable claim). We already have high rates of suicide among Bt cotton farmers attributed squarely to Bt cotton for an assortment of reasons. It would appear that the government regulator is prepared to risk our small-scale resource-poor farmers to promote GM crops and back Monsanto.
6. There is the further problem of insect shifts which we have already seen since the commercialisation of Bt cotton and which has apparently devastated the Bt cotton crop in several States. The potential for secondary pests in Bt brinjal has been examined only “cursorily” by EC II despite the “common occurrence of secondary pests on Bt crops around the world”. Given the economic plight of our small-scale brinjal farmers, a thorough evaluation of this problem was mandatory. It should have been done first for Bt cotton before examining the similar potential of a secondary pest on Bt brinjal.
   • “Imagine if the government claims there are no risks of secondary pests, and then a secondary pest arises. The government might be perceived as favouring GM seed companies at the expense of small-scale farmers”. (Andow, pg 37).
7. Finally, Andow’s thinking and analyses rightly go beyond science, as do the Cartagena Protocols and Jairam Ramesh, when he judged the evidence that underscored his decision to impose a moratorium on Bt brinjal; he was both “responsive” to society and “responsible” to science. Andow elegantly recognises that“Brinjal plays a unique role in Indian society, and it will be important to evaluate if and how Bt brinjal may affect these values– The narrow utilitarian analysis used by the GEAC in EC-II and the Dossier assumes that the only relevant human value is related to money, – Human flourishing is reduced to whatever money can buy, and issues of equity and fairness are irrelevant to this way of thinking”. (pg 6 & 47).

For civil society, Andow’s environmental appraisal must signal a high alert. Critically, a regulator should be supported either by its own internal capacity to perform safety testing or by a specialist community of fundamental safety researchers with clear career pathways that allow them to work without the need for industry or political associations. This is presently not the case.

My own reaction is one of profound unease for our country: The Regulators' approval of Bt brinjal is a breathtaking impertinence. They thought they could use their statutory powers to pull one over the entire nation, to hand down a decision that amounted to an unacceptable betrayal of India.

Aruna Rodrigues, 15 September 2010.