You can download here the TEC final report, TEC final rpt covering ltr-jun 30 2013, the Corrigendum filed by the TEC and an Annexure to the final report.
July 23rd 2013
To:
Dr Manmohan Singh,
Prime Minister,
Government of India.
Dear Sir,
Sub: Supreme Court Technical Expert Committee’s final report in the PIL regarding GMOs – urging the government to act upon the recommendations – reg.
Greetings!
The Technical Expert Committee (TEC) set up by the Supreme Court in the Public Interest Litigation related to GMOs has in their final report submitted on 30/06/2013, reiterated and further substantiated the recommendations made in their Interim Report submitted to the Court in October 2012. The report is a strong indictment of the state of regulatory affairs with regard to modern biotechnology in the country.
The Committee notes that issues related to (biosafety) tests can be meaningfully considered only after major gaps in the biotechnology regulatory system are addressed first and foremost; this is a point worth noting and acting upon. Until this is done, it is obvious that public confidence in regulation is going to be lacking.
We urge that the Government of India takes these sagacious recommendations of the Committee seriously and acts on them in the interests of food safety, security, and sovereignty as well as protection of environment and farm livelihoods.
We would like to bring to your attention the major recommendations of the Committee:
1. “It would not be advisable to conduct more field trials till such time that major gaps in the regulatory system are addressed (these gaps need to be addressed before issues related to tests can be meaningfully considered)” (Page 77, Recommendations, first para).
2. The TEC’s comments with regard to biosafety dossiers that were approved by the current biotechnology regulator is a scathing indictment of the failings of the existing regulatory regime. The TEC found that “in several cases, the reporting of data as well as methods and analysis has been incomplete and cursory; there are also deficiencies in selection of samples, methods of analysis, and statistical tests, making it difficult to draw meaningful conclusions…..the number of such cases that have come to the notice of the TEC also reflect on the manner in which the toxicology data has been examined and the Regulatory Body for having accepted the reports”.
The TEC also stated “there are serious deficiencies in reporting of the data in the dossiers and more importantly in the way in which these have been examined and conclusions accepted by the regulatory body”. The TEC rightly points out that “unless the purpose of the tests is kept in mind, the risk assessment is likely to fail to meet its Objectives”.
The TEC has recommended that a secretariat comprising of dedicated scientists with area expertise as well as expertise in biosafety needs to be established. They have also emphasised the importance of considering the socio-economic issues in the Indian context. The TEC also recommends that the regulatory body should have area-wise sub-committees/expert groups such as human and animal health; environment and ecology; agro economics and socio-economics; molecular biology; entomology; agricultural and aqua-cultural systems; public health; soil science and microbiology; plant biology; regulatory toxicology; plant and animal breeding and genetics etc. “A single Committee such as the GEAC or RCGM doing all the evaluation is not sufficient”, according to the TEC.
3. “Conflict of interest in terms of the location of the regulatory body needs to be addressed”, notes the TEC yet again. The TEC has said that regulatory bodies should be located in the Ministry of Environment & Forests (MoEF) and the Ministry of Health & Family Welfare (MoHFW). Further, members of the regulatory bodies should also be free of conflict of interest. Clearly, this recommendation is applicable in the context of the BRAI Bill also.
4. The TEC has said that “stakeholder participation, need, socioeconomic considerations, societal impact, and sustainability should be some of the dimensions that need to be incorporated in the risk assessment and it should be done at an early stage in the risk assessment process”.
5. The TEC could not find any compelling reason for India to be the first country where Bt transgenics are widely consumed in large amounts for any major food crop that is directly used for human consumption. The TEC has therefore reiterated its recommendation made in the Interim Report that there should be a moratorium on field trials for Bt in food crops, until there is more definitive information from sufficient number of studies as to the long term safety of Bt in food crops. (page 81, recommendation 5).
6. The conclusion of the TEC with regard to herbicide tolerant (HT) GM crops is that these would most likely exert a seriously adverse impact over time on sustainable agriculture, rural livelihoods and the environment. The TEC finds HT GM crops completely unsuitable in the Indian context and recommends that field trials and release of HT crops not be allowed in India. (Page 81, Point 6, along with Corrigendum Point 6).
7. “The release of a GM crop into an area or region which is the centre of origin or diversity of that crop has far greater ramifications and potential for negative impact than for other species. There needs to be extraordinarily compelling reasons and only when other choices are not available, can introduction of a GM crop in its centre of origin or diversity be justified. GM crops that offer incremental advantages or solutions to specific and limited problems are not sufficient reasons to justify such release. The TEC did not find any such compelling reasons under the present conditions”. According to the TEC, unlike the situation in 1960s, there is no desperate shortage of food and India is in a reasonably food secure position. The TEC therefore recommends that release of GM crops for which India is a centre of origin or diversity should not be allowed.
8. With regard to the sequence of testing of GM crops, tests “should be carried out in order of increasing environmental exposure required to perform the test, and tests should be done under the minimum conditions of exposure required for the test”, recommends the TEC.
9. The TEC has reiterated that there is a need to include chronic and trans-generational toxicity testing.
The following points are also noteworthy from the TEC’s final report:
– the TEC notes the value of chronic toxicity testing which is missing as of now;
– the TEC talks about the need to capture unintended effects which is discounted as of now;
– the TEC has raised concerns about the numerous GM crops being experimented in India;
– post release monitoring is sorely missing right now, and is important;
– segregation is next to impossible in India. Incidentally, this is something that the Government submissions to the TEC have stated unequivocally too. This obviously presents a huge challenge in terms of upholding choices of consumers and farmers.
While the sixth member inducted into the TEC in November 2012 (Dr R S Paroda) did not sign off on the final report, this is not surprising given the fact that his very inclusion in the Committee was controversial and objectionable – his organization receives funding from biotech majors like Monsanto and Mahyco and this constitutes a clear conflict of interest. It is ironical that even this SC-appointed Committee has had to face such conflict of interest situation, given that this has been the case with almost all GM-related issues in India so far.
The TEC also pointed out, rightly so, quoting from the Ministry of Agriculture’s submission to the Committee, that there is really no locus standi or rationale for the MoA to challenge the TEC’s interim report – for one thing, they are a conflicted party; for another, and by their own admission, they have no mandate in biosafety assessment and are only carrying out the role of promotion with regard to transgenic technology. The TEC’s final report (with its corrigendum) has cogently and meticulously responded to the MoA’s rejoinder in the Court on the interim report of the TEC.
These recommendations are science-based and well-reasoned. Therefore, we urge the Government of India to accept the well-reasoned, reasonable and sound recommendations of the TEC and to start overhauling the process of modern biotechnology regulation in India. Vested interests should not be allowed to prevail and prevent the acceptance of this report which is based on sound science, justice and the principle of sustainability. We look forward to the Union of India accepting these recommendations in the Supreme Court and ensuring the delivery of justice.
We would like to point out that the recommendations of the TEC report also has ramifications for the Biotechnology Regulatory Authority of India (BRAI) Bill which is with the Standing Committee on Science and Technology, Environment and Forests. When read together with the TEC final report and the existing critiques of the Bill, it is evident that the BRAI Bill that your government has introduced in the parliament should be withdrawn as it is designed to be a single window mechanism for easy approval of GMOs without regard for independent, rigorous scientific assessments and pertinent issues beyond science.
Yours Sincerely,
Sridhar Radhakrishnan Pankaj Bhushan Rajesh Krishnan
Co-Convenor
Copies to: Minister for Agriculture, Minister for Science & Technology, Minister for Environment and Forests.
Annexure 1:
In an Interim Report signed off on 7th October 2012 (D.No.1944/2005/SC/PIL in the Assistant Registrar PIL (WRIT)’s office, dated 17th October 2012), a 5-member Technical Expert Committee (TEC) appointed by the Supreme Court of India in the Writ Petition (Civil) No. 260 of 2005, with Aruna Rodrigues and others as the petitioners in a PIL pertaining to GMOs (Genetically Modified Organisms), unanimously presented its view that all field trials should be stopped until the following conditions have been met:
i) Specific sites for conducting field trials have been designated and certified and sufficient mechanisms for monitoring the trials put in place.
ii) A panel of scientists, qualified in evaluation of the biosafety data of GM crops has been engaged for scrutiny and analyses of the safety data.
iii) Conflict of interest in the regulatory body has been removed (as discussed above).
iv) The requirement for preliminary biosafety tests prior to field trials including sub-chronic toxicity in small animals has been included.
More importantly, the TEC recommended the following with regard to certain classes of products:
“1. Based on the current overall status of food safety evaluation of Bt transgenics including the data on Bt cotton and Bt brinjal examined by the TEC and in accordance with the precautionary principle, the TEC recommends a ten year moratorium on field trials of Bt transgenics in all food crops (those used directly for human consumption).
2. In view of the concerns bearing on health, environmental and socio-economic considerations, the TEC recommends a moratorium on field trials of herbicide tolerant (HT) crops until an independent committee comprising of experts and stakeholders has examined and assessed the potential impact of HT technology and its suitability in the Indian context.
3. India is a signatory to the Cartagena Protocol which recognises the crucial importance of biodiversity as a long term resource. The TEC accordingly recommends a ban on field trials of transgenics in those crops for which India is a centre of origin or a centre of diversity, as transgenics can contaminate and adversely affect the biodiversity.”
The TEC specifically recommended for a re-examination of all biosafety data for applications in process as well as those that have been approved for release by scientists who are qualified in biosafety science and experienced in evaluation of biosafety dossiers for transgenic plants. Citing its rationale as “given the findings of the TEC that there have been several cases of ignoring problematic aspects of the data in the safety dossiers”, the Committee recommended that the re-examination, “if necessary, be done by international experts who have the necessary experience”.
It also recommended long term and inter-generational studies in rodents to be added to the tests and performed for all products whether already approved or yet to be approved.
Further, “acute and sub-chronic feeding studies for all applications including those in progress should be completed before BRLI, as also molecular analysis and allergenicity tests. If these studies indicate potential risks of any kind, the GM event should be rejected outright to save time, resources and contamination”, the report said.
“Genome-wide expression analysis in the toxicity studies of the test organism (eg. rodent) that is being exposed helps to identify changes in biomarkers that are indicative of toxicity. This is an important test to be included as biomarkers are sensitive indicators and are capable of revealing changes before visible symptoms appear” read specific recommendation 4 of the TEC.
For BRLI and BRL II trials, ‘the regulator needs to designate and certify a defined number of sites in different parts of the country. All field trials should be carried out only at these sites. These sites should be used only for growing GM plants and not the non-GM material. Trials should not be conducted in farmers’ fields. This also applies to those trials for which permission may have previously been given by the regulator’, the TEC stated.
When India has so much heritage of info, support them with evolved green farming technologies around farming & agri related business which will deter them from poisoning mother earth,themselves & all of us.
With much love & abundance.
we have enough resources.
None of the claims made by GM companies have been proved suitably.
Besides their final aim of capturing the seed market of a country and thus the Food Sovereignty of the Country will be at their mercy.
No one, not even GM companies speak about it, but it is their final aim
I work in thane dist with afarmers groupe.groupe of farmers have agreed to grow organic paddy and veggies,because it is giving them more income and sustainable produce.