THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

 

Dear friends and colleagues,

 

 

The Scientific Panel set up by the Indian Supreme Court has unanimously recommended a moratorium on field trials of GM crops in the country, as a result of a public interest petition filed by civil society seeking a ban on GM crops.

 

Among the key recommendations of the Panel:

 

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.

 

iv) The requirement for preliminary biosafety tests prior to field trials including sub-chronic toxicity in small animals has been included.

 

Specifically, the Panel recommended:

 

·      A ten-year moratorium on field trials of Bt food crops on the basis of the current overall status of food safety evaluation of Bt transgenics

 

·      A moratorium on field trials of herbicide tolerant crops until an independent committee of experts and stakeholders “has examined and assessed the potential impact of herbicide tolerant technology and its suitability in the Indian context”

 

·      A ban on field trials of transgenics of those crops for which India is a centre of origin or diversity

 

The Panel also recommended the 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, “given the findings of the technical expert committee that there have been several cases of ignoring problematic aspects of the data in the safety dossiers.

 

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, among other studies and tests recommended.

 

Finally, the Panel also stressed that needs and socioeconomic assessment is critical and should be conducted well before the product has been developed. It also highlighted the importance of post-release monitoring.

 

The Technical Expert Committee’s Interim Report is available at: http://indiagminfo.org/wp-content/uploads/2012/10/SC-TEC-interim-report-oct17th-2012-GMO-PIL.pdf

 

The Supreme Court Order setting up the TEC, its constitution and terms of reference is available at: http://indiagminfo.org/wp-content/uploads/2012/10/2012_STPLWeb_294_SC.pdf

 

With best wishes,

 

 

Item 1

 

PANEL OF SCIENTISTS RECOMMENDS TEN-YEAR MORATORIUM ON FIELD TRIALS OF ALL GENETICALLY MODIFIED CROPS

 

The Economic Times, India, 19.10.2012

 

 

NEW DELHI: A panel of scientists set up on the orders of the Supreme Court has recommended a ten-year moratorium on field trials of all genetically modified or Bt food crops.

 

The six-member committee of technical experts set up by the Supreme Court came to this conclusion on the basis of the current overall status of food safety evaluation of Bt transgenics, including a review of the data on Bt cotton and Bt brinjal.

 

The panel submitted an unanimous report calling for moratorium till specific sites for conducting field trials have been designated and certified, and sufficient mechanisms for monitoring the trials put in place. They have said that a panel of scientists, qualified in evaluation of the biosafety data of GM crops must be appointed to scrutinize and analyse safety data. They made it mandatory for inclusion of preliminary biosafety tests prior to field trials including sub-chronic toxicity in small animals. Any conflict of interest in the regulatory bodies should be removed.

 

Given the concerns over the impact on health, environment and other social-economic consideration, the panel’s interim report called for a moratorium on field trials of herbicide tolerant crops. The moratorium will be in place until an independent committee of experts and stakeholders “has examined and assessed the potential impact of herbicide tolerant technology and its suitability in the Indian context”.

 

India is a signatory to the Cartagena Protocol which recognises the crucial importance of biodiversity as a long term resource. In this context, the panel has recommends a ban on field trials of transgenics of those crops for which India is a centre of origin or diversity, “as transgenics can contaminate and adversely affect the biodiversity.”

 

The panel calls for re-examination of all biosafety data for applications in process as well as those that have been approved for release. This should be done by scientists who are qualified in biosafety science and experienced in evaluation of biosafety dossiers for transgenic plants. The panel explains that this move is necessary “given the findings of the technical expert committee 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.

 

The panel comprised eminent scientists — Imran Siddiqui, plant development biology scientist and group leader at the Hyderabad-based Centre for Cellular & Molecular Biology; P S Ramakrishnan, emeritus professor of environmental sciences and biodiversity from Delhi’s Jawaharlal Nehru University; P C Chauhan, an expert in genetics toxicology and food safety; P C Kesavan, a former BARC scientist noted for his work on genetics toxicology and radiation biology who is currently distinguished fellow, M S Swaminathan Research Foundation, Chennai, and B Sivakumar, former director, National Institute of Nutrition, Hyderabad. The sixth member recused himself after the panel was announced in May.

 

The Supreme Court had asked the environment ministry to constitute the panel following hearings on a public interest petition filed by Aruna Rodrigues and others seeking a ban on field trials of GM crops.

 

Item 2

 

SUPREME COURT PANEL RECOMMENDS STOPPING GM CROP TRIALS

 

Jacob P. Koshy, Livemint, India, 18.10.2012

 

 

New Delhi: In a severe blow to the future of genetically modified (GM) food crops in the country, a high-level committee appointed by the Supreme Court has recommended stopping all ongoing open field trials on such crops for 10 years until a new set of conditions is enforced.

 

In spirit, the committee’s recommendations are similar to those made by former environment minister Jairam Ramesh, who’d recommended a moratorium on the commercial release of Bt brinjal. These fresh recommendations, however, are more significant as they constitute a key input to the Supreme Court of India, which has been hearing a public interest litigation (PIL) filed by a clutch of independent scientists as well as activist organizations.

 

Key recommendations by the committee include a reassessment of the biosafety data that is generated by field trials; ensuring there is no conflict of interest (that is, those tasked with evaluating the biosafety of GM crops are themselves not stakeholders in promoting such crops); a ban on outsourcing or subcontracting field trials; and ensuring that crops being considered for testing be evaluated by rodent-feeding trials.

 

The recommendations are significant because the committee was peopled by scientists, said Kavitha Kuruganti of the Coalition for a GM-Free India.

 

“The committee had scientists from the Centre for Cellular and Molecular Biology and the National Institute of Nutrition, and the decision has followed an extensive review process,” said Kuruganti, “But as of today, field trials will be illegal only if the Supreme Court says so.”

 

She added that further deliberations on the case are expected on 29 October.

 

India’s seed industry, several constituents of which have bet on the future of GM crops, described the recommendations as “adverse”.

 

“I haven’t seen this report and know no details. But if this is the recommendation, that could have adverse implications for the industry,” said V. Ram Kaundinya, managing director, Advanta India Ltd, one of India’s largest agrochemical companies with interests in seeds and biotechnology.

 

The committee’s recommendations also come on the back of an August parliamentary panel report criticizing the introduction of Bt cotton as well as tests on GM food crops.

 

The panel’s study on Cultivation of Genetically Modified Food Crops Prospects and Effects was among the most extensive studies conducted by a parliamentary standing committee. The panel received 467 memorandums and 14,862 documents, and reviewed evidence given by 50 organizations during its 27 sittings on the subject.

 

While the development was discouraging, there will be further debate, said another seed industry executive.

 

“It’s bad news, but there will be more hearings,” said K.K. Narayanan, managing director, Metahelix Life Sciences Ltd, which has interests in both GM cotton as well as GM rice. “I don’t think it’s curtains for the industry yet.”

 

A Supreme Court bench headed by former chief justice S.H. Kapadia had in May sought a report within three months from an expert committee on whether there should be a blanket ban on field trials for GM crops, and if not, had asked it to detail a procedure to establish the safety of such crops.

 

The orders came on a PIL filed by non-governmental organization Gene Campaign and activist Aruna Rodrigues, who had sought a complete moratorium on field trials for GM crops.

 

Item 3

 

ALL FIELD TRIALS TO BE STOPPED, UNLESS CONDITIONS MET: SC TECHNICAL EXPERT COMMITTEE SUBMITS INTERIM REPORT

 

Press Release, Coalition for a GM-free India, 18.10.2012

 

 

“10-year Moratorium on field trials of Bt food crops, Moratorium on field trials of Herbicide Tolerant crops (till independent assessment of impact and suitability) and Ban on field trials of GM crops for which India is Centre of Origin/Diversity”

 

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:

 

“9. 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).

 

10. 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.

 

11. 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.

 

YOU CAN DOWNLOAD THE TECHNICAL EXPERT COMMITTEE’S INTERIM REPORT HERE.

 

 

THE SUPREME COURT ORDER SETTING UP THE TEC, ITS CONSTITUTION AND ITS TERMS OF REFERENCE CAN BE DOWNLOADED HERE.

 

 

The Coalition for a GM-Free India welcomes this interim report from the Technical Expert Committee set up by the apex court of India and awaits the Supreme Court’s hearing on the 29th of October 2012 in the matter. While earlier inquiries and debates have been discounted by GM proponents as ‘political’, or ‘emotional’, or ‘non-scientific’‚ inquiries and recommendations/decisions, it is worth noting that the TEC consists only of scientists, including of scientists from the government as its representatives. Further, 22 of the 31 submissions studied by the TEC in their nearly 4-month-long inquiry/study were from people with scientific background.