India’s Supreme Court Expert Committee Recommends Indefinite Moratorium on GE Field Trials

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

 

Dear Friends and Colleagues 

Re: India’s Supreme Court Expert Committee Recommends Indefinite Moratorium on GE Field Trials 

An Indian Technical Expert Committee (TEC) has called for an indefinite moratorium on the field trials of genetically engineered (GE) crops in the country. This committee of scientists was set up by the Supreme Court last year following the 2010 moratorium issued against the commercial introduction of Bt brinjal and the call by the Parliamentary Standing Committee on Agriculture in August 2012 for a ban on GE food crops in India. 

In its final report to the Supreme Court, the TEC said, ""Based on the examination of the safety dossiers, the Technical Expert Committee has found in unambiguous terms that at present, the regulatory system has major gaps….These need to be addressed before issues related to tests can be meaningfully considered. Till such time, it would not be advisable to conduct more field trials." 

On Bt food crops intended for commercialisation, the Committee said categorically that it could not find any compelling reason for India to be the first country to consume a Bt food crop (such as Bt brinjal) and called for a moratorium on field trials of Bt food crops "until there is more definitive information from (a) sufficient number of studies as to their long-term safety." The Committee further stated that the "release of GM crops for which India is a centre of origin or diversity should not be allowed".  In addition, the TEC recommended a ban on GE herbicide-tolerant crops citing expected adverse impacts on agriculture, rural livelihoods and the environment. 

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Item 1

Indefinite moratorium on GM field trials recommended

Latha Jishnu

Down To Earth (India), July 22 2013

http://www.downtoearth.org.in/content/indefinite-ban-gm-field-trials-recommended 

Supreme Court’s expert panel of scientists call for ban on herbicide tolerant crops for India 

A committee of technical experts comprising scientists from top public research laboratories and academic institutions set up by the Supreme Court last year has changed the 10-year moratorium on field trials of Bt transgenics that it recommended in October 2012 to what appears to be an indefinite moratorium on food crops in its final report. 

Based on "the examination/study of the safety dossiers, it is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully considered. Till such time it would not be advisable to conduct more field trials," the experts say in their final report without specifying any time frame. 

In other significant recommendations, the panel finds herbicide-tolerant (HT) crops "completely unsuitable" in the Indian context and recommends that field trials and release of HT crops should not be allowed in India. 

Noting that a single committee such as GEAC or RCGM-these are the main regulatory agencies for biotech crops-doing all the evaluation is not sufficient, the expert panel has called for the setting up of a secretariat comprising dedicated scientists with area expertise as well as expertise in biosafety. "This will require consultation with experts having experience at the international level in biosafety testing and evaluation of GM safety dossiers in reputed regulatory bodies," the expert panel said, while suggesting that this should be done in collaboration with the Norwegian government. 

Its reason for singling out Norway is that the Norwegian system has "an established commitment" and is one of the few attuned to considering socio-economic issues that would be important in the Indian context. 

The report said the new regulatory body should have area-wise subcommittees/expert groups in the following fields: health (human and animal); environment and ecology; agro-economics and socio-economics; molecular biology; soil science and microbiology; plant biology and regulatory toxicology among other specializations. 

The report signed by its original five members was not endorsed by Rajendra Singh Paroda. A former director-general of the Indian Council of Agricultural Research (ICAR), he was nominated by the National Academy of Agricultural Sciences (NAAS) to fill the gap left by V L Chopra who did not serve on the Technical Expert Committee (TEC), as it is called, for unspecified reasons. Paroda, according to the letter sent by TEC to the Supreme Court on June 30, did not attend the final meeting of the committee in Chennai. Nor has he appended a dissent note. 

The five TEC members are eminent scientists in their respective areas of specialisation: Imran Siddiqui, plant development biology scientist & 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 S Chauhan, genetics toxicology and food safety expert; P C Kesavan, 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 of National Institute of Nutrition, Hyderabad. 

Since the single largest number of applications for field trials to GEAC is for Bt transgenics, including in food crops such as rice, the scientists are of the view that the safety of Bt transgenics with regard to chronic toxicity needs to be established before it can be considered safe for human consumption. In this regard it pointed out the largest deployment of transgenics worldwide is in soybean, corn, cotton, and canola, all of which are used primarily for oil or feed after processing. 

"Nowhere are Bt-transgenics being widely consumed in large amounts for any major food crop that is directly used for human consumption." The TEC could not find any compelling reason for India to be the first to do so. TEC has, therefore, reiterated its interim recommendations see  that there should be a moratorium on field trials for Bt in food until there is more definitive information from sufficient number of studies as to the long-term safety of Bt in food crops. 

GEAC had approved the commercial release of Mahyco’s Bt brinjal in 2009 but then environment minister Jairam Ramesh had put a moratorium on its release in the wake of widespread public protests against the first transgenic food crop in the country. 

If TEC’s recommendations are accepted, crops which originate in India, such as brinjal, cannot be genetically modified. "To date, no GMO that is intended primarily and directly for food production has been commercially released into its centre of origin," says the panel. It notes that the US has restrictions on the growth of Bt-cotton in Hawaii where a weed related to cotton is found. For good measure it emphasizes that cotton is not even a food crop. 

Crops in their centres of origin and diversity often have "a deep cultural significance that can easily get lost when utilitatarian issues dominate the discourse", says the 94-page report. Ceremonial and medicinal varieties can also be put at risk from GM crops by reduction of diversity and genetic purity, and to justify their release, "there needs to be extraordinarily compelling reasons and only when other choices are not available. GM crops that offer incremental advantages or solutions to specific and limited problems are not sufficient reasons to justify such release." 

In the present circumstances, there is no such compulsion, according to the scientists, who were categorical that release of GM crops for which India is a centre of origin or diversity should not be allowed. 

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Item 2

INDIAN SUPREME COURT COMMITTEE SAYS NO TO GM CROPS

By IANS, 23 July 2013

http://twocircles.net/2013jul23/supreme_court_committee_says_no_gm_crops.html 

A Supreme Court technical expert committee Monday recommended an indefinite moratorium on the field trials of Genetically Modified (GM) crops till the government comes out with a proper regulatory and safety mechanism. 

The expert committee in its report to the Supreme Court said there should be a moratorium on field trials for Genetically Modified food crops like Bt Brinjal intended for commercialization until there is more definitive information from sufficient number of studies as to their long-term safety. 

"Based on the examination of the safety dossiers, it is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully considered. Till such time it would not be advisable to conduct more field trials," it said. 

On the genetic modification of crops for which India is a centre of origin like rice, brinjal, and mustard, the committee recommended that "release of GM crops for which India is a centre of origin or diversity should not be allowed". 

The expert committee also said a no to the herbicide tolerant (HT) crops, saying they would most likely exert a highly adverse impact over time on sustainable agriculture, rural livelihoods and environment. 

The report comes at a time when there are differences over the Biotechnology Regulatory Authority of India (BRAI) Bill, 2013, which is pending with the Parliamentary Standing Committee on Science and Technology, Environment and Forest. 

In 2010, the then environment and forests minister Jairam Ramesh imposed an indefinite moratorium on the commercial introduction of GM brinjal following several public hearings. 

The Parliamentary Standing Committee on Agriculture, in a report August 2012 had asked for ban on GM food crops in the country, while industry has been calling for their introduction to ensure food security. 

More than 150 scientists wrote to the Environment and Forest Minister Jayanthi Natarajan early this year, raising concerns about GM crops. 

Their primary concern was that the agriculture ministry is allegedly making a case for GM crops by stating that the technology is absolutely needed for India’s food security. 

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Item 3

INDIA SUPREME COURT PANEL: GM CROP TRIALS ON HOLD FOR NOW 

The Economic Times, 23 July 2013

http://economictimes.indiatimes.com/news/economy/agriculture/put-genetically-modified-crop-trials-on-hold-for-now-supreme-court-panel/articleshow/21259129.cms 

NEW DELHI: A technical committee appointed by the Supreme Court (SC) has recommended an indefinite moratorium on open field trials of genetically-modified (GM) crops till the deficiencies in the regulatory and safety systems are effectively addressed. The recommendations, if accepted by the court, would have a serious impact on the commercialisation of GM crops. In its final report, which was submitted to the court last week, the six-member committee reiterated the recommendations made in its interim report last October. 

"Based on the examination of the safety dossiers, the Technical Expert Committee has found in unambiguous terms that at present, the regulatory system has major gaps and these will require rethinking, investment and relearning to fix. These need to be addressed before issues related to tests can be meaningfully considered. Till such time, it would not be advisable to conduct more field trials. A deeper understanding of the process of risk assessment is needed within the regulatory system for it to meet the needs of a proper bio-safety evaluation," the final report states. 

On Bt food crops intended for commercialisation, the committee has reiterated that there should be a moratorium on field trials until there is a definitive number of studies on their long-term study. The 10-year moratorium suggested in the interim report has been dropped. Of the 91 applications for field trial before the GEAC, 44 are GM food crops. 

The committee felt that the safety of Bt food crops particularly on the issue chronic toxicity has not been established. "This needs to be done before it can be considered safe," it said. The report stressed that the largest deployment of transgenics world-wide is in soybean, corn, cotton, and canola, all of which are used primarily for oil or feed. "Nowhere are Bt-transgenics being widely consumed in large amounts for any major food crop that is directly used for human consumption. The TEC could not find any compelling reason for India to be the first to do so," the committee’s final report states. 

The report makes the case that the quality of information in several of the applications is far below what is required for rigorous evaluation by a regulatory body and is unlikely to meet international regulatory guidelines. The committee has suggested setting up a secretariat comprising dedicated scientists with area and bio-safety expertise. It has suggested collaborating with the Norwegian government and the GM regulatory body as it "is one of the few that are attuned to considering socio-economic issues that would be important in the Indian context." It recommends that the new bio-technology regulatory be housed in the environment and health ministry, identification of specific sites for conducting of field tests and mandatory stakeholder participation as part of risk-management strategy. The Technical Expert Committee suggested that trials should be only allowed on land owned by GM crop applicant and not on leased land.

India’s Supreme Court Expert Committee Recommends Indefinite Moratorium on GE Field Trials

 Item 1

Indefinite moratorium on GM field trials recommended

Latha Jishnu

Down To Earth (India), July 22 2013

http://www.downtoearth.org.in/content/indefinite-ban-gm-field-trials-recommended

 

Supreme Court’s expert panel of scientists call for ban on herbicide tolerant crops for India. 

A committee of technical experts comprising scientists from top public research laboratories and academic institutions set up by the Supreme Court last year has changed the 10-year moratorium on field trials of Bt transgenics that it recommended in October 2012 to what appears to be an indefinite moratorium on food crops in its final report. 

Based on "the examination/study of the safety dossiers, it is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully considered. Till such time it would not be advisable to conduct more field trials," the experts say in their final report without specifying any time frame. 

In other significant recommendations, the panel finds herbicide-tolerant (HT) crops "completely unsuitable" in the Indian context and recommends that field trials and release of HT crops should not be allowed in India. 

Noting that a single committee such as GEAC or RCGM-these are the main regulatory agencies for biotech crops-doing all the evaluation is not sufficient, the expert panel has called for the setting up of a secretariat comprising dedicated scientists with area expertise as well as expertise in biosafety. "This will require consultation with experts having experience at the international level in biosafety testing and evaluation of GM safety dossiers in reputed regulatory bodies," the expert panel said, while suggesting that this should be done in collaboration with the Norwegian government. 

Its reason for singling out Norway is that the Norwegian system has "an established commitment" and is one of the few attuned to considering socio-economic issues that would be important in the Indian context. 

The report said the new regulatory body should have area-wise subcommittees/expert groups in the following fields: health (human and animal); environment and ecology; agro-economics and socio-economics; molecular biology; soil science and microbiology; plant biology and regulatory toxicology among other specializations. 

The report signed by its original five members was not endorsed by Rajendra Singh Paroda. A former director-general of the Indian Council of Agricultural Research (ICAR), he was nominated by the National Academy of Agricultural Sciences (NAAS) to fill the gap left by V L Chopra who did not serve on the Technical Expert Committee (TEC), as it is called, for unspecified reasons. Paroda, according to the letter sent by TEC to the Supreme Court on June 30, did not attend the final meeting of the committee in Chennai. Nor has he appended a dissent note. 

The five TEC members are eminent scientists in their respective areas of specialisation: Imran Siddiqui, plant development biology scientist & 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 S Chauhan, genetics toxicology and food safety expert; P C Kesavan, 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 of National Institute of Nutrition, Hyderabad. 

Since the single largest number of applications for field trials to GEAC is for Bt transgenics, including in food crops such as rice, the scientists are of the view that the safety of Bt transgenics with regard to chronic toxicity needs to be established before it can be considered safe for human consumption. In this regard it pointed out the largest deployment of transgenics worldwide is in soybean, corn, cotton, and canola, all of which are used primarily for oil or feed after processing. 

"Nowhere are Bt-transgenics being widely consumed in large amounts for any major food crop that is directly used for human consumption." The TEC could not find any compelling reason for India to be the first to do so. TEC has, therefore, reiterated its interim recommendations see  that there should be a moratorium on field trials for Bt in food until there is more definitive information from sufficient number of studies as to the long-term safety of Bt in food crops. 

GEAC had approved the commercial release of Mahyco’s Bt brinjal in 2009 but then environment minister Jairam Ramesh had put a moratorium on its release in the wake of widespread public protests against the first transgenic food crop in the country. 

If TEC’s recommendations are accepted, crops which originate in India, such as brinjal, cannot be genetically modified. "To date, no GMO that is intended primarily and directly for food production has been commercially released into its centre of origin," says the panel. It notes that the US has restrictions on the growth of Bt-cotton in Hawaii where a weed related to cotton is found. For good measure it emphasizes that cotton is not even a food crop. 

Crops in their centres of origin and diversity often have "a deep cultural significance that can easily get lost when utilitatarian issues dominate the discourse", says the 94-page report. Ceremonial and medicinal varieties can also be put at risk from GM crops by reduction of diversity and genetic purity, and to justify their release, "there needs to be extraordinarily compelling reasons and only when other choices are not available. GM crops that offer incremental advantages or solutions to specific and limited problems are not sufficient reasons to justify such release." 

In the present circumstances, there is no such compulsion, according to the scientists, who were categorical that release of GM crops for which India is a centre of origin or diversity should not be allowed. 

———————————————–

Item 2

INDIAN SUPREME COURT COMMITTEE SAYS NO TO GM CROPS

By IANS, 23 July 2013

http://twocircles.net/2013jul23/supreme_court_committee_says_no_gm_crops.html 

A Supreme Court technical expert committee Monday recommended an indefinite moratorium on the field trials of Genetically Modified (GM) crops till the government comes out with a proper regulatory and safety mechanism. 

The expert committee in its report to the Supreme Court said there should be a moratorium on field trials for Genetically Modified food crops like Bt Brinjal intended for commercialization until there is more definitive information from sufficient number of studies as to their long-term safety. 

"Based on the examination of the safety dossiers, it is apparent that there are major gaps in the regulatory system. These need to be addressed before issues related to tests can be meaningfully considered. Till such time it would not be advisable to conduct more field trials," it said. 

On the genetic modification of crops for which India is a centre of origin like rice, brinjal, and mustard, the committee recommended that "release of GM crops for which India is a centre of origin or diversity should not be allowed". 

The expert committee also said a no to the herbicide tolerant (HT) crops, saying they would most likely exert a highly adverse impact over time on sustainable agriculture, rural livelihoods and environment. 

The report comes at a time when there are differences over the Biotechnology Regulatory Authority of India (BRAI) Bill, 2013, which is pending with the Parliamentary Standing Committee on Science and Technology, Environment and Forest. 

In 2010, the then environment and forests minister Jairam Ramesh imposed an indefinite moratorium on the commercial introduction of GM brinjal following several public hearings. 

The Parliamentary Standing Committee on Agriculture, in a report August 2012 had asked for ban on GM food crops in the country, while industry has been calling for their introduction to ensure food security. 

More than 150 scientists wrote to the Environment and Forest Minister Jayanthi Natarajan early this year, raising concerns about GM crops. 

Their primary concern was that the agriculture ministry is allegedly making a case for GM crops by stating that the technology is absolutely needed for India’s food security. 

——————————————                      

Item 3

INDIA SUPREME COURT PANEL: GM CROP TRIALS ON HOLD FOR NOW 

The Economic Times, 23 July 2013

http://economictimes.indiatimes.com/news/economy/agriculture/put-genetically-modified-crop-trials-on-hold-for-now-supreme-court-panel/articleshow/21259129.cms 

NEW DELHI: A technical committee appointed by the Supreme Court (SC) has recommended an indefinite moratorium on open field trials of genetically-modified (GM) crops till the deficiencies in the regulatory and safety systems are effectively addressed. The recommendations, if accepted by the court, would have a serious impact on the commercialisation of GM crops. In its final report, which was submitted to the court last week, the six-member committee reiterated the recommendations made in its interim report last October. 

"Based on the examination of the safety dossiers, the Technical Expert Committee has found in unambiguous terms that at present, the regulatory system has major gaps and these will require rethinking, investment and relearning to fix. These need to be addressed before issues related to tests can be meaningfully considered. Till such time, it would not be advisable to conduct more field trials. A deeper understanding of the process of risk assessment is needed within the regulatory system for it to meet the needs of a proper bio-safety evaluation," the final report states.

On Bt food crops intended for commercialisation, the committee has reiterated that there should be a moratorium on field trials until there is a definitive number of studies on their long-term study. The 10-year moratorium suggested in the interim report has been dropped. Of the 91 applications for field trial before the GEAC, 44 are GM food crops. 

The committee felt that the safety of Bt food crops particularly on the issue chronic toxicity has not been established. "This needs to be done before it can be considered safe," it said. The report stressed that the largest deployment of transgenics world-wide is in soybean, corn, cotton, and canola, all of which are used primarily for oil or feed. "Nowhere are Bt-transgenics being widely consumed in large amounts for any major food crop that is directly used for human consumption. The TEC could not find any compelling reason for India to be the first to do so," the committee’s final report states. 

The report makes the case that the quality of information in several of the applications is far below what is required for rigorous evaluation by a regulatory body and is unlikely to meet international regulatory guidelines. The committee has suggested setting up a secretariat comprising dedicated scientists with area and bio-safety expertise. It has suggested collaborating with the Norwegian government and the GM regulatory body as it "is one of the few that are attuned to considering socio-economic issues that would be important in the Indian context." It recommends that the new bio-technology regulatory be housed in the environment and health ministry, identification of specific sites for conducting of field tests and mandatory stakeholder participation as part of risk-management strategy. The Technical Expert Committee suggested that trials should be only allowed on land owned by GM crop applicant and not on leased land.

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