Keep up with the latest news and comment on genetically modified foods          

Indefinite moratorium on GM field trials recommended in India

Indian Supreme Court

Indian Supreme Court’s expert panel of scientists recommend ban on herbicide tolerant crops.

1. Indefinite moratorium on GM field trials recommended
2. Press brief - final report

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 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.
---
---
2.PRESS BRIEF: FINAL REPORT OF THE SUPREME COURT-APPOINTED TECHNICAL EXPERT COMMITTEE (TEC)
Writ Petition (Civil) No. 260 of 2005, Aruna Rodrigues and Ors vs. Union of India

“The quality of information in several of the applications is far below what would be expected and required for rigorous evaluation by a regulatory body and is unlikely to meet international regulatory guidelines (pg 35) --- Based on the examination of the safety dossiers the TEC has found in unambiguous terms that at present, the regulatory system has major gaps and these will require rethinking, investment, and relearning to fix. A deeper understanding of the process of Risk Assessment is needed within the regulatory system for it to meet the needs of a proper biosafety evaluation.” (Pg. 77)
_____
The Final Report (FR) of the TEC has been submitted to the Supreme Court (SC). It was signed by those present on 30 June 2012, ie 4 members. Dr Siva B Kumar who has been out of the country gave his assent in writing. Dr RS Paroda was absent. The main body of the report has been written by scientists keeping the science of GMOs at the forefront. The final recommendations commence from pg 77 onwards. The TEC in their FR have held to the essential findings of their Interim Report (IR), but have now, completed their mandate with regard to a recommendation on herbicide tolerant crops (HT). They were able to take this further step benefiting from the extended time that was made available to them of several months, to inform themselves of the data on and facts of HT crops. The main recommendations of their FR and a brief review of the reasons for these recommendations are provided in this Brief and are as follows:
 

RECOMMENDATIONS relating to TOR a, b and d (pg 1) and as reflected in the SC Order of 9 Nov 2012SC ORDER: "In the event and for any reason whatsoever, the Committee is unable to submit its final report to the Court within the time stipulated in this order, we direct that the Committee should instead submit its interim report within the same period to the Court on the following issue:Whether there should or should not be any ban, partial or otherwise, upon conducting of open field tests of the GMOs? In the event open field trials are permitted, what protocols should be followed and conditions, if any, that may be imposed by the Court for implementation of open field trials." (Emphasis by the TEC)

1. Recommendations with regard to open field trials TOR a & b (pg 77 onwards)
 a. Overall recommendation for open field trials: Based on and in particular, “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.”
 b. Bt food crops: The TEC “reiterates its recommendation made in the Interim Report that there should be a moratorium on field trials for Bt in food crops (those that are directly used for food) intended for commercialization (not research) until there is more definitive information from sufficient number of studies as to the long term safety of Bt in food crops”. (pg 81) (Note by AR: the 10 year time factor has been removed).

The single largest number of applications for field trials (44 of 91) to the GEAC is for Bt transgenics (including food crops such as rice and a range of vegetables, pg 11). “With regard to the nature of tests for Bt in food crops, the TEC was of the view that the safety of Bt transgenics with regard to chronic toxicity has not been established and this needs to be done before it can be considered safe. In this regard it may be noted that by far the largest deployment of transgenics worldwide 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.” It may be noted that this moratorium is now indefinite, the cap of 10 years being removed, in the mode of the imposition of a moratorium by the Minister of the MoEF on Bt brinjal, until conditions are met. These conditions, which are required before conducting any open field testing, deal with two broad aspects namely regulatory independence and expertise and the requirement of comprehensive risk assessment and hazard identification protocols to ensure biosafety. It is clear that for the TEC BIOSAFETY is the THRUST. Having examined the dossiers of Bt cotton and Bt brinjal and found “significant difference in biological indicators”, the “greater concern was the finding that these problems had gone unnoticed and unaddressed in the course of the regulatory process leading to approval. This led the TEC to consider the examination process and it became apparent that the scrutiny of the biosafety information was being done by the committee of the regulatory body which lacked full-time qualified personnel for the purpose (pg 23) – problematic data led the TEC to conclude that the data as a whole did not establish health safety for Bt-cotton and Bt-brinjal and left unanswered questions about the overall safety of Bt in food crops.--- The TEC also recommends reexamination of the safety data of the approved applications to ensure that all the biosafety issues have been addressed” and this includes long-term multigenerational feeding studies for chronic toxicity.
In brief, as conditions for FT the TEC, therefore, requires rigour in regulation and the necessity for acquiring expertise across several dimensions of risk assessment and hazard identification, which are difficult to master, which is clearly lacking and therefore, recommends seeking help from international experts including a collaboration with the “regulatory body of a country which has an established and reputed regulatory system through workshops and training of personnel as well as exchanges”. “Norway is one country that has experience in integrating socio-economic considerations into GMO regulation-- the Norwegian Gene Technology Act includes the criteria of sustainable development and societal utility”; removal of conflict of interest, independent testing, compliance with the CAC (codex) and the CBD at a minimum; but the emphasis is on compliance and comprehensive risk assessment protocols. The TEC is very clear that the aim is full compliance for biosafety, to remove uncertainties at every level. (See pgs 77 -79 for specific recommendations abbreviated here).
 c. Herbicide Tolerant crops: The TEC finds them completely unsuitable in the Indian context and recommends that field trials and release of HT crops "not be allowed in India." (pg 81 and corrected in point 6 of the corrigendum).

The second largest number of applications was for HT crops. The TEC has examined the issues in relation to HT, particularly with regard to sustainability and the likely socioeconomic impact on major sections of rural society. On both these counts, based on the reasons presented in the section on Herbicide Tolerance, the conclusion of the TEC is that HT crops would most likely exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment. The TEC finds them completely unsuitable in the Indian context exert a highly adverse impact on sustainable agriculture, rural livelihoods, and environment.
 d. Crops in their Centre of Origin or Diversity: The TEC therefore recommends that release of GM crops for which India is a centre of origin or diversity should not be allowed". (pg 82-83) “To date, no GMO that is intended primarily and directly for food production has been commercially released into its centre of origin (Samuels, 2013a). In the US, there are restrictions on the growth of Bt-cotton in Hawaii. The release of a GM crop into its area of origin or diversity has far greater ramifications and potential for negative impact than for other species. To justify this, 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. The TEC did not find any such compelling reasons under the present conditions."

2. Other recommendations and TOR a & b: Nature and sequencing of risk assessment and point of release for Open Field Trials (pg 79-83):
  To introduce a “consultation step to start with, ideally prior to the GM product intended for field trials having been developed”, encompassing the scope of issues that need to be addressed, relating to health and environmental safety -- on a “case-wise basis keeping in mind the overall phases of risk assessment: hazard identification; hazard characterization; exposure assessment; risk characterization; and mitigation options. Need, socioeconomic factors, and sustainability should also be considered and thoroughly discussed at this stage with involvement of all the stakeholders.”
  There is a need to include chronic and trans-generational toxicity testing in feeding studies of rodents based on the fact that food is consumed over the entire lifetime and that nutritional stress can also lead to adverse or unintended effects over long-term exposure. The sensitive stages of reproduction also need to be included.
  The regulatory process should be open to new scientific information that may have a bearing on the risk assessment, if necessary even after deregulation of an event.
 The applicant is responsible for providing to the regulator all information that has a bearing on the risk assessment, regardless of whether it was obtained for the purpose of the risk assessment.
  Stakeholder participation, need, socioeconomic considerations, societal impact, and sustainability should be some of the dimensions to be incorporated in the risk assessment and this should be done at an early stage in the risk assessment process.
 The TEC noted that Post Release Monitoring (PRM) is also an important aspect of environmental safety as well as health safety (if the plant is consumed as food) and this has not received adequate attention in the regulatory system (1R: p3, 9) or in practice.
“The sequence of testing should be carried out in order of increasing environmental exposure required to perform the test. Tests should be done under the minimum conditions of exposure required for the test. The testing therefore, proceeds in a progressive manner that increases confidence regarding safety, with increasing exposure.” The TEC was also informed by the Secretary, DoA that it will not be possible to segregate GM from non-GM material during the overall process of collection, handling, and storage in India. (Pg 27) – see comment 3 below by AR.
The Committee comprised:
Prof. PC Kesavan
Dr Imran Siddiqi
Dr PS Chauhan
Prof PS Ramakrishnan
Dr B Sivakumar
Dr RS Paroda
----------
Comments by Aruna Rodrigues
1. It is significant that this report of the TEC, cautioning the court on the absolute need for rigorous safety regulation, comes at a time when in the last 72 hours, Monsanto has withdrawn applications for GMOs in the EU because of non-acceptance on scientific grounds and rejection by civil society. It is also noteworthy, that the TEC report is the 4th official report which finds common ground on the lack of integrity and independence in the regulator and the presence of a pervasive conflict of interest which make sound and rigorous regulation of GMOs impossible . It is the 3rd official report barring GM crops/field trials singly or collectively. Furthermore, it is now no longer necessary to prove that the GMO regulators, MoA (Ministry of Ag) and MoS&T (Science and Technology), are acting together to collude with Monsanto and the biotech Industry to willy-nilly impose GMOs into Indian agriculture, in the face of clear scientific evidence that suggests abundant caution. The latest Affidavit filed by the MoA with the MoEF as a co-signatory, but in a subordinate position, opposed the Interim Report of the TEC tooth and nail, and clearly provides this evidence.

2. The fact is that we have little that can be called rigour or comprehensive regulation. We don’t even have the expertise in the areas needed. The member from the CCMB has made a scathing indictment of the regulators with regard to their oversight of the very first stage of risk assessment, i.e. the molecular analyses. Having examined the data submitted to him, even the "blots" were blurred and could not be read and were far from robust. The international appraisal of the Bt brinjal dossier confirmed this and much more. Prof Heinemann demonstrated that the Bt brinjal construct of a fusion gene (like Bt cotton Cry 1Ac) could have a difference of as many as 70 proteins, NOT 1 as claimed by the regulators and the subsequent EC II report. Thereafter, there were more tests not done than were done in the RA protocols including the ERA.

3. It is disquieting indeed that the government intends to introduce GM crops with the full realisation that there will be no segregation of GM produce and no labelling for GM content. Two Ministries (Agriculture and S&T) are attempting to railroad GM crops into India in a manner which is unconstitutional, contrary to our federal structure, contrary to the science, and which is suggestive of an hidden agenda, with suspicions of cronyism and corruption of a kind for which Monsanto in particular has become notorious worldwide.

Any biosecurity /GM-triggered failure will devastate our agriculture and export markets which are growing exponentially, including a Rs 12000 crore export market for rice, and agro-ecological farming systems. This is also in the light of the firm evidence that higher yield and reduced pesticide use in GM crops is a myth; it is conventional breeding methods that are delivering real increases in yield. We must look to investing in modernising agro-ecological farming methods as reported by the IAASTD (to which India is a signatory), for food security and virtually every UN Body says the same thing. This is the clear evidence.

Aruna Rodrigues
Lead Petitioner
GM PIL
22 July 2013