Technical Expert Committee Interim Report oct 17 th- 2012 Genetically Modified Organisms

7/30/2019 Technical Expert Committee Interim Report oct 17 th- 2012 Genetically Modified Organisms

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SUPREME COURT OF INDIANEW DELHI

Dated : 1 7 ~ ~ctober, 2012From : Assistant Registrar PIL (WRIT)

Mr. Prashant Bhushan, A dvocate,301, New Lawyers Cham ber2 . Mr. S. Hariharan, Advocate24, Lawyers Chamb er3. Ms. Jitendra M ohan Sha rma, Advocate,141, New Lawyers Chamber4. Mr. A. P. Medh, Advocate,22, Lawyers Chamb er5. Mrs. Sreekala G .K., Advocate,D-29, (FF), Gulmohar Park, New Delhi - 110049.6. Ms. Kamini Jaiswal, Advocate,43, Lawyers Chamb er7. Mr. Subramanium Prasad,104, Lawyers Cha mber8. Mr. S.N. Terda l, Advocate,Central Agency

IN THE MATTER OF:WR -IT P ET ITIO N (C IVTL) N O i 260 O F 2005( U n d e r A r t i c l e 3 2 o f th e C o n s t i t u t i o n o f I n d i a )W I T H

W R I T P E T I T IO N !C)NO i 1 1 5 OF 2004W I T HC O N T E M P T P E T I T I O N ( C ) N O . 2 9 5 O F 2 0 0 7INW R I T P E T I T IO N (C! NO, 260 OF 2005

Amn a Rodrigues & Ors. etc. etc. .. .PetitionersVersus

Uni on o f Ind i a & O r s . . R e s p o n d e n t s


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As per Hon'ble Court's Order dated 15.10.2012, I am directed toenclosed herewith a copy of the Interim Report dated 07.10.2012 receivedfrom Dr. Imran Siddiqui, the Member of the Technical Expert Committee.

This is for your information, compliance and necessary action.

Yours faithfully,elk-/ssistant Registrar

Encl.: As above

pkl-


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CONFIDENTIALInterim Report of the Technical Expert Committee

Background

In accordance with the Order of the H onourable Supreme Court oflndia dated M ay 10, 2012 on the W rit Petition (Civil) No. 260 of 2 005 of ArunaRodrigues Vs Union of India, a Technical Expert Committee (TEC) wasconstituted by the Honourable Supreme Court of India. The HonourableSupreme Court of lndia had also fixed seven Terms of Reference (TOR) forthe TEC to examine and submit a report to the Honourable Supreme Courtwithin three months with effect from 1 2 ' ~ ay 2012. The Honourable SupremeCourt had also directed that in the event and for an y reason whatsoever, theCommittee is unable to submit its final report to the Court within the timestipulated in the O rder, the C omm ittee should instead submit its interim reportwithin the same period to the Court on the following issues: "whether thereshould or should not be any ban, partial or otherwise, upon conducting ofopen field tests of the G MO s? In the event open field trials are p ermitted, whatprotocol should be followed and conditions, if any, that may be imposed bythe Court for implementation of open field trials. "

The present report is an interim report submitted by TEC. Therecommendations of this report were arrived at by consensus of all the fivemembers of the TEC. I

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General ConsiderationsGM technology comes with the prom ise of a number of benefits as well

as associated risks with regard to health and environmental safety. Theserisks need to be clearly recognized and ad dressed in order for G M products togain societal acceptance and the potential benefits to be realized. Given thenovelty of the technology and the issues of food safety as well as possibility ofeffects on and transgene spread to other organisms, it is impo rtant that safety


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analysis also identifies areas of uncertainty and suggest strategies to addressthese uncertainties. lndia is a signatory to the Cartagena Protocol onBiosafety (CPB) to the Convention on Biolog ical Diversity. Article 1 of the CPBincorporates reference to Principle 15 of the Rio Declaration (1992) onEnvironment and Development that states:

"In order to protect the environment, the precautionary approach shall be widelyapplied by State s according to the ir capabilities. W he re there are th re ats ofserio usor irreversible dama ge, lack o ff il l scientific certainty shall n ot be used as a reasonfor postponing-cost-eflectivemeasures to prevent environmental degradation."

The objective of Article 1 is specified as under:" In accordance with the precautionary approach contained in Principle

15 of the Rio Declaration on E nvironment and Development, the objective ofthis Protocol is to contribute to ensuring an adequate level of protection in thefield of the safe transfer, handling and use of living modified organismsresulting from modern biotechnology that may have adverse effects on theconservation and sustainable use of biological diversity, taking also intoaccount risks to human health, and specifically focusing on transboundary

Imovements" ().

The Article 10.6 an d 11.8 state:"Lack of scientific certainty due to insufficient relevant scientific

information and knowledge regarding the extent of the potential adverseeffects of an LMO on conservation and sustainable use of biodiversity in theParty of import, taking into account risks to human health, shall not preventthat party from taking a decision, as appropriate, with regard to the import ofthe LMO in question . ., in order to avoid or minimize such potential adverseeffectsJJhttps://bch.cdb.int/protocol/cpb fasshtml).- 3

The Precautionary Principle and potential for risk to the environment,biodiversity, and human health is thus clearly recognized by lndia and it isincumbent upo n the national regulatory process to incorporate steps to ensure


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that potential biosafety risks should be identified and minimized. It is the viewof this Committee that such steps should be included from theconceptualization and design stage of a GM product right through itsdevelopment, biosafety evaluation, and upto and after its commercialrelease, including post-release monitoring. In fact, a comprehensiveassessment including a risk assessment should start from an assessment ofneed for the product~technology,and encompass a socio-economic a nalysisthat includes the impact that the product would have o n different sections ofsociety and the economy. This is pa rticularly important for GM foods given thenovelty of the technology and the far reaching consequences that thecultivation and use of GM crops can have. As will be discussed below(Annexure I), it does not always follow that a particular technology will lead toa benefit for all u sers of the technology/product and others who are impacted.In the case of herbicide tolerance which was introduced to eliminate the nee dfor manu al weeding, th e technology has been used mainly in scenarios wherethe farm size is very large (hundreds of acres). Its relevance to India whereaverage farm size is much smaller (around 2.5 acres) has beeri seriouslyquestioned. On the other hand introduction of Ht transgenics may also lead tohealth and environmental risk. Moreover, the use of herbicide tolerant cropswould also take away a source of employment in rural areas for the weakersections (mostly rural women); so it is not at all clear whether herbicidetolerant crops would benefit a broad spectrum of Indian farmers.

Given the broad range of possible products that GM can be used tocreate, biosafety issues need to be addressed on a casewise basis, takinginto account, the transgene(s) being introduced, the crop, and the specifictransgen ic event, and the predom inant traditional agricultural systems in India.Some of the issues involving health and environmental safety include thepossibility of effects that may not be immediately apparent and require longterm study, so it is important to recognize that safety analysis does not stopwith approval for commercial release, and that post-release monitoring ofenvironmental and/or health safety needs to be continued even after approvalfor commercial release. Post-release monitoring also provides valuableinformation that would have a bearing on longterm effects and sustainability of


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a GM product and should be made mandatory. At the same time, it needs tdbe recognized that it is very difficult to guarantee that a product will beentirely risk-free. Biosafety evaluation would therefore need to assess risks,identify uncertainties, and balance potential benefits against possible risks tothe he alth of consumers, n ontarget organisms, and environment.

Response to the Terms of Reference (TOR)

The TEC held its first two meetings at MoEF, Paryavaram Bhavan,Delhi where the terms of reference, scope of work, and components of thetask were discussed. The TEC also drew attention to the need for certainclarifications in the T OR as detailed in the minutes of the first meeting. As perthe decisions take n-in the first meeting, in accordance with the direction of theHon'ble Supreme Court, invitations were sent to the petitioners, governmentof lndia respondents, and experts whose knowledge and -experience wereconsidered of relevance and importance by the TEC. This was followed bythree meetings of two days each at the Centre for Cellular and MolecularBiology (CCM B)', Hyderabad where the TEC held deliberations and hearddepositions from respondents and experts including petitioners, Governmentof lndia representatives, civil society groups, NGOs, representatives ofindustry, media persons o f proven expertise, and farmers associations.A listof those deposingJsubmitting materials before the committee is provided asAnnexure II, along with a list of submitted materials. In addition a number ofrespondents sent in written submissions. The members of the TEC thenconsidered the submissions and information that had been collected,including co nsultations. and discussions over the phone and ,by email. Theythen .prepared their points and held two meetings over four days to discuss,and assem ble the report in the light of their understanding and views. In viewof the com plexity of the issues and the num ber of factors involved, the TEC isof the view that a lot more time is required to arrive at a set ofrecommendations that addresses all the TO RS in sufficient depth and detail.

The choice of CC MB as venue was with the concurrence of M oEF and was based on the availability offacilities on site including guesthouse accommodation, and infrastructure support for holding meetings


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Therefore the com mittee opted to submit an interim report as directed by theHon'ble Supreme Court.

For the purpose of the interim report, the TEC has considered thoseissues that relate to the conducting of field trials and food safety and exposureto the environment that have been raised by the petitioners. The TEC hasalso examined some of the biosafety data that is available from the GEACwebsite that provides an idea of the biosafety evaluation process, as one ofthe dimensions for making specific recommend ations.

Biosafetv and Field Trials

The process of making transgenic plants involves generatingtransgenics in the laboratory followed by growth of transgenic plants in thegreenhouse where initial selection of prom ising candidate plants showing thedesirable properties is carried out and those plants that show obvious defectsare eliminated. However, to shortlist the transgenic plants for the bestagronomic performance, a further round of selection called "event selection"needs to be performed. Event Selections are typically performed on familiesof small number of plants (of the order of a hundred or less), each family orline representing progenyldescendants of a single p rimary transgenic plant.

Some of the respondents who deposed before the committee haveindicated that event selections cannot be performed in the greenhouse asperformance in field conditions can be quite different from that in thegreenhouse. The TEC in its own deliberations learnt that in other cases, eventselections have been done under contained conditions in the greenhouse.The TEC is therefore of the view that event selections should be performedunder contained conditions in the greenhouse (specially designed) as far aspossible. The TEC recommends som e basic laboratory-based tests relating totoxicity and allergenicity (e.g. Ames test, micronucleus test for genotoxicity,allergenicity screening) should be carried out on the selected events whilethey are in contained conditions in the greenhouse. In case the developerfinds that event selection c annot be done in the greenhouse under contained-


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conditions, they should apply to the regulator giving specific reasons why thetests cannot be done in the greenhouse. In this case the preliminarylaboratory-based biosafety tests would need to be done on all the materialthat is proposed to be subjected to event selection, while it is still undercontainment (i.e. prior to performing event selections outside greenhousecontainment). In any case, the event selections should not be done on leasedland or in farmer's fields, or in areas that are in close proximity to farmer'sfields. Event selections should only be done at a designated location,whichhas been certified by the regulatory agency. Once the events have beenselected, biosafety and toxicity studies on the selected events should becarried out.

With regard to the sequence of testing for biosafety, the TEC has beeninformed that the "Guidance Document for InformationIData Generation andDocumentation for Safety Assessment of Regulated Genetically Engineered(GE) Plants" is what is operationally being followed for the last approximatelyfour years. This is a draft document that is still under discussion in GEAC,outlining the biosafety tests and the seq uence in which these are to be carriedout. The document as it stands does not direct the applicant to conduct anyexperimental biosafety tests on the transgenic plant before the BiosafetyResearch Level I and II (BRLIIBRLII) field trials. The studies required to bedone before BRLIIBRLII relate to descriptions of the genetically engineeredplant, the biology of the non-transgenic host plant, the genetic modificationsand how the genetic modifications were introduced into the organism, anassessment of possible toxicity and allergenicity based on theoreticalconsiderations, and an experimental confirmation that the new trait is stableand inherited over successive generations. All experimental biosafetyinformation is to be obtained either in parallel or during the course of BRLland B RL ll trials. Thus, there is nothing in the p resent guidelines that requiresanv experimental biosafetv tests to be carried out before the start of fieldtrials. This is a serious weakness in the present guidelines.

The TEC is of the view that some basic information on biosafety isrequired before field trials and that it is necessary to carry out some tests forbiosafety before the BRLl trials. These should cover food safety and toxicity-


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tests on rodents (rats) and include sub-chronic feeding studies. The TEC alsorecommends that those studies listed in the guidance document underchecklist 1 2 (Molecular C haracterization of the Genetically Engineered Plant),checklist 13 (Assessment of Possible toxicity - Proteins), and checklist 14(Assessment of Po ssible Allergenicity) should be done prior to BRLI. Materialto be used for sub-chronic feeding studies may be grown under the sameconditions as Event Selection trials. Taken together, the results of thesestudies should provide preliminary information with regard to food safety andtoxicity of the transgen ic plant.

Although longterm feeding studies are not part of the current set oftests, the TEC is of the view that both longterm and intergenerationfeeding studies in small animals (e.g. rodents) should be included in theset of tests. The nee d for this is highlighted by,th e fact that food is somethingthat is consumed throughout the lifetime of individuals, and longterm studiesare, therefore, essen tial for determining safety including at different stagesof development starting from conception to end of the life cycle. Theearly stages of development and reproductive phases are particularlysensitive and it is quite possible that some risks may come to light only inlong-term studies and therefore the TEC is of the view that the inclusion ofthese tests is justified. Longterm and and intergeneration studies may bedone after the start of BRLI.

A second point of concern is the process of choosing a site forconducting BRLIIBRLII trials. The TEC notes that in the Guidelines andStandard Operating . Procedures for Confined Field Trials of Regulated,Genetically Engineered Plants (2008), the site selection is left entirely to theapplicant (Permitted Party) whose responsibility it is "to ensure compliancewith all of the terms and conditions for authorization of a confined field trial"(p10, Section 7). According to the Guidelines, the applicant is also allowed tosubcontract the testing to another party. The TEC is of the view that thepolicy of delegating responsibility by leaving the choice of site selectionto the applicant and also allowing the work to be subcontracted iscontrary to the basic safety requirements and is most likely to lead to


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violation of the conditions of safety. Both practices should be haltedimmediately. The regulator should designate a certain number of sites inICAR ins titutes or State Agricultural Universities where the required cond itionsof isolation are established and certify that these are the sites for BRLIIBRLIItrials. Sites in the company's premises may also be considered forcertification for trials. These designated sites should be used only for growingGM plants and not the non-GM crops so as to avoid contamination of non-GMby GM seeds. In any case BRLIIBRLII trials should not be conducted infarmer's fields and this practice should be immediately stopped includingthose trials that have bee n already approved.

Examination of biosafetv dataIn order to examine the tests that have been done and how biosafety

issues have been addressed as part of the evaluation process leading toapproval, the TEC examined the toxicology data on Bt transgenic cottonhybrids that have been approved for commercial release. The approvedmaterial for which data is publicly available (igmoris.nic.in) comprises sixdifferent Bt hybrid cotton events.

The TEC found several instances where the number of samples wasless than the prescribed m inimum value resulting in a reduction in the qualityand sensitivity of the test (e.g. Mahyco CrylAc (HD73) vol 1: p161-173:Tables-17-42). In other cases, there were significant differences in biologicalindicators such as blood cell parameters (WBC and RBC counts), tissue andorgan health and integrity, and milk yield between Bt and control samples.Small but consistent changes in some bio-indicators were discernable andwhich appear not to have received due attention for possible impact. It isnecessary to point out that even small but consistent and apparentlyinsignificant changes in a set of indicators, if observed repeatedly in differentbut related experimental situations, become important and these wouldrequire further testing. Some of the problematic issues that the TE C found aresimilar to th,ose that h ave been pointed out in the case of Bt-brinjal by others,including international experts, and which contributed to the declaration of a


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moratorium on Bt-brinjal. The TEC is of the considered view that takentogether these findings point to serious weaknesses in the review of safetydata by the regulator. The TEC also noted that the mode of feeding of apowder that has not been characterized, by gavage does not reflect thehuman mo de of consum ption of brinjal.

Post-release m onitoring

A further issue which requires serious attention is the fact that a broad-based post-release monitoring of Bt cotton does not appear to have beencarried out. Given that the technology is novel and represents the firstintroduction of a GM crop in India, this should have be en u ndertaken from thebeginning. Based on the information the TEC was able to get related to post-release monitoring, there has been only limited post-release studies withregard to the emergence of resistance and secondarylnew pests whereasother factors such as effects on non-target organisms, soil microflora, fertility,and performance under irrigated vs non-irrigated conditions have not beenextensively studied. This is an important requirement which has not beenaddressed so far.

Strenqtheninq the Evaluation Process

In considering the areas where the evaluation process needs to bestrengthen ed, the TEC has identified three major factors tha t require attention:

Apparent lack o f qualified full-time perso nnel n the regulatory bodiesA basic question that can be asked is "Who in the regulatory bodies(GEAC and RCG M) unde rtakes the detailed scrutiny of the data in the safetydossiers?" RCG M and GEAC , the two com mittees resp'onsible for review andsafety evaluation consist of about 30 members each and the TEC has beeninformed that the examination of the applications is done primarily by themembers. The members are from various public sector institutions,universities, and government departments. Almost all of them have-otber


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primary responsibilities and are expected to be able to devote only a smallfraction of their time to the matters that come before the GEACIRCGM. Theonly memb er who may be working full-time for the GEAC is its Secretary, whois from the MoEF. The Secretary is supported by 1-2 officers whose role ismostly to provide administrative support to process applications and materialthat comes before the committee. The same is the case with the RCGM.Overall there is limited expertise in biosafety science and the capacity tocritically evaluate the safety data being submitted by theapplicants/developers. Given the voluminous amount and diverse nature ofmaterial that comes before these bodies, the TEC is not convinced that theregulatory bodies in their present form are in a position to rigorously evaluateand interpret all aspects of the data that comes before them. If this is indeedthe case, and the applications are receiving only limited scrutiny, then theeffectiveness of the entire evaluation process is called into question.

While a great deal of effort has been invested by DBTIMoEF inorganizing and preparing documents and procedures for safety testing,including guideline documents, listing of tests and how to conduct them,formats etc., the actual operational mechanisms appear weak. Many of theresponsibilities (including for field trials) seem to have been delegated or leftto the applicant, and there seems to be very limited mechanisms and overallcapacity to en sure compliance and accountability. The impression of the TECis that the evaluation process has a pipeline which 'lays down a set ofprocedures and steps but is short on substance and requisite rigour.

The regulatory b ody would need a d edicated team of scientists who arewell qualified in the science of biosafety, environmental impact, and socio-economic aspects to scrutinize and take responsibility for examining thesafety data and dossiers. The examination process should ensure withaccountability: (i) that the data are of a sufficient scientific standard and (ii)that the data are ana lyzed rigorously so as to determine whether or not theyestablish the biosafety. The examiners should sign and certify that the datahave been exa mined and point out the deficiencies if any. This should not beleft in an informal way to the committee whose members cannot be


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reasonably expected to scrutinize all the data at the necessary level of detail.The com mittee's job would be to provide additional inputs and oversight to theevaluation process.-Ne ed for removing conflicts o f nterest

For the regulatory process as a whole to have public confidence (this isa must on something as fundamental as food safety), it is important for theregulatory structure to be free of conflict of interest. The fact that a majorregulatory arm, the RCGM is located within DBT is at variance with thisrequirement, given that DBT's mandate is to promote and supportbiotechnology and the development of biotechnological products including GMcrops. The location of RCGM within DBT significantly compromises theregulatory process and this is independ ent of how good a job RCG M may infact be doing. It is neither in the interests of the regulatory body nor DBT forthe latter to be associated with the regulatory process. Whereas RCGM cancontinue to be involved in evaluation of applications for research projects,when it comes to product development, RCGM should not have a role. Theregulatory bod y. for GM products should be located entirely outside of theDBT, and a suggestion is that it could be either in the MoEF or Ministry ofHealth and Family Welfare or both (environmental and health safetyrespectively). It is also important that members of the regulatory bodiesshould not have any interests, explicit or implicit, in thedevelopmentlpromotion of transgenic products that would be deployedcommercially.

Broadening perspectives and increasing inclusiveness of stakeholders withregard to decision ma king on G MproductsGM food impinges on agriculture and society in very many ways andthe regulatory and decision-making process has to include representation bya larger set of stakeholders from an early stage itself in order to: (i) identifyscope of issues and address these in a way that meets the concerns of allstakeholders; (ii) build trust, (iii) achieve an understanding of the advantagesand limitations so as to maximize benefits and minimize negative fallouts tostakeholders. If this is n ot done, then the process has a high likelihood to fail


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?I

as appears to have happened. In a country such as lndia where the numberof stakeholders connected to agriculture is large, it would be highlyappropriate to ha ve wider representation in the regulatory body (G EAC) so asto include agricultural economists, sociologists, members of civil society,farmers representatives, representatives of organizations working onagriculture and farmer-related issues, besides technical expe rts in toxicology,cell and molecular biology, ecology, and plant breeding (see Annexure I for anexample on po ssible impact of G M on export related issues).I I 1 0 ."

Recommendations of the TEC.1 I - . I -(a) General: ll - 7 , -The TEC deliberated on a number of issues related to the field trialsand regulatory processes. All the members of the TEC unanimously felt thatthe present regulatory system and protocol for conducting the field trials wasunsatisfactory and inadequate, requiring major changes, restructuring, andstrengthening. These include removal of conflict of interest as discussedearlier (pag e 1I),esignation and certification of specific sites for conductingfield trials, and access to a pa nel (in the short term), along w ith developmentof a secretariat (in the long term) of qualified scientists for scrutinizing andanalyzing the safety data. There was also a need to include some basiclaboratory based toxicity and allergenicity tests under contained (greenhouseor laboratory) conditions before the GMO is released for field trials incontainment. Furthermore, additional toxicity tests comprising longtermand intergenerational studies should be added to the , existingrequirement which stops at sub-chronic studies.

Finally, the TEC draws a ttention to the fact that the Cartagena Protocolto which lndia is a signatory, recognizes the crucial importance of biodiversityand in taking all steps to preserve it as a longterm resource. If the rate atwhich GM cotton has proliferated in lndia is any indication of things to come,then it is highly likely that the introduction of transgenics in crops for whichlndia is a centre of origin or a centre of biodiversity will contaminate thebiodiversity and this should not b e allowed to ha ppen.


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(b) Specific:

1. Given the findings of the TEC that there have been several cases ofignoring problematic aspects of the data in the safety dossiers, all biosafetydata for applications in process as well as those that have been approved forrelease will need to be reexamined by scientists who are qualified inbiosafety science and experienced in evaluation of biosafety dossiers fortransgenic plants. If necessary, this should be done by international expertswho have the necessary experience.

2. Longterm and intergenerational studies in rodents need to be added tothe tests and performed for all products whether already approved or yet to beapproved.

3. Acute and sub-chronic feeding studies for all applications includingthose in progress should be completed before BRLI, as also molecularanalysis and allergenicity tests. If these studies indicate potential risks of anykind, the GM event should be rejected outright to save time, resources andcontamination.

4. Genome-wide expression analysis in the toxicity studies of the testorganism (e.g. rodent) that is being exposed helps to identify changes inbiomarkers that are indicative of toxicity. This is an important test to beincluded as biomarkers are sensitive indicators and are capable of revealingchanges before visible symptoms appear.

5. The regulator needs to designate and certify a defined number of sitesin different parts of the country to be used for BRLIIBRLII trials. All BRLIIBRLIIfield trials should be carried out only at these sites. These sites should beused only for growing GM plants and not the non-GM material. Trials shouldnot be conducted in farmer's fields. This also applies to those trials for whichpermission may have previously been given by the regulator.

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Keeping all these in view, the TEC is unanimously of the view that allfield trials should be stopped until the following conditions have beenmet as discussed above:

iii)

iv)

Specific sites for conducting field trials have been designated andcertified and sufficient mechanisms for monitoring the trials put inplace.A panel of scientists, qualified in evaluation of the biosafety data ofGenetically modified crops has been engaged for scrutiny andanalyses of the safety data.Conflict of interest in the regulatory body has been removed asdiscussed above.The requirement for preliminary biosafety tests prior to field trialsincluding sub-chronic toxicity in sm all animals has b een included.

Outsourcing/subcontracting of field trials should be banned.

7. Assessment of need should be carried out for products/technologiesand involve analysis by scientists, agricultural economists, sociologists,farmers' representatives and agriculture department officials.

8.above.

Representation on regulatory bodies should be expanded as discussed

In addition the TE C recomme nds the following with regard to certain classesof products:

9. Based on the current overall status of food safety evaluation of Bttransgenics including the data on Bt cotton and Bt brinjal examined by theTEC and in accordance with the precautionary principle, the TECrecomme nds a ten year moratorium on field trials of Bt transgenics in all foodcrops (those used directly for human consum ption).


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The TE C is of the view that a period of ten years is a reasonable lengthof time for restructuring and operationalization of a strengthened regulatoryregime, developing a cadre of experts in areas of relevance to food safetyevaluation, environmental impact assessment etc. It is also expected thatduring this time additional data should emerge relating to post-releasemonitoring, and longterm toxicity tests as proposed above. T he issue m ay bereappraised at that time.

10. In view of the concerns bearing on health, environmental, andsocioeconomic considerations, the TEC recommends a moratorium on fieldtrials of herbicide tolerant (Ht) crops until an independent committeecomprising of experts and stakeholders has examined and assessed thepotential impact o f Ht-technology and its suitability in the Indian context.

11. lndia is a signatory to the Cartagena Protocol which recognizes thecrucial importance of biodiversity as a longterm resource. The TECaccordingly recommends a ban on field trials of transgenics in those crops forwhich lndia is a centre of origin or a centre of diversity, as transgenics cancontam inate and adverse ly affect the biodiversity.

The a bove comprises the interim report of the TEC relating to the conduct offield trials and the conditions to be imposed. The TEC has also felt itnecessary to comm ent on the regulatory process as a who le since that is anoverarching issue that also bears on the field trials and their evaluation. Theremaining TOR S will be add ressed in the final report.

Dr. P.S.ChauhanMember

prof. P.C. KesavanMember


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MemberDr lmran Siddiqi,

Member

Oct 7 t h , 2012


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Annexure I -- Need, Socioeconomic Assessment, and Post ReleaseMonitorinq

Need and socioeconomic assessment is a critical thing that needs tobe done at a preliminary stage, well before the product has been developed.The regulatory body must anticipate the possible impact a product can haveon society and particularly the farmer, rather than being driven purely bygeneral technical considerations and adopting a laissez faire approach,assuming that a successful technology will also lead to a successful productthat will benefit society as a whole. Examples of questions that need to beasked include: In what product context is the technology to be developed andused? Whom will it benefit and to what extent? Whom will it not benefit? Is itlikely to pose a risk or hazard to a section of farmers or society? What is theextent of that risk and can it be avoided? Some of these factors also need tobe examined through post-release monitoring which provides importantinformation on environmental and societal impact of usage of the GMO. Postrelease monitoring has been almost completely absent.

There have been reports that Bt cotton hybrids currently deployed (inIndia all Bt cotton so far has been been deployed as hybrids and not asstraight varieties) are not 'suitable for rainfed (non-irrigated) areas which arescarce in water as the projected high yield is highly sensitive to the availabilityof water. In rainfed areas if rainfall has been low and the soil is dry by lateseason when boll setting takes place, then yield can be greatly reduced.Coupled to the high input costs for Bt hybrids, including seed and fertilizer,and large fluctuation in yield in rainfed areas, this can result in putting thefarmer at greater risk. This has been considered an important contributingfactor to farmer distress and suicides. Has this been considered at all in thedecision making process on regulation? The TEC's understanding is itprobably has not and yet it can have such a major impact. Post-releasemonitoring of the performance of Bt-cotton (the first GM crop to be released inIndia) has not been done under different conditions which could haverevealed some of these factors.


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Another factor is the possibility of contamination of non-GM food byGM food. In lndia given the small plot size and relative lack of control inharvesting, storage, transport, it is likely that such contamination would behigh. Organic farmers whose products need to be certified as being free ofchemicals/pesticides a nd non-GMO w ould be particularly strongly affected. In201 1-12 lnd ia was the largest exporter of rice in the world. I f we assume thatcontamination will be high, how will it affect the non-GM product. In case ofe.g. export of Basmati and non-Basmati rice, what will happen? If the rice iscontaminated with GM rice, then essentially lndia stands to lose the entireEuropean market. The total value of rice export from lndia worldwide is aboutRs. 14 ,000 cr. (2011-12 data). If the'value is small and mu ch less thanprojected benefits, that is one thing, but if it is high then it could do gravedamage. To the best of the TEC's knowledge this possibility has not beenconsidered by regulatory bodies when allowing development of transgenicrice in lndia which is presently.in full swing and there are several applicationsbefore GEAC. Is there a mechanism for compensation of the farmer whoseproduct is affected, and who w ould pay the compe nsation? To the best of theTEC's knowledge there are no statutory mechanisms in place to addressthese issues.


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Annexure II - List of Respondents and SubmissionsMs. Aruna Rodrigues: Slides and written submissionDr. G.V. Ramanjaneyulu (CSA): Slides and written submissionMs Kavitha Kuruganthi: Slides and written submissionDr. Sagari Ramdas (ANTHRA): Slides and written submissionDr. Ramesh V. Sonti (member, GEAC): Written submissionDr. Pushpa M. Bhargava: Written submissionMr. Rajesh Krishnan (Greenpeace): Slides

8. Dr. Usha Barwale and team (Mahyco): Slides and written submission-I 1.Mr. Raju Kapoor and team (National Seeds Assocn. of India): Slidesand written submission I

I

10. Dr. K.K. Narayanan (Metahelix): Slides11. Dr. Ranjini Warrier (GEAC): Written submissions- 012. Dr. Balasubramanian (TNAU): Slides13. Dr. N. Seetharama (ABLE):14. Dr S.R. Rao (DBT):

Slides and written submissionsSlides and written submission

15. Prof. Deepak Pental (Univ of Delhi): Slides16. Prof. Swapan Datta (ICAR): Slides17. Dr. O.P. Govila (DoA):18. Mr. K. Nageswara Rao:19. Mr. P. Sainath:

SlidesWritten submissionPrint material and visual media

20. Mr. P.V. Satheesh (Deccan Dev Soc): Media and written submission21. Prof. Asis Datta: Written submission22. Dr. Vandana Shiva: Written submission23. Dr. Suman Sahai:


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24. Dr. R.R. Hanchinal (UAS Dharwad): Written submission25. Prof. Jack Heinemann: Written submission26. Dr. Doug Gurian-Sherman: Written submission27. Dr. David Andow: Written submission28. Dr. Keshav Kranthi (CICR): Written submission29. Dr. V.S. Vijayan (Salim Ali Foundation) Written submission30. Department of Agriculture Written submission31. Mr. P. Chengal Reddy (CIFA) Written submission

Documents

Technical Expert Committee Interim Report oct 17 th- 2012 Genetically Modified Organisms