decision-making on bt brinjal in india

8/14/2019 decision-making on bt brinjal in india

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DECISION MAKING ONDECISION MAKING ON

BT BRINJAL IN INDIABT BRINJAL IN INDIA

Issues related to scientificity,

transparency, democracy & credibility


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BRINJAL IN INDIABRINJAL IN INDIA

King of Vegetables, with its own crown Extent of cultivation: Above 5 lakh hectares

India: Second largest producer in the world,

with 26% of production (China, India, Egypt,Turkey, Indonesia have 85% cultivation)

Indias production > 8 mn tons; within India,

Potato, Tomato and Brinjal dominate Major states: WB, Bihar, Maharashtra, AP,

MP, Karnataka, Gujarat, Assam


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Brinjal: the poor persons richBrinjal: the poor persons rich

vegetable?vegetable? Brinjal besides dietary fiber containing carbohydrates,

proteins and lipids has almost all the essential amino acids

Arginine, Lysine, Tryptophan, Phenylalanine, Methonine,Crystine, Theonine, Cystine, Threonine, Leucine, Isoleucineand Valine.

It is high in histamines. It also has vitamins Thiamine, Riboflavin, Niacin, Panthothenic

acid, Vitamin C, Folic Acid.

Rich in minerals like Calcium, Iron, Magnesium, Phosphorus,Potassium, Zinc and Manganese.

Eggplant is ranked among the top ten vegetables in terms of itsantioxidant content and has fourteen different phenoliccomponents, among them Chlorogenic acid amounted to 93percent of total phenolic compounds.

It helps to block the formation offree radicals and yieldsenergy 82 kj.

The roots of the eggplant are used against internalhemorrhage and asthma; the leaves and bark againstdysentery. This plant is also effective in the treatment ofhypercholesterolemia and in the control of cholesterol.
http://en.wikipedia.org/wiki/Free_radicalshttp://en.wikipedia.org/wiki/Free_radicals


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Brinjal in IndiaBrinjal in India

Socio-cultural significance Mattu Gulla, Marari brinjaletc.

Used in Ayurveda and Siddha for various medicinalpreparations

Used in treatment of diabetes and also a source of folicacid, potassium etc.

More than 2500 varieties

CENTRE OF ORIGIN/DIVERSITY (no GM crop ever

introduced in the crops Centre of Origin/Diversity so far)


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Bt Brinjal in IndiaBt Brinjal in India

Mahyco, with Monsantos gene construct

ABSP II project has Indian public sector

bodies drawn in (TNAU, UAS-D and IIVR)

IARIs Bt Brinjal with Bejo Sheetal and

other companies

One closest to our plates is a Cry1Ac-gene-Bt Brinjal by Mahyco


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Decision-making should be basedDecision-making should be based

onon Precautionary approach: Need for Bt Brinjal are there no safe, affordable, sustainablealternatives?

Safety assessment: Health & Environment comprehensive, scientific, long term, transparent

and independent Larger impact assessment: Impact on Ayurveda,

for instance; on fertiliser use possibly going up? Regulatory capabilities do state governments

have any powers to regulate marketing? Seedprices? Labeling, Liability/Redressal/Remediation

regimes


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Biosafety testingBiosafety testing

Field trials ran parallel with biosafety testing,rather than following biosafety clearance (from2004 onwards)

No independent research on biosafety Not even independent analysis forms part of

the current regulatory assessment

Getting biosafety data into the public domainfor scrutiny took 33 months & SC orders


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Biosafety testingBiosafety testing

No long term testing: longest studies are 90-days old (3months vs. 36 months: 1/12th of its lifespan Goats,Rabbits etc.?)

Tests required in the comprehensive regime as per therecommendations of the Supreme Court observer not

put into place Issues with study protocols as well as analysis of data

not addressed to this day

Safety conclusions drawn despite statistically significantdifferences between the study and control group

animals in feeding studies: no safety can be concluded


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Timeline of developmentsTimeline of developments 2000: Event imported and backcrossing begins (2002 itself,

when backcrossing was still on, pollen flow studies!) 2004 onwards: Limited field trials in farmers fields (violations

captured of food chain contamination) ABSP II projectinitiated

2006: Large scale trials permission was applied for by the

corporation: Expert Committee 1 headed by Dr DeepakPental set up

2007: EC1 recommends Large Scale Trials with severalconditionsThe EC1 report is put into the public domain onlyafter decisions are taken

LARGE SCALE TRIALS TAKE PLACE WITHOUT BIOSAFETYBEING CLEARED, A VIOLATION OF NORMS IN INDIA


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EC1 recommendationsEC1 recommendationsEC1 recommendations were apparently not based on the complete raw

data analysis.

While the data generated by the Applicant concludes that the Btbrinjal is safe and equivalent to its non Bt counterpart, the Committeewas of the opinion that more independent studies especially withrespect to toxicity assay in NABL accredited laboratories may berequired to reaffirm the findings made in the earlier studies.

The Committee further opined that the short term data generated onthe environmental safety and socio economic aspects needs to be

further substantiated with additional trials/tests to explicitly concludethe benefits from Bt brinjal and superiority of the technology withrespect to existing technologies especially the available methods forpest management and pesticide reduction.

Bt brinjal being a food crop, a flavour analysis of Bt and non-Bt fruitsmay be included as an additional parameter and this study may beundertaken at CFTRI.

The Company to review if the highest MIC95 value should be kept formonitoring rather than the average for the target pest vis--vis Cry1Acprotein expression levels.


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EC1 recommendationsEC1 recommendations The Food / Feed Safety assessment should include foliage toxicity

study in Goats.

The skin sensitization test of transgenic material in guinea pigs aslaid down in the DBT guidelines has not been taken up. TheCommittee recommended the study may be conducted.

Additional toxicity / allergenicity / compositional / nutritional studiesas recommended by Director, NIN after examining the raw data onfood and feed safety generated by the Applicant.

NIN Director sent some comments to GEAC on October 4th 2007. Helooked at only three studies: 90 days oral toxicity study (18 differentcomments but no specific recommendations), Acute Oral ToxicityTest (13 comments) and Allergenicity study (3 comments, on theRallis study). For all the three studies, one of the things he pointed

out was that characterization/authentification of the test articleprovided by the sponsor did not happen.


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EC2 mandate: GEAC 91EC2 mandate: GEAC 91stst meetingmeeting

minutes (January 14minutes (January 14thth 2009)2009)

5.1.4 After detailed deliberations, the Committee decidedto set up a Sub-committee comprising of representativesfrom the Ministry of Health and Family Welfare, NIN,ICMR, CFTRI, CCMB, IIVR, NDRI, CFIE, MoEF, DBT,TNAU and UAS Dharwad with the following terms ofreference:

to review the adequacy of the biosafety data on Bt brinjal to review the adequacy of the toxicity and allergenicity

protocols to suggest further studies, if any, based on the review of

the international practices in biosafety assessment and representations received by the GEAC based on such reviews make suitable recommendations

for consideration of the GEAC.


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EC2 Terms of ReferenceEC2 Terms of Reference

Created on 29/5/2009 through an OfficeMemorandum by GEAC:

to review the findings of the data generatedduring the large scale trials ;

to review the biosafety data of Bt brinjal in lightof the available scientific evidence, reports frominternational/national experts andrepresentations from NGOs and other

stakeholders; to make appropriate recommendations forconsideration of the GEAC based on the abovereview.


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EC2 ConstitutionEC2 Constitution1. Prof. Arjula R. Reddy, Vice Chancellor,Yogi Vemana University, Hyderabad and Co-chairman,

GEAC (Chairperson of the EC2).2. Dr Vasantha Muthuswamy, Former Chief(BMS), ICMR, New Delhi: Member

3. Dr. B. Sesikaran, Director, NationalInstitute of Nutrition, Hyderabad: Member

4. Dr. Lalitha R. Gowda, Scientist, CFTRI,Mysore: Member

5. Dr. N. Madhusudan Rao, Deputy Director,CCMB, Hyderabad: Member

6. Dr. C. M. Gupta, Former Director, CentralDrug Research Institute, Lucknow: Member

7. Dr S. B. Dongre, Director (F&VP), FoodSafety and Standards Authority (FSSA), New

Delhi -(Representative of MoH&FW): Member

8. Dr. Dhir Singh, ADG (PFA), FSSAI -(Representative of MoH&FW): Member

9. Dr. K. Satyanarayan, Scientist G, ICMR,New Delhi: Member

10. Dr. Dharmeshwar Das, Director, Indian

Veterinary Research Institute, Izatnagar:Member

11. Dr. A. K. Srivastava, Director, NationalDiary Research Institute, Karnal: Member

12. Dr. Dilip Kumar, Director, Central Instituteof Fisheries Education, Mumbai: Member

13. Dr. Mathura Rai, Director, Indian Instituteof Vegetable Research, Varanasi: Member

14. Dr. P. Anand Kumar, Project Director,NRCPB, IARI, New Delhi: Member

15. Dr. K. K. Tripathi, Adviser, DBT, NewDelhi: Member

16. Dr R Warrier, Director and MS GEAC:

Convener


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EC2: Designed to approve?EC2: Designed to approve? Chair under tremendous pressure is admitting to

the need for long term tests Key regulator has a CVC complaint being examined

sat in the EC2 which was looking at Mahycosapplication

One member part of ABSP II developing Bt Brinjal,generated large scale trial findings and sat in EC2 toreview his own findings

Another member is a Bt Brinjal developer in IARI

CIFE did a Mahyco-sponsored biosafety study earlier Two health ministry people as OBSERVERS


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EC2 some issuesEC2 some issues

EC1 recommendations overthrown

Mandate of assessing compliance with

guidelines principle of substantial

equivalence being applied

Compares with guidelines in countries like

USA, Australia, Canada etc. Does not

compare specifically with Norway, Hungaryetc!


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Some major issues from EC2Some major issues from EC2

reportreport

Checks for compliance on guidelines when theguidelines/safety regime itself is being questioned

Concludes that India is not the Centre of

Origin/Diversity Ignores and almost ridicules rights of OrganicFarmers

Re-writes what even the company is admitting on

sub-chronic tests(Page 59)


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Some major issuesSome major issues

Goes back on what key members have said in2007: test materials authentification; additionaltests to be done etc.

Relies its assessment on some studies onCry1Ac protein whereas Bt Brinjal has a

chimeric protein; brings down safety issues tojust one gene (that too a wrong one) while latestresearch is pointing to Genetic Engineeringprocess itself

Denies that horizontal gene transfer occurs!(Antibiotic resistant genes in Bt Brinjal) Conclusions on long-term studies not needed

based on unscientific rationale


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Main conclusion centred around:Main conclusion centred around:

Raising the bar of the regulatory process

as recommended by Dr. P.M.Bhargava

based on hypothetical concerns and

apprehensions would be highlydetrimental for research and development

in the area of agricultural biotechnology

especially for public sector institutions andthe benefits to the society at large


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Decision to be made on:Decision to be made on:

Whether Bt Brinjal decision should be equated withall GM crops and the technology itself?

Whether Bt Brinjal should be opted for when thereare safer, sustainable, affordable and farmer-centric alternatives?

Whether Brinjals Centre of Origin/Diversity shouldhave its GM version?

Whether Bt Brinjals larger impact should beassessed or not (Ayurveda, farmers rights etc.)

Whether Bt Brinjal should be allowed even thoughconsumer rights to informed choices will beviolated?


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Decision to be made on:Decision to be made on: Whether Bt Brinjal should be taken to be safe in the

absence of any credible, comprehensive, long term,independent assessment?

Whether Bt Brinjal pricing can be controlled by stategovts and through what means?

Whether Bt Brinjal should be allowed even if other inputslike chemical fertilisers might increase?

Whether it is ok to contaminate and violate the rights ofnon-GM and organic farmers?

Whether it is alright to approve without liability, redressaland remediation regimes WHO IS ACCOUNTABLE?

Whether it can be approved even though at least sevenstate governments have already taken a stand againstit?

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decision-making on bt brinjal in india