goi affidavit on gm crops

7/22/2019 GOI affidavit on GM crops

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I N D E X

SR.NO. PARTICULARS PAGES

1. Affidavit on behalf of the Union of

India. 1-123

2. Annexure:R-l

True copy of the Observations on

process adopted and consideration

of its submission by Five Members

of Tec. 124-144

3. Aonexure:R-1A

True copy of the Key points from

the Minutes of the meetings of TEC

prior to Appointment of DR Paroda

as member. 145-163

4. Annexure : R-1B

True copy of the Key Points from

the Minutes of the Meeting TEC

After Appointment of DR.R.S.

Paroda 164-179

5. Annexure : R1C

True copy of the E-mai! from

Dr.Imran Siddiqqi to Dr.R.S.Paroda

dated 12.5.2013 180

6. Annexure:R1D

True copy of the E-mail dated June

26,2013. 181-184


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7. Annexure:R1E

True copy of the Comments of UOI

on observations by Five Members

of TEC Regarding Safety Dossiers[page 26-51 of the Final Report]. 185-203

8. Annexure:R1F

True copy of the some

recommendations in the Interim

Report which were objected to bythe Union of India, but have been

still included in the Final Report, 204-210

9. Annexure :R1G

True copy of the Most damaging

Changes in the Corrigendum to Thefinal Report by the Five Members of

the TEC. 211-217

10. Annexure:R-2

True copy of the Meeting of

Scientific Advisory Council of PM on

Biotechnology and Agriculture. 218-226

11. Annexure R-3

True copy of the Relevant Excepts

from the report of the working

Group on biotechnology 12thplan

(2012-2017) 227-228

12. Annexure R-4

True copy of the Coments in

Detail for item 1 of Para

IS.r Ecommendations Specific to 5

Members of TEC. 229-231


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13. Annexure : R-5

True copy of the recent scientific

review by Agnes E. Ricroch (2013)

published in international journals. 232-237

14. Annexure:R-6

True copy of the a recent scientific

review by Chelsea Sneil (2012)

published in international journals 238-252

15. Annexure : R-7

True copy of the National Corn

Growers Association 2013 Metric

Edition. 253-262

16. Annexure:R-8

True copy of the peer-review

behind the article -EisevierAnnounces Article Retraction from

journal Food and Chemical

Toxicology. 263-265

17. Annexure:R-9

True copy of the Process of Needs

Assessment by ICAR. 266-267

18. Annexure : R-10

True copy of the Export of

Herbicide Tolerant (HT) Canoia

Seeds and Seedmeai by Canada

and Comparison of Yeilds between

India and Canada. 268


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IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

CIVIL WRIT PETITION NO 260 OF 2006

WITH CIVIL WRIT

PETITION NO 115 OF 2004

IN THE MATTER OF:

ARUNA RODRiGUES & ORS ... PETITIONERS

VERSUS

UNION OF SNDSA & ORS ...RESPONDENTS

AFFIDAVIT ON BEHALF OF THE UNION OF INDIA

I, Smriti Sharan, Director, Ministry of Agriculture,

Department of Agriculture and Co-operation, Government

of India, New Delhi, do hereby solemnly affirm and declare

as under:

1. I am working as Director, Ministry of Agriculture,

Department of Agriculture and Co-operation,

Government of India, New Delhi and am fully

conversant with the facts and circumstances of the

case. I have been authorized by the Union of India to

swear this affidavit on its behalf.


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2. The Respondents No. 1,2 and 3 had filed a counter

affidavit as well as several affidavits/ applications in

the above said Writ Petition since 2005. The

contents of the sameand the documents annexed

thereto may be adopted and treated as part and

parcel of the present affidavit as the same are not

being repeated herein for the sake of brevity. Union

of India craves permission to place additional

material before this Hon'ble Court if required.

3. It is submitted that the present affidavit is being filed in

response to the report submitted by five members of

the Technical Expert Committee (TEC) constituted

by this Hon'ble Court vide order dated 10thMay 2012

to provide technical advice to this Court, on matters

related to field trials of Genetically Modified (GM)

crops and the separate report by Dr. R.S. Paroda,

Member, TEC, specifically appointed by this Hon'ble

Court vide order dated November 9, 2012.

I. BACKGROUND


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4. It is submitted that the above Writ Petition was filed by the Petitioner

seeking to put in place a protocol that shall mandate the sound

scientific examination of all relevant aspects of bio safety, before each

genetically modified organism (GMO) is sought to be approved and

released into the environment.

The Petitioner has repeatedly sought for a moratorium on release

of any GMOs into the environment pending a comprehensive,

transparent and rigorous bio safety protocol in the public domain

conducted by independent expert bodies. The petitioners have called

for a moratorium, for GM products on the grounds that there is a need

to put in place (i) comprehensive protocols for bio safety study, (ii) a

review of the biosafety study by independent experts, (Hi) a

mechanism for public consultation/public hearing, and (iv) a

mechanism for mandatory labeling.

5. Detailed responses to the above issues have been filed by the Union of

India. The matter pertaining to IA No. 25 in the said Writ Petition

came up for hearing on 7thOctober 2009 and 19

thJanuary 2010


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wherein this Hon'bie Court directed the Union of India to file its

response on whether (i) field trials of GM plants can be done in Green

House and (ii) the rules framed for these experiments are adequate.

Response of the Union of India was filed on 18thMarch 2010 and 27th

April 2010 confirming that proper expression of the plant phenotype

and genotype is possible only in natural field conditions

and therefore field trials are a must. Guidelines and standard operating

procedures (SOP) prescribed for conduct of field trials are as per

international norm and are adequate

6. It is submitted that this Hon'bie Court recognizing that matters relating

to modern biotechnology are highly technical in nature-directed to set

up a "Technical Expert Committee" to advise the court on issues related

to GM crop field trials and bio safety assessment.

7. The Hon'bie Supreme Court had constituted a Technical Expert

Committee by an order dated 10th May 2012 to address issues

relating to GM crop


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field trials and other related issues. The committee comprised of the

following members:

(i) Prof. V.L. Chopra, President, National Academy of Agricultural

Sciences (NASC)

(ii) Dr Imran Siddiqi, Scientist & Group Leader, Centre for Cellular &

Molecular Biology

(iii) Prof. P.S. Ramakrishnan, Emeritus Professor Jawaharlal Nehru

University

(iv) Prof. P.C. Kesavan, Emeritus Professor, IGNOU

Distinguished Fellow, MSSRF, Chennai.

(v) Dr. B. Sivakumar, Former Director, National Institute of Nutrition

(NIN)

(vi) Dr. P. S. Chauhan, Formerly, ICMR Emeritus Medical Scientist and

Retd. Head, Cell Biology Division, BARC

The Terms of Reference (TOR) of the committee as assigned by Hon'ble

Supreme Court were as under:

a) To review and recommend the nature ofsequencing of

risk assessment (environment and health safety) studies that need to be

done


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e) Examine the feasibility of prescribing validated

protocols and active testing for contamination at

a level that would preclude any escaped

material from causing an adverse effect on the

environment.

f) To advise on whether institutions/laboratories in

India have the state-of-art testing facilities and

professional expertise to conduct various bio

safety tests and recommend mechanism to

strengthen the same. If no such institutions are

available in India, recommend setting up an

independent testing laboratory/institution.

The court also directed that 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:


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"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 protocol should be

followed and conditions, if any, that may be imposed by the Court

for implementation of open field trials.!l

8. The TEC submitted its interim report on October 9,

2012

9. It is placed on record that the interim report of TEC was examined by

UOI and it was submitted to the Hon'bie Supreme Court that "the

report, was scientifically flawed, did not address the TOR and had not

only exceeded the mandate assigned to TEC but is also outside the

scope of the Writ Petition itself and therefore merited outright

rejection".

10. It is further brought on record that Hon'bie Supreme Court after

perusing the submissions by respondents, ordered that the objections

filed by the


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respondents, interested parties and Government of India be referred to

the TEC for consideration.

The Court also noted the contentions raised by the representatives of

respondents that a person from the field of Agriculture and Plant

Genetic Resources should also be included as a member of the TEC.

Having considered various aspects and with consent of the parties, the

Hon'ble Supreme Court had appointed Dr. Rajendra Singh Paroda as a

member of the TEC. The Court also directed that all the parties to

approach the TEC by filing written objections.

11. In accordance with the above order, UOI submitted its objections to all

the six members of TEC.

12. After period of nine months, UOI learnt that instead of one report by the

TEC, two different reports have been submitted to the Hon'ble Supreme

Court, one by five members of the TEC and a separate report by Dr.

R.S. Paroda, Member, TEC. The report by five members of TEC was

submitted to the Hon'ble


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members of TEC is merely an extension of the interim report,

ignoring submissions of respondents or concerns expressed by the

sixth member. Further, the Hon'ble Supreme Court has been

misled by placing recommendations of sixth member as

Annexure-IS to the five members of TEC report, without inclusion of his

views in the main body of the report. In fact, the report was not even

shared with the sixth member.

17. Divergent views in the two reports: it is submitted that both the reports

have given a wide range of suggestions for improvement in current

regulatory mechanisms. The key difference being that white the report

of five members of the TEC suggests stopping all the field trials till

such systems are implemented, the report by the sixth member, Dr.

R.S. Paroda acknowledges that current systems are sufficient to take

care of the existing regulatory requirements, but need to be

strengthened on a continuous basis ' taking into account global

advances.


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18. Acceptance of necessity of field trials in both reports: Both the reports

have accepted the need for field trials. The Uol's contention that

greenhouse trials cannot replace field trials has been accepted in both

the reports which only underscores the fact that field trials are

necessary to generate bio safety data.

19. Suggestions for improvement in existing regulatory system: The UOI

firmly believes that the present system of regulating field trials and

safeguards employed for conduct of such trials are science based,

robust and comparable to international best practices. Moreover,

improvement in regulatory system is a dynamic process based on

advances in science. UOI is committed to continuously follow and

update regulatory oversight based on scientific advancement but

without halting the research and development in the country. It is

submitted that any recommendations to improve regulatory oversight

merit consideration and UOI is not opposed to the same. However,

there is no basis to accept


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recommendation for halting field trials on the pretext of improvements in

regulatory mechanism as suggested by the five members of TEC.

20. Non-existent distinction between trials for research vs.

commercialization: Five members of TEC have presented a

non-existent distinction between conduct of field trials for research and

trials for commercial release, it is submitted that any research itself is

initiated with the ultimate aim of commercial use for the benefit of

society and farmers. Whether or not a GM crop is fit for commercial

release is a decision that will depend on the outcome of the research and

therefore there are no separate trials for research or commercialization.

The suggestion of the five members of TEC that the field trials must be

for research only and not for commercial release reflects unscientific

approach of five members of TEC and demonstrates that they have

arrived at such conclusion about the outcome of the research possibly

with a closed mind.The entire purpose of the field trials is to study the

performance of the GM crop under Indian


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conditions, its impact on the surroundings and the feasibility for its

release.

21. incomplete response to TOR by five members of TEC: Even though

this was a final report, five members of the TEC have responded to

only A-D, where they have taken a strong position and have refrained

from commenting on remaining TORs despite taking over a year to

prepare the report. This is despite the fact that UO! and other

respondents had given their views on all the TORs. On the other hand,

Dr. R.S. Paroda has provided responses on all the TORs.

22. Basis of two reports: An in-depth analysis of the two reports clearly

indicates that while the report by five members of the TEC is based on

selected reports and references, socio-economic issues, examination

of dossiers, and features of Norwegian system of regulation, Dr.

Paroda's report is based on scientific principles, current situation in

India, regulatory framework in other countries and internationally

accepted practices.


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23. Socio-economic evaluation taken as basis for suggesting nature and

sequence of testing: Regarding the nature and sequence of testing

required prior to permitting field trials (TOR A & B), the five members of

TEC have repeatedly commented on issues such as need,

sustainability, generation of employment and other socioeconomic

considerations. This is in contrast to advising on scientific issues such

as safety for which the TEC was set up. Socio-economic

considerations are outside the terms of reference defined by the

Hon'ble Supreme Court and also not the area of expertise of the TEC

members. It is submitted that there is no example in any country with a

functional regulatory system, wherein such issues are addressed at

early stages of research or prior to permitting confined field trials.

Socioeconomic assessment is applicable only when safety and

efficacy is proven and the product is being considered for release.

Further, assessment of socio-economic concerns is a policy matter and

is within the exclusive domain of the Government.


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24. Selective reliance on only parts of documents / dossiers: Five members

of TEC have pointed out gaps in the regulatory system on the basis of

examination of safety dossiers/documents of already approved GM

crops in the country. These safety dossiers are sets of documents

submitted by the applicant containing the information/data generated

by them in field trials and laboratory experiments during the process of

development of a GM crop. These dossiers are analyzed threadbare

by subject specific members of regulatory committees in a long drawn

process involving a series of meetings. However, the five members of

TEC have undertaken a cursory review of limited documents and

quoted selective examples to make their recommendations to stop

research in agricultural biotechnology and approval of GM crops. It is

interesting to note that they have not done a detailed review, rather

picked up certain examples which are illustrative and not

comprehensive. Particular documents within dossiers and in some

cases, particular parts of


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documents have been extracted and selectively relied on by the TEC

without reference to the context and surrounding information in which

they appear and without taking note of other balancing considerations.

25. Citing controversial reports such as the

International Assessment of Agricultural Science and

Technology for Development (IAASTD) report in place of national

policy documents: Repeated references have been made to IAASTD

report, which was a study initiated in 2002 by the World Bank and the

FAO as a global process to determine whether an International

Assessment of Agricultural Knowledge, Science and Technology

Development was needed. The report referred to as IAASTD report

covers a wide range of issues relating to reduction of hunger and

poverty, improvement of rural livelihoods and human health, equitable,

socially, environmentally and economically sustainable development

and a set of cross cutting themes including bio technology. The section

on biotechnology with


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particular reference to modern biotechnology has been one of the

contentious issues while formulating the 1AASTD report, in fact, the

countries at the forefront of biotechnology and embracing agricultural

biotechnology in a big way viz. USA, Canada and Australia had

expressed their serious reservations on these recommendations.

There is no example of any country, having predominance of

agriculture, putting ban on conduct of field trials or open field research

of GM crops, as a follow up of recommendations of iAASTD.

26. Recommendations for additional studies not scientifically tenable: Both

the reports have emphasized on testing as per the guidelines of Codex

Alimentarius Commission (CAC), a body established by FAO and WHO

for health issues and the Cartagena Protocol on Bio safety, an

international agreement for environmental issues. UOI is an active

participant under the programmes on GMOs under both these foras

and is committed to compliance of their recommendations. However,

the five members of TEC have not correctly


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represented the facts and recommended additional tests based on

perception rather than scientific analysis. For example, the long term

and transgenerational toxicity studies have been recommended for all

GE crops whereas requirement of such studies has been suggested by

Dr. Paroda, based on international consensus document to be

undertaken on a case by case basis taking into account the

characteristics of the genetic modification, new proteins being

expressed, etc.

27. Over-emphasis on the Norway model which has no similarity with

India: Further, the five members of TEC have suggested formulating a

regulatory framework on the Norwegian mode! ignoring the fact that

agricultural situation and policies of Norway are in no way comparable

to Indian conditions. Norway is one of wealthiest nations of the world

with no concerns relating to food security. The contribution of

agriculture to the GDP of Norway is only 2%. Further, it has no

expertise or experience


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in safety assessment of GMOs, as it has never approved a GM crop.

28. Sweeping ban instead of case-by-case assessment: It is also

submitted that UOI is concerned about the moratorium suggested for

certain classes of GM crops, namely Bt food crops, HT crops and crops

for which India is a centre of origin or diversity, based on concerns

such as health safety, socio-economic considerations, gene flow, etc.

Such recommendations are not only beyond the mandate of the TEC,

but are also based on selected reports and references, which are

scientifically flawed. It is internationally accepted norm that each GM

crop requires a case by case safety assessment in view of specific

scientific considerations involved and thus sweeping recommendations

for classes of products are not scientifically tenable. It is submitted that

Bt and HT are globally the most cultivated traits and the countries that

have adopted these crops have benefitted enormously.


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29. International trends and wealth of data ignored: In

response to the health safety concerns on Bt food

crops, it is submitted that food safety status of

several Bt food crops has been extensively

established in both the peer reviewed scientific

literature and more importantly by regulatory

authorities in 13 countries plus European Union. The

considerations quoted for banning HT crops are

absolutely irrelevant and do not keep in mind

present day realities of agriculture sector in India.

30. Implementing suggestions for strengthening the

conduct of field trials: Both the reports have given

suggestions such as setting up dedicated Risk

Assessment Unit (RAU), creating notified field trial

sites, strengthening the monitoring system (TOR-D)

etc. Similar suggestions have been given by the

Scientific Advisory Committee to the Prime Minister.

UOl is committed to implement all such suggestions

with the involvement of network of institutions and

subject specific experts across the country.


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31 Steps taken by UOI to strengthen regulatory

mechanisms: The UOI also submits that,

independent of the recommendations of TEC, it has

proactively taken several steps to strengthen the

regulatory oversight of GM crops including setting

up specific Task Forces in 2004, introduction of

Biotechnology Regulatory Authority of India Bill, etc.

The concerned ministries/ departments of UOI have

been regularly taking steps to update consultative

processes at the national level and taking, account

of recommendations by international organizations

such as FAO, WHO, OECD etc. in fact, this has

been acknowledged in both the reports.

32. Implications of accepting the TEC

recommendations: It is submitted that the most

immediate and negative effect of accepting

recommendations to halt the process of field trials

or moratorium on any class of products, will be on

agricultural biotechnology research for India's own

public and home grown private sector institutions.

Further, such suggestions will lead to

isolating


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leading scientists in this sector whose skills have been built with

painstaking efforts and large investment besides discouraging and

demoralizing the young researchers who would like to take up research

in plant biotechnology. Once the existing talent leaves the country to

pursue careers in other jurisdictions, it will no longer be possible for

India to resume research from where it left off after a few years when

the suggestions of five members of TEC for strengthening the

regulatory mechanism are fully implemented. The cascading effects of

putting such road blocks will push India behind in terms of technology

and the knowledge gaps would eventually force India to eventually

import technology and even food grain by paying much higher price

from developed countries. It is thus important to maintain trust in our

scientists who are well aware of the social realities in this country and

have effectively used -scientific advances to meet ever growing

challenges in agriculture.

33. In view of the above facts and taking into account highly scientific,

technical and evolving nature of


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biotechnology regulations, the UOl commits to

strengthen the regulatory processes by employing the

best global practices also taking into account

recommendations of the two reports. DETAILED

SUBMISSION

34. The UOl has examined both the reports with respect to

process of preparation, consideration of views of

various stakeholders, rationale used and

recommendations. It is submitted that UOl has strong

reservations on the process followed and basis of

recommendations by five members of TEC, which

have been elaborated in Annex-R-1(124-1441 with

supporting Annexes 1A-1G. The key concerns are as

under:

Procedure for conducting meetings, and for

recording their minutes/evidence was neither

transparent nor objective (Annex R1A (pages

145-163) & R1B (pages 164-179)

Objections by respondents were not considered

(Annex 1C(180). On the other hand, responses

have been selectively picked to justify

preconceived views


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Deliberations of the TEC appear to be non-inclusive and

non-participatory as is evident from the fact that the final report, by five

members of TEC was not shared with sixth member specifically

appointed by the Hon'ble Supreme Court. On the contrary, it has been

incorrectly indicated that Dr. Paroda, the sixth member was not available

for signing the final report (Annex-ID (pages : 81-184).

The five members of TEC continue to rely on selected reports and

references, which are not only scientifically flawed but are also outside

the scope of the TOR.

Selective review of dossiers has been made the basis for making

sweeping recommendations to stop research in agricultural

biotechnology and approval of GM crops rather than identifying areas

where guidelines needs to be strengthened(Annex 1E (pages :

185-203).

Changes have been made in the final report by way of corrigenda to

make the recommendations further restrictive without any scientific basis

and explanation (Annex 1G (pages 211-217).


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It is submitted that Annex-1 and supporting Annexes 1A-1G may be

considered as part of the affidavit.

35. While UOl has the reservation expressed above, UOI is fully committed

to move forward with an inclusive approach to strengthen the

regulatory system on a case by case basis to ensure highest standards

of safety in research , field trials and safe use of GM crops. It is

submitted that on some issues, there are recommendations common to

both reports, whereas on others there is a difference of opinion. Both

the reports have identified the need for strengthening the regulatory

mechanisms. There is also convergence of views on the fact that field

trials are an integral part of research - and development and are

necessary to generate data on the efficacy, stability and agronomic

valuation of a GM crop. However, the areas of most serious divergence

between the two reports concern (a) whether or not confined field trials

(CFTs)be allowed until all recommendations are implemented and (b)

whether or not there ought to be a moratorium on


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It is submitted that Annex-1 and supporting Annexes 1A-1G may be

considered as part of the affidavit.

35. While UOI has the reservation expressed above, UOl is fully committed

to move forward with an inclusive approach to strengthen the

regulatory system on a case by case basis to ensure highest standards

of safety in research , field trials and safe use of GM crops, it is

submitted that on some issues, there are recommendations common to

both reports, whereas on others there is a difference of opinion. Both

the reports have identified the need for strengthening the regulatory

mechanisms. There is also convergence of views on the fact that field

trials are an integral part of research and development and are

necessary to generate data on the efficacy, stability and agronomic

valuation of a GM crop. However, the areas of most serious divergence

between the two reports concern (a) whether or not confined field trials

(CFTs) be allowed until all recommendations are implemented and (b)

whether or not there ought to be a moratorium on


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certain classes of transgenics (Bt food crops,HT crops andcrops for

which India is a center of origin/diversity). It may be noted that some of

the recommendations go beyond the scope of the TORs into the realm

of policy and call for decisions best left to the regulatory system or

policy enacted by the Union or State Governments.

38. The UOl's views on each of the key recommendations contained in

both the reports have been provided in paragraphs 20 to 22 below;

whereas the UOI's views on recommendations/issues raised outside

the scope of TOR have been provided inparagraphs 23.

II. RECOMMENDATIONS BY TEC SN TWO REPORTS AND VIEWS

OF UOS

37. It is submitted that UOI has specifically reviewed the recommendations

by Dr. R.S. Paroda, member, TEC and by five members of TEC with

respect to their scientific validity, relevance to Indian regulatory

requirements and the practicability. The said


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recommendations along with the views of UOI are set out below.

38. RECOMMENDATIONS COMMON TO BOTHTHEREPORTS

TOR A To review and recommend the nature of

sequencing of risk assessment (environment and health

safety) studies that need to be done for ail GM crops

before they are released into the environment.

1. Recommendation by 5 Recommendation by Dr.

TEC members Paroda

Risk Assessment (RA) Development of

procedure to follow the comprehensive guidelines

Flowchart for the Risk for Environmental Risk

Assessment Process in Assessment (ERA) should

the Guidance for Risk be undertaken on priority

Assessment of living with consultation with all

modified organisms stakeholders and general

(LMOs) of

the Cartagena Protocol

on Biosafety

(CPB), particularly

keeping in

public


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technology, etc., and to facilitate structured approach

for ERA, DBT, MOEF and ICAR have already set up a

committee for the preparation of ERA guidance. The

work of the committee shall be finalized in

consultative process.

The Flowchart for the Risk Assessment Process in

the Guidance for Risk Assessment of LMOs of the

Cartagena Protocoi on Biosafety (CPB) is basically a

scoping exercise to determine the case specific TOR

for ERA.Presently the RA document under CPB is

under negotiation and when adopted by the Conference

of the Parties serving as the meeting of theParties to the

Protocol (COP-MOP) will be binding on India as it is a

Party to the Protocol.

2 Recommendation by 5 Recommendation by Dr.

TEC members Paroda

A secretariat comprising A full time RAU

with

of dedicated scientists permanent staff comprising

with area expertise as of multi-disciplinary team of

well as expertise in scientists shouldbe

biosafety should be established.


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established. This should

be in collaboration with

Norway. The regulatory

body shouid have

area-wise

subcommittees/expert

groups.

Comments of Uol:

As a follow up of recommendations by Scientific

Advisory Council of Prime Minister on Biotechnology

and Agriculture (SAC-PM) (placed at Annex-2 (Page

218-226) to establish a Biotechnology Regulatory

Secretariat with high level of scientific and technical

trained manpower to support RCGM and GEAC, DBT

has already initiated the process of setting up a non-

statutory body or RAU to assist in the above functions.

The same has been approved by the Planning

Commission as part of 12th Plan and the

implementation process is underway.

Regarding collaboration with Norway, it is submitted


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established. This should

be in collaboration with

Norway. The regulatory

body should have

area-wise

subcommittees/expert

groups.

Comments of Uol:

As a follow up of recommendations by Scientific

Advisory Council of Prime Minister on Biotechnology

and Agriculture (SAC-PM) (placed at Annex-2 (Page

218-226) to establish a Biotechnology Regulatory

Secretariat with high level of scientific and technical

trained manpower to support RCGM and GEAC, DBT

has already initiated the process of setting up a non-

statutory body or RAU to assist in the above functions.

The same has been approved by the Planning

Commission as part of 12th Plan and the

implementation process is underway.[Annex,R-3 (227-

228)

Regarding collaboration with Norway, it is submitted


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that several bilateral cooperation initiatives are in

place with various countries for sharing and -exchange

of information including with Norway for setting up of

Centre for Biodiversity Policy and Law (CEBPOL)

though National Biodiversity Authority (NBA).

Biosafety issues are also part of work plan.

It is also submitted that UOl also has access to

international developments in regulatory issues

through regular participation in international forums

such as CODEX Commission of FAO

and WHO; Cartagena Protocol on Biosafety and

capacity building programmes of UN Environmental

Programme Global Environment Fund (UNEP-GEF).

Thus, the Indian regulatory system takes into account

at best international practices from all sources and

adopts them through consultative processes as

required.


TEC members Paroda


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The signing of Confidentiality Agreement regarding

non-disclosure and avoiding any conflict of interest by

qualified scientific experts/ members of various

disciplines is mandatory for ail members of RCGM/

GEAC.

In the existing regulatory system, the apex regulatory

body i.e. GEAC is already located in MoEF. It has

representation from ail concerned Ministries including

Ministry of Health and Family Welfare. GEAC is

supported by other departments and agencies on

case by case basis. UOI reiterates its stand that the

various ministries and government perform their

duties as per Allocation of Business. In any case, it is

the ministries or departments with relevant expertise

can only deal with the subject area.

Further, it is envisaged that setting up a dedicated

RAU complemented with maintaining a roster of

experts in multi-disciplinary areas including pre and

post release monitoring would be adequate to

address this issue.

TOR C: To advice on. whether a proper evaluation of the


41/128

genetically engineered crop/plants is scientifically tenable

in the green house conditions and whether it is possible to

replicate the conditions for testing under different agro-

ecological regions and seasons in greenhouse?


TEC members Paroda

Not generally possible Proper evaluation of a GE

to replicate the plant is scientifically not

conditions of . testing tenable in a contained

under different agro- green house. Confined field

ecological zones in the testing, as under the

greenhouse.present system, is the right

option for a

realistic evaluation of any GE

Comments of Uol:

UoI's contention that greenhouse trials cannot replace field

trials have been accepted in both the reports which only

underscores the fact that field trials are necessary to generate

biosafety data.

TOR DTo advice on whether specific conditions imposed


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by the regulatory agencies for Open Field Trials are

adequate. If not, recommend what additional

measures/safeguards are required to prevent potential

risks to the environment.


TEC members Paroda

Specific sites for field In consultation with ICAR,

trials should be RCGM and GEAC should

designated, develop a system of

certified. The sites could notification of CFT sites

be in ICAR institutes or located in different agro-

SAUs and required ecological zones within

conditions for isolation public sector and/or private

shouid be established sector institutions/facilities,

and supported meeting the specified

appropriately by ICAR.

Sites in ' company

premises may also be

considered, provided the

land is permanently owned

by tester/applicant.

conditions. No trials on

non-notified fields.


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S Recommendation of 5 Comments of Uol

No. Members of TEC

risk characterization; are developed through

and mitigation options.extensive stakeholder's

consultation.

As per the existing practice, the

applicant submits the

application along with the

information pertaining to the

GM product, purpose,

experimental design, protocols,

all existing data about the

product at national and global

level etc. to the Institutional

Biosafety Committee (which is

the statutory committee

constituted by institutions

involved in recombinant DNA

research as per Rules 1989 of

Environmental Protection


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s. Recommendation of 5 Comments of Uol

No. Members of TEC

Act 1986) for risk

assessment and

approval.AII scrutinized

cases for conducting

confined field triais on GE

crops are recommended by

IBSC to RCGM/GEAC for

further consideration and risk

assessment. For details of

scoping of hazard

identification etc., of risk

assessment Annex-R-4

(pages-229-231) can be

seen.

Further, meaningful

consultation can take place

only if it is supported by

adequate scientific data

which would include ex-ante

socio-economic assessment.

As scientific


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No. Members of TEC

data

on biosafety/agronomic

performance etc. can

be generated only

through' field trials,

preliminary consultation

and, need

assessment should not be

a pre-requisite for a field

trial. The focus should be

on a robust

monitoring mechanism

to ensure compliance

with stringent norms

prescribed by the

2 if a GMO is initiallyAssessing the commercial

declared for research viability of a product is part

and later it is desired to of researchand

commercialize it, treat it development. However,

as a fresh application. authorization

for commercial use is


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No. Members of TEC

to existing acts/rules of the

government (Central and

State).

Research and deveiopment

of GM crops follows a five

stage process right from

identification of gene of

interest,transformation in the

laboratory, green house

research, field trials for

confirmation of stability,

efficacy and safety which

culminates into a decision to

allow the commercial release

of GM crops or not.

In view of a staged safety

assessment process several

elements are interrelated

and common to


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No. Members of TEC

both research

and commercial

application cases. Therefore

no meaningful result will

be obtained by

such segregation.

3 In the case of health Uol is committed to follow

safety, the regulator internationally harmonized

should expect a guidance - for risk

suitable response to all assessment. As mentioned

relevant paragraphs of earlier, the food safety

the Codex Alimentarius guidelines are based on

Commission (CAC) principles and guidelines

Guideline for the for Codex Al imentarius

Conduct of Food Safety Commission (CAC). The

Assessment of Foods existing safety assessment

derived from rDNA process in India takes into

Plants and any other account principles and


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No. Members of TEC

chosen risk guidelines of CAC, and has

assessment procedure.been prepared in

association with ICMR

through. consultative

process.

4 There is a need to As per the international

include chronic and best practice, the chronic

trans-generational toxicity tests are to be

toxicity testing in followed case by case and

feeding studies of cannot be generalized.

rodents based on the Codex Alimentarius

fact that food is Commission (CAC)

consumed over the Guideline for the Conduct

Entire life time and that nut of Food Safety Assessment

Ritional stress can also lea of Foods derived from

Dtoadverseor rDNA Plants is being

unintended effects over followed in all cases and if

long-term exposure. prescribed, long term

The sensitive stages of toxicity studies would be

reproduction also need conducted.


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No. Members of TEC

to be included.It is submitted that the

requirement of toxicology

studies for different GM

products is based on a

number of factors and has to be

prescribed on a case-by-case

basis. The toxicology

requirement would vary within a

group of

products also. Accordingly,

chronic toxicity studies are

not generalized

and/or transgenerational

and undertaken on a case-

by-case basis. It has

been stated in the

Codex guidelines as also in

Indian guidelines for GM

food safety that

safety


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S Recommendation of 5 Comments of UoS

No. Members of TEC

safely in food.

However in case

the expressed substance is a

non- protein that has no

history of

safe consumption, it should

be assessed on a

case-by-case basis

depending on the identity

and biological function in the

plant of the substance

and dietary exposure.

The type of studies

to be performed may

include studies on

metabolism, toxicokinetics,

sub-chronic toxicity, chronic

toxicity/carcinogenicity,

reproduction

and development

toxicity according to the

traditional


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S Recommendation of 5 Comments of UoS

No. Members of TEC

toxicological approach.

5 The regulatory process The Uol acknowledges that

should be open to new regulatory process is

scientificinformation

dynamic nature and the

that may havea

requirements vary from

bearing on therisk

time to time depending

assessment,if

upon the complexities of

necessary evenafter

technology development of

deregulation of

an

GM crop, and science of

event.safety assessment. lt is

understood that such

decisions are to be based on

emerging consensus among

scientists and not to individual

studies/papers/opinions.

6 The applicant is responsi It is being strictly followed

Ble for providing to

the regulator. all

information that has a

in the existing system.
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OB

Recommendation of 5 Comments of Uo!

No. Members of TEC

intended

for commercialization (not

State Governments.

research) until there is The food safety status of Bt

more definitive crops is based on the

information from safety of the novel

sufficient number of expressed protein, Cry 1 Ac

studies as to the long which has been

term safety of Bt in food exhaustively established in

crops.both the peer-reviewed

literature and, more

importantly, by regulatory

authorities in 13 countries plus

the European Union.

As regards insufficient

information on the long

term safety of Bt in food crops, it

is submitted that as per a

recent scientific review by

Agnes E. Ricroch (2013) and

Chelsea Snell


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s. Recommendation of 5 Comments of UoS

No. Members of TEC

(2012) published

in international

journals enclosed at

Annex-R-5 (pages 232

-237) and

Annex-R-6(238-252),

globally, 17

long-term animal feeding

studies ((of more than 90

days, up to 2 years in

duration) as well as 18

multigenerational studies

(from 2 to 5

generations) have

been conducted on animals

such quail, poultry, cows,

pigs, goats sheep,

rabbits, rats and mice

feeding them with Bt

maize and in one case

Bt rice on


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5> Recommendation of 5 Comments of UoS

No. Members of TEC

,..

histological examination of

specific organs, hematology

and the detection of

transgenic DNA. Results

from all the studies do not

suggest any health hazards

and, in general and have no

biological or toxicological

significance.

As per the statistics

published by US Corn

growers association, about

35 metric million tonnes of

predominantly GM corn is

consumed as food and food

ingredients in form of, High

Fructose Corn syrup: 14

MMT;sweeteners: 7 MMT;

Starch: 8 MMT;Cereal/

Others: 5


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No. Members of TEC

MMT (includes corn flakes/

nachos/ tortilla/ chips etc); and

beverage/ Alcohol: 3

MMT.Another 139 million

metric tonnes goes for the

Feed industry as direct feed or

in feed ingredients.

While the proportion of total

Corn output that goes in to the

feed industry in US may be

higher; in absolute terms the

usage of Corn as food or as

food ingredient in US is 35

million metric tonnes which is

75% more than what the

whole of India produced in

2012 (around

14 million tonnes). (Annex-

7 (pages 263-261)

The distinction created by


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No. Members of TEC

five members of TEC

regarding food vs. non food

crops or research vs.

commercialization are not

relevant as the non-food

crops like cotton, castor, etc.

referred to in the TEC report,

also enter the food chain and

therefore safety assessment

process are rigorous for all

crops in view of stringent

guidelines in place,

commitment to further

strengthen the existing

regulatory mechanisms and

the evidence provided by

long term toxicity studies, the

recommendation cannot be

accepted.


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s, Recommendation of 5 Comments of Uol

No. Members of TEC

It is also submitted that

waiting for so called sufficient

number of studies in other

countries instead of

remaining at the cutting edge

of scientific research would

put us back several years

and would make us

dependent to the West for

research and development

and eventually for food

security itself. Once the

existing talent leaves the

country to pursue R&D in

other jurisdictions, it will no

longer be possible for India to

resume research in a few

years from where it left off.

8 HT crops would most This is beyond the scope of

likely exert ahighly

the TOR and calls for a


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No. Members of TEC

adverse impact over judgment best left to the

time on sustainable

agriculture, rural

regulatory system.

livelihoods, and Regarding suitability of HT

environment. The TEC GM crops inIndian

finds them completely conditions, it is submitted

unsuitable in the Indian that the current practices of

context.weed control

through manual/

mechanical methods,

though effective, have

certain limitations such

as unavailability of

labour during the

peak period, high

labour cost, involves

drudgery largely to women,

unfavourable environment

particularly in rainy season

etc. Most of the weeding

operations around the


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No. Members of TEC

have emerged. But the damage to

the crop is already done and the

total efficiency of the crop reduces

drastically.

In addition, the manual labour

traditionally being employed for

weeding is gradually becoming

scarce and expensive owing to

rapid urbanization and

industrialization. As per the

Directorate of Weed Science

Research, by the year 2020,

nearly 50 per cent of the

population would be living in

urban areas, creating

unprecedented shortage of labour

force for use in


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Recommendation of 5 Comments of Uol

No. Members of TEC

agriculture. Therefore,

in future, management

of weeds through

improved technologies

involving herbicides and

improved weeding tools

will attain more significance

which will result in l abour

cost saving, better and

timely weed control and

increased food production

besides promoting gender

equality and reducing

human drudgery. The labour

saved through

adoption of improved

weed management

practices, can be utilized in

other related and more

productive rural enterprises

such as livestock


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No. Members of TEC

fishery,

mushroom cultivation,

sericulture, bee keeping etc.

which would yield greater

income. This will also raise

the esteem of rural women.

Further it is submitted that

more than a dozen

herbicides are extensively

used in agriculture even

without any HT-GM crop

since decades. HT GM crop

is only a value addition to

increase the effectiveness of

these herbicides. The area

under cultivation globally to

the extent of 100 million

hectares in 2012 is clear

indication of significant


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No. Members of TEC

benefits of using such crops in

the countries where HT crops

have been adopted.

10 The release of a GM The release of a GM crop

crop into its area of into the area of origin or

origin or diversity has diversity does not

far greater ramifications necessarily lead to gene

and potential for contamination or loss of

negative impact than for other

species. To justify

diversity.

this, there needs to be Phenomena of gene flow

extraordinarily which depends on the

compelling reasons and extent of pollination and

only when other choices presence of related species

are not available. are not specific to GM

Therefore release of crop. In spite of that,

GM crops for which diversity among crops of

India is a centre of the same species is

origin or diversity maintained for 100 of years


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No. Members of TEC

should not be allowed. which is a testimony to the

fact that there are natural

barriers which do not allow

pollination of the. related

species.

Accordingly these factors

are taken into consideration

while prescribing ERA

studies. Even the CPB does

not impose any ban or

restriction on release of GM

crops in the centre of

origin/diversity. It only

emphasizes the need for

special attention during the

problem formulation stage of

the ERA.

It is important to understand

that the basic


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s.No. Recommendation of 5

Members of TEC

Comments of Uoi

principle of

safety assessment process

is to establish

comparative safety of a GM

crop with respect to its

non GM counterpart and

once the same is

established, it is as safe or

unsafe for release in "centre

of origin" as its non GM

counterpart. It is submitted

that a case by case

approach will be

followed in all such cases in

accordance with the best

TOR B To recommend the sequencing of these tests in

order to specify the point at which environmental

release though Open Field Trials can be permitted.

11

The sequence of testing

should be carried out in

in accordance with

the principles of ERA, this


69/128

o. Recommendation of 5 Comments of Uol

No. Members of TEC

order of

increasing environmental

exposure required to

perform the test. Tests

should be done

under the

minimum conditions of

exposure required

for the test.

already in practice.

12Certain minimum tests

should be ossible to

Accepted.

undertake under The minimum tests are

contained conditions, recommended on a case-

before GMOs are first by-case basis in the

taken out of existing process.At each

containment. Tests to stage of GM crop

be performed under development, beginning

containment may be with the laboratory and

judged by regulator on green house tests and

a case-vise basis.trials; the safety, efficacy and

stability of the inserted


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No. Members of TEC

gene is evaluated before a

decision to allow field trials

is taken.

13Where appropriate and

necessary, tests such

as for genera! growth

characteristics and plant

habit as part of event

selections may be

performed under

confined conditions in

consultation with the

regulator.

Already in practice.

TOR E Examine the feasibility of prescribing validated

protocols and active testing for contamination at a

level that would preclude any escaped material from

causing an adverse effect on the environment

14 Tests for detecting No clear recommendation


71/128

s. Recommendation of 6 Comments of Uoi

No. Members of TEC

contamination at the

stipulated level (0.01%)

offered.

are possible and have UOi has already submitted

been demonstrated in in the court to do away with

some of thedossiers.lt the requirement of 0.01%

should be emphasized LOD at the time of CFTs.

that these in Contamination is an issue

themselves do not at the time of

preclude material from commercialization and the

escaping.

Trade implications duesame is included as part of final

approval requirements.

to export losses is an It is accepted that tests for

area of concerndetecting contamination at the

level of (0.01%) is possible.

However, this is a trade related

issue for the purpose of

labeling and applicable at the

time of commercialization /export.

The level of
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detection is arbitrary and

country specific; varying from

0.9% in EU to 5% in Japan.

Harmonized approaches for identity

preservation in agricultural

commodities especially premium

export commodities is not new and

can be done without

impacting trade.

TOR F To advise on whether Institutions/laboratories

in India have the state-of-art testing facilities and

professional expertise to conduct various biosafety

tests and recommend mechanism to strengthen the

same. If no such institutions are available in India,,

recommend setting up an independent testing

laboratory/institution.

15 It is very difficult and Nospecific


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No. Members of TEC

beyond the scope of the

report to comment

recommendations.

comprehensively on the It is submitted that there an

various institutions and already 21 private and si:

laboratories in India public sector organization:

with regard to facilities engaged in biosafety testing

and professional These laboratories an

expertise. This would accredited by one or the

require detailed review other authorized agencies:

of institutions such as ISO, NABL and GLf

themselves.systems.

Additional capacity through

network of laboratories with a

specialized notification system

would be put in place during the 12th

Plan of DB" under EPA (1986).

16 Deeper understanding Will be considered, as

of the process of risk capacity building is an

assessment may be ongoing activity which

developed through needs to keep pace with


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No. Members of TEC

consultation, scientific advancement. We

collaboration and may be opento

capacity building India collaboration on specific

should consider issues with other countries,

collaboration with among which we may

Norway experts in the consider Norway as one

same lines as Norway and

South Africa for

option.

developing a strong It is submitted that UoI has

and state-of-the-art access to international

biosafety regulatory systems of regulations

system.through its interactions and

participation in international

forums e.g. for in

food safety assessment,

Indian delegates participate

in meetings.

Under United

Nations Environment

Programme (UNEP). Ministry

of


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s. Recommendation of 5 Comments of UoI

No. Members of TEC

Environment and Forests (

MOEF) being the nodal

agency has

been implementing

capacity building programmes

since last decade on

biosafety including

safety assessment The

UNEP-GEF(Global

Environment Fund) Biosafety

projects aim to implement the

strategy by assisting

countries to establish

NBFs,

promoting information sharing

and collaboration, especially at

the regional and

sub-regional levels.

Finally, the respondent

ministries/ departments


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No. Members of TEC

have several protocols of

bilateral cooperation

initiatives with various

countries for sharing and

exchange of information

including one such initiative

with Norway for setting up of

Centre for Biodiversity Policy

and Law (CEBPOL) though

National Biodiversity

Authority (NBA). Biosafety

issues are also part of the

work plan.

Therefore, it is clarified that

Uol is committed to

incorporate international

best practices tailored to the

requirements ofthe country

and it is not advisable to

depend on a


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S. Recommendation of 5 Comments of UoI

No. Members of TEC

single regulatory system.

39. RECOMMENDATIONS THAT ARE SPECIFIC TO DR.

PARODA'S REPORT.

S, Recommendation by Comments of Uol

No. Dr. Paroda

TOR A To review, and recommend the nature of

sequencing of risk assessment (environment and health

safety) studies that need to be done for all GM crops

before they are released into the environment.

1 The sequence of The Guidance document

studies in "Guidance for has been developed by

Information/Data RCGM/ GEAC through

Generation and extensive stakeholder

Documentation for consultation which is in

Safety Assessment of line with the latest OECD

Regulated, Geneticaliy

Engineered (GE)

and CODEX guidelines.

Piants" should be Even though formal

formally adopted by approval is pending due to

RCGM and GEAC.administrative reasons, the data

generation in all the


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s. Recommendation by Comments of UoI

No. Dr. Paroda

applications as per the

Guidance Document is in

practice.

2 The sequence of Updating at regular

studies presented in intervals of Guidelines of

"Guidance for ail types matching with GM

Information/Data technological innovations

Generation and and tools of scientific

Documentation for biosafety is

an

Safety Assessment of international best practice

Regulated, Genetically and is already being

Engineered (GE) followed by the Indian

Plants" should be

reviewed every three years

to ensure consistency

with internationally accepted

best practices and test

standards.

system.

3 After approval for The approved GM event


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s. Recommendation by Comments of Uo!

No. Dr. Paroda

commercial release is based seed is already

granted, GM crops treated at par with non-GM

should be treated like seeds under the Seed Act

their non GM

counterparts for the

purpose

of variety/hybrid release

and registration, seed

multiplication and

cultivation. IVIoA and

ICAR to play proactive role

in the three steps above.

1986,

4 National Agriculture Currently , the technical

Research System experts from NARS are

(NARS) should lead already deployed for

agronomic performance monitoring of CFTs. which

testing and release of includes reporting of

GM varieties/hybrids in parameters on agronomic

line with the National performance

orSeed Policy while unintended effects of


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s. Recommendation by Comments of Uol

No. Dr. Paroda

making use of already genetic modification. The

existing procedures system will be further

under A1CRP.strengthened by involving

concerned

Ministries/departments after

wider consultations and

reviewing the possibilities

within the existing

regulatory provisions under the

Seed Act 1966 and the

EPA 1986, etc.

5 Appropriate post The work related to post

release monitoring release monitoring is in

mechanisms have to be progress jointly through

put in place to-ensure MoEF and DBT and is part

effective of the UNEP-GEF

implementation of supported phase -ii

defined conditions as Capacity Building Project

laid out by the GEAC on Biosafety.


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s. Recommendation by Comments of Uoi

No. Dr. Paroda

during the

approval process.

TOR B To recommend the sequencing of these tests

in order to specify the point at which environmental

release though Open Field Trials can be permitted.

6 In the list of required In practice, molecular

information to obtain characterization is already

permission for confined part of application dossier

field trials (CFTs), for confined field trials.

molecular The matter will be further

characterization and reviewed and necessary

phenotypic stability amendments to the CFT

over generations be

brought

under "desirable"

category from "not

required" category.

guideline will be issued.

7Submissions

for confined field

This is already in practice.


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Recommendation by Comments of Uol

No. Dr. Paroda

must be permitted only

when they

strictly adhere to

the "Application

for confined- field trial"

and is as per

the "Guidelines and

SOPs for confined field

trials of regulated

GE Plants."

8Tests required prior to

obtaining a permit for

CFTs are:

a. Amino acid

sequence homology

comparisons to

assess the extent to

which the

transgenic protein is

similar in

Already in practice


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No. Dr. Paroda

structure

to known toxins. b.

Amino acid

sequence homology

comparisons to

assess the extent to

which the

transgenic protein is

similar in

structure to

known allergens

9It may be

desirable (and not

mandatory) to generate

data on molecular

characterization

and phenotypic

stability over

generations and

Accepted.


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No. Dr. Paroda

maximum level

of expression of

the transgenic protein

in the edible portions

of the plant.

TOR D To advise on whether specific conditions imposed

by the regulatory agencies for Open Field Trials are

adequate. If not, recommend what additional

measures/safeguards are required to prevent potential

risks to the environment.

10 Guidelines for

the Conduct of

CFTs of Regulated,

GE Plants (1998) and

Guidelines and SOPs

for CFTs (2008)

may be reviewed

to include certain

details from the 1998

Work is in progress.

11 Implementation

and

This is already in practice;


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No. Dr. Paroda

ICAR must work

hand-in-hand to

plan, coordinate and monitor

the conduct of the

CFTs as well as

improve the quality and

timeliness of

inspections by qualified

monitoring teams.

be further strengthened

13 A roster of such The roster of experts is

monitors with required already available and is

expertise needs to be

maintained and

updated regularly.

being updated regularly.

14 A schedule of site visits A schedule of site-visits of

needs to be defined BRL -I and II are usually

and followed diligently, worked out by Secretariats

including the of RCGM and GEAC

maintenance of proper, respectively. However, the


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No. Dr. Paroda

required duration of

post-harvest restrictions on

the trial site and iv)

methods for onsite/offsite

disposal of regulated GE

plants.

Procedures to be

developed immediately for

those crops for which

CFTs are already

approved.

16 Funds available to DBT Adequate Provision has

through XII Plan for already been made in the

required improvement 12thplan proposals of DBT

of regulatory system for strengthening of

including conduct and regulatory infrastructure

monitoring of CFTs and human resource

should be used for (Annex-R-3)

strengthening the

regulatory system (both

infrastructure and


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No. Dr. Paroda

of new GM events, so A1CRP system is engagedas to address the twin routinely in screening of a

objectives of variety of crop specific

environmental germplasm at various

safety/biosafety and stages of development.

agronomic Therefore, introduction of

performance. The several GM crops/events

agronomic evaluation into the AICRP trials

should be against the preceding the completion

best national check, of safety assessment is

regional check, and the not advisable to avoid

latest released potential contamination

variety/hybrid in the

state concerned.

All BRL I and BRL II trials for

generation of biosafety data

under Rules 1989 will be

conducted under the aegis of

RCGM/GEAC and not under

AICRP trials under

ICAR. Agronomic


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No. Dr. Paroda

biologist, a pathologist, experts, guidelines and

an entomologist, an criteria for selection of

agronomist, and a monitoring panel, fee to be

physiologist from the levied, guidelines for

same institution

responsible for

conducting the CFT.

evaluation, training etc.

21 An already approved The GEAC is following an

event in a new genetic event based approval

background, after its mechanism as per the

stability is verified, recommendations of the

should be evaluated Task Force on Agricultural

independently by the Biotechnology under the

AICRP protocol for Chairmanship of Prof.

agronomic performance M.S. Swaminathan.

and the expression of Accordingly, once an

the event for a period of event is declared biosafe,

two years.subsequent products

derived from conventional

backcrossing need not be again

tested for biosafety


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S Recommendation by Comments of Uol

No. Dr. Paroda

but only for agronomic

performance and trait

expression. Currently, two years

agronomic performance

data generated is mandatory

which follows AICRSP

protocols.

22 Varieties/hybrids Currently, the approved

evaluated by the above event in new genetic

process shall then be background (varieties/

approved for general hybrids) are evaluated by

cultivation by GEAC constituted

constituting a Central Standing Committee

GM-Crop Release chaired by a senior level

Committee on par with subject expert, for

the Variety Release Stability ,agronomic

Committee under the performance and the

MoA. The existing TOR expression of the event

of the Standing based on field trial data for


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No. Dr. Paroda

Committee under the a period of two years

MoEF could be conducted by State

subsumed under the TOR

of the Central

Agricultural University.

GM-Crop Release As suggested, constituting

Committee to be a Central GM-Crop

serviced by the MoA in Release Committee on par

collaboration with the with the Variety Release

MoEF. The committee Committee under the MoA

should include in place of existing

representatives from all Standing Committee

stakeholders including system shall be

farmers, socio- considered addressing

economists, NGOs, administrative and legal

private sector provisions of relevant Acts

representatives.and Rules through

consultative process with

departments/ ministries and

other stake holders associated.


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o. Recommendation by Comments of Uol

No. Dr. Pardda

human resource) as a matter of

high priority.

17 NOC from state This is a matter of policy

government not and outside the scope of

required at the CFT stage.

Permission from

TOR assigned to TEC.

state government may As suggested by the two

be sought at the time of TEC reports, notification

finai release for general mechanism forthe specific

cultivation.

field sites shall be

implemented involving

State Department of

Agriculture to suitably

address the NOC

requirement.

18 BRL I and BRL II may The first and foremost

be synchronized with >objective of GM crop

the AiCRP. An testing is to ascertain its

integrated 3-year

protocoi for joint testing

safety.


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No. Dr. Paroda

The Seed Act 1966 does not

differentiate the

mechanism for release

and notification of a GM or a

non-GM variety.The matter

will be deait as per Seed Act

1966.

23 MoA may consider Under the present

issuing a separate regulatory mechanisms it

notification on priority is not feasible. However,

for the general release as suggested, constituting

of GM crops on par a Central GM-Crop

with New Seed Policy, Release Committee on par

while legally ensuring with the Variety Release

harmonization of both Committee under the MoA

EPA under MoEF and in place of existing

the Seed Act under Standing Committee

MoA.system shall

be considered addressing

administrative and legal

provisions of relevant Acts


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No. Dr. Paroda

and Rules

through consultative process

with departments/ministries

and other stake holders

associated.

24 A well-designed case- Protocols for post release

by-case post-release monitoring would be

monitoring system must decided on a case by case

be put in place jointly basis depending on the

by the DAC, ICAR and findings of therisk

other concerned assessment during the

ministries to address

specific post-release

issues identified during the

event approval by GEAC.

event approval by GEAC.

TOR E Examine the feasibility of prescribing validated

protocols and active testing for contamination at a


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No. Dr. Paroda

level that would preclude any escaped material from

causing an adverse effect on the environment

25 RCGM and GEAC Currently isolation

should review the distance prescribed for

isolation distances for confined field trials are

CFTs and based on the National

requirement/suitability MinimumSeeds

of additional measures Certification Standards.

so as to follow best The same shall be

possible practices. reviewed.

26 DBT, ICAR and MoEF DBT as part of 12t plan

must fund research programmes is launching

projects specifically a Task ForceOn

designed to: (1) identify Regulatory Science R&D

the appropriate spatial' with aim tofund

isolation distances for investigators in universities

plant species that are and institutions for

likely to undergo CFTs research on wide ranging

in the next 10 yrs; and biosafety issues included

_______ (2) identify other in the suggested list.


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NO. Dr. Paroda

the UNEP/GEF being steered

by MoEF.

TOR F: To advise on whether institutions/laboratories

in India have the state-of-art testing facilities and

professional expertise to conduct various biosafety

tests and recommend mechanism to strengthen the

same. If no such Institutions are available In India,

recommend betting up an independent testing

laboratory/institution.

28 It will not be advisable There are already 21

to set up a single private and six public

institution for all sector organizations

biosafety tests.Instead, engaged in biosafety

a network of testing. These laboratories

laboratories of high are accredited by one or

international standard the other authorized

be established which agencies such as ISO,

are duly accredited from NABL and GLP systems.

NABL and National Additional capacity


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No. Dr. Paroda

GLP Compliance through network of

Monitoring Authority as laboratories with a

appropriate. For specialized notification

required public system would be put in

confidence, safety data place during the 12t Plan

be generated in

accredited laboratories.

of DBT under EPA (1988).

29 DBT must take up In addition to several

major human resource capacity building

development initiative programmes undertaken

for training in highly under UNEP-GEF Phase

reputed national and II programme, provision

international institutions.has been made under the

proposed RAU for

advanced biosafety

training.

30 GOI may establish an Uol would evolve an inter-

inter-ministerial ministerial mechanism for

coordination and

monitoring mechanism

the purpose.


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OsRecommendation by Comments of Uoi

No. Dr. Paroda

for taking

necessary financial

and administrative

steps towards

creating/strengthening

relevant public research

institutions

for regulatory processes.

III. OTHER KEY ISSUES

40. The final report by five members of TEC raises

several issues which were also raised in their

interim report, which had been responded to in the

affidavit already affirmed by UOI on November 8,

2012. This section briefly addresses these issues in

the light of current developments and with a view to

providing further clarifications:

(i) Safety of Bt crops: The TEC continues to

disregard the vast amount of data available

globally on safety of Bt protein including

decisions of regulatory agencies, peer


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reviewed journals etc. In fact to support their point of view, they have made

intentional distinctions such as food vs. feed, food vs. non food crops etc. it is

well recognized across the regulatory system not only in India but globally that

regulation has to be dealt with on a case by case basis.

The TEC also stated that there is no evidence of human consumption of GM

crops and long term toxicity assessment has not been done quoting the

published article by a French scientist Seralini et a! 2012, who is President of

the Science Council of a NGO named CRIIGEN (Committee for Research

and Independent Information on Genetic Engineering ) based in France,

which is an independent non-profit organization of scientific

counter-expertise to study GMOs, pesticides and impacts of pollutants on

health and environment, and to develop non polluting alternatives. However,

globally several regulatory organizations such as EFSA of


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European Union, Food standards of Australia and New Zealand and other

similar agencies from Brazil, Argentina, France, USA, etc., have clarified on

unequivocal basis that the methodology, statistics and interpretation of

Seralini is non-scientific and should not be acknowledged.

It may be noted that the journal Food and Chemical Toxicology has recently

retracted the article "Long term toxicity of a Roundup herbicide and a

Roundup-tolerant genetically modified maize," which was published in this

journal in November, 2012 and has also been quoted by five members of

TEC as the basis of their recommendation for a moratorium on field trials for

Bt in food crops. This retraction comes after a thorough and time-consuming

analysis of the published article and the data it reports, along with an

investigation into the peer-review behind the article (Annex R-8 (pages 262

to 265).

Similarly, presently all the countries using GM crops have given approval for

both food and


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socio-economic issues prior to imports or use of the products in their

countries.

All public funded research is driven by priorities set by muiti-stakeholder

platforms and are continuousiy monitored throughout the project cycle by a

range of experts. In fact, because of this reason, traditionally ail the ICAR

institutions and SAUs have agricultural economics, extension and rural

sociology & development as an integral part of National Agricultural Research

System (NARS) (Annex-R-9(pages 266-267).

Further, it may be noted that the very purpose of inter-ministerial participation

in regulatory framework (GEAC and RCGM)from both science and

technology and developmental ministries/ departments is also to ensure such

relevance of products considered in these committees in terms of national

needs and priorities In addition, socio-economic studies independent of

scientific risk assessment are


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undertaken by the GEAC case-by-case. For

example, ex ante socio-economic assessment

studies were also considered during approval

process of Bt cotton and Bt brinjal in India.

The UNEP/GEF supported Phase Il Biosafety

Capacity Building project being implemented

by MoEF has a major component on socio-

economic considerations in the context of

developing appropriate guidelines and

methods for the same. India is actively

participating in working g

goi affidavit on gm crops

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