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CHAPTER-3 DEVELOPMENT OF GM SEEDS IN

INDIA

140

DEVELOPMENT OF GM SEEDS IN INDIA Agriculture is the backbone of Indian economy contributing

approximately 23 percent of the national GDP. It is the source of livelihood for

over 70 percent of its population, in other words, about tow-thirds of the Indian

population derives their livelihood directly from agriculture either as

landowners or as landless labor. Having the largest arable area, (70 million

hectares), India ranks second to the USA in sheer size of agriculture. By

virtue of its large arable land area, sizeable irrigated area, rich agriculture

biodiversity, diverse agro-climate and well developed research system, the

country has all potential to emerge as a global power in agriculture. The

country has achieved self –sufficiency in foodgrains production and has tripled

its grain harvest over the half century. However, in order to maintain the

same level of per capita consumption of food, the country has to add another

40 million tones by 2010 (Joshi ,1998)1, and (Thamarajakshi , 1999)2 .With no

more arable land and productivity of major crops plants plateau (a hill or

mountain with a level top), the prospects of achieving the target especially

with the aid of currently available technologies is a challenging position.

Even in countries with aggregate surpluses of food, people remained

unable to afford enough to eat, unless they are able to increase their incomes

from employment. India has 60 million tones of staple foods, over a third of its

annual consumption and production in public grain stores. Yet, access is

limited. Despite slow and steady improvements over the last few decades,

over half of all children under five years old are stunned, even higher

proportion than in Africa (Asia Pulse/PIT, 2006)3, but this does not mean that

extra food production is irrelevant to India’s undernourished. Most of them are

poor, and therefore hungry, because they can neither produce enough food

on their small farms nor obtain sufficient employment by working on those of

others. Enhancement of yields on small farms which tends to increase the

demand and hence rewards for poor labours addresses this problem. This is

only possible through new technology of agriculture.

Many of the problems that impede the productivity of our varieties and

hybrids have defied solution through conventional breeding approach. These

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include widespread moisture stress, 65 percent of the area are particularly

rainfed and dry land, expanding salinity, new pests and biotypes of higher

virulence and poor self –life. The high yielding technology that heralded the

Green Revolution has, no doubt, reduced the country from chronic food

deficiency and starvation but it has its adverse effects too. The high input

cultivation of rice and wheat had led to excessive water use and eroded soil

quality; indiscriminate use of chemical pesticides has led to pesticide

resistance making pest management difficult. Any scope for pest through

host plant resistance is becoming limited on account of shrinking sources of

resistance of weed infestation causes heavy crops losses, if not controlled in

time. The estimates of losses caused due to pests and weeds range between

10 percent to 40 percent but in some cases the losses could be much more.

Beyond herbicides which are weeds specific, there are no means to manage

the wide weed spectrum –limited variability for yield- related traits is slowing

down the progress in yield enhancement. In crops like Indian mustard and in

pulses like pigeon pea through exploitable hybrid vigor is quite sizeable, for

want of stable male sterility /restorer system and lack of economic hybrid

seeds production technology, the scope of increasing yield has been limited.

Many of our staple food are characterized by one or the other nutrients

deficiency related to health disorders.

Transfer of useful traits from distantly related species, which don’t

sexually cross with crop plant, is not possible through conventional

recombination breeding procedures. There is need for alternative technology,

that is, recombinant DNA technology that enables movement of genes of

interest across sexual incompatibility barriers, is the approach plant scientists

are relying upon worldwide today to find genetic solutions to specific

problems. Paroda (1999)4, and Sawaminathan (1999)5 are recognizing the

potential of the engineering and biotechnology and its relevance to India. The

Government of India realized the need for creating a separate institutional

framework to strengthen biology and biotechnology research during 1980s.

Modern biological research is supported by the government agencies such as

Council of Scientific and Industrial Research, Indian Council for Agricultural

Research, Indian Council of Medical Research, and the funding agencies like

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the Department of Biotechnology , Department of Science and Technology

and the University Grants Commission. Biotechnology was given a boost in

1982 with the establishment of the National Biotechnology Board. The

success and impact of the National Biotechnology Board prompted the

Government to establish a separate Department of Biotechnology (DBT) in

1986. The DBT has close interaction with the State Governments particularly

through State Science & Technology Councils for developing biotechnology

application projects, demonstration of proven technologies, and training

resource in States and Union Territories.

The first transgenic Bt cotton underwent field testing in 1995. Today, near

about 185 institutions and private research laboratories are engaged in

transgenic research. Transgenic research is being done on several field crops

–cotton, Indian mustered, corn , potato, tobacco, and rice and in vegetable

crops namely tomato ,brinjal, cauliflower , cabbage, chilies and bell pepper.

The problems receiving priority attention includes insects pest control,

hybridization system and improvement (Gordon, 1997)6. At present only Bt

cotton is grown commercially in India. Research is being carried out on rice,

chickpea, tomato, potato, tobacco, rapeseed, mustard, brinjal, cauliflower,

chilli, bell, pepper, banana, cabbage, muskmelon, black gram, coffee, pigeon

pea, wheat, citrus fruits and ground nut. Genetically engineering hybrids and

hybrid with unique characteristics such as pest resistance are of special

interest to the private sector institutions as they provide the degree of

certainty, offsetting the risks to their investments in biotechnology. Two

transgenics, that is, Bt cotton hybrids against bollworm complex and Indian

mustard, under field–testing, (Brassing junea) for exploitation of hybrid vigor

are of this kind.

The experience with regulation can be seen with reference to the first

product that was commercialized. The first event to be approved was a Bt

gene from Monsanto that was inserted in three cotton hybrid cultivars (MECH

12, MECH 162, MECH 184), belonging to Indian seed company, Maharashtra

Hybrids Seeds Company Ltd. (MAHYCO). This event was commercialized by

a joint venture called Monsanto-MAHYCO Biotech (MMB), which is owned by

the two partners. After backcrossing was done, the first biosafety tests was

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done in 1997. The approval for commercial release came five years later in

2002. The varieties were approved for cultivation in southern, western and

central India for a period of 3 years. As of 2006, a total of 58 hybrids are

approved for planting in different zones all over the country. The entire

schedule of the regulatory process is shown below:

Time Line of Approval of MMB Hybrids

Bollgard Development Process in India

▼ Mahyco Institutional Biosafety Committee established in 1995

▼ Review Committee on Genetic Manipulation

▼ Import of Seeds 1996

▼ Backcrossing

▼ Studies conducted

▼ Environmental Safety Bioefficy &

Agronomic Benefit Biosafety Studies

Pollen Flow 1997 Field Trials AllergenicityStudies 1998 Aggressiveness Studies

1997-98 Year No.of trials

Goat Study 1998

Pollen Flow 2001 1998-99 40 Cow Study 2001 Soil Studies 2001-02 1999-

2000 19 Buffalo Study 2001

Gene stability 2001 2000-01 25 Chicken Study 2001 2001-2 376 Fish Study 2001

Protien detection in oil

2001

▼ GEAC Data Evaluation 2001

▼ Seed Bulk-up Approval 2001

▼ Commercialization 5th April, 2002

Source: Sharma (2005)7

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Cotton provides a livelihood to more than 60 million people in India by

way of support in agriculture, processing and use of cotton in textiles. Cotton

contributes 29.8 percent of the Indian agriculture gross domestic product, and

nearly nine million hectares of land in India is used to produce 14.2 million

bales of cotton lint. Indian cotton is third in the world in the quality, although

the productivity is substantially very low, in other words, although it has the

world’ s largest acreage of 8.9 million hectares under cotton , India is only the

third largest global cotton producer, with about 2.86 million tones of cotton lint

a year. The average productivity of cotton lint at 320 kilogram per hectare is

among the lowest in the world. The productivity ranges from 200 kg per

hectare to 600 kg for hybrid varieties (Sharma, 2001)8. Since many of the land

holding is characterized by small –scale and resource-poor farming, a sudden

and high increase in productivity using present methods is unlikely. Nearly 70

per cent of the crop is cultivated under rain fed conditions in the central and

southern regions of the country i.e., Gujarat, Maharashtra, Madhya Pradesh,

Tamil Nadu, Andhra Pradesh and Karnataka. Only in the northern region of

the county, mainly the states of Punjab, Haryana, and Rajasthan, cotton

predominantly irrigated.

3.1 Commercialization of GM Crops Decision of Genetic

Engineering Approval Committee (GEAC)in India:

a) North India (Punjab, Haryana, Rajasthan):

Approvals: Ankur 651Bt, Ankur 2534 Bt of Ankur Seeds for 2 years on March

4th, 2005; MRC 6301 Bt , MRC6304 B t of MMB for 2 years on March 4th,

2004 ;RCH 134B t and RCH 317 Bt of Rassi Seeds for 2 years on March 4th,

2005

b) Central India (Madhya Pradesh, Gujarat, Maharashtra, Chattisgarh): Approvals: MECH 12, MECH- 162& MECH 184, of MMB are approved for all

regions for three years in April 2002. RCH of Rassi Seeds for Madhya

Pradesh and Chattisgarh for 3 years in April 2004; RCH 138 Bt of Rassi

Seeds approved on April 13th, 2005 for 2 years; MECH-12, MECH 162,

MECH 184 of MMB are renewed permission on 3rd, May 2005 for 2 years;

RCH -144 Bt , RCH 118Bt of Rassi Seed, approved for 2 years on 3rd May

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2005, MRC-6301Bt of MMB, approved for 2 years on 3rd, May 2005; and

Ankur 681 and Ankur 09 of Ankur Seeds approved for 2 years on 3rd, May

2005

c) South India (Karnataka, Andhra Pradesh, Tamil Nadu): Andhra Pradesh:

Approvals: MECH -12, MECH-162, MECH-184, approved for 3 years in

2002, however in case of MECH 62, MECH 162 and MECH 184 permissions

are not renewed MRC06322, and MRC 6918 Bt of MMB approved for 2 years

on 3rd, May 2005, RCH-20 Bt and RCH -368 Bt of Rassi Seeds approved for

2 years in May 2005

Karnataka and Tamil Nadu Approvals: MECH-12, MECH-162, MECH-184

approved for 3 years in 2002; MRC-6322,Bt and MEC-6918 Bt of MMB

approved for 2 years on 3rd May, 2005; RCH-20-Bt and RCH-368 Bt of Rassi

Seeds approved for 2 years on 3rd May, 2005. however, in case of Mech-12

permission is not renewed.

Table-1: Status of the Zone-Wise Approval of Bt Cotton Hybrids in India (2002-06) Zone/State

2002 2003 2004 2005 2006

North Zone

6 Hybrids One Event 3Companies

14 Hybrids Three Events 6 Companies

Haryana …………. …………. ……….. RCH 134 ………..

Punjab ………… …………. ……….. RCH 317 ………..

Rajasthan ………… ………… ……….. MRC 6304 ………..

…………. ………… ………… MRC6301 ………..

…………. ………… ………… Ankur 651 ………..

…………. …………. …………. Ankur 2534 ………..

Central zone 3 hybrids 3 hybrids 4 hybrids 12 hybrids One Event 4 Companies

29 Hybrids Four Events 14 Companies

Gujarat Mech 12 Mech 12 Mech 12 Mech 12 ………….

Madhya Mech 162 Mech 162 Mech 162 Mech 162 ………….

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Pradesh

Maharashtra Mech 184 Mech 184 Mech 184 Mech 184 ………….

…………. …………. RCH 2 RCH 2 ………….

…………. …………. …………. RCH 118 ………….

…………. …………. …………. RCH 138 ………….

…………. …………. …………. RCH 144 ………….

…………. …………. …………. Ankur 109 ………….

…………. …………. …………. Ankur 165 ………….

…………. …………. …………. MRC 651 ………….

…………. …………. …………. MRC 6301 ………….

…………. …………. …………. NCS 145 Bnny

………….

…………. …………. …………. Bt ………….

…………. …………. …………. NCS-207 Malika

………….

…………. …………. …………. Bt ………….

South zone 3 hybrids 3 hybrids 4 Hybrids

9 Hybrids One Event 3 Companies

26 hybrids Four Events 16 Companies

Andhra Pradesh

Mech12 Mech 12 Mech 12 Mech 162* ………….

Karnataka Mech 162 Mech 162 Mech 162 Mech 184* ………….

Tamil Nadu Mech 184 Mech 184 Mech 184 RCH 2 ………….

…………. …………. …………. RCH 20 ………….

…………. …………. …………. RCH 368 ………….

…………. …………. …………. MRC 6322 ………….

…………. …………. …………. MRC 6918 ………….

…………. …………. …………. NCS 145 Bnny

………….

…………. …………. …………. Bt ………….

…………. …………. …………. NCS-207 Malika

………….

…………. …………. …………. Bt ………….

Total No. of hybrids for sale

3 3 4 20 58 Hybrids Four Events 16 Companies

Source: Newell-McGloughlin Martina9 and M. Sabesh, (CICR) “Bt Cotton Hybrids Approved for Commercial Cultivation in India At various Zones”,

147

All approved hybrids belong to sixteen major seed companies from

India i.e. Mahyco (MECH, MRC), Rasi (RCH), Ankur Seeds (Ankur),

Nuziveedu Seed (NSC), JK Seeds (JKCH), Nath Seeds (NCEH), Ganga

Kaveri Seeds (GK), Tulasi Seeds (Tulsi), Ajeet Seeds (ACH), Emergent

Genetics (Brahma), Vikki Agrotech (VICH), Vikram Seeds (VICH),Pravardhan

Seeds (PRCH), Krishidhan (KDCHH), Prabhat (PCH) and Vikram

(VICH)seeds.

In 2002, Maharashtra Hybrids Seeds Company Ltd (Mahyco) received

first approval for three Bt cotton hybrids i.e. MECH 12, MECH 162 and MECH

184 for commercial cultivation in Central & Southern cotton growing zones in

India. Of the total 58 varieties of Bt cotton hybrids approved for commercial

cultivations till now,14 hybrids containing three events to be sold by six

companies in Northern zone, 29 hybrids containing 4 events to be sold by

fourteen companies in Central zone, and 27 hybrids containing four events to

be sold be sixteen companies in Southern zones. Out of the total 58 varieties

of Bt cotton hybrids approved for commercial cultivations:

i- 44 Bt cotton hybrids containing Cry1Ac gene known as event BG-I

ii-7 Bt cotton hybrids containing stacked Cry X (Cry I Ac and Cry 2 Ab) genes

known as event BG-II

iii- 4 Bt cotton hybrids containing Cry1Ac gene known as Event-1, and

iv-3 Bt cotton hybrids containing fusion genes (Cry 1Ab and Cry Ac) known as

GFM event.

Table-2: Event-Wise Approval of Bt Cotton Hybrids in India (2006) Event

North Zone

Central Zone South Zone

Total Hybrids

Bollgard-I (Mahyco)

12 22 21 44

Bollgard-II (Mahyco)

0 5 2 7

Event 1 (JK Seeds)

1 1 2 4

GFM Event (Nath Seeds)

1 1 1 3

Total Hybrids 14 29 26 58

Source: Newell-McGloughlin Martinaop.cit

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Interestingly, the GEAC has approved three new events of biotech cotton in

2006:

i- First developed by M/s JK Seeds Pvt Ltd. containing the Cry1Ac gene

known as (Event 1) sourced from IIT Kharagpur, India;

ii-Second developed by M/s Nath Seeds Pvt Ltd. containing fusion genes (Cry

1Ab and Cry Ac) known as (GFM event) sourced from China, and

iii-Third developed by Mahyco containing stacked Cry X (Cry I Ac and Cry 2

Ab) genes (Event MON 15985 or BG-II) sourced from Monsanto.

The fact that 23 private sector institutions have (today) their own

institutions bio-safety committee (IBSC) ,which is mandatory under the

guidelines for institutes engaged in genetic engineering research , is indicative

of the fact that private companies are also serious and interested in pursuing

transgenic research (Salvarajan, Dinesh, Toole and John, 1999)10.A strong

regulation system for assessing biosafety of genetically engineering plants

and food items before they are released in the environment is mandatory. A 3-

tier regulatory system for field–testing of transgenic plants structure on the

basis of guidelines issued by the DBT under the Environment Protection Act,

1986 is in place . The rules for the manufacture, use, import, export, and

storage of hazardous microorganisms, genetically engineering organisms or

cells were framed in 1989 under the Environment Protection Act of 1986.

Biosafety guidelines were formulated by Recombinant DNA Advisory

Committee (RDAC) in 1990 and were adopted by the Government .They were

revised in 1994 and 1998 incorporating allergenicity and toxicity evaluation of

transgenic material. The guidelines incorporating changes up to August 1998

have published recently .These guidelines prescribe the codes for assessing

safety. It is pertinent that no testing of transgenic can be done without

permission of the Review of Committee on Genetic Manipulation (RCGM)

under the Environment Protection Act. The Indian regulatory system is a three

tier structure. It consists of: Institutional Biosafety Committee (IBSC),set up at

each institution for monitoring institute level research in genetically modified

organisms: Review Committee on Genetic Manipulation (RCGM) set up at

DBT to monitor ongoing research activities in GMOs. A Monitoring and

Evaluation Committee (MEC) comprising agricultural scientists ,was

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constituted in July 1998 by RCGM to monitor and supervise field trials

permitted by Genetic Engineering Approval Committee (GEAC) in the

ministry of Environment and Forests has been set up to authorize large scale

trials and environmental release of genetically modified organism11. Table-3

deals with the summary for regulatory process leading to commercial release

of Bt cotton in India.

Table-3: Development of GM Crops in India Years Studies undertaken Government of India

oversight Committee 1995-1996 Application and permit for importation

of Bt cotton seed containing the CryAc gene

DBT

1996-2000 Greenhouse breeding for integration of the CryAc gene into Indian germplasm, seed purification, and stock increase

DBT

1996-2000 Limited field studies for potential of pollen escape, aggressiveness, and persistence

RCGM(DBT)

1998-2000 Multinational field trials : agronomic and entomology performance of first generation Bt cotton hybrids , conducted by Mahyco and State agricultural universities

RCGM(DBT),MEC

1998-2001 Biochemical and toxicology studies RCGM(DBT),GEAC

2000-2001 Soil rhizosphere evaluations and protein expression analysis from multinational field trials

RCGM(DBT),GEAC

2001 Advanced stage multiplication field performance trials of first –generation Bt cotton hybrids , conducted by ICAR

GEAC, ICAR , DBT,MEC

2002 Submission of final biosafety environmental safety, gene efficacy and performance documentation to GEAC, commercial release of first generation Bt cotton hybrids by GEAC

GEAC

2002-

Till date

Continued field trials of second generation Bt cotton hybrids for regulatory approvals

RCGM(DBT),GEAC,ICAR,MEC

DBT= Department of Biotechnology,GEAC=Genetic Engineering Approval Committee,RCGM= Review Committee for Genetic Modifcation (constituted by DBT ),ICAR=Indian Council of Agricultural Research, MEC= Monitoring &Evaluation Committee(constituted by GEAC and RCGM)

Source: Barwale (2004)12

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3.2 Awareness of GM Crops and Foods among Indians:

Although India is considered to be a third world country, it boats a

rapidly growing economy, attracting several western biotech firms such as

Monsanto and Arthur Daniel Midlands, who view India as a nation that could

truly benefit from GM technology. India is a nation that is home to a very

different population. India consists of people of different religions, cultures,

castes and mindsets. Being that Indian government is on the border of making

many key decisions regarding GM foods, many believe that it is imperative

that the public’s knowledge and perceptions of such technology be noted.

Most research was aimed at understanding the complex, deep rooted,

psychological and social factors that may affect the common Indian’s

knowledge and perceptions of genetically modified (GM) foods. A study was

conducted by Azeez Athif in 2005 both in India (New Delhi) and the United

States (New York). In India, the city of New Delhi was chosen because of

being the capital of the nation, and focal point of much of the country’s GM

food activity. The city of New York was chosen because of its diversity and

eclectic features. In many ways the city serves as a western reflection of New

Delhi. Both cities share many demographic parallels in size and diversity. The

cities diversity allows for the accumulation of well sampled data, reflecting the

various values of their citizens. Although the two cities encompass unlike

standards of living, similar dynamics of socio-economical levels are present.

Such factors as age, sex, religion, and socioeconomic level were considered.

The study aimed to differentiate between ones personal and cultural values.

Values are often a compilation of ones goals, mode of thought and willingness

to take risks. This study has also evaluated risk as a primary factor. Finally,

mirrored research in the United States was conducted, adding richness to the

study through a cross cultural analysis.

The study showed that In New Delhi, results show that a shocking 41

percent have “Never heard” of GM foods, while 39 percent have “Never

heard” of biotechnology. In New York results of awareness was significantly

better-24 percent have not heard of genetically modified foods, while 31

percent have not heard of biotechnology.

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Table-4: Knowledge of GM Crops among Selected Cities

(Percent)

City Favor (VF+SF) Unfavorable(VF+SF) Don’t Know

New Delhi 36 59 7

New York 59 32 9

Source: Azeez A.(2006)13

Note: SF=Strongly Favour,

VF=Very favourable, In India, subjects from age groups 17-29 years and 30-44 years

showed the highest percentage of both knowledge and strong opinion on the

issue of GM foods. New York subjects featured a wider margin of age related

awareness. Subjects from age groups 17-29 years, 30-44 years and 45-59

years ranked highest in awareness and opinion. In both cities, religion was

proven to show no role in the subject’s decision making process. The middle

and upper-class showed the most knowledge, with incomes ranging from

10,000-100,000 rupees per month. Data from India also shows rift between

the rich and the poor. In New York most knowledgeable participants had a

minimum income of 35,000 dollars per year. Income levels also affected

levels of opinion. Middle class and upper class showed strong opinions, while

lower income classes showed little opinion towards the matter. Income in the

U.S was not as great as a determining factor as it was in India.

Answers were measured on a Likert scale (a psychometric scale

commonly used in questionnaires) with the fallowing options: Strongly Favor

(SF), Favor (F), Oppose (O), Strongly Oppose (SO) and Don’t Know (DK).

Excluding those who selected, “Don’t Know”, In Delhi 39 percent of

participants favored the introduction (SF+F), while 61 percent opposed it

(SO+O). In New York, results were exactly the opposite with 67 percent

favoring it and 33 percent opposing itop.cit.

A direct study in the state of Gujarat involving 1000 farmers has been

conducted by Koch, M., Chandran, M.-Bhatt, V. P. and Portelance, C.,

(2007)14. The study covered a cross section of farmers across the state

representing different economic, educational and agro-climatic backgrounds,

gender, age, etc. The study focused on finding of their level of understanding

of biotechnology, the most preferred extension method for farmers and key

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factors affecting their decision of adoption of new technology like the GM

technology. A number of observations were made one of them is most

respondents (97.2 per cent), regardless of their economically and educational

backgrounds were interested in knowing about biotechnology were cautious

and needed to be personally convinced that the use of the technology will be

economically beneficial to them (Bhatt, P.M., Ebora R. V., Cohen J. I., Zepeda

J. F. and Zambrano P. 2005)15.

In Gujarat, the social channels of knowledge transfer also produced an

interesting discussion on the nature of Bt gene. In response to the question of

“whether the Bt effect would gradually reduce in the new generation of seeds,

if multiplied in this fashion (high degree of adoption of Bt cotton by the farmers

and producers)” farmers described Bt as similar to cancer, “once you get it

you can’t get rid of it, it becomes part of the anatomy” was one kind of answer

(Shah, E., 2005)16.

Dr. Tom Wahl, Director, International Marketing Program for Agricultural

Commodities and Trade (IMPACT) Centre, Washington State University

(U.S.A) presented a study conducted by his group in 2004 to assess the

willingness to pay for and the acceptance of two types of GM wheat chapatti

among Indian consumers. The study included surveys of 600 consumers (400

in metro Delhi and 200 in Patna, in the rural state of Bihar) at four grocery

stores in each city. There were three information treatments: the first group

was surveyed without additional information; the second with positive

additional information about the first generation trait; and third with negative

additional information about the first generation trait. Of a sample surveyed,

54 percent of consumers had no knowledge of biotechnology, 5 percent had

good knowledge; 41 percent had some knowledge. Sixty eight percent did not

have any opinion on the risks of biotechnology. Eighty–seven percent of the

respondents said that they would buy the product if it helps to reduce

pesticides (International Food Policy Research Institute and Research and

Information System for Developing Countries, 2007)17.

The assessment of the biotechnology information workshops held for

state-level agricultural extension workers, 172 candidates by telephone

interviews were randomly sampled from the entire group of delegates to the

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first three workshops in Gujarat, Andhra Pradesh and Maharashtra, indicates

that the interventions have been effective at addressing an identified need for

information in this sector. The South Asia Biosafe Program (SABP) ran five

training of trainer workshops in five states in 2005 and 2006. The materials

and formats of these workshops have been tested and proven to be effective.

In addition, the expertise to implement workshops that are appropriate to each

state‘s language requirements and priorities resides in India. Based on this

proof of concept and the available expertise it is hoped that planning and

implementation of subsequent workshops will be forthcoming from the Indian

government and state agricultural departments. Ultimately these workshops

should increase the level of information available to farmers and enable them

to make informed decision on the adoption of biotechnology planting materials

(Koch, M., Chandran, M.-Bhatt, V. P. and Portelance, C., 2007)op.cit. While the

workshops proved to be effective in addressing the information need of

extension offers, the vast size of the agricultural sector in India will require

more extensive outreach mechanisms to address the information needs of the

large number of farmers.

From the above, it is clear that the experiments and plantation of

genetically modified seeds have been performed at different Indian institutes

and centres of biotechnology. The experiments provided positive result but

there is a need of guidelines to Indian farmers regarding the new technology

so that they can differentiate Bt cotton from non-Bt cotton and obtain good

yield without affecting environment and other species of the country.

3.3 Adoption of GM Crops among Indian Farmers: []

The preference of Indian farmers for Bt cotton or genetically modified

crops has been assessed by direct and indirect ways. The word ‘direct way’

itself explains that the farmers straight forward are accepting the technology,

and indirect way involves the evaluation and benefit of the crop , trend of

cultivation and demand for packet of seed sold by seed producing

company/companies to the farmers . These two methods have been applied

on the following analysis presented in table-5.

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Table-5: Adoption of Bt Cotton Among Indian farmers

Table-5 shows that in India, approximately 2.3 million farmers planted

on average 1.65 hectares of Bt cotton in 2006. The number of farmers

growing Bt cotton has increased from 300,000 in 2004 to 1 million in 2005,

and further to 2.3 million farmers with over two-fold increase in 2006. In brief,

we can say that Bt cotton crop has spreaded in different states of India.

The Indian Market Research Bureau International (IMRB), which is also

associated with the Government of India for market surveys, was

commissioned by MMB to analyze the performance of Bt cotton during 2004-

05. The IMRB then interviewed 3,199 farmers across 20 cotton-growing

districts in Andhra Pradesh, Karnataka, Tamil Nadu, Madhya Pradesh,

Maharashtra, and Gujarat. In 2005-06, IMRB considerably increased the

base and interviewed 4,779 farmers across 31 cotton-growing districts in

Punjab, Haryana, Rajasthan, Andhra Pradesh, Karnataka, Tamil Nadu,

Madhya Pradesh, Maharashtra, and Gujarat, during January and February,

2006, to analyze the performance of Bt cotton during the 2005-06

season. These two surveys showed that both the small and large farmers

have benefited by Bt technology and indicate that in 2005 Bollgard 1 was

grown on about 3.1 million acres in these nine states(Rao, C K)18.

The survey of AC Nielson ORG-Marg covered five of the six Bt cotton-

growing States: Maharashtra, Madhya Pradesh, Andhra Pradesh, Karnataka,

and Gujarat. According to this survey, the introduction of Bt cotton in India has

enabled the farmers to realise better yields and earn higher profits(Reddy,C.

P., 2004)19.

Year Area under Bt cotton (ha)

No. Of Farmers

2002-03 44,500 ---

2003-04 100,000 ----

2004-05 500,000 300,000

2005-06 13,00,000 10,00,000

2006-07 38,00,000 23,00,000

Source: ISAAA(2006) “ Global Status of Commercialized Biotech/GM Crops”

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Thousands of farmers from Gujarat, Andhra Pradesh, and

Karnatakacultivated so-called “pirated” or “illegal” seeds in at least 10,000

acres supplied originally by the Navbharat seed company under the name of

Navbharat-151 (hereafter N-151) at least three years before(2001) the Bt

seeds of Mahyco-Monsanto Biotech (patent protected by Monsanto) were

approved by the Genetic Engineering Approval Committee (GEAC). It is also

reported that a survey of 363 farmers conducted in 2000 in Gujarat that MMB

seeds gave the highest yield. Even after the seeds supplied by the Mahyco-

Monsanto Biotech (hereafter MMB) have been commercially released in India,

farmers continue to cultivate “illegal” seeds, which are multiplied locally (Shah,

E., 2005)20. The government is unable to stop the illegal supply of the seeds.

It is also evident that there is fault in the mechanism of government

institutions to tackle down the prevailing conditions.

The area under cotton in Gujarat marginally grew from 16.15 lakh

hectares in 2000-01 to 16.28 lakh hectares in 2003-04, both total production

and yield were more than tripled in 2003-04. Almost 19 lakh hectares are

expected to be under cotton cultivation in the year 2004-05 when total

production seems to have touched 54 lakh bags and average yield 483 kg per

hectare. The increase in total production and yield are often attached to the

cultivation of Bt cotton seeds, though some scholars have argued that the

increase in yield could also be due to good rainfall in the past three years

(Sahai and Rehman 2004)21. What is being claimed widely is that locally

multiplied seeds of generic N-151 (more on the multiplication of N-151

follows) were cultivated in a minimum of 60 per cent to a maximum of 80 per

cent of the total area under cotton in Gujarat in the last two years(Shah, E.,

2005)op.cit.

During the year 2004-05, N-151 seeds were multiplied in 20,000 acres

in Gujarat, from which 60 lakh packets of seeds were prepared (one packet

contains 450 gm of seeds which is roughly enough for one acre). Gujarat

alone has a demand of roughly 24 to 25 lakh packets, of which only 2 to 3

lakh packets were supplied by the MMB, the rest were N-151. That also

means that roughly half of the seed packets produced in Gujarat are sent to

other states (Rao, C. K)op.cit. According to the survey of 650 farmers

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conducted by J. V. Shah (as published in Diwya Bhasker, January 11, 2005),

128 farmers cultivated illegal Bt varieties for more than three years, 305

farmers for two years, and 217 farmers for one year(Shah, E., 2005)op.cit.

A study in the state of Gujarat involving 1000 farmers revealed that

farmers were interested in demonstration of the technology of their own

village/area(Bhatt, P.M., Ebora R. V., Cohen J. I., Zepeda J. F. and Zambrano

P., 2005)22. The development and diffusion of Bt seed technology by farmers

themselves implies that the technology finds a smooth insertion in the social

and agrarian space shaped by the technological culture.

Another study in the state of Karnataka found that for 100 farmers

sampled, Bt cotton growers used lower numbers of pesticides applications

than non-Bt cotton farmers, but the promise of higher yields was only realized

for irrigated farms. Local varieties appear to perform better than Bt hybrids

under rainfed conditions (Smale, M., Zambrano P., Flack-Zepeda J. and

Gruere G., 2006)23

Narayamamoorthy and Kalamkar (2006)24 collected data for the 2003

rainy season in two districts in the Vidarbha region of Maharashtra, targeting

their analysis to pairwise yield comparisons of two Bt and non-Bt varieties

hybrids (MECH 162 and MECH 184 for Bt; Bunny 145 and Ankur 651 for non-

Bt). They found that yield advantages differed for the same hybrid by region

and within regions, by hybrid.

At CICR, in Nagpur districts of Maharashtra, after getting the approval

from Govt. of India, the MAHYCO/Rasi Seed companies has marketed the

genetically engineered cotton hybrid with Bt gene which makes the crop

resistant to Heliothis. Considering the potential for Bt cotton and adverse

publicity it was decided to assess this technology on farmers field under TMC

MM-I MM 5.1 project of the Central Institute for Cotton Research, Nagpur.

When the proposal was mooted, many farmers refused to take Bt cotton on

their lands because of the bad publicity it has received in press. One brave

farmer Sh. Dhanraj Hiwase, aged 50 years of Tishty village in Kalmeshwar

Taluka of Nagpur district came forward to sow the Bt cotton on his one acre

farm. One packet of RCH-2 Bt. cotton hybrid which contained 450 gm of Bt

cotton and 120 gm of Non-Bt cotton as refugia was sown on his one acre plot

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on June. 21, 2004. The Team members of TMC MM 5.1 under the leadership

of Dr. Hemchandra Gajbhiye, utilized the trait of innovativeness possessed by

Sh. Hiwase and trained him in the use of Bt cotton technology at the Central

Institute for Cotton Research, Nagpur. Very close watch was kept by the TMC

MM 5.1 team, which visited the field every week. Because the seed was

treated with Imidacloprid, the sucking pests did not attack the crop, so was his

other cotton crop which was also treated with Imidacloprid. Difference was

noticed by one of the neighbor of Sh. Dhanraj, when the crop came to

squaring stage. He noticed that Heliothis has already made a way in adjoining

fields, where as Dhanraj’s Bt cotton field is free from heliothis. The news

spread like wild fire and hundreds of villagers started flocking to Dhanraj’s Bt

cotton field. They suspected that Dhanraj might have sprayed some

pesticides, but Dhanraj’s father who himself was astonished to see the crop

free of heliothis, swear that not a single spray of pesticide has been given to

this particular field. From then onwards Dhanraj’s stature in village kept on

raising with every development of crop. It was almost a drought like situation

that year, which gives water stress to plants during the second fortnight of

November, thus reducing the yield considerably. But Dhanraj was a happy

man with harvesting his first picking in first fortnight of November itself. He did

four pickings and every picking became neighbors envy. He has harvested

520 kg of seed cotton from 0.32 ha, whereas refugia non-Bt gave him only

150 Kg from 0.08 ha. His other non- Bt give him 350 kg from 0.40 ha. Putting

in terms of money he has earned additional Rs.9400/- from growing Bt.

Cotton(CICR, Nagpur)25.

Two agricultural scientists, Dr Abdul Qayum and Mr Kiran Sakkhari,

conducted the APCCD-DDS study on 164 farmers in 28 villages in Warangal,

Adilabad and Kurnool districts of Andhra Pradesh. The study underlined the

argument that genetically modified crops need more investment per unit area

than non-GM crops and net profits from GM crops were less than the non-GM

crops(Qayum A,and Sakkhari .K., 2005)26. With regard to their future

preference for Bt crop there was made a variety of answers in Andhra

Pradesh: 50.7 percent farmers categorically said that they would not plant Bt

crop again. 11.1 percent said they would not grow Bt in the next year, as cost

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of cultivation was higher than non-Bt crop. 4.4 per cent showed interest in

growing the Bt crop again without any hesitations, 8 per cent opined that they

would try again to have a full understanding of the crop to see as to how it

performs in the normal season. 8.9 per cent said that they would go for Bt

again if a better hybrid with good boll size is available. Only 0.4 per cent of the

farmers were undecided about their future plan. In addition to the above

responses, farmers in general have the following opinions regarding Bt cotton.

MECH Bt 162 appears to mature 15-20 days earlier than non-Bt hybrids. It

was very much susceptible to moisture stress and drought situations

compared to non-Bt hybrids. Market price for Bt was less by 10 percent.

Therefore, in order to offset the difference, farmers mixed both the Bt and

non-Bt before marketing. The 190-day cotton varieties could not hold this

resistance after 120 days of growth. Consequently, borers were observed in

the fields in the later stages, pushing up costs of cultivation (Ravikiran ,G.,

2006)27.

A study undertaken by the Centre for Economic and Social Studies

(CESS) during 2004-05 kharif season, was taken up in four districts of

Warangal, Nalgonda, Guntur and Kurnool, representing the four agro-climatic

zones and covering 14 villages in nine mandals of Andhra Pradesh. The

sample size was 623. The proportion of adopters (to Bt) and non-adopters

was about 70 per cent and 30 per cent. The physical yield obtained in Bt

cotton was 9.49 quintals an acre as against 7.21 quintals in non-Bt cotton, an

increase of 32 per cent. The increase could be attributed to the lower

bollworm damage in Bt. The official Bt cotton or approved varieties yielded 24

per cent more than unofficial version. But the cost of production in official Bt

was higher by 37 per cent than the unofficial one (Kurmanath , K.V., 2007)28. Bennett et al. (2005) show that official Bt varieties significantly outperform the

unofficial varieties but unofficial, locally produced Bt hybrids can also perform

better than non-Bt hybrids. They report that second generation F2 Bt seed

appears to have no yield advantage compared to non- Bt hybrids but can

save on insecticide use. The Bt gene still confers some advantage, and

farmers regard it as GM.

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The above observations directly and indirectly reveal that the farmers

of different states of India are ever-increasing acreage under Bt cotton that

are strong indicators of accepting of and good performance of Bt cotton. It is

also obvious that there are some areas where the performance of Bt cotton is

below optimum and the farmers are discarding genetically modified seeds.

Unsuitable areas, faulty management production, vagaries of weather, lack of

control of government institution over the new technology are some of the

factors that are resulting in bad performance of the technology. The reasons

should be pointed out and government and private sector as well as individual

should look into and remedy.

3.4 Legal Framework for the Regulation of GM Crops: A) International Regulation: There are five main elements of international regulation relating to

research into, and the trade and use of GM crops:

i) Agreements by the World Trade Organization (WTO) which aim to control

barriers to international trade. It is within this framework that the US and a

number of other countries have most recently challenged the EU on the

authorisation of GM crops.

ii) The Codex Alimentarius, a set of international codes of practice, guidelines

and recommendations pertaining to food safety. The WTO currently relies

upon the Codex in making its adjudications.

iii) The Cartagena Protocol on Biosafety under the Convention on Biological

Diversity (CBD), a multilateral agreement covering the movement across

national boundaries of living modified organisms (LMOs) that might have an

adverse effect on biological diversity.

IV) The International Treaty on Plant Genetic Resources for Food and

Agriculture by the UN FAO, a multilateral agreement relating to any genetic

material of plant origin of value for food and agriculture (not yet entered into

force).

v) Directives and Regulations by the EU and its regional policies on

agriculture, environment and genetically modified organisms (GMOs) (Nuffield

Council on Bioethics, 2004)29.

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I) The World Trade Organization: The primary purpose of the WTO is to facilitate international free trade.

It aims to achieve this by establishing trade rules, serving as a forum for trade

negotiations and assisting in the settlement of disputes. There are two

principal agreements that relate to GM crops. They concern the negotiation of

free trade (the Technical Barriers to Trade Agreement, TBT), and the

protection of public health and welfare standards in member states of the

WTO (the Sanitary and Phytosanitary Agreement, SPS)

a) Technical Barriers to Trade Agreement (TBT):

The TBT obliges members of the WTO to ensure that their national

regulations do not unnecessarily restrict international trade. Three

components make up the agreement. First, members are encouraged to

accept ‘standard equivalence’ which means that the standards of other

countries are mutually recognised through explicit contracts. Second, the TBT

promotes the use of internationally established standards. Third, the TBT

requires members of the WTO to inform each other of relevant changes in

policy. This means that members must establish centres that compile all

available information on product standards and trade regulations. These

centres must answer questions raised by other countries and consult with

trading partners as requested, to discuss the relevant requirements for trade.

b) Sanitary and Phytosanitary Agreement (SPS)

The SPS allows members of the WTO to temporarily block trade in the

interest of protecting public health. However, such decisions must be based

on scientific principles, internationally established guidelines and risk

assessment procedures. When there is insufficient scientific evidence to

determine the likely risk arising from the import of particular goods, members

of the WTO may adopt measures on the basis of available information.

Additional information which can support the initial decision must be submitted

within a reasonable period of time. The SPS does not permit members to

discriminate between different exporting countries where the same or similar

conditions prevail, unless there is sufficient scientific justification for doing so.

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ii) The Codex Alimentarius: The Codex Alimentarius was established by the Codex Alimentarius

Commission, a subsidiary body of the FAO and the WHO. The Commission is

the principal international body on food standards and represents more than

95 percent of the world’s population. The primary aim of the Codex is ‘to guide

and promote the elaboration and establishment of definitions and

requirements for foods to assist in their harmonisation and in doing so to

facilitae international trade. The Codex consists of a collection of food

standards, guidelines and other recommendations. It also includes a Code of

Ethics which aims to encourage food traders to adopt voluntarily ethical

practices to protect human health and to ensure fair practices in food trade.

The standards set out by the Codex have been used widely as the benchmark

in international trade disputes. They are explicitly referred to and adopted in

the SPS agreement of the WTO, and the TBT agreement implicitly refers to

them. Issues relating to the use of GM crops have recently been considered

by the Codex Commission. At its meeting on 30 June – 7 July 2003 the

Commission agreed three standards relating to GM crops:

a) Principles for the Risk Analysis of Foods derived from Modern

Biotechnology;

b) Guidelines for the Conduct of Food Safety Assessment of Foods derived

from Recombinant-DNA Plants; and

c) Annex on the Assessment of Possible Allergenicity to the Guidelines for the

Conduct of Food Safety Assessment of Foods derived from Recombinant-

DNA Plants.

The principles include a science-based, pre-market risk assessment,

performed on a case by case basis, and also an evaluation of both direct

effects (from the inserted gene) and unintended effects (that may arise as a

consequence of insertion of the new gene). Risk management should be

based on the risk assessment and be proportionate to the risks identified.

Effective post-market monitoring may in some cases require mechanisms of

traceability and labelling to allow the withdrawal of products that pose risks to

human health.

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iii) Cartagena Protocol on Biosafety: The Protocol contains procedures rather than substantive measures,

relating to the provision of information and the carrying out of tests to assess

the safety of GMOs such as GM crops. Some of the main procedures

introduced by the Protocol are as follows:

a) Advanced Informed Agreement Procedure (AIA): Before exporting

GMOs which are intended for release in the environment, the recipient

country must be notified. The notification must include a detailed description

of the GMO, including reference to existing risk assessment reports. The

export may take place only upon the consent of the recipient county.

b) Risk assessment: Parties to the Protocol decide whether or not to accept

GMOs primarily on the basis of scientific risk assessment procedures. Parties

may decide to apply a precautionary approach and refuse the import of GMOs

if the available scientific evidence is considered insufficient. Parties may also

take into account socio-economic implications likely to result from the import

of GMOs. Article 15 of ‘Cartagena Protocol on Biosafety’ enables a potential

recipient to require the exporter to carry out a risk assessment. It may also

charge the exporting country the full cost of the regulatory approval.

c) Capacity-building and involvement of the public: Article 22 expects the

parties to the Protocol to cooperate in the development and/or strengthening

of human resources and institutional capacities. Article 23 requires the

involvement of the public in the decision making process.

d) Biosafety clearing house: In order to assist parties of the Protocol in its

implementation and in order to facilitate the exchange of scientific, technical,

environmental and legal information on, and experience with, GMOs, the

Protocol established the Biosafety Clearing House as a central source of

reference.

e) GMOs intended for direct use as food or feed: Parties in developing

countries can declare through the Biosafety clearing house that they wish to

take a decision based on risk assessment information before agreeing to

accept an import.

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IV) The International Treaty on Plant Genetic Resources for Food

and Agriculture: The International Treaty on Plant Genetic Resources for Food and

Agriculture was unanimously adopted by members of the FAO’s Conference

of November 2001. The objectives of the Treaty are the conservation and

sustainable use of plant genetic resources, and the fair and equitable sharing

of benefits derived from their use, so as to promote sustainable agriculture

and food security. ‘Plant genetic resources’ are defined as ‘any genetic

material of plant origin of actual or potential value for food and agriculture.

The exchange of plant genetic resources is indispensable for research

and development of improved crops. Over recent decades, it has become

increasingly common for the exchange of resources used for academic or

commercial research to be covered by material transfer agreements (MTAs).

The new Treaty will establish a multilateral system for access and benefit-

sharing for 33 important crops that are under the management and control of

the Contracting Parties and in the public domain.

The Treaty also provides that the Treaty’s Governing Body, which

consists of those countries which have ratified the Treaty, shall determine at

its first meeting the level, form and manner of the payment, in line with

commercial practice. The Governing Body may decide to establish different

levels of payment for various categories of recipients who commercialise such

products. It may also choose to exempt from such payments small-scale

farmers in developing countries and in countries with economies in transition.

Levels of payment are to be reviewed from time to time, as well as provisions

which concern the question of whether benefit-sharing should also be

mandatory where access to the product is not restricted.

v) Directives and regulations by the European Union (EU): The EU introduced the following measures to ensure that the regulation

of GMOs would meet the demands of EU regulators and consumers:

a) Principles for environmental risk assessment;

b) Mandatory post-market monitoring requirements, including any long-term

effects arising from the interaction with other GMOs and the environment;

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c) Mandatory information for the public; a requirement for member states to

ensure labelling and traceability at all stages of marketing;

d) Commercial approvals for the release of GMOs to be limited to a maximum

period of ten years;

e)Directive 2001/18/EC-It requires a step by step approval process for GMOs.

The procedure is as follows: a company wishing to market a GMO must first

submit an application to the relevant national authority of the EU member

state where the product is to be marketed. This application must contain a full

environmental risk assessment. The assessment needs to take into account

direct or indirect effects on human health and the environment which may

arise from the deliberate release or marketing of the GMO(s). The

assessment must also consider whether these effects might be manifested

immediately, cumulatively or on a long term basis. If the national authority is

satisfied with the application, the authority informs the other EU member

states through the European Commission (EC). If, within a specified time limit,

no objections from other states are received, approval is granted and the

product can be placed on the market throughout the EU.

f) Regulation 1830/2003/EC on Traceability and Labelling

Regulation 1830/2003/EC concerning traceability and labelling of

genetically modified organisms and traceability of food and feed products

produced from genetically modified organisms and amending Directive

2001/18/EC was formally adopted by the Council of Ministers in July 2003. It

has the objective of controlling and verifying labelling claims; facilitating the

monitoring of potential effects of GMOs on the environment; and enabling the

withdrawal of products that contain or consist of GMOs that might prove to

pose unforeseen risks to human health or the environment. The Regulation

requires the labeling of all foods produced from GMOs. However, in

November 2002, the European Council agreed that food and feed do not have

to be labelled if the amount of genetically modified material is below a

threshold of 0.9 percent, and if its presence could be shown to be

unintentional and technically unavoidable. The threshold for the presence of

GMOs which have not yet received approval in the EU was set at 0.5 percent.

Although the primary criterion for labelling is detectibility, processed foodstuffs

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such as highly refined oils derived from GM crops, which do not contain

genetic material of the original GM crop, still have to be labelled as ‘GM’

according to the new Regulation. With regard to traceability, the Regulation

requires that GMOs must be traceable throughout the entire production and

distribution process. Thus, a company selling GM seed must inform any

purchaser that the seed has been genetically modified, supplying specified

information on the identity of the individual GMO(s). The company is required

to keep a register of all recipients of the seed concerned for five years.

Similarly, farmers who buy GM seed must transmit relevant information to

those who buy their harvest, and keep a register of recipients. In the case of

food and feed produced from GM crops, the process is repeated throughout

the production and distribution chain.

g)Regulation 1829/2003/EC on GM Food and Feed

Another Regulation which was formally adopted by the Council of

Ministers in July 2003, is Regulation 1829/2003/EC on genetically modified

food and feed. The new component which the Food and Feed Regulation

introduces is a centralised authorisation procedure for GMOs used as food or

animal feed. This means that those wishing to market GM crop in the EU

need not request separate authorisations for the use of the crop as food or

feed. A crop is either authorised for both uses, or for neither. The use of

GMOs in animal feed did not previously require a specific authorisation

procedure. The Regulation will thus have an impact on imported GM crops,

which are predominantly used as feed for animals. In view of the current

stance of EU consumers, the Regulation is likely to give a considerable

advantage to those producers who offer non-GM crops. The labelling

requirements for GM crops which are used as feed follow the Traceability and

Labelling Regulation, outlined above. However, the Food and Feed

Regulation exempts products such as milk and meat, obtained from animals

fed on GM crops, from mandatory labelling.

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B) Regulation of GM Crops in Developing Countries: At present, most developing countries do not have appropriate legal

and administrative systems in place to regulate biotechnology-related

activities as required by the Cartagena Protocol. However, initiatives such as

the joint project by the United Nations Environment Programme and the

Global Environment Facility (UNEP/GEF) on the Development of National

Biosafety Frameworks (2002-2004) have recently been initiated. The aims of

the project are to prepare parties of the Cartagena Protocol for entry into force

of the treaty; to assist countries which are eligible under GEF to prepare

frameworks for national biosafety; and to facilitate regional cooperation

between countries. The project brings together more than 100 countries and

has close working relations with other relevant organisations. It has received

support from the UK Department for International Development (DFID), which

seeks to devise guidelines for participation by the public in decision making

processes for biosafety frameworks, and also from the EC. The EC recently

offered to fund an initiative to help develop guidelines for establishing risk

assessment and management systems for participating countries. It is clear

that regulation needs to be established primarily at the national level.

However, diverse regulations, requiring that every new GM crop is assessed

for possible risks to human health and the environment in each country, can

cause problems. For most developing countries, it will be a major financial

and logistical challenge to provide the capacity and resources to undertake

such evaluations. The absence of appropriate testing facilities could delay the

granting of approval for much needed improved crops. We, therefore,

recommend that particular attention should be given to measures that will

enable the sharing of methodologies and results. An example is

environmental risk assessments for countries which have similar ecological

environments. It should also be considered whether harmonised regional

policies can be established, for example by the Southern African

Development Community (SADC) and the Common Market for Eastern and

Southern Africa (COMESA). In this context, we welcome the recent initiative

by SADC to produce guidelines on food safety assessment and management

of GM crops. We also recommend that developing countries should

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implement as far as possible standardised procedures for the assessment of

environmental and health risks. Established international guidelines such as

the Cartagena Protocol on Biosafety (the guidelines of the Codex

Commission) should be considered. Care must be taken to avoid an overly

restrictive interpretation of the precautionary approach.

The transfer of experience from advisory and regulatory bodies in

developed countries to the developing world is urgently needed . Poor

compliance of farmers with technical specifications, illegal planting of Bt

cotton in India and the smuggling of GM soybean seeds from Argentina to

Brazil are already raising concerns. By ensuring appropriate public

awareness, and by insisting on transparent arrangements for overview and

enforcement, costs and any risks associated with GM crops can be

minimized. Nevertheless, local communities should be included as far as

possible in decision making processes, for example by means of

consultations with stakeholders. In this context, formal and non-formal

programmes that promote the dissemination of balanced information,

communication, education and training of those involved are essential. In

particular, farmers need to be informed about the technological potential and

management requirements of GM crops. Expectations are sometimes

inappropriately high, and knowledge about specialised farm management

practices may be absent. We recommend that companies marketing GM

crops in developing countries should share with governments the costs of:

Locally appropriate schemes to elicit small-scale farmers’ preferences

regarding traits sought by GM-based breeding;

Their participation, where appropriate, in plant breeding; and

Subsequent mechanisms to improve dissemination of balanced information,

education and training about the use of GM crops.

Such measures can help to ensure that the views of farmers and other

stakeholders are considered in the decision making processes about the

possible use of GM crops. However, the most appropriate approach would

normally be a centralized and evidence-based safety assessment at the

national or regional level. Environmental and health risks should be assessed

on a case by case basis. Wherever possible, such assessments should

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consider information which is available from international sources, particularly

with respect to data about food safety assessments, which are more

transferable than environmental risk assessments.

In addition, the same standards of liability need to apply in both developing

and developed countries. Where there is clear evidence of damage

attributable to the seed producer, compensation will need to be provided,

regardless of whether the seed is GM or non-GM. We note that in previous

instances of crop failures in developed countries compensation has been

negotiated successfully. We recommend that possible scenarios, which

include the principle of compensation, be considered by policymakers and the

seed industry. Agreed standards should be published widely, taking into

account in particular the situation of small-scale farmers in developing

countries. Illiteracy and lack of adequate infrastructure for effective

communication can present additional obstacles that need to be considered.

Wherever possible, agreements should be established, to facilitate

compensation of small-scale farmers who, in the event of loss or damage, are

unlikely to be able to afford appropriate legal action.

C) Regulation of GM Crops in India: The government regulates the seed industry and the seed trade in

various respects. The Seed Act of 1966, the Seeds Control Order of 1983,

and the Seeds Policy of 1988 are the major components of policy specific to

the industry. The Seed Act of 1966 and the Seeds Control Order of 1983

provide statutory backing to the system of variety release, seed certification

and seed testing. Varieties are released after evaluation at multi-location trials

for a minimum of three years. Varieties approved are “notified” which is an

obligatory for certification. While all public sector varieties go through this

process, it is not compulsory for private varieties (Guidelines for Research in

Transgenic Plants, 1998)30.

Major changes in this system of regulation are proposed in the National

Seeds Policy of 2002. Under this policy, variety registration (i.e., notification)

is mandatory for all varieties, new and extant. The evaluation is done over

three seasons of field trials. Besides regulating quality, the government has

also controlled imports and exports of seed. The Seed Policy of 1988 allowed

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limited imports of commercial seed. The proposed new Seed Policy of 2002

allows imports and exports of seeds of all crops. However, all imported seed

is also required to go through the process of registration.

The emphasis on registration in the new seeds policy ties in with the

demands of the Plant Variety Protection and Farmer’s Rights Act passed in

2001. This Act provides for plant breeder’s rights, which requires extant and

new plant varieties to be registered on the basis of characteristics relating to

novelty, distinctiveness, uniformity and stability.

The other major change in intellectual property protection has been the

change in patent laws. The Trade Related Aspects of Intellectual Property

Rights (TRIPs) Agreement came into force in WTO member countries in

1995. This requires member countries to comply with fixed minimum

standards for intellectual property rights protection. As a result, India has

amended its Patent Act in 1999, 2002 and 2005. The major impact of these

provisions has been to provide product patents in the area of

pharmaceuticals. However, the changes have implications for biotechnology

innovations as well. The TRIPs agreement requires that patents be provided

for micro-organisms. It is unclear, however, to what extent the Indian law is

consistent with this provision. It is also not known how the Indian patent office

will choose to define micro-organisms. Six patent applications related to

cotton have been filed in India till December 2003. None have been granted

yet. The regulatory framework for GM crops in India consists of the following

rules and guidelines:

Rules and policies Rules 1989 under Environment Protection Act (1986) Seed Policy 2002

Guidelines Recombinant DNA guidelines, 1990 Guidelines for research in transgenic crops, 1998

Source: Recombinant DNA Guidelines, 199031

i-No person shall import, export, transport, manufacture, process, use or sell

any GMOs, substances or cells except with the approval of the GEAC.

ii-Use of pathogenic organisms or GMOs or cells for research purpose shall

be allowed under the Notification, 1989 of the EPA, 1986.

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iii-Any person operating or using GMOs for scale up or pilot operations shall

have to obtain permission from GEAC.

iv-For purpose of education, experiments on GMOs, IBSC can look after, as

per the guidelines of the Government of India.

v-Deliberate or unintentional release of GMOs not allowed.

vi-Production in which GMOs are generated or used shall not be commenced

except with the approval of GEAC.

vii-GEAC supervises the implementation of rules and guidelines.

vii-GEAC carries out supervision through SBCC(State Biotechnology

Coordination Committee), DLC (District Level Committee) or any

authorized person.

ix- If orders are not complied, SBCC/DLC may take suitable measures at the

expenses of the person who is responsible.

x-In case of immediate interventions to prevent any damage, SBCC and DLC

can take suitable measures and the expenses incurred will be recovered

from the person responsible.

xi-All approvals shall be for a period of 4 years at first instance renewable for

2 years at a time.

xii-GEAC shall have powers to revoke approvals in case of:

a-Any new information on harmful effects of GMOs.

b-GMOs cause such damage to the environment as could not be envisaged

when approval was given.

c-Non-compliance of any conditions set by GEAC.

I) Recombinant DNA Guidelines, 1990:

Department of Biotechnology had formulated Recombinant DNA

Guidelines in 1990. These guidelines were further revised in 1994 to cover

R&D activities on GMOs, transgenic crops, large-scale production and

deliberate release of GMOs, plants, animals and products into the

environment, shipment and importation of GMOs for laboratory research. The

guidelines have been classified into three categories:

Category I activities include those experiments involving self cloning using

strains and also inter-species cloning belonging to organism in the same

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exchanger group which are exempt for the purpose of suggestion and

approval of competent authority.

Category II activities which require prior intimation of competent authority

and include experiments falling under containment levels II, III and IV

(details of each containment level provided separately in the guidelines).

Category III activities that require review and approval of competent

authority before commencement include experiments involving toxin gene

cloning, cloning of genes for vaccine production, and other experiments as

mentioned in the guidelines.

.[[[

II) Guidelines for Research in Transgenic Plants, 1998:

In 1998, DBT brought out separate guidelines for carrying out research in

transgenic plants called the Revised Guidelines for Research in Transgenic

Plants. These also include the guidelines for toxicity and allergenicity of

transgenic seeds, plants and plant parts. Genetic engineering experiments on

plants have been grouped under three categories:

Category I includes routine cloning of defined genes, defined non-coding

stretches of DNA and open reading frames in defined genes in E. coli or other

bacterial/fungal hosts which are generally considered as safe to human,

animals and plants.

Category II experiments include experiments carried out in lab and green

house/net house using defined DNA fragments non-pathogenic to human and

animals for genetic transformation of plants, both model species and crop

species.

Category III includes experiments having high risk where the escape of

transgenic traits into the open environment could cause significant alterations

in the biosphere, the ecosystem, plants and animals by dispersing new

genetic traits the effects of which cannot be judged precisely. This also

includes experiments having risks mentioned above conducted in green

houses and open field conditions.

To monitor the impact of transgenic plants on the environment over a

period of time, a special Monitoring and Evaluation Committee (MEC) has

been set up by the RCGM. The committee undertakes field visits at the

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experimental sites and suggests remedial measures to adjust the trial design,

if required, based on the on-the-spot situation. This committee also collects

and reviews information on the comparative agronomic advantages of the

transgenic plants and advises the RCGM on the risks and benefits from the

use of transgenic plants under evaluation.

III) The Seed Policy, 2002: The Seed Policy 2002 issued by Ministry of Agriculture, Government of

India contains a separate section (No. 6) on transgenic plant varieties. It has

been stated that all genetically engineered crops/varieties will be tested for

environment and biosafety before their commercial release as per the

regulations on guidelines of the EPA, 1986. Seeds of transgenic plant

varieties for research purposes will be imported only through the National

Bureau of Plant Genetic Resources (NBPGR) as per the EPA, 1986.

Transgenic crops/varieties will be tested to determine their agronomic value

for at least two seasons under the All India Coordinated Project Trials of

ICAR, in coordination with the tests for environment and bio-safety clearance

as per the EPA before any variety is commercially released in the market.

After the transgenic plant variety is commercially released, its seed will be

registered and marketed in the country as per the provisions of the Seeds Act.

After commercial release of a transgenic plant variety, its performance in the

field will be monitored for at least 3 to 5 years by the Ministry of Agriculture

and State Departments of Agriculture(Seed Policy, 2002)32.

IV) The Food Safety and Standards Bill, 2005:

The “genetically modified food” has been defined in the Bill as the food,

which is produced through techniques in which the genetic material has been

altered in a way that does not occur naturally by mating or having adequate

human intervention or both. Techniques of Genetic Engineering or

modification include, but are not limited to recombinant DNA, cell fusion, micro

and macro injection, gene deletion, addition and doubling. The Bill has also

mooted the establishment of a Food Safety Appellate Tribunal to hear the

appeals of disputed parties (Food Safety and Standards Bill, 2005)33.

There is a provision for a separate scientific panel on genetically

modified organisms. As per the provisions of the Bill, no person shall

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manufacture, process, export, import or sell genetically modified articles of

food, organic foods, functional foods, health supplements etc. except in

accordance with the regulations made-there for under this Act. Various

Acts/Orders which would stand repealed on commencement of this Act,

include the Prevention of Food Adulteration and sections relating to food

under the Environmental (Protection) Act, 1986 and the Environment

Protection Rules, 1989.

(V) Overview of Ministries and Departments Involved In Regulation of GM Foods in India:

Several central ministries and departments are involved in India’s

program of food quality and safety and hence each one of them has a role to

play in the activities related to GM foods in India. These include:

i) Ministry of Environment and Forest: This ministry holds the Secretariat of

the Genetic Engineering Approval Committee, the apex body that gives

approval for manufacture, sale, import and export of all GMOs and products

thereof including foodstuff , ingredients in foodstuff and additives using

genetically modified (GM) organisms or cells.

ii) Department of Biotechnology: This department holds the Secretariat of the

Review Committee on Genetically Modification that gives approval for

research and small scale field trials involving GMOs and products thereof. It

also interacts with the Institutional Biosafety Committees (IBSCs) set up in all

organizations undertaking activities involves GMOs.

iii) Department of Health in the Ministry of Health and Family Welfare:

Department of Health is responsible for implementation of the PFA Act under

which the quality and safety of food is regulated.

iv) The officials from ICAR and Ministry of Agriculture have an important role

to play in the approval of GM crops as per Seed Policy, 2002.

Thus, the goal of the Indian regulatory system is to ensure that their

genetically modified crops pose no major risk to food safety, environmental

safety, agricultural production, and that there are no adverse economic

impacts on farmers. This last goal is one that many developing countries do

not include in their regulatory systems.

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The basic legal framework governing GMOs (both GM crops and GM

food products) in India is the Environment (Protection) Act, 1986 (the 'EPA').

The Central Government formulated the Manufacture, Use, Import, Export

and Storage of Hazardous Micro-organisms, Genetically Engineered

Organisms or Cells Rules, 1989, that have been effective since 13th

September, 1993 (the ‘Rules’). These Rules regulate all areas of research as

well as large-scale application of GMOs and products made from them in

India, or imported into India. The Rules mandate risk assessment and

regulatory approval for every proposed release of GMOs or GM products. The

Rules and Guidelines mandate the following lines:

Prohibition of unintentional discharge or release of GMOs; and

Prohibition of production, sale, import or use of substances and products

including food stuff, ingredients in food stuff and additives, which contain

genetically engineered organisms or cells or microorganisms, without the prior

approval of the designated authorities.

The functions and responsibilities of the authorities are specified under

the 1989 Rules as well as the 1990 and 1998 Guidelines.

VI) Division of Jurisdiction under the Rules:

Broadly, the Rules envisage division of jurisdiction, authority and

responsibility between the Department of Biotechnology (DBT) and the

Ministry of Environment and Forests (MoEF), which has led to instances of

both conflict and cooperation. The DBT was constituted under the Ministry of

Science and Technology in 1986, for the general purposes of planning,

promotion and coordination of biotechnological programs.

The 1989 Rules constitute regulatory committees under the DBT and

the MoEF for the purpose of considering and giving approvals for GMOs for

research and commercial use. While the DBT committees are responsible for

considering GMO applications for research and small-scale field trials, the

committee under the MoEF is responsible for large-scale trials and

commercial use of GMOs. Applications for food safety before

commercialization of food products containing GMOs is also considered by

the authority under the MoEF.

175

The distribution of powers and responsibilities between the various

committees under the DBT and the MoEF can be given below.

I) GMO Activities & Their Regulation

The 1989 Rules mandate the creation of six competent authorities,

each having jurisdiction over a particular aspect of biotechnology. The

Recombinant DNA Advisory Committee (RDAC) and the Review Committee

on Genetic Manipulation (RCGM) are committees under the DBT. The RDAC

is responsible for making recommendations on rules and procedures for

ensuring biosafety in research and applications of GMOs. The RCGM is

responsible for granting approvals for and monitoring safety aspects of

research projects involving GMOs. It can also give approval for controlled field

experiments.

The Genetic Engineering Approval Committee (GEAC) functions under

the MoEF, and is responsible for the approval of proposals relating to release

of genetically engineered organisms and products into the environment

including large-scale field trials. Given its broad mandate for granting

approvals before commercial release of all GMOs and their products, the

GEAC is the authority responsible for food safety approvals for GM food

products as well.

State Biotechnology Co-ordination Committee (SBCC) are to be

constituted at the state level, and have responsibility for periodic review of

safety and control measures in the various industries and institutions handling

GMOs. The SBCCs function under the supervision of the GEAC at the MoEF.

District Level Committee (DLC) is too constituted under the District

Collectors in every district of a State to monitor safety regulations in

installations engaged in the use of GMOs.

The 1998 Guidelines introduced a seventh committee- the Monitoring

and Evaluation Committee (MEC). It is authorized to conduct field visits at

experimental sites, collect data on comparative agronomic advantages of

transgenic plants and advice the RCGM on risks and benefits, including

recommending changes and remedial measures to the trial designs. The

following table-6 provides information on the composition of each committee.

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Table-6:Committees of Regulation of GM Crops in India

Authorities Composition Recombinant DNA Advisory Committee (RDAC)

The Committee comprises of members nominated from the Department of Biotechnology.

Review Committee on Genetic Manipulation (RCGM)

The Committee comprises of representatives from the Department of Biotechnology, Indian Council of Medical Research, Indian Council for Agricultural Research, Council of Scientific and Industrial Research, Department of Science and Technology and three experts in their individual capacity. The RCGM may appoint sub-groups to monitor specific projects.

Institutional Biosafety Committee (IBSC)

The Committee comprises of the Head of the Institution, scientists in the institution engaged in GM technology, a medical expert and a nominee from the Department of Biotechnology.

Genetic Engineering Approval Committee (GEAC)

The Committee is to be chaired by the Additional Secretary from the Department of Environment, Ministry of Environment and Forests and co-chaired by a representative from the Department of Biotechnology. The other members of the Committee are representatives from all concerned agencies and departments, including Ministry of Industrial Development, Department of Biotechnology and Department of Atomic Energy; expert members who include the Director-General of the ICAR, Director-General of the ICMR, Director-General of Health Services, Plant Protection Adviser, Chairman of the Central Pollution Control Board, and three outside experts in their individual capacity. The Committee may co-opt members/experts as necessary.

Source: Anuradha R.V.(2005)34 The following table-7 provides in a nutshell the jurisdiction of the authorities with regard to various aspects of GMOs.

Table-7: Nature of Responsibility of Regulation Committee

Nature of Activity Responsible Authority Import/Exchange of GMOs or GM products (including plants and food products) for Research

Application to be submitted to RCGM for approval. In addition, a phytosanitary certificate issued by the country of export is required, which is to be routed through the National Bureau of Plant Genetic Resources (NBPGR).

Research for Development of r-DNA products

Application to be submitted to RCGM for approval.

Research for Development of Transgenic Plants

Application to be submitted to RCGM for approval.

Environmental Approval for large scale use of Food Products, and Clinical and

Application to be submitted to GEAC for approval. As a matter of practice, the

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Veterinary processes containing GMOs GEAC refers decision on health safety of GM foods to the Indian Council for Medical Research (ICMR).

Environmental Clearance for Transgenic Plants

Application to be submitted to GEAC for approval.

Field visits to experimental sites and collection of data on comparative agronomic advantages of GM plants

Monitoring and Evaluation Committee of the RCGM

Source: Anuradha R.V.(2005)opcit

3.5 Evaluation of the Regulatory Structure in India:

One of the first controversies as regards the jurisdiction of the RCGM

(under the DBT) and GEAC (under the MoEF) was with regard to when would

a ''contained field trial'' be regarded as a large scale one and the GEAC's

approval would be required. This issue arose in the context of the Bt cotton

field trials. It led to an amendment in September 1999 to the Revised

Guidelines of 1998, clarifying that RCGM would have jurisdiction over trials

conducted in greenhouses and in very small plots. The small experimental

field trials would however be limited to a total area of 20 acres, and each such

area would not exceed 1 acre, in multi-locations in one crop season. Field

trials more than this specified area required approval from the GEAC. Another

issue is that some states in India are yet to constitute SBCCs and DLCs- the

authorities mandated by law to be constituted at the state and district levels.

This has been criticized by many NGO activists, who believe that the absence

of this essential component of the regulatory framework would severely

undermine the implementation of the regulations. There is no infrastructure at

the state level – the mandatory state BCC and DLC that were no conduct

inspections or risk assessments were not even aware of GMOs being grown

in their territories(Shiv Visvanathan and Chandrika Parmer, 2002, Pray ,C.E.,

Bengali ,P. and Ramaswami ,B.,2004 )35, 36. Though the GEAC has permitted

the commercial cultivation of Bt cotton in selected states , there is no

mechanism to check its entry or use in other states that are yet to receive an

approval.

There are concerns about the efficiency and particularly the awareness

of the country in dealing with the large-scale cultivation of GMOs and the risks

arising from them. Poor coordination, breakdown of communication between

the centre and the state authorities and absence of monitoring agencies are

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some of weakness observed in the system. For instance, the GEAC approved

Bt cotton in Andhra Pradesh, despite the absence of a State Biotechnology

Coordination Committee (BCC) and the District Level Committee (DLC). Both

the BCC and DLC are constituted to oversee the implementation of the

regulation as well as the performance of the GM crop. Even during the trial of

MAHYCO’s Bt cotton, BCCs were not constituted where trials took place.

The regulatory institutions have three layers. At the bottom institutional

biosafety committees (IBCs) must be established in any institute using rDNA

in their research. They contain scientists from the institute and also a

member from Department of Biotechnology (DBT), which is part of the

Ministry of Science. There are 230 plus IBCs in India of which 70 deal with

agricultural biotechnology. They can approve contained research at Institutes

unless the research uses a particularly hazardous gene or technique. That

type of research must be approved by RCGM, which is the next layer of the

system.

One of the criticisms of the regulatory processes is regarding its

composition, the process of appointment of members to the various

committees and the lack of checks and balances to ensure independent

functioning. Members of the various committees are primarily from the various

Government departments. The RCGM also comprises of scientists from

several public sector institutions and Government departments engaged in

transgenic research. Both the RCGM and the GEAC also provide for non-

Government ''experts''. Such experts are to be nominated by the Government.

There are no guidelines as to the qualifications of such experts. Most of the

existing experts are academics and scientists in public sector research

institutions or universities engaged in GM research. They are recommended

by official members of the various committees and appointed by the

Government.

The rules and guidelines do not prescribe any terms for any of the

members of the committees for aspects such as appointment, tenure,

disqualification or removal. There is also no independent source of funding for

the committees. The budget for the committees is part of the budget of the

Government departments under which they function, namely the Department

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of Biotechnology and the Ministry of Environment and Forests. Neither the

Rules nor Guidelines prescribe the frequency and time lines for the committee

meetings. As a matter of practice, the number of meetings depends on the

number of applications to be considered.

Certain practical measures are being considered by the Department of

Biotechnology to streamline the existing process. For instance, one

suggestion being considered is to announce in advance on the official website

the time and dates during the year when the RCGM and the GEAC would

meet, so that applicants could schedule their experiments and file the relevant

forms well in advance to be considered at a particular meeting. Another

suggestion being considered is that the Government should compile a list of

institutions that generally meet the criteria and standards for conducting the

trials prescribed by the Guidelines, and the applicant should be able to

choose from these institutions for relevant studies pertaining to its product.

One of the demands from industry representatives has been for greater

frequency of meetings of the GEAC and the RCGM. Another suggestion is for

replacement of committee members of the regulatory bodies who are absent

at the meetings.

A Task Force on Agricultural Biotechnology , constituted to study the

potential and problems of GM crops , suggested the setting up of an

autonomous body , National Biotechnology Regulatory Authority under a

biosafety and technical expert to handle GMOs and that the powers of the

GEAC be limited to only environmental clearance. Like in several other

jurisdictions, regulators in India frequently rely on assessments conducted on

a case-by-case basis using information submitted by the developer of a GM

crop which draws on private tests and field trials also conducted by the

developer. The process is therefore almost like to a private one between the

applicant and the regulator, with the latter dependent on the integrity of the

former. An independent impartial decision-maker, transparency in decision-

making and public accessibility to information, are highlighted as critical

features that are found lacking in the Indian legal framework. This has drawn

criticism from both NGOs and the media, as one of the biggest short-comings

of the Indian regulatory mechanism.

180

There is concern that the unwillingness of the Government and the

private sector to make the research data public and to involve various

sections of society prior to granting an approval indicates the GM crops are

''being pushed through the backdoor.'' Several NGOs have reportedly written

to the Chief Vigilance Commissioner (the authority under the Government of

India responsible for vigilance against corruption in public offices) alleging that

there was scope for manipulation by the private industry of the data regarding

GM products, and since the GEAC relies solely on this data, the matter needs

to be investigated. The fact that the GEAC was not making the data public, is

cited by the NGOs to be another cause for concern.

Several government officials also emphasize that the legal framework

in India is an evolving one that has been responding to criticisms and

incorporating changes. Two such changes often highlighted are:

i) Clearer demarcation of jurisdiction between the RCGM and the GEAC

(which was incorporated in the Regulations), and

ii) Ensuring independent verification of tests on the GM product pending

approval. The tensions between ensuring complete transparency in the

regulatory process and protecting commercial confidentiality, remains to

be determined under the regulatory process.

There has been an absolute explosion of entrants into the transgenic

cotton-seed field in India, some sanctioned by the state and some generated

by an opportunistic rural anarcho-capitalism .This outcome had been

presaged by the announcement of the Government of Maharashtra that its

farmers were to be allowed to grow transgenic cotton as of January 1, 2002,

before Delhi had completed its biosafety assessment and the refusal of the

Government of Gujarat to enforce the order from Delhi to destroy its

transgenic cotton crops in November of 2001 (Sahai 2002)37. The final

statement from Delhi of the Genetic Engineering Approval Committee in

March 2002 simply ratified facts on the ground. GEAC approval was out of the

hands of regulators and scientists and in the hands of politicians, farmers and

operatives of the underground anarcho-capitalism allowed to run free by

stealth seeds.

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3.6 Regulatory Reforms:

Two recent developments that reflect attempts by the Government of

India to re-evaluate the regulatory structure for biotechnology, and chalk the

way ahead for improvements in the same are:

(I)The Report of the Task Force on Application of Agricultural Biotechnology,

formulated by an independent committee commissioned by the Ministry of

Agriculture, and

(II) The Draft National Biotechnology Development Strategy, developed by an

independent committee appointed by the Department of Biotechnology.

Regulatory structures for GM crops was an aspect that was addressed in a

fair amount of detail by the Task Force on Agricultural Biotechnology, and its

conclusions have been endorsed by the Draft National Biotechnology

Development Strategy. The findings of the Task Force have also been

formally adopted by the Government of India, and are expected to be

implemented through legislative amendments. On the regulatory structure, the

basic points of the Task Force are:

(i) The procedures under the existing regulatory structure described above

are lengthy and require to be rationalized. One way in which this could be

done is to make biosafety and agronomic assessments concurrently,

rather than one after another.

(ii) Given the public, political and professional concern about GM products

with reference to their short and long term impacts on human health and

the environment, their testing, evaluation and approval needs to be strict,

elaborate and science-based.

(iii) The Government needs to devise a policy on segregation, traceability and

labeling of products, which would arise on commercial release of GM

crops.

(iv) The GEAC (the entity under the Ministry of Environment and Forests that

is currently responsible for biosafety assessments), should be replaced by

an autonomous statutory authority called the National Biotechnology

Regulatory Authority (NBRA) which would comprise of members qualified

in biotechnology and biosafety. Such an autonomous entity with obligatory

expertise is seen as fundamental to generating the “necessary public,

182

political, professional and commercial confidence in the science based

regulatory mechanism”(Lianchaw, 2005)38.

(v) For transboundary movements, mechanisms for implementing the

Advanced Informed Agreement (AIA) under the Cartegena Protocol should

be established.

With regard to GM food products, the Task Force makes the following

additional suggestions:

(i)There should be a Food Safety Protocol which covers the production,

processing, marketing and consumption of GM crops.

(ii)Mechanisms for segregation, identity preservation and certification and

labeling, is also strongly recommended.

Making rules and guidelines are one aspect of regulation, but, if

required, implementation of these rules by farmers is another aspect to be

considered. For example, in India, it is observed that the majority of cotton

farmers have not planted refugia lines (non-Bt varieties) as required by the

national biosafety laws. This requires infrastructure and capacity at state and

village levels . In many countries, such as India, delay in releasing varieties

are also one of he major causes for illegal trade, where some transgenic

cotton varieties were reported to be planted illegally before the official release

of GM cotton. This type of illegal trade causes serious regulatory, policy, and

trade implications. 11,000 hectares of farm land were cultivated with the

Navbharat seeds and remained undetected for so long reveals the weakness

of the regulatory mechanism. The episode also exposed the GEAC’s inability

to use its legal authority over those who cultivated unapproved seeds and

also upon those who failed to maintain the compulsory refuge belt, ie. 20 per

cent of the total land area. This was a clear indication of the lack of official

capacity to implement the regulatory mechanism. Those who violated the

regulations are unlikely to be prosecuted since the GEAC has no judicial

powers (Kurugant ,K., 2006)39.

The authorities came under severe criticism for their lack of

transparency while giving clearance to the Bt cotton. More democratic forms

of decision- making that involve greater public participation and debate could

be one of the most critical factors that contribute to an effective biosafety

183

regime. Furthermore, for effective implementation of the regulation it is

necessary to strengthen the institutional infrastructure.

184

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