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CHAPTER-3 DEVELOPMENT OF GM SEEDS IN
INDIA
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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
148
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”
155
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
172
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
173
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.
174
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.
176
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
177
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
178
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
179
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.
181
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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