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Legal Framework Around GM Crops

First Published: February 11, 2016 | Last Updated:February 11, 2016

Globally, the Convention on Biological Diversity (CBD), particularly its

Cartagena Protocol is related to GM crops. The basic focus of Cartagena
protocol is Biosafety. This protocol is based upon the premise that the LMOs
have become ingredients of an increasing number of products, including
foods and food additives, beverages, drugs, adhesives, and fuels; and there is
a need of international framework on Biosafety including risks to biological
diversity. The rst important provision under this protocol is that it allows
governments to signal whether or not they are willing to accept imports of
agricultural commodities that include LMOs. If they want it or not want it,
they can communicate their decision via a Biosafety Clearing House, a
mechanism set up to facilitate the exchange of information on and experience
with LMOs.

Second important provision is that the export commodities which have LMOs
as ingredients should be cleared labelled.

The third important provision is of stricter Advanced Informed Agreement

procedures, which apply to seeds, live sh, and other LMOs that are to be
intentionally introduced into the environment. In these cases, the exporter
must provide detailed information to each importing country in advance of
the rst shipment, and the importer must then authorize the shipment.

The objective of the above three provisions is to ensure that the recipient
countries have both the opportunity and the capacity to assess risks involving
the products of modern biotechnology.

Moreover, the Cartagena protocol adopts the precautionary principle and

allows the countries, particularly developing countries to have a say in
balancing public health against economic benets.

Another protocol of CBD i.e. Nagoya Protocol is focussed around Access to

Genetic Resources and the Fair and Equitable Sharing of Benets Arising from
their Utilization. When a microorganism, plant, or animal is used for a
commercial application, the country from which it came has the right to
benet. Such benets can include cash, samples, training and research
participation and other prots.

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Contents [hide]

Legal Framework on GM Crops in India

Environment Protection Act and GEAC
National Biological Diversity Act 2002
Biotechnology Regulatory Authority Bill
Complexity of Legal Framework: Case Study of Mahyco

Legal Framework on GM Crops in India

Since as early as 1980s, the government of India has shown an interest in the
area of farm biotechnology. To identify priority areas and to develop a long
term plant, the government established National Biotechnology Board
(NBTB). In 1986, it was transformed in Department of Biotechnology, under
the Ministry of Science and Technology. The Government research institutes
have been involved in biotech research for a variety of the crops. In our
country, the GM crops are regulated under the following:

Environment Protection Act and GEAC

All transgenic crops in India require environmental clearance under 1989

Rules for Manufacture, Use, Import, Export and storage of hazardous
microorganisms/Genetically Engineered Organisms or Cells notied under
the Environment (Protection) Act, 1986. Via these rules, a Genetic
Engineering Approval Committee (GEAC) was established in 1989, as apex
body for this matter. The rules 1989 are also known as Biosafety regulatory
framework, which were issued by MOEF in 1989 and amended from time to
time. This framework covers areas of research as well as large scale
applications of GMOs as well as hazardous microorganisms which may not be
genetically modied. The rules cover activities involving manufacture, use,
import, export, storage and research. The structure of various competent
bodies under this framework is as follows:

At every institutional level, an Institutional Bio safety Committee (IBSC)

headed by the Vice-Chancellor oversees the safety needs of the research.

There are committees at the district, State and Central levels, including the
Review Committee on Genetic Manipulation (RCGM), State Biotechnology
Coordination Committee (SBCC) and District Level Committee (DLC) for
handling of various aspects of the rules. GEAC is the apex body. It is the
clearing house for all GM crops in India.

The following graphics shows how a GM crop is released in India.

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National Biological Diversity Act 2002

National Biological Diversity Act 2002 has provisions to deal with the possible
risks associated with the application of modern biotechnology. The apex body
constituted under this act is National Biodiversity Authority (NBA). As per
this act, all foreign nationals require approval from NBA for obtaining
Biological Resources. All Indian individuals/entities are required to seek NBA
approval before transferring knowledge / research and material to foreigners.
Prior approval of NBA is needed before applying for any kind of IPR based on
research conducted on biological material and or associated knowledge
obtained from India. Thus, non-citizens, non-residents, and body corporate
not registered in India or with non-Indian shareholders need NBAs approval
for accessing biological resources of India under section 3 of this act. People
in the region and communities, growers and cultivators of biodiversity, and
vaids and hakims do not need NBAs approval. On state level this act makes
provisions for state level biodiversity board.

Biotechnology Regulatory Authority Bill

The government had also introduced in April 2013 the Biotechnology

Regulatory Authority Bill, which proposed to give easy access to GM crops in
India. The bill is in cold storage as of now.

Complexity of Legal Framework: Case Study of Mahyco

Despite of such complex system of Biosafety regulatory framework, our

capacity to deal with various issues is limited mainly due to shortcomings in
the laws, constraints of nancial and institutional nature and vastness of
Indias primary economy.

The deciency of our countrys regulatory framework around the GM crops

was rst revealed in 1998
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(Mahyco) started eld trials of Bt Cotton in nine states and no one exactly
knew which authority allowed it to do so. The authority to sanction these
trials was GEAC as all transgenic crops in India require environmental
clearance under 1989 rules. However, it was reported that Mahyco proceeded
with letter of authority from RCGM and did not consult the state level
committees.

Moreover, it was never clear whether Bt Cotton was safe or not. But anyhow,
initial formal sector studies found the positive agro-economic eects of Bt
Cotton. These studies were reported in the Parliament from ocially
sanctioned eld trials of Bt cotton. The studies were conrmed by the
advocates of the Bt Cotton that it resulted in increased yield because of
superior bollworm control; bringing down cost of bollworm control and
thereby raising the net incomes of the farmers. Thus, ocial approval of Bt
Cotton was granted in March 2002, and Bt Cotton became the rst GM crop
approved in India. Mahyco became the rst Indian company to commercialize
transgenic cotton hybrids in India in 2002.

Similarly, the problems with the NBA act 2002 is that it does not say anything
on Public Institutions and many of its provisions overlap with that of
Environmental law and rules released under it.

Thanks to RTI act and Indian Judiciary which directed the government to
make public within 10 working days all the relevant data on genetically
engineered brinjal, okra, mustard and rice which have been approved for
multi-location trials. The decision established the position that if a GM food
causes allergies or contains toxins, the government cannot refuse to disclose
such bio-safety information on the grounds that it involves commercial
condence or trade secrets and that it will compromise the competitive
position of the biotech company concerned.

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