Legal Framework Around GM Crops

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 first 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 fish, 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 first 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 benefits.

Another protocol of CBD i.e. Nagoya Protocol is focussed around Access to Genetic Resources and the Fair and Equitable Sharing of Benefits 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 benefit. Such benefits can include cash, samples, training and research participation and other profits.

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” notified 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 modified. 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.

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 NBA’s 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 NBA’s 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 financial and institutional nature and vastness of India’s primary economy.

The deficiency of our country’s regulatory framework around the GM crops was first revealed in 1998 when Maharashtra Hybrid Seeds Company Ltd. (Mahyco) started field 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 effects of Bt Cotton. These studies were reported in the Parliament from officially sanctioned field trials of Bt cotton. The studies were confirmed 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, official approval of Bt Cotton was granted in March 2002, and Bt Cotton became the first GM crop approved in India. Mahyco became the first 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 confidence or trade secrets and that it will compromise the competitive position of the biotech company concerned.