Dealing with GM plants

India's capacity to deal with the problems associated with genetically modified plants is limited by the shortcomings in the structure of the relevant law, financial and institutional constraints and the vastness of its agricultural economy.

R.V. ANURADHA

"For the introduction of genetically modified crops, every country needs to create a biosafety system with clear and coherent guidelines, skilled personnel to guide decision-making, an adequate review process and mechanism for feedback from farmers and consumers."

- United Nations Development Programme's Human Development Report, 2001.

INTERNATIONALLY, countries are divided on the use of genetically modified organisms (GMOs). In the United States, an estimated 60 per cent of processed foods in the supermarkets contain genetically modified ingredients. Commercial application of genetic modification of crops began in the mid-1990s in the U.S., Canada and Argentina, with the cultivation of corn, cotton and soybean varieties that were genetically engineered to be tolerant to herbicides or resistant to pests and viruses. There were no special regulations in the initial stages of testing of such crops. These countries allowed commercial application without making segregation and labelling of products an essential requirement. This trend, however, is changing, with increased awareness of the environmental and health risks associated with GM plants.

European countries have been more cautious in allowing commercial application of GM crops. The European Union began imposing labelling requirements on GM crops and foods in 1997. This was followed in 1998 by a moratorium on registration of new varieties of GM crops till such time as greater consensus and understanding were achieved on the impact of such plants on environment and health. Australia, Brazil, Japan and the United Kingdom are among countries that have made labelling compulsory for products containing GMOs so that consumers can make a choice.

GM crops are slowly making an appearance in South Asia. The lack of informed debate has, however, led to some degree of scepticism and fear about the effectiveness of the Indian legal and regulatory framework in dealing with GM plants. There are also fears that stringent standards in Europe have forced biotechnology companies to seek to shift their activities to countries like India which have large agricultural potential and weak legal and policy regimes.

The chinks in the Indian regulatory framework were first revealed in 1998, when there was no clarity as to which authority gave the Maharashtra Hybrid Seeds Company Ltd. (Mahyco) permission to conduct field trials of Bt cotton in nine States. The authority to sanction field trials vests in the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests. The apprehension was that Mahyco proceeded with field trials with a letter of authority from the Review Committee for Genetic Manipulation (RCGM), Department of Biotechnology, the jurisdiction of which is confined to monitoring the safety of ongoing research relating to biotechnology. Contrary to what is required under the law, the State-level committees were also not consulted.

Questions have also arisen regarding the capacity of a country as large and diverse as India to monitor the use of restricted GM technology in the context of reports of unauthorised cultivation of GM cotton in Gujarat (Frontline, December 7, 2001). Several farmers in Gujarat had purchased GM seeds from Navbharat, a company based in Ahmedabad, which is thought to have developed the seed as a hybrid from GM seeds imported from the U.S. The unauthorised use of GM seeds over the past three years even as field trials were under way to determine their safety raises serious concerns about the feasibility of using this technology in a contained and restricted manner.

EFFECTIVE risk assessment and monitoring mechanisms are the basic pre-requisites of any legal framework to deal with GM plants. In this context, it will be relevant to see how the Indian regulatory framework is structured and explore its weaknesses in view of the peculiar challenges posed by GM technology. The GEAC has recently given conditional approval for the commercial production of Bt cotton in India. Careful monitoring of the conditions for risk assessment are essential since this approval marks a step towards introducing genetically modified crops in India.

Any regulatory framework would essentially have to be structured in a manner that can adequately address the risks and watch out for new risks. What complicates the decision-makers' job is the existence of scientific uncertainties with regard to the GMO under consideration, which preclude the possibility of taking a categorical decision on the existence of risks. The challenge is to manage those risks as and when approval is given. The control and containment procedures would have to be structured separately for each GMO in view of its potential environmental and health risks. This leaves open the space for regulatory authorities to exercise their "discretion" in each case. An ideal law would, therefore, have to incorporate comprehensive procedures to assess risks and to guide the discretion of the deciding authorities, examine lessons learnt in other jurisdictions; communicate to and generate feedback from the public; and provide for an effective inbuilt monitoring system with the power to modify or revoke approvals.

HOW to deal with the problem of scientific uncertainty? This question lies at the heart of any regulatory system for GMOs. It is in this context that the "precautionary principle" has emerged as a basic guideline for the exercise of governmental discretion. However, the problem is that there is not much consensus on the exact scope of the principle. An international debate on its exact application is on.

The disagreements hinge on the fact that every activity is fraught with certain risks, and there can never be full scientific certainty. As has been observed by one commentator, full scientific certainty is a bit of a red herring, because the adverse effects of activities are never "fully understood"; taken literally, the principle would be: "Don't do anything". 1

In a communication dated February, 2000, the European Commission dealt with the various aspects of implementing the precautionary principle and stated that it would be applicable where preliminary objective scientific evaluation indicates that there are reasonable grounds to believe that the potentially dangerous effects on the environment and human, animal or plant health may be inconsistent with the high level of protection chosen for the community. The communication points out that decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information, and that judging what is an "acceptable" level of risk for society is an eminently political responsibility.

In India, under the Environment (Protection) Act, 1986, the Central government formulated in 1989 the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells Rules, which have been effective since September 13, 1993.

The Rules mandate, inter alia, that unintentional discharge or release of GMOs be prohibited and that substances and products, including foodstuff, ingredients in foodstuff and additives (including those used for processing and those used as ingredients) that contain genetically engineered organisms or cells or microorganisms, cannot be produced, sold, imported or used except with the prior approval of designated authorities.

The rules also mandate the creation of six competent authorities, each with jurisdiction over a particular aspect of biotechnology: the Recombinant DNA Advisory Committee, the Review Committee on Genetic Manipulation, the Institutional Biosafety Committee, the Genetic Engineering Approval Committee, the State Biotechnology Co-ordination Committee, the District Level Committee.

Many States are yet to constitute State Biotechnology Committees and District Level Committees on the grounds that the need for their existence was not there.2 Putting in place an institutional machinery and building its capacity to address the peculiar challenges of GM technology is a critical pre-requisite for using the technology in the field.

ANOTHER limitation of the law in India is the lack of adequate standards for risk assessment. While the country has institutions with well-defined roles, the law is vague on what each of the regulatory authorities should look for while regulating a particular GM crop or food. In the absence of legal standards, the possibility of the authority concerned exercising discretion is high.

The Department of Biotechnology issued guidelines for research in GM plants in 1998 (known as Revised Guidelines for Research in Transgenic Plants). The guidelines specify the procedures to be followed in developing GM plants and monitoring them with a view to ensuring environmental safety. Several recommendations are made to minimise risks arising from the limited release of GM plants. These include special separation for isolation, control and monitoring of the plant in the experimental field and appropriate training of field personnel. However, the guidelines do not lay down the procedure and information required for a full environmental risk assessment, and appropriate safety and emergency responses.

There are no published guidelines that the GEAC follows while dealing with approvals for experimental field trials. The GEAC's mandate under the Rules of 1989 is to consider for approval import, export, manufacture, processing, use or sale of any genetically engineered organism or cell. GEAC approval is also required at the stage of developing, testing and experimenting with GMOs. The procedure for risk assessment prior to the grant of approval by the GEAC, however, is not specified in the law.

Under the law, GEAC approval is required for production, sale, import or use of foodstuffs containing GMOs. The Revised Guidelines specify the procedure for import and shipment of GMOs for research purposes. Unlike the laws of many other countries, however, the Indian law also does not provide for instructions and conditions for use or labelling and packaging of products containing GMOs.

The Indian law is yet to incorporate the detailed safeguards recommended in the international law on biosafety as embodied in the Cartegena Protocol on Biosafety, which was concluded in February 2000. The Biosafety Protocol sets out the procedural and substantive obligations of an exporter or importer of GM crops and foods. The Protocol intends to regulate the transboundary movement of GMOs by mandating an Advance Informed Agreement (AIA) between the parties of export and import. An exporter is required to notify the competent authority in the country of import regarding the proposed import of GMOs. The exporter is also required to prepare a risk assessment report regarding the GMO and file it with the competent authority in the country of the importer, so as to enable such authority to take informed decisions regarding the GMOs.

The Protocol recommends a precautionary approach. Article 10 provides that "lack of scientific certainty shall not prevent a party from taking a decision as appropriate... in order to avoid or minimise such potential adverse effects."

WHILE there are shortcomings in the structure of the law itself, certain other constraints prevalent in India, as in most of the developing world, are those related to the capacity of its institutional framework to monitor and implement the law.

One basic limitation is the size and diversity of the country. In the "Navbharat scandal", one aspect that stood out starkly was the practical difficulties faced by the State in testing and monitoring the use of GM seeds (Frontline, November 23, 2001). The farmers who were using the seeds neither knew that they were genetically modified nor were aware of the implications of using them.

Added to the inherent limitations of the vast size of India's agricultural economy are several institutional and financial constraints. Even in financially better-off countries such as the U.S., well-funded agencies involved in regulating GMOs demand budget increases to deal with the new challenges raised by biotechnology. Human Development Report, 2001 has identified several factors that may increase the risks and reduce the ability of developing countries to handle change safely and may therefore constitute a "critical bottleneck" in the use of such technology. These factors, applicable to India as well, are summarised here:

* A shortage of skilled personnel - from laboratory researchers to extension service officers - can seriously constrain a country's ability to create a strong regulatory system.

* The cost of establishing and maintaining an effective regulatory framework can place a severe financial demand on many countries.

* Risk communication would have to be an essential feature of the regulatory framework. Transparent and credible decision-making involves exchange and communication of risks between all stakeholders in the risk management process. But in many countries there is no official communication strategy to inform the public about the risks and about the ways to handle biosafety.

* A user's ability to follow safety procedures determines whether the benefits of technology can be reaped or not. But mechanisms to provide information to and gather feedback from users may not be well-developed. Even in the U.S., where farmers have multiple sources of support and advice on safety procedures, a survey in 2000 found that 90 per cent of the farmers planning GM maize crops believed that they were following the correct safety procedures but in reality only 71 per cent were doing so. In developing countries, such mechanisms for providing information and gathering feedback are typically weaker.

* While developing countries could take advantage of the regulatory experience and expertise of other industrialised countries, risks, especially environmental risks of biotechnology, are often specific to individual ecosystems and need to be addressed case by case.

It is, therefore, evident that India has a bit of catching up to do with regard to GMO regulation. The basic question is: is it wise to go ahead with the commercial application of GMOs till the country achieves the capacity to deal with their peculiar risks?

Endnotes

1. Chirstopher D. Stone, "Is there a precautionary principle?", Environmental Law Reporter, July 2001. 2. Chandrika Mago, "Modified crop regulations can't nip the weed", The Times of India, October 21, 2001.

Author's note: In Part I of this article (Frontline, April 26, 2002), a finding regarding genetic contamination of corn in Mexico was reported - (Risk iii). The original study regarding this finding was published by Nature in November last year. However, in a recent issue (April 11, 2002), an editorial note states that 'Nature has concluded that the evidence available is not sufficient to justify the publication of the original paper'. In view of this retraction, the debate on whether DNA from genetically engineered corn contaminated native Mexican corn remains unresolved.

R.V. Anuradha is a lawyer who has worked on issues pertaining to environment and trade laws.