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Policies Toward GM Crops In India cont.,

III. Biosafety Policy

Biological safety has not been, historically, a strong public policy thrust in Indian agriculture. Rural biological systems have long been threatened by low resource farmers who clear new lands and destroy natural habitat in order to graze animals or plant crops. Mismanagement of irrigation water has left once fertile croplands poisoned with salt. Careless application of chemical nutrients has contaminated rivers, streams and ponds, making water unsafe for human consumption and poisoning fish and amphibian species. Improper use of insecticides has killed non-target species while making target pests increasingly resistant to the poisons. Even after the enactment of India’s powerful 1986 Environmental Protection Act (EPA), such conventional biohazards from farming were seldom put under effective regulation. It is thus somewhat surprising to see Indian officials paying so much attention to the biological safety of GM crops. India's official interest in genetic resource IPRs would have been strong even without GM crops as an issue, but the nation's current official interest in rural biological safety is to a large extent a product of the GM crop revolution itself.

India’s first embrace of a formal national biosafety policy dates from the first emergence of rDNA agricultural and human health technologies in the 1980s. We might expect, given India’s strong development aspirations and its prior history of low attention to the rural biohazards, that the nation's biosafety policies toward GM crops would have been permissive or even promotional, rather than precautionary or preventive. Instead, the Indian Government adopted from the start a set of procedures that ensured significant precaution, and as implemented - in the context of a growing global controversy over GM crops - these procedures sufficed to slow the progress of the technology considerably. As of 2000 farmers in India were not yet permitted to grow any GM crops, because none had yet received final approval from the nation's biosafety regulators.

The Indian Government first issued rules and procedures for handling GM organisms in December 1989. The Department of Biotechnology, inside the Ministry of Science and Technology, published these rules and procedures in January 1990 (Department of Biotechnology 1990). These "Recombinant DNA Safety Guidelines" were revised slightly and republished as "Revised Guidelines for Safety in Biotechnology" in 1994 (DBT 1994). They describe the biosafety measures that must be undertaken in India both for contained research activities and also for large scale open environmental release of genetically altered agricultural and pharmaceutical materials. A subsequent 1998 revision of the Guidelines elaborated procedures for screening transgenic plants and seeds for toxicity and allergenicity (DBT 1998).

India's crop biosafety Guidelines were written to require a screening of GM crop technologies for scientifically demonstrated risks, borrowing heavily from the demonstrated risk approach employed by USDA's Animal and Plant Health Inspection Service (APHIS) in the United States. This has given the Guidelines considerable permissive content on paper. Yet the implementation of the Guidelines is ultimately shared with India's Ministry of Environment, a procedure which inclines India's policy somewhat more toward precaution. The Guidelines create two separate review committees: a Review Committee on Genetic Manipulation (RCGM) which is empowered to approve (or not approve) applications for all small scale research activities in India designed to generate information on transgenic organisms, and a Genetic Engineering Approval Committee (GEAC) empowered to approve (or not) large scale research activities, plus actual industrial use or environmental release of all GM organisms. 2

Because the RCGM mostly screens research activities for biosafety, it is composed of representatives from India’s leading public universities and research Institutes, including the Indian Council of Agricultural Research (ICAR), the Indian Council of Medical Research (ICMR), the Council of Scientific & Industrial Research (CSIR), and others. It is constituted by the Department of Biotechnology (DBT), and its member-secretary is adviser to DBT. It has thirteen members in all, and operates by majority vote. In contrast the GEAC is a statutory body under the Ministry of Environment and Forests (MoEF) and is empowered to approve or disapprove all large-scale use and environmental release of GM organisms. GEAC is thus India’s most powerful biosafety policy gatekeeper. It is chaired by the Additional Secretary of MoEF, co-chaired by an expert nominee from DBT, and it includes representatives from DBT, from the Ministry of Industrial Development, the Ministry of Science and Technology, and the Department of Ocean Development.3 GEAC is designed to perform more than a technical function. It is the lead interministerial body empowered to shape - by consensus - the Government’s final disposition toward large-scale use and environmental release of GM organisms. The GEAC is empowered to authorize or prohibit, conditionally or unconditionally, the import, export, transport, manufacture, processing, use, or sale of any GM organism (Ghosh and Ramanaiah 2000).

This Indian biosafety system was intended to be permissive at the research stage, where RCGM was given the final word. Since RCGM is constituted by DBT - the agency explicitly tasked with promoting biotechnology in India - its membership comes from the very research institutes (in some cases the very individuals) who conduct biotech research and who rely on DBT for funding. When RCGM hands the regulatory process over to GEAC, after the research stage, a precautionary bias takes over, since GEAC is chaired by MoEF. This built-in tension between permissive research versus precautionary release might have some advantages in theory. By allowing research to go forward, India's process is capable of generating the necessary empirical data (e.g., from field trials) needed to make sound final release decisions(Ghosh 1997). India's system may also be potentially useful for avoiding last minute jurisdictional disputes between biotechnology commissions and environmental ministries, of the kind seen in Brazil between CTNBio and IBAMA. In India, biosafety regulation stays legally under the EPA and within the jurisdiction of GEAC from start to finish. The public sector dominated Indian system also excludes representatives of private industry from direct participation, another contrast to Brazil, and it requires that RCGM send a Monitoring Committee to visit the experimental sites that are being employed by applicants to generate biosafety data (DBT 1998). 4

India's Guidelines are quite thorough regarding the biosafety questions that must be answered prior to commercial release of GM technologies. In the area of transgenic plants, basic information must be provided on the characteristics of the donor organisms, the vectors used, the transgenic inserts, and then on the resulting transgenic plants themselves. Through lab, growth chamber, greenhouse and field trials, evaluations must be generated by applicants regarding toxicity and pathogenicity, possibility and extent of transgenic pollen escape and transfer to wild relatives, and consequences for both the environment and human and animal health. The data may be generated in India or anywhere else (Ghosh 1997). Guidance is provided on proper (biosafe) procedures for conducting these experiments, along with the proper format for presenting this information as a formal registration document. Some of the data required by India's procedures go well beyond biosafety. RCGM is required in the latest version of the Guidelines to solicit from applicants and assemble information "on the comparative agronomic advantages of the transgenic plants" to assure GEAC that the technologies under review are "economically viable" as well as environmentally safe (Department of Biotechnology 1998, p. 6). While this might seem an added barrier to approval, it could also favor approvals in some cases by allowing evidence of social benefits to be presented alongside evidence of possible environmental risks.

This being the structure of India’s biosafety review system for GM organisms, how has it operated in practice? In the area of health care, a number of GM products have been reviewed successfully with little controversy. As of March 2000, a total of ten different transgenic health care products in India (two locally produced, 8 imported) had moved all the way through the system and had been cleared for biosafety deregulation by GEAC. Social confidence regarding the biosafety of GM health care products has been consistently high in India. In the area of transgenic plants, however, the system has not moving so smoothly. Under criticism from NGOs, even RCGM has been forced into a highly cautious posture, and as of 2000 GEAC had yet to grant a commercial release for any GM crops.

India's biosafety review system for GM plants was pushed into this cautious posture in 1998, when RCGM was accused by NGOs in India of having exceeded its mandate by giving approval to limited field trials for Mahyco/Monsanto’s Bt cotton plants. The original Guidelines had been ambiguous as to where RCGM’s authority to manage small-scale research activities would end and where GEAC’s authority to manage large-scale activities and "environmental release" would begin. When Mahyco applied to conduct contained field trials of its Bt cotton in 1998, RCGM assumed it had the authority to approve such trials, in part because it had earlier approved contained field trials of transgenic mustard in 1995 without incident. Yet the Bt cotton field trials approved for 40 locations in nine different states India in 1998-99 soon became a focus of intense national controversy, as noted above. NGOs in India, led by RFSTE, claimed that only GEAC had authority to approve field trials of GM crops, since even contained and limited trials constituted an environmental release. In February 1999, RFSTE then filed a PIL against the DBT for the manner in which it had authorized the trials (and also against Mahyco plus several other ministries), asking - without success - that further field trials be blocked.

RFSTE's challenge to the Bt cotton field trials was motivated not so much by any specific biosafety worry. The "Bollgard" Bt cotton seeds that Monsanto had brought in to cross with local Indian varieties had previously undergone extensive testing and monitoring in the United States to meet the biosafety standards set by APHIS and EPA. Bt cotton had been grown successfully in the United States on a commercial scale since 1996, and by 1998 it covered 40 percent of total U.S. cotton area. By 1998 it was also being grown widely and successfully in Australia, South Africa, and China. Bt cotton was potentially attractive in India as a solution to the bollworm infestations that farmers could no longer control with chemical sprays due to resistance in the pest population. This emergence of a real pest resistance problem from non-GM technologies made it harder to invoke hypothetical pest resistance problems as a reason not to plant GM cotton. resistant pest population in India in response to non-GM cotton production techniques made it harder to invoke hypothetical "superbugs" as a reason not to use GM cotton. Food safety risks were also hard to invoke for Bt cotton, since cotton is an industrial crop rather than a food. RFSTE was using biosafety rules and procedures as its means to try to block Bt cotton, but the core of its argument against this GM crop was that it was being introduced by the Monsanto company from abroad, the company which owned rights to a dreaded "terminator" technology.

Yet RFSTE also sought to make its case by pointing to procedural irregularities in RCGM's approval of the field trials. RCGM was faulted for having given field trial authority directly to a private company applicant, and for then allowing that applicant to launch the trials directly on leased farmers’ fields, rather than on government research farms under direct public sector management. While this would seem a logical way to handle an application filed by a private company, RCGM might have known it would be seen in India as trusting the private sector too much. Second, RCGM had not secured advance approval from government authorities in several of the states where the trials were located, and in at least one of those states the trials even began before a local biosafety committee had been fully constituted. These several irregularities were exploited by RFSTE, and left RCGM and DBT politically isolated when fears regarding the terminator gene subsequently broke. Nor did it help that RCGM’s procedures in this case had been largely non-transparent. RCGM could point out that there was no formal obligation to publish deliberations or invite public comment prior to approving the limited trials, but when the trials became controversial RCGM and DBT were criticized all the more heavily for having operated behind closed doors (Raj 1999). In the midst of this controversy in 1999, DBT’s biosafety Guidelines were amended to clarify that GEAC’s approval would be required for all field trials larger than one acre per location, or larger than 20 acres per year nationally. DBT also directed that the 1999 field trials for Mahyco’s Bt cotton would take place either on university research farms or under closer national institute supervision. This, plus a DBT-led public awareness campaign in 1999, plus ministerial promises that the terminator gene would not be allowed into India, helped calm the public mood considerably.

Although India's Bt cotton trials went forward under protest and criticism, they did manage to generate important evidence of the GM plant's effectiveness against bollworm infestations. These pest attacks on cotton in India had emerged as a visible social issue due to the growing resistance of the pests to chemicals, and the resulting desperation of some small farmers. Excessive spraying of diluted and adulterated chemical insecticides - in some parts of India as many as 14 sprayings a season - had brought on the pest resistance problem, and some poorer cotton farmers in India who had borrowed heavily at a high rate of interest to buy chemicals that no longer worked were falling heavily into debt. Their plight came to public attention when bad weather worsened the pest crisis in 1998, and as many as 500 farmers resorted to suicide as their only way out (Sharma 2000). The first 1998 field trials of Bt cotton in India had seemed to confirm, meantime, that Bt varieties could provide at least a short-term solution to the pest control problem. DBT reported in 1998 that on average (in controlled field trials planted in eight different states in India) Bt cotton was able to reduce insect damage dramatically: yields for Bt cotton were 40 percent higher than for the non-Bt controls, and with an average of five fewer chemical sprays (Ghosh and Ramanaiah 2000; James 2000). For an Indian farmer with 5 ha of cotton, such a reduction in chemical use from switching to Bt cotton might by itself represent a savings of roughly Rs 2000 per crop (about $50).

RCGM was pleased and reassured by the 1998 field trial data, but nonetheless asked Mahyco in 1999 for ten more field trials, seeking more data on commercial advantages to farmers and also on a hypothetical geneflow concern, the possibility that insects could take Bt cotton pollen far enough away from the plant to result in unwanted gene transfer to other plants. Only after these additional trials had been completed did RCGM, in April 2000, formally express its technical confidence in Bt cotton. RCGM noted that its latest evidence showed farmers growing Bt cotton obtained 25-75 percent higher yields, while using six fewer chemical sprays, and with no evidence of harm to crops in adjacent plots.

Having received this approval at the research stage from RCGM, Mahyco promptly applied to GEAC for permission to begin large scale trials, and in response to this application, GEAC did approve large scale field trials for Bt cotton (up to 85 total hectares) in July 2000. Additional acreage was also permitted for seed production, in anticipation of a possible commercial release as early as 2001. To appease protesters GEAC made large scale field trials conditional on obtaining an independent Indian laboratory certification that the cotton plants did not contain the "terminator" gene. Even so, RFSTE was antagonized and submitted an additional petition against the trials. GEAC's prompt field trial approval increases somewhat the likelihood of an eventual commercial release for Bt cotton in India, although the first release may be only within a tight acreage restriction, once again on grounds of biosafety caution.

Has the Indian system been precautionary in this case only because the Bt cotton is a Monsanto variety? A second application working its way through India's system, from another company (ProAgro-PGS) to develop transgenic hybrid mustard, also met a cautious response from RCGM. Contained field trials of GM mustard began in 15 different locations in 1995, followed by open field trials, and none of these field trials was ever disrupted by an anti-GM activist, yet the process of bioscreening was highly precautionary just the same. In 1999, India's regulators asked ProAgro-PGS for one more year of field trials to screen for effects on soil micronutrients, an issue that had never been highlighted before. ProAgro-PGS hoped for eventual deregulation from GEAC, but recognized that it may be a conditional release only, perhaps with a requirement (hard to enforce) that farmers planting the GM mustard seeds separate themselves at least 40-50 meters from non-GM fields, as an extra precaution against unwanted geneflow. While India's anti-GM NGOs may be focused almost exclusively on keeping Monsanto's products out of the country, biosafety regulators in India have thus been highly precautionary toward all GM crop applications, whether from Monsanto or not.

2. Four additional institutional mechanisms are created by the Guidelines as well, but these perform mostly advisory or implementing functions. These are the Recombinant DNA Advisory Committee, the Institutional Biosafety Committees, the State Biotechnology Coordination Committees, and the District Level Committees.

3. It also has as expert members the DGs from ICAR, ICMR, CSIR, Health Services within the Ministry of Health, the plant protection adviser from the Ministry of Agriculture, the Chair of the Central Pollution Control Board, plus a member-secretary from MoEF and three individual outside experts.

4. These screening procedures for GM crop biosafety in India were set in place after the passage of a comprehensive national environmental protection law (the EPA of 1986), and were based firmly on that law. India's Parliament will soon be considering a new Cabinet-approved Biodiversity Act, which will provide formal legal backing for implementation of the 1992 CBD, but the sections of this Act touching on the biosafety of GM crops were written to be compatible with the existing Guidelines, so DBT expects no jurisdictional challenge to develop. Brazil's CTNBio and Kenya's NBC were not comparably protected.

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