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 Indias 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. Indias 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 Indias 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 2 research activities, plus actual industrial use or environmental release of all GM organisms. Because the RCGM mostly screens research activities for biosafety, it is composed of representatives from Indias 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 Indias 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 3 Development. GEAC is designed to perform more than a technical function. It is the lead interministerial body empowered to shape - by consensus - the Governments 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 4 to visit the experimental sites that are being employed by applicants to generate biosafety data (DBT 1998). 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 Indias 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/Monsantos Bt cotton plants. The original Guidelines had been ambiguous as to where RCGMs authority to manage small-scale research activities would end and where GEACs 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 RCGMs 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, DBTs biosafety Guidelines were amended to clarify that GEACs 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 Mahycos 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 ProAgroPGS 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.

Policies Toward GM Crops In India cont.,

As innovative and ambitious as these provisions for financial compensation to farmers might be, they have not gone far enough to satisfy Indias most determined critics of UPOV-style plant variety protection. In 1998, Indias activist Research Foundation for Science, Technology and Ecology (RFSTE) headed by Vandana Shiva, who is an internationally known opponent of GM crops, the green revolution, and all other market-led scientific advances in Indian agriculture. RFSTE proposed an alternative Biodiversity Rights and Protection Bill that would give local farming communities not just financial compensation but actual property rights over the crop varieties to which their traditional on-farm breeding efforts had made contributions. The Bill specifie that local communities would share these property rights with the Central Government of India so that private companies suspected of seeking to pirate away valuable genetic materials would not be able to approach local communities separately to gain access to these materials on unequal terms (Cullet 1999). The intent of this proposal was to reject any movement in India toward a western-style IPR system in the area of plant genetic resources; when th Government persisted with its PVPA approach, RFSTE initiated a public interest litigation action (PIL) against the Government.

The issue of GM crops only adds new complication to this already intense internal debate in India over plant variety IPRs. In 1998, when the Monsanto Company of the United States purchased a 26 percent share of Indias own Maharashtra Hybrid Seeds Company Limited (Mahyco), a Monsanto executive was quoted in the Indian press saying "We propose to penetrate the Indian agriculture sector in a big way. Mahyco is a good vehicle." (The Economic Times, New Delhi, April 26, 1998). Opponents of transnational corporations within India took this as a direct challenge, and began directing harsh criticism at all of Monsantos GM crop technologies, especially the "terminator gene" patent it had recently acquired, which was presented as a direct threat to the tradition of seed saving in India. It was Monsantos misfortune that word this new gene use restriction technology (GURT) reached India just at the time limited trials of Mahyco's Bt cotton were being authorized for the first time. A Canadian based NGO, the Rural Advancement Foundation International, or RAFI, spread the alarm that Monsanto's terminator gene might be turned loose in India. Local NGOs opposed to international companies and non-traditional farm technologies were thus mobilized easily against GM crops. In November 1998, a local political leader in Karnataka state who had previously gained attention by attacking both the Cargill seed company and a Kentucky Fried Chicken restaurant in Bangalore, staged for the media a brief attack on some of Mahycos Bt cotton field trials. Soon thereafter local communist party leaders in Andra Pradesh pressured the Chief Minister into calling for an end to the Mahyco Bt cotton field trials underway there as well.

Gene use restrictions technologies had not yet been inserted into GM crops anywhere let alone the Bt cotton being tried out in India, but this issue made Monsanto and Mahyco easy targets for NGO and opposition party criticism. The mere existence of a terminator gene patent seemed to confirm suspicions that international seed companies were seeking to take away from Indias farmers their traditional right to replicate seed on their own farms. In India, 92 percent of all wheat seed planted is home grown, and 88 percent of paddy rice seed. NGOs and globalization critics feared that India's small farmers would be pressured by Monsanto or Mahyco into purchasing expensive GURT seeds, only to discover too late that they had to keep purchasing them year after year. The same argument could have been made against conventional non-GM hybrid seeds, which are currently used and repurchased annually by small as well as large farmers in India growing maize, sorghum (jowar), mille (bajra), sunflower, cotton, and vegetables, but the terminator technology was far more inviting as a proxy for criticizing profit-making foreign companies. Monsanto announced in the fall of 1999 that it was not going to commercialize the technology, yet by then the damage was already done, including damage to the Government's continuing efforts to move the PVPA law through Parliament. Enactment of the PVPA in India was also made more difficult by links to the TRIPs agreement in WTO. Many of the same groups who saw IPRs for plants as the opening wedge for external corporate domination of India also feared the WTO, which is often criticized in India as an instrument used by rich countries to bully poor

countries. Under the TRIPS agreement India was technically obliged to change its patenting system from processes to products, and to have a plant variety protection law in place by January 2000, but this deadline came and went without parliamentary action. Prospects for eventual Parliamentary passage of some version - probably a weakened version - of the Governments PVPA bill were nonetheless strong in 2000. The National Democratic Alliance government sent its most recent version of the bill to Parliament for approval in December 1999, just before its January 2000 WTO deadline for TRIPs compliance. It was then referred to a thirty-member joint committee of both Houses which redrafted the bill so as to strengthen its farmers' rights provisions, by recommending that appeals be heard not by the High Courts but by a specially formed tribunal. The delays continued, but WTO was unlikely to criticize India for not having a PVPA in place so long as the delay seemed to reflect the slow movement of democratic procedures.

This failure of India through 2000 to set in place any formal IPR protections for plants was not, however, the principal reason that GM crop technologies were not yet in use by farmers. Because of the size of India's commercial seed market, private international companies have at times been eager to bring GM technologies into the country even in the absence of IPR guarantees. Their preferred means for doing this has been to seek to introduce hybrid varieties, which carry their own inherent biological protections against seed saving and replanting. It has not so far been a corporate unwillingness to bring valuable proprietary GM crops into India that has kept this technology out of farmers' hands. India's weak IPR policies do, however, place some limits on what international private companies are willing to do, as well a on what India's own breeders have an incentive to do. Because of weak IPRs, private companies do not like to conduct advanced research in India labs. In its Bt cotton venture the Monsanto company conducted no plant transformations within India itself; instead it brought in hybrid cotton seeds that had already been transformed abroad. Nor did not begin field trials until it owned a secure share of a local corporate partner that had been entrusted to do the backcrossing. A Belgian biotechnology firm, Plant Genetic Systems, was almost as cautious when it decided to bring its transgenic "seedlink" technology into India, to develop an improved brassica (mustard). It invested an initial US$1 million in a joint venture with a trustworthy local private sector partner, Pro Agro, and even so it limited its transfer of transgenic materials to local Indian hybrids only.

If India wishes to partner with foreign companies to secure access to GM technologies for plants other than hybrids (for example, glyphosate resistant soybeans), passage of a credible plant variety protection law will be critical. Up to a point, bilateral contracts can be used to compensate for a weak internal IPR law, yet without at least a UPOV 1978 plant breeders rights system in place, Indias public sector researchers risk being passed over as unsafe technology development partners by the more dynamic international private sector. Guarding Indias own nationally managed germplasm accessions from private appropriation could also become more difficult, public registration strategies notwithstanding. For these reasons India's Council f Scientific and Industrial Research (CSIR) has been campaigning for a stronger IPR and patenting system in India, in agriculture as well as in other sectors.

In the longer run, IPR guarantees even stronger than those contained in the current draft PVPA may be necessary if India wishes to keep pace in GM science. The draft PVPA has been criticized by the private seed companies as unattractive for their purposes in several respects. The draft PVPA lays a basis (in Chapter X) for compulsory licensing after three years to meet "the reasonable requirements of the public for seeds." It creates a registration process open to delay and challenge which could add another three years to the already long time period (currently 6-7) years required in India to get a new seed variety completely de-regulated and eligible for commercial release. And by embracing the UPOV 1978 standard the PVPA does not provide scientists with sufficient incentive to innovate at the molecular level, since protection of GM varieties may not be extend to included essential derivations from those varieties. The President of Indias private Seed Association, while a supporter of the PVPA, has stated his view that it "does not provide sufficient protection for bioengineered plants." (Selvarajan, Joshi, and OToole 1999, p. v). Private seed companies would of course prefer product paten as the best means to encourage innovations in biotechnology, but Indian scientists working at the molecular level inside the national research system als want stronger standards; they would prefer the UPOV 1991 standard over the weaker UPOV 1978 standard contained in the current draft PVPA .

Without a plant variety protection law formally in place, India as of 2000 must be classified as taking a preventive stance toward GM crops in the IPR area and even after the draft PVPA is eventually enacted India's posture in this area will be no more than precautionary. Still, it has been India's biosafety policies, not its IPR policies, that have most conspicuously slowed down the nation's GM crop revolution. Previous Next

BIOSAFETY GUIDELINES
1 (c) (i) Genetic Engineering Approval Committee (GEAC) and Cartagena Protocol on Biosafety (CPB)

A.

BACKGROUND

Biosafety concerns have led to the development of regulatory regimes in various countries for research, testing, safe use and handling of GMOs and products thereof. India is one of the earliest countries to establish a biosafety system for regulation of GMOs. The Ministry of Environment & Forests (MoEF) had enacted Environment and Protection Act in 1986 to provide for the protection and improvement of environment and the related matters. Environment includes water, air and land and the interrelationship, which exists among and between water, air and land, and human beings, other living creatures, plants, micro-organisms and property. Under this act, the Rules for Manufacture, Use/Import/ Export & Storage Of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells, 1989 were notified by MoEF through Notification No. 621 in Official Gazette of Govt. of India on December 5, 1989. A brief overview of the rules and procedures for the manufacture, import, use, research and release of GMOs as well as products made by the use of such organisms is given below.

B. RULES FOR THE MANUFACTURE, USE, IMPORT, EXPORT & STORAGE OF HAZARDOUS MICRO ORGANISMS/ GENETICALLY ENGINEERED ORGANISMS OR CELLS, 1989

I.

SCOPE

The above rules commonly known as Rules 1989 are applicable to the manufacture, import and storage of micro-organisms and Gene-Technological products. The rules cover the areas of research as

well as large scale applications of GMOs and products made therefrom throughout India. The rules also cover the application of hazardous microorganisms which may not be genetically modified. Hazardous microorganisms include those which are pathogenic to human beings animals as well as plants.

There are 20 paras in the Rules 1989 and some of the important paras along with relevant details given in Table 1 below: Table 1: Important paras of Rules, 1989

Para 7

Deals with Approvals to individuals on the import, export, transport, manufacture, process, use or sale of GMOs and use of GMOs for research Authorization for production of genetically modified microorganisms, plants and animals Approval for deliberate or unintentional release of GMOs into the open environment Approval for production, sale and import of substances and products which may contain GMOs or cells. Approval for production, sale and import of foodstuff, ingredients in foodstuff including processing aid which may contain GMOs or cells Procedures for obtaining approvals in different conditions Conditions of approval of GMOs Mechanism for supervising the implementation of term and conditions given with authorization for commercial use Penalties that can be levied for non compliance of measures for safe use of GMOs and products thereof Redress mechanism through National Environment Appellate Authority

10

11 12 13 14

15

19

II.

IMPLEMENTING AGENCIES

The implementation of Rules 1989 is being administered by the Department of Biotechnology (DBT) and Ministry of Environment and Forests (MoEF). These rules define the competent authorities and composition of such authorities for handling of various aspects of the rules. Presently there are six Competent Authorities i.e. The Recombinant DNA Advisory Committee (RDAC), Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC), State Biotechnology Coordination Committee (SBCC), District Level Committee (DLC). While RDAC has an advisory role, IBSC, RCGM and GEAC are involved in regulations and SBCCs and DLCs are involved in monitoring. The functions of each of the committees have been explained in the Rules which may be viewed at http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html

In accordance with Rule 4 (iv) of Rules, 1989, the Genetic Engineering Approval Committee (GEAC) was reconstituted by the Ministry vide OM No.10(20)/90-CS dated 24.3.2006. Shri B. S. Parsheera, Special Secretary, MoEF is the Chairman of the GEAC, Dr. C.D. Mayee, Chairman, ASRB is the Co-Chairman of the GEAC, Shri A. K. Goyal, Joint Secretary, MoEF is the Vice Chairman of the GEAC and Dr. R. Warrier, Director, MoEF is the Member Secretary of the GEAC. In addition the GEAC is represented by 12 experts and 16 inter-ministerial representatives.

III.

BIOSAFETY GUIDELINES

The Rules 1989 are implemented through a series of guidelines which are updated from time to time. The existing biosafety guidelines are listed below:

Recombinant DNA Safety Guidelines, 1990 Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts, 1998 Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999 Guidelines for the Conduct of Confined Field Trials of Regulated, Genetically Engineered Plants, 2008 Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered Plants, 2008 Guideline for the Monitoring of Confined Trials of Regulated, Genetically Engineered Plants, 2008 Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 Protocols for Food and Feed Safety Assessment of GE crops, 2008

A brief overview of the existing biosafety guidelines are summarized below:

i.

Recombinant DNA Safety Guidelines and Regulations, 1990

The Recombinant DNA Guidelines in 1990 were further revised in 1994, Revised Guidelines for Safety in Biotechnology. The revised guidelines includes guidelines for 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 issues relating to genetic engineering of human embryo, use of embryos and fetuses in research and human germ line, and gene therapy areas have not been considered while framing the guidelines. The research activities have been classified into three categories based on the level of the associated risk. Accordingly, the requirement for the approval of competent authority is envisaged as follows: Category I activities include those experiments involving self cloning using strains and also inter-species cloning belonging to organism in the same exchanger group which are exempt for the purpose of intimation and approval of Competent Authority. Category II activities require prior intimation of Competent Authority and include experiments falling under containment levels II, III and IV (details of each containment level have been provided separately in the guidelines). Category III activities require review and approval of Competent Authority before commencement of experiments involving toxin gene cloning, cloning of genes for vaccine production, and other experiments as mentioned in the guidelines. The levels of risk and classification of the organisms within these categories have been defined in these guidelines. Appropriate practices, equipment and facilities necessary for safeguards in handling organisms, plants and animals in various risk groups have been recommended. The guidelines enumerate the concept of physical and biological containment and the principles of good laboratory practices. For containment facilities and biosafety practices, recommendations of the WHO laboratory safety manual on genetic engineering techniques involving microorganisms of different risk groups have been incorporated therein.
The guideline gives principles of occupational safety and hygiene for large-scale practice and containment. Safety criteria have also been defined in the guidelines. Physical containment conditions that should be ensured for largescale experiments and production have been specified in the guidelines.

ii.

Revised Guidelines for research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant parts, 1998

The Revised Guidelines for Research in Transgenic Plants brought out in 1998 cover areas of recombinant DNA research on plants including the development of transgenic plants and their growth in soil for molecular and field evaluation. The guidelines also deal with import and shipment of genetically modified plants of research use. These also include the Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant parts.

The guidelines include complete design of a contained green house suitable for conducting research with transgenic plants. Besides, it provides the basis for generating food safety information on transgenic plants and plant parts.

iii.

Guidelines for generating Pre-Clinical and Clinical Data for r-DNA based Vaccines, Diagnostics and other Biologicals, 1999

A set of guidelines was issued in 1999 to provide guidance for generating relevant pre-clinical and clinical data for rDNA based Vaccines, Diagnostics and other Biologicals for submission to regulatory authorities. The guidelines specially focus on safety, purity, potency and effectiveness of the products.

iv.

Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials of Genetically Engineered Plants

Guidelines for the conduct of confined field trials of regulated, GE plants and Standards Operating Procedures (SOPs) have been prepared to provide instructions to help applicants meet requirements for the application and authorization/ approval of confined field trials of regulated, GE plants under Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells Rules, 1989 of the Environment (Protection) Act, 1986. These guidelines approved by RCGM and GEAC in June 2008, summarize the information requirements and procedures used by the two regulatory committees, that are responsible for evaluating and approving applications for confined field trials. These guidelines cover all GE/transgenic plants modified through recombinant DNA (rDNA) technology.

The guidelines describe the application process and general requirements for confined field trials and the SOPs are for transport, storage, management, harvest/termination and post harvest management during the conduct of the trials.

These Guidelines supplement the biosafety measures for field trials given in Section 7 of the Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998 .

v.

Guidelines for Safety Assessment of Foods Derived from Genetically Engineered Plants

The Indian Council of Medical Research (ICMR), in its capacity as the scientific and technical advisory body to the Ministry of Health and Family Welfare (MoHFW), has formulated Guidelines for Safety Assessment of Foods Derived from Genetically Engineered Plants, to establish the safety assessment procedures for foods derived from GE plants taking into consideration the international Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.

These guidelines apply to all whole foods, food products, and foods used as ingredients that are derived from GE plant sources. These guidelines are intended to provide guidance to both applicants and reviewers for regulatory purposes. They are not intended to explicitly define all the data that might be required in the course of a safety assessment as further data requirements may be identified during the safety assessment process

The safety assessment of foods derived from GE plants in these guidelines is based on the evaluation of these foods relative to their conventional counterparts that have a history of safe use.

vi.

Protocols for Food and Feed Safety Assessment of Genetically Engineered Plants

A series of protocols to provide guidance to applicants seeking approval for environmental release of genetically engineered (GE) plants in India under Rules, 1989 has been formulated. These protocols include:

1. Acute Oral Safety Limit Study in Rats or Mice 2. Subchronic Feeding Study in Rodents 3. Protein Thermal Stability 4. Pepsin Digestibility Assay 5. Livestock Feeding Study

These protocols address key elements of the safety assessment of foods and/or livestock feeds that may be derived from GE crops.

The protocols are based on international best practices, including guidance and peer reviewed publications available from the Codex Alimentarius Commission, the Food and Agriculture Organization, the World Health Organization, the Organization for Economic Cooperation and Development, and the International Life Sciences Institute.

For additional guidance the ICMR Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants provide a comprehensive summary of the information and data requirements that must be provided to regulatory authorities to demonstrate the human health safety of foods derived from GE plants.

IV.

APPROVALS AND PROHIBITIONS

The approvals and prohibitions under Rules 1989 are summarized below:
No person shall import, export, transport, manufacture, process, use or sell any GMOs, substances or cells except with the approval of the GEAC. Use of pathogenic organisms or GMOs or cells for research purpose shall be allowed under the Notification, 1989 of the EPA, 1986.

Any person operating or using GMOs for scale up or pilot operations shall have to obtain permission from GEAC. For purpose of education, experiments on GMOs IBSC can look after, as per the guidelines of the Government of India. Deliberate or unintentional release of GMOs not allowed. Production in which GMOs are generated or used shall not be commenced except with the approval of GEAC GEAC supervises the implementation of rules and guidelines. GEAC carries out supervision through SBCC, DLC or any authorized person. If orders are not complied, SBCC/DLC may take suitable measures at the expenses of the person who is responsible. 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. All approvals shall be for a period of 4 years at first instance renewable for 2 years at a time. GEAC shall have powers to revoke approvals in case of:

i. ii.

Any new information on harmful effects of GMOs. GMOs cause such damage to the environment as could not be envisaged when approval was given. Non-compliance of any conditions stipulated by GEAC.

iii.

V. Notifications under Rules, 1989

Various notifications issued under Rules, 1989 from time to time to address various issues are: Notification (S.O. 843) (E) dated, July 2000) listing the laboratories allowed to use pathogenic micro-organisms or genetically engineered organisms or cells for the purpose of research. Notifications (G.S.R. 584) (E) to 589 (E)) dated 1st September, 2006 empowering Seed Inspectors/Seed Analyst/ Laboratories notified under Seed Act, 1966 and Seed Control Order, 1983 under Environment (Protection) Act, 1986. Notification (G.S.R.616) (E) 1st September, 2006) exempting certain categories of recombinant pharmaceutical products for purview of Rules, 1989 Notification (S.O. 1519) (E) dated, 23rd August, 2007) exempting GM food stuffs, ingredients in food stuffs and additives from the purview of Rules, 1989. This notification has been withdrawn at the behest of Ministry of Health and Family Welfare who have informed that it would take some more time for the Food Safety and Standards Authority to become

operational. During the interim period the GEAC has been requested to continue with the regulation of GM foods.

PROCEDURE FOR CONVENING THE MEETINGS OF THE GEAC

In accordance with the guidelines for best practices in environmental regulations, the meetings of the GEAC are convened on every second Wednesday of the month. All proposals received in the Ministry 30 days prior to the meeting are placed in the agenda for consideration of the GEAC. Information regarding the agenda items for the GEAC meeting, decisions taken therein and other relevant documents (policy issues, Sub committee / Expert Committee reports, Biosafety data etc.) are posted on the GEAC website on a regular basis and may be viewed at http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html.

Project proponents / NGOs / other stakeholders are given an opportunity for personal hearing in the GEAC meetings on request.

STATUS OF GEAC APPROVALS

A.

Commercial Release of transgenic Crops:

Bt cotton is the only transgenic crop approved for commercial cultivation in India. Bt technology was deployed in cotton crop through genetic engineering techniques for control of bollworms the major pest thereby reducing the risk of crop failures and use of pesticides. Bt cotton producing a natural insecticide that comes from the ubiquitous soil bacterium known as Bacillus Thuringiensis was approved by the Genetic Engineering Approval Committee (GEAC) for introduction in India in 2002 in the nine cotton growing states namely Andhra Pradesh, Gujarat, Haryana, Karnataka, Madhya Pradesh, Maharashtra, Punjab, Rajasthan and Tamil Nadu after extensive biosafety and agronomic testing.

As of date the GEAC has approved Bt cotton hybrids expressing Cry 1 Ac gene (MON 531 event) and stacked genes Cry1 Ac and Cry 2Ab (MON 15985 event)BG-II developed by M/s Mahyco, encoding

fusion genes (cry 1Ab+Cry Ac) GFM developed by M/s Nath Seeds and cry 1Ac gene (Event-1) developed by M/s J. K. Agrigenetics Ltd during 2002 to 2007.

In addition the GEAC also approved the commercial release of BN Bt (variety) developed by CICR, Nagpur. For the first time Bt technology has been introduced in a varietal background whereby the farmers can save seeds.

During the period 2002 to 2008 the GEAC has approved 267- Bt cotton hybrids of which 132 were approved during 2008.

B.

Status of approval of GM Food crops in India:

The large scale field trials of Bt brinjal developed by M/s Mahyco expressing cry 1Ac gene from Bacillus thuringiensis tolerant to the fruit and shoot borer is under progress at 11 locations within the research farms of Indian Institute of Vegetable Research(IIVR) /State Agricultural Universities/ Indian Council of Agriculture Research. The trials are being conducted under the supervision of Director IIVR, Varanasi.

Details of other GM crops under various stages of field testing are as follows:

FIELD TRIALS OF GM CROPS (CONTAINING NEW GENES/EVENTS) APPROVED BY THE GEAC IN YEAR 2008:

S.No. 1

Crop

Company Name

Trial

Trait Insect Resistance

Gene/Event cry1Ac

Seeds BRL-I Cauliflower Sungro Research Ltd.

Nunhems Pvt. Ltd 2 Cotton

India Event selection BRL-I

Insect Resistance

cry1b and cry 1C cry1Ac& cry1F (WideStrike = Event 3006210-23 and Event 281-24236) cry1Ac (Event1) and cry1EC (Event-24)

Dow AgroSciences India Pvt. Ltd.

Insect Resistance

JK Agrigenetics BRL-I Ltd.

Insect Resistance

MAHYCO

BRL-I

Insect resistance and cry1Ac & cry2Ab (MON Herbicide tolerance 15985) and CP4EPSPS (MON 88913) Insect Resistance cry1C (MLS9124 event) cry 1Ac

Metahelix Sciences

Life LST

Central Institute LST for Cotton Research 3 Bayer Bioscience Event Pvt. Ltd. selection Rice Avesthagen Ltd. Event Selection Event selection Event selection

Insect Resistance

Insect resistance

cry 1 Ab, cry 1C & bar Orya sativa taipae 309

Oxdative stress

Tomato

Avesthagen Ltd.

Increased lycopene unedited NAD9 content Tobacco streak virus Coat against peanut stem gene necrosis disease. Insect Resistance` protein

Groundnut

ICRISAT

6,

Cabbage

Nunhems Pvt. Ltd

India Event selection

cry1b and cry 1C

7.

Potato

Central Potato Event Research selection Institute. Monsanto India BRL-I Ltd.

Late resistance

blight RB gene

8.

Corn

Insect resistance and Cry 1A.105 (chimeric gene) herbicide tolerant and cry2Ab2

BRL-I: Biosafety Research Level-I BRL-II: Biosafety Research Level-II LST:

Large Scale Trial

The present status and locations of field trials may be viewed at www.igmoris.nic.in

C. a.

Streamlining of the Regulatory Procedure for transgenic crops.

The GEAC has adopted the event based approval mechanism in respect of Bt cotton expressing approved events in its meeting held on 2.4.2008. In accordance with the decision taken by the GEAC in its meeting held on 14.1.2009 a new procedure for commercial release of Bt cotton hybrids expressing approved events has been notified and shall be applicable from 1.3.2009. The new procedure may be viewed at http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html

b.

Review of the existing national regulatory biosafety framework with a view to harmonize the obligations under Cartagena Protocol on Biosafety (CPB) has been initiated.

c.

Development of a new biosafety website has been initiated.

D.

Capacity Building to facilitate compliance of Biosafety regulation:

Extensive capacity building activities have been planned for efficient management of field trials of GM crops covering 12 states where the field trials are being undertaken. Training of 16 SAUs with respect to use of new guidelines for confined field trials, safe operational practices (SOPs), formats for monitoring and recording of data etc. have been recently completed.

As part of the USDA Capacity Building project on biosafety, the 3rd DVC was organized in June 2008. As an outcome of the 3rd DVC deliberations, a Short Term course for Confined field trials was organized jointly by the Ministry, DBT and Michigan State University (MSU) in August, 2008 at MSU, USA. The exchange program was attended by 10 scientists from State Agriculture Universities, Indian Institute of Agriculture and ICAR institutions. The second short term course for Risk Assessment of GM crops at Michigan State University is tentatively scheduled in June, 2009.

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CARTAGENA PROTOCOL ON BIOSAFETY

INTRODUCTION

Although many countries have enacted national biosafety legislations to ensure the safe use of genetically modified organisms (GMOs) and products thereof, biotechnology being a global industry and GMOs traded across borders, international rules are needed as well. Cartagena Protocol on Biosafety (CPB) is an attempt to produce a globally harmonized regime for biosafety under the Convention of Biological Diversity (CBD). The Protocol named after the Colombian city where the final round of talks was launched, sets out a comprehensive regulatory system for ensuring the safe transfer, handling and use of Living modified organisms (LMOs) subject to transboundary movement. In every day usage LMOs are considered to be same as GMOs although definitions and interpretations vary widely. The Protocol deals primarily with LMOs that are to be intentionally introduced into the environment (such as seeds, trees or fish) and with genetically modified farm commodities (such as corn and grain used for food, animal feed or processing). It does not cover pharmaceuticals for humans addressed by other international agreements and organizations or products derived from LMOs, such as cooking oil from genetically modified corn.

ORIGIN

The objectives of the Convention on Biological Diversity (1992) are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. When developing the Convention, the negotiators recognized that biotechnology can make a contribution towards achieving the objectives of the Convention, if developed and used with adequate safety measures for the environment and human health. The Contracting Parties agreed to consider the need to develop appropriate procedures to address the safe transfer, handling and use of any Living Modified Organism (LMO) resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity (Article 19.3 of the CBD). The Biosafety Protocol is the result of that process.

STATUS

The protocol entered into force from September 11, 2003. India ratified the Cartagena Protocol on Biosafety on January 23, 2003. As on 5.3.2009, 153 countries are Parties to the Protocol.

OBJECTIVE

The objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.

SALIENT FEATURES

The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling, and use of LMOs, with specific focus on transboundary movements of LMOs. It features a set of procedures including one for LMOs that are to be intentionally introduced into the environment (Advance Informed Agreement procedure), and one for LMOs that are intended to be used directly as food or feed or for processing. Parties to the Protocol must ensure that LMOs are handled, packaged and transported under conditions of safety. Furthermore, the shipments of LMOs subject to transboundary movement must be accompanied by appropriate documentation specifying, among other things, identity of LMOs and contact point for further information. These procedures and requirements are designed to provide importing countries with the necessary information needed for making informed decisions about whether or not to accept LMO imports and for handling them in a safe manner. The importing country makes its decisions in accordance with scientifically sound risk assessments. The Protocol sets out principles and methodologies on how to conduct a risk assessment of the Protocol. In case of insufficient relevant scientific information and knowledge, the importing countries may use precaution in making their decisions on import. Socio-economic considerations may also be taken into account, consistent with their international obligations, in reaching decisions on import of LMOs. Parties must also adopt measures for managing any risks identified by the risk assessment, and they must take necessary steps in the event of accidental release of LMOs. To facilitate its implementation, the Protocol establishes a Biosafety Clearing-House for Parties to exchange

information, and contains a number of important provisions, including capacity-building, financial mechanism, compliance procedures and public awareness and participation.

GOVERNING BODY OF THE PROTOCOL

The governing body of the Protocol is the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol (COP-MOP). The main function of this body is to review the implementation of the Protocol and make decisions necessary to promote its effective operation. As of date, four meetings of the COP-MOP have been convened. Decisions taken therein may be viewed at CBD website http://www.cbd.int/biosafety/.

BENEFITS OF BECOMING A PARTY TO THE PROTOCOL

Becoming a Party to the Protocol presents a number of benefits, such as :

o o

o o o o o

Influence on the implementation of the Protocol and shaping of its further development through participation in the decision-making processes of the COP-MOP. For developing country Parties and Parties with economies in transition, eligibility for financial support from the Global Environment Facility (the financial mechanism for the Protocol) for capacity-building, as well as other support for implementation of the Protocol and participation in its processes; Enhanced visibility and credibility of national systems for regulating biosafety within the global community; Contribution to harmonized rules, procedures and practices in managing the transboundary movement of LMOs; Facilitation of mechanisms and opportunities for governments to collaborate with other governments, the private sector and civil society on strengthening biosafety; Improved access to relevant technologies and data, and benefiting from a regular exchange of information and expertise; and Demonstration of commitment to conservation and sustainable use of biological diversity through the implementation of biosafety measures.

The full text of the protocol is placed at CBD website http://www.cbd.int/biosafety/

INSTITUTIONAL ARRANGEMENTS AT THE NATIONAL LEVEL

Parties are required to designate national institutions to perform functions relating to the Protocol. Each Party needs to designate one national focal point to be responsible on its behalf for liaison with the Secretariat. Each Party also needs to designate one or more competent national authorities, which are responsible for performing the administrative functions required by the Protocol and which shall be authorized to act on its behalf with respect to those functions.

In accordance with the above requirement, the Ministry of Environment and Forests has been designated as the competent national authority. The National Focal Point for the CPB is Shri A. K. Goyal, Joint Secretary, MoEF and the BCH Focal Point is Dr. R. Warrier, Director, MoEF.

NATIONAL REPORTING ON THE IMPLEMENTATION OF THE PROTOCOL

Towards fulfillment of our obligations under Article 33 of the CPB to which we are a Party, India has submitted its Interim National Report and First National Report in 2005 and 2008 respectively. These reports are available on CBD website http://www.cbd.int/biosafety/.

BIOSAFETY CLEARING HOUSE (BCH)

In accordance with Article 20 of CPB, the India BCH has been launched in 2006 (http://indbch.nic.in/).

CAPACITY BUILDING

The Ministry of Environment and Forests (MoEF) has successfully completed the Phase-I Capacity Building project on Biosafety through GEF-World Bank assistance in June, 2007. Project details may be viewed at http://envfor.nic.in/divisions/csurv/biosafety/default.htm.

The MoEF has initiated the Phase-II Capacity Building Project on Biosafety through GEF-UNEP assistance. The PIF has been approved by the GEF council in its meeting held in October, 2008. The preparation of Full Scale Project (FSP) has been initiated.

STATUS OF LIABILITY AND REDRESS NEGOTIATION UNDER ARTICLE 27. The issue of liability and redress for damage resulting from the transboundary movements of LMOs was one of the themes on the agenda during the negotiation of the CPB. The negotiators were, however, unable to reach any consensus regarding the details of a liability regime under the Protocol. The matter was, nevertheless, considered both critical and urgent. As a result, an enabling clause to that effect was included in the final text of the Protocol. Article 27 of the Cartagena Protocol on Biosafety required the Conference of Parties /Meeting of Parties (COP/MOP) to adopt, at its first meeting, a process with respect to the appropriate elaboration of international rules and procedures [instrument] in the field of liability and redress for damage resulting from transboundary movements of living modified organisms (LMOs). Accordingly, at its first meeting, the COP/MOP established an Open-ended Ad Hoc Working Group of Legal and Technical Experts on Liability and Redress (hereafter referred to as the Ad Hoc Group on Liability and Redress) to carry out the process pursuant to Article 27 of the Protocol within a period of four years (September, 2007). Accordingly, at its first meeting, the Conference of the Parties serving as the meeting of the Parties to the Protocol established an Ad Hoc 0pen-ended working Group on Liability and Redress to review information relating to liability and redress for damage resulting from transboundary movements of living modified organisms (LMOs); analyze general issues relating to the potential and/or actual damage scenarios of concern, and application of international rules and procedures on liability and redress to the damage scenarios; and elaborate options for elements of rules and procedures on liability and redress, with a view to completing its work in 2007.

As of date five meetings of the Ad Hoc 0pen-ended working Group on Liability and Redress has been convened. In the absence of a consensus, it was decided during the fifth meeting of the Ad Hoc 0pen-ended working Group on Liability and Redress held at Colombia during March 2008, to convene a meeting of the Friends of the Co-Chairs with a view to further negotiate the rules and procedure and further streamline the operational text. The meeting of the Friends of the Co-Chairs was held at Bonn, Germany from May 7-9, 2008 back to back with COP-MOP-4. While the group did not complete its mandate to adopt an international regime to liability and redress, it reached a consensus for adopting a legally binding regime on an administrative approach but including a provision on civil liability that will be complemented by non-legally binding guidelines on civil liability. The Group was also successful in streamlining the operational text substantially. The recommendations of the Friends of the Co-Chairs were considered in the fourth meeting of the COP-MOP held at Bonn from 12-16 May 2008. The major decisions adopted by COP-MOP-4 are as follows:

To continue negotiations on international rules and procedures in the field of liability and redress on the basis of the annex; Decided to set up a group called Group of the Friends of the Co-Chairs. The composition of the group will be: six representatives of the Asia-Pacific region; two representatives of the EU; two representatives of Central and Eastern Europe; six representatives of the African Group; six representatives of the Latin American and Caribbean Group; and New Zealand, Norway, Switzerland and Japan; Advisors are selected by the Friends of the Co-Chairs and their participation may be facilitated subject to the availability of funds; Observers may be invited to be participants in the meeting at the discretion of the CoChairs; and The outcome will be presented to COP/MOP 5 for its consideration.

In accordance with the above decision, the first meeting of the Group of the Friends of the CoChairs was held at Mexico from 23-27 February 2009.
MoEF has been working towards evolving country position on the issues related to liability and redress in consultation with the Consultative Group on Biodiversity and Biosafety since 2004. Indias country position and negotiating text on the proposed Liability and Redress regime was finalized based on a consultative approach as follows:

1.

An Expert Advisory Committee comprising of legal and scientific experts for preparation of An approach paper on Liability & Redress (L&R) was set up by the Ministry to prepare an approach paper. Seven meetings of the Expert Advisory Group were convened.

2.

The recommendations of the Expert Advisory Committee was further discussed by the Consultative Group on Biodiversity constituted by the Ministry to advise the Government on matters related to the Convention on Biological Diversity, Cartagena Biosafety Protocol and Ramsar Convention. Two meetings of the Consultative Group were convened.

3.

A national consultation for obtaining stakeholder feedback from the L&R regime and Indias country position is also proposed in January, 2008. The national consultation was attended by more than 50 participants represented by the Government, Industry, NGO, Academia etc.

Hosting International Meetings

The Fourth Coordination Meeting for Governments and Organizations Implementing or Funding Biosafety Capacity Building Activities during 11-13 February, 2008 and the Fifth Meeting of the Liaison Group on Capacity Building for Biosafety during 14-15 February, 2008 at International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi was organized by the Ministry of Environment and Forests jointly with the Convention on Biologically Diversity.

****************

IMPORTANT NATIONAL AND NATIONAL LINKS ON BIOSAFETY

NATIONAL

Ministry of Environment and Forests, Government of India

http://www.envfor.nic.in/

The Ministry of Environment & Forests is the nodal agency in the administrative structure of the Central Government, for the planning, promotion, co-ordination and overseeing the implementation of environmental and forestry programmes. The Ministry is also the nodal agency for the implementation of the Convention on Biological Diversity (CBD) and Cartagena Protocol on Biosafety. The decisions of GEAC are also hosted on this website. Capacity Building on Biosafety
http://www.envfor.nic.in/divisions/csurv/biosafety/default.htm

Information on the activities under GEF-World Bank project on capacity building in biosafety is available as part of the website of Ministry of Environment and Forests (MoEF) i.e. http://www.envfor.nic.in (sub heading BiosafetyNew). The website also has information on the related topics such as regulatory framework, lists of various statutory committees, lists of approved GMOs and products thereof, links for further reading, list of upcoming events etc.

India Biosafety Clearing House

http://www.indbch.nic.in

Under the GEF-World Bank Capacity Building project, the India Biosafety Clearing House has been established by the Ministry of Environment and Forests, Government of India at http://www.indbch.nic.in. The website has information under various headings as defined by the CBD secretariat. These include national contacts, laws and regulations, decisions and declarations, capacity building and roster of experts.

Department of Biotechnology, Government of India http://www.dbtindia.nic.in

The Department of Biotechnology (DBT), under the Ministry of Science and Technology is the nodal department for biotechnology in Government of India. In more than a decade of its existence, the department has promoted and accelerated the pace of development of biotechnology in the country. Through several R&D projects, demonstrations and creation of infrastructural facilities a clear visible impact of this field has been seen. The department has made significant achievements in the growth and application of biotechnology in the broad areas of agriculture, health care, animal sciences, environment, and industry. Along with MoEF, DBT is the implementing agency for biosafety regulations in the country.

Indian GMO Research Information System (IGMORIS) http://www.igmoris.nic.in

Indian GMO Research Information System (IGMORIS) is a database on activities involving the use of GMOs and products thereof in India. The primary purpose of this website is to make available objective and realistic scientific information relating to GMOs and products thereof under research and commercial use to all stakeholders including scientists, regulators, industry and the public in general. It is also expected to promote collaborations and avoid duplication of work. National Research Centre on Plant Biotechnology
http:// 203.122.19.19/gmdb/gmdbhome.html

National Research Center on Plant Biotechnology (NRCPB) has established an integrated database on post release risk assessment and monitoring transgenics in order to share the information from India and other countries. The database is divided into two main modules, i.e., Transgenics and GM publications. The module Transgenics contains information on genetically modified crops. It has been divided into several sub-databases, which have information on genes and promoters that are being used for the production of transgenic crops, unique features of transgenic crops, effect of GM crops on soil microflora, possible environmental hazards and gene flow. The second module, GM Publications contains published literature on biosafety and all issues related to GMOs.

Department of Agriculture and Cooperation, Ministry of Agriculture, Government of India

http://www.agricoop.nic.in/ The Department of Agriculture and Cooperation is responsible for the formulation and implementation of national policies and programmes aimed at achieving rapid agricultural growth through optimum utilization of the countrys land, water, soil and plant resources.

Biotech Consortium India Limited (BCIL) http://www.biotech.co.in

BCIL provides linkages amongst research institutions, industry, government and funding institutions, to facilitate accelerated commercialization of biotechnology. The Company is engaged in technology transfer, project consultancy, fund syndication, information dissemination and manpower training and placement related to biotechnology. INTERNATIONAL

Cartagena Protocol on Biosafety (CPB) http://www.biodiv.org/biosafety

This is the main site for information about the CPB, including the background and full text of the agreement, articles, updated list of signatures and ratifications, meetings, and documents of the Intergovernmental Committee for the Cartagena Protocol (ICCP), the Biosafety Clearing House, and a database of biosafety capacity-building activities.

Biosafety Clearing-House http://bch.biodiv.org/

As per the article 20 of the Cartagena Protocol on Biosafety, the Biosafety Clearing House (BCH) has been established which serves as an information exchange mechanism to assist Parties to implement its provisions and to facilitate sharing of information and experiences with Living Modified Organisms (LMOs). It provides a one stop shop where users can readily access or contribute relevant biosafety related information with an objective to assist governments to make informed decisions regarding the importation or release of LMOs. The BCH also facilitates scientific and technical cooperation between parties and stakeholders by allowing interested stakeholders to access or contribute information on existing biosafety capacity building activities, thus facilitating coordination and synergy between various initiatives. For industry and other stakeholders the BCH allows easy access to information vital to their activities including details of the national contacts, relevant laws and regulations governing LMO activities and the decisions and declarations made by Parties, especially regard to transboundary movements.

The central portal of BCH is at http://bch.biodiv.org. All the Parties to the Protocol are expected to participate in BCH either by providing information through the central portal or setting up their own websites linked to the central portal.

UNEP-GEF Biosafety Project http://www.unep.ch/biosafety

The UNEP-GEF Biosafety Project is funded by the Global Environmental Facility and is based on its Initial Strategy for assisting countries to prepare for the entry into force of the Cartagena Protocol on Biosafety (GEF/C.16/4). The main objectives of this strategy are to assist countries in the establishment of their national biosafety frameworks; promote information sharing and collaboration, especially at the regional and subregional level; and promote collaboration with other organizations to assist capacity-building for the Cartagena Protocol on Biosafety.

Codex Alimentarius http://www.codexalimentarius.net

The Codex Alimentarius, or the food code, has become the seminal global reference point for consumers, food producers and processors, national food control agencies, and the international food trade. Codex standards have become the benchmarks against which national food measures and regulations are evaluated. This site carries provisional agendas for forthcoming meetings and working papers and reports of Codex Meetings. Of particular interest is the Preliminary Report of the ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology (final report due in 2003).
OECD - BioTrack http://www.oecd.org/ehs/service.htm

BioTrack Online, the web site of OECD's Programme on the Harmonization of Regulatory Oversight in Biotechnology, was created in 1995. This site focuses on information related to the regulatory oversight of products of biotechnology. BioTrack Online aims, not only to help member country governments and industries with biotechnology product notifications/assessments, but also to make the information,

developed by the Working Group on Harmonization of Regulatory Oversight in Biotechnology, accessible to all who need it, including non-OECD countries that might find it useful. World Health Organization (WHO) Biotech Foods http://www.who.int/fsf/GMfood/index.htm

WHO has been addressing a wide range of issues in the field of biotechnology and human health, including safety evaluation of vaccines produced using biotechnology, human cloning, and gene therapy. This site briefly describes the activities of WHO in regard to biotechnology and food safety.

Food and Agriculture Organization (FAO) of the United Nations http://www.fao.org/biotech/index.asp?/lang=en

This site on food and agriculture is available in Arabic, French, Chinese, Spanish, and English. It carries news and events, FAO documents, sectoral overviews, and a glossary (English only).

BioBin http://www.oecd.org/ehs/biobin

BioBin is a cooperative resource on safety in biotechnology developed between OECDs BioTrack Online and Biotechnology Information Network and Advisory Service (BINAS) sponsored by the United Nations Industrial Development Organization (UNIDO). A resource for regulations, field trials, biotechnology product database, biotechnology libraries, and tools related to biosafety.
AgBioWorld

http://www.agbioworld.org

This site provides information about technological advances in agriculture to the developing world; particularly to teachers, scientists, journalists, and the general public on the relevance of agricultural biotechnology to sustainable development; maintains the declaration of Scientists In Support Of Agricultural Biotechnology, and offers a discussion list serve.

AgBioForum Online Magazine http://www.agbioforum.org/

Publishes articles which enhance the on-going dialogue on the economics and management of agricultural biotechnology. The purpose of AgBioForum is to provide unbiased, timely, information and new ideas leading to socially responsible and economically efficient decisions in science, public policy and private strategies pertaining to agricultural biotechnology.

Agricultural Biotechnology Support Project II (ABSPII) http://www.absp2.cornell.edu/

The Agricultural Biotechnology Support Project II (ABSPII) focuses on the safe and effective development and commercialization of bio-engineered crops as a complement to traditional and organic agricultural approaches in developing countries. The project helps boost food security, economic growth, nutrition and environmental quality in East and West Africa, Indonesia, India, Bangladesh and the Philippines. Funded by the United States Agency for International Development (USAID) and led by Cornell University, ABSPII is a consortium of public and private sector institutions.

Biotechnology and Development Monitor http://www.biotech-monitor.nl

The Monitor provides a forum for discussion on the positive and/or negative impact of biotechnological innovations and international regulations on issues such as economic growth, agricultural production, food security, shifts in national and global markets, access to technology, employment, social differentiation, and human rights. The analyses are interdisciplinary and emphasize the integration of theoretical and empirical information from social sciences and natural sciences.

Biotechnology Industry Organization http://www.bio.org

This organization is the largest trade organization to serve and represent the emerging biotechnology industry in the United States and around the globe. The site includes a media guide to biotechnology; a biotechnology food products list; a citizens guide to biotechnology; laws and policies; and a guide to bioethics.

Biotechnology Information Center http://www.nal.usda.gov/bic/

The Biotechnology Information Center (BIC), is one of ten information centers at the National Agricultural Library of the US Department of Agriculture - ARS. BIC provides access to a variety of information services and publications covering many aspects of agricultural biotechnology.

Biosafety Information Network and Advisory Service (BINAS) http://www.binas.unido.org/binas

BINAS, a service of the United Nations Industrial Development Organization (UNIDO), monitors global developments in regulatory issues in biotechnology providing information on worldwide national regulations and field trials.

Biotechnology Australia

http://www.biotechnology.gov.au

Biotechnology Australia is a multi departmental government agency responsible for coordinating non-regulatory biotechnology issues for the Commonwealth Government. It seeks to provide balanced and factual information on biotechnology to the Australian community.

Canada: Canadian Food Inspection Agency http://www.inspection.gc.ca/english/ppc/biotech/bioteche.shtml

The Canadian Food Inspection Agency (CFIA) is responsible for the regulation of products derived through biotechnology including plants, animal feeds and animal feed ingredients, fertilizers, and veterinary biologics. For genetically modified crop plants, the CFIA assesses the potential risk of adverse environmental effects and authorizes and oversees import permits, confined trials, unconfined release, and variety registration.

Electronic Forum on Biotechnology in Food and Agriculture http://www.fao.org/biotech/forum.htm

This site provides an open forum that will allow a wide range of parties, including governmental and nongovernmental organizations, policy makers, and the general public, to discuss and exchange views and experiences about specific issues concerning biotechnology in food and agriculture for developing countries.

European Federation of Biotechnology (EFB) Agri-Biotechnology (Europe)

http://www.agbiotech.org

The EFB is an association of European scientific and technological societies in biotechnology together with universities, scientific institutes, companies, biotechnology associations, and individual members. Their mission is . . . to promote the safe, sustainable, and beneficial use of Natures resources in the life sciences and technologies; to facilitate exchange of people and ideas; and to contribute to a better understanding and perception of biotechnology by the general public in Europe.

European Federation of Biotechnology (EFB) Task Group on Public Perceptions of Biotechnology http://www.efbpublic.org

This group works to increase public awareness and understanding of biotechnology and the life sciences throughout Europe, to advance the public debate about their applications, and to facilitate dialogue between interested parties. The sites primary aim is to foster greater public awareness and understanding of biotechnology and to encourage public debate.

Information Systems for Biotechnology (ISB) http://isb.vt.edu

This site has documents and searchable databases pertaining to the development, testing, and regulatory review of genetically modified plants, animals, and microorganisms within the United States and abroad.

International Centre for Genetic Engineering and Biotechnology (ICGEB) http://www.icgeb.trieste.it/~bsafesrv

The role of the International Centre for Genetic Engineering and Biotechnology(ICGEB) is to promote the safe use of biotechnology world-wide, with special regards to the need of the

developing world. It has played, since its inception, an important role on issues related to biosafety and the sustainable use of biotechnology.
The Biosafety Unit of the ICGEB is dedicated to biosafety and risk assessment for the environmental release of genetically modified organisms. It offers information on biosafety concerns, upcoming meetings and training courses, and a regularly updated index of selected scientific articles published on biosafety and risk assessment from 1990 onward. This site also carries an outstanding collection of links to databases on GMO releases, scientific bibliographies, decision support systems, patents, and numerous other topics.

International Service for the Acquisition of Agri-biotech Applications (ISAAA) http://www.isaaa.org

The International Service for the Acquisition of Agri-biotech Applications. ISAAAs objectives are the transfer and delivery of appropriate biotechnology applications to developing countries and the building of partnerships between institutions in the South and the private sector in the North, and by strengthening South-South collaboration.
The primary site describes ISAAAs activities and initiatives in biosafety, food safety, intellectual property, and technology transfer. The Global Knowledge Center on Crop Biotechnology section (http://www.isaaa.org/activities/ knowledge_center.htm) is organized into several main areas. Global Network provides a status of biotechnology in the developing countries of Asia, South America, and Africa. Crop Biotech Update is a weekly summary of world developments in agricultural biotechnology for developing countries. Separate pages cover GM products and biotechnology issues.

International Field Test Web Sites http://www.isb.vt.edu/cfdocs/globalfieldtests.cfm

This site has a list of links to information about field tests conducted in twenty-nine countries.

International Life Sciences Institute (ILSI) http://www.ilsi.org/site_search/index.cfm

ILSI is a nonprofit, worldwide scientific research foundation seeking to improve the well being of the general public through the pursuit of sound and balanced science. It works towards understanding of scientific issues relating to nutrition, food safety, toxicology, risk assessment, and the environment. This site lists ILSI publications pertaining to biotechnology.

ILSI Crop Composition Database http://www.cropcomposition.org

The ILSI Crop Composition Database is a project of the International Life Sciences Institute. Additional support has been provided by Covance Laboratories Inc. Through ILSI, contributors have standardized and pooled their crop data in order to make the data available to scientists from academia, government agencies, and industry, and to the general public.
Program for Biosafety Systems http://www.ifpri.org/themes/pbs/pbs.htm

The Program for Biosafety Systems (PBS) supports partner countries as they develop the policy and legal framework, administrative procedures, technically qualified personnel and outreach mechanisms integral to their national biosafety systems. PBS work emphasizes sound, sciencebased, decision making and research, while also addressing socioeconomic considerations.

Transgenic Crops: An Introduction and Resource Guide http://www.colostate.edu/programs/lifesciences/TransgenicCrops

This Colorado State University site provides broad coverage of the subject, including the history of plant breeding, a clear explanation of what transgenic plants are and how they are made, biosafety evaluation and regulation, current and future transgenic products, and a question-and-answer format for information on risks and concerns.

United Kingdom: Advisory Committee on Releases to the Environment (ACRE) http://www.defra.gov.uk/environment/acre

The site has extensive background information on the release of GMOs in the European Union, lists of applications for experimental trials and to market GMOs, application formats for deliberate releases and marketing of higher plants and organisms other than higher plants, a statement on GM animals, and more. The Guidance on Principles of Best Practice in the Design of Genetically Modified Plants documents how the design and construction of GM plants could be used to further improve their safety and/or to simplify the risk assessment.

United States: Regulatory Oversight of Biotechnology http://www.aphis.usda.gov/biotech/usregs.htm

This site is a portal to the agencies primarily responsible for regulating biotechnology: the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Products are regulated according to their intended use; some products are regulated under more than one agency. U.S. Food and Drug Administration (FDA):Biotechnology
http://vm.cfsan.fda.gov

The FDA regulates foods and feed derived from new plant varieties (GMOs) as well as conventional products. The biotechnology site carries extensive documentation on regulations, labeling, consumer information, and products approved for commercial sale.
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