|Extracts from important official report on GM regulation in India (9/4/2007)|
The following extracts come from pages 7-13 of the newly published report of the (Indian Government's) Planning Commission Task Force on Biodiversity & Genetically Modified Organisms.
The report finds substantial problems with India's existing regulation of GMOs, implying that as it currently operates it could pose "immense danger to the environment of this country and the health of its people". The report also accuses India's apex regulatry body for GMOs (the GEAC) of flagrantly disregarding the law.
The report also calls for a "moratorium on commercial cultivation of GM crops until the regulatory system is demonstrably improved" and for no further GM crop commercialisation before a legally enforceable regime for liability and redress is put in place. It also supports a block on herbicide tolerant GM crops and on GMOs which could damage valuable export markets calls.
There is repeated emphasis throughout the report on achieving far greater transparency and public participation in regulatory decision making.
The full report can be read at
FOR THE ENVIRONMENT & FORESTS ELEVENTH FIVE-YEAR PLAN (2007-2012)
III. PROPER MANAGEMENT OF GMOs
*There is an urgent need to radically change the composition and functions of the [official regulatory] bodies that are designated to manage GM technology. Maintaining status quo and ignorance could lead to wrong decisions that could end up hurting Indian farmers.
Choices made without adequate communication and information could pose immense danger to the environment of this country and the health of its people. [page 7]
*Create with immediate effect legally mandated State Level Committees and District Level Committees for release, monitoring and documentation, and analysis of GMOs. The unbridled spread of the illegal Bt cotton, Navbharat 151 and the failure of the GEAC to control the situation even many years down the line do not inspire confidence in its capabilities. The fact that GEAC authorized commercial cultivation of Monsanto's Bt cotton even when there were no State or District level Committees to oversee and monitor its release and cultivation, did stir several controversies some of which are campaigns against the biosciences in general. The lack of State and District level authorities, especially in any of the six states where Bt cotton varieties (legal and illegal) are being cultivated, raises disquiet about the GEAC's flagrant disregard of the law.
*All regulatory bodies - especially the GEAC should be technically competent. Specific competence on Risk Assessment and Risk Management of GM crops as also on Monitoring and Information Systems skills are necessary in regulatory bodies or committees. At present members of the GEAC are not qualified to understand the process of Bio safety Assessment, Environmental Assessment or Environmental Impact Assessment, which are central to their functioning. This means that they are not qualified to interpret the data that is placed before them for evaluation. The regulatory structure must be competent and independent to inspire confidence. It should be able not just to assess Biosafety and should be able to seek/contract assessment of aspects like social and economic impacts. The latter are, particularly important to understand the processes of change induced by GMOs and impact on small farmers, agricultural workers, other traditional livelihoods like traditional medicine, herding, etc. [page 8]
*A process of consultation and redefining methods and best practices of risk assessment may be initiated for All-India and State levels... [page 8]
*It is proposed that the regulatory function be divided into two parts, one Advisory, the other Statutory.
The Advisory body should have a broad based multidisciplinary membership that includes all relevant scientific disciplines, social scientists, environmentalists, civil society groups, members of farming and adivasi communities, representatives of panchayati raj institutions, legal experts, and civil servants (bureaucrats). A person of the highest technical caliber and social commitment who has experience in the regulation of GM crops should head the GEAC.
The statutory body should be an independent body staffed by people skilled in Bio safety Assessment, Environmental Assessment and Environmental Impact Assessment. This body should have overall responsibility for all aspects of risk assessment, risk management, risk communication leading up to decision-making about the safety of a GM crop for the environment, human and animal health and post release monitoring. It is important to ensure that there is no conflict of interest and rules should be framed in a clear and unambiguous manner so that it is not possible to stack the Agency with any particular kind of people. The regulatory process should be transparent, accountable and technically competent. Data from field trials and the rationale for decisionmaking should be available to the public. A cost benefit and a risk benefit analysis should be conducted before decisions are taken and clear-cut channels should be created for the public to participate in the decisionmaking process and to voice concerns. There should be an annual review of the decisions taken on GM products and the rationale for these decisions. This review should be presented to Parliament. The future of biotechnology in general and GMOs in particular rests on the confidence that the country has on its regulatory authorities and processes. [page 9]
*Develop protocols and reporting procedures for technology providers in GM crops/seeds: To manage GMOs it is crucial to have technical competence, transparency and accountability on the part of the technology providers so that they are made accountable for the GM seeds they sell. [page 9]
*The Government of India must put in place a legally enforceable regime for liability and redress BEFORE any further commercialization of GM crops. Technology providers must be made accountable for any harm caused by their products and be made responsible for the recall of dangerous products. [page 9]
*Within research institutes/programmes, procedures and standards must be set with respect to varieties and locations, for the conduct of Field Trials, Large Scale Trials and for All India Coordinated Trials of GM varieties. Right now this information is not public. Information on all these trials must be made public. Right now, these trials and their actual and potential collaboration with others (private sector, panchayats, etc.) and processes of participatory varietal selection etc. have not been organically linked to the organizational practices and working conditions of scientists/technical personnel. [page 10]
*Each State must initiate capacity building exercises for proper management of GM crops. Capacity must be built at the level of Panchayats, District Level Committees and State Level Committees to enable them to competently monitor trials and detect and report violations. [page 10]
*The national regulatory authorities and the DBT itself must facilitate awareness and understanding within the judiciary on issues related to agro biodiversity, its conservation and sustainable use as well as the need for stringent regulatory systems for GMOs. [page 10]
*Public participation must be ensured in key decision making bodies, including setting the research agenda, evaluating alternative research programmes to achieve stated purpose/goals, evaluating field trial data, assessing cost and riskbenefit analyses and final approval for commercialization. [page 10]
*A Citizens Jury of eminent experts should be set up to monitor the overall direction of the GMO program in the country, suggest mid term correctives and hear public concerns. This jury may be treated as a Supreme Court for GMOs, where every actor, the State, private and public sector organizations, farmers/indigenous communities, political parties, environmental movements etc. can register their views/complaints/criticisms are expect suggestions/advise on ways to address these issues. It must be mandatory that all actors respond to a querry or suggestion made by this jury, with an explanation on agreement or otherwise, action taken or not, etc. [page 10]
Creating appropriate Policy Framework for GMOs
*The policy framework for proper management of GMOs is located within a wider biotechnology policy, agricultural policy, S&T policy, and environmental policy. Proper management of GMOs will be confined to printing ink and paper unless and until policy dialogue among different compartments of the Indian bureaucracy that shapes or has an impact of Indian agriculture, is facilita ted.
The Government of India, through its DBT must initiate this process, and a comprehensive policy for GMOs be developed within two years. The national policy on GMOs should follow the recommendation of the M.S. Swaminathan Task Force on Agbiotechnology, which says the implementation of Agbiotechnology must seek the 'economic well-being of farm families, food security of the nation, health security of the consumer, protection of the environment and the security of our national and international trade'.
Thereby, specific issues to be considered are:
+To start with, a comprehensive biotechnology policy approved by stakeholder consultations must be put in place.
+The current ad hoc programs on GMOs in agriculture must be stopped until a policy framework has been finalized. A policy must be developed for transgenic varieties for which India is a center of origin and diversity, particularly rice. Commercialization of GM rice should be deferred until a body of data is built up on its safety under Indian conditions. India has a special responsibility to protect the native germplasm of rice from incursion of alien genes.
+Herbicide tolerance trait will displace agriculture labor which does manual weeding, destroy vegetation that is used by rural communities as supplementary food, fodder and medicinal plants and disallow multiple cropping systems...
+The GM crop research agenda must be sensitive to India's trade
+interests. It would be foolish to indulge in Bt Basmati and jeopardize
+the Basmati export market to Europe. It would be [foolish] to produce
+GM soybean when India is the only certified non-GM soybean producing
+country in the world. [page 11]
+Review the policy of promoting GM crops vs Organic crops... [page 12]
*...India must exercise caution in the IPR regime that it adopts. [page 12]
*Alternatives to the GM approach must be carefully evaluated in each case before deciding on the GM route... [page 12]
*A protocol to assess long term environmental and ecological impact of GM crops must be developed. There should be provisions for post-market surveillance and monitoring of GM products. [page 12]
*There should be a moratorium on commercial cultivation of GM crops until the regulatory system is demonstrably improved. Research on GM crops, however, should continue. [page 12]
*GM food crops must be evaluated with utmost caution using vastly improved food and feed safety testing systems before any decisions are taken on commercialization. [page 12]
*The bureaucracy must be made accountable for departmental mandates and performance that hinders or impairs conservation or do not facilitate appropriate monitoring of GMOs or that impede essential and timely flow of information. These can be taken up by the NBRA and the Citizens Jury and implemented by the DBT in collaboration with other actors as will be identified by the NBRA. [page 13]