Posted on Thursday, February 18th, 2010
Reflections on the Proposed National Biotechnology Regulatory Authority (NBRA) and National Biotechnology Regulatory Bill, 2008
By Dr. Vandana Shiva
Genetically Engineered Organisms (GMOs) are transgenic organisms made by introducing genes across species boundaries. Thus Bt. Cotton, or Bt. Rice or Bt. Brinjal has genes for a toxin taken from a soil bacteria and put into the food crop. In addition, GMO’s use anti-biotic resistance markets, viral promoters and cancer genes as vectors. These new genes can have risks for public health and the environment. Ensuring safety in the context of genetically engineered organisms is referred to as Biosafety.
India has one of the most sophisticated Laws of Biosafety in the world. The “Rules for the Manufacture, Use / Import / Export and storage of Hazardous micro-organisms / genetically engineered organisms or cells”, 1989, notified under the Enviornmental Portection Act, 1986 is science based public interest oriented legislation created long before the commercialization of genetically engineered organisms (GMOs) and crops and long before the International Biosafety Protocol of the UN Convention on Biological Diversity came into force.
The genetic engineering industry, in particular Monsanto, which controls 95% of all GM seeds sold worldwide, first tried to by pass India’s Biosafety Law when it started field trials without approval of the Genetic Engineering Approval Committee, the statutory body for Biosafety regulation. The rules clearly state –
9(i) Deliberate or unintentional release of genetically engineered organisms / hazardous microorganisms or including, deliberate release for the purpose of experiment shall not be allowed.
Note : Deliberate release shall mean any intentional transfer of genetically engineered organisms / hazardous micro-organisms or cells to the environment or nature, irrespective of the way in which it is done.
Field trials of GMO’s are clearly a deliberate release. That is why when Monsanto – Mahyco started field trials of Bt. Cotton in 1997-98, without approval of the GEAC we initiated a case in the Supreme Court of India to challenge the illegal trials. As a result commercialization of Bt. Cotton was delayed upto 2002.
The sequence of events, which took place in implementing the illegal trials in India, can be briefly outlined as:
24th April 1998 Mahyco files to Department of Biotechnology for field trials
May 1998 Joint venture between Mahyco and Monsanto formed
13th July 1998 Letter of Intent issued by DBT without involving Genetic Engineering Approval Committee (GEAC).
15th July 1998 Mahyco agrees to conditions in letter of intent.
27th July 1998 Impugned permission by DBT for trials at 25 locations granted.
5th August 1998 Permission for second set of trials at 15 locations granted
6th January 1999 PIL filed by Research Foundation for Science Technology and Ecology in the Supreme Court of India
8th February 1999 RCGM expresses satisfaction over the trial results at 40 locations.
12th April 1999 RCGM directs Mahyco to submit application for trials at 10 locations before Monitoring and Evaluation Committee
25th May 1999 Revised proposal to RCGM submitted by Mahyco.
June–Nov 1999 Permission granted for different trial fields
Oct–Nov 1999 Field visits
May 2000 Mahyco’s letter to GEAC seeking approval for “release for large scale commercial field trials and hybrid seed production of indigenously developed Bt cotton hybrids”.’
July 2000 GEAC clears for large-scale field trials on 85 hectares and seed production on 150 hectares and notifies through press release.
October 2000 RFSTE filed an application for amendment in the petition challenging the fresh GEAC clearance.
04.03.2005 GEAC orders uprooting of “Navbharat-15”, which was found to contain transgenic Bt.
26.03.2002 32nd Meeting of the GEAC was held to examine the issue of commercial release of Bt Cotton. Members of GEAC from ICHR, Health Ministry, Commerce Ministry, CSIR, ICAR did not attend the meeting. Inspite of the absence of important members of the GEAC, approval was granted to three out of four of Monsanto Mahyco’s transgenic hybrids.
05.04.2002 Formal approval granted to mach-12, Mach – 162 and Mach 184 by A.M. Gokhale, Chair of GEAC. Order of 05.04.2002 is a conditional clearance valid for three years. The stipulated conditions/restrictions are a clear implied admission on the part of the government that the tests are far from complete. In effect, the commercialisation was an experiment. Monsanto-Mahyco had been asked to gather further data and submit annual reports on the resistance that the insects develop over a period of time to GM seeds and to conduct studies on resistance to bollworm, susceptibility tests, and tests for cross pollination.
02.03.2005 In March, RFSTE releases results of continued failure of Bt Cotton, especially in Andhra Pradesh.
04.03.2005 GEAC rejects renewal of the 3 Bt Cotton varieties planted in the Southern States. However, other Bt varieties are cleared in Northern States.
In any case the Review Committee of Genetic Manipulation (RCGM) does not have the authority to approve field trials. According to the “Rules”. The RCGM “shall function in the Department of Biotechnology to monitor the safety related aspects in respect of on-going research projects and activities involving genetically engineered organisms / hazardous microorganisms”. Clearly RCGM is not an approving authority. The industry has repeatedly used the RCGM and the Biotechnology Department to subvert India’s Biosafety Laws. Now that citizens have used this law effectively, industry is trying to have it dismantled.
The latest attempt at Biosafety Deregulation by the Biotechnology Department is to float the proposal for a National Biotechnology Regulatory Authority and a National Biotechnology Regulatory Bill, 2008. As the proposal states “DBT is considering to promulgate new legislation National Biotechnology Regulatory Act (NBR Act).
The false argument being used is that biotechnology regulation is currently spread over multiple acts. This is not true. There is only one Act, the Rules for GMO’s under the EPA, regulating GMO’s in all fields. It is also being argued that the NBRA will promote public confidence. The public will not and cannot have confidence in an industry driven, centralized, undemocratic, unaccountable law and institution floated by the agency which is a biotechnology promoting agency, and has done everything in the last decade to undermine citizens rights and the public interest. This is a direct attempt to replace India’s excellent Biosafety Law with industry friendly legislation, and to replace the GEAC as a Biosafety Regulation Authority with the National Biotechnology Regulatory Authority to promote biotechnology, not biosafety.
The National Biotechnology Regulatory Bill refers to “consolidation of regulatory policies, rules and services under a single biotechnology authority”. There is already a single biosafety authority for all biotechnology approvals – the GEAC. It needs strengthening, not substitution and dismantling. Further, the proposal authority, like the GEAC is restricted to modern biotechnology or genetic engineering, defined as “the application of in vitro nucleic acid techniques, including recombinant direct injection of nucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.
The proposed authority undermines the regulatory role of diverse ministries and the rights of states and districts. The GEAC consists of members from different ministries, agencies and departments, as well as expert members who are heads of Agricultural Research, Medical Research, Scientific and Industrial Research, D.G Health Services, Directorate of Plant Protection, Chairman Pollution Control Board. The existing law allows creates State Biotechnology Coordination Committee (SBCC), District Level Committee (DLC). In the proposed authority, the statutory bodies role of diverse ministries has been replaced by an Inter-Ministerial Advisory Board, with no authority, but only to promote Central Government Cooperation. The checks and balances, and the decentralized institutions reflecting our federal, democratic structure that are part of the existing law are being destroyed to make it easy for industry to get approvals. As the proposed law states 6(3). “The Inter-ministrial Advisory Board and the National Biotechnology Advisory Council will have no authority to intervene on product specific decisions made by the NBRA.”
Both the different Ministries, diverse agencies and the States have thus been robbed of decision making powers which is vital to the functioning of democratic structures in the public interest.
The functions of the proposed Authority totally overlap with the functions of CEAC. Thus this is a proposal to displace GEAC. The Authority also proposes to displace the Ministry of Environment as the nodal agency for international negotiations for regulating the risks of genetic engineering.
Instead of a multi-ministerial committee, all powers for decision making are proposed to be concentrated in one individual, the chairperson, who will be a biotechnologist, with skills in genetic engineering but no skills or expertise in Biosafety.
The proposed authority is thus centralized, individualistic biased in favour of genetic engineering and hence will lend itself to easy influence of the genetic engineering industry.
The Bill clearly states that the following laws will stand repealed when the Bill becomes an Act. Among the Acts mentioned are –
1. Rules for the manufacture, use, import, export and storage of hazardous micro-organisms, genetically engineered organisms or cells, 1989 issued under Environment (Protection) Act, 1986. To be amended to exclude genetically engineered organisms or cells from the mandate / scope of the Rules.
2. Food Safety and Standards Act, 2006
1. Section 13(3)(c) : The Scientific Panel may be established for genetically modified foods. Genetically modified organisms to be taken out of the mandate of FSSA.
2. Section 22(2) : The definition of genetically engineered or modified food to be amended to exclude foods and food ingredients composed of or containing genetically modified or genetically engineered organisms.
3. Drugs and Cosmetics Act, 8th Amendment :
1. The definition of recombinant drug to include all therapeutic proteins derived from recombinant organisms, but exclude recombinant biologics (eg. DNA vaccines, gene therapy products etc)
4. The Drugs and Cosmetics (Amendment) Bill, 2007
1. To exclude clinical trials, pre commercial safety assessment, product approval and post release monitoring of recombinant biologics.
5. The Seed Bill, 2004 :
1. Section 15 on Special provision for registration of transgenic varieties: In clause 1 Environment (Protection) Act, 1986 to be replaced with National Biotechnology Regulatory Act.
6. Proposed Plant Quarantine Bill
1. Section 6(2)(o): Regulating the import of transgenic materials, to be modified as “regulating the import of transgenic material subject to the approval of the National Biotechnology Regulatory Authority”.
In other words, all safety regulation for health and environment will be demolished in one fell swoop if the National Biotechnology Regulatory Bill is passed and the National Biotechnology Regulatory Authority is established.
The existing Biosafety Law needs to be upheld. It is an excellent Law. Weakness in implementation needs strengthening of institutions and processes. Not the dismantling of a good Law and its replacement by a centralized, biased Law which is good for industry but a disaster for citizens right to health and environmental safety.