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I NDIA’ S G ENETIC M ONSTERS
ABSTRACT
Twenty years ago the American seed-giant
Monsanto introduced a genetically modified
variety of cotton seed into the Indian agricultural
system resulting in large scale crop failure,
massive environmental degradation and
innumerable farmer suicides. Consequently the
Indian legal and economic system awoke to the
fact that it was not entirely prepared to embrace
what the world was hailing as a panacea to all
problems of food scarcity- Genetically Modified
Organisms (or GMOs). It has been over a decade
and today Monsanto is fast moving from its
controversial Bt-cotton cash crops to futuristic GM
brinjal food crops. India today, has a three tier
structure in place to check and control the entry
of GMO imports into the country, both for
scientific and commercial purposes, which
includes the Department of Biotechnology and
the Ministry of Environment and Forests. This is
considered essential because GM crops, with their
altered gene codes, have potential impacts not
only on food security but also on the environment
in the form of genetic pollution, increased pest
resistance coupled with fatal effects on beneficial
biological indicators like birds as well as the
livestock and humans which feed on these crops.
In short, they pose a threat to the very balance of
the ecosystem and biodiversity. Given these
fears, what is more worrisome is that India is still
not adequately equipped to deal with a second
Monsanto. The Departments’ directives were
disregarded then and can be now as well. This
apprehension is strengthened by the fact that
despite flouting several of the prevailing
environmental laws in the country (the
Environment Protection Act, 1986, being one of
them), Monsanto has not been made answerable
to the Indian government till date. The
Convention on Biological Diversity gave us the
“Cartagena Protocol on Biosafety”, which came
into
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force on September 11, 2003, to which India is a signatory. This Protocol includes the precautionary principle which gives its signatories the right to have domestic systems in place to prohibit the import of GMOs from other nations, even on a mere apprehension of adverse environmental or health effects. To this extent the Protocol provides an effective safeguard. However, the problem arises when this is juxtaposed with the World Trade Organisation (WTO) standards which are in direct conflict with this principle because under them scientific certainty is essential for such bans on trade. This conflict reduces the environment of developing nations such as India to experimental labs. It is in the above framework that the authors intend to present this paper which would provide an insight into GMOs and their effect on the environment. In the process, the authors seek to outline the legal mechanisms present in India to deal with GMOs, and bring out the lacunae in such laws. A third dimension to the study would be the domestic laws vis-à-vis the Cartagena-WTO conflict, thereby dwelling upon the underlying conflict of development, elimination of food scarcity on one hand and the preservation of health and environment on the other.
I.] INTRODUCTION
Since the 1970s the focus of science has been genetic engineering 1 which essentially entails movement of specific genes with desirable traits from one organism to another, within or across species. The product of such gene alteration is a Genetically Modified Organism (GMO) or Living Modified Organism (LMO). Ever since their introduction, a swirl of controversy has existed regarding the adverse impacts of such crops. The benefits of GM crops include reduction of pesticide use, greater food security 2 and enhanced nutritional quality of food. 3 There exist equally real risks, including risks to human health by the introduction of new food allergens, risks to the
- David. J. Schiner, Genetically modified organisms and the Cartagena Protocol , 12 Fordham Envtl. L.J. 379 (2000-2001).
2_. Ibid_ , 385.
3_. Id_ , 388.
India’s Genetic Monsters
decision of banning an import due to the potential risk it poses to human health and environment even in the absence of sufficient scientific information about the kinds and extent of risk. The Protocol also prescribes labelling and identification procedures, in pursuance of which a distinction between GMOs intended for direct release into the environment and LFFPs is drawn. Only the former are required to be identified and documented. 14 The Protocol 15 places a duty on national governments to educate the public regarding genetic engineering and involve them in decision making. Provision is also made for socio-economic considerations in decision making. 16 The Protocol fails to provide any kind of dispute settlement mechanism or liability for environmental damage resulting from GM technology. The Protocol doesn’t clearly establish its relationship with pre- existing agreements 17 thereby creating a conflict in parties’ obligations especially with respect to the WTO.
III.] WTO A GREEMENTS
Relevant WTO agreements that impact GMOs include provisions under General Agreement on Tariffs and Trade (GATT), Agreement on
import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects”.
- See, Barbara Eggers and Ruth Mackenzie, The Cartagena Protocol on Biosafety, 3 J. Int’l Econ. L.533 (2000).
- Article 23.
- Protocol, Art. 26- “1. The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.
- The Parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous and local communities”.
- The savings clause present in the Preamble lays down that the Protocol will “not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements”, while at the same time providing that the above clause is “not intended to subordinate this Protocol to other international agreements”.
Technical Barriers to Trade (TBT) and Agreement on the Application of Sanitary and Phytosanitary Measures (SPS). GATT covers all the international trade in goods. Article I, Article III and Article XI, ensure that nations do not take protectionist stands by striking at discrimination between like products. 18 However Article XX (b) provides an exception to protect human health while XX (g) talks of environmental protection and any measure taken under the said exceptions must be based on relevant scientific evidence. 19 The TBT covers all technical regulations on imported goods including industrial and agricultural products. 20 Among the reasons for technical regulations, measures to protect human health and environmental protection are recognized. Such measures may be introduced after a risk assessment based on available scientific and technical information. 21 SPS measures seek to protect human or plant life or health while promoting trade concerns. Articles 2.2 and 5. lay down that an SPS measure may be enforced only after appropriate risk assessment is undertaken Economic factors may be considered when determining the appropriate level of protection. 22 Articles 5.5, 5.6, 8 and Annex C urge parties to ensure that the measures are not more trade restrictive than necessary. 23 Article 5.7 embodies the precautionary principle. However these measures are only provisional and a member invoking such a measure must collect adequate additional information within reasonable time. 24
- See, Olivette Rivera Torres, The Biosafety Protocol and the WTO , 26 B.C. Int’l& Comp L. Rev 289 (2003).
- Laurent Ruessmann, Putting the Precautionary Principle in its Place: Parameters for the Proper Application of a Precautionary Approach and the implications for Developing Countries of the Doha WTO Ministerial , 17 Am. U. Int’l L. Rev. 915 (2001-2002).
- Torres, supra note 18, 292.
- TBT, Art. 2.2.
- Protocol, Art. 5.3.
- (^) Eggers and Mackenzie, supra note 14, at 538.
- See , Robert Howse and Petros C. Mavroidis, Europe’s Evolving Regulatory Stratergy for GMOs- The issue of Consistency with WTO law: Of Kine and Brine , 24 Fordham Int’l L.J. 330 (2000-2001), for prescribed method of risk assessment, at 350.
to biosafety measures. 31 This precludes the Protocol as an international standard setter with relation to GMOs under the SPS. In the absence of set standards, restrictions may be based solely on scientific justification again bringing into play the conflicting precautionary principles.
c. Burden Of Proof
In the Japanese Apples case, 32 it was ruled by the WTO that the burden to justify restriction was on the country of import. In contrast by specifying detailed notification requirements on the exporting country, burden under the Protocol is placed on the country of export. 33
d. Dispute Redressal
Given the absence of a Dispute Redressal Agency under the Protocol, the WTO becomes forum to determine disputes with regard to GMO trade. The dominance of the WTO in settling disputes is further compounded by the fact that all WTO members are not signatories to the Protocol.
V.] THE BIOSAFETY REGIME I N INDIA W ITH RESPECT TO GM P RODUCTS
India is a prominent member of the WTO as well as a signatory to the Protocol, thus a review of its domestic regulatory regime is worthwhile in light of the above discussion. Relevant legislations include The Environment Protection Act, 1986 (EPA) in so far as it permits the Central Government to regulate and restrict handling of hazardous substances 34. Under Sec. 25 of the EPA the
- Interestingly the TBT doesn’t within its framework provide for any particular international organization as the recognized body of standard setting, in such a situation, the Protocol may be recognized as the standard setting body with respect to GMOs.
- Japan – Measures Affecting the Importation of Apples, WT/DS245/R.
- Patrick J. Valley , supra note 29, at 376.
- EPA, 1986, § 2(e): “Hazardous substance” means any substance or preparation which, by reason of its chemical or physico-chemical properties or handling, is liable to cause harm to human beings, other living creatures, plant, micro-organism, property or the environment. Section 6 authorizes the Central Government to make rules with respect
India’s Genetic Monsters
Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro organisms/ Genetically Engineered Organisms or Cells, 1989 (Rules) were formulated which established a regulatory body to approve, prohibit and regulate GMOs even providing for dispute resolution and penalties in cases of non-compliance. In order to supplement these rules Guidelines were issued by the Department of Biotechnology (DBT). The guidelines relate to research activities including confined field trial. 35 The Institutional Framework 36 divides of authority between the DBT under the Ministry of Science and Technology (MoST) and the Ministry of Environment and Forests (MoEF). A series of bodies are created under the two ministries with no particular hierarchy. Under the DBT there exists The Review Committee on Genetic Manipulation (RCGM) to ensure environmental safety in the areas of GMO research including field experiments 37 and the Monitoring and Evaluation Committee (MEC) that assists the RCGM with monitoring of research bodies. 38 The Genetic Engineering Approval Committee (GEAC) on the other hand is under the MoEF, it is the apex body to authorize the commercial use (including imports) of GMOs and release into the environment. 39 There are three other bodies under the de- centralized framework as the Institutional Biosafety Committee (IBSC) 40 the State and District Level Committees (SBCC and DLC) 41 the advisory Recombinant DNA Advisory Committee (RDNA). 42
to procedures and safeguards for and prohibitions and restrictions on the handling of hazardous substances. Section 8 which prohibits a person from handling hazardous substances except in accordance with the prescribed procedural safeguards.
- See, Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) 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. Damodaran, Re-Engineering Biosafety Regulations In India: Towards a Critique of Policy, Law and Prescriptions , Law, Environment and Development Journal, (2005) at 3.
- Damodaran, supra note 36, at 4.
- Damodaran, supra note 36, at 5.
- Aarti Gupta, Ensuring ‘Safe Use’ of Biotechnology: Key Challenges , Economic and Political Weekly, (July 6, 2002), at 2763.
- Damodaran, supra note 36, at 4.
- Damodaran, supra note 36, at 5.
- Damodaran, supra note 36, at 4.
a. The Lacunae In Status Quo
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choosing to ignore to assess the socio-economic impact of GMOs. 50 A poor liability regime is another concern. Two kinds of liabilities can arise- first, in the case of non-compliance with the legal requirements and second, damage caused to the environment as well as socio-economic and other forms of damages. Ours completely fails to address the latter. 51 There is no provision for any sort of compensation or confiscation. It is only under the EPA that there is provision for fine and imprisonment. 52 Our international commitment to the Precautionary Principle has not been translated into a legally binding instrument in our domestic regulatory mechanism. In the existing mechanism there is no provision for labelling of GM products in order to segregate transgenic crops from the non-transgenic ones. 53 Despite the shortcomings in existing laws, the government continues to remain apathetic as is reflected in the tabling before Parliament of the Biotechnology Regulatory Authority of India Bill (BRAI), 2009, which envisages a National Biotechnology Regulatory Authority (NBRA).The Bill emanates from the MoST and proposes to place the NBRA under the DBT, thus cutting away all the other spheres of interest which have an impact on the biotechnology scenario in India, namely
- Damodaran, supra note 36, at 11.
- Sahai, supra note 45.
- Section 15, The Environment Protection Act, 1986 - “Penalty for contravention of the provisions of the act and the rules, orders and directions - (1) Whoever fails to comply with or contravenes any of the provisions of this Act, or the rules made or orders or directions issued there under, shall, in respect of each such failure or contravention, be punishable with imprisonment for a term which may extend to five years with fine which may extend to one lakh rupees, or with both and in case the failure or contravention continues, with additional fine which may extend to five thousand rupees for every day during which such failure or contravention continues after the conviction for the first such failure or contravention.(2) If the failure or contravention referred to in sub-section (1) continues beyond a period of one year after the date of conviction, the offender shall be punishable with imprisonment for a term which may
extend to seven years”.
- Alexander G. Haslberger, Monitoring and Labelling for Genetically Modified Products , Science, (Washington, D.C., 21st January 2000), at 431.
social, agricultural and economic spheres. 54 It does not address any of the prevailing lacunae in the regulatory mechanism, be it the lack of public participation or the non- recognition of the Precautionary Principle. Sample, for instance, the highly controversial provision which penalizes a person who, without any scientific evidence or scientific record, ‘misleads’ the public about the safety of the organisms and products with imprisonment and fine. It overrides state authority and gives them only an advisory role when agriculture is in reality a state subject under the constitution. 55 This discourages state participation and further weakens the monitoring mechanism.
VI.] I NDIAN REGULATION I N L IGHT OF T HE C ARTAGENA -
WTO C ONFLICT
Given the fact that India is a member of the WTO as well as a signatory to the Protocol, Indian laws reflect which side of the divide India is on. During negotiations to Cartagena, India was part of the like minded group 56 that was heavily in favour of intense regulation through the Protocol. A review of national laws hardly reflects this position. The mechanism of regulation omits critical principles set out under the Protocol such as a precautionary principle, socio-economic considerations and public participation indicating a tilt towards the WTO however even the WTO provides for considering economic and region specific considerations while enforcing measures. 57 Although the failure to incorporate provisions of the Protocol may suggest a tilt towards the WTO, the failure to enforce even WTO measures negates such an impression.
- P.V. Satheesh and Kanchi Kohli, A Call to “ Reject” the Biotechnology Regulatory Authority (BRAI) Bill, 2009 on Grounds of Ethical, Social and Political Concerns, (February 15, 2010), available at http://curezone.com/blogs/fm.asp?i=1575316; http://current.com/items/ 92164511_new-gmo-bill-in-india-threatens-critics-with- prison.htm (last visited on March 5, 2010).
- Mahim Pratap Singh, Activists Voice Concern over Biotech Regulatory Authority Bill, (Bhopal, February 18, 2010), available at http://beta.thehindu.com/news/national/article108821.ece (last visited on March 8, 2010).
- Schiner, supra note 1, at 403.
- SPS, Art.5. 3 and Art. 6.
