CHAPTER VI

BIOSAFETY- INDAIN LAW, POLICY AND PRACTICE

The first chapter of this study shed some light on different aspects of Indian biosafety

regulations. The Rules for Manufacture, Use, Import, Export, and Storage of

Hazardous Micro-organisms, Genetically Engineered Organisms or Cells,

1989 promulgated under the Environment (Protection) Act, 19861 entered into

force on 13 September 1993. This chapter attempts a detailed look at the existing

Indian biosafety regulatory mechanism. _For making meaningful comparisons, the

Biosafety Protocol is used as the minimum yardstick.

6.1. Scope of the Rules

The Rules purport to protect the .environment, nature and health in relation

with the application of gene technologies and micro-organisms. They regulate

'genetically engineered organisms2, micro-organisms, celJs and any substance,

and products and foodstuffs etc. of which such cells, organisms or tissues

form part' (rule 2(2)). The Rules extends to the following activities:

(a) sale, offer for sale, storage for the purpose of sale, offers and any kind of handling over with or without a consideration;

(b) exportation and importation of genetically engineered cells or organisms:

(c) production, manufacturing, processing, storage, import, drawing off, packaging and replacing of the genetically engineered products;

(d) production, manufacture etc. of drugs and pharmaceuticals and food stuffs, distilleries and tanneries etc. which make use of genetically engineered mJcro­organisms in one way or other (rule 2(4)).

1 The Rules are formed under sections 6(Central Government may make Rules to deal with hazardous substances, preventions of accidents which may cause environmental damage and the necessary remedial measures), 8 (hazardous substances shall be handled only in accordance with' the prescribed procedure and safeguards) and 25 (power of the Central government to make Rules laying down the procedure and safeguards to handle hazardous substances) of the Act. 2 Gene technology is the application of the genetic engineering techniques including self­cloning, deletion and cell hybridization (rule 3(3)). Genetic engineering is defined as "the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. 1t shall also mean the formation of new combinations of genetic material by incorporation of a ceH into a host cell, where they occur naturally (self cloning) as we11 as modification of an organism or in a cell by deletion and removal of parts of the heritable material" (rules 3(4)). Other modern gene technologies, resulting or,ganisms,

_ cells, products and substances are also regulated (rule 2(3)). GMOs and micro-organisms are classified into animal pathogens and plant pests for purpose of the Rules (rule 5).

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The Indian Rules cover any foodstuff, ingredients in foodstuff and additives,

containing or consisting of GMOs. A deeper reading of these provisions is necessary

to realize whether products of LMOs, from which novel genes are undetectable, are

covered. Insertion of genetic material at the ceJlular ]eve} which result in self c1oning

or modification by deletion and removal of parts of the heritable material are also can

be used to produce GMOs, whereas the Bios~fety Protocol definition of modem

biotechnology is limited to in vitro technologies for the insertion of novel genetic

material. 'Other modern gene technologies' suggest that the Rules are anticipatory in

nature to regulatory products of modem biotechnology that are non-existent. The

Biosafety Protocol excludes pharmaceutical LMOs regul~ted by other international

agreements. In India, biosafety regulations along with other relevant regulations deal

with the activities related to pharmaceutical LMOs, which will be discussed in the

later parts of this chapter.

6.1.1. Safety Guidelines

The National Biotechnology Board of India formulated a set of safety guidelines for

the protection of workers in laboratory environment as early as 1983. The rDNA

Advisory Committee of the Department of Biotechnology prepared the first Indian

Recombinant DNA Biosafety Guidelines in 1990 for conducting research and

handling of GMOs3• In 1994 and subsequently in 1998, the Review Committee

of Genetic Manipulation revised the 1990 guidelines. The scope of the 1990

Guidelines extends to research, large-scale operations and environmental

risks. The Revised Guidelines for Safety in Biotechnology, 1994 pertain to research

involving GMOs, vaccine and diagnostics development using rDNA technology, large

scale production of GMOS and their deliberate and accidental production, GMO

import and shipments for laboratory research and large scale use. Principles relevant

to the quality control of biologicals produced by rDNA technology are also provided

for in the Guidelines. The Revi~ed Guidelines for Research in Transgenic Plants and

Guidelines for Toxicity and Allergenicity Evaluation a/Transgenic Seeds, Plants and

Plant Parts, 1998 recommends norms for research in rDNA plants (their development

and growth in soil for molecular and field evaluation) and import and shipment of

transgenic material for research. A protocol for allergenicity testing of GM products

3 The guidelines should be put into practice by the funding agency responsible for the approval and cle"!ance of research proposals.

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in animal model is also suggested, even in the absence of any established animal

models. Guidelines for the Conduct of Confined Field Trials of Regulated, GE plants

in India (2008) increments the 1998 guidelines. Standard Operating Procedures

(SOPs) for Confined Field Trials of Genetically Engineered Plants: Transport. ·

Storage, Management, Harvest or Termination and Post Harvest Management set

down safety requirements, conditions for labelling and accompanying

documentations, records and corrective actions in case of accidental releases.

6.1.2. Regulatory Institutions

The 1989 Rules describe the hierarchy of competent authorities, their

composition and functions.

6.1.2.1. Recombinant DNA Advisory Committee

The Advisory Committee functions under the Department of Biotechnology.

The Committee scrutinizes national and international biotechnology

developments. It shaH make periodic recommendations, 'suitable and

appropriate safety regulations', for GMO research and application (rule. 4(1 )).

The Committee is to develop the long-term policy for research and

development and educate researchers and technicians on the hazards and the

methods to avoid those hazards ( 1990 Guidelines).

6.1.2.2. Review Committee on Genetic Manipulation (RCGM)

The RCGM4 is constituted by the .Department of Biotechnology to monitor

safety related aspects in the ongoing research projects and activities involving

genetically engineered organisms or micro-organisms. The Committee also

brings out manuals on guidelines with respect to activities involving GMOs in

research, use and appl~cations. Every ongoing project involving 'high-risk

category and control1ed field experiments',requires review by the RCGM for

ensuring strict adherence to adequate precaution and containment. RCGM

may appoint sub-committees. The RCGM can lay down procedures restricting

or prohibiting the production, sale, importation and use of GMOs (rule 4(2)).

4 The constituent members are the representatives of the Department of Biotechnology (DBT), Indian Council of Medical Research (JCMR), Indian Council of Agricultural Research (ICAR), Council of Scientific and Industrial Research (CSJR), and individual experts. The Committee was reconstituted by Jhe DBT in 2006 to include more subject experts. Sti11 there are no legal experts or civil society representatives.

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Use of GMOs or micro-organisms shall be carried out only in laboratories or

inside laboratory areas notified by Environment Ministry (Rule 7(2)). Educational

experiments may be performed outside the notified laboratories and areas, provided

they are overseen by the Institutional Biosafety Committees (Rule 7(5)).

6.1.2.2.A. Risks and Containment Levels

The risks and classification of organisms for research are based on 'the.

pathogenicity and local prevalence of diseases and on epidemic causing strains'

present in India. For foreign micro-organisms, highest degree of safety is suggested.

Biological and physical containment5 and principles of good laboratory practice are to _

be foJlowed. ~our biosafety levels based on the hazardous nature of the organisms

involved are proposed. The higher the biosafety level the more stringent is the

proposed safety conditions. Three types ofrDNA research activities are instructed6.

6.1.2.2.B. Mechanisms Developed by the RCGM

The RCGM has to maintain a computerized Central.Registry for collecting periodic

reports. The RCGM should form a small Research Monitoring group with powers

of inspection and making recommendations for violations under the EP Act,

1986 (1990 Guidelines). The RCGM shall meet at least twice in a year. It can

permit smaJJ field trials not exceeding 'a total area of 20 acres in multi-locations in

one crop season'7• The trial designs are either planned by the RCGM or Principal

5 Biological containment is the selection of. a combination of vector and host, which 'limit the infectivity of vector to specific hosts and control the host-vector survival in the environment'. Physical containment means the confining of the organism to prevent exposure to the researcher and environment. The measures for physical containment consist of good laboratory practice, usage of safety equipments like cabinets and enclosed containers and designing of secondary barriers for protecting workers outside the laboratory. 6 These are activities for which; no intimation to and approval by the competent authority is needed; prior intimation is needed and approval and review of competent authority. is mandatory before initiation (1990 Guidelines). Three categories of experiments and their containment levels are envisioned in the 1998 Guidelines. Catl:gory I comprises 'routine

t c1oning of defined genes' and involves hosts 'which are generally considered as safe' io

humans, animals and plants. The RCGM should prepare a Jist of such safe micro-organisms and communicate it to the Principal Investigator on request. In Category ll, lab and green house or net house experiments in contained environment are to be conducted with defined DNA fragments and no-pathogens. Prior intimation to the RCGM (which shall keep this on record) is necessary in such cases. Category III and above experiments are highly risky and pertain to the transgenes that may escape and cause significant alterations to the biosphere and ecology. The consequences of the alterations cannot be predicted accurately. Clearance of the RCGM is mandatory for these types of experiments. · 7 RCGM is the body regulating Biosafety Research Level I (BRL/) trials (no more than 1 acre per trial site location and a maximum cumu_lative total of 20 acres for aB locations for individual/stacked events) for each applicant and crop season (2008 Guidelines).

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Investigator in the research conducting institution (on approval by the RCGM). Data

on animal and human health need to be generated. Co.llection of long-term

. environmental safety data is to be assured when applications are put forward for

release of GMOs into the environment.- The Monitoring cum Evaluation Committee

instituted by the RCGM will perform filed visits at the experimental sites. The

Monitoring Committee, guided the RCGM has to prepare designs and fom1ats for the

collection of scientific information. The Monitoring Committee can propose remedial

measures to fine-tune the original design for the collection, consolidation and analysis

of data on environmental risks. It gathers or orders the gathering of information on the

'comparative agronomic advantages' ofGM plants and on a periodic basis advises the

RCGM on the risks and benefits of GM plants. Minimum one yearly trial with four

replications is required. The applicant has to highlight the biological benefits of the

new plants. The RCGM after analyzing the environmental safety and viability of the

new plant, seed or plant part, would recommend it to the GEAC for environment

release decision (1998 Guidelines)8.

6.1.2.3. Genetic Engineering_ Approval Committee (GEAC)

The GEAC9 functions under the Ministry of Environment and Forests and 1s

responsible for approval of activities involving large-scale use of GMOs in

research, industrial production and application. The GEAC issues clearance

only from the environmental angle. The Committee authorises release of

GMOs and products into the environment, including field trials. That means

large-scale experiments beyond RCGM's jurisdiction have to be authorized by

the GEAC only. The import, export, manufacture, processing or sale of any

hazardous GMOs is approved by the GEAC. Normally, deliberate release of

GMOs for experimental purposes into the environment ·or nature is not

8 For conducting confined field trials, fol1owing policy decisions are developed by the GEACffiCGM; the tria] should be on biosafety and efficacy of the trait rather than agronomic performance; permission only for the entities _developing the technology (permission wi11 not be given for conducting agronomic performance unless the biosafety of gene/event is approved); indication by the proponent of the biosafety studies and protocol for studies; strict adherence to the time of sowing and performance of trial in the proponent's own research farm (GEAC Decisions, 13.82008). 9 The Additional Secretary of Department of Environment (Chairman), representatives of DBT, Ministry of Jndustria) Development, DBT and the Department of Atomic Energy, experts(heads) of ]CAR, JCMR, CSlR, General Health Services, Directorate of Plant Protection, Quarantine and storage, Central PolJution Control Board, three outside individual experts and other co-opted members or experts comprise the GEAC. The reconstituted GEAC (2007), consists of independent experts in different streams inc1tJding Jaw and economics, nominee~ of scientific institutions and inter ministerial representatives.

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allowed. However in exceptional cases the GEAC may permit such release.

GEAC authorisation is mandatory for the production10, sale, import and use of

foodstuff, ingredients in foodstuff and additives including processing and

containing or consisting_.of GMOs l1. Scale up er pilot operatkms also need

license from the GEAC. The GEAC shall give directions to the occupier on

-··---~discharge (-also the prohibition of discharge and the necessary measures) of

GMOs or micro-organisms. GEAC approvals shall be for a maximum period

of four years at the first instance; which are to be renewed every two years.

The GEAC may fix the fee for meeting the expenses (in whole or part)

incurred for approvals, examinations, supervisions and control. The GEAC

approvals can be revoked on the basis of any new information on the harmful

effects of GMOs, any damage to the. environment, nature or health, not

visualised at the time of approval and any instance of non-compliance with

the prescribed conditions. Monitoring of the implementation of the terms and

conditions of the approvals is done by the GEAC. The Committee can

authorise the State Biotechnology Coordination Committee or State Po1lution

Control Board or District Level Committee or any other person to do the

necessary supervision. The Committee can take (or authorise any person to

take) punitive actions for the violations of the Environment (Protection) Act

(rules 4( 4), 7 and 18(3)).

6.1.2.3.A. Large Scale Field Trials and Risk Assessment

Large-scale experiments are experiments exceeding '20 litres capacity' for research

and industrial purposes. For such experiments proper safety and control measures

should be adopted. The host organism and GMO should not be pathogens. The

selected vector also should be safe12• For environmental release, the geographical

location, the size and nature of the site, the predicted effects on ecosystems, method

and quantity of release, monitoring capabilities and contingency plans are to be kept • in mind. Independent risk reviews on a case-by-case are to be carried out before

10 Production involving GMOs for development, testing and experiments (Rule 8) . . 11

Substance or products, foodstuff, ingredients in food stuffs and additives (processing also) containing or consisting of GMOs shall be imported, sold or used only if permitted by the GEAC (rules IOand 1 1). 12 An extended history of safe use of the host organism is desirable. The organism should have best growth in the bioreactor but limited survivabiJitv in the environment. The vector should be smaH enough to carry out the purpose and should not in~rease the stability in the environment unle~s it is the target.

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•

environmental release ( 1990 Guidelines). The GEAC is to approve all large-scale

(handling of 20 liter or more) operations13• The applicant should submit plans on

operational details and management of hannfu} wastes to the GEAC. In-house and

. ____ .out-side agencies should regularly monitor-control measures, safety equipments and

the organism in outside environment. Before field trials, evaluation of the GMO in

laboratory, growth chamber and greenhouse conditions, is necessary. Model

experiments for collecting environmental data and predicted effects of release with

the prior permission ofRCGM, are to be submitted to the regulatory agencies. Proper

facilities are to be provided to guarantee safety and to prevent accidental release. Bio­

wastes should be destroyed or neutralized before environment disposal. The -

prescribed measures for field testing of GM plants are; m!lintenance of minimum

isolation distance, growing of non-compatible crop in the isolation distance, growing

some layers of the same non-transgenic crops beyond isolation distance as pollen trap

and experiments to assess pollen transfer. Pre-release tests include requirements of

vegetative growth and persistence and stability of GM crops in sma11 plots and

experimental field trials for two years. After harvesting suggested measures are,

destruction of the vegetative parts and any plants generated out of the GM seeds, no

cultivation in the land in the next year and the performance of soil tests before

disposal into the ehvironment to ascertain the absence of any viable cells. The GEAC

may consent large-scale trials without demanding data on environmental impact in

proper cases. Factors in risk assessment include the susceptibility of GM plants to

temperature, humidity etc. and ecological stresses (1994 Guidelines).

6.1.2.3.B. Risk assessment for Releases into the Environment

The factors to consider are; the nature of the novel organism, particulars of

modification, genetic stability of the GMO, the GMO's stability for long term

survival, specifics of targeted organisms, the known effects of non-GMO and !

predicted effects of GMO. Even when there is containment for release into the

environment and safety may be assumed, experimental field use permit from GEAC

should be obtained. The (iEAC has to review safety control measures, monitor

13 The GEAC, polices Biosafety Research Level 11 (BRL/1) trials (no more than 2.5 acres per trial site location and number of locations to be decided) on a case by case basis. An applied product has to go through confined field trials of first crop season (Level 1 ), second crop season (Level 2) and third crop season (Level 2) (2008 Guidelines).

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large-scale re1eases 14 and provide information to the RCGM on the

supervision of experiments for industrial purposes (1990 Guidelines). For

identifYing risks, factors like characteristics of the donor organism, vector, transgenic

· insert, GMO and the method of modification would be-considered15. For the risk

management in limited releases the following measures are advised; keeping isolation

distance16 to prevent fertilization, biological prevention of flowering and human

intervention in controlling reproduction, control and destruction of volunteer plants,

keeping humans away if the GMO has some allergic properties, emergency p1ans17,

training of personnel and documentation of prior information ( 1998 Guidelines) 18•

6.1.2.4. State Biotechnology Co-ordination Committee (SBCC)

The SBCCs 19 can 'inspect, investigate and take punitive actions' ·against

statutory violations through the nodal department and the State Pollution

Control Board or the Directorate of Health or Medical Services. The

Committee sha11 undertake periodic; reviews of the safety and control

measures in industries and institutes (rule 4(5).

6.1.2.5. District Level Committee (DLC)

The DLCs20 at the district levels are to monitor the safety regulations in

insta1Iations. The DLC or its representatives shall make on-site visits and find

out hazards and risks associated, with a view to meeting any emergency. They

14 Safety, risks and accidents related with environmental release. 15 The DBT released the Protocols for Food and Feed Safety Assessment ofGE crops in 2008. 16 RCGM/GEAC can change the minimum spatial isolation distance for specific applications. The permitted party shall dispose of the material used in 'trials, post-harvest land use restrictions and post­harvest monitoring' (2008 Guidelines). 17 There must be timely (within 24 hours) intimation of any 'accidental or unauthorized escape like spillage, theft, encroadunent by unauthorized persons, vandalization etc.' involving GEOs (2008 Guidelines). 18 It is criticized that the 1998 guidelines developed by the RCGM are lacking in providing for a full environmental risk assessment and are only suitable for judging the safety related aspects of pesticide residues. The non-mandatory requirements are prone \o encourage administrative discretion. Further, the Guidelines allow data generated in other countries to be used in India (Anuradha, D.V., 2002). But the government officials claim that the Indian risk assessment standards are stricter than the other available models across the world (Gupta, Arati, 2002). 19 The members of the Committee are the Chief Secretary, Secretaries of departments of environment, agriculture, forests, industry and commerce, public health engineering, chairman of State PolJution Control Board and state microbiologists and pathologists. 20 The Committee members are the District collector, factory inspector, District Chief Medical Officer,· Municipal Commissioner, representatives of the PoHution Control Board, public health engineering department, district microbiologists and pathologists and district agricultural officers.

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shall prepare off-site emergency plans21 and shall regularly submit reports to

the SBCC or the GEAC (rule 4(6).

6.L2.6. Institutional Bio-safety Committee (IBSC)

An IBSC is to be constituted by an occupier or any person conducting

research activities and handling GMOs. The Committee shall consist of the

head of the institution, a medical expert, a scientist well versed in DNA work

and a candidate of the DBT. The occupier or research institution shall prepare

an up-dated on-site emergency plan (with the help of the lBSC) according to

the manual or guidelines of the RCGM. The copies of the plans shall be

served to the State, District Level Committees and the GEAC (rule 4(3)). A

designated Principal Investigator (P.I.) in every research organization should acquaint

the IBSC about the nature of experiments being carried out. The Investigator should

obtain permission from the IBSC or from the RCGM (through the IBSC), if the risk

falJs in a higher category ( 1998 Guidelines).

6.1.3. Procedure for Submitting Applications

For proposed trials 60 days advance detailed application22 is to be submitted with the

initial review made within 7 working days of receipt. Authorities may require

additional information. The receiving authority shaH give copies of the application to

other agencies, experts or institutions for reviews. Reasoned decisions (authorizations

or denial of authorizations) shal1 be communicated to the applicant. Renewals of

authorization (including ongoing trials of perennial GE plants), may be granted for

identical trials. A separate complete written application with justifications for

confidentiality sha11 be submitted for deciding on the fate of confidential business

claims keeping in mind the fact that insufficient information will hamper the

assessments. Monitoring bodies incJude Monitoring cum Evaluation Committee

(MEC) and pre release monitoring teams set up by the state agricultural universities •

21 Off-site plans are prepared by the DLC to. deal with emergencies ansmg from major accidents after considering the information supplied by the occupier (rule 17) .

• n Especially information on the unmodified plant and its reproductive biology for designing isolation distances and detailed map of the trial site and the trial protocol. Applicant must be a permanent resident oflndia, or must designate an Indian Authorised Signatory.

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(SAUs) or other bodies or persons directed by RCGM/ GEAC/SBCC/DLC23 (2008

Guidelines )24•

6.1.4. GMO Imports and Shipments

The Biosafety Guidelines ( 1994 and 1998) and the Plant Quarantine (Regulation of

Import into India) Order, 200325 lay down the standards for GMO imports into India.

Quarantine regulations apply to import and receipt of pathological agents and vectors

or their carriers. Imports for research purposes are regulated by the RCGM and

imports for industrial use are regulated by the GEAC. lBSCs authorize inter-state

23 These bodies will make inspections at the time of planting, during growing and harvesting season, and the period of post-harvest land use. Th_e permitted party will co-ordinate monitoring activities. 24 The National Seeds Policy, 2002 recommends that every GE crop/variety will be tested for environment and bio-safety before commercial approval as required by the 1989 Rules. The Policy also calls for the formulation of a list on the Indian experience of environmentally safe transgenic cultivars. GE materials are importable only through the National Bureau of Plant Genetic Resources (NBPGR) and with the approval of the GEAC. Imports must be accompanied by accompanied by a certificate from the Competent Authority of the exporting country. Agronomic value of GE crops will be tested for at least two seasons under the All India Coordinated Project Trials ofiCAR in coordination with the bicisafety clearance. After commercial release registration under the Seeds Act is mandatory. The transgenic varieties after commercial cultivation will get the same treatment as non-transgenic varieties under the PVP Act Post-market monitoring (performance in the field) of released items will be done by the Ministry of Agriculture and State Departments of Agriculture for- at least three to five years. Packages of transgenic seeds/planting materials shall carry a label indicating information including the agronomic/yield benefits and names of the transgenes. Attention is sought for creating facilities the testing, identification and evaluation of transgenic planting materials (section 6). 25 The Order issued by the Ministry of Agriculture under section 3 of the Destructive Insects and Pests Act, I 9 I 4 regulates or prohibits (when infested or infected with a quarantine pest or contaminated with noxious weed species) the import of agricultural articles. Permits issued under the Order are necessary for the import of plants and plant products and other regulated articles (hereinafter consignments). The application for permit is to be submitted by the importer or his agent along with the prescribed fees and a Phytosanitary Certificate issued by the country of origin. Approval of commercial import of certain seeds and fruits are based on the recommendation of the EXIM Committee of Department of Agriculture & Cooperation. A pest risk analysis as per the guidelines (based on the international standards) is necessary for consignments except when they are exempted from the analysis. The analysis, made after the filing of a request by the importer, involves the classification of pests, evaluation of their introduction potential, the consequent economic and environmental impact and risk mitigating measures. Phytosanitary experts may visit the export country to examine the pre-shipment inspections, post-harvest treatment technologies and quarantine and certification facilities. The issued permits are valid for six months and are extendable. Permits are non-transferable and cannot be amended except for the authorized change of entry points. Consignments are to be imported only through the notified point of entries.• The Plant Protection Adviser or other authorized officers inspect imports on arrival. The importer has to perform inspection related duties like providing information, samples, dealing with the inspected consignments and bearing· the . necessary costs. Transit consignments are to be packed properly to avoid·spi11age and shall not be opened anywhere in India. For the import of soil, earth, compost, sand, plant debris along with agricultural articles as well as insects, microbial cultures or bio-control agents, permits are needed (Chapter 2). Plants and seeds are grown by the importer or his agent (at his cost) in the post-entry quarantine facilities for the purpose of post-entry quarantine. This facility is to be certified by the Inspection Authority as per the instructions of the Plant Protection Adviser. The Inspection Authority shaH supervise the quarantine and order the destruction of consignments (in whole or part) containing exotic pest or disease or to take curative measures if the pests or diseases are non-exotic. The Plant Protection Adviser (the person has jurisdiction for _hearing appeals and revisions), takes decision on the basis of a report from the Inspection Authority (Chapters 4 and 5).

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shipping with the knowledge of RCGM. Such shipments are subject to packaging,

labeling and shipment requirements (1994 Guidelines). The Plant Quarantine

(Regulation of Import into India) Order, 2003 is the 1egaHy binding instrument

regulating LMO imports for research. purposes. Valid pennits issued by the Director

ofNational Bureau of Plant Genetic Resources (NBPGR) are necessary for the import

of 'consignments of germplasm or transgenics or GMOs' for research or experimental

purpose26• Such consignments sha11 not be opened at the point .of entries before being

sent to the NBPGR. The permit is issued subject to the approval of and conditions and

restrictions prescribed by the RCGM. Bulk shipments of GMOs and their products

shaH be treated under the 1989 Rules or the m~chanisms established as per the

provisions of the Biosafety -Protocol (sections 6 and 8 of Chapter 2 of the 2003

Order). Section 18 of the Government of India Notification no. 2(re-2006) I 2004-

2009 spells down the conditions for importing GM food, feed GMOs and LMOs for

the purpose of Rand D, food, feed processing in bulk and environmental releases.

Approvals for the import of 'food, feed, raw or processed or any ingredient of food,

food additives or any food product that contains GM material and is being used either

for industrial production, environmental release, or field· application' sha11 be given by

the GEAC. Importing entities sha11 submit applications to the RCGM for R and D

purposes and if these materials are used for commercial purposes, approval of the

GEAC is needed. A11 required consignments shall carry a declaration that the product

is GM. Penal provisions under the Foreign Trade (Development and Regulation) Act,

1992 wi11 apply (from July 6, 2006) if a consignment not carrying such a dedaration

is later found to be GM.

6.1.4.1. GM Food Imports

For the purpose of import regulation, GM foods are divided into three categories; 1)

for LMOs as food or fGed perse, (like maize, mustard com etc.) demonstration of

detailed environmental and food safety studies (additional conditions to check

26 As per the 1998 Guidelines, the RCGM is the authority issuing import license of transgenic material for research purpose. The safety of the material, national need and faci1ities available for soil. tests wiJJ be examined. The import shall accompany the appropriate phytosanitary certificate of the export country. Once the import license is delivered by the DBT on the basis of the RCGM recommendation, the import is directed to the NBPGR. The NBPGR examines the safety evaluation· in a time bound manner. The importer may be present (if requested) at the time of evaluation. Non-delivery of a phytosa!)itary certificate by the NBPGR results in the cancellation of the import permit. The material shall be used as a 'source material' in the event of a legal dispute.

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accidental release) and compliance with the provisions are needed for GEAC

approval; 2) for foods derived from LMOs (like com flour and potato chips), details

should be provided by the applicant regarding the genes or events expressed in

approved crops in country of origin, food safety studies conducted there, al1alytical

and compositional reports and plans for additional processing; 3) for processed food

which contains an ingredient derived from approved LMOs (like non-GM potato fried

with GM oil) falling within the above two categories, only a declaration to that effect

at the entry point is needed27• Otherwise, a complete procedure as required for the first

two categories is needed. For Categories 1 and 2, shipping documents as required by

the Biosafety Protocol are necessary. For processed food, the s~ipping documents

shall contain contact details of the importer, -country of export, and declaration by the

export country that the genes are approved by the GEAC28. Applications in the

prescribed format (available on the website) shall be submitted to the GEAC, 90 days

before the ship leaves the country of export. The applicants will have the opportunity

to express their views, if needed (GEAC, Procedure for cJearance by GEAC for

import of GM Products). MoEF notification S.O. 1519 E (2007) exempt food stuffs,

ingredients in food stuffs and additives including processing aids derived from LMOs

where the end product is not LMO from the application of rules 7-11 of the 1989

Rules, was kept in abeyance by SO 411E (2008) until further notification by Ministry

of Health and Family Welfare or Food Safety and Standards Authority, whichever is

earlier.

6.1.4.2. The Food Safety and Standards Act, 2006

The Food Safety and Standards Act, (FSSA, 2006) replaces the Prevention of

Food Adulteration Act, 1954. The Act regulates food 'Yhich include

processed, unprocessed and GM food or food containing such ingredients.

General obligations Jike risk asseisment29, risk communication, fixing of

appropriate level of protection and adoption of measures which are not more

27 Soybean oil importers were successful in getting temporary exemption from labeling till March 31, 2007 (Notification No. 21 (RE-2006)/ 2004-2006. 28 Date and number of the approval are needed. 29 The JCMR Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 demands the description of GE plant, host plant(history of safe use and dietary exposure),donor organism, genetic modification(s). and characterization of genetic modification(s). Safety assessment is conducted for possible aHergenicity, toxicity, compositional analysis of key components, intended nutritional modifications and unintended effects.

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trade restrictive than necessary and review of decision·s do figure in the Act.

The manufacture, distribution, sale or import 'geneticaJly engineered or

modified food' has to satisfy the obligations under the Act. GM :food is

defined as "food and food ingredients composed of or containing genetically

modified or engineered organisms obtained through modem biotechnology, or

food and food ingredients produced from but not containing genetically

modified or engineered organisms obtained through modern biotechnology"

(Chapters 3 and 4), which means that even if novel genes or proteins are

undetectable in the final food product, it will be considered as GM food 30•

The FSSA punishes deceptive practices and misleading statements made

without scientific justification.

6.1.4.2.1. Authorities in Charge

The FSSA puts forward a comprehensive hierarchy of authorities. The Food Safety

and Standards Authority will be responsible for the enforcement of the proposed act

inch:iding scientific advice and technical assistance to governments. The role of the

Central Advisory Committee is co-coordinative and advisory. The Food Authority

shall establish scientific panels (including for matters related to genetically modified

organisms and foods), which shall consist of independent scientific experts. The Food

Authority can to constitute scientific Committee for giving scientific opinions (on

multi-sectoral issues) and also can make use of working groups and public hearings.

The Commissioner of Food Safety (who may delegate authority to designated officers)

may prohibit food articles and sanction prosecutions. Food Safety Officers at the local

level to carry out measures like sampling to deliver it to the Food Analyst in

accredited labs. Then the Designated officer will decide upon the culpability. The

Commissioner of Food Safety will decide on jurisdictional matters on the basis of the

grav.ity of offences. Defense of due diligence is available but mistaken and reasonable

belief is not recognized as a defense in proceedings. Various penaJties are prescribed

30 The definition is same as contained in the proposed Draft Rules to Amend Prevention of Food Adulteration Rules, 1955, 37- E Labelling of Genetically Modified Food mandated compulsory labeJJing of a11 GM foods (primary or processed or any ingredient of food, food additives or any food product that may contain GM material). Labels of all packages of GM foods (imported and domestica11y produced) had to indicate the information on (this product is 'subject to genetic modification') genetic modification. Labels of imported GM food needed to additiona}]y indicate the clearance in the country of origin to facilitate verification so as to avoid testing. Since the PF A is not in force now labelling requirements have to be pr<!mulgated under the FSSA.

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for the violations. Food Safety Appellate Tribunals are to hear the appeals. Authorities

under the Sea Customs Act, 1878 shall have powers to prohibit such imports (article

6).Though the GEAC is the relevant authority to give market approval for LMO-FFP,

it is not an all-rounder, screening each and- every consignment. It is doub-tful whether

authorities under the FSSA or Sea Customs Act, who are in charge at the point of

entries, do have sufficient facilities to detect the GMO presence. Laboratories notified

under section 4 of the Seed Act and persons notifed under section 12 oft he Seed Act

wi11 analyze the seed samples of GM crop varieties to ensure quality. The power to

co11ect samples is delegated to the Seed Inspectors (under Section 13 of the Seeds Act

and Section 12 of the Seeds (control Order), 1983 (G.S.R. 586 E., 2006).

6.1.5. Approval of rDNA Pharma Products

Apart form the authorities functioning under the 1989 Rules, Drugs Controller

General of India (DCGl) and the State Drugs Contro11er under the Drugs and

Cosmetics Act 1940 and the Rules 1945 also have jurisdiction to deal with rDNA

pharma products31• Five categories of activities involving pharmaceutical LMOs and

LMO products are visualized by the Mashelkar Task Force Report for the purpose of

streamlining the regulatory process. The first category is the indigenous development,

manufacture and marketing of products derived from LMOs, but the end product is

not a LMO (Protocol 1). Fo11owing the pre-clinical studies conducted under the

supervision of the RCGM, a recommendation is submitted to the DCGl for human

cJinicaJ trials. The GEAC has no approval authority, since the end product is not a

GMO and hence no question of environmental release arises. The DCGI is the

authority to decide on the safety and marketing of the product, taking into account the

views of the GEAC, when it is ~o mandated. The protocols for clinical trials sha11 be

prepared by the DCGl in consultation with the rDNA Advisory Committee. Final

decision on marketing is communicated to the GEAC32• LMOs should be categorized

into three risk groups (1, II and II1 and above) for ~afety assessment. Th~ RCGM shaH

31 The ICMR Guidelines for Generating Pre-Clinical and Clinical Data for rDNA Vaccines, Diagnostics and other Biologicals ( 1999) propose the specification and characterization of information on GMOs and products, pre-clinical (in animal models) and clinical evaluations (in human beings; in cJinical phase monitoring of immunolgiclal parameter is suggested to genrate data on ethnic, socio­economic and cultural variations) for ensuring the 'safety, purity, potency and effectiveness' of products~. Fast clearance procedures are advised for vaccines already in use and combination vaccines. Data of post-market survey should be analyzed. 32 Earlier, GEAC approval was required for research l!Ctivities exceeding 20 liters of fermentation capacity.

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judge on the adequacy of containment facilities for Categories II and I. The role of

GEAC is to be limited to giving views from the environmental angle. The GEAC will

approve research with category III and above GMOs, taking into account pre-clinical

studies and ·containment recommendations of the--RCGM. Approvals are made and

communicated to the DCGI after considering 'the product and processes

specifications, containment facilities and human clinical studies'. In regulating

indigenous activities where the end product is a LMO (Protocol), the GEAC is given

a more active role because chances of accidental release and replication are high. The

RCGM makes recommendations to the DCGI and GEAC. The GEAC approves large­

scale release and phase III clinical trials and forwards safety opinions to the DCGI.

Decisions on environmental release are taken by the GEAC after a cost-benefit

analysis. This approval by the GEAC is a prerequisite for the final commercial

approval by the DCGI. A different procedure is in place for importing and marketing

of products in finished formulation where the end product is a LMO (Protocol JJI).

Less environmental risks are anticipated from this category of products. The GEAC

authorizes human clinical trials in principle on the basis of the studies in the country

of origin and the studies in other countries where the product is tested. GEAC gives

the final environmental clearance after studying the clinical study results. The DCGI

authorizes the marketing after consulting the toxicity, allergenicity, quality control

tests and the GEAC clearance. DCGI is responsible for conducting the safety and

product efficacy tests and post-market monitoring. For the import and marketing of

products in bulk for marketting finished formulation where end product is a GMO

(Protocol IV), the GEAC shaH give environmental cJearance and refer it for c1inical

trials to the DCGI because probability of environment risks of bulk shipments is high.

IBSCs are to be fonned at the facilities instituted for making finished formulations.

This is a Protocol Il similar situation and as a result, that specific procedure applies.

Import and marketing of products in bulk or finished form where the end product is ,

not GMO (Protocol V), fa1ls in the least environmental risk cat,egory. Here the 1989

ruJes are not applicable. The DCGI gives consent in consultation with the RCGM

(which may be asked to review the initial proposal), after analyzing the necessary

foreign data and trials. Generally RCGM is the ultimate authority sanctioning imports

for research. When both DCGI and GEAC are involved in decision-making, the

agencies can move ahead with their examinations concurrently. No interlinking is

expecte.d in such instances. Time limits are alSQ prescribed for the decision-making by

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various authorities33. On fresh applications where there is a change in the host

organism or expression construct, fresh permission will be needed from the RCGM. lf

the bio-equ:ivaJence data is insufficient, limited trails may be prescribed. Regarding

imports, evidence of adequate evaluation in the exporting country-and evaluation of

efficacy and safety for Indian population has to be tested34• The Ministry of

Environment adopted the Mashelkar Task Force proposals (only applicable to

pharmaceutical products produced through rDNA technology) with effect from

1.4.2006. MoEF Notification (G.S.R. 616(E)) exempts (under rule 20 of the 1989

rules) the foJlowing from application of section 7 to 11 of the 1989 rules; indigenous

product development and marketing of pharmaceuticals derived from organisms

falling under risk Group 1 and II of the 1 990 rDNA guidelines and import and

marketing of products derived from LMOs as drugs and pharmaceuticals in bulk

and/or finished formulations (where the end product being imported is not a LM0)35•

6.1.6. Administrative Powers and Appeal Provisions under the 1989 Rules

The State Level and District Level Committees can take necessary measures

(including emergency measures for preventing negative effects) at the

expense of the responsible person, to check any violation of orders. The

Committees can take samples for further evaluations. The Committees may

require the assistance of other government authority to implement the

instructions (rule 15). Responsible persons shall notify State Level and

District Level Committees, the state medical officer, any interruption of operations

or accidents, which may cause harmful discharges. Still, the responsible person is not

relieved of the duty to minimise or prevent the effects (rule 16). The GEAC, DLC,

SBCC or authorised persons sha11 be admitted to the premises and localities for

supervision. Required information (on financial conditions and accounts as well) of

the responsible persons shall be submitted to these Committees. The Ministry of

Environment and Forests may exempt an occupier from the obligations bx (rule

33 For RCGM approval for pre-clinical animal studies; 45 days, for DCGI approval for Human Clinical Trials protocol; 45 days, for DCGI examination of clinical trial data and response: 90 days, for DCGI and GEAC decisions which are to be made simultaneously; 45 days. 34 There is a need to strengthen authorities under Drugs. and Cosmetics Act and Rules. The Report also suggests methods to enhance Indian exports, which arte not LMOs. There shall be an independent expert committee to supervise manufacturing and containment facilities. The Ministry of Environment is in the process of constituting a Standing Technical Advisory Committee on Biotechnology Regulation (STACBR) to look aftenegulatory aspects and to make issue-based recommendations on a case-by-case basis. 35 But this notification is kept in abeyance by SO 411E (2008).

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18). The GEAC or SBCC decisions made under the 1-98.9 Rules may be

appealed to the authority appointed by the Ministry of Environment, within 30

days of the decision (rule 1 9).

6.2. Indian Biosafety Law in Action

The multi layered Indian biosafety regulatory system had often been caught

off guard. Green Peace India a1leged that an independent laboratory test bad

revealed that Proctor and Gamble's Siomil Baby food with traces of

Monsanto's GM round up ready crops (Times of india (New Delhi), June7, 2001).

Greenpeace again complained to the GEAC on the import of Dorito's Cool Ranch

Com chips containing GM ingredients. The matter was to be evaluated by the

Ministry of Health and Family Welfare, Food Safety and Standards Authority and

Ministry of Food Processing Industries as directed by the GEAC. But Greenpeace

could not submit the old samples (rather submitted one set of sample from a new

round of sampling) up on which the allegations were made. The NGO was criticized

by the GEAC for its irresponsible behaviour (absence in the date of presenting the

case) and was asked to approach Director General of Foreign Trade as Pepsico denied

any usage of GM crops36 (GEAC Decisions on 9.7.2008 and 13.8.2008). Cultivation

of transgenic cotton in India without any prior approval of the GEAC and the

a11eged irregularities in the Bt cotton approval process, both at the field trial

and marketing stages, speak volumes for the lack of effective implementing

mechanisms. In the Navabharat cotton chapter, the GEAC quickly reacted by

directing the Gujarat SBCC to destroy crops by burning. It also ordered the

destruction of a11 breeding lines, seed production plots, harvested seeds,

plucked cotton bo1ls and breeding material with the companl7• However the

failure of the GEAC to take timely action against the illegal cotton is

criticized as the Indian mechanism's incapacity to regulate GMOs. Despite the

36 When representatives of Greenpeace presented their case, th~ GEAC clarified that neither the

Ministry of Environment and Forests nor the GEAC are directly involved in the import, sale or distribution of any GM commodity including GM food products, though the 1989 Rules require the prior approval of the GEAC in such cases. In the instant case, the GEAC has informed the concerned Ministries (including the Ministry of Health and Family Welfare, Ministry of Food Processing and Industries and Ministry of Commerce and Industry /DGFT) that prior approval of GEAC has not been obtained (GEAC Decisions 14.1.2009). 37 The company was blacklisted and dealers' licenses were cancelled. The state government suggested the GEAC to spare the plants and seeds from being destroyed in order save the already troubled farmers (Frontline, 2001 ).

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GEAC order for destruction and prohibition of the accused company from further

production, the damage already was done. Small seed companies were already in

possession of the seed lines that allowed them to move ahead with the production,

The farmer lobbying forced the Gujarat government to remain as a silent spectator

when confronted with the destruction of standing illegal crops (Pray, C.E.,

Ramaswami and others, 2006). Another instance of flouting rules is the manner

in which Bt cotton field trials were conducted. The clearance for all the trials

of Bt cotton came through the advisor of the RCGM, where permission is to

be granted only by the GEAC. The timing of the sowing exposed that the

seeds had been sown before the trial permissions were obtained in July 1998

(Shiva, Vandana and others, 2000, Chapter 2). The GEAC was forced to defer

the approval decision for GM mustard, the first GM food crop to be approved

in India. The contentious issues were the performance claims (the yield

potential not exceeding 20% of the existing varieties), high probability for

cross-pollination with several wild relatives of the crops and the usage of

marker genes (Raj Gopal, 2002). Another controversy was related to a

statement made by the head of the Indian Government's Department of

Biotechnology, regarding the distribution of GM potato in government schools to

counter the problems of malnutrition (Ghosh, Pallab, 2003). A responsible

authority made this irresponsible public statement even before any conclusive

assessments were made. Regarding the approval of Bt brinjal, the studies

referred to by the GEAC in support of the authorization oflarge scale filed trials were

attacked for being inconcJusive and biased towards the industry (Sahai, Suman, 2006).

Taking into account these criticisms, the Ministry of Environment had constituted an

expert committee to study the responses to the biosafety data published by the

GEAC38 (List ofProposals before GEAC as on 9.3.2007).

6.2.1. Legal Disputes

The Research Foundation for Science, Technology and Ecology (RFSTE), a Delhi

based NGO, filed a suit before the Supreme Court in 1999, alleging violations

of Indian biosafety regulations. The supposed violations were with respect to

38 The representatives of the Ministry of Health and Family Welfare informed the GEAC of the reports

on the adverse impacts of Bt brinja) on human health. The GEAC decided to set up a Sub-committee for looking at the biosafety data on Bt brinjal (GEAC Decision 14.1.2009).

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Jhe GM cotton seed import and subsequent spreading through multi location

trials in the open environment. Measures to counter po11en flow and isolation

dis.tance observance were not adhered to (Saxena, Sachin, 2001 ). The

Supreme Court (1999) issued a temporary injunction forbidding further field

trials until amendments were made to protect against risks to biodiversity,

human health and the environment. An amendment authorising RCGM to

conduct small-scale field trials, was the reaction from DBT. The RFSTE later

approached the appropriate authority i.e., Appellate Authority constituted

under Rule 19 of the 1989 Rules questioning the approval of Bt cotton and the

appeal was dismissed (Research Foundation for Science, Technology and Ecology Vs

Vol and Others, 2003). It was held that the permission for Bt cotton was given after

examining the biosafety and agronomic data acquired through tests in Indian

conditions for a period of six years. The authority made the following observations.

Foreign studies were considered only for the laboratory trial purposes. 'No haste' was

found in granting approval and the decision was in accordance with the precautionary

principle. Any violation of the Rules or safety guidelines was not proved (para. 9).

The institutional set up and standards formed under the 1989 rules are competent to

address the biosafety concerns. Several SBCC's (in 15 states) and DLC's (in 13 states)

have been constituted under the 1989 Rules39. On the matter of the inadequacy of the

5 meter refugia for Bt cotton plantations, it was observed that cotton pollen is 'sticky

and heavy' and the chances of wind pollination are minimal. The allegation of

permission given by the RCGM as violative of the Rules was dismissed as RCGM can

authorize restricted filed trials and can design open field trials to control the escape of

GMOs into environment. Overlapping of jurisdiction does occur between the DBT

and Ministry of Environment. Under the Allocation of Business Rules 1961, the

Department of Biotechnology is the main authority 'for the import of genetically

manipulated ~aterials. The DBT was in close contact with lBSCs, while monitoring

the Monsanto-Mahyco Cotton trials. Anyway, the final approval was based on the

trials conducted under the GEAC, which assessed the reports of the ICAR and

Monitoring cum Evaluation Committee (paras. 6 and7). The studies did not prove that

the performance of Bt cotton was 'unsatisfactory'. The failure of Bt cotton in some

39 The Chairman of the Maharashtra SBCC and the DLC were informed about the alleged illegal field trial permissions (para.9). But the Planning Commission Task Force Report confirmed that the State Level Committees and District Level Committees were absent in some states where Monsanto's Bt cotton was approved.

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areas was due to 'water scarcity under rain fed conditions' and not because of the

presence of the trans gene (para.8).

6.2.2. Pending Cases

The Supreme Court of India has ordered the GEAC 'to withhold approvals of till

further orders are issued' in a writ petition (M/s Aruna Rodrigues vs. Union of

India40,2005) against the approval of different Bt cotton hybrids. While preparing for

its position before the Court, the GEAC decided to discuss the results of the field

trials without disturbing the order. The Court in 2007 demanded the information on

the implications and biological results of the ongoing-field trials. The SC in an interim

order (2008) requested the GEAC to consult Dr.P.M.Phargava and Dr.M.S.

Swaminathan before arriving at final decisions. The GEAC was permitted to process

app1ications in accordance with the Jaw overruling the earlier directions to withhold

research approvals for new varieties excluding Bt cotton. Another public interest

litigation (Gene Campaign & another Vs Union of India & Others, 2004) is pending

before the Supreme Court chaJlenging that 1989 Rules are unconstitutional as they are

·not helpful in pursuing the protection of environment and public health guaranteed by

articJe 21 of the Constitution41 and do not recognize the legally acdaimed

environmental notions like the inter-generational equity, precautionary principle and

po11uter pays principle. The requests in the writ petition include publication of data

even in the face of inte11ectua1 property daims and a moratorium on

commercialization of GM crops, till a proper regulatory structure is in place.

40 This case sought the ban of any releases (import, manufacture, use or any other manner) in the absence of specific precautionary actions. The prayer include ban of imports of GMOs, GM food and feed lacking certification and labeling by the exporting country and compulsory labeling marketed GMOS. 41

The Genecampaign public interest litigation challenges the constitutionality of the Rules on the basis that they are not in consonance with article 21 of the Constitution and that they have not been brought in line with the Biosafety Protocol. The regulatory agencies under the 1989 Rules Jack technical competence, transparency, and public participation. The petition requested for amending the present Rules and the formation of a High Powered Committee to formulate a National Policy on GMOs through a multi-stakeholder consultations. And also there should be a moratorium on commercial approval of GMOs (till the setting up of Monitoring System) for which the country is a Centre of Origin! Diversity, ti11 the Rules are amended and a sound regulatory mechanism is put in place. AU India Rice :Exporters Association (AJR:EA) had filed an impleading petition in the Aruna Rodrigues case for declaring a moratorium on Bt rice field trials.

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6.3. Initiatives for Regulatory Reforms

The civil society demands tighter appraisals, representation of representatives

from science streams, tribal populations, local self-government institutions

and legal profession, more attention to risk management and risk

communication and transparent decision-making (publicising of data and

reports) as well as more active role for the SBCCs and DLCs. The industry is

critical of the time taken for approvals and the invoking of non-biosafety

considerations (like economic performance of GM crops and clinical trial data

of drugs) by the GEAC and demands the dethroning of GEAC. as the

independent apex decision-making body (Damodaran, A., 2005). Dr.

Swaminathan Task Force Report proposed a reduction in the levels and number of

steps in the approval of GM crops. 'Transparency and professionalism' are the two

qualities that need to be injected into the decision-making process. As per the

recommendations, contained and open field trials remain under RCGM's authority42.

The ICAR and the applicant are exclusively accountable for 'multi-locational farmer's

field trials for yaJue for Cultivation and Use (VCU)'. The Monitoring and Evaluation

Committee has to report to the GEAC till the formation of the proposed

Biotechnology Authority. JCAR or Department of Agriculture should commercially

approve or register agricultural GMOs and monitor the performance of approved

varieties or hybrids43. The JCAR should develop mechanisms for simultaneously

conducting the VCU trials along with the GEAC clearance. Once the GEAC approves

multi-locational large-scale field trials in different agronomic zones, the planting

material should be given to the ICAR. The matter should be conveyed by the GEAC

to all "stake holders' including the State Governments. The GEAC should prepare

trial designs in association with the ICAR. Derivatives of approved varieties or

hybrids should undergo only 'need based trials' by the RCGM, to ascertain gene

stability and expression levels 44• The information to be provided by the applicant

should contain information on, biosafety, environmental, a11ergenic, toxicity,

42 Two protocols are suggested, one for release of a new variety and the other for approval of a released event. Both procedures are similar in nature .

. 43 State agricu1tural universities should be involved in the post-market monitoring of gene flow, effect on no-target organisms, resistance development and maintenance of refuge etc. 44 Jf the gene is not in a new gene background, one year field trial is enough.

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agronomic performance45 parameters and other matters46. The proposed autonomous

National Biotechnology Regulatory Authority (NBRA/7 should have two wings, one

on agricultural and food biotechnology and the other for medical and pharmaceutical

biotechnology. NBRA should function in the company of State Level Regulatory

Advisory Boards and District Level Communication Committees. Matters like

harmonisation of data requirements and protocols, publication of evaluation reports48

(paced on an authorised website) and approvals, scheduled meetings of regulatory

meetings etc. should be given adequate attention. A National Food Safety Protocol

covering production and post harvesting of GM crops is desirable. Ministry of

Science and technology "Yith the lCMR and Ministry of Health should guide the

implementation of codex standards on GM food. A mechanism to monitor

'segregation, identity preservation and labe1ling' of GM or non-GM products is also

recommended. Scientific exhibition of biosafety and regulatory appraisals are

important (but not the single most) tools in engineering public acceptance of

biotechnology (chapter 29). Seed registrahon should be mandatory to prevent piracy

(chapter 32). The Ministry of Agriculture has to evolve a special insurance scheme for

GM plants and crops to guarantee the benefits of technology to poor farmers (chapter

33). The Report of the Task Force on Recombinant Pharma (2005; chaired by Dr.

R.A. Mashelkar) also backed the founding of a National Biotechnology Regulatory

Authority/Commission with a single window clearance system. The Authority would

comprise of four wings; a) agricultural products I transgenic Crops; b)

pharmaceutical/ drugs and industrial products; c) transgenic foods/feed; and d)

transgenic animals/ aquaculture" (Chapter 6).49 The Planning Commission Task Force

Recommendations advocated the setting up of certain bodies in the GMO approval

process; 1) an advisory body consisting of subject experts (scientific, social sciences,

law), representatives of civil society organizations, traditional communities,

~bureaucrats and panchayati raj: 2) a statutory body of scient(fic experts for risk

assessment which shaH be ' transparent, accountable and technically competent'.

45 The factors to consider include 'yield performance, response to major diseases and insect­pests and cost-benefit ratio'. 46 The rationale for development, description of the crops and host, centres of origin or diversity of the species. 47 A five member Committee consisting of agriculture, environment, health and legal experts. 48 Right to information of farmers on the risk and benefits is to be respected. A procedure is to be chalked out for participatory assessment and transparent evaluation (chapter 25). 49 The Report advised to look for alternatives in the creation of the Authority.

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Added to that public participation shall be mandatory for agenda setting, risk

assessment, cost-benefit analysis and final approval and a Citizens Jury of eminent

experts to make periodic reviews and to function a:s a forum for an effective discourse

onGMOs.

6.3.1. Draft National Biotechnology Regulatory Bill, 2008

The DBT produced (2008) a Drafi National Biotechnology Regulatory Bill (the draft

bil1) for the regulation of GEOs50. The draft bill is accompanied by a Draft

Establishment Plan for the National Biotechnology Regulatory Authority (draft plan)

which is explanatory in nature. The Preamble in the same breath lauds the vista of

opportunities offered by modem biotechnology and is cautious about the need to

develop modem biotechnology 'in a responsible way in harmony with ecological and

ethical values and goals'. Issues like 'effectiveness and efficiency of regulatory

procedures', 'uniform and consistent approach to address' safety, identification of

risks and risk management, also are able to find a place in the pre-amble. The pre­

amble is considered as the key to a legal instrument, so it will be interesting to see

how the key influences the content, once the doo:r js opened.

6.3.1.A. National Biotechnology Regulatory A111thority

The Central Government is to appoint a body cmporate cal1ed National Biotechnology

Regulatory Authority (NBRA), which has the capacity to establish (may establish)

branch offices anywhere in India 51. The Authority wi11 consist of; the Chairperson,

Chief Regulatory Officers, Regulatory Branches, Risk Assessment Unit and Cross­

Sectoral Offices.52 The Chairperson is responsible for; the implementation of work

programmes and decisions adopted by the Authority; and ensuring timely and quality

service and co-coordinating the Central Government and various stakeholders through

relevant committees to guarantee a regular dial()gue. 53 The Inter-Ministerial Advisory

Board shall be responsible for promoting co-operation with the central government to

50 Modern biotechnology is the application of in vitro nucleic acid techniques excluding traditional biotechnologies like breeding and selection (Section 2(1))-51 Sections 3. 52 Section 4. The cross-sectoral units of the NBJR.A are; national and international policy co­ordination units, legal unit, monitoring, compliallCe and accreditations unit, state or zonal

_ offices and communication and outreach {the draft ]Jain}. 53 Section 5.

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implement the biotechnology regulatory system.54 The provision on the duty of the

National Biotechnology Advisory Council is drafted in an interesting manner: " ... to

provide the Authority with independent, strategic advice from various stakeholders on

developments in modem biotechnology and their implications for Indian society".55

The Board and Council shall not interfere with any 'product-specific decisions' made

by the Authority. 56 Thus the Authority is the real power wielding body under the draft

bill. Further, under Section 12, the Authority is responsible for the implementation of

the Act. 57

6.3.l.A.l. General Powers of the Authority

The Authori_ty as dictated by rules (lobe formulated), sha1158; render scientific advice

and technical support to the concerned Governments on matters of policy and rules

directly affecting GEO safety issues and crisis management; serve as the national

point of contact for international activities for policy measures and monitor, review

and analyze national and international policies that may affect government priorities

in the biotechnology sector; develop and implement guidelines for risk assessment

methodologies and feed the concerned Governments on safety matters; establish a

network of organizations for the exchange of information, expertise and best

practices; provide access to process and criteria for risk assessment and risk

management to the stakeholders and the public to uphold the 'credibility and

predictability of risk assessment'; notify the public, all clinical and field trials and

regulatory decisions; design public outreach programmes to inform the public on the

Authority's mandate and programmes59; commit to continued 'quality improvement

54 Inter-Ministerial Advisory Board (IMAB) includes representatives of the concerned Ministries, DBT, Department of Science and technology, ICMR,ICAR,CSIR, Drug Controller General of India, Directorate of Plant Protection, Quarantine and Storage and, Food Safety and Standards Authority. 55 lt is unclear whether the Council just passes on the opinion gathered from stake holders or makes its own evaluation before transmitting ~ to the Authority. The words independent and strategic tilt the scale in favour of the second possibility. But the Plan is dear on this aspect when it articulates that "the NBAC will provide the Chairperson with independent strategic advice'' and the body will consist of representatives (up to 20 members) from "the scientific community, private sector and civil society in diverse fields such as science, business, law, nutrition, environment, human health and public advocacy". 56 Section 6. 57 The Central Government shall institute a National Biotechnology Regulatory Authority Fund to meet the expenses arising under the proposed act or rules made there under (Section 23). 5~ Section 9(3). 59 The Communit;ation and Outreach Unit will coordinate stakeholder consultations, opportunities for public participation in the regulatory system, and wi11 be the primary of contact point (draft plan).

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and professional development' in the scientific front; contribute to the development of

international technical standards; and promote consistency between international

technical standards and domestic standards.

6.3.1.A.2. Rule Making Powers ofthe Authority

The Authority· may by rules specify measures60; for the importation genetically

engineered organisms (GEOs); to regulate the containment of GEOs; to regulate

clinical studies of GEOs and derived medicines; to regulate the environmental release

of GEOs; to regulate the use of GEOs and 'products derived thereof as, or in, food

and use in human or animal health. agriculture or other applications'; procedures and -

standards for the accreditat_ion and notification of research facilities61; on the amount

of fees and other charges payable under the proposed Act; and any other matter for

giving effect to the implementation of the Act.

6.3.1.A.3. Regulatory Branches of the Authority

The Authority shall have at least three branches.62 The Agriculture, Forest and

Fisheries Branch shall be responsible for regulating biotechnology products and

processes used in agriculture, forestry and fisheries, including aquaculture.63 The

Human and Animal Health Branch shall control process and products with

applications in human and veterinary health.64 The Industrial and Environmental

Applications Branch will take care of products and processes used in industrial

manufacturing and in environmental applications.65 A combination of products (GE

60 Section 9. 61 The Authority may notify any laboratory and research institutions accredited by any agency to carry out the activities under the rules to be made. The Authority also may recognize any organization or agency for the purpose of auditing notified laboratories and research (sections 14 and 15). institutions 62 Section 9. 63 'Any GE plant, animal, micro-organism, virus or dther animate organism or product(s) derived thereof' (First Schedule) 64 'DNA vaccines intended to induce or increase an antigen specific immune response for prophylactic or therapeutic immunization, regardless of the composition or method of manufacture; vaccines for use in humans or animals containing GEOs; recombinant gene therapy products and recombinant plasma and blood and derived products (First Schedule). The DCGI will regulate all other therapeutic proteins derived from recombinant organisms (draft plan) 65 'Any GE plant, animal, micro-organism, virus or other animate organism or product(s) derived

· thereof that may be released into the environment (excluding the already mentioned categories) having application in industrial production or manufacturing processes' (First Schedule). Each Branch will have a Regulatory Policy Unit (RPU) constituted by permanent professionals, assigned with the responsibility for developing and _implementing Branch specific policies, rules and guidance and communications and outreach programmes (the draft plan).

276

biological components with a drug component) will be reviewed and regulated by an

authority on the basis of its primary mode of action. When the primary mode of action

attributable a type ofbiological product is in-the NBRA's purview, the product will be

assigned to the NBRA 6~..--lf the characteristics of the product require oversight of more

than one branch of the NBRA, the regulatory branches will cooperate to regulate that

product.67 Other branches may be established meeting particular needs and enhancing

efficiency. Each branch will be headed by a Chief Regulatory Officer (CRO), an

eminent scientist with expertise in the concerned subject matter. The Authority can

constitute Scientific Advisory Panels on an ad hoc basis for obtaining scientific

advice, information and recommendations on safety issues that could impact human

and animal health, and the environment. The members of the Panel will be selected

from a roster of qualified scientific experts established by each regulatory branch.

6.3.l.B. Treatment of Applications

Entities involved in the 'research, import, manufacture and/or use the subject .

genetica11y engineered organism or product derived thereof shall make an application

to the Chairperson of the Authority in writing accompanied by the necessary

information (to be specified in the rules).68 Only after receiving the Chairperson's

authorization, the above-mentioned activities shall be undertaken.69 The applications

wil1 be processed by a Product Rulings Committee (comprising of the Chairperson

and CROs of the regulatory branches) launched by the Authority. For processing

applications, three members from the roster of experts of the respective regulatory

branches wil1 be included additionally in the Committee.70 The Risk Assessment Unit

of the Authority (RAU) shall make a science based evaluation of information attached

66 Otherwise, the DCGI will review (draft plan). This is in consonance with the Mashelkar Task Force Proposal of denying the GEAC any role when the final rDNA pharma product is not an LMO. In such cases, the DCGI is the final authority. • 67 First Schedule. • 68 Section I 0 and 11 exhibit minor inconsistencies. Section I 0( 1) mentions activities of 'research, import, manufacture and use a GEO or product derived thereof ', whereas in Section I 0(1 )(a) they are 'research, import, manufacture and/or use the subject GEOs .... ". What is intended by the word 'subject' can only be explained by the drafters. Again in Section 11(2), which makes a specific reference to section IO(a) the usage is 'research; manufacture and/or use of biotechnology products for various applications'. Legal writings may take liberty in the employment of words and usages, but a piece of legislation shall be consistent to the core in that respect. 69 Section 10. 70 The Committee will meet regularly (no less than once every two weeks). The designation, Products committee is a misnomer , because th_e Committee is to handle application with respect to both products and processes.

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with the applications and submit its opmton on safety to the Products Ruling

committee71. After considering this opinion and other relevant matters, the Authority

shaH; authorize the proposed undertaking and. where necessary impose risk

management conditions to reduce risks; or refuse authorization in the face of

unacceptable risks. The decision shall be communicated to the public.72 The draft

plan portrays a slightly different picture. According to it, applications will be received

by the NBRA Secretariat and then referred to the appropriate Branch CRO. The CRO

will then forward the application to the RAU. The CRO will consider the RAU's

recommendation and relevant non-safety considerations (if required by the future

legislation) to prepare a draft decision. Each CRO will present the draft decisions for

applications received before the meetings of Product Rulings Committee convene-d by

the NBRA Chairperson. The Products Ruling Committee will publish the draft

decision for public comment. The Product Rulings Committee after making a review

of each file for compliance with the risk assessment and other procedural

requirements; will arrive at a final decision73. A combined reading of the draft bill and

Plan produces a confused understanding as to the ultimate decision-making authority,

whether it is the Authority as a whole or concerned Regulatory Branch or CROs or

the Products Ruling committee.

6.3.1.C. Monitoring

The Authority may appoint Monitoring Officers to perform the functions or to

exercise the powers under the proposed Act. More importantly, the Authority 'may

establish cooperative mechanisms with state governments and panchayati raj

institutions' to facilitate its enforcement.74• As per the draft plan, the NBRA, state or

zonal offices will work in tandem with the concerned state government departments,

research institutions and organizations for inspection and monitoring. Inspection and

monitoring activities will be undertaken according to NBRA best practices through ad

71 Case-by-case assessment of products by a multi-disciplinary team of in house scientists will provide a degree of consistency and address the issue of conflict of interests (draft pain). 72 The Products Committee may refuse to grant authorization, if it has reasonable grounds to believe that the applicant may not comply with conditions that would be imposed (Section 11 ). 73 NBR Act rules will specify the time frame for each step in the processing of application. 74 Section 13. The Authority is bound by the Central Government bound by such directions on questions of policy, other than technical and administrative matters. lf there is dispute on the nature of a question, the opinion of the Central government shall be fmal. In both iJlstances, the Authority will be given an opportunity to express its views (Section 24).

278

hoc committees trained by the NBRA. Confined field trials of GE crops- will be

carried out with the participation of State Agriculture Departments and Stat~

Agriculture Universities (SAUs). Jn the draft plan, participation of panchayati raj

institutions is not referred. The association of local_ se}f government bodies is

significant for two reasons; for compensating the possible non-formation of local

level statutory bodies (as happened in the case of state and district level committees in

several states under the 1989 Rules) and for guaranteeing public involvement in the

participation programmes.

, 6.3.l.D. Offences and Penalties

Non-compliance by a person with the provisions of the proposed act and rules is an

offence. So does the case with acts of knowingly providing false or misleading

information or documents. Meddling with exercise of power by an officer of the

Authority, acting under the act or rules, without reasonable excuse also is an offence.

The penalties will be prescribed by the rules to be made75. Section 28 forbids any suit,

prosecution or other legal proceedings against the functionaries acting in good faith

under the proposed act or rules, much in contrast to the absence of any specific

provision in the draft bill regarding the liability of any functionary at fault in the

fulfilment of specified obligations.

6.3.l.E. National Biotechnology Regulatory Appellate Tribunal

The Tribunal shall consist of one Judicial Member and two Technical Members 76• A

person aggrieved by a decision under Section 11, within 30 days from the date of

communication of the decision to the applicant, shall request to convene the Tribunal.

An appeal of a decision includes reference to making, suspension, revocation, or

refusal to make decision 77 and imposition of conditions or restrictions as part of a

decision. The appeal shaH be disposed (after giving both parties an opportunity of

being heard) within a period of six months from the date of filing the appeal. The

order of the Tribunal is executable as a decree of a civil court.78 Section 26 bars the

jurisdiction of civil court or other authority to entertain any appeal in respect of any

75 Sections 16 to 19. 76 One T echnica1 Member from hea1thcare and a11ied fields and the other from agriculture and allied fields. 77 Also, issuing, suspending, revoking or refusing to issue a decision. 78 Section 20.

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matter with which the Authority is empowered.79 It is doubtful here whether the

drafters meant the Authority or Tribunal, because it is the Tribunal and not the

Authority, which is authorized to sit over appeals.

The drafters should be congratulated for choosing to settle with 'impact human and

animal health, and the environment' instead limiting to 'adverse effects on

conservation and sustainable use of biodiversity taking also into human health'.

Barring t_he odd curable vague provisions, the bill promises_ a well orchestrated I

decision making process with qualities of transparency and predictability. The

employment of the soft verb 'may' in several places like, Authority's rule making

powers, establishment of regional branches of the Authority, appointment of

Monitoring Officers and striking co-operative mechanisms for monitoring, is a

worrisome aspect. The rule making powers of the Authority regarding importation is

confined to that of GEOs, which should be extended to the products derived from

GMOs or products constituting or containing GMOs. GM food or feed articles not

containing replicating genetic materials and substantially not equivalent to the

traditional counterparts also should be required to undergo the safety assessment

process80. The range of activities to be regulated are 'research, import, manufacture

and/or use' of GEOs or products derived thereof. Absent from the list are activities of

handling, transportation and commercialization, though commercialization may be

inferred from other usages (like use of GEOs or product specific decisions).

Transportation and handling are issues deserving special attention because spillages

can easily cause contamination. Measures for handling, packaging and transportation

of LMOs (the DBT had formulated the Standard Operating Procedures for these

activities following a direction from the Supreme Court) under conditions of safety

shall be undertaken as directed by the Biosafety Protocol.

6.4. GMO Related Liability

There is not statutory law on GMO or environmental liability in India. But thi~

does not mean that an aggrieved person is deprived of effective legal remedies.

Liability for damage or injuries caused by GMOs or violation of the biosafety

79 But this section can not rule out the writ and appellate jurisdictions of the High Courts and

the Supreme Court. 80

As discussed above, the Food. Safety and Standards Act, 2006 can regulate GM foods even if novel genes or proteins are undetectable in the final food product.

280

regulations may anse from the specific legal provisions, the law of tort,

consumer protection laws or liability principles by the judiciary.

6.4.1. Some Specific GMO Liability Provisions

A violation of the 1989 Rules attracts the application section 15 of the

Environment (Protection) Act, 1986. A failure to comply with the Rules shall

be punishable for a term, which may extend up to 5 years or a fine up to rupees

1 lakh or with both. An additional fine may be imposed, which may extend up

to Rs.5000 for every day, if such failure or contravention continues81• A court

can take cognizance under the Act only on a complaint made by (i) the central

government or any authorized officer; or (ii) any person who has given at least

a 60 days notice in the prescribed manner (on the alleged offence showing the

intention to make a complaint) to the central government or authorised officers

(section 19). But the liability provisions under the Act are considered weak and

time consuming (Chauhan, K P S, Tyagi, R. K., 2000). Varieties of any genera

or species, which involve any technology, that are injurious to the life or health

of human beings, animals or plants, shall not be registered under the Protection

of Plant Varieties and Farmers' Rights Act, 2001 (section 29(3)). An

explanation to the sub-section clarifies that the expression 'any technology'

includes genetic use restriction technology and terminator technology. The Act

deals specifically with liability regarding non-performing propagating material

of a variety registered under the Act. The breeder of such variety has to

disclose to the farmers, the expected performance under the given conditions.

Upon the failure to provide such performance under the given circumstances,

the aggrieved farmers may claim compensation before the Plant Variety

Protection Authority under the Act, which may order appropriate compensation

(Section 39(2)).

6.4.2. General Environmental Liability

Articles 32 and 226 of the Indian Constitution guarantee the right to move the

Supreme Court and High Court respectively to enforce the fundamental rights

81 Punishment, which may extend up to 7 years, is prescribed, if such failure or contravention continues beyond one year from the date of convic.tion.

281

guaranteed under part III of the Constitution and both can issue appropriate

writs or directions for the enforcement of those rights82. The Supreme Court

through its judicial pronouncements has relaxed the rule of locus standi in

proceedings under the writ jurisdiction. As a result, public interest litigations

for the enforcement of the fundamental rights of the socially and economically

deprived persons, who are unable to approach these Courts, are possible. The

creative interpretations of article 21 of the Constitution, has elevated certain

rights like the right to health, the right to clean environment, and the right to

livelihood to the status of fundamental rights, enabling persons to directly

approach the Supreme Court or High Courts for their violations (Pandey, J.N.,

1994, pp.l65-191 ). The Supreme Court and High Courts employ mechanisms

like fact-finding commissions and expert committees. The remedial measures

include c1osure of polluting enterprises and requirements of caution deposits.

Several decisions emphasized the need to establish environmental courts to

deal with complex scientific and technical issues (Indian Law Commission,

2003). Environmental liability principles in India are built up on certain

Supreme Court decisions, the prominent among them being M. C. Mehta v.

Union of India (1987), popularly known as the "oleum gas leak' case. The

Court examined the "liability of enterprises engaged in hazardous or inherently

dangerous industry', in case of accidents. The Ryland v. Fletcher rule,

developed in a period when science and technology were not fully developed

was held to be inadequate for the "present day economy and social structure'.

Such enterprises causing harm are strictly and absolutely liable to compensate

all those who are affected by the accident. This liability is not subjected to the

exceptions allowed under the Ryland v. Fletcher rule (para.31 )83• The quantum

82 The jurisdiction of High Court is not limited to the protection of fundamental rights but also for other legal rights. 83 The Public Liability Insurance Act, 1991, gives statutory recognition to this absolute liability principle intends the quick delivery of compensation. Owner of a hazardous enterprise is liable to pay only a maximum compensation of Rs.25000 for the physical or material loss (injury to human beings and damage to private property; damage to the environment is not covered). irrespective of any proof of fault. If the owner has an insurance, liability to compensate shifts to the insurer. The Act contains details on conditions of inSurance polices with respect to the owner and the maximum aggregate liability of the insurer. If the liability exceeds that amount, the amount shall be met by a relief fund and beyond the limits of the fund, the owner shall be liable. The National Environmental Tribunal Act,l995 upholding the no-fault liability, authorizes claims for damage to death or injury or damage to property or the environment, resulting from a hazardous industrial

282

of compensation must be correlated to the magnitude and capacity of the

enterprise. The amount of compensation payable shall be directly proportional

to the size and prosperity of the enterprise. This would help to create a

deterrent effect (para.32). Ranganath Misra, CJ., in Union Carbide Corporation

v. Union of India (1992) treated the propositions in Oleum Gas Leak case as

obiter dicta because the SC did not make a conclusion that the wrongdoing

company was 'state' within the meaning of article 12 of the Constitution84

(paras.14 and 15). The Supreme Court had a different perspective in Indian

Council for Enviro-Legal Action v. Union of India ( 1996). It was noted that

though there was a failure to pay compensation, the Constitution Bench in the

Oleum Leak case had directed the parties and other organizations to institute

suits on the basis of the law declared. Thus the absolute liability principles

were followed in the Indian Council for Enviro-Legal Action case. The Court

also noted that any principle evolved in connection with the polluter pays

principle should be 'simple, practical and suited to the conditions' of the

country. Absolute liability extends to the compensation for the victims as well

as to the costs of restoring the environmental degradation (which is a part of

the process of sustainable development) (para.65). The M. C.Mehta (M. C.

Mehta v. Kamal Nath and Others, 2002) decision viewed pol1ution as a tort

against the 'community as a whole'. Therefore the guilty person is liable to pay

compensation to those who have suffered loss and also compensate towards the

restoration of environment and ecology. The person can be liable to pay

exemplary damages so that it may act as a deterrent for others (para.4). A

categorization of different types of liabilities associated with environmental

po11ution is possible. They are: (a) criminal liabilities; though fines are the

normal penalty, sentences of imprisonment are not ruled out; (b) administrative

sanctions like variation, suspension or revocation of licenses; (c) clean-up

costs; (d) civil liability, based on strict Jiability; and (e) adverse publicity

(K.M. Chinnappa, T.N. Godavarman Thirumalpad v. Union of India, 2002,

para.30).The polluter pays principle was subjected to further clarifications in

Research Foundation for Science Technology and Natural Resources Policy v.

accident. The compensation amount is unlimited but double recovery IS prohibited. The Tribunal is not yet established. 84 Hence Part Ill of the Constitution was found inapplicable.

283

Union of India and Another (2005). The principle extends to the costs of

preventing or dealing with any pollution. Thus liability includes environmental

costs as well as direct cost to the people or property. The principle does not

suggest that the polluter can po11ute and pay for it later (para.27). Liability of

the importers for the costs of destroying hazardous goods is not doubted by the

application of the polluter pay and precautionary principles (para.24).

6.4.3. Liability under Law of Tort

Liability under tort arises from the breach of duty primarily fixed by law towards

persons generally and unliquidated damages can be claimed for its breach. Duties

under law of tort are independent of any contractual obligations or consent of persons

subjected to them (Rogers W.V.H., 1979, p.5). Liability may arise from the adverse

effects caused by po11en flow, mixing of GMOs with other conventional organisms85

(for examples products of organic farming) or presence of GM plants as volunteers.

Considering the fact that pol1en transfer is a biological fact, to invite Jiability, _some

kind of damage has to be proved. So far no domestic disputes between farmers are

reported. Trends in the US and Canada show that cases are filed by non-transgenic

plant growers against the developers. Genetic contamination caused by GM crops

might hold farmers and seed companies liable for claims under trespass to land,

nuisance, negligence, or strict liabilitl6 (Kershen, Drew L, 2004). Smyth and

'Kershen anticipate five instances in the context of the US and Canadian disputes87,

where GMO liability may come into play; damages from the mingling of GMOs and

conventional crops; damages arising from the loss of premium for a non-transgenic

commodity or food product; co-mingling resulting in the Joss of identity registration,

for example organic products; damage from the loss of markets (for example even if

there is no evidence for the a11owed or disa11owed presence of GMOs) and; damage

85 A permissible limit of GMOs in no-GM grains is fixed in India by the GEAC. Regarding the field trials of transgenic ground nut the company was asked to guarantee the level of detection (LOD) of the selected event at 0.01% level as directed by the Supreme Court. As per the guidelines the assessment of percentage contamination and tolerance levels are relevant only for approved products to ensure _ segregation and labelling process are well adhered to. The com contamination episode did not attract the tolerance level criteria since GM corns in question were not approved by the GEAC (GEAC Decisions, 9.7.2008 and 25.6.2008). 86 The strict liability rule is discussed in Chapter 5. US decisions held the view that commercial release of the approved transgenic crop did not fall within the scope of strict liability rules because the escapes were not from property owned or controlled by the companies (Smyth, Stuart J. and Kershen, Drew L, 2006). 87 Regarding the Star Link episode, a consolidate class action lawsuit was preferred to represent several individual c1aims.

284

from a decision not to plant a crop because of the close presence of transgenic crops

(Smyth, Stuart J. and Kershen, Drew L., 2006). Trespass to land means meddling

unlawfully with the legal possession of land, wb1ch could be committed by a person

himself or through some material object. Trespass claims have no legal standing

because pollen transfer or volunteers reaching plaintiffs' farmland are not direct

entries (Smyth, Stuart J. and Kershen, Drew L., 2006). Nuisance occurs when

someone unlawfulJy interferes with a person's use or enjoyment of land or some

rights over or in connection with it. This interference need not cause property

damages. Just the adverse effects on the ability of a person to use and enjoy property

would make pos~ible nuisance claims (Rogers W.V.H., 1979, pp. 335, 352). The

nuisance based claims before the US courts failed because the approved GM crops

were not treated harmful per se or did not make other crops unfit for consumption or

there was no failure from the part of the GM seed developers to conform to conditions

for commercial release (Smyth, Stuart J. and Kershen, Drew L., 2006). A failure to act

reasonably under the circumstances and harm resulting to others generate liability

under the tort of negligence. The elements constituting negligence are '(1) the

existence of a duty on the part of defendants to protect plaintiff from injury; (2)

failure of the defendant to perform that duty; and (3) injury to the plaintiff resulting

from that failure' (Rogers W.V.H., 1979, p.66). A duty of care is expected from

persons dealing with GMOs. A breach of that duty (like adopting safety measures)

would invite liability. On negligence claims, the US decisions took the stand that

certain factors like the market rejection or the farmers' refusal to grow organic grains

were not foreseeable. Absent was any 'adequate relational proximity or any physical

damage to property, or a special relationship between the parties'. Further more,

policy considerations related to pure economic loss (because liability is claimed for an

indeterminate amount for an indeterminate time to an indeterminate class) would

defeat a claim under negligence. Persons whose crops were physicalJy contaminated

(adulteration by an unapproved substance) and who subsequently lost markets had

valid legal claims through negligence, private nuisance, and public nuisance (Smyth,

Stuart J. and Kershen, Drew L., 2006).

285

6.4.4. GMOs and Product Liability

Liability for products causing injury has roots in the House of Lords decision in

Donoughe v. Stevenson (1932). A manufacturer of products owes a reasonable duty of

care to the consumer, with the knowledge that there is no reasonable possibility of

intermediate examination and that absence of such reasonable care in the preparation

or putting up of products will result in an injury to the consumer's life or property

(Rogers W.V.H., 1979, pp. 231-244).

6.4.4.1. The Consumer Protection Act, 1986

The Act st?eks inter alia to promote and protect the consumer rights, such as the right

to be protected against the marketing of hazardous goods; right to be informed about

the quality, quantity, purity, standard and price of goods and right to consumer

education88• All movable properties except actionable claims and money are

considered goods (section 2(i)89. Thus GMO products are covered by the Act. A

consumer90 can institute complaints91 against a trader92 for defective goods93 or

88 The Consumer Protection Council and the State and District Consumer Protection Councils aim to attain the objectives of the Act (Chapter 2). The District Forum enjoys pecuniary jurisdiction where the 'value of the goods or services and the claimed compensation, does not exceed rupees twenty lakhs' (section 11). The District Forum may remove the defects or deficiencies, replace the goods, return the price (along with the charges), award compensation, order the discontinuation of the unfair trade or restrictive practice, prohibit manufacture or sales, withdraw products, order corrective advertisements etc. The State Commission has original jurisdiction above 20 lakhs rupees which does not exceed rupees one crore. Appeals can be filed in the State Commission against any order of District Commissions within the stipulated period (sections I 5 and 17). The National Commission has original pecuniary jurisdiction above one crore rupees. Appeals from the orders of the State Commissions are possible within the time prescribed (section 19). An appeal to the Supreme Court is possible from the decision of the National Council (section 23). 89 The section adopts the definition in the Sale of Goods Act, 1930. Section 2(7) of the Sale of Goods Act defines goods to include "every kind of movable property other than actionable claims and money; and incJudes stock and shares, growing crops, grass, and things attached to or forming part of the land which are agreed to be severed before sale or under the contract of sale". 90 A consumer is any person who buys goods for consideration, which is paid or promised or partly •paid or promised or paid under any deferred system of payment. The user of a good bought by a person is also a consumer, provided the use is with the approval of the person who bought it. Persons who obtain goods for resale or commercial purposes are not included. A person avails or hires service for considenition and any beneficiary of service with the approval of the first person also is a consumer. A person availing a service for commercial purpose is not a consumer .Use of goods bought or services availed by a person for earning livelihood as a means of self-employment, is not a commercial purpose (section 2(d)). 91 Section 2 para (b) defines a complainant to include a consumer, registered voluntary organization, state or central governments, one or more consumers when several consumers have the same interest or in the case of a death of a consumer his legal representatives. 92 A manufacturer is a person who makes or manufactures goods. or just assembles parts of the goods .A person who puts or causes to put his own mark on a mark also is considered to be a manufacturer (section 2(j)).

286

deficient service94 availed or agreed upon to avail. Thus actions are maintainable

under the Act with respect to defective GMOs or deficient services in lieu of the

GMO licence agreements, if there are any. Charging of excess price95, the use or

offering for sale of hazardous goods and hazardous or likely to be hazardous

services96 can be subject matters of complaints (section 2(c)). Restrictive trade

practices97 that have the potential to cause manipulation of prices and the conditions

of delivery, which affect the flow of delivery of goods or services imposing,

unjustified costs or restrictions are also dealt with by the Act. Spurious goods and

services (goods and services which are claimed to be genuine but actually are not so)

and deceptive or unfair trade practices which target the promotion of supply or use of

any goods or the provision for any service, are covered by the Act. Any false

representation of the standard, quantity, grade, composition is an unfair trade

practice98• Marketing GMOs without labels, when there is a legal requirement to label

GMOs would amount to a false representation of standard or composition and

consequently ari unfair trade practice.

6.5. Precautionary Approach

The precautionary approach, one of the central components of decision making in the

Biosafety Protocol does not have any explicit statutory standing in India. However,

93 Defect is any fault, imperfecti~n or shortcoming in quality, quantity, potency, purity or standard which is required to be maintained by or under any Jaw for the time being in force under any contract, express or implied or as is claimed by the trader in any manner whatever in relation to any goods (section 2(f)). 94 Deficiency is any 'fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance', which is required to be maintained under any law or has been undertaken to be performed by any person in furtherance of a contract (section 2(g)). 95 of what is determined by law or displayed (in the label or price list) or agreed by the parties. 96 The trader in such cases 'could have known with due diligence that the goods offered for sale are unsafe. 97

, Delay in the agreed delivery time leading to a price rise and any trade practice which requires the buying of a~y goods or hiring or availing of any service as a condition precedent for buying other goods and hiring or availing other services', are restrictive trade practices (section 2(nnn)). 98 Unfair practices include the following; 1) representation of goods or services having the sponsorship, approval, accessories, characteristics, uses or benefits which they do not actually have; 2) any misleading representation regarding the 'need for or usefulness of any goods or services'; 3) giving 'any warranty or guarantee of the performance, efficacy or length of life of a product or of any goods without an adequate or proper test'; 4) existence of a guarantee or warranty or 'a promise to promise to replace, maintain or repair an article or any part thereof or to repeat or continue a service until it has achieved a specified result' and there is no reasonable chance of this promise being carried out; and 5) 'material misleading of the price of goods (or like products) or services at which they have been or are ordinarily sold.

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some Supreme Court decisions have treated the principle as a part of the law of the

land in an implied manner. In Vel/ore Citizens' Welfare Forum Vs Union of India and

Others, (1996), the precautionary principle and polluter pays principle were seen as

-ess.ential to the features of sustainable development. Precautionary Principle in the

context of the municipal law suggests that: (i) authorities have to 'anticipate, prevent

and attack the causes of environmental degradation';(ii) no postponement of cost­

effective measures in the face of scientific uncertainty and irreversible consequences;

and (iii) the proponent bears the burden to prove that a proposal is environmentally

friendly (para.ll ). The Court opined that even if it is not accepted that the principle is

not embedded in articles 21, 47, 48-A and 51-A (g) of the Constitution and several

environmental legislations, the status ofthe principle as a customary international law

(which is not contrary to the municipal law) presumes that it is incorporated in the

domestic law and is to be followed by the judiciary (paras.l3 to 15)99. Reversal of the

burden of proof, good governance (rule of law, transparency, accountability of Sate

institutions, effective public participation) and principle of intergenerational equity

are essential parts of the precautionary principle (A. P. Pollution Control Board v.

Prof M. V. Nayudu 1999, para.30). The S:npreme Court held in Narmada Bachao

Andolan v. Union Of India, (2000) that the precautionary principle is applicable when

the ecological effects are unknown. If the effects are known, mitigative steps are

needed. A mere change in the ecology100 cannot be equated with an ecological

disaster, which dictates the proponent to prove the environmentally benign nature of

the proposed activity.

6.6. Socio-economic Considerations

The Protocol offers the leeway of socio-economic considerations in LMO decision­

making. The Indian regulations (1998 guidelines) check the comparative agronomic

performance and continuing cost-b~efit analysis of GMOs. But this is only a '

guideline requirement. The Bt cotton approval conditions to some extent reveal the

state of socio-economic considerations in GMO decision-making. The transgenic

99 1t was reiterated that the principle is a customary rule of international law status of the principle and part of the Indian law (Research Foundation for Science Technology National Resource Policy v. Union of India and another, 2003). · 100 Here the activity was the construction of a large dam. The Court refused to equate dams with a nucJear establi~hment or polluting industry, by commenting that there has been an environmental upgradation with the construction of a dam.

288

cotton will have to be grown with an insect regime of 20% non-Bt cotton, making it

impossible for small-scale farmers to, cultivate such crops (Sahai, Suman, 2002). In

fact, the small-scale farmers are not growing the required refugia, search for

alternative risk-management measures is proposed (Report of the Sub-committee on

Bt Cotton and Related Issues, 2006). The Sub Committee recommended that no

extensive biosafety and agronomic testing is needed for hybrids with approved genes

or events. After approval, their treatment should be equivalent to non-Bt hybrids and

the case-by-case approval method should be replaced by an 'event based approved

system'. For other hybrids due consideration shall be given for agronomic

performance and the testing by ICAR for commercialization of varieties unde_r the

Seeds Act, 1966 will be made mandatory. The obligation for continued cost-benefit

analysis will be defeated if the suggestions regarding hybrids with approves genes or

events are implemented101• The Indian law or practice has been non-responsive to the

demands by the Protocol regarding the evaluation of the socio-economic impact of

LMOs on indigenous communities or promotion of research on socio-economic .

effects. The policy developed by the RCGM/GEAC for confined field trials also gives

importance to the trait rater than agronomic performance. The draft plan envisions the

formation of an Economic Analysis Unit by the Authority to study the possible

economic impact of modem biotechnologies including commercial release of specific

products on rural and the whole India. The formation of this Unit depends on the

inclusion in the expected legislation, of non-safety considerations in product specific

decision making. Apart from being uncertain, the draft bill or plan does not make any

special reference to indigenous and local communities, groups which are increasingly

marginalized in a globalized world. In effect, the tentative provision on economic

impact would in no way go beyond the existing agronomic performance evaluation.

6.7. Transparency, Public Participation and the Right to Information

t

Public participation is a mandatory criterion in the decision-making process

under the Protocol. The Indian rules or guidelines do not provide for such a

101 Applications for the commercial approval of Bt cotton hybrids expressing approved events shall be

filed along with affidavits to the 'Standing Committee' (an expert in plant breeding, an entomologist, an agronomist and a plant pathologist; members are to be serviced by the Department of Biotechnology; representative of the RCGM/GEAC may be included in the Standing Committee for continuity) to be constituted by the GEAC C_bairman (GEAC Decision 14.1.2009).

289

requirement. The 2008 guidelines only talks about providing copies of the

application to other agencies, experts or institutions for reviews. The GEAC

even does not tolerate publicizing dissenting opinionsto2• Criticisms have

been leveled against the lack of transparency in decision-making, especia11y

by the GEAC and RCGM. Lack of transparency, according to the industry

creates doubts in the public mind. NGOs consider that the absence of

transparency and democratic decision-making, contribute to an increasing

industry influence in the formulation and implementation of guidelines

(Chauhan,K.P.S. and Tyagi, R.K., 2000). If the Bt cotton experience is taken

as an example, the farmers were not properly educated about the draw-backs

of the technology, the value of leaving non-Bt refuge regime to prevent

pollination (Sahai, Suman, 2003). Anyway, the draft bill and plan have

extensive arrangements for public participation. The public participation

requirement in product specific decision making (though only required by the

draft plan) is an apt response to the criticisms of undemocratic functioning of

the existing structure. But there is scope for improvement. The final reasoned

decision shall mention the extent to which the decision makers incorporated

the interacting public's opinion. As far as the transparency aspect is

concerned, the authorities are forced to divulge information on biosafety

matters, particularly at the instance of some NGOs making applications under

the Right to Information Act, 2005. An understanding of this legislation and

the usage of the same in extracting the otherwise secret biosafety information

would be helpful.

6.8.1. The Right to Information Act, 2005

This piece of legislation was enacted to harmonize the efficiency of government

machinery and the promotion of democratic- ideals. Public authorities 1~3 shall maintain

102 The GEAC expressed concerns over the unethical press statements made by Dr. P. M.

Bhargava, (an invitee to the GEAC meetings) who called for a moratorium on filed trials Bt brinjal, because of the absence of tests conducted in independent laboratories and unreliable data submitted by the applicant. But the GEAC claimed that tests were conducted in several public institutes and the minutes of the GEAC meetings testify that Dr. Bhargava had accepted and appreciated the records of the meetings. The outer world is entitled know 'the combined wisdom and decisions of the Committee and not the individual views' (GEAC Decisions, 9.7.2008). 103 Authorities established or constituted under the constitution or central or state legislature or government notifications (article 1 (h)).

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duly catalogued and indexed records so as to facilitate the right to information of

every citizen. The particulars of the organization and its functioning mechanisms shall

be published (articles 3 and 4). Information is any material, in any form which include

"records, documents, memos, e-mails, opinions, advices, press releases, circulars,

orders, logbooks, contracts, reports, papers, samples, models, data material held in

any electronic form and information relating to any private body which can be

accessed by a public authority under any other law for the time being in force" (article

1 (f)).

6.8.1.1. The Procedure

A person desirous of availing information shaH submit an _application with the

prescribed fees (reasonable) to the Central Public Information Officer or State Public

Information Officer, as the case may be, of the concerned public authority104• No

reasons along with the application except the contact address need to be submitted.

The information is to be provided as expeditiously as possible (in any case within

thirty days of the receipt of the request). Otherwise the information is deemed to have

been refused. If the information is rejected an intimation shall set out the reasons and

details of the appeal (articles 6 and 7). The Act also puts in place a Central

Information Commission (CIC) and State Information Commission (SIC) to deal with

the decisions taken (refusal to provide information, disclosure of incomplete or

misleading information or excessive fees or other related matters) by a Central Public

Information Officer (CPIO) or State Public Information Officer. The CIC or SIC can

be approached when no such officer has been appointed (articles 12 to 19). The CIC

or SIC may take appropriate decisions as provided in the Act105•

6.8.1.2. Exceptions

The Act contains a detailed list of information to which the obligations imposed art '

not applicable. The exceptions which are relevant to the GMO decision making are;

disclosure of information which would prejudicially strategic, scientific or economic

104 Or to the Centra) Assistant Public Information Officer or State Assistant Public Information Officer, as the case may be. · · 105 The CIC or SIC may impose a penalty of two hundred and fifty rupees for each day till application is received or information is furnished. But the total amount of such peHahy shall not exceed twenty-five thousand rupees (articles 19 and 20). No legal proceedings shall lie against any bonafide act under the Act (article21).

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interests to the State (article 8(1) (a)); disclosure ofinfonnation including commercial

confidence, trade secrets or intelJectual property, which would harm the competitive

position of a third party. But in case it is satisfied that the larger public interest

demands such disclosure, this exception can be neglected (article 8(1) (a)). In general,

if the 'public interest in disclosure outweighs the hann to the protected interests', no

exception including those provided under the Official Secrets Act, 1923 are not

applicable (article 8(2)). When the information to be provided is related to or has been

supplied by a third party which it considers as confidential, the third party is to be

given the opportunity to present its view within the prescribed time. The decision also

shalJ be intimated to the third party (article 11 ).

6.8.1.3. The Central Information Commission on Biosafety Information

Several applications under the RTJ Act were made with respect to the administration

ofbiosafety Jaw. This part of the study examines the important observations made by

the CIC in relation to the appeals falling in that category106• In Piyush Mahapatra v.

Ministry of Environment & Forests (2006), the appeal (on behalf of Gene Campaign)

was related to the six applications made to the Ministry of Environment and Forest

regarding information on bt cotton, GM crops and risk and cost benefit analysis of

GM crops. Infonnation was supplied except on two applications (where applications

were transferred to the Department of Biotechnology). But the disclosure was not

within the prescribed period under article 7. The appellant pleaded for the imposition

of penalty under article 20 of the RTI Act. The CIC observed no adversarial relation

between the information seeker and provider under the Act. The complaints were

made simultaneously with the enforcement of the Act and as a reason the public

authority was not in place to deal with the applications. No penalty was imposed,

though the MoEF was cautioned against any repeat of such delay. The CIC again in

Piyush Mahapatra v. Ministry of Environment & Forests (2006) took note of the fact ~ ,

that in several intimations sent by CPIO advising appeHants to seek information from

the DBT, the procedure under article 6(3) was not complied with107•

106 Using the RTJ Act, the Centre for Sustainable Agriculture has obtained and publicized information · like approvals, biosafety data (as well as data on which decision is made), monitoring reports, performance reports, compliance to laws and public private partnerships in consortium projects etc. 107 When the requested information is held by another public authority or the subject matter is closely connected with the functions of another public authority, the authority which receives the application shaH transfer the application or part of it to the appropriate authority (articJe 6(3)). .

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6.8.1.4. Confidential Business Information and the RTI

The 2008 Guidelines suggest a procedure for the identification of confidential

business information. The draft bill is silent on the issue of confidentia} business

information. The draft plan· makes a passing reference that clauses relating to

confidential commercial information must be in tune with other associated

legislations; especially the Right to Information Act, 2005 (RTI Act). The confidential

nature of the biosafety data was analyzed by the CIC in Divya Raghunandan v.

Department of Biotechnology (2007). A Greenpeace representative applied for

information on the locations of multi location field trails and 'data on toxicity,

allergenicity and other relevant, material' of GM brinjal, okra, mustard and rice,

authorized for multi-location field trials. But only a list of locations was provided.

The data was not delivered because it was felt that the 'competitive position' of the

companies in question would have been jeopardized as 'trade secrets, commercial

confidence and IPR related issues' were involved. On appeal, only the data related to

Bt brinjal was given, because data on other crops was still being processed. Ruling on

a second appeal, the Central Information Commission directed the DBT to ·divulge the

data. The Commission also suggested the publication of the information in printed

form because the matter was of' considerable concern to the educated public'. Though

the revealing of RCGM deliberations and materials would 'lead to the application of

the patented technology', the 'greater public interest and sensitivity' of the matter

would make it a fit case for the competent authority to disclose. It was opined that the

disclosure based on expert opinion should at the best be done at the government

level 108•

6.9. Conclusion

The authorization of new varieties of Bt cotton even in the midst of

conflicting claims of efficacy and the clumsy management of the approvals

stamps the claims of inefficiency regarding the Indian regulatory system.

More comprehensive and well-defined standards and mechanisms are needed

to ensure safe development and use of modern biotechnology products in

108 In an appeal regarding the non-compliance with the earlier order, the Authorities claimed that the voluminous data (Bt brinjal) can only be examined in the presence of the GEAC officials. The CJC discarded this stand of aiJowing evaluation only in a restricted environment to members representing Civil Society. The sought information at best be delivered in the form of a CD on payment of the usual fee (Divya Raghunandan v. Department of Biotechnology,2007).

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India. The new procedure for the approval of rDNA pharma products seems to

be built on the opinions of the industry and the elite class of biotechnology

and pharma experts. The Task Force Reports (Dr. Swaminathan Task Force

Report had done an excellent job in identifying the GMO related issues in

India) and Dr.Mashelkar ·proposals shall be discussed at every possible

spheres of public life before being given the final shape of a legislation. On

GMO liability questions, remedies do exist for countering dangerous GMOs,

deceptive practices, overpricing, false claims, misbranding of foods etc. But

the US and Canadian decisions show that except when physical damage is

proved, law of tort is an inefficient tool to address the problems caused by

cross-pollination and co-mingling of GMOs and conventional organisms.

Indian law should be prepared to address this situation. The draft bill and plan

ignores the precautionary approach is quite appalling. Despite the legal

requirements, over a period time, the industry and researchers have developed

an al1ergic attitude towards precautionary approach for its capacity to stifle

technological development. This allergic-aversion is possibly reflected in the

drafters' refusal to recognize the approach anywhere in the drat bill or plan.

This is not simply a negation of the Protocol obligations, but is equivalent to

showing irreverence to the law of the land as pronounced by the highest court

in the country. Gene technology is still perceived as uncertain owing to the

limited experience and evolving scientific knowledge, which necessitate the

monitoring of approved GMOs. Post-market monitoring109 of GMOs might

reveal adverse effects. Then review of a decision is necessary to

accommodate the new evidence. That is why several municipal regimes settle

for renewable and reviewable decisions. The draft bill and plan are unmindful

of these aspects (monitoring and inspection are meant for research and field

trials; of course risk management measures are aimed at reducing or

preventing risks). GMO labeling (useful as precautionary measure and a

helpful tool in traceability and the widely accepted method to provide

109 Industry itself was responsible for post-market monitoring of the approved Bt cotton varieties. The new procedure for the approval of pharmaceutical LMOs requires responsible authority to conduct post-market monitoring of approved products.

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consumer information) central to the ongomg debates, ts unsuccessful m

getting the attention of the draft bill.

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