ENVIRONMENTAL LAW-INTERNAL ASSESSMENT II

RESEARCH PROJECT:

RULES FOR THE MANUFACTURE, USE, IMPORT, EXPORT, STORAGE

OF HAZARDOUS MICROORGANISMS, GENETICALLY ENGINEERED
ORGANISMS OR CELLS: AN ANALYSIS.

By
Anwita Bhattacharyya
[PRN: 19010421089, Division ‘B’, 2019-2024]
 INTRODUCTION

The National Geographic Magazine, in its encyclopaedic entry, has defined “genetically
modified organisms” as “an animal, plant, or microbe whose DNA has been altered using genetic
engineering techniques”. This definition has then been aided by adequate explanations that the
genetic modification which essentially involves the introduction of a gene not naturally heritable
by such plant or animal-is done in every case for a “specific purpose”; such purpose in most
cases being either research or commerce. While this definition is adequately representative of the
informed reasonable understanding of genetically modified organisms, it is imperative to take
note of how the Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous
Microorganisms, Genetically Engineered Organisms or Cells , 1989 (hereinafter referred to as
“the 1989 Rules”) deriving its validity from its apex parent statute-the Environment Protection
Act, 1986 legally define the relevant terminologies.

The 1989 Rules define “Gene Technology” as “the application of the gene technique called
genetic engineering, including self-cloning and deletion as well as cell hybridization.”

And in this context, “Genetic Engineering” has been 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.
It shall also mean the formation of new combinations of genetic material by incorporation of a
cell into a host cell, where they occur naturally (self-cloning) as well as modification of an
organism or in a cell by deletion and removal of parts of the heritable material.

The discourse regarding the environmental and ethical implications surrounding the advent and
subsequent incorporation of genetically modified organisms into the food chain for purposes of
commerce is essentially rooted in the same crossroads of economic development and
environmental protection. The underlying theme between all academic debates and discourses
aimed at the general biological safety of genetically modified organisms strike at the same
considerations of whether human intervention to alter the natural environmental process of
evolution aimed solely towards higher commercial productivity outweighs the ethical,
environmental and health concerns that it invariably carries with itself. Interestingly, the
employment of genetically modified organisms in the regular food chain is a topic of debate that
is significantly well balanced. Most genetic modifications that have been implemented so far
have been aimed at the enhanced protection, preservation and growth of commercially viable
commodities- a common instance would be genetic modification of agricultural crops. The
genetic modification of agricultural crops yielded for the specific purpose of human and animal
consumption is the major target of employing genetic engineering in the present day with
specific goals aimed at increasing resistance and tolerance of such crops, effectively mutating
them to ensure higher productivity that inevitably translates to higher profitability.

Keywords: Genetically Modified Organisms, Genetically Modified Foods, the utility and harm
posed, balanced overview of 1989 Rules, powers and functions of Genetic Engineering Appraisal
Committee.

THE DOUBLE-EDGED SWORD OF BIOTECHNOLOGY: GENETIC ENGINEERING

THROUGH THE EMPLOYMENT OF GENE TECHNOLOGY TO EVOLVE
GENETICALLY MODIFIED ORGANISMS.

The motivation therefore for the employment of genetic engineering, it may be argued, is indeed
well-founded. The most desired traits for which the employment of genetic engineering has
started gaining a widespread importance across the world and specifically for the purposes of this
paper, in India, are recognised and listed hereunder:

Pest resistance: In the past, the agricultural sector had been heavily reliant on the widespread
employment of chemical pesticides for making the agricultural crops pest-resistant. However, it
must be understood that the heavy reliance on pesticides created a reasonable aversion among
consumers towards the regular consumption of food treated with pesticides, on account of
various potential health hazards. Apart from extremely probable health concerns of consumers,
the equally potent environmental threat that the over-dependence on pesticides and fertilizers
caused was the run-off of agricultural wastes with the excessive usage of pesticides and
fertilizers resulting in the definite and regular poisoning of water. In this context, the cultivation
of genetically modified foods such as B.T. corn has the potential to help to eliminate the
excessive application of chemical pesticides. The elimination of the excessive use of pesticides
also brings with it an economic advantage by effectively reducing the cost of bringing a crop to
market.

Herbicide tolerance: The underlying rationale behind building herbicide tolerance stems from
the logic that crop plants genetically-engineered to be resistant to one very powerful herbicide
could help to prevent environmental damage by reducing the amount of herbicides needed. A
relevant instance of the same would be the creation and employment by Monsanto of a strain of
soybeans genetically modified to be not affected by their herbicide product Roundup. A 2010
study has found that long-term exposition to the environment of relevant concentrations of a
Roundup formulation causes metabolic disruption in Megaleporinus obtusidens (a South
American charachid with the common name: boga) 1. In this context, a farmer growing these
soybeans would only require one application of weed-killer instead of multiple applications,
reducing production cost and limiting the dangers of agricultural waste run-off 2.

Disease resistance: There are many viruses, fungi and bacteria that cause plant diseases. Plant
biologists are therefore working towards genetic engineering to create plants with genetically-
engineered resistance to these diseases3.

1 Salbego J, Pretto A, Gioda, C, et al. Herbicide formulation with glyphosate affects growth, acetylcholinesterase
activity, and metabolic and hematological parameters in piava (Leporinus obtusidens). Arch Environ Contamin
Toxicol 2010; 58(3): 740-5.
2 Ohkawa H, Tsujii H, Ohkawa Y. The use of cytochrome P450 genes to introduce herbicide tolerance in
crops: a review. Pestic Sci 1999; 55(9): 867-74.
3 Dahleen LS, Okubara PA, Blechl AE. Transgenic approaches to combat fusarium head blight in wheat and barley.
Crop Sci 2001; 41(3): 628-37. Scorza R, Callahan A, Levy L, Damsteegt V, Webb K, Ravelonandro M Post-
transcriptional gene silencing in plum pox virus resistant transgenic European plum containing the plum pox
potyvirus coat protein gene. Transgenic Res 2001; 10(3): 201-09.
Cold tolerance: It has been reported that an antifreeze gene from cold water fish has been
introduced into plants such as tobacco and potato. The incorporation of the anti-freeze gene
effectively enables these plants to tolerate cold temperatures that normally would kill unmodified
seedlings4.

Drought tolerance or Salinity tolerance: The growth of human population in any given
national territory also marks an increased utilisation of available land for habitation and the
developmental and industrial aspects arising out of such habitation. This inevitably translates to a
a dearth of available agricultural land, forcing the agricultural sector, in its entirety, to move
towards the utilisation of such land in such locations that was previously characterised as
unsuitable for cultivation. As the world population grows and more land is utilised for housing
instead of food production, farmers will need to grow crops in locations previously unsuited for
plant cultivation. Therefore, the creation of plants with the ability to withstand long periods of
drought or high salt content in soil and groundwater will facilitate the harmonious growth of
such crops in formerly inhospitable places5.

Nutrition: Specifically keeping the demographic of the Indian population in mind where it is an
acknowledged fact that even with the label of a fast developing country, a major population of
the country falls below the poverty line and the disparity between the haves and the have-nots
pervades every aspect of socio-economic life in India. Therefore, a vast magnitude of
impoverished population are regularly and heavily reliant on a single crop as the main staple of
their diet, for instance, rice. But it is also a proven fact that rice lacks the necessary nutrients for
the health, growth and sustenance of the target population most of whose energy output is higher
than the rest of the population on account of being engaged in the manual labour industry. In this
context, if rice could be genetically engineered to contain additional vitamins and minerals,
nutrient deficiencies could be alleviated. For example, blindness due to vitamin A deficiency is a
common problem in third world countries. Therefore, researchers at the Swiss Federal Institute

4 Kenward KD, Brandle J, Mc Pherson J, Davies PL. Type II fish antifreeze protein accumulation in transgenic
tobacco does not confer frost resistance. Transgenic Res 1999; 8(2): 105-17.
5 Zhang HX, Blumwald E. Transgenic salt-tolerant tomato plants accumulate salt in foliage but not in fruit. Nat
Biotechnol 2001; 19(8): 765-8. Tang W. Peroxidase activity of desiccation-tolerant loblolly pine somatic embryos.
In Vitro Cell Dev Biol Plant 2000; 36(6): 488-91.
of Technology Institute for Plant Sciences have created a strain of "golden" rice containing an
unusually high content of beta-carotene (vitamin A)6 .

Phytoremediation: Reportedly, genetic engineering has been employed in plants such as poplar
trees with the specific aim of cleaning up heavy metal pollution from contaminated soil 7
genetically engineered to clean up heavy metal pollution from contaminated soil.

The author of the present paper contends that what is indeed blazingly apparent from the above
exploration is that the employment of genetic technology and the most common narrative
furthered in the agenda against such employment is more often than not lacking the requisite
nuance. The narrative furthered against it sees genetic engineering and its introduction into the
food sector as the appropriation of scientific advancement to manipulate biological evolutionary
trends with the sole purpose of commercial output efficiency. While commercial output
efficiency in terms of a greater better yield of all commodities that are domestically produced
and consumed constitutes of a major part of the motivation behind the employment of genetic
technology to create genetically modified organisms, the above exploration is a testament to the
fact that the appropriation of this specific scientific advancement is or has not been in complete
disregard of the environmental, biological and social well-being of its consumers.

However, well-intentioned or not, the use of genetically modified organisms directly gives rise to
many legitimate environmental and health concerns that continue to be too grave to ignore.

Having explored the motivation behind and the utility of the employment of genetic engineering,
the author now intends to categorically explore the pervasive negative environmental impact,
human health risks as well as economic concerns that the employment of genetic engineering and
the resultant creation of genetically modified organisms giving way for genetically modified
food being introduced for mass consumption practically produce.

6 Paine JA, Shipton CA, Chaggar S, et al. Improving the nutritional value of Golden Rice through increased pro-
vitamin A content. Nat Biotechnol 2005; 23: 482-7.
7 Ahmed M, Focht DD. Phytodetoxification of hazardous organomercurials by genetically engineered plants. Nat
Biotechnol 2000; 18(2): 213-17.
The environmental hazards that can be traced to the actual employment of genetically modified
organisms in the food chain to the present day has been explored; such exploration however is, in
no manner, exhaustive.

Unintended harm to other organisms: A relevant instance would be reportedly, the direct
causation of high mortality rates in monarch butterfly caterpillars by pollen from BT. corn.
Monarch caterpillars consume milkweed plants, not corn, but the connection between the death
of monarch caterpillars with pollen from B.T. corn stems from the reasonable speculation that, if
pollen from B.T. corn is blown by the wind onto milkweed plants in neighbouring fields, the
caterpillars could eat the pollen and perish. B.T. toxins reportedly kill many species of insect
larvae.

Reduced effectiveness of pesticides: The specific concern amongst scientists and researchers is
that insects may potentially become resistant to B.t. or other crops that have been genetically
modified to produce their own pesticides. The concern is not unfounded if one takes note of the
resistance developed by some populations of mosquitoes to the now banned pesticide DDT
Gene transfer to non-target species: Another concern is that crop plants engineered for
herbicide tolerance and weeds will cross-breed, resulting in the transfer of the herbicide
resistance genes from the crops into the weeds. These "superweeds" would then be herbicide
tolerant as well.

The feared and hence most deliberated upon impact of introduction of genetically modified
organisms in the food chain however is not limited to the environment but poses substantial
harm to the health of its target consumers.

Allergenicity: Many children mostly in the US and Europe have developed life-threatening
allergies to peanuts and other foods. In such a context it is only a reasonable possibility that
introducing a gene into a plant may create a new allergen or cause an allergic reaction in
susceptible individuals. A proposal to incorporate a gene from Brazil nuts into soybeans was
abandoned because of the fear of causing unexpected allergic reactions8.
8 Nordlee JA, Taylor SL,Townsend JA, et al. Identification of a Brazil-nut allergen in transgenic soybeans. N Engl J
Med 1996; 334(11): 688-92.
Unknown effects on human health: A recent article published in Lancet examined the effects
of Genetically Modified potatoes on the digestive tract in rats 9. Moreover, the gene introduced
into the potatoes was a snowdrop flower lectin, a substance known to be toxic to mammals.

Lastly, the rampant adoption of genetic modification in the production majorly aimed to increase
output efficiency in plants and animals, viable to be consumed or appropriated for economic gain
ironically also gives rise to legitimate economic concerns.

Bringing a genetically modified food to the market is a lengthy and costly process. Yet the
consumer advocates are worried that patenting these new plant varieties will raise the price of
seeds so high that small farmers and third world countries will not be able to afford seeds for
Genetically Modified crops, Patent enforcement may also be difficult, as the contention of the
farmers that they involuntarily grew Monsanto-engineered strains. One way to combat possible
patent infringement is to introduce a "suicide gene" into GM plants. These plants would be
viable for only one growing season and would produce sterile seeds that do not germinate.
Farmers would need to buy a fresh supply of seeds each year. However, this would be financially
disastrous for farmers.

This exploration of the socio-economic utility as well as legitimate environmental, health and
economic concerns that the employment of genetic engineering majorly in the food industry
would generate gives rise to an important space for discourse where it cannot possibly be
established that the good outweighs the bad or vice-versa.

THE LEGISLATIVE FRAMEWORK FOR THE MANUFACTURE, USE, IMPORT,

EXPORT AND STORAGE OF HAZARDOUS MICROORGANISMS, GENETICALLY
ENGINEERED ORGANISMS OR CELLS: THE 1989 BIOSAFETY RULES
9 Hartmann B, Subramaniam B, Zerner C. Effect of diets containing genetically modified potatoes expressing
Galanthus nivalis lectin on rat small intestine. Lancet 1999; 354(9187): 1353-4,Mitchell P. Safety of genetically
modified food questioned: Interview with gene scientist, Dr Arpad Pusztai
(http://www.wsws.org/articles/1999/jun1999/gmo-j03.shtml)
After establishing the substantial need for the debate around the ethical and environmentally
sound implementation of genetic engineering, the author acknowledges that in the past decade
alone, there has been a substantial rise in the number of groups that take a stand against the
release of such organisms into the food chain. This opposition to the development and sale of
genetically modified organisms has been, to date, successfully countered by the lobbying
juggernaut of the major players in the genetic engineering industry who seek to capitalise on the
established advantages of such organisms like higher yielding capacity and higher resistance to
pests and diseases in the case of genetically modified agricultural crops.

It is however attempted to be highlighted through the above exploration of the practical use and
implementation of genetic engineering in the cultivation of plants and growth of animals and
alternatively, the legitimate concerns surrounding such implementation that– the propaganda
against and in support of genetically modified organisms is dangerous as it leads to the formation
of an extremely reductionist view of the issue in the eyes of a layman who either sees the strictly
against or staunchly for stance of the interest groups involved. Education regarding the existence
of a common ground between the two stands needs to be imparted. It has become an imperative
objective to inform the layman about the credible advantages and potential disadvantages of
introducing a product of human intervention in the process of evolution and natural selection.

Hence, the primary objective of this paper is to present an overview of the law on regulation and
release of genetically modified organisms in India that is presently being covered by the 1989
Rules.

In India, the Ministry of Environment, Forest and Climate Change (MoEFCC) introduced the
Environment (Protection) Act, 1986 as an umbrella legislation to provide a holistic framework
for the protection and improvement of the environment. Thereafter, a series of Rules were
notified to address various problems such as hazardous chemicals, hazardous wastes, solid
wastes, biomedical wastes, etc.
In connection with the use of microorganisms and application of gene technology, the MoEFCC
notified the “Rules for manufacture, use/import/export & storage of hazardous
microorganisms/genetically engineered organisms or cells, 1989” as per powers conferred by
Sections of “Regulation of Genome Engineering Technologies in India'', 8 and 25 of
Environment (Protection) Act, 1986. These rules are very broad in scope essentially covering the
entire spectrum of activities involving GMOs and products thereof. They also apply to any
substances, products, and food stuffs, etc., of which such cells, organisms or tissues hereof form
part. New gene technologies apart from genetic engineering have also been included.

The 1989 Biosafety Rules therefore essentially applies to the products made from genetically
engineered microorganisms and other gene-technology produce and regulate their manufacture,
storage and import. These Rules also cover the pre-release facet of genetically modified
organisms, namely their research and development besides the large scale applications and trials.
Hazardous organisms which are not genetically modified are also regulated by the 1989
Biosafety Rules. The Rule 8 of this statute mandates the requirement of an approval by the
regulatory bodies prior to the discharge or even the production of genetically modified organisms
and cells. The Rules no. 10 and 11 necessitates the requirement of an approval for any such
substances that contain genetically engineered organisms or even cells. However, the Rule 9 of
this statute is the foremost in significance as it expressly prohibits the deliberate and/or
unintentional discharge of genetically modified organisms (for experimental purposes) covered
under its schedule, barring a situation where it has been approved as a ‘special case’ by the
appropriate authority. The abovementioned schedule is a feature of the 1989 Biosafety Rules
which classifies human and animal pathogens in terms of their risk profiles. The 1989 Biosafety
Rules have been augmented aptly by the Biotechnology Safety Guidelines which have been put
into effect by the Department of Biotechnology10. The Biotechnology Safety Guidelines are the
consequence of Rule 4(2) of the 1989 Biosafety Rules which mandates the requirement of
guidelines manuals which are to be stipulated by the Review Committee on Genetic
Manipulation. This committee is a departmental off-shoot of the, and serviced by the Department
of Biotechnology. These guidelines are concerned with the assessment of biosafety levels of
which it carries a detailed analysis. A detailed admonishment on recombinant DNA or rDNA

10 Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation,
1998.
related activities, experiments, shipments and quality control produced by genetic engineering is
also provided. The Biotechnology Safety Guidelines, before reaching its current form and after
being issued by the Department of Biotechnology in 1990 were revised and amended two times
and finally amended in 1998 in accordance with the progressive strides made in the field of
rDNA research.

Regulatory Committees:
Typically, there are four stages of departmental structures involved in the life-cycle of a
genetically modified organism or of a GMO based product. These are the pre-research, research,
release and post-release stages. The pre-research stage is monitored by the Recombinant DNA
Advisory Committee as it is the body which authorises and approves the research to be
undertaken. The release stage in the life-cycle of a GMO is governed by the Review Committee
on Genetic Manipulation and the Genetic Engineering Appraisal Committee. The RCGM
reviews the procedure of research and experiment-based releases whereas the commercial
discharge of GMOs directly or indirectly, is monitored by the GEAC. The occupants of the post-
release stage are the Monitoring and Evaluation Committee, the State Biotechnology
Coordination Committee and the District Level Committee. Although, these committees tend to
overlap into the research stages as well through data-provisioning submitted to the RCGM.
Lastly, the Institutional Biosafety Committee implements the standard safeguards at the research
and development sites under the headship of the RCGM, the SBCC and the DLC. A brief
description of the undertakings of the respective committees is elucidated below.

● Recombinant DNA Advisory Committee (RDAC):

The Department of Biotechnology is the parent body of this committee. The committee bears the
responsibility of studying and reviewing the changes and developments made in the field of
biotechnology at the national and international arenas. Consequently, it renders apposite
suggestions to enhance safety regulations in the area of recombinant research and their applied
utilities.
 ● Review Committee on Genetic Manipulation (RCGM):
Just like the RDAC, this committee is also monitored and constituted by the Department of
Biotechnology. However, this committee concerns itself with the safety and precautionary
aspects of research in genetic engineering. In order to ensure the same, the committee has to
stipulate the specific guidelines regarding the activities involving genetic engineering of
organisms and their consequent use or release. The utmost importance is given to its prime
objective which is to ensure environmental safety. It also bears the responsibility of monitoring
the products, field experiments, production, sale and shipment involving even a fraction of
genetically engineered organisms and cells which are classified as so in the schedule.

● Institutional Biosafety Committee (IBSC):

The duty of constituting the IBSC lies with the institution which is conducting research that
includes the usage of even the smallest proportion of genetically modified organisms and even
microorganisms that aren’t natural to the local conditions. This committee needs to comprise of
the head of the parent institution directly invested in the research, the scientists hired by the
institution for the genetic engineering of organisms, at least one medical expert and one nominee
of the Department of Biotechnology. The parent institution is required to prepare an up-to-date
emergency procedure(s) with the aid of the IBSC which conforms to the guidelines of the
RCGM. It is also imbibed with the duty of providing the copies of such a contingency plan and
procedure to the District Level Committee and the Genetic Engineering Appraisal Committee.

● Genetic Engineering Appraisal Committee (GEAC):

The GEAC is constituted by the Ministry for Environment and Forests and grants the requisite
approvals for activities or procedures involving large-scale commercial use and discharge of
potentially hazardous microorganisms not excluding any such import consisting of GMOS and
recombinant DNA. This committee has the authority to prohibit the production, sale, shipment or
use of GMOs if it deems it a threat to the environment.

● State Biotechnology Coordination Committee (SBCC):

The SBCC is constituted by the respective State Governments of India and acts as the State nodal
agency monitoring and assessing the damages caused by the release of genetically modified
organisms. The SBCC yields the power to enforce punitive action against the violations after it
has conducted an appropriate investigation. This committee bears the additional responsibility of
periodically reviewing the safety and control measures employed by the industries or institutions
invested in the occupation of handling genetically modified organisms and hazardous
microorganisms.

● District Level Committees (DLC):

The DLC is constituted at the districts where biotechnology projects are to be undertaken. Its
authority is subject to that of the SBCC. The head of the DLC is the District Collector and it is
him who reviews and assesses the safety regulations employed by the industries or institutions
engaged in the use of GMOs or hazardous microorganism. The committee’s responsibilities
include the checking of the institution’s compliance with recombinant DNA guidelines and
reporting the violations, if any, to the SBCC or the GEAC. It needs to coordinate the activities of
the concerned institution or industry to the effect that it becomes easier to contain emergency
situations caused from accidental or even intentional discharges.

● Monitoring and Evaluation Committee:

This committee has the duty of undertaking regular visits to the sites of experiment and
recommend procedures in case any remedial measure is required to adjust any potential threat
from discharges. The committee also aids the RCGM in tabulating and analysing primary data
from the field so as to ascertain the comparative agronomic advantages of genetically engineered
crops or plants.

Approvals and Prohibitions:

Aided by the institution of these committees, the 1989 rules play a substantial and significant
role in the actual approvals and prohibitions relating to the commercial utilisation of genetically
modified organisms. In pursuance of the same, the 1989 Rules provide for compliance of the
biosafety safeguards and any violation and non-compliance in this area attracts punitive actions
provided under the EPA, 1986.

The approvals and prohibitions under Rules 1989 are categorically summarised below:

● No person shall import, export, transport, manufacture, process, use or sell any GMOs,
substances or cells except with the approval of the GEAC.

● Use of pathogenic organisms or GMOs or cells for research purposes shall only be
allowed in laboratories or inside laboratory areas notified for this purpose under the EPA,
1986.

● Any person operating or using GMOs for scale up or pilot operations shall have to obtain
permission from GEAC.

● Experiments for the purpose of education involving GMOs can be undertaken with the
oversight of IBSCs.

● Deliberate or unintentional release of GMOs not allowed.

● Production in which GMOs are generated or used shall not be commenced except with
the approval of GEACAll approvals shall be for a period of 4 years at first instance
renewable for 2 years at a time.

● While it has been already stated above that GEAC would have the powers to approve as
well as prohibit, the specific scenarios in which the GEAC can exercise its powers to
revoke approvals are:

i. Any new information on harmful effects of GMOs.

ii. GMOs cause such damage to the environment as could not be envisaged when
approval was given.
 iii. Non-compliance of any conditions stipulated by GEAC.

Supervision and Penalties:

Not only is the GEAC empowered to issue approvals and impose prohibition, the GEAC also
exercises wide supervisory powers under the 1989 Rules. GEAC supervises the implementation
of the terms and conditions laid down in connection with the approvals accorded by it. GEAC
may carry out supervision through SBCC, DLC or any authorised person. If orders are not
complied, SBCC/DLC may take suitable measures at the expense of the person who is
responsible. In case of immediate interventions to prevent any damage, SBCC and DLC can take
suitable measures and the expenses incurred would be recovered from the person responsible.

LEGAL DISPUTES ARISING OUT OF “THE 1989 RULES” IN THE PAST TWO
DECADES

Upon this in-depth exploration of the legislative framework that Rules for the Manufacture, Use,
Import, Export, and Storage of Hazardous Microorganisms, Genetically Engineered Organisms
or Cells , 1989 provide for the creation and subsequent commercial introduction of genetically
modified foods through the employment of genetic engineering into the natural animal-human
food chain, it now becomes imperative to analyse the practical implementation of these rules and
the questions raised to such implementation, if any. Therefore, in the last segment of this paper,
the author explores the significant legal disputes that have arisen in connection with the 1989
Rules in the past two decades.

In the case of Research Foundation for Science, Technology and Natural Resource Policy v.
Union of India,11 the petitioners alleged that the respondents had violated certain provisions of
the Indian biosafety regulations. The alleged violations stemmed from genetically modified
cotton seeds which were imported and had subsequently spread through trials which had been
conducted on multiple sites in an open environment. It was also alleged that the respondents

11 (2005) 13 SCC 186.

were not adhering to the adequate measures for countering pollen flow or maintaining a safe
distance. The Supreme Court barred any further field trials by issuing a temporary injunction
against the respondents and concurrently directed them to make amendments which had the
effect of securing against any potential threats to biodiversity, environment and human health.
Accordingly, the Department of Biotechnology responded by authorising the Review Committee
on Genetic Manipulation to conduct small-scale field trials. The petitioners aggrieved by this
approached the appellate authority constituted under Rule 19 of the 1989 Biosafety Rules by
challenging the approval of Bt Cotton. This appeal was dismissed and it was held that the
approval of the Bt Cotton was granted after due examination of the biosafety and agronomic data
collected via tests over a period of six years. The allegation directed against the permission
granted by the Review Committee on Genetic Manipulation as being violative of the 1989
Biosafety Rules was dismissed as RCGM has the authority to permit restricted field trials to
control and prevent the escape of GMOs into the environment. It was reiterated that in
accordance with the Allocation of Business Rules, 1961, the Department of Biotechnology is the
central department to monitor and regulate the import and shipment of genetically modified
organisms.

A public interest litigation filed before the Supreme Court by Gene Campaign in 2004 is pending
under the head of Gene Campaign v. Union of India12. The petition challenges the constitutional
validity of the 1989 Biosafety Rules and attacks its utility and alleges that the rules are
inconsistent with their intended objective of protecting the environment and public health
guaranteed by the Article 21 of the Constitution of India. It is also alleged that the 1989
Biosafety Rules are not in conformity with the Biosafety Protocol of which India is a signatory
and has ratified. The petitioners claim that the regulatory agencies under the 1989 Biosafety
Rules lack technical competence, transparency, and public participation. It is further alleged that
many important and legally established notions like the precautionary principle, inter-
generational equity and polluter pays principle have not been accrued with due recognition under
the rules.

12 Writ Petition (Civil) No. 606/2007.

 CONCLUSION
The latest development of biotechnology, particularly molecular biology, genetic engineering
and transgenic technology has a very large number of potential applications in food production,
including microorganisms, plants and animals. Transgenesis is much more difficult to apply to
farm animals than to plants or microorganisms. Genetic modification has increased production in
some crops. But the technology has too few challenges in a few crops. Genetic modification,
although inherently not an entirely and undisputedly positive innovation in itself but it is a tool
where public and private science can balance each other for social, biological and economic
development. It is an acknowledged fact that Genetically modified foods have various
advantages like high yield, salinity tolerant, insect resistance etc. but the same advantages also
carry with it multiple environmental, ethical and health concerns on living beings, as has been
extensively ignored in the paper. Therefore, a black or white polarising categorisation of
genetically modified organisms would indeed be reductive and as the age old tug of war between
development and environmental preservation continues, the safe employment of gene technology
must be continually regulated through a comprehensive and updated legislative framework with
adequate instruments for implementation.