CENTRAL UNIVERSITY OF SOUTH BIHAR

SCHOOL OF LAW AND GOVERNANCE

BIOTECHNOLOGICAL ADVANCEMENTS AND BIOSAFETY

LAWS IN INDIA

SUBMITTED TO- DR. SUCHI KUMARI

ASSOCIATE PROFESSOR
SLG
CUSB

SHIVAM SAKET
B.A. LLB (SEVENTH SEMESTER)
CUSB1513125043

1
 CONTENT

SR. TITLE PAGE

NO. NO.
1 ACKNOWLEDGEMENT 03
2 PREFACE 04
3 INTRODUCTION 05
4 THE NATIONAL BIOTECHNOLOGY AND BIOSAFETY 08
BILL, 2012
5 WHAT IS BIOSAFETY? 11
6 IMPORTANCE OF BIOSAFETY 15
7 CASE LAWS 18
8 CONCLUSION 20
9 BIBLIOGRAPHY 21

2
 ACKNOWLEDGEMENT

FIRSTLY, I WOULD LIKE TO EXPRESS MY SINCEREGRATITUDE TO MY

PROFESSOR DR. SUCHI KUMARI FOR GIVING ME THIS ASSIGNMENT AND
HELPING ME ACQUIRE A COMPREHENCIVE KNOWLEDGE OF
ENVIRONMENT LAW IN OUR COUNTRY.
I WOULD LIKE TO THANKS MY CLASSMATES. I BENEFITTED A LOT FROM
THEIR DISCUSSION. I WOULD LIKE TO THANK MY UNIVERSITY AND ITS
ADMINISTRATION, LIBRARY AND COMPUTER CENTE STAFF FOR
PROVIDING ME WITH THE INFRASTRUCTURE AND A CONDUCTIVE
ENVIRONMENTTO COMPLETE MY PROJECT.

3
 PREFACE
The word ‘bio’ indicates life and all forms of biological life. Safety itself is about being
protected against damage or secured against harm. Biological safety, commonly referred to as
‘biosafety’, is a concept that came into use in 1970s. Biosafety is about insisting on safe
practices in the handling and use of those life forms – plants (including food and cash crops),
animals or micro-organisms, which have been altered at the genetic level. The idea of biosafety
has developed in parallel with the development of modern biotechnology. This is different from
traditional biotechnology, such as cheese-making, setting curd, use of biological agents such
as yeast in bread, wines, etc. For modern biotechnology involves modifying the genome of a
life form thereby altering its inherent characteristics.

4
 INTRODUCTION

As defined by international law is the application of Modern Biotechnology is:

a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and
direct injection of nucleic acid into cells or organelles, or
b. Fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive or recombination barriers and that are not
techniques used in traditional breeding and selection;

Paragraph 3(i) of the Cartagena Protocol on Biosafety

The term biosafety is sometimes used interchangeably with ‘biosecurity’, but the latter has now
acquired a specific meaning with respect to the efforts to prevent the transmission of infectious
pests and/or diseases.

Biosafety is to be practiced both inside the laboratory where life forms are being altered and
tested, and outside in the open environment where they may be released. Biosafety can be with
reference to various sectors like pharmaceuticals, nutrition and industrial applications. In this
unit, because the context is environmental law, the focus will be on the importance of biosafety
laws in agriculture and biodiversity.

What are LMOs?

The subject matter of biosafety laws are living modified organisms (LMOs). These organisms
are quite literally constructed in a laboratory. They are organisms that would not normally be
found in nature, but are made from the rearrangement of the organism’s own genes (sysgenics)
or by the introduction of gene(s) foreign to its original genetic structure (transgenics). In other
words, LMOs are living forms that nature has not made, but have been made by human
intervention in naturally-existing life forms.

As per international law, an LMO is ‘any living organism that possesses a novel combination
of genetic material obtained through the use of modern biotechnology’ (Article 3, Cartagena
Protocol on Biosafety). The words popularly used to describe such altered life forms are either
genetically modified (GM) or genetically engineered (GE).

Role of Law
Law as a body of rules has twin objectives in biosafety. One, as with every other law, is to
regulate human actions. Two, is to impose penalties if certain legally prescribed rules for
biosafety or procedures laid down for approval of GM products are violated. In doing so the
aim is to either prevent harm or provide redress for damage that might have been caused by
LMOs.

Biosafety laws are required in a country, irrespective of whether its people have agreed upon
the need for products of modern biotechnology to be used/researched/commercialised or not.
These could be GM crops or as the international non-governmental organisation Third World
Network explains, a biosafety law could be used to either:
- say ‘no’ to and prohibit the use of LMOs
- or say ‘yes’ to the use of GM products and processes and thereby regulate the same

5
- or impose a temporary moratorium on the use of potentially hazardous outputs of
modern biotechnology
- or prescribe the safety conditions in which R&D in biotechnology in different sectors
is to be undertaken.

Biosafety laws in effect establish the relationship between law and science in a society. Modern
biotechnology came to its current form only in the last two decades. Before that legal systems
were not so challenged to address the concerns posed by its products. Biosafety laws can be
taken as a test case of how humankind will embrace emerging science and technology and at
the same time address environmental concerns.

Biosafety for the environment

For the purposes of biosafety, there is need for not only well-drafted legal texts but also
supportive administrative and other measures. These include having the necessary technical
infrastructure, scientific expertise and the institutional capacities, as well as public awareness
on how to handle the possible risks to environment.

Biosafety could become a serious concern when LMOs are released in the open environment.
The smallest part of living matter – a gene, by itself may not be potentially hazardous. But
when that gene is isolated and subsequently inserted in another living form, which does not
normally possess it, the genetic structure of that living organism is fundamentally altered. It
can make the LMO/GMO interact in unpredictable ways with the natural world around it. This
introduces the element of uncertainty. The law then has to factor in the element of risk to the
environment. For that very reason the law has to provide for both risk assessment and risk
management.

There is no agreement worldwide on the degree of risk from LMOs. Nonetheless, what makes
biosafety a risk-prone endeavour in itself is that LMOs do not follow the laws of the land; they
follow the laws of nature. Lawmakers might make the best laws and scientists may make
unique LMOs, but no one has the power to control every interaction that happens in the natural
environment amongst its different components. There are no means to recall a LMO that has
been unleashed into the open environment. Though the core focus of biosafety laws has to be
both prevention of contamination and the protection of both human and ecological health, yet
there are inherent limits to laws on biosafety.
Today the most hotly debated topic in biosafety is that of GM seeds and to some extent GM
animal breeds, including fish (see the Special Report (Agenda 2014): ‘The GM Crop Debate’
on Rajya Sabha TV: https://www.youtube.com/watch?v=3h9qe6kB1q0).

Learning Outcomes
The reading of this unit is intended to make the reader familiar with the concept of ‘biosafety’
and the range of legal issues involved around LMOs. The reader will not only learn about the
international law and the national rules and regulations on the subject, but also the
environmental principles on which they are based. The unit will also briefly point to the
developing case law in this area. The Indian experience will give the reader an insight into the
many challenges in the design and implementation of a domestic biosafety regulatory regime.

Environmental Law Principles

6
There are two well-established principles in environmental jurisprudence, namely:

The precautionary principle

Principle 15 of the Rio Declaration on Environment and Development, 1992 makes it clear that
In order to protect the environment, the precautionary approach shall be widely applied by
States according to their capabilities. Where there are threats of serious or irreversible damage,
lack of full scientific certainty shall not be used as a reason for postponing cost-effective
measures to prevent environmental degradation.

The principle really asks for one to tread with caution when the risks from a technology are not
fully known. This is with an end to protect the environment. When applied to biosafety, it
implies that given the lack of scientific consensus on the safety of LMOs, there is no reason to
relax the preventive actions or precautionary measures. The biosafety regime can be made less
stringent only once there is adequate proof that LMOs/GM products are safe; but one cannot
be any less cautious while awaiting scientific proof. Until then the onus is on the user/promoter
of LMOs to handle the technology with care and show that they are safe. The standard of care
to be taken is to be prescribed by the biosafety law.

The ‘polluter pays’ principle

Principle 16 of the Rio Declaration lays down another idea central to environmental laws:
National authorities should endeavour to promote the internalisation of environmental costs
and the use of economic instruments, taking into account the approach that the polluter should,
in principle, bear the cost of pollution, with due regard to the public interest and without
distorting international trade and investment.
Requiring the polluter to pay has both ethical and other more practical considerations. At an
ethical level, it is about insistence on taking responsibility for the harm caused to human or
ecological health from the use of potentially hazardous products. It is normative in terms of
suggesting ‘what ought to be’; in doing so it prescribes the morally correct behaviour that is to
be enforced by law.
At a more pragmatic level it gives direction to legal system to impose liability on the person(s)
causing environmental harm.

Sustainable development
There is a third overarching principle for future actions that is now further developing, i.e.
sustainable development. In 1987, the World Commission on Environment and Development
had in its report ‘Our Common Future’ posited the idea of ‘sustainable development’ as
‘(d)development that meets the needs of the present without compromising the ability of future
generations to meet their own needs’. Post Rio+20 United Nations Conference on Sustainable
Development, there is an ongoing international process to draft Sustainable development goals
(SDGs). The proposed Goal 15 among other things, aims ‘to take urgent and significant action
to reduce degradation of natural habitat, (and) halt the loss of biodiversity’.1

While the capacity of LMOs to contribute to sustainable development is still questionable, the
role of biosafety laws that embody the above principles cannot be undermined.

1
Outcome Document – Open Working Group on SDGs on URL
http://sustainabledevelopment.un.org/focussdgs.html.

7
International Law

Convention on Biological Diversity

The international law on the subject of biosafety has been evolving under the framework of the
United Nations’ Rio conference. In particular, it is the multilateral environmental agreement
(MEA) – the Convention on Biological Diversity (CBD), which is the source of international
law on biosafety. Amongst the articles in its text, Article 19 specifically deals with the
‘Handling of Biotechnology and Distribution of its Benefits’. It requires that countries that are
members of the CBD:
shall consider the need for and modalities of a protocol setting out appropriate procedures,
including, in particular, advance informed agreement, in the field of the safe transfer, handling
and use of any living modified organism resulting from biotechnology that may have adverse
effect on the conservation and sustainable use of biological diversity.

As of 2014, 194 countries the world over are members of the CBD. But the success of this
international law depends on the capacities and commitment of individual countries to the very
idea of biosafety. Amongst the many challenges in the implementation of CBD is the fact that
one of the key proponents of biotechnology products – the United States of America (USA), is
not a party to the CBD. Moreover, in its own biosafety framework, USA regards GM products
such as novel foods ‘substantially equivalent’ to those that are made without the use of GE.

Cartagena Protocol on Biosafety (CPB)

The CPB is a daughter treaty of the CBD. This international protocol2 – a kind of sub-treaty,
in its 40 articles elaborates the international regime on biosafety. It is based on the idea that a
country cannot regulate LMOs unless it is aware of them being transported into its area.

Therefore, it requires for Advanced Informed Agreements (AIA) to be signed before LMOs
are shipped to another country. This means both the biosafety regulation of both the exporting
and the importing country must provide for an AIA procedure. The Protocol in a way accepts
that there will be trade in LMOs between countries for most products of modern biotechnology
have commercial applications. As per the Protocol, GM products to be exported as food, feed
and for processing do not require an AIA.

Negotiations for this Protocol began under the CBD in 1994 and it took nearly a decade for the
text to enter into force. This was due to the opposing viewpoints on the issue of safety of LMOs.
For there are countries that are opposed to LMOs, while those pro LMOs are opposed to any
strong legal restrictions on their use. Today there are 168 countries that are members of this
Protocol. They meet every two years alongside the meetings of the CBD, through a process
called the Meeting of Parties (MOP).

Supplementary Protocol on Liability & Redress (SP)

In international law, a protocol is a legal instrument that is subordinate to a convention and is
meant to take forward the convention’s objectives, while also either amending the convention
or further detailing an aspect of it (as in the case of the Biosafety Protocol).

The international law dealing with the liability and redress (L+R) dimension of biosafety is
contained in the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to
the Cartagena Protocol on Biosafety (SP). The SP deals with what kind of measures can the

8
law insist upon for reparation and restoration, if and when the case for damage is made and
liability is established. It prescribes that the damage be both ‘significant’ and ‘measurable’
against scientifically established baselines. If and when damage is proved, the SP imposes
liability on the operator. The SP defines the ‘operator’ as any person in direct or indirect control
of LMO which could as determined by domestic law, include the permit holder, the person
who placed the LMO on the market, as well as the developer, producer, notifier, exporter,
importer, carrier or supplier (Article 2(c)). Article 3 the SP makes it applicable only to damage
that occurs in an area under the national jurisdiction of a country from an LMO that crosses
borders through transboundary movement.
Though the SP was adopted on 15 October 2010, it has not yet come into force; it requires a
minimum number of 40 countries to have ratified it. Only countries that are party to the
Cartagena Protocol on Biosafety can become members of this Supplementary Protocol.

Current Biosafety Regime in India

The biosafety regime in India comprises a set of executive rules, which have been issued by
different governmental ministries/departments. The key instrument is the Rules for the
Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically
Engineered Organisms or Cells, 1989, which were issued by the Ministry of Environment and
Forests (MoEF) under India’s key environmental law – the Environment (Protection) Act,
1986.

Important Definitions
In Rule 3 of the 1989 Rules, please read the definitions of:
1. Biotechnology
2. Gene Technology
3. Genetic Engineering

Under the Rules, several committees have been set up to oversee different aspects of biosafety:
- Review Committee 7on Genetic Manipulation (RCGM),
- Institutional Biosafety Committee (ISBC) and
- Genetic Engineering Appraisal Committee (GEAC)

The GEAC is the main governmental agency that recommends approvals or rejections for the
wide-scale application and commercial release of LMOs, including GM crops. Rule 7(1) lays
down that:

no person shall import, export, transport, manufacture, process, use or sell any hazardous
microorganisms or genetically engineered organisms/substances or cells except with the
approval of the GEAC.

Composition of GEAC [Rule 4(3)(1)] Chairperson: Additional Secretary, MoEF

Co-Chair: Representative of Department of Biotechnology
Members: Representative of concerned Agencies and Departments, namely, Ministry of
Industrial Development, Department of Biotechnology and the Department of Atomic Energy
Expert members: Director General (DG) Indian Council of Agricultural Research, DG Indian
Council of Medical Research, DG Council of Scientific and Industrial Research, DG Health
Services, Plant Protection Adviser, Directorate of Plant Protection, Quarantine and storage,
Chairman, Central Pollution Control Board and three outside experts in individual capacity
Member Secretary: An official of the MoEF

9
The GEAC follows a case-by-case system of screening applications. The Ministry of
Environment and Forests, Government of India (MoEF) then takes the final call.
Similarly rules on biosafety are also issued by the Department of Biotechnology (DBT)2, which
functions under the Ministry of Science and Technology. These include:
1. Recombinant DNA Safety Guidelines, 1990
2. Revised Guidelines for Research in Transgenic Plants, 1998
Protocols for Food and Feed Safety Assessment of GE Crops, 2008
The full list of rules and their texts can be downloaded from the DBT web site:
The decisions of the GEAC, as well as the process by which they are taken, have often come
under public criticism. The most controversial of the decisions have been those giving approval
either for open field trials or commercial use of GM crops. To get an idea of the nature of
approvals, please visit the section on ‘GEAC Approvals’ on the MoEF’s website:
http://envfor.nic.in/major-initiatives/geac-clearances.

Court Cases
Environmental law is not only enacted through legislative processes or made by rules and
regulations notified by executive bodies. The judiciary through its various decisions also
develops the body of law in this area. Across the globe, various aspects of biosafety have also
come before regular courts, quasi-judicial bodies and other fora, such as consumer disputes
redressal commissions (see, for example, Consumer Dispute No. 03/2004 between Nalla
Yadagiri versus Monsanto India Ltd.).

Supreme Court of India

Over the years, NGOs and ordinary citizens have filed cases in public interest for a proper
biosafety system to be set up in the country. The one currently ongoing in the highest court of
the land – the Supreme Court of India - is Aruna Rodrigues & Others v. Union of India &

Others, Special Leave Petition (Civil) No. 260 of 2005. The full text of the original petition
filed in 2005 can be accessed here: http://ddsindia.com/www/PDF/PIL_October27.pdf.
In this case, the petitioners approached the Court to ask for necessary directions so that
biosafety regulation is undertaken by independent scientific agencies. Till such a system is put
in place, the petitioners are seeking that the Court not allow any release of GMOs into the
environment by way of import, manufacture, use or any other manner, unless the following
precautions are taken:

(a) a protocol for all the required biosafety tests of GMOs proposed to be released is prepared
by the GEAC, and
(b) the GMO has been subjected to all the required biosafety tests by agencies of independent
expert bodies.

An important aspect of the petition is that it attempts to democratises the debate on biosafety.
The petitioners have reiterated that biosafety cannot be dealt as a purely scientific or technical
matter. Public involvement, and the processes of public notice and public hearings have to be
institutionalised within a biosafety regulatory regime. The Rules of 1989 do not require

2
http://dbtbiosafety.nic.in/.

10
mandatory public consultation. Confidence in the biosafety law and its implementation can
only come with transparency in results of GM research and if and when the results of scientific
testing and of a particular GM product analysis are made public. It also necessitates removal
of any conflict of interest situations, where the regulator might have an interest in the clearance
for a certain GM product. The process of decision-making has to be open for public scrutiny.
Accessibility to information from public authorities is an essential element of that. Right to
information (RTI) activists suggest that there ought to be voluntary disclosure of research
results at every stage of experiments/trials, and that clearance for the next stage be given only
thereafter.

OTHER CASES

Supreme Court of Canada

Percy Scheimser’s3 legal battle is that of an organic farmer taking on the US MNC Monsanto
Inc. for contaminating his field, after the company sued him for patent infringement.

‘The Biowatch case’4 is one in which an NGO named Biowatch in South Africa fought a nine-
year legal battle pursuant to their request for information on all GM crops being grown in the
country.

For more details on the case and a book on the subject, please go to:

Green Bench of the Lahore High Court, Pakistan

The Kisan Board Pakistan has challenged the existence of the National Committee on Biosafety
and its decisions to approve operating licenses for GM crops (Writ Petition 11290 filed in April
2014).

BIOSAFETY LAW IN-THE-MAKING IN INDIA

Legislative attempts

India does not have a full-fledged legislation on biosafety though the matter has come up in
different contexts in the Union Parliament, for example, through the questions raised in the
Houses of Parliament, as well as through multi-party Parliamentary Standing Committees
addressing the issue.

In May 2003, the Union Ministry of Agriculture set up a Task Force, chaired by the agricultural
scientist Dr. M.S. Swaminathan, to formulate a policy on the application of genetic engineering
in agriculture. The Task Force recommended that a national law be legislated and an
independent biotechnology regulatory authority, which would oversee biosafety concerns, be
established. The Government of the day moved to revamp the biosafety regime of the country
through first drafting a National Biotechnology Development Strategy, 2007. This was
followed by the Union Ministry of Science and Technology, through the DBT, drafting a new
biosafety law: National Biotechnology Regulatory Authority Bill, 2008.

3
http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/2147/index.do
4
http://www.seedsoffreedom.info/a-landmark-victory-for-justice-the-biowatch-case-laid-bare- in-new-book/.

11
There were serious concerns about the independence of the proposed Authority, with the draft
law emanating from the very governmental agency whose function is to promote
biotechnology. In the light of strong public opposition, a revised version of the proposed law
followed. This Bill, namely the Biotechnology Regulatory Authority of India (BRAI) Bill,
2012, is still in draft form. It assigns the same definition to environment as in the Environment
(Protection) Act, 1986.

In the 37th Report of the Committee on Agriculture dated 7 August 2012 on ‘Cultivation of
Genetically Modified Food Crops – Prospects and Effects’, the committee members
recommended that an encompassing biosafety authority through an Act of Parliament should
be debated. Another version -- the BRAI Bill, 2013 too was attempted.3 But not much has
moved on the matter since.

Centre-State Relations
An important aspect of biosafety law and governance is the political system in which it
develops. The supreme law of the land – the Constitution of India - provides for the distribution
of legislative functions and executive powers between the Centre, the states and local bodies.
The protection of wild animals and birds, as well as forests, comes under the Concurrent List,
which means both the Centre and the States have the power to make laws on the subject (under
Article 246 of the Constitution). Meanwhile, agriculture is on the State List (Entry 14 of List
II).

This federal feature has led some states to voice their objection to the Centre’s decision to go
ahead with GM crop field trials. This was also the case in India, when the Central Government
wanted to approve the first GM food crop – Bt brinjal/eggplant, for commercial application,
but several state governments did not want this. Some state governments re- asserted federalism
by reminding the Central Government that agriculture was a state subject and therefore the
decision of GM crops ought to be of the state governments. Under the current biosafety regime,
the Rules of 1989 provide for a State Biotechnology Coordination Committee and District-
level Committees under the District Collectors to oversee biosafety regulations, but by and
large these have not been very active on the ground.

Decentralising Biosafety
Decentralisation is an important aspect in biosafety regimes, which can create more
possibilities for public involvement. This is particularly important to move the discussions5
closer to the ground with products such as GM crops being used by farmers and rural
communities. In Pakistan, the Constitution (Eighteenth Amendment) Act, 2010 devolved
decision-making powers on environmental pollution and ecology to the provinces. Thereafter,
the Punjab province passed its own Punjab Biosafety Rules, 2014 while asking for the national-
level Biosafety Rules of 2005 to be made non-applicable.6

5
http://www.prsindia.org/billtrack/the-biotechnology-regulatory- authority-of-india-bill-2013-2709/.
6
www.twnside.org.sg/title/national-cn.htm.

12
Related Laws

A law dealing with biosafety may not singularly be able to deal with all aspects of the problem.
It has linkages to other laws as well.

Intellectual property legislation, particularly patent laws in some countries allow for LMOs to
be ‘inventions’ that are eligible for patent protection. This is linked with the World Trade
Organisation (WTO)’s Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS), which requires all WTO member countries to provide for IPR laws including patents
on life forms. Such legislation define the economic rights of those who claim de facto
ownership over genes and processes of biotechnology. This can also have an impact on
biosafety. For instance, if scientists, either have restricted or no access to the gene/process (with
the patent holder determining the terms of use) then even undertaking research on the safety of
the LMO in question is not possible.

Competition laws and the relevant competition authorities also have to remain vigilant that
those marketing and selling GM products are not distorting the market, enjoying monopoly
positions and in the bargain also pushing out other eco-friendly products.
Labelling laws require mandatory labelling of all products, particularly food and feed that
contain GM ingredients.

Food safety laws in some countries regulate the import of GM food products and also test for
presence of unwanted GM ingredients. The reference point for this is the international food
code – Codex Alimentarius - developed under the United Nations Food and Agriculture
Organisation.

Seed laws would also need to specify if GM seeds will or will not be registered for marketing,
keeping in view the concerns of human and ecological health.
Plant quarantine laws are also made in the interest of protection of the home environment
thereby prohibiting the import of potentially hazardous LMOs.

Conflict of interest laws can help to ensure that the decision-making bodies are not filled by
those with vested interests, so that the process stays independent. Biodiversity conservation
laws have a mandate for the conservation of biological diversity. In India, the Biological
Diversity Act, 2002 makes it the legal duty of the Central Government to regulate, manage or
control the risks associated with the use and release of living modified organisms resulting
from biotechnology likely to have an adverse impact on the conservation and sustainable use
of biological diversity and human health (section 36(4)(ii)).

Access and benefit sharing (ABS) laws that are being made in those countries which are rich
in biological resources, lay down the terms and conditions under which genetic material for
use in the biotechnology industry can be accessed from the provider countries.

13
INDIAN BIOSAFETY RULES AND REGULATIONS

1) Framework legislation for biosafety regulations in India is the EPA(Environment

Protection Act).

2) Apply to:
 manufacture, import & storage of micro-organisms and gene-technology products&
include products made of micro-organisms that are genetically engineered.

 rules cover research and large-scale applications of Genetically Modified Organisms &
products.

 also deal with hazardous organisms that are not genetically modified.

 rules encompass manufacture, use, import, export, storage and research.

3) MoEF and DBT are responsible for implementing rules MoEF and DBT are responsible
for implementing rules
4) Maintained by DBT, Ministry of Science & Technology, Govt. of India.
5) Vision: Vision:
 To advise, facilitate & regulate modern biotechnology work at different stages to
achieve the objectives of protecting environment including human and animal health
from the possible adverse effects of GMOs and products thereof.

Ministry of Health and Family Welfare (MoHFW)

 Responsible with ensuring the availability of food

14
AUTHORITIES INVOLVED IN BIOSAFETY ASSESSMENT
 Recombinant DNA Advisory Committee (RDAC)Recombinant DNA Advisory
Committee (RDAC)

 Review Committee on Genetic Manipulation (RCGM)Review Committee on Genetic

Manipulation (RCGM)

 Genetic Engineering Approval Committee (GEAC)Genetic Engineering Approval

Committee (GEAC)

 Institutional Biosafety Committee (IBSC)

 State Biotechnology Coordination Committee (SBCC)

 District Level Committee (DLC)District Level Committee (DLC)

CONSEQUENCES

 Cancelled patents on natural product inventions Cancelled patents on natural product

inventions

 Loss of profits from illegal removal of biological Loss of profits from illegal removal
of biological material

 Lack of clean title to biological material Lack of clean title to biological material

 Backlisting a biopirate

 Denial of access to samples Denial of access to samples

 Legal penalties Legal penalties

15
BT BRINGLE AND BT COTTON
Effect on the following
 productivity and nutrition value
 pest management and environmental impact
 biodiversity
 human health and biosafety
 livelihood and economic considerations

THE NATIONAL BIOTECHNOLOGY AND BIOSAFETY BILL, 2012

PURPOSE OF THE BILL

• The Bill is for an Act to ensure the safe development and use of modern biotechnology;
• To provide mechanisms to regulate research, development and use of genetically modified
organisms.

KEY TERMS USED IN THE BILL

The Bill defines the following:

(a) “biosafety” means the safe development, transfer, application and utilisation of
biotechnology and its products

(b) “biotechnology” means any technique that uses living organisms or substances from living
organisms to make or modify a product, improve plant, animal breeds or micro-organisms for
specific purposes

(c) “genetically modified organism or GMO”(also called transgenic or product of modern

biotechnology) means an organism, consisting of any of the genes or other genetic material
that have either been:–

• modified by means of modern biotechnologies; or

• inherited from genes or other genetic material which were so modified.

16
OBJECTIVES OF THE BILL (CLAUSE 2)

 to ensure the safe development and use of modern biotechnology for national
development;

 to establish procedures application and approval to use modern biotechnology at

various levels including research and general release;

 to strengthen consumer protection and public understanding of products and the

benefits of biotechnology;

 to build human and institutional capacity to promote safe generation and use of modern
biotechnology products.

RISK AND SAFETY ASSESSMENT

• All GMO research and development activity approvals are based on thorough risk and safety
assessment
• The risk and safety assessment shall be carried out in accordance with international best
practices and guidelines
• All applications must contain emergency plans to manage unintentional environmental
releases

RESTORING DAMAGE CAUSED BY A GMO

In the event that an activity involving a GMO causes damage to human health or the
environment, the Competent Authority may issue a restoration order to the person causing the
damage. Such orders can also be issued for

 Activities relating to a GMO without or beyond the approval of the Competent

Authority;

 In cases of damage caused by the unintentional release of a GMO attributable to a

person;

 Where the Competent Authority has issued an order to the person to stop research or
general release of a GMO;

 In any other cases where the activity of a person has caused damage.

17
OFFENCES AND PENALTIES

Offence Penalty
Research or making general release of a Max. 120 currency7 points or max. 5 years
GMO without approval or both

Failing to disclose any information as Max. 48 currency points or max. 24 months

required by this Act or both

Furnishing false information Max. 48 currency points or max. 24 months

or both

Releasing or using any confidential Max. 48 currency points or max. 24 months

information for any purpose not authorized or both
under the Act

Using a GMO in a manner inconsistent with Max. 24 currency points or max. 12 months
the approval granted under the Act or both

Using a GMO to deliberately harm or injure Max. 240 currency points or max. 10 years
the environment or human health or both

Obstructing the Competent Authority or an Max. 24 currency points or max. 12 months

officer of the Competent Authority from the or both
performance of their duties under the Act

Neglecting, refusing or failing to take Max. 120 currency points or max. 5 years or
emergency safety measures in case of both
unintentional release of a GMO

7 One currency point is currently equivalent to UGX 20,000 and is set by the government.

18
REGULATIONS
The Minister responsible for science and technology may, after consultation with the
Competent Authority, make regulations for the purpose of carrying into effect the provisions
of this Act. Some of these regulations will include:

 Procedures for conducting research

 Procedures for general release
 Procedures for handling, transport, labeling, packaging
 Bioethical considerations
 Penalties
 Any other regulation for effective implementation of the proposed Act.

SCHEDULES
1. Currency point

2. NBC conduct of business

3. Forms
a. Lab research
b. Contained testing
c. Confined testing
d. General releasee. Import/export, transit

4. Risk and safety assessment procedure

19
 CONCLUSION

Biosafety is concerned with the safety of human and ecological health when products developed by
modern biotechnology are used, either in laboratory conditions or in the open environment. LMOs are
living modified organisms, which are not normally found in nature, but are constructed in laboratory
conditions. Biosafety relies heavily on the use of law. But it also requires technological infrastructure
to be able to test for the presence of genetic material. The international law on biosafety has
developed under the Convention on Biological Diversity. There are two specific Protocols on the
issue. There are environmental law principles that form the basis of biosafety legislation. The law on
biosafety in India is still developing. The country’s biosafety Rules of 1989 are poised for change.
The biosafety agencies set up thereunder might be replaced with a full-fledged law establishing a
biotechnology regulatory authority. There are several other laws, apart from core biosafety laws,
which also have a bearing on the issue of biosafety.

20
 BIBLIOGRAPHY

BOOKS

ENVIRONMENTAL LAW BY P Leela Krishnan

ENVIRONMENTAL LAW BY Arvind Jaiswal

ENVIRONMENTAL LAW BY R Rastogi

ENVIRONMENTAL LAW BY P Srivastava

ENVIRONMENTAL LAW BY T Malik

ENVIRONMENTAL LAW BY Swati Krishnan

INTERNET

www.mondaq.com/india/x/26049/Healthcare/Biotechnology+Laws+in+India

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069684/

epgp.inflibnet.ac.in/epgpdata/uploads/.../law/06...law/...biosafety/.../7611_et_08_et.pd...

https://www.lawctopus.com/academike/biotechnology-regulatory-authority-bill-2013/

www.dbtindia.nic.in/.../Regulations-Guidelines-for-Reocminant-DNA-Research-and-B...

https://www.omicsonline.org/.../biosafety-issues-of-genetically-modified-organisms-2...

21