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Law

Environmental Law

Biosafety

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QUADRANT-I (A) – PERSONAL DETAILS

Role Name Affiliation

Principal Investigator Prof (Dr) Ranbir Singh Vice Chancellor, National

Law University Delhi

Co-Principal Investigator Prof (Dr) GS Bajpai Registrar, National Law

University Delhi

Paper Coordinator, if any Ms Lovleen Bhullar School of Oriental and

African Studies,

University of London

Content Writer/Author Ms Shalini Bhutani Legal Researcher and

Policy Analyst, New Delhi

Content Reviewer Ms Kanchi Kohli Independent Researcher,

New Delhi

Language Editor Ms Lovleen Bhullar School of Oriental and

African Studies,

University of London

QUADRANT-I (B) – DESCRIPTION OF MODULE

Items Description of Module

Subject Name Law

Paper Name Environmental Law

Module Name/Title Biosafety

Module Id ENLAW/10

Pre-requisites Law, Basic Science,

Environmental Principles, Ethics,

International Treaties

Objectives To understand the concept of

biosafety and the legal issues

around the use of modern

biotechnology

Keywords LMOs, Biodiversity,

Biotechnology

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QUADRANT-I – E-TEXT

1. Introduction - Biosafety and the law

1.1 Biosafety

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.

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.

1.2. 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).

1.3. 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

BOX: Modern Biotechnology

As defined by international law is the application of:

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

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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

- 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.

1.4. 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).

2. 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

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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.

3. Environmental Law Principles

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

3.1 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.

3.2 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. [See section 3.3 on Liability & Redress.]

3.3 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)evelopment 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

1 Outcome Document – Open Working Group on SDGs on URL

http://sustainabledevelopment.un.org/focussdgs.html.

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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.

4. International Law

4.1. 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.

4.2. 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).

Watch the AudioVisual on CPB here:

https://www.youtube.com/watch?v=PjEhlB5J_AY.

4.3. Supplementary Protocol on Liability & Redress (SP)

2 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).

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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

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.

The CBD, its protocols on biosafety issues and their links to global environmental

principles:

5. 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.

Under the Rules, several

committees have been set up

to oversee different aspects of

biosafety:

- Review Committee

Rio Principles

(1992)

Convention on Biological Diversity

(in force since 1993)

http://www.cbd.int/

Cartagena Protocol on Biosafety

(in force since 2003)

http://bch.cbd.int/protocol/

Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress

(not in force)

http://bch.cbd.int/protocol/supplementary/

BOX: Important Definitions

In Rule 3 of the 1989 Rules, please read the definitions of:

1. Biotechnology

2. Gene Technology

3. Genetic Engineering

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on 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.

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),

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

3. 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:

http://dbtbiosafety.nic.in/.

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.

6. 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.).

6.1. 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 &

BOX: 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

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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 democraticise 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

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.

6.2. Other cases

6.2.1. Supreme Court of Canada

Percy Scheimser’s 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. See

http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/2147/index.do

Trailer: A Farmer who took on Monsanto

https://www.youtube.com/watch?v=OLzELDt3d2I

6.2.2. Constitutional Court, South Africa

‘The Biowatch case’ 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:

http://www.seedsoffreedom.info/a-landmark-victory-for-justice-the-biowatch-case-laid-bare-

in-new-book/.

6.2.3. 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).

7. Biosafety law in-the-making in India

7.1 Legislative attempts

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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.

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.

7.2 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.

7.3 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 discussions

3 See full text and its analysis on URL http://www.prsindia.org/billtrack/the-biotechnology-regulatory-

authority-of-india-bill-2013-2709/.

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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.

For more information, please see TWN’s Model National Biosafety Law for any country:

www.twnside.org.sg/title/national-cn.htm.

8. 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 ecofriendly

products.

- Labeling laws require mandatory labeling 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.

9. Summary

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1. 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.

2. LMOs are living modified organisms, which are not normally found in nature, but are

constructed in laboratory conditions.

3. 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.

4. The international law on biosafety has developed under the Convention on Biological

Diversity. There are two specific Protocols on the issue.

5. There are environmental law principles that form the basis of biosafety legislation.

6. 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.

7. There are several other laws, apart from core biosafety laws, which also have a

bearing on the issue of biosafety.