16 Biosafety

Ms Shalini Bhutani

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.

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

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 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 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’.

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).

4.3.Supplementary Protocol on Liability & Redress (SP)

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.

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.

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

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 & 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

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

See full text and its analysis on URL http://www.prsindia.org/billtrack/the-biotechnology-regulatory-authority-of-india-bill-2013-2709/.

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

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.

Web links

• Biodiversity and Genetic Resources section of the web site of La Via Campesina –
• International Peasant‟s Movement:http://viacampesina.org/en/index.php/main-issues-mainmenu-27/biodiversity-and-genetic-resources-mainmenu-37.