Introduction

1. The aim of this Introduction is:

2. The Introduction is structured as follows:

I. Origin and history

3. The Convention on Biological Diversity (CBD) was adopted in May 1992 in Nairobi, and was opened for signature in Rio de Janeiro on 5 June 1992 at the UN Conference on Environment and Development. It entered into force on 29 December 1992, and as of 20 August 2002 has 185 Parties. Its objectives are:

4. The treaty is a landmark in the field of environment and development. It takes a comprehensive, rather than sectoral, approach to the conservation of the biological diversity of the planet and the sustainable use of bioogical resources. And it also encompasses related socio-economic issues, such as the sharing of benefits from the use of genetic resources and access to technology, including biotechnology.

5. The CBD contains three provisions directly related to living modified organisms (LMOs). One (Article 19(3)) has generated the negotiations of the Cartagena Protocol (see below paragraphs 10–11). The two others (Article 8(g) and 19(4) contain obligations applicable to all Parties to the CBD independently of their becoming Parties to the Protocol.

6. Article 8(g) deals with domestic measures generally. It requires Parties to regulate, manage or control risks associated with LMOs resulting from biotechnology which are likely to have impacts on the conservation and sustainable use of biological diversity, taking also into account the risks to human health. Article 19(4) considers transfers of LMOs from one Party to another. It requires each Party to provide information on domestic regulations concerning use and safety to any other Party to which a LMO is provided, as well as any available information on the adverse effects which the introduction may have for this Party.

7. The term “living modified organism” used in the Protocol stems from its use in the CBD, in particular Article 19(3), which is at the origin of the Protocol. The content of the term was, however, narrowed by CBD COP Decision II/5 (which set the mandate for the Protocol negotiations) to those LMOs resulting from modern biotechnology (see Box 15).

8. While the CBD is comprehensive, it also provides the possibility for the Conference of the Parties (COP) to the CBD to negotiate additional annexes and protocols, to better implement its objectives.

9. Article 28 of the CBD mandates Parties to cooperate in the formulation and adoption of protocols and sets out basic rules as to their consideration and adoption. It does not specify which subject matter covered by the CBD might be addressed by future protocols. Article 28 therefore leaves it to the Parties to the CBD to decide (through the CBD COP), in the course of the implementation of the CBD, whether and on which subject a protocol would be a useful additional tool in the achievement of the objectives of the CBD.

Box 1. What is a protocol?

A Protocol is a binding international instrument, separate from, but related to, another treaty.

It is a separate instrument: a protocol must be individually negotiated, signed and eventually ratified. It is only binding on States that become Parties to it. It thus has its own Parties, and creates separate rights and obligations for them, as any other treaty.

The unique characteristic of a protocol is that it is related to a ‘parent’ treaty, through substantive, procedural, and institutional links. Most importantly, a protocol under a specific treaty must comply with the parent treaty's provisions authorizing and regulating the adoption of protocols under its auspices. Any protocol adopted as a result of these ‘enabling’ provisions in the parent treaty must comply with them. In particular it may not deal with subjects which are beyond the purview of these provisions, or if these provisions are not restrictive in this regard, with subjects which are beyond the purview of the parent instrument. Such enabling provisions usually restrict (as is the case for the Cartagena Protocol) participation in a protocol to Parties to the parent treaty.

In addition, the parent treaty usually defines basic institutional and procedural links between the two instruments, for example it may indicate that provisions in the treaty itself (e.g. related to dispute settlement) will also apply to any protocol adopted under it.

The protocol itself may, however, add further links to the parent treaty, for example by designating mechanisms existing under the treaty (e.g. the Conference of the Parties) also to serve the protocol. This is the case for the Cartagena Protocol (see commentary to Articles 2931).

10. However, in Article 19(3), the negotiators of the CBD singled out living modified organisms for special treatment. Article 19(3) provides:

The Parties 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 LMO resulting from biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity.

11. The content of Article 19(3) of the CBD was contentious, as views differed on the need for internationally agreed rules on biosafety. During the negotiation of the CBD, the debate centred on two alternatives: (i) language making the development of a protocol on biosafety mandatory; or (ii) language not explicitly calling for a protocol, but instead requiring the Parties to consider the need for one. The latter view prevailed.

12. In 1994, at the first meeting of the Conference of the Parties to the CBD in Nassau, Bahamas, two meetings were authorized to consider the need for and modalities of a protocol on biosafety. Accordingly, a panel of experts met in Cairo in May 1995, and was followed by an open-ended (i.e. open to all Parties to the CBD and to observers) Ad Hoc Group of Experts on Biosafety which met in Madrid in July 1995. The large majority of delegations present at the Madrid meeting favoured the development of a protocol on biosafety. But while there was general agreement that certain issues, such as an advance informed agreement procedure, should be included in a protocol, other possible elements, such as liability and compensation and socio- economic considerations, were the subject of considerable disagreement.

Box 2. The road to the cartagena protocol on biosafety (and beyond)

13. At its second meeting in 1995 in Jakarta, Indonesia, the COP considered the results of the experts' work. After lengthy debate, the COP decided to establish an open-ended Ad Hoc Working Group on Biosafety (BSWG) to elaborate a protocol on biosafety for consideration by the COP, and provided it with the following terms of reference (Decision II/5):

i.   The Open-ended Ad Hoc Working Group should be composed of representatives, including experts, nominated by Governments and regional economic integration organizations.

ii.   The Open-ended Ad Hoc Working Group shall, in accordance with operative paragraph 1 of the present decision:

(a)    elaborate, as a priority, the modalities and elements of a protocol based on appropriate elements from Sections I, II and III, paragraph 18 (a),1 of Annex I of the report of the Open-ended Ad Hoc Group of Experts on Biosafety;

(b)    consider the inclusion of the elements from Section III, paragraph 18 (b),2 and other elements, as appropriate;

iii.   The development of the draft protocol shall, as a priority:

(a)    elaborate the key concepts and terms that are to be addressed in the process;

(b)    include consideration of the form and scope of advance informed agreement procedures;

(c)    identify relevant categories of LMOs resulting from modern biotechnology.

iv.   The protocol will have to reflect that its effective functioning requires that Parties establish or maintain national measures, but the absence of such national measures should not prejudice the development, implementation and scope of the protocol.

v.   The protocol will take into account the principles enshrined in the Rio Declaration on Environment and Development and, in particular, the precautionary approach contained in Principle 15 and will:

(a)    not exceed the scope of the CBD;

(b)    not override or duplicate any other international legal instrument in this area;

(c)    provide for a review mechanism;

(d)    be efficient and effective and seek to minimize unnecessary negative impacts on biotechnology research and development and not to hinder unduly access to and transfer of technology.

vi.   The provisions of the CBD will apply to the protocol.

vii.   The process will take into full account the gaps in the existing legal framework identified through analysis of existing national and international legislation.

viii.   The process shall be guided by the need for all Parties to cooperate in good faith and to participate fully, with a view to the largest possible number of Parties to the CBD ratifying the protocol.

ix.   The process will be carried out on the basis of the best available scientific knowledge and experience, as well as other relevant information.

x.   The process of developing a protocol should be conducted as a matter of urgency by an open-ended ad hoc group, which will report on progress to each subsequent meeting of the Conference of the Parties. The Open-ended Ad Hoc Working Group should endeavour to complete its work in 1998.3

14. Decision II/5 is important as it set the mandate of the BSWG and provided guidance to the negotiators on specific points. In particular, it modified the content of the term ‘LMO’ provided in Article 19(3) of the CBD by limiting it to those resulting from ‘modern biotechnology’ rather than from ‘biotechnology’. (For further discussion of this issue, see Box 15)

15. The BSWG was chaired by Veit Koester of Denmark. Six meetings of the BSWG were held, between July 1996 and February 1999. After four meetings, by February 1998, it became clear that the goal set by the COP for the BSWG to complete its work in 1998 was not feasible. Two further meetings were authorized. After the fifth meeting, in August 1998, a set of 43 draft articles of the Protocol had been prepared, but 15 of these remained entirely in ‘square brackets’, indicating a lack of agreement on their inclusion in the Protocol, and another 650 square brackets remained throughout the text, enclosing particular words or phrases on which agreement was still elusive.

16. It is against this background that the sixth and final meeting of the BSWG was held in Cartagena, Colombia, in February 1999, which was to be immediately followed by the first Extraordinary Meeting of the Conference of the Parties (ExCOP) to the CBD. Progress was made on some issues. Towards the end of BSWG 6, the Chair put forward a draft consolidated text of the Protocol and proposed to BSWG that this be adopted and forwarded to ExCOP.4 This was a ‘clean text’– i.e. it contained no provisions in square brackets. Instead, the Chair had attempted to find compromise solutions to outstanding areas of disagreement. The text was forwarded to the ExCOP. However, in spite of much discussion and negotiation, by the end of the ExCOP meeting the Parties to the CBD had failed to reach agreement on the text of the Protocol, and the ExCOP was formally suspended.5

17. During the course of the meetings in Cartagena, five distinct negotiating groups of countries had emerged with different views on the outstanding core issues. They were:

The Miami Group: Argentina, Australia, Canada, Chile, Uruguay, USA
The Like-minded Group: the G77 countries (less the three members in the MiamiGroup) The European Union
The Central and Eastern Europe Group
The Compromise Group: Japan, Korea, Mexico, Norway and Switzerland, later joined by Singapore and New Zealand.
These groups played a significant role in the negotiations during and after the ExCOP.

18. Following the suspension of the ExCOP, informal consultations by the Chair of the ExCOP, Minister Juan Mayr of Colombia, took place in order to ascertain whether there was a political will to resume negotiations. This being the case, two informal meetings took place in Vienna (September 1999) and Montreal (January 2000). These negotiations focused on the remaining core issues which were crucial to the overall agreement of the Protocol. At this stage, these core issues were: the scope of the Protocol; LMOs intended for direct use as food or feed, or for processing (LMO-FFPs); the precautionary principle; identification and documentation requirements; and the relationship between the Protocol and other international agreements, notably the World Trade Organization (WTO) Agreements. Other aspects of the Protocol remained untouched afterBSWG6.

19. The final negotiation of these core issues took place at the resumed session of the ExCOP which immediately followed the January 2000 informal meeting in Montreal. Of a highly political nature, with the participation of more than thirty Ministers, the final compromise on core issues was struck during the night of 28/29 January 2000. The Protocol was adopted at 5 a.m. on 29 January 2000.6

20. The Protocol contains important new rights and obligations for its Parties, relating to the transboundary movement, handling and use of LMOs. Its central operational provisions create an Advance Informed Agreement (AIA) procedure, whereby an exporter wishing to export certain categories of LMOs to a country for the first timemust notify the Party of import in advance and provide certain information relating to the LMO. The Party of import then has an opportunity to examine this information and may decide to accept or reject the import, or attach conditions to it, based on a risk assessment. The Protocol also contains provisions on information exchange, capacity-building and financial resources. These provisions are described in more detail below (see Section V).

Box 3. 1996–2000. The negotiation phase

1. Elements definition phase

2. Drafting and negotiation phase

3. Final negotiation phase

II. Status and interim measures

21. The Protocol was opened for signature at the fifth meeting of the CBD COP in Nairobi, Kenya in May 2000 and 68 Parties to the CBD signed. Thereafter, the Protocol was open for signature at UN Headquarters in New York until June 2001. Altogether, 103 Parties have signed the Protocol. Parties to the CBD which have not yet signed the Protocol may accede to it. Expectations appear to be high at present that the Protocol may enter into force in 2003. Entry into force requires 50 ratifications (see Article 37).

22. In the interim, the Extraordinary Meeting of the COP in January 2000 established an Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP), to undertake preparatory work for decisions to be taken at the first meeting of the Parties,7 which will take place shortly after the Protocol enters into force (see Article 29). The President of the ICCP is Ambassador Philémon Yang of Cameroon. CBD COP 5 adopted a decision regarding the work plan and budget of the Intergovernmental Committee.8 The CBD COP requested countries to designate a national focal point for the ICCP and to inform the Executive Secretary of the CBD accordingly.

23. ICCP held its first meeting in Montpellier, France in December 2000, its second meeting in Nairobi in October 2001 and a third meeting in The Hague in April 2002. At the end of these meetings, considerable progress had been made in preparing for the tasks and decisions of the first meeting of the Parties to the Protocol.

III. The issue: biosafety

A. Selective breeding and genetic modifications

24. Throughout human history farmers have used selective breeding to improve crops and stock by breeding from the plants or animals that had qualities they wanted to strengthen. The deliberate retention of the best of the agricultural production for future use as seed for sowing, or animals for breeding, has meant that quality has been continuously enhanced over the ages. In this way, farmers have for centuries developed animals and crops for desired characteristics, such as resistance to disease, or ability to cope better with specific climatic and environmental conditions, and for increased production.

25. In addition, biological fermentation processes have been used for centuries to process food in order to improve taste, palatability and safety, and to increase the period for which foods may be stored. Examples include the production of yoghurts and cheeses from milk, fermentation of grains to produce beer, wine production, and the use of yeast in bread making.

26. The selective breeding techniques used by farmers, and more recently by specialist crop and animal breeders, rely on the genetic variation already present in the population, which includes mutations that occur spontaneously in nature. These techniques have been responsible for the development of all the major crops and animals used in farming today, and continue to be of central importance in agriculture. Commercial chickens, for example, have been selected over about 50 generations for growth rate and they now grow more than four times faster than the original breeds.9

27. Breeding processes may, in some cases, overcome natural barriers in that new varieties can be made through human intervention in ways that may not easily happen naturally. Plants that are sexually compatible, but which would not normally come into contact for physical reasons, can successfully be cross-pollinated. In addition, vegetative propagation of many varieties enables production of disease free plants which can then be used in agriculture.

28. Genetic modification, which is also referred to as ‘genetic engineering’, uses a variety of methods to isolate single genes from one or more micro-organisms, plants or animals and insert them into the genetic material of the cells of another. These methods are collectively termed ‘in vitro nucleic acid techniques’, and have been developed since the 1970s. Through genetic modification, genes are transferred and modified in ways that are not possible in nature, i.e. between different species and between animals and plants and micro-organisms. Once inserted, these genes may be transferred to offspring of the modified individual through normal reproductive processes. Box 4 describes the historical background to the development of these techniques, and Box 18 outlines the stages in making a new LMO using insertion of genetically modified (‘recombinant’) DNA.10

Box 4. History11

The knowledge on which the techniques of genetic modification are based dates from the 1950s, when James Watson, Francis Crick, Maurice Wilson and Rosalind Franklin discovered the structure of DNA, the nowfamiliar double helix of nucleotides that bears the genetic information for the biosynthesis of proteins like enzymes, certain hormones (e.g. insulin) and whole parts of the body (e.g. nails, hair). This new understanding opened up the possibility that the genetic coding of organisms could be altered to give them new characteristics that natural evolution or selective breeding could not produce.

When, in the 1970s, it became possible to isolate individual genes, refashion them and copy them in cells, huge commercial possibilities opened up. Ways of applying this new technology to medicine were developed quite rapidly. The technology could also be used in industry to produce new fine chemicals and pharmaceuticals using living organisms as “factories”. Applying these methods successfully to plants took longer; the first genetically altered whole food, Flav'r Sav'r tomatoes came on the market in 1994 in the USA. Since then the growth in the number and range of genetically modified products has steadily increased. As the general public has become more aware of the impact of these discoveries, concerns over the use and safety of genetic modification have also been raised.

29. Genetic modification and selective breeding differ in important ways:

30. The commercial use of genetically modified organisms (GMOs) in agriculture is currently limited almost exclusively to different varieties from four crop species: soybeans, maize (corn), oilseed rape (canola), and cotton. In 2001, 99% of all GMO crop area world-wide was grown in four countries:13 68% of the crop area planted with GMOs was in the USA, 22% in Argentina, 6% in Canada, and 3% in China. World-wide, 46% of the total area that was sown with soybeans was sown with genetically modified (GM) soybean varieties, and for maize 7% of the total crop area was sown with GM maize varieties.14

31. Since 1994 the number of GMOs that may be marketed as human food has increased. For example, up to 52 approved crop varieties (from 13 different species) in the USA;15 43 (six different species) in Japan;16 12 (five different species) in Australia and New Zealand;17 five (two different species) in the EU;18 and four (three different species) in South Africa.19 While only a few approved GMOs may be used directly as food, products from approved GMOs, especially flour from GM maize, and oils extracted from GM soya and GM oilseed rape, are used in the production of processed foods, generally mixed with products derived from non-GMOs.

B. Genetic modification: the debate

32. Genetic modification is only one of the techniques of modern biotechnology (used in its general sense, rather than in the specific way modern biotechnology is defined in the Protocol: see Article 3(i)). Others – for example, the use of tissue culture techniques – differ from genetic modification in that they do not involve the modification of individual genes, and are not regarded as controversial. It is thus important to note that while genetic modification is a contested issue, the debate does not relate to these other techniques of modern biotechnology.

33. Agenda 21, adopted at the 1992 Conference on Environment and Development, states that modern biotechnology “promises to make a significant contribution in enabling the development of, for example, better health care, enhanced food security through sustainable agricultural practices, improve supplies of potable water, more efficient industrial development processes for transforming raw materials, support for sustainable methods of afforestation and reforestation, and detoxification of hazardous wastes”. As illustrated in Box 5, genetic modification has already numerous scientific and some commercial applications and is likely to be further developed due to high expectations of its potential in healthcare, agriculture, industrial production, and environmental protection.

34. There are, however, also serious concerns about genetic modification. They range from ethical considerations to potential risks to human health and the environment, and encompass also a number of socio-economic issues. These concerns are heightened given the relatively small amount of experience with the application of the technology to date, and the fact that any adverse effects may only be manifested over the long term. Avigorous, and often polarized, debate is taking place, centred on potential risks and benefits of genetic modification.

35. Advocates argue that application of genetic modification can help to provide:

Box 5. Examples of genetic modification

GM bacteria

Possibly the most important area of genetic modification, albeit in containment, is that of single-cell organisms modified to act as chemical factories for the production of food additives (including flavour enhancers) and fine chemicals. In 1997, the U.S. Environmental Protection Agency approved the first genetically engineered bacteria for agricultural use. The bacterium, a strain of Rhizobium meliloti, contained genes from five different species and was genetically altered to enhance its ability to provide nitrogen to alfalfa plants on farmland.21

GM agricultural crops

One of the most prominent developments of genetic modification technology has been the creation of transgenic agricultural crop varieties. Many millions of hectares of commercial transgenic crops are grown annually, although it is impossible to obtain exact figures as official data are not always available. In 2001 alone there were 35.7 million hectares of GM crops grown in the United States, 3.2 million hectares in Canada, 11.8 million hectares in Argentina and at least 1.5 million hectares in China.22 From the two traits currently used, herbicide-tolerant crops are grown on 77% of the area, crops producing the Bt-toxin on 15%, “stacked” varieties producing Bt-toxin and showing herbicide-tolerance on 8%. Most of the harvest is used as animal feed. Many other traits have been inserted into agricultural crops but are grown on a small scale or have not yet been commercialized. Papaya has been modified to provide resistance to papaya ringspot virus.23 Rice yellow mottle virus attacks rice in Africa – modern biotechnology has produced a rice resistant to the virus.24 Vaccines against diseases of the gastro-intestinal tract have been produced in bananas and potatoes.25

GM trees

Biotechnology companies have linked up with key players in the industrial forest sector to support research that will increase tree growth rates, modify wood structure, alter trees' reproductive cycles, improve tolerance to certain herbicides and even store more of the gases that are responsible for global warming. While forest-related biotech research is still in its infancy compared with agriculture, field trials of GM trees have proliferated around the world. Recent research shows that, since 1988, there have been 184 GM tree field trials globally. More trials have been conducted with poplar than any other species due to its popularity as a pulp and paper species. The U.S. has released the largest number of GM trees via field trials, with 74% of the world-wide total.26

GM animals

The first GM animal was a mouse,27 which was developed in early 1988, when the Harvard Oncomouse was patented in the USA. The technology has been applied during the 1990s to some mammals, including cattle, pigs, sheep,28 and mice.29 It has also been applied to poultry. The creation and use of GM animals continues to increase. In Great Britain in 2000 there were 581,740 procedures in which GM animals were used or bred, 14% more than in 1999. Around 99% of these involved mice.30

GM fish

Commercial aquaculture has made use of GM technology and there is also specialist interest for aquarium species. The Atlantic and Pacific salmon has received most media attention, particularly those that contain an additional gene for growth hormone production and an anti-freeze gene. These fish have shown three-fold growth rate increases and potential to exploit colder waters. Reports indicate that transgenic salmon have also displayed severe deformities.31

GM insects

The fruitfly Drosophila melanogaster was one of the first organisms to be genetically engineered over 20 years ago, and has been regularly used in medical and scientific research.32 The genetic modification of other insects has begun only recently. For instance, researchers are trying to create mosquitoes engineered not to host the malaria virus.33

36. On the other hand, critics argue that:

C. Genetic modification and biological diversity

37. Against this background, specific concerns about genetic modification have emerged in relation to biological diversity conservation.

38. Advocates of the application of genetic modification argue that it could result in benefits for biodiversity and the broader environment, suggesting, for example, that the effects of genetic modification could include:

39. However, a number of concerns regarding the effects of GMOs on biodiversity have also been raised. At a general level, it has been suggested that GMOs released into the environment may pose similar types of risks to those presented by invasive alien species. In relation to deliberate release (for example, for the field-testing or commercial growing of GM crops, or the release of GM fish in aquaculture or mariculture projects), concerns about the effects of GMOs on biological diversity include, for example:

40. In addition, socio-economic considerations related to biological diversity conservation are a subject of concern. The lifestyles, livelihoods and cultures of traditional and indigenous communities, rural communities, and others may be directly or indirectly affected.

41. Reports and events have documented these risks and exemplified them in specific cases over the past few years. For instance, a recent report of the European Environment Agency34 indicates that GM and non-GM crops will intermingle their genetic materials “at higher frequencies and at greater distances than previously thought” and considers the significance of pollen-mediated gene flow from six major crop types that have been genetically modified.

D. The challenge: regulating for biosafety

42. As a result of the debate outlined above, there have been increasing policy discussions on how to regulate the application of genetic modification techniques at the national level and a number of national regulatory frameworks have been established. As activities involving the technology expanded, and in particular as actual and potential commercial use increased, the scope of national regulations tended to expand. Designing frameworks for GMO regulations has not been easy, as the main challenge was perceived to be establishing an appropriate balance between potentially important technological benefits and appropriate environmental and human health safeguards. But as the debate evolved, the role of law as a “provider” of biosafety, i.e. as the provider of mechanisms to ensure the safe handling, transfer and use of genetically modified organisms, increasingly came to the fore.

43. The challenges of biosafety, in particular in the context of the transboundary movement of GMOs, made an international regime a prerequisite for an efficient regulatory system: biosafety cannot be achieved without a coordinated approach between countries. This is why the Protocol has been negotiated.

IV. Cross-cutting issues

44. In the negotiation of the Protocol, a number of issues were controversial and difficult to resolve. Among them, several are relevant to a number of provisions of the Protocol – these include provision of information important for the implementation of the Protocol, in particular through the Biosafety Clearing-House (BCH, see Article 20), and socio-economic considerations. Others are cross-cutting though the Protocol as a whole. Issues which permeate the Protocol as a whole include:

A. The Protocol and human health issues

45. The appropriate treatment of human health issues in the Protocol was contentious from the outset of the negotiations. Article 19(3) of the CBD makes no reference to human health. In the discussion of the mandate to negotiate a Protocol, the subject of human health was nevertheless considered – and proved controversial. To some, an instrument on biosafety which failed to cover human health issues was not a viable proposition; for others, however, human health should not be covered at all in the context of a Protocol to the CBD.

46. Ultimately, the negotiators compromised, and the final version of the Protocol recognizes throughout that risks to human health are to be “taken also into account”. Thus, the Protocol specifically mentions human health in various provisions, including in Article 4 on Scope:

This Protocol shall apply to ... [LMOs] that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

47. The wording “taking also into account risks to human health” has its origin in Article 8(g) of the CBD. Independently of any other instrument in this field, including the Protocol, Article 8(g) requires Parties to the CBD to “regulate, manage or control the risks associated with use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts, that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health”.

48. In the absence of any additional explanatory provision in either the CBD or the Protocol, however, the meaning of the phrase “taking also into account the risks to human health” remains somewhat unclear. This is all the more so as not much of the debate on this subject during the negotiations has been recorded. The wording was introduced by the European Union at an early stage. Several delegations considered that direct impacts of LMOs on human health should not be covered by the Protocol – as they were dealt with in other contexts. However, many others– including particularly those from developing countries – wished to give the same weight to impacts of LMOs on human health and on biological diversity.

49. The first approach leads to the conclusion that risks posed by a LMO to human health are taken into account under the Protocol only if they result from the potential adverse effects of the same LMO on biological diversity.

50. The other approach leads to the conclusion that risks posed by a LMO to human health are to be taken into account under the Protocol also in the absence of, or separately from, potential adverse effects of the LMO considered on biological diversity. This would be the case, for instance, for any change in allergenic properties of pollen as a result of genetic modification, or the consumption of GM food.

51. Both interpretations can be supported by the phrase “taking also into account risks to human health”. The practical effect of the absence of unambiguous guidance in the Protocol itself on this issue, along with the lack of consensus on one or the other above mentioned interpretations, appears to be that, under the Protocol at least, Parties will have a certain latitude and flexibility in deciding which human health aspects to cover in their implementation of the Protocol – unless and until they decide upon an authoritative interpretation collectively in the meeting of the Parties to the Protocol.

B. The Protocol and precaution

52. It has long been recognized that prevention of environmental harm must be “the Golden Rule for the environment”,35 for both ecological and economic reasons. At best, it is difficult to remedy environmental injury, and in many cases the damage is simply irreversible. Even where damage is reparable, the cost of restoration or rehabilitation is often prohibitive.

53. The “principle of prevention” has thus become a cornerstone of environmental law, both domestic and international. It involves the use of special techniques such as risk assessment and analysis, or environmental impact assessment, of the potential effects of the planned activity, followed by a decision to allow it (with or without management measures), or to prohibit it.

54. Applying preventive measures requires and presupposes sufficient scientific knowledge, and clear scientific evidence presented in the various assessment processes regarding the consequences of the contemplated action. The question is then, from a policy point of view, whether the risk is considered acceptable (ecologically, economically, socially) and should be taken, or whether it should be prevented.

55. A special, but not infrequent situation arises, however, when lack of scientific certainty or consensus prevails. It is for such circumstances that the legal concept of precaution has been developed in the 1970s. It has subsequently increasingly been reflected in international treaties, as well as national law, and has become known as the precautionary principle. Its most commonly referred to formulation is that contained in Principle 15 of the Rio Declaration, adopted by States at the UN Conference on Environment and Development in 1992 – the single most important non-binding international instrument adopted by States after the Stockholm Declaration of 1972.

56. In short, the precautionary principle holds that uncertainty regarding serious potential environmental harm is not a valid ground for refraining from preventive measures. In this sense, the principle's chief characteristic is to operate as enabling action, and authorizing preventive measures, in circumstances of scientific uncertainty.

57. Whether and to what extent there is scientific uncertainty is therefore critical in the context of precautionary action. There is no internationally agreed definition of “scientific uncertainty”, nor are there internationally agreed general rules or guidelines to determine its occurrence. Those matters are thus dealt with – sometimes differently – in each international instrument incorporating precautionary measures.

58. While there is no controversy about the usefulness of the concept of precaution per se, there has been much debate recently about its nature, in particular whether it is a legal principle in addition to being a sound policy approach. Some argue that the concept of precaution has not attained the status of a principle of law, and hence does not as such constitute a legal obligation. The controversy arose at international level in particular because, while the precautionary principle has been reflected in a number of international agreements, they utilize different formulations and differences remain as to the proper scope of application of the principle and its practical implications. This generated concerns that states may apply the precautionary principle in such a way as to cause potential conflicts with international trade rules.

59. The issue of precaution is thus likely to continue to arise within the WTO, now perhaps more directly in the context of the WTO negotiations on trade and the environment, mandated at the November 2001 WTO Ministerial Conference in Doha, Qatar.

60. While the debate continues, the use of precautionary provisions in international treaty law as well as in national legislation continues to grow. Moreover the formulation of these provisions appears to be becoming increasingly concrete and specific.

Precautionary provisions in the Protocol

61. Decision II/5 of the Conference of the Parties, which provided the detailed negotiating mandate for the Protocol, provided that “the Protocol will take into account the principles enshrined in the Rio Declaration on Environment and Development and, in particular, the precautionary approach contained in Principle 15” (see Box 6).

Box 6. Principle 15 of the Rio Declaration

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.

62. Precaution is relevant to the regulation of LMOs as there remains a lack of scientific certainty and consensus as to their potential impacts on the environment and human health, particularly over the long-term.

63. During the Protocol negotiations, the need for some reference to precaution was widely accepted (as indicated by Decision II/5 of the COP.) Controversy surrounded the questions of how precaution should be reflected, and in particular: (i) whether references to precaution should be characterized as the “precautionary principle” or the “precautionary approach”; and (ii) whether there should be any reference to precautionary measures in the operative part of the Protocol or merely in the Preamble and Objective.

64. Those who opposed operative provisions on precaution argued that the Protocol was itself a precautionary instrument, since no specific damage associated with LMOs had been proved. They also feared that the precautionary approach would be used as a justification for protectionist trade measures – i.e. restrictions on the import and use of LMOs not backed up by scientific evidence.

65. Proponents of precautionary provisions stressed the relative novelty of LMOs and the lack of experience with them – particularly in some receiving environments and in developing countries. They argued that even with proper risk assessment, some uncertainty may still remain and that in such circumstances countries should have the right to adopt precautionary measures to protect biodiversity and human health.

66. The Protocol refers to or reflects the concept of precaution in a number of its provisions:

C. Biosafety and the World Trade Organization (WTO)

67. Another area of contention during the negotiations was the relationship between the Protocol and relevant provisions in the WTO Agreements.

68. Under the Agreements of the WTO, Members are bound by certain obligations that limit their right to restrict imports. Any country that joins the WTO automatically becomes a Party to a “package” of multilateral trade agreements, including the General Agreement on Tariffs and Trade 1994 (GATT), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), and the Agreement on Technical Barriers to Trade (TBT Agreement).

69. Inevitably, the question of compatibility has arisen regarding the relationship between the Protocol provisions and WTO commitments: a number of countries in the Protocol negotiations were concerned that rights and obligations of Parties under the Protocol should not conflict with, or take precedence over, the rights and obligations of Members under the WTO Agreements. They sought to insert a “savings” clause into the Protocol stating that the provisions of the Protocol would not affect the rights and obligations of any Party deriving from any existing international agreement (including the WTO Agreements). This was unacceptable to many other countries which were concerned that such a provision would limit their right to rely on the Protocol in restricting or prohibiting the import of any LMO which they considered potentially damaging to the environment or to human health. Their concern was exacerbated by the fact that, unlike the Protocol, the WTO has a mandatory and binding dispute settlement procedure, to which disputes between WTO Members involving trade in LMOs might be submitted.

70. In the end, it was agreed that the relationship of the Protocol with other international agreements would be dealt with in three paragraphs of the Protocol's Preamble. A commentary on these three preambular clauses appears in the section of this Guide on the Preamble below. A more detailed discussion of the possible interactions between the provisions of the Protocol and those of relevant WTO Agreements is contained in the Appendix to this Guide.

V. Overview of the Protocol36

71. This section provides a general overview of the provisions of the Protocol. More detailed analysis is contained in the article-by-article commentary.

72. The objective of the Protocol is, in accordance with the precautionary approach, “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs, taking also into account risks to human health, and specifically focusing on transboundary movement” (Article 1).

73. The term “living modified organism” is defined in the Protocol (Article 3) as those living organisms that “possess a novel combination of genetic material” and are “obtained through the use of biotechnology”.

A. Scope of the Protocol and AIA procedure (Articles 47)

74. The Protocol's general coverage includes the transboundary movement, transit, handling and use of all LMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account also risks to human health (Article 4). However, some categories of LMOs or transboundary movements are excluded. In some cases the exclusions are limited to specific provisions relating to the AIA procedure, in others they operate as general exclusions from all of the Protocol's provisions. An overview of the scope of the Protocol is set out in Box 7 and explained further below. Even where certain LMOs are excluded from some or all of the Protocol's provisions, they may, of course, still be subject to national regulation.

Box 7. Scope of the Protocol and of the AIA procedure: Articles 47

LMOs subject to the provisions of the Protocol

LMOs subject to AIA provisions

LMOs excluded from the protocol's aia provisions

LMOs excluded from the protocol's provisions on transboundary movements

75. There were extensive discussions during the negotiations of the Protocol regarding the inclusion of products of LMOs, i.e. processed materials of LMO origin. These were referred to throughout the negotiations as “products thereof”. In the end, products of LMOs were not generally included. However, they are addressed in Article 23(3)(c), Annex I(i) and Annex III(5) in relation to risk assessment, in as far as such products contain detectable novel combinations of replicable genetic materials obtained through the use of biotechnology.

B. Advanced Informed Agreement (AIA) procedure (Article 7)

76. The AIA procedure applies on the first occasion that a LMO covered by Article 7 is intentionally moved from a Party into another Party. The elements of the AIA procedure are described below.

Competent authority

77. All Parties must designate one or more national competent authorities, which will be responsible for performing the administrative functions required by the Protocol, and authorized to act on the Party's behalf with regard to those functions (Article 19).

Notification and information

78. The first step in the AIA procedure is the notification of the proposed transboundary movement to the Party in which the LMO is to be imported. This notification must contain certain information relating to, inter alia, the exporter, the LMO and its intended use. Annex I to the Protocol specifies the particular information that must be supplied in conjunction with the notification.

Decision of Party of import

79. Within 90 days of receiving the notification, the Party of import must acknowledge receipt. Within 270 days of receiving the notification, the Party of import must communicate its decision to the notifier and to the Biosafety Clearing-House established under the Protocol (see below). In its decision, the Party of import may either:

80. Failure by a Party of import to communicate its decision within 270 days does not imply its consent to the import of the LMO.

Risk assessment

81. A Party of import must base its decision on a risk assessment carried out in a scientifically sound manner. Risk assessment requirements are addressed in Article 15 and Annex III of the Protocol. The risk assessment must be based at a minimum on information provided in the initial notification and other available scientific evidence to identify and evaluate possible adverse effects of the LMO on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

82. While it is the obligation of the Party of import to ensure that its decision is based on a risk assessment, it may require the exporter to carry out and/or bear the costs of the risk assessment.

83. In reaching a decision on whether to approve the import of a particular LMO, a Party of import may also take into account the precautionary principle, and certain socio- economic considerations. As discussed above, the Protocol provides that lack of relevant scientific information and knowledge does not prevent the Party of import from taking a decision to avoid or minimize such potential adverse effects (Article 10(8)). The Protocol also allows the Party of import, in reaching a decision, to take into account socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities (Article 26). In considering socio- economic impacts, Parties must act consistently with their other international obligations, including, for Members of the WTO, relevant WTO rules.

84. Carrying out and/or evaluating a risk assessment on a LMO will require a broad range of technical and scientific expertise. Decisionmaking may require the development or significant adaptation of domestic institutions in addition to the competent national authority designated under the Protocol.

Confidential information

85. Under Article 21, the Party of import must permit the notifier to identify which information provided under the notification and information procedure is to be treated as confidential. Where requested, the notifier must give justification for this designation. If there is disagreement as to which information should qualify as confidential, the Party of import should consult with the notifier, prior to any disclosure. Parties must not disclose confidential information received under the Protocol, or use it for a commercial purpose, except with the written consent of the notifier. The Protocol specifies certain information which cannot be considered confidential, including a general description of the LMO, a summary of the risk assessment of its effects on biodiversity and human health, and methods and plans for emergency response.

National discretion

86. Although the Protocol sets out a specific AIA procedure for imports of certain LMOs, it allows Parties a fair degree of flexibility in the way this is applied. This flexibility, however, is subject to an overriding obligation to act in accordance with the objective of the Protocol.

C. LMOs not subject to AIA provisions

87. As indicated in Box 7, the Protocol's specific AIA procedure does not apply to the transboundary movements of certain LMOs. However, the other provisions of the Protocol remain applicable to such LMOs. This exclusion also does not affect the right of Parties to subject all LMOs to risk assessment prior to decisions on import.

Lmos in transit

88. The Protocol's specific AIA procedure does not apply to LMOs in transit. This exclusion is without prejudice to any right of a Party of transit to regulate the transport of LMOs through its territory. Parties may make available to the Biosafety Clearing-House its decisions regarding the transit of specific LMOs through its territory.

Lmos destined for contained Use

89. Again, the Protocol's AIA procedure does not apply to the transboundary movement of LMOs destined for contained use undertaken in accordance with the standards of the Party of import. Contained use is defined in Article 3(b) of the Protocol to include activities in which LMOs are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.

90. Once again, this exclusion does not affect any right of a Party to subject all LMOs to risk assessment prior to decisions on import and to set standards for contained use in its jurisdiction. i.e. although the AIA procedure does not apply under the provisions of the Protocol, a Party (or any other State) can, through its national legislation, require risk assessment and prior authorization before the import of a LMO for contained use.

LMOs intended for direct use for food, feed or for processing (LMO-FFPps)

91. The term “LMOs intended for direct use as food or feed, or for processing” (LMO-FFPs) covers activities such as exports of genetically modified agricultural commodities, such as GM soybeans or maize for food or feed use, or GM tomatoes. The potential application of the Protocol, and in particular the AIA procedure, to LMO-FFPs was among the most controversial issues in the negotiation of the Protocol.

92. As noted above, the specific AIA procedure set out in Articles 8, 9, 10 and 12 of the Protocol does not apply to LMO-FFPs. However, the other provisions of the Protocol do apply to LMO-FFPs and certain specific obligations regarding LMO-FFPs are set out in Articles 11 and 18(2)(a).

93. Article 11 establishes a multilateral information exchange procedure on LMO-FFPs through the Biosafety Clearing-House. Where a Party makes a decision on domestic use of a LMO that may be exported for direct use as food or feed or for processing, it must notify the other Parties through the Biosafety Clearing-House within fifteen days. Information specified in Annex II of the Protocol must be provided.

94. Parties to the Protocol may require prior consent for import of LMO-FFPs under their relevant domestic regulatory framework. Parties with laws or regulations applicable to the import of LMO-FFPs must make these available through the Biosafety Clearing- House. The Protocol recognizes, however, that some countries may not yet have applicable laws and regulations in place. It therefore provides that developing countries (and countries with economies in transition), which do not have an applicable domestic regulatory framework in place, may declare through the Biosafety Clearing-House that they will take a decision on the first import of a LMO-FFP in accordance with a risk assessment, and within a time frame of not more than 270 days. The Protocol does not specify when this 270 period begins to run, nor does it specify any direct notification procedure between the exporter and the Party of import. Failure by a Party to communicate its decision within 270 days may not be interpreted as either consent to or refusal of the import of the LMO-FFP concerned.

95. As under the AIA procedure, Parties are entitled to take into account the precautionary principle in reaching decisions on imports of LMO-FFPs (Article 11(8)).

96. Under Article 18, LMO-FFPs must be accompanied by documentation specifying that they “may contain” LMOs, and that they are not intended for intentional introduction into the environment. This means that if a Party to the Protocol receives a shipment from another Party of agricultural commodities which may contain LMOs, it should be alerted to this fact by the accompanying documentation, even if it has not explicitly subjected imports of LMO-FFPs to a prior consent procedure under Article 11. In the Protocol negotiations, many countries argued that shipments of LMO-FFPs should clearly be identified as LMOs. However, certain agricultural exporting countries objected to such a requirement as this would require producers to segregate GM and non-GM grains at all stages of production, whereas current practice is to commingle them. They argued that such a requirement would be too costly. The meeting of the Parties to the Protocol is to take a decision on any detailed requirements in this respect within two years of the Protocol entering into force.

97. Parties are also entitled, in their domestic regulatory framework, to require advance notification and approval of the proposed transboundary movements of LMO-FFPs, provided that these measures are consistent with the objective of the Protocol (Article 11(4)).

LMOs identified by the meeting of the parties to the protocol as being not likely to have adverse effects

98. Article 7(4) allows the Meeting of the Parties, at a later date, to decide to exclude specific LMOs or categories of LMOs from the application of the AIA procedure. This provision was included to take account of developments in the future: there may come a time when certain LMOs will have been shown to be sufficiently safe to exempt their transboundary movement from the AIA procedure.

LMOs that are pharmaceutical for humans that are addressed by other relevant international agreements or organizations

99. Under Article 5, these LMOs are excluded from the AIA procedure, and from the other provisions of the Protocol related to transboundary movement.

D. Other provisions

Biosafety Clearing-House

100. The Protocol establishes a Biosafety Clearing-House as part of the Clearing- House Mechanism under Article 18(3) of the CBD. The function of the Biosafety Clearing- House is to facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, LMOs and to assist Parties to implement the Protocol. Article 20(3) sets out certain categories of information that Parties are to make available to the Biosafety Clearing-House. These include:

101. As noted above, the Biosafety Clearing- House has specific functions regarding LMO-FFPs. In relation to transboundary movement of LMO-FFPs, the Biosafety Clearing-House plays a vital role: it is the central mechanism through which Parties will be made aware of the use of LMO-FFPs and their potential transboundary movement, as well as the national laws which will apply to imports of LMO-FFPs. It is also the mechanism through which Parties with no domestic regulatory framework in place will be able to declare that they require notification and risk assessment prior to a first import of a LMO-FFP.

Capacity-building and financial resources

102. The Protocol requires Parties to co-operate in the development and strengthening of human resources and institutional capacities in biosafety in developing country Parties, particularly least developed countries and small island developing States. Despite references to cooperation in capacity-building, there are no specific commitments from developed countries with regard to capacity-building.

103. The financial mechanism established under the CBD (operated by the Global Environment Facility (GEF)) is to be the financial mechanism for the Protocol. Guidance to the financial mechanism with regard to financial resources for implementation of the Protocol will go through the CBD COP. No specific guidance is given in the Protocol as to the level of financial resources that may be needed for implementation of the Protocol.

104. The fifth meeting of the CBD COP emphasized the importance of financial support for capacity-building for implementation of the Protocol.37 A number of capacity-building initiatives in relation to biosafety are already either underway or in the pipeline. COP 6 reinforced this by providing additional guidance to the GEF regarding the provision of financial resources, requesting GEF to support national capacity building in biosafety.38

Unintentional transboundary movement of LMOs

105. In addition to its extensive provisions on intentional transboundary movements of LMOs, the Protocol also addresses, in Article 17, unintentional transboundary movements. It sets out notification and consultation requirements with regard to releases of LMOs that lead or may lead to unintentional transboundary movements that are likely to have significant adverse effects. Parties must provide to the Biosafety Clearing-House details of a contact point for receiving any such notifications.

Illegal transboundary movements of LMOs

106. The Protocol requires Parties to adopt domestic measures to prevent and penalize transboundary movements of LMOs that occur in contravention of domestic measures implementing the Protocol. In the case of such illegal movements, the affected Party may request the Party of origin to dispose of the LMOs by repatriation or destruction. The Biosafety Clearing-House must be notified of all cases of illegal transboundary movement.

Liability and redress for damage caused by LMOs

107. The question of liability and redress for any damage caused by LMOs was another contentious issue in the negotiations. It was not possible to resolve this issue during the negotiations, and the Protocol requires the first meeting of the Parties to the Protocol to adopt a process with respect to the appropriate elaboration of international rules and procedures for liability and redress for damage arising out of the transboundary movements of LMOs. This process is meant to be completed within four years.

Institutional arrangements

108. The Protocol establishes institutional arrangements to carry out further work on the elaboration and review of rules for the safe transboundary movement, handling and use of LMOs. It will “share” institutions with the CBD in that the CBD COP will serve as the “meeting of the Parties” to the Protocol. This body is known by the cumbersome title “the Conference of the Parties serving as the meeting of the Parties to the Protocol” (COP/MOP)(see Article 29). However, only countries that become Parties to the Protocol will be able to participate in decision-making by the meeting of the Parties. Non-Parties to the Protocol (including non-Parties to the CBD) will be able to participate in the meeting of the Parties only as observers. The COP/MOP will play an important role in the evolution of the Protocol and may undertake further work on some of the areas on which the Protocol text does not presently provide clear guidance.

109. Subsidiary bodies established under the CBD, such as the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) may also serve the Protocol (Article 30). Similar rules as for the meeting of the Parties will apply with regard to participation.

110. The Secretariat of the CBD will also act as the Secretariat for the Protocol. Countries that become Parties to the Protocol will have to contribute to any additional costs of Secretariat services for the Protocol, and the first meeting of the Parties will decide on budgetary arrangements in this regard.

111. At its first meeting, the meeting of the Parties is due to consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of the Protocol and to address cases of non-compliance (Article 30). This may result in the establishment of additional institutions.

Dispute settlement and compliance

112. The Protocol does not contain specific provisions on the settlement of disputes arising under the Protocol, but it refers back to the relevant provisions of the CBD (Article 32). Article 27 of the CBD provides for optional recourse to judicial settlement or arbitration, or a conciliation procedure that is mandatory at the request of one of the parties to a dispute. Separate from the dispute settlement procedure, as mentioned above the Protocol mandates the development by the meeting of the Parties of procedures and mechanisms to promote compliance with the provisions of the Protocol (Article 34).

Non-Parties

113. Under the Vienna Convention on the Law of Treaties, a protocol cannot create rights and obligations for non-Parties without their consent. However, the Protocol, in Article 24, does regulate the conduct of Parties in relation to transboundary movements of LMOs involving non-Parties. Such transboundary movements must be consistent with the objective of the Protocol and may be the subject of bilateral, regional and multilateral agreements between Parties and non-Parties in accordance with Article 24.

VI. Implications of the Protocol

114. The overview of the provisions of the Protocol above suggests that it is likely to have significant implications for countries that become Party to it. Developing and implementing appropriate national reguations to regulate imports of LMOs is likely to require significant human, financial and technical resources. As noted above, while the Protocol does address capacity-building and financial resources, the scope of these provisions is not yet clear, and will require further development in the form, in particular, of further guidance from the Conference of the Parties to the GEF. However, GEF has already provided financial resources for capacity-building in the form of a significant project on national biosafety frameworks being implemented by UNEP. A number of other intergovernmental and national agencies are undertaking capacity-building initiatives in relation to national biosafety frameworks.

115. The Protocol offers to its Parties significant benefits in that it provides a potentially globally accepted set of rules on LMOs, important in particular to ensure transparency in the transboundary movement of LMOs and application of advance informed agreement regarding imports. At the same time, the Protocol sets in place an institutional mechanism through which implementation can be fostered, and continued dialogue and cooperation can be effected. The overall goal, and resulting benefit, is to provide a degree of legal certainty in the field of biosafety regulation.

116. These benefits will be realized only to the extent that the Protocol is widely ratified and effectively implemented. The latter is to a large extent dependent on effective individual national regulatory systems addressing not only imports and exports, but also the use and release of LMOs at domestic level. Developing such legislation will require extensive consultation with a range of relevant departments and agencies, as well as the public, local industry and agriculture, and research institutions.

VII. Other international instruments relevant to the Protocol

117. The development of new technologies of genetic modification since the early 1970s has prompted discussions on safety in biotechnology in many international organizations. A number of intergovernmental agencies are active in this field. Some instruments have been adopted which explicitly address biosafety, generally in the form of guidelines, and some are in preparation. It is beyond the scope of this introduction to go into these in any detail. Global instruments which were, or are, most relevant to the Protocol are briefly addressed below.

Two international instruments played an important role prior to the adoption of the Protocol:

UNIDO Voluntary Code of Conduct for the Release of Organisms into the Environment (1992)

118. Two of the aims of the UNIDO Code of Conduct were to outline the general principles governing standards of practice for all parties involved in the introduction of organisms or their products into the environment, and to encourage and assist the establishment of appropriate national regulatory frameworks, particularly where no adequate infrastructure yet existed.

Box 8. Possible elements of national biosafety regulations

In the elaboration of a national biosafety legal framework, some elements which States have considered include the following:

A useful reference material is the Implementation tool kit prepared by the ICCP (Recommendation 3/5, Annex III) which provides a compilation, as a checklist, of obligations found in the Protocol. It divides these obligations into administrative tasks, legal requirements and/or undertakings, and procedural requirements. The Implementation tool kit is reproduced in the Supplementary Materials.

UNEP International Technical Guidelines for Safety in Biotechnology (UNEP Guidelines) (1995)

119. These Guidelines were adopted by the Global Consultation of Government-designated Experts in 1995, under the auspices of UNEP. The CBD COP recognized the UNEP Guidelines as a useful interim mechanism to facilitate the management of risks, pending finalization of the Protocol. The UNEP Guidelines provide technical guidance on evaluating biosafety, identifying measures to manage foreseeable risks and to facilitate processes such as monitoring, research and information exchange.

120. The Guidelines were developed on the basis of common elements and principles found in existing national, regional and international instruments, regulations and guidelines, and draw on experience gained through their implementation.

121. Other international instruments, albeit adopted well before the Protocol, address issues which are of relevance to specific aspects of its implementation.

International Plant Protection Convention (IPPC) (adopted 1951, amended 1979, Revised 1997)

122. The IPPC is an international treaty for cooperation in plant protection, which aims to “to secure common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control”. The IPPC allows Parties to take phytosanitary measures to prevent the introduction and/or spread of pests, based on a pest risk analysis, which covers both economic and environmental factors including possible detrimental effects on natural vegetation. LMOs that could be considered a plant pest could fall within the scope of the IPPC and be subject to its provisions.

123. The IPPC, which was originally adopted in 1951, amended in 1979 and revised in 1997, incorporates a process for the development of International Standards for Phytosanitary Measures. Pending entry into force of the 1997 IPPC, an Interim Commission on Phytosanitary Measures (ICPM) has been established. At the second meeting of ICPM, an exploratory open-ended working group was set up to address issues of GMOs, biosafety and invasive species in relation to IPPC and report back to ICPM. The working group recommended the development of a supplementary standard to specifically address the plant pest risks of LMOs/products of modern biotechnology, as amatter of urgency. This is to include a review of plant pest risks associated with LMOs/products of modern biotechnology carried out in cooperation with the CBD.

124. Under the WTO SPS Agreement, sanitary and phytosanitary measures which conform to certain international standards, guidelines or recommendations are deemed to be necessary to protect human, animal or plant life or health, and thus presumed to be consistent with the SPS Agreement and GATT 1994 (see Appendix). These include standards and guidelines adopted under the IPPC, as well as the Office International des Epizooties and Codex Alimentarius (see below).

The Office International des Epizooties (OIE) (1924)

125. The OIE plays a similar role to the ICPM, in relation to animal health and disease. The OIE produces and assesses scientific evidence and operates by consensus to develop harmonizing standards, guidelines and recommendations, especially for trade in animals and products of animal origin. In relation to GMOs, OIE has carried out work on scientific evaluation of GMOs which are pharmaceuticals for animals (which are subject to the Protocol's AIA procedure). The OIE Standards Commission has had an Ad Hoc Working Group on Biotechnology since 1996, but has not yet adopted any international standards in this field.

The Codex Alimentarius

126. This is a non-binding Code developed by the Codex Alimentarius Commission, a body of FAO/World Health Organization which elaborates standards, general principles, guidelines, and recommended codes of practice in relation to food safety and related issues.39 The Codex is significant in relation to LMOs because standards may be adopted in future on safety of foods derived from biotechnology (for example, addressing issues of potential allergenicity; possible gene transfer from LMOs; pathogenicity deriving from the organism used; nutritional considerations; risk assessment and authorization procedures; and appropriate labelling).

127. The Codex has underway at least three processes of relevance to LMOs. The Task Force on Foods Derived from Biotechnology is working, inter alia, on Principles for Risk Analysis of Foods Derived from Modern Biotechnology. The Committee on General Principles is elaborating Draft Working Principles for Risk Analysis. The Committee on Food Labelling is preparing recommendations for the Labelling of Food Obtained through Biotechnology (See also Box 12).

FAO's Regional Fisheries Bodies

128. Members of this group of interrelated institutions have adopted codes of practice on the use of introduced aquatic and marine species and GMOs. Work is ongoing within FAO, with ICLARM (International Center for Living Aquatic Resources Management) and OIE, to develop appropriate biosafety policies for aquatic genetic resources. In so far as genetically modified aquatic species are intended for deliberate release into the environment, their transboundary movement will be subject to the AIA procedure of the Protocol.

The Convention on Access to Information, Public Participation and Access to Justice in Environmental Matters (Aarhus, adopted 1998, Entered Into Force 2001)

129. Measures of both a binding and non-binding character are contemplated within the UN/ ECE Aarhus Convention framework for further developing access to information, public participation and access to justice with respect to GMOs.40 Guidelines on this subject41 have been prepared for adoption at the first meeting of the Parties to the Convention in October 2002, and for use by all Parties as a non-binding, voluntary instrument. In addition, possible legally-binding options for further developing the application of the Convention in the field of GMOs are being considered, and this work will be continued by the Working Group on Genetically Modified Organisms to be established at the first meeting of the Parties to the Aarhus Convention with a view to preparing decisions for adoption by the Parties at their second meeting.

Cooperation regarding implementation of the Protocol

130. All the above activities are of relevance to the Protocol, and cooperation between the organizations mentioned, and many others, and the Secretariat of the Protocol will be important in the future. The subject has already been raised before the ICCP and, for some activities, co-operation is already ongoing or contemplated.


1 18(a)Consensus was reached on the following items:

(i)     All activities related to LMOs resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, including research and development, handling, transfer, use and disposal.

(ii)    Transboundary movement of LMOs resulting from modern biotechnology and other transboundary issues, including unintended movement of LMOs resulting from modern biotechnology across national boundaries and their potential adverse effects.

(iii)   The release of LMOs resulting from modern biotechnology in centres of origin and genetic diversity.

(iv)   Mechanisms for risk assessment and risk management.

(v)    Procedure for advance informed agreement.

(vi)   Facilitation of exchange of information from all publicly available sources, including to local communities.

(vii)  Capacity-building in all the aspects required for biosafety.

(viii)  Implementation mechanisms.

2 18(b)The following issues, though not enjoying consensus, were supported by many delegations:

–   Socio-economic considerations

–   Liability and compensation

–   Financial issues.

3 Decision II/5, UNEP/CBD/COP/2/19.

4 UNEP/CBD/ExCOP/1/2, Appendix 1.

5 Decision EM-I/1, UNEP/CBD/ExCOP/1/3, Annex 1.

6 For further information on the negotiations, see for example Earth Negotiations Bulletin (http://www.iisd.ca/linkages); Bail, C. Falkner, R. and Marquard, H. (eds.), The Cartagena Protocol on Biosafety: Reconciling Trade in Biotechnology with Environment and Development? (Earthscan, 2002); Newell, P. and Mackenzie, R. “The Cartagena Protocol on Biosafety: Legal and Political Dimensions”, Global Environmental Change, Vol.10 (3) (2000); Gupta, A. “Governing Trade in Genetically Modified Organisms: the Cartagena Protocol on Biosafety”, Environment 42:4 (2000), 23–33; and Falkner, R. “Regulating biotech trade: The Cartagena Protocol on Biosafety”International Affairs 76:2 (2000), 299–313.

7 Decision EM-I/3, UNEP/CBD/ExCOP/1/3, Annex.

8 Decision V/1, UNEP/CBD/COP5/23, Annex III.

9 The Royal Society “The Use of Genetically Modified Animals” May 2001, Science Advice Section. See http://www.royalsoc.ac.uk/files/statfiles/document-139.pdf.

10 DNA is deoxyribonucleic acid, which is present in almost all living cells and contains information coding for cellular structure, organisation and function.

11 Based On: “genetic Modification: An Overview For Non-scientists”, Report Of The New Zealand Royal Commission On Genetic Modification, Wellington, 2001, P.363.

12 Wright, S. Molecular Politics – Developing American and British Regulatory Policy for Genetic Engineering 1972–1982, (University of Chicago Press, 1994), p.76.

13 James, C. Global Review of Commercialized Transgenic Crops: 2001, ISAAA Briefs No. 24, p.6.

14 James, C. Global Review of Commercialized Transgenic Crops: 2001, ISAAA Briefs No. 24, p.15.

15 U.S. Food and Drug Administration/Center for Food Safety & Applied Nuturition/Office of Food Additive Safety, March 2002: List of completed Consultations on Bioengineered Foods, available at: http://vm.cfsan.fda.gov/~lrd/biocon.html

16 Japanese Ministry of Health, Labour and Welfare/Department of Food Safety, Oct 2002: List of the products whose safety assessments were completed by MHLW, available at: http://www.mhlw.go.jp/english/topics/food/sec01.html

17 Food Standards Australia New Zealand/Te Mana Kounga Kai – Ahitereiria me Aotearoa, as of September 2002: Genetically modified or GM Foods – Current Applications and Approvals, available at: http://www.foodstandards.gov.au/whatsinfood/gmfoods/gmcurrentapplication1030.cfm

18 Belgian Biosafety Server, April 2001: Novel Food Notifications persuant to Article 5 of Regulation (EC) N° 258/97 of the European Parliament and of the Council, available at: http://biosafety.ihe.be/NF/Gmfoods/Notifications_art5_258_97.html

19 South African National Department of Agriculture, 2002: Genetically modified organisms that have been cleared for commercial release and/or for food and animal feed only http://www.nda.agric.za/geneticresources/AnnexureB.htm

20 The Royal Society, Non-Food Crops: Response to the House of Lords Select Committee Inquiry on Non-Food Crops, June 1999. See http://www.royalsoc.ac.uk/files/statfiles/document-31.pdf

21 Van Aken, J. Genetically engineered bacteria: U.S. lets bad gene out of the bottle, Greenpeace report (January 2000).

22 James, C. Global Review of Commercialized Transgenic Crops: 2001, ISAAA Briefs No. 24, p.17.

23 Gonsalves, D. “Annual Review of Phytopathology” (1998) 36: 415–437.

24 Pinto, Y. M. et al. “Nature Biotechnology” (1999) 17: 702–707.

25 Thanavala, Y. et al. “Proceedings of the National Academy of Sciences of the USA” (1995) 92(8): 3358–3361.

26 Asante-Owusu, R. GM technology in the forest sector. WWF International, Gland (1999).

27 Gordon J.W., Ruddle F.H. “ Integration and stable germ line transmission of genes injected into mouse pronuclei”, Science (1981) 214:1244–1246.

28 Hammer R.E., Pursel V.G., Rexroad Jr., C.E. et al. “Production of transgenic rabbits, sheep and pigs by microinjection”, Nature.( 1985) 315:680–683.

29 Simons J.P., McClenaghan M., Clark A.J. “Alteration of the quality of milk by expression of sheep betalactoglobulin in transgenic mice”, Nature (1987) 328:530–532.

30 The House of Lords Select Committee on Animals in Scientific Procedures, Report July 2002. Available at: http://www.publications.parliament.uk/pa/ld200102/ldselect/ldanimal/150/1500

31 Royal Society of Canada. Elements of precaution: Recommendation for the regulation of food biotechnology in Canada (Ottawa, 2001).

32 Rubin, G. and Spradling, A. (1982) “Genetic transformation of Drosophila with transposable element vectors”, Science; 218:3448–3453.

33 Zitner, A. “Splicing the sting out of bugs”, LA Times, (April 9, 2000) 10–22.

34 Genetically modified organisms (GMOs): The significance of gene flow through pollen transfer (EEA, 2002, Environmental issue report no. 28).

35 Kiss, A. Introduction to International Environmental Law, Programme of Training for the Application of Environmental Law, Course 1, UNITAR (1997).

36 This Section is based on an information package on the CBD for Pacific Island Countries (2000) produced by the South Pacific Regional Environment Programme (SPREP), the Foundation for International Environmental Law and Development (FIELD) and the World Wide Fund for Nature-South Pacific Program (WWF-SPP) as part of A UK Department of Environment, Food and Rural affairs (DEFRA) Darwin Initiative project.

37 Decision V/11, paragraph 11, UNEP/CBD/COP/5/23.

38 Decision VI/17, UNEP/CBD/COP/6/20.

39 In relation to the IPPC and Codex Alimentarius, see FAO and the Biosafety Protocol to the Convention on Biological Diversity, 28 July 1998, website of the FAO, http://www.fao.org

40 MP.PP/2002/5, 12 August 2002 (ECE).

41 MP.PP/2002/6, 15 August 2002 (ECE).

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