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The Cartagena Protocol on Biosafety
by
Hartmut Meyer
Keywords:  Biosafety, Convention on Biological Diversity
Correct citation: Meyer, H. (2000), "The Cartagena Protocol on Biosafety." Biotechnology and Development Monitor, No. 43, p. 2-7.

On 30 January 2000, the Cartagena Protocol on Biosafety (CPB) was adopted in Montreal by delegates of 128 Parties to the Convention on Biological Diversity (CBD). This must be seen as a landmark in the development of multinational environmental agreements. With it the Precautionary Approach (PA) became the guiding principle for the import of genetically modified organisms (GMOs). It subjects this import to an Advance Informed Agreement (AIA) and secured its legal status in relation to the World Trade Organization (WTO). By 15 September 2000, 75 governments including those of 44 developing countries had signed this environmental agreement.

The CPB is to set internationally binding safety standards for the import of genetically modified organisms (GMOs), and defaults for the risk assessment of these GMOs for biological diversity taking also into account risks to human health. It is also intended to guarantee the right of member states to make a decision about the import of GMOs after being informed in advance. These GMOs can, amongst other things, be food. However, such food that does not contain living organisms is not regulated by the CPB but by national or regional regulations like the Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. Minimal standards for risk assessment and safety measures for the transboundary movement of GMOs can be set using the CPB. This is particularly significant for importing countries that do not yet have GMO regulations. The CPB can thus be seen as an instrument that protects biological diversity in developing countries and this explains why it has received such strong support from these quarters.

The Precautionary Approach

Two of the documents from the United Nations Conference on Environment and Development held Rio de Janeiro (Brazil) in 1992 deal with the role of genetic engineering in sustainable development. Agenda 21 and the Convention on Biological Diversity (CBD) both contain provisions for avoiding or minimizing possible risks from GMOs. These protocols contain contradictions, however, reflecting the different legal approaches to GMOs in the USA and the European Union (EU). The European Precautionary Principle (PP) enables states to take preventive measures in situations of scientific uncertainty or before full scientific proof has been provided. The Precautionary Approach as laid down in Principle 15 of the Rio Declaration is a lighter version of the PP and was accepted as a compromise by the USA in 1992. It is referred to in the CBD. By contrast there is no mention of precautionary measures in Agenda 21. The Principle of Familiarity is mentioned as fundamental to risk assessments which, according to the regulatory system in the USA, serves as the basis for decision-making procedures.
The PA is invoked four times in the CPB. In the Preamble, Article 1, Annex II and in Article 10.6/11.8 where it is stated that “lack of scientific certainty due to insufficient relevant scientific information and knowledge shall not prevent [the importing country] from taking a decision, as appropriate, with regard to the import of that living modified organism […] in order to avoid or minimize such potential adverse effects.” This includes the possibility of prohibition, as was formulated in the draft text in 1999, but is not seen as a trigger for possible WTO actions against the CPB (see article of van Dommelen)

The regulations

The CPB regulates the transboundary movement of specific categories of GMOs.

Scope of the CPB

The CPB regulates the transboundary movement of GMOs but there are several exceptions with modified regulations.

Commodities

During the biosafety negotiations a new category of GMOs was created: living modified organisms intended for direct use as food or feed, or for processing (LMO-FFPs). It replaces the expression “commodities” and makes a clear distinction between GMOs as seeds, and GMOs that are intended for food or feed and which are therefore not supposed to be released into the environment. This distinction does not take into account that in crisis situations in developing countries GMOs intended for food might also be used as seeds.
While the draft text totally excluded LMO-FFPs from the AIA procedure, the final negotiations in Montreal led to the development of a weaker form of AIA for LMO-FFPs. This ‘AIA-light’ is closely connected to the development of an internet-based Biosafety Clearing House (BCH), an information system that is part of the clearing house mechanism of the CBD. The BCH will be a central portal with basic information and links to other relevant web  pages. Meanwhile there are 144 national CBD focal points, 122 of them with e-mail, but only 52 with a CBD clearing-house mechanism website. The CBD has started an international project that will try to improve this situation within the next four years paying particular attention to the development of the BCH structure.
Every Party to the Protocol must be informed about any approval given for the market introduction of an LMO by another Party either in writing or through the BCH. However, the actual import itself does not have to be announced. The potential importing Party “may request additional information” and “may take a decision on the import [...] under its domestic regulatory framework that is consistent with the objective of this Protocol” (Article 11). Most developing country expressed their concerns about this procedure which imposes the burden of monitoring the world-wide registration of LMO-FFPs on the potential importing countries and which relies entirely on highly developed telecommunication systems that are often not accessible to developing countries.
Under the regular AIA procedure, explicit consent is needed for the import of an LMO. However, Art. 11.7 states that the “failure by a Party to communicate its decision [...] shall not imply its consent or refusal to the import” of LMO-FFPs. The Party’s decision has to be announced through the BCH. In practice, this might lead to a matrix showing which country has allowed the import of which LMO-FFP. This matrix can help exporters decide whether a particular consignment of agricultural commodities that “may contain” LMO-FFPs can be exported legally into a given country or not.

Exporting countries

How do the three main GMO growing countries and other potential GMO growers react on these CPB requirements? The USA as the main producer of GMOs cannot be a Party to the CPB until they ratify the CBD, which at present seems very unlikely. It is also unclear whether Canada as the third biggest exporter of GMOs and Australia as a potential GMO growing country will sign the CPB. On the other hand, the developing countries Argentina, the second biggest GMO exporter, and Chile, both members of the Miami-Group, signed the CPB very early on.
It will be extremely difficult if major exporting countries refuse to enter the CPB and accept its obligations. In the draft text, the transfer of LMOs from non-Parties to Parties was forbidden, but this provision could not be maintained. The CPB now states that the movement of LMOs between Parties and non-Parties “shall be consistent with the objective of this Protocol” and might be performed under bilateral agreements. Non-Parties shall be encouraged “to adhere to this Protocol and to contribute appropriate information to the [BCH].”

Transit

LMOs in transit or intended for contained use are included in the CPB but they are neither subject to the AIA procedure, nor to a risk assessment. The exclusion of LMOs for contained use from risk assessment does not reflect the position of the majority of the Parties to the CBD or ‘green’ NGOs, and has the potential to counteract the spirit of the CPB. This provision invites exporters to evade risk assessment by declaring that the imported LMOs are meant for contained use, for example, by postponing field releases for a year. In such cases, the responsibility for risk assessments would be shifted from the exporter to the importing country; that is if national legislation exists in that country. Furthermore, the definition of contained use as “any operation, undertaken within a facility, installation or other physical structures, which involve living modified organisms that are controlled by specific measures that effectively limit their contact with, and impact on, the external environment” is extremely vague. The introduction of the term “or other physical structures” by the USA may encourage exporters to claim, for instance, that field trials surrounded by hemp plants or other pollen traps can be regarded as contained use.

Pharmaceutical LMOs

The CPB “shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations” (Article 5). To date, the only pharmaceutical LMOs are living, genetically modified viruses serving as vaccines. Currently no other agreement explicitly addresses their transboundary movement and effects on biodiversity. They have to be approved after a medical risk assessment conducted according to national and international pharmaceutical legislation. It is still unclear whether and how this open issue of the CPB will be solved.
The exclusion of pharmaceutical LMOs from the Protocol reflects the common interest of countries with powerful pharmaceutical industries. Many developing countries fear that genetically engineered plants that produce vaccines or drugs might fall under this article and will be able to enter their territory unannounced. Such plants will exhibit substantial variability in vaccine or drug concentration due to variations between each organism, climate, soils etc. Taking into account the unpredictable concentration of the active ingredient in a particular plant, the plants will not fulfil the criteria that would lead to them being classified as drugs. They will provide the raw material for industrial processes, in contained use, necessary to extract the active ingredient and produce pure drugs. The importation of this type of plants is therefore most likely to fall under Article 6 (Transit and Contained Use) since they cannot be used as medicine themselves. This still implies import without the application of AIA and a biodiversity risk assessment. However, labelling requirements will have to be fulfilled and this will enable LMOs to be monitored and/or become subject to national legislations.

Relation to the WTO

During negotiations about the biosafety protocol, the Miami Group tried to subordinate the CPB to WTO regulations despite the strong objection of the other countries involved. A subordination such as that formulated in the so-called saving clause Article 31 of the draft text would have devalued the PA as a political guideline. The Miami Group regarded the WTO as a bulwark against attempts to impose “unjustified” import restrictions on GMOs. According to WTO regulations, such restrictions can only be imposed after damage has occurred and its cause has been identified. Without any statement about its relation to other international treaties, and in accordance with the Vienna Convention on the Law of Treaties, the CPB as the more recent and more specific agreement would prevail over the WTO. As a compromise, the CPB preamble reads that the parties “recognis(e) that trade and environment agreements should be mutually supportive with a view to achieve sustainable development, emphasiz(e) that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, understand that the above recital is not intended to subordinate this Protocol to other international agreements”.
Nonetheless, it is unclear how the formal equalization of the CPB and WTO agreements would fare in a law suit arising from an import restriction. The WTO has its own jurisdiction and is able to impose fines worth millions of dollars. This makes it structurally much stronger than the Rio documents, which cannot be enforced in court.

Technical assistance and capacity building

The CPB calls for co-operation between Parties with regard to financial and technical assistance and to capacity-building. Canada and the USA, and some EU countries have been funding biosafety meetings for many years. These mainly serve to promote modern biotechnology and the Technical Guidelines of the United Nations Environment Programme (UNEP) which are not legally binding, are not based on the Precautionary Principle and do not anticipate labelling. The promotion of these guidelines can be seen as an extension of the USA regulatory system. It would be fatal for the biosafety process if the implementation of the CPB were to be led by countries that are opposed to the Precautionary Principle and the spirit of the CPB.

Conclusion

What does the adoption of international environmental safety standards for the transboundary shipment of GMOs mean for the export of such organisms as seed and/or food to developing countries? Will the commodity markets of these countries be flooded with GMOs because of the weaknesses in the CPB as mentioned above, the absence of appropriate national regulations and a lack of local capacity to deal with the problem? As far as LMO-FFPs are concerned this seems unlikely because, in the first place, commodity flows follow market capacities. The big, prosperous commodity markets are in Europe and in some Asian-Pacific countries not in developing countries. Those markets are the target of GMO exports from the three GMO growing countries - USA, Canada and Argentina - even though in most of these importing countries strong biosafety legislation exists.
The GMO market entered a critical stage when European and Japanese retailers reacted to the wide spread critical consumer attitude towards genetically modified (GM) food and started to import GMO free raw products. The USA reacted to this by stabilizing the market for GMOs by indirect agricultural subsidies. Non-marketable harvests could be sold to the government and then distributed in food aid programmes. The amount of GMOs entering developing countries in this way - and not following the provisions of the CPB - may well be grossly in excess of regular commodity flows. NGOs from developing countries have been critically analysing this issue recently.
The import of GM seeds into developing countries will be subject to the full provisions of the CPB. The analysis of the ongoing development of modern biotechnology in developing countries show that the major efforts of private and public development programs focus on establishing research facilities that can produce GMOs on national territory. This investment is closely connected to efforts to convince the countries concerned to establish the legal framework for exclusive intellectual property rights, e.g. through patents on plants or through the adoption of the International Union for the Protection of New Varieties of Plants (UPOV) agreement from 1991.
Given this situation, the necessary biosafety evaluation depends exclusively on the legal framework of the individual developing country. Recognizing the efforts being made by developing countries to elaborate a CPB with high protective standards, attempts must now focus on implementing the CPB and on drafting of appropriate national biosafety legislation. They must be supported by the industrialized countries that signed the CPB.

Hartmut Meyer

Co-ordinator Working Group on Biological Diversity, German NGO Forum on Environment & Development, Kleine Wiese 6, D-38116 Braunschweig, Germany.
Phone (+49) 531 5168746; Fax (+49) 531 5168747; E-mail hartmut.meyer@bund.net

Sources
Cartagena Protocol on Biosafety: http://www.biodiv.org/biosafe/Protocol/Protocol.html

Convention on Biological Diversity: http://www.biodiv.org/conv/background.html

Catalogue of Biosafety Documents: http://irptc.unep.ch/biodiv/docs01.html.



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