Die Art und Sicherheit gentechnisch veränderter Nutzpflanzen und Lebensmittel

7. Are GMOs regulated by international agreements?

• 7.1 How is international agricultural trade regulated?
• 7.2 Do international conventions address environmental effects of GMOs?
  • 7.2.1 The Convention on Biological Diversity and the Cartagena Protocol on Biosafety
  • 7.2.2 The IPPC and living modified organisms

7.1 How is international agricultural trade regulated?

The source document for this Digest states:

BOX 18 International standards to facilitate trade
1 Since renamed the World Organisation for Animal Health, although the acronym OIE has been retained.
Opportunities for agricultural trade have increased dramatically over the past several years as a result of reforms in international trade under the World Trade Organization (WTO). To a large extent, these reforms centred on reducing tariffs and subsidies in various sectors. The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) was also adopted under the WTO in 1994 and entered into force in 1995. The SPS Agreement establishes that countries retain their right to ensure that the food, animal and plant products they import are safe, and at the same time it states that countries should not use unnecessarily stringent measures as disguised barriers to trade. The SPS Agreement concerns in particular: the protection of animal or plant life or health arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms; the protection of human or animal life or health from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; the protection of human life or health from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; and the prevention or limitation of other damage from the entry, establishment or spread of pests. The SPS Agreement states that countries should use internationally agreed standards in establishing their requirements for sanitary and phytosanitary measures. To meet this objective, three international standard-setting bodies are identified: the Codex Alimentarius Commission for food safety, the International Office of Epizootics (OIE)1 for animal health and the IPPC for plant health. By using standards, countries can reach the level of protection needed to protect human, animal or plant life or health. Countries may also adopt measures that differ from standards, but in these cases, the measures should be technically justified and based on risk assessment.

Source & ©: FAO "The State of Food and Agriculture 2003-2004"
Chapter 5: Health and environmental impacts of transgenic crops , Box 18

For details on:	Sea FAO report:
The gene revolution and Intellectual property issues related to biotechnologies	Chapter 3 , Section "The Gene Revolution: a changing paradigm for agricultural R&D"

7.2 Do international conventions address environmental effects of GMOs?

• • 7.2.1 The Convention on Biological Diversity and the Cartagena Protocol on Biosafety
  • 7.2.2 The IPPC and living modified organisms

The source document for this Digest states:

International environmental agreements and institutions

Several international agreements and institutions are relevant to the environmental aspects of certain transgenic products, among them the Convention on Biological Diversity, the Cartagena Protocol on Biosafety and the International Plant Protection Convention. The roles and provisions of these bodies are described below.

Source & ©: FAO "The State of Food and Agriculture 2003-2004"
Chapter 5: Health and environmental impacts of transgenic crops 
Section International environmental agreements and institutions

7.2.1 The Convention on Biological Diversity and the Cartagena Protocol on Biosafety

The source document for this Digest states:

Most of the measures of the Convention on Biological Diversity (CBD) (Secretariat of the Convention on Biological Diversity, 1992) focus on the conservation of ecosystems; however, two aspects concerning the conservation of biological diversity are relevant for biosafety - the management of risks associated with LMOs resulting from biotechnology and the management of risks associated with alien species.

In the context of in-situ conservation measures, the Convention requires contracting parties “… to regulate, manage or control the risks associated with the 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 …”. This provision goes beyond the general scope of the Convention in that it requires also that risks to human health are taken into account.

The Convention establishes that contracting parties have the obligation to prevent the introduction of alien species and to control or to eradicate those alien species that threaten ecosystems, habitats or species. Invasive alien species are considered as species introduced deliberately or unintentionally outside their natural habitats where they have the ability to establish themselves, invade, replace natives and take over the new environment.

The Cartagena Protocol on Biosafety (Secretariat of the Convention on Biological Diversity, 2000) was adopted by the CBD in September 2000 and came into force in September 2003. The objective of the Protocol is to protect biological diversity from the potential risks posed by safe transfer, handling and use of LMOs resulting from modern biotechnology. Risks to human health are also considered. The Protocol is applicable to all LMOs, except pharmaceuticals for humans that are addressed by other international agreements or organizations.

The Protocol sets out an Advance Informed Agreement (AIA) procedure for LMOs intended for intentional introduction into the environment that may have adverse effects on the conservation and sustainable use of biodiversity. The procedure requires, prior to the first intentional introduction into the environment of an importing party:

• notification of the party of export containing certain information;
• acknowledgement of its receipt; and
• the written consent of the party of import.

Four categories of LMO are exempted from the AIA: LMOs in transit, LMOs for contained use, LMOs identified in a decision of the Conference of Parties/Meeting of Parties as not likely to have adverse effects on biodiversity conservation and sustainable use, and LMOs intended for direct use as food, feed or for processing.

For LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing, Article 11 provides that a party that makes a final decision for domestic use, including placing on the market, must notify the Biosafety Clearing-House established under the Protocol. The notification is to contain minimum information required under Annex II. A contracting party may take an import decision under its domestic regulatory framework, provided this is consistent with the Protocol. A developing country contracting party, or a party with a transition economy that lacks a domestic regulatory framework, can declare through the Biosafety Clearing-House that its decision on the first import of an LMO for direct use as food, feed or for processing will be pursuant to a risk assessment. In both cases lack of scientific certainty because of insufficient relevant scientific information and knowledge regarding the extent of potential adverse effects shall not prevent the contracting party of import from taking a decision, as appropriate, in order to avoid or minimize potential adverse effects.

Risk assessment and risk management are requirements for both AIA and Article 11 cases. The risk assessment must be consistent with criteria enumerated in an annex. In principle, risk assessment is to be carried out by competent national decision-making authorities. The exporter may be required to undertake the assessment. The importing party may require the notifier to pay for the risk assessment.

The Protocol specifies general risk management measures and criteria. Any measures based on risk assessment should be proportionate to the risks identified. Measures to minimize the likelihood of unintentional transboundary movement of LMOs are to be taken. Affected or potentially affected states are to be notified when an occurrence may lead to an unintentional transboundary movement.

The Protocol also contains provisions on LMO handling, packaging and transportation (Article 18). In particular, each contracting party is to take measures to require documentation that:

1. For LMOs intended for direct use as food or feed, or for processing, clearly identifies that they “may contain” LMOs and are “not intended for intentional introduction into the environment”, and a contact point for further information;
2. For LMOs destined for contained use, clearly identifies them as LMOs and specifies any requirements for safe handling, storage, transport and use, and a contact point and consignee;
3. For LMOs intended for intentional introduction into the environment of the party of import, clearly identifies them as LMOs and specifies the identity and traits/characteristics, any requirements for safe handling, storage, transport and use, and a contact point, the name/address of the importer/exporter and a declaration that the movement conforms to the Protocol's requirements applicable to the exporter.

Information exchange is envisaged in the Protocol through the establishment of the Biosafety Clearing-House. The Biosafety Clearing-House is intended to facilitate the exchange of information on, and experience with, LMOs and to assist parties in implementation of the Protocol. Pursuant to Article 20, paragraph 2, it shall also provide access to other international biosafety information exchange systems. Information that parties are required to provide to the Clearing-House includes existing laws, regulations and guidelines for implementation of the Protocol; information required for the AIA; any bilateral, regional and multilateral agreements within the context of the Protocol; summaries of risk assessment and final decisions.

Public participation is specifically addressed in Article 23. Contracting parties shall:

1. promote and facilitate public awareness, education and participation concerning safe transfer, handling and use of LMOs;
2. endeavour to ensure public awareness and education encompasses access to information on LMOs identified by the Protocol that may be imported;
3. consult the public in the decision-making process regarding LMOs and shall make decisions available to the public in accordance with national laws and regulations. Confidential information is to be respected in those activities.

Socio-economic considerations are allowed in decision-making. Contracting parties may account for socio-economic considerations arising from the impact of LMOs on biodiversity conservation and sustainable use, especially with regard to the value of biodiversity to indigenous and local communities. The parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of LMOs. A process to address liability and redress for damage resulting from LMO transboundary movements is to be set up by the first meeting of parties to the Protocol.

Source & ©: FAO "The State of Food and Agriculture 2003-2004"
Chapter 5: Health and environmental impacts of transgenic crops 
Section International environmental agreements and institutions,
Subsection The Convention on Biological Diversity and the Cartagena Protocol on Biosafety

7.2.2 The IPPC and living modified organisms

The source document for this Digest states:

The purpose of the International Plant Protection Convention (IPPC) is to secure common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote measures for their control. Although the IPPC makes provision for trade in plants and plant products, it is not limited in this respect. Specifically, the scope of the IPPC extends to the protection of wild flora in addition to cultivated flora, and covers both direct and indirect damage from pests, including weeds. The IPPC plays an important role in the conservation of plant biodiversity and in the protection of natural resources. Hence, standards developed under the IPPC are also applicable to key elements of the CBD, including the prevention and mitigation of impacts of alien invasive species, and the Cartagena Protocol on Biosafety. As a consequence, the CBD, FAO and IPPC have established a close collaborative relationship. This has in particular extended to the inclusion of CBD concerns in the development of new international standards for phytosanitary measures (ISPMs).

ISPMs developed under the auspices of the IPPC provide internationally agreed guidance to countries on measures to protect plant life or health from the introduction and spread of pests or diseases. One of the most important concept standards developed under the IPPC is ISPM No. 11, Pest risk analysis for quarantine pests (FAO, 2001b), adopted by the Interim Commission on Phytosanitary Measures (ICPM) at its 3rd Session in 2001. In addition, the ICPM, at its 5th Session in 2003, adopted a supplement to ISPM No. 11 to address risks to the environment in order to take into account CBD concerns, especially with regard to invasive alien species. More recently, the IPPC has drafted another supplement to ISPM No. 11 to address pest risk analysis for LMOs.

This draft standard has undergone extensive technical discussion and consultation throughout its development. At the request of the ICPM, an open-ended expert working group was convened in September 2001 and included government-nominated experts from developed and developing countries and experts representing both plant protection and environmental concerns. The purpose of the meeting was to discuss the development of this standard and the need to provide detailed guidance on conducting risk analyses to address the potential plant health effects of LMOs with particular attention to the needs of developing countries.

The working group considered that potential phytosanitary risks of LMOs that may need to be considered in a pest risk analysis include (FAO, 2002b):

• Changes in adaptive characteristics that may increase the potential invasiveness including, for example: drought tolerance of plants; herbicide tolerance of plants; alterations in reproductive biology; dispersal ability of pests; pest resistance; and pesticide resistance.
• Gene flow including, for example: transfer of herbicide resistance genes to compatible species; and the potential to overcome existing reproductive and recombination barriers.
• Potential to affect non-target organisms adversely including, for example: changes in host range of biological control agents or organisms claimed to be beneficial; and effects on other organisms such as biological control agents, beneficial organisms and soil microflora that result in a phytosanitary impact (indirect effects).
• Possibility of phytopathogenic properties including, for example: phytosanitary risks presented by novel traits in organisms not normally considered a phytosanitary risk; enhanced virus recombination, trans-encapsidation and synergy events related to the presence of virus sequences; and phytosanitary risks associated with nucleic acid sequences (markers, promoters, terminators, etc.) present in the insert.

Subsequently, a small working group, including CBD/Cartagena Protocol and plant protection experts, met to prepare a draft standard that would provide general guidelines on the conduct of pest risk analysis with respect to the potential phytosanitary risks identified above. In the process of drafting the standard, the working group noted several important issues with regard to the scope of the IPPC and potential phytosanitary risks of LMOs. In particular, the working group noted that whereas some types of LMO would require pest risk analyses because they could present phytosanitary risks, many other categories of LMO, e.g. those with modified characteristics such as ripening time or storage/shelf life, do not present phytosanitary risks. Similarly, it was noted that pest risk analysis would only address the phytosanitary risks of LMOs, but that other potential risks may also need to be addressed (e.g. human health concerns for food products). It was also noted that the potential phytosanitary risks identified above could also be associated with non-LMOs, or conventionally bred crops. It was acknowledged that risk analysis procedures of the IPPC are generally concerned with phenotypic characteristics rather than genotypic characteristics and it was noted that the latter may need to be considered when assessing the phytosanitary risks of LMOs.

At the time of the publication of this document, the draft standard has been reviewed by the Standards Committee and been distributed to all members for review and comment. Comments on the draft standard received from countries were reviewed by the Standards Committee in November 2003. The draft standard will be modified taking into account received comments, and should be submitted to the ICPM at its 6th Session in April 2004 for its approval.

Source & ©: FAO "The State of Food and Agriculture 2003-2004"
Chapter 5: Health and environmental impacts of transgenic crops 
Section International environmental agreements and institutions,
Subsection The IPPC and living modified organisms