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Risk Assessment of LMOs - Training Manual

Module 1: Overview of Biosafety and the Cartagena Protocol on Biosafety


Contents of this Module

       
1. Introduction to biosafety and the Cartagena Protocol on Biosafety »
  1.1. History of the Protocol »
  1.2. What is biosafety? »
  1.3. What are living modified organisms? »
    1.3.1. Examples of commercialized LMOs »
  1.4. Objective and scope of the Protocol »
  1.5. Living modified organisms for intentional introduction into the environment – Advanced Informed Agreement »
  1.6. Living modified organisms for direct use as food or feed, or for processing (LMOs-FFP) »
  1.7. Competent national authorities »
  1.8. Risk assessment (Article 15 and Annex III) »
  1.9. Biosafety Clearing-House »
  1.10. Other provisions under the Protocol »
2. Other international biosafety-related bodies »
  2.1. International Plant Protection Convention »
  2.2. Codex Alimentarius Commission »
  2.3. Food and Agriculture Organization »
  2.4. World Organisation for Animal Health »
  2.5. Organisation for Economic Co-operation and Development »
  2.6. World Trade Organization »
  2.7. Bilateral, regional and multilateral agreements »
3. References »

Using this module

This module contains introductory sections explaining basic concepts in biosafety and an introduction to the Cartagena Protocol on Biosafety and other international biosafety-related bodies and organizations. Under the section on biosafety, an overview of modern biotechnology and its techniques is included. The section on the Cartagena Protocol on Biosafety explains the scope and objective of the Protocol, and provides an overview of Article 15, Annex III, the Biosafety Clearing-House and the precautionary approach.

This module also includes a section on other international bodies involved in risk assessment in the context of biosafety, such as the Food and Agriculture Organization of the United Nations (FAO), the Codex Alimentarius, the International Plant Protection Convention (IPPC), the World Organisation for Animal Health (OIE), the World Trade Organization (WTO), the Organisation for Economic Cooperation and Development (OECD), as well as bilateral and multilateral agreements.

1. Introduction to biosafety and the Cartagena Protocol on Biosafety

1.1 History of the Protocol

The United Nations Conference on Environment and Development (also known as the “Earth Summit”), held in Rio de Janeiro in 1992 marks a significant achievement in the overall policy of the United Nations on the environment. Several documents resulting from that meeting constitute the basis of the international law on biosafety: Agenda 21, the Rio Declaration on Environment and Development and the United Nations Convention on Biological Diversity.

Agenda 21 is a comprehensive programme for action in social and economic areas and for conserving and managing the natural resources. Its chapter 16 addresses the “Environmentally sound management of biotechnology” (see Example 1) and outlines the need for international agreement on principles to be applied to risk assessment and management and set out the implementation of safety mechanisms on regional, national, and international levels.

The Rio Declaration on Environment and Development is a series of principles defining the rights and responsibilities of States. Principle 15 addresses the possibility of harm from actions or decisions when extensive scientific knowledge on the matter is lacking (see Example 2).

     
 
Example 1 – Agenda 21, Chapter 16, Paragraph 29

“There is a need for further development of internationally agreed principles on risk assessment and management of all aspects of biotechnology, which should build upon those developed at the national level. Only when adequate and transparent safety and border-control procedures are in place will the community at large be able to derive maximum benefit from, and be in a much better position to accept the potential benefits and risks of, biotechnology.”

Source: UNCED (1992a).
 
     
 
Example 2 – Principle 15 of the Rio Declaration on Environment and Development

“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.”

Source: UNCED (1992b).
 

The Convention on Biological Diversity (CBD) was inspired by the world community's growing commitment to sustainable development. It represents a dramatic step forward in the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the use of genetic resources. The issue of safety in biotechnology is addressed in articles 8(g) and 19(3) of the CBD. More specifically, in Article 8(g), Parties to the CBD are called upon to establish or maintain means to regulate, manage or control the risks associated with the use and release of LMOs resulting from biotechnology which are likely to have adverse impacts on the conservation and sustainable use of biological diversity. In Article 19(3) the Parties are called upon to consider the need for and modalities of a protocol for the safe transfer, handling and use of LMOs resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity (see Examples 3 and 4).

     
 
Example 3 – CBD Article 8. In-situ Conservation

“Each Contracting Party shall, as far as possible and as appropriate: Establish or maintain means 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, taking also into account the risks to human health.”

Source: Convention on Biological Diversity (1992).
 
     
 
Example 4 – CBD Article 19. Handling of Biotechnology and Distribution of its Benefits

“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 living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.”

Source: Convention on Biological Diversity (1992).
 

Taking into account the provisions above, the Conference of the Parties to the Convention on Biological Diversity decided, at its second meeting, to develop a protocol on biosafety, specifically focusing on transboundary movement of LMOs that may have adverse effects on the conservation and sustainable use of biological diversity taking into account human health.

As a preliminary tool to serve as interim guidance for biosafety, a set of International Technical Guidelines for Safety in Biotechnology was drafted by UNEP and adopted by the Global Consultation of Government-designated Experts in Cairo, Egypt in December 1995.

In 1996, the Conference of the Parties for the Convention on Biological Diversity established an Open-ended Ad Hoc Working Group on Biosafety to develop a draft protocol. This Working Group met six times between 1996 and 1999 and, at the conclusion of its last meeting, a draft protocol was submitted for consideration by the Conference of the Parties at an extraordinary meeting in February 1999, in Cartagena, Colombia. The Conference of the Parties was not able to finalize its work in Cartagena. As a result, the Conference of the Parties suspended its first extraordinary meeting and agreed to reconvene as soon as possible.

The Conference of the Parties reconvened and adopted the Cartagena Protocol on Biosafety on 29 January 2000 in Montreal, Canada. The Protocol entered into force on 11 September 2003 upon ratification by the fiftieth Party. As of September 2011, 161 Parties had acceded/ratified the Protocol.

1.2 What is biosafety?

In its broad sense, the term biosafety refers to the protection of human health and the environment from potential harm due to biological agents.

Under the Convention on Biological Diversity (CBD), and more specifically under the Cartagena Protocol on Biosafety (hereinafter “the Protocol”, 1) the term biosafety essentially refers to safety procedures aimed at regulating, managing or controlling the risks associated with the use and release of living modified organisms (LMOs) 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. Biosafety comprises multidisciplinary scientific fields including, but not limited to biology, ecology, microbiology, molecular biology, animal and plant pathology, entomology, agriculture and medicine as well as legal and socio-economic considerations, and public awareness.

1.3 What are living modified organisms?

According to the Cartagena Protocol on Biosafety:2
   
(a) “Living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;  
   
(b) “Modern biotechnology” means the application of:  
   
  i. in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
   
  ii. fusion of cells beyond the taxonomic family,
   
that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.

An LMO is therefore an organism that results from (i) in vitro modification of nucleic acid (DNA or RNA) molecules; or (ii) cell fusion between organisms of different taxonomic families.

Modern biotechnology techniques include, but are not limited to, in vitro DNA and RNA techniques for the modification of genetic material (e.g. by insertion, modification or deletion of genes or other nucleic acid sequences) in all types of organisms, such as plants, animals, microbes and viruses.

1.3.1 Examples of commercialized LMOs

In 1978, the first LMO was produced at the commercial level by the creation of an Escherichia coli strain (a bacteria) producing the human protein insulin. In 1996, the first genetically modified seeds were planted in the United States for commercial use. 3

To date, the most broadly commercialized LMOs introduced into the environment are agricultural crops. According to the International Service for the Acquisition of Agri-biotech Applications (ISAAA), the worldwide area cultivated with LM crops has been growing steadily since 1996, and in 2009, the cultivation of LM crops accounted for 134 million hectares (James, 2009). Soy, maize, cotton, and rapeseed that are resistant to herbicides and/or able to produce pesticidal proteins account for the majority of LM crops being currently commercialized (see LMO Registry in the Biosafety-Clearing House at http://bch.cbd.int/database/lmo-registry).

In 2009, a goat that produces an anticoagulant drug for humans was the first LM animal to be approved for commercial production. 4 Zebra fish containing fluorescent protein genes are another example of LM animals in the market. Moreover, a number of LM vaccines for humans and animals are being commercialized.

To date, there are no examples of commercialization of LMOs resulting from cell fusion.

1.4 Objective and scope of the Protocol

The objective of the Protocol is “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.

The Protocol establishes rules and procedures for the safe handling, transfer, and use of LMOs. The Protocol focuses on the transboundary movement of LMOs destined for introduction into the environment and those intended for use directly as food, feed or for processing. The protocol seeks to protect biological diversity, taking into account human health, from the potential risks posed by living modified organisms resulting from modern biotechnology (UNEP, 2006).

All LMOs that may have adverse effects to biodiversity or human health are within the scope of the Protocol. Nevertheless, some types of LMOs may be excluded from some provisions.

     
 
Example 6 – Scope of the Cartagena Protocol on Biosafety
  • LMOs subject to the provisions of the Protocol -> All LMOs which may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health (Article 4).
  • LMOs excluded from the Protocol’s provisions on transboundary movements -> LMOs that are pharmaceuticals for humans that are addressed by other international organizations or agreements (Article 5).
Source: IUCN (2003).
 

1.5 Living modified organisms for intentional introduction into the environment – Advanced Informed Agreement (AIA)

The Advanced Informed Agreement (AIA) defines mandatory procedures to be applied to the first transboundary movement of an LMO for intentional introduction into the environment. LMOs intended for direct use as food or feed, or for processing are subject to a different procedure (see 1.6).

The AIA procedure begins with the Party of export or the exporter notifying the Party of import of the proposed transboundary movement of an LMO for intentional introduction into the environment. The notification must contain at a minimum the information specified in Annex I of the Protocol including, among other things, contact details of the exporter and importer, name and identity of the LMO and its intended use, as well as a risk assessment report consistent with Annex III of the Protocol.

The Party of import has 90 days to acknowledge the receipt of the notification, and 270 days to communicate its decision to the notifier and the Biosafety Clearing-House (BCH). In its decision, the Party of import may approve 5 or prohibit the import of the LMO, request further information or extend the decision period for a defined amount of time. If a Party of import does not communicate its decision within 270 days, it should not be understood that consent was given.

     
 
Example 7 – Application of the Advanced Informed Agreement (AIA) procedure
  • LMOs subject to AIA provisions
    • LMOs intended for intentional introduction into the environment (Article 7(1)).
  • LMOs excluded from the Protocol’s AIA provisions
    • LMOs in transit (Article 6(1)).
    • LMOs destined for contained use in the Party of import (Article 6(2)).
    • LMOs intended for direct use as food or feed, or for processing (LMO-FFPs) (Article 7(2)).
    • LMOs identified by the meeting of the Parties to the Protocol as being not likely to have adverse impacts (Article 7(4)).
Source: IUCN (2003).
 

1.6 Living modified organisms for direct use as food or feed, or for processing (LMOs-FFP)

According to article 11 of the Protocol, a Party that takes a decision regarding an LMO that may be subject to transboundary movement for direct use as food, feed, or for processing shall submit to the BCH information specified in Annex II of the Protocol, within fifteen days. This information includes, among other things, the name and identity of the LMO and its approved uses, as well as a risk assessment report consistent with Annex III of the Protocol (see Article 11.1).

1.7 Competent national authorities

Each Party should designate one or more competent national authorities who will perform the administrative functions required by the Protocol and are authorized to take decisions on the LMOs for which they are designated (see Module 2).

1.8 Risk assessment (Article 15 and Annex III)

Article 15 of the Protocol sets out the provisions for Parties to conduct risk assessments of LMOs. It requires that risk assessments be carried out in a scientifically sound manner in accordance to Annex III and taking into account recognized risk assessment techniques.

While the Party considering permitting the import of an LMO is responsible for ensuring that a risk assessment is carried out, it has the right to require the exporter to do the work or to bear its cost. This is particularly important for many developing countries (SCBD, 2003).

The Protocol, therefore, empowers governments to decide whether or not to accept imports of LMOs on the basis of risk assessments. These assessments aim to identify and evaluate the potential adverse effects that an LMO may have on the conservation and sustainable use of biodiversity in the receiving environments.

Annex III sets out the general principles and methodology for the risk assessment process.

The general principles for risk assessment under the Protocol are that (i) it must be carried out in a scientifically sound and transparent manner and on a case-by-case basis, (ii) lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk, and (iii) risks of LMOs should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.

Individual Parties use these general principles to guide the development and implementation of their own national risk assessment process (see Module 2).

The following are considerations about some of the general principles for risk assessment:

Scientific soundness - The Cartagena Protocol explicitly states that risk assessments should be carried out in a scientifically sound manner. The principle of scientific soundness entails that risk assessments are to be undertaken in a systematic way on the basis of verifiability and reproducibility of information by, for example, reporting on methods and data in sufficient detail to enable others to repeat the steps of the risk assessment independently. Some countries have integrated this principle into their own procedures with specific suggestion about what type of information can be appropriately used in a risk assessment. In many cases different sources and criteria for scientifically sound information have been set, ranging from scientific literature, studies presented by the notifier and expert opinions, etc. Consultations among scientific experts may also be considered an appropriate means for gathering such information.

Transparency – Annex III states that risk assessments should be conducted in a transparent manner. Most countries with NBFs have procedures in place to ensure the transparency of risk assessments. The CNAs often show what transparency mechanism is in place to handle notifications and how the mechanism is applied in each case. The level of transparency, however, may range from public notification to broad public involvement.

Some countries, for instance, make the necessary requirements for conducting risk assessments available online and, if an approval is granted for release of an LMO into the environment, a public notification is usually done by posting the release online (see also provisions of Article 23 on “Public Participation” and the section 4.4 below on Stakeholder Participation).

     
 
Example 8 – Transparency

“ERMA New Zealand strives to be transparent as is practicable and appropriate in its processes. In general, applications for substances or organisms that can significantly affect the environment must be publicly notified, and anybody can then make a written submission - within 30 working days of public notification - and a hearing will be held if any submitter requests to be heard, or if the Authority thinks it is necessary.”

Source: ERMA NZ (website).
 

Case-by-case – Annex III states that risk assessments should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the LMO concerned, its intended use and the likely potential receiving environment.

The legal frameworks of some countries may also specify other elements to be taken into consideration in each “case”.

     
 

Example 9 – The case-by-case basis is fundamental to risk assessment of LMOs

A case-by-case approach is one where each release of an LMO is considered relative to the environment in which the release is to occur, and/or to the intended use of the LMO in question. A risk assessment performed for a particular LMO intended to be introduced into one environment may not be sufficient when assessing the possible adverse effects that may arise if that LMO is to be released under different environmental conditions, or into different receiving environments. A risk assessment performed for a particular use of a particular LMO may not be sufficient when assessing the possible adverse effects that may arise if that LMO is to be used in different ways. Because of this, it is important for each case to be addressed separately, taking into account specific information on the LMO concerned, its intended use and its potential receiving environment.

Source: IUCN (2003).
 

Considerations on how to apply these two general principles when conducting a risk assessment are included Module 3.

Annex III also contains a number of steps for conducting the risk assessment as well as points to consider on technical and scientific details regarding, for example, the characteristics of the genetic modification, biological characteristics of the LMO, differences between the LMO and its recipient organism, its intended use, the likely receiving environment, etc.

Module 3 of this training manual explains each of the steps of the risk assessment process according to Annex III of the Protocol.

1.9 Biosafety Clearing-House

The Biosafety Clearing-House (BCH; http://bch.cbd.int) is a mechanism set up under the Cartagena Protocol on Biosafety to facilitate the exchange of information on LMOs and assist countries that are Parties to the Protocol to better comply with their obligations.

The BCH provides open and easy access to a variety of scientific, technical, environmental, legal and capacity building information provided in all 6 languages of the UN.

The BCH contains information that must be provided by Parties to the Protocol, such as decisions on release or import of LMOs, risk assessments, competent national authorities, and national laws.

Governments that are not Parties to the Protocol are also encouraged to contribute information to the BCH, and in fact a large number of the decisions regarding LMOs have been registered in the BCH by non-Party governments.

The records of decisions, risk assessments, LMOs, donor and recipient organisms, and DNA sequences are cross-referenced in a way that facilitates data retrieval. For instance, while looking at an LMO record, all the records for the risk assessment that reference that specific LMO can be easily accessed and retrieved.

The BCH also contains other relevant information and resources, including information on national contacts, capacity-building, a roster of government-nominated biosafety experts, and links to other websites, publications and databases through the Biosafety Information Resource Centre.

1.10 Other provisions under the Protocol

In addition to the provisions above, the Protocol also requires the Parties to the Protocol to consult the public during the decision-making process regarding LMOs (Article 23); make the results of such decisions available to the public (Article 23) and allow the decision-making process to take into account socio-economic considerations arising from the impact of the LMOs on the conservation and sustainable use of biodiversity (Article 26).

2. Other international biosafety-related bodies

Several other international bodies and organizations carry out activities that are relevant to the trade and environmental aspects of LMOs. A brief overview of these bodies is provided below.

2.1 International Plant Protection Convention

The International Plant Protection Convention (IPPC; http://www.ippc.int) is a multilateral treaty for international cooperation in plant protection. It aims to protect plant health while facilitating international trade. The IPPC applies to cultivated plants, natural flora and plant products and includes both direct and indirect damage by pests (including weeds). The IPPC was adopted by the Conference of the FAO in 1951. There are currently 173 contracting parties to the IPPC.

The governing body of the IPPC is the Commission on Phytosanitary Measures (CPM). The CPM has adopted a number of International Standards for Phytosanitary Measures (ISPMs) that provide guidance to countries and assist contracting parties in meeting the aims of the convention. The IPPC is recognized by the World Trade Organization as the relevant international standard setting body for plant health. Application of ISPMs is not mandatory; however under the WTO-SPS Agreement (see 2.5) phytosanitary measures based on international standards do not need additional scientific or technical justification.

ISPM No. 11 (IPPC, 2004) describes the factors to consider when conducting a pest risk analysis (PRA) to determine if a pest is a quarantine pest. The main text of the standard (indicated with “S2” throughout the text) and particularly Annex 3 of this ISPM includes guidance on conducting PRA on LMOs.

In order to increase member countries' capacity to conduct pest risk analysis, the IPPC has developed a training course and training materials. 6

2.2 Codex Alimentarius Commission

The Codex Alimentarius Commission (CAC; www.codexalimentarius.net) is a subsidiary body of the FAO and the World Health Organization (WHO) established in 1961-63 to protect the health of consumers and ensure fair practices in food trade. It currently has 166 members.

Codex Alimentarius, which means "food code", is a compilation of standards, codes of practice, guidelines and recommendations on food safety prepared by the Commission. In the area of foods derived from biotechnology, the Codex provides guidance on human health risk analysis in its “Principles for the Risk Analysis of Foods Derived from Modern Biotechnology” (CODEX, 2003) and in its “Working Principles for Risk Analysis for Food Safety for Application by Governments” (CODEX, 2007).

2.3 Food and Agriculture Organization

The Food and Agriculture Organization (FAO; www.fao.org) of the United Nations also carries out activities on biosafety and biosecurity. Among these, the FAO Working Group on Biosafety is responsible for two of FAO’s Priority Areas for Interdisciplinary Action (PAIAs), namely “Biosecurity for Agriculture” and “Food Production and Biotechnology Applications in Agriculture, Fisheries and Forestry”.

2.4 World Organisation for Animal Health

The World Organisation for Animal Health (OIE; www.oie.int) is an international intergovernmental organization founded in 1924 for improving animal health worldwide. As of June 2010, the OIE had 176 member countries.

The objectives of the OIE are to: (a) guarantee the transparency of animal disease status world-wide; (b) collect, analyze and disseminate veterinary scientific information, (c) provide expertise and promote international solidarity for the control of animal diseases; and (d) guarantee the sanitary safety of world trade by developing sanitary rules for international trade in animals and animal products.

Within the mandates of the OIE, the principal aim of import risk analysis is to provide importing countries with an objective and defensible method of assessing the disease risks associated with the importation of animals, animal products, animal genetic material, feedstuffs, biological products and pathological material.

2.5 Organisation for Economic Co-operation and Development

The Organisation for Economic Cooperation and Development (OECD; www.oecd.org) provides a setting where governments compare policy experiences, seek answers to common problems, identify good practice and coordinate domestic and international policies.

With regard to risk assessment, the OECD has published the “Recombinant DNA Safety Considerations” (OECD, 1986) and consensus documents, which focus on the biology of the recipient organisms or introduced traits and are useful in background preparation for an LMO risk assessment. 7

2.6 World Trade Organization

The World Trade Organization (WTO; www.wto.org) is an international organization responsible for establishing the rules of trade between nations. It has a number of agreements that affect the trade of LMOs. One such agreement is the international treaty of “Agreement on the Application of Sanitary and Phytosanitary Measures”, also known as the SPS Agreement.

The SPS Agreement concerns the application of sanitary and phytosanitary measures for food safety and animal and plant health regulations and may apply to LMOs. Article 5 of the SPS Agreement is of interest in the context of this training material since it addresses risk assessment and the determination of the appropriate level of sanitary or phytosanitary protection. Article 3 of the SPS Agreement recognizes the standards, guidelines and recommendations set by IPPC, OIE and Codex Alimentarius Commission.

Other WTO agreements, such as the Technical Barriers to Trade (TBT) Agreement, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) and the General Agreement on Tariffs and Trade (GATT) may also apply to LMOs.

2.7 Bilateral, regional and multilateral agreements

In addition to international treaties and standards, countries may engage in bilateral, regional and multilateral agreements, such as free-trade agreements (FTAs), provided they are consistent with the objective of the Protocol and do not result in a lower level of protection than that provided for by the Protocol. Such agreements could also be used to undertake shared responsibilities in assessing risks to facilitate decisions on LMOs. 8

3. References

  1. CODEX (2003) Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. Organisation for Economic Cooperation and Development (OECD). Available at http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf (access June 2010).

  2. CODEX (2007) Working Principles for Risk Analysis for Food Safety for Application by Governments. Organisation for Economic Cooperation and Development (OECD). Available at http://www.codexalimentarius.net/download/standards/10751/CXG_062e.pdf (access June 2010).

  3. Convention on Biological Diversity (1992) Available at http://www.cbd.int/convention/text (access August 2012).

  4. ERMA NZ (website) Environment Risk Management Authority New Zealand. New Organisms FAQs. Available at http://www.epa.govt.nz/publications-resources/faqs/Pages/New-Organisms-FAQs.aspx (access August 2012).

  5. IPPC (2004) ISPM No. 11: Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms. Available at https://www.ippc.int/file_uploaded/1146658377367_ISPM11.pdf (access June 2010).

  6. IUCN (2003) An Explanatory Guide to the Cartagena Protocol on Biosafety. Available at http://bch.cbd.int/database/record-v4.shtml?documentid=41476 (access June 2010).

  7. James C (2009) Global Status of Commercialized Biotech/GM Crops: 2009. ISAAA Brief No. 41. ISAAA: Ithaca, NY.

  8. Mirkov TE (2003) The molecular basis of genetic modification and improvement of crops. In: Chrispeels MJ, Sadava DE (eds.) Plants, Genes and Crop Biotechnology. Jones and Bartlett Publishers, 2nd edition.

  9. North Carolina State University (website) Available at http://www.ces.ncsu.edu/resources/crops/ag546-1 (access July 2010).

  10. OECD (1986) Recombinant DNA Safety Considerations. Available at Recombinant DNA Safety Considerations

  11. SCBD-UNEP (2003) An introduction to the Cartagena Protocol on Biosafety. Secretariat of the Convention on Biological Diversity (SCBD) and United Nations Environment Programme (UNEP)Available at http://www.cbd.int/doc/press/presskits/bs/cpbs-unep-cbd-en.pdf (access June 2010).

  12. UNCED (1992a) Agenda 21. United Nations Conference on Environment and Development (UNCED), Rio de Janerio, Brazil, 3-14 June 1992. Available at http://www.un.org/esa/dsd/agenda21 (access June 2010).

  13. UNCED (1992b) Rio Declaration on Environment and Development. United Nations Conference on Environment and Development (UNCED), Rio de Janerio, Brazil, 3-14 June 1992. Available at http://www.unep.org/Documents.Multilingual/Default.asp?documentid=78&articleid=1163 (access June 2010).

   
   
1.
The text of the Cartagena Protocol on Biosafety is available at http://bch.cbd.int/protocol/text/.
2.
Article 3, Paragraphs (g) and (i).
3.
FLAVR SAVR(TM) Tomato by Calgene Inc.
4.
5.
A decision that approves the use of an LMO may be done with or without conditions. If there are conditions, the decision must set out the reasons for the conditions.
6.
The IPPC training materials are available at http://www.ippc.int/index.php?id=186208.
7.
8.
According to the WTO (http://www.wto.org/english/tratop_e/region_e/region_e.htm), the overall number of Regional Trade Agreements (RTAs) in force has been increasing steadily, a trend likely to be strengthened by the many RTAs currently under negotiation. Of these RTAs, Free Trade Agreements (FTAs) and partial scope agreements account for 90%, while customs unions account for 10 %. The Regional Trade Agreements Information System (RTA-IS), at http://rtais.wto.org/UI/PublicMaintainRTAHome.aspx, contains information on those agreements that have either been notified or for which an early announcement has been made to the WTO.