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Frequently Asked Questions (FAQs) on the Cartagena Protocol

 

Index

Biosafety and Biotechnology

  1. What is biotechnology?
  2. What is biosafety?
  3. What is a Living Modified Organism (LMO)?
  4. What are LMO products?
  5. What are some potential benefits of biotechnology?
  6. What are some potential risks of biotechnology?
  7. Why do we need an international biosafety agreement?
     

    The Biosafety Protocol and its Implementation

  8. What is the exact name of the Biosafety Protocol?
  9. What is the objective of the Protocol?
  10. What is the "precautionary approach"? How is it reflected in the Protocol?
  11. What does the Biosafety Protocol cover?
  12. What are the main features of this Protocol?
  13. What is the Advance Informed Agreement (AIA) Procedure?
  14. What is the procedure for LMOs intended for direct use as food or feed, or for processing?
  15. What is the Biosafety Clearing House (BCH)?
  16. How does the Protocol address handling, transport, packaging and identification of LMOs?
  17. What must Parties do in the event of unintentional transboundary movements of LMOs?
  18. How does the Protocol address the issue of non-Parties?
  19. How does the Protocol address capacity-building?
  20. What initiatives have been taken towards capacity building for the effective implementation of the Protocol?
  21. How does the Protocol protect confidential information?
  22. How does the Protocol address public awareness and participation ?
  23. Does the Protocol address the issue of compliance?
  24. Does the Protocol deal with liability and redress for damage resulting from transboundary movements of LMOs?
  25. What institutional arrangements does the Protocol require at the national level?
  26. What is the governing body of the Protocol?
  27. What is the relationship between the Protocol and the WTO?
  28. Where can I get a copy of the text of the Protocol?
     

    Becoming a Party to the Protocol

  29. What is the difference between signing and ratifying the Protocol?
  30. How does one become a Party to the Protocol?
  31. What is the procedure to deposit instruments of ratification, acceptance, approval or accession with the Depositary?
  32. How many countries have ratified the Biosafety Protocol?
  33. When did the Biosafety Protocol enter into force?
  34. Are there any financial obligations resulting from becoming a Party to the Protocol?
  35. What are the benefits of becoming a Party to the Protocol?

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Biosafety and Biotechnology

1. What is biotechnology?

The term `biotechnology' refers to any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for a specific use.

Biotechnology, in the form of traditional fermentation techniques, has been used for decades to make bread, cheese or beer. It has also been the basis of traditional animal and plant breeding techniques, such as hybridization and the selection of plants and animals with specific characteristics to create, for example, crops which produce higher yields of grain.

The difference with modern biotechnology is that researchers can now take a single gene from a plant or animal cell and insert it in another plant or animal cell to give it a desired characteristic, such as a plant that is resistant to a specific pest or disease.

In the Biosafety Protocol, modern biotechnology means the application of:

  1. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
  2. 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. (see Article 3)

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2. What is biosafety?

Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products. For the purposes of the Biosafety Protocol, this is based on the precautionary approach, whereby the lack of full scientific certainty should not be used as an excuse to postpone action when there is a threat of serious or irreversible damage (see "What is the precautionary approach?"). While developed countries that are at the center of the global biotechnology industry have established domestic biosafety regimes, many developing countries are only now starting to establish their own national systems.

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3. What is a Living Modified Organism (LMO)?

A Living Modified Organism (LMO) is defined in the Cartagena Protocol on Biosafety as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. The Protocol also defines the terms 'living organism' and 'modern biotechnology' (see Article 3). In everyday usage LMOs are usually considered to be the same as GMOs (Genetically Modified Organisms), but definitions and interpretations of the term GMO vary widely.

Common LMOs include agricultural crops that have been genetically modified for greater productivity or for resistance to pests or diseases. Examples of modified crops include tomatoes, cassava, corn, cotton and soybeans.

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4. What are LMO products?

LMOs form the basis of a range of products and agricultural commodities. Processed products containing dead modified organisms or non-living GMO components include certain vaccines; drugs; food additives; and many processed, canned, and preserved foods. They can also include corn and soybean derivatives used in many foods and nonfoods, cornstarch used for cardboard and adhesives, fuel ethanol for gasoline, vitamins, vaccines and pharmaceuticals, and yeast-based foods such as beer and bread.

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5. What are some potential benefits of biotechnology?

Genetic engineering promises remarkable advances in medicine, agriculture, and other fields. These may include new medical treatments and vaccines, new industrial products, and improved fibres and fuels. Proponents of the technology argue that biotechnology has the potential to lead to increases in food security, decreased pressure on land use, sustainable yield increase in marginal lands or inhospitable environments and reduced use of water and agrochemicals in agriculture.

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6. What are some potential risks of biotechnology?

Biotechnology is a very new field, and much about the interaction of LMOs with various ecosystems is not yet known. Some of the concerns about the new technology include its potential adverse effects on biological diversity, and potential risks to human health. Potential areas of concern might be unintended changes in the competitiveness, virulence, or other characteristics of the target species; the possibility of adverse impacts on non-target species (such as beneficial insects) and ecosystems; the potential for weediness in genetically modified crops (where a plant becomes more invasive than the original, perhaps by transferring its genes to wild relatives); and the stability of inserted genes (the possibilities that a gene will lose its effectiveness or will be re-transferred to another host).

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7. Why do we need an international biosafety agreement?

While advances in biotechnology have great potential for significant improvements in human well-being, they must be developed and used with adequate safety measures for the environment and human health.

The objectives of the 1992 Convention on Biological Diversity are "the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources." When developing the Convention, the negotiators recognized that biotechnology can make a contribution towards achieving the objectives of the Convention, if developed and used with adequate safety measures for the environment and human health. The Contracting Parties agreed to consider the need to develop appropriate procedures to address the safe transfer, handling and use of any LMO resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity (see Article 19.3 of the CBD). The Biosafety Protocol is the result of that process.

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The Biosafety Protocol and its Implementation

8. What is the exact name of the Biosafety Protocol?

The full name of the Biosafety Protocol is "the Cartagena Protocol on Biosafety to the Convention on Biological Diversity." Cartagena is the name of the city in Colombia where the Biosafety Protocol was originally scheduled to be concluded and adopted in February 1999. However, due to a number of outstanding issues, the Protocol was finalized and adopted a year later on 29 January 2000 in Montreal, Canada.

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9. What is the objective of the Protocol?

In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, 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. (see Article 1)

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10. What is the "precautionary approach"? How is it reflected in the Protocol?

One of the outcomes of the United Nations Conference on Environment and Development (also known as the Earth Summit) held in Rio de Janeiro, Brazil, in June 1992, was the adoption of the Rio Declaration on Environment and Development, which contains 27 principles to underpin sustainable development. One of these principles is Principle 15 which states that "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."

Elements of the precautionary approach find reflection in a number of the provisions of the Protocol, such as:

  • The preamble, reaffirming "the precautionary approach contained in Principle 15 of the Rio Declaration on environment and Development; ".
  • Article 1, indicating that the objective of the Protocol is "in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on environment and Development";
  • Article 10.6 and 11.8, stating:
    "Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of an LMO on biodiversity, taking into account risks to human health, shall not prevent a Party of import from taking a decision, as appropriate, with regard to the import of the LMO in question, in order to avoid or minimize such potential adverse effects."
  • Annex III on risk assessment, stating:

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11. What does the Protocol cover?

The Protocol applies to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. (see Article 4)

However, LMOs that are pharmaceuticals for humans are excluded from the scope of the Protocol if they are covered by other international agreements or arrangements. (see Article 5)

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12. What are the main features of the Protocol?

The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling, and use of LMOs, with specific focus on transboundary movements of LMOs. It features a set of procedures including one for LMOs that are to be intentionally introduced into the environment (advance informed agreement procedure, see question 13), and one for LMOs that are intended to be used directly as food or feed or for processing (see question 14). Parties to the Protocol must ensure that LMOs are handled, packaged and transported under conditions of safety. Furthermore, the shipment of LMOs subject to transboundary movement must be accompanied by appropriate documentation specifying, among other things, identity of LMOs and contact point for further information (see question 16). These procedures and requirements are designed to provide importing Parties with the necessary information needed for making informed decisions about whether or not to accept LMO imports and for handling them in a safe manner.

The Party of import makes its decisions in accordance with scientifically sound risk assessments (see Article 15). The Protocol sets out principles and methodologies on how to conduct a risk assessment (see Annex III of the Protocol). In case of insufficient relevant scientific information and knowledge, the Party of import may use precaution in making their decisions on import. (see question 5). Parties may also take into account, consistent with their international obligations, socio-economic considerations in reaching decisions on import of LMOs (see Article 26).

Parties must also adopt measures for managing any risks identified by the risk assessment (see Article 16), and they must take necessary steps in the event of accidental release of LMOs (see Article 17).

To facilitate its implementation, the Protocol establishes a Biosafety Clearing-House for Parties to exchange information (see question 15), and contains a number of important provisions, including capacity-building (see question 19), financial mechanism (see Article 28), compliance procedures (see question 19) and public awareness and participation (see question 21).

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13. What is the Advance Informed Agreement (AIA) Procedure?

The "Advance Informed Agreement" (AIA) procedure applies to the first intentional transboundary movement of LMOs for intentional introduction into the environment of the Party of import. It includes four components: notification by the Party of export or the exporter, acknowledgment of receipt of notification by the Party of import, decision procedure and review of decisions. The purpose of this procedure is to ensure that importing countries have both the opportunity and the capacity to assess risks that may be associated with the LMO before agreeing to its import.

Specifically, the Party of export or the exporter must notify the Party of import by providing a detailed, written description of the LMO in advance of the first shipment. The Party of import is to acknowledge receipt of this information within 90 days. Then, within 270 days of the date of receipt of notification, the Party of import must communicate its decision: (i) approving the import, (ii) prohibiting the import, (iii) requesting additional relevant information, or (iv) extending the 270 days by a defined period of time. Except in a case in which consent is unconditional, in other cases the Party of import must indicate the reasons on which its decisions are based. (see Article 7, Article 8, Article 9, and Article 10)

A Party of import may, at any time, in light of new scientific information, review and change a decision. A Party of export or a notifier may also request the Party of import to review its decisions. (see Article 12)

However, the Protocol`s AIA procedure does not apply to certain categories of LMOs:

  • LMOs in transit (see Article 6);
  • LMOs destined for contained use (Article 6);
  • LMOs intended for direct use as food or feed or for processing (see Article 7.3).

It should be noted that, while the Protocol`s AIA procedure does not apply to certain categories of LMOs, Parties have the right to regulate the importation on the basis of domestic legislation.

In addition, the Party of import may also specify in advance to the Biosafety Clearing-House that it will exempt certain imports of LMOs from the AIA procedure (see Article 13). Also, the Conference of the Parties serving as the meeting of the Parties to the Protocol may in future decide to exempt additional LMOs from application of the AIA procedure (see Article 7.4).

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14. What is the procedure for LMOs intended for direct use as food or feed, or for processing?

LMOs intended for direct use as food or feed, or processing (LMOs-FFP) represent a large category of agricultural commodities. The Protocol, instead of using the AIA procedure, establishes a more simplified procedure for the transboundary movement of LMOs-FFP. Under this procedure, A Party must inform other Parties through the Biosafety Clearing-House, within 15 days, of its decision regarding domestic use of LMOs that may be subject to transboundary movement.

Decisions by the Party of import on whether or not to accept the import of LMOs-FFP are taken under its domestic regulatory framework that is consistent with the objective of the Protocol. A developing country Party or a Party with an economy in transition may, in the absence of a domestic regulatory framework, declare through the Biosafety Clearing-House that its decisions on the first import of LMOs-FFP will be taken in accordance with risk assessment as set out in the Protocol and timeframe for decision-making.

In case of insufficient relevant scientific information and knowledge, the Party of import may use precaution in making their decisions on the import of LMOs-FFP. (see Article 11.8)

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15. What is the Biosafety Clearing House (BCH)?

The Protocol established a Biosafety Clearing-House (BCH) as part of the clearing-house mechanism of the Convention, in order to facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms; and to assist Parties to implement the Protocol (see Article 20 of the Protocol).

The Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) recommended that the Biosafety Clearing-House should be established in a phased manner beginning with a pilot phase. The first meeting of COP-MOP approved the transition from the pilot phase to the fully operational phase and adopted modalities for its operations (Decision BS-I/3).

Further information about the development of the Biosafety Clearing-House is available in the archives relating to the work of the ICCP. The BCH website also contains a section devoted specifically to Frequently Asked Questions about the Biosafety Clearing-House.

Go to the Biosafety Clearing-House Central Portal now...

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16. How does the Protocol address handling, transport, packaging and identification of living modified organisms?

The Protocol provides for practical requirements that are deemed to contribute to the safe movement of LMOs. Parties are required to take measures for the safe handling, packaging and transportation of LMOs that are subject to transboundary movement. The Protocol specifies requirements on identification by setting out what information must be provided in documentation that should accompany transboundary shipments of LMOs. It also leaves room for possible future development of standards for handling, packaging, transport and identification of LMOs by the meeting of the Parties to the Protocol. The first meeting of COP-MOP adopted decisions outlining identification requirements for different categories of LMOs (Decision BS-I/6).

Each Party is required to take measures ensuring that LMOs subject to intentional transboundary movement are accompanied by documentation identifying the LMOs and providing contact details of persons responsible for such movement. The details of these requirements vary according to the intended use of the LMOs, and, in the case of LMOs for food, feed or for processing, they should be further addressed by the governing body of the Protocol – the Conference of the Parties serving as the meeting of the Parties. (see Article 18) Further information on Article 18 is available on the Protocol home page.

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17. What must Parties do in the event of unintentional transboundary movements of LMOs?

When a Party knows of an unintentional transboundary movement of LMOs that is likely to have significant adverse effects on biodiversity and human health, it must notify affected or potentially affected States, the Biosafety Clearing-House and relevant international organizations regarding information on the unintentional release. Parties must initiate immediate consultation with the affected or potentially affected States to enable them to determine response and emergency measures. (see Article 17)

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18. How does the Protocol address the issue of non-Parties?

The Protocol addresses the obligations of Parties in relation to the transboundary movements of LMOs to and from non-Parties to the Protocol. The transboundary movements between Parties and non-Parties must be carried out in a manner that is consistent with the objective of the Protocol. Parties are required to encourage non-Parties to adhere to the Protocol and to contribute information to the Biosafety Clearing-House. (see Article 24) The first meeting of COP-MOP adopted a decision providing guidance on transboundary movements of LMOs between Parties and non-Parties (Decision BS-I/11).

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19. How does the Protocol address capacity-building?

The Protocol promotes international cooperation to help developing countries and countries with economies in transition to build human resources and institutional capacity in biosafety. Parties are encouraged to assist with scientific and technical training and to promote the transfer of technology, know-how, and financial resources. Parties are also expected to facilitate private sector involvement in capacity building (see Article 22). The first meeting of COP-MOP adopted two decisions to promote capacity-building for the effective implementation of the Protocol, through the establishment of a roster of experts on biosafety (Decision BS-I/4) and an Action Plan for building capacities (Decision BS-I/5).

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20. What initiatives have been taken towards capacity building for the effective implementation of the Protocol?

A number of initiatives have been implemented at various levels to support countries to meet their capacity-building requirements under the Biosafety Protocol. The Action Plan for building capacities adopted by the first meeting of COP-MOP (see Decision BS-I/5) provides a framework to assist governments and organizations to better address priority capacity-building elements in a strategic, systematic and integrated manner. A Coordination Mechanism was established to facilitate coherent and collaborative implementation of the Action Plan and to ensure mutual supportiveness among different initiatives. Capacity-building databases have been developed in the Biosafety Clearing-House to allow exchange of information on on-going activities, identification of gaps and improved targeting of available resources and opportunities to meet specific country needs and priorities. In addition, a roster of experts has been established to provide advice and other support, as appropriate and upon request, to developing country Parties and Parties with economies in transition, to conduct risk assessment, make informed decisions, develop national human resources and promote institutional strengthening, associated with the transboundary movements of living modified organisms.

Governments and organizations have also initiated various capacity-building activities, projects and programs related to biosafety. One example of such initiatives is the UNEP/GEF global project entitled "Development of National Biosafety Frameworks" which is aimed at assisting developing countries to develop national biosafety regulatory and administrative regimes, decision-making systems including risk assessment, and mechanisms for public participation. There are also many other initiatives of varying sizes and scope supported by other donors and organizations. More than sixty such on-going initiatives are registered in the project database in the Biosafety Clearing-House. Further information is available on the Protocol home page.

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21. How does the Protocol protect confidential information?

In accordance with the advance informed agreement or other procedures specified by the Protocol, the notifier is required to submit information to the Party of import so as to allow the latter to take decision on the import of the living modified organism in question. In return, the Party of import has an obligation to permit the notifier to identify information that needs to be treated confidential. The Party of import may request the notifier to justify why certain information should be kept confidential, and in the event of difference, it should consult the notifier prior to any disclosure.

Each Party is required to protect confidential information received under the Protocol. It has to put in place procedures to protect and treat such information in no less favourable manner than it treats confidential information in connection with domestically produced living modified organism. The Party of import shall not use confidential information for commercial purposes without the written consent of the notifier. Unless the notifier withdraws or has withdrawn the notification, information regarding (a) the name and address of the notifier; (b) general description of the living modified organism; (c) summary of risk assessment; and (d) methods and plans for emergency response, will not be considered confidential. (see Article 21)

It should also be noted that once information is made available to the BCH in accordance with Article 20 and other provisions of the Protocol, it will not be considered confidential as the objective is to make this information publicly available (see decision BS-I/3, Annex, Section B, paragraph (q)).

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22. How does the Protocol address public awareness and participation?

The Protocol requires Parties to promote and facilitate, on their own and in cooperation with other States and international bodies, public awareness, education and participation concerning the subject of the Protocol and to ensure that the public has access to information on LMOs that may be imported. In accordance with the laws and regulations of Parties, the public is to be consulted in the decision-making process regarding LMOs, made aware of the results of such decisions and informed about the means of public access to the Biosafety Clearing-House. (see Article 23)

According to the medium-term programme of work adopted by the first meeting of COP-MOP (see Decision BS-I/12), the issue of public awareness and participation will be considered at the second meeting of COP-MOP, to be held in the second quarter of 2005 (see Decision BS-I/13).

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23. Does the Protocol address the issue of compliance?

The Protocol envisages procedures and mechanisms to promote compliance of Parties with their obligations and address the cases of non-compliance. At its first meeting, the Conference of the Parties serving as the meeting of the Parties to the Protocol considered and approved such procedures and mechanisms, including a compliance committee of 15 members nominated by Parties and elected by COP-MOP (see Decision BS-I/7). The compliance procedures shall be separate from, and without prejudice to, the dispute-settlement procedures and mechanisms established by Article 27 of the Convention on Biological Diversity. (see Article 34 of the Protocol). Further information is available on the Protocol home page.

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24. Does the Protocol deal with liability and redress for damage resulting from transboundary movements of LMOs?

The Protocol contains an enabling provision by which the Conference of the Parties serving as the meeting of the Parties shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms. The Parties shall endeavor to complete this process within four years. (see Article 27 of the Protocol.) As envisaged in the Protocol, the first meeting of COP-MOP established an open-ended ad hoc working group of legal and technical experts on liability and redress in the context of the Protocol to elaborate international rules and procedures regarding liability and redress for damage resulting from transboundary movements of LMOs. The ad hoc group is expected to complete its work in 2007 (see Decision BS-I/8).

The Working Group completed its work and submitted its report to COP-MOP at its fourth meeting held in May 2008. Because there were still unresolved issues, COP-MOP 4 decided (decision BS-IV/12) that the negotiations should continue within a regionally balanced small group setting, known as Group of Friends of the Co-Chairs. The small group completed its work and submitted to COP-MOP 5 its report along with an agreed text of a supplementary protocol - Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. COP-MOP 5 adopted the Supplementary Protocol on 15 October 2010 in Nagoya, Japan. Further information is available on the Supplementary Protocol web page.

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25. What institutional arrangements does the Protocol require at the national level?

Parties are required to designate national institutions to perform functions relating to the Protocol. Each Party needs to designate one national focal point to be responsible on its behalf for liaison with the Secretariat. The functions for liaison may include, for example, receiving notifications of meetings relating to the Protocol issued by the Secretariat and invitations to submit views on matters under discussion, and acting accordingly (see Article 19).

Each Party also needs to designate one or more competent national authorities, which are responsible for performing the administrative functions required by the Protocol and which shall be authorized to act on its behalf with respect to those functions. A Party may designate a single entity to fulfill the functions of both focal point and competent national authority. Each Party must, no later than the date of entry into force of the Protocol for it, notify the Secretariat of the names and addresses of its focal point and its competent national authority or authorities. The Secretariat maintains lists of designated NFPs and CNAs for the Protocol which are searchable on the BCH.

In addition to these institutional arrangements stipulated by the Protocol, the first meeting of COP-MOP called upon Parties, as well as Governments, organizations and other users interested in entering into partnership with the Biosafety Clearing-House to nominate an appropriate national focal point to carry out this role (see Decision BS-I/3).

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26. What is the governing body of the Protocol?

The governing body of the Protocol is the Conference of the Parties to the Conventionserving as the meeting of the Parties to the Protocol (COP-MOP). The main function of this body is to review the implementation of the Protocol and make decisions necessary to promote its effective operation. Decisions under the Protocol can only be taken by Parties to the Protocol. Parties to the Convention that are not Parties to the Protocol may only participate as observers in the proceedings of meetings of the COP-MOP. (see Article 29 of the Protocol.)

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27. What is the relationship between the Protocol and the WTO?

A number of agreements under the World Trade Organization (WTO), such as the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement), and the Agreement on Trade-Related Intellectual Property (TRIPs), contain provisions that are relevant to the Protocol. The Protocol states in its preamble that it:

  • Recognizes that trade and environment agreements should be mutually supportive;
  • Emphasizes that the Protocol is not interpreted as implying a change in the rights and obligations under any existing agreements; and
  • Understands that the above recital is not intended to subordinate the Protocol to other international agreements.

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28. Where can I get a copy of the text of the Protocol?

The original of the Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, has been deposited with the Secretary-General of the United Nations. The text of the Protocol is available on this site in all the 6 official UN languages and through the Protocol home page.

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Becoming a Party to the Protocol

29. What is the difference between signing and ratifying the Protocol?

At the closing date for signature i.e. 4 June 2001, the Protocol had 103 signatures. By signing the Protocol, States indicate general support for its objective and provisions, as well as their intention to become parties to the Protocol in the future and be legally bound by it. However, the Protocol does not become legally binding until a State joins the Protocol by depositing an instrument of ratification, accession, acceptance, or approval with the Depositary – the Secretary-General of the United Nations, signed by the Head of State or Government or the Minister for Foreign Affairs. Once a State deposits such an instrument, the Protocol enters into force for that State ninety days later provided the Protocol itself has already entered into force at that time; at this point the State is bound by the provisions of the Protocol and must comply with the obligations therein.

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30. How does one become a Party to the Protocol?

Only a Party to the Convention on Biological Diversity can become a Party to the Protocol (see Article 32.1 of the Convention), through one of the following legal means: ratification, acceptance, approval or accession. Each of these has the same legal effect.

If a Party to the Convention signed the Protocol during the time period specified in Article 36 of the Protocol, it may, depending on domestic legal requirements, choose to become a Party to the Protocol through ratification, acceptance or approval.

If a Party to the Convention did not sign the Protocol during the time period specified in Article 36, it may become a Party to the Protocol through accession.

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31. What is the procedure to deposit instruments of ratification, acceptance, approval or accession with the Depositary?

The procedure to deposit instruments of ratification, acceptance, approval or accession with the Depositary is outlined in: http://www.cbd.int/doc/legal/cp-proc-rat-en.pdf

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32. How many countries have ratified the Biosafety Protocol?

A regularly updated list of Parties to the Protocol is maintained on the Cartagena Protocol web pages.

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33. When did the Biosafety Protocol enter into force?

Article 37 states that the Protocol enters into force 90 days after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention on Biological Diversity. As the fiftieth instrument of ratification was deposited on 13 June 2003, the Protocol entered into force on 11 September 2003.

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34. Are there any financial obligations resulting from becoming a Party to the Protocol?

In accordance with Article 29.5 of the Protocol, the financial rules of the Convention apply, as appropriate, to the Protocol. Under the financial rules of the Convention, every Party to the Convention is required to make an annual contribution to cover the costs of the administration of the Convention, including the functions of the Secretariat. The scale for assessing the levels of contributions that each Party is to pay is based on the United Nations scale of assessment for the apportionment of the expenses of the Organization. Contributions by developing country Parties, in particular the least developed ones, are relatively small and usually nominal. In fact, as far as the least developed country Parties are concerned, they are not, as a rule, required to pay more than 0.01 per cent of the total budget approved for any budget year.

It should be noted that, according to Article 31.1 of the Protocol, the Secretariat of the Convention serves also as the Secretariat to the Protocol. The costs of the Secretariat services for the Protocol, to the extent that they are distinct from those to the Convention, shall be met by the Parties to the Protocol. At its first meeting, the Conference of the Parties serving as the meeting of the Parties to the Protocol appvoed a core budget programme for the distinct costs of the Protocol and provisionally adopted a scale of assessment to apportion those costs among the parties to the Protocol (see Decision BS-I/10).

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35. What are the benefits of becoming a Party to the Protocol?

Becoming a Party to the Protocol presents a number of benefits, such as the following:

  • Influence on the implementation of the Protocol and shaping of its further development through participation in the decision-making processes of the Conference of the Parties serving as the meeting of the Parties to the Protocol;
  • For developing country Parties and Parties with economies in transition, eligibility for financial support from the Global Environment Facility (the financial mechanism for the Protocol) for capacity-building, as well as other support for implementation of the Protocol and participation in its processes; (see Decision COP VII/20)
  • Enhanced visibility and credibility of national systems for regulating biosafety within the global community;
  • Contribution to harmonized rules, procedures and practices in managing the transboundary movement of LMOs;
  • Facilitation of mechanisms and opportunities for governments to collaborate with other governments, the private sector and civil society on strengthening biosafety;
  • Improved access to relevant technologies and data, and benefiting from a regular exchange of information and expertise; and
  • Demonstration of commitment to conservation and sustainable use of biological diversity through the implementation of biosafety measures.

   
   
 
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The Secretariat has prepared these questions and answers to assist public understanding of the Cartagena Protocol on Biosafety. It is not intended to provide legal interpretation of the Protocol. Please refer to the original text of the Protocol for any further information.

Update on 2012-02-29
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