Cartagena Protocol on Biosafety Frequently Asked Questions on the Biosafety Protocol Source : http://www.biodiv.org/biosafety/faqs.asp
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:
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. 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. 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. 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. 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). 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 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. 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) 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 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) 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 16). 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) 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. 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)
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). 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) 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) 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 pilot phase of the BCH is available at http://bch.biodiv.org. The BCH website also contains a section devoted specifically to Frequently Asked Questions about the Biosafety Clearing-House. Further information about the development of the Biosafety Clearing-House is also available on the Protocol homepage.
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. 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. 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) 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 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).
A number of initiatives have been implemented at various levels to support countries to meet their capacity-building requirements under the Biosafety Protocol. At the global level, the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) developed, in 2001, a global "Action Plan for Building Capacities for the Effective Implementation of the Protocol" which 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 is being developed 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 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. 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) The Protocol envisages procedures and mechanisms to promote compliance of Parties with their obligations and address the cases of non-compliance. The Conference of the Parties serving as the meeting of the Parties to the Protocol shall, at its first meeting, consider and approve such procedures and mechanisms. 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.
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.) Further information is available on the Protocol home page 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. The governing body of the Protocol is the Conference of the Parties serving as the meeting of the Parties (COP/MOP) to the Protocol. 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.) 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:
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 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. 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
The procedure to deposit instruments of ratification, acceptance, approval or accession with the Depositary is outlined in: http://www.biodiv.org/doc/legal/cp-proc-rat-en.pdf A regularly updated list of Parties to the Protocol is maintained on this site. The Protocol will enter 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. For the purpose of entry into force of the Protocol, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization. (see Article 37.3) 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. Becoming a Party to the Protocol presents a number of benefits, such as the following:
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