Cartagena Protocol on Biosafety to Convention on Biological Diversity: briefing

Meeting Summary

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Meeting report

LAND AND ENVIRONMENTAL AFFAIRS SELECT COMMITTEE; ECONOMIC AFFAIRS SELECT COMMITTEE: JOINT SITTING
1 March 2002
CARTAGENA PROTOCOL ON BIOSAFETY TO CONVENTION ON BIOLOGICAL DIVERSITY: BRIEFING

Chairperson:
Rev P Moatshe

Documents handed out:
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Cartagena Protocol on Biosafety to Convention on Biological Diversity by Mr Mathew Parks, Parliamentary Information Services: Research on Protocol (see Appendix 2)
Cartagena Protocol on Biosafety: Executive Summary (see Appendix 1)
Cartagena Protocol: Powerpoint Presentation by Dr Willemse

Summary
Acting Manager of Biodiversity Management on Genetically Modified Organisms briefed both committees on the impact of these organisms on economic foreign policy, especially in importing genetically modified goods.

Members agreed that there were several risk implications of such Genetically Modified Organisms. Committee members felt that more research and consultations were required, before it could be decided that South Africa would accede to the convention.

Minutes
Cartagena Protocol
Dr Willemse, the Acting Manager of Biodiversity Management including Biosafety, briefed the Committee on  the Cartagena Protocol and its objectives behind the Convention on Biological Diversity.



There were many concerns about how best to deal with such GMO's in South Africa. He noted that living modified organisms (LMO's) and GMO's were used interchangeably, especially in South Africa. However in the Protocol there was a difference. When one spoke about a GMO, one is referring to an organism that has a foreign genetic component incorporated into that organism which was inserted by way of Biotechnology. In the negotiations around the protocol, if one spoke about a GMO, one would by implication include a Dead Modified Organism (DMO). This had trade implications because if one spoke about a DMO as a GMO, (which is included in the Protocol), this meant that all components that had a DMO could be identified as a GMO.

In South African Biotechnology, GMO's form a large part of technology. He identified First, Second and Third Generation Biotechnology. First Generation biotechnology was something practised widely. Fermentation, for example used an organism to convert something into something else (yeast for example). Second Generation Biotechnology was advanced to the stage where organisms could be manipulated, for example cell cultures and tissues from plants were removed and were grown into another organism. He also gave the example of plant cloning. Third generation Biotechnology referred to that Biotechnology that related to the removal of genetic components and inserting them into another. This lead to the transfer of a characteristic from one organism to another. Dr Willemse stated that this developed out of scientific curiosity, but the application of Third Generation Biotechnology to transfer the resistance to some other organism had major successes. For example, the transfer of the resistance of an insect to a plant would make that plant resistant to insect attacks in the future. Mealie borer had been combated by taking the gene from the borer bacterium and transferring it to the maize. There had also been the development of the transfer of draught resistant genes to maize in order to make them more hardy and withstand draught.

Therefore, the technology had a huge potential for development and ensuring food security in the future. However, Dr Willemse stated that there was a measure of risk associated because the technology was based on not knowing what was going to happen. To this end, he gave the example of the Brazil nut. The intention was to increase the protein levels by transferring the gene from another nut to it. The technology used was successful, but the same gene was responsible for an increase in protein levels in the nut, which in turn led to an increase in the allergenic activity of the nut. For that reason it was recognised throughout the world that technology needed to be managed and subject to stringent risk assessment procedures.

That was where the Cartagena Protocol originated. In the Convention on Biodiversity it was already recognised that in addition to having health hazards, GMO's might also pose a risk to the environment. For example, if the drought resistance was increased of a particular plant this might lead to a proliferation of the plant beyond what may be contained. This lead to genetic pollution of an indigenous species of plant in a particular area. He gave the example of Mexico, where the maize was contaminated by genetically modified maize from the United States. However, on repeated tests on the maize, there was no indication of the pollution. He stated that the way of testing and risk assessment had not been adequately sorted out. This lead to the need for repeats of tests done, and the need for the development of specific markers to track GMO's. Out of those concerns, the Protocol was developed.

Cartagena Protocol on Powerpoint Presentation
Dr Willemse referred to Articles 8[g] and 19[3]. Please refer to Powerpoint presentation attached  He stated that although the Convention aimed at Biodiversity and specified that the means to regulate relations to organisms that had a potential for threat, Article 19 had the realm of human health in mind.

Dr Willemse stated that there was a need to establish expert groups to look at the components and modalities of the human realm. The second open-ended meeting held meant that any interested person from anywhere in the world could attend, however only parties to the negotiations could make a decision. Therefore the Protocol was renegotiated with all interested parties, NGO's and Governmental representatives present. This led to a hiccup in 1999 because of the large input from such a large sector, negotiations were slowed down tremendously. As the WTO too had representatives at the meetings negotiations slowed down considerably. One of the reasons which contributed to the protracted negotiations was that in the latter part of 1998, the First Globalisation of the International Non-Governmental Community took place. NGO's and state parties were separated at further the meetings, because the NGOs were lobbying with state parties which caused disruption in the meetings. It was then decided that NGO's would be given the opportunity to give input at the beginning of each meeting, hence negotiations continued amicably.

Because of the strong lobbying action of the NGO's who wanted to ban biotechnology, a group of countries which were strong WTO members and were strong international traders, formed a loose alliance to push their cause forward. These Included the United States, Australia, New Zealand, Japan and Canada, who pushed their case forward at the negotiations. This caused a difficulty for South Africa because South Africa is part of the African Group which took an opposing view to the countries above mentioned. South Africa's took a position in between the African group and the countries listed above. As a result South Africa was castigated for taking this alternate view and not siding with the African group of countries at the negotiations. In the end, the negotiations were saved by the fact that the European Union took a different stance. South Africa played a major role at the negotiations as it developed the Annexes to the Protocol.

Dr Willemse stated that the objectives of the Convention were not to provide absolute level of safety as that cannot be guaranteed, but rather to contribute to ensuring adequate level of protection. When the decision was made that technology was required, there had to be Risk Assessment: just as a vehicle required a licence and a roadworthy test, Biotechnology required permits and licences for its techniques and procedures. The Protocol was such a safety management system.

Dr Willemse stated that one needed to look at the objectives that the Protocol should address:  that is, the safe transfer, safe handling and safe use of LMO's resulting from modern Biotechnology [3rd generation] taking into account risks to human health, and specifically focussing on transboundary movement .If one included under this definition GMO's resulting from all technology it would be impossible to handle and track. The reason for including “3rd generation� in the objectives was because one could introduce a normal genetic component which was genetically modified, into another organism, but which is however was not a 3rd generation.

Dr Willemse stated that the meat of the provisions was to include all GMO's and LMO's but to exclude pharmaceuticals used for human beings. With regards to the Advance informed Agreement [AIA], there was a 90 day time frame in which time reasons for refusal or acceptance or during which more information could be requested from the country receiving the GMO, in order to be given the full opportunity to assess whether it wanted to receive the GMO. He stated further that there were huge implications in this regard, especially where food production was concerned, and that there was a need for it to be transferred quickly. However, there was an escape route to this time frame. There was the so-called 'simplified procedure' whereby the Protocol made provision for parties to take a quick delivery of the GMO. This required the party to notify the other that it would accept such a GMO/LMO at the same time notification for that GMO/LMO was given. Therefore the full AIA procedure was not followed. The party importing the organism had the opportunity of saying that it was satisfied with the organism, but could at the same time request notification of shipment of such organism. The importing party also had the right to list LMO's where no AIA procedure was required. There was a shorter procedure for LMO FFP's, that was one intended for food, feed and processing. In terms of the Protocol this was subject to different AIA. Annex II of the Protocol deals with this issue, whereas Annex I deals with information required normal LMO's, and Annex III deals with what risk assessment should contain.

AIA on LMO FFP's stated further that there was a legal requirement for the information supplied to be accurate. In other words, it provided an avenue  where inaccurate information about an organism was supplied,  the exporter could be held liable for its inaccuracy.
With regards to the Competent Authority, different sectors of LMO's for food, environmental concerns, and industry had representatives, for example the competent authority for the SADEK region. It required a Biosafety Clearing House to be set up which ensured that information made available was approved and put on a data base which could be accessed by all interested parties.

Dr Willemse stated that there was a need to harmonise the provisions of the Protocol with existing legislation, being the GMO Act, and Foodstuffs, Cosmetics & Disinfectants Act. Article 18 of the Protocol had made provision for labelling of GMO foods. However the compliance and liability aspect had not as yet been sorted out. Some countries have insisted that liability be widened to include trade and socio-economic issues, for example Ethiopia. He gave the hypothetical example of South Africa developing a coffee bean which took away the market from Kenya. South Africa would as a result be held liable for Kenya's losses in the international market. These negotiations were however now only open to the Parties to the Protocol.

Discussion
Mr Theron (DP) enquired firstly, if we can be sure that if we accede to the Convention, other countries would not resort to dump materials on us which had not been properly tested, and secondly, he asked for a list of the countries which had ratified the Convention.

Dr Willemse replied that one needs to see how committed we were to the whole process. hat Ultimately we decide our destiny; nobody can dump anything on us which we do not want. The danger arises if we do not have regulatory systems in place. The GMO Act which required assessments before any further steps are taken.

He gave the example of Lesotho, who has acceded to the convention but has no Biotechnology of note, no field testing, and has not produced any GMO's which results in them importing GMO's from South Africa. Why then does Lesotho need protection? Lesotho was convinced that it would be given assistance from the  Germans to develop implementation plans, and the Germans assured them that they will do field testing on the organisms. Therefore Lesotho was duped into acceptingGMOs not tested in Germany but would be tested in Lesotho. As a consequence, South Africa had to be vigilant that no dumping occurs.

With regards to the countries which have ratified the convention, Dr Willemse was not exactly sure about which countries they were, but stated Lesotho, Botswana, Swaziland and five Eastern Block Countries had already ratified the Convention. He stated that Norway deals with LMO's in pharmaceuticals, and they do not accept maize, soy beans and cotton GMO's. Netherlands is the host country, therefore there are political connotations for their accession to the Convention. Other countries were still in the process of assessing the impact of this on them.

Mr Nyakane (UDM) enquired if genetic modification could lead to the development of new diseases and/or side effects in human beings upon consumption, secondly if the technology could impact positively on historically disadvantaged people, and thirdly if this technology could be a boon for humans especially in connection with combating HIV/AIDS.

Dr Willemse replied that there was definitely a possibility of side effects and there was no sense in denying this possibility or down playing these side effects.  He stated that recently there was the scare of pollen from a GMO which caused the death of certain butterflies in the United States. However the potential risks were picked up in the risk assessment phase, and there was no single case where a GMO had reached the market which has had a risk attached to it.

He stated that there were risks and benefits and these need to be weighed up. Where risks did crop up, such a GMO never went into production and reached the market. Also there was provision in the Protocol for Labelling of GM products, giving the individual consumer the option of choosing a GM product or a 'normal' product.

With regard to the second question he stated that the farmers in the Makatini Flats in Kwa-Zulu Natal have had enormous success with GM cotton. Whereas they had marginal success with their crops in the past, they had achieved considerable financial gain and had been very complementary about this technique.

Dr Willemse stated that there might be a possibility that this research could develop an immunity for Aids.

Mr Moosa (Chairperson of Economic Affairs) enquired who the stake holders in the negotiating process were. What would be the position if South Africa does not accede to the Convention and 50 countries do accede. Where pollution occurs in a natural form of maize, does South Africa want to become the bearers of non pollutant organisms?

Dr Willemse replied that wide consultations were held with all sectors, including civil society. Three workshops were held with participation by among others agricultural unions and research committees. People who now constitute Biowatch were also present. On the South African delegation there were members from the government, business sector and NGO's.

He stated that we could only postulate about the consequences of South Africa  not acceding to the Convention. What is clear is that from the way the Protocol operates, there is a choice that can be made. The EU has approached the negotiations as a tool for circumventing their obligations in terms of the 5 year moratorium. What it would hold for South Africa ? It is a technology which has a good and a bad side -depending on how one approaches it. For example, the climate changes will hit South Africa harder. The technology has the potential to be able to increase the production of agricultural systems, on the other hand unless South Africa implements the Protocol there will be a negative impact on trade. Therefore there is the need to promote the technology in Africa and at the same time to manage it adequately.

The chair thereafter asked the committee members whether South Africa should accede to the Convention.

Mr Moosa stated that the there is the need for further reflection on the issue, and that there is no urgency for the ratification issue, as it is not something which needs to be done immediately. As a result, he felt that there was no need to agree at the meeting about South Africa's stance toward the Convention. He stated that he would like to consult with Trade and Industry and other NGO's to ascertain their feelings about where this debate is headed.

Mr Nyakane (UDM) suggested that the pace be slowed down a bit as up to now only a handful of countries have ratified the Convention. He stated that more consultative work needs to be done, greater observation and interaction with those countries is required, and consequently agreed with Mr Moosa's stance.

Ms. Dlulane (ANC) stated that she needs greater input on the nature of the risks attaching to GMO's, but said she was uncertain about the time frame in which the ratification needs to be done.

The chair felt that both committees were not sure whether South Africa should accede to the Convention as yet, and that further consultations and more clarity about these issues were required. However he stated that there was the need to speed up the process and reach finality soon.

The meeting was adjourned.

Appendix 1:
CARTAGENA PROTOCOL ON BIOSAFETY
EXECUTIVE SUMMARY

History and Objectives
The negotiations of the Cartagena Protocol on Biosafety (CPB) that started in Aarhus, Denmark in 1997, culminated in adoption of the CPB at an extended session of the Extraordinary Meeting of the Conference of Parties (ExCOP) to the Convention of Biological Diversity (CBD) in Montreal, Canada in January 2000. The CPB was opened for signature and ratification at the Fifth Meeting of the Conference of the Parties (COP V) to the CBD in Nairobi, Kenya in June 2000 and remained open for signature at the United Nations in New York until June 2001. The CPB will enter into force when 50 State Parties have ratified or acceded to the CPB.

Negotiation of the Cartagena Protocol on Biosafety (CPB) was concluded in January 2000 in Montreal, Canada and opened for signature in June 2000 in Nairobi, Kenya. The CPB gives effect to Article 19.3 of the Convention on Biological Diversity (CBD) "…setting out appropriate procedures, including, in particular, advance informed agreement, in the field of 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. The CPB sets mechanisms and procedures to control the transboundary transfer, handling and use of Living Modified Organisms (LMO's). Parties to the protocol are obliged to observe provisions relating to advanced informed agreement, risk assessment, risk management and information sharing. Provisions addressing compliance and liability issues are still to be elaborated upon.

The Draft National Biotechnology Strategy for South Africa contemplates third generation biotechnology to be one of the most important growth sectors nationally and also within the Millenium Africa Recovery Plan. This document highlights the fact that South Africa has largely failed in the utilisation of third generation advances in biotechnology characterized by the emergence of the genetics and genomics sciences.

It is in this context that Cabinet was approached to approve accession to the Cartagena Protocol on Biosafety, with the proviso that: (a) a capacity building plan and (b) an implementation strategy are developed and implemented before the instrument of accession is deposited.

Implications
The CPB requires inter alia of contracting parties to take appropriate measures to ensure:
Advance notification of intended transboundary transfer of LMO's, including minimum information as set out in an annex to the protocol, to the importing country which has to inform of its decision to allow the intended transfer within a specified time.
An advance informed agreement (AIA) to be entered into between country of export and country of import before transboundary transfer of LMO's may commence. In addition to the AIA requirements for LMO's in general, the protocol also provides for a simplified procedure for LMO's intended for food, feed or processing (LMO-FFP's).
Risk assessments, at a minimum in accordance with the requirements set out in an annex to the protocol, to inform approval of activities involving LMO's including transboundary transfer, handling and use.
Take legislative measures to ensure the effective implementation of the CPB including the legal obligation for accuracy of information provided.
Designation of one or more dedicated competent national authorities, a national focal point and a national biosafety clearing house.

The biosafety protocol will thus have wide ranging implications not only for the conservation and sustainable use of biodiversity, but also for the development and use of LMO's resulting from modern biotechnology. These potential implications will inevitably impact on South Africa's sectors of agriculture, forestry, trade and industry (particularly the food industry) and possibly also health.

The provisions relating to documentation and time frames for notification and AIA hold serious implications for implementation of the protocol. Considering the fact that LMO's already commonly used or being traded on the open market in South Africa and globally include maize, cotton, soybean, yeast used for production of alcoholic beverages etc., the implications of having to carry out risk assessments and obtaining AIA for transboundary movement of these products are considerable. Even given the simplified AIA procedure for LMO's to be used for food, feed and processing the implications with respect to possible impact on the national economy and capacity requirements for implementation become self-evident. In addition to the above considerations, constraints placed on internationa trade in the event of ineffective and inefficient implementation of the provisions of the CPB would also have implications with respect to South Africa's obligations in terms of international trade agreements.

The direct implications of the CPB for South Africa at national level will relate almost entirely to the implementation of the provisions of the protocol. Import, handling (including research and development) and use (including release for commercial production) of LMO's in South Africa (LMO=GMO) is regulated by the Genetically Modified Organisms (GMO) Act (Act No. 15 of 1997), administered by the Department of Agriculture. Throughout the negotiations of the CPB, South Africa's position sought to ensure the provisions in the protocol would facilitate integration with the GMO Act.

Implementation of some of the provisions relating to risk assessment and approval of development, handling and use of LMO's are already integrated into the functions of the institutional structure created in the Department of Agriculture for administration of the GMO Act, fulfilling in part the function of a Competent National Authority as required by the protocol.

At international level the biosafety protocol potentially may impact on South Africa's foreign trade and political relations and access to modern biotechnology.

Implementing the Cartagena Protocol on Biosafety will require a collective effort from the Department of Environmental Affairs and Tourism, Department of Agriculture and Department of Health, as well as the cooperation of several other national government departments and civil society.

The core institutional component(s) required for the implementation of the CPB is one or more Competent National Authorities. The latter component is already partly in existence within the Department of Agriculture as the Executive Council and Advisory Committee under the GMO Act, 1997. However, if South Africa accedes to the CPB, the functions and mandate of the GMO Executive Council would need to be revised in accordance with the CPB provisions. Alternatively additional institutional structures, including an additional Competent National Authority, provided for in the protocol, may be created for this purpose. A Biosafety Focal Point and Biosafety Clearing House (BCH), as a component of the National Biodiversity Clearing House Mechanism (CHM), will also need to be created.

A communication strategy to inform on the development and use of LMO's (=GMO's) and to ensure continued public awareness of biosafety issues has already been developed by the Department of Agriculture. This communication strategy could be extended to include issues pertaining ot the CPB and its implementation.

As part of the law reform programme of the Department of Environmental Affairs and Tourism, a Biodiversity Bill is being developed to legislate the White Paper on the Conservation and Sustainable Use of South Africa's Biological Diversity. A chapter of the Biodiversity Bill makes provision for the institutional framework and provisions of the CPB.

Development and release of genetically modified organisms in South Africa is controlled by the Genetically Modified Organisms (GMO) Act (Act No. 15 of 1997), administered by the Department of Agriculture. Implementation of the biosafety protocol in South Africa will need to be integrated and harmonised with the GMO Act, 1997 to avoid duplication of function and/or institutional structures. The GMO Act, 1997 may need to be amended to make provision for additional aspects of the CPB.

3.         Domestic and international law (opinion from Senior State Law Advisor)
The State Law Advisers remark to the acceptability of the CPB where that:
The Protocol on Biosafety to the Convention on Biological Diversity was scrutinized with a view to possible conflict with the domestic law of the Republic of South Africa, and (that the State Law Advisers) are of the opinion that there appears to be no such conflict.

However, the Department's attention should be drawn to the provisions of section 231 of the Constitution of the Republic of South Africa, 1996 (Act No 108 of 1996), which must be complied with.

4.         Self-executing provisions
Self-executing provisions under the Cartagena Protocol which do not require legislation include:
Article 20: Information Sharing and the Biosafety Clearing-House.
Article 22: Capacity-Building
Article 23: Public Awareness and Participation

5.         Financial implications
The full and effective implementation of the Cartagena Protocol on Biosafety will require increased budgetary commitment from national government. In view of the fact that implementation of the CPB would need to be integrated into the existing institutional structures, and the need for sharing of functions between government departments, the magnitude of additional budgetary commitment cannot be determined as yet. In order to determine this aspect in detail, it is proposed that it be included in the terms of reference of the Steering Committee that is recommended to take the process forward.

Appendix 2:
PARLIAMENT INFORMATION SERVICES: RESEARCH
1012 Regis House, Adderley Street, Cape Town, 8000
Matthew Parks: Telephone: (021) 403 8177; Fax (021) 403 8118
e-mail address: mparks@parliament.gov.za

28 February 2002
CARTAGENA PROTOCOL ON BIOSAFETY to the convention on biological diversitY
Executive Summary

Introduction
The Convention on Biological Diversity was finalised in Nairobi and opened for adoption at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.  It came into effect in 1993 and is the main international agreement dealing with biodiversity issues.  It covers the conservation of biological diversity, sustainable use of natural resources and the equitable sharing of the benefits of genetic resources. 

Biosafety is based upon the need to protect human health and the environment from modern biotechnology's negative side effects.  Modern biotechnology also plays an important role in providing food, agriculture and health care.  The Convention caters for the access to and transfer of technology needed for conservation and sustainable development, the safety of biotechnology, reducing threats to biodiversity and human health, and what the signatories need to do to deal with these issues of biosafety.

In 1995 The Conference of the Parties' to the Convention set up an Ad-Hoc Working Group on Biosafety.  It focused especially on the transboundary movement of modern biotechnology created living modified organisms and their potential negative effects on the conservation and sustainable use of biological diversity.  They produced the Cartegena Protocol on Biosafety to the Convention on Biological Diversity.  It was adopted in 2000 in Montreal, Canada.  It has been lauded for creating an international regulatory framework, balancing the needs of the fast growing biotechnology industry and trade with those of environment and human health. 

Article 1 - Objective
The Protocol's objective is to achieve sufficient safety levels for the transfer, transboundary movements, handling and use of living modified organisms created from modern biotechnology.  Particular concern is given to conservation, the sustainability of biological diversity and human health.
           
Article 2 - General Provisions
Signatories to the Protocol are required to take the necessary legal, administrative and other steps in order to meet its obligations.  This includes that the development and use of living modified organisms is done in ways sensitive to biological diversity and human health.  The Protocol does not affect state sovereignty over territorial seas, exclusive economic zones and continental shelves as well as the rights and freedoms of ships and aircraft.  It also does not limit the rights of states to take action to protect their biological diversity, as long as it is consistent with the Protocol and international law. 

Article 3 - Use Of Terms
Key term definitions include:
“Living organism� covers biological entities which can transfer or replicate genetic material, i.e. sterile organisms, viruses etc.;
“Living modified organism� refers to any living organism which has genetic material from modern biotechnology;
“Modern Biotechnology� is the use of in vitro nucleic acid techniques, i.e. DNA and the injection of nucleic acid into cells; and the fusion of cells outside the taxonomic family that use non-traditional breeding methods;
“Transboundary movement� means the movements of organisms amongst parties and non-parties to the Convention.

Article 4 - Scope
The Protocol applies to the movement and use of living organisms that may impact negatively on biological diversity and human health.

Article 5 - Pharmaceuticals
It does not cover the transboundary movement of living modified organisms used for pharmaceutical use and are covered by other agreements.

Article 6 - Transit And Contained Use
Whilst states have the right to regulate the transit and transboundary movement of living modified organisms in their territory, the Protocol's provisions on advanced informed agreement procedure do not apply in this regard.

Article 7 - Application Of The Advance Informed Agreement Procedure
Advance informed agreement procedure is applicable prior to the first transboundary movement of living modified organisms for intentional introduction into the importer's environment and those used for food, feed or processing.  It does deal with those deemed not to be a threat to biological diversity and human health.

Article 8 - Notification
Exporters shall inform the relevant national authority of the importer before hand of the movement of living modified organisms.  This information shall include correct relevant contact details, details of the movement, the organisms' identity, origins, modifications, intended use, quantity, risk assessment, methods for safe usage, regulatory status and export history.

Article 9 - Acknowledgement Of Receipt Of Notification
Importers shall acknowledge receipt of notification, within 90 days, in writing.  They shall indicate whether or not to proceed with the transaction.  Failure to acknowledge does not imply consent to the transaction.

Article 10 - Decision Procedure
The importer's decision on whether to proceed with the transaction shall be based upon a risk assessment.  The importer must inform the exporter and the Biosafety Clearing-House in writing, within 270 days of its decision and relevant reasons, with regards to the approval of the transaction and any conditions. 

Article 11 - Procedure For Living Modified Organisms Intended For Direct Use As Food Or Feed, Or For Processing
Decisions made regarding the domestic use of living modified organisms that involve transboundary movement, shall inform the Biosafety House and other

Parties with in 15 days.  They shall include the same information as required
in the notification under Article 8.  The Party shall make available to the House

copies of any relevant domestic regulations.  Developing countries lacking such regulations may make decisions with regards to imports within 270 days and based upon a risk assessment.  This assessment shall include its objective, use, general principles, methodology and relevant points to consider.  Failure to communicate decisions does not imply a decision, either way, unless specified by the Party.  Parties needing financial and technical assistance and capacity  -building with regards to living modified organisms may request and receive such. 

Article 12 - Review Of Decisions
Importers may review their decisions if new scientific information on the impacts upon biological diversity and human health become available or relevant circumstances change.  They must inform the exporters and the Biosafety Clearing-House of this within 30 days.  The exporter may request the importer to review this change.  The importer shall respond within 90 days and provide their relevant reasons.  Importers may request risk assessments to for future imports.

Article 13 - Simplified Procedure
Importers may, providing safety measures are applied, inform the Biosafety Clearing-House of transboundary movements to take place and those to be exempted from the advance informed agreement procedure.

Article 14 - Bilateral, Regional And Multilateral Agreements and Arrangements
Such agreements and arrangements may be made with regards to the transboundary movement of living modified organisms so long as they are consistent with the Protocol.  They shall inform the House of these and any domestic equivalents.  These shall not be retrospective.

Article 15 - Risk Assessment
Such assessments shall be conducted scientifically and upon recognised techniques and evaluate possible threats to biological diversity and human health.  The importer shall see to these whilst the exporter shall pay the costs.

Article 16 - Risk Assessment
Parties shall take appropriate measures to identify and manage risks posed by the use of living modified organisms to biological diversity and human health.  This includes unintentional transboundary movements.  They shall also ensure that these organisms are subject to observations of a life-cycle prior to use. 

Article 17 - Unintentional Transboundary Movements And Emergency Measures
Parties shall immediately inform the House, and relevant states and organisations of any threats to biological diversity and human health and develop appropriate responses with them.  This notification shall include such relevant information as quantities, characteristics, circumstances, date of release, use of the organism and potential threats. 

Article 18 - Handling, Transport, Packaging And Identification
Parties are required to take the necessary safety measures to protect biological diversity and human health, whilst living modified organisms are in use.  Packages are required to include information on the type of organisms, their use, handling, storage and transport, and relevant contact details.

Article 19 - Competent National Authorities And National Focal Points
Each party to the Convention shall inform its Secretariat of its national body or bodies responsible for liaison with it and the administration of functions required by the Convention.  Changes to these must be communicated to the Secretariat and it will then in turn inform other Parties.

Article 20 - Information Sharing And The Biosafety Clearing-House
The Biosafety Clearing-House facilitates the exchange of scientific, technical, environmental, experiences and legal information relating to living modified organisms.  It also assists developing and small island countries to implement the Protocol.  Parties shall submit to the House any required information, i.e. on laws, risk assessments etc.  Its operating framework shall be determined by the Conference of the Parties.

Article 21 - Confidential Information
Confidential information relating to importers may be provided to exporters with regards to advance informed agreement procedure, where justified.  Contact details, descriptions of organisms, risk assessments and emergency plans are not considered to be confidential.

Article 22 - Capacity-Building
Parties and the private sector shall assist developing and small island nations to build human resource and institutional capacities in biosafety and technology as well as in securing access to financial resources and know-how. 

Article 23 - Public Awareness And Participation
Parties shall cooperate with each other to develop public awareness of and participation in the various aspects surrounding the usage of living modified organisms, in the interests of biological diversity and human health. 

Article 24 - Non-Parties
Transboundary movements from Parties to Non-Parties to the Convention must be consistent with the Protocol.  Parties should encourage Non-Parties to adhere to the Protocol.

Article 25 - Illegal Transboundary Movements
Parties shall take steps to prevent and punish illegal transboundary movements, as well as to inform the House of them.  The offending parties may be asked to pay for the costs resulting from these illegal movements.

Article 26 - Socio-Economic Considerations
Importers may take into account the socio-economic impacts on biological diversity of the use of living modified organisms and the value to indigenous and local communities of these.  Parties are encouraged to cooperate in these areas.

Article 27 - Liability And Redress
The Conference of the Parties shall develop appropriate procedures for liability and redress for damage resulting from transboundary movements within 4 years.

Article 28 - Financial Mechanism And Resources
The Conference of the Parties shall bear in mind the need for finances and resources by developing nations, in order for them to build capacity.  Developed countries are asked to assist in this regard.  The Convention shall be the financial mechanism for the Protocol.

Article 29 - Conference Of The Parties Serving As The Meeting Of The Parties To This Protocol
The Conference of the Parties is the meeting of the Parties to the Protocol.  It is headed by a Bureau and run by a Secretariat.  Parties to the Convention but not the Protocol are observers at the Convention.  The United Nations, its agencies and the International Atomic Energy Agency may also serve as observers.  The Conference shall review the implementation of the Protocol and make any necessary decisions to facilitate this as well as perform other functions assigned to it by the Protocol. 

Article 30 - Subsidiary Bodies
The Conference may establish and determine the roles of subsidiary bodies as part of its mandate.  The role of observers also applies here. 

Article 31 - Secretariat
The Convention provides for a Secretariat to the Protocol.  Its budget is set and paid for by the Conference of the Parties.

Article 32 - Relationship With The Convention
The provisions of the Convention apply to the Protocol, unless indicated otherwise. 

Article 33 - Monitoring And Reporting
Parties shall monitor the implementation of their obligations to the Protocol and report on their progress in this regard to the Conference.

Article 34 - Compliance
The Conference shall adopt procedures and mechanisms to ensure compliance and deal with non-compliance to the Protocol.  This includes providing advice and assistance.

Article 35 - Assessment And Review
The Conference will evaluate the effectiveness of the Protocol after its first 5 years and at least every 5 years after that. 

Article 36 - Signature
The Protocol was signed at the United Nations Office in Nairobi and New York in 2000 and 2001.

Article 37 - Entry Into Force
The Protocol enters into force 19 days after being signed by a party. 

Article 38 - Reservations
No reservations may be made to it.

Article 39 - Withdrawal
2 years after signing the Protocol a Party may withdraw from it.  It would come into effect 1 year after the notification of withdrawal.

Article 40 - Authentic Texts
The Protocol was released in Montreal January 2000.  Its original is deposited with the Secretary General of the United Nations. 

Conclusion
The Protocol has been hailed internationally as a major instrument in ensuring the conservation and sustainable use of biological diversity and protecting human health, whilst at the same time encouraging the development of biosafety and biotechnology.  With the advent of democracy in South Africa, the country has become increasingly integrated into the world economy and experienced both its positive and negative elements.  As a leading economic, industrial and scientific power in the region and continent, South Africa has a responsibility to lead and assist its neighbours in this area.  It also has the burden of significant environmental and other problems to deal with domestically.  This Protocol may help the country to meet these challenges successfully.

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Reference
Secretariat of the Convention on Biological Diversity (2000).  Cartegena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes.  Montreal: Secretariat of the Convention on Biological Diversity.



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