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
Rev P Moatshe
Documents handed out:
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
Cartagena Protocol on Biosafety: Executive Summary (see Appendix 1)
Protocol: Powerpoint Presentation by Dr Willemse
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
Dr Willemse, the Acting Manager of Biodiversity Management including
Biosafety, briefed the Committee onÂ the
Cartagena Protocol and its objectives behind the Convention on Biological
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. Please refer to Powerpoint
presentation attachedÂ 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
Dr Willemse stated that one needed to look at the objectives that the Protocol
should address:Â 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 â€œ3rd
generationâ€? 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 avenueÂ where inaccurate information about an
organism was supplied,Â 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.
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
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
theÂ 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.Â 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
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
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
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
AfricaÂ 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.
CARTAGENA PROTOCOL ON BIOSAFETY
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) "â€¦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.
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
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.Â Â Â Â Â Â Â Â 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.Â Â Â Â Â Â Â Â Self-executing provisions
Self-executing provisions under the Cartagena Protocol which do not require
Article 20: Information Sharing and the Biosafety Clearing-House.
Article 22: Capacity-Building
Article 23: Public Awareness and Participation
5.Â Â Â Â Â Â Â Â 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.
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: email@example.com
28 February 2002
CARTAGENA PROTOCOL ON BIOSAFETY to the convention on biological diversitY
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.Â It came into
effect in 1993 and is the main international agreement dealing with
biodiversity issues.Â It covers the
conservation of biological diversity, sustainable use of natural resources and
the equitable sharing of the benefits of genetic resources.Â
Biosafety is based upon the need to protect human health and the environment
from modern biotechnology's negative side effects.Â Modern biotechnology also plays an important role in providing
food, agriculture and health care.Â 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.Â 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.Â
They produced the Cartegena Protocol on Biosafety to the Convention on
Biological Diversity.Â It was adopted in
2000 in Montreal, Canada.Â 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.Â
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.Â
Particular concern is given to conservation, the sustainability of
biological diversity and human health.
Â Â Â Â Â Â Â Â Â Â Â
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.Â This includes that the development and use
of living modified organisms is done in ways sensitive to biological diversity
and human health.Â 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.Â 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.Â
Article 3 - Use Of Terms
Key term definitions include:
â€œLiving organismâ€? covers biological entities which can transfer or replicate
genetic material, i.e. sterile organisms, viruses etc.;
â€œLiving modified organismâ€? refers to any living organism which has genetic
material from modern biotechnology;
â€œModern Biotechnologyâ€? 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;
â€œTransboundary movementâ€? 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
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.Â 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.Â 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.Â They shall indicate whether or
not to proceed with the transaction.Â
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.Â 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.Â
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.Â They shall
include the same information as required
in the notification under Article 8.Â
The Party shall make available to the House
copies of any relevant domestic regulations.Â
Developing countries lacking such regulations may make decisions with
regards to imports within 270 days and based upon a risk assessment.Â This assessment shall include its objective,
use, general principles, methodology and relevant points to consider.Â Failure to communicate decisions does not
imply a decision, either way, unless specified by the Party.Â Parties needing financial and technical
assistance and capacityÂ -building with
regards to living modified organisms may request and receive such.Â
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.Â They must inform
the exporters and the Biosafety Clearing-House of this within 30 days.Â The exporter may request the importer to review
this change.Â The importer shall respond
within 90 days and provide their relevant reasons.Â 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
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.Â They
shall inform the House of these and any domestic equivalents.Â 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.Â 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.Â This includes unintentional
transboundary movements.Â They shall
also ensure that these organisms are subject to observations of a life-cycle
prior to use.Â
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.Â
This notification shall include such relevant information as quantities,
characteristics, circumstances, date of release, use of the organism and
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.Â 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.Â
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.Â It also assists
developing and small island countries to implement the Protocol.Â Parties shall submit to the House any
required information, i.e. on laws, risk assessments etc.Â 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.Â 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.Â
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.Â
Article 24 - Non-Parties
Transboundary movements from Parties to Non-Parties to the Convention must
be consistent with the Protocol.Â
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.Â 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.Â 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
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.Â Developed countries are asked to assist in
this regard.Â 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.Â It is headed by a Bureau and
run by a Secretariat.Â Parties to the
Convention but not the Protocol are observers at the Convention.Â The United Nations, its agencies and the
International Atomic Energy Agency may also serve as observers.Â 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.Â
Article 30 - Subsidiary Bodies
The Conference may establish and determine the roles of subsidiary bodies
as part of its mandate.Â The role of
observers also applies here.Â
Article 31 - Secretariat
The Convention provides for a Secretariat to the Protocol.Â 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
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.Â
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.Â
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.Â
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.Â It would come into effect 1 year after the
notification of withdrawal.
Article 40 - Authentic Texts
The Protocol was released in Montreal January 2000.Â Its original is deposited with the Secretary
General of the United Nations.Â
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.Â 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.Â 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.Â It also has the burden of significant
environmental and other problems to deal with domestically.Â This Protocol may help the country to meet
these challenges successfully.
Secretariat of the Convention on Biological Diversity (2000).Â Cartegena Protocol on Biosafety to the
Convention on Biological Diversity: text and annexes.Â Montreal: Secretariat of the Convention on Biological Diversity.