PROCEEDINGS OF THE FIRST NATIONAL
BIOSAFETY WORKSHOP
DEPARTMENT OF AGRICULTURAL RESEARCH
Bio--safety Framework
UNEP/GEF Project on the Development of a National Bio
NATIONAL VETERINARY
LABORATORY, SEBELE, APRIL 28-29, 2004
Table of contents
Table of contents .......................................................................................................................ii
List of Abbreviations................................................................................................................ iv
Project Administration and Coordination ................................................................................. v
Members of the National Coordinating Committee for the Project.......................................... v
1. INTRODUCTION ............................................................................................................ 1
1.1 Background ..................................................................................................................... 1
1.2 Workshop Objectives ...................................................................................................... 1
2. OVERVIEW ..................................................................................................................... 2
3. OPENING SESSION ........................................................................................................ 3
3.1
Welcome Remarks .................................................................................................... 3
3.2
Opening speech by the Deputy Permanent Secretary, Ministry of Agriculture, Dr M.
Chimbombi............................................................................................................................ 3
3.3
Address on expected outcomes of the workshop ...................................................... 3
4. SESSION 1: PAPER PRESENTATIONS ........................................................................ 4
4.1
Biotechnology, Biosafety and Botswana’s Implementation Status .......................... 4
4.2 Development and Implementation of NBFs (Namibia’s experience)............................. 7
5. SESSION 2: CONSULTANTS’ PRESENTATION ........................................................ 9
5.1
Surveys methodology (N. Mlobeli, NFTRC)............................................................ 9
5.2
Survey results (B.T. Bulawayo, NFRTC) ............................................................... 10
5.3
Recommendations (B. T. Bulawayo, NFTRC) ....................................................... 11
6. SESSION 3: GROUP PRESENTATIONS AND WORKSHOP RECOMMENDATIONS
6.1
National biotechnology policy/strategy (working Group 1) ................................... 12
6.1.1 Principle ................................................................................................................. 12
6.1.2 Scope ...................................................................................................................... 12
6.1.3 Institutional framework.......................................................................................... 13
6.1.4 Risk assessment and management ......................................................................... 13
6.1.5 Containment standards ........................................................................................... 13
6.1.6 Finance ................................................................................................................... 13
6.2 National legislation and regional harmonization (Working Group 2) .......................... 13
6.2.1 Scope .......................................................................................................................... 13
6.2.2 Requirements/facilities........................................................................................... 14
6.2.3 Competent authorities ............................................................................................ 14
6.3 Administrative Mechanisms (Working Group 3) ......................................................... 14
6.3.1 Monitoring and inspection ..................................................................................... 14
6.3.2 Notifications and requests ...................................................................................... 16
6.4 Public awareness, participation and information (Working Group 4) .......................... 16
6.4.1 Timing of notifications ........................................................................................... 16
6.4.2 Gazetting of applications, requests and notification ............................................. 16
6.4.3 Medium of communication..................................................................................... 16
6.4.4 Sustainability of funding and budget, interest of competent authority .................. 17
6.5 Workshop recommendations......................................................................................... 17
6.5.1
National Policy/Strategy ................................................................................. 17
6.5.2 Biotechnology and Biosafety Bill ........................................................................... 18
6.5.3 Handling of Notifications and Requests................................................................. 19
6.5.4 Monitoring and Inspection..................................................................................... 19
6.5.5 Public Awareness and Participation...................................................................... 21
7. OFFICIAL CLOSING ........................................................................................................ 21
ii
12
Appendix 1: Workshop Programme .................................................................................... 23
Appendix 2: List of Participants .......................................................................................... 25
Annex 3: Opening speech by the Deputy Permanent Secretary, Ministry of Agriculture, Dr M.
Chimbombi.............................................................................................................................. 27
Appendix 4: Group-work guidelines.................................................................................... 31
iii
List of Abbreviations
AIA
Advance Informed Agreement
BCH
Biosafety Clearing House
BOCCIM
Botswana Confederation of Commerce, Industry and Manpower
BOCOBONET
Botswana Community Based Organisations Network
BOCONGO
Botswana Council of Non-governmental Organizations
CBD
Convention on Biological Diversity
CPB
Cartagena Protocol on Biosafety
EU
European Union
FFPs
Food, Feed, or Processing
GCC
Gaborone City Council
GMOs
Genetically Modified Organisms
KCS
Kalahari Conservation Society
LMOs
Living Modified Organisms
MFDP
Ministry of Finance and Development Planning
MOA
Ministry of Agriculture
NBF
National Biosafety Framework
NCSA
National Conservation Strategy Coordinating Agency
NFTRC
National Food Technology Research Centre
RCZ
Research Council of Zimbabwe
SADC
Southern African Development Community
UNEP-GEF
United Nations Environment Program – Global Environment Facility
iv
Project Administration and Coordination
UNEP/GEF Project on the Development of a National Bio-safety
Framework for Botswana (Project No: GF /2716 – 0 – 4319)
1.
Dr E. Baipoledi
(Chairman, National Coordinating Committee for the NBF Project)
Department of Animal Health and Production
2.
Dr M. Manthe-Tsuaneng
(National Project Coordinator and NCC member, NBF Project)
Department of Agricultural Research
3.
Mr M. Kemo
(Assistant National Project Coordinator, NBF Project)
Department of Agricultural Research
Members of the National Coordinating Committee for the Project
Mr B. Podisi
Department of Agricultural Research
Dr E. Peloewetse
University of Botswana
Mr H. Tarimo
Ministry of Health
Ms B. Matlhaga
Ministry of Finance & Development Planning
Mr M. Modise
Department of Crop Protection
Mrs. J. Ditlhong
National Conservation Strategy Agency
Mr P. P. Valashia
Department of Customs and Exercise
Mr P. Butale
Attorney General’s Chambers
Mr S. Dambuza
Dept. of Agricultural Planning and Statistics
Ms K. Segomelo
Botswana Bureau of Standards
Ms M. Motladiile
Kalahari Conservation Society/BOCONGO
Dr C. Taolo
Department of Wildlife and National Parks
Dr I. T. Ndzinge
Gaborone Veterinary Clinic (BOCCIM)
Mrs. B. Sekhute-Batungamile
Botswana Community Based Organisations Network
v
1.
INTRODUCTION
1.1 Background
The first National Consultative Workshop on Biosafety was conducted as part of the process
of developing a National Biosafety Framework (NBF) for Botswana that will put in place the
policy, legal and administrative instruments for the management of risks associated with
applications of modern biotechnology. The workshop brought together 51 participants
representing different stakeholder institutions in the public and private sectors.
1.2 Workshop Objectives
The main objective of the workshop was to consider the results of the surveys undertaken on
current activities and capacity in biotechnology and biosafety in Botswana, and to make
recommendations towards the development of the;
i.
National Biotechnology strategy/policy
ii.
Biosafety and Biotechnology legislation
iii.
Mechanisms for the handling of notifications and requests, as well as monitoring
and inspection
iv.
Mechanisms to facilitate public participation
1
2.
OVERVIEW
The workshop consisted of plenary sessions and group discussions. On the first day of the
workshop, following the official opening, participants were briefed on the objectives and
expected outputs of the workshop by the Chairperson of the NCC. This was followed by
background information on the Biosafety situation in Botswana delivered by the National
Biosafety Project Coordinator. Since the UNEP-GEF project for the development of NBFs is
an international effort, a guest speaker from the Namibia’s NPCC was invited to share
Namibia’s experience under the theme ‘development and implementation of NBF’s’.
The consultants engaged to conduct the surveys on biotechnology and biosafety activities in
Botswana then made presentations on the survey methodology, the results, and
recommendations. The presentations were followed by discussions in plenary sessions open
to all workshop participants.
On the second day, workshop participants were divided into four groups to discuss, and make
propositions and recommendations on the themes outlined in the second part of the workshop
objectives. This was followed by group presentations in a plenary, followed by discussions
and adoption of the recommendations.
2
3.
OPENING SESSION
3.1
Welcome Remarks
Invited guests and participants were welcomed by the Director of the Department of
Agricultural Research, Dr S. G. Maphanyane.
3.2
Opening speech by the Deputy Permanent Secretary, Ministry of Agriculture,
Dr M. Chimbombi
The workshop was opened by Dr M. Chimbombi (Deputy PS MoA). In his speech he
emphasized the importance of biotechnology, in particular modern biotechnology which
produces Genetically Modified Organisms (GMOs). He highlighted opportunities available
in areas like medicine, industry and agriculture, citing the example of the production of
insulin in the medicine area, which nowadays many people world wide depend on for
survival. He however raised concerns regarding possible risks associated with biotechnology
such as human health and the environment. Other concerns were of social, economic and
ethical in nature. He then summarized the process of developing the protocol which started in
1992 during the Earth Summit in Rio. One of the key agreements adopted at this Summit was
the CBD which addresses the issues of management of biological diversity. Out of this CBD
the CPB was developed to address the safe use of LMOs. Botswana is a signatory to the CPB
and has the responsibility to implement it. He concluded his speech by urging the participants
to deliberate on how Botswana should develop her own NBF to insure that the country is
protected from the potentially hazardous products of modern biotechnology. The full speech
is attached as Annex A.
3.3
Address on expected outcomes of the workshop
Dr Baipoledi gave an outline of the expected workshop outcomes as follows: 1. Discuss the findings of the surveys
2. Identify gaps on the study
3. Provide inputs to address the gaps, and
4. Provide inputs and guidelines for the development of NBF for control and regulatory
mechanisms for the safe handling and transfer of LMOs, including mechanisms for
public awareness and participation.
3
4.
SESSION 1: PAPER PRESENTATIONS
4.1
Biotechnology, Biosafety and Botswana’s Implementation Status
Dr Mmasera Manthe-Tsuaneng, National Biosafety Project Coordinator, (Department of
Agricultural Research
Biotechnology and Biosafety in Botswana
Biotechnology is an old technology that has over the recent years rapidly grown due to the
advances being made particularly with modern biotechnology. It is now a huge industry
providing products in the areas of medicine, industrial processing, veterinary, and food and
agriculture.
Biotechnology is the use of living organisms or substances from these organisms to make or
modify a product, improve plants or animals or develop products for specific uses. The
techniques often used in Biotechnology include fermentation, tissue culture, marker assisted
breeding and genetic engineering. Biotechnology in the form of fermentation techniques has
been used for decades to make bread, cheese, wine 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.
Modern biotechnology, often referred to as genetic engineering, allows scientists to 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 resistance to a specific pest or disease. Genetically Modified
Organisms (GMOs) are organisms whose genetic material (DNA) has been altered in a way
that does not occur naturally by mating or natural recombination, usually obtained through
the use of recombinant DNA techniques. Thus, during genetic engineering, genes may be
isolated from plants, animals, bacteria or viruses, hence allowing movement of genes across
species.
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. It 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. Increased yields
and nutritional benefits are of importance to improved sustainable development.
However, the use of GMOs has triggered heated debates on the complex issues of costs and
benefits and divergent views on their positive and negative impacts to the environment and
human health. The potential areas of concern on biological diversity might be unintended
changes in the competitiveness, virulence or other characteristics of the target species, and
ecosystems; the potential of weediness in genetically modified crops, and the stability of
genes. The potential areas of concern to human health might be toxicity, allergenicity,
digestibility, nutrition, unexpected products and stability.
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Needless to say, there are other non-safety issues of concern with GMOs that are mainly
social and economic in nature. Socio-economic consequences are potentially severe, for
example, through the displacement of cash crops or traditional crops and disruption of small
scale farming systems that are prevalent in developing countries like Botswana. Ethical
issues based on religious beliefs are also of concern as well as issues of affordability and the
impact on trade.
Although 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. Biosafety is a term used to describe efforts to reduce and
eliminate the potential risks resulting from Biotechnology and its products.
Convention on Biological Diversity and the Cartagena Protocol on Biosafety
Two of the important 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
were the adoption of Agenda 21 and the Convention on Biological Diversity (CBD). Chapter
16 of Agenda 21 deals with the environmentally sound management of Biotechnology and
recognizes two important facts, that: i) modern Biotechnology promises significant
contributions to sustainable food production, improved health care and environmental
protection, ii) the community at large can only benefit maximally from the potential of
modern biotechnology, if it is developed judiciously and adequate safety mechanisms are set
in place.
The objectives of the convention are the conservation of biological diversity, the sustainable
use of its components and the fair and equitable sharing of benefits arising out of the
utilization of genetic resources. The convention addresses, in two different articles, the issue
of biosafety, namely in article 8 about in-situ conservation, and in article 19 about handling
of Biotechnology and distribution of its benefits. Article 8(g) lays down the obligation for
Parties to establish or maintain means to regulate, manage or control the risks associated with
the use and release of living modified organisms. Article 19.3 call upon Parties to consider
the need for and modalities of a protocol setting out appropriate procedures, including, in
particular, advance informed agreement, in the field of the safe transfer, handling and use of
living modified organisms.
On the basis of article 19.3 and after 5 years of negotiations, the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity was adopted on 29 January 2000 and
entered into force on 11 September 2003.
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 into account
risks to human health, and specifically focusing on trans-boundary movements. Principle 15
states that ‘in order to protect the environment, the precautionary approach shall be widely
used by States according to their capabilities. Where there are threats of serious or
5
irreversible damage, lack of full scientific certainty shall not be used as a reason for
postponing cost-effective measures to prevent environmental degradation’.
The key provisions of the Protocol include issues on advance informed agreement; risk
assessment and risk management; handling, transport, packaging and identification;
information sharing and the biosafety clearing house; capacity building; public awareness
and participation; socio-economic considerations; liability and redress; and compliance.
Implementation Status of Botswana
Botswana has signed and ratified both the Convention on Biological Diversity (1992) and the
Cartagena Protocol on Biosafety (2001) and is therefore bound by the obligations of the
Protocol. Article 19 of the Protocol requires countries to designate the Biosafety Focal Point
responsible for the coordination of biosafety issues with the CBD secretariat, and the
National Competent Authority responsible for the implementation of the Protocol. Through
Presidential Directive Cab. 21/2001, the National Conservation Strategy Agency (NCSA)
and the Department of Agricultural Research were designated the Focal Point and the
National Competent Authority respectively.
A national coordinating committee on biosafety has been established, composed of relevant
stakeholders from the following institutions/organizations: Botswana College of Agriculture,
Department of Animal Health and Production (MoA), University of Botswana, Ministry of
Health, Ministry of Finance & Development Planning, Department of Crop Production and
Forestry (MoA), National Conservation Strategy Agency, National Food Technology
Research Centre, Department of Customs & Exercise, Attorney General’s Chambers,
Botswana Bureau of Standards, Department of Agricultural Planning and Statistics,
Department of Wildlife and Tourism, Botswana Council of Non-Governmental
Organizations (BOCONGO), Botswana Confederation of Commerce Industry and Manpower
(BOCCIM) and Botswana Community Based Organisation Network (BOCOBONET). The
committee is responsible for advising the implementing institution (DAR) on all issues
relating to biosafety.
Botswana has signed an 18-month project with the United Nations Environmental
Programme/Global Environment Facility (UNEP/GEF) to develop the National Framework
on Biosafety. A national biosafety framework is a combination of policy, legal,
administrative and technical instruments that are set in place to address safety for the
environment and human health in relation to modern biotechnology. The key components of
the national biosafety framework are therefore: biosafety policy, regulatory regime, system
to handle requests (administrative, risk assessment & management, decision making), followup activities/enforcement, monitoring for environmental effects), public awareness and
participation.
The project is being implemented in three stages/phases. Phase 1 is the preparatory stage of
information gathering (mainly through surveys) on the current uses of biotechnology,
existing legislation related to Biotechnology and biosafety, development of the roster of
experts and existing information on sub-regional biosafety frameworks and mechanisms for
harmonization of risk assessment and management. The second phase is an information
6
analysis, the development of the national biosafety database, mechanisms for adequate
involvement of stakeholders and identification of components of the framework. The final
phase will be on the preparation of the draft framework that will have all the components of a
framework. We are currently on phase 1 where the results of the surveys will be presented
during the workshop and we hope to have a draft framework by the end of the year.
4.2 Development and Implementation of NBFs (Namibia’s experience)
Dr Martha Kandawa-Schulz, Namibian Biotechnology Alliance (NABA)
History/Background
Namibia received assistance from the Convention on Biological Diversity, Focal Point in the
establishment of the Namibian Biotechnology Alliance. After the formation of NABA,
Biotechnology and Biosafety Surveys and related activities were carried out to determine
what the situation was. There was also a country study on the status of Biotechnology and
Biosafety in Namibia, from which a database of institutions – their infrastructure and
competence was created.
National Workshop
A national workshop was held to consider technical guidelines to deal with GMOs based on
examples from the EU and UNEP. The workshop also considered elements for a national
biosafety policy to enable the safe use of biotechnology in Namibia. The policy has since
been finalized and adopted by the Namibian government.
Competent authority – Ministry of Science and Technology (MST)
Namibia’s MST was chosen as the competent authority on biotechnology and biosafety
issues. One of the criteria used in choosing the competent authority was to avoid ministries
or department that could have a conflict of interest. An interim advisory body comprising of
scientists, consumers and members of NABA was formed to advise the competent authority.
Guidelines recommended by a consultant were used to formulate a National Biotechnology
policy/strategy for Namibia, which is now in place.
Scope
A determination was made on whether there was a need for new legislation or a modification
of existing instruments/procedures. It was decided that a separate law was necessary. The
law has a wide scope, covering LMOs, GMOs and their products. The list of products is
gazetted. The law specifies procedures and terms for the application process, monitoring,
enforcement, inspection, and mechanisms of public participation and confidentiality of
information.
Objective of policy
•
Guide protection of human health/animal health
7
•
Facilitate research and safe use of Biotechnology
•
Fulfilling of obligations under Cartagena protocol
Implementation
Criteria for finding what we do within the framework
Framework
Check gaps in framework developed
Responsibility sharing – cold runs – (last discussion)
Inspection and enforcement mechanisms (training)
Public involvement at different stages
Areas of concern – who is going to do what
How do we implement?
Database. How it is used
Patience is needed to deal with issues of political will
Include lawyers in the process – drafting the law
Conclusion
In conclusion, it is important to set up policies with due consideration to the country’s
capacity to implement. For example, in most African countries food aid and other
emergency situations or measures lead to almost no difference between seed and grain. It is
important to determine at an early stage who the stakeholders are, and involve all of them. It
is also important to know what your trading partners are doing.
8
5.
SESSION 2: CONSULTANTS’ PRESENTATION
Consultants were engaged to carry out a study based on the following Terms of References;
1. Survey of existing uses of biotechnology and the arrangements for safe use of
biotechnology, including review of existing legislation that may impact on the use of
modern biotechnology. This should include, among others, food safety, plant/animal
quarantine, phyto-sanitary, pesticide, herbicide, import and export legislation and
guidelines.
2. Survey of existing national, bilateral and multilateral cooperative programmes in
capacity building, research and development, and application of biotechnology. The
consultant(s) should endeavour to provide detail on existing programmes in capacity
building related to biotechnology in the public and academic institutions, private
sector and non-governmental institutions.
3. Survey on existing national biosafety frameworks in the SADC sub-region.
4. Survey on existing mechanisms for harmonisation of risk assessment/risk
management, mutual acceptance of data and data validation.
5. Survey on extent and impact of release of LMOs and commercial products.
6. Identify how information should be stored and managed for input in the Biosafety
Clearing House (BCH) and for promoting public participation.
7. Create a database listing national experts in fields related to biotechnology and
biosafety, as well as fields relevant to risk assessment and risk management of LMOs.
8. Create a database detailing relevant outputs of the national surveys.
The results of the study was presented to the meeting by the consultants in two parts – (i)
Survey Methodology, and (ii) Results and recommendations
5.1
Surveys methodology (N. Mlobeli, NFTRC)
The study constituted the first phase (six months) in the development of Botswana’s NBF
project. Information was gathered to produce inventories on current uses, techniques,
facilities, containment levels, legislation, active or planned projects; report on existing subregional NBFs, their stages in development or implementation of NBF, mechanisms of
harmonization of risk assessment/management activities; and prepare rosters of relevant
expertise.
The study methodology was as follows:
9
a) Inventories of capacity, facilities and programs were obtained through a structured
questionnaire. The questionnaire was structured to solicit information on institutional
profiles, capacity and expertise; activities in biotechnology and initiatives in
biosafety; and current information on the handling, movement and use of LMOs in
Botswana.
b) Legislation and policy were reviewed in a desk study of government publications.
c) Information on existing sub-regional NBFs was collected through Internet searches
and by contacting responsible authorities in some SADC countries.
d) Other information was collected in oral interviews and by reviews of published
documents.
A hundred and five (105) potential stakeholders among government, private, parastatal and
NGO institutions that could participate in the study were identified. A decision was made to
reduce the number to representative clusters and visit only some of the institutions in the
information gathering exercise. Hence, visits were made to 52 institutions in various parts of
the country to observe facilities and administer the questionnaire.
5.2
Survey results (B.T. Bulawayo, NFRTC)
In the second part of the consultants’ presentation, participants were briefed on the findings,
conclusions and recommendations of the study. The study found that biotechnology products
handled in Botswana included live microbial cultures, animals and animal products, plants
including seedlings, seeds and grains, diagnostic kits for medical and veterinary use; vaccines
and pharmaceutical products. It was observed that Botswana’s compliance with the
provisions of the Cartagena protocol was constrained by: •
Absence of a national biotechnology policy/strategy
•
Divided regulatory responsibilities (different acts empower diff’ agencies)
•
Lack of a unified system
•
Insufficient institutional capacity indicated by shortage of risk assessment and risk
management
•
Limited information resources & shortage of authoritative sources
There were no modern biotechnology activities in Botswana
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5.3
Recommendations (B. T. Bulawayo, NFTRC)
Despite lack of activities on the application of modern biotechnology in Botswana, it is
important for the country to have the policy, regulatory and administrative mechanisms
necessary for the regulation of modern biotechnology products and to ensure adequate levels
of biosafety. Therefore, the following are recommended;
1.
A national policy on biotechnology be drafted and adopted at the highest level,
highlighting national priorities, expected benefits, guidelines for responsible and safe
use, and designating responsibilities. Stakeholders should help to identify the stated
elements of the policy and a draft document should be submitted to government.
2.
A new unitary piece of legislation be adopted to specifically deal with biotechnology
and biosafety. Attempts to amend existing legislation dealing with aspects of
biotechnology and biosafety activities would perpetuate fragmentation of
implementation authority.
Current legislation is implemented by different
government agencies, which already have separate functions. A new biotechnology
act, if adopted, should create a new regulatory authority for biotechnology.
3.
A new regulatory authority for biotechnology, created under (2) above, should also
take on the functions of registration, monitoring, and inspection of biotechnology and
biosafety activities involving LMOs; as well as facilitating public participation,
awareness and information on biotechnology. It should also be the local contact point
for the dissemination of information to and from the Biosafety Clearing House.
In conclusion, the most efficient way to honour Botswana’s obligations under the Protocol is
to adopt a national biotechnology strategy and draft a new act of Parliament. The act should
be drafted to enhance the safe use of biotechnology and regulate development, handling,
contained use, environmental release, and introduction into the market, of LMOs and
products of LMO origin.
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6.
SESSION 3: GROUP
RECOMMENDATIONS
PRESENTATIONS
AND
WORKSHOP
On the second day of the workshop, the consultants’ proposals for Botswana’s NBF were
considered by the participants working in four groups on the different aspects of the NBF
(see Appendix 4 for the group work guidelines). The major points from the deliberations of
the groups were discussed at a plenary session of all participants and formulated into
workshop resolutions and recommendations for the different themes identified.
6.1
National biotechnology policy/strategy (working Group 1)
6.1.1 Principle
The working group considering aspects of the ‘national biotechnology policy/strategy’
proposed that the policy should be guided by the general principles of protection of health
and the environment, management of safe use (biosafety), compliance with the Cartagena
Protocol, regulation of biotechnology, public education, assuring sustainability and cost
effectiveness, safe adoption and research of biotechnology. The policy should embrace any
obligations under international conventions such as the Convention on Biological Diversity,
Cartagena Protocol, World Trade Organisation, and International Treaty on Plant Genetic
Resources.
6.1.2 Scope
The group proposed that the policy should address national development objectives such as
food security, poverty alleviation, economic diversification, women and youth
empowerment, Vision 2016 and rural development with reference to National Development
Plan 9 and other relevant government policies.
The national policy should include mechanisms of full participation in research and
development, education and trade, and harnessing of the benefits of biotechnology. The
policy should outline comprehensive strategies for implementation, taking into consideration
the provision of regulatory mechanisms, capacity building for administrative and legal
systems, and provisions for combinations of conventional and modern biotechnology.
The development of comprehensive strategies for implementation should be through a
process covering identification and assignment of duties according to capacity:
1. development of an information system
2. provisions for financial and human resources
3. creation of public awareness and mobilization on biotechnology
4. political sensitization and mobilization
5. development of monitoring and enforcement mechanisms
6. establishment of an evaluation and review system
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6.1.3 Institutional framework
An institutional framework should be developed under a Competent Authority with an
Advisory Board and an Appeals Board; and institutions with relevant competence should be
identified for involvement in the framework.
6.1.4 Risk assessment and management
The policy should provide plans and standards for risk assessment, management, mitigation,
minimization and communication with full information on approved techniques and their
development. There should also be provisions for risk management including management
plans, contingency plans, insurance and decontamination.
6.1.5 Containment standards
The policy should specify containment standards for laboratory, greenhouses, field trials and
decontamination in the event of accidental release.
6.1.6 Finance
The working group proposed that funding should be provided by the government through the
office of the competent authority. The office can also raise funds by charging administration
fees for provision of services and levies on sales of technology.
6.2 National legislation and regional harmonization (Working Group 2)
6.2.1 Scope
The working group, in considering elements of the Biotechnology and Biosafety Bill,
recognized that the current legislative environment is ineffective because regulatory authority
is fragmented, and does not specifically cater for activities involving products of modern
biotechnology. There is need to set up such legislation and the assessment of their potential
risk proposed that the bill should regulate the import and export of GMOs, LMOs and their
products; as well as conditions of transportation, storage and handling of GMOs and LMOs
in transit and within the country. The bill should also cover the use, development,
production, application, disposal, distribution, release, research and development and field
trials involving GMOs, LMOs and their products.
Other elements to be covered by the legislation include licensing, inspection, border control,
registration, and provisions for the gazetting of a scheme of approved LMOs, GMOs and
their products by the Minister through a designated Competent Authority. This is especially
important because at present, the current status is ineffective, fragmented and does not cater
for GMOs. There is need to set up legislation that will specifically address GMOs, and
address the issues of risk assessment, management, mitigation, minimization and
communication. In order to make the regulations flexible, the working group suggested that
13
the legislation should take cognizance of and be harmonized with existing regional
regulations.
6.2.2 Requirements/facilities
The implementing authorities for the legislation will need access to testing facilities such as
laboratories and equipment. There will also be a need to develop human resources such as
registration personnel, laboratory technologies, technicians, monitors and inspectors. There
should also be provisions for on-going development of capacity through training.
6.2.3 Competent authorities
The working group suggested that candidate institutions for the competent authority that will
implement the policy include the following agencies; Department of Agricultural Research in
the Ministry of Agriculture, Ministry of Health, Ministry of Wildlife, Tourism & the
Environment, Ministry of Trade & Industry, Botswana Bureau of Standards, Attorney
General’s Chambers, BOCCIM, BOCONGO, BOCOBONET, Farmers Association,
University of Botswana, and Ministry of Communications Science and Technology. During
discussions in the plenary session, participants agreed that the choice of competent authority
should ultimately be guided by criteria that combine both the ability to act effectively without
a conflict of interest and to make decisions at the highest levels of government. It was agreed
that final regulatory approval authority should lie with the office of the Minister responsible
for the competent authority.
6.3 Administrative Mechanisms (Working Group 3)
The working group on administrative mechanisms deliberated on issues relating to the
conduct of monitoring and inspections (Section 5.3.1) and notifications and requests (Section
5.3.2).
6.3.1 Monitoring and inspection
Monitoring and inspection were dealt with in the context of questions 1-6 below:
Question 1.
What should be monitored?
a)
All modern biotechnology activities in Botswana
b)
Modern biotechnology products within Botswana
c)
Modern biotechnology products/entities in transit through Botswana
d)
Food and feed products as well as pharmaceuticals marketed in Botswana derived
from modern biotechnology
Question 2.
a)
Why should items 1 (a) to (d) be monitored?
To minimize risk to human life and the environment.
14
b)
To ensure abidance with relevant regulations and legislation.
c)
To gather relevant information about specific modern biotechnology activities or
product uses.
Question 3.
How should the monitoring be done?
a)
Surveillance – short term and long term
b)
Routine inspection and spot checks
c)
Investigative inspection and spot checks
d)
Auditing
e)
All modern biotechnology activities and product uses should be registered with
the BCH, and product-specific permits with specified validity periods must be
issued.
Question 4.
Who should do the monitoring?
The monitoring should be conducted by the national focal point of the Biosafety Clearing
House (BCH) as the competent authority.
Question 5.
a)
What is the existing situation?
Available information is scattered across ministries and it is peripheral to
biotechnology and biosafety
b)
Available legal provisions are peripheral to biotechnology and biosafety
c)
Personnel in the institutions that currently do inspection is inadequately trained
for biosafety monitoring
Question 6.
What is the way forward?
a)
Establish roster of adequately trained personnel
b)
Build capacity (infrastructure development and manpower training) to adequately
deliver on the demands of the Cartagena Protocol.
c)
Establish legislation that entitles monitors to enter premises at any reasonable
times for purposes of monitoring.
d)
It should be a condition of the issuing of licenses or permits for holders to
guarantee access to premises by authorized monitors for purposes of monitoring.
15
6.3.2 Notifications and requests
The group recommended that drafting of specific procedures for notifications and requests
for the handling and movement of GMOs, LMOs and their products be left to the regulating
authority and the BCH once they have been designated. This was consistent with the
consultants’ recommendation that a new regulatory authority for biotechnology, created
under the biotechnology bill should also assume the functions of registration of notifications
and requests. The consultants had also recommended that the notifications should be made
public and be gazetted by the Minister responsible for the office of the competent authority.
6.4 Public awareness, participation and information (Working Group 4)
Recognizing
• the important role of members of the public as stakeholders and consumers of
products of modern biotechnology, and
•
the importance of public awareness on the effects of modern biotechnology,
the working group emphasized that the public needs to be informed of modern
biotechnological research, use, transport, storage or marketing of LMOs, GMOs or their
products in Botswana. Mechanisms should be in place for the public to access and
understand information, and participate in decisions involving GMOs, LMOs and their
products, where such decisions may affect them. Some of the specific issues that the
working group deliberated and resolved on are listed under Subsections 6.4.1 to 6.4.3
6.4.1 Timing of notifications
Notifications about field trials should be for a stipulated period of time, and must reach all
stakeholders to the level of the particular villages(s) where trials are to be conducted.
6.4.2 Gazetting of applications, requests and notification
The group suggested that gazetting of applications, requests and notification be effected by
the Minister responsible for the office of the competent authority. Information about
applications for use, transport and marketing of GMOs, LMOs and their products should be
made available to the public through press releases, adverts, occasional bulletins, pamphlets
and public access websites.
6.4.3 Medium of communication
Considerations should be made on the appropriateness of language and approach. Trainers of
trainers should be adequately informed. These should include stakeholders such as the press,
politicians, religious leaders, officials at points of entry, special interest groups, educational
institutions, organizers of fairs and other parties with access to various constituencies.
The working group also proposed that there should be surveys to evaluate public
understanding of the issues involved and impact of awareness education campaigns so as to
16
determine if objectives are being met. A forum should also be created to accommodate
inputs from the public.
6.4.4 Sustainability of funding and budget, interest of competent authority
The working group emphasized that the momentum of efforts to cultivate public interest,
promote awareness and provide information should be sustainable in terms of resources and
long-term commitment. The group proposed that government should commit some of the
necessary resources; and that institutions and organizations involved in the production, use
and movement of GMOs/LMOs should pay some kind of levy to boost the resources.
6.5 Workshop recommendations
The major points from the deliberations of the sub-groups were discussed at a plenary session
of all participants and formulated into workshop recommendations under the following areas
of the NBF:
(a)
National policy/strategy
(b)
Biotechnology and biosafety Bill
(c)
Handling of notifications and requests
(d)
Monitoring and inspections
(e)
Public participation
6.5.1
National Policy/Strategy
Botswana needs to develop a policy that is guided by the general principle of protection and
regulation of Biosafety, compliance with the Cartagena Protocol, regulation of Biotechnology,
public education, assuring sustainability and cost effectiveness, safe adoption and research of
biotechnology. The policy should embrace any obligations under International Conventions
such as the Convention on Biological Diversity, the Cartagena Protocol, any World Trade
Organisation, Conventions and Protocols and International Treaty on Plant Genetic Resources.
The legislation should also be well defined as to what National priorities are being addressed.
These should address the National Development Objectives including Food security, Poverty
alleviation, Economic diversification, Women and youth empowerment, Vision 2016 and
Rural Development, all in relation to NDP 9 and any future NDPs.
The mechanisms of full participation in Research and Development, education and trade and
harnessing the benefits could be achieved by the provision of regulatory mechanisms,
17
capacity building for administration and a legal system and provision for combination of
conventional and modern biotechnology. The Legislation should outline a comprehensive
strategy for implementation. These should be dealt with by a process covering identification
and assigning of duties according to capacity. It is essential to develop an information
system, allocate funds and make provisions for financial and human resources by;
Creating Public awareness and mobilisation on biotechnology
Encouraging Political mobilisation geared towards ensuring a political will
Developing monitoring and enforcement mechanisms
Establishing an evaluation and review system
An institutional framework should be developed and a competent authority should be
identified, an Advisory Board established, an Appeals Board established and institutions with
relevant competence should be identified.
In accordance with Articles 15 and 16 of the Cartagena Protocol, the issue of Risk
Assessment and Risk Management should form an integral part of the Biosafety Framework.
Risk assessment is the identification, quantification and characterisation of the level of
exposure to potential hazards and harm to human health and the environment.
Risk
management is the use of sustainable mechanisms of process to mitigate, reduce or control
risks.
To accomplish these, certain requirements and facilities should be put in place, among which
are laboratories and equipment, human resource and capacity, as well as registration
procedures. The competent authorities should be identified and regulatory mechanisms set in
place, including who should give the final regulatory approval authority and harmonisation of
regional regulations.
On the issue of Risk assessment and management, there is a need to have in hand information
on development techniques. Regarding Risk management there should be a Management
plan, Contingency plan, Insurance and processes of decontamination in the worst-case
scenario. Containment standards should be established at laboratories, greenhouses, and field
trials.
6.5.2 Biotechnology and Biosafety Bill
18
The Biotechnology and Biosafety bill should clearly indicate the regulation of import and
export of GMOs, LMOs, and their products, transport, storage and handling of GMOs in
transit and within the country. Furthermore, the use, development, production, application,
disposal, distribution, release, research and development and field trials should adhere to
formulated regulations.
Regulation should be through licensing, inspection, border control, registration (Scheme of
approved GMOs), by the Minister through a designated Competent Authority.
This is
important because the current status is ineffective and fragmented, does not cater for GMOs
and therefore suggest setting up legislation that will address GMOs specifically.
6.5.3 Handling of Notifications and Requests
A new regulatory authority for biotechnology, created under the biotechnology bill should
also take on the functions of registration of notifications and requests. Notifications should
be made public and the timing of notification should be an essential element in public
involvement. Notifications and requests should be gazetted by the Minister under which the
Competent Authority falls.
The process of notification should take into account the
following steps;
Request procedure; first and subsequent transboundary movements
Notification (forms for notification and requests)
Food, Feed, or Processing - article 11 (provided use does not change)
Identification of primary entry points; referrals to BCH
Liaison with relevant stakeholders and regulators in neighbouring countries to make
the identification of products as ‘may contain’ LMOs routine. (Article 18)
There should also be surveys to evaluate understating and impact on public awareness (are
objectives being met).
6.5.4 Monitoring and Inspection
It has already been established that at present, any available information is scattered across
ministries and it is peripheral to biotechnology and biosafety; available legal provisions are
peripheral to biotechnology and biosafety; personnel in the institutions that currently do
19
inspection is inadequately trained for biosafety monitoring. It is then apparent that measures
should be put in place to monitor all modern biotechnology activities in Botswana, modern
biotechnology products within Botswana, modern biotechnology products / entities in transit
through Botswana, food and feed products (FFPs) as well as pharmaceutical products
marketed in Botswana.
These should be monitored in accordance with the Cartagena
Protocol, in order to minimise risk to human life and environment, ensure abiding to relevant
information about a specific modern biotechnology activity or product use.
Processes of monitoring should include surveillance, both short term and long term; routine
inspection, which will include sport checks; investigative inspection; auditing. Furthermore,
all modern biotechnology activities/products used should be registered with the Biosafety
Clearing House, where product specific permits will be issued and all permits will carry a
specified validity.
All the monitoring should fall under the auspices of the assigned
Competent Authority (BCH).
What needs to be done as a way forward is to establish a roster of adequately trained
personnel; build capacity (infrastructural and manpower training) to adequately deliver to the
demands of the Cartagena Protocol; establish legislation that entitles monitors to cater
premises at any reasonable time for purposes of monitoring. It should be a condition of the
license/permit to allow access to the monitors for purposes of monitoring
20
6.5.5 Public Awareness and Participation
Public awareness should be understood to mean imparting relevant information to
stakeholders about specific issues, providing an informed balance in the pros and cons,
providing access to the information at any given time and enlightening the public by
translating the available information in order to empower them. On the other hand, public
participation means the involvement of stakeholders in decision-making and all processes,
getting opinions, expressions and getting feedback from people and using a democratic
process in reaching a common understanding and solution. On that note, public awareness
and participation should be considered on issues that affect people directly or indirectly to
insure implementation of decisions, create transparency, facilitate inclusiveness, harmonise
bodies that provide awareness to remove bias and build a sense of ownership, collective
responsibility and confidence.
Public awareness and participation in developing the NBF should be incorporated by creating
a forum for all stakeholders to accommodate inputs from the public, targeting decisionmakers, educating the press, politicians, pastors of religion, officials at points of entry, press
conferences, special interest groups, educational institutions, fairs, print media.
In order that all these considerations become plausible, there is a need for financial
obligation. This could be achieved by commitment from Government, through the competent
authority, provision of services, e.g. administration fees, sales of technologies. Institutions
and organisations involved in producing and or importing GMOs/LMOs should pay some
kind of levy and pay for advertisements in bulletins, pamphlets and websites.
7. OFFICIAL CLOSING
The workshop was officially closed by the Chief National Resource Officer of the National
Conservation Strategy Coordination Agency, Mr E. K. Maloiso, representing the Executive
Secretary. In his remarks, he thanked the workshop participants for finding the time to
contribute to the deliberations. He also extended special thanks to Dr Kandawa-Schultz for
accepting the invitation to share Namibia’s NBF development and implementation
experience with the participants.
21
APPENDICES
22
Appendix 1: Workshop Programme
First National Consultative Workshop on Biosafety
DAY ONE
09:00-09:30
Registration
Opening Session Chairperson:
NCC Chairperson, Dr Baipoledi
09:30-09:40
Welcome address
Dr S. G. Maphanyane, Director; Department of Agricultural Research
09:40-09:55
Official opening
Dr Chimbombi, Deputy Permanent Secretary, Ministry of Agriculture
09:55-10:10
Objectives and expected outputs of the workshop
Dr E. Baipoledi, NCC Chairperson
10:10-10:30
Tea Break
10:30-11:30
Background on biosafety situation in Botswana
Dr Manthe-Tsuaneng, National Biosafety Project Coordinator
11:30-11:45
Discussions
11:45-12:30
Development and implementation of NBFs (Namibia’s experience)
Dr Martha Kandawa-Schultz (Namibia Biotechnology Alliance)
12:30-12:45
Discussions
12:45-13:45
Lunch
SESSION 2
Chairperson: Dr I. Ndzinge (NCC member)
13:45-14:30
NBF for Botswana Part 1 (Surveys and methodology)
N. T. Mlobeli, NFRTC
14:30-15:15
NBF for Botswana Part 2 (Survey results and recommendations)
B. T. Bulawayo, NFRTC
Discussions of findings
15:15-16:00
DAY TWO
Session 3
Chairperson: NCC Chairperson
08:00-11:00
Group Discussions and propositions
A.
National policy/strategy
23
B.
National legislation and harmonized regional regime
C.
Notification and requests
D.
Monitoring and inspection
E.
Public awareness, participation and information
11:00-12:45
Group presentation, resolutions, propositions and recommendations
12:45-13:45
Lunch
Session 4
Chairperson: NPC
13:45-16:00
Group presentations, resolutions, propositions and recommendations continue
16:00-16:30
Closing Remarks – Mr M. L. Nchunga, Executive Secretary, National
Conservation Strategy Coordinating Agency
24
Appendix 2: List of Participants
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
NAME OF INSTITUTION
Attorney General’s Chambers
P/Bag 009, Gaborone
Botswana Bureau of Standards
P/Bag BO 48, Gaborone
Botswana Bureau of Standards
P/Bag BO 48, Gaborone
Dept. Animal Health & Production
P/Bag 12, Lobatse
Botswana Vaccine Institute
P/Bag 0031, Gaborone
Botswana Vaccine Institute
P/Bag 0031, Gaborone
Diagnofirm Medical Lab
P/Bag 283, Gaborone
GCC (Waste Water Treatment)
P/Bag 0089, Gaborone
Meat Inspection Training Centre
P/Bag 45, Lobatse
Department of Agricultural Research
P/Bag 0033, Gaborone
Department of Agricultural Research
P/Bag 0033, Gaborone
Department of Agricultural Research
P/Bag 0033, Gaborone
Food Control Unit
P/Bag 00269, Gaborone
University of Botswana
P/Bag UB 00704, Gaborone
University of Botswana
P/Bag UB 00704, Gaborone
Veld Products Research & Dev.
Box 2020, Gaborone
MFDP Food Security Unit
P/Bag 008, Gaborone
Gaborone Veterinary Clinic
P/Bag 00336, Gaborone
Ministry of Agriculture of Health,
Gaborone
KCS/BOCONGO
Box 859, Gaborone
NCSA
P/Bag 0068, Gaborone
NCSA
P/Bag 0068, Gaborone
NAME
Ms C. Thembe
TEL.
3613792
Ms K. Segomelo
3164044
FAX.
3957089,
3181518
3164042
Ms T. N. Marudu
3164044
3164042
Dr K. Matlho
5330244
5330243
Dr O. G. Matlho
3912711
3956798
Mr B. K. Obusitse
3912711
3956798
Mr M. Mangwendeza
3950007
3957980
Ms I. Koorapetse
3657400
3900141
Dr A. O. Aganga
5330671
5332259
Dr G. S. Maphanyane
3668135
3928965
Dr M. Manthe-Tsuaneng
3668169
3928965
Mr M. Kemo
3661875
3928965
Ms A. Fernandes
3974351
3974354
Dr S. Mpoloka
3552594
3185097
Dr E. Peloewetse
3552604
3184747
Ms M. Kriger
B. Matlhaga
3947047, 3947363
3947029
3950242 3900763
Dr I. Ndzinge
3914121
Dr O. Mine
Mr M. Motladiile
8184635, 3901284
3914106
3974557 3914259
Ms J. Ditlhong
3902050
3902051
Mr E. K. Maloiso
3902050
3902051
25
3914121
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
Food & Agricultural Organization
Box 54, Gaborone
Botswana Agricultural Union
Farmer
Farmer
Agricultural Resources Board
P/Bag 003, Gaborone
Agricultural Information Services
P/Bag 003, Gaborone
Department of Non-formal Education
P/Bag 0043, Gaborone
Dept. of Curriculum & Evaluation
P/Bag 005 Gaborone
National Museum & Botanical
Gardens, P/Bag 00114, Gaborone
Department of Agricultural Research
P/Bag 0033, Gaborone
Department of Agricultural Research
P/Bag 0033, Gaborone
Department of Agricultural Research
P/Bag 0033, Gaborone
Botswana College of Agriculture
P/Bag 0027, Gaborone
Botswana College of Agriculture
P/Bag 0027, Gaborone
The Writer Magazine
P/Bag BO 102, Gaborone
Dept. of Information & Broadcasting
P/Bag 0060, Gaborone
Phala Scientific
Wave Sanitation Services
Box 80073, Gaborone
Dept. of Animal Health & Production
Dept. of Crop Production & Forestry
BOCOBONET, Gaborone
NFRTC, P/Bag 008, Kanye
NFRTC, P/Bag 008, Kanye
NFRTC, P/Bag 008, Kanye
NFRTC, P/Bag 008, Kanye
NFRTC, P/Bag 008, Kanye
Dept. of Agric. Planning & Statistics
P/Bag 003, Gaborone
National Veterinary Laboratory
P/Bag 0035, Gaborone
Sanitas Nurseries & Garden Centre
Box 606, Gaborone
Mr D. Thibe
3952121
3956093
Mr B. S. Masilo
Mr B. Lekoma
Mr J. Maseng
The Secretary
3900961
5486290
5300875
3950500
3975805
Mr O. Monthe
3950571
3956027
Ms C. M. Matlapeng
3656300
3913199
Mr T. B. Selema
3973842
Mr N. E. Mosesane
3952990
3647500
3973860
3911186
Dr P. O. P. Mosupi
3668112
3928965
Dr J. Macala
3153068
3928965
Mr T. Ofentse
3668100
3928965
Mr S. Ramabu
3650100
3928753
Mr S. Ngwako
3650100
3928753
Mr E. Moloi
3170209
3165453
Daily News
3635001
3900051
Ms J. Tshabang
Mr K. Meswele
3952729
3162999
3974327
3931928
E. Bodika
Ms R. L. Kgosi
Ms
B.
SekhuteBatungamile
Dr B. V. Kgarebe
Mr J. Wambete
Mr B. T. Bulawayo
Ms N. T. Mlobeli
Ms D. Motsisi
Mr S. Dambuza
3950500
3185081
3185081
3956027
3185081
3185081
5440441
5440713
3950572
3975805
Dr E. Baipoledi
3928816
3928956
Dr G. F. Nilsson
3952538, 3907143
3931358
26
Annex 3: Opening speech by the Deputy Permanent Secretary, Ministry of Agriculture,
Dr M. Chimbombi
It is my pleasure and honor to be here on the occasion of the First National Consultative
workshop on biosafety, which will contribute towards the development of the Biosafety
Framework for Botswana.
Your participation in this workshop is as sign of your commitment and dedication to the
provision of an adequate level of the safe transfer, handling and use of Living Modified
Organisms (LMOs) or Genetically Modified Organisms (GMOs) resulting from modern
Biotechnology.
I cannot overemphasise the importance of Biosafety, which is the subject of your workshop.
However, I cannot talk about Biosafety without first discussing Biotechnology.
Biotechnology is any technology application that uses biological systems, living organisms,
or derivatives thereof, to make or modify products or processes for specific use. This, in a
broad sense covers many tools and techniques for agricultural, industrial, medicinal and
environmental purposes. Biological processes using microorganisms have been used over
the years with the process of fermentation to make food products such as wine, bread,
yoghurt and cheese. This is now referred to as the first generation biotechnology. The
narrow sense of Biotechnology considers tissue culture, new DNA techniques, molecular
biology and reproductive technological applications such as gene manipulation, gene
transfer, DNA typing and cloning of animals and plants. This is often referred to as the
second generation Biotechnology and the emphasis is on modern biotechnology.
Modern Biotechnology is a very powerful tool that offers opportunities to mankind. Several
opportunities exist in medicine, industry, environment and agriculture. There are a number
of developments that are of commercial application in agriculture. Transgenic varieties and
hybrids of cotton, maize and potatoes containing genes that effectively control some of the
serious insect pests in the world are in commercial use. The use of such varieties greatly
reduces the need for insecticide sprays and dusts. A lot of progress has also been made in the
development of transgenic plants of oil seed rape, soybean, sugar beet and wheat with
tolerance to a number of herbicides. Transgenic tomatoes and strawberries that have been
modified using a gene from a cold water fish to protect plants from frost are also now in the
market.
Many of you are aware of the use of Biotechnology in medicine, especially in the production
of insulin. A lot of people all over the world depend on this drug for survival. I am also
informed that microorganisms that degrade oil have been developed through modern
Biotechnology and these can play an important role in cleaning the seas and the environment
in the event of oil spills.
Therefore the Biotechnology industry has rapidly developed over a very short period to
become multi-million Pula industry-providing products in the areas of medicine, industrial
processing, veterinary, and food and agriculture.
27
Despite these rapid advances, modern Biotechnology has raised concerns about the possible
risks associated with its application, mainly to human health and the environment. I
therefore come back to biosafety, which is a term used to describe the safe application of
modern biotechnology. Biosafety refers to the safe and environmental sustainable use of all
biological products and applications for human health, biodiversity and environmental
sustainability in support of improved global food security.
The potential risks of GMOs to biological diversity and human and animal health are now
widely acknowledged. Of particular consequences are risks associated with the potential for
horizontal gene transfer, including the spread of antibiotic resistance marker genes that
would render infectious diseases untreatable; the generation of new viruses and bacteria that
may cause diseases; and harmful mutations which may lead to new diseases. The
introduction of transgenic crops to wild populations can negatively impact the recipient
populations and their ecosystems. I am informed that spontaneous hybridization can occur
between cultivated crops and their wild relatives across large areas of at least 1 km. Gene
flow resulting from hybridization can influence the genetic structure of populations by
counter balancing the effects of natural selection and genetic drift.
I am also informed that there are non-safety issues of concern with GMOs that are mainly
social and economic in nature. Socio-economic consequences are potentially severe, for
example, through the displacement of cash crops or traditional crops and disruption of small
scale farming systems that are prevalent in many developing countries like Botswana.
Ethical concerns are also of importance, as well as the issue of affordability and the impact
on trade. I hope you will take these into consideration during your deliberations.
These concerns and opportunities resulting from modern Biotechnology make it necessary to
develop appropriate policies and regulations to promote the safe use of the technology.
In 1992 during the Earth Summit in Rio de Janeiro, Brazil, the international community
approved chapter 16 of Agenda 21 that deals with the environmentally sound management of
Biotechnology and recognized two important facts, that:
1) Modern Biotechnology promised significant contributions to sustainable food production,
improved health care and environmental protection
2) The community at large can only then benefit maximally from the potential of modern
biotechnology, if it is developed judiciously and adequate safety mechanisms are set in place.
One of the key agreements adopted at the Earth Summit was the Convention on Biological
Diversity (CBD). The objectives of the convention are the conservation of biological
diversity, sustainable use of its components and fair and equitable sharing of the benefits
arising out of the utilization of genetic resources.
The convention addresses, in two different articles, the issue of biosafety, namely in article 8
about in-situ conservation and in article 9 about handling of Biotechnology and distribution
of genetic resources.
28
Article 8(g) lays down the obligation for Parties to establish or maintain means to regulate,
manage or control the risks associated with the use and release of Living Modified
Organisms (LMOs).
Article 19.3 calls upon Parties to consider the need for and modalities of a Protocol setting
out appropriate procedures, including, in particular, advanced informed agreement, in the
field of the safe transfer, handling and use of LMOs. It is on this basis that the Cartagena
Protocol on Biosafety to the Convention on Biological Diversity was developed.
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 in the conservation and sustainable use of biological diversity, taking into account
risks to human health, and specifically focusing on transboundary movement’.
The key elements of the Protocol include procedures on Advance Informed Agreement, and
for transboundary movement of LMOs that are to be intentionally introduced into the
environment and for LMOs that are intended to be used directly as food or feed or for
processing (LMOs)-FFP). The Party of import makes its decisions in accordance with
scientifically sound risk assessment. The Protocol sets out principles and methodologies on
how to conduct a risk assessment.
The Protocol also requires Parties to ensure that LMOs subject to intentional transboundary
movement are handled, packaged and transported under conditions of safety and are
accompanied by appropriate documentation.
Lastly, the Protocol also establishes a Biosafety Clearing House (BCH) to exchange
information, and contains a number of important provisions including capacity building,
financial mechanisms, compliance procedures, and public awareness and participation.
As you know, Botswana has signed and ratified the Convention on Biological Diversity as
well as the Cartagena Protocol on Biosafety. Consequently, Botswana is bound by the
requirements of the Protocol. Botswana exists in a dynamic global world where modern
Biotechnology is rapidly being adopted. Therefore there is no doubt that sooner or later,
Botswana may apply modern Biotechnology in different areas of development in order to
meet the needs of its people. It is therefore imperative that mechanisms are put in place to
regulate such applications and a national biosafety framework is developed.
During the two days you will be gathered here to deliberate on the elements to be included in
the national biosafety framework for Botswana, which will ensure that Botswana can protect
its people and the environment from the potentially hazardous products of modern
biotechnology.
I wish you fruitful deliberations and I am confident that your workshop will provide the
relevant policy and decision makers with the necessary advice in order to formulate a
framework for biosafety for our country. I therefore urge you all participants to freely and
29
constructively contribute to the workshop in order to ensure that positions on key issues of
interest are adequately covered and well articulated for challenges before us.
Let me end by expressing confidence for the best outcome of your workshop.
Last but not least, I would like to thank the United Nations Environment Programme (UNEP)
and the Global Environment Facility (GEF) for generously providing funds for the
development of our National Framework on Biosafety. I also thank all the institutions
represented in the National Coordinating Committee on Biosafety for providing competent
members to the committee, which has been giving valuable technical advice to the
Competent National Authority – the Department of Agricultural Research on issues relating
to Biotechnology and Biosafety. Finally I thank you all participants for having spared your
valuable time for this workshop.
It is now my honor to declare the workshop officially open.
PULA
PULA
PULA
30
Appendix 4: Group-work guidelines
A.
NATIONAL POLICY/STRATEGY
Objective:
To make proposals for a national policy on biotechnology to be drafted and
adopted at the highest level, highlighting national priorities, expectations of benefit,
guidelines for responsible and safe use, and designating responsibilities. Stakeholders should
help to identify the stated elements of the policy.
Elements of the biotechnology policy:
B.
a.
Guiding principles
b.
Existing national policies
c.
Obligations under existing international conventions
d.
National development objectives
e.
Biotechnology and Biosafety objectives
f.
Strategy for implementation
g.
Institutional framework
h.
Regulatory mechanisms
i.
Administrative structure
j.
Procedures for applications and review
k.
Research and development structures
l.
Risk assessment and management
m.
Containment standards
n.
Finance – who should pay and how?
BIOTECHNOLOGY AND BIOSAFETY BILL
Objective: To identify essential elements of legislation to be adapted to specifically deal
with biotechnology and biosafety issues and provide for a facilitative regulatory regime.
1. Interim measures - temporary law committing the country to implementation of the
protocol
2. Procedure for legislative process to implement conventions and protocols.
3. Permanent measures – act of parliament specific to biotechnology and biosafety, but
providing for regulations dealing with matters that include and go beyond protocol
requirements.
4. Control or regulation of development, handling, contained use, environmental release,
and introduction into the market, of LMOs and products of LMO origin.
The legislation needs to specifically deal with the questions of: 31
i)
What will be regulated?
ii)
How it will be regulated?
iii)
Who will regulate?
iv)
What is the current status of the regulatory environment?
v)
What is the potential cost of compliance with the regulations?
vi)
Who are the competent authorities and what should be the composition of the
committees?
vii)
How can the regulations be made flexible?
viii)
And, who has final regulatory approval authority?
The regulatory regime has to ultimately achieve the objectives of assuring:a)
Facilitation of research, nurturing of innovation and limitation of liability
b)
Safety of workers in biotechnology facilities, regulate deliberate release
and prevent accidental release into the environment
C.
c)
Protection of biotechnological inventions (intellectual property)
d)
Labeling, consumer protection and public information, and
e)
Beneficial trade in biotechnology products and strategic assets
HANDLING OF NOTIFICATIONS AND REQUESTS
A new regulatory authority for biotechnology, created under the biotechnology bill should
also take on the functions of registration of notifications and requests.
Requests procedure should specify how to deal with first and subsequent transboundary
movements of LMOs, and any specific elements to be included in forms for notification and
requests.
How to deal with LMOs-FFPs.
Identification of primary entry points; referrals to BCH.
Liaison with relevant stakeholders and regulators in neighbouring countries to make the
identification of products as ‘may contain’ LMOs routine. (Article 18)
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MONITORING AND INSPECTION
D.
Establishment of a system of monitoring and inspection of imports from parties and nonparties, to restrict all movement LMOs and products of LMO origin to the AIA procedure.
The system should ensure that no products are currently on the market without decisions
regarding such having been communicated to the BCH.
1.
2.
3.
4.
5.
E.
Existing inspectors
Compliance
Application and permit procedure
Field, lab, practices, claims
Validity of permits
PUBLIC PARTICIPATION
Development of mechanisms to facilitate public participation, awareness and information on
biotechnology and biosafety issues in Botswana.
Issues to be resolved include:
1.
2.
3.
4.
5.
Timing of public notifications
Gazetting of applications, requests and notifications
Awareness and general knowledge about biotechnology
Medium of communication
Sustainability-funding, budgeting, interest of permanent competent authorities
33