NATIONAL BIOSAFETY AUTHORITY (NBA) Presentation on the status of Biotechnology and Biosafety in Zambia Filipo Zulu Curriculum Development Centre Building Haile Selassie Road Longacres P.O. Box 51309 Lusaka Tel: 2554558/257196 Fax: 257194
Introduction Convention on Biological Diversity - CBD Zambia signed the CBD on 11 th June, 1992 and ratified it on 28 th May, 1993 Triggered work on drafting of relevant Policy framework (Biotechnology & Biotechnology Policy of 2003) Cartagena Protocol On 7 th April, 2004, Zambia acceded to the Cartagena Protocol on Biosafety (CPB) and the CPB came into force on 25 th July, 2004 This Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health
POLICY AND LEGISLATIVE ENVIRONMENT FOR BIOTECHNOLOGY & BIOSAFETY IN ZAMBIA Mission: The Biotechnology & Biosafety Policy of 2003 The mission of the Biotechnology and Biosafety Policy is to guide the judicious use and regulation of modern Biotechnology for the sustainable development of the nation, with minimum risks to human and animal health as well as the environment. Objectives: To support the development of research and industrial capacity to safely apply biotechnology techniques for the enhancement of Zambia s socio-economic and environmental well being.
Policy Environment for GMOs in ZAMBIA (Cont.) Guiding principles: The Precautionary Principle Advanced Informed Agreement Recognition of undesirable effects of GMOs Risk assessment Socio-economic impact Public participation Liability and redress Recognition of possible conflict between conservation of biodiversity and trade Recognition of rights of both developers and innovators over genetic resources and technologies.
The Biosafety Act No. 10 of 2007 The scope of Biosafety Act No. 10 of 2007applies to the; Research Import Development Export Contained use Release or placing on the market Whether intended for ANY GENETICALLY MODIFIED ORGANISM Release into the environment Use as a pharmaceutical Food Feed Processing or, Product of a genetically modified organism
The Biosafety Act No 10 of 2007 continued An Act to ensure that any activity involving the use of any genetically modified organism or a product of a genetically modified organism prevents any socio-economic impact or harm to human and animal health, or any damage to the environment, non-genetically modified crop and biological diversity; set and implement standards for the assessment, evaluation and management of any potential risk involving the use of any genetically modified organism or product of a genetically modified organism;
Cont d. establish the National Biosafety Authority and prescribe its powers and functions; provide for the establishment of the Scientific Advisory Committee; provide for Public participation, information and consultation in the field of biosafety; provide for a mechanism for liability and redress for any harm or damage caused to human and animal health
NBA COMPOSITION: The NBA comprising 13 members was appointed by the Minister of Education, Science, Vocational Training and Early Education (MESVTEE) in July, 2013, and include the following: 1 from Ministry responsible for Science & Technology 1 from Ministry responsible for Environment and Natural Resources 1 from Ministry responsible for Agriculture 1 from Ministry responsible for Health 1 from Ministry responsible for Commerce, Trade and Industry 1 from Ministry responsible for Information 1 from Ministry responsible for Justice 1 from Consumer group 1 from Religious group 1 from Farmer group 1 from Traditional Authority 2 other persons
FunctionsNational Biosafety Authority : 1. Receive, respond to and make decisions on any notification and application, in consultation with the Scientific Advisory Committee, in accordance with the requirements of the Act; 2. Establish administrative mechanisms to ensure the appropriate handling, dissemination and storage of documents and data in connection with the processing of applications and notification and other matters covered by the Act; 3. Promote public awareness and education concerning the activities regulated under this Act, through the publication of guidance and other materials that explain and elaborate on the risk assessment, risk management and authorization process; 4. Establish and maintain a data base on genetically modified organisms and products of genetically modified organisms intended for direct use as food, or feed, or for research and production processing and make available such information to the public;
NBA Functions: cont d 5. Prescribe criteria, standards and guidelines as may be necessary for the implementation of the provisions of this Act; 6. Take into account the policy recommendations and other guidelines of the Scientific Advisory Committee in making decisions on the import, export, development, transit, research, contained use, release or placing on the market of any genetically modified organism or product of a genetically modified organism; 7. To cause to establish and appoint members of institutional biosafety committees at relevant institutions and constitute any other organ of experts, as appropriate, as technical and scientific advisors on issues of biosafety; 8. To keep any genetically modified organism or product of a genetically modified under review and where the NBA has reasonable grounds to believe thereof poses any risk to human and animal health, biological diversity or the environment, to ban its transit, import, export, development, research, use or release in Zambia;
NBA Functions: cont d 9. Review or have made a risk assessment of any genetically modified organism or product of any genetically modified organism; 10. Take any measures to protect human and animal health, biological diversity and the environment from risks that may be posed by any genetically modified organism or product of any genetically modified organism; 11. Designate inspectors and undertake inspection as well as any other control measures to ensure compliance with this Act; and 12. Carry out any other activity which is necessary or conducive to the performance of its functions under this Act. 13. The NBA shall serve as the National Biosafety Focal Point and receive, process and respond to information and notification from the Secretariat of the Cartagena Protocol on Biosafety 14.
Scientific Advisory Committee (SAC) Provide scientific & other technical advice and assistance to the Authority (Board) Conduct Risk Assessment Membership Agronomy, Breeding & Genetics, Weed Science, Ecology, Entomology, Pharmacoloy, Toxicology, Virology, Micobiology, Pathology, Food science, Molecular biology,
Current National Capacity for Surveillance, Importation, Identification and Use of GMO Ministry of Agriculture and Cooperatives (MACO): Zambia Agriculture Research Institute (ZARI); Plant Quarantine and Phytosanitary Services Plant Pest and Disease Act No. 233 and Noxious Weeds Act No. 231 Seeds Act Plant Breeders Act Ministry of Health (MOH): Public Health/Importation of Food & Pharmaceautical Products Food & Drug Act Ministry of Local Government: Public Health The National Biotechnology Reference Laboratory under NISIR
Continued. Zambia has built a National Biotechnology Reference Laboratory which is being used for GMO testing; Skilled manpower has been, and is still being trained, recruited as part of human resource capacity building. This is a continuous activity because of the nature of issues dealing with modern biotechnology and the development of biotechnology/gmos require experts in different fields.
Current Status of the NBA NBA Board in place and functional Scientific Advisory Committee (SAC) in place and functional The interim secretariat in place/ Permanent Secretariat to be operationalized early 2015 National Biosafety Clearing House Focal Point Person in place Technical Activities such as inspections, receipt & evaluation of permit applications being handled. Currently handling 10 permit applications for importation of GMOs/ Products of GMOs Interactions with key stakeholders such as industry, research institutions, green groups and the academia scaled up through various initiatives such as workshops, seminars etc Mapping/Survey of GMO presence/absence /detection
Current Status of the NBA (Cont.) The following draft Guidelines and Regulations have been prepared and : Approved by Government : Regulations: The Biosafety (Genetically Modified Organisms for food, feeds, and processing) SI No 42 of 2010 Awaiting submission to the Ministry of Justice Regulations: The Biosafety (importation of Genetically Modified Organisms for field testing, propagation and contained) use; Regulations: The Biosafety (Exemption of Genetically Modified Organisms) Approved Guidelines by the NBA Guidelines: Public participation, information sharing and access to justice with respect to Genetically Modified Organisms and products of Genetically Modified Organisms; Guidelines: Field work and planned release of Genetically Modified Organisms;
Challenges: Insufficient number of staff trained Misinformation Inadequate awareness on Modern Biotechnology Slow processes in getting specific legislative approval for certain proposed Regulations. Inadequate infrastructure to effectively support GMO research Absence of adequate in-country inspectors difficult to detect consignments that enter through unmanned entry points Start up challenges with inter agency colloboration
Thank for your kind attention