The Regulation of Modern Biotechnology for National Development by Rufus Ebegba. Federal Ministry of Environment, Abuja

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1 The Regulation of Modern Biotechnology for National Development by Rufus Ebegba 1. Introduction: Federal Ministry of Environment, Abuja The development of the Nigeria requires various sustainable approaches. One of this approaches is the adoption of biotechnology as a tool for the improvement of the agricultural, industrial, health and environmental sectors of the economy. With the advent of modern biotechnology which is an advance form of biotechnology, genetically modified Organisms (GMOs), and products thereof, coupled with their perceived adverse impacts on the environment and human health, Nigeria joined the league of nations that took precautionary safety measures by signing and ratifying the Cartagena Protocol on Biosafety. The consciousness to regulate modern biotechnology started when researchers became competent in modern biotechnology research and apprehension of possible adverse impacts of the technology and its products on the environment and human health became pronounced. Moreover, Nigeria is endowed with enormous biodiversity, which requires conservation and sustainable utilization. The regulation of modern biotechnology seeks to harness the potentials the technology has to offer in the field of improved food production, medicine/health, Industrial growth and environmental protection. 2. Modern Biotechnology: Modern Biotechnology entails: a) In-vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into the cells or organelles: or b) Fusion of cells beyond the taxonomic family that overcomes natural physiological reproductive or combination barriers and that are not techniques used in traditional breeding and selection. Modern Biotechnology has been identified as an important tool that can help nations to achieve food sufficiency/food security, industrial growth, health improvement and environmental sustainability as earlier stated. Specifically Modern Biotechnology can do the following in agriculture: Produces plants that can reduce Green House Gases thereby reducing effect of Climate Change. Develop plants that have greater tolerance to stress in marginal environment Improve growth and productivity Improve food quantity, quality, nutritional improvement and consistency for healthy living

2 Produce new breeds of food Reduced use of pesticides and herbicides, Reduced farming land area. The practice of the technology, handling and use of Genetically Modified Organisms and products thereof are however perceived to possess some adverse impacts on the environment and human health. After the adoption of Biotechnology policy in 2001 as an alternative tool to achieve the objectives of biotechnology for national development, a National Biotechnology Development Agency was established in 2001 to actualize the policy. As laudable as modern Biotechnology has been found to be, there is limited public awareness on the technology s basic applications, opportunities, utility and its safe use as well as perceived risks associated with the technology and Genetically Modified Organisms which are out puts of the technology. With the concern of the potential adverse impacts that modern biotechnology, genetically modified Organisms (GMOs), and the products thereof may pose on the environment and human health, the Nigerian government has put in place an appropriate draft legal instrument known as the Nigeria National Biosafety Bill to ensure that the practice of the technology is carried out in a responsible and safe manner. This is to protect our enormous biodiversity, which requires conservation and sustainable utilization in addition to protect human health. This is based on the tenets of Biosafety. 3. Biosafety: Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from modern biotechnology, GMOs and products thereof. Biosafety is, therefore, intended to : minimize or eliminate the possible harmful effects of Modern biotechnology on the environment, biodiversity and human health using, policies, laws and guidelines determine in advance when hazards to human health and natural systems will result if any particular GMO is released into the environment; anticipate when a given GMO or any of its product(s) will be harmful if it becomes part of human food; discern whether a GMO will actually yield the benefits it was designed to provide; and make as certain as possible that hazards will not arise when GMOs are transported intentionally or unintentionally, between different ecosystems and countries. The Biosafety mission of Nigeria is to promote the basic tenets of biosafety as enunciated in the Cartagena Protocol on biosafety and to enforce Nigeria s National Biosafety Regulatory Regimes to ensure the safe application of modern biotechnology, use of GMOs and their products in order to balance the need for modern biotechnology. The Biosafety vision of Nigeria s is to ensure that the practice, processes and procedures of modern biotechnology are undertaken within the limits of a regulatory system that guarantees its

3 safe use, protects Nigeria s biodiversity, and provides minimum risk to human health and the environment. The Federal Ministry of Environment as the National Focal Point and Competent National Authority on Biosafety in Nigeria, has the mandate to regulate the practice of modern Biotechnology, handling transit and use of Genetically Modified Organisms and products thereof to ensure their safety to the Environment and human health. 4. The need for Nigeria to Regulate Modern Biotechnology practice, GMOs and products thereof: The regulation of the practice of modern biotechnology, GMOs and products thereof is to ensure environmental and human safety in addition with socio-economic consideration while harnessing the benefits associated with the practice of modern biotechnology and its outputs. Specifically the regulation is to: exercise the sovereign right over all her natural resources and authority to regulate access to such resources. harness the potentials modern technology has to offer in the field of improved food production, medicine/health, Industrial growth environmental protection, job and wealth creation. allay the fear of the populace on the socio-economic consequences of modern biotechnology, especially among the small scale farming systems that are prevalent in Nigeria. reaffirm Nigeria s commitment to the principles of the World Trade Organization (WTO) agreements, especially technical barriers to Trade (TBT). reaffirm Nigeria s commitment to the goals and objectives of the convention on Biological Diversity (CBD), and the Cartagena Protocol on Biosafety which Nigeria has signed and ratified. give confidence to the practice of modern biotechnology,use and handling of GMOs and products thereof. There is currently a lot of concern regarding the possible toxicity and allerginicity of food products derived from GMOs. The regulation is, therefore, to minimize risks to human, There are equally concerns on the environmental consequences of the release of GMOs into the environment, in particular the effects on biological diversity. 5. Developmental stages of Biosafety Regulation in Nigeria: Modern biotechnology regulation in Nigeria started in the early 1990s as researchers in biotechnology became competent in modern biotechnology practice and when the need for precaution in the development of modern biotechnology became glaring globally particularly among the scientific community in advanced world. The development of a Biosafety legal regime in Nigeria has followed an evolutionary pattern.each successive step being an improvement on the preceding level, while taking cognizance of our national and international obligations in the field of Biosafety.

4 a. The Cartagena Protocol on Biosafety: The Convention on Biological Diversity (CBD), which Nigeria signed in 1992, identified Genetically Modified Organisms (GMOs) or Living Modified Organisms (LMOs) as a group of items produced by modern biotechnology that needed special attention because of their potential adverse impacts on biodiversity and human health The Convention, therefore recommended that a protocol to control the trans - boundary movement of GMOs be negotiated as soon as possible. An instrument, the Cartagena Protocol on Biosafety (CPB) was eventually negotiated and became available for signature in It was signed by Nigeria in 2000 and its instrument of ratification was signed by the President on 30th November, The protocol came into force on the 11th of September, The protocol s major plank is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on conservation and sustainable use of biodiversity, taking into account risks to human health and specifically focusing on trans-boundary movements. b.biosafety Guidelines: i) 1994 Biosafety Guidelines: These guidelines only covered agricultural modern biotechnology, and were not actually approved by the government. These guidelines were developed before the advent of the Cartagena Protocol on Biosafety (CPB) as such was not consistent with the protocol. ii) 2001 Biosafety Guidelines:. These guidelines were approved by the Federal Executive Council as a fast track approach to encourage research and development of GMOs and the regulation of modern biotechnology in the country, having signed an internationally binding protocol These guidelines are more encompassing in all biosafety issues beyond modern agricultural biotechnology and in line with the Cartagena Protocol on Biosafety The biosafety guidelines, however, cannot be said to be legally binding, consequent upon this, there was the need to develop a policy and law in biosafety that would address the subject of regulating modern biotechnology in a more robust and encompassing manner The Federal Executive Council approved the development of a bill on biosafety and a national committee was inaugurated in 2002 for that purpose.

5 6. Development of National Biosafety Framework (NBF): In recognition of the role of the Federal Government of Nigeria in the protection of human health and the environment (Biodiversity) from potential risks that may arise from the practice of modern biotechnology and the handling and use of its products, the Federal Government inaugurated a National Coordinating Committee to draft the National Biosafety Framework under the UNEP/GEF Development of National Biosafety Framework project on the 2nd of December 2002 which produced Biosafety Bill and Policy in Draft Nigeria National Biosafety Bill: The overall objective of the draft biosafety Bill is to provide a regulatory regime and guidance for the sustainable development of modern biotechnology, its application and safe use of GMOs and the products thereof without prejudice and risk to public health, environmental health, national sovereignty, human dignity and fundamental human rights. The Draft Nigeria National Biosafety Bill arrived the National Assembly in January 2009 and it has passed through the first and second readings and public hearing at the House of Representatives. Its due for the final reading at the House.The Bill covers all modern biotechnology activities - genetically modified organisms and other products of modern biotechnology, including all germplasm. The Biosafety bill: Defines modules of practice of modern biotechnology and the handling of its products (GMOs) to ensure safety to the environment and to human health. Intends to guide different segments of society in contributing to safe application of modern biotechnology. Recognizes the complex issues to be addressed by central authorities in the judicious application of modern biotechnology. Ensures that modern biotechnology activities and their products (GMOs) are safe for the environment and to human health. bases the deliberate release of GMO on advance informed agreement defines responsibilities among designated bodies/institutions. contains powers to authorize release of GMOs and practice of modern biotechnology activities. confers power to carry out risk assessment/management defines offences and Penalty for violation of the act covers all genetically modified organisms/living modified organisms, products food/feed and processing. covers socio-economic consideration in risk assessment, labeling of all GM products has 8 parts: i Establishment of a biosafety Management Authority ii Functions of the Authority: iii Establishment and Composition of National Biosafety Committee (NBC): iv - Establishment and Composition of National Biosafety Technical Subcommittees: (agriculture, health, industry and Environment)

6 v- Request and Authorization, vi - Risk Assessment and Risk Management, Vii - Offences, Enforcement Powers, Failure to obtain approval or permit before import or release of GMOs into the Environment carry the following penalties: Individuals can be fined N2.5m or imprisonment for a period not less than 5 years or both; Body corporate would pay a fine of not less than N5m and the directors or officers of the body shall each be liable to a fine not less than N2.5m or imprisonment for a term not less than 5 years or to both such find and imprisonment. False information same penalty as failure to obtain approval. Obstruction N2.5m fine or imprisonment for not less than 3 years or both. General Penalty same as above. = viii Miscellaneous Provisions. Schedules: Power to make Regulations. Modification, etc. of the Schedules to this Act. Inconsistency of other laws with this Act Interpretation. short title: National Biosafety Act,2007 There are 4 schedules: i) Required Information to be contained in the application for approval or permit. ii) Additional Information Required in the case of Notification for Placing on the Market. iii) Risk Assessment Parameters iv) Risk Management plans 8. The implications of the delay in the passing of the Nigeria National Biosafety Bill into Law: The consequences of the delay in passing the biosafety bill into law on the Environmental, human health and on our economy may be unquantifiable, which might pose serious threat to our national security, particularly now that Modern Biotechnology has come to occupy a center stage globally in nearly all facets of human endeavour. Specific implications are: The delay in passing the bill into law will militate against incentives in the use of modern biotechnology in various sectors of the economy. It will greatly hamper responsible Research and Development in Modern Biotechnology. There will be apprehension among the populace on the socio-economic consequences of modern biotechnology and GMOs, especially among the small scale farming systems that are prevalent in Nigeria. Since there will be no law to protect them.

7 Another scenario is that farmers might result to the smuggling of GMO seeds they consider that will enhance their earning. Nigeria s commitment to the goals and objectives of the convention on Biological Diversity (CBD), and the Cartagena Protocol on Biosafety which Nigeria has signed and ratified will be seen to be lacking. Generation of Employment and wealth creation in the Modern Biotechnology industry will be lacking. If there is no biosafety law Nigeria will not be able to guarantee the purity of its agricultural products for the international market, there by losing her international partners and also foreign earning. Brain and brain decay will take place Nigeria will be denied the opportunity to harness the potentials modern technology has to offer in the field of improved food production, medicine/health, Industrial growth and environmental sustainability, There will be lack of confidence in the practice of modern biotechnology and its products. Nigeria will serve as a dumping ground for unregulated Genetically Modified Organisms which may have adverse impact on our Environment and human health, Nigeria will not be able to exercise the sovereign right of protecting her natural resources and authority to regulate access to such resources. It should be noted that in the absence of law offence cannot be said to have been committed. the Cartagena Biosafety Protocol which Parties, including Nigeria signed and ratified requires parties to develop national administrative and legal Biosafety frameworks to address their national need. Therefore the absence of a biosafety law will amount to Nigeria breaching the Cartagena Protocol on Biosafety it has signed and ratified. Nigeria might face international sanctions for failing to abide by international agreement (,CPB,) The delay in passing the Biosafety Bill into law will make it difficult to address the following Biosafety concerns :.. a, Environmental safety. gene flow (of GMOs will contaminate our indigenious crops). invasiveness (of GMOs might become predominant). non-target organisms. other effects on ecology and dynamics b.food/feed safety/human health. Nutrition. Allergy. Toxicity. Substantial equivalence c. Agricultural sustainability. Weediness. pest resistance development. chemical imputs. Higher Costs. Others ( Socio-Cultural, acceptability etc) The way forward on the passing of the Nigeria National Biosafety Bill into Law : All stakeholders must as a matter of great priority support the passing of the Biosafety Bill into law.

8 The Members of the National Assembly should give the debate on the biosafety Bill and the passing of it into law its desired attention., Research Institutes/Scientists dealing in Modern Biotechnology and GMOs should enlighten the public on the importance of modern biotechnology and its products. The Mass medial should make conscious effort to publicize the Biosafety bill and its imperative to national development Research Institutes/Scientists dealing in Modern Biotechnology and GMOs should pool resources together to ensure support for the passing of the Biosafety Bill into law Public confidence through awareness on the Bill should be built by the relevant Institutions and stakeholders 9. The interim regulatory arrangements : The following regulatory measures and documents are in place: i) The use of Cartagena protocol on Biosafety ii) The use of the Nigeria National Biosafety Guidelines to process biosafety applications, iii) Biosafety application form iv) Biosafety Containment Facilities Guidelines v) Any Institute that intends to practice modern biotechnology or deal on GMOs must seek accreditation of the Institute and certification of its Biosafety containment t Facilities, vi) Review of biosafety application by National Biosafety Committee, vii) Guidelines for Confined Field Trials viii) Monitoring and Inspection Manuals ix) GMOs import/ship form. 10. Biosafety Regulation in Africa The issue of biosafety regulation in Africa is rapidly gaining momentum as more African countries are embracing GMOs. Nigeria must take a leader in biosafety regulation in Africa taking into consideration the large size of its population and biodiversity endowment. Nearly all African countries have signed and ratified the Cartagena Protocol on Biosafety and also developed their bills and some are already passed into Laws. South Africa already has a biosafety law and is currently growing and consuming GM Corn and cotton. Kenya also recently passed a biosafety law and is currently carrying out GM Potato field trials. Egypt also has Biosafety law.mali and Burkina Faso, in West Africa, also has Biosafety laws and Burkina Faso is presently carrying out GM cotton Confined field trials/commercial release. The African Union has developed a model biosafety law to assist member states develop their biosafety laws which was made reference to in the development of the draft Nigeria National Biosafety Bill. To further strengthen biosafety system in Africa, the NEPAD-African Biosafety Net work of Expertise project has been put in place to develop the capacity of member states in biotechnology and Biosafety.

9 In addition the ECOWAS Commission is currently developing a common Biosafety regulation in line with National Biosafety laws/regulations for the sub-region. This is due to the fact that Africa has embraced modern biotechnology. More also West Africa states have common boarders and free trade that may be very difficult to monitor 11Conclusion: The development of Nigeria s Biosafety Regulatory System has evolved from one stage to another taking cognizance of our national responsibility of protecting the environment, human health and our socio-economic interest from possible impact of the practice of modern biotechnology, handling, transit and use of genetically modified organisms and products thereof. So far the experimental GMOs. confined field trials in the country have been under strict biosafety conditions. The application of safe practice of modern biotechnology as an alternative tool to achieving national economic growth cannot be over emphasized. The passing of the Biosafety bill into law will serve as catalyst for responsible and safe practice of modern biotechnology for the enhance of our National economic growth by opening up our research potentials for product development and deployment. Nigeria cannot afford to sit on the fence in the regulation of the Practice of Modern Biotechnology. handling and use of GMOs for national development. Thank you.