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Legal Aspect of Biosafety in Tanzania
Legal Aspect of Biosafety in Tanzania
Project : Capacity Building of Regulatory Agencies for Safe Handling of Modified Plants and Plant Materials in Tanzania. (TCP/URT/3102)
Genetically
Food and Agriculture Organization of the United Nations Developed by George Mandepo, International FAO Consultant Legal Officer Ministry of Agriculture Food Security & Cooperatives United Republic of Tanzania
January 2007
Table of contents
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2.1 International Instruments that aim to ensure development/ promotion and transfer of technology (IPR regime) 7
A) CONVENTION ESTABLISHING WORLD INTELLECTUAL PROTECTION ORGANIZATION (WIPO) .............................................................................................................. 8 B) UNION FOR THE PROTECTION OF PLANT VARIETIES (UPOV) ................................ 9
3.0 Section 3 - International Trade regimes Versus Modern Biotechnology in the Developing countries .................. 24 4.0 4.1 4.2 Section 4 National Policies and legislation related to Biotechnology/ Biosafety in Tanzania ................... 27 Implementation of International Agreement in Tanzania ............................................................................. 28 Relevant Policies for regulation GM technology and biosafety .................................................................... 30
4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.3 4.4 4.5 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5 4.6.6 4.6.7 4.6.8 4.6.9 4.6.9.1 4.6.9.2
Draft Tanzanian Biotechnology Policy ......................................................................................................... 30 National Trade Policy 2003 .......................................................................................................................... 30 The National Environmental Policy (1997) .................................................................................................. 30 National Science and Technology Policy for Tanzania (1996) ..................................................................... 31 The National Forest Policy 1998................................................................................................................... 31 National Agriculture and Livestock Policy ................................................................................................... 31 National Biosafety framework ...................................................................................................................... 31 National Biosafety Forum ............................................................................................................................. 32 Weakness of the existing biotechnology and biosafety framework .............................................................. 33 Legal Instruments relevant for GM technology and Biosafety regulation in Tanzania ............................... 34 Constitution of the United Republic of Tanzania .......................................................................................... 34 Tanzania Food, Drugs and Cosmetics Act No.1 of 2003 .............................................................................. 34 The Industrial and Consumer Chemicals (Management and Control) Act No 3 of 2003 ............................. 35 The Environmental Management Act, NO. 20 0f 2004 ................................................................................ 35 Forestry Act No 10 0f 2002 .......................................................................................................................... 39 The Plant Protection Act No. 13 of 1997 ...................................................................................................... 39 The Seed Act No.18 of 2003 ......................................................................................................................... 39 Animal Diseases Act No. 17 of 2003 ............................................................................................................ 40 Intellectual Property Rights legislation. ........................................................................................................ 40 Patents (Registration) Act No. 1 of 1987 ................................................................................................. 40 The Plant Breeders Act No.22 of 2002 .................................................................................................... 41
What this Section is about The objective of this Section is to just to give in a nutshell an introduction to GM technology and Biosafety. Aims of this Section To provide some background information for the GM technology and Biosafety in the legal context.
What you will learn Background for GM technology and biosafety in the context of the existing international agreements . Rationale for international, regional and national biotechnology/ biosafety legal framework.
The potentials of modern biotechnology in improving agricultural, industrial, and health sectors as well as environmental conservation cannot be overemphasized. For the developing countries like Tanzania, advances in the GM technology hold great promise for addressing key challenges in agriculture, human health and the environment. However, there are concerns over the potential adverse effects of modern biotechnology to human health and the environment. In view of this reality, various international and national institutional and legal frameworks have been developed in order to facilitate adaptation of new technology as safe form as possible. In the collective term, measures, policies and procedures for minimizing potential risks that GM technology may pose to the environment and human health are technically referred to as biosafety. Biosafety is concerned with regulatory aspects of GM technology. It embraces the safe introduction, handling and use of Genetically Modified Organisms.
Article 1 of the Convention on Biological diversity, as concluded in Rio de Janeiro on 5 th June 1992
The need to ensure food security for present and future generations, to conserve and sustainable use natural resources, to respect human rights, and to share the benefits of technology in an equitable manner, has resulted to the changes in policies and legislation in various part of the world. The term Biosafety is not expressly defined in reviewed international instruments. However, by impliedly construction of Cartagena Protocol to CBD, the terminology may means all policies and regulatory measures that intend to ensure that safely use of modern biotechnology.
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What this Section is about The objective of this Section is to examine how various international instruments attempt to regulate modern biotechnology. It discusses interaction between international trade and modern biotechnology in the developing countries. Aims of this Section To show how International Agreements/ Treaties impacting on modern biotechnology. To show what are the obligations of member countries to such international agreements. To identify challenges which developing countries have to comply with international agreements. To create awareness to the participants on the existing international instruments impacting on GM technology.
What you will learn Role of international Treaties in the GM technology and Biosafety regulation.
At the international level, there are number of international agreements that impacting on regulation of modern biotechnology. Some are primarily trade agreements whilst others are primarily concerned with protection of the environment and sustainability. The International legal instruments for GM technology can be categorized into three groups, namely: (a) Instruments that aim to ensure development/ promotion and transfer of technology by providing protection of innovations (Intellectual Property Rights); 6
(b) Instruments that provide for environmental protection and ensuring rational utilization and sustainable development of technology; (c) Instruments that facilitate trade and ensuring safety of products of modern biotechnology.
2.1 International Instruments that aim to ensure development/ promotion and transfer of technology (IPR regime)
The international instrument that aim to ensure development/ promotion and transfer of technology are the instruments which facility technological transfer by provided sort of incentive to the innovator, discovers or developers of a particular technology with view to compensate their material and mental efforts incurred in discovering such technology. The system referred to as Intellectual Property Protection (IPR).
Trade Marks have a small role, though important, as far as agricultural biotechnology is concerned. Trade Marks are relevant in identification of plant products such as seeds of a particular enterprise. They can convey to customers an indication of the quality of the products. Traders of new variety may want to use trademarks of a particular enterprise because of that enterprise known attributes or qualities. The IPR system in agriculture provides a way of ensuring the financial revenues required to make the technology profitable. In the modern biotechnology, IPR law has the following main objectives: (i) It provides legal rights to creators and innovators as a reward for investing time and energy in research and for their consequential achievements; (ii) By protecting rights of originators, it provides incentives for creativity and innovation and for economic, social and cultural progress; and, (iii)It is a legalized mechanism for the transfer of technology.
a)
World Intellectual Protection Organization (WIPO2) was established to encourage creativity through protection of intellectual property throughout the world through cooperation among States and, where appropriate, in collaboration with any other international organization. WIPO works to harmonise intellectual property rights, standards and legal provisions internationally. WIPO administers 23 international IP treaties. However it is not obligatory for member states of WIPO to be parties to these treaties. The treaties administered by WIPO fall into three categories: Intellectual Property Protection (defining internationally agreed basic standards); Global Protection System, including PCT; and Classification, systematising IP information. In the area of IPR relevant to biotechnology (patents), the most significant treaties are the The Patent Cooperation Treaty (PCT), 1970 (providing for a unified procedure for filing patent applications to protect inventions internationally) and The Patent Law Treaty (PLT) of 2000 (a multilateral treaty aims to harmonize formal procedures for a patent application). Under the
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Signed at Stockholm on July 14, 1967 and amended on September 28, 1979
referred Treaties, WIPO classifies the PCT as a global protection system treaty and it allows patents to be applied for through a single international route as an alternative to the submission of separate applications to each state in which the patent is desired. Through patent rights recognized under WIPO, in some countries, (for instance USA) a patent legislation is used to protect plant verities where by protection is for sexually reproduced plants (and genes, tools, methods to produce varieties). Another WIPO treaty relevant to the area of biotechnology is the 1977 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure. Under this Treaty, states that require deposit of the microorganism for which a patent is being applied must accept its deposit in an International Depositary rather than on a national basis.
b)
The objective of UPOV Convention is the protection of new varieties of plants by an intellectual property right by granting plant breeder rights to the innovators of new plant varieties. Under the Convention, the plant breeders right is granted where a variety is new (novel) and meets condition of Distinctness, Uniformity and Stability (DUS test). Under UPOV system of sui generis, any variety that fulfills the DUS criteria and that is new (in the market) is eligible for protection, and there is no need to demonstrate an inventive step or industrial application, as required under a patent regime. A DUS examination involves growing the candidate variety together with the most similar varieties of common knowledge, usually for at least two seasons, and recording a comprehensive set of morphological (and in some cases agronomic) descriptors.
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see http://www.wipo.int/edocs/prdocs/ en/2006/wipo_pr_2006_470.html The Convention was adopted in Paris in 1961 and it was revised in 1972, 1978 and 1991
The purpose of the UPOV Convention is to ensure that the member States of the Union acknowledge the achievements of breeders of new plant varieties, by making available to them exclusive property right, on the basis of a set of uniform and clearly defined principles.
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c)
The TRIPs Agreement is the first and only IPR treaty that seeks to establish universal, minimum standards of protection across the major fields of intellectual property. TRIPS set minimum standards which individual members may supplement. It covers the areas of copyright, patents, trademarks, geographical indications, industrial designs, integrated circuit designs and trade secrets. Particularly relevant to the field of biotechnology are the patent rules.
Article 27.1 of TRIPs provides that [...] patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application [...]. Under this Article, the terms "inventive step" and "capable
of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively.
Article 27.2 on the other hand envisages that certain inventions can be excluded by Members (of WTO) from patentability in order to protect [...] ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment [...]. In this regard, article 27.3. b permits Members to exclude from patentability [...] plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non biological or microbiological processes. However, this provision also stipulates that Members [...] shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.
It should be noted that TRIPS sets out minimum standards and does not prevent Members from increasing the rights and by implication introducing new intellectual property rights so long as these are consistent with the general TRIPS provisions. Through Article 27.3(b), countries could enact a plant varieties protection law based on patent, sui generis or any combination of those two regimes. Many countries members to WTO opted to enact their IPR law on PVP based on sui generis. Article 7 of TRIPs requires protection under IPR should contribute to the soci-economic development of a member country. It provides that the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
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do not refer to or incorporate any preexisting intellectual property agreements, including the 1978 and 1991 UPOV Conventions. This is opposed to other fields of intellectual property, such as patents, copyrights and trademarks, for which TRIPs expressly requires its members to comply with the standards of protection contained in preexisting IPR agreements some administered under World Intellectual Property Organization (WIPO), such as the Berne Convention for the Protection of Literary and Artistic Works and the Paris Convention for the Protection of Industrial Property. As a result of such omission on IPR on plant varieties, TRIPS members are neither required neither to become members of UPOV nor to enact national laws consistent with either UPOV Convention. Other members to WTO agreements still concerned that different national standards of protection would be an obstacle to free trade. There have been various trade discussions to review the provision of TRIPs Agreement, the TRIPS Council Meeting held in Doha Qatar in 2001 agreed upon the framework for a new round of trade negotiations. The Doha Ministerial Council suggested for the broadening the discussion on TRIPs to cover biodiversity and traditional knowledge. The topics raised in the TRIPs Councils discussions include: the pros and cons of various types of protection for new plant varieties (patents, UPOV,etc); how to handle moral and ethical issues and harmonization of TRIPs Agreement and the Biological Diversity (CBD).
2.1.2 Instruments that provide for environmental protection and ensuring rational utilization and sustainable development of technology.
The International that protect environment and ensuring rational utilization and sustainable development of technology are Convention on Biological Diversity (CBD), its Cartagena Protocol on Biosafety and FAO - International Treaty for Plant Genetic Resources for Food and Agriculture, 2001.
Article 1
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CBD defines genetic resources to mean any genetic material of actual or potential value. On the other hand, term genetic material is defined as any material of plant, animal, microbial or other origin containing functional units of heredity. The CBD provided for in situ conversation of plant genetic resources. Conservation in situ involves the preservation of ecosystems and natural habitats and the maintenance of viable populations of species in those settings. Conservation of resources occurs where farmers and indigenous communities safeguard traditional plant varieties in the locations where they grow naturally or are cultivated. The CBD provides guiding principles for the preservation of biodiversity and it requires that states carry out national biodiversity assessments and have conservation strategies. It has a 'clearing house' for exchange of information, which aims to give universal access to its database, country reports and scientific case studies. A Conference of Parties (COP) was established under CBD to deal with themed biodiversity programmes such as agricultural biodiversity and marine biodiversity and also with 'crosscutting' issues that include biosafety, access to genetic resources and intellectual property rights.
Although the CBD does not expressly deal with IPR agreements, it contains numerous provisions relating to IPRs. In particular, Articles 16(2)-(4) state that the transfer of technology and measures taken to gain access to such technology shall be consistent with the adequate and effective protection of IPRs recognized in international law. Thus, for example, where a government encourages foreign direct investment of industrial technologies (such as a biotechnological process used to insert new genetic sequences into existing plant varieties) it must respect any patent rights that the owner of that technology has acquired to protect it. Article 16(5) of CBD recognizes that patent and other IPRs may have an influence on the implementation of the CBD. Through this Article, member states are obliged to cooperate in order to ensure that IPRs are supportive of and do not run counter to the objectives of CBD. Furthermore, Article 11 of CBD calls on each contracting party to adopt economically and socially sound measures that act as incentives for conservation and sustainable use. This provision constitutes the very core of the relationship between IPRs and genetic resources, raising the question whether IPRs act as a positive or negative incentive for the conservation of genetic resources. It should be noted that indirect or direct appropriation of genetic resources (or products containing genetic resources or biologically derived materials, including synthesized products), especially through patents and plant breeders rights - PBRs, is, one of the main reason why Access and Benefit Sharing principles and rules were incorporated in the CBD as part of the great political bargain between developed and developing countries. CBD as one of the ABS instruments, seeks to ensure that access to biological and genetic resources is subject to certain conditions (sovereignty, mutually agreed terms, prior informed consent), which guarantee that benefits derived from the use of these resources are fairly and equitably shared among the user and the country providing them.
The Protocol entered into force on 11th September 2003. The Protocol was called the Cartagena Protocol on Biosafety after the city of Colombia where it was originally scheduled to be concluded and adopted.
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modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary9. The Protocol applies to all parties who are members to the Convention on Biological Diversity (CBD). The Protocol does not change the rights and obligations of parties under any existing international agreements and does not restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for under the Protocol, provided that such action is consistent with the objective and the provisions of the Cartagena Protocol (CPB).
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regulation may be done by placing the information on such regulation in the Biosafety Clearing-House (BCH).
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The aim of AIA is to promote a shared responsibility between exporting and importing Countries in protecting human health and the environment from the effects of the LMOs.
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Under the CPB, LMOs intended for direct use as food, feed or for processing are subject to a simplified form of the AIA procedure. The simplified procedure does not require information on the intended date or dates of transboundary movement, the quantity or volume of the LMO to be transferred, the regulatory status of the LMO in the Party of export, and previous notification about the LMO made to other Parties. It is assumed that this information may be made available through the BCH, where can be accessed by any Party who requires it.
Socio-economic considerations
Article 26 of the Protocol is on socio-economic considerations when making decisions on import of LMOs. Although it gives special regard to impacts on the value of biological diversity to
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Article 15
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indigenous and local communities, it allows these considerations only so long as they are consistent with their international obligations, mostly meaning the WTO trade agreements. Dispute and Settlement The Protocol does not contain provisions related to dispute settlement, but refers to those of the Convention on Biological Diversity, which provides for optional recourse to judicial settlement, arbitration, or conciliation (Articles 27 and 32 of the Convention CBD). .
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transboundary movement, the affected Party may require the Party of origin to dispose at its own expense of the illegal LMO. The Parties have to notify the BCH each time there is an illegal transboundary movement of LMO into its country (Article 25).
(c) International Treaty on Plant Genetic Resources for Food and Agriculture 2001
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The objectives of FAO- International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) are the conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) and the fair and equitable sharing of the benefits arising out of their use17. This Treaty entered into force in April 2004.
How the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) operates?
ITPGR applies to all Plant genetic resources for food and agriculture. It refers to the modern biotechnologies in the preamble and acknowledges that PGRFA are indispensable as raw material for crop genetic improvement including that through modern biotechnologies. The PGRFA Treaty mainly incorporates the philosophy of the CBD but adopts the multilateral approach on access and benefit sharing (ABS) in contrast to the bilateral approach under the CBD. The Treaty provides for the conservation, exploration, collection, characterization, evaluation and documentation of plant genetic resources for food and agriculture18. The Treaty also requires cooperation in development and transfer of appropriate technologies leading to an efficient and sustainable system of ex situ conservation. 19 The technology may include the modern biotechnologies. Under Article 5.2, the ITPGRFA requires contracting parties to take steps to minimize or, if possible, eliminate threats to PGRFA. By interpretation of Article 5.2, the threat to PGRFA may include threats posed by modern biotechnology such as GMOs. Article 9 provides for the farmers rights. However, it leaves it upon member countries to determine mode of legislation of farmers rights.
In its context, ITPGRFA addresses both issues of IPR and protection of genetic diversity that used in the formal breeding process. It seeks to modify existing IPR legal regime so as to permit farmers themselves to claim exclusive rights in the plant varieties they cultivate informally and it recognizing farmers rights not through IPRs but through benefit sharing mechanisms, such as payments and technology transfers, that compensate farmers for their contributions to plant genetic diversity.
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The access and control provided under the Treaty is consistent with the CBD, which grants states the sovereign right to control their plant genetic resources. Further the CBDs benefit sharing objectives is covered under ITPGRFA by conditioning access upon the current or future payment of compensation or the transfer of technology to the authority providing access. The specific conditions of access will be specified in Material Transfer Agreements (MTAs) entered into between the entity (whether governmental or private) that owns or controls the germplasm and the entity (usually private) that seeks access to it. The right of farmers to participate in decision-making at the national level on matters related to the conservation and sustainable use of PGRFA is among the measures to protect and promote Farmers Rights20. This could be interpreted to include the right of farmers to participate in biosafety decision-making processes and to have access to information which is provided under CPB. Though under IPR regime (WIPO, TRIPs and UPOV) it envisaged that innovator of new technology would depend on the genetic materials from either in situ or ex situ conservation, the regime is not concerned much with the mechanisms for protecting Traditional Knowledge (TK) or sources of breeding materials for sustainable breeding process as provided for in CBD or CPB. On the other hand, the ITPRFA may be considered as the only instrument providing a compromise for implementation of IPR and benefit sharing instruments that are impacting on modern biotechnology. The current negotiations are going on including the Doha negotiation which intend to bring
2.1.3 Instruments that facilitate trade and ensuring safety of products of modern biotechnology.
The international instruments deals with standards and safety adoption and use of products of modern biotechnology include WTO- Sanitary and Phytosanitary Standard Agreement, Technical Barrier to Trade, Codex Allimentarius, OIE, IPPC etc. the full discussion of such instruments is as given here below:
(a) Sanitary and Phytosanitary Standard Agreement (SPS) What does SPS agreement provides and how is it relevant to GM technology/biosafety?
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Sometimes, Farmers Rights are mistaken for the Farmers Privilege under PBR UPOV regimes. The Farmers Privilege is basically the right of farmers to use and consume the seeds from protected varieties after these has been sown. UPOV 91 leaves countries the option on whether to implement this exceptional right.
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The SPS is a WTO agreement which provides for a multi-lateral framework of rules to guide development, adoption and enforcement of sanitary and phytosanitary measures to minimize their negative impacts on trade. The SPS applies to all sanitary and phytosanitary measures that may directly or indirectly effect on international trade21. The SPS sets out a code of good practice for the preparation, adoption and application of standards to be enforced by the member countries. The agreement requires countries to use standard or harmonized measures measure necessary for the protection of human, animal or plant life or health based on scientific principles provided under the SPS and other relevant international organization22. The agreement provides for the sovereignty of countries to apply precautionary measures when relevant scientific evidence is insufficient but such measures should not be arbitrary, unjustifiable or restrictive to the international trade23 The SPS Agreement recognizes the standards and guideline developed by three relevant organizations: the FAO/WHO Codex Alimentarius Commission (for food and food safety), the International Office of Epizooties (for Animal Health), and the International Plant Protection Convention (IPPC) (for plant health)24. Those standard-setting bodies all have their working groups on safety aspects of GMOs and GM foods. Though SPS agreement does not explicitly mention biotechnology or GMOs, when GMOs are in international trade, and may pose a threat to human, animal or plant life or health in an importing country, the SPS Agreement would apply to national sanitary or phytosanitary measures (SPMs) designed to address the threats prior to import. Under SPS, WTO member States must ensure that sanitary and phytosanitary measures are based on an assessment of risks to human, animal or plant life or health (Article 5(1)). Risk assessment techniques developed by relevant international organizations must be taken into account. Risks are to be assessed taking into account a number of enumerated factors including available scientific evidence (Article 5(2)). Pursuant to Article 5 (3) of the SPS Agreement, Member States can also take "relevant economic factors" into account when assessing the risk, and establishing risk management measures (i.e. establishing the appropriate level of protection as manifested by a sanitary or phytosanitary measure). Economic measures include (1) the potential damage to production or lost sales; (2) costs of control or eradication; and (3) relative cost effectiveness of alternative approaches to limit risks.
21 The SPS defines of Sanitary to mean any measures that applied to protect animal or plant health from risks arising from entry, establishment or spread of pests, diseases and other organisms; additive, contaminants, toxins or diseases organisms in foods, beverages or food stuffs; diseases carried by animals, plant or plant products, and any other damages within the territory .
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Article 2.1 Article 2.3 read together with Article 3.3 24 Article 3.4 and Clause 3 in Annexure A
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animal products. In regards, to GMOs the OIE has conducted work on scientific evaluation of GMOs that are pharmaceuticals for animals.
3.0 Section 3 - International Trade regimes Versus Modern Biotechnology in the Developing countries
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The International Plant Protection is an FAO agreement which was originally adopted in 1951. It has been subsequently revised with the latest revision adopted in 1997. 26 (Article .I (4)). 27 Article II(2)
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To discuss in brief how international instruments affect policies and legislative frameworks of developing countries. To examine challenges that developing countries such as Tanzania may face in deciding for an appropriate policy and legal framework for regulating issues of modern biotechnology technology.
Aims of this Section To show what should be an appropriate GM technology/biosafety regulatory regime for the developing countries. What you will learn How international instruments can be of assistance to developing countries in establishing appropriate national regulatory structures for GM technology and biosafety. As we have seen from discussion on international instruments, developments in GM technology are compelling for revising the approach towards the policy and legal regimes for members of WTO. In that regards, various national governments are bringing in changes in the national laws in order to protect and encourage investments in GM technology. These policy changes have further widened the scope of the ongoing debate28. Along with this, the negotiations are taking place in other international organizations such as the WTO, which may have impact on international trade. They include Technical Barriers to Trade (TBT), the Sanitary and Phytosanitary Measures (SPS), Trade-related Aspects of Intellectual Property Rights (TRIPs) and Agreement on Agriculture. Biotechnology issues also become relevant in the overarching trade issues such as market access and competitiveness. While developed countries have established their national frameworks to deal with GM technology and biosafety focusing primarily on domestic priorities and strategies, most developing countries are doing so under less flexible circumstances. They increasingly seem to be expected to set up their national regulatory schemes based on the requests and expectations of their main trade partners. For example, some developing countries like India, Egypt etc have embarked on the GM adoption for some years, this includes development of regulatory mechanisms for handling GM. However, in most of those countries, no agricultural biotechnology product has yet been approved. The regulatory regime in different countries has emerged at different pace and has taken all different directions. The national responses have largely been driven by specific national situations. In other countries such as Tanzania, specific policies for GM technology or regulatory framework to accommodate the safe handling of GMOs are yet to be approved despite being members to CBD and CPO for more than three years.
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Sachin Chaturvedi S. R. Rao: Biotechnology and International Trade Regime: Options before Developing Countries, at http://scholar.google.com/scholar%3Fq%3Dauthor:%22Chaturvedi%22+intitle:%22Biotechnology+and+I ternational+Trade+Regime:+Options+...%22+%26hl%3Den%26lr%3D%26oi%3Dscholarr
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On the other side, implementation of International agreement relating to IPR has brought a lot of debates in the trade regime of the world. Though patents were designed for industrial application, with biotechnology, in some countries, patent are now granted on micro-organisms. In context of developing countries patents for plants seems to be a recent phenomenon, though it has been there for sometimes. Impact of IPR on biodiversity has been the subject of intense debates among countries and commentators. Although reliable data and information has been produced regarding the social and economic impacts and importance of IPRs in developing countries, limited information actually exists regarding impacts of IPRs on conservation and sustainable use of biodiversity per se. For the developing countries, it is argued that one verified impact of IPRs (specifically patents) is interference on the principle of sovereign rights of countries over their genetic resources and to some degree on sustainable use. The regime allows direct and indirect misappropriation of biological and genetic resources and traditional knowledge (biopiracy). It is also argued that IPRs has negative impacts on developing countries agriculture by enhancing the concentration of research and development capacities in hands of private sector conglomerates (usually involving biotechnology companies, universities, research institutions) or dependent on private sector funds, promote widening of the technology gaps between North and South, limit availability of research materials, etc. As we have seen from discussion in the International Agreements, the CBD has specifically recognized the complex and controversial relationship between IPRs an biodiversity (articles 15, 16, 19) Article 16(5) is particularly relevant in the sense that it take cognizance of the impacts of IPR (patents and other intellectual property rights) on conservation, sustainable use and benefit sharing of biodiversity. It is expected also that through on going negotiation on implementation of various international agreements, developing countries will have proper option to choose in drafting their IPR and ABS legislation. We have also seen that through option provided under the WTO- TRIPs, many developing countries decided to legislate their own national PVP laws based on sui generis system. However, within the regional trading blocks, countries are indirectly compelled to adopt a new legal and policy approaches. For example, recently, Southern Africa Development Community (SADC) has started to prepare a Regional Protocol on Plant Breeders Rights which is compatible with UPOV. However, within the region, only two countries (South Africa and Zimbabwe are members of UPOV. These two countries and Tanzania are only countries having PVP legislation. As far as adaptation of modern biotechnology on aspect of GMOs, there remains a degree of unpredictability of outcome with regard to the application of regulatory measures governing GMOs, and with regard to potential challenges to such measures. Policy ambiguities and uncertainties, as well as gaps, exist. On the other hand, while many developing countries are members to various binding and non- binding International instruments relating to safety and standards, the ability of those countries to participate in standard setting bodies, and to implement international standards, has been lacking. It seems also that WTO agreements are increasingly being replicated or reflected in other fora, For example, CPB provided expressly not
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to limit its members obligations to other international commitments, while other WTO or FAO agreements gives rooms for members to participated in other international or regional agreements which in one way or another may apply inconsistent with WTO or FAO agreements29. What should be done by developing countries? Most of the international legal regimes are worded in a manner that can accommodate member countries divergences. What shape will a policy or regulatory framework of a particular country take, will depend on the available options to that particular country for furtherance of its developmental goal. The options will have to be well though out, taking into consideration various factors including the countrys natural resources, its capacity to exploit and protect them, its economic development goals and other social factors such as culture and customary norms of its communities and people.
What this Section is about This Section examines policies and national legislation related to biotechnology and biosafety in Tanzania. It covers also existing national biotechnology and biosafety forum and international agreement which Tanzania is a party. Aims of this Section To identify exiting national policies and legislation impacting on GM technology/biosafety. To show extent of compliance by Tanzania to the International Agreements. To show the existing strength and gaps in policies and legal framework that may hinder friendly adoption of modern biotechnology.
What you will learn International agreements which Tanzania is obliged to implement. Existing policy, national regulatory framework for GM technology and biosafety regulation. Existing strength and gaps in GM technology/biosafety regulation.
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For example Draft OAU Model for Biosafety is criticized for having some provisions which are inconsistent with the Cartagena Protocol on Biosafety
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4.1
Tanzania is a member to the following international agreements which it is obliged to implement: (i) Cartagena Protocol on Biosafety (acceded on 16th March 2003) (ii) International Treaty for Plant Genetic Resources for food and Agriculture (ratified in February 2004). (iii) WTO Agreements (TRIPs, SPS, TBT, etc) - (since 1995) (iv) International Plant Protection Convention - acceded in February 2005. (v) WIPO since 1983 (vi) CBD ratified on 8th March 1996. Apart from being a member to the above referred international instruments that are impacting on GM technology and biosafety, Tanzania has also shown commitment to join UPOV in a near future.
4.1.1 What obligations does Tanzania has under the International agreements
(d) Among obligations that are provided to the contracting Cartagena Protocol on Biosafety and IT-PGRFA include: parties under the CBD,
To build capacities for research, assessment identification, evaluation and monitoring of biodiversity and develop strategies for conservation and sustainable utilization of her biological resources. To designate of the national Focal Point (NPF) to be responsible for its behalf to liaison with the Protocol Secretariat. To designate of the one or more competent national authorities (CAN) to be responsible for performing administrative functions required under the protocol. Provide the Biosafety Cleaning House (BCH) with detail of national contact points and other information etc. Make some information available through the BCH as provided for under Article 20 of the Cartagena Protocol (Information on the competent national authority(ies); through the BCH information on existing laws, regulations or guidelines relevant to LMOs and all other information resulting form implementation of Cartagena Protocol) Formulate relevant legislation that comply with CBD, CPO and IT-PGRFA
(e) Under IPPC, Tanzania is required to have a National law that provides for among other thing (National Organization mandated for Plant Protection issues (National Plant Protection Organization); Procedures for Pests risk analysis etc.
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(f) Under TRIPs Tanzania is obliged to ensure protection of IPR through it own national legislation be in the form of patent, sui generis or combination of the two.
Apart from policy and legal reform, Tanzania participated in the following programs for capacity building: UNEP/GEF project aimed at supporting capacity building for on Biosafety regulation. USAID funded Association to Strengthen Agricultural Research in East and Central Africa (ASARECA). ASARECA facilitates collaborative research between those countries linked to ASARECA (e.g. Uganda, Kenya, Ethiopia, Eritrea), East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Development (BIO-EARN). BIO-EARN is a programme designed to build policy and research capacity in agricultural biotechnology.
At regional level (SADC and East African Community): Tanzania is participating in the SADC programme for harmonization of policies and regulatory framework for seed Industry in order facilitates regional Trade. Harminsation covers Seed certification, phytosanitary and quarantine issues). Also at SADC, Tanzania is involved in the development of regional common protocol for the Plant Breeders Rights which is compatible with UPOV.
At East African Community, Tanzania is or may be bound to implement the following documents that may have legal implications in the modern biotechnology (a) East African Community, Environmental Assessment Guidelines (this guidelines requires projects that occur on one country but that may impact one or more countries to have a single EIA); and (b) Harmonized Sanitary and Phytosanitary Standard Measures (these documents are in the process of adaptation for use in the form of Protocol). (c) Harmonized procedures for regulation of GMOs ( in the negotiation process)
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further states, Strategic measures shall be put in place for the development of biotechnology, especially to ensure fair and equitable sharing of the results and benefits arising out of utilization by foreign recipients, of genetic resources originating from Tanzania, and biosafety. The Policy puts emphasis on environmental impact assessment (Paragraphs 63-67) as an important policy instrument that would facilitate the integration of environmental concerns in the decision-making process. It further states that one of the cornerstones of the environmental impact assessment process will be the institution of public consultations and public hearings in the EIA procedures. It further acknowledges the need to have an environmental management legislation to implement it (Paragraphs 68-72).
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In Tanzania National Biosafety Framework was approved in the last year 2006 and contains the following main objectives: (i) To establish science-based, holistic and integrated, efficient, transparent and participatory administrative and decision making system so that Tanzania can benefit from modern biotechnology while avoiding or minimizing the inherent environmental, health and socio-economic risks; and To Ensure that the research, development, handling, transboundary movement, transit, use, release and management of GMOs are undertaken in a manner that prevents or reduces risks to human and animal health, biological diversity.
(ii)
The approved NBF appears to have an objective of encouraging and assisting the establishment of an appropriate national regulatory framework. In its face, the Framework is neither a policy nor a binding legal document for biosafety regulation.
Institutional Biosafety Committee. According to National Biosafety Framework, role of the National Biosafety Committee include: (i) (ii) (iii)
Review of relevant applications; Advise on policies, legislation and other policy instruments; Undertake study and evaluation of biotechnology research and control and minimize the concomitant risks and hazards associated with the deliberate release of GMOs in the environment.
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(iv) (v)
Undertake study and evaluation of biotechnology research and control and minimize the concomitant risks and hazards associated with the deliberate release of GMOs in the environment; and Advise the NBFP and Competent Authorities.
Competent Authorities which will be responsible for following up, supervising and controlling the implementation of the biosafety regulations are designated NBFP. The roles and responsibilities of the Competent Authorities include: (i) (ii) (iii) (iv) (v) To review relevant applications or proposals for development, introduction, import, export, transit, contained use, release or placing on the market; To review, make or have made risk assessments of GMOs or products thereof. To advise the NBFP; Designate inspectors and undertake inspection as well as other control measures to ensure compliance with the Biosafety Regulations; and To undertake assessment of socio-economic impacts as well as ethical and cultural impacts.
Institutional Biosafety Committee (IBC) are designated by Institutions which are involved in the import, export, handling, contained use, release or placing on the market of GMOs or products of GMOs. The Roles of IBC are:
(i) (ii) (iii) To review the containment and confinement levels required by the Guidelines for the proposed research; To hold discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purpose/objectives of the proposed GMO and other services; To report immediately to the relevant Ministries/Competent Authorities and appropriate official in the concerned organization, any significant GMO activities, problems with or violations of the regulations and any significant research related accidents and illness.
procedures. In the context of the Protocol, a single entity may be designated to fulfill the purposes. However, a CNA is required to have capacity in terms of financial and human resources to handle issues of LMOs. One of the major challenges for the designated NFP for Tanzania is lack of resources. It is not clearly provided in the existing framework, how the institution for implementing biotechnology and biosafety will be funded and capacitated. The existing policies are implemented in parallel, without harmony. Some of these policies, which are very important to biotechnology, for example National Agriculture and Livestock policy (a Policy that could have assisted in agricultural biotechnology) is outdated and need to be reviewed.
the Biosafety Protocol, on pharmaceuticals and procedure for GMOs intended for direct use as food or feed, or for processing. Though TFDA is only institution responsible for ensuring quality and safety of food and food products in the country and it participants in various international fora for standards such as Codex, its legislation is silent on capacity of TFDA to handle regulation of food or food products resulting from modern biotechnology.
4.6.3 The Industrial and Consumer Chemicals (Management and Control) Act No 3 of 2003
The Act provides for the management and control of production, importation, transportation, exportation, storage, dealing and disposal of chemicals. The Act defines risk assessment to mean an act of assessing the risk of exposure and adverse effect to human and animal health and environment. It further defines risk management as a process and procedure of reducing or possibly eliminating risks associated with exposure to chemicals. However, this Act, as much as it does not express provision on biosafety, has useful provisions on risk assessment and risk management.
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Section 67 (1) of the EMA empowers the Minister responsible for environment in consultation with relevant sector Ministry to make regulations providing for in-situ conservation of biological diversity. Sub- section (2) (g) (h) provides that the regulations made under Section 67 may prescribe among other things establishment or management of the risks associated with the use and release of living modified organisms resulting from biotechnology which are genetically modified and which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health as well as social, economic cultural and ethical concern and prevention of the introduction of control or eradicate of alien species which may threaten ecosystems, habitats or species. The described harm, injury or loss include personal injury, damage to property, financial loss, and damage to environment or to biological diversity. Under sub-section (3) of section 67 the law defines ''organisms'' to mean any active, ineffective or dormant stage or life from of an entity characterized as living, including plants, bacterial, fungi, mycoplasmas like entities vertebrate and invertebrate animals, as wells as entities such as various, viruses or any living entity related to it. Under section 69, the EMA provides for a general provision on Genetically Modified Organisms as follows: Without prejudice to any law governing biosafety and biotechnology, any person who develops, handles, uses, imports or exports genetically modified organisms (GMO) and, or their products, shall be under the general obligation to ensure that such organisms do not harm, cause injury or loss to the environment and human health including socioeconomic, cultural and ethical concerns31. By word without prejudice to any law governing biosafety and biotechnology EMA seems not to be a specific legislation for dealing with GM technology and biosafety and therefore it recognizes existence of other specific laws on biosafety and GM technology, which in fact do not exist.
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Sub- section (2) of the section 69 defines harm, injury or loss to include personal injury, damage to property, financial loss, and damage to environment or to biological diversity.
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On the other hands, biosafety is defined as avoidance of risk to the protection of the environment and to human health, as a result of the use for research and commerce of genetically modified organisms and "risk assessment is defined under Section 2 of EMA to mean the evaluation of the direct and indirect risks to human and animal health, the environment, biological diversity and to the socioeconomic conditions and ethical values of the country or its populace which may be posed by the import, contained use, deliberate release or placing on the market of GMOs or its products.
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Government Notice No. 349 as published on 4 November 2005. 34 Government Notice No. 348 as published on 4 November 2005 35 Regulations 9 and 10. 36 Regulation 17 provides that during the process of conducting EIA study the developer or proprietor shall in consultation with NEMC, seek the views of any person who is or is likely to be affected by the project.
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The EIA statement shall contain among others, information a description of the potentially affected environment including information necessary for identifying and assessing the environmental effects of the projects; the environmental effects of the project including the social and cultural effects and direct, indirect, cumulative, irreversible, short term and long term effects anticipated; the measures to prevent health hazards and economic and social analysis on the project37. In review of the Environmental Impact Statement (EIS), NEMC may set up cross-sector technical advisory committee and invite for general public comments 38 . The EIA & Audit Regulations provides for access of the general public to the EIA statement and Information. 39 In order to keeping track of activities so as to determine whether they are on schedule and whether they are meeting the target objective, the EIA and Audit Regulation provides for auditing and monitoring possible environmental impacts of the of the approved projects.
The National Biosafety Framework of provided that A person who imports, arranges transit, makes contained use of, releases or places on the market a GMO or product of a GMO shall be strictly liable for any harm caused by such a GMO or product of a GMO. The harm shall be fully compensated. Under EMA 2004, the following provisions may be relevant for labiality and readdress:o Section 100 (2) which gives powers to NEMC to institute proceedings in a court of law for against the holder of certificate of Environmental Impact Assessment in order to recover damages for any injury that may have occurred as a result of non compliance with terms and condition provided in the certificate of Environmental Impact Assessment, apart from the holder; o Section 188 provides for a criminal offence punishable with a fine not exceeding ten million shillings or to imprisonment for a term not exceeding five years or to both for any person who trades, possesses, disturbs the habitat of a component of biological diversity in contravention of guidelines and measures prescribed under sections 66, 67 and 68 or other provisions. It is important to note that Section 67 of EMA deals with powers of the Minister responsible for environment to make regulations for dealing among other things, the establishment and management of the risks associated with the use and release of LMOs and prevention of the introduction of control or eradicate of those alien species which threaten ecosystems, habitats; o Section 192 (1) allows for the institution of any civil proceeding for violation of the Act;
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Section 225 give an injured party a right to civil action in the court of law for obtaining compensation from the violator of any provision of the Act.
4.6.7
Quality seed is one of the requirements of attaining food security to the Tanzanian farmers. Quality seed can be obtained through internal production or importation. Seed import has advantages of introducing new verities to the farmers which may sometime reduce costs of procuring seeds. However, imported seed may associate with risk of introducing dangerous exotic pests that threaten agricultural development. The Seeds Act No18 of 2003 provides the Tanzania Official Seed Certification Institute established under Section 10 with the authority to regulate the quality, testing, inspection and sale of seeds in Tanzania.
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The Act defines term seed to mean part of plant which is or is intended to be used for propagation and includes any true seed, any vegetative material including seedling, corm, cutting, bulb, bulbils, layer, marmot, root, runner, scion, set, split, stem, stock, stump, sucker or tuber so used or intended to be so used. The Act requires any person, who intends to deal with importation, exportation, production, processing, distribution, sale or advertisement for sale of seeds to have a permit and registration certificates obtained the Director responsible for crop development with the Ministry of Agriculture in terms of Sections 13 and 15 of the Act. The Act requires the seed dealers to comply with the standards and conditions for importation or production of seeds, as provided for in the Plant Protection Act. The Seed Act may indirectly used to control introduction of GM plants/seed by requiring all seed that are intended for commercialization in Tanzania to be of registered varieties for use in Tanzania. The Seed Act empower the Director responsible for crop development with the Ministry of Agriculture to establish a National Catalogue of the registered seed and crop verities approved commercialization in Tanzania. Also, before the seed is approved for commercialization, it has to pass some certification and approval system for quality certification. Though the Seed Act does not cover specifically regulation of GM seed, it is true that before commercial cultivation or importation of seed including GM seed, an approval shall be required under seeds legislation, and also under Plant Protection.
4.6.9.1
The Patent Act as operationalized through GN. No. 262 of 1995 provide for regulation and control of IPR relating to industrial inventions. As opposed to some countries, (for instance USA) where patents legislation is used to protect Plant Varieties, in Tanzania, under section 7(2) of the Patents Act, plant or animal varieties or essentially biological processes for the production of plants or animals, other than microbiological and products of such process are
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not part of invention. It should be noted that this Act was enacted prior to WTO- TRIPs Agreement and it only considers protection of industrial inventions. Under the Patents Act for an invention to qualify for patenting, it must meet the three requirements of novelty, inventive step and industrial application (Section 8). The Patent Act is administered by the Ministry responsible of Industries Trade and Marketing through the Business Registrations and Licensing Agency (BRELA).
4.6.9.2
The Plant Breeders rights Act for Tanzania is in the form of IPR regime based on sui generis. The Act provides for protection of rights of breeders of new plant varieties in order to promote agriculture and ensure food security. The varieties which are protected under the Act are new varieties and qualify for the test of Distinctness, Uniformity, and Stability (DUS). As to other PVP regimes for the developing countries, the Tanzania PBR Act is compatible with the benefit sharing regimes by providing for farmers rights/privilege though exempting from infringements, acts done by farmers with the purposes of propagating, on their own holdings the product of the harvested palnts which they have obtained by planting the protected variety or a variety (section 34(d)). In the circumstances, Farmers may save and use their own seed of protected varieties without infringing on the holder's rights. Furthermore, Section 57(1) of the Act requires the Minister responsible for Agriculture to ensure that the implementation of the Act does not affect the fulfillment of the Government obligations pertaining to the protection of farmers' rights to equitably share and access to traditional cultivars and germplasm; national and international commitments towards sustainable use of biological diversity taking into account the human health. Sub section (2) requires the Minister, after consultation with the Minister responsible for finance, to direct certain percent of the fees paid to the Registrar of Plant Breeders Rights under the Act, be set aside for the benefits of traditional farmers and the preservation of traditional cultivars of agricultural products. In order to comply with ITPGRFA as ratified in April 2001, Tanzanian is in the process of formulating a legal framework for benefit sharing regime40. The Act allows has a provision for compulsory licensing in which a compulsory licence may be granted for public interests. It is further interesting the Act empowers the Minister enter into any multilateral or bilateral arrangements for PVP under which will allow for technological transfer.
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The new law on IPR and indigenous knowledge will, among other things, provide for a system that will recognize and protect the rights of an individual as well as communities of indigenous knowledge, at the same time ensuring fair and equitable benefitsharing with communities from those who are using and profiting from that knowledge.
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Is the existing policy and legal environment in Tanzania adequate for accommodating modern biotechnology? As we have seen from discussion of each legislation, legal framework for facilitating adoption of modern biotechnology in Tanzania is not so adequate or and effective. There are several pieces of sectoral legislation covering food safety, environmental conservation, plant protection, animal and human health, which would implicitly address issues of GM technology and biosafety in their respective mandates. However, these legislation are either outdated or implemented by different institutions in uncoordinated manner. The review show that that there is yet no single legislative instrument that addresses biosafety concerns in the country. On policy aspect, many policies that are supposedly meant to deal with GM technology or biosafety issues provide statements that do not explicitly address biosafety concerns.
Since legal and policy aspects are important tool for effective realization of benefits of modern science, formulation of specific policy and updating legislation for regulation of GM technology and biosafety in Tanzania can not be avoided. The development of efficient and effective GM technology and biosafety systems is important not only to accelerate the growth of science and technology and in particular the application of R&D in GM technology in Tanzania, but also to ensure safe access to new products and technologies developed elsewhere. The absence of a suitable regulatory framework hinders the ability of both the public and the private sectors to invest in new technologies within the country and to make new products available to the society.
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It is worth noting that in Tanzania lacks specific Policy of Biotechnology/Biosafety. However, that can not affect adaptation of modern technology. On the legal aspect, the Environmental Management Act No. 20 of 2004 (EMA) seems to be the only effective legal tools that addresses some important issues of GM technology/ biosafety like protection of biological resources and regulation of Genetically Modified Organisms before release to the environment . However, unless regulations that are addressed in the Act for the purpose of regulating biotechnology are formulated and effective institutional coordination is established, EMA 2004 can not apply to regulation of all activities relating to biotechnology and biosafety e.g. controlling of GMOs food or products approved for commercialization. This gap, invites for specific policy and regulatory framework that covers every aspect of GM technology. For effective regulation of GMOs, the only means to achieve the goal is to consider for amendments of existing law or to have an umbrella legislation that cures the mischief. On the other hand, apart from having policy documents and regulatory system for facilitating safely adaptation of modern biotechnology, it is also very essential to build capacity for effective implementation of such policies on legal framework. The international instruments can be of assistance to Tanzania in establishing appropriate regulatory structures that deal with potential concerns while, at the same time, promoting harmonization of national regulations for GM technology and biosafety. The numerous pros and cons of IPRs in biotechnology in agriculture clearly underscore the need for comprehensive policy and legislatives guidelines, which should promote dialogue and partnerships with the private sector, as a prerequisite for the application of GM technology in food and agricultural production. On IPR, Tanzania make a different between IPR for industrial innovation and IPR for new Plant Varieties, sooner or later it will have to harmonized these with the International instruments requirements. As far Biotechnology policy and legal framework is concerned, division or disharmony on the international level influences delays in having a clear and well defined framework at national level. The regional initiatives may probably set a light to effectively regulation of GM technology .
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B.S. Kasonta & Kullaya : The need for the Biotechnology Policy and Bio-safety Guidelines; Concept, Formulation and Implementation: Paper Presented at the Biotechnology Stakeholders Workshop, 8th October 2001. Bio- Earn Resource Book for Biosafety & Biotechnology, at http://www.bioearn.org/resource%2book/chapter.htm. last visited on 11 September 2006 Biotechnology in Africa: A Regional Synthesis. Working Paper No 1 for FANRPAN/IFPRI Regional Dialogue on Biotechnology, Agriculture and Food Security in Southern Africa, April 2003 WISARD Agricultural R&D server. Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2000. Secretariat of the Convention on Biodiversity on Biological Diversity, Montreal CBD (Convention on Biological Diversity) Secretariat: 2000. Cartagena Protocol on Biosafety to the Convention on Biological Diversity: Text and annexes. Montreal . http://www.biodivrsity .org/doc/legal/cartagena protocol.en.pdf Claudia Martans, Implementing the Biosafety Protocol, Draft, 30 June 2002. David K. Wafula and George M. Sikoyo: Trends in Modern Biotechnology and Biosafety: Implications on Trade for the Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA)/ Common Market for Eastern and Southern Africa (COMESA) Countries, 2005, ACTS Press Nairobi, Kenya. FAO, WHO, 2000. Understanding the Codex Alimentarius. Food and Agricultural Organisation of the United Nations and World Health Organisation. Rome. Gregory Jaffe Comparative Analysis of the National Biosafety Regulatory Systems in East Africa, Discussion Paper 146, International Food Policy Research Institute, 2033 K Street, NW, Washington, DC 20006-1002 USA , 2006. http://www.upov.int/en/publications/conventions/1991/pdf/act1991.pdf Hosea, K.M et al. Genetically Modified Organisms (GMOs) in Tanzania, Envirocare Organisation, Dar es Salaam, Tanzania, 2004. IUCN-ELC 2003. An explanatory guide to the Cartagena Protocol on Biosafety. IUCN Environmental Policy and Law Paper No. 46. John Orchard et al: Draft Report on Establishment of Institutional and Legal Framework on Hygiene and Safety and Agricultural and Natural Resources Products Natural Resources Institute Kent, (UK) and Tropical Pesticides Research Institute, Arusha, 2006 Kitch, L., Koch, M. and Sithole-Niang, I., 2002. Crop Biotechnology: A Working paper for Administrators and Policy Makers in Sub-Saharan Africa. Lyle Glowka; Law and modern biotechnology, Selected issues of relevance to food and agriculture, Food and Agriculture Organization of the United Nations, Rome, 2003. P a t r i c i a K a m e r i - M b o t e : Regulation of GMO Crops and Foods: Kenya Case Study, 2006
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Prof. Col. Y.M Kohi: Role of Biotechnology in the Implementation of the Vision 2025 for the Economic Development of Tanzania: Paper Presented at the Biotechnology Stakeholders Workshop, 8th October 2001. Rose Anne Mohamed: Regulations on Safe Movement of Germplasm and Transboundary Issues: Paper Presented at the Biotechnology Stakeholders Workshop, 8th October 2001. United Republic of Tanzania. Draft National Biotechnology Policy, 2002. Sachin Chaturvedi S. R. Rao: Biotechnology and International Trade Regime: Options before Developing Countries at http://scholar.google.com/scholar%3Fq%3Dauthor:%22Chaturvedi%22+intitle:%22Biotec hnology+and+I, WTO (World trade organization), 1994a. Agreement on establishing the World trade organization. Geneva. WTO (World trade organization), 1994b. Agreement on the application of sanitary and phytosanitary measures (SPS Agreement) Geneva. Http//www.wto.org/English/tratop_e/sps_e.htm. Laurence R. Helfer. Intellectual Property Rights In Plant Varieties: An Overview with options for National Governments July 2002, FAO Legal Paper, available at http://www.fao.org/Legal/pub-e.htm. Legislation Parent Act 1. 2. 3. 4. 5. 6. Environment Management Act No. 20 0f 2004. Plant Protection Act No. 15 of 1997 Animal Diseases Act No. 17 of 2003. Fisheries Act No of 2003. Standards Act No. 3 of 1975 The Tanzania Commission For Science And Technology Act No. 7 of 1986
Subsidiary Legislation 7. The Environmental Impact Assessment and Audit Regulations, 2005 , G.N. No. 349 of 2005.
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