LEGAL AND INSTITUTIONAL FRAMEWORK FOR BIOSAFETY IN TANZANIA BY: ISAKWISA L. MWAMUKONDA LEGAL COUNSEL VICE PRESIDENTS OFFICE LEGAL SERVICES UNIT.

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1 LEGAL AND INSTITUTIONAL FRAMEWORK FOR BIOSAFETY IN TANZANIA BY: ISAKWISA L. MWAMUKONDA LEGAL COUNSEL VICE PRESIDENTS OFFICE LEGAL SERVICES UNIT.

2 Introduction Tanzania is a party to the Convention on Biological diversity. Tanzania is also a party to the Cartagena Protocol to the Convention of Bioasafety. Tanzania also signed the Nagoya Kuala Lumper Supplementary Protocol on liability and Compensation.

3 Implementation of Biosafety Convention/ Protocol in Tanzania As a dualist state under international law, MEAs have to be domesticated first in order to give them legitimacy and recognication as part of laws implementable enforceable in the country. The country has to date put into place enabling instruments in terms of strategies, legislation, regulations and guidelines for implementing the above signed MEAS.

4 Constitution of the United Republic of Tanzania 1977 (as amended) The Constitution of URT recognizes the right to life, which judicial interpretation includes the right to a safe clean and healthy environment. The right to information has also been guaranteed to citizens. The constitution also provides freedom of expression and participation on all matters. The constitution also provided the right to adequate compensation in the event that ones rights have been infringement or property is damaged or consificated.

5 Environment Management Act, Establishes the administration and institutional arrangement for environment management and coordination in the country. The Act is supported by sector legislation and implemented by subsidiary legislation. It sets the general principles for environmental management in the country, i.e the polluter pays principle, precautionary principle etc etc.

6 Environment Management Act.continues EMA requires projects for the introduction on GMOs to undergo EIA ( see third schedule) and risk assessment prior to its introduction GMOs into the environment. Requires any person who develops, handles, uses, imports or export GMOs and their products to ensure that such GMOs do not harm, cause injury or loss to the environment and human health. Empowers minister to make regulations biosafety.

7 The EIA & Audit Regulations 2005 Call for the conducting of an Environmental Impact assessment for all such projects listed in the Act and respective regulations, or as the minister may determine. All projects related to GMO are subjected to mandatory EIA. (See part A of 1 st schedule)

8 Tanzania Food, Drugs and Cosmetics Act No.1 of 2003 Establishes the TFDA and mandates it to control the quality, safety of food, drugs, cosmetics and medical devices. legislation sets out the procedure for controlling the importation, manufacture,labeling, marking or identification, storage, selling and distribution of such products or any material or substances. The Act is relevant in as far as applications for GMO food, feed and process is concerned.

9 The Animas Diseases Act 2003 Provides for the control and prevention of animal diseases, monitoring the production of animal products, manages disposal of animal carcasses and for related matters. The Act bars the importation of GMOs without the permission of the Director responsible for animal diseases.

10 The Standards Act, 2009 The Standards Act provide for standardization of specifications of commodities and services. The Act mandates TBS to ensure the health, safe environment and general welfare of the people of the Tanzania. - provide facilitation for examination and testing of commodities and manner in which they may be manufactured, produced or processed; The Act is therefore relevant in setting standards for products of GMOs.

11 The Plant Protection Act 1997 Provides for the prevention and control of attacks by or spread of harmful organisms or diseases. In order to implement the above, the Act contains provisions on national quarantine measures and plant import and export control. Thus all plants including plant substances and products, be GMOs or non GMOs ought to be certified under the Act prior to their introduction in the country for any purposes.

12 The Seed Act No.18 of 2003 Regulate the quality, testing, inspection and sale of seeds in Tanzania. Requires any person, who intends to deal with importation, exportation, production, processing, distribution, or sale of seeds to have a permit and registration certificates from director of crop development. Application for GMO seeds will have to comply with the provisions of this Act.

13 The East African Community Customs Management Act 2005 The Act controls, manages and administers customs amongst the East African community partner s states. Section 18 restricts goods listed in Part B of the second schedule, the importation of which needs to be regulated in partner states. GMOs have been listed as restricted goods in the schedule.

14 The Biosafety Regulations 2009 Is the major legal instrument that address issues on biosafety. The regulations set out the legal and institutional frame work for regulation biotechnology and biosafety. The regulations apply in addition to any other written laws, regulations and guidance.

15 General Principles Precautionary Principle: is to the effect lack of scientific evidence s should not be used as a basis for not taking preventive measures to protect the environment as a result of threats or risks the GMOs may pose. Principle of Prevention: subjects all GMO approvals to compliance with of preventive measures such as risk assessment and EIA. Strict liability Principle: subjects all GMO approvals to a condition that the applicant is strictly held liable for any damage caused to any person or environment.

16 Administration and Institutional Arrangement The Office of the Minister responsible for Environment has been designated as the National Bio safety Focal Point. (NBFP). Its functions are to: facilitate both domestic and international coordination of all matters relating to biosafety; coordinate, monitor and control the implementation of the biosafety regulations; review and approve or reject applications for importation, exportation, research and release of GMOs.

17 National Environment Advisory Committee has been established under EMA to provide advisory functions to the Minister responsible for Environment, or any sector ministry on any environmental matter referred to it. NEAC may also make recommendation where there is a degradation of the environment. Review and advise on any environmental standards, guidelines and regulations. Receive and deliberate on reports from sector ministries. The composition of NEAC include members from the public sector, private sector, civil societies etc..

18 National Biosafety Committee Is as an advisory body established to advice the National Biosafety Focal Point, the Minister, Competent Authority or Sector Ministry on all matters related to biotechnology and biosafety. The committee is composed of members appointed by the minister from government and non government institutions.

19 NBC Functions Review applications submitted to it on various applications. Advise on policies, legislations and other policy instruments on biosafety; Advise on undertakings on studies and undertaking of research on biotechnology; Advice generally the NBFP and CA; Institute and control safety mechanism and approval procedures at the national level.

20 Ministerial Competent Authorities Are designated by the minister responsible for enviornment in each Ministry that deals with GMOs. The Competent authorities shall be responsible for ensuring the compliance of the regulations by the sector ministry.

21 Functions of MCAs Review applications or proposals for development, introduction, import, export, transit, contained use, release or placing on the market of GMOs or its products thereof. Review or cause to be undertaken risk assessment of GMOs or products thereof. Advise the NBFP Coordinate biosafety inspectors appointed by the Minister for ensuring compliance and enforcement of the regulations. Undertake assessment of socio economic impacts as well as ethical and cultural impacts

22 Institutional Biosafety Committees Institutions that are involved in any activity relating to GMOs or their products thereof are required to establish institutional biosafety committees (IBCs). The composition of IBCs shall be multidisciplinary.

23 Functions of IBCs Review contained and confined levels required under the regulations. Conduct discussions on comparative ecological, economic and social impacts of GMOs; Institute and control safety mechanisms and approval procedures at the institutional level; Report to the NBFP, MCA, or appropriate authority on any significant GMO activities, research, illness, accident or on the violation of these regulations.

24 Biosafety Center of Excellence Was established to strengthen cooperation in all technical matters on biotechnology and bio safety and provide the necessary backstopping to institutions involved in biotechnology and bio safety in Tanzania.

25 Members of CoE The selection and evaluation criteria for the CoE was based on scientific merits, research competence, and availability infrastructure to support research and capacity building needs of different stakeholder. The centre consist of TEN institutions which are the University of Dar es salaam, TPRI, MARI, SUA, IHI, GCLA, TBS, TFDA, CVL, kizinmbani research Institute Zanzibar. The UDSM Department of molecular Biology and Biotechnology is designated as the coordinating institution of the CoE.

26 Functions of COE Carry out capacity building needs and research on risk assessments, risk management, risk communication, GMO detection at the national and regional level; Provide short and long term training for required competencies on bio safety and biotechnology; In collaboration with NBFP develop and maintain a database of national biosafety experts; provide scientific advice on emerging social cultural, ethical, economic, legal and political issues that surround the development, dissemination and marketing of biotechnology and its products.;

27 Functions of CoE mobilise funding for the development and delivery of the biosafety programmes; facilitate the sharing of biosafety information and resources, including educational materials; collaborate closely with the relevant national authorities, particularly the NBFP, NBC and competent authorities on matters related to biosafety; provide a forum for scientists, policy makers, civil society, farmers, NGOs, private sector players and other stakeholders to objectively debate and exchange information on GMOs.

28 Ofisi ya Makamu wa Rais Wizara ya Mawasiliano, Sayansi na Tekinolojia Wizara husika (Competent Authorities) SUA MARI IHI NIMR Mitandao na Programu za Kikanda na Kimataifa TBS CVL KIZIMBA NI UDSM (DMBB) GCLA TPRI TFDA Taasisi nyinginezo za utafiti Mamlaka za Udhibiti na Usimamizi Wadau wengine (AZISE, vyombo vya habari n.k.)

29 Approval of Activity Requires persons who intend to import, export, transport release, use in contained condition, confined condition or place on the market the GMOs to submit an application in writing to the NBFP for approval. Applications for food or feed processing shall be submitted to NBFP with references from the Clearing House of the CP. NBFP shall through the media or BCH provide a forum of public participation before decisions on applications are made.

30 Mapitio ya kitaalam Wasilisha kwa ajili ya mapitio Mashauriano Mapitio na ushauri mashauriano Application Procedure Mwombaji maombi maamuzi Ofisi ya Kitaifa ya Uratibu (Ofisi yenye Dhamana ya Mazingira) UFUNGUO mashauriano yasiyo rasmi mahusiano rasmi ya kikazi Kamati ya Kitaifa ya Matumizi Salama ya Biotekinolojia ya Kisasa Wizara husika mashauriano Wadau

31 Risk Assessment Applicants who intend to introduce GMOs into the URT are required to carryout or cause to be carried out an risk assessment of the impacts and risks posed by the GMOs or their products. Reports of risk assessment shall be prepared by the applicant and submitted to the NBFP. The attributes of risk assessment and decision making are as specified in the fifth and sixth schedule respectively. Mandates the NBFP to make an evaluation of the risk assessment report which shall be done on a case to case basis.

32 Decision Making Procedure NBFP Shall only approve applications if there is sufficient evidence that the GMOs or products thereof pose no risk to human, animal health and the environment. Applications may be approved, approved with such conditions or refused. An applicant may appeal the decision within 30 days from date of decision. Any approvals are subject to a condition that the applicant conducts monitoring and evaluation of the activity approved. As a condition for approval, the applicant shall be required to take out an insurance policy against liability to pay compensation for damages.

33 Risk Management NBFP may where necessary impose such measures to prevent adverse effects of GMOs are there products thereof. NBFP may exercise such powers as to restrict importation, exportation, contained research releases, or placing on the market of GMOs, or order cessation of an ongoing activity. Require the development of emergency management plans prior to the introduction of GMOs into the environment.

34 GMO Transportation All applicants are required to notify the NBFP upon occurrence of any accident. NBFP is obligated to put in place measures to ensure that GMOs are handled, packaged and transported under conditions of safety. All GMOs or products containing GMOs are required to be labeled and packaged according to the spelt out requirements in the regulations.

35 Liability and Compensation Strict liability (R.56): holds persons or their agents who carryout any GMOs activity to be strictly liable for any harm, injury or loss caused directly or indirectly by such GMOs or there products thereof. Channelling of Liability: shall be attached to the applicant, the person responsible for the activity which resulted in the damage, injury or loss as well as the supplier, provider or developer of GMOs or there products. In case of harm, compensation shall include costs of reinstatement, rehabilitation and costs of preventive measures. Recent amendment to regulation 56 exempts GMO researchers/ research activities from the strict liability principle. Researchers will now be liable under a fault based liability regime.

36 Liability and Compensation continues Joint and Several Liability ( R.57): extends liability of a body cooperate to any director, manager, secretary or similar officer of the body corporate, unless they can prove that they did everything within their powers to prevent the importation, contained use or placing on the market of the GMO which caused the damage. Fault based liability: Application of s.255 of EMA Administrative approach: R.42 (1) mandates the NBF to take such measures as to minimize damages/ eminent threats. Costs of such measures shall be recover all costs incurred from the responsible person.

37 Offences and Penalties Criminal liability ( R.66) Makes it an offence to do the following; transport, release, places on the market any GMO or product thereof without written approval of the NBFP; Violate any condition of grant of approval; fails to furnish information as required by law; provides false or misleading information ; does not label, package or indemnify any GMO or products; exports GMOs without adhering to PIC procedures; fails to have a valid policy of insurance against liability to pay compensation for damage; violates any provision of these regulations, commits an offence will be liable to a fine of not less than 5M or to a term of imprisonment of not less than 5 year or to both such fine and imprisonment.

38 The End THANK YOU FOR LISTENING