pbs tanzania revised workplan oct 2013-sept 2014 internal work plan

TANZANIA COMMISSION FOR SCIENCE

AND TECHNOLOGY(COSTECH)

PROGRAM FOR BIOSAFETY SYSTEMS (PBS)

WORKPLAN - CAPACITY BUILDING TOWARDS A

FUNCTIONAL BIOSAFETY SYSTEM IN TANZANIA:

OCT 2013-SEPT 2014

SUBMITTED TO: USAID TANZANIA

OCTOBER 2013

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Program for Biosafety Systems (PBS): Biosafety Policy Implementation in Tanzania

Proposed Work Plan, October 1, 2013 – September 30, 2014

EXECUTIVE SUMMARYThe Government of Tanzania under the support of UNEP-GEF has accomplished developing the National Biosafety Framework (NBF) that consists of a legal and institutional regulatory framework. However, one of the challenges with this framework is the stringent liability and redress provision in the biosafety regulations (2009). Other challenges include limited capacity in terms of skilled human resource base, infrastructure, funding, and sketchy understanding of the benefits and safety of GM technology by the general public, regulators, decision makers, lawyers and scientists among others.

This work plan addresses the above mentioned challenges through implementation of activities addressing 3 strategic objectives: (i) Strengthening the biosafety regulatory framework through the review of strict liability clause in the biosafety regulations 2009 so as to ensure it supports the development and responsible use of GMOs in Tanzania; (ii) enhancing capacity of the regulatory authorities by developing/finalizing specific guidelines i.e. for Confined Field Trials (CFT) and for commercialization, and (iii) implementing collaborative outreach and awareness activities that promote public understanding of modern biotechnology and biosafety.

PBS/Tanzania will implement these activities in the work plan in collaboration with COSTECH, the Vice President’s Office-Division of Environment (VPO), the Tropical Pesticides Research Institute (TPRI) and the Agricultural Innovation Research Foundation (AIRF) among others.

The main focus of the proposed FY 2014 work plan includes building an enabling environment for a functional biosafety framework in Tanzania and ultimately promoting acceptance and adoption of the GM technology in Tanzania.

1. Background

Tanzania’s national policy on biotechnology (2010) emphasizes the technology’s potential to enhance the country’s food security and trade position. The broad objective of the policy is to ensure that Tanzania has the capacity and capability to capture the proven benefits arising from health, agriculture, industry and environmental applications of biotechnology while protecting and sustaining the safety of the community and environment. However, it has become apparent

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that key stakeholders believe Tanzania’s current biosafety regulations are too stringent and that the national objectives for biotechnology development might not be achieved.

Furthermore, Tanzania's Biosafety Regulations of 2009 employ the "Precautionary Principle" which means that a lack of scientific evidence is not a basis for refusing or restricting GMOs or biotech products. The regulations also employ the "Strict Liability" principle, which broadly states that any “person who imports, arranges transit, makes 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”, which should be "fully compensated". The liability for any perceived "harm, injury or loss", even to vaguely defined "social or cultural principles, livelihoods, indigenous knowledge systems or technologies" extends to all players associated with the GMO/biotech product such that even a secretary working for an agro-processing firm donating a gene for research could be sued if someone perceived harm from the biotech product. This "guilty until proven innocent" approach is contrary to most of the rest of the world, including neighbors Kenya and Uganda, which base their legislation on a "Fault Based Liability" principle, where harm and negligence must be proved. On the other hand, human medical trials and nuclear power plants do not typically employ strict liability principles.

This work plan focuses mainly on creating understanding to policy and decision makers on the consequences of having strict liability in the Tanzania biosafety regulations and influencing them to review the regulations. Specific communication and outreach activities using various tactics will be deployed accordingly. The review of strict liability will allow R&D in genetic engineering, technology transfer and availability of full range of tools to improve the livelihoods of smallholder farmers in the Tanzania.

PBS, financially supported by USAID, engages with the Government of Tanzania’s institutions and other stakeholders as they embark towards communication & outreach and capacity enhancement in managing modern agricultural biotechnology. This work plan has been developed based on recommendations from key ministries and a task force meeting held in September 2013 involving key national partners.

2. RationaleCurrently a wide range of public R&D institutions are involved in agricultural biotechnology in Tanzania, with projects on virus-resistant cassava and drought-tolerant maize as notable examples of GM applications. There is also an increasing interest in the application of GM,

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insect-resistant cotton following positive experiences in other African countries such as Burkina Faso.

A regulatory framework for modern biotechnology in Tanzania was developed under the Environmental Management Act of 2004, which was revised to incorporate provisions for regulating the development, handling and use of GMOs. Section 69 of the law addresses biosafety issues. Implementing regulations were issued in 2009. The key areas covered by the regulations are general guiding principles, institutional arrangements, procedures for notification and approval, export, deliberate release, confined use, contained use, transit and placing on the market of GMOs and their products, risk assessment and management, liability and redress, offences and penalties and schedules.

COSTECH, as the focal point for promoting biotech in the country, initiated a consultative process in 2010 through the Ministry of Communication, Science & Technology (MCST) to advise the government regarding the unnecessary restrictive provisions in the biosafety regulations. This process is ongoing with active collaboration of the Ministry of Communication Science and Technology (MCST) and the Ministry of Agriculture Food Security and Cooperatives (MAFC).

3. PBS/Tanzania: Goal and ObjectivesPBS supports partner countries in Africa and Asia in the responsible development and use of agricultural biotechnology; hence, PBS/Tanzania is proposing 3 key strategic objectives (below) for implementation with partners in Tanzania. PBS has partnered with COSTECH and the Vice President’s Office (VPO) Department of Environment as the local implementing organizations and it has a country coordinator who interfaces with the Government of Tanzania, USAID and all relevant stakeholders. The Coordinator is also connected to a larger PBS-Africa network and therefore acts as a conduit for sharing information and best practices from other African countries.

3.1 Overal l Goal and Strategic Objectives

Overall goal: To strengthen the biosafety regulatory framework in Tanzania

3.2 Strategic objectives

a) Strengthening the biosafety regulatory framework through the review of strict liability clause in the biosafety regulations 2009 so as to ensure it supports the development and responsible use of GMOs in Tanzania;

b) Enhancing capacity of the regulatory authorities by developing/finalizing specific guidelines (i.e., for CFTs, commercialization), improving system efficiencies and training of regulators;

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c) Developing and implementing a strategy for collaborative outreach and awareness that improves the understanding and communication skills of decision-makers and enhances public understanding of modern biotechnology and biosafety.

4. Proposed Activit ies by Strategic Objectives

4.1 Strengthening the biosafety regulatory framework through the review of strict liability clause in the biosafety regulations 2009 so as to ensure it supports the development and responsible use of GMOs in Tanzania (strategic objective 1)

Given the importance in achieving a functional biosafety regulatory framework, PBS will place priority on providing the necessary legal and technical assistance in this area. The following activities are anticipated:

a) The problem StatementPolicy makers and enforcers in the Ministry of Environment, Vice President’s Office (VPO), Divi-sion of Environment (DOE) and other key Ministries do not consider strict liability in the Biosafety Regulations 2009 as a barrier to technology transfer in Tanzania while developers and end users see it as a barrier to GM crop development. Furthermore there has been personaliza-tion of strict liability issue and resistance to change for a number of government employees.

What needs to be doneFace-to- face dialogue with the Minister for Environment to inform her on the implications of strict liability to the agricultural sector and national development in general. The face-to-face dialogue will be conducted through a meeting with the Minister.

Specific activities to be conductedi. Identify champions; ii. Prepare talking notes;

iii. Organize a meeting of 10 influential people (DG COSTECH, Director Research and Development (DRD) MAFC, Director, Ministry of Communication Science and Technology (DST), Prof. Jumanne Maghembe (Minister for water and irrigation) and 6 other influential persons and experts (tbd) to meet with the Minister for Environment and discuss consequences of strict liability clause in the regulations.

b) Problem statementThe Attorney General's Office are draftsmen of laws and regulations but they have limited understanding on the benefits of GM technology and the consequences of having strict liability in the Tanzania biosafety regulations.

Specific Activities

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To create understanding to the AG Chambers staff and other relevant ministerial lawyers on how prohibitive regulatory framework hinders biotechnology development in Tanzania through a workshop using case studies on the impact of restrictive/prohibitive biosafety regulatory framework on biotech in agricultural sector development. PBS will conduct this activity in collaboration with COSTECH and MAFC.

c) Problem StatementMany decision makers are unaware that the ongoing genetic engineering cassava research in the laboratory at ARI-Mikocheni will not progress further until and unless strict liability clause is reviewed. Furthermore they also are unaware that the state of art confined field trial (CFT) facility at Makutopora, Dodoma has become a white elephant despite of huge investment.

Specific ActivitiesTo arrange for visits of the Ministers from Ministry of Communication Science and Technology (MCST), MAFC, Ministry of Livestock and Fisheries Development (MLFD), Ministry of Trade and Industry (MTI), Tamisemi, Ministry of Environment, Ministry of Natural Resources, Ministry of Constitution and Laws, Ministry of Health and Ministry of Youth and Social Services to ARI Mikocheni and Makutopora.

d) Problem Statement

The Permanent Secretaries in various ministries have limited understanding and limited ability to grasp and use science based information to make informed decisions.

Specific ActivitiesRaising awareness and understanding on biotechnology and biosafety issues of Permanent Secretaries through the following activities:

To conduct a workshop for Permanent Secretaries so as to raise awareness and understanding on biotechnology & biosafety and how strict liability affects biotech development in the country. PBS will conduct the workshop in collaboration with COSTECH, MCST and MAFC.

SO 1: Deliverables and performance indicators

Policies/regulations/administrative procedures analyzed as a result of USG assistance

Minister endorsed the review of the biosafety regulations (2009). Government leaders recognizing the need to review prohibitive regulations that hinder

the progress of research in emerging technological fields, including biosafety regulations.

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Increased ability to use science based information to make effective decisions related to technology and GM crops R&D.

Policies/regulations/administrative procedures drafted and presented for public/stakeholder consultation as a result of USG assistance

Enabling and practical biosafety regulations and guidelines in place

Number of individuals who have received US government (USG) supported short-term agricultural sector productivity or food security training

At least 30 policy and decision makers exposed on legal aspects of biosafety regulation

4.2 Enhancing capacity of the regulatory author ities by developing / final iz ing specific guidel ines on CFTs and for commercial i zation (strategic objective 2)

PBS/Tanzania has established close collaboration with VPO/Environment focusing on technical, legal and regulatory factors associated with contained and confined field-testing, and relevant risk assessment and risk management procedures.

This work started, in FY 2013, with a technical review of current guidelines for field trial developed over the past years with UNEP-GEF support and development of new guidelines for commercialization. It will be followed by discussions of the two documents by various stakeholders. PBS will work with the Ministry of Agriculture’s Agricultural Biotechnology Scientific Advisory Committee and the VPO to address any remaining gaps and necessary adjustments. In addition, consultations will be held with technology developers such as the WEMA/maize project in order to identify their plans for CFTs and technical training needs. Specific activities will include:

a) To support a stakeholders' workshop on their inputs of the revised CFT guideline and the newly developed commercialization guidelines during FY 2013;

b) To support development of 2 additional, key guidelines and SOPs to support research and commercialization of GM products.


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Policies/regulations/administrative procedures drafted and presented for public/stakeholder consultation as a result of USG assistance

Set of 2 enabling guidelines for reviewing and implementing confined field trials and commercialization of GM products.


At least 60 stakeholders gave inputs on the revised and new developed CFT and commercialization guidelines.

4.3 Implementing col laborative outreach and awareness activities that enhance publ ic understanding of modern biotechnology and biosafety (strategic objective 3)

A PBS/Tanzania awareness and outreach component for decision makers will be implemented with national and international partners such as ISAAA, ABNE and AATF in order to enhance familiarity with current developments around GM crops and biosafety decision-making. This will include information sharing and activities geared to a broader audience including farmers, policy makers, politicians, and media. In preparation for CFTs, there will be a need to develop user-friendly materials to target key stakeholders in government, farming and media communities. PBS will concentrate on policy makers and decision makers’ needs to be conversant with the technology to make informed decisions.

Field visit programs to various countries, which are ahead of Tanzania in the utilization of biotech products, will be targeted to the key influential stakeholders.

There is a need to develop a strategic approach to biotechnology/biosafety communication and outreach, building on the diverse but disparate initiatives currently active in Tanzania. A positive recent development is the launching of the Open Forum on Agricultural Biotechnology (OFAB), spearheaded by COSTECH and AATF. PBS has already developed close collaboration with OFAB.

PBS/Tanzania will develop practical, hands-on training events based on successful approaches applied in other partner countries such as Kenya, Uganda and Burkina Faso. The main target group for such training will be regulators and reviewers (e.g., VPO, ABSAC, and the National Biosafety Committee), and CFT inspectors. Training events may be conducted in a neighboring country (Uganda or Kenya) where cassava, cotton and maize CFTs are ongoing.

i. In collaboration with other service providers such as ABNE and AATF to organize a field

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trip of 20 influential decision makers and regulators to Uganda to observe ongoing GM research and exchange ideas with their counterparts.

ii. To develop biosafety communication strategy using netmapping data in collaboration with OFAB / AATF.



Increased awareness with at least 60 influential decision makers regarding biotechnology, biosafety and strict liability provisions;

At least 30 regulators and inspectors acquired training on commercialization guidelines.

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pbs tanzania revised workplan oct 2013-sept 2014 internal work plan

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