INFORMATION ON BIOSAFETY AND BIOTECHNOLOGY

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INTRODUCTION

Biotechnology became more prominent in Uganda in 1993 when the Department of Animal Science in the Faculty of Agriculture at Makerere University proposed a study of bovine somatotropin (BST) hormone (produced through genetic engineering) on growth and milk production in Ugandan cattle.[2] At the time, there was heightened debate in the United States of America and the European Union (EU) over trade on Genetically Modified Organisms (GMOs). In fact, later that year, in November 1993, the EU placed a moratorium on the sale of BST.

Two years later, in 1995, another proposal was made to conduct a Phase 1 clinical trial of a candidate HIV-1 vaccine based on a live attenuated recombinant canary pox vector (ALVAC vCP 205),[3]. These proposals (of BST and ALVAC vCP 205 vaccine) made to Uganda National Council for Science and Technology (UNCST) stimulated the formulation of national biosafety guidelines and led to the establishment of a National Biosafety Committee in 1996.

Like most developing countries, Uganda lacked the capacity to handle issues on biotechnology and biosafety. Training of personnel on biotechnology and biosafety and putting in place the necessary infrastructure and systems for biotechnology and biosafety was thus very critical for Uganda. Training of man personnel is on-going and this will help Government in handling issues on biotechnology and biosafety, including institutionalization of biotechnology and biosafety matters. The biosafey bill has been approved by Cabinet and will soon be tabled before Parliament for approval.

2.        KEY MILESTONES ON BIOTECHNOLOGY AND BOSAFETY

a.       The legal framework for Biosafety and Biotechnology is the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety (CPB). Uganda signed the CBD on 12th June 1992 and ratified it on 8th September 1993. Furthermore, Uganda also signed the CPB on 24 May 2000 and ratified it on 30th November 2001. These provided the basis for Uganda to benefit from technical assistance and financial support to carry out activities in the field of biotechnology and biosafety. The Uganda National Council for Science and Technology (UNCST) established in 1990 by an Act of Parliament is a semi-autonomous agency under the Ministry of Finance, Planning and Economic Development. UNCST facilitates and supports the development and promotion of science and technology for national development. UNSCT is the National Competent Authority (NCA) for  biosafety in Uganda while the Ministry of Water and Environment is National Focal Point for the Cartagena Protocol on Biosafety. The National Environment Management Authority (NEMA) established by Act of Parliament in 1995 is the National Focal Point for Convention on Biological Diversity. UNCST works closely NEMA on matters concerning biosafety and biotechnology.

b.      The BIO-EARN project (East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechonology Policy Development) provided Uganda the opportunity to begin building capacity in the area of biotechnology and biosafety. The project was implemented between1996-1998.  Uganda was chosen as the focal point. BIOEARN supported Uganda in capacity development as well as the drafting of the national policy on biotechnology and biosafety.

c.       Between 1998-2001, Uganda received further support from the Global Environment Facility (GEF) which provided additional resources for further work on the policy and development of a National Biosafety Framework (NBF) for Uganda. Between 2002 –2005, Uganda received additional support from the GEF. This was phase II of GEF support to Uganda on biotechnology and biosafety. This phase concentrated on the implementation of NBF, including mapping of experts, capacity building, finalization of the biotechnology and biosafety policy. From 2004/05, just as GEF Phase II was ending, the Programme for Biosafety Systems (PBS) was launched in Uganda. The project its final stages of implementation. The NBF was finalized in 2000 and it provided a framework for Uganda to lay the foundation for use of genetically engineered (transgenic) organisms and products derived from them.

d.      The National Biosafety Committee put in place in 1996 is operational. The NBC provides technical advice on biosafety to Government and maintains links with research centers /institutions through Institutional Biosafety Committees. The NBC is composed of not more than 15 expertise from different fields namely: Plant Breeding, Chemsitry/Biochemistry, Microbiology, Entomology, Human Medicine, Veterinary Medicine, Social Work, Law, Trade, Biosafety and Phytosanitary/Zoosanitary.

e.       The NBC is a specialist committee of UNCST and is guided by the National Biotechnology and Biosafety Policy (2008) which provides a framework for the safe application of modern biotechnology for national development. NBC reviews biotechnology, biosafety as well as GMO related research proposal and applications for Confined Field Trials (CFT). Fig.1 summarizes the evaluation process.

NBBP has the potential to contribute to poverty alleviation and national development. Government of Uganda has put in place the necessary institutional and policy framework as well as the National Biosafety Frame work to move the process further. Thus Government put place a policy on biotechnology to harness the benefits from modern biotechnology and is evidenced by the goal of the policy which is to contribute to poverty eradication, improved healthcare, food security, industrialization and the protection of the environment through the safe application of biotechnology. The objectives of the policy are to:

  1. Build and strengthen national capacity in biotechnology research, development and application;
  2. Promote the utilization of biotechnology products and processes as tools for national development
  3. Provide a regulatory and institutional framework for safe and sustainable biotechnology development and applications; and
  4. Promote ethical standards in biotechnology research and development.

The provisions of NBBP are consistent with the principles laid out in the National Environment Act, CBD and the Cartagena Protocol on biosafety.

f) The following guidelines have been developed:

i.            National Guidelines for Containment (2007) for regulating research on Genetically Modified Organisms and Microbes.

ii.            Confined Field Trial Guidelines for Uganda (2006) for field experiments with Genetically Engineered Plants

iii.            Trial Manager’s Handbook Procedures and Forms (2006) for field experiments with Genetically Engineered Crops.

iv.            Biosafety Inspection Manual for Field Experiments involving Genetically Engineered Crops (2007)

v.            Crop Specific Compliance Handbooks for bananas, cotton and cassava.

 

g) There are on-going CFTs using transgenic materials to genetically improve g carried out resistance to banana bacterial wilt, nematodes and weevils as well as to enhance its nutritional value. CFT of bio-engineered bananas begun in 2007 to confer resistance against black sigatoka disease caused by the fungus Mycosphaerella fijiensis. The table below gives a summary of completed and on-going CFTs in Uganda as well as the scientists undertaking the research.

 

 

 

 

 

 

 

Table 1: Status of CFTs in Uganda

Dates

Biotechnology Research Project/GMO Application

Intended use/Purpose

Institutional involvement

Principal Investigator/Project Lead

Status

1993

Recombinant Bovine Somatotropin (rBST) trial

Testing of rBST for enhanced milk production in Ugandan cattle.

Department of Animal Science, Faculty of Agriculture, Makerere University.

 

Completed

1995/6

ALVAC trial

Phase 1 clinical trials to demonstrate safety and efficacy of theALVAC vCP 205 HIV-1 recombinant DNA vaccine (Aventis Pasteur)

Makerere University-Case Western University Research Collaboration, JCRC, UVRI

Peter Mugyenyi, H Cao

Completed

2005

Banana  Black Sigatoka Disease trial

Field evaluation of transgenic Banana resistant Black Sigatoka Disease (Rice Chitinase )

NARO-NaCRRI, KU – LEUVEN, ABSP II,

Wilberforce Tushemereirwe

Completed

2007

Cotton Bollgard II trial

Field evaluation of transgenic Cotton  resistant to Bollworm (Cry 1Ac & Cry 2Ab2)

NARO-NaSSARI, Makerere University, APEP, Monsanto S.A. (Pty)

Thomas Emeetai Areke/ Beatrice Akello

On going

2007

Cotton Round-up Ready Flex (RRF) trial

Field evaluation of Herbicide Tolerant Cotton ( CP4 gene   EPSPS analogue)

NARO-NaSSARI, Makerere University, APEP, Monsanto S.A. (Pty)

Thomas Emeetai Areke/ Beatrice Akello

On going

2008

Cassava Mosaic Disease trial

Field evaluation transgenic  Cassava resistant to Cassava Mosaic Disease (RNAi technology)

NARO-NaCRRI, DDPSC

Titus Alicai

Completed

2009

Banana Biofortification  trial

Field evaluations of transgenic Banana biofortified for pro-Vitamin A, Vitamin E and Iron

NARO-NaCRRI, QUT, Bioversity

Wilberforce Tushemereirwe/ Geoffrey Arinaitwe

Completed

2009

Banana Xanthomonas Wilt trial

Field evaluation of transgenic banana resistant to

Xanthomonas Wilt Banana

(Pflp, Harpin mediated resistance)

NARO-NaCRRI, IITA, AATF, ABSP-II, Academia Sinica (Tn) & Gatsby Charitable Trust.

Wilberforce Tushemereirwe/ Leena Tripathi

On going

2009

Cassava Brown Streak Disease trial

Field evaluation transgenic  Cassava resistant to Cassava Brown Streak Disease (RNAi technology)

NARO-NaCRRI, DDPSC

Titus Alicai

Completed

2009

Water Efficient Maize for Africa (WEMA)

Drought tolerant maize

(Event MON87460)

NARO-NaCRRI, AATF, CIMMYT, Monsanto Fn.

Godfrey Asea

On going

2010

Virus resistant Sweet Potato trial

Sweet potato resistant to sweet potato virus disease (RNAi technology)

NARO-NaCCRI, CIP

Titus Alicai

Deffered

2010

Insect Resistant Sweet Potato trial

Sweet potato resistant to insect pests endemic to east Africa (Cry proteins)

NARO-NaCCRI, CIP

Gorreti Semakula

Deffered

2011

EACMV/ACMV trial

EACMV/ACMV resistant cassava

NARO-NaCRRI, DDPSC

Titus Alicai

On going

2011

Banana Nematode trial

Field evaluation of Banana and plantain engineered for Nematode resistance

NARO-NARL, Uni. Of Leeds, IITA, RAHAN Meristems, ABSP II

Wilberforce Tushemereirwe/

Charles Changa

On going

2011

Nitrogen Efficient and Water Efficient Rice (NEWEST) trial

Nitrogen and water efficient/(salt tolerant) rice

NARO-NaCCRI, AATF, DDPSC, Arcadia Biosciences

Jimmy Lamo

On going

2012

Insect Resistant Maize trial

Field evaluation of transgenic Maize resistant to stem borers (Cry Proteins)

NARO-NaCRRI, Monsanto S.A. Gates Foundation

Michael Otim

Anticipated

 

MAAIF oversees inspection for compliance with phytosanitary and other terms and conditions of approval.

 



[1] Biotechnology refers to a variety of techniques involving living organisms or their parts as a means of production (Mila Avramovic, 1996). Traditionally bread, beer, cheese and yoghurt -making employ biotechnology. In this study, however, biotechnology is closely associated with transgenic organisms or use of rDNA techniques.

[2] BST is a hormone produced in small quantities by the cow’s pituitary glands and it regulates metabolic processes. The growth hormone that was to be evaluated was produced in Europe through genetic engineering of agrobacteria.

[3] The vaccine construct was a live recombinant canarypox vector expressing HIV-1 gp120 (MN), the anchoring region of gp41 (LAI), the entire gag and a portion of the pol. This was the first preventative HIV-1 vaccine study in Uganda and in Africa aimed to evaluate the safety and immunogenicity of the ALVAC-HIV vCP205 in seronegative Ugandan

volunteers (Cao H, et al., 2003).

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