Presentation by Teresa Sengooba, Coordinator PBS, Uganda Delivered at the B4FA Media Dialogue Workshop, Kampala, Uganda - November 2012 www.b4fa.org

1. Agricultural biotechnology and
the regulatory environment
Theresa Sengooba
Coordinator, Program for Biosafety systems
B4FA Media Training workshop , Munyonyo Uganda
31st October -3rd November

2. Definitions
 Biotechnology =any technological application that makes use of
biological systems, living organisms, or their derivatives to make or
modify products or processes for a specific use
 genetically modified organism or GMO” means an organism where
genetic material have been modified by means of modern
biotechnologies
 Genetic engineering is usually done with diverse aims varying from
improving an organism’s physical and chemical characteristics,
increasing its resistance to pests and diseases, tolerance to
environmental stress to increasing nutritive values, among others
 Biosafety = all measures put in place to ensure that the development,
transfer and application of modern biotechnology is done in a manner
safe to biological diversity, the environment and human health

3. Background
Historical
 Progress in conventional biotech prior 2000
 enhancement of milk fermentation,
 tissue culture and
 rhizobia Rhizobium- soil nitrogen fixation
 UNCST received an application to test a recombinant
bovine somatotrophin (BST) hormone (BST) in 1993
 UNCST received a 2nd application to conduct research
on HIV-1 vaccine in 1995

4. Historical background cont…..
 UNCST and NARO organized a national forum on
Biotech 1995
 NBC formed by UNCST in 1996
 UNCST/UNEP-GEF conducted a study that led to
development of NBF 1998
 The Cartagena Protocol ratified by Uganda 2001
 President appointed AYUME committee to come with
a national position on GM foods in 2003.
 Drafting of a single policy addressing both
biotechnology & biosafety began

5. Uganda NBF
 The NBF is derived from the UNCST Statute 1 (1990)
which designates the Council as the competent authority
in developing strategies for integrating S&T in national
development process
 NBF
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is composed of:
Focal point
Competent Authority
Policy
Law
Regulations, guidelines and SOPs as may be necessary
Mechanism to handle requests
Mechanism for risk assessment and management
Mechanism for monitoring for compliance/enforcement
Mechanism for public participation and information

6. How are GMOs regulated in
Uganda?

7. Uganda Focal Point
 Location: MWE
 Responsibility:
1. Contact point for the Secretariat of the Convention on
Biological Diversity.
2. provide coordinated flow and exchange of information
between(a) relevant ministries, other bodies on transboundary movement of
GMOs;
(b) Governments through formally approved diplomatic channels; and
(c) the Secretariat to the CPB and other international organisations,
 Achievements: Effective participation in the CPB negotiations
 Challenges: Domesticating the protocol has been slow

8. Competent Authority
 Located with UNCST /MFPED—Why
 UNCST was originally in min. of planning that
merged with finance to make MFPED
 R&D is regulated under UNCST act
 UNCST initiated NBF
 Biotech is cross cutting and where it is located is a
political decision (1st applications came from medical)

9. ey Responsibilities of Competent Authority:
(a) to approve the development, testing and use of a GMO in
Uganda;
(b) to ensure safety of biotechnology to human health and the
environment during development, testing and use of a GMO;
(c) to prescribe conditions, standards, procedures and
guidelines for development, testing , transit and general
release of a GMO;
(d) to advise Government on matters of biotechnology and
biosafety;
(e) to coordinate the roles of other lead agencies handling
biosafety
(f) to promote awareness and education concerning biosafety
and to
coordinate public participation;

10. National Biosafety Committee
responsible:
 to review, and make recommendations on applications
received by the Competent Authority;
 to advise the Competent Authority on comments received
from the public on biotechnology and biosafety;
 to recommend to the Competent Authority mitigation measures
to be undertaken in case of an accident or any other issues
related to biosafety;
 to advise the Competent Authority on the implementation of
biosafety;
 to recommend to the Competent Authority new scientific
information in respect of biotechnology and biosafety;

11. Institutional Biosafety Committee
responsible:
 approve laboratory experiments and contained
testing;
 regularly review, monitor and supervise
laboratory experiments, contained testing and
confined testing;
 recommend to the Competent Authority
applicants for confined testing and general
release;
 ensure that research is conducted in accordance
with this approved, regulations and guidelines
issued by the Competent Authority.

12. Biotechnology and Biosafety (BaB)Policy
objectives:
 Build and strengthen national capacity in biotechnology
through research and development
 Promote the utilization of biotechnology products and
processes as tools for national development
 Provide a regulatory and institutional framework for
biotechnology development and applications
 Ensure public and environmental safety in biotechnology
development and application
 Provide for measures for biotechnology and biosafety
monitoring and evaluation

13. BaB Bill and its purpose
 To facilitate the safe development and application
of biotechnology; to designate the national focal
point, and a competent authority; to establish a
national biosafety committee and for related
matter

14. BaB Bill Objective
 to facilitate the safe development and application of
biotechnology;
 facilitate and promote research, development and use of
modern biotechnology;
 to establish procedures for bio-ethical considerations in
biotechnology research;
 to strengthen public and consumer understanding and
appreciation of products and benefits derived from
biotechnology;
 facilitate safe use of biotechnology to address national
development challenges in food security, healthcare,
biodiversity conservation and industrialisation;

15. The application process:
Critical steps in the application process:
© Halsey, 2006

16. Key questions in the application
1. Administrative data --Who, what, where,
when?
2.
3.
Technical data --Proposed management;
Host or parental organism; Inserted genes and
sequences
Proposed Methods of Risk assessment
1.
4.
Host
organism;
Inserted
genes/sequences;
Characteristics of the GMO; Intended use ; Existing
situation/environment…
Proposed Risk Management strategies
1.
What is the consequence?; Is it measurable?; What
steps can be taken to reduce identified risks? e.g.

17. Assessment for safety
 Risk assessment is the responsibility of the applicant
 An application must be accompanied with a risk
assessment report
 NBC will conduct risk assessment following standard
procedures
 Risk assessment to be be carried out in a scientifically
sound and transparent manner
 risk associated with a GMO may be considered in the
context of the risks posed by -(i) the non-modified recipient ;
(ii)the parental organisms and the receiving environment

18. Monitoring for regulatory
compliance
 M&E is a job of Competent Authority
 Compliance:
The responsibility of the Authorised party
(PI) is to ensure compliance with the terms
and conditions of authorisation of the trial
by closely supervising and guiding his
research team
The Authorised Party is legally responsible
in case of trial noncompliance

19. Compliance is assured thru:
regulations, guidelines and SOPs

20. Examples of SOPs for Field Trials
 Sections of the Inspection Manual include:
 SOP for shipping and storage
 SOP for Confinement
 SOP for Termination of the Trial
 SOP for Post Harvest Monitoring
 SOP for reporting and
 SOP for Incidents and contingency Planning

21. Capacity
 Human
 Formal
 Msc : Biosafety is one of the course units in agriculture
 New degree course at Makerere on biotech
 Informal
 Workshops
 Short courses and study tours
 Gaps
 GMO detection
 Biotech reporting

22. Capacity
 Infrastructure

23. Public participation and Information

24. Visit by NaSARRI staff

26. Challenges
 NBF not yet complete
 Law and regulation not yet in place
 Media coverage?
 Certainty about products?
 Capacity still wanting in various aspects

27. Thank you