Agricultural biotechnology and
the regulatory environment
Theresa Sengooba
Coordinator, Program for Biosafety systems

B4F...
Definitions
 Biotechnology =any technological application that makes use of

biological systems, living organisms, or the...
Background
Historical
 Progress in conventional biotech prior 2000
 enhancement of milk fermentation,
 tissue culture a...
Historical background cont…..
 UNCST and NARO organized a national forum on

Biotech 1995
 NBC formed by UNCST in 1996
...
Uganda NBF
 The NBF is derived from the UNCST Statute 1 (1990)

which designates the Council as the competent authority
i...
How are GMOs regulated in
Uganda?
Uganda Focal Point
 Location: MWE
 Responsibility:

1. Contact point for the Secretariat of the Convention on
Biological...
Competent Authority
 Located with UNCST /MFPED—Why
 UNCST was originally in min. of planning that
merged with finance to...
ey Responsibilities of Competent Authority:
(a) to approve the development, testing and use of a GMO in

Uganda;
(b) to en...
National Biosafety Committee
responsible:
 to review, and make recommendations on applications

received by the Competent...
Institutional Biosafety Committee
responsible:
 approve laboratory experiments and contained

testing;
 regularly review...
Biotechnology and Biosafety (BaB)Policy
objectives:
 Build and strengthen national capacity in biotechnology

through res...
BaB Bill and its purpose
 To facilitate the safe development and application

of biotechnology; to designate the national...
BaB Bill Objective
 to facilitate the safe development and application of

biotechnology;
 facilitate and promote resear...
The application process:
Critical steps in the application process:

© Halsey, 2006
Key questions in the application
1. Administrative data --Who, what, where,

when?
2.

3.

Technical data --Proposed manag...
Assessment for safety
 Risk assessment is the responsibility of the applicant

 An application must be accompanied with ...
Monitoring for regulatory
compliance
 M&E is a job of Competent Authority

 Compliance:

The responsibility of the Autho...
Compliance is assured thru:
regulations, guidelines and SOPs
Examples of SOPs for Field Trials
 Sections of the Inspection Manual include:
 SOP for shipping and storage
 SOP for Co...
Capacity
 Human
 Formal
 Msc : Biosafety is one of the course units in agriculture
 New degree course at Makerere on b...
Capacity
 Infrastructure
Public participation and Information
Visit by NaSARRI staff
Challenges
 NBF not yet complete

 Law and regulation not yet in place
 Media coverage?
 Certainty about products?

 ...
Thank you
Agricultural biotechnology and the regulatory environment in Uganda - November 2012
Upcoming SlideShare
Loading in …5
×

Agricultural biotechnology and the regulatory environment in Uganda - November 2012

758 views

Published on

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

Published in: Technology
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
758
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
23
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Agricultural biotechnology and the regulatory environment in Uganda - November 2012

  1. 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. 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. 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. 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. 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          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. 6. How are GMOs regulated in Uganda?
  7. 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. 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. 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. 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. 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. 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. 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. 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. 15. The application process: Critical steps in the application process: © Halsey, 2006
  16. 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. 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. 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. 19. Compliance is assured thru: regulations, guidelines and SOPs
  20. 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. 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. 22. Capacity  Infrastructure
  23. 23. Public participation and Information
  24. 24. Visit by NaSARRI staff
  25. 25. Challenges  NBF not yet complete  Law and regulation not yet in place  Media coverage?  Certainty about products?  Capacity still wanting in various aspects
  26. 26. Thank you

×