Agricultural biotechnology and the regulatory environment in Uganda - November 2012

Theresa Sengooba

Coordinator, Program for Biosafety systems

B4FA Media Training workshop , Munyonyo Uganda

31st October -3rd November

Agricultural biotechnology and

the regulatory environment

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

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

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

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

How are GMOs regulated in

Uganda?

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

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)

Key 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;

(g) to build capacity for biotech regulation and management

.

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;

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.

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

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

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;

The application process: Critical steps in the application process:

© Halsey, 2006

Key questions in the application

1. Administrative data --Who, what, where, when?

2. Technical data --Proposed management; Host or parental organism; Inserted genes and sequences

3. Proposed Methods of Risk assessment 1. Host organism; Inserted genes/sequences;

Characteristics of the GMO; Intended use ; Existing situation/environment…

4. Proposed Risk Management strategies 1. What is the consequence?; Is it measurable?; What

steps can be taken to reduce identified risks? e.g. reproductive isolation

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

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

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 Confinement

SOP for Termination of the Trial

SOP for Post Harvest Monitoring

SOP for reporting and

SOP for Incidents and contingency Planning

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

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?

Capacity still wanting in various aspects

Thank you