Uganda National Council for
Science and Technology
Uganda National Academy of
Sciences
The Scope of Biosafety and Biosecurity in Uganda: Policy
Recommendations
A paper presented at the Uganda Medical
Association and Uganda Veterinary Association
Joint Scientific Conference Hotel Africana, Kampala
14th-16th February 2013
by
Dr. Maxwell Otim Onapa, BVM, MSc, PhD, MBA
Deputy Executive Secretary, UNCST
Presentation Outline
Background of the Study
Findings of the UNAS workshop
VERTIC study on Biosecurity in Uganda
The Uganda National Biosafety and Biotechnology Bill
Work Processes
UNAS response
statement of task (SOT)
goal of the report
Conclusions
Recommendations
BACKGROUND TO THE STUDY
1.The Biotechnology/
Biosafety Bill in Uganda
Establishes a system whereby the country
can benefit from safe applications of
modern biotechnology while at the same
time assess and address any potential
risks from those applications
Act to operationalize the policy underway
Concern
Biosafety and biosecurity measures for medical
and scientific laboratories working with
pathogens and infectious agents
2.
Findings of the UNAS
workshop
3.
VERTIC study on
Biosecurity in Uganda
UNAS RESPONSE
To address these issues, UNAS convened a
multidisciplinary committee of experts who
responded to a defined Statement of Task by
drafting a report containing their findings.
Work Processes
Statement of Task (SOT)
To review and assess the
current state of knowledge
pertaining to the meaning and
scope of biosafety and
biosecurity with a view to
informing both policymakers
and legislators in Uganda to
guide them in making a
pertinent national policy and
regulatory framework.
Specifics
Clarify the meaning and scope
of biosafety and biosecurity in
the context of Uganda;
Establish areas of overlap
and agreement between
biosafety and biosecurity;
Examine activities in and out
of laboratories and research
facilities with a bearing on
either biosafety or
biosecurity or both;
Examine the risks those
activities pose to human,
animal, plant life and the
environment; and
Guide the development of
appropriate policies, laws
and regulations on biosafety
and biosecurity.
Work Processes………..
Role of the COEs
Responded to a SOT by
drafting a report containing
their findings.
Goal of the report
To clarify the overlap of
biosafety and biosecurity
Reason
To better position government
officials as they weigh the pros and
cons of government intervention in
laboratories and the sorts of
regulatory frameworks that might be
implemented to ensure safe and
secure labs while minimizing undue
burdens
Approach
Information gathering
Technical testimonies
Deliberations
Literature review
Peer reviewing
The expert committee that undertook
this study reached ten conclusions
and six recommendations
ASSESSING THE RISK
Conclusion 1:
The greater the risk of the organism to the health or life
of humans, plants, or animals, and the environment, the
more stringent the biosafety measures and the need to
add biosecurity measures.
Microorganisms vary significantly in virulence mode of
transmission, toxin production, preventive and control
measure...
It is important to establish risk based on the type of
organism in question!!
ENSURING SAFE AND SECURE LABORATORIES
Conclusion 2:
The primary risks from work in medical and scientific
laboratories with pathogens or toxins are unintentional
exposure/infection of workers, community, and the
environment (including plants and animals) to those
pathogens or toxins.
Assignment to risk groups and corresponding biosafety levels.....type,
mode, virulence, host range, prevention and treatment options...
Biosecurity measures prevent malicious exposure/infection
Conclusion 3:
Biosafety guidelines and protocols should always be in
place for laboratory work involving any pathogens and
toxins.
Recent lab infection, bioterrorism...
Need for standards, practices, safety measures, equipment and
facilities for safety
COMPLYING WITH INTERNATIONAL AGREEMENTS ON
BIOSECURITY
Conclusion 4:
Based on the results of a survey of existing Ugandan
law to implement the Biological Weapons Convention
(BWC) and the United Nations Security Council
Resolution 1540 (Resolution 1540), the current legal and
regulatory framework in Uganda does not
comprehensively prevent or prohibit the malicious use
of pathogens and toxins, i.e., biological weapons as
defined in the BWC.
Implementation of instruments......
National legislative framework.......
Monitor and supervise peaceful activities ....domestic research and
disease control and transfers of pathogens and toxins.
CLARIFYING RISKS FROM AGRICULTURAL LABORATORY
RESEARCH WORK WITH GMOs
Conclusion 5:
The primary risks from agricultural laboratory
research with genetically modified organisms
(GMOs) are the unauthorised release of the
organism to the environment and any potential
adverse impacts on agricultural interests and
biological diversity. Laboratory containment
practices are implemented to prevent such
impacts.
Conclusion 6:
There are no known risks of infection to
humans and animals from laboratory research
involving agricultural GMOs. Biosecurity
measures are therefore not foreseen as an
issue in this context.
DEFINING RISKS FROM AGRICULTURAL RESEARCH WORK WITH
GMOs
Conclusion 7:
The potential risk level of a confined GMO field
trial can be determined by the persistence of
the crop and the potential for harm from the
introduced trait to the environment. It is at the
confined field trial stage, not the laboratory
stage, when some potential risks from research
with GMOs become more relevant. The most
relevant risks are to the environment and
biodiversity.
CONTROLLING BIOSECURITY RISKS FOR POTENTIAL BIOLOGICAL
WEAPONS DEVELOPMENT
Conclusion 8:
Some nations have developed control lists
and/or risk levels of certain pathogens and
toxins that have the potential to be used as
biological weapons. Enhanced biosecurity
measures are triggered by any activities
involving pathogens and toxins on these control
lists, and ideally build on biosafety measures in
place for all laboratories.
Examples: the US select Agent lists;
The Australia group lists and dual-use
technology...
RECOMMENDATION 1
CATALOGUE SCIENTIFIC AND MEDICAL LABORATORIES AND
DANGEROUS ORGANISMS IN THE LABS
Uganda does not currently have an accurate
inventory of scientific and medical laboratories
and the organisms (pathogens and infectious
agents) they are working with, nor of the levels
of biosafety and biosecurity in those particular
laboratories. This information is critical to
ensuring appropriate biosafety and biosecurity
in Uganda. Therefore, Uganda National Council
of Science and Technology (UNCST), in
consultation with relevant stakeholders, should
undertake a study to catalogue the scientific,
research and medical laboratories and the
(most dangerous) organisms they are working
with.
RECOMMENDATIONS 2&3
ADOPT OR DEVLEOP CONTROL LISTS FOR UGANDA
Recommendation 2:
Since some nations (like the US) have already developed
control lists and/or risk levels of certain pathogens and toxins
that have the potential to be used as biological weapons,
Uganda may wish to consider these lists and either adopt one
of these as its own or develop its own, taking into account its
own national security and public health situation, concerns and
strategies.
Recommendation 3:
Many nations have already addressed laboratory biosafety and
biosecurity issues. Uganda should study and learn from those
experiences and then use aspects of those systems that apply
to the situation in Uganda. This could include adopting risk
control levels and associated lists of highly pathogenic
organisms and toxins that trigger biosecurity measures, and
codes of conduct, guidelines, manuals, and procedures that
address biosafety and/or biosecurity.
RECOMMENDATION 4
AMEND OR DEVLEOP LEGISLATION TO PREVENT AND PROHIBIT
BIOLOGICAL WEAPONS IN UGANDA
Recommendation 4:
Uganda to consider amending existing
legislation or developing a stand alone Act for
the comprehensive prevention and prohibition
of biological weapons proliferation. This could
include provisions referring to the biosafety and
biosecurity measures discussed in the
conclusions.
RECOMMENDATION 5
ESTABLISH A NATIONAL AGRICULTURAL GMO LAW WITHOUT
BIOSECURITY MEASURES
Agricultural GMO activities require different
biosafety measures than scientific and medical
laboratory work on human, plant and animal
pathogens and toxins. Therefore, Uganda
should move to establish a separate national
GMO law and regulations to address issues
around the research and commercial
development of genetically engineered plants
and animals.
RECOMMENDATION 6
BASE DEFINITIONS OF BIOSAFETY AND BIOSECURITY
ACCORDING TO THEIR CONTEXT
Consensus was reached on definitions on
biosafety in the GMO context and biosafety and
biosecurity in the laboratory context and also in
the BWC context:
(1) Biosafety and Biosecurity in a Laboratory
Context with Pathogens and/or Infectious
Agents
(2) Biosafety and Biosecurity from the Biological
and Toxin Weapons Convention Perspective
(3) Biosafety as it Relates to Research and
Commercialisation of GMOs for Agricultural
Purposes
Acknowledgements
This Study was supported by
Uganda National Academy of
Sciences (UNAS)
Thank You For Your Kind Attention