Présentation de Hazar Belli Abdelkefi, du ministère de l'environnement, durant le symposium organisé conjointement entre le Robert Koch Institute et l'Institut Pasteur de Tunis "Current challenges of Biological Risks and Heealth Security" (22-23 septembre 2016)

1. CURRENT REGULATION ON BIOSAFETY AND BISECURITY IN TUNISIA
HAZAR BELLI EP ABDELKEFI (MLDE / PRESIDENT ATB2E)
HAZAR.BELLI.ABDELKEFI@GMAIL.COM
Current challenges of biological risks and health security 22- 23 september 2016

2. Biosafety and biosecurity definition
Laboratory biosafety describes containment principles, technologies and practices implemented
to prevent unintentional exposure to pathogens and toxins, or their accidental release.
'Protect people from pathogens'
Prevention of accidental or 'deliberate' release from laboratories
Laboratory biosecurity describes the protection, control and accountability for Valuable
Biological Materials (VBM) within laboratories, in order to prevent their unauthorized access, loss,
theft, misuse, diversion or intentional release.
'Protect pathogens from people'

3. Standards,Regulations,SOPs
andBestPractices
International Legal
Frameworks and
Guidance Principles
(BWC, UN1540, IHR, CBD,
cartagena protocol )
International
Guidance
(E.g. WHO LBM)
International
Standards / Consensus
Agreements
(E.g. CWA 15793,
ISO 9001)
Mandatory
Voluntary

4. Biosafety regulations worldwide
 Mature biosafety regulations that cover worker protection, contained use of
biological agents and environmental release of GMOs and some times Natural
Invasive Alien Species (Most devlopped countries) ;
 Biosafety regulations limited to environmental regulations on GMOs based on
Cartagena Protocol on Biosafety (Number of Asian and African countries);
 Non existent biosafety regulations (Some developping and emerging countries ).

5. What should ideally be covered by biosafety regulation?
 The protection of workers from infectious biological agents (natural or modified)
and materials.
 The protection of Community and Environement from biological risks generated by
the use of biological agents, genetically modified organisms and invasive species:
contained use, deliberate release.

6. Tunisian Legislation « Biosafety & Biosecurity »

7. International Response to Biological Risk
 1925 Geneva Protocol
• Prohibits use of CW and BW in warfare Ratification / Accession of Tunisia on : 12 july 1967
 1972 Biological Weapons Convention
• Prohibits development, production, stockpiling, acquisition, retention or transfer of BW
Ratified under the law N° 73/12 - 23/03/1973
 2004 UN Security Council Resolution 1540
• Requires all states to take measures to prevent WMD (including BW) terrorism
 2005 International Health Regulations
• Framework for coordinating events that may constitute a public health emergency of concern

8. International Response to Biological Risk (cont …)
Tunisia signed the Cartagena Protocol on the
prevention of biotechnological risks on April
19th, 2001 and ratified the Protocol
on June 25th , 2002

9. Tunisia's Constitution of 2014
 Preamble (paragraph 4)
Being aware of the necessity of contributing to the preservation of a healthy environment that guarantees
the sustainability of our natural resources and bequeathing a secure life to future generations,….
 Article 38
Health is a right for every human being. The state shall guarantee preventative health care and treatment
for every citizen and provide the means necessary to ensure the safety and quality of health services.
 Article 45
The state guarantees the right to a healthy and balanced environment and the right to participate in the
protection of the climate.
The state shall provide the necessary means to eradicate pollution of the environment.

10. State of the art in Tunisia
 Law n° 2003-75 of December 10, 2003, concerning the support of international efforts to combat
terrorism and repress money laundering as modified and completed by law n°2009-65 of August 12,
2009: The current law ensures the right of the society to live in security and peace
 Plead of texts has…
• Promoted health and safety in the field of work
• Developed risk prevention programs and setting standards
• strengthened the legislative and regulatory framework related to environmental protection
• established a national emergency intervention plan
 For pollution
 for waste and control of their management and their disposal

11. State of the art in Tunisia (cont)
Since 1999, Tunisia engaged a process of development of a National Legal Framework for Biosafety,
in order to secure and adequately control the contained use, the deliberate release and the
marketing of GMOs, in accordance with the precautionary principles of the Cartagena Protocol.

12. 2001
• The first draft of the legal farmework (elaborated by a national consultant):
Two draft laws
• Contained use, import, transit, deliberate release of GMOs;
• Direct use for food or feed.
2005
• We opted for one draft law for contained use, direct use for food or feed,
import, export, transit & deliberate release of GMOs.

13. 2009
• Not consensus reached between the ministries
• Series of meetings of the National Biosafety Committee (NBC) held at the
Prime Ministry
• The NBC drafted a new version of a Law on GMOs and GMO products
2011
• Tunisian revolution Arab Spring: Post revolutionary context

14. Training
Handling of
request
(Dec 2012)
Training
RA & RM
(dec 2012)
Training
Bioafety , biosecurity and
biorisk management
(2013 – 2014)
UNICRI / ICIS / EU
Training
Monitoring &
Inspection
(2011 – 2012)

15. 1/ Are all the elements covered?
- Contained use and deliberate release?
- GMOs and GMO products?
- Risk assessment & management?
2/ Should other aspects also be covered?
3/ Feasibility?
4/ Does the system of consultation decision appear functional or
not?

16. National days for Biodiversity & Biosafety (May 2013)
 Revision of the proposed draft Law focused on GMOs to a national legal framework on
Biosafety / biosecurity (GMOs, pathogens, toxins, Invasive Alien Species,…);
 Creating a permanent Commission on Biosafety taking into account the existing team having
worked in this field;
 Preparing a national plan on communication & public participation;
 Promoting technical cooperation between laboratories dealing with GMO detection &
quantification;
 Emphasizing the need to mobilize the necessary financial resources for capacity building in
biorisk management & the continuity of this process.

17. National Technical Commission on Biosafety
Communication,
sensibilisation & public
participation
Network laboratories
GMO detection & Quantification
(ongoing)
Pathogens
(BSL2+ / BSL3)
IAS
Legal Framework
Commision

18. June
2014
• Better understanding of biosafety and biosecurity issues
(important impact of the integration of Tunisia in the CoE Project 3
(UE-UNICRI-ICIS))
• The NTBC drafted a new version of the Law on biosafety (GMO
part) and we agreed to integrate the pathogens: three working
days in Hammamet
December
2014
• Three working days in Tunis to examine and draft the part on pathogens
and we agreed to integrate the Invasive Alien Species
• Integration of the National experts of CoE Project 3 in the NTBC

19. March
2015 • Three working days in Tunis to examine and draft the part of Invasive Alien
Species
April
2015
• Three working days organized in Tunis to examine and draft the part of liability
and redress

20. GMO
(2002 – 2015)
Specific provisions for GMOs
Pathogens
(2014 – 2015)
Specific provisions for
pathogens
Invasive Alien species
(2015)
Common provisions (GMO +
P + IAS)
+
Specific provisions for IAS

21. National Stakeholders
NTCB: Ministries (Agriculture, Environment,
Health, Trade, Industry, Higher Education, Research,
Justice, Prime Ministry), National Gene Bank, INORPI,
ANCSEP, CITET, LCAE, CTAA, UTAP, ODC (NGO)
GMO
NTCB + NE + Experts IAS
GMO + Pathogens + IAS
NTCB + National Experts P3 (Ministry
defense, civil protection, Pasteur Institute)
GMO + Pathogens

22. Preparing a draft of Decree to creat a: National Authority on biosafety
-Propose the national strategies & orientations in the field of biosafety and biosecurity;
-Preparing the final draft of the biosafety legal framework ( law, orders & decrees) ;
-The coordination of the National Network Laboratories for GMO, pathogens and IAS;
-Preparing and updating the list of national experts in the field of biosafety and biosecurity
in accordance with the international requirements;
-Facilitate the exchange of scientific, technical, environmental and legal expertise in
the field of biosafety and biosecurity;
-Development of international cooperation in bilateral and multilateral biosafety and
biosecurity;
- Prepare an annual report summarizing the overall activities and displays all relevant
structures.

23. Project
Biosafety Staff
2007
National Technical
Commission on
Biosafety
2013

24. Draft Law on biosafety for Tunisia

25. Common provisions
Goal:
 Protect humans, animals, environment and biological diversity and the sustainable use of its components against the
dangers related to the use of the organisms their metabolites and waste.
Organisme: GMOs, Pathogens & IAS
 Ensure consumer choice (GMOs);
 Ensuring the necessary biosecurity measures.
Purpose and scope:
The use of organisms, their waste and their metabolites in the environment
Use: Confined use, deliberate release, placing on the market, import, export, transit, transport, storage, destruction of
organisms.

26.  Classification of biological agent in to risk groups according to WHO classification
(group 1 to 4);
 Organisms should not be used directly in the environment:
1/ If they are part of the group 3 & 4
2/ Aquatic IAS
3/ If they contain introduced genes for resistance to antibiotics
4/ If the host organisms are invasive
 The establishment of the National Authority on Biosafety

27. Specific provisions
Requirements for the use of GMOs
Procedures of agreement, authorization and notification
For the first use Notification nearby the National Authority on
Biosafety
 Request of agreement from the ministry charged of Environnement

28. OK
INSCRIPTION OF THE GMO
IN THE NATIONAL REGISTRY
REQUEST OF AUTHORIZATION FROM
THE CONCERNED MINISTER
( According to existing national procedures)
NO

29.  Specific provisions on the contained use;
 Specific provisions on the deliberate release to the marketing, import,
export, transit and transport of GMOs Mandatory labeling;
 Risk Assesment traceability, official control &emergency response
plan;
 Information and public participation in decision making.

30. Requirements on the use of pathogens
Proceeding for notification and authorization
Risk group 1&2 Risk group 3 & 4
Notification Authorization
Specific provision
-Packaging, storage, handling and transportation;
- Containment;
- Traceability procedures and official control;
- Emergency response plan in case of accident;

31. Requirements for the use of
Invasive Alien Species
 Procedures for notification and authorization according to risk
groups;
 Detection measures and early eradication;
 Proceedings of control and containment;
 Restoration and mitigation.

32. Accompanying measures

33. 1/ Achievement and implementation of the National Strategy and Action Plan on Biosafety;
2/ Set up a national Laboratories Network for GMO detection & quantification;
4/ Achievement of the national plan of communication and public awareness;
3/

34. BIORIM- Tunisia 2017
1st Annual Biorisk Management Symposium
MENA – Biosafety Associations (MENA-BA)
“safe, secure and responsible work with biological materials”
Pre-conference workshops Conference
4th – 5th April 2017 6th – 8th April 2017
www.atb2e.tn/biorim2017

35. Thanks for your attention