current regulation on biosafety and bisecurity in tunisia
TRANSCRIPT
CURRENT REGULATION ON BIOSAFETY AND BISECURITY IN TUNISIA HAZAR BELLI EP ABDELKEFI (MLDE / PRESIDENT ATB2E)
Current challenges of biological risks and health security 22- 23 september 2016
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'
Standards, Regulations, SOPs and Best Practices
Constitution
National Laws / regulations National guidance / national
standards
Facility Specific biosafety and biosecurity manuals
--------------------------Laboratory Specific Standard Operating Procedure (SOPs)
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
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 ).
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.
Tunisian Legislation « Biosafety & Biosecurity »
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
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
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.
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
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.
1999
2011Biosafety =GMO
2013 Biosafety & biosecurity
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.
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
NLFB
?
TrainingHandling of
request(Dec 2012)
Training RA & RM
(dec 2012)
TrainingBioafety , biosecurity and
biorisk management (2013 – 2014)
UNICRI / ICIS / EU
Training Monitoring &
Inspection
(2011 – 2012)
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?
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.
National Technical Commission on Biosafety
Communication, sensibilisation & public
participation
Network laboratories
GMO detection & Quantification (ongoing)
Pathogens (BSL2+ / BSL3)
IAS
Legal FrameworkCommision
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
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
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
National Stakeholders
General direction of Environnement and Quality of Life
(NFP – CP)
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 IASGMO + Pathogens + IAS
NTCB + National Experts P3 (Ministry defense, civil protection, Pasteur Institute)
GMO + Pathogens
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.
Project Biosafety Staff
2007
National Technical Commission on
Biosafety2013
National Authority on
biosafety2016 - 2017
Draft Law on biosafety for Tunisia
Common provisionsGoal: 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.
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 antibiotics4/ If the host organisms are invasive
The establishment of the National Authority on Biosafety
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
OKINSCRIPTION OF THE GMO IN THE NATIONAL REGISTRY
REQUEST OF AUTHORIZATION FROM THE CONCERNED MINISTER
( According to existing national procedures)
NO
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.
Requirements on the use of pathogensProceeding 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;
Requirements for the use ofInvasive Alien Species
Procedures for notification and authorization according to risk groups;
Detection measures and early eradication; Proceedings of control and containment; Restoration and mitigation.
Accompanying measures
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/ The creation of the Tunisian Association for Biosafety and Environmental Education (ATB2E)
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
Thanks for your attention