EU CBRN Action Plan: Action B2 and biosecurity regulation in France. Side Event, BWC Geneva Tuesday 10 December

Transcription

1 EU CBRN Action Plan: Action B2 and biosecurity regulation in France Side Event, BWC Geneva Tuesday 10 December

2 Summary 1.EU CBRN Action plan and the action B2 2.Action B2 : Biosecurity regulation in France

3 EU CBRN Action Plan (history) On 24 June 2009 the Commission adopted its communication on strengthening chemical, biological radiological and nuclear (CBRN) security in the European Union. The EU CBRN Action Plan was based on the finding of a CBRN Task Force established by the Commission in February 2008, involving both public and private stakeholders (closing seminar in Prague in January 2009).

4 EU CBRN Action Plan (goals) The EU CBRN Action Plan is aimed at strengthening CBRN security in the European Union. Its overall goal is to reduce the threat and damage from CBRN incidents of accidental, natural and intentional origin. The EU CBRN Action Plan is broadly based on an all-hazard approach, including terrorist threats, and contributes to the implementation of the EU Counter Terrorism Strategy. CBRN-E (explosives) Action Plan Malmö 2012

5 EU CBRN-E Action Plan (structure) Four chapters : 1. Prevention 2. Detection 3. Preparedness and response 4. Actions applicable to CBRN prevention, detection and response 67 Horizontal actions (RN, B and C) 15 Chemical actions (C) 25 Radiological-Nuclear actions (RN) 17 Biological actions (B)

6 EU CBRN-E Action plan Action B2 The Member States should establish: a registry of facilities possessing any of the substances on the EU list of high risk biological agents and toxins within each Member State while allowing access to law enforcement, taking security requirements into account; a process to verify whether security arrangements of facilities are adequate, including diagnostic laboratories handling and possessing any of the EU list of high risk biological agents and toxins; a mechanism within facilities storing biological agents and toxins on the EU list of high risk biological agents and toxins to regularly review the need of such biological agents and toxins while keeping a good record of stored materials. Involved actors : MS/Commission/relevant stakeholders Implementation period : from Task Force Recommendations n 98, 100, 104

7 B2 Working Group Call to participate to the working group (mail from DG Home in July 2012) Denmark France Netherlands Sweden United-Kingdom + Switzerland Three one-day meeting hold in Paris with appropriate experts -1 st meeting the 3 rd April nd meeting the 12 th June rd meeting the 7 th November 2013 Workshops in Brussels in 2014 (closing seminar)

8 Objectives of the B2 WG Feedback on implementation of national regulation in accordance with B2-action. Identification of adequate security arrangement for facilities storing human, animal and plant pathogens on the EU list (action H1). Guidelines for B2 implementation Creation of a European network in biosecurity : identification of national point of contact. Identification of common needs: informatics tools, etc.

9 Laboratories Member States Guideline for B2 Action implementation B2 Guideline Biosecurity CWA15793 Laboratory biorisk management standard

10 Guideline for B2 Action implementation CWA : Laboratory biorisk management standard Resolution 1540 WHO biorisk management B2 BTWC European and national regulations

11 Guideline for B2 Action implementation : table of contents 1. Foreword 2. Introduction 3. Terms and definitions 4. Scope 5. Inventory of facilities (a registry of facilities ) 6. Assessment and security plan (a process to verify ) 7. Personnel 8. Biological agents and toxin inventory and information (a mechanism within ) 9. Inspection-control 10. Non-compliance 11. Cost and benefits 12. Conclusion

12 Guideline for B2 action implementation : annex Examples of biosecurity regulatory system from : Denmark France Netherlands Sweden Switzerland United-Kingdom

13 1.EU CBRN Action plan and the action B2 2.Action B2 : Biosecurity regulation in France

14 France and the B2 action 14 The Biological and Toxin Weapons Convention Defense code Art. L It s not allowed to develop, manufacture, possess, stockpile, acquire and transfer microbiological agents, other biological agents and biological toxins, whatever their origin and mode of production, types and in quantities that are not intended for prophylactic, protective or other peaceful purposes. All biological agents Labor code Art. R Declaration prior to 1 st use European directive 2000/54 CE Highly pathogenic biological agents and toxins (MOT) Public Health code Art. L Requires a license Specific French regulation (2001)

15 France and the B2 action France has a strong expertise in this field since 2001 : specific regulation to control high risk biological agents and toxins. Feedback from its implementation and verification processes has led to up-date this regulation (decree in 2010 and application orders in 2010, 2011, 2012 and 2013). This regulation allows for: a national map of facilities using the listed biological agents, an assessment and inspection process to verify the appropriateness of security arrangements of facilities, and requires an annual declaration to keep a good record of stored materials. In France, ANSM is in charge of the regulation of high risk biological agents and toxins (MOT).

16 The Microorganisms and Toxins (MOT) 16 Annex I : the most pathogenic Bacteria Yersinia pestis Extensively drug-resistant (XDR) Mycobacterium tuberculosis Viruses Lassa virus Machupo virus Sabia virus Andes virus Crimean-Congo hemorrhagic fever virus Ebola virus Marburg virus Hendra virus Nipah virus Smallpox virus Monkeypox virus SARS coronavirus

17 Bacteria Toxins Bacillus anthracis all Brucella except Brucella ovis Burkholderia mallei Burkholderia pseudomallei Clostridium botulinum Francisella tularensis Rickettsia prowazekii Rickettsia rickettsii Ricin The Microorganisms and Toxins (MOT) Annex II : the pathogenic MOT Staphylococcus aureus enterotoxin B (> 1mg) Saxitoxins (> 1mg) Botulinum toxins Epsilon toxin from Clostridium perfringens Viruses Guanarito virus Junin virus Lujo virus Chapare virus Whitewater Arroyo virus Rift Valley Fever virus Sin Nombre virus Hantaan virus Seoul virus Laguna Negra virus Dobrova-Belgrade virus Choclo virus Kyasanur forest disease virus Omsk hemorrhagic fever virus Avian influenza virus type A subtypes H5N1, H7N7 and H7N3 responsible for human infection Poliomyelitis virus (WHO) 17

18 The Microorganisms and Toxins (MOT) 18 Annex II : MOT genetic material is also subjected to license, biological material that is not infectious All genetic elements from MOT (> 500 bases or base pairs) Genetically Modified Organisms (GMO) containing more than 500 base pairs of MOT Part of toxins (> 167 aa)

19 Assessment Evaluation process Examination of the criminal record Examination of competence and skills Biosafety & Biosecurity risk control measures Decision 90 days Notification Admissibility option Approval or not Application form Requests further information Applicant options Requests further information Request inspection Requests for advice to Anses

20 Inspection process Contradictory procedure >30 days 60 days 30 days 45 days (1) (2) (3) 1 st contact Official letter Inspection (2-3 days) Answers from the holder and the lab manager Preliminary Report Final report 1 or 2 inspectors (ANSM) Together with other inspector (depending of the ministry of environment, agriculture etc.) Inspection on site Biosafety and biosecurity risk control measures Assessment -Restriction, suspension or prohibition -Penal sanction

21 Biosafety and biosecurity control Containment measures To avoid unintentional release of MOT To avoid intentional release of MOT Security assessment of the facility

22 The duties (for the holder of the licence) Provide each year, the updated list of staff Provide each year, an annual statement of stocks (quantity used, quantity transferred ) Report any loss or theft of a MOT Report any incident or accident and any fact which might lead to their release Keep a record of any transfer, import or export of MOT

23 Conclusions France has a strong expertise in the implementation of a specific regulation to control high risk biological agents and toxins (MOT) France has proposed to lead the action B2 of the CBRN-E action plan in 2012: Action B2 WG : Denmark, the Netherlands, Sweden, United-Kingdom + Switzerland, Action B2 : european initiative to improve and harmonize biosecurity practices in Europe, B2 guidelines for Future of the B2 WG? Advisory committee for EU countries willing to implement a biosecurity regulation system.

24 Thanks for your attention! Christophe GENISSET, Ph.D. The General Secretariat for Defense and National Security : Fax : (key-word : MOT)