BWC/CONF.VIII/INF.2/Add.1

Transcription

1 Eighth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction 4 November 2016 English only Geneva, 7-25 November 2016 Item 10 of the provisional agenda Review of the operation of the Convention as provided for in its Article XII: Articles I-XV Compliance by States Parties with their obligations under the Convention Background information document submitted by the Implementation Support Unit Addendum Summary The Preparatory Committee decided to request the Implementation Support Unit (ISU) to prepare a background information document on compliance by States Parties with all their obligations under the Convention, to be compiled from information submitted by States Parties (see BWC/CONF.VIII/PC/9, paragraph 26(f)). The ISU duly requested submissions from States Parties, and all submissions provided to the ISU by 27 September 2016 were included in document BWC/CONF.VIII/INF.2. This addendum includes submissions received from States Parties since that date, as well as submissions that have been translated from languages other than English. The information in this document is reproduced as submitted by States Parties, in some cases with minor editing. GE (E)

2 Contents Page Cuba... 3 Sweden GE

3 Cuba A. Confidence-building measures 1. Since 1991 Cuba has, without interruption, participated in the exchange of information by annually submitting the forms that are part of the confidence-building measures provided for under the Convention. 2. The process of filling in the forms each year involves all the principal relevant institutions in Cuba, including the following: (a) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) (n) (o) Civil Defence Scientific Research Centre Institute of Veterinary Medicine Central Quarantine Laboratory of the National Plant Health Centre Pedro Kourí Institute of Tropical Medicine National Environmental Health Directorate of the Ministry of Public Health Finlay Institute, a research centre producing serums and vaccines Genetic Engineering and Biotechnology Centre National Centre for Biopreparedness (BIOCEN) National Centre for Plant and Animal Health (CENSA) Biological Pharmaceutical Laboratories (LABIOFAM) National Centre for the Production of Laboratory Animals (CENPALAB) National Centre for Scientific Research (CNIC) National Centre for Agricultural Sciences (INCA) Cuban Institute for Research on Sugar Cane Derivatives (ICIDCA) Plant Health Research Institute (INISAV) B. Legal framework 3. For more than 10 years, Cuba has had a range of legal instruments in place regarding biological matters, the principal function of which is to protect humankind and the environment. In Cuba, legislation specifically addressed at ensuring the implementation of the Biological Weapons Convention is firmly rooted in other existing biosafety legislation. It has always been State policy to support the implementation of the Convention in the country s legal framework for biosecurity as the most effective way to achieve the Convention s objectives. 4. The legislative structure on biological safety remains the same but has been supplemented recently by two standards on biological risk management and other biosecurity-related factors. The main legislation currently in force includes the following: (a) Agreement No. 4728/2003, by which the Executive Committee of the Council of Ministers designates the Ministry of Science, Technology and the Environment as the national authority for the Biological Weapons Convention. GE

4 Resolution No. 38/2006, which updates the risk classification scheme of biological agents and toxins affecting the health of humans, animals and plants. It also contains new classification criteria and makes express mention of genetically modified agents. Resolution No. 8/2000, which brings the General Regulations on Biosafety into force. The Regulations are applicable at sites where biological agents and their products, organisms and fragments thereof containing genetic information are handled. (d) Resolution No. 180/2007, which regulates procedures for the granting of biosafety permits. (e) Resolution No. 103/2002, which establishes biosafety requirements and procedures for sites where biological agents and their products, organisms and fragments thereof containing genetic information are used. (f) Resolution No. 112/2003, which establishes biosafety requirements and procedures for sites working with plants and animals that present a biological hazard. (g) Resolution No. 2/2004, which establishes regulations for the accounting and control of biological material, equipment and related technology. (h) Resolution No. 103/2008, which establishes regulations for government inspections of environmental regulatory activities. (i) Resolution No. 136/2009, which establishes regulations on the comprehensive management of hazardous waste. (j) Cuban Standard 1134 (2016), on biological risk management in laboratories. (k) Cuban Standard 1135 (2016), on biological risk management in the laboratory a guide for the application of Cuban Standard 1134 (2016). 5. Resolution No. 2/2004, which was drafted specifically for the Biological Weapons Convention, sets down norms for the implementation of the national system for accounting and control of biological material, equipment and related technology. The various facilities comprising the system must submit a set of declarations, logs and reports with a view to strengthening the mechanisms in place to monitor biological agents relevant to the Convention and any related equipment and technology. A facility becomes part of the system upon its registration in the internal safeguard register, which was especially created by the National Biosafety Centre and which includes facilities that carry out any of the following activities: (a) Producing vaccines for human use; Producing vaccines for veterinary use; Producing biopesticides and biofertilizers; (d) Using the biological materials listed in annex 1, which forms an integral part of the Regulations; (e) (f) (g) (h) Working with inoculants for plants; Performing genetic modifications; Transferring technology that involves any of the activities mentioned above; Using the following equipment: Static, dynamic or explosive aerosol chambers; Equipment to generate aerosols of microorganisms or toxins and simulants; 4 GE

5 Biosafety cabinets of class III or of class I convertible to III; Flexible film isolators or other chambers equivalent to class III and anaerobic chambers. 6. In addition to the institutions listed above, those with facilities at biosafety levels three and four must also be registered, as must those that carry out activities involving any new technology or scientific knowledge. 7. Thanks to these Regulations, Cuba has made it a domestic legal obligation for national institutions to provide information that can be used for completing the forms that are part of the confidence-building measures, which Cuba submits every year. This is proof of political commitment at the highest level to this form of exchange of information and is also a guarantee of the quality and relevance of the information that Cuba provides. 8. With regard to the implementation of penal measures related to compliance with the bans established in the Biological Weapons Convention, Counter-Terrorism Act No. 93 was passed into law in December The Act takes account of various ways in which terrorist activities may be perpetrated, including those involving the use of chemical or biological agents, which have recently been the focus of particular interest on the part of the international community. 9. One innovation of the past five years was the promulgation of Standards 1134 and 1135, whereby Cuba adopted, with slight modifications, European Committee for Standardization Workshop Agreements (CWA) (2011) and (2012). The objective and scope of Standard 1134, on laboratory biological risk management, is to lay down the requirements for controlling risks associated with the handling, storage or destruction of biological agents and toxins in laboratories and other facilities. Under the Standard, institutions can: (a) Establish and maintain a biological risk management system to control or minimize to acceptable levels the risks posed to workers, the community, third parties and the environment, all of which may find themselves directly or indirectly exposed to biological agents or toxins; Ensure that those requirements have been effectively implemented in practice; Request and obtain certification or verification of the biological risk management system from an independent third party; (d) Establish a framework to use as a basis for training and awareness-raising on biosafety and biosecurity guidelines and best practices in the scientific community. 10. For its part, Standard 1135 (corresponding to CWA (2012)) is intended to support organizations and professionals operating in the field of biosafety, helping them to implement a viable and robust biological risk management system by giving detailed explanations of each of the requirements set forth in Standard C. Control mechanisms 11. Cuba has also reinforced its control mechanisms by setting up an inspection system to verify compliance with existing national legislation. The system covers all facilities in the country presenting a biological hazard as well as facilities that form part of the national accounting and control system. Among the system s key elements are its control methods, which include different forms of inspection: (a) Routine inspections; Inspections for the issuance of biosecurity permits; GE

6 (d) Inspections to verify compliance with the conditions of existing permits; Safeguard inspections. 12. The latter, which take place every two years, serve to ensure compliance with the provisions of the Convention. A total of 39 safeguard inspections, with different objectives and levels of complexity, have been carried out over the last five years. (a) Inspections for the internal safeguard register. The aim of this type of inspection is to ensure that the facility concerned undertakes activities for which provision is made in the rules governing the accounting and control of biological material, equipment and related technology (Resolution No. 2/2004). If the facility does undertake such activity, it is entered into the system by logging it in the internal safeguard register and assigning it an identification number. Inspections to verify the implementation of Resolution No. 2/2004. Once a facility is registered, it has one year in which to create its own mechanisms for the implementation of an accounting and control system in the areas concerned and in accordance with regulations. The inspection serves to verify whether the facility has established formal procedures for the implementation of a control system and whether those procedures are duly updated and in line with requirements. Inspections of operations logs. This is the most detailed and thorough of the inspections. Its purpose is to undertake an on-site verification of the information provided in the six-monthly reports, which is compared with the information in the logs that have to be kept at the location where listed agents and equipment are used. 13. The overall conclusion that can be drawn from an analysis of the reports of all the aforementioned inspections is clear: there is transparency and traceability in the use of biological agents and their associated technology. The fact that biological agents and the associated technology are used for pursuing medical research to improve standards of living, for increasing yields of crops that are important to the country or for other scientific purposes is a sound indicator of the fundamental importance of biological sciences in Cuba. 14. In order to reinforce control mechanisms, a system of authorizations has been designed to ensure that activities involving a biological hazard are subjected to security regulation procedures. This helps to assess any risks that may arise for human health and the environment. This important system is made up of various elements including the following methods of authorization: (a) (d) Licences Permits Notifications Certificates. 15. The certificates in this case are a safety clearance, granted for activities relevant to the Convention that are covered by the accounting and control system. The main purpose of a clearance certificate is to certify transparency with regard to the peaceful use of biological material in Cuba. It is compulsory for the following activities: (a) The receipt, dispatch or transfer following request and evaluation by relevant bodies of biological agents, toxins and organisms contained in the predetermined risk classifications and of equipment, technology and material in general between the national facilities that use them or between Cuba and other States. The aim is to ensure that they are not used for activities that are prohibited at the national or international level; 6 GE

7 The destruction or neutralization of biological agents and toxins which, because of their volume, characteristics or location, are considered to be dangerous or which could be in violation of international treaties to which Cuba is a party; The established uses of biological materials, equipment and technology; (d) Other activities related to the fulfilment of obligations that Cuba has assumed under relevant international legal instruments. 16. At present, a total of 43 clearances have been issued for activities such as the transfer and use of listed biological agents. Implementation of Resolution No. 2/ Over the last five years, the rules for the accounting and control of biological material, equipment and related technology have been enforced in practice as described below. 18. Currently, a total of 15 facilities are registered in the system and are involved in various activities. The majority of them produce vaccines, biopesticides and biofertilizers; use listed biological materials and equipment; undertake genetic modifications; or work with inoculants for plants. Those facilities submit an annual inventory to the relevant authorities showing all the biological material held at the facility, whether listed or not. 19. Every six months they also submit, where appropriate, an operations report containing information relative to listed agents and equipment. This is a useful tool that enables the regulatory authorities to evaluate how the inventory has changed over the course of a calendar year. Thanks to the report, it is possible to monitor each movement of a reported agent or piece of equipment. 20. Every year, Cuba holds a national workshop on the implementation of the Biological Weapons Convention that brings together persons involved in the implementation of Resolution No. 2/2004 and of the Convention and its follow-up mechanism. 21. Cuba is currently in the process of restructuring its biosafety legislation. The three resolutions that currently regulate biosafety in facilities handling biological agents and genetically modified or exotic organisms will be brought together into a single set of biosafety regulations on the use of biological agents and their products, organisms and fragments thereof containing genetic information. 22. At the same time, Resolution No. 2/2004 is being reformulated. However, the proposed modifications do not alter the essence of the Resolution, which was specifically devised for the Convention and has the aim of implementing the national system for accounting and control of biological material, equipment and related technology. 23. These measures to eliminate existing legislative fragmentation and to reinforce the domestic legal framework are the expression of a firm commitment on the part of Cuba to abide by the provisions of the Convention. D. Capacity-building 24. As regards the training of personnel involved in biosafety in general, Cuba has undertaken a number of forms of capacity-building for technical and managerial staff. 25. Capacity-building incorporating aspects of the Convention has been carried out by the National Biosafety Centre and its provincial branches as well as by other institutions that face biological hazards and by the State agencies designated as focal points for biosafety issues. GE

8 26. The Higher Institute of Applied Science and Technology is a main provider of training in this area. Its master s programme in biosafety, which is now being run for the fifth time and has been extended to different parts of the country, has been instrumental in training and building the scientific capacities of hundreds of specialists over the last five years. In parallel, the Institute has offered, on different occasions, a diploma programme on facilities that present a biological hazard. The course gives prominence to Conventionrelated subject matter. It, along with five other short-term courses for persons new to the field, has helped to disseminate an awareness of the Convention and has contributed to the safe handling of biological agents and toxins. 27. Other universities have also been closely involved in training activities. Over the period under consideration, the Faculty of Biology of the University of Havana offered five postgraduate courses on biosafety, which were attended by some 500 people and which covered subjects related to the Convention. 28. Further initiatives to disseminate the Convention include two elective undergraduate courses aimed at university students studying their third year of biology or microbiology. Students were also offered an elective course on biosafety and genetically modified organisms. 29. In addition, the Ministry of Science, Technology and the Environment, being the national authority for the Biological Weapons Convention, has continued to run annual courses to produce certified biosecurity inspectors. Over the period covered by this report and until the present time, around 150 specialists have been certified in the three areas of regulation: humans, animals and plants. Five courses on biosafety authorizations have also been held; they cover system procedures with a focus on risk analysis. 30. During the period, Cuba introduced a new level of professionalization that is of great significance for the Convention in the form of a series of courses for border inspectors (4) in the three areas (human, animal and plant health). The aim of the initiative is to make biosafety part of import and export mechanisms and to strengthen the customs service, which is the country s first line of defence at its borders. 31. Basic elements of biosafety and biosecurity, which must be taken into account before relevant materials or equipment are allowed to enter the country, have been imparted to customs and other officers who have a permanent presence at the country s borders. 32. Another initiative worthy of being highlighted concerns four courses aimed at engineers, architects and others working in the field of design and planning. The courses, which focus on the design of facilities that will be exposed to biological hazards, are intended to supplement the training offered to other professionals specializing in related subjects. 33. In December 2015, a workshop was held at the Pedro Kourí Institute of Tropical Medicine in Havana on the design and commissioning of biosafety level 3 laboratories. The workshop was run by specialists from a Canadian firm (Merrick) and was attended by a broad range of experts from institutions such as the National Biosafety Centre and the Ministry of Public Health. E. Other Convention-related activities 34. In addition to specific measures for the implementation of the Convention at the national level, Cuba has submitted national reports under Security Council resolution 1540 (2004), which concerns terrorism and weapons of mass destruction and was adopted on 28 April The reports covered both legislation and relevant operational measures. 8 GE

9 35. Cuba responded to the call for assistance from sister countries in Africa by sending a medical team to help deal with the Ebola outbreak amid the panic and lack of international support which marked that recent global health crisis. 36. In the context of the Convention s current intersessional mechanism, Cuba has participated actively in meetings, both those involving technical experts and those between States parties, and in the last two sessions of the Preparatory Committee for the Eighth Review Conference. It has actively contributed to the various discussions and provided documentation that detailed its own experience and that served to enrich the debate. Cuban representatives recently took part in three preparatory workshops for the Eighth Review Conference, which were held in Brasilia, Brazil; Wuxi, China; and Wilton Park, United Kingdom. 37. In September 2015, the National Biosafety Centre represented the national authority for the Convention on Biological Diversity and its Protocols at a meeting of experts on the emerging issue of synthetic biology, which is a dual-use technology also relevant to the Biological Weapons Convention. The Centre participated in the pre-meeting online exchanges and in the post-meeting peer review process. The outcome of those debates and the risks and benefits of these new scientific advances were shared with the community of biosafety and biosecurity specialists in Cuba. 38. Cuba has submitted various requests and offers for assistance to the database established under article X of the Convention, and it recently updated that information. 39. Among other activities, the National Biosafety Centre of Cuba has made a formal request to become an observer at the International Federation of Biosafety Associations, a prestigious organization that brings together biosafety professionals from all over the world and imparts knowledge on issues relating to biosecurity. 40. During the last three months of 2015 and in September 2016, the National Biosafety Centre performed, as part of its mandated functions, biosafety and biosecurity inspections at the country s only small-scale facility with a biosafety level of 3. The inspections took place during the facility s start-up period following the completion of renovations. Sweden 41. Sweden provides the following report on compliance with the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (biological) and Toxin Weapons and on their Destruction after the request decided by the Preparatory Committee for the Eighth Review Conference in April A. Article I 42. Sweden is in full compliance with its obligations under Article I and has not developed, produced, stockpiled, or otherwise acquired or retained microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes. B. Article II 43. Sweden is in full compliance with its obligations under Article II. GE

10 C. Article III 44. Sweden complies fully with the undertaking not to transfer to any recipient whatsoever, directly or indirectly, and in any way to assist, encourage, or induce any state, group of states or international organisations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of the Convention. 45. Sweden continues to fulfil its obligations through national legislation and administrative arrangements and guidelines. The following legislation is the principal means of implementation: (a) (d) (e) (f) (g) War Crimes (h) Penal Code of Sweden Customs Act Act on Penalties for Smuggling Military Equipment Act Act on Control of Dual-use Items and Technical Assistance Act on Criminal Responsibility for Terrorist Offences Act on Criminal Responsibility for Genocide, Crimes against Humanity and Act on Transport of Dangerous Goods Relevant EU-legislation is also important in the implementation of the convention, in particular regulation (EC) 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items. Sweden applies the control list of the Australia Group and coordinates export policies with other AG members in order to ensure that transfers are in accordance with Article III of the Convention. D. Article IV 46. In accordance with Article I, Sweden has taken the necessary measures to prohibit and prevent activities forbidden under this article. Such measures apply to the territory of Sweden and the territory under the jurisdiction or control of Sweden. Relevant legislation includes the Penal Code of Sweden which makes activities prohibited under the Convention into offences under domestic criminal legislation. The legislation also specifies penalties for the offences. In addition the Act on Criminal Responsibility for Terrorist Offences provides for penalties for an act of terrorism which uses dangerous pathogens or toxins, which could endanger life or cause serious harm. Other important means of legislation are the Communicable Diseases Act and provisions of Microbiological Work Environment Risks Infection, Toxigenic Effect and Hypersensitivity. 47. The effectiveness of the necessary measures to prohibit and prevent the proscribed activities under the Convention is regularly reviewed. 48. In accordance with paragraph 15 of the Final declaration of the Seventh Review Conference, Sweden has designated a national focal point for coordinating national implementation of the Convention. 10 GE

11 E. Article V 49. Sweden supports fully the decisions of States Parties recorded in the final declaration of previous Review Conferences with regard to consultation and cooperation mechanisms. Sweden has not requested a formal Consultative Meeting of State Parties under the provisions of Article V between 2012 and In accordance with the relevant decisions of States Parties at the Second, Third, Sixth and Seventh Review Conferences of the Convention Sweden has submitted confidence-building measures (CBM) to States Parties, via the Implementation Support Unit (ISU) within the UN Office for Disarmament Affairs each year F. Article VI 51. Sweden has not lodged any complaints with the Security Council concerning any other State Party acting in breach of obligations under Article I or II. 52. Sweden under the UNSG s mechanism for the investigation of alleged use of chemical and biological weapons, organized Laboratory Network Workshops in 2015 and 2016.Furtermore, in 2014 and 2016 arranged training courses for nominated experts and continues to nominate experts and laboratories available to the UNSG. G. Article VII 53. See separate document as requested by the ISU. H. Article VIII 54. Sweden ratified the 1925 Geneva Protocol in I. Article IX 55. Sweden ratified the Chemical Weapons Convention on 17 June The Swedish Agency for Non-proliferation and Export Controls is the national authority responsible for the implementation of the CWC in Sweden. Every year the agency provides the Government with a report on the implementation of CWC. Information on the implementation of the CWC in Sweden can also be found at the Agency s website. J. Article X 56. See separate document as requested by the ISU. K. Other activities which support compliance with the BTWC 57. Sweden undertakes a wide range of activities to fulfil its obligation under the Convention. Examples include: (a) support for UN Security Council Resolution 1540, including the submission of reports as required; support for the Proliferation Security Initiative; GE

12 active participation in the Australia group. 58. Sweden has supported the Council Decision of support for the Convention ( ). 12 GE