2024/645

20.2.2024

COUNCIL DECISION (CFSP) 2024/645

of 19 February 2024

in support of strengthening biological safety and security in Latin America in line with the implementation of United Nations Security Council Resolution 1540 (2004) on non-proliferation of weapons of mass destruction and their means of delivery

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Articles 28(1) and 31(1) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1) On 12 December 2003, the European Council adopted the EU Strategy against Proliferation of Weapons of Mass Destruction.

(2) On 21 March 2022, the Council approved a document entitled ‘A Strategic Compass for Security and Defence’, which refers to the persistent threat of the proliferation of weapons of mass destruction and their means of delivery, and expresses the Union’s objective of reinforcing concrete actions in support of the goals of disarmament, non-proliferation and arms control.

(3) The Union is actively implementing the EU Strategy against Proliferation of Weapons of Mass Destruction and is giving effect to the measures listed in Chapter III thereof, in particular those measures related to the reinforcement, implementation and universalisation of the Biological and Toxin Weapons Convention (BTWC), and by providing resources for projects for technical assistance and expertise with regard to a wide range of non-proliferation measures, and by fostering the role of the United Nations Security Council (UNSC).

(4) On 28 April 2004, the UNSC adopted Resolution 1540 (2004) (‘UNSCR 1540 (2004)’), which established binding obligations for all States, and aimed to prevent and deter non-State actors from obtaining access to weapons of mass destruction and related material. The UNSC also resolved that all States are to take and enforce effective measures to establish domestic controls to prevent the proliferation of nuclear, chemical and biological weapons and their means of delivery, including by establishing appropriate controls over related materials. The objectives of the UNSC set out in UNSCR 1540 (2004) were reinforced by UNSC Resolution 2663 (2022).

(5) In 2017 and subsequently in 2023, the Council adopted Decisions in support of the implementation of UNSCR 1540 (2004), namely Decisions (CFSP) 2017/809 (1) and (CFSP) 2023/654 (2). The technical implementation of the activities under Decision (CFSP) 2023/654 is entrusted to the UN Office for Disarmament Affairs (UNODA) in cooperation with relevant regional international organisations, including the Organization of American States (‘OAS’).

(6) The Union also supports the work and implementation of the Biological and Toxin Weapons Convention, through Council Joint Actions 2006/184/CFSP (3) and 2008/858/CFSP (4), and through Council Decisions 2012/421/CFSP (5), (CFSP) 2016/51 (6) and (CFSP) 2019/97 (7).

(7) In the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction, Council Decision (CFSP) 2019/2108 (8) supports the activities of the OAS on strengthening overall biological safety and security in Latin America in line with the implementation of UNSCR 1540 (2004). The Union’s support should be continued.

(8) The OAS/Inter-American Committee against Terrorism (‘CICTE’) Secretariat should be entrusted with the administration and management of the projects to be carried out under this Decision.

(9) The OAS/CICTE Secretariat should ensure efficient cooperation with relevant international organisations and bodies such as the BTWC Implementation Support Unit, the UNSC Committee established pursuant to UNSCR 1540 (2004), the World Organisation for Animal Health, and the Global Partnership Against the Spread of Weapons and Materials of Mass Destruction. The OAS/CICTE Secretariat should also ensure the complementarity and synergy of projects undertaken on the basis of this Decision with relevant completed and ongoing projects, with activities in Latin America that are supported by individual Union Member States, and with other Union-sponsored programmes in this field, including the Instrument contributing to Stability and Peace and the EU Centres of Excellence on Chemical, Biological, Radiological and Nuclear Risk Mitigation,

HAS ADOPTED THIS DECISION:

Article 1

1. In accordance with the EU Strategy against the Proliferation of Weapons of Mass Destruction adopted on 12 December 2003, the Union shall further support the activities of OAS/CICTE through an operational action in support of strengthening biological safety and security in Latin America.

2. The overall objectives of the action referred to in paragraph 1 shall be to:

strengthen existing national normative frameworks related to biological safety and security in beneficiary States;

foster greater compliance with international regimes by promoting collaboration and cooperation between participating States through innovative exercises such as ‘peer review exercises’ and also by helping participating States with their submissions and declarations related to relevant biological weapons instruments;

strengthen public and private sector capacity to secure biological weapons through training activities;

create a regional community or network of public and private sector actors engaged in biological safety and security.

3. A detailed description of the action referred to in paragraph 1 is set out in the Annex.

Article 2

1. The High Representative of the Union for Foreign Affairs and Security Policy (‘HR’) shall be responsible for the implementation of this Decision.

2. The technical implementation of the action referred to in Article 1 shall be carried out by the OAS/CICTE.

3. The OAS/CICTE shall perform the task referred to in paragraph 2 of this Article under the responsibility of the HR. For that purpose, the HR shall enter into the necessary arrangements with the OAS/CICTE.

Article 3

1. The financial reference amount for the implementation of the action referred to in Article 1 shall be EUR 2 686 427.

2. The expenditure financed by the reference amount set out in paragraph 1 shall be managed in accordance with the rules and procedures applicable to the general budget of the Union.

3. The Commission shall supervise the proper management of the expenditure financed by the reference amount referred to in paragraph 1. For that purpose, it shall conclude a grant agreement with the OAS/CICTE. The grant agreement shall stipulate that the OAS/CICTE is to ensure the visibility of the Union’s contribution, appropriate to its size.

4. The Commission shall endeavour to conclude the agreement referred to in paragraph 3 as soon as possible after the entry into force of this Decision. It shall inform the Council of any difficulties in that process and of the date of the conclusion of the agreement.

Article 4

1. The HR shall report to the Council on the implementation of this Decision on the basis of regular reports by the OAS/CICTE. The reports shall form the basis of the evaluation carried out by the Council.

2. The Commission shall provide information on the financial aspects of the implementation of the action referred to in Article 1.

Article 5

1. This Decision shall enter into force on the date of its adoption.

2. This Decision shall expire 36 months after the conclusion of the agreement referred to in Article 3(3). However, it shall expire six months after the date of its entry into force if no such agreement has been concluded within that period.

Done at Brussels, 19 February 2024.

For the Council

The President

J. BORRELL FONTELLES

(1) Council Decision (CFSP) 2017/809 of 11 May 2017 in support of the implementation of United Nations Security Council Resolution 1540 (2004) on the non-proliferation of weapons of mass destruction and their means of delivery (

OJ L 121, 12.5.2017, p. 39

(2) Council Decision (CFSP) 2023/654 of 20 March 2023 in support of the implementation of United Nations Security Council Resolution 1540 (2004) on the non-proliferation of weapons of mass destruction and their means of delivery (

OJ L 81, 21.3.2023, p. 29

(3) Council Joint Action 2006/184/CFSP of 27 February 2006 in support of the Biological and Toxin Weapons Convention, in the framework of the EU Strategy against the Proliferation of Weapons of Mass Destruction (

OJ L 65, 7.3.2006, p. 51

(4) Council Joint Action 2008/858/CFSP of 10 November 2008 in support of the Biological and Toxin Weapons Convention (BTWC), in the framework of the implementation of the EU Strategy against the Proliferation of Weapons of Mass Destruction (

OJ L 302 13.11.2008, p. 29

(5) Council Decision 2012/421/CFSP of 23 July 2012 in support of the Biological and Toxin Weapons Convention (BTWC), in the framework of the EU Strategy against Proliferation of Weapons of Mass Destruction (

OJ L 196, 24.7.2012, p. 61

(6) Council Decision (CFSP) 2016/51 of 18 January 2016 in support of the Biological and Toxin Weapons Convention (BTWC) in the framework of the EU Strategy against Proliferation of Weapons of Mass Destruction (

OJ L 12, 19.1.2016, p. 50

(7) Council Decision (CFSP) 2019/97 of 21 January 2019 in support of the Biological and Toxin Weapons Convention in the framework of the EU Strategy against Proliferation of Weapons of Mass Destruction (

OJ L 19, 22.1.2019, p. 11

(8) Council Decision (CFSP) 2019/2108 of 9 December 2019 in support of strengthening biological safety and security in Latin America in line with the implementation of United Nations Security Council Resolution 1540 (2004) on non-proliferation of weapons of mass destruction and their means of delivery (

OJ L 318, 10.12.2019, p. 123

ANNEX

Union support for strengthening biological safety and security in Latin America in line with the implementation of United Nations Security Council Resolution 1540 (2004) on non-proliferation of weapons of mass destruction and their means of delivery

Background

In accordance with the European Union (EU) strategy against the proliferation of weapons of mass destruction adopted on 12 December 2003, which sets the objective of fostering the role of the United Nations Security Council and of enhancing its expertise in addressing the challenges of proliferation, the EU has further supported the implementation of UN Security Council Resolution 1540 (2004) (‘UNSCR 1540 (2004)’) and its subsequent resolutions.

The implementation of Council Joint Action in support of the implementation of UNSCR 1540 (2004) has been delivered by the United Nations Office for Disarmament Affairs (UNODA) through the technical implementation of previous projects, as the Office has been mandated to provide the 1540 Committee and its experts with substantive and logistical support.

Project Summary

This project ‘Strengthening Biological Safety and Security in Latin America’ (the ‘Project’) aims to strengthen implementation of biological safety and security measures in 11 countries from Latin America (Argentina, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Panama, Paraguay, Peru, Uruguay) in line with UN Security Council Resolution 1540 (2004) (hereinafter ‘UNSCR 1540’). The Project also seeks to increase the capacity of those 11 countries to effectively anticipate and respond to any large-scale incidents involving biological agents.

Through a combination of national and regional activities, the Project will bring together government authorities, as well as key representatives from the private sector, civil society and academia to raise awareness and build greater biological safety and security capacity throughout the Americas. Specifically, the Project has four principal objectives: 1) to strengthen existing national normative frameworks (including regulations and standards); 2) to increase compliance with international regimes by encouraging submission of national reports called for under those instruments; 3) to develop training and outreach activities; and 4) to promote a regional community/network of public- and private-sector stakeholders involved in biological safety and security.

1. Introduction and objectives

1.1. Introduction

The UN Security Council adopted Resolution 1540 (‘UNSCR 1540’) in 2004 to counter any threats posed by non-State actors having access to nuclear, chemical, biological weapons, their related materials and means of delivery. Among other things, UNSCR 1540 requires States to take and enforce effective measures to establish domestic controls to prevent the proliferation of nuclear, chemical and biological weapons and their means of delivery. According to operative paragraph 3(a) and (b), such measures shall include establishing appropriate controls and developing and maintaining effective measures to account for and secure such items in production, use, storage, or transport.

One way that States can meet their 1540 obligations is by becoming party to and implementing their obligations under key non-proliferation agreements. For example, the Biological Weapons Convention (‘BWC’) entered into force in 1975 and has been ratified by almost all OAS Member States. The BWC establishes that each State Party shall, in accordance with its constitutional processes, take any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition or retention of the agents, toxins, weapons, equipment and means of delivery, which includes, the implementation of laboratory biosafety and biosecurity measures specified in Article IV.

Even though the proposed participating States in this Project are, in many cases, parties to these key international instruments, they frequently lack the domestic legal and regulatory frameworks needed to fully implement their obligations under the BWC and related implementing instruments. Furthermore, in its last Comprehensive Review of States’ compliance with UNSCR 1540 obligations, the 1540 Committee released a final document that showed relatively low level of compliance with 1540 obligations worldwide, and an even lower level of compliance within the Americas.

For instance, concerning measures related to biological weapons, only a minimal improvement in implementation levels has been noticed worldwide, and in the Latin American and Caribbean region the situation is even weaker: only 19% of biological weapons-related measures were taken.

The latest Global Health Security Index (1) data also shows similarly low levels of compliance. Of particular concern, there are several Biosafety Level (BSL) 3 (2) laboratories and animal BSL-4 laboratories (according to the World Organization for Animal Health standards) in the region that have not fully implemented effective biosecurity policies. And at least two more BSL-4 laboratories are under construction in the proposed States for this Project.

Given this context, the final report of the 1540 Committee’s Comprehensive Review process noted that the full and effective implementation of UNSCR 1540 by Member States remains a long-term objective, and further noted that many of the OAS States need assistance to achieve this goal. (3) In addition, the Committee concluded that States should take urgent action to adopt measures to account for and secure materials related to biological weapons.

The use of BWC confidence-building measures is another way to assess implementation of biosafety and biosecurity standards. These measures, established by BWC States Parties in 1986, are designed ‘to prevent or reduce the occurrence of ambiguities, doubts and suspicions and in order to improve international cooperation in the field of peaceful biological activities’. However, only 10 of 34 OAS Member States submitted their CBMs to the BWC Implementation Support Unit (‘ISU’) in 2022. (4)

The low level of engagement from governments of the region regarding biological safety and security stems from a combination of factors, including insufficient awareness of policymakers regarding the threat and potential costs of a large scale biological incident; security-related priorities that compete for scarce resources available at the national level; and the inherent challenges of developing an integrated national bio-incident readiness and response capability.

An incident involving the intentional spread of a pathogenic agent, whether by an actor intending to harm to a target population or by naturally occurring means, has the potential to cause significant social, economic, and political consequences. One example is the large and disproportionate death toll in the Americas from the 2009 global outbreak of H1N1 highlights the region’s vulnerabilities. Similarly, and more recently, if the Highly Pathogenic Avian Influenza (HPAI) H5N1 viruses gain the ability for efficient and sustained transmission among humans, an influenza pandemic could result, with potentially high rates of illness and death worldwide. Therefore, this epizootic continues to pose an important public health threat that requires advancing measures of prevention and improving the existing controls even further.

These challenges highlight the need within the OAS region for a coordinated response to a biological incident. Such a response should involve multiple actors, including government ministries (health, agriculture, security, justice, defence, intelligence, transportation, foreign affairs, international commerce, economy, science and technology, and others), the law enforcement community and other first responders, private sector entities (especially industry and academia), and civil society.

1.2. Objectives

This three-year project seeks to strengthen biological safety and security practices in 11 countries of Latin America, in line with resolution 1540 (2004), including the establishment and enforcement of effective measures to prevent the proliferation of biological weapons.

Activities, which are detailed in Section 5 below, will be based on the following four key objectives:

— strengthening existing national normative frameworks related to biological safety and security in beneficiary States.

— fostering greater compliance with international regimes by promoting collaboration and cooperation between participating States through innovative exercises such as ‘peer review exercises’ and also by helping participating countries with their submissions and declarations related to relevant biological weapons instruments.

— strengthening public and private sector capacity to secure biological weapons through training activities.

— creating a regional community or network of private and public sector actors engaged in biological safety and security.

2. Selection of implementing agency and coordination with other relevant funding initiatives

2.1. Implementing Agency – the Organization of American States (OAS)

The Inter-American Committee against Terrorism of the Organization of American States (‘OAS/CICTE’) has been actively supporting non-proliferation efforts in the Americas since 2005. In 2010, OAS/CICTE was given a specific mandate to help its Member States implement UNSCR 1540. Since then, OAS/CICTE has assisted Member States in various ways: drafting of UNSCR 1540 national action plans, strengthening legal and regulatory frameworks; building capacity to prevent and combat nuclear, radiological, biological and chemical material trafficking and smuggling; promoting the exchange of effective practices through the use of the peer review methodology; and facilitating coordination at the political level to identify areas for regional and sub-regional cooperation.

Since 2009, CICTE/OAS has led several national bio-incident crisis management exercises aimed at raising awareness of biosecurity threats and bringing together officials and representatives from agencies and organizations to learn how to coordinate their responses to a bio-incident. In response, several OAS Member States have specifically requested CICTE’s assistance to draft or update National Bio-Emergency Response Plans.

Most recently, CICTE has implemented an EU-funded three-year project entitled ‘In support of strengthening biological safety and security in Latin America in line with the implementation of United Nations Security Council Resolution 1540 (2004) on non-proliferation of weapons of mass destruction and their means of delivery’ (Council Decision (CFSP) 2019/2108). This groundbreaking initiative has been instrumental in encouraging the establishment of effective measures to prevent the proliferation of biological weapons and their means of delivery in eight Latin American countries (Argentina, Chile, Colombia, the Dominican Republic, Mexico, Panama, Paraguay, and Uruguay). CICTE has also contributed to the recent approval of a decree in Uruguay and draft legislation in Paraguay; has contributed to the legislative drafting process in Argentina and Colombia; and has advised on legislative proposals in the Dominican Republic, as well as on a law regarding strategic control of sensitive commercial transactions, which is currently under legislative review in Chile.

In addition, and with support from the United States, OAS/CICTE also recently implemented two other projects on related matters. One, entitled ‘Strengthening Strategic Control Regimes in Latin America and the Caribbean (2020- 2021 Phase One)’, worked to promote more robust controls on the transfer of sensitive goods, including biological and chemical agents. A second project entitled ‘Countering Illicit Trade of CBRN (Chemical, Biological, Radiological and Nuclear) materials in Free Trade Zones of Latin America’ was implemented in 2022 to prevent and counter the proliferation of materials and technologies related to weapons of mass destruction in six Latin American countries (Argentina, Brazil, Chile, Mexico, Panama, and Paraguay) situated in four Free Trade Zones by securing and optimizing supply chains and strengthening strategic trade controls.

These and other efforts to enhance bio-incident readiness and response capabilities have yielded important results. For example, the OAS/CICTE has developed a network of over 240 political and technical professionals (including scientists and laboratory personnel) from throughout the region who currently are receiving virtual or in-person trainings. Through this new Project, OAS/CICTE will build on the existing network and promote access to an OAS-created platform with contacts, publications, libraries, activities and events from international organizations, think tanks, non-government organizations, among others, on biosafety and biosecurity topics, etc. (5) These kinds of networks have proven critical for timely information sharing.

The OAS’s regional framework provides a comparative advantage due to the transnational nature of the threats, which necessarily entail cooperation between neighbouring countries to meet those challenges. It also helps ensure efficiency and avoids duplication of efforts. In fact, due to an agreement between CICTE/OAS and the United Nations Office for Disarmament Affairs (UNODA), the 1540 Hemispheric Coordinator for the Americas has been housed at OAS/CICTE since 2017. This critical leadership role has allowed CICTE/OAS to take the lead on promoting greater regional understanding of the importance of the resolution, as well as in the national and regional implementation of its measures.

In this regard, the OAS —as the premier regional organization in the Americas— is in a unique position in the Hemisphere to demonstrate effectiveness due to its existing network of national points of contact; its extensive presence throughout the region and its ability to work in the field with the proposed beneficiary countries. With respect to policy development, OAS/CICTE will continue to work through key political bodies within the OAS, such as the Committee on Hemispheric Security of the OAS Permanent Council and through CICTE’s regular annual meetings.

The proposal outlined below is designed to build on the above-referenced efforts and continue to strengthen the region’s level of preparedness and implementation of measures on biosecurity and biosafety.

2.2. Coordination with Other Relevant Funding Initiatives

As a general practice, OAS/CICTE coordinates its activities with other agencies and organizations receiving funds from both the same and different donor governments and international bodies.

OAS/CICTE has a longstanding strategic partnership with the UN Office for Disarmament Affairs (UNODA) – including its regional Latin American office UNLIREC --, and the 1540 Committee Group of Experts, to streamline and facilitate technical assistance and capacity building in the region around UNSCR 1540.

OAS/CICTE already works closely with organizations receiving support from the European Union for work related to the activities proposed under this Project. In addition to those listed above, other entities include the Biological Weapons Convention Implementation Support Unit (BWC-ISU), the Regional Centre for Peace, Disarmament and Development in Latin America and the Caribbean (UNLIREC), and the World Organization for Animal Health (WOAH). Coordination with these bodies will be carried out by a management team based at OAS Headquarters, to ensure all efforts are complementary and to avoid duplication, and to ensure that project activities are aligned with UNSCR 1540 and BWC obligations.

Proposed activities will target policy makers, legislators and life scientists from the public and private sectors that work in the field of biosafety and biosecurity. Activities include in-person training courses for beneficiary countries, as well as an online training course to reach even more beneficiaries in the region. For highly specialized training and tasks, the OAS may also contract short-term support (e.g. experts, trainers and researchers), and will work with its partners in those areas (including the BWC-ISU, UNODA, WOAH and the EU and academia) in order to ensure that personnel meets all the technical requirements, including, where possible, drawing from the rosters maintained by those organizations.

This Project also is clearly in line with the 2019 European Council Decision to support implementation of the BWC outside the EU by helping to reduce the threat of proliferation of biological weapons in the region. To do so the Project would help ensure that governments’ legal and regulatory frameworks are adequate to take into consideration rapid advancements in life sciences and that they meet current international standards.

Since the 2022 Comprehensive Review clearly states that the levels and scope of security and accountability measures in the region remain low, additional efforts are needed to foster greater biological safety and security throughout the region. Important advances have been made, particularly thanks to the financial contribution of the European Union, but more work remains to be done. This new Program phase would help build on the numerous results already achieved, reach additional countries in the region, and ensure sustained impact of the significant financial and technical investments already made.

3. Project description

3.1. Description

The Project will bring together national authorities, representatives of the private sector and civil society, and international experts from up to 11 States in Latin America to explore steps that can be taken to ensure strengthened biological safety and security capabilities in these areas. The Project will seek to leverage the Secretariat’s prior experience working on these matters in the Americas, along with its well-established network of contacts and partners, including the professionals who participated in the project implemented during 2019 –2024 on biosafety and biosecurity.

The Project will employ a two-pronged approach that incorporates both national and sub-regional activities. National-level efforts will focus on working with individual OAS Member States to enhance national capacities, draft legislation and regulations and develop country-specific action plans for strengthening operational capabilities. At the regional level, capacity-building activities will focus on promoting the exchange of information and good practices, as well as on defining the structural, substantive, and functional parameters from a regional approach.

Furthermore, as part of its regional approach, the Project will seek to leverage a ‘peer review’ process which has been developed in recent years pursuant to which States voluntarily agree to work together to assess their mutual strengths and weakness in implementing UNSCR 1540 obligations and identify effective practices and areas for continued bilateral cooperation. Following the three successful 1540 peer review exercises in the region —between Chile and Colombia (2017), the Dominican Republic and Panama (2019) and Paraguay and Uruguay (2019)—, the follow-up exercise between Dominican Republic and Panama (2022) and the activities scheduled for 2023 with Mexico, Brazil and Chile (September/October 2023) and Uruguay and Chile (October 2023), the Project will seek to launch additional peer review exercises for these states. Some of these additional peer review exercises would have a specific focus (e.g., strategic trade control and/or biological oriented), for countries that have not yet undertaken such exercises.

Finally, the Project seeks to promote and enhance continued cooperation between countries, promote best practices and promote the practice of publishing technical papers (in addition to the final reports submitted by the States) to capture the advances made in these peer reviews.

3.2. Methodology

3.2.1. Organizational structure

This project will be implemented by OAS/CICTE, in coordination with supported OAS Member States. The OAS/CICTE management team for the project will consist of three staff members and an administrative/financial support assistant based at OAS headquarters in Washington, DC, in coordination with external, contracted personnel based on specific activities to be executed, and under the general supervision and guidance of the CICTE Executive Secretary.

As noted above, the externally contracted personnel will include a legal specialist and technical specialist for capacity building. For highly specialized training and tasks, the OAS may also contract short-term support (experts, trainers, and researchers) from other technical partner organizations’ expert rosters, including the BWC-ISU, UNODA, WOAH, and the European Union.

The OAS/CICTE program management team will coordinate directly with national authorities of the Member States that have previously requested support on resolution 1540 (2004). In several cases, the OAS has existing cooperation agreements to assist Member States in the areas of 1540 implementation that will form the basis for technical assistance.

3.2.2. Technical approach

Requests for legislative and technical assistance will require an initial assessment and analysis of the existing legislation and regulations to be conducted by a legal specialist in coordination with the project management team and relevant authorities in the beneficiary countries through legislative and technical assistance missions, to identify specific gaps and country priorities. The findings and lessons learned from the previous project on biosafety and biosecurity will be used as a basis for future trainings. The regional network created amongst the participants of the in-person and Massive Open Online Courses (MOOC) activities will also be used to distribute update technical information concerning biosafety and biosecurity fields with the aim of creating a discussion forum for these topics and enhancing regional cooperation.

Activities to promote and enhance

national cooperation

would include:

— Analysis of the existing legislation and regulations in beneficiary countries to identify specific gaps.

— Drafting and adoption of control lists of biological agents and toxins (based on a biosafety or biosecurity criteria depending on the risk classifications for pathogens), and export control lists.

— Development and adoption of national response plans for biological threats.

— Development of national guidelines for the protection of biological agents from accidental or deliberate dissemination, including appropriate effective measures to account for and secure such items in production, use, storage or transport and their physical protection.

— Development of guidelines to register, compile and submit the information requested by the BWC ISU in terms of CBMs.

Activities to promote and enhance

regional cooperation

would include:

— Development of follow-up capacity-building and cooperation activities for countries in the region that have carried out peer review exercises related to UNSCR 1540 implementation.

— Creating additional peer review exercises with a strong focus on the UNSCR 1540 obligations related to biological weapons.

— Strengthening the regional network of professionals interested in engaging on biological safety and security issues.

— Drafting and publishing of technical papers on peer review related activities.

OAS/CICTE will carry out training courses on biological safety and security in each of the beneficiaries to support the technical and legislative assistance and regional cooperation efforts contemplated in this Project. These training courses will build on previous efforts; will be conducted by international experts; and will be coordinated by the OAS/CICTE management team. The courses also will serve to build capacity and establish a group of trainers and networks of professionals from among the different scientific institutions of the beneficiaries. These cadres of experts could further disseminate knowledge, best laboratory practices, techniques, and methods for bio risk management in laboratories and research institutes.

OAS/CICTE will work with academics and researchers to maintain an already established online course for laboratory personnel and policy makers. Maintaining that course will contribute to the improvement of current resources for further dissemination of knowledge and awareness raising on biosafety, biosecurity, and bioethics amongst academics, teachers, students and researchers in life sciences and other relevant stakeholders. Additionally, OAS/CICTE will develop new MOOC modules or courses on responsible science, dual use research, dual use research of concern (DURC), and oversight mechanisms.

Finally, outreach and awareness raising on biosafety, biosecurity, UNSCR 1540 and implementation of the BWC will be conducted among policymakers, parliamentarians and industry during the technical and legislative assistance missions and the regional and subregional activities included in the proposal.

3.2.3. Gender perspective

OAS/CICTE, through its 1540 program, plays a key role in supporting Member States’ efforts to build capacity to implement resolution 1540 (2004) and counter proliferation, as well as to promote gender equality. All these outcomes contribute to achieving the UN Sustainable Development Goals and complement OAS Member States’ efforts to implement relevant instruments in the global disarmament and non-proliferation regime areas.

OAS/CICTE will seek to secure gender equity in the hiring process to assist beneficiary countries of the project and will encourage beneficiary countries to meaningfully engage women at all stages of the project. A special effort will be made to incorporate a gender perspective and to position women at the centre of the topics under discussion.

In addition, OAS/CICTE promotes diversity, equity, inclusion and accessibility (DEIA) efforts through an ‘Institutional Policy on Gender Equality, Diversity, and Human Rights’ and a Communications Guide designed to ensure that policies, programs, projects and practices take into account and visually represent different groups, including vulnerable groups. Every project goes through a formal inter-departmental ‘clearance process’ during which OAS subject-matter experts provide feedback that implementers are required to address.

OAS/CICTE is also guided by an institutional policy against sexual harassment. Prior to commencing any activity, OAS/CICTE distributes a Code of Conduct for all participants (including high ranking governmental authorities) to ensure respect, dignity, and inclusivity throughout each program and to encourage reporting of any behaviour that makes others uncomfortable.

3.2.4. External coordination

In addition to coordination and collaboration with national authorities throughout the region, the OAS will coordinate and collaborate with other institutions and organizations during the execution of the project. The entities, listed below, may be in a position to provide support on specific issues and help promote the initiative in the region:

— Security Council Committee established pursuant to UNSCR 1540 and its Group of Experts.

— United Nations Office for Disarmament Affairs (UNODA), including the Biological Weapons Convention Implementation Support Unit.

— United Nations Regional Centre for Peace, Disarmament and Development in Latin America and the Caribbean (UNLIREC).

— World Health Organization (WHO), including the Pan American Health Organization (PAHO).

— World Organization for Animal Health (WOAH).

— Civil society organizations, academia and private sector organizations whose objectives are in line with the objectives of this proposal, including Sandia National Laboratories; James Martin Center for Nonproliferation Studies – CNS, Johns Hopkins Center for Health Security, International Federation of Biosafety Associations (IFBA), and other national association of biosafety and biosecurity in the beneficiary countries.

3.3. Project Objectives and Activities

Objective 1. Strengthening the existing national normative frameworks related to biological safety and security in each of the Project’ beneficiary States.

Supporting Activities

— Activity 1.1: Review of the existing legislative and regulatory frameworks in each beneficiary State to identify gaps and priority areas of need.

— Activity 1.2: Provide legislative assistance as needed, including drafting legislation and regulations to implement update or create national plans, control lists, update or create national response / emergency plan for biological incidents.

— Activity1.3: Carry out a technical assessment in each beneficiary state with key national stakeholders to assess needs and identify gaps related to the implementation of the UNSCR1540 and BWC, which will be part of an assessment report.

— Activity 1.4: Based on needs and resources and previous findings of projects already implemented, facilitate training in one or both of the following areas: implementation of safety and security biological measures in the national plan for responding and/or preventing to biological threats.

— Activity 1.5: Contribute to developing national guidelines for the protection of biological agents from accidental or deliberate release, as well as national guidelines on accounting for and secure biological agents in production, use, storage or transport and their physical protection.

— Activity 1.6: Develop and provide in-situ support on an online platform in Spanish to assist states in the process of registering institutions to facilitate the compilation of the information contained in the CBMs to be reported to the BWC-ISU.

Expected results

— Assessment report containing recommendations per State and per agency.

— At least one legislative assistance mission per country to provide support in drafting control lists and/or national plans and/or draft relevant legislation/regulations.

— List of pathogens according to a risk classification, and/or export control lists in accordance with State’s needs.

— National plans by State considering their gaps and priorities.

— Guidelines containing measures to account for and secure biological agents in production, use, storage or transport and their physical protection.

— Development of online platforms for networks to facilitate capacity building in the areas of biological safety and security.

Objective 2. Fostering compliance with international regimes by promoting collaboration and cooperation between beneficiary States and assisting in submissions and declarations related to relevant instruments regarding biological weapons.

Supporting Activities

— Activity 2.1: Facilitate up to three peer review exercises with a strong focus on biological safety and security implementation measures, strategic trade controls, transport of biological agents, among others.

— Activity 2.2: Carry out three regional workshops on peer review exercises related to UNSCR 1540 implementation.

— Activity 2.3: Draft and publish technical papers on peer review related activities.

— Activity 2.4: Design and develop a training module, using a recently developed massive open online course (MOOC) platform to guide national authorities on how to gather and compile relevant information for the CBMs and submit them to the BWC-ISU (complementing the information provided by the Guide to Participating in the BWC Confidence-Building Measures issued by the BWC-ISU in 2015).

— Activity 2.5: Develop a regional/subregional activity to raise awareness about the importance and potential benefits of submitting the CBMs to the BWC-ISU.

— Activity 2.6: Organize a regional conference on biosafety and biosecurity to, among other things, increase coordination key national agencies and promote information sharing with the academic sector, NGOs and other relevant stakeholders.

— Activity 2.7: Organize a regional conference on the status of UNSCR 1540 (2004) implementation in the Americas to raise awareness of complying with the relevant regimes.

Expected results

— Raising awareness of international obligations compliance regarding UNSCR 1540 and BWC in the beneficiary states’ public and private sectors.

— Peer review exercises facilitated for six beneficiary countries.

— Increased coordination and cooperation among agencies of the beneficiary states in terms of biological safety and security best practices.

— Strengthening security measures in free trade zones regarding biological weapons related materials.

— Raising awareness of international obligations compliance regarding BWC through the presentation of relevant submissions and declarations and through the policy makers’ attendance to State Parties Conferences and other international fora, as appropriate.

Objective 3. Developing training activities in beneficiary States on biological safety and security.

Supporting Activities

— Activity 3.1: Organize and conduct up to eight in-country training sessions, with ‘train-the-trainer’ approach, on biological safety and security. Biosafety and biosecurity trainings will consider, among other subjects, high consequence pathogen (HCPs) safeguards as well as their synthetic biological materials (SBMs) and related bioscience infrastructure. Both biological safety and security courses will have a strong risk management component as well as promotion of a safety and security culture. Subjects like dual use research, dual use research of concern and establishing oversight mechanisms will also be considered.

— Activity 3.2: Establish a network of biological safety and security trainers in each beneficiary country, and amongst other beneficiary States.

— Activity 3.3: Design and develop a training module, taking as a basis the already developed MOOC platform, with the purpose of raising awareness of dual use research, dual use research of concern, ethics and life science, codes of conduct and possible oversight mechanisms, in order to reduce the risk of possible misuse of materials, equipment, information, including tacit knowledge, during the research process.

— Activity 3.4: Organize and conduct (they can be delivered on the margins of the biological safety and security courses), a tabletop exercise using a scenario where biological safety and security should be reinforced or implemented. During the activity, subjects related to international standards, chain of custody, segregation of hazardous materials as well as transportation risk management will be considered.

Expected results

— Network of trainers and specialists on biosecurity and biosafety established in each country.

— Open Online Courses created, and eight courses conducted.

— Scientists from agencies related on biosecurity and biosafety trained in the beneficiary States.

— Encourage IFBA (International Federation of Biosafety Associations) certifications among participants of the training sessions and the establishment of biosafety/biosecurity/microbiology associations.

Objective 4. Consolidating a regional community or network of stakeholders by promoting within each beneficiary active participation of representatives from the private and public sectors in relevant international fora related to biological safety and security.

Supporting Activities

— Activity 4.1 This project will seek to enlarge a recently created network of life science professionals. In addition, the Project will seek to promote interactions among those life science professionals through online seminars to discuss different topics related to their expertise and create a space to exchange experiences and lessons learned.

— Activity 4.2 Promote the participation of the professionals, high level authorities, technicians in internationals, regionals and other forums about biological safety and security events, side events and meetings that allow increase the knowledge and active participation.

Expected results

— Network of trainers and specialists on biosecurity and biosafety established in the region.

— Increase raising awareness of high-level authorities and their technicians that promote the develop of measures of regulation to effectively implement UNSCR1540 and BWC.

4. Beneficiaries

The direct beneficiaries in recipient States are national institutions and authorities responsible for biosafety and biosecurity implementation in 11 countries from Latin America (Argentina, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Panama, Paraguay, Peru, Uruguay).

5. European Union visibility

OAS/CICTE will ensure that all project activities recognize the European Union for its financial support through multiple means. Press releases, social media, and interviews with news media for high visibility events will highlight EU support. All equipment, printed materials or computer software donated to beneficiary countries will be labelled as being funded by the Union. Project personnel will display EU logo and/or flag on all hats, coveralls, or work uniforms as a clear method of branding. Union support will be well published and visible on OAS websites and publications related to the project and the programs that are supported.

6. Duration

The intended timeframe for project execution is 36 months.

7. General set-up

Technical implementation of the project will be carried out by OAS/CICTE through its existing 1540 program.

8. Partners

OAS/CICTE will implement the project in partnership with national authorities in beneficiary States, in collaboration with strategic partners.

9. Reporting

Narrative progress reports and financial status will be presented on a yearly basis to allow for adequate and timely monitoring and evaluation and OAS/CICTE will maintain close communications with the donor.

(1) Global Health Security Index. Available at: https://www.ghsindex.org/

(2) Mapping Biosafety Level-3 Laboratories by Publications. Center for Security and Emerging Technology. August 2022. Available at: CSET Mapping BSL3 Labs

(3) https://documents-dds-ny.un.org/doc/UNDOC/GEN/N22/725/80/PDF/N2272580.pdf?OpenElement

(4) https://bwc-ecbm.unog.ch

(5) Interactive prototype of the. Platform: https://xd.adobe.com/view/68f5f48c-1813-4dff-8840-b5113a7c9a22-3da6/?fullscreen&hints=off

ELI: http://data.europa.eu/eli/dec/2024/645/oj

ISSN 1977-0677 (electronic edition)