02019D2108 — EN — 18.11.2022 — 001.001

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Amended by:









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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







Article 1

1. For the purpose of promoting peace and security, and effective multilateralism at global and regional levels, the Union shall pursue the following objectives: — improving the legislative and regulatory basis of biosafety and biosecurity in the beneficiary countries, through the adoption and enforcement of appropriate effective laws which prohibit non-State actors from manufacturing, acquiring, possessing, developing, transporting, transferring or using biological weapons and their means of delivery, in particular for terrorist purposes; — improving biosafety and biosecurity in beneficiary countries by raising awareness among relevant sectors, including through the enforcement of effective domestic measures to prevent the proliferation of biological weapons and their means of delivery.

2. In order to achieve the objectives referred to in paragraph 1, the Union shall undertake the following projects: — technical and legislative assistance to strengthen regulations on biosafety and biosecurity, to ensure harmonization of such regulations with international standards, and to promote and enhance regional cooperation; — awareness raising, education and training on biosafety and biosecurity.

Article 2

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

2. The technical implementation of the projects referred to in Article 1(2) shall be carried out by OAS/CICTE Secretariat. It shall perform this task under the control of the High Representative. For this purpose, the High Representative shall enter into the necessary arrangements with OAS/CICTE Secretariat.

3. A detailed description of the projects is set out in the Annex to this Decision.

Article 3

1. The financial reference amount for the implementation of the projects referred to in Article 1(2) shall be EUR 2 738 708,98 .

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

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

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

Article 4

The High Representative shall report to the Council on the implementation of this Decision, and shall do so on the basis of regular reports prepared by OAS/CICTE Secretariat. Those reports shall form the basis for the evaluation carried out by the Council. The Commission shall provide information on the financial aspects of the projects referred to in Article 1(2).

Article 5

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

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2. This Decision shall expire on 20 February 2024.

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ANNEX

PROJECTS 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

1. Introduction and objectives

1.1. Introduction

The Biological Weapons Convention entered into force in 1975 and has been ratified by all but one country (Haiti) in Latin America and the Caribbean. Nonetheless, after more than forty years, many of those same countries lack the domestic legal and regulatory framework needed to fully implement the BWC. That Convention sets out, among other things, certain biosafety standards for reducing bacteriological and other biological threats which may result in harm to life on earth.

In an effort to further efforts to counter such threats, the UN Security Council adopted United Nations Security Council Resolution 1540 in 2004 (‘UNSCR 1540 (2004)’). That resolution requires all 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. Under Operative Paragraph 3a of UNSCR 1540 (2004) such measures shall include establishing appropriate controls over related materials and, to this end developing and maintaining appropriate effective measures to account for and secure such items in production, use, storage or transport.

Every five years the 1540 Committee conducts a comprehensive review of the efforts made by Member States to implement obligations under UNSCR 1540 (2004). The final document of the 2016 Comprehensive Review drew some important conclusions. First, the document notes that while States have made some progress in securing and protecting sensitive materials, gaps in these areas remain. Second, the Committee noted that efforts to account for and secure materials related to biological weapons lag behind those for safeguarding materials related to nuclear and chemical weapons. Third, the Committee noted that there has been no increase in States’ implementation of measures called for by UNSCR 1540 (2004) since 2011. As a result, the Committee concluded that States should take urgent action to adopt measures to account for and secure materials related to biological weapons.

An incident involving the introduction and potential spread of a pathogenic biological agent, whether by an actor intending harm to a target population or by naturally occurring means, has the potential to cause significant human, economic, and political harm in the OAS region. In light of that potential threat, the OAS has sought to increase biosafety and biosecurity awareness and capacity in the Americas. Since 2009, for example, the Inter‐American Committee Against Terrorism (‘OAS/CICTE’), through its Secretariat (the ‘Secretariat’), 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 organisations to learn how to coordinate their responses to a bio‐incident. Furthermore, a number of OAS Member States have specifically requested the Secretariat’s assistance to draft or update National Bio-Emergency Response Plans.

While these and other efforts to enhance bio-incident readiness and response capabilities have yielded important results, there nonetheless remains a lack of engagement and investment in biosafety and biosecurity among many OAS Member States. This is reflected in the lack of needed infrastructure, capacity, and legal frameworks to effectively detect and respond to a biological incident. The large and disproportionate death toll in the Americas from the 2009 global outbreak of H1N1 highlights the above vulnerabilities and underscores the need for a greater focus on biosafety and biosecurity. It is believed, for example, that more people died in the Americas from the 2009 H1N1 swine flu than in the rest of the world.

The lack of engagement on the part of governments in the region on biosafety and biosecurity 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. These challenges highlight the need within the OAS region for a coordinated response to biological incidents. Such a response should involve multiple actors at the national and local levels, 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

Through this three-year project, CICTE aims to improve biosafety and biosecurity in beneficiary countries in line with UNSCR 1540 (2004), in particular through the establishment and enforcement of effective measures to prevent the proliferation of biological weapons and their means of delivery.

Technical assistance and cooperation with Member States that support the overall aim of the project will be based upon the following main objectives:

— strengthening biosafety and biosecurity standards in beneficiary countries;

— enhancing legal and regulatory frameworks on biosafety and biosecurity and harmonising them with existing international standards;

— strengthening collaboration and cooperation, in particular through 1540 peer review exercises;

— facilitating continuous training on biosafety and biosecurity.

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

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

The OAS has been actively supporting Member States’ non-proliferation efforts in the Americas since 2005. In 2010 the CICTE Secretariat was given a specific mandate to develop a programme to assist in the implementation of UNSCR 1540 (2004). Consequently, a strategic partnership was formed between the UN Office for Disarmament Affairs (UNODA), the 1540 Committee Group of Experts, and the OAS/CICTE Secretariat to implement a technical assistance and capacity building pilot project in the Americas to facilitate Member States’ efforts to implement the different areas covered by UNSCR 1540 (2004).

One of OAS/CICTE’s main objectives has been to work with countries whose governments are fully engaged in the physical protection and accounting of chemical, biological, radiological and nuclear defence (‘CBRN’) materials as part of those states’ non-proliferation efforts. Another objective has been to seek to help the beneficiary states implement UNSCR 1540 (2004) by identifying specific needs and challenges in order to tailor legislative assistance and specialised capacity-building activities aimed at strengthening Member States’ preventive framework against the use of CBRN materials by non-state actors.

The regional framework provided by OAS carries a comparative advantage due to the transnational nature of the threats, which necessarily entail cooperation between neighbouring countries in order to meet those challenges. CICTE’s regional approach to these issues will ensure consistency so that efforts are not duplicated and it can maximise efficiency. In this regard, the OAS, as the premier regional organisation 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.

More generally, OAS/CICTE has worked closely with the governments of numerous OAS Member States and achieved important results in the biosafety and biosecurity area. For example, OAS/CICTE has assisted Member States in various ways, such as:

— drafting 1540 national action plans and strengthening legal and regulatory frameworks;

— building capacity to prevent and combat nuclear, radiological, chemical and biological 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.

2.2. Coordination with Other Relevant Funding Initiatives

As a general practice, OAS/CICTE coordinates its activities with other agencies and organisations receiving funds from both the same and different donor governments and international bodies. In the case of organisations receiving support from the European Union for work related to the activities proposed under this project, the United Nations Office for Disarmament Affairs (UNODA), the 1540 Committee and its Group of Experts, and the Biological Weapons Convention Implementation Support Unit (BWC‐ISU) are directly relevant to the project, and it is worth noting that OAS/CICTE already works closely with them. The coordination with these bodies will be carried out by the management team based at OAS Headquarters, to ensure all efforts are complementary and to avoid duplication, and project activities will be aligned with 1540 and BWC obligations.

In this regard, OAS/CICTE believes the Project is clearly in line with the 2019 European Council Decision to support implementation of the Biological Weapons Convention outside the European Union (‘the Decision’). The proposed Project would further the Decision by helping to reduce the threat of proliferation of biological and toxin weapons in the region. In doing so, the Project would take into account the rapid advancements in life sciences, in order to ensure that governments’ legal and regulatory frameworks to counter such threats meet current international standards. As a result, the Project would help to ensure that OAS Member States are well prepared to respond quickly to any threats that may arise.

With respect to policy development, OAS/CICTE will continue to work in this area by way of its Regular Sessions and the Committee on Hemispheric Security of the OAS Permanent Council.

The main objective of this proposal is to improve biosafety and biosecurity in beneficiary countries by raising awareness and building capacity among relevant sectors, in line with UNSCR 1540 (2004), including the enforcement of effective domestic measures to prevent the proliferation of biological weapons and their means of delivery. These efforts will be aimed at life scientists in the field of biosafety and biosecurity in the public and private sectors, as well as at policymakers and legislators. Activities include training courses for life scientists in beneficiary countries, as well as the development of an online training course to reach even more beneficiaries in the region. OAS/CICTE will carry out these activities in coordination with our strategic partners and, as noted in the Methodology section, for highly specialised training and tasks, the OAS may also contract short-term support (experts, trainers and researchers), and will work with its partners in those areas (including the BWC-ISU, UNODA, OIE and the European Union) and academia in order to ensure that personnel meet all the technical requirements, including, where possible, drawing from the rosters maintained by those organisations.

3. Project description

3.1. Description

Our proposal aims to improve biosafety and biosecurity in beneficiary countries, in line with UNSCR 1540 (2004), and to further increase beneficiary states’ capacity to effectively anticipate and respond to large-scale incidents involving a biological agents, whether man-made or naturally occurring. The Project also would serve to improve interagency and international cooperation and information-sharing among OAS Member States in order to prepare for and respond to biological incidents. In addition, the Project seeks to address legislative gaps that currently exist in some of the target countries and complement efforts to implement the BWC.

The Project will bring together the responsible national authorities of up to eight OAS Member States, appropriate representatives of the private sector and civil society, and qualified international experts, to explore steps that can be taken to ensure improved biosafety and biosecurity capabilities in those states and, more broadly, in the OAS region. The Project will employ a two-pronged approach that incorporates both national and sub‐regional activities. 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 (especially in the public sector). 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, the 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, the Project will seek to leverage a ‘peer review’ process which has been developed in recent years, under which States voluntarily agree to work together to assess their mutual strengths and weakness in implementing 1540 obligations and to identify effective practices and areas for continued bilateral cooperation. Following recent successful 1540 peer review exercises between Chile and Colombia (2017), the Dominican Republic and Panama (2019) and most recently Paraguay and Uruguay (2019), we are proposing to provide specific follow-up assistance and cooperation activities for these three sets of countries. In doing so, we would seek to follow up on the close bilateral ties forged between these States during the peer review process and would seek to further promote these countries’ demonstrated commitment to continuing 1540 cooperation beyond the initial peer review exercises. We would also propose to promote additional peer review exercises in the region, with a strong focus on biosafety and biosecurity for countries that have not yet undertaken such exercises, such as Mexico and potentially other partners in the region. Finally we would seek to revisit existing peer review processes to promote and enhance the continued cooperation between the 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 forums.

3.2. Methodology

3.2.1. Organisational structure

This project will be implemented by OAS/CICTE, in coordination with and supported by 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 contracted external personnel, depending on the specific activities to be executed, under the general supervision and guidance of the CICTE Executive Secretary.

The externally contracted personnel will include a legal specialist who will execute the legislative assistance portion of the project. For highly specialised training and tasks, the OAS may also contract short-term support (experts, trainers and researchers) from other technical partner organisations’ expert rosters, including the BWC-ISU, UNODA, OIE and the European Union.

Initially, the OAS/CICTE programme management team will coordinate directly with national authorities of the Member States that have previously requested support with respect to UNSCR 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 to strengthen regulations on biosafety and biosecurity will require an initial assessment and analysis of the existing legislation and regulations would be carried out by a legal specialist in coordination with the project management team and relevant authorities in the beneficiary countries through legislative and technical assistance missions, in order to identify specific gaps and country priorities. Based on this assessment, the specific measures related to legislative and regulatory improvements in the field of biosafety and biosecurity requiring priority implementation which will be directly supported by this project could include:

— analysis of the existing legislation and regulations in beneficiary countries in order to identify specific gaps;

— drafting and adoption of an export control list;

— development and adoption of a national action plan for responding to biological threats;

— development of national guidelines for the protection of biological agents from accidental or deliberate dissemination, their proper and safe storage and transportation, including their in-house security.

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 1540 implementation;

— additional peer review exercises with a strong focus on biosafety and biosecurity;

— drafting and publication of technical papers on peer review related activities.

For the awareness raising, education and training on biosafety and biosecurity component of this proposal, to be carried out in parallel to the technical and legislative assistance and regional cooperation component, a training course will be organized in each of the beneficiary countries. These training courses will be coordinated by the OAS/CICTE management team and conducted by international experts. These courses will serve to build capacity and establish a group of trainers from among the different scientific institutions of the beneficiary countries who will be able to disseminate knowledge on biosafety and biosecurity principles, best laboratory practices, techniques and methods for bio risk management in laboratories and research institutes.

OAS/CICTE will work with academics and researchers in order to develop an online course, contributing 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.

Furthermore, outreach and awareness raising on biosafety, biosecurity, UNSCR 1540 (2004) 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 programme, plays an important role in supporting Member States to build capacity in order to implement UNSCR 1540 (2004) and to combat proliferation, as well as to promote gender equality. All of these outcomes contribute to the achievement of 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 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 is always made to incorporate a gender perspective and to position women at the centre of the topics under discussion.

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 organisations during the execution of the project. The entities listed below may be in position to provide support on specific issues and help promote the initiative in the region:

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

— Security Council Committee established pursuant to UNSCR 1540 (2004) and its Group of Experts;

— World Organisation for Animal Health (OIE);

— World Health Organisation (WHO), including the Pan American Health Organisation (PAHO);

— civil society organisations, academia and private sector organisations whose objectives are in line with the objectives of this proposal, including Sandia National Laboratory; Subcomisión de Bioseguridad y Bioscustodia de la Asociación Argentina de Microbiología; James Martin Center CNS; Asociación Latinoamericana de Biocontención y Biocustodia.

3.3. Project Objectives and Activities

Objective 1: Biosafety and biosecurity standards in beneficiary countries strengthened.

Supporting Activities

— Activity 1.1: Carry out a technical assistance mission per country with agencies involved on biosafety and biosecurity in order to assess needs and draft an assessment report.

— Activity 1.2: Based on needs and resources, facilitate training in one or both of the following areas: adoption of an export control list or adoption of a national action plan for responding to biological threats. Provide an evaluation report.

— Activity 1.3: Develop national guidelines for the protection of biological agents from accidental or deliberate dissemination, as well as national guidelines regarding their proper and safe storage and transportation, including their in-house security.

Expected results

— Assessment report drafted with recommendation per country and per agency.

— Export control list created according of needs of countries.

— Evaluation report provided by country of national action plan responding and guidelines of biological threats, accidental events, safe storage and transportation.

Objective 2: Legal and regulatory frameworks on biosafety and biosecurity enhanced and harmonised with existing international standards.

Supporting Activities

— Activity 2.1: Review existing legislative and regulatory frameworks in each beneficiary country to identify gaps and priority areas of need.

— Activity 2.2: Provide legislative assistance as needed, including drafting legislation and regulations to implement export control lists and/or a national action plans.

— Activity 2.3: Compile and publish document with guidelines for best laboratory practices, techniques and methods for bio-risk management in laboratories and research institutes and disseminate it to promote awareness of good practices among relevant stakeholders.

Expected results

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

— Best laboratory practices published with different components: academic, techniques and different methods.

Objective 3: Collaboration and cooperation strengthened particularly through 1540 peer review exercises.

Supporting Activities

— Activity 3.1: Facilitate up to three new peer review exercises with a strong focus on biosafety and biosecurity.

— Activity 3.2: Carry out three bilateral workshops to follow up on peer review exercises already conducted in the region related to 1540 implementation.

— Activity 3.3: Draft and publish technical papers on peer review related activities.

— Activity 3.4: Organise regional conference on biosafety and biosecurity to, among other things, increase coordination and promote information sharing.

— Activity 3.5: Organise regional conference on the status of UNSCR 1540 (2004) implementation in the Americas.

Expected results

— Peer review exercises facilitated for six beneficiary countries.

— Follow-up report of peer review drafted and published for Chile / Colombia, Dominican Republic / Panama and Paraguay / Uruguay.

— Coordination between agencies related with biosecurity of biosafety of beneficiaries countries increased.

Objective 4: Continuous training on biosafety and biosecurity facilitated.

Supporting Activities

— Activity 4.1: Establish a network of biosafety and biosecurity trainers in each beneficiary country.

— Activity 4.2: Design and develop a training module for scientists to reduce risk of possible misuse of materials and equipment during their research.

— Activity 4.3: Coordinate with relevant national training institutes to encourage inclusion in academic curricula of modules and/or materials related to biosafety and biosecurity, including implementation of UNSCR 1540 (2004) and the BWC.

— Activity 4.4: Organise and conduct up to eight training sessions on biosafety and biosecurity (one per beneficiary country).

Expected results

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

— Open online courses created and six courses conducted.

— Scientists from agencies related on biosecurity and biosafety trained in the beneficiaries countries.

4. Beneficiaries

The direct beneficiaries of objectives 1 through 4 are national institutions and authorities responsible for biosafety and biosecurity in each beneficiary country (up to eight States depending on funds received: Argentina, Chile, Colombia, the Dominican Republic, Mexico, Panama, Paraguay and Uruguay). With the creation of the online course and inclusion of these topics in university curricula, an even broader array of beneficiaries will be reached.

5. European Union visibility

OAS/CICTE will ensure that all project activities recognise the Union for its financial support of the project 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 programmes 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 programme.

8. Partners

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

9. Reporting

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