IEGBBR Mobile Application of Biosafety, Biosecurity and Dual-Use Oversight
The IEGBBR mobile app is a reference tool for countries that aim to develop or strengthen their national biosafety, biosecurity or dual-use oversight. By providing 11 detailed examples of the national oversight systems of the IEGBBR member countries, the app can serve as an information resource to remove the necessity for extensive legwork prior to the development and implementation of oversight systems. The mobile app was launched as a publicly available, searchable mobile application in English and French in March 2022.
You can get it from the Google Play or Apple app store using your Android or Apple mobile device.
The app has the following two modules:
1. Biosafety and Biosecurity - The IEGBBR Compendium of International Biosafety and Biosecurity Oversight Systems for Human and Animal Pathogens and Toxins
- Provides 11 detailed descriptions of the national regulatory oversight systems in the IEGBBR member countries for activities involving human and animal pathogens and toxins
2. Dual-Use - The Review of Oversight of Dual-Use (DU) in Life Sciences in IEGBBR Countries
- Provides 11 detailed descriptions of regulatory and non-regulatory oversight for dual-use issues in life sciences among the IEGBBR member countries
Uses of the Mobile App
The mobile app can contribute to a country’s improved national or regional compliance with international commitments by serving as an information resource. By detailing the 11 IEGBBR member countries’ national oversight systems, the IEGBBR mobile app can be used as a reference tool for countries that want to strengthen their public health capacities related to biosafety, biosecurity or dual-use oversight.
International Health Regulations Compliance (IHR): The mobile app can contribute to improving national/regional compliance with the International Health Regulations. Under the IHR, States Parties are mandated to report annually on 13 public health capacities, including Legislation and Financing (C1) and Laboratory Biosafety and Biosecurity Regime (C5). Also under the IHR, the Joint External Evaluation assessments are a rigorous in-country evaluation of a country’s core public health capacities. The technical areas relevant to biosafety, biosecurity and dual-use oversight include Prevent (P1): National legislation, policy and financing, and Prevent (P6): Biosafety and Biosecurity.
Biological Security: The COVID-19 pandemic has placed a heightened focus on public health and identified challenges to public health control in national regulatory systems around the world. Theories about the origins of SARS-CoV-2 have also garnered focus on international biosafety and biosecurity, which points to the need to build capacity on oversight of dual-use issues, as well as to build strong international understanding and strengthen oversight around responsible conduct in the life sciences. Oversight of biosafety, biosecurity and dual-use is tied to national health security because accounting for highly pathogenic biological agents and storing them safely and securely mitigates public health and biological security risks. The mobile app can contribute to the following biological security priorities:
- Develop and maintain appropriate and effective measures to identify dual use potential and reduce the risk of deliberate misuse of biological agents
- Reinforce and strengthen biological non-proliferation principles and practices
- Reduce proliferation risks through the advancement and promotion of safe and responsible conduct in the biological sciences
- Secure and account for materials that represent biological proliferation risks, strengthening accountability through strong regulation.
Other International Commitments: The mobile app can also contribute to ongoing international biosafety and biosecurity efforts and commitments, and can be used hand in hand with other available reference tools.
Biological and Toxins Weapons Convention: Descriptions of the IEGBBR oversight systems for biosafety, biosecurity and dual-use show how the signatory achieves compliance to the BTWC, in particular for:
Article I: … “undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain”…,
Article III: … “undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organisations to manufacture or otherwise acquire” …, and
Article IV: … “take any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition or retention”…
United Nations Security Council Resolution 1540:
Descriptions of the IEGBBR oversight systems for biosafety, and biosecurity and dual-use oversight systems demonstrate how the signatory has achieved compliance with the requirement to “adopt and enforce appropriate laws to this effect as well as other effective measures to prevent the proliferation of these weapons and their means of delivery to non-State actors, in particular for terrorist purposes”.
The Wassenaar Arrangement and Australia Group:
The described export control regimes in place aim to prevent the spread and development of destabilising accumulations of weapons and the proliferation of biological weapons. This is done through adopting Wassenaar Arrangement policies and recommendations on transfers, and having in place harmonized export controls through Australia Group.
Canada’s Analytical Approach:
The IEGBBR mobile app provides 11 examples of national biosafety, biosecurity, and dual-use oversight systems, including detail of the policy instruments used. It therefore can serve as a complementary tool to the modules of the Analytical Approach that can remove the necessity for extensive legwork prior to the development and implementation of oversight.
Resources: How to use the mobile App (.pdf)
The IEGBBR Model of Standardized Regulatory Practices for Biosafety and Biosecurity Incidents
In the wake of the COVID-19 pandemic, there has been elevated attention on biosafety and biosecurity internationally. This includes heightened awareness regarding the impacts of potential biosafety and biosecurity incidents leading to loss of containment of human pathogens or toxins stored in facilities, which may impact national and international public health. Given the potential impact of biosafety and biosecurity incidents on a global scale, there has been increased scrutiny towards, and re-evaluation of, incident reporting practices internationally. This has identified a need to update and improve incident reporting systems worldwide. Our model addresses this need as it provides stakeholders with information on how to develop or strengthen their own national incident reporting systems. If implemented by regulatory authorities around the world, this model will contribute to global health security.
An incident reporting system is a part of a national regulatory biosafety and biosecurity oversight framework which functions to require facilities that handle or store human pathogens or toxins to report, assess and implement corrective actions for biosafety and biosecurity incidents to the regulatory authority. The IEGBBR Model of Standardized Regulatory Practices for Biosafety and Biosecurity Incidents describes the integral components of an incident reporting system. It is based on the analysis of the collective incident reporting systems belonging to the regulatory authorities of the eleven member countries of the IEGBBR. This model was developed by the IEGBBR as a capacity-building tool for the international community to improve incident reporting systems and their standardization globally. Regulatory biosafety and biosecurity authorities and policy makers around the world can use this model as a reference tool to develop or strengthen their regulatory frameworks to prevent and manage the risks of biosafety and biosecurity incidents and to strengthen the associated regulatory response.
The model was launched in September of 2023. It is available in both English and French, and is hosted on the Public Health Agency of Canada (PHAC)’s training portal (IEGBBR Model of Standardized Regulatory Practices for Biosafety and Biosecurity Incidents - phac-aspc.gc.ca).
About the Model
The IEGBBR Model of Standardized Regulatory Practices for Biosafety and Biosecurity Incidents contains an interactive model that identifies twelve biosafety and biosecurity incident types reportable within an incident reporting system, twelve standardized practices that serve as the foundation for an incident reporting system, and seven optional enhancements to strengthen an incident reporting system. Both the standardized practices and enhancements have examples described from the IEGBBR member countries, so as to provide additional information and insight for stakeholders for use within their own systems. In addition, a self-assessment section provides stakeholders with the opportunity to identify the standardized practices that are implemented within their regulatory framework. The resulting report provides a visual of the self-reported standardized practices that are fully, partially or not implemented and therefore identifies possible areas for improvement. Stakeholders can also compare their incident reporting system against the collective result of the eleven member countries of the IEGBBR, which may help stakeholders to prioritize practices to implement. Overall, this model provides a range of information about incident reporting systems that will help stakeholders to develop or strengthen their own systems.
- A list of biosafety and biosecurity incident types, including exposure and non-exposure events, that are reportable within an incident reporting system.
- A glossary to define terms associated with an incident reporting system.
- A set of standardized practices that serve as the foundation for an incident reporting system, and necessary for effective function.
- A list of optional enhancements, which are aspects in which to strengthen an incident reporting system, as they incorporate other beneficial elements in which to support the system.
- An interactive self-assessment tool for stakeholders to identify the standardized practices they have in place within their own incident reporting systems, and which can help point out possible improvements.
Resources for the Development or Strengthening of Biosafety and Biosecurity Oversight
The collaborative exchange of regulatory information and expertise from the perspectives of the established biosafety and biosecurity regulatory systems of the IEGBBR member countries enables the development of capacity-building reference tools and information for the international community. These capacity-building reference materials can be used by international stakeholders towards the establishment or strengthening of biosafety and biosecurity oversight systems and can therefore contribute to increased global health security.
The IEGBBR develops reference tools and materials that are relevant to all countries, including developing countries and countries that already have established biosafety and biosecurity oversight frameworks, such as those of the IEGBBR members. This is due to the universal nature of the IEGBBR’s reference materials that can benefit the international community, regardless of the level of development or resources.
The IEGBBR has listed 19 topics in biosafety and biosecurity that are based on the expertise common to its membership—the regulatory authorities that administer the national biosafety/biosecurity oversight systems within their countries. The topics drill down from the more general concepts of biosafety or biosecurity oversight to elements that form a part of the national oversight systems at the working level. To prevent duplication of effort, some topics have been excluded because they are covered by other available resources, such as programs offered by the International Federation of Biosafety Associations. The World Health Organization’s Laboratory Biosafety Manual is suggested as a key reference document that can provide information for all topics. An additional suggested key resource for all topics is the IEGBBR Mobile Application of Biosafety, Biosecurity, and Dual-Use Oversight, available for download on your Android or Apple mobile device. To be of further assistance to our international beneficiaries as they work on developing or strengthening their biosafety and biosecurity oversight systems, the IEGBBR has developed a map of suggested resources, mostly from the IEGBBR member countries, which can serve as a foundation of knowledge for each of the biosafety and biosecurity topics.
The resource map, entitled “Resources for the Development or Strengthening of Biosafety and Biosecurity Oversight” is available for download as an interactive pdf.
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