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

- 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.

IEGBBR Virtual Event

Building Capacity for DU Oversight in the Life Sciences through the IEGBBR.
Held Tuesday, May 30, 2023.

The 2 hour event described how to identify, assess, and mitigate dual-use concerns in the life sciences, using two examples of oversight measures from the national oversight systems of 2 of the IEGBBR member countries. There was a question and answer session after each of the presentations. The three PowerPoint presentations are available for download as a pdf.

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.

Technical Expertise Program

Capacity-building reference tools and information are relevant to many beneficiary countries because they provide a wealth of regulatory information. However, providing information that is helpful on a broad scale might not be helpful or relevant to specific national or regional situations. This new IEGBBR program will provide tailored technical expertise and enable beneficiaries to obtain help in areas of need or to address gaps in their biosafety/biosecurity oversight systems, enabling the strengthening of the national biosafety and biosecurity programs and the associated oversight measures. This tailored assistance can help overcome situations where the specific needs or obstacles to the implementation of oversight systems are not addressed by available resources.

Regional biosafety and biosecurity organizations are best placed to understand the capacity-building needs in their region. During the current one-year funding term, the program will be delivered to a regional organization (with developing country membership) that has identified needs. The technical expertise program will comprise a series of virtual sessions set up to support and work within existing frameworks of the regional organization. Topics will be selected based on the needs of the regional organization and areas of expertise from IEGBBR member countries related to biosafety and biosecurity oversight systems, such as inspector training, licensing/authorizations, and pathogen risk assessments.