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.

The IEGBBR Model of Standardized Regulatory Practices for Biosafety and Biosecurity Incidents – Anticipated Completion in August 2023

Continued attention to the possible involvement of a laboratory leak as the origin of the global COVID-19 pandemic underscores the critical role that regulatory oversight plays in mitigating public health risks in relation to laboratory accidents involving pathogens and toxins. The SARS outbreak of 2003/4 in separate laboratory accidents also demonstrated the potential impacts of such incidents on public health. Furthermore, public scrutiny of work with pathogens and toxins has increased. It is considered a right for the public to know that regulatory oversight is in place to ensure that work with pathogens and toxins is conducted in a safe and responsible manner, and that hazards are mitigated. This IEGBBR project will help define the critical role that regulatory authorities perform in overseeing and responding to biosafety and biosecurity incidents.

The IEGBBR is collecting, collating and analyzing current practices around biosafety and biosecurity incident reporting and the associated regulatory response from the established oversight systems of IEGBBR member countries. The most well-known type of incident that falls within the scope of this project is a laboratory accident. However, the scope of the project includes both biosafety and biosecurity incidents, and both exposure and non-exposure events. Information from IEGBBR member countries on current regulatory incident reporting practices will be collated and analyzed to develop a model of standardized regulatory practices for biosafety and biosecurity incidents.

By considering the standardized and best regulatory practices of the IEGBBR model, other national governments will be able to develop or strengthen their national regulatory response to biosafety and biosecurity incidents that can help mitigate their impacts. Implementation of the model in multiple countries will enable international analysis of incidents and provide meaningful data that could contribute to international capacity-building in biosafety and biosecurity. A global alignment of incident reporting would set the base for international comparisons and enhance sharing of laboratory incidents. These would all in turn contribute to global health security.

IEGBBR capacity-building tools and information can be used regardless of the level of development or resources in a beneficiary country, and can reduce the need for extensive legwork or environmental scanning of international oversight systems.

The IEGBBR anticipates completing this project in August 2023.