Biosecurity Risk Management: Effective Strategies for Biosecurity Risk Assessment

1. What is biosecurity and why is it important?

Biosecurity is the prevention and mitigation of biological threats that could harm human, animal, or plant health, or the environment. These threats could be natural, accidental, or intentional, and could involve pathogens, pests, invasive species, or bioweapons. Biosecurity is important for several reasons, such as:

- protecting public health and safety from infectious diseases, bioterrorism, and biological warfare.

- preserving biodiversity and ecosystem services from invasive alien species and genetic pollution.

- Supporting food security and agricultural productivity from crop and livestock pests and diseases.

- Enhancing economic development and trade by complying with international standards and regulations on biosafety and biosecurity.

- Fostering scientific and technological innovation by ensuring the safe and ethical use of biotechnology and synthetic biology.

biosecurity risk management is the process of identifying, assessing, and managing biosecurity risks in a systematic and evidence-based manner. It involves four main steps:

1. biosecurity risk assessment: This is the process of estimating the likelihood and consequences of biosecurity threats, taking into account the sources, pathways, and receptors of exposure, as well as the existing measures and controls to prevent or reduce the risks.

2. Biosecurity risk communication: This is the process of exchanging information and opinions about biosecurity risks among stakeholders, such as policy makers, regulators, researchers, industry, civil society, and the public. It aims to inform, consult, or involve the relevant parties in the biosecurity risk management process, and to enhance trust and transparency.

3. Biosecurity risk treatment: This is the process of selecting and implementing the most appropriate options to prevent, mitigate, or respond to biosecurity risks, based on the results of the risk assessment and communication. It could involve legal, regulatory, technical, operational, or behavioral measures, such as quarantine, surveillance, vaccination, decontamination, or education.

4. Biosecurity risk monitoring and evaluation: This is the process of measuring and reviewing the performance and effectiveness of the biosecurity risk management process, and identifying any gaps, weaknesses, or opportunities for improvement. It could involve indicators, audits, feedback, or lessons learned.

An example of biosecurity risk management in practice is the Global Health Security Agenda (GHSA), which is a multilateral initiative launched in 2014 to strengthen the capacity of countries to prevent, detect, and respond to infectious disease outbreaks, whether natural, accidental, or deliberate. The GHSA has 11 action packages that cover various aspects of biosecurity, such as zoonotic diseases, antimicrobial resistance, biosafety and biosecurity, laboratory systems, surveillance, emergency operations, and workforce development. The GHSA uses a standardized assessment tool to measure the progress and gaps of each country in achieving the GHSA targets, and provides technical and financial assistance to support the implementation of the action packages. The GHSA also fosters collaboration and coordination among various stakeholders, such as governments, international organizations, civil society, and the private sector, to address the common biosecurity challenges and opportunities.

2. A systematic process to identify, analyze, and evaluate biosecurity threats and vulnerabilities

Biosecurity risk assessment is a crucial component of biosecurity risk management, which aims to prevent, detect, and respond to biological threats that could harm human, animal, or plant health, or the environment. Biosecurity risk assessment involves a systematic process of identifying, analyzing, and evaluating the sources, pathways, and consequences of biosecurity risks, and the likelihood and uncertainty of their occurrence. The process can be applied at different levels, such as national, regional, sectoral, or organizational, depending on the scope and objectives of the assessment. The following steps are commonly used in biosecurity risk assessment:

1. Define the context and scope of the assessment. This step involves clarifying the purpose, scope, and objectives of the assessment, as well as the stakeholders, decision-makers, and end-users involved. It also involves defining the biosecurity hazards, scenarios, and endpoints of interest, and the criteria and methods for risk estimation and evaluation.

2. Identify the biosecurity risks. This step involves identifying and describing the sources and characteristics of the biosecurity hazards, such as pathogens, pests, invasive species, or genetically modified organisms, and the pathways and activities that could introduce, spread, or amplify them. It also involves identifying and describing the potential exposure and susceptibility of the receptors, such as humans, animals, plants, or ecosystems, and the factors that could influence their vulnerability and resilience.

3. Analyze the biosecurity risks. This step involves estimating the likelihood and consequences of the biosecurity risks, and the associated uncertainty and variability. Likelihood estimation can be based on historical data, expert judgment, modeling, or a combination of these methods. Consequence estimation can be based on qualitative or quantitative indicators, such as morbidity, mortality, economic losses, environmental impacts, or social disruption. Uncertainty and variability can be expressed using ranges, distributions, or confidence intervals, depending on the availability and quality of the data and information.

4. Evaluate the biosecurity risks. This step involves comparing the estimated risks with the predefined criteria and thresholds, and ranking or prioritizing them according to their significance and acceptability. Risk evaluation can be based on qualitative or quantitative methods, such as risk matrices, scoring systems, cost-benefit analysis, or multi-criteria decision analysis. Risk evaluation can also involve considering the ethical, legal, and social implications of the biosecurity risks, and the values and preferences of the stakeholders and decision-makers.

5. Communicate and document the biosecurity risks. This step involves presenting and explaining the results and limitations of the biosecurity risk assessment, and the assumptions and uncertainties involved, to the relevant stakeholders, decision-makers, and end-users. It also involves documenting the methods, data, and information used in the biosecurity risk assessment, and the rationale and evidence for the risk estimates and evaluations.

An example of a biosecurity risk assessment is the one conducted by the Australian Government Department of Agriculture, Water and the Environment for the importation of fresh dragon fruit from Vietnam. The assessment identified and analyzed the biosecurity risks associated with the potential introduction and establishment of pests and diseases that could affect Australian agriculture and the environment, such as fruit flies, mealybugs, nematodes, and fungi. The assessment evaluated the biosecurity risks using a qualitative matrix that considered the likelihood and consequences of the risks, and the level of uncertainty and variability. The assessment concluded that the biosecurity risks of importing fresh dragon fruit from Vietnam are negligible, provided that the recommended risk management measures are applied. The assessment was communicated and documented in a report that was published on the department's website and subjected to public consultation and peer review.

3. A proactive approach to prevent, mitigate, and respond to biosecurity risks

Biosecurity risks are the potential threats posed by biological agents or materials to human, animal, or plant health, or to the environment. These risks can arise from natural, accidental, or intentional sources, and can have significant impacts on public health, food security, biodiversity, and economic stability. Therefore, it is essential to adopt a proactive approach to biosecurity risk management, which involves the following steps:

1. Biosecurity risk assessment: This is the process of identifying, analyzing, and evaluating the biosecurity risks associated with a specific activity, location, or scenario. The risk assessment should consider the likelihood and consequences of exposure, transmission, or release of biological agents or materials, as well as the existing biosecurity measures and their effectiveness. The risk assessment should also take into account the uncertainty and variability of the available data and information, and the assumptions and limitations of the methods and models used. The risk assessment should be conducted by a multidisciplinary team of experts, using a transparent and systematic approach, and following the relevant standards and guidelines.

2. biosecurity risk mitigation: This is the process of implementing appropriate biosecurity measures to reduce the biosecurity risks to an acceptable level. The risk mitigation should be based on the results and recommendations of the risk assessment, and should follow the principles of proportionality, feasibility, and cost-effectiveness. The risk mitigation should also be aligned with the objectives and priorities of the stakeholders involved, and should comply with the legal and ethical obligations and responsibilities. The risk mitigation should include both preventive and responsive measures, such as:

- Preventive measures: These are the actions taken to prevent or minimize the introduction, establishment, or spread of biological agents or materials that pose biosecurity risks. Examples of preventive measures are: screening and quarantine of travelers, animals, or plants; surveillance and monitoring of biosecurity threats; biosecurity education and awareness; biosafety and biosecurity standards and practices; and biosecurity regulation and enforcement.

- Responsive measures: These are the actions taken to respond to or manage the occurrence or outbreak of biological agents or materials that pose biosecurity risks. Examples of responsive measures are: detection and diagnosis of biosecurity incidents; notification and reporting of biosecurity events; containment and control of biosecurity hazards; eradication and disposal of biosecurity agents or materials; and recovery and restoration of biosecurity systems.

3. Biosecurity risk communication: This is the process of exchanging information and opinions about biosecurity risks and risk management among the relevant stakeholders, such as policy makers, regulators, researchers, industry, media, and the public. The risk communication should aim to inform, consult, and engage the stakeholders, and to foster trust, understanding, and collaboration. The risk communication should also address the concerns and expectations of the stakeholders, and provide timely, accurate, and consistent messages. The risk communication should be planned and implemented as an integral part of the biosecurity risk management cycle, and should follow the best practices and principles of risk communication.

4. Key principles and best practices for biosecurity risk management

Biosecurity risk management is the process of identifying, assessing, and mitigating the potential threats posed by biological agents or materials to human, animal, or plant health, or the environment. It involves applying scientific knowledge, technical skills, and ethical principles to prevent, detect, and respond to biosecurity incidents. Biosecurity risk management is essential for safeguarding public health, food security, biodiversity, and economic stability. Some of the key principles and best practices for biosecurity risk management are:

- Adopting a holistic and multidisciplinary approach. Biosecurity risks can arise from various sources, such as natural outbreaks, accidental releases, or deliberate misuse of biological agents or materials. Therefore, biosecurity risk management requires the collaboration and coordination of multiple stakeholders, such as governments, researchers, industry, civil society, and international organizations. A holistic and multidisciplinary approach can help to address the complex and interrelated dimensions of biosecurity, such as scientific, technical, legal, ethical, social, and political aspects.

- Applying the precautionary principle. The precautionary principle states that when there is uncertainty or insufficient evidence about the potential harm of an activity or technology, precautionary measures should be taken to avoid or minimize the risk. This principle is especially relevant for biosecurity risk management, as biological agents or materials can have unpredictable and irreversible effects on human, animal, or plant health, or the environment. For example, the precautionary principle can guide the regulation and oversight of emerging biotechnologies, such as synthetic biology or gene editing, that may pose novel biosecurity risks.

- Implementing the risk analysis framework. The risk analysis framework is a systematic and transparent method for biosecurity risk assessment, risk management, and risk communication. Risk assessment is the process of estimating the likelihood and consequences of a biosecurity event. Risk management is the process of selecting and implementing measures to reduce or eliminate the risk. Risk communication is the process of exchanging information and opinions about the risk among different stakeholders. The risk analysis framework can help to ensure that biosecurity decisions are based on sound science, evidence, and stakeholder input.

- adhering to the international standards and norms. There are various international standards and norms that provide guidance and obligations for biosecurity risk management. Some of the most relevant ones are the Biological Weapons Convention (BWC), the International Health Regulations (IHR), the Codex Alimentarius, the World Organisation for Animal Health (OIE) standards, and the Convention on Biological Diversity (CBD). These standards and norms can help to harmonize and strengthen the national and global biosecurity capacities and cooperation.

- Promoting a culture of responsibility and awareness. A culture of responsibility and awareness is the shared commitment and understanding of the ethical and social implications of biosecurity among the individuals and organizations involved in the handling or use of biological agents or materials. A culture of responsibility and awareness can foster the adoption of good practices and behaviors, such as following the biosafety and biosecurity guidelines, reporting any suspicious or unusual activities, and engaging in education and outreach activities. A culture of responsibility and awareness can also enhance the trust and confidence among the biosecurity stakeholders and the public.

5. Examples and applications

Biosecurity risk management is the process of identifying, assessing, and mitigating the potential threats posed by biological agents or materials to human, animal, or plant health, or the environment. It involves applying scientific knowledge, technical skills, and ethical principles to prevent, detect, and respond to biosecurity incidents. Biosecurity risk management frameworks and tools are essential for guiding and supporting biosecurity practitioners and decision-makers in conducting biosecurity risk assessments and implementing biosecurity measures. Some examples and applications of biosecurity risk management frameworks and tools are:

- The World Organisation for Animal Health (OIE) tool for the Evaluation of performance of Veterinary Services (PVS): This tool is designed to help countries evaluate the quality and performance of their veterinary services, which are responsible for ensuring animal health and welfare, preventing and controlling animal diseases, and facilitating safe trade in animals and animal products. The tool consists of four components: a questionnaire, a mission, a report, and a gap analysis. The tool covers 12 critical competencies and 47 fundamental elements of veterinary services, such as legislation, surveillance, emergency preparedness, laboratory capacity, and biosecurity. The tool helps countries identify their strengths and weaknesses, prioritize their needs, and develop action plans to improve their veterinary services and biosecurity.

- The World Health Organization (WHO) International Health Regulations (IHR) Monitoring and Evaluation Framework (MEF): This framework is a comprehensive approach to assess and strengthen the capacities of countries to prevent, detect, and respond to public health emergencies of international concern, as required by the IHR. The framework consists of four components: annual reporting, joint external evaluation, after action review, and simulation exercises. The framework covers 19 technical areas and 48 indicators of core capacities, such as legislation, coordination, surveillance, laboratory, points of entry, and biosafety and biosecurity. The framework helps countries monitor their progress, identify gaps, and implement corrective actions to enhance their public health and biosecurity capabilities.

- The Food and Agriculture Organization (FAO) Biosecurity Toolkit: This toolkit is a practical guide for developing and implementing national biosecurity frameworks and strategies. It covers the three sectors of agriculture, namely, animal health, plant health, and food safety. It provides a step-by-step process for conducting biosecurity situation analysis, developing biosecurity vision and goals, identifying biosecurity options and priorities, and implementing and monitoring biosecurity actions. The toolkit also includes tools and templates for conducting biosecurity risk analysis, stakeholder analysis, gap analysis, and cost-benefit analysis. The toolkit helps countries harmonize and integrate their biosecurity policies and practices across the three sectors and improve their biosecurity outcomes.

6. How to inform and engage stakeholders and the public?

Biosecurity risk communication is a vital component of biosecurity risk management, as it aims to inform and engage stakeholders and the public about the potential threats and consequences of biological agents, whether natural, accidental, or deliberate. Effective biosecurity risk communication can enhance awareness, understanding, trust, and collaboration among various actors involved in biosecurity, such as governments, researchers, industry, media, and civil society. However, biosecurity risk communication also faces many challenges and complexities, such as uncertainty, ambiguity, controversy, and ethical dilemmas. Therefore, biosecurity risk communication requires careful planning, implementation, and evaluation, based on the following strategies:

1. identify and analyze the target audiences. Different audiences may have different levels of knowledge, interest, concern, and influence on biosecurity issues. Therefore, biosecurity risk communicators should identify and segment their audiences, and tailor their messages and channels accordingly. For example, a biosecurity risk communication campaign for the general public may use simple and clear language, visual aids, and social media platforms, while a biosecurity risk communication workshop for biosecurity experts may use technical and detailed information, scientific evidence, and interactive formats.

2. establish and maintain trust and credibility. Trust and credibility are essential for biosecurity risk communication, as they can affect the acceptance and adoption of biosecurity measures and recommendations. Therefore, biosecurity risk communicators should be transparent, honest, consistent, and respectful in their communication, and acknowledge the limitations and uncertainties of their information. They should also seek to build and sustain relationships with their audiences, and involve them in the biosecurity risk assessment and management processes. For example, a biosecurity risk communication project for a biotechnology company may involve regular consultations, feedback, and updates with its employees, customers, regulators, and community members, and demonstrate its commitment to biosecurity standards and practices.

3. provide relevant and timely information. Information is the core of biosecurity risk communication, as it can inform and influence the perceptions, attitudes, and behaviors of the audiences. Therefore, biosecurity risk communicators should provide information that is relevant, accurate, complete, and timely to their audiences, and avoid information overload, misinformation, or sensationalism. They should also use appropriate language, tone, and format to convey their information, and avoid jargon, acronyms, or technical terms that may confuse or alienate their audiences. For example, a biosecurity risk communication bulletin for a health agency may provide factual and updated information on the outbreak, transmission, prevention, and treatment of a novel infectious disease, and use plain and respectful language, graphs, and tables to illustrate the information.

4. Address the emotions and values of the audiences. Emotions and values are important factors that shape the responses and reactions of the audiences to biosecurity risks and issues. Therefore, biosecurity risk communicators should recognize and address the emotions and values of their audiences, such as fear, anger, anxiety, curiosity, or compassion, and empathize with their concerns and needs. They should also appeal to the values and motivations of their audiences, such as safety, security, responsibility, or solidarity, and highlight the benefits and costs of biosecurity actions and inactions. For example, a biosecurity risk communication video for a school may address the fears and anxieties of the students and teachers about a potential bioterrorism attack, and appeal to their values of learning, resilience, and cooperation, and show them how to prepare and respond to such a scenario.

7. How to coordinate and oversee biosecurity risk management activities and policies?

Biosecurity risk governance is the process of ensuring that biosecurity risks are identified, assessed, and managed in a consistent, transparent, and accountable manner. It involves the coordination and oversight of various actors and stakeholders who have roles and responsibilities in biosecurity risk management, such as governments, regulators, researchers, industry, and civil society. Biosecurity risk governance aims to achieve the following objectives:

- To protect human, animal, and plant health and the environment from the adverse effects of biological agents and toxins, whether natural, accidental, or deliberate.

- To promote the safe and responsible use of biotechnology and bioscience for the benefit of society and the advancement of science.

- To foster trust and confidence among the public and the international community in the biosecurity risk management practices and policies of different countries and organizations.

Some of the key challenges and strategies for effective biosecurity risk governance are:

- Establishing a clear and comprehensive legal and regulatory framework that defines the roles, responsibilities, and authorities of different actors and stakeholders in biosecurity risk management, and that sets the standards and guidelines for biosecurity risk assessment and mitigation.

- Developing and implementing a national biosecurity strategy and action plan that outlines the vision, goals, and priorities for biosecurity risk management, and that allocates the necessary resources and capacities for its execution.

- Enhancing the coordination and collaboration among different sectors and levels of government, as well as with the private sector and civil society, to ensure a coherent and consistent approach to biosecurity risk management, and to avoid duplication and gaps in biosecurity risk assessment and mitigation.

- Strengthening the biosecurity risk assessment and mitigation capabilities and practices of different actors and stakeholders, by providing them with the appropriate tools, methods, and training, and by ensuring the quality and reliability of the biosecurity risk information and data they produce and use.

- Promoting the awareness and engagement of the public and the international community in biosecurity risk management, by communicating the biosecurity risks and benefits of biotechnology and bioscience, and by soliciting their input and feedback on biosecurity risk management policies and practices.

An example of biosecurity risk governance in action is the Global Health Security Agenda (GHSA), which is a multilateral initiative launched in 2014 to accelerate the implementation of the International Health Regulations (IHR) and to enhance the global capacity to prevent, detect, and respond to infectious disease threats. The GHSA has 11 action packages that cover different aspects of biosecurity risk management, such as biosafety and biosecurity, antimicrobial resistance, zoonotic diseases, and laboratory systems. The GHSA involves the participation and contribution of more than 70 countries and organizations, who commit to achieving specific targets and milestones for each action package, and who report on their progress and challenges through a peer review mechanism. The GHSA also fosters the collaboration and coordination among different actors and stakeholders in biosecurity risk management, such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE), and the Interpol. The GHSA is an example of how biosecurity risk governance can be achieved at the global level, by aligning the interests and actions of different countries and organizations, and by creating a common framework and platform for biosecurity risk management.

8. Current and emerging issues and trends

Biosecurity risk management is a complex and dynamic process that requires constant adaptation and improvement to address the evolving threats and opportunities posed by biological agents and materials. The following section will explore some of the current and emerging issues and trends that influence biosecurity risk assessment and the strategies that can be employed to mitigate them.

Some of the challenges and opportunities that biosecurity risk management faces are:

- The increasing accessibility and advancement of biotechnology and life sciences. On one hand, this offers tremendous benefits for human health, agriculture, environment, and innovation. On the other hand, it also increases the potential for misuse, accidental release, or theft of biological agents and materials that could pose serious risks to public health, security, and economy. For example, the development of synthetic biology and gene editing tools such as CRISPR-Cas9 could enable the creation of novel pathogens or the enhancement of existing ones. Biosecurity risk assessment needs to keep pace with the rapid changes in biotechnology and life sciences and anticipate the possible scenarios and consequences of their misuse or mishandling.

- The globalization and interconnectedness of the world. The movement of people, animals, plants, and goods across borders and regions facilitates the exchange of knowledge, resources, and opportunities. However, it also increases the vulnerability and exposure to biological threats that could originate from anywhere and spread quickly and widely. For example, the COVID-19 pandemic demonstrated how a novel coronavirus that emerged in China could rapidly become a global health emergency that affected millions of lives and livelihoods. Biosecurity risk assessment needs to adopt a holistic and systemic approach that considers the interdependencies and interactions among different sectors, regions, and actors that could influence the emergence, transmission, and impact of biological threats.

- The diversity and uncertainty of the biosecurity threat landscape. Biological threats can arise from various sources and have different characteristics, objectives, and impacts. They can be natural, accidental, or intentional; they can be caused by known or unknown agents; they can target humans, animals, plants, or the environment; they can have immediate or delayed effects; they can be isolated or widespread. For example, the anthrax attacks in 2001 in the United States were an intentional and targeted use of a known agent that caused immediate and localized harm. In contrast, the Ebola outbreak in 2014 in West Africa was a natural and unanticipated emergence of an unknown agent that caused delayed and widespread damage. Biosecurity risk assessment needs to be flexible and adaptable to cope with the diversity and uncertainty of the biosecurity threat landscape and to account for the variability and unpredictability of the biological agents and their behavior.

9. Summary and recommendations for biosecurity risk management

The article has discussed the importance and challenges of biosecurity risk management, as well as the various methods and tools for biosecurity risk assessment. Based on the analysis, the following recommendations are proposed to enhance the effectiveness and efficiency of biosecurity risk management:

- Adopt a holistic and multidisciplinary approach. Biosecurity risks are complex and dynamic, involving biological, environmental, social, economic, and political factors. Therefore, biosecurity risk management should not be limited to a single sector or discipline, but rather involve multiple stakeholders and perspectives. For example, a biosecurity risk assessment for a new plant pest should consider not only the potential impact on agriculture, but also on biodiversity, trade, public health, and national security.

- Use a combination of qualitative and quantitative methods. Biosecurity risks are often uncertain and variable, requiring different levels of information and analysis. Therefore, biosecurity risk management should not rely on a single method or tool, but rather use a combination of qualitative and quantitative methods to capture the full range of biosecurity risks and uncertainties. For example, a biosecurity risk assessment for a novel pathogen should use qualitative methods such as expert elicitation and scenario analysis to identify the possible sources, pathways, and consequences of the pathogen, as well as quantitative methods such as mathematical modeling and risk mapping to estimate the likelihood and magnitude of the pathogen spread and impact.

- Apply a precautionary and adaptive principle. Biosecurity risks are often unpredictable and emergent, requiring timely and flexible responses. Therefore, biosecurity risk management should not wait for complete and conclusive evidence, but rather apply a precautionary and adaptive principle to prevent or mitigate the potential harm of biosecurity risks. For example, a biosecurity risk assessment for a genetically modified organism should use a precautionary principle to assess the potential adverse effects of the organism on the environment and human health, as well as an adaptive principle to monitor and review the actual effects of the organism and adjust the risk management measures accordingly.

These recommendations aim to provide a general framework and guidance for biosecurity risk management, but they are not exhaustive or prescriptive. Biosecurity risk management is a context-specific and dynamic process, requiring continuous learning and improvement. Therefore, biosecurity risk managers should always consider the specific characteristics and circumstances of each biosecurity risk, and apply the most appropriate and effective methods and tools for biosecurity risk assessment and management.