08 BIOSAFETY AND BIOSECURITY

A whole-of-government multisectoral national biosafety and biosecurity system with biological agents of high consequence identified, held, secured and monitored in a minimal number of facilities according to best practices. Country-specific biosafety and biosecurity legislation, laboratory licensing and pathogen control measures are in place as appropriate, and on include risk- and evidence-based approaches. Biological risk management training and educational outreach are conducted to promote a shared culture of responsibility. Reduce high consequence research activities where appropriate to mitigate risks associated with dual-use research of concern and proliferation of biological agents of high consequence, for examples. Safe and secure transport and transfer of infectious substances are ensured.

IMPACT:

A comprehensive, sustainable and legally embedded national oversight programme for biosafety and biosecurity which includes the safe and secure use, storage, disposal and containment of biological agents of high consequence in all laboratory and holding facilities across human health, animal health and agricultural sectors. Strengthened, sustainable biological risk management best practices are in place in relevant sectors and safe and compliant transport of infectious substances occurs according to national and international regulations.

MONITORING AND EVALUATION:

(1) Existence of a national framework for biosafety and biosecurity, strain collections and containment laboratories that includes identification and storage of national strain collections in a minimal number of facilities from relevant sectors. (2) Existence of a comprehensive oversight and monitoring system.

Benchmark 8.1

Whole-of-government biosafety and biosecurity system is in place for relevant sectors including human, animal (domestic animals and wildlife) and agricultural facilities

Objective To develop and implement a biosafety and biosecurity system for relevant sectors including human, animal (domestic animals and wildlife) and agricultural facilities to minimize the risk of accidental or intentional infection of laboratory staff or release of biological agents of high consequence

01 NO CAPACITY

  1. Elements of a comprehensive national biosafety and biosecurity system, such as policy instruments and proper financing, are not in place.

02 LIMITED CAPACITY

  1. Establish a multisectoral technical advisory board to advise and guide decision-makers in relation to risk- and evidence-based recommendations for mitigating and managing biosafety and biosecurity threats and incidents that may arise. *
  2. Review and develop or revise national legislation and regulations for biosafety and biosecurity in the human health, animal health and agricultural sectors. *
  3. Identify and document human and animal health facilities that store and maintain biological agents of high consequence and toxins and health professionals responsible for them. *
  4. Identify all departments, facilities and settings that handle or may handle biological agents of high consequence and toxins in relevant sectors (e.g. food safety, agriculture, points of entry, internal security, fire services, defence, customs, postal services, waste management, agriculture, etc.). *
  5. Establish a mechanism for laboratory licensing in relevant sectors and ensure that biosafety and biosecurity requirements are included in general licensing requirements. *
  6. Conduct assessments of current biosafety and biosecurity practices, procedures and policies at the national level. *
  7. Develop biological management measures, including options for containment, operational handling and failure of reporting systems *
  8. Conduct a biosafety and biosecurity assessment of animal health laboratories to identify critical needs.

03 DEVELOPED CAPACITY

  1. Develop a national biosafety and biosecurity regulatory framework, including guidelines and recordkeeping obligations for all laboratories working with biological agents of high consequence. *
  2. Develop and maintain inventories for biological agents of high consequence. *
  3. Secure biological agents of high consequence and toxins at a minimum number of national level laboratories. *
  4. Develop and test SOPs that include standard requirements of PPE and other safety measures for departments, facilities and settings that store, maintain or handle biological agents of high consequence and toxins. *
  5. Establish an information security system for all sensitive documentation in facilities where biological agents of high consequence and toxins are stored. *
  6. Develop a strategy for identifying and preventing biohacking and unsafe research performed outside of official laboratories, including safety oversight associated with biosafety regulations in collaboration with internal security and defence staff. *
  7. Implement national biosafety and biosecurity regulations and guidelines in relevant sectors (e.g. human health, animal health, agriculture, defence, etc.) with standardized classification and accreditation that cover pathogen control and personnel reliability programme requirements. *
  8. Recommend alternative laboratory techniques that are associated with a lower risk to replace the need for proliferation of biological agents of high consequence. *
  9. Develop incident and emergency response programmes for facilities storing biological agents of high consequence and toxins. *
  10. Develop and implement equipment operation and maintenance plans at laboratories storing biological agents of high consequence or security concern. *
  11. Establish biosafety and biosecurity officers and, where necessary, biosafety and biosecurity committees at least in national reference laboratories (with potential expansion to all laboratories across relevant sectors), supported by the appropriate regulatory base, training or certification, and competency.. *
  12. Conduct a risk assessment and survey for accidental or intentional misuse of biological agents of high consequence and toxins in relevant sectors.

04 DEMONSTRATED CAPACITY

  1. Implement the biosafety and biosecurity national framework in all laboratories at the national and subnational levels. *
  2. Develop site-specific biosafety and biosecurity supporting documents that include incident and emergency response plans (e.g. in case of explosion, fire, flood, worker exposure, accident or illness, major spillage, waste management, etc.) for laboratories at national and subnational levels. *
  3. Develop SOPs for identifying and addressing high consequence research, such as dual-use aspects of research, and include a responsible code of conduct for scientists and other staff. *
  4. Develop and implement an incident reporting system that includes identifying incidents, reporting according to regulations, and addressing action items that improve safety and security. Share reports with the relevant sectors. *
  5. Establish external monitoring and oversight of biosafety and biosecurity programmes and activities. *
  6. Develop guidelines and procedures for the management of suspicious packages (for example, Anthrax letters) in collaboration with relevant sectors (e.g. police, defence, postal services, customs, etc.) at national and subnational levels. *
  7. Develop a national strategic stock of medicines (including antibiotics, antitoxins, serums and vaccines) for prevention or emergency treatment related to biosafety or biosecurity threats and incidents. *
  8. Conduct SimEx to test procedures for the management of biosafety and biosecurity threats and incidents and confirm functionality. *
  9. Develop (in collaboration with occupational health services and other relevant parties) protocols for emergency care of workers and victims of biosafety- and biosecurity-related incidents, procedures for emergency medical evacuation to specialized health facilities, and decontamination protocols. *
  10. Share records of biosafety- and biosecurity-related threats and incidents occurring in relevant sectors with health authorities.

05 SUSTAINABLE CAPACITY

  1. Secure sustainable funding and oversight and enforcement mechanisms to support biosafety and biosecurity programmes and initiatives at the ministry level. *
  2. Maintain records of all biosafety and biosecurity accidents that happen in the country to preserve institutional memory, inform risk assessment and mitigation review, and enable improvements to biosafety and biosecurity policies and practices. *
  3. Establish mandatory reporting of all laboratory-associated infections, at least onannual basis. *
  4. Adjust strategy, guidance and protocols for management of biosafety and biosecurity threats and incidents based on M&E exercises. *
  5. Evaluate implementation of national biosafety and biosecurity legislations and practices, and document and generate best practices for biosafety and biosecurity arrangements which are aligned with international best practices at all levels. *
  6. Contribute to internationalsurveillance information sharing and risk assessments for biosafety and biosecurity at the global level. *

Benchmark 8.2

Biosafety and biosecurity training and practices in relevant sectors including human, animal (domestic animals and wildlife) and agriculture

Objective To develop a public health workforce that is trained and available to enable early detection, prevention, preparedness and response to potential events of international concern at all levels of the health system to effectively implement IHR

01 NO CAPACITY

  1. No biosafety and biosecurity training programme or plans are in place in any sector.

02 LIMITED CAPACITY

  1. Assess biosafety and biosecurity training needs and gaps in relevant sectors. *
  2. Conduct an engagement meeting to develop biosafety and biosecurity training programmes that align academic curricula with international best practices. *
  3. Develop training programmes for both trainers and trainees as required. *
  4. Emphasize risk- and evidence-based approaches to biosafety and biosecurity and include risk assessment in training programmes and curricula. *
  5. Identify and create a directory of laboratory staff that have basic training, at least, in biosafety and biosecurity working in laboratories and related fields. *
  6. Identify laboratory staff by category that require training in biosafety and biosecurity, determine the level of training required and conduct required training regularly. *

03 DEVELOPED CAPACITY

  1. Adapt in-service and continuing education training curricula, SOPs, toolkits, good microbiological practices and procedures, risk assessment and procedures to comply with biosafety and biosecurity rules and regulations and align with international best practices. *
  2. Train and oversee facilities that are housing or working with biological agents of high consequence and toxins to comply with biosafety and biosecurity rules and regulations. *
  3. Begin developing sustained academic curricula, continuing education and training programmes for biosafety and biosecurity that align with international best practices. *
  4. Develop and/or adapt biosafety and biosecurity training module for specialized and continuing education of healthcare professionals.
  5. Develop specific training programmes on biosafety and biosecurity for staff in relevant sectors (e.g. animal health, defence, security, points of entry, etc.).

04 DEMONSTRATED CAPACITY

  1. Implement training programmes and oversight to assess compliance with biosafety and biosecurity rules and regulations, and ensure alignment with international best practices. *
  2. Implement sustainable training programmes, that are aligned with international best practices, in institutions that train those who maintain or work with biological agents of high consequence and toxins. *
  3. Review training programmes and needs assessments on a regular basis and update training materials and curricula as required. *
  4. Conduct mandatory training on biosafety and biosecurity for all staff working with biological agents and biological materials of high consequence and toxins. *
  5. Align relevant sector training programmes in biosafety and biosecurity with health sector trainings.

05 SUSTAINABLE CAPACITY

  1. Guarantee sustained funding from the national government to support training programmes. *
  2. Include biosafety and biosecurity training courses in university curricula of pre-training education in human and animal healthprogrammes. *
  3. Implement periodic training programmes on emergency response procedures. *
  4. Participate in international initiatives to support capacity-building and staff training at the global level. *

* Participation and contribution of other sectors to action.

Tools