De eisen die verband houden met de uitvoering van Resolutie WHA71.16 van de Wereld Gezondheidsorganisatie luiden als volgt:

1. Element 1 – Biorisk Management System

1.1 Biorisk Management System

1.1.1 The organization must establish, document, implement and maintain a biorisk management system according to the requirements of this poliovirus biorisk management standard.

1.2 Biorisk Management Policy

1.2.1 The policy clearly states the overall biorisk management objective and a commitment to improving biorisk management performance.

1.2.2 Management demonstrates commitment to the policy concerning the management of facility biorisk (biosafety and biosecurity) including development of the organizational biorisk policies, authorization of resources to meet the requirements of the policies and signing of institutional biorisk policies.

1.2.3 The policy is appropriate to the nature and scale of the risk associated with the facility and associated activities.

1.2.4 The policy commits to:

1. protecting staff, contractors, visitors, the community and the environment from poliovirus materials that are stored or handled within the facility;

2. reducing the risk of the unintentional release of, or exposure to, poliovirus materials to an acceptable level;

3. reducing the risk of the unauthorized intentional release of hazardous biological materials to an acceptable level;

4. complying with all legal requirements applicable to the poliovirus materials that will be handled or possessed and with the requirements of this standard;

5. ensuring that effective biorisk management takes precedence over all non-’health and safety’ operational requirements;

6. effectively communicating individual obligations regarding biorisk to all personnel and relevant third parties;

7. continuously improving biorisk management performance;

8. conduct risk assessments and implement the required risk and evidence-based control measures.

1.3 Biorisk Management Review

1.3.1 Management reviews the biorisk management system at planned intervals to ensure its continued suitability, adequacy and effectiveness.

1.3.2 The review includes assessing opportunities for improvement and determining the need for changes to the system, procedures, policies and objectives.

1.3.3 Records are maintained from the management review.

1.4 Objectives, Targets and Programme

1.4.1 Objectives and targets for effective biorisk management throughout the organization are established, implemented and maintained.

1.4.2 Management must establish the biorisk controls and enact documented procedures for monitoring the effectiveness of those controls to reduce or eliminate the risks identified in the risk assessment process.

1.5 Roles, Responsibilities and Authorities

1.5.1 Top management takes ultimate responsibility for the organization's biorisk management system.

1.5.2 Top management ensures that roles, responsibilities and authority related to biorisk management are defined, documented and communicated to those who manage, perform and verify work associated with the control of polioviruses.

1.5.3 Top management demonstrates its commitment by ensuring the availability of resources to establish, implement, maintain and improve the biorisk management system.

1.5.4 A senior manager is designated operational responsibility to oversee the biorisk management of the facility. An alternate is assigned should the senior manager be unable to fulfil their oversight role.

1.5.5 The designated senior manager is responsible for:

1. providing appropriate resources to ensure the adequate provision of personnel, facilities and other resources deemed necessary for the safe and secure operation of the facility;

2. reporting to top management on the performance of the biorisk management system and any need for improvement;

3. ensuring adoption and promotion of the biorisk management system throughout the organization;

4. instituting review, audit and reporting measures to provide assurance that the requirements of this standard are being implemented and maintained effectively.

1.5.6 A biorisk management committee is constituted to act as an independent review group for biorisk issues associated with the poliovirus facility.

1.5.7 The biorisk management committee reports to the designated senior manager and:

1. has documented function and scope;

2. includes representatives from a cross section of expertise, appropriate to the nature, scale, safety and security concerns of the activities undertaken;

3. ensures issues addressed are formally recorded and actions are allocated, tracked and closed out effectively;

4. is chaired by a senior individual with experience in biorisk management;

5. meets at a defined and appropriate frequency, and when otherwise required.

1.5.8 One or more competent individuals are designated to provide advice and guidance on biorisk management issues.

1.5.9 The role of the biorisk management advisor is independent of the functions of those responsible for implementing the programme of work.

1.5.10 The biorisk management advisor:

1. reports directly to the designated senior manager;

2. advises the biorisk management committee;

3. has delegated authority to stop work in the event that it is considered necessary to do so.

1.5.11 One or more individuals responsible for the scientific programme within the facility are designated with responsibilities relevant to biorisk management.

1.5.12 The scientific manager is responsible for:

1. ensuring all work is conducted according to established policies described in this standard;

2. supervising workers, including ensuring only trained, competent and authorized personnel can enter and work in the facility;

3. planning and conducting work activities, and ensuring adequate staffing levels, time, space and equipment are available;

4. ensuring required authorizations for work are in place;

5. ensuring facility biosafety and biosecurity risk assessments have been performed, reviewed and approved, and the required control measures are in place;

6. ensuring all at-risk personnel have been informed of risk assessments and/or provisions for any recommended precautionary medical practices (e.g., vaccinations or serum collections).

1.5.13 One or more individuals responsible for occupational health within the facility are designated with responsibilities relevant to biorisk management.

1.5.14 The organization must establish an occupational health programme commensurate with the facility’s activities and risks.

1.5.15 One or more facility managers are designated with responsibilities relevant to the facilities and equipment requirements established in this poliovirus biorisk management standard.

1.5.16 A security manager is designated with responsibilities conforming to the security requirements established in this poliovirus biorisk management standard.

1.5.17 One or more individuals responsible for emergency response within the facility are designated with responsibilities relevant to biorisk management.

1.5.18 In laboratories where animals are kept, an animal-care manager is designated with animal- related responsibilities conforming to the requirements established in this poliovirus biorisk management standard.

1.6 Contractors and Suppliers

1.6.1 Purchases (including services) must conform to specified requirements. Controls on purchases (including services) are applied depending on the potential impact to the biorisk involved.

1.6.2 Suppliers are evaluated and selected based on their ability to provide products/services that meet the requirements of this poliovirus biorisk management standard.

1.6.3 Criteria for selection, evaluation and re-evaluation of suppliers are established.

1.6.4 Records are maintained of evaluation results and any necessary actions arising from the evaluation.

1.7 Records, Documents and Data Control