Bijlage 2 Regeling publieke gezondheid: ex artikel 14b, eerste lid, van de Regeling publieke gezondheid

Regeling publieke gezondheid

De eisen die verband houden met de uitvoering van Resolutie WHA71.16 van de Wereld Gezondheidsorganisatie luiden als volgt: Artikel II van Stcrt. 2025/6534 bevat overgangsrecht m.b.t. deze wijziging.

• 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
• 1.7.1 Records, documents and data are established, controlled and maintained to provide evidence of conformity to the requirements of this poliovirus biorisk management standard.
• 1.7.2 Records, documents and data are handled in such a way that they remain legible, readily identifiable and retrievable. Documented records are maintained in paper or electronic form for a minimum of six years from their original containment certification audit and are available for review during subsequent containment certification audits. If not already in place, the collection and retention of records, documents and data must start immediately.
• 1.8 Analysis of Data
• 1.8.1 The suitability of the biorisk management system is assessed by identifying, collecting, and analysing appropriate data. This analysis is used to evaluate where continual improvement of the system can be made.
• 1.9 Programme of Work
• 1.9.1 The programme of work for the facility is defined, documented and reviewed.
• 1.9.2 Work that requires prior approval is defined by established criteria. Any change to the poliovirus programme of work or processes that affect biorisk are required to be reported to the NAC to maintain certification, as outlined in the Containment Certification Scheme to support the WHO Global Action Plan for Poliovirus Containment (GAP-CCS).
• 1.10 Change Management
• 1.10.1 All changes associated with the design, operation and maintenance of the facility are subject to a defined and documented change management process.
• 1.11 Consultation and Communication
• 1.11.1 Relevant biorisk information related to an organization’s activities is communicated to and received from personnel and other relevant parties.
• 1.11.2 Involvement of personnel in communication and consultation arrangements is documented.
• 1.11.3 Personnel have access to adequate and up-to-date information about the biorisks and the mitigation measures in place to control those risks.
• 1.12 Legal Requirements
• 1.12.1 The organization ensures that all relevant legal requirements are identified and fulfilled within the biorisk management system. Legal requirements include national/federal, regional/state, provincial, city and local regulations with which the organization must comply. If this standard differs from regulations or legislation, facilities must satisfy the more rigorous requirement.
• 1.13 Preventive Action
• 1.13.1 Action is taken to identify and eliminate the causes of potential nonconformities to prevent their occurrence.
• 1.13.2 Preventive actions must be commensurate to the effects of the potential nonconformities.
• 1.14 Inspection and Audit
• 1.14.1 An inspection and audit programme that is appropriate to the risk associated with the facility is conducted in accordance with the guidance provided in the GAP-CCS.
• 1.14.2 Internal inspections and audits are conducted at planned intervals to determine if the biorisk management system conforms to the documented plans and the requirements of this Biorisk Management Standard and if it is effectively implemented and maintained. An external audit programme is conducted regularly by the relevant national authorities to determine if the biorisk management system conforms to the requirements of this standard and is functioning properly and to ensure necessary corrective actions are taken and verified without undue delay.
• 1.14.3 Management responsible for the area being inspected/audited ensures that any corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
• 1.14.4 Follow-up activities include verification of the actions taken and reporting of the verification results to top management.
• 1.15 Control of Nonconformities
• 1.15.1 Situations that do not conform to the requirements of the site-specific biorisk management policy are identified and controlled to prevent undesirable consequences.
• 1.15.2 Records of the nature of the nonconformity and any subsequent corrective action taken are maintained.
• 1.16 Corrective Action
• 1.16.1 To prevent the recurrence of any nonconformities, action is taken to develop a procedure that enables elimination of their causes using the requirements of this poliovirus biorisk management standard.
• 1.16.2 Corrective actions are in proportion to the effects of the nonconformities encountered. For containment certification audits, they are prioritized by the classification of the nonconformity as major (category 1) or minor (category 2), as described in the GAP-CCS.
• 1.17 Continual Improvement
• 1.17.1 The organization continually improves the effectiveness of the biorisk management system through:
• 1. the policy;
• 2. its objectives;
• 3. the internal audit programme;
• 4. audit results;
• 5. the analysis of available data;
• 6. risk assessments;
• 7. corrective and preventive actions;
• 8. management review.
• 2.1 General Risks
• 2.1.1 A formal process is in place to identify and manage risk that may compromise general safety.
• 2.2 Process, Methodologies and Procedures
• 2.2.1 The organization ensures that a risk assessment system is established, implemented and maintained.
• 2.2.2 The performance of the risk management system is reported to the designated senior manager for review. This review is used as a basis for improvement.
• 2.2.3 Relevant personnel within the organization identify those operations and activities associated with risks, including possible biological risk and where control measures are to be applied.
• 2.2.4 Activities associated with possible biological risk, including maintenance, are carried out under conditions specified by the risk management system.
• 2.3 Assessment Timing and Scope
• 2.3.1 The approach to risk assessment is defined according to its scope, nature and timing to ensure it is proactive rather than reactive.
• 2.4 Roles and Responsibilities for Risk Assessment
• 2.4.1 Resource requirements are identified, and adequate resources are allocated, including assigning competent personnel to perform risk assessments and evaluation activities, such as internal review of risk control measures in place.
• 2.5 Hazard Identification
• 2.5.1 The hazards associated with proposed work are identified and documented.
• 2.6 Risk Evaluation and Control
• 2.6.1 Suitable methodologies for assessing and recording risks are identified, implemented and maintained. Risk assessment methodology and outcomes are documented.
• 2.7 Implementing Risk Control Measures
• 2.7.1 Suitable methodologies for assigning actions that result from risk assessments are identified, implemented and maintained, including timelines, responsible persons and associated reporting and approval mechanisms.
• 2.8 Monitoring Effectiveness
• 2.8.1 Risk controls are monitored for effectiveness and revised when needed.
• 3.1 Worker Health Programme
• 3.1.1 The organization ensures that the risk to worker health, and that of other personnel whose health could be directly harmed by exposure to poliovirus materials, is managed effectively, including through preventive and protective measures.
• 3.1.2 The requirements of the health surveillance programme are determined by a defined health hazard identification and risk assessment process that involves all relevant personnel.
• 3.2 Vaccination of Personnel
• 3.2.1 Personnel, contractors, and visitors must demonstrate established immunity to poliovirus through evidence of poliovirus antibodies before entering the containment perimeter. The need for subsequent vaccination and antibody titre testing is determined based on risk assessment and is consistent with national occupational health guidelines.
• 3.2.2 A vaccination policy is defined and implemented.
• 3.2.3 Access to laboratories or work is restricted for individuals until they comply with the vaccination policy.
• 3.3 Medical Emergencies
• 3.3.1 A system is established to effectively manage medical emergencies, including but not limited to identifying potentially infected workers and providing immediate medical care to exposed, ill or injured workers. This system is in alignment with the legal framework for reporting public health events involving polioviruses set forth in Annex 2 of the International Health Regulations 2005.
• 4.1 Recruitment
• 4.1.1 Qualifications, experience, and reliability to observe appropriate codes of practice and aptitudes related to biorisk are considered as part of the recruitment process.
• 4.2 Training
• 4.2.1 Requirements and procedures for biorisk-related training of personnel are identified, established and maintained.
• 4.2 Competence
• 4.3.1 Personnel who have responsibilities and/or perform tasks within the poliovirus facility that may impact biorisk management are competent to execute those responsibilities and tasks. No personnel are exempt from demonstrating competence, irrespective of rank, experience or background.
• 4.3.2 Competence levels are judged on appropriate education, training, experience together with a demonstrated ability to correctly perform their assigned responsibilities in a safe and secure manner.
• 4.3.3 Personnel who conduct activities within the facility are under close supervision until they have demonstrated competency.
• 4.3.4 The organization must define required levels of competency in accordance with this standard and with any existing legal regulations. The designated manager is responsible for ensuring only competent personnel access the facility (see Element 1.5.12).
• 4.3.5 Records are maintained that show staff members have attained and demonstrated those levels of competency.
• 4.4 Human Factors
• 4.4.1 The organization establishes and maintains a programme to address risk associated with human behaviour, including the management of how personnel interact with each other, the facility and its equipment.
• 4.5 Continuity and Succession Planning
• 4.5.1 Adequate backup and contingency measures are in place to address the need for continuity and succession planning.
• 4.6 Exclusion and Reinstatement
• 4.6.1 Measures are put in place for the removal and exclusion of personnel (both temporary and, if appropriate, permanent) from the facility, where deemed necessary through risk assessment.
• 4.6.2 Measures are put in place and documented for re-evaluation of temporarily excluded personnel when deemed appropriate through risk assessment.
• 5.1 Biosafety Manual
• 5.1.1 The biosafety manual contains site-specific information for promoting a safe, secure workplace and reducing the probability of a release of poliovirus containing material and is based on risk assessments focused on hazards associated with poliovirus/poliovirus containing materials.
• 5.1.2 All personnel in the facility where poliovirus materials are used or stored or who may encounter poliovirus materials during the course of their job duties must read and adhere to the biosafety Manual.
• 5.2 Good Microbiological Practice and Procedure
• 5.2.1 All personnel handling poliovirus materials must be competent in good microbiological practices and procedures. All manipulations of poliovirus infectious materials are performed within primary containment as described in Element 8.3.4.
• 5.2.2 Appropriate resources (including time and equipment) are available to ensure good microbiological practices are adhered to effectively.
• 6.1 Clothing and Personal Protective Equipment (PPE)
• 6.1.1 PPE needs are identified through project-specific risk assessment.
• 6.1.2 Suitable PPE is specified, made available, used and maintained appropriately within the facility.
• 7.1 Physical Security
• 7.1.1 A risk assessment process for identifying physical security needs is in place in accordance with Element 2. Controls are implemented and maintained for the physical security of cultures, specimens, samples, animals and potentially contaminated materials or waste, determined as part of the risk assessment process.
• 7.2 Information Security
• 7.2.1 A policy and procedures are in place to identify sensitive information.
• 7.2.2 A review and approval process is used to control access to sensitive information.
• 7.3 Personnel Control
• 7.3.1 A personnel reliability policy is defined and implemented.
• 7.3.2 The organization ensures that personnel access to facilities or work is controlled, according to the policy.
• 7.4 Personal Security
• 7.4.1 A policy is in place to provide personal security awareness training, where appropriate. Documented security drills and exercises are conducted and prepare personnel to learn from any deficiencies.
• 7.5 Contractors, Visitors and Suppliers
• 7.5.1 The organization ensures that suppliers, contractors, visitors and subcontractors adhere to the requirements of the management systems and do not compromise the facility’s biorisk management system.
• 8.1 Planning, Design and Verification
• 8.1.1 A formal planning, design and redesign process is adopted for the facility, based on an assessment of risk associated with the materials to be used and activities undertaken.
• 8.1.2 The design process identifies and incorporates all relevant legislative requirements, recognized standards, considers guidelines from the WHO Laboratory Biosafety Manual Fourth Edition and associated monographs, industry good practices and facility-specific risk assessments.
• 8.1.3 The design process identifies and facilitates consultation with all relevant parties associated with the facility and its operation.
• 8.1.4 All design features, construction techniques, materials and equipment selected are documented in line with the needs of the design specifications.
• 8.1.5 New construction and physical facility modifications, including refurbishing and retrofitting, are carried out according to an approved plan.
• 8.2 Commissioning and Decommissioning
• 8.2.1 A formal process exists for the initial commissioning of facilities and the final decommissioning of facilities.
• 8.3 Infrastructure and Operational Management
• 8.3.1 Facilities, equipment and processes are safely and securely designed and operated. With respect to biorisk management, the poliovirus facility incorporates features that are guided by biosafety and biosecurity risk assessments for the loss of poliovirus from containment.
• 8.3.2 Poliovirus facilities are either poliovirus dedicated or non-dedicated laboratories. Non-dedicated facilities must demonstrate effective segregation and decontamination procedures between work with poliovirus and other pathogens to prevent cross-contamination.
• 8.3.3 Existing facilities must provide a containment perimeter sealable for fumigation and with sealed penetrations to prevent uncontrolled outward airflow irrespective of the choice of primary containment. New facilities and those undergoing retrofitting or refurbishing must ensure the sealable containment perimeter, irrespective of the choice of primary containment.
• 8.3.4 The use of devices that are validated to maintain primary containment are required for all procedures using live poliovirus unless otherwise specified (Element 8.3.16).
• 8.3.5 Controlled entry into the containment perimeter is through a double-door personnel airlock. Features include alarms, interlocking doors or an equivalent system to ensure that more than one door cannot be opened at a time and associated operating procedures to ensure the building systems function effectively at all times. Anterooms, material airlocks, and personnel airlocks for entry are considered to be within the containment perimeter, must be sealable for fumigation and meet all requirements of spaces within the containment perimeter.
• 8.3.6 All containment facilities where live poliovirus is stored, handled, treated and disposed of must be marked with biohazard signs. Signs are posted in prominent locations at the entry to the working area where poliovirus is being stored, handled, treated and/or disposed of and that only authorized personnel are permitted to enter. An emergency contact phone number must be displayed at all times and kept up to date.
• 8.3.7 Handwashing sinks operated by a hands-free mechanism with running water and soap are provided within and near the exit of the containment perimeter.
• 8.3.8 Controlled exit from the containment perimeter includes appropriate steps and procedures to prevent exposure to contaminated PPE or personnel. Procedures for exiting the containment perimeter and the requirement for an exit shower must be determined by a facility-specific risk assessment.
• 8.3.9 All exits are clearly marked. Emergency exit doors from the containment perimeter are alarmed.
• 8.3.10 The controlled air system maintains directional airflow via a dedicated ventilation system with ductwork sealable for fumigation. HEPA filtration of exhaust, backflow protection on supply, and monitors/alarms to ensure directional airflow can be readily validated. For facilities working with small quantities (volume and concentration) of poliovirus alternative mitigation measures may serve as a substitute for HEPA filtration of exhaust as determined by a risk assessment approved by the NAC.
• 8.3.11 The decontamination of all effluent (including emergency shower water, eyewash, handwash, unsterilized autoclave condensate) from within the containment perimeter is achieved through a validated inactivation procedure. Backflow prevention is implemented on all liquid services/utilities passing across the poliovirus containment boundary and measures to prevent release through traps, sinks and emergency shower drains. Non-dedicated effluent treatment systems must include appropriate mitigations for cross-contamination risk as determined by a risk assessment approved by the NAC.
• 8.3.12 The decontamination of materials exiting the containment perimeter is achieved through a validated sterilization/decontamination procedure or otherwise meets the standards for transport described in Element 12.
• 8.3.13 Kill-tank rooms or equivalent must meet all construction, sealing, and HVAC requirements of the primary containment space and are required to have an anteroom/personnel airlock for controlled entry as described in Element 8.3.5.
• 8.3.14 Storage of poliovirus must be performed under appropriate containment conditions as outlined in Sub-element 10.5.
• 8.3.15 Manufacturing processes and transfer of intermediates must be carried out in closed systems that have been leak tested and validated.
• 8.3.16 A poliovirus animal facility will incorporate features according to risk assessments and will meet all poliovirus containment criteria as described in this biorisk management standard, including:
• 8.3.17
• 1. complying with containment criteria for animal facilities, consistent with all other controls outlined in this document;
• 2. specially training and supervising personnel responsible for safe handling of poliovirus infected animals, including inoculating, harvesting, sampling, performing animal necropsies, and for any other manipulations so as to prevent personal injury and exposure;
• 3. requiring the use of devices (e.g., BSCs, flexible film isolators, or local exhaust ventilation) that are validated to maintain primary containment for all animal manipulations with live poliovirus. Specific manipulations that cannot be performed within primary containment without increasing the risk to the lab worker may be performed outside of primary containment devices as determined by a risk assessment with enhanced mitigation procedures approved by the NAC;
• 4. handling infected animals as poliovirus infectious materials and housing them in primary containment, separate from uninfected animals;