human pathogens and toxins act : bill c-11
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Human Pathogens and Toxins Act : Bill C-11. Gaps of the Current Regulatory Regime. The Human Pathogens Importation Regulations (HPIR) were established in 1994 to provide mandatory oversight for only imported human pathogens or toxins. - PowerPoint PPT PresentationTRANSCRIPT
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Human Pathogens and Toxins Act:
Bill C-11
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Gaps of the Current Regulatory Regime
• The Human Pathogens Importation Regulations (HPIR) were established in 1994 to provide mandatory oversight for only imported human pathogens or toxins.
• Under the Regulations, the 3,500 facilities which import these agents must:– obtain an importation permit for human pathogens of a Risk
Group (RG) 2, 3 or 4;– allow mandatory inspection for facilities handling human
pathogens of RG 3 or 4 to ensure that they comply with the Laboratory Biosafety Guidelines;
– comply with these requirements in order to avoid the penalties defined by the Regulations, including a possible fine of $200 and/or an imprisonment of up to 3 months.
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Gaps of the Current Regulatory Regime
• This regime cannot be expanded to
cover domestically-acquired human
pathogens and toxins.• There are an estimated 4,000
laboratories that work with
domestically acquired pathogens
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The Act: Basics
• Human Pathogens and Toxins Act was tabled in Parliament February 9, 2009 (Bill C-11).
• Application: applies to all persons who carry on activities with a RG 2, 3 or 4 human pathogen (see schedules)– Non-exhaustive lists of pathogens– Application of Act based on risk group classification of agent
in question.
• Will require regulations in order to bring the entire policy framework into effect – the specifics regarding security screening, inventories, and licencing will be in regulations, subject to consultations.
• Will replace the HPIR.
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The Act: Prohibitions and Requirements• General duty of care provisions.
• General prohibition to possess, transfer, store, dispose of, import, export a human pathogen of RG 2, 3 or 4 or toxin without a license.
• Absolute prohibition to possess listed pathogens (i.e. smallpox.)
• Requirement to report incidents that may have caused a laboratory acquired infection.
• Requirement to follow the widely-accepted Laboratory Biosafety Guidelines, as Canada’s national biosafety standard.
• Provisions for significant penalties
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The Act: On Royal Assent
• Upon Royal Assent, all facilities in Canada will be required to register with Office of Laboratory Security (OLS) - (basic information only).
• New facilities that commence operations between Royal Assent and promulgation of regulations will also have to register.
• Labs will have to appoint a contact person to facilitate contact with the OLS.
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Transition
• Laboratories certified under the Human Pathogens Importation Regulations (HPIR), will have a simplified transition to the new program.
• PHAC will make inspectors available to non-regulated laboratories that voluntarily request site visits to assess their compliance.
• PHAC will advise all laboratories prior to implementation of new requirements, which will take some years to fully implement.
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Schedule 1Description of Pathogens
Toxins
Requirements:• Registration and licensing• Self-Attestation• Maintenance of an inventory - annual updates• Spot/risk-based inspections• Possible security clearance for select toxins
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Schedule 2
Requirements:• Registration and licensing;• Maintenance of an inventory - must provide current inventory upon request;• Spot/risk-based inspections;• There is no requirement for security screening.
Description of Pathogens
Risk Group 2
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Schedules 3 and 4
Requirements:
• As per Schedule 2 plus;• Filing of inventory;• Security clearances for personnel, but not for
visitors.
Description of Pathogens
Risk Group 3 and 4
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Schedule 5
• No person in Canada is permitted to possess
human pathogens in Schedule 5, regardless of
level of containment or security clearance.
Description of Pathogens
Prohibited Pathogens and Toxins
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Defined Exclusions from Application of Act
• Organisms in their natural environment.
• In a human suffering from a disease.
• Expelled from a person suffering from a disease.
• In a cadaver, body part or other human remains.
• A drug in dosage form.
• Controlled activity under the Assisted Human Reproduction Act.
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Exemptions from Application of Act
• An inspector under this Act
• A peace officer
• Sample collection for a licensed facility
• Carrying out a function under any federal or provincial Act
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Registration process
• Internet-based
• Self-assessment tool will be
developed/utilized
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Possible Licensing ProcessTo be Defined by Regulations following consultations
• All facilities handling RG 2-4 human
pathogens will require licensing.
• RG 2– Checklist every year and inventory
maintenance available upon request– Spot and risk inspections
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Possible Licensing process: RG 3-4
To be Defined by Regulations following consultations
• On-site visit by PHAC-OLS before license: physical and operational documents and biosecurity plan
• Detailed inventory of pathogens: quantity, location and concentration
• Security clearances for anyone who could access RG 3-4 pathogens, but not for visitors.
• Regular reports of changes in inventories
• On-going inspections
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Possession and Handling
• Compliant with the mandatory
successor document to the Laboratory
Biosafety Guidelines.
• Possible supplementary conditions of
licence.
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Importation
• Permits for RG 2 pathogens would be
granted on a yearly basis.
• Separate permit required for importing
each RG 3 and 4 human pathogen.
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Transfer
• Sending and receiving laboratories
required to have a permit for transfer
of any human pathogen or toxin.
• Not required for intra-facility transfers.
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Export
• Export of agents on the Export Control List
would require authorization from DFAIT.
• PHAC could regulate the export for those
pathogens not listed on Export Control List.
• One option could be that an exporting lab
could be required to show due diligence.
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Disposal
• Laboratories would be required to
notify PHAC of the nature of pathogens
disposal.
• Laboratories responsible to ensure that
a pathogen’s disposal rendered it non-
viable or non-functional.
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Next Steps
• Consultations: Commencement of
consultations on the regulations.
Consultations are required in
development of regulations.