Strengthening Canada’s Regulatory System of Biosafety, Biocontainment and Biosecurity Oversight for Human Pathogens and Toxins

Public Health Agency of Canada Centre for Biosecurity

Stacey Mantha Presentation Overview

• Current Framework – policy instruments – program components – institutional controls

• Capacity Building Outreach and Engagement

• How We Got There

• Lessons Learned

2 Canada’s Oversight Framework for Pathogen Biosafety, Biocontainment & Biosecurity

3 New Human Pathogens and Toxins Regulations

• The Human Pathogens and Toxins Regulations (HPTR) came into force, with the remaining sections of the 2009 Human Pathogens and Toxins Act (HPTA), on December 1st, 2015

• The regulations strengthen Canada’s biosafety, biocontainment and biosecurity oversight to protect the health and safety of the public against risks posed by human pathogens and toxins

• From 2010 to 2014, the Public Health Agency of Canada conducted in-depth consultations with stakeholders across the country Scope of Oversight

• The HPTA and HPTR applies to all sectors/persons/institutions in Canada that are conducting activities with Risk Group 2, 3, or 4 human pathogens or biological toxins listed in Schedule 1 of the HPTA

• Oversight includes:

– domestically acquired and produced human pathogens and toxins

– inadvertent production and possession

– individuals working with, or with access to, Security Sensitive Biological Agents (SSBA)

– gain of function research

5 Exemptions

The HPTA and HPTR do not apply to a human pathogen or toxin:

• if it is a drug in dosage form whose sale is permitted or otherwise authorized under the Food and Drugs Act or is in such a drug

• if it is in an environment in which it naturally occurs and has not been cultivated or intentionally collected or extracted

– a human pathogen or toxin is in the environment in which it naturally occurs when a sample of that environment is collected, even if the sample has been modified by the addition of other ingredients

6 Regulatory Objectives

• Standardise requirements for domestically acquired or produced human pathogens and toxins with requirements for imported human pathogens and toxins

• Prevent and reduce the risk of an accidental or deliberate release of a human pathogen or toxin into the community

• Strengthen the safe use and secure containment of human pathogens and toxins used in laboratories across Canada

• Promote a culture of responsibility by strengthening individual and institutional risk management practices and accountability

• Safe guard science

• Enhance regulatory alignment with other international partners

7 Regulatory Oversight In Canada

The HPTR requires the following:

• Licensing of labs/work areas in institutions, with some exemptions

• Core functions and qualifications for designated biological safety officers

• HPTA Security Clearances for those with access to the highest risk pathogens, known as Security Sensitive Biological Agents (SSBA)

The Agency also uses licence conditions, standards, guidelines, and training resources to strengthen pathogen accountability and oversight

8 Licensing

• A licence is required to conduct the following activities with human pathogens and toxins in Canada: – possessing, handling, using – producing – storing – permitting any persons access to – transferring – importing or exporting – releasing or otherwise abandoning

• A key licence condition for all licence holders is compliance with the applicable requirements (physical and operational) set out in the Canadian Biosafety Standard – e-versions are now available at canadianbiosafetystandards.collaboration.gc.ca

9 Licensing (continued)

• Institutions working with various Risk Groups (RG) will require separate licences issued by the Agency (e.g., licence for RG 2, licence for RG3, SSBA licence)

• The regulations set out maximum licence terms; a term will be established based on the risks present in the institution (e.g., up to 5 years for RG2 )

• A licence is not required for: – veterinary clinical practices conducting laboratory analysis or diagnostic testing with Risk Group 2 human pathogens – a facility conducting laboratory analysis or diagnostic testing if the facility is not producing a human pathogen – if there is production, a licence is not required if the activity is done in a sealed container that is decontaminated before disposal or reuse

• Facilities exempted from licensing still have a duty of care obligation and can be inspected at any time

10 HPTA Security Clearance

• The HPTA Security Clearance is intended to complement the personnel suitability component of a licence holder's biosecurity plan

• It is required for individuals who need access to prescribed Risk Group 3 or 4 human pathogens and toxins known as Security Sensitive Biological Agents (SSBA)

– can pose a risk to Canada’s national security if they are misused

– will impact approximately 60 labs in Canada

– when toxins are used in quantities that exceed the “trigger” amounts set out in the regulations

• The Agency’s SSBA list is based on the List of Human and Animal Pathogens and Toxins for Export Control published by the Australia Group and amended from time to time

• The HPTA Security Clearance is specific to an individual, valid for up to 5 years, and portable if there is a change in work location

11 Exposure & Incident Reporting

• A licence holder must report the following 4 types of incidents:

– exposure to a human pathogen or toxin that has or may have caused a disease

– inadvertent release of a human pathogen or toxin

– inadvertent production of a human pathogen or toxin

– human pathogen or toxin that is lost or stolen

• Persons conducting activities under the authority of a licence must inform the Biological Safety Officer (BSO) of incidents so the BSO can inform the Agency

12 Promoting a Culture of Responsibility

• Institutions conducting scientific research (as defined in the regulations) must submit a Plan for the Administration Oversight of Pathogens and Toxins in a Research Setting when applying for a licence

• The Plan is to show how a licence holder will identify, assess and manage biosafety and biosecurity risks, including risks from gain of function research and research with dual- use potential

• It will also include governance and reporting structures and show the integration of risk management practices with oversight bodies (e.g., funding bodies, biosafety oversight committee(s), etc…)

• Elements to be included have been developed in consultation with multiple research institutions across Canada

13 Biological Safety Officer

• Before a licence is issued, a licence applicant must designate a Biological Safety Officer (BSO) to carry out the following compliance and monitoring functions set out in the regulations: – verify the accuracy and completeness of a licence application – act as the main point of contact with the Agency – request specific information on practices and procedures, or inventory records from anyone working under the licence – arranging for appropriate training related to biosafety and biosecurity – assist in the maintenance of the Biosafety Manual – conduct inspections to ensure compliance with any licence conditions – inform Agency of incidents regarding pathogens or toxins – assist in internal investigation of incidents

• The BSO must also be informed: – before arrangements are made to receive or transfer a human pathogen or toxin – when a pathogen or the toxin is lost in transit

14 Biosecurity Plan

• A licence holder must have a biosecurity plan in place that documents mitigation strategies for risks associated with:

– physical security

– personnel suitability and reliability

– accountability for pathogens and toxins

– incident and emergency response

– information management

• If the institution is working with Security Sensitive Biological Agents (SSBA), the plan must be submitted when applying for a licence

15 Material Management

• A licence holder is required to know what risks they possess through inventory establishment and maintenance

– each work area must identify and document what is in their possession for more than 30 days and where it is located

– for RG3 and RG4 samples and SSBAs, an inventory is to include a list of specific human pathogens and toxins, and a means to allow for the timely detection of a missing or stolen sample

• A licence holder is to determine its inventory system and management process

– the level of detail will be informed by an internal assessment of the risk presented by the substance

16 Safeguarding Science: Academic Outreach and Engagement

• Characteristics that make the academic community leaders in scientific innovation (something that we need to facilitate) is at times contrary to compliance behavior, which increases risk to public health and safety

• To counter this risk, and raise awareness about biosecurity, dual use and counter proliferation efforts, the Agency has partnered with the Royal Canadian Mounted Police, Public Safety Canada and the Canadian Security Intelligence Services to initiate a biosecurity academic outreach initiative

• Phase I involved consultation on models of engagement

• Phase II will pilot the preferred model

• Dependent on the success of Phase II, Phase III will fully launch the outreach initiative which could be leveraged for wider counter-proliferation activity awareness raising

17 Building Capacity

National • Compliance promotion with all stakeholders through provision of technical expertise, guidance, tools and training to build capacity for biosecurity • E-learning Portal on Laboratory Biosafety and Biosecurity • Biosecurity Guidelines, templates, tools for threat risk assessment, risk management and biosecurity planning • Pathogen Partners and Pathogen Security Partners for interdepartmental awareness and capacity building

International • Global Health Security Agenda; co-leading action package for biosafety and biosecurity • Technical biosafety, biocontainment and biosecurity expertise provided to Global Affairs Canada for BTWC, Australia Group, UNSCR1540 and Global Partnership Program • Assistance with development of program and regulatory frameworks to strengthen pathogen control and oversight • iGEMS (member of safety panel and developed synthetic biology safety standards) • WHO collaborations

18 E-learning Portal on Laboratory Biosafety and Biosecurity

• The Agency’s e-learning portal offers free online biosafety learning resources

• 19 courses on different biosafety topics  Introduction to Biosafety  Microbiology Overview  Introducing Biosecurity  And many more!

• 3 instructional videos  Biosafety 101  Containment Level 2 Laboratories  Containment Level 3 Laboratories www.publichealth.gc.ca/training 19 Consultation Approach

• The Agency implemented an extensive multi-year consultation strategy to inform the development of Canada’s regulations and other key national program elements

• This commitment allowed the Agency to:

– be open and transparent

– establish, maintain, and nurture constructive relationships with stakeholders and manage expectations

– engage stakeholders on the nature and implications of a new oversight system based on available evidence and sound science

– incorporate diverse stakeholder interests, points of views, and considerations resulting in tangible changes to the regulatory proposal

• The Agency believes that stakeholder involvement throughout the process will lead to increased buy-in, ownership, and the potential to champion institutional change

20 Consultation Process

21 Lessons Learned

• External experts are imperative to enhancing biosafety and biosecurity

• Early and ongoing involvement of interested and affected parties is important for regulatory development and implementation; it has the potential to influence a culture of safety in organizations for several reasons:

– it involves individuals in decisions that affect them

– it helps to identify better, more generally acceptable decisions and strategies that are often easier to implement, more effective, more timely, and in some cases less costly

– it helps to clarify conflicting interpretations about the nature and significance of risks

– it facilitates the exchange of information and ideas essential for enabling all parties to make informed decisions about reducing biosafety and biosecurity risks

– it leads to risk management practices and decision-making that is participatory, open and transparent, and equitable

22 Lessons Learned (continued)

• Ongoing collaboration with other government departments is essential to reducing regulatory burden

• Sectors have unique risks and behaviors that need to be understood and addressed; this investment can lead to higher rates of regulatory compliance, organizational performance, and minimize the gap between the expectations of regulators and the behaviours of the regulated

• Governments can regulate in the public interest while respecting and preserving the existing practices of the institutions they regulate; the establishment of performance- based standards reinforces there are different ways to achieving biosafety and biosecurity outcomes

• Involving stakeholders led to unexpected benefits, including opportunities to promote compliance, increased voluntary reporting of incidents, and requests for inspections

• Keeping pace with scientific advancements is challenging

23 Moving Forward

Moving forward the Agency will:

• monitor and evaluate the impact of the new regulations and pathogen oversight system through: − stakeholder inquiries and feedback − compliance verification and auditing − plan for administrative oversight − incident reporting − enforcement activities

• continue to raise awareness about institutional oversight and accountability to facilitate on-going improvements to biosafety and biosecurity practices in institutions

• develop tailored guidelines, directives, and advisories, provide training, and conduct educational outreach

• continue to leverage opportunities with domestic and international partners to ensure consistency in the approach to controlling access to the most dangerous human pathogens and toxins

• In keeping with the Government of Canada’s life-cycle approach to regulatory development, the Agency will also evaluate the effectiveness of the HPTR in meeting its objectives in 2020

24 Questions

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