Evaluation of the Biosecurity Program 2009–10 to 2013–14

Prepared by
Evaluation Directorate
Health Canada and the Public Health Agency of Canada

March 2014

Table of Contents

• Executive Summary
• Management Response and Action Plan
• 1.0 Evaluation Purpose
• 2.0 Program Description
  • 2.1 Program Context
  • 2.2 Program Profile
  • 2.3 Program Logic Model and Narrative
  • 2.4 Program Alignment and Resources
• 3.0 Evaluation Description
  • 3.1 Evaluation Scope, Approach and Design
  • 3.2 Limitations and Mitigation Strategies
• 4.0 Findings
  • 4.1 Relevance: Issue #1 – Continued Need for the Program
  • 4.2 Relevance: Issue #2 – Alignment with Government Priorities
  • 4.3 Relevance: Issue #3 – Alignment with Federal Roles and Responsibilities
  • 4.4 Performance: Issue #4 – Achievement of Expected Outcomes (Effectiveness)
  • 4.5 Performance: Issue #5 – Demonstration of Economy and Efficiency
• 5.0 Conclusions
  • 5.1 Relevance Conclusion
  • 5.2 Performance Conclusions
• 6.0 Recommendations
• Appendix 1 – Logic Model
• Appendix 2 – Evaluation Description
• Appendix 3 – Definition: Pathogens and Toxins
• Appendix 4 – Human Pathogens and Toxins Regulations Consultations
• Appendix 5 – Operational Processes
• Appendix 6 – Summary of Findings By Evaluation Question
• Appendix 7 – References
• Appendix 8 – Endnotes

List of Tables

• Table 1a – Financial Data
• Table 1b – 2009 Funding Allocation
• Table 2 - Limitations and Mitigation Strategies
• Table 3 - Core Evaluation Issues and Questions

Executive Summary

This evaluation covered the biosecurity program for the period from 2009-10 to 2013-14. The evaluation was undertaken in fulfillment of a condition of the 2009 program approval and the Treasury Board of Canada's Policy on Evaluation (2009).

Evaluation Purpose and Scope

The purpose of the evaluation was to assess the relevance and performance of the biosecurity program. It reviewed the regulatory activities led by the Centre for Biosecurity, including stakeholder engagement, ongoing operations and other activities related to the development of regulations to support the full implementation of the Human Pathogens and Toxins Act. It was designed also to look specifically at how compliance awareness activities were conducted and supported regulated parties. This evaluation did not cover the implementation of the Single Window Initiative or activities internal to the Public Health Agency laboratories.

Program Description

"Biosafety" is the prevention of an inadvertent release and subsequent infection with pathogens and toxins whereas "biosecurity" refers to the measures taken to prevent the intentional misconduct – for malicious purposes – with respect to pathogens and toxins. A biosafety risk may exist due to improper biosafety controls. Biosecurity risks exist owing largely to a lack of security measures including security screening controls for people in possession of higher risk human pathogens or toxins.

The Public Health Agency is the national authority on biosafety and biosecurity for human pathogens. For many years, the primary tools applied by the Centre for Biosecurity were the Human Pathogens Importation Regulations (1994), which include inspecting and certifying laboratories importing human pathogens and toxins into Canada, and the Canadian Biosafety Standards and Guidelines. In 2009, the Human Pathogens and Toxins Act expanded the Public Health Agency's ability to reduce the risks posed by human pathogens and toxins by standardizing controls over activities involving these agents, whether they are imported or domestically acquired. Further, effective April 1st 2013, some of the Canadian Food Inspection Agency (CFIA) regulatory functions related to most animal pathogens under the Health of Animals Act and Regulations (1990) were merged with the Public Health Agency's Centre for Biosecurity.

Conclusions – Relevance

Continued Need

There continues to be a need to address laboratory biosafety and biosecurity in Canada. Although the potential risk may be low, the threat of a deliberate release of a human pathogen is real and such a release could potentially be catastrophic. A comprehensive system of biosafety and biosecurity controls over imported and domestically acquired human pathogens and toxins helps Canada mitigate the risk of exposure, whether through an accidental or deliberate release.

Alignment with Government Priorities

Through its regulatory and outreach activities, the objectives of the biosecurity program align well with Government of Canada and Public Health Agency priorities in biosafety and biosecurity in Canada. A priority to support the safety and security of Canadians through laboratory biosafety and biosecurity continues to be reflected in a variety of Government of Canada and Public Health Agency strategic policy and planning documents.

Alignment with Federal Roles and Responsibilities

The Public Health Agency is implementing controls for biosafety and biosecurity through a legislative framework, which includes: the Health of Animals Act (1990), Human Pathogens Importation Regulations (1994), and the Human Pathogens and Toxins Act (2009). Overlap with provincial/territorial roles and responsibilities exists and is necessary. The program is working with other jurisdictions to minimize the impact of overlap or duplication on stakeholders.

Conclusions – Performance

Achievement of Expected Outcomes (Effectiveness)

Through its consultation activities on both the proposed Human Pathogens and Toxins Regulations and Canadian Biosafety Standards and Guidelines, as well as other compliance awareness activities (training, inspections, collaborations, etc.), the Centre for Biosecurity has successfully engaged its stakeholders. Importantly, through these efforts, it has enhanced awareness of biosafety and biosecurity and implementation of laboratory biosafety and biosecurity practices. Organizations have adopted additional safety practices as a result of their engagement with the Centre for Biosecurity, including addressing physical containment requirements and/or operational practices. There has been minimal need for administrative or penal enforcement actions to be taken by the Centre for Biosecurity in the last five years. The Centre for Biosecurity has demonstrated leadership nationally (including within the federal regulatory community) and internationally (supporting Canada's biosecurity international obligations as well as multinational efforts).

Demonstration of Economy and Efficiency

The Centre for Biosecurity has established operational practices with a view to mitigating the administrative burden to regulated organizations and demonstrating excellence in regulatory administrative practices. There are opportunities to further enhance current operational efficiencies and apply lessons learned to support the efficient implementation of the full Human Pathogens and Toxins Act. It will be critical to have a timely, nimble and effective informatics system to support the implementation of the future Human Pathogens and Toxins Regulations in place when these regulations come into force in 2015. There are also opportunities to further enhance performance data collection (and use) for program outcome indicators in particular.

Recommendations

Recommendation 1

Enhance the effectiveness of program delivery by:

• (a) Reviewing and strengthening operational processes and tools to improve the timeliness and quality of services to regulated parties. Where needed, review and communicate service standards to address identified gaps.
• (b) Having a timely and nimble informatics system in place to support the full implementation of the Human Pathogens and Toxins Act and the Health of Animals Act.

A program challenge highlighted in the evaluation was the ongoing appeal by regulated parties for enhanced operational practices that better address client service needs and employ more modern informatics solutions. To better support operational tools and processes, a nimble, reliable, timely and integrated informatics system is integral to the full success of this regulatory program.

Recommendation 2

Enhance the performance measurement approach to better inform program decision making by:

• (a) Developing and implementing a tracking system for ongoing feedback from regulated parties.
• (b) Identifying, tracking and analysing indicators that focus on monitoring program outcomes.

While there was some performance measurement data available to assess activities and outputs for this evaluation, there is a gap in terms of tracking ongoing client feedback on program service delivery. More effort to track and analyse additional immediate and intermediate outcome indicators (e.g. in particular related to compliance awareness and behavior change) is required. Improvements to the performance measurement approach can enhance the ability to assess program success on a continuous basis.

Management Response and Action Plan

Evaluation of the Biosecurity Program

1.0 Evaluation Purpose

The purpose of the evaluation was to assess the relevance and performance of the biosecurity program for the period of 2009-10 to 2013-14.

The evaluation was required by the Treasury Board of Canada's Policy on Evaluation (2009). As well, the 2009 funding approval for the program indicated that, as part of program reporting requirements, an evaluation would be required in 2013-2014.

2.0 Program Description

2.1 Program Context

Canada's laboratory biosafety program, in existence since the 1980s, became formalized when the first edition of the Laboratory Biosafety Guidelines was published by Health Canada in 1990. This document was developed to guide government, industry, university, hospital, and other public health or microbiological laboratories in their development of biosafety policies and programs.

More recently, the issues of biosafety and biosecurity were further addressed by the Government of Canada when the Human Pathogens and Toxins Act (HPTA) received Royal Assent in 2009. The purpose of this Act is to establish a comprehensive safety and security regime to protect the health and safety of the public against the risks posed by activities involving human pathogens and toxins. It builds on Canada's existing biosafety program for imported human pathogens and toxins, currently supported by the 1994 Human Pathogen Importation Regulations (HPIRs).

This regime will include the Human Pathogens and Toxins Regulations, which are currently under development and expected to come into force in 2015. The proposed regulatory approach will be risk-based, with more stringent requirements for higher risk human pathogens and toxins.

Effective April 1st 2013, some of the Canadian Food Inspection Agency (CFIA) regulatory functions related to most animal pathogens under the Health of Animals Act and Regulations (1990) were merged with the Public Health Agency's Centre for Biosecurity. CFIA has retained the regulatory authority over pathogens that cause emerging or foreign animal diseases, i.e. very high consequence animal pathogens, as well as pathogens that arrive within animals and other animal products.

The Public Health Agency's biosecurity program is led by the Centre for Biosecurity within the Health Security Infrastructure Branch (HSIB). The Centre for Biosecurity is led by a Director General who has a direct reporting relationship with the Branch Head within HSIB.

2.2 Program Profile

The biosecurity program is responsible for administration and enforcement activities related to human pathogen and toxins, as well as the administration and some enforcement activities related to terrestrial animal pathogens. This program has specific responsibility under the Human Pathogens and Toxins Act, the Human Pathogens Importation Regulations, and select sections of the Health of Animals Act and Health of Animals Regulations to promote and enforce safe and secure biosafety practices and laboratory environments. Through the fostering of a foresight-based collaborative Canadian framework for pathogen oversight and accountability, the program further contributes to public health security by assessing and addressing emerging risks and by mitigating risks posed by the malicious use of pathogens with the intent harm.

Its main methods of intervention include: compliance promotion and education through the provision of knowledge products and training; guidance; the publication of biosafety and biosecurity standards; risk assessments; laboratory certification and verification; the issuance of import permits; laboratory inspections; and enforcement activities.

Researchers, industries, hospitals, public health and federal laboratories that handle pathogens and toxins are provided with regulatory oversight. This program works in close collaboration with a variety of key stakeholders, most of whom are also regulated parties.

Key players in the field of laboratory biosafety and biosecurity in Canada include:

• academic institutions – scientific researchers at academic institutions, primarily colleges and universities, use pathogens for research and teaching in a number of areas
• industry – the pharmaceutical industry uses human pathogens and toxins in products, and for research and development activities; the biotechnology industry may use human pathogens in product development for bioremediation, e.g. waste treatment; the cosmetics and food industries may work with pathogens as a part of quality control on the products they produce
• hospitals, public health laboratories – these laboratories diagnose diseases in humans and may also perform research, the work often involves isolation of human pathogens from patient or environmental specimens
• government laboratories – federal, provincial and territorial government laboratories use human and animal pathogens for reasons listed above, as well as for diagnostic testing, and defence and environmental purposes
• federal government departments and Health Portfolio colleagues, including: federal security colleagues such as the Royal Canadian Mounted Police, Canadian Security Intelligence Service, Canada Border Services Agency and Public Safety Canada; Health Portfolio colleagues such as Canadian Food Inspection Agency, Canadian Institutes of Health Research and Health Canada; Department of Foreign Affairs and Trade Development Canada, including a link to the Biological Toxins and Weapons Convention
• provincial and territorial policy and issue experts, including the Canadian Public Health Laboratories Network and the Biosafety Officer Network
• service providers (engineers, architects, equipment suppliers and repair). Other stakeholders include: national associations (e.g. academic, biotech) and individual members of the public who are interested in the topic.

2.3 Program Logic Model and Narrative

According to the Public Health Agency's 2013-14 Performance Measurement Framework, the expected result of the Public Health Agency's biosecurity program is "safe and secure biosafety practices and laboratory environments."

The activity areas, outputs, and immediate/intermediate outcomes to achieve this final outcome were outlined in a Performance Measurement and Evaluation Plan developed in 2012. This Plan is organized around three phases linked to the implementation of the Human Pathogens and Toxins Act. Activities, outputs and immediate/intermediate outcomes are closely linked but also vary somewhat across the three phases.

The assumption underlying the program theory is that "compliance awareness" activities will lead to behavior change in terms of compliance with the regulatory requirements, i.e. laboratory practices that lead to safe and secure laboratories in Canada. All activities/outputs incorporate the engagement of stakeholders and the dissemination of information, including: issuing of letters of compliance/certification and permits, conducting inspections, providing training/education, publishing documents such as standards and guidance, and undertaking broad-based consultations.

The connection between these activity areas and the expected outcomes is depicted in the logic model (see Appendix 1). The evaluation assessed the degree to which the defined outputs and outcomes were being achieved over the evaluation timeframe.

Immediate outcomes are awareness and acceptance of the value of biosafety and biosecurity practices in laboratories, including current and future regulatory requirements. Intermediate outcomes relate to behavior change and increased compliance with existing regulations, including current biosafety standards and guidelines.

The intended reach for the program is the individuals, groups or organizations that the regulatory activity is intended to influence. It includes both the regulated parties (laboratories working with risk-group levels 2, 3 or 4 human and/or animal pathogens or toxins that have been imported and/or acquired domestically) and other key groups who are important to the success of the initiative (e.g. public, private and not-for-profit organizations, other institutions, and individual Canadians).

2.4 Program Alignment and Resources

The program was part of the Public Health Agency's 2013-14 Program Alignment Architecture (PAA): program 1.3 Health Security, sub-program 1.3.3 Biosecurity. This program contributes to the health security of the population by mitigating risks posed by pathogen misuse such as a deliberate release or the intentional production of bioterrorism agents.

The program's financial data for the years 2009 through 2014 are presented below (Tables 1a and 1b). Overall, the program had a budget of $43M over five years.

The cornerstone of the funding for the biosecurity program is the 2009 Human Pathogens and Toxins Act and associated approved funding submission. New authorities and funding under this Act significantly augmented the funding allocated to the existing biosafety program for imported human pathogens and toxins, in place since 1990. In 2012-13, additional financial resources were allocated to the biosecurity program to support the Public Health Agency's participation in the Single Window Initiative ($252,000 in 2012-13 and $1,081,962 in 2013-14) led by the Canada Border Services Agency. Finally, in April 2013, with the consolidation of federal programs that issue pathogen import permits, staff resources (four FTEs) were transferred from the Canadian Food Inspection Agency to the Public Health Agency.

The capital allocation and spending listed in the above tables (1a and 1b) reflect resources identified in the 2009 approved funding submission for the information technology deliverable. The information technology deliverable is being phased-in to support the information management and security requirements of the current import program in place for human pathogens and toxins, and the future licensing program to be established under the Human Pathogens and Toxins Act.

The document review has highlighted that a number of factors shifted the timing for overall program implementation, which has postponed the information technology deliverable to 2015 (initially planned to be substantively completed by March 2014). The Public Health Agency of Canada deferred $633K from 2010-11 to 2012-13 and $607K from 2012-13 to 2013-14 fiscal years. Of note, internal program staff have indicated that the overall project outcome has not been impacted.

The following factors have deferred the year over year program spending on this deliverable.

• Prior to the coming into force of the Human Pathogens and Toxins Act, the Public Health Agency made a commitment to Parliament to engage provinces, territories and a broad range of stakeholders both in the development of the regulations as well as on the consultation process itself. These "pre-consultations" were requested by the government and had not been factored into initial timelines including in the approved funding submission. It led to a one year delay on deliverable timelines. A comprehensive approach to consultations (2009-2014) was developed. This approach to engaging stakeholders as full partners in shaping and delivering results was consistent with the Cabinet Directive on Regulatory Management.
• The comprehensive consultation approach also impacted timelines for the original model of achieving the information technology deliverable. The business requirements for the information technology component can only be fully known once consultations have been completed.
• In 2011-12 there was transformational change in the Government of Canada's approach to information management/technology. Overall this function was centralized through Shared Services Canada and the Public Health Agency's internal hub was transitioned to Health Canada. A decision was made to reduce the pace of the development of the information technology component to accommodate organizational transformation.

In 2012-13, the program staff consisted of a total of 54 FTEs. As the program continues to ramp up toward full implementation of the Human Pathogens and Toxins Act, this number is expected to grow to 70 FTEs. There are five Divisions: Office of Biosafety Programs and Planning (14), Office of Biosafety and Biocontainment Operations (32), Office of Pathogen Security (10), Office of Outreach and Stakeholder Engagement (3), Office of Regulatory Policy and Affairs (4), and the Office of the Director General (7). The staff complement consists of 2 Directors, 3 Divisional Managers, 13 Program Managers, 13 Inspectors, 8 Analysts, 5 Scientific Program Resources, 4 Technologists, 2 Biocontainment Engineers, and 4 Licensing Clerks.

3.0 Evaluation Description

3.1 Evaluation Scope, Approach and Design

The scope of the evaluation covered the period from April 1, 2009 to January 1, 2014 and encompassed all activities currently managed within the Centre for Biosecurity. Program components included: outreach and stakeholder engagement, biosafety and biocontainment operations, biosafety programs and planning, pathogen security, engineering and science support, and regulatory policy and affairs.

The following topics are out of scope for this evaluation. It did not include an analysis of the longer term outcome of regulatory compliance with the Human Pathogens and Toxins Act (2009) because these regulations will not be in force until 2015. While Single Window Initiative activities will be described (see section 4.5.2), this evaluation will not include an analysis of activities associated with this recently launched electronic Initiative led by the Canada Border Services Agency. The focus of the evaluation is on the Agency's regulatory role and therefore it will not include analyses of activities led by the Public Health Agency laboratories, including the National Microbiology Laboratory and the Laboratory for Foodborne Zoonoses.

The evaluation issues were aligned with the Treasury Board of Canada's Policy on Evaluation (2009) and considered the five core issues under the two themes of relevance and performance, as shown in Appendix 2. Corresponding to each of the core issues, specific questions were developed based on program considerations and these guided the evaluation process.

An outcome-based evaluation approach was used for the conduct of the evaluation to assess the progress made towards the achievement of the expected outcomes, whether there were any unintended consequences and what lessons were learned.

The Treasury Board's Policy on Evaluation (2009) also guided the identification of the evaluation design and data collection methods so that the evaluation would meet the objectives and requirements of the Policy. A non-experimental design was used based on the evaluation framework document, which detailed the evaluation strategy for this program and provided consistency in the collection of data to support the evaluation. The evaluation was also designed to look specifically at how compliance awareness activities supported regulated parties' compliance with regulatory requirements under the Human Pathogens and Toxins Act and Human Pathogens Importation Regulations.

Data for the evaluation was collected using various methods, which were: literature review, media analysis, document and file review, financial data review, performance data, key informant interviews – both internal and external, and a stakeholder survey. More specific details on the data collection and analysis methods are provided in Appendix 2. In addition, data were analyzed by triangulating information gathered from the different methods listed above. The use of multiple lines of evidence and triangulation were intended to increase the reliability and credibility of the evaluation findings and conclusions.

3.2 Limitations and Mitigation Strategies

Most evaluations face constraints that may have implications for the validity and reliability of evaluation findings and conclusions. The following table outlines the limitations encountered during the implementation of the selected methods for this evaluation. Also noted are the mitigation strategies put in place to ensure that the evaluation findings can be used with confidence to guide program planning and decision making.

4.0 Findings^{Footnote A}

4.1 Relevance: Issue 1 – Continued Need for the Program

Finding #1 - There continues to be a need for biosafety and biosecurity efforts to protect the health and safety of the public against risks posed by activities involving human and animal pathogens and toxins in laboratory settings.

The program was developed in response to the need to enhance proper laboratory controls in Canada. Human and animal pathogens (e.g. Influenza viruses, Ebola virus) and toxins pose a risk to public health and safety. For definitions of human pathogens and toxins, see Appendix 3.

According to the World Health Organization, biorisk is defined as the probability that a particular adverse event, such as accidental infection or unauthorized access, loss, theft, misuse, diversion or intentional release, possibly leading to harm will occur. In the same context, biosafety is defined as "the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release". World Health Organization also defines biosecurity as the "protection, control and accountability for valuable biological materials within laboratories, to prevent their unauthorized access, misuse, or intentional release".^{Endnote 1}

Working with pathogens in laboratories requires protective measures to prevent unintentional or intentional release of harmful agents. The impact of intentional or unintentional misuse of pathogens and toxins from laboratory environments can be significant and continues to pose a risk for serious health, social and economic consequences for Canadians. Biosafety or biosecurity incidents may result in catastrophic and expensive consequences including: a public health disease outbreak with multiple illnesses or deaths, environmental contamination, and economic loss.

Below are two illustrative examples.

• The global outbreak of SARS virus in 2003, which infected more than 8000 and killed 774 people worldwide, triggered a global effort to understand and contain this health threat.^{Endnote 2} In Canada, the disease killed 44 people and caused illness in a few hundred more but it also had a significant impact on the healthcare system and the economy. It was estimated that the direct and indirect costs of SARS were close to $2 billion. After the outbreak ended in 2004, several cases of SARS transmission in laboratory settings were reported. These cases of laboratory acquired SARS underline the potential risk of a new outbreak originating with personnel in laboratory settings.^{Endnote 3,Endnote 4} The outbreak raised biosafety concerns and prompted public health organizations around the world to develop biosafety guidelines for handling the virus in clinical, research or production laboratories.^{Endnote 5,Endnote 6,Endnote 7,Endnote 8}
• The use of human pathogens and toxins as a weapon is not new. In October 2001, shortly after the terrorist attacks of September 11th, powdered anthrax spores were deliberately put into letters that were mailed through the US postal system, infecting 22 people, and killing five.Endnote 9 The impact of this act was far-reaching: two branches of the US federal government and the postal operations around the country were shut down temporarily; more than 33,000 people required post-exposure prophylactic treatment; more than 1,000 physicians, epidemiologists and public health practitioners were involved in the investigation; thousands of police officers, FBI agents and government officials contributed to the criminal investigation; and the clean-up costs were in the millions of dollars.Endnote 10

These events had a ripple effect around the world and showed that some of the most serious threats are likely to emerge without warning and the world has to be ready and prepared. In a rapidly changing and increasingly interconnected global environment, the public health security of all countries depends on the capacity of each to act effectively and contribute to the security of all.^{Endnote 11} These concerns prompted many countries to update their countermeasures to be better prepared to respond.^{Endnote 12} In Canada, Threat and Risk Assessments conducted by the Canadian Security Intelligence Service in 2005, 2007 and 2012 underscored the importance of a robust regulatory framework and related program to enhance oversight of all laboratory handling of biological agents.

Prior to the Human Pathogens and Toxins Act receiving Royal Assent in 2009, federal oversight was limited to facilities importing biologic agents. This limited approach prevented the Government of Canada from watching over the safe and secure management of human pathogens acquired from domestic sources. The complete Human Pathogens and Toxins Act program will strengthen the management of these agents, requiring their secure containment and the consistent application of safe laboratory practices, regardless of whether they were imported or domestically acquired, to mitigate the associated risks. The activities conducted by the Centre for Biosecurity respond to the need for a more comprehensive, systematic and consistent approach to protecting the health and safety of Canadians that will include a licensing regime for all laboratories, personnel reliability screening, pathogen inventory, and systematic reporting of laboratory incidents.

Regulatory frameworks to limit unauthorized access to pathogens and toxins from microbiological laboratories are being considered and implemented worldwide.

• Australia enacted the National Health Security Act in 2007. The provisions of the Act are implemented through the National Health Security Regulations (2008). Both the Act and the regulations were amended in 2013.^{Endnote 13}
• The United Kingdom passed the Antiterrorism Crime and Security Act in 2001 and Security of Pathogens and Toxins (Exception to Dangerous Substances) Regulations in 2002.^{Endnote 14,Endnote 15}
• United States enacted the Public Health Security and Bioterrorism Preparedness and Response Act along with the Select Agent Regulations and the Foreign Quarantine Regulations.^{Endnote 16,Endnote 17}

The regulations, implemented at national and international levels, are intended to govern the management of pathogens, the operation of high containment facilities, the use of genetically modified organisms. For more details on international efforts, see Annex B.

A review of the literature indicates that there is an increasing number of high containment microbiology laboratories of all levels being built around the world, the majority in the United States. This expansion is due in part to concerns about emerging diseases, but also to governments' efforts to advance biodefense research. Bioscience has been identified as a key economic driver for the 21st century.Endnote 18 In addition to government investments, many private and public institutions are constructing new high-containment facilities and funding biomedical research involving high-risk pathogens and outbreaks.

The number of laboratories has increased over the last decade. In the United States due to their size, the number of CL-3 laboratories registered with the Centre for Disease Control more than tripled between 2004 and 2010 with half of them being academic institutions.Endnote 19 In Canada the number of CL-3 laboratories has also continued to increase however, given the relative differences in demographics, not as dramatically as in the United States. In 2004 in Canada there were 85 CL-3 facilities. Currently, there are 52 entities in Canada made up of 97 CL-3 facilities. Of those 97 facilities, 81 have been certified and can be actively working with pathogens; 14 are in the process of being certified before work commences; two facilities are actively pursuing decommissioning at this time (both are Agency CL-3 laboratories located in Ottawa and are part of the JC Wilt Decommissioning Project). There are two entities with a total of two CL-4 facilities which are located in Winnipeg. Data is limited on the trends in the number of CL-2 laboratories over the past five to ten years. While the exact number of CL-2 labs in Canada is not known, it is projected to be about 8500.

4.2 Relevance: Issue 2 – Alignment with Government Priorities

Finding #2 - Laboratory biosafety and biosecurity is a priority for the Government of Canada and the Public Health Agency.

Over the past five years, laboratory biosafety and biosecurity have been identified as priorities for the Government of Canada and the Public Health Agency. The 2008 Speech from the Throne highlighted the safety and security of Canadians as a priority of the Government of Canada and as the most fundamental duty of any national government to its citizens. The Budget 2008 set aside significant funds for important initiatives to protect the health and safety of Canadians, including resources to improve the safety of laboratories dealing with viruses and bacteria.

The Centre for Biosecurity's activities are aligned with the Government of Canada priority to protect the safety of Canadian citizens against threats to our national security. The Public Health Agency takes an all hazards approach to health security, which provides the Government of Canada with the ability to prepare for and respond to public health threats within a context of globalization, environmental change and scientific discovery. These actions are carried out through the administration and enforcement of legislation, including the Human Pathogens Importation RegulationsEndnote 20,Endnote 21,Endnote 22, the Health of Animals Act and the Human Pathogens and Toxins Act. Other federal legislation, including the Emergency Management Act, the Quarantine Act, and the Transportation of Dangerous Goods Act also play an important role in strengthening Canada's emergency preparedness and response capacity.Endnote 23,Endnote 24

Building Resilience Against Terrorism, published by Public Safety Canada in 2013, is Canada's first counter-terrorism strategy. It indicates that the first priority of the Government of Canada is the safety and security of Canadians at home and abroad. The Strategy outlines the ongoing activities of government departments and agencies that are involved in counter-terrorism and how these activities contribute to the Government of Canada's strategy for countering terrorism. It highlights the role of the Public Health Agency in denying terrorists' access to biological agents by regulating the importation and use of biological agents to prevent their use as weapons. The strategy also indicates the importance of continual adaptation of domestic policy to maintain compliance with international non-proliferation measures.

The biosecurity program aligns well with the Public Health Agency's priorities. Over the last five years, through various corporate planning and reporting documents (Report on Plans and Priorities, Departmental Performance Report, Management Resources and Results Structure), the Public Health Agency has acknowledged the significant public health risk posed by infectious diseases and identified laboratory biosafety and biosecurity as a priority, with the goal to reduce the level of this risk.Endnote 25 The Public Health Agency Corporate Risk Profile 2012-13 identifies "Managing the Risk to Canadians" as the most important Public Health Agency priority. The program aims to minimize the public health risk and increase safety and security in microbiology laboratories across the country. The application of legislative and regulatory tools, where appropriate, has strengthened the Public Health Agency's ability to prevent and respond to both real and potential public health risks and protect the health of Canadians.Endnote 26,Endnote 27,Endnote 28

The Public Health Agency's five-year strategic plan Strategic Horizons 2013–2018 identifies "enhanced public health security" as a key priority, reflecting on the public health needs of Canadians and in harmony with Public Health Agency's strategic outcome of protecting Canadians and empowering them to improve their health. The strategy specifically details, as a priority, the need to reduce risks to the health and safety of the public posed by activities involving human pathogens and toxins. Also, the activities undertaken by the program address this priority in the context of regulatory renewal, including enhanced service delivery and reduced administrative burden for regulated parties.

4.3 Relevance: Issue 3 – Alignment with Federal Roles and Responsibilities

Finding #3 - There is a leadership role for the Government of Canada and the Public Health Agency in laboratory biosafety and biosecurity.

Within Canada

The Department of Health Act sets out the powers, duties and functions of the Minister of Health, which include the "protection of the people of Canada against risks to health and the spreading of diseases". The Public Health Agency of Canada Act established the Public Health Agency of Canada for the purpose of assisting the Minister in exercising or performing the Minister's powers, duties and functions in relation to public health.

The Human Pathogens Importation Regulations, enacted in 1994 under the Department of Health Act, are currently administered and enforced by the Public Health Agency of Canada. The Human Pathogens and Toxins Act was passed by the Parliament of Canada in 2009, and provides the Public Health Agency with the legislative authority to develop a program and a regulatory framework to protect Canadians against the risks posed by human pathogens and toxins. This Public Health Agency program is the national authority on human pathogen biosafety and biosecurity in Canada. It participates in the development of national biosafety standards, and is currently developing regulations under the Human Pathogens and Toxins Act to support a licensing program.^{Endnote 29} There was a broad consensus among internal and external key informants that the Public Health Agency is the most appropriate federal organization to address biosafety and biosecurity at the national level.

Other federal government departments have a role in providing services and information that are critical in the implementation of the biosecurity program. Colleagues in other government departments (Canadian Food Inspection Agency, Public Safety Canada, Royal Canadian Mounted Police, Canadian Security Intelligence Service, Department of Foreign Affairs and Trade Development Canada, Canada Border Services Agency) and those internal to the Health Portfolio (Health Canada, Canadian Institutes for Health Research) indicated that there has been a complementary working relationship with the Centre for Biosecurity at the Public Health Agency. As well, National Microbiology Laboratory colleagues have indicated that they are satisfied with their working relationship with the Centre for Biosecurity.

International

The Health Portfolio's authority to engage in international activities is mandated by legislation. The Department of Health Act allows the Minister of Health to do or fund work outside Canada provided it relates to promoting and preserving the health of the people of Canada. Also, the Preamble to the Public Health Agency of Canada Act expresses the desire of the Government of Canada to foster co-operation and collaboration with foreign governments and international organizations, as well as other interested persons or organizations. The appropriateness of the federal role in international activities was further supported by the fact that membership in international organizations, such as the United Nations and the World Health Organization, are comprised of States and these States are represented by government officials. Membership cannot be delegated to a third-party organization or another level of government.

In collaboration with other federal government departments and international organizations, the Public Health Agency provides technical support to other developing countries to help build local expertise in biosafety, biosecurity and biocontainment. Canada is involved in international collaborative groups and initiatives as a result of informal obligations and a common goal of prohibiting the proliferation and development of biological weapons. Some examples include: the Australia Group; the Global Health Security Initiative (GHSI); the World Health Assembly (WHA) resolution; and the World Health Organization's International Health Regulations (IHRs).

On behalf of the Government of Canada, the Public Health Agency's activities support the national implementation of international commitments: the Biological and Toxin Weapons Convention and the United Nations Security Council Resolution 1540. The ultimate goal of both of these documents is the total elimination of weapons of mass destruction, including biological weapons, as well as the introduction of effective controls on their means of delivery. Each of these initiatives sets out legal requirements for which its members must take action to fulfill their obligations. To date, Canada has been able to meet these international obligations with the implementation of various Acts, Regulations, Standards, and Guidelines. For a detailed description of the articles and Canada's action to fulfill its international obligations, refer to Annex A.

In collaboration with the United States, Canada is participating in the 2011 Beyond the Border: A Shared Vision for Perimeter Security and Economic Competitiveness. It is a long-term partnership that aims to enhance security and economic competitiveness through measures taken at our shared perimeter and border. The document review highlighted that this initiative is intended to contribute to reduce the shared health security risks, advance North American biosecurity and pathogen control, and enhance interoperability of emergency management and response systems. In 2013 the Government of Canada announced that over the next five years, action will be taken to achieve the outcomes set out by the Canada-US Beyond the Border Action Plan. This includes implementing a single window for companies to submit electronically all the data required by government departments for arriving shipments such as imported pathogens and toxins, in turn reducing red tape, delays and business costs.

Finding #4: An analysis of provincial/territorial legislation related to the laboratory management of human pathogens and toxins indicates that provincial/territorial (a) occupational health and safety programs and (b) medical/diagnostic laboratory accreditation programs are areas of potential duplication with the biosafety and biosecurity requirements outlined in the 2009 federal Human Pathogens and Toxins Act and the federal Canadian Biosafety Standards and Guidelines.

In terms of the federal role on workplace safety, Part II of the Canada Labour Code and its regulations have been enacted to prevent work place related accidents and injury including occupational diseases. However, this legislation applies explicitly to a variety of interprovincial and international industries (transportation, broadcasting, banking, and others), including employees of the federal public service. Workplace safety, pertaining specifically to laboratory management, is a matter of provincial jurisdiction.

Occupational Health and Safety Programs

To minimize risks in the workplace, and protect the health and safety of employees, each province and territory has in place occupational health and safety legislation. As part of this legislation, every province/territory appoints inspectors to verify compliance and make orders to stop work or take other measures to confirm work is being carried out safely.

Common areas of overlap between the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines and the occupational health and safety legislations set out by the provinces/territories include requirements to put in place:

• Training and procedures for hazardous substances
• Safety committees (usually for workplaces with over 20 workers)
• Decontamination of workers and materials
• Protective clothing
• Maintenance of equipment so that it does not create a risk to health or safety
• Ventilation systems
• Maintenance of inventories of pathogens and toxins (BC, NB, PE, QC, SK)
• Reporting of, and response to workplace illness and injuries
• Policies for storage, handling and disposal of hazardous materials.

Medical/Diagnostic Laboratory Accreditation Programs

Formal mandatory laboratory accreditation programs are in place in many provinces. Alberta, British Columbia, Manitoba, Ontario and Saskatchewan require medical/diagnostic laboratories to meet certain standards set out by the Colleges of Physicians and Surgeons to obtain accreditation. Newfoundland and New Brunswick have mandated a requirement for medical laboratories to obtain accreditation from the Ontario accreditation program. In Québec, a provincial directive requires all medical laboratories (both private and public) to comply with standards of medical laboratories (CAN/CSA-15189) set out by the Canadian Standards Association (CSA). Also, the province requires all private laboratories to hold a permit issued by the Minister of Health and Social Services.

Areas of overlap between provincial/territorial medical/diagnostic accreditation programs and the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines include requirements such as:

• Safety program and manual
• Maintenance and certification of equipment
• Laboratory safety officers
• Protective apparel
• Incident reporting
• Decontamination.

Québec's requirement to comply with standards of medical laboratories set out by the Canadian Standards Association includes areas of overlap with the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines such as:

• To train workers and maintain records of training
• Incident or accident reports
• Laboratories must be designed to minimize the risk of injury and occupational illness
• Laboratory equipment must be maintained and calibrated, with records kept
• Requirements for personal protective equipment
• Safe handling, transport, storage and use of equipment to prevent contamination.

All provincial/territorial accreditation programs require laboratories to be inspected and to hold a licence or permit, which is valid for a set period of time (generally between three to five years). This licence or permit demonstrates they have met the necessary requirements.

Many laboratories, where provincial accreditation is not mandatory, enroll in voluntary accreditation programs, such as those offered through Accreditation Canada. The Canadian Society for Medical Laboratory Science (CSMLS) sets qualification standards for medical laboratory science and certifies individuals who work in laboratories, through an exam. Quality assurance and quality control are common areas of focus for voluntary accreditation standards. In addition, biosafety issues are also addressed.

Gaps with existing provincial/territorial programs

Although there appear to be areas of overlap between occupational health and safety programs and provincial accreditation programs with the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines, there are also gaps in occupational health and safety programs and provincial accreditation programs that are covered by the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines.

There are two key biosecurity requirements that are included in the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines that are not included in either of the provincial legislative programs. These biosecurity requirements include:

• Security clearances – security clearances are required for individuals to access facilities with controlled activities in relation to human pathogens that fall under the subset of RG-3 and RG-4 human pathogens, and toxins listed on Schedule 1 that also appear on the List of Biological Agents for Export Control published by the Australia Group (Security Sensitive Biologial Agents or SSBAsFootnote B).
• Report missing pathogens – an individual is required to inform the federal Minister of Health if they believe that a human pathogen or toxin that was in their possession has been stolen or is otherwise missing.

Neither the provincial accreditation nor occupational health and safety legislations specify or provide information on the following:

• Timelines on how often inspections are to be carried out
• The expertise provincial inspectors must possess
• If provincial inspectors will have the knowledge and ability to verify compliance with the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines.

Finally, some provinces have exemption of accreditation for certain facilities. For instance, accreditation is not required for:

• Alberta: approved hospitals, Government of Canada hospitals, Government of Canada or Government of Alberta health care facilities, hospitals, clinics or centres operated by a regional health authority or accredited health centres
• Manitoba: diagnostic facilities under the jurisdiction of the provincial or municipal governments and those approved as hospitals under The Hospitals Act
• Saskatchewan: laboratories used exclusively for medical or scientific research
• Québec: Only laboratories located outside a public institution require a permit; however, all medical laboratories are required to comply with CAN/CSA-15189.

There does not appear to be any jurisdiction that effectively covers all provisions of the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines through either occupational health and safety requirements or accreditation of laboratories. It is not clear that, even if a province has legislation for biosafety and biosecurity, the laboratories are inspected for these aspects. Public Health Agency staff indicated that research is suggesting that many provincial programs do not regularly inspect microbiology laboratories. Many accreditation programs only cover certain laboratories. Although other programs exist, they are not applied universally, and as such, there are gaps in coverage by other programs with respect to biosafety and biosecurity.

Finding #5 – The Centre for Biosecurity is actively working to address overlap and duplication with roles of the provinces and territories.

Mitigating overlap and duplication

In 2009, the Public Health Agency made a commitment to Parliament to look at options for minimising regulatory duplication. To address this commitment and reduce the overlap and duplication with the provinces/territories, the document review and key informant interviews illustrate that the Centre for Biosecurity has, and intends to continue to, engage in consultations with stakeholders and the provinces/territories .

Over the past five years, the Centre for Biosecurity has been actively involved in bilateral government to government relations and consultations with regulated laboratories across Canada (see section 4.4.1 on consultations). Key informants from provincial and territorial governments, and regulated laboratories, indicated that these consultations had been timely, well managed and productive in terms of exploring approaches to minimize the impact of overlap and duplication. The feedback received during these discussions has informed policy to support the drafting of the three Human Pathogens and Toxins Regulations.

In addition, the Public Health Agency plans to engage provinces/territories at the working level to understand how operational requirements are applied in practice, and compliance is verified. To accomplish this, the Public Health Agency has proposed the following:

• work with delegated provincial/territorial focal points to establish the right program contacts
• share the environmental scan of provincial/territorial legislation for validation
• request additional information from existing provincial or territorial programs
• hold program to program teleconference calls to begin the joint identification of potential opportunities to minimize duplication and regulatory burden
• report back the findings and options to the Pan-Canadian Public Health Network Council (PHNC)/Council of Chief Medical Officers of Health (CCMOH).

Potential strategies have been proposed for federal/provincial/territorial alignment and the reduction of overlap between legislations. These strategies will be looked at in detail in 2014 as part of the Overlap and Duplication Strategy and Workplan for the Implementation of the Human Pathogens and Toxins Act. They include:

• setting provincial/territorial requirements such as adoption of the Canadian Biosafety Standards and Guidelines
• implementation of the Human Pathogens and Toxins Act requirements using provincial/territorial mechanisms to support Human Pathogens and Toxins Act compliance
• potential exemptions from the requirement of a Humans Pathogen and Toxins Act licence
• aligning processes, for example the timing of federal Humans Pathogen and Toxins Act inspections and licence renewals with provincial/territorial programs.

To reduce overlap, duplication and administrative cost burden for impacted parties, two federal programs have been consolidated. This effort involved a transfer of authority from the Canadian Food Inspection Agency to the Public Health Agency which is now responsible for issuing importation permits for terrestrial animal pathogens, in addition to its original mandate for controlling the importation of human pathogens (see section 4.5.2). With just one Agency and one set of application procedures for most human and animal pathogens, this consolidation has reduced administrative burden for regulated parties.

4.4 Performance: Issue 4 – Achievement of Expected Outcomes (Effectiveness)

4.4.1 To what extent have Centre for Biosecurity stakeholder engagement activities led to compliance with the regulations?

Finding #6 - Consultation with stakeholders, for the development of the Human Pathogens and Toxins Regulations and the Canadian Biosafety Standards and Guidelines, was conducted in an inclusive and meaningful manner. Stakeholder concerns about the implications of implementation of the Human Pathogens and Toxins Act, Human Pathogens and Toxins Regulations and the Canadian Biosafety Standards and Guidelines continue to be actively managed.

In 2009, when the Human Pathogens and Toxins Act (Bill C-11) was first tabled in Parliament, the Public Health Agency was criticised for not adequately involving stakeholders during the development of the Act. The Human Pathogens and Toxins Act requires that proposed regulations be introduced in the House of Commons and the Senate of Canada before being made. This was an amendment put forward by the Health Committee in 2009 to ensure any proposed regulations would: undergo adequate regulatory consultation; consider less stringent requirements for RG-2 pathogens; and increase transparency in the federal regulatory development process.

Since 2010, the Public Health Agency has been working closely with stakeholders (provinces and territories, federal government departments, industry, academia, public interest groups and other interested parties) to develop the Human Pathogens and Toxins Act regulatory framework and the consolidated Canadian Biosafety Standards and Guidelines. Of note, there has been early, frequent, targeted and direct engagement with Bill C-11 witnesses to understand and address their concerns.

The formal consultation strategy for the development of regulations under the Human Pathogens and Toxins Act has four phases (2010-14). For an overview of the timeline, approach, target audience, outcome and status for each phase, please see the table in Appendix 4.

• A pre-consultation phase (or phase one) took place in the spring of 2010. The Centre for Biosecurity heard from key informants in every province and territory, a representative cross-section of national stakeholder associations, as well as the Canadian Public Health Laboratory Network (CPHLN), about the most effective approaches to engage stakeholders moving forward.
• Phase two took place in the winter of 2012. There were 21 full day cross-country face-to-face consultations as well as online engagement. These listening sessions provided participants with the opportunity to contribute preliminary advice on policy directions and the program framework for the Human Pathogens and Toxins Act. The purpose was to collect views on the operational requirements and input into the key program elements to support the drafting of the regulations. There were five key issues discussed: licensing; functions and qualifications of Biosafety Officers; inventory; laboratory acquired infections and exposure reporting; and security clearances.
• Phase three, in the spring of 2013, was informed by input gathered during the phase two consultations, Human Pathogens and Toxins Regulations requirements and policy decisions. Stakeholders were provided with an opportunity to challenge and test specific ideas and options in implementing key program elements. Their input was used to inform the program and policy framework in support of the drafting of the Human Pathogens and Toxins Regulations, which included the development of the licensing program, security clearances and exemptions.
• In phase four, the Agency will hold live webcast information sessions on the proposed program and regulatory framework, concurrent with the publication of proposed regulations in Canada Gazette Part I which is targeted for June 2014. The Agency has decided to streamline this process to consider the impact on stakeholder time and resources required to review the draft regulations. The live webcast will be structured around situation notes for the specific activity which aim to demonstrate the requirements of regulated parties under the Human Pathogens and Toxins Regulations (HPTR) in a real life context.
• All input received through Canada Gazette Part 1 will be carefully considered before the final regulations are posted in Canada Gazette Part 2 which is targeted for Fall 2014.

A separate but complementary consultation strategy was undertaken to consolidate and update the Canadian Biosafety Standards and Guidelines (for details on harmonization, see section 4.5.2). The first of four phases of consultations took place in 2010-11 to develop a seed document. Phase two took place between November 2011 and July 2013. It included the establishment and work of an Expert Working Group of 21 individuals that provided technical advice in key areas including: prions, toxins, animal work, science and research, large scale, planning/design/biosafety equipment, and biosafety program management. Phase three took place in the fall 2012 and provided an opportunity for stakeholders to review a draft document. The final phase included the printing and distribution (hard copy and electronically) of the final product in July 2013.

Key informant interviews, document review and web metrics illustrate that the implementation of the consultation strategy has been thoughtful and comprehensive. Supporting details include:

• Engagement approaches for both the Human Pathogens and Toxins Regulations and the Canadian Biosafety Standards and Guidelines have included: public workshops, technical workshops (subject matter experts speak to physical and operational realities), written submissions, subscription to email service that provided regular updates, a consultation webpage with an online workbook, and social media.
• Background documents were sent in advance for face-to-face consultations and were available on the Public Health Agency website. The Centre for Biosecurity prepared consultation reports after each phase of the consultations and each phase of the consultation built upon lessons learned from the previous phases.
• Additionally, various methods (subscription service, consultation participant lists, registrant database, conference attendees, business cards, etc.) were used to populate a stakeholder engagement database which was in turn used to generate mass mailing lists to provide updates and request feedback on a variety of issues from stakeholders who expressed an interest in being further engaged.
• Web metrics analyses show that the number of website visits to the "Laboratory Biosafety and Biosecurity Section" of the Public Health Agency website has increased steadily over the last three years. It is a very popular section within the Public Health Agency site overall, accounting for approximately 7% of the total website visits (see 4.4.1 section on disseminating information products).
• To enhance awareness, relationships and interaction between federal pathogen regulators and the law enforcement and intelligence community, the Centre for Biosecurity collaborated with Public Safety Canada to convene the Federal Pathogen Security Partners. This group meets on a quarterly basis to address items highlighted in a thematic work-plan and also convenes ad hoc meetings to discussion emerging issues or challenges and has been instrumental in providing feedback on the Human Pathogens and Toxins Act program and regulatory framework development.

Feedback received during key informant interviews and through a survey of regulated parties (n=467), indicates that formal engagement with external stakeholders has been characterized as: "well organized", "transparent", "inclusive" and "constructive". Some key informants indicated that visible efforts have been made by the Centre for Biosecurity to streamline processes and demonstrate robust cost-benefit analyses. They also indicated that engagement activities have led to: validated and more risk-based regulatory policy direction and guidance documents; enhanced laboratory biosafety and biosecurity awareness and practices; and greater acceptance and confidence in the Public Health Agency's leadership role in biosafety and biosecurity.

Key informant interviews with other government departments, and Health Portfolio contacts, suggest that internal Government of Canada engagement also has been well received. Colleagues within the federal government indicated that the Centre for Biosecurity has brought the right people together at the right levels and with the right timing. There have been numerous bilateral meetings with a strong emphasis on building productive working relationships.

• In terms of the federal security community (Public Safety Canada, Canadian Security Intelligence Service, Royal Canadian Mounted Police, Canadian Food Inspection Agency), the regulations are seen as a key element of Canada's national security framework. The Centre for Biosecurity is a participant in the Director General level Counter Proliferation Policy Committee. It consists of 15 federal government departments, led by Public Safety Canada, with the objective to exchange information of importance for national security. The Centre for Biosecurity has routinely engaged this committee on the development of the security elements of the Human Pathogens and Toxins Act.
• As mentioned, the Human Pathogens and Toxins Act is a key tool to support Canada's international commitments through the Department of Foreign Affairs and Trade Development Canada (see section 4.3 and Annex A). The Public Health Agency provides technical expertise and supports Canadian efforts to prevent proliferation of biological weapons.
• The Canadian Institutes of Health Research have been supportive and the Institute of Infections and Immunity will be a key resource in facilitating compliance moving forward given their ties to research funding to advance knowledge with respect to biosafety practices in Canada.
• Public Health Agency colleagues have been actively engaged (e.g. National Microbiology Laboratory, Laboratory for Foodborne Zoonoses, and Strategic Policy, Planning and International Affairs). Their guidance and expertise has been integral to Human Pathogens and Toxins Act policy development and development of the Canadian Biosafety Guidelines and Standards.

There has been active and ongoing consultation with provincial/territorial stakeholders. Key informant interviews and the document review highlight several key networks through which the Centre for Biosecurity has engaged these collaborators.

• With a view to providing updates and facilitating discussion, on several occasions the Centre for Biosecurity has presented to the senior provincial/territorial officials through the Canadian Public Health Laboratories Network (CPHLN).
• At the working level, the Biosafety Officers Network (BSON) has provided a key opportunity for the Centre for Biosecurity to gain technical expertise from other government jurisdictions. In turn, these networks are able to brief up within their respective jurisdictions on the development of the regulatory framework and guidelines.

Additionally, the Biocontainment Engineering Science Working Group (BESWG) was established to identify, challenge and re-define biosafety requirements where biocontainment engineering principles may be outdated. Expert representation on this 15 member group has been sought from relevant academic, public and private sectors. This group challenged engineering requirements during the development of the Canadian Biosafety Standards and Guidelines resulting in more relevant and germane requirements.

It was noted, through key informant interviews and the document review, that managing the expectations of some stakeholders remains a challenge. The Centre for Biosecurity has developed a series of strategies recognizing the characteristics and contexts that affect specific regulated groups or parties (e.g. academic sector, Government of Quebec).

• Given their specific context, it may be a challenge to achieve transformative buy-in from some newly regulated parties such as the academic community. Key informants indicated that there are unique concerns within this community: the potential for increased costs can create apprehension given that much of their funding comes from grants, and some scientists are reticent to accept regulations that might be perceived as interfering with their research. To address these concerns, consultations with this community are ongoing and have been targeted at various levels (Vice Presidents of Research, Principal Investigators, and Biosafety Officers) to help reach a common understanding and way forward.
• In 2009, the Québec Minister of Health expressed constitutional concerns (authority of the federal government to regulate in this area) regarding the Human Pathogens and Toxins Act. Since then, there has been liaison and collaboration between the Centre for Biosecurity and the Government of Québec. Senior-level discussions resulted in the Public Health Agency moving forward with consultation workshops in Québec in June 2012 with the private sector, and a commitment from the Government of Québec to consult independently with their public sector laboratories. The Government of Québec has agreed to meet with the Public Health Agency again in the near future to discuss consultation feedback and implementation concerns, including potential overlap and duplication with existing program in Québec.

Fiding #7 - Enhancing stakeholder awareness of the regulatory requirements is a fundamental component of the biosecurity program. Program activities have led to greater awareness of biosafety and biosecurity practices within laboratories in Canada.

The Centre for Biosecurity has adopted and operationalized the philosophy that "compliance awareness" or raising awareness about the value of compliance will lead to an increased likelihood of compliance with biosafety/biosecurity guidelines and regulations. This theory of change, also articulated in section 2.3.7 of the Canadian Biosafety Standards and Guidelines, states that "regulatory compliance requires an understanding of the relevant legislation and regulations".^{Endnote 30}

Compliance promotion is a proactive approach to achieving compliance through education and information sharing. This approach includes assisting regulated parties in understanding their obligation to comply with legislative requirements and/or providing training on how to meet those requirements. On the other hand, compliance monitoring involves verifying that regulated activities are carried out in accordance with the provisions of the relevant Acts and Regulations. The Centre for Biosecurity monitors compliance in a number of ways including: conducting on-site inspections, verifying shipping and custom declaration documents, and evaluating biosafety programs. Finally, enforcement action may be taken where non-compliance is identified (see next finding on compliance).

The Centre for Biosecurity has carried out a number of engagement activities to enhance awareness among stakeholders. A recent survey of regulated organizations registered with the Public Health Agency indicates that work to engage stakeholders has had considerable reach: 66% (307 out of 464) of respondents from all sectors indicated that they had been engaged through at least one of the engagement activities used by the Centre for Biosecurity (i.e. consultations, training, processing import permit requests, and inspections) while 34% (157 of 464) of respondents said they had been engaged in none of these activities. Of those who had been engaged, 83% (194 out of 235) of respondents who answered this question indicated that they have an increased awareness about biosafety and biosecurity in a laboratory environment as a result of the Centre for Biosecurity's engagement with them over the past four years.

Consultation and Engagement

Consultations have been one of the main activities that the Centre for Biosecurity has used to raise awareness and promote knowledge and understanding among stakeholders about the development of the Human Pathogens and Toxins Regulations, including the development of the Canadian Biosafety Standards and Guidelines. As noted in the previous section, the consultations have been identified as having been well planned, meaningful and comprehensive. This process has been positively described by many key informants, both internal and external to the Public Health Agency. The Centre for Biosecurity also developed sector-specific engagement strategies for the academic sector and for sector associations tailored to the specific characteristics and context affecting each regulated group.

Training

As part of its work to promote compliance and reduce the risk to public health and safety, the Centre for Biosecurity has been providing biosafety training and resources for those who work with human pathogens and toxins. These tools have helped standardize laboratory procedures and mitigate risks, contributing to biosafety and biosecurity practices that strengthen safe handling of pathogens and toxins, which in turn, protects the general public.

The Centre for Biosecurity recently launched a new Biosafety e-Learning and Training Resources Portal (www.publichealth.gc.ca/training/) which has over 4200 registered users. The portal provides a one-stop shop for the online delivery of biosafety training and resources for individuals working in laboratory containment facilities in Canada. It has been used to help promote the compliance of regulated parties with the Human Pathogens Importation Regulations and sections of the Human Pathogens and Toxins Act in force. The types and content of the training materials have been informed by gaps/needs analyses through environmental scans (see section 4.5.4).

Overall there has been a high degree of satisfaction with these online tools. In a recent survey of regulated parties, 44% (174 of 398) of respondents indicated that they had used these online tools in the last five years. Over 83% (142 of 171) of the users of these tools indicated that they were either satisfied or very satisfied with these online training tools. Finally, 95% (161 of 170) of users indicated that they would continue to use these training products in the future as they find the material very useful and relevant.

Some stakeholders and Centre for Biosecurity staff indicated that moving forward, future opportunities for collaboration could be further explored. Biosafety and biosecurity training across Canada is not consistent in terms of both its content and delivery across jurisdictions and sectors.

• Some key informants suggested that there may be potential benefit in embedding training within the curricula of biological science educational programs.
• Other key informants highlighted that there may be potential benefits in having this key program component delivered either in partnership or working with a third party (with academic institutions, other labs).

Increased consultation and collaboration with other entities that offer education and training programs in biosafety and biosecurity may be desirable to support the long-term sustainability and effectiveness of the training available across the country. This approach would continue to build upon existing initiatives, thus leveraging the strengths and capacities of different actors.

Participating in Collaborations and Networks

Awareness efforts have consistently involved working with other collaborators (both internal and external to the Public Health Agency). Examples of recent collaborative activities include:

• development of a pilot training program with Carleton University and the University of Bradford (UK)
• leadership in the Annual Canadian Biosafety Symposium
• involvement at the Canadian Food Inspection Agency's Annual Safety Meeting
• participation at the Ontario Biosafety Officers Annual Meeting and the Eastern Biosafety Meeting
• engagement with the federal/provincial/territorial Canadian Public Health Laboratories Network (CPHLN) and its Biosafety Officers Network (BSON)
• development of the terms of reference for the Academic Biosafety Network (ABSON), being led out of the University of Alberta
• engagement with the Canadian College of Microbiologists (CCM) and the Canadian Association for Clinical Microbiology and Infectious Diseases (CACMID)
• maintenance of a close engagement and collaboration with the National Microbiology Laboratory.

Disseminating Information Products

Another way the Centre for Biosecurity has promoted awareness and understanding of biosafety and biosecurity requirements is through the dissemination of information products.

• The publication and distribution of updates of the Laboratory Biosafety Standards document has been a key deliverable since 1990, including major updates in 1996 and 2004. In 2013, those standards were harmonized with two other Canadian standards for the handling and storing of human and terrestrial animal pathogens into the Canadian Biosafety Standards and Guidelines (see section 4.5.2).
• The Centre for Biosecurity has also disseminated useful information through of a variety of other products, including: Pathogen Data Sheets and advisories on emerging human pathogens. One key way the Centre for Biosecurity disseminates information is through its online web-based resources. The Centre for Biosecurity web pages have seen increased traffic over the last three years.

The web analytics graph below shows a spike in the number of visits to the section on standards and guidelines coinciding with the release of the updated Canadian Biosafety Standards and Guidelines in July 2013. Since February 2011, there have been 28,000 visits, 74,000 page views, and 4,000 PDF downloads. The average visit duration is two minutes and 48 seconds and an average of 2.7 pages viewed per visit.

Figure 1: Centre for Biosecurity Web Analytics

Enlarge Figure 1

Similarly, the main Public Health Agency entry page to information on laboratory biosafety and biosecurity has experienced a steady increase in visits. Since February 2011, there have been 1.5 million visits, 2.2 million page views, and 11,000 PDF downloads of various applications for permits. The average visit duration was one minute, and 52 seconds. An average of 1.7 pages were viewed per visit. The majority of visitors come to the Pathogen Safety Data Sheets and Risk Assessment homepage and proceed to view one of the data sheets during their visit. As mentioned, this entry page accounts for approximately 7% of the Public Health Agency website visits.

Figure 2: Public Health Agency Web Analytics

Enlarge Figure 2

Finding #8 - There are indications that "compliance awareness" activities have led to increased compliance by regulated parties.

The Centre for Biosecurity's compliance and enforcement approach is premised on a compliance awareness strategy, i.e. playing a supportive educator role in assisting stakeholders to achieve program goals rather than through strict regulatory enforcement (such as permit cancellations or penalties). Similar approaches are being adopted internationally as well. At a recent International Export Control Cooperation and Outreach Dialogue event in Belgium (June 2013), participants highlighted that compliance promotion and risk-based approaches were often more cost-effective methods to achieve regulatory compliance.Endnote 31

Chapter two of the Canadian Biosafety Standards and Guidelines states that "an effective biosafety program will promote and reinforce safe work practices, improve safety performance, and increase regulatory compliance through a combination of training, documentation, inspections, evaluation, review and clear communication".^{Endnote 32} The Centre for Biosecurity has had a long tradition of providing guidance and advice to regulated parties through its program activities. Its approach is to work with the regulated party to support laboratory compliance with biosafety standards and guidelines.

The value of compliance awareness is also reflected in Section 1.2 (Regulatory Authorities) of the Canadian Biosafety Standards and Guidelines.Endnote 33 It states that the Public Health Agency and the Canadian Food Inspection Agency will review non-compliance items on a case-by-case basis and will determine, in consultation with regulated parties, a timeframe for compliance based on the level of risk and the risk mitigation strategies in place for these items. The Centre for Biosecurity implements a risk-based approach to its enforcement interventions. Interventions take into consideration several factors, including the level of risk or potential risk posed by the incident, compliance history of the party, whether the act is one of indifference or premeditation, the likelihood of the problem reoccurring, and finally the anticipated outcome of the enforcement action itself. The primary objective of the Centre for Biosecurity's enforcement action is to manage the risk and have the regulated party comply with the Acts and Regulations using the most appropriate level of intervention, starting from the least intrusive level of intervention to the most invasive. It may respond to non-compliance through one or a combination of tools at its disposal: Notice of Non-Compliance, cancellation of an importation permit, and seizure and detention.

Survey data suggests that recent engagement activities have increased awareness and led to changed behaviour. 71% (181 of 234) of survey respondents indicated that their organization had adopted additional safety practices as a result of their engagement with the Centre for Biosecurity, including addressing physical containment requirements and/or operational practices, in line with the 2013 Canadian Biosafety Standards and Guidelines. The types of changes reported include: instituting mandatory training and enhancing awareness among staff; strengthening controlled access to certain areas; and enhancing documentation like standard operating procedure (SOPs) and manuals. Many of the remaining 29% (53 of 234) of survey respondents reported that their organization was already in line with the requirements.

Since the Human Pathogens Importation Regulations came into force in 1994, there have been no significant enforcement actions taken to date, such as the revocation or suspension of a permit imposed. Also, very few administrative enforcement measures have been applied. There have been only five notices of non-compliance issued: one in 2010 for illegal importation; two in 2011 for illegal importations; one non-compliance identified during an inspection in 2012; and one in 2013 for illegal importation. Since the current Human Pathogens and Toxins Act came into force in 2009, there has been only one prosecution. In 2013, a former Canadian Food Inspection Agency scientist was charged after one was allegedly trying to export 17 vials of live brucella bacteria to China.Endnote 34

4.4.2 To what extent have support systems been put in place to facilitate implementation of the regulations?

Finding #9 - The Centre for Biosecurity is learning from previous operational challenges and is working to develop and implement practical solutions that will mitigate the administrative impact of the Human Pathogens Importation Regulations, Human Pathogens and Toxins Act and future Human Pathogens and Toxins Regulations for their stakeholders.

The analysis of support systems included a review of operational activities that are currently in place for implementation of the Human Pathogens Importation Regulations (1994) and Human Pathogens and Toxins Act (2009), as well as activities being undertaken to develop support systems in advance of the coming into force of the Human Pathogens and Toxins Regulations in 2015. Support systems reviewed included: registration, compliance/certification letters, import permits, inspections, security clearances, exposure reporting, and an advisory committee.

Registration, Compliance/Certification Letters, and Import Permits (Active and Planned)

When the Human Pathogens and Toxins Act came into force in 2009, it included a requirement for all persons responsible for activities with human pathogens and toxins to register their facilities within 90 days. An extensive media campaign was launched to broadcast the requirement to register by the deadline. In October 2013, there were over 1000 entities registered with the Public Health Agency. A recent survey of these registrants has helped to update this database of regulated parties.

The Public Health Agency has been implementing the Human Pathogens Importation Regulations since they came into force in 1994. To obtain a permit to import a RG-2, RG-3 or RG-4 pathogen, regulated parties must first apply to obtain a Compliance Letter (for CL-2 facilities) or a Certification Letter (for CL-3 or CL-4 facilities). (An outline of these steps is provided in Appendix 5). Before issuing letters or permits, the Centre for Biosecurity works with each applicant to review current biosafety standards and guidelines to help the laboratory meets the requirements. The Centre for Biosecurity receives many emails and telephone calls from regulated parties with questions about the requirements and the applications.

To obtain a Compliance Letter, organizations must first complete a self-assessment checklist and provide the required documentation. The submission is reviewed then approved by the Public Health Agency. A letter is issued to the principal investigator for the room in which they will be working with the pathogen. Compliance Letters need to be renewed every two years and Certification Letters need to be renewed annually. Because they work with regulated parties (compliance awareness), to date the program has not had to turn down an application for a Compliance Letter or a Certification Letter. Annually, the Public Health Agency issues about 1000 Compliance Letters and 70 Certification Letters. As mentioned, since 2009 only four routine letters of non-compliance have been issued.

Once they have a letter, the investigator can then apply for an import permit or a transfer letter for the pathogen. The review/approval of these permit applications includes a Public Health Agency review before they are approved. Import permits for CL-2 pathogens are valid for 12 months and are multiple entry, while permits for CL-3 or CL-4 pathogens are valid for three months and are single-use. Annually, the Public Health Agency issues between 800-1000 CL-2 permits, between 65-100 CL-3 permits, and 0-2 CL-4 permits.

With the full implementation of the regulations for the Human Pathogens and Toxins Act, there will be a new risk-based licencing program for laboratories. Instead of both letters and permits, laboratories will be required to apply for one or more licences. A separate licence will be required for toxins and RG-2 human pathogens, RG-3 human pathogens, RG-4 pathogens, and for Security Sensitive Biological Agents (SSBAs). Licences will authorize activities (not limited to import) with RG-2 pathogens and non-SSBA toxins for five years; three years for RG-3 human pathogens and SSBA toxins, and one year for RG-4 pathogens. The approach for this licencing program is being developed in consultation with regulated parties and other stakeholders. It is expected that this new approach, while time intensive at the outset, will reduce the administrative burden on regulated parties and improve operational efficiency within the Centre for Biosecurity. The Centre for Biosecurity is currently conducting a cost-benefit analysis to better detail these efficiencies.

Inspections (Active and Planned)

In the past, only laboratories that imported pathogens under the Human Pathogens Importation Regulations were inspected. Since the Human Pathogens and Toxins Act came into force in 2009, all domestic laboratories that work with RG-2, RG-3 or RG-4 pathogens must follow the federal standards and guidelines for biosafety. With an increased number of laboratories being regulated, it is anticipated that this expanded mandate will lead to a similar increase in the number of laboratory inspections that will be required as well.

There has been a flexible risk-based approach taken to prioritizing inspections. Both CL-4 laboratories in Winnipeg, Manitoba (Canadian Science Centre for Human and Animal Health) are inspected annually. For CL-3 laboratories, the trend over the last five years has been 13-15 laboratories inspected annually. All new CL-3 laboratories are initially inspected before they are issued a letter or a permit. They are also inspected if there are any major modifications. Currently, the majority of inspections are for brand new laboratories. In the recent past, there have been relatively few inspections of CL-2 laboratories (four in 2011-12 and ten in 2012-13). Triggers for inspection have been: the types of activities taking place in the laboratory (types of pathogens); the laboratory's history of compliance (CL-3 and CL-4 receive higher scrutiny); as well as rare tips received from other departments for spot checks.

The Centre for Biosecurity inspectors work closely with the organization's Biosafety Officers to help enhance laboratory compliance with the biosafety standards and guidelines. Each inspection may take a day or two and involve up to three inspectors. Public Health Agency key informants indicated that, with advice and guidance from inspectors (compliance awareness), any missing requirements tend to get resolved within a month or two. Leading up to inspections, Centre for Biosecurity staff work with laboratories to offer guidance and support (for examples: reviewing drawings, reviewing procedures, and answering questions about ventilation and controls).

Over the past few years, operational resources have focussed on capacity building, including the training of new inspectors. An expanded requirement for inspections is expected with the implementation of the Human Pathogens and Toxins Regulations starting in 2015. Currently, the CL-2 inspection program is comprised of two lead inspectors and an additional six inspectors with varying levels of experience. Each new inspector trainee must partake in three site visits (first as an observer, then as a participant, and finally as the lead) under the supervision of a lead inspector. With respect to the high-biocontainment laboratory inspection program, which involves CL-3 and CL-4 laboratories, there are a total of nine inspectors, six of whom are trained as leads. Due to the increased complexity and potential risks associated with these facilities, each new CL-3/CL-4 inspector trainee must partake in four site visits (first as an observer, then as a participant, and finally two as the lead) under the supervision of a lead inspector. Inspectors within each program need to be exposed to a variety of environments to be able to respond to evolving biosafety technology and practices. When training inspectors, there is a focus on compliance awareness as a key element of this role.

Security Clearances (Planned)

With the full implementation of the Human Pathogens and Toxins Act, there will be a requirement for those who enter a part of a facility in which controlled activities relating to Security Sensitive Biological Agents (SSBAs) have been authorized to hold a security clearance. In terms of the internal administration of the "HPTA security clearances", the Centre for Biosecurity will leverage existing security management infrastructure within the Health Portfolio to conduct security clearances for employees.

The Centre for Biosecurity has been actively working with the Royal Canadian Mounted Police (RCMP), the Canadian Security Intelligence Service (CSIS) and the Departmental Security Office of the Security Management Division of Health Canada, to develop effective working arrangements to administer "HPTA security clearances" for individuals working with SSBA's. Key informants from these federal organizations have indicated that communication from the Centre for Biosecurity has been well managed from the start. There have been numerous bi-lateral meetings, lots of lead time to put arrangements in place, and a strong emphasis on building effective working relationships.

As these activities are part of the routine operations of these organizations, an MOU will be put in place to establish the parameters of this working relationship. It is anticipated that requests for information will be made by the Health Canada Security Management Division to the RCMP through a secure internet portal. The Canadian Police Information Service (RCMP) will perform a criminal records check and the Security Intelligence Background Section (RCMP) will provide information regarding an individual's criminal history. CSIS will provide information as to whether or not an individual constitutes a terrorist threat, is a spy or is involved in proliferation activities in any way. There will be a 20 day and 10 day service standard to turn around routine applications for RCMP and CSIS respectively, with longer turn around times possible depending on the complexity of each request. The decision to approve or deny the clearance rests with the Minister of Health's delegate. Clearances will be valid for up to five years.

Some external key informants (regulated parties) expressed concerns about the potential negative impact on their work of having to apply for clearances for individuals working with SSBAs. Their concerns related to the potential for an additional administrative burden taking time away from their research or, more critically, potential delays in obtaining clearances impacting on their ability to conduct or complete research. The Centre for Biosecurity is aware of these concerns and has been actively working with impacted parties to address their concerns and balance their needs with the security objectives of the HPTA.

Exposure Reporting (Planned)

Historically it has been recognized that there has been limited data available on the number and types of incidents of LAIs (laboratory acquired infections) domestically and internationally. The literature review confirmed that, currently in Canada, there is limited data available on the rates of LAIs.

With the full implementation of the Human Pathogens and Toxins Act, there will be an "exposure reporting" requirement for all regulated parties. A licence holder will be required to inform the Public Health Agency without delay if there is reason to believe that an incident involving a human pathogen or toxin in the licence holder's possession has or may have caused a disease in an individual. In addition, the licence holder will be responsible for completing an investigation into the exposure incident and for completing a follow up report through an online reporting tool. The follow up report will be required within 30 days for most incidents. Currently there is no formal requirement to report incidents to the Public Health Agency, however the Centre for Biosecurity has communicated to regulated parties that it is available to provide advice and guidance.

Since February 2013, the Centre for Biosecurity has established a separate program to formalize tools and processes to address the future requirement for reporting of exposures. To help develop effective approaches and clarify expectations, consultation with regulated parties and other stakeholders is ongoing. The Centre for Biosecurity intends to establish a baseline on incident rates in Canada (by 2017) and learn from these incidents to enhance future biosafety policies and practices.

Advisory Committee (Planned)

Under the Human Pathogens and Toxins Act, the Minister must consult an advisory committee before making or recommending additions to or deletions of pathogens or toxins from Schedules 1 to 5 of the Human Pathogens and Toxins Act. The requirement to consult an advisory committee was an amendment to Bill C-11, brought forward by the Standing Committee on Health, due to stakeholder concerns regarding transparency in decision-making that may have administrative and compliance cost implications for regulated parties. The Advisory Committee will also have an expanded role in providing other scientific advice or recommendations that will assist in addressing domestic and international biosafety and biosecurity risks.

Secretariat support will be provided by the Centre for Biosecurity. The advisory committee will consist of a Chair and up to 11 additional members. Voting members will be external to the federal government. The advisory committee will meet in person once per year and via teleconference once or twice a year, or as necessary, to conduct business.

The Centre for Biosecurity has been working to identify committee members and coordinate the timely launch of this advisory committee. The process for getting nominations for and selecting the chair were completed in 2013, the process for nominating the 12 experts with backgrounds in virology, bacteriology, prions as well as different categories of pathogens is expected to be complete in 2014. It is anticipated that this committee will be in place by December 2014.

4.4.3 To what extent has the Centre for Biosecurity adapted to changing needs in the context of biosafety and biosecurity in Canada?

Finding #10 - The current risk landscape is becoming more complex. The Centre for Biosecurity has sought out opportunities to engage other stakeholders to focus on issues in this evolving field that are relevant to its regulatory role.

Synthetic biology is a new area of research that combines engineering principles with biology. It aims to design and produce new biological systems with improved biological function, able to fight current and future challenges. The first successful attempt to synthetize artificial life forms was made in 2010 by researchers at Craig Venter Institute (United States) who were able to inject man-made DNA into a single bacteria cell, which then grew and divided. Globally, an expansion in accessibility to pathogens and enabling technology has led to considerable growth in this field of research. Synthetic biology is also gaining global interest as a potential public health and environmental risk. A number of unintended consequences have been identified.^{Endnote 35}

• There is a risk of potential dual-use of legitimate scientific research for malevolent purposes. An example is the controversial research conducted in United States and the Netherlands that resulted in the creation of an engineered H5N1 bird flu virus that is easily transmissible by aerosols to ferrets (the best animal model for human disease). The research findings have led to a broader debate among the life-science and biosecurity community about whether this research should have been conducted. The main concern was that if the easily transmissible virus were released into the public, there would be global devastation. The event indicated a need for better oversight of research with potential for dual-use.^{Endnote 36,Endnote 37}
• Experiments with pathogens of a certain biosafety level could, unintentionally, lead to the creation of new pathogens of elevated safety risk for which the laboratory biosafety measures may be inadequate. A good example is the Australian mousepox experiment: recombinant DNA technology created to induce sterility for pest control resulted in development of a lethal strain of the mousepox virus that killed all the mice.^{Endnote 38}
• Some genetically modified organisms could carry antibiotic resistance genes and power the evolution of new drug-resistant pathogens.^{Endnote 39}

Wider access to biotechnology tools has contributed to a growing movement known as "do-it-yourself" biology (DIYbio). The limited information about this research community has raised biosafety and biosecurity concerns.^{Endnote 40} The first ever survey, conducted in 2013 by an international group of scholars, found out that the DIY biology practitioners are a well-networked community that on average is younger and more educated than the general population. They are more likely to work in shared labs and prefer to share their accomplishments over the internet. Aware of the potential biorisks, the community is actively engaged in developing codes of conduct, safety protocols and is discussing the various regulations that may affect it. As the DIYbio movement continues to grow, greater and different oversight may be required.^{Endnote 41}

Following the international trend, Canadian research in synthetic biology is rapidly growing. The document review and key informant interviews highlighted that Canada is represented in international events such as the International Genetic Engineering Machines (iGEM) - a global undergraduate synthetic biology competition.

Canada has been responsive to increased international efforts to enhance the safe pursuit of life sciences research. From the early stages, the Centre for Biosecurity understood the significance of this new research field as well as the possible biosafety and biosecurity implications. In 2011, the Centre for Biosecurity initiated a dialogue with other Government of Canada colleagues to examine the legislative and regulatory frameworks in Canada, to identify overarching considerations, and make suggestions for how to approach the issue of oversight of synthetic biology. As a result of this dialogue, a Director General-level Interdepartmental Synthetic Biology Steering Committee was established, supported by a Synthetic Biology Working Group, with the objective to address key questions and obtain senior management consensus on a forward plan. The Centre for Biosecurity is co-chairing this committee, along with the Public Health Agency's Chief Science Officer. It was agreed that risks posed by the advancements in the field of synthetic biology need Government of Canada and interdepartmental attention with a focus on education as well as global engagement. A legislative and regulatory review confirmed that the Public Health Agency has the authority to address some aspects of the issue. The proposed plan will allow the Government of Canada to contribute to the mitigation of the risk while recognizing the benefits.^{Endnote 42,Endnote 43,Endnote 44}

In 2012, the issue of synthetic biology was integrated in the Public Health Agency's Corporate Risk Profile and in 2013 it was included in the first edition of the Canadian Biosafety Standards and Guidelines. The issue was also presented to the Executive Committee who supported the work done to date by the Centre for Biosecurity with its federal colleagues.Endnote 45 Future work in this field is on the way. The Centre for Biosecurity is leading the development of a Government of Canada Synthetic Biology Framework (2014) and the publication of a Synthetic Biology Guidance Document (2015).

Through the Centre for Biosecurity, the Public Health Agency is including synthetic biology as part of a larger conversation nationally and internationally on effective pathogen control. The activities are focused on facilitating discussions and educating the researchers and the public about dual use potential. The Centre for Biosecurity raised awareness on biosafety at the International Genetically Engineered Machine (iGEM) Competition as a member of the safety committee and a judge for Human Practices. Through this work, the Centre for Biosecurity led the development of iGEM's biosafety questionnaire which guided participants in clearly identifying the risks associated with their work, from a biosafety and biosecurity perspective, as well as mitigation strategies that can be used. The Public Health Agency also continued to discuss this matter at international forums such as: the Biological Toxins and Weapons Convention, the World Health Assembly, the Global Health Security Initiative, and the Australia Group.^{Endnote 46}

4.5 Performance: Issue 5 – Demonstration of Economy and Efficiency

The Treasury Board of Canada's Policy on Evaluation (2009) and guidance document, Assessing Program Resource Utilization When Evaluating Federal Programs (2013), defines the demonstration of economy and efficiency as an assessment of resource utilization in relation to the production of outputs and progress toward expected outcomes. This assessment is based on the assumption that departments have standardized performance measurement systems and that financial systems link information about program costs to specific inputs, activities, outputs and expected results.

The data structure of the detailed financial information provided for the program did not facilitate the assessment of whether program outputs were produced efficiently, or whether expected outcomes were produced economically. Specifically, the lack of output/outcome-specific costing data limited the ability to use cost-comparative approaches. In terms of assessing economy, challenges in tracking funding within the broader program envelope limited the assessment. Considering these issues, the evaluation provided observations on economy and efficiency based on findings from the literature review, key informant interviews and available relevant financial data.

In addition, the findings below provide observations on the adequacy and use of performance measurement information to support economical and efficient program delivery and evaluation.

4.5.1 Observations on achievement of regulatory excellence

Finding #11 - Throughout the development of the proposed Human Pathogens and Toxins Regulations, the Public Health Agency has addressed or exceeded the requirements for regulatory reform codified in the 2012 Cabinet Directive on Regulatory Management and outlined in the Red Tape Reduction Action Plan.

When creating regulations, the Government of Canada must follow the requirements set out in the 2012 Cabinet Directive on Regulatory Management. In October 2012, Canada released the Red Tape Reduction Action Plan. The Directive incorporates the regulatory reforms outlined in the Red Tape Reduction Action Plan and sets out a list of requirements for creating regulations and provides direction to federal regulators on implementing systemic regulatory reforms.

The Centre for Biosecurity has demonstrated that it addressed the standards set out by the Cabinet Directive on Regulatory Management (see Annex C). It volunteered to participate in the pilot of the Red Tape Reduction Action Plan. This Action Plan consists of three themes: 1. Reduce burden on business; 2. Make it easier to do business with regulators; and 3. Improve service and predictability.

1. Reduce burden on business

The Government of Canada has committed to reducing regulatory burden. This is done by using two strategies: "One-for-One Rule" and "Small Business Lens".

The One-for-One rule aims to reduce regulatory burden in two ways: remove a regulation when a new one is set in place; and when a new or amended regulation increases administrative burden on business, there should be an offset with an equal amount of administrative burden cost on business. The Public Health Agency will comply with the One-for-One by repealing the Human Pathogens Importation Regulations (1994) once the Human Pathogens and Toxins Regulations come in to force. The expected short term increase in administrative burden on business will be partially offset by administrative burden reduced when repealing the Human Pathogens and Toxins Regulations. The remainder will be offset using the Health Portfolio's bank of administrative burden savings.Footnote C As previously stated, the Centre for Biosecurity has developed the proposed regulations and will develop an implementation plan in such a way as to minimize burden for regulated parties (see section 4.5.2).

The Small Business Lens requires regulators to take into account the impact of the new or amended regulations on small businesses. As noted, stakeholders, including small businesses, have had the opportunity to provide input into the development of the regulatory framework. The Centre for Biosecurity has taken this input into account to minimize the administrative burden related to the regulations and their implementation. For example, during 2010-11, the Centre for Biosecurity worked with a small biotechnology company in Prince Edward Island to address challenges they were having with regulatory processes related to their work, which were potentially impacting their ability to remain competitive. The Centre for Biosecurity convened all implicated regulatory departments as well as Industry Canada in an effort to better understand the challenges and needs of small to medium business enterprises and streamline compliance promotion and monitoring activities, and enhance information sharing.

2. Make it easier to do business with regulators

Treasury Board Secretariat will require all departments and agencies to publish policies setting out how they interpret their regulatory requirements. These policies are to provide clarity on how regulators interpret regulations.

The Centre for Biosecurity has been developing these policy documents to support the implementation of the Human Pathogens and Toxins Regulations in 2015. These documents etail the scope, definitions, and implementation of the proposed regulations. Importantly, with a view to bringing into force a minimal number of regulations, a mix of policy instruments will support the full implementation of the Human Pathogens and Toxins Act including: updated standards and guidelines, training resource materials, and a new advisory committee.

3. Improve service and predictability

The Government of Canada has committed to improving service and predictability. The Public Health Agency has been able to fulfill these commitments through the use of the following three strategies:

a) Service standards

To help increase predictability in the regulatory system, the government will develop service standards for high-volume regulatory authorizations (e.g., permits, licences and certifications) that specifically address the timeliness of decision making.

The Public Health Agency has posted on its website a commitment to a service delivery standard of 20 business days for the issuance of a permit to import human pathogen(s) from the receipt of a complete application and any additional information or materials requested. Service standards, performance targets and results are also posted. Going forward, the Centre for Biosecurity will develop additional service standards for relevant regulatory authorizations as the new framework comes into force.

b) Forward planning

A forward regulatory plan is a description of anticipated regulatory changes or proposals that a department or agency intends to bring forward within a particular time frame. Annually, forward regulatory plans, describing upcoming regulatory proposals for the next two years, are to be made available to the public on each department's and agency's website. The Public Health Agency published its first Forward Regulatory Plan in March 2013.

The Public Health Agency has improved transparency by posting anticipated regulatory changes for the Human Pathogens and Toxins Act and Regulations on its website. In addition, in the Public Health Agency's most recent five-year strategic plan (Strategic Horizons 2013–2018), there is a commitment to a more inclusive and comprehensive approach to engaging stakeholders. A comprehensive consultation strategy, for the development of the Human Pathogens and Toxins Regulations, was created through the use of a national pre-consultation (phase one of four) and ongoing engagement with provincial and territorial counterparts.

c) Annual Scorecard Report

To demonstrate results to business and to Canadians, in an open and accountable way, an Annual Scorecard Report will be published to show how regulators are implementing the regulatory reform initiatives. It will also showcase highlights of flexibility provided to small business and service performance improvement measures. The first Annual Scorecard Report for the Health Portfolio was published in the fall 2013 and showed that the Public Health Agency met 100% of requirements.

To summarize, the Centre for Biosecurity has been a proactive leader federally in its pursuit of regulatory excellence. As detailed above, it has demonstrated that it achieved the objectives that are included in the Red Tape Reduction Action Plan. While the proposed Human Pathogens and Toxins Regulations will result in an increase in administrative burden, this cost has been minimized to the extent possible while ensuring that the health and safety of Canadians is not compromised. In 2012, the Centre for Biosecurity received the Community of Federal Regulators award for regulatory excellence in "Service Excellence in Program Delivery". With a view to engagement and sharing lessons learned in regulatory practice among federal departments, it co-chaired the Community of Federal Regulators (CFR) Compliance and Enforcement Community of Practice from 2011-13.

4.5.2 Observations on recent initiatives linked to economy and efficiency

Finding #12- There have been several initiatives launched and/or implemented recently that have enhanced the economy and efficiency of the delivery of activities to support the implementation of the regulatory activities within the Centre for Biosecurity.

Harmonization of Standards

Joint collaboration between the Canadian Food Inspection Agency (CFIA) and the Public Health Agency on the harmonization of standards culminated in July 2013 with the release of a streamlined publication that updated and consolidated into a single publication three previous standalone standards and guidelines for human and terrestrial animal pathogens:

• Public Health Agency's Laboratory Biosafety Guidelines, 3rd Edition (2004),
• CFIA's Containment Standards for Veterinary Facilities 1st Edition (1996), and
• CFIA's Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Animal Prion Disease Agents, 1st Edition, (2005).

This single reference document – the "Canadian Biosafety Standards and Guidelines, First Edition" – details the requirements for the design, construction, and operation of facilities in which pathogens or toxins are handled or stored. Stakeholders, through key informant interviews and survey responses, indicated that this harmonization has saved considerable time and effort in referencing regulatory requirements for laboratory safety.

Merge with Related Canadian Food Inspection Agency Functions

Effective April 1st 2013, some of the CFIA's Office of Biohazard Containment and Safety (OBCS) functions were transferred to the Public Health Agency's Centre for Biosecurity. This transfer of authority for regulatory oversight of terrestrial animal pathogens was undertaken to reduce the overlap, duplication and administrative cost burden for regulated parties. Key informants, including respondents to the survey of regulated parties, indicated that administrative efficiencies have been gained by providing a single window for client service delivery for most human and animal pathogens. In terms of issuing importation permits, for example:

• only 12 CL-3 facilities previously subject to dual regulation (out of a total of 78) will continue to have Canadian Food Inspection Agency review their documentation
• all CL-3 facilities previously subject to dual regulation will now communicate directly with the Public Health Agency as their single window
• all 28 TSE (Transmissible Spongiform Encephalopathy) facilities will communicate and be certified solely by the Public Health Agency who is their single window for compliance verification (17 out of 28 had dual oversight by the Public Health Agency and CFIA previously).

Non-indigenous animal pathogens or emerging animal disease pathogens that are also human pathogens continue to be regulated by both the Public Health Agency and the CFIA.

Single Window Initiative^{Footnote D}

The Canada Border Services Agency (CBSA) has a long history of supporting the Public Health Agency on the administration of Human Pathogens Importation Regulations by facilitating verifications of importation permits at the border. The Public Health Agency has been participating in a multi-departmental electronic Single Window Initiative project led by the CBSA. Currently, the CBSA administration of the Public Health Agency pathogens and toxins import permits requires that CBSA staff physically review a paper-based permit document to determine if a shipment is accompanied by a valid import permit.

Adopting an electronic system for communication about controlled human pathogens and toxins between the Public Health Agency and the CBSA, that also aligns with Public Health Agency's human pathogen importation regulatory processes and the CBSA trade requirements, is expected to:

• improve the ability of the Public Health Agency and the CBSA to identify high-risk human pathogens before they reach the border, while facilitating the efficient flow of low risk human pathogens across the border
• reduce the time spent by regulated parties in reporting information, and obtaining appropriate and timely information regarding regulated goods importation processes
• more efficiently address threats and hazards that are critical to the health and safety of Canadians.

In addition, activities under the Single Window Initiative have been identified as one of 32 joint priorities in support of the Beyond the Border Initiative with the United States (for more information on Beyond the Border: A Shared Vision for Perimeter Security and Economic Competitiveness, see section 4.2.2).

PDF smart form for CL-2 import permits

In April 2013, based on suggestions from regulated parties, the Centre for Biosecurity introduced a new PDF smart form for import permit applications for CL-2 pathogens and toxins^{Footnote E}. This form, once signed, can be scanned and submitted electronically by email. Before this new approach was introduced, stakeholders were required to complete hand written forms and submit them via facsimile.

Key informant interviews and survey results indicated that stakeholders appreciate the time and effort saved because of this new form/approach and indicated it is: quicker, simpler, shorter, and more concise. Internally, key informants also mentioned the value of having a "greener" process that provided a truer original than the faxed copies, especially with greater resolution for signatures.

In a recent stakeholder survey, when asked to indicate their overall satisfaction with this new permit email process, 70% (145 of 200) of respondents were "very satisfied" or "satisfied" (14% were "neutral", 16% indicated the question was "not applicable"). Of note, respondents offered a number of suggestions to continue to improve upon the efficiency of the approach taken. For example, some suggested that they would like more clarity on some of the questions on the form and the ability to re-use or update previously typed submissions, especially when no major changes have occurred since the last submission.

Electronic system for reviews and approvals

In 2011, the Centre for Biosecurity implemented an internal electronic system (called ISTOP) to enhance the efficiency of the internal review and approval of import permit submissions. The previous approach was paper-based. Internal key informant interviews suggest that this new electronic system has increased the efficiency of the Centre for Biosecurity in both the tracking and handling of stakeholders' requests. The Centre for Biosecurity received a "Service in Excellence Award" from the Community of Federal Regulators in 2012 related to this effort (see section 4.5.1).

Service standards

As mentioned, in 2010, service standards were established for processing the applications for permits to import human and terrestrial pathogens. The service target rate was a 20 business day turnaround to be met 80% of the time. As stated in the "Service in Excellence Award" from the Community of Federal Regulators, the Centre for Biosecurity had achieved a 20-day service standards rate of 94% by 2012 (see section 4.5.3).

Risk-based approach

Adopting a risk-based approach in the execution of its regulatory powers contributes to ensuring that resources (both human and financial) are directed to where the needs and risks are higher. Specifically, the Centre for Biosecurity takes into account the unique characteristics of individual sectors/laboratories and the varying levels of risk posed by the human pathogens and toxins they handle and/or store. This approach means there would be more stringent requirements established for higher risk pathogens and toxins. The previous compliance records of specific laboratories is another consideration. Ultimately, the objective is to strike the right balance between enhanced biosafety and biosecurity in Canadian laboratories, while supporting science and innovation.

All these efforts taken together are expected to allow the Public Health Agency to streamline pathogen control in Canada and direct resources to where the needs and risks are higher.

4.5.3 Observations on operational challenges linked to economy and efficiency

Finding #13 - There are continuing opportunities to enhance the efficiencies of operational processes and tools. In particular, an effective informatics system remains a critical component – and a challenge – to realizing the full success of this program.

Throughout the consultation processes for the Human Pathogens and Toxins Regulations and the Canadian Biosafety Standards and Guidelines, the Centre for Biosecurity emphasized to their stakeholders their intention to develop and implement efficient processes and an electronic interface with regulated parties to help mitigate the burden of current and new regulations. Through key informant interviews and a recent survey, internal staff and external stakeholders expressed an interest in seeing more operational efficiencies, including improvements to service delivery practices and informatics systems.

Service delivery practices

Stakeholders have indicated three areas where the Centre for Biosecurity could continue to make efforts to decrease concerns at the working level through service improvements.

• Enhance service standards – To establish a reference on how program activities will be carried out and to monitor the quality of the services offered to regulated parties, the Centre for Biosecurity developed Standard Operation Procedures (SOP) for permit issuing activities, and initiated a process to develop communication standards. As mentioned, the current service target rate for the processing of applications for compliance/certification letters and permits is a 20 business day turnaround to be met 80% of the time. In a recent survey of stakeholders, only 69% (180 of 261) respondents indicated that the Centre for Biosecurity had met this service standard for their applications. This difference from previous program reporting on the achievement of service standards (94%) could be attributable to a communication issue – the 20-day service standard may be interpreted differently by the Centre for Biosecurity and stakeholders. Some stakeholders indicated that they did not always understand the reasons for delays in the processing of applications. Other stakeholders indicated that they felt that delays were attributed to inconsistency in feedback provided by reviewers, or changes in the application forms and messaging about detailed information required for the new forms. Better communication with regulated parties about content required for forms, and definitions and expectations related to service standards, may alleviate these concerns.
• New tools for compliance – Stakeholders made suggestions to enhance both application forms and develop other tools to support their compliance with regulatory requirements. One suggestion made by survey respondents was to develop online forms with the ability to save, revise/update and submit them electronically. Another suggestion was that more comprehensive electronic information, including checklists and use of innovative tools to deliver this information, would be helpful in responding to frequently asked questions.
• Operational service delivery and advice – Some stakeholders expressed concern about slow response times for requests for information or advice sent via email or telephone. They indicated that it would be helpful to have more timely responses after leaving a message – particularly when stakeholders are completing time sensitive application forms. Concerns were expressed that it could take several days to receive a response to a routine request for information or clarification about the application forms. Internal key informants indicated that informal interactions with regulated parties, such as inquiries and advice communicated through phone calls or emails, has not been systematically tracked or analysed. Establishing a formal electronic tracking system for these types of requests may help to address this concern. Also, clearer communication to stakeholders about anticipated response times and the availability of more electronic information could also be considered.

Informatics systems

Internal staff and external stakeholders indicated that there have been operational challenges with the various approaches and informatics systems that have been used to support the information management needs of the biosecurity program at the Public Health Agency over the past five years. Some of these concerns included: need for more integration of data, inability to access or share some data, multiple electronic and paper-based tracking systems, and forms that are time consuming to complete and submit by stakeholders.

A variety of electronic and paper-based systems have been in place to manage a number of program information needs, including but not limited to: a Lotus Notes system, MS Excel spreadsheets, and a DOS-based card system. In 2011, the Centre for Biosecurity moved to an internal electronic system (called ISTOP) to enhance the efficiency of one line of its business – the internal review and approval of import permit submissions. ISTOP has continued to evolve over the last 2 years, moving from version 1.1 to the current version 1.6. The system has enhanced the internal efficiency of this line of business by providing a more integrated tracking mechanism for staff. One challenge with the current ISTOP system is that it was not designed to produce queries or reports. It was not built as a relational database and therefore it is challenging to pull data from the system for performance measurement to inform business intelligence. There continues to be a variety of electronic and paper-based systems in place to manage various information needs within the Centre for Biosecurity.

One ongoing operational challenge for the Centre for Biosecurity has been the broad "secret" classification of the information it manages. It has meant that many electronic records needed to be restricted to a secure server and paper documents to secure cabinets. Because of password and key requirements, access to some information has been restricted among Centre for Biosecurity staff. In December 2012, a classification review determined that many elements of this information are actually classified as "Protected B or C" and data elements can be separated rather than have all records treated as a "solid security element". It will now be possible to have more flexibility in systems used to store and share information, including the ability to use email. Since informatics solutions have evolved, secure and non-secure data can now be stored in different places with ways to continue to link them.

Internal staff and external stakeholders indicated that a reliable and nimble informatics system will be required for the full operational implementation of the Human Pathogens and Toxins Act in 2015. Since the context for biosafety and biosecurity in Canada continues to evolve, this informatics system will need to be agile enough to respond to future information requirements. Ongoing stakeholder consultations have helped to define the requirements for this system. The vision for this new integrated system (ISTOP 2.0) has been articulated by the Centre for Biosecurity.

The new system will regroup and harmonize a variety of current electronic databases and paper-based information tracking systems. It includes the management of information with respect to the following program elements:

• management and risk level assessment of biological agents
• descriptions of the facilities used by regulated parties
• case management capability for the inspection and review of laboratories
• licence administration
• workflow management for reviewing and acting upon incident reports.

The new system will have a number of benefits:

• It will provide tools for data analysis and reporting (business intelligence), e.g. allow benchmarking and comparisons over time, track service standards, provide information on number and types of pathogens being imported.
• It will provide regulated parties with a secure interface (portal) to interact with the Centre for Biosecurity for more "self-serve" functionality when providing required information for reviews and approvals.
• It will be integrated with the data sharing requirements of the Single Window Initiative (see section 4.5.2), i.e. validation of permits by the Canadian Border Service Agency at the border prior to crossing. Internal key informant interviews have indicated that the Centre for Biosecurity is working closely with the Corporate Services Branch to develop and implement a timely and comprehensive informatics solution to support the full implementation of the Human Pathogens and Toxins Act in 2015.

4.5.4 Observations on the adequacy and use of performance measurement data

Finding #14 - The program has a detailed logic model and a performance measurement strategy. There has been limited outcome level performance measurement data collected.

In 2012, to confirm that regulatory activities continue to meet their initial policy objectives and in response to the requirements under Cabinet Directive on Streamlining Regulation, the Centre for Biosecurity developed a detailed Performance Measurement and Evaluation Plan (PMEP), which includes a logic model. This plan provides an overview of how the Centre for Biosecurity will achieve the objectives of the biosecurity program. It describes a clear and logical strategy that ties resources and activities to outputs and expected outcomes. To measure the progress over time, this plan also lists potential indicators for each phase of program implementation. Performance data on selected activities and outputs have been collected and used to inform program direction.

For example, in 2012, the Centre for Biosecurity conducted an analysis of the biosafety training environment by conducting an online survey to identify the training needs of biosafety professionals, engineers, teachers, scientist and researchers, biosafety officers and laboratory workers of all levels and from all sectors. The results of the survey guided the development of a stakeholder education and training strategy.

Throughout the Human Pathogens and Toxins Regulations and Canadian Biosafety Standards and Guidelines consultations, the Centre for Biosecurity engaged stakeholders and provided them with the opportunity to identify challenges in implementing the proposed regulations and non-regulatory instruments. In response to the feedback they received, the Centre for Biosecurity prepared new products to support the development of draft regulations, and refined operational practices (e.g. introduced automated forms) to better address stakeholders' needs.

A review of routine program performance measurement information suggests that performance data collected to date consists largely of output measures (e.g. number of permits issued annually, number of inspection completed per year) intended to assess the program's accomplishments in the first phase of implementation.

A review of the current PMEP highlights that many of the outcome indicators listed are not yet systematically tracked. For example:

• Awareness about obligations under the select sections of the Human Pathogens and Toxins Act already in force was an immediate outcome of the first phase of program implementation.
• Awareness of consultations and key stakeholders having an understanding of the principles and policies is the first outcome for the consultation phase of implementation.
• Awareness and acceptance of the need for the full implementation of the Human Pathogens and Toxins Act by the affected laboratories is the immediate outcome for the final phase of program implementation.

Client feedback that is informally received in all program areas through phone calls and emails, has not been systematically tracked or analysed. Systematic electronic tracking of client service activities would help the Centre for Biosecurity better understand gains in awareness and compliance achieved through their activities. e.g. tracking laboratory responses to advice and guidance that has been provided.

Collection, analysis and use of performance data has been limited by challenges with electronic information management tools. One of the business requirements for the ISTOP system was to provide the capacity to report on data stored in the system. However, as it is currently not a relational database, it is not possible to do queries or produce reports from the system. The benefit of this enhanced functionality would be improved reporting and increased support for decision making.

There is the potential for more outcome data analyses through recently completed or planned surveys. Some data on immediate outcome indicators has been collected in a recent survey of over 1000 laboratory contacts. The survey gathered data on stakeholder compliance awareness and behaviour change. A pilot survey on the burden of regulations (cost-benefit analyses) is currently in the field and is expected to be completed early in 2014. Plans are in place to collect performance data related to program outcomes including stakeholder surveys of laboratory acquired infections. In 2015, the Centre for Biosecurity will start reporting through the Public Health Agency level Performance Measurement Framework on high level outcomes indicators, as well as one efficiency indicator.

Several internal key informants noted that performance measurement capacity of the Centre for Biosecurity is an area where continued effort is required.

5.0 Conclusions

5.1 Relevance Conclusion

There continues to be a need to address laboratory biosafety and biosecurity in Canada. A comprehensive system of biosafety and biosecurity controls over imported and domestically acquired human pathogens and toxins helps Canada mitigate the risk of exposure, whether through an accidental or deliberate release. Although the potential risk may be low, the threat of a deliberate release of a human pathogen is real and such a release could potentially be catastrophic.

Through its regulatory and outreach activities, the objectives of the biosecurity program align well with Government of Canada and Public Health Agency priorities and roles in biosafety and biosecurity in Canada. A priority to enhance the safety and security of Canadians through laboratory biosafety and biosecurity continues to be reflected in a variety of Government of Canada and Public Health Agency strategic policy and planning documents, including: the federal Speech from the Throne and a recent counter-terrorism strategy, as well as all the major Public Health Agency corporate strategic planning and reporting documents.

The Public Health Agency is implementing controls in the form of a legislative framework, which includes: the Health of Animals Act (1990), Human Pathogens Importation Regulations (1994), and the Human Pathogens and Toxins Act (2009). Overlap with provincial/territorial roles and responsibilities may still exist given the lack of consistency across jurisdictions and gaps that are left by provincial and territorial schemes. There are areas, such as Occupational Health and Safety and Medical Accreditation Programs, where there is uneven coverage across provinces and territories. There does not appear to be any jurisdiction that effectively covers all provisions in the Human Pathogens and Toxins Act and the Canadian Biosafety Standards and Guidelines. The program is working to minimize the impact of any overlap or duplication on stakeholders.

5.2 Performance Conclusions

Through its consultation activities on both the proposed Human Pathogens and Toxins Regulations and Canadian Biosafety Standards and Guidelines, as well as other compliance awareness linked activities (training, inspections, collaborations, etc.), the biosecurity program has successfully engaged its stakeholders. Organizations have adopted additional safety practices as a result of their engagement with the Centre for Biosecurity, including addressing physical containment requirements and/or operational practices. There has been minimal need for administrative or penal enforcement actions to be taken by the Centre for Biosecurity in the last five years.

The Centre for Biosecurity has demonstrated leadership nationally and internationally. It has worked to proactively anticipate and understand the changing context in the fields of biosafety and biosecurity, e.g. leading discussions with federal colleagues on possible oversight of synthetic biology research in Canada. Through its considerable initiative in proactively addressing recent requirements related to federal regulatory reform, and active work with the Compliance and Enforcement Community of Practice, the Centre for Biosecurity has shown itself to be a leader within the Community of Federal Regulators.

The Centre for Biosecurity has established operational practices with a view to mitigating the administrative burden to regulated organizations and demonstrating excellence in regulatory administrative practices. To support the successful passage and implementation of the Human Pathogens and Toxins Regulations, it will be important for the Centre for Biosecurity to continue to establish effective and efficient service delivery practices. By enhancing and streamlining service delivery to regulated parties, the Centre for Biosecurity will be better able to brand the Public Health Agency as a trusted and fair regulator.

There are opportunities to enhance current operational efficiencies and apply lessons learned to support the efficient implementation of the full Human Pathogens and Toxins Act. Opportunities include: enhancing service standards, developing new tools to support compliance, and enhancing approach to offering some services. Historically there have been challenges with informatics systems that supported program implementation. It will be critical to have a timely, nimble and effective informatics system to support the implementation of the future Human Pathogens and Toxins Regulations when these regulations come into force in 2015.

The program has developed and implemented some performance measurement activities. Much of the past performance data collected has been on outputs and additional data is needed on outcomes. There is no systematic tracking of client feedback or of laboratory responses to advice and guidance provided. There are opportunities to further enhance performance data collection (and use) for program outcome indicators in particular.

6.0 Recommendations

Recommendation 1

Enhance the effectiveness of program delivery by:

• (a) Reviewing and strengthening operational processes and tools to improve the timeliness and quality of services to regulated parties. Where needed, review and communicate service standards to address identified gaps.
• (b) Having a timely and nimble informatics system in place to support the full implementation of the Human Pathogens and Toxins Act and the Health of Animals Act.

There is evidence of continuous improvement across operational practices over the past five years, in particular reflecting lessons learned through ongoing activities. Key informants, both internal staff within the Centre for Biosecurity and regulated parties and/or stakeholders, agree that there have been adaptations made to support more efficient client service delivery. One of the challenges outlined in the evaluation was the ongoing appeal by regulated parties for enhanced operational practices that better address client service needs and employ more modern informatics solutions. To better support operational tools and processes, a nimble, reliable, timely and integrated informatics system is integral to the full success of this regulatory program. The Information Management Services Directorate, in collaboration with the Centre for Biosecurity, has made the development of an effective and efficient informatics system a priority moving forward.

Recommendation 2

Enhance the performance measurement approach to better inform program decision making by:

• (a) Developing and implementing a tracking system for ongoing feedback from regulated parties.
• (b) Identifying, tracking and analysing indicators that focus on monitoring program outcomes.

The biosecurity program has recently advanced their collection of performance measurement information, partially through the development of a Performance Measurement and Evaluation Plan in 2012. While there was some performance measurement data available to assess activities and outputs for this evaluation, there is a gap in terms of tracking ongoing client feedback on program service delivery. The demonstrated ability of the Centre for Biosecurity to assess success in terms of achieving longer term program outcomes was not as straightforward. More effort to track and analyse additional immediate and intermediate outcome indicators (e.g. in particular related to compliance awareness and behavior change) is required. Of note, there are three indicators in the Public Health Agency's Performance Measurement Framework for tracking longer term outcomes and plans are in place to collect data (e.g. exposure reporting). Improvements to the performance measurement approach can enhance the ability to assess program success on a continuous basis.

Appendix 1 – Logic Model

Appendix 2 – Evaluation Description

Evaluation Scope

The scope of the evaluation included an assessment of the relevance and performance of the Agency's biosecurity program between April 2009 and November 2013, including its objectives and activities:

• to support compliance with the Health of Animals Act (1990)
• to support compliance with the Human Pathogens Importation Regulations (1994) and the Human Pathogens and Toxins Act (2009), including through implementation of the Canadian Biosafety Standards and Guidelines to support the development of regulations under the Human Pathogens and Toxins Act (2009).

Program components included: biosafety programs and planning, biosafety and biocontainment operations - including engineering science support, pathogen security, regulatory policy and affairs, and outreach and stakeholder engagement.

This evaluation did not include analyses of:

• the longer term outcome of regulatory compliance with the Human Pathogens and Toxins Act (2009) because these regulations will not be in force until 2015
• activities associated with the recently launched Single Window Initiative led by the Canada Border Services Agency (see section 4.5.2)
• activities internal to Public Health Agency laboratories, including the National Microbiology Laboratory and the Laboratory for Foodborne Zoonoses.

Evaluation Issues

The specific evaluation questions used in this evaluation were based on the five core issues prescribed in the Treasury Board of Canada's Policy on Evaluation (2009). These are noted in the table below. Corresponding to each of the core issues, evaluation questions were tailored to the program and guided the evaluation process.

Data Collection and Analysis Methods

Evaluators collected and analyzed data from multiple sources. Sources of information used in this evaluation included:

• Literature review – a search for Canadian and international literature from the past 10 years on biosafety, biocontainment and biosafety
• Media analysis – a media scan of print, online and broadcast coverage was completed with a focus on articles published biosecurity and biosafety in Canada, and abroad, between May 2011 and May 2013
• Document and file review – a review of approximately 450 program documents on all aspects of the program's activities
• Financial data review – a review of financial data from 2009-10 to 2013-14, including budgeted and actual expenditures
• Performance data – a review of data on implementation of program activities between 2009-10 to 2013-14, including the number of laboratories, inspections, permits, letters and enforcement actions
• Key informant interviews – approximately 50 interviews with both internal and external key stakeholders, including program staff and management; data analysed with NVIVO
• Stakeholder survey – an online survey was in the field between October 5 and November 29, 2013; it was sent to all 1087 contacts (entities) registered in the Centre for Biosecurity's regulated parties database since 2009 – 467 entities responded for a 43% overall response rate.

Data were analyzed by triangulating information gathered from the different sources and methods listed above. This included: systematic compilation, review and summarization of data to illustrate key findings; statistical analysis of quantitative data from databases; thematic analysis of qualitative data; and comparative analysis of data from disparate sources to validate summary findings.

Appendix 3 – Definition: Pathogens and Toxins

Human pathogens may be contained in cultures, diagnostic specimens, or tissue. Examples include Salmonella spp., Bacillus anthracis (anthrax), SARS virus, and Ebola virus. These organisms are classified into four risk groups based on the relative hazards to human health. The four risk groups range from Risk Group 1 organisms, which are very low risk and not covered by the Human Pathogens and Toxins Act, to Risk Group 4 human pathogens, which are highly infectious and often untreatable. Examples are:

• Risk Group 1 (RG-1) – no or low individual and community risk with treatment available (e.g. brewer's yeast) and not considered a pathogen;
• Risk Group 2 (RG-2) – moderate individual risk, low community risk with treatment available (e.g. Influenza, Salmonella, E. coli);
• Risk Group 3 (RG-3) – high individual risk, low community risk with treatment available (e.g. SARS, Tuberculosis, Anthrax, Avian Influenza, HIV); and,
• Risk Group 4 (RG-4) – high individual and community risk with treatment not normally available (e.g. Ebola, Smallpox).

The Human Pathogens and Toxins Act defines a toxin as a substance that is produced by, or derived from, a micro-organism and is able to cause disease in a human. For transparency, the Act includes a prescribed list of toxins. Toxins are not classified by risk group as, unlike pathogens, there is no risk of spread (a criterion used to categorize a pathogen into one of the above risk groups.

Human pathogens and toxins pose a risk to human health and public safety because of their ability to cause disease and/or death. These substances are found naturally in a diseased person (e.g. E. coli), animal (e.g. rabies), or contaminated environmental source (e.g. anthrax). They can be isolated from these natural sources for research and development purposes (e.g. vaccine development), grown to large quantities and are often transported between laboratories and between facilities. Due to their inherent risk, possession is generally restricted to facilities conducting research or diagnostic activities.

Appendix 4 – Human Pathogens and Toxins Regulations Consultations

Below is an overview of the phases of the consultations to develop the regulations for the Human Pathogens and Toxins Act.

Appendix 5 – Operational Processes

Below is an overview of the following processes: registration, compliance/certification letters, import permits, and transfers.

Appendix 6 – Summary of Findings By Evaluation Question

List of Acronyms