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Report of the Auditor General of Canada - December 2000, Chapter 24

The Government of Canada responded:

Protecting the health and safety of Canadians is a core responsibility of the Government. This responsibility is exercised through statutes adopted by Parliament which state the Government’s obligations, objectives and standards in this regard.

The Government adopted the Regulatory Policy to support Ministers and Cabinet in making informed decisions on the development and implementation of regulations which are in the best interests of Canadians. The principles and requirements stated in the Regulatory Policy have been applied by the Government, have been subsequently endorsed by the Organization for Economic Cooperation and Development, and are being followed by other jurisdictions in formalizing their own regulatory governance regimes.

While it believes the Regulatory Policy is sound, the Government shares the Auditor General’s concern and has recognized the need to ensure that regulatory authorities have the capacity to meet the expectations of the policy -- to properly develop and to appropriately implement regulations and regulatory programs. As evidenced in this audit, the Government has already identified many of the issues raised, and has already undertaken significant good work to address these shared concerns. In particular, the Government is committed to strengthening risk management, to monitoring and reporting on the effectiveness of federal regulatory programs, and to ensuring the continued integrity of our health and safety programs.

The Government is pleased with the recognition by the Auditor General of the good practices which exist within departments and agencies. The Government will build on this work, continuing to identify and disseminate best practices in such areas as managing risks, in the use of advisory committees, in the use of a range of public policy instruments, in measuring outcomes, and in communicating and consulting with Canadians.

Clear and appropriate lines of accountability exist for reporting through Parliament to Canadians on the effectiveness of federal health and safety programs. Each Minister is accountable to Canadians, through Parliament, for the effective and efficient operations of his or her portfolio, and each Minister reports to Parliament on their department’s or agency’s plans, priorities and performance.

Through the Speech from the Throne and through federal budgets, the Government has articulated a comprehensive set of policies and measures aimed at "Building a higher quality of life for all Canadians". Well-designed and well-managed regulations are in everyone’s interests, and can contribute to this goal. For this reason, the Government of Canada is constantly seeking ways to improve the effectiveness and efficiency of its regulations and regulatory programs and welcomes this contribution of the Auditor General.

The following action plan reflects the Government’s commitment to continuous improvement of its regulatory programs to respond to the evolving challenges in protecting the health and safety of Canadians. In responding to specific recommendations, the plan addresses federal regulatory programs horizontally and includes examples of department-specific initiatives as indications of practical implementation. More specific information may also be found in Departmental Reports on Plans and Priorities and in responses and action plans developed as a result of the referenced audit and study findings (reference 24.7 of Chapter 24).

Finally, the action plan underscores the Government’s response to the broad themes identified by the Auditor General:

• capacity, in terms of human and financial resources required to perform its mandate, and in terms of guidance instruments/processes to improve the effectiveness of its regulatory interventions (e.g., continuous learning);
• transparency and public involvement in how regulatory programs are developed, implemented and assessed;
• accountability of Government; and
• actions to strengthen the implementation of the Government’s Regulatory Policy.

The federal government should explain to Canadians and the government’s regulatory and inspection community its priorities for health and safety regulatory programs, particularly the balance that the Government has reached to protect Canadians and address budget, social, economic and trade objectives. The Government should revise its regulatory policy and other policies to reflect this emphasis.

The Government Action Plan:

The Government is committed to transparency and communicates regularly with Canadians and its regulatory and inspection community about its priorities for health and safety regulatory programs, particularly the balance that it has reached to protect Canadians and address budget, social, economic and trade objectives. Further, the Government believes that all its policies are consistent with this premise.

The Government outlines its social and economic priorities for health and safety regulatory programs through the Speech from the Throne and through regular federal budgets. The Government also advises Canadians about its plans and priorities on notable occasions which warrant it, such as in the wake of the events of September 11, 2001. These statements reflect the Government’s commitment to achieve a higher quality of life for all Canadians as well as demonstrate in concrete and timely terms the balance that Government has reached to protect Canadians while addressing budget, social, economic and trade objectives.

The Government believes that the Regulatory Policy is sound, that it promotes the use of the Government’s regulatory powers for the greatest net benefit to Canadian society and that it clearly requires that a balance of perspectives and constituencies be brought into each regulatory initiative. The Regulatory Policy requires that regulatory authorities ensure that Canadians are consulted, and that they have an opportunity to participate in developing or modifying regulations and regulatory programs. The Government continues to strengthen its review of regulatory proposals to ensure that they address, on balance, cost effectiveness but also the social and environmental impacts. It is also pursuing a number of initiatives to enhance how regulatory programs address the substance of the underlying issues of the above recommendation.

As will be the case throughout this action plan, many of the following initiatives are horizontal in nature and directed to all regulatory programs. As such, they do impact on health and safety regulatory programs and demonstrate the Government’s commitments with regards to the issues raised by the recommendation.

Actions and Time lines

• Pursue activities to build and enhance departmental capacity to meet Regulatory Policy requirements and promote professionalism in the regulatory community. Actions include:

• providing and updating process guides;
• holding departmental workshops on policy requirements and regulatory process; and
• holding best practice seminars.

2002 / Ongoing

• Develop and implement capacity-building initiatives, such as the creation of a series of on-line learning tools in August 2001 to assist in the efficient making of regulations. These include an interactive, self-paced and self-directed learning and information tool to train regulatory officials on the requirements of the Regulatory Policy; and widespread use of the Internet to communicate regulations, regulatory requirements, and as a consultation tool.

August 2001 / Ongoing

• Following a consultation period, departments and agencies will implement the Government’s recently announced Innovation Strategy that identifies the need to ensure effective decision making for new and existing policies and regulatory priorities, including health and safety. The goals of the Strategy include:

- By 2004, fully implement the Council of Science and Technology Advisors’ guidelines to ensure the effective use of science and technology in government decision making; and

- By 2010, complete systematic expert reviews of Canada’s most important business and regulatory regimes.

• The Communications Policy of the Government of Canada, that came into effect on April 1, 2002, includes specific requirements for risk communications.

April 2002 / Ongoing

• Departments and agencies have undertaken an initiative to develop a common understanding of performance measurement in the context of the Regulatory Policy, to take stock of current "regulatory performance measurement" practices in the management of regulatory programs and to identify potential indicators. The initiative will also identify existing work in pertinent domestic or international institutions, including the identification of common aspects (e.g., performance indicators, approaches) and areas of marked differences and best practices.

July-August 2002

• Canada is participating in a review of its regulatory programs by the Organization for Economic Coordination and Development (OECD), including, broadly, the balance that the government has reached to protect Canadians and address budget, social, economic and trade objectives. Work as a result of recommendations can be used to effectively advance the Canadian regulatory agenda.

Fall 2002

• The Government is revising the guidelines on consulting and engaging citizens – this will strengthen guidance on how to engage Canadians in risk management decisions and improve transparency.

2002/2003

Departmental-specific initiatives:

• Individual departments and agencies articulate their priorities for health and safety specifically in their Report on Plans and Priorities and more generally through consultations and communications with Canadians on a regular basis. Ongoing

• For example, in line with the Regulatory Policy, where the Ministers of Health and the Environment determine regulations are the appropriate form of control, after risk assessments under the Canadian Environmental Protection Act (CEPA) to determine human health and environmental impacts of substances and consultations, Environment Canada publishes the proposed regulatory plan in the Report on Plans and Priorities. Then, regulations are developed with extensive public input and a regulatory impact analysis statement (RIAS), developed in accordance with government policy. Therefore, through the full process, the balance between social, economic and trade objectives is made clear.

Ongoing

Recommendation 24.104

The Government Action Plan

The Government recognizes the need to ensure that regulatory authorities have adequate capacity to properly develop and to appropriately implement regulations and regulatory programs relating to risks to health and safety. As evidenced in the audit, the Government had already identified many of the issues raised and has already undertaken significant good work to address these shared concerns. Risk Management for Canada and Canadians - Report of the ADM Working Group on Risk Management, March 2000, the result of discussions amongst assistant deputy ministers from science and regulatory departments, provides context in which to discuss, examine and seek out interrelationships between issues associated with public policy decisions in an environment of uncertainty and risk. Several horizontal initiatives related to risk management were supported, for example, the Canadian Centre for Management Development’s Roundtable on capacity building, the PCO-led initiative on the precautionary approach/principle and the TBS-led initiative on an integrated risk management framework.

In keeping with the commitments set out in Results for Canadians – A Management Framework for the Government of Canada, in April 2001 the Government issued the Integrated Risk Management Framework to provide guidance for strengthening risk management practices and developing a

risk-smart workforce and environment across the federal public service. In advancing the use of a more corporate and systematic approach to risk management, the Framework recognizes that one size does not fit all and proposes four elements for departments and agencies to adopt or adapt to their specific circumstances and mandate. Based on their specific situation and risk exposure, the Framework encourages organizations to periodically take stock of their risk management capacity and to continuously build it at both the corporate and local levels.

Departments have been working horizontally to take stock of their risk management approaches, tools and training and to share their lessons learned in strengthening risk management within their regulatory programs.

Action and time lines:

• As evidenced over the last few fiscal years, the Government has supported the establishment and development of surveillance systems and risk assessment methodologies (see below and under recommendation 24.105).

Ongoing

Departmental-specific initiatives:

• Guidelines have been developed in October 1999 by Health Canada to support the application of the Decision Making Framework (formerly known as the risk management framework), which is the core risk management tool for the Department. The guidelines focus on the following areas: environmental risk assessment; public involvement in risk management; risk communication; considering risk perception and social, cultural and ethical information; considering industry, trade and international information; developing health-based outcome measures; integrating population health and risk management decision making; priority setting; and socio-economic analysis. The guidelines are intended as non-binding guidance to facilitate use of the Decision Making Framework and programs can develop specifically tailored procedures to meet their particular needs. For example, the Pest Management Regulatory Agency has released a series of science policy papers which provide risk assessment tools for Agency regulators and help the public understand risk assessment processes. In addition, the creation of the Marketed Health Products Directorate will ensure a consistent risk management approach and focus greater attention on the safety of marketed pharmaceuticals, medical devices, biologics, natural health and other products through the surveillance of serious adverse events associated with the use of those products.

Ongoing

• The Canadian Food Inspection Agency (CFIA) and Health Canada work together closely in the identification of risk related to food safety. The Canadian Food Inspection Agency has developed significant capabilities for this work, as well as in identification of risks related to animal health and plant protection, and has developed in 2001 a Risk Analysis Framework based on accepted international models. It has also developed in 2001 a model and process for setting priorities for food safety risk management based on the level of risk. The Agency conducts extensive monitoring and surveillance activities and establishes databases related to potential hazards in foods.

Ongoing

• The Canadian Nuclear Safety Commission (CNSC) has developed a formal regulatory compliance program taking into account risk factors. It is also developing an integrated corporate framework and strategy for its risk management initiative. The implementation of formal risk-based approaches has commenced in selected areas.

Ongoing

• Environment Canada’s regulatory programs are supported by its research institutions most notably the National Water Research Institute (NWRI), Atmospheric Integrated Research Monitoring and several other research facilities known to be the best in Canada and the world. For example, NWRI conducts research on priority substances of concern including potential endocrine-disrupting substances that can have an effect on the environment and human health. In addition, NWRI and Health Canada have co-chaired a multi-stakeholder workshop on the environmental assessment of human health and personal care products and agricultural pharmaceutical products in the Canadian environment.

Ongoing

• Environment Canada also monitors the status of the environment, especially in the monitoring of air quality through the National Air Pollution Surveillance network. Ongoing

• Amongst others, the 2001 Budget provided an additional $36.2 million to the Canadian Food Inspection Agency for public security and anti-terrorism. These resources will be instrumental in increasing the Agency's capacity in the areas of border controls, surveillance and detection, and for upgrading its related science and laboratory capacity.

Ongoing

The Government Action Plan:

The allocation of adequate funding and staffing resources to health and safety regulatory programs is a key consideration of the Government.

Under the Canadian system, ministers are responsible for the integrity of programs within their departments and for considering appropriate measures to identify the resources needed to address risk. Canadians and Parliament have a very important challenge role in terms of any new initiatives on risk and the priority which is allocated to it. Other factors that are considered include delivering programs or services that fulfill departments’ legal mandates, international conventions or agreements, federal - provincial - territorial agreements, and Government priorities.

Departments and agencies continue to exercise sound stewardship in resource allocation and management across the Government to ensure that existing risks and pressures are considered alongside new policy initiatives. This approach to decision making helps ensure that identified risks that are deemed unacceptable are given high priority and dealt with.

Actions and Time lines:

• In keeping with its commitment to allocate adequate resources to health and safety priorities, the Government has allocated additional resources to many departments and agencies named in Chapter 24. Budget 2001 approved $7.7 billion, over 6 years, and $1 billion, ongoing, to enhance personal and economic security.

Ongoing

• Over the past several years, the government has provided funding to various departments to help address program risks affecting the health, safety and security of Canadians. The government will continue to ensure that unacceptable risks are identified and dealt with on a priority basis. Ongoing

Departmental-specific initiatives:

• Health Canada has identified safety and the management of risks as one of its five corporate priorities. The Department continues to implement programs associated with funding received in the past few years to address concerns or risks associated with blood, pesticides, tobacco control, management of toxic substances, pharmaceutical and biological drugs, food or products manufactured using biotechnology, veterinary drug residues in food producing animals, and strengthening food safety and nutrition programs. The requests for funding in these areas were based on the assessment of several factors including the risks to the health of Canadians and how those risks can be mitigated or eliminated.

Ongoing

• The Canadian Food Inspection Agency, operating within its legislative and regulatory mandate, assigns resources and priorities based on risk within each of its food inspection programs. The concept of relative risks, or the ability to compare different risks across programs is still evolving at the international level – the Agency is actively involved in discussions to develop models that could be adopted (e.g., Codex Alimentarius).

Ongoing

• In keeping with the ongoing funding of health and safety programs, Environment Canada obtained, through Budget 1999, a 5 year investment to toxic risk assessment and risk assessment/risk management capacity.

• The National Energy Board has developed a program which identifies the relative risk of the over 650 facility locations under its regulatory authority and allocates its inspection personnel and resources accordingly.

Ongoing

• Transport Canada maintains centres of expertise to aid departmental groups in identifying risks and tracking corresponding data. The Department participates in interdepartmental activities to improve the overall application of risk management.

Ongoing

The Government Action Plan:

The human resources management challenges facing regulatory authorities in staffing, retention and other areas, as described by the Auditor General, are shared by many federal departments and agencies at the present time. In response the Government has launched a major change process in people management in the public service.

In the 2001 Speech from the Throne, the Government identified Human Resource (HR) management modernization as a priority for the public service and committed to making the necessary reforms. Following this in April 2001, the Prime Minister created the Task Force on Modernizing HR Management in the Public Service (the Task Force) with a mandate to recommend a modern policy, legislative and institutional framework for the management of human resources in the public service.

Actions and Time lines:

• The Task Force has consulted widely on human resources management issues and is developing proposals. It is expected that the legislative changes required to improve human resources management in the public service will be introduced in Parliament in the near future.

Fall 2002

• In his Ninth Annual Report to the Prime Minister on the Public Service of Canada, the Clerk of the Privy Council and Secretary to the Cabinet stressed the need for greater efforts towards recruitment, workplace well-being, and learning. As a consequence, departments, agencies and central agencies are taking important steps in the right direction. For example:

• The Public Service Commission of Canada is delegating recruiting authority to those departments willing to take on additional responsibility and accountability to achieve their unique objectives.

• Several departments have formed partnerships to meet human resource needs collectively. For example, seven science departments are working together to increase Aboriginal employment in the science and technology fields. As well, focussed job fairs have helped recruit qualified people representative of Canada's diversity. Ongoing

Departmental-specific initiatives:

• Transport Canada is championing and resourcing the Regulatory/Inspection Community and hosting the Secretariat for this community. With its partners in this initiative, including other departments referenced in Chapter 24, a number of initiatives designed to enhance recruitment, retention and knowledge transfer have been undertaken.

Ongoing

• The Canadian Food Inspection Agency’s 2000-2003 Human Resource Strategy focuses on HR issues. The Strategy has three key objectives: maintain a qualified workforce, attract and retain skilled employees and continue to build a supportive work environment. The Agency is undertaking a number of initiatives to address issues related to recruitment and retention. These initiatives include the introduction of an officer training program, succession planning, on-campus recruitment and co-operative programs with appropriate universities and colleges.

Ongoing

• The Canadian Nuclear Safety Commission has received funding/assistance to increase compensation for highly specialized scarce human resources a year ago. The Commission will continue to seek ways to stabilize their funding at the necessary level. As a separate employer, the Commission has already taken steps to address non-financial issues, including improved human resources planning and more aggressive recruitment and retention measures.

Ongoing

• The National Energy Board (NEB) is located in Calgary and has been established as a separate employer under the Public Service Staff Relations Act to enable it to compete more effectively in the local labour market for qualified technical staff.

Ongoing

• Health Canada staffing levels and recruitment needs are constantly re-evaluated so that new initiatives may be strategically targeted. Human resource strategies have been or are being developed by Branches and Directorates and designed to respond to their particular needs. In recent years, special teams have been established and charged with addressing human resource issues and conducting recruitment and staffing activities. Two major staffing initiatives have been conducted to find highly specialized scientists and physicians to assess and regulate therapeutic products.

Ongoing

Recommendation 24.112

The Government Action Plan:

The Government agrees that regulatory authorities need a sound capacity to identify risks to health and safety and that they should make broad use of independent expert scientific advisory committees. The Government has established numerous independent expert scientific advisory committees during the last years to bring together widely-recognized and credible individuals who bring impartial advice for consideration by decision-makers, hence enhance the credibility of the decision-making process.

These advisory bodies provide ministers with impartial and expert advice on matters relating to their mandate, including assessing the benefits and risks of science developments as well as all aspects of the Government’s mandate, including providing advice on new regulatory programs and priorities to address emerging issues.

As well, the Government often establishes ad hoc advisory groups to respond to special circumstances of an urgent nature. In these circumstances, the groups provide ready expertise, credible and respected advice, peer-reviewed perspectives and support informed decision-making and follow-up.

In 2000, the Government issued "A Framework for Science and Technology (S&T) Advice: Principles and Guidelines for the Effective Use of Science and Technology Advice in Government Decision Making" to ensure that government policy, regulatory and management decisions are informed by sound science and technology advice. The Framework derives from the work of the Council of S&T Advisors, an external advisory committee and reflects extensive consultation within government and with external stakeholders. The issuance of the Framework not only builds on many of the practices currently employed by the Government but also promotes adoption of, and ensures accountability for, its principles and guidelines across government.

Actions and Time lines:

• Develop a Checklist for the integration of Science and Technology advice in the preparation of the Memorandum to Cabinet and Regulatory Impact Analysis Statement (RIAS), in keeping with the Framework for Science and Technology Advice. The checklist will list questions to guide departments and central agencies in assessing whether S&T Framework guidelines and principles were integrated into the policy process.

2002/2003

• In line with the Government’s recently announced Innovation Strategy, a key priority is the renewal of the Government of Canada’s science and technology capacity to respond to emerging public policy, stewardship and economic challenges and opportunities. The Government will consider a collaborative approach to investing in research in order to focus federal capacity on emerging science-based issues and opportunities. A goal is to build collaborative networks across government departments, universities, non-government organizations and the private sector.

Departmental-specific initiatives

• The Canadian Food Inspection Agency has several mechanisms to improve the scientific independence and credibility of its health and safety programs, such as the Minister’s Advisory Committee, established in 1997, the President’s Advisory Committee on Bio-technology, established in 2001, and the Canadian Institute for Food Inspection & Research, established in 2000. The Agency expands the use of independent expert scientific advisory committees as needs arise.

Ongoing

• Health Canada has several subject specific Expert Advisory Committees (e.g., the regulation of drugs, blood and food). Further, it may use external experts to address second level appeals in drug review and establishes ad-hoc panels for short-term special issues. It is also developing an inventory of Canadian experts. On a broader scale, the Science Advisory Board advises the Minister of Health on priorities, emerging trends and strategic linkages with respect to science and research conducted in Health Canada.

Ongoing

• The new proposed Pest Control Product Act (tabled in the House of Commons in March 2002) includes provisions that would give the Minister of Health the authority to establish an advisory council of persons whose interests and concerns are affected by this Act.

Ongoing

• The Canadian Nuclear Safety Commission will employ an independent advisory committee to coordinate the review of research within its mandate. It has a framework to establish other advisory committees as required.

Ongoing

• The Canadian Environmental Protection Act (CEPA) assessments have multi-stakeholder advisory panels and a peer review process for science assessments. Environment Canada uses Expert Scientific Committees to address scientific and technical issues related to the existing substances assessment program. In the development of risk management approaches, Environment Canada employs science and technical advisory panels.

• In December 1999, the Ministers of Agriculture, Health and the Environment asked the Royal Society of Canada, to establish an expert panel to examine future scientific trends in food biotechnology in Canada. The Government received the Panel’s report in February 2001 and has subsequently responded with a Federal Action Plan which can be found at http://www.hc-sc.gc.ca/english/protection/royalsociety. Ongoing

Recommendation 24.113

The Government Action Plan:

The Government considers the Regulatory Policy as a solid base and notes that the Policy requires departments and agencies to follow other directives from Cabinet concerning policy and law making, as established. As interpretive documents that reflect an evolution in the thinking on regulations are developed, they are immediately considered to be pertinent to the implementation of the Regulatory Policy and to keep its implementation evergreen.

In keeping with Regulatory Policy requirements for consultation and transparency, some science advisory committees were established and added impetus was given to many existing committees.

Actions and Time lines:

• The Government promotes the sharing of best practices and the development of a professional regulatory community through various capacity-building initiatives. By way of example, in March 2002, the Privy Council Office and the Canadian Centre for Management Development recently co-hosted the first of a series of learning events where the regulatory community shared and discussed regulatory policy issues and approaches to regulatory program development and management. The Government is also promoting best practices through highlighting practices such as Health Canada’s Science Advisory Board which is used to consult on complex and contentious science issues.

Ongoing

• As mentioned above, the Government continues to support guidance provided by the Framework on Science and Technology Advice, as it promotes the use of credible advisory processes, including science advisory committees.

Ongoing

• In its proposed Innovation Strategy, the Government addresses effective decision making for new and existing policies and regulatory priorities. Two specific initiatives are seen as ways for Canada to benefit from the best science-based advice available:

• The first is to support a Canadian Academies of Science to build on and complement the contribution of existing Canadian science organisations. The Academies could provide a source of credible, independent expert assessment on the science underlying pressing new issues and matters of public interest.

• The second initiative is to undertake systematic expert review of existing stewardship regimes through international bench marking and collaborate internationally to address shared challenges.

Ongoing

Departmental-specific initiatives:

• The Canadian Food Inspection Agency continuously reviews its internal regulatory procedures and policies to ensure that they are the most efficient and effective possible. To this end, the Agency solicits input from subject matter experts on the contents of its Regulatory Proposal Assessment template, which expands on the information required by the Regulatory Impact Analysis Statement and ensures that all essential policy questions are answered.

Ongoing

• Health Canada is assessing best practices with respect to advisory committees. For example, the Therapeutic Products Directorate is currently developing criteria to assist in ascertaining when external advice is needed and the type of expert body best suited to the need.

Ongoing

The Government Action Plan:

The Government agrees that the development of standards for conducting risk analysis is key to ensuring that risks are measured and compared. As indicated in Risk Management for Canada and Canadians - Report of the ADM Working Group on Risk Management, March 2000, "Over time, significant effort has been expended by agencies, scientists and standards organizations to develop clear definitions of the sometimes philosophical and sometimes scientific concepts surrounding risk, its measurement and management."

The Government’s Framework for Science and Technology Advice: Principles and Guidelines for the Effective Use of Science and Technology Advice in Government provides key advice for risk analysis. This framework is based largely on the advice of the Government’s Council of Science and Technology Advisors (CSTA), comprised in their report of 1999, Science Advice for Government Effectiveness (SAGE). In fact, the CSTA continues to be an important advisor, in keeping with the Government’s commitment to ensuring that its policy decisions are guided by expert advice.

The Government’s Integrated Risk Management Framework establishes the broad framework for the management of risk and outlines a common, continuous risk management process that can assist an organization in understanding, managing and communicating risk. It must be recognized that there are many standards available in conducting risk assessment/analysis. Traditionally, such standards have been developed based on need in particular sectors, e.g., science and technology. As mentioned earlier, there is no ‘one size fits all’. This ensures that risk analysis, while consistent with overall principles of good science, is flexible enough to adapt to the particular needs of sector-specific situations.

In keeping with this broad guidance, and more specific to particular program sectors, departments and agencies have developed and implemented policies and guidelines for risk management within their mandate. In addition, departments and agencies work cooperatively with regulators and scientists at home and abroad so that risk assessment and risk management procedures remain current with new scientific practices.

As noted previously, the concepts of relative risks and how to measure and report on relative risks are evolving. In measuring and comparing risks, departments balance several factors, including the need to respond to identified risks to the health and safety of Canadians, delivering programs or services that fulfill the department’s legal mandate, international conventions or agreements, provincial or territorial agreements, and federal government priorities.

Actions and Time lines:

Departments and agencies continue to work on the development and implementation of program – or sector-specific standards for conducting risk analysis. Ongoing

Departmental-specific initiatives:

• Health Canada has set out its risk management approaches in its Decision-making Framework (described earlier). Health Canada is also involved in standardization and harmonization at the international level through working groups and committees (e.g., the Organization for Economic Co-operation and Development (OECD), CODEX, the North American Free Trade Agreement (NAFTA) and the International Conference on Harmonization (ICH)). As another example, the Pest Management Regulatory Agency (PMRA) is holding multi-stakeholder (including other federal departments and agencies) workshops to establish generic environmental assessment endpoints to strengthen risk management decisions.

Ongoing

• The Canadian Food Inspection Agency has a policy and model for risk management, established in 2001. The model includes standards for the practice of risk management. The Agency has a listing of approximately 300 formal risk assessments that have been completed since April 1, 1997.

Ongoing

• Environment Canada and Health Canada have published their science assessments and approaches for the Priority Substance List (including guidance manuals). The two departments use OECD and other internationally recognized methodologies for risk assessments. This information can be found on their websites: and .

Ongoing

The Government Action Plan:

• In keeping with its commitment to support broader participation by Canadians in the management of risk, Canada was the first parliamentary government to publish regulatory initiatives to encourage public access and direct participation in the regulatory process through the publication of the Regulatory Impact Analysis Statement along with the text of the proposed regulations. This publication, along with the wide variety of electronic consultation tools being used by departments, has led to more effective consultation mechanisms and underscored the need for objectivity.

  Further, the review and comment, by the public, of regulatory proposals enhance transparency in regulation making and ensure that public input is always a factor in the finalization of regulations.

  One of the key responsibilities of the Privy Council Office, Regulatory Affairs and Orders in Council Secretariat, is to review regulatory proposals and to ensure that proper analysis using credible methodologies have been utilized in the creation of the proposal. In addition, the Secretariat posts on its web site a range of documents and manuals which provide regulatory authorities with guidance in areas such as:

  • assessing regulatory alternatives;
  • undertaking cost-benefit analysis;
  • composing Regulatory Impact Analysis Statements;
  • developing compliance policies;
  • international regulatory collaboration;
  • the federal regulatory process; and
  • enlightened practices in regulatory programmes.

  Actions and Time lines:

• Strengthen capacity to meet the requirements of the Regulatory Policy through targeted initiatives, such as identifying best practices in the regulatory development process and creating fora for their dissemination; assessing the feasibility of tailoring RIAS requirements to better reflect the nature and significance of regulatory proposals; and enhancing the interactive web-based learning and information tool.

Ongoing

• To improve RIAS quality standards, the Privy Council Office is developing an assessment and definition of graduated RIAS standards, based on historical assessment of regulatory activity.

Ongoing

Departmental-specific initiatives:

• Individual departments, such as Health Canada, have taken concrete steps to ensure quality regulatory impact assessments are objective and scientifically sound. For example, a regulatory affairs curriculum is being developed within Health Canada to increase the knowledge, ability and skills of staff involved in the development, implementation and evaluation of regulations. Courses will be offered in the fall of 2002. In addition, the Healthy Environments and Consumer Safety Branch has established the Economic Analysis and Evaluation Division which provides objective economic analysis.

Ongoing

• In May 2000, the Canadian Food Inspection Agency established a process for the development of new and amending regulations. Based on the Government’s Regulatory Policy and the Regulatory Process Management Standards, the process is designed to improve the Agency’s scrutiny of regulatory proposals and to enhance the quality of regulations promulgated by the Agency. The Regulatory and Intergovernmental Affairs Directorate initiated the process and, at the same time, sought to increase its capacity to assist the Agency in achieving its regulatory goals by centralizing the regulatory drafting and cost benefit analysis function.

Ongoing

• Transport Canada undertakes wide-ranging consultations on regulatory matters. For example, in the aviation sector, consultations are conducted through the Civil Aviation Regulation Advisory Council and its various technical committees, where broad-based representation is encouraged (e.g., industry, government, labour and technical experts).

Ongoing

• Environment Canada has developed a standard, consistent and objective approach for assessing the environmental and socio-economic aspects of regulations, consisting of a Technical and Socio-economic Background Study; a Qualitative Screening of Potential Management Instruments; and a Quantitative Assessment of the Most Promising Management Instruments. The Department continues to research, develop and apply new tools to support and improve RIASs, including areas such as risk assessment, competitiveness impacts, macro and micro economic modeling, and new developments in benefit-cost analysis.

Ongoing

The Government Action Plan:

Federal employees can use existing departmental processes to voice any such concerns. In addition, the Government has established the "Policy on the Internal Disclosure of Information Concerning Wrongdoing in the Workplace" (effective November 30, 2001). The Policy will be reviewed in three years.

The objective of the policy is to allow employees to bring forward information concerning wrongdoing, and to ensure that they are treated fairly and are protected from reprisal when they do so in a manner consistent with this policy.

With this policy, deputy heads are responsible to put in place internal mechanisms to allow employees to disclose, in good faith, information concerning wrongdoing within their organizations; to ensure that these disclosures are addressed in an appropriate and timely fashion; and to ensure that employees who disclose information are treated fairly and protected from reprisal.

The policy establishes a government-wide review mechanism outside departmental processes where employees, who, having unsuccessfully exhausted departmental mechanisms, may turn to disclose information concerning wrongdoing in the workplace. The processes so established will allow employees to deal with the vast majority of instances of wrongdoing. However, in certain exceptional circumstances an employee might be justified in making an external disclosure: for example, when there is an immediate risk to the life, health or safety of the public. Employees also might be justified in making an external disclosure where they have exhausted all internal procedures. As any unauthorized external disclosure could expose the employee to disciplinary action, the policy recommends that an employee obtain advice or assistance from his or her union, trusted adviser or independent counsel before taking action.

The policy creates an Office of the Public Service Integrity Officer to act as a neutral, third-party agent, available to deal with disclosures an employee believes cannot be raised internally, or have not been dealt with adequately within a department or agency. The Public Service Integrity Officer will make an annual report to the President of the Privy Council Office for tabling in Parliament. On November 8, 2001, the Government of Canada announced the appointment of Dr. Edward Keyserlingk as the first Public Service Integrity Officer.

In addition to this formal policy, there is a strong culture of Values and Ethics, exemplified by the work of the late John Tait, in the Public Service. Many departments have articulated statements of Values and Ethics which are supported internally. (Reference the Ninth Annual Report to the Prime Minister on the Public Service of Canada.)

The Government Action Plan:

The Government is committed to transparency and public involvement in addressing health and safety risk. Models for decision making emphasize the need for effective and comprehensive risk communications and broad consultations/engagement strategies. The Government recognizes that one of the ongoing challenges facing it is to continually improve the way it does business, for the benefit of Canadians, in an increasingly complex and ever-changing environment. It recognizes that an effective risk management approach, one that promotes and is underscored by principles of transparency, is an important tool to respond to this ongoing challenge.

In developing the Integrated Risk Management Framework, the Treasury Board Secretariat was informed by shared knowledge and experience - it led research and consultations in collaboration with federal organizations, academics and private interests. Similarly, departments and agencies, in developing decision-making frameworks for application within their programs, have also been informed by the views and concerns of Canadians.

With regard to policy development on the application of precaution in risk management, Risk Management for Canada and Canadians - Report of the ADM Working Group on Risk Management, March 2000, recognizes that uncertainty in science, together with competing policy interests (including international obligations) has led to increased focus on the precautionary approach/principle. The Government initiated an inter-departmental initiative to develop a federal consensus on the precautionary approach. The overall aims are: to develop a coherent and cohesive position for use in federal areas of responsibility (both domestic and international laws, policies and treaties in areas where science is implicated) and for integration into the broader process of risk management, and to assist departments in developing operational guidelines in their particular area of responsibility. One of the guiding principle is the need for greater transparency and public involvement.

Recent developments in the area of bio-diversity and trade protocols highlight the need to come to terms with the precautionary approach in Canadian public policy. While the actual implementation of a precautionary approach may vary sector-by-sector to ensure coherence in its use and to strengthen credibility and trust of Canadians in precautionary decisions, the guiding principles by which it is to be applied need to be reviewed in a comprehensive manner.

Actions and Time lines:

• The Government has consulted on a discussion document A Canadian Perspective on the Precautionary Approach/Principle outlining proposed "guiding principles" for the application of the precautionary approach/principle. The consultations were intended to inform Canadians and international parties about Canadian perspectives and seek their views on the guidance contained in consultation documents. The feedback will serve to inform the government's thinking on whether the guiding principles are appropriate, would improve consistency, provide an appropriate balance of flexibility and predictability and be adaptable.

• Arriving at a federal framework for the precautionary approach/principle will build confidence with the Canadian public on how the government makes science-based decisions to manage risk; it will enhance coherence in the implementation of the principles; it will maintain flexibility in the application; and it will assist Canada in international discussions on the issue of precaution.

Ongoing

• The federal discussion document A Canadian Perspective on the Precautionary Approach/Principle reflects the efforts of a multi-departmental approach, comprising Agriculture and Agri-Food Canada, Canadian Environmental Assessment Agency, Canadian Food Inspection Agency, Department of Fisheries and Oceans, Department of Foreign Affairs and International Trade, Environment Canada, Finance Canada, Health Canada, Industry Canada, Justice Canada, Natural Resources Canada, Privy Council Office, Transport Canada and Treasury Board Secretariat.

Departmental-specific initiatives:

• Departments and agencies maintain an active dialogue with Canadians and maintain numerous consultative committees. For example, Health Canada has established the Office of Consumer and Public Involvement to provide information and opportunities for Canadians (and especially consumers of the products regulated) to become meaningfully involved in the decision-making processes regarding priorities, policies and programs. This Office is also establishing a Public Advisory Committee in response to Canadians’ desire for more information about health protection issues, and the need for more involvement in the development of policies and programs designed to protect their health and safety.

Ongoing

• Departments and agencies undertook stakeholder consultations on the discussion document between November 2001 and April 2002 to help define and address key issues and build consensus on the broad principles that should guide decision making in the use of the precautionary approach/principle.

Completed

• The Pest Management Review Agency releases Proposed Regulatory Decisions Documents to consult with stakeholders prior to making a final decision for full registration on a newly registered active ingredient, or a major new use for an already registered active ingredient. The document summarizes the Agency’s review of data supporting the application and outlines the reasons for the proposed regulatory decision.

Ongoing

The federal government should identify major health and safety objectives that, to be achieved, require significant interdepartmental cooperation and ensure accountability for achieving them

The Government Action Plan:

With regard to horizontality in regulatory program performance, there are time-tested approaches which provide a basis for interdepartmental coordination and accountability, including:

• Cabinet and its Committees’ key role in addressing horizontal issues. The Committee structure is sectoral and inherently addresses competing interests, inconsistencies, cross-cutting linkages and potential conflicts in policy and resource trade-offs.

• Parliament inherently operates as a major contributor to horizontal, cross-sectoral decision making.

• In addition, central agencies have responsibilities for bringing departments and agencies together for "holistic" decision making.

Actions and Time lines:

• The Government’s guidance to prepare the Report on Plans and Priorities (RPP) and Departmental Performance Report (DPR) has been strengthened to encourage departments to identify and report on horizontal issues and specifically includes regulatory initiatives.

Ongoing

• Departments form interdepartmental committees, which include central agency representatives, to ensure the coordinated interaction amongst departments on a large number of issues. For example:

• the Canadian Food Inspection Agency works closely with other federal departments and agencies and there is significant interdepartmental cooperation. The Agency’s Report on Plans and Priorities (RPP) indicates key federal partners by business line;

• the Government has established an interdepartmental working group to coordinate the interaction between departments that have responsibility for regulation of pesticides and those that have research responsibilities. The coordinating committee will facilitate exchange of information as well as provide opportunities for collaboration on research projects;

Ongoing

• in the wake of September 11, 2001 events, there has been recent inter-departmental efforts to update security requirements in a broad base of legislation. Many departments and agencies responded quickly and effectively to develop and support the implementation of renewed national security programs;

Ongoing

• as a result of the 1999 Toxics Audits, Environment Canada created Assistant Deputy Ministers and Directors General Toxics committees to promote interdepartmental cooperation around the management of toxics.

Ongoing

Recommendation 24.137

The Government Action Plan:

The Government’s intention with respect to reporting to Parliament is to provide Parliamentarians and the public with relevant, accurate, consolidated and timely information. Departments and agencies, including those with significant regulatory responsibilities relative to health and safety, are required to provide on an annual basis:

• Departmental Reports on Plans and Priorities (RPP), tabled in Parliament each spring; and

• Departmental Performance Reports (DPR), tabled each fall.

To assist departments and agencies in their effort to support their ministers’ direct accountability to Parliament, the Government develops guidelines for departmental performance reports including those involving health and safety regulatory programs. The Government’s departmental performance report guidelines have been recently revised to better emphasize the focus on strategic outcomes, to enhance the quality of information and to strengthen the linkages between resource allocation and results. All departments including those with regulatory focus are encouraged to report on their own initiatives as well as those they jointly engage in with other organizations. Recognizing the diversity of departmental programs and activities, the revised guidelines also allow for departmental or agency discretion on content and format to best provide meaningful, results-based performance information.

Actions and Time lines:

• The Government is currently working to continually improve on the way organizations plan for and report on performance across government. Through the provision of renewed guidance, learning seminars and supporting tools, departments and agencies, including those responsible for health and safety, are being encouraged to focus on overall effectiveness and the achievement of outcomes in their annual planning and reporting documents to Parliament.

Ongoing

• Organizations are also being encouraged to provide a balanced portrait of the environment in which they work and the risks they manage, as part of their planning and reporting.

Ongoing

• The Government has also recognized the importance of including horizontal, or shared results, in a planning and performance discussion. The renewed guidance for the preparation of Departmental Performance Reports encourages organizations to make specific reference to horizontal initiatives and how they contribute to shared results. Where appropriate, the lead department in a horizontal issue area is encouraged to summarize performance of shared initiatives.

Ongoing

Departmental-specific initiatives:

• Every year, departments prepare and present their departmental reports to Parliament. Within this report, they identify issues which are the joint responsibilities of several departments and address progress against established objectives.

Ongoing

• Transport Canada has instituted an approach to measure the effectiveness of its safety regulatory programs that involves a continuum of three levels of results with a focus on outcomes. Departmental reports such as the Report on Plans and Priorities and the Departmental Performance Report provide a means to present planned and actual accomplishments and their contribution to the effectiveness of safety regulatory programs.

Ongoing

• Environment Canada submits an annual report on CEPA activities carried out by Environment Canada and Health Canada to protect the environment and human health against harmful substances. The Annual Report includes a report on the activities of the National Advisory Committee, a committee of representatives from provincial, territorial and aboriginal governments. The National Advisory Committee was established under CEPA to provide the Ministers of the Environment and Health with advice on environmental protection related to CEPA and explicit recognition that provincial, territorial and aboriginal governments also play a role in environmental management in Canada.

Ongoing

The performance of senior managers of each contributing regulatory authority should be assessed based on the extent to which joint objectives are achieved.

The Government is undergoing a phase of fundamental reform that will enable the Public Service to become a modern, people-centred institution which gets results that matter to Canadians. Within this process, it has identified touchstones of where it has been and where it is going.

The Government has established a performance management program for senior managers, the objectives being to:

- encourage excellent performance by recognizing and rewarding the achievement of results that are linked to business plans and government objectives, and the demonstration of leadership competencies, values and ethics; and

- provide a framework within which a consistent and equitable approach to performance management can be applied.

Within this context, one of the ongoing commitments for deputy ministers is to demonstrate excellence in corporate-wide leadership, contribution and collaboration. Performance Measures include the identification of emerging issues which require coherence across departments and with other jurisdictions and the initiation of discussion on matters requiring consultation.

Further, within the context of the Deputy Minister Performance Agreements
Corporate Priorities for the Public Service of Canada 2002/2003, the Clerk has specifically noted the importance of collaborative working relationships:

"Collaboration, co-ordination and partnership are essential to advancing the Government’s policy agenda and improving service delivery in today’s global, connected environment. Economic, social and management policy are converging, while domestic and international issues are becoming increasingly interdependent. Strong collaborative working relationships, although challenging, broaden the scope of the possible and enable innovative solutions to new and old challenges."

Actions and Time lines:

• The Government will develop a statement of principles for the public service to provide a shared direction for all public servants and to underpin the organizational culture. Those principles will include a shared commitment to professional values, be they traditional values like neutrality and merit, or new ones like teamwork and innovation.

• Where a deputy minister has concluded a performance agreement including collaborative working relationships, for 2002-2003, he or she will be expected to develop collaborative working relationships to improve service delivery and policy development. Performance measures could include:

• joint work program on policy development developed and managed with other departments, governments and stakeholders;

• regional perspectives better integrated into policy development, with particular attention to regional advice on program implementation in the field and between departments;

• initiatives which fully use information technologies (taking into account the need for interoperability of systems) to provide more client-focussed, integrated services to Canadians, developed in partnership with otherdepartments or with provincial or municipal governments; and

• collaborative approaches to departmental challenges consistently fostered and rewarded.

2002/2003

Departmental-specific initiatives:

• The Canadian Food Inspection Agency has implemented a performance management program for senior managers that ensures those senior managers with responsibility for regulatory programs are assessed based on their performance vis-à-vis these responsibilities.

Ongoing

The federal government should develop collaborative arrangements with the provinces and territories to reduce risks to the health and safety of Canadians and assess the achievement of joint objectives. The arrangements should also allow for the effective development of a Canadian position in international work-sharing and standard-setting exercises.

The Federal Regulatory Policy requires that intergovernmental agreements are respected, and full advantage is taken of opportunities for coordination with other levels of Government. Federal/Provincial/Territorial cooperation is the norm in regulatory areas and there is an extensive range and number of intergovernmental mechanisms that operate on a number of different levels.

Concrete examples of collaborative arrangements from the health and safety area include:

• The Agreement on Internal Trade, which came into force in July 1995, provides for the elimination of trade barriers caused by differences in regulations across the country. Progress has been made in a number of areas, including transportation (truck safety) and the environment.

• The Canadian Council of the Ministers of the Environment promotes co-operative approaches to inter-jurisdictional issues and co-ordinated policies on a variety of topics (e.g., toxic substances). Under a Canada Wide Accord on Environmental Harmonization, work is underway to develop Canada-wide standards in six areas.

• The Canadian Food Inspection System Implementation Group (CFISIG), comprised of officials from federal and provincial ministries, aims to harmonize standards, integrate inspection delivery systems, and as well, provide an inter-jurisdictional forum for harmonizing standards, procedures and methods for food inspection.

• The Committee on Environment and Occupational Health, a federal/provincial/territorial working group, has been established to provide leadership and direction in developing effective policy measures to address environmental health issues in an integrated, coordinated and holistic manner.

• The Department of Foreign Affairs and International Trade provides overall leadership to support the effective development of a Canadian position in international work-sharing and standard-setting exercises. In addition, the Department maintains a close relationship with the provinces and territories in the area of international trade policy through of a variety of different mechanisms. Federal, provincial and territorial officials participate in the Federal-Provincial-Territorial Committee on Trade (C-Trade) which meets quarterly (or more frequently) in order to exchange information, share perspectives and develop Canadian positions on a range of trade policy issues, including negotiations. In addition to these regular meetings, Canadian Ministers responsible for trade (federal, provincial and territorial levels) as well as deputy ministers meet at least once a year to develop further the cooperative relationship that exists with the provinces in trade/investment policy, to update the provinces on recent trade developments and to discuss further cooperation on key issues. The Department also maintains an intranet network and schedules numerous conference calls with the provinces to facilitate the sharing of documents and current information.

Actions and Time lines:

Departmental-specific initiatives:

• In 1994, the Federal Provincial and Territorial Ministers of Agriculture established the CFISIG to ensure implementation of the Blueprint for the Canadian Food Inspection System.

• CFISIG includes government representatives involved in food inspection at the federal, provincial, territorial and municipal levels. There are three co-chairs: one from the provincial health stream, one from the provincial agriculture stream and one from the federal government.

Ongoing

• The Canadian Food Inspection Agency has a long history of bilateral cooperative arrangements with provinces to coordinate their efforts in food inspection and food safety, delineate each government’s roles and responsibilities, identify areas of further cooperation and establish work sharing arrangements in the area of food inspection. Typically the goal of these bilateral arrangements are to:

• overcome inefficiencies, clarify roles and responsibilities;

• assist in dealing with the reduction of overlap and duplication; and

• establish protocols to deal with emerging "horizontal" or cross-cutting issues that may be under the jurisdiction of more than one department or government.

Ongoing

• Health Canada is committed to collaborate extensively with the provincial and territorial governments as well as with its international counterparts. Federal/provincial/territorial committees exist for numerous functions, including environmental and occupational health, pesticide regulations, pharmaceutical issues, and food safety. Health Canada is also involved in standardization and harmonization at the international level through working groups and committees (e.g., World Trade Organization, Organization for Economic Cooperation and Development, North American Free Trade Agreement, and the International Conference on Harmonization).

Ongoing

• Although nuclear regulation is under federal jurisdiction, the Canadian Nuclear Safety Commission has collaborative arrangements with provincial authorities in a number of areas, including harmonization of regulatory requirements for mining with Saskatchewan, inspection of nuclear pressure vessels with Ontario’s Technical Standards and Safety Authority and other collaborative arrangements with provincial authorities in other provinces.

Ongoing

• Environment Canada, through its work on the Canadian Council of the Ministers of the Environment, collaborates with the provinces and territories to set goals for the reduction of risk to the environment and human health. In 1998, the Minister of the Environment signed the Canada-wide Accord onEnvironmental Harmonization, and under these accords, the Canada-wide Environmental Standards Sub-Agreement (CWSs). The CWSs can include qualitative or quantitative standards, guidelines, objectives and criteria for protecting the environment and reducing risks to human health. Since the signing of this Accord, a number of negotiations have been successful in establishing CWS for six substances of national interest, most notably, Particulate Matter and Ozone, which create smog and are known to cause health problems of significant concern. Ongoing

• The National Energy Board works collaboratively through the Canadian Standards Association to develop technical safety standards for pipeline systems which are adopted by the Board and all provincial regulatory authorities. The Board has also established the Pipeline Technical Regulatory Authority Council of Canada which is a forum for all pipeline safety regulatory authorities to exchange information and best practices.

Ongoing