Formative Evaluation of CEPA 1999

2.5 Part 5: Controlling Toxic Substances

Part 5 of the Act is comprehensive in nature and includes provisions relating to:

• assessing and managing risks of new substances - those not included on the Domestic Substances List;
• placing the onus on industry for notifying the government of new substances prior to their manufacture in or importation into Canada;
• assessing the risks of existing substances - those substances on the original Domestic Substances List; and
• managing the risks of substances added to the CEPA 1999 Schedule 1 List of Toxic Substances.

The Risk Assessment Directorate is responsible for the new substance provisions and risk assessment of existing substances. The Pollution Prevention Directorate and the Air Pollution Prevention Directorate share responsibilities for risk management provisions in Part 5. Following this functional separation, information relating to this Part of the Act has been separated into four subsections:

• New Substances - Chemicals and Polymers;
• Assessing Existing Substances;
• Risk Management (General); and
• Risk Management (Air).

2.5.1 New Substances - Chemicals and Polymers

Expected Outcomes

The evaluation identified three expected outcomes for this component of Part 5:

1. Eliminate overlap and duplication with other acts.
2. CEPA 1999 functions as an effective safety net for areas not covered by other federal acts
3. Unauthorized use of new substances will be prevented.

Overview of the Act and Its Provisions^xvi

CEPA 1999 is the key authority for the government to ensure that all new substances to Canada are assessed for their potential to harm human health or the environment.

Anyone (person or company) who wants to import, manufacture or sell any new substance is required to notify the appropriate Canadian regulatory authority so the new substance can be evaluated for potential effects on human health and the environment prior to its importation, manufacture or sale. Provisions under Part 5 of CEPA 1999 ensure that no new substances are introduced (imported or manufactured) into the Canadian marketplace before they have been assessed to determine whether or not they are toxic or capable of becoming toxic to the environment or human health. The risks of substances determined to be or suspected of being toxic or capable of becoming toxic may be managed, as necessary, through the imposition of conditions or the prohibition of their import or manufacture.

Recognizing that other acts provide for such an assessment process, CEPA 1999 includes a provision whereby substances regulated by other acts are exempt from the Act's obligations to provide the required information under CEPA 1999. This avoids regulatory duplication, while ensuring that standards for protection of the environment and human health are met and applied to all substances. Under CEPA 1999, the government determines, by order, which acts and regulations meet the above criteria for providing appropriate notification and assessment and lists them in published schedules (or "annexes") to CEPA 1999. Acts and regulations relating to new substances that are chemicals or polymers are listed in Schedule 2, and those relating to new substances that are animate products of biotechnology are listed in Schedule 4.

Ministerial Obligations

The evaluation found that all Ministerial obligations are being satisfied:

• Sections 83(1)-(4) - The New Substances Branch operates a database that tracks progress and changes in status at each key step of a new substance notification.
• Section 87(1) - The New Substances Branch publishes additions to the Domestic Substances List every six to eight weeks. The tracking system notifies the Branch when key steps have been completed, including when a substance should be added to the List.
• The other Ministerial obligations are administrative in nature and have been met through publications in the Canada Gazette.

Major Accomplishments

Since the coming into force of CEPA 1999, the joint Environment Canada - Health Canada New Substances Program has processed approximately 4000 new substance notifications (about 800 per year). Three prohibitions, 40 conditions and 29 significant new activity notices^xvii were issued during that period.

Proposed New Substances Notification Regulations³² were published in 2004. These regulations incorporate revisions to the existing New Substances Notification Regulationsrecommended through the New Substances Notification multistakeholder consultative process held from 1999 to 2001. The regulations are projected to be in force by late 2005.

The New Substances Fees Regulations³³ came into effect on January 1, 2003. Importers and manufacturers of a new chemical or polymer who notify the government that they are introducing a new substance to Canada must pay a fee, in addition to providing the information prescribed in the New Substances Notification Regulations. These fees cover approximately 22% of the costs in administering the program, a level consistent with that imposed under similar initiatives in the United States.

Environment Canada is very active internationally in the area of new substances. For example, Canada is working towards the mutual recognition of new substance assessments, both on a bilateral basis with Australia and the United States and through an Organisation for Economic Co-operation and Development pilot project. As well, Environment Canada is participating in the United Nations Environment Programme Strategic Approach to Chemicals Management. Having completed its assessments, Canada shares its information with the international community, such as the Stockholm Convention on Persistent Organic Pollutants.

Implementation of Priority Actions

Where applicable, work has been initiated on all identified priority actions:

1. Implement changes in response to New Substances Notification Regulation consultations - Environment Canada published a formal "Response" to the consultation Final Report. The Response committed the Department to pursue the implementation of all of the recommendations of the consultation Final Report. In 2003, Environment Canada issued a Progress Report describing its progress towards implementing its commitments. It plans to issue another progress report in 2005.
2. Assess growing number of New Substances Notifications- The program has continued to assess all new substances notified under the Act and to impose risk management instruments where appropriate. Contrary to the projections in the Operational Review, however, the number of notifications has not increased. According to departmental officials, new substances programs in other Organisation for Economic Co-operation and Development jurisdictions have experienced a similar levelling-off of notifications.
3. Continue to exercise leadership in Organisation for Economic Co-operation and Development initiatives with goal of international harmonization - See international activities under Major Accomplishments, above.
4. Provide environmental risk assessment advice and support to Health Canada and other government departments - The New Substances Branch continues to lead and collaborate in various initiatives with the Existing Substances Branch and other parts of Environment Canada and Health Canada to develop or refine risk assessment tools and techniques (e.g., organometallic toxics testing, compiling and developing exposure assessment methods). The New Substances Branch has also advised Environment Canada and Health Canada personnel on a small number of specific risk assessments of existing substances.
5. Maintain support for compliance promotion and enforcement - The New Substances Branch helped prepare compliance promotion materials and helps fund compliance promotion activities, largely through financial transfers to the regions. The New Substances Branch publishes decisions on the CEPAEnvironmental Registry, including regular updates to the Domestic Substances List³⁴ and Non-Domestic Substances List³⁵ amendments. Despite these efforts, however, data on overall compliance rates and the effectiveness of the new substances notification requirements under CEPA 1999 is not available. The New Substances Branch sees its role as providing compliance promotion support and responding to notifications and assumes that the Enforcement Branch staff, in collaboration with regional staff, are responsible for monitoring and reporting on compliance. The New Substances Branch has ongoing relationships with most of the "regular" notifiers (e.g., large manufacturers and importers of chemicals and polymers) and is confident that these organizations comply routinely. The Branch has less contact with and information about less frequent notifiers.
6. Continue to develop and modernize the operation of the New Substances Program - For the past two years, the New Substances Branch has been developing a Service Delivery Improvement Strategy. In 2004, the New Substances Branch issued a revised Operational Policy Manual, which incorporates numerous operational changes in response to the new substances notification consultations and lessons learned. The New Substances Branch is also working towards a long-term initiative to develop an e-filing system.
7. Implement the New Substances Fees Regulations for chemicals/polymers - See discussion under Major Accomplishments, above.

Issues and Challenges

Some of the most significant challenges facing the new substances notification process pertain to scheduling other acts. While progress has been made towards scheduling the Food and Drug Act and the Fisheries Act, as well as certain products under the Health of Animals Act, final scheduling is still outstanding. As a result, Environment Canada and Health Canada remain responsible for these assessments under CEPA 1999, despite not having expertise or funding. Second, even when an act has been scheduled, the Ministers of Health and Environment need to be assured that activities undertaken by other government departments remain consistent with CEPA 1999.

Another challenge for Environment Canada is to be aware of and stay ahead of novel technologies, such as nanotechnologies.

Finally, Environment Canada needs to obtain better information on overall compliance rates in order to fully comprehend the impact that the regulations are having.

Conclusions

The expected outcomes of eliminating overlap and duplication with other acts and of CEPA 1999 functioning as an effective safety net for areas not covered by other federal acts are being achieved. Since CEPA 1999 came into force, three other acts have been listed under Schedule 2, and work is under way to list others.

The evaluation was unable to determine the degree to which the expected outcome of preventing the unauthorized use of new substances will be achieved. All notifications submitted are processed, and all prohibitions, conditions and significant new activities issued are enforced. Based on ongoing relationships, Environment Canada is confident that large notifiers (i.e., those responsible for the vast majority of the manufacture and import of new substances) comply with notification requirements. However, the Department does not have solid intelligence on overall levels of compliance with notification requirements.

2.5.2 Assessing Existing Substances

Expected Outcomes

The evaluation identified one expected outcome for this component of Part 5:

1. All substances on the Domestic Substances List are categorized by September 2006.

Overview of the Act and Its Provisions^xviii

CEPA 1999 requires that all substances on the Domestic Substances List that have not been subject to notification and assessment as new substances^xix be categorized within seven years of Royal Assent, which occurred on September 14, 1999.

Categorization involves the systematic identification of substances on the Domestic Substances List that should be subject to screening-level risk assessment. For this purpose, categorization identifies substances that:

• are inherently toxic and display either of the characteristics of persistence (take a long time to break down) or bioaccumulation (collect in living organisms and end up in the food chain); or
• may present to individuals in Canada the greatest potential for exposure.

Environment Canada plays the lead role in conducting categorization activities concerning "persistent, bioaccumulative and inherent toxicity to environmental organisms" aspects. Health Canada plays the lead role in conducting activities concerning "greatest potential for exposure and inherent toxicity to humans" aspects. The departments share the categorization deadline of September 2006.

For substances "categorized in," screening assessment activities will be undertaken to determine whether the substances are "toxic" or capable of becoming "toxic" in accordance with the criteria stipulated in CEPA 1999. The outcomes of the screening assessments may result in one of the following decisions:

• No further action is taken.
• If the substance is not already listed, it could be added to the Priority Substances List.
• The Ministers of Environment and Health recommend that the Governor in Council add the substance to the List of Toxic Substances (Schedule 1 of CEPA 1999).

Ministerial Obligations

The evaluation found that all but one of the Ministerial obligations that have been triggered have been satisfied:

• Section 66 - The Domestic Substances List and the Non-Domestic Substances List are maintained and are published on the CEPAEnvironmental Registry.
• Section 73(1) - Categorization of substances on the Domestic Substances List is under way. Current planning documents predict that the categorization will be concluded by the CEPA 1999 deadline of September 2006.
• Section 74 - Both Health Canada and Environment Canada have processes in place to identify and conduct screening assessments on substances that either meet the Domestic Substances List categorization criteria in Section 73 or are added to the Domestic Substances List under Section 105. The departments are in the process of completing a pilot screening assessment exercise to prepare for and refine screening assessment procedures and techniques.
• Section 75 - Procedures to implement the obligation to review decisions of other jurisdictions are under development, but not yet implemented.
• Section 76(4) - The Ministerial obligation to respond to requests for additions to the Priority Substances List³⁶ within 90 days has been met. There have been two requests for additions to the Priority Substances List since CEPA 1999 came into force: perfluorooctane sulfonate and forest-fire retardants containing ferrocyanides. The Minister responded to both requests within 90 days.
• Section 76.1 - A weight of evidence approach and the precautionary principle are applied when conducting and interpreting the results of risk assessments.^xx
• Section 77(3) - The Department is now completing the first screening assessments and has not yet completed the process of adding any of the substances assessed under this process to Schedule 1, although it plans to do so. For both polybrominated diphenyl ethers and perfluorooctane sulfonate, the Canada Gazette Notices indicate that the Ministers of the Environment and Health propose addition to Schedule 1.
• Section 77(4) - The Persistence and Bioaccumulation Regulations³⁷ set the criteria used to determine whether a substance is persistent or bioaccumulative under CEPA 1999. In 2003, the Ministers of the Environment and Health published a proposal to establish the Virtual Elimination List and to add hexachlorobutadiene³⁸ to it. For both polybrominated diphenyl ethers and perfluorooctane sulfonate, the draft Canada Gazette Notices indicate that some of these substances meet the criteria for virtual elimination and that the Ministers propose addition to the Virtual Elimination List.
• Section 77(6) - Environment Canada and Health Canada have published summaries of the screening assessments and proposed measures for polybrominated diphenyl ethers and perfluorooctane sulfonate under Section 77(3) and Section 77(4), as well as the summaries and proposed measures under the sections of all Priority Substances List assessments completed since the Act came into force. Appendix XII provides an overview of the assessment decisions made on all Priority Substances List 1 and 2 and Domestic Substances List substances since the coming into force of CEPA 1999.
• Section 77(6)(c) - For substances recommended for addition to Schedule 1, the Minister of the Environment has published statements indicating the manner in which the Department intends to develop a proposed regulation or instrument (such as proposed risk management strategies).
  • Section 77(9) - All Section 77(6) statements are published in the CEPAEnvironmental Registry, and there is a record of all Governor in Council decisions about additions to Schedule 1.

Additional Ministerial obligations, under Sections 76(2), and 79 have not been triggered.

Major Accomplishments

Environment Canada and Health Canada have identified nearly 1000 substances on the Domestic Substances List that did not meet the criteria for addition to the list. The departments are in the process of arranging for these substances to be removed from the Domestic Substances List.

Environment Canada has developed, tested, consulted on and revised categorization approaches for determining persistence, bioaccumulation and inherent toxicity to environmental organisms of various categories of the remaining 22 000 Domestic Substances List substances.

Environment Canada has released preliminary categorization decisions³⁹ on 17 000 of the remaining 22 000 Domestic Substances List substances (as of January 31, 2005).

A screening assessment pilot project is under way, involving 123 substances, to test and improve approaches for screening assessments.

All but two of the remaining assessments on Priority Substances Lists 1 and 2 substances have been completed, and Notices providing a summary of assessments have been published (see Appendix XII). The remaining two Priority Substances List assessments (aluminum salts and ethylene glycol) are under legal suspensions due to the need for further research studies.

Implementation of Priority Actions

Work is under way on each of the four identified priority actions:

1. Establish priorities for risk assessments - Results of the categorization have been grouped by chemical or sector uses and also by (tentative) priority for assessment. The pilot project is being used, in part, to learn how to set priorities for screening assessments. Further, Environment Canada is developing policies and procedures for setting priorities for reviewing decisions in other jurisdictions (as required in Section 75). Setting priorities for risk assessment will remain an extremely important and difficult task for the Department for the foreseeable future.
2. Leverage and harmonize with other jurisdictions - International collaboration is a very important strategy for the Existing Substances Branch. Slow progress in addressing the legacy of existing substances in other jurisdictions has meant that the availability of foreign information has been less than anticipated.
3. Work closely with Health Canada - Environment Canada is committed to working with Health Canada. However, technical barriers have inhibited sharing confidential information databases between the two departments. Other aspects of the Environment Canada - Health Canada relationship were excluded from the scope of this evaluation.
4. Place onus on industry to provide information - The Industry Coordinating Group has been effective. Ongoing improvements are being made to processes for obtaining information from industry in ways that minimize burden and respect confidential business information.

Issues and Challenges

Some of the issues and challenges facing Environment Canada regarding the assessment of existing substances include:

• identifying and assessing the risks from toxic substances contained in or created and released by the use or disposal of manufactured articles;
• ensuring that sufficient information is available such that industry does not choose alternatives to toxic substances that might themselves pose significant risks;
• conducting assessments to support sectoral, multipollutant risk management approaches; and
• making ongoing refinements to the use of surveys and developing other information- gathering tools under Section 71.

In addition:

• A significant proportion of the substances on the Domestic Substances List may no longer be of commercial interest. Nonetheless, CEPA 1999 does not provide the Minister the authority to remove any of the originating substances from the Domestic Substances List. As a result, Environment Canada and Health Canada are required to categorize all of these substances and to then perform a screening assessment on any that meet the categorization criteria - even if the substance is not currently used in Canada.
• The obligation on industry to inform the Minister of suspected toxic substances (Section 70) is providing less information than anticipated. For example, Environment Canada is receiving only 1% of the reports received under a similar requirement in the United States. Environment Canada has not identified a reason for the low reporting levels.

Conclusions

The expected outcome of meeting the obligation to categorize all existing substances on the Domestic Substances List by September 2006 is likely to be met. Environment Canada continues to expect to categorize about 3450 substances from the Domestic Substances List for screening assessments. Some of these substances will be high priorities for assessment (persistent, bioaccumulative and inherently toxic, or high volume persistent). Some substances that meet categorization criteria will be assigned lower priorities for assessment.

2.5.3 Risk Management (General)

Expected Outcomes

The evaluation identified three expected outcomes for this component of Part 5:

1. Releases of toxic substances are prevented or reduced.
2. Releases of known persistent, bioaccumulative and inherently toxic substances from human-caused sources are virtually eliminated.
3. The use of existing substances in products and industrial and commercial processes is better managed.

Overview of the Act and Its Provisions^xxi

Where the Ministers of Health and Environment have determined a substance to be toxic, following a Priority Substances List assessment, a screening assessment or the review of a decision by another jurisdiction, and where they have proposed that the Governor in Council add the substance to the List of Toxic Substances, Section 91 requires the Minister of the Environment to publish a proposed regulation or instrument using the authorities under CEPA 1999 to establish preventive or control actions for managing the substance. The proposed regulation or instrument must be published in the Canada Gazette within two years of the Ministerial recommendation that the substance be added to the List of Toxic Substances. Section 92 requires the regulation or instrument to be finalized and published in the Canada Gazette within 18 months of the publication of the proposed regulation or instrument.

Based on the scientific information available, risk management strategies are developed to determine how best to manage each toxic substance. Social, economic and technology factors are integral to risk management decision-making, including considering which risk management instruments are the most cost-effective. While CEPA 1999 provides for certain instruments that can be developed under the Act, such as regulations, pollution prevention plans, guidelines and codes of practice, other tools outside the Act, such as voluntary agreements, other Acts of Parliament or provincial and territorial actions, also may be suitable for managing particular risks posed by a toxic substance.

Ministerial Obligations

The evaluation found that all Ministerial obligations with regard to legislative timelines and priority actions are being satisfied:

• Sections91(1) and 92(1) - Environment Canada has developed proposed regulations or instruments within 24 months of recommendation for addition to Schedule 1 in all cases (see Appendix X).
• Section 90(1.1) - The Department has continued to focus on pollution prevention through a variety of initiatives, such as leading the development of the Canadian Council of Ministers of the Environment's National Commitment to Pollution Prevention 1996. For eight years (until 2004), Environment Canada reported annually on progress made towards the objectives in the Cabinet-approved Federal Pollution Prevention Strategy 1994. One indicator of the impact of this commitment is that, whereas the first progress report was signed only by Environment Canada, all 25 federal departments signed the eighth report.
• The Virtual Elimination List (Section 65(3)) has not yet been formally established, although the Act does not specify a time frame for such action.A proposal to establish the Virtual Elimination List (Section 65(2)) was published in the Canada Gazette, Part I, in 2004. Final establishment of the Virtual Elimination List has been delayed by industry challenges, which are now resolved. Environment Canada anticipates establishing the List in June 2005.

Major Accomplishments

The Department has developed and made ongoing revisions to the Toxics Management Process⁴⁰ to guide the development of risk management strategies for toxic substances. It has also developed a guidance document to assist risk managers and external stakeholders in understanding and implementing the revised process. The document sets out expectations and guidance regarding issues such as roles and responsibilities; procedures for developing risk management strategies; selecting appropriate public engagement practices; and selecting and designing individual risk management measures and tools.

Environment Canada has developed numerous risk management measures and tools within the legislated timelines, including:

• 13 regulations;
• five final and one proposed Pollution Prevention Planning Notices;
• four Codes of Practice;
• five CEPA 1999 Guidelines; and
• four Environmental Performance Agreements.

In addition to initiating actions as prescribed under the Act, the Department has developed or supported the development of several other relevant risk management measures and tools that contribute to the achievement of the intended results associated with the Act. For example:

• Environment Canada played a key role in the development of several Canada-wide Standards and Guidelines under the Canadian Council of Ministers of the Environment process, including Canada-wide Standards for:
  • particulate matter and ozone;
  • mercury;
  • dioxins and furans; and
  • benzene.
• The Department also played the lead role in engaging the provinces to initiate work that is expected to lead to more standardized management of municipal wastewater effluents across Canada.
• Environment Canada has worked closely with the Forest Products Association of Canada on a "smart regulations" initiative for the forest products sector. A key component of this initiative is a joint agreement to develop a 10-year agenda for addressing air emissions from the forest products sector.

A listing of all risk management measures and tools developed and implemented by the Department during the evaluation period is included as Appendix IX to this report. Appendix X provides an overview of the risk management measures and related timelines for those substances added to CEPA 1999 Schedule 1 during the evaluation period. Appendix XI provides a similar overview of risk management measures and tools introduced for substances already existing on CEPA 1999 Schedule 1 at the time the Act entered force in March 2000.

Implementation of Priority Actions

Work has been initiated on all identified priority actions:

1. Develop an effective priority-setting mechanism that facilitates resource allocation by highest priority - The Pollution Prevention Directorate continues to refine the processes used to set priorities and to facilitate resource allocation by highest priority.
2. Establish priorities in conjunction with the risk assessment program - Risk managers work with risk assessors through the CEPA Management Committee Toxics Management Subcommittee to identify strategies for risk assessment that will lead to a predictable set of priorities for both risk assessment and risk management. They are exploring options such as focusing on certain types of chemicals (e.g., persistent organic pollutants) and focusing assessments on groups of substances relevant to a particular sector (as is being explored through the forest products smart regulations initiative). The recent split of the Risk Assessment Directorate from the Pollution Prevention Directorate has made collaboration more difficult, at least in the short term.
3. Leverage the work of, and seek harmonization with, other jurisdictions - There are some good examples of leveraging work of other jurisdictions, most notably with respect to Extended Producer Responsibility and the fuel, vehicle and small equipment regulations.
4. Seek efficiencies by leveraging generic instruments to reduce development and implementation costs - Various steps have been taken to leverage generic measures and tools, including pollution prevention planning notices, environmental performance agreements and standardized fuel regulations.
5. Increase the application of voluntary initiatives to reduce the use of suspected toxics by industry, through environmental performance agreements - There has been mixed success in increasing the application of voluntary initiatives. However, the Policy Framework for Environmental Performance Agreements⁴¹ has made the approach more systematic.

Issues and Challenges

Environment Canada faces several external and internal challenges as it strives to manage the risks posed by toxic substances and other substances of concern while also satisfying the time-bound obligations of CEPA 1999. Tension exists within the Department as to how much risk management is enough for any given substance. Tension also exists externally, as the shared jurisdiction for environmental protection under the Constitution creates an ongoing need to consult closely with the provinces and territories and to adopt pragmatic approaches to risk management that respect both existing authorities and local perspectives.

The Act itself also poses several additional challenges:

• The requirement that a regulation or instrument must be proposed within 24 months and finalized within a further 18 months, has created challenges in the development of optimal risk management approaches.
• It may not always be appropriate or even possible to establish either a Ministerial release limit or a level of quantification for every persistent, bioaccumulative and toxic substance. The requirement to develop these limits may result in delays before the Minister can add a substance to the Virtual Elimination List.
• The limited range of economic instruments authorized under the Act, the limitations associated with tradable units and fees and broader Government of Canada policies on economic instruments and fees and charges restrict the Department's ability to manage risks as efficiently as possible. This undermines the Department's ability to ensure that the market fully accounts for environmental costs and to satisfy the Act's explicit principle of "polluter pays."
• Resource and information limitations can limit the Department's ability to develop effective multipollutant risk management approaches.

Despite reviews of most major risk management measures and ongoing efforts to review and share lessons learned, not all risk management measures and tools developed to date included mechanisms to support assessment and reporting of effectiveness. This limits the Department's ability to assess progress or make subsequent instrument choices.

Other emerging issues for Environment Canada include the need to have better information and clearer legal authority to manage all relevant aspects of toxic substances that are in or are created and released by the use or disposal of manufactured articles. The Department will need to have the ability to keep current with and respond to emerging technologies, including nanotechnologies. In addition, the Department will need to keep pace with the expected outputs of the screening assessment process following completion of Domestic Substances List categorization.

Conclusions

The expected outcome that releases of toxic substances will be prevented or reduced is likely to be achieved, in part. At least one risk management measure has been implemented for each toxic substance. These measures, however, may not address all sources of the substance. Also, some measures may not result in aggregate reductions. For instance, total emissions may increase in cases where the specified measure limits emissions per unit of activity, but where overall activity increases at rates greater than the prescribed reductions.

The expected outcome of "virtual elimination" of releases of known persistent, bioaccumulative and inherently toxic substances from human-caused sources is likely to be achieved.

The expected outcome that the use of existing substances in products and in industrial and commercial processes is better managed is likely to be achieved, in part. Through CEPA 1999, more substances, processes and products are being managed. The use of a wider range of measures and tools may imply more efficient management. Nevertheless, little documentation exists on the relative efficiency or effectiveness of ongoing management efforts. Moreover, while there is evidence that use, emission levels and exposures are declining for some toxics (e.g., benzene, dioxins and furans), trends for others are increasing, and data are insufficient for still others to make such determinations.

2.5.4 Risk Management (Air)

Expected Outcomes

The evaluation identified five expected outcomes for this component of Part 5:

1. Reductions of releases of smog-forming emissions from major industrial sources.
2. Reduction of nitrogen oxide emissions.
3. Reductions of volatile organic compound emissions from various products.
4. Protect the ozone layer from ozone-depleting substances.
5. Reductions of acid deposition below critical levels.

Overview of the Act and Its Provisions

CEPA 1999 does not contain air-specific provisions, with the exception of those included under Part 7, Divisions 4, 5 and 6. During the evaluation period, however, Environment Canada placed a high priority on addressing air quality issues. Given the assigned priority, the extent of resources assigned to the issue and the volume of outputs produced with respect to air quality, it was determined that a separate analysis of progress made in this area would be instructive.

Ministerial Obligations

There are no specific Ministerial obligations in this area. Related obligations are addressed under Section 2.5.2 - Risk Management (General).

Major Accomplishments

One of the most significant accomplishments with respect to risk management of air pollutants is the Government of Canada's Ten-year Action Plan on Clean Air,⁴² published in 2001. This agenda articulates the government's commitment to work with the provinces, territories and the private sector to develop strategies that will ensure cleaner air for all Canadians. The agenda includes an articulation of planned activities, expected outcomes and resource requirements under six specific elements:

1. Targets are continuously improved.
2. Transboundary flows of air pollution are reduced.
3. Emissions for vehicles, engines and fuels are reduced (see discussion under Part 7 - Divisions 4 and 5).
4. Emissions from industrial and other sectors are reduced.
5. Canadians take action to reduce air pollution.
6. Canadians understand how to interpret air quality information.

The Department received funding of $120 million through fiscal year 2005–06 for implementation of the Clean Air Agenda. Resources granted by the Government of Canada for implementation of CEPA 1999 resulted in funding levels provided for under the Clean Air Agenda being regularized into the Department’s annual allocations beginning in fiscal year 2006–07. In addition, the Department realized a further $59.9 million over the period 2003–2007 for implementation of the Border Air Quality Strategy. The Department prepares annual progress reports documenting activities and outputs related to the implementation of the Clean Air Agenda.

Ground-level ozone and soot, also known as particulate matter, are key components of smog. As part of the efforts to promote cleaner air for Canadians, Environment Canada added Precursors to Respirable Particulate Matter Less than or Equal to 10 Microns (sulphur dioxide, nitrogen oxides, ammonia and volatile organic compounds) to the CEPA 1999 Schedule 1 List of Toxic Substances Additionally, ozone and its precursors (nitrogen oxides [composed of nitric oxide and nitrogen dioxide] and volatile organic compounds) has been added to Schedule 1.

The decision to list these substances as toxic under Schedule 1 acted as the primary driver for the multitude of activities and outputs that have materialized under the Clean Air Agenda. The following provides an overview of what has been done to meet the six Intermediate Outcomes of the Clean Air Agenda, as well as what has been done with respect to other air- related aspects (i.e., ozone-depleting substances, hazardous air pollutants, and acid rain) not covered by the agenda.

1. Targets Are Continuously Improved

Environment Canada led the development of the new Canada-wide Standards for Particulate Matter and Ozone⁴³ and co-chaired the subsequent federal-provincial committee tasked with implementing provisions of the standards. The long-term air quality management goal for particulate matter and ozone is to minimize the risks of these pollutants to human health and the environment. However, recent scientific evidence indicates that there is "no apparent lower threshold" (i.e., safe exposure limit) for the effects of these two pollutants on human health. As such, the parties to the standards have agreed to revisit the standards as additional information is made available, beginning with a planned review of the fine particulate matter and ozone standard beginning in 2005 as well as a recommendation on whether or not to have a coarse fraction standard. Environment Canada also plays the lead role in information gathering and the provision of scientific and technical activities in support of the standards and any future reviews.

2. Transboundary Flows of Air Pollution Are Reduced

Environment Canada played a key role in both the negotiation of and the strategy to implement the Canada - United States Air Quality Agreement (including the Ozone Annex⁴⁴ and Acid Rain Annex and the Border Air Quality Strategy).The Canada - United States Air Quality Agreement now includes targets for sulphur dioxide regionally and nationally and for nitrogen oxides and volatile organic compounds within pollutant emission management areas. These targets have been adjusted to reflect new scientific understanding. Canada and the United States continue to measure and report publicly on progress in achieving the objectives of the agreement.

3. Emissions from Vehicles, Engines and Fuels Are Reduced

A Ten-year Federal Agenda on Cleaner Vehicles, Engines and Fuels⁴⁵has been developed and implemented. See the discussion under Part 7 - Divisions 4 and 5 for additional details.

4. Emissions from Industrial and Other Sectors Are Reduced

Environment Canada has developed a range of instruments and tools to reduce harmful air emissions from industrial and other sectors (see Box 4).

5. Canadians Take Action to Reduce Air Pollutionand
6. Canadians Understand How to Interpret Air Quality Information and Are Aware of Actions They Can Take

Environment Canada has worked to help Canadians reduce air pollution and protect their health by supporting community-level programs geared at reducing emissions and giving them better access to information related to air quality in their community. These community-level programs include Clean Air Day activities and the Commuter Challenge.

Agreements with provinces, territories, municipalities and health organizations led to the decision to expand the air quality forecasting program, both geographically and scientifically. The Air Quality Forecasting and Advisory Program is now in place nationally, and the National Air Pollution Surveillance Network⁵³ and the Canadian Air and Precipitation Monitoring Network⁵⁴ have been expanded through further investment in monitoring equipment and technology.

The National Pollutant Release Inventory Communities Portal⁵⁵ provides information about community-level air pollutants and is searchable by location or postal code. Other air quality programs provide daily forecasts and advisories in various Canadian regions.

7. Ozone-depleting Substances

Since 2000, Canada has:

• established a Canadian Council of Ministers of the Environment National Action Plan for the Environmental Control of Ozone-depleting Substances and Halocarbon Alternatives;
• regulated the phase-out of chlorofluorocarbons (CFCs) in metered dose inhalers;
• phased out methyl bromide consumption by 50% in 2001, by 70% in 2003 and by 100% in 2005;
• reduced its consumption of hydrochlorofluorocarbons (HCFCs) by 35%; and
• published proposed Regulations Amending the Ozone-depleting Substances Regulations, 1998 in the Canada Gazette, Part I, on April 3, 2004. A revised draft, for information purposes, was published in November 2004.

8. Hazardous Air Pollutants

Hazardous air pollutant initiatives over the evaluation period involved extensive consultations and achieved the following:

• Canada signed and ratified the Stockholm Convention on Persistent Organic Pollutants.
• Canada ratified the United Nations Economic Commission for Europe Protocols on Persistent Organic Pollutants and Heavy Metals.
• Canada established the five-year, $20 million Canada Persistent Organic Pollutants Fund to assist capacity building in developing countries.

9. Acid Rain

The federal government continues to implement its commitments under the 1998 Canada- wide Acid Rain Strategy for Post-2000. Under the strategy, the federal government continues to seek further emission reductions from the United States, maintain an adequate science and monitoring program and work with Ontario, Quebec, New Brunswick and Nova Scotia as they develop measures to further reduce sulphur dioxide emissions. Canada's total sulphur dioxide emissions have decreased by about 50% since 1980 and remain 25% below the national total agreed to under the Canada - United States Air Quality Agreement.

Issues and Challenges

A variety of challenges confront the clean air efforts of Environment Canada. For example, much of the anticipated improvement in air quality is dependent on the provinces meeting the commitments outlined in the Canada-wide Standards for Particulate Matter and Ozone. At this point, however, it is still unclear whether all provinces will meet performance expectations related to the standards.

Similarly, Environment Canada is currently assessing Ontario's proposed implementation plan under the Ozone Annex emission cap for nitrogen oxides from large fossil fuel-fired power plants in southern and central Ontario. The Ministers of the Environment and Health have determined that Ontario's strategy is insufficient for achieving the nitrogen oxides cap under the Canada - United States Air Quality Agreement.

Awareness and outreach activities included in the Clean Air Agenda have not been sufficiently funded and have relied on reallocation of existing funds to produce results.

With respect to sectoral programs, environmental outcomes have not been fully developed or articulated, although efforts are under way to do so with respect to the forest products sector. As well, many of the risk management measures and tools lack measurement and reporting structures to determine and communicate their impacts and effectiveness.

Finally, the Act does not include provisions for the Minister to regulate finished products that generate air toxics during their operation, such as wood stoves.

Conclusions

The Intermediate Outcomes under the Clean Air Results-based Management and Accountability Framework are all likely to be achieved. The realization of these outcomes will make an important contribution towards the realization of the ultimate expected outcomes described above and as articulated under the Clean Environment Business Line Plan's Air Result:

• Targets are continuously improved- This expected outcome is likely to be realized. For instance, targets under the Canada - United States Air Quality Agreement (including the Ozone Annex and Acid Rain Annex) have been adjusted over time. Targets under the Canada-wide Acid Rain Strategy for Post-2000 have also been adjusted to reflect new science. There is less certainty regarding performance targets included in sector-based initiatives (e.g., those included under environmental performance agreements, codes of practice); while some initiatives include targets, it is uncertain how progress towards these targets is monitored or if there is a formal process for ensuring that targets remain relevant and up to date.
• Transboundary flows of air pollution are reduced - This expected outcome is likely to be realized. Performance targets have been established under the Canada - United States Air Quality Agreement (including the Ozone Annex and Acid Rain Annex). Canada has surpassed initial sulphur dioxide and nitrogen oxides emission targets and will continue to work towards elements of the Canada-wide Acid Rain Strategy for Post-2000, the Canada-wide Standards for Particulate Matter and Ozone and caps on stationary sources of nitrogen oxides outlined in the Ozone Annex.
• Emissions for vehicles, engines and fuels are reduced- See Part 7, Divisions 4 and 5.
• Emissions from industrial and other sectors are reduced - This expected outcome is likely to be realized. Sector-specific instruments that have been designed and implemented include regulations, memoranda of understanding, codes of practice and guidelines. Multipollutant emission reduction strategies have been developed for six sectors: electricity; pulp and paper; lumber and allied wood products; iron and steel; base metals smelting; and hot mix asphalt plants and concrete batch plants.
• Canadians take action to reduce air pollution and understand how to interpret air quality information - These expected outcomes are likely to be realized. Information is available to the public through several monitoring networks. Additional information on Canada - United States air quality can be found on the United States Environmental Protection Agency's AIRNow⁵⁶ web site (with contributions from Environment Canada).

^xvi Source: Factsheet - Regulatory Roadmap for New Substances in Canada.

^xvii When the New Substances Program suspects that a "significant new activity" in relation to the substance may result in the substance becoming toxic, a notice is issued to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import or use the substance for activities not specified by the notice. The additional information allows Environment Canada and Health Canada to assess the potential environmental and human health risks associated with such new activities.

^xviii Source: Factsheet - The New CEPA and the Assessment of Existing Substances.

^xix This affects approximately 23 000 substances.

^xx The Department has consistently asserted that it has always used a "weight of evidence" approach in its assessment activities, and its current assessment guidance manual explicitly refers to weight of evidence. Departmental officials explained that, in practice, recent assessments account for weight of evidence more clearly than in the past. In particular, CEPA 1999's focus on "persistent, bioaccumulative and toxic" has required assessors to account for more lines of evidence than was typically the case for most Priority Substances List assessments conducted under CEPA 1988. The Department similarly emphasizes that the precautionary principle informs all aspects of the risk assessment process, from the type of risks examined to the safety factors utilized to the overall interpretation of the results. A guidance document regarding the operationalization of the precautionary principle under CEPA 1999 has been prepared, and a number of presentations on the subject have been made.

^xxi Source: Factsheet - Identifying Risk Management Tools for Toxic Substances Under CEPA 1999.