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ARCHIVED - CEPA Annual Report for Period April 2001 to March 2002
- 1. Administration
- 2. Public Participation
- 3. Information Gathering, Objectives, Guidelines, and Codes of Practice
- 4. Pollution Prevention
- 5. Controlling Toxic Substances
- 6. Animate Products of Biotechnology
- 7. Controlling Pollution and Managing Wastes
- 8. Environmental Emergencies
- 9. Government Operations, Federal and Aboriginal Land
- 10. Enforcement
- 11. Miscellaneous Matters
- National Library of Canada cataloguing in publication data
5. Controlling Toxic Substances
- 5.1 Risk Assessments of Existing Substances
- 5.2 Management of Toxic Substances
- 5.3 Substances and Activities New to Canada
- 5.4 Export of Substances
The Act provides the authority to identify, screen, and assess substances to determine if they are toxic. To be found toxic under the Canadian Environmental Protection Act (CEPA) 1999, substances must enter the environment in amounts that have or may have an immediate or long-term harmful effect on the environment or human health.
5.1 Risk Assessments of Existing Substances
There are currently about 23 000 substances manufactured in, imported into, or used in Canada on a commercial scale that have not been assessed for the risks they pose to human health or the environment. These substances are on the Domestic Substance List (DSL). The DSL distinguishes between substances that are assessed and managed under the Existing Substances Program, and those that are subject to the New Substances Program.
Existing substances are assessed in three ways. First, a screening level assessment must be conducted on all substances identified through categorization of the DSL. Second, the Ministers of Environment and Health are required to establish a Priority Substance List (PSL), which identifies substances to be assessed on a priority basis. Third, the Ministers must review the decisions of other OECD countries to ban or seriously restrict a substance for environmental or health reasons, and determine if the substance meets the definition of toxic under CEPA 1999. Canada is the only country in the world taking such a comprehensive approach to examining all substances in commerce.
Categorizing the Domestic Substances List (DSL)
The Act requires the Ministers to categorize all 23 000 substances listed on the DSL by September 2006, identifying those substances that pose the greatest potential for human exposure in Canada that are persistent, bioaccumulative, and inherently toxic to human and non-human organisms. If a substance meets these criteria, then a screening-level risk assessment is required to determine whether the substance is toxic under the Act.
Notable accomplishments in 2001-02 included the following:
- Environment Canada generated estimates and collected data on the persistence, bioaccumulation potential, and aquatic toxicity for approximately 12 000 discrete organic chemicals on the DSL. The estimates and data were made available to the public in March 2002. Work is continuing on generating and collecting data on the remaining substances.
- Environment Canada published the Guidance for Categorizing Organic Substances on the Domestic Substances List for public comment in spring 2002. The document describes the methodology and criteria for categorizing the approximately 12 000 organic substances on the DSL.
- Health Canada is focusing on developing and refining the approaches for identifying those substances on the DSL that pose the greatest potential for human exposure or are inherently toxic to humans. As part of that development process, a number of scientific consultations with external experts were held.
- Environment Canada drafted and consulted on criteria for determining inherent toxicity to non-human organisms. The criteria were discussed with the Technical Advisory Group, a multistakeholder group created to provide expert advice to Environment Canada on issues of a scientific and technical nature. The results of the pilot project will be used to finalize these criteria.
Screening-level Risk Assessments
In 2001-02, Environment Canada focused on developing tools to conduct screening-level ecological risk assessments, based on lessons learned from the PSL assessments. Work continued on the pilot project involving 123 organic substances. Final results from the pilot project will be used to refine the screening-level risk assessment methodology, the criteria for moving to a more thorough assessment, and the methodology for prioritizing substance assessments.
Health Canada continued to develop and refine the approach and criteria for decision-making for conducting screening-level risk assessments on substances identified through categorization of the DSL, by focusing on screening-level risk assessments on a number of high-production-volume chemicals as well as on specific classes of substances (groups of related substances that have a similar molecular structure) such as the polybrominated diphenyl ethers.
Health Canada continued to develop a screening-level risk assessment on those perfluoroalkyl substances on the DSL that are related to perfluorooctanylsulfonate. A health and environmental screening-level risk assessment on this group of compounds is expected to be released for public comment in 2002-03.
Long description of Figure 5.1
CEPA 1999 requires the Minister of the Environment and the Minister of Health to categorize the substances that are on the Domestic Substances List (DSL) for the purpose of identifying the substances on the List that, in their opinion and on the basis of available information,
- may present, to individuals in Canada, the greatest potential for exposure; or
- is persistent or bioaccumulative, in accordance with the Persistence and Bioaccumulation Regulations, and inherently toxic to human beings or to non-human organisms, as determined by laboratory or other studies.
Environment Canada is responsible for determining whether substances are persistent or bioaccumulative and inherently toxic to non-human organisms. Health Canada is responsible for determining if substances are persistent or bioaccumulative and inherently toxic to humans, and for identifying substances that have the greatest potential for human exposure.
A substance meeting the above categorization criteria then proceeds to a second phase, a screening assessment (SA).
A SA involves a more in-depth analysis of a substance to determine if the substance is "toxic" or capable of becoming "toxic" under the Act. A SA results in one of the following outcomes:
- no further action is taken at this time in respect of the substance, if the SA indicates that the substance does not pose a risk to the environment or human health;
- the substance is added to the CEPA Priority Substances List in order to assess more comprehensively the risks associated with the release of the substance, if the substance is not already on the List; or
- it is recommended that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA, and considered for regulatory or other controls (and possible virtual elimination).
Updates for Substances on the First Priority Substances List
There were 13 substances on the first PSL (PSL1) for which there was insufficient information to conclude on "toxicity" to the environment or human health. Seven of these substances required follow-up by Environment Canada, five required follow-up by Health Canada, and one substance required follow-up by both departments. Environment Canada and Health Canada addressed the data gaps for all of these assessments in 2000-01. In addition, chlorinated paraffins, also a PSL1 substance, is being re-evaluated by both Health Canada and Environment Canada. In 2001-02, the draft follow-up reports for 15 substances went through peer review. They will be released for public comment in 2002-03.
The Second Priority Substances List
Of the 25 substances on the second PSL (PSL2), published in 1995, risk assessments on 23 subsances were completed by December 2000 within the five-year time frame prescribed under CEPA 1999. In 2001-02, five PSL substances were added to the List of Toxic Substances: PM10, acetaldehyde, acrolein, acrylonitrile, and 1,3-butadiene. Final Ministerial decisions were also published in the Canada Gazette indicating that eight additional PSL substances were determined to be toxic and were proposed to be added to the List of Toxic Substances: ammonia dissolved in water, textile mill effluents, nonylphenol and its ethoxylates, inorganic chloramines, road salts, ethylene oxide, formaldehyde, and n-nitrosodimethylamine. Work is progressing on the final reports for the remaining substances.
Two assessments (ethylene glycol and aluminum salts) were suspended in order to collect necessary data. Health Canada has initiated work with stakeholders and others to collect the necessary data that will permit completion of these assessments with respect to human health impacts.
Long description of Figure 5.2
CEPA requires the Ministers of the Environment and of Health to identify substances to be assessed to determine whether they pose a significant risk to the health of Canadians or to the environment. There are a number of sections of CEPA 1999 under which substances can be assessed including s. 74, screening assessments; s. 76 priority substance assessment; and s. 75 review of decisions in other jurisdictions.
After an assessment or review is complete, with stakeholder input as needed, an assessment report is prepared, including proposed conclusions regarding toxicity. EC and HC jointly publish a summary of the assessment report and statement of proposed measures in Canada Gazette, Part I (s.77(1)). The public then has 60 days to provide comments on the summary of the assessment report and proposed measures. Revisions, as needed based on comments received, are made to the assessment report, including conclusions regarding toxicity.
If it is proposed to recommend adding the substance to Schedule 1, then a statement indicating the process the Ministers intend to follow in order to develop a control instrument or regulation is published in the Canada Gazette, Part I (s.77(6)). A summary of public comments is also posted on the EC website. If the substance is considered to be toxic, EC has 2 years to publish a proposed control instrument, starting from the date of the final recommendation (s.91(1)).
If a substance is considered to be toxic through this process, or if the Minister is otherwise satisfied that a substance is toxic, then the Minister can recommended to the Governor in Council that the substance be added to the List of Toxic Substances (s.77(9)), and the proposed order is considered by the Privy Council Office (PCO) and the Special Committee of Council (SCC). If approved by the SCC, the proposed order to add the substance to the List of Toxic Substances is published in the Canada Gazette, Part I (s.332(1)). Following a 60 day public comment period (s.332(2)), public comments are considered and final recommendations are made by Ministers. If the Ministers recommend adding the substance to the List of Toxic Substances, then the adding order is submitted to the PCO and SCC for SCC approval. If approved by the SCC, the final order adding the substance to the List of Toxic Substances is published in Canada Gazette, Part II.
- Ozone-depleting Substance - The Parties to the Montreal Protocol, including Canada, decided to ban the production of bromochloromethane beginning January 1, 2002. They also decided to continue research to determine ifn-propyl bromide is hazardous to the ozone layer. To support these commitments, Environment Canada issued a section 71 notice on August 12, 2000, requiring any persons engaged in an activity involving the substances to notify the Minister. This information will be used for the purpose of assessing whether these substances are toxic or are capable of becoming toxic or for the purpose of assessing whether to control these substances.
- Trichloroethylene and Tetrachlororethylene - In support of taking action on the releases of TCE and PERC into the environment, a notice was published on August 4, 2001, requiring companies to provide information on trichloroethylene or tetrachloroethylene used in solvent degreasing.
- Hydrofluorocarbons and Perfluorocarbons - Environment Canada conducted CEPA 1999 section 71 surveys on for 1999 and 2000. The surveys support the development of Canada's climate change policy. A study to evaluate the usefulness of CEPA 1999 as a vehicle for managing the reduction of these greenhouse gases was also completed. Greenhouse gases are being considered for addition to the NPRI.
5.2 Management of Toxic Substances
The Act requires that toxic substances be managed to minimize the risks they pose to the environment and human health. The most dangerous toxic substances (those that are found to be persistent, bioaccumulative inherently toxic and primarily the result of human activity) are targeted for virtual elimination.
The Act imposes strict timelines for taking preventive or control action to manage the risks posed by toxic substances. For substances that have been determined to be toxic under section 77 (i.e., assessed as a result of the PSL, screening of the DSL, or review of another jurisdiction's decision), two years are allowed to develop a proposed instrument containing preventive or control measures, such as pollution prevention plans, regulations, or certain guidelines.
Once the proposed instrument is published, interested parties have 60 days to comment on the proposal or file a notice of objection and request the establishment of a board of review. The final instrument must be published within 18 months after the publication of the proposed instrument.
The Act also imposes requirements for the virtual elimination of releases into the environment of substances that are persistent, bioaccumulative inherently toxic and that result primarily from human activity. Section 65 further requires the Ministers of Environment and Health to specify the level of quantification (LOQ) for each substance whose discharges to the environment are targeted for virtual elimination on a Virtual Elimination List.
The LOQ is the lowest concentration of a substance that can be accurately measured using sensitive but routine sampling and analytical methods. Table 2 summarizes the management tools that were under development in 2001-02. It should be noted that the tools include regulations under Part 5 of the Act as well as other parts of CEPA 1999, such as agreements under Part 2, guidelines and codes of practice under Part 3, P2 plans under Part 4, and regulations under Parts 7, 8, and 9.
|Management Tool: Regulations||Status|
|Amendments to the PCB Waste Export Regulations||Under development|
|Contraventions Regulations (under the federal Contraventions Act)||Finalized October 25, 2001|
|Disposal at Sea Regulations||Finalized August 15, 2001|
|Environmental Emergencies Regulations||Under development|
|Export of Substances under the Rotterdam Convention||Under development|
|Federal Halocarbon Regulations, 2002||Finalized August 28, 2002|
|Federal Hazardous Waste Regulations||Instructions given to Justice Canada for the drafting of the proposed regulation - February 2002|
|Federal Petroleum Products and Allied Petroleum Products Storage Tank Systems Regulations||Under development|
|Interprovincial Movement of Hazardous Waste Regulations||Under development|
|New Substances Fees Regulations||Proposed June 30, 2001|
|On-Road Vehicle and Engine Emission Regulations||Proposed March 30, 2002|
|Prescribed Non-hazardous Wastes Regulations||Consulted March 2001|
|Prohibition of Certain Toxic Substances Regulations, 2001 (benzidine and hexachlorobenzene)||Proposed September 29, 2001|
|Regulations Amending the Export and Import of Hazardous Wastes Regulations||Under development|
|Regulations Amending the New Substances Notification Regulations||Finalized June 6, 2001|
|Regulations Amending the Ozone Depleting Substances Regulations, 1998||Finalized March 13, 2002|
|Regulations Respecting the Form and Content of an Application for a Permit for Disposal at Sea||Finalized August 15, 2001|
|Sulphur in Diesel Fuel Regulations||Proposed December 22, 2001|
|Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations||Proposed August 18, 2001|
|Management Tool: Pollution Prevention Plans||Status|
|Acrylonitrile releases from synthetic rubber manufacturing facilities||Under development|
|Dichloromethane from aircraft paint stripping, flexible polyurethane foam blowing, pharmaceutical and chemical intermediates, adhesive formulations, and industrial cleaning||Under development|
|Textile mills effluent and nonyphenol and its ethoxylates from the wet processing textile industry||Under development|
|Nonylphenol and its ethoxylates in manufacture and imported products||Under development|
|Management Tool: Codes of Practice||Status|
|Integrated Steel Mills and for Non-Integrated Steel Mills||Finalized December 2001|
|Dichloromethane-based Paint Strippers||Consultations held early 2001|
|Base Metal Smelters and Refineries||Proposed March 2002|
|Management Tool: Environmental Quality Guidelines||Status|
|CCME water quality guidelines (inorganic fluorides, nonylphenol and its ethoxylates)||Under development|
|CCME sediment quality guidelines (nonylphenol and its ethoxylates)||Under development|
|CCME soil quality guidelines (dioxins and furans, selenium, nonylphenol and its ethoxylates)||Under development|
|CCME water quality guidelines (aluminum, mercury, nitrate, phosphorus, methyl tertiary-butyl, sulfolane, diisopropanolamine)||Under development|
|CCME soil quality guidelines (uranium, sulfolane, diisopropanolamine)||Under development|
|Environmental Choice Guidelines on Renewable Low-impact Electricity||Proposed December 8, 2001|
|Management Tool : Environmental Performance Agreements||Status|
|Voluntary Action through the Responsible Program (Canadian Chemical Producers' Association)||Finalized February 2002|
|Refractory Ceramic Fibres (six companies)||Finalized February 13, 2002|
|1,2-Dichloroethane (Dow Chemicals)||Finalized October 26, 2001|
|Management Tool: Administrative Agreements||Status|
|Quebec Pulp and Paper Administrative Agreement sector||Under development|
|Canada-wide Standards: Benzene (Phase II)||Endorsed September 2001|
|Canada-wide Standards: Petroleum Hydrocarbons in Soil||Endorsed May 2001|
|Canada-wide Standards: Mercury-containing Lamps||Endorsed September 2001|
|Canada-wide Standards: Mercury in Dental Amalgams||Endorsed September 2001|
|Canada-wide Standards: Dioxins and Furans from Waste Incineration and Coastal Pulp and Paper Boilers||Endorsed May 2001|
|Canada-wide Standards: Dioxins and Furans from Iron Sintering Plants and Steel Making Electric Arc Furnaces||Proposed September 2001|
Summary of Actions on PSL1 Toxic Substances
The following tools for managing PSL1 toxic substances were under development in 2001-02:
- Proposed Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations were published on August 18, 2001.
- To aid in developing a regulation, a notice, published on August 4, 2001, required companies to provide information on trichloroethylene or tetrachloroethylene used in solvent degreasing.
- Proposed Prohibition of Certain Toxic Substances Regulations, 2001 (covering benzidine and hexachlorobenzene) were published on September 29, 2001.
- An Environmental Performance Agreement for Refractory Ceramic Fibres was signed in February 2002 with six companies respecting environmental emissions monitoring, inspection, and product stewardship.
- Codes of Practice for Integrated Steel Mills and for Non-integrated Steel Mills were published in December 2001. Implementation is currently under way.
- An Environmental Performance Agreement was signed with Dow Chemical in October 2001 respecting the production and distribution of 1,2-dichloroethane.
- Consultations were held on the development of a code of practice on dichloromethane-based paint strippers in commercial furniture refinishing and other stripping applications.
- A draft Code of Practice for Base Metal Smelters and Refineries was discussed at a national workshop on the environmental performance of the base metal smelting sector in March 2002.
Toxics Management Process
The Toxics Management Process is a new, more streamlined approach to controlling substances declared toxic under CEPA 1999. It is the result of a 2001-02 review of Environment Canada's risk management process, and is designed to fulfill the new requirements of CEPA 1999.
The Toxics Management Process deals both with substances identified for virtual elimination and substances slated for life-cycle management. Under the process, risk management strategies that identify a range of management tools, including preventive and control instruments, are developed. The risk management strategies also serve as the basis for public consultations.
The Toxics Management Process is initially being used to manage PSL2 toxic substances and is being further refined to deal with other toxic substances. Highlights of actions taken on the risk management strategies for PSL2 toxic substances slated for life-cycle management in 2001-02 include:
- Road Salts - A risk management strategy was developed for road salts to address the need for reducing releases of road salts to the environment while maintaining road safety. Consultations were initiated through a Working Group comprising representatives from the federal, provincial, territorial, Aboriginal, and municipal governments, environmental non-governmental organizations, and industry. Meetings were held in April, June, and September 2002.
- Nonylphenol and its Ethoxylates (NPEs) - A risk management strategy was developed for nonylphenol and its ethoxylates to manage releases from four priority sectors: products containing nonylphenol and its ethoxylates, wet processing textile industry, pulp and paper industry, and municipal wastewater effluents. P2 planning under CEPA 1999 is also being proposed for textile mills, manufacturers and importers of products containing NPEs in order to manage NPEs upstream from municipal wastewater treatment plants. The proposed reduction targets are 50% after two years and 100% after five years in the use of NPEs, mainly through product reformulation.
- Wet Processing Textile Industry - A risk management strategy was developed for the wet processing textile industry addressing textile mill effluents and nonylphenol and its ethoxylates. Environment Canada initiated development on the use of P2 plans for this sector, with the objective of a 97% reduction in the use of nonylphenol and its ethoxylates and reducing the toxicity of textile mill effluents. Consultations were initiated in June 2000.
- Municipal Wastewater Effluents - These effluents are major sources of several toxic substances, including ammonia, inorganic chloramines, textile mill effluents, and NPEs. In March 2002, Environment Canada hosted a workshop to consult with Canadian experts on using P2 planning as a tool to manage wastewater effluents. The workshop helped shape Environment Canada's risk management strategy for municipal wastewater effluents and identified issues and challenges that need to be addressed. Among many suggestions, the participants advised that P2 for toxic substances must consider broader wastewater management, and that defined roles, responsibilities, cooperation and participation between all jurisdictions are critical to a successful municipal wastewater effluent strategy.
Toxic Substances Management Policy
Canada continues to promote actions both domestically and internationally on the virtual elimination of releases of substances under the federal Toxic Substances Management Policy, a leading-edge policy among industrialized countries. The Policy calls for the virtual elimination of releases of toxic substances that are persistent and bioaccumulative and that are present in the environment primarily due to human activity (Track 1 substances) and life-cycle management of other toxic substances and substances of concern (Track 2 substances). Nine of the 12 Track 1 substances were active ingredients in pesticides that are now prohibited in Canada. Environment Canada continues to take action to severely limit the others under CEPA 1999 and other Acts or programs.
Under the Act, the Ministers of Environment and Health must propose virtual elimination for substances that are toxic under CEPA 1999 and persistent (take a long time to break down), bioaccumulative (collect in living organisms and end up in the food chain), and primarily the result of human activity. The ultimate objective of virtual elimination is to reduce releases to the point where they can no longer be measured (below the Level of Qualification (LOQ)).
Since CEPA 1999 came into force, there have been no final assessments of substances that would trigger its virtual elimination provisions. However, the department is preparing for this eventuality. In 2001-02, Environment Canada initiated the development of an approach to implement the virtual elimination provisions of the Act that will also be consistent with the Toxics Substances Management Policy. It will outline the approach to be taken for substances identified for virtual elimination under CEPA 1999 and for the 12 substances identified for virtual elimination under the Toxics Substances Management Policy.
In 2001-02, work was ongoing on the development of level of qualifications for hexachlorobutadiene and chlorobenzenes. These LOQs will be finalized following consultations with stakeholders in concert with consultations on risk management strategies for these substances.
A regulation imposes conditions on an activity related to a substance or limits the concentrations that can be used, released to the environment, or present in a product. In 2001-02, four regulations regarding toxic substances were at various stages of development:
- Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations - The proposed regulations were published on August 18, 2001. These regulations will reduce releases of tetrachloroethylene to the environment from dry-cleaning facilities by requiring newer, more efficient dry-cleaning machines, by minimizing spills of this solvent and by managing the collection and disposal of residues and wastewater. The reporting provisions apply to persons who import or recycle tetrachloroethylene for any use, to persons who sell it to dry cleaners.
- Trichloroethylene and Tetrachloroethylene (Solvent Degreasing) Regulations - A notice was published on August 4, 2001, requiring companies to provide information on trichloroethylene or tetrachloroethylene used in solvent degreasing. Based on the information received, Environment Canada is developing regulations that will apply to companies that used over 1000 kilograms of trichloroethylene or tetrachloroethylene in solvent degreasing in 2000. The new regulations will reduce the use of these substances in solvent degreasing by approximately 97%. Survey information also indicated that trichloroethylene and tetrachloroethylene consumption in solvent degreasing has decreased, respectively by 45% and 70% between 1995 and 2000.
- Prohibition of Certain Toxic Substances Regulations - The proposed regulations were published for consultations on September 29, 2001. The regulations feature a schedule listing toxic substances subjected to prohibition for manufacture, use, process, sale, offer for sale, or import. The proposed regulations will add two substances (benzidine and its salt) to the current schedule and set specific conditions on one substance (hexachlorobenzene).
- Ozone-depleting Substances Regulations, 1998 - Environment Canada published the finalRegulations Amending the Ozone-depleting Substances Regulations, 1998 on March 13, 2002. The regulations phase out one of the last imports of CFCs into Canada, those from metered dose inhalers. It required the cooperation and coordination of Health Canada, health groups, and the pharmaceutical industry.
Environmental Performance Agreements
An Environmental Performance Agreement (EPA) is an agreement that is negotiated among parties to achieve specified environmental results. EPAs are second-generation voluntary instruments that flow from Environment Canada's experience with Memoranda of Understanding (MOUs) with industry sectors. Negotiation and implementation of MOUs during the 1990s provided Environment Canada with valuable lessons, and led to the development of a Policy Framework for Environmental Performance Agreements (June 2001).
An EPA must consider specific core design criteria in the negotiating process. The Policy Framework provides assurance of transparency and accountability as well as a solid basis for negotiating agreements.
In 2001-02, three MOUs or agreements meeting the criteria outlined in the Policy Framework for Environmental Performance Agreements were signed:
- MOU with the Canadian Chemical Producers' Association - Signed by Environment Canada, Health Canada, Industry Canada, and the provinces of Alberta and Ontario, the MOU commits the parties to reduce the release of chemical substances through voluntary action under the Canadian Chemical Producers' Association's Responsible Care Program. The MOU meets all the criteria set out in Environment Canada's Policy Framework for Environmental Performance Agreements. It includes an annex setting out specific targets and timelines to reduce releases of VOCs. A significant aspect of this MOU is the active participation of non-governmental organizations.
- Environmental Performance Agreement Respecting the Production, and Distribution of 1,2-Dichloroethane - In 1997, releases from Dow Chemical accounted for approximately 79% of emissions of 1,2-dichloroethane, a toxic substance under CEPA 1999. An environmental performance agreement, signed in October 2001, commits Dow Chemical to prepare an environmental management plan, establish emission reduction goals, conduct air monitoring, and report on releases.
- Environmental Performance Agreement respecting Refractory Ceramic Fibres - This agreement, signed in February 2002 with six companies, applies to environmental emissions monitoring, inspection, and product stewardship. The data collected under the monitoring program will be used by health and environment specialists to better evaluate the risks associated with this substance.
Progress reports on agreements respecting environmental performance signed with Dofasco in 1997 and Algoma in 2000, show that these companies are on track in meeting the targets set under the Strategic Options Report for Steel Manufacturing.
EPA Design Criteria
EPAs must address the following core design criteria:
- Senior-level commitment from participants;
- Clear environmental objectives and measurable results;
- Clearly defined roles and responsibilities;
- Consultation with affected and interested stakeholders;
- Public reporting;
- Verification of results;
- Incentives and consequences; and
- Continual improvement.
Many toxic substances that are produced, used, and released into the environment are of global concern. In order to efficiently and effectively address the assessment of risk for existing substances, a concerted international approach has been taken. Key international activities in 2001-02 included:
- Climate Change - The Government of Canada announced its intention to ratify the Kyoto Protocol to the Framework Convention on Climate Change. The Protocol requires that, in the commitment period of 2008-12, Canada reduce its aggregate releases from human sources of carbon dioxide equivalent emissions of selected greenhouse gases by 6% below 1990 levels. The greenhouse gases include carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons, and sulphur hexafluoride. In 2001, the science assessment of climate change was conducted globally by the Intergovernmental Panel on Climate Change. Environment Canada conducted CEPA 1999 section 71 survey on hydrofluorocarbons and perfluorocarbons for 1999 and 2000. The surveys support the development of Canada's climate change policy. A study to evaluate the usefulness of CEPA 1999 as a vehicle for managing the reduction of these greenhouse gases was also completed. Greenhouse gases are being considered for addition to the NPRI.
- Children's Environmental Health - Environment Canada and Health Canada participated along with 70 other representatives in a Trilateral Workshop on Children's Health and the Environment in North America, hosted by the North American Commission for Environmental Cooperation (CEC), in November 2001. The workshop focused on developing an action-oriented agenda for collaborative work to better protect the health of North American children from environmental threats. The key areas of focus for the workshop included: asthma and respiratory diseases, lead poisoning and other effects of lead exposure, effects of other toxic substances including pesticides, and environmental/health databases and indicators. (The CEC Cooperative Agenda for Children's Health and the Environment in North America was finalized in June 2002.)
- Dioxins, Furans, and Hexachlorobenzene - A CEC Task Force completed the Phase 1 North American Regional Action Plan (NARAP) on Dioxins, Furans, and Hexachlorobenzene. It focuses on monitoring and assessment activities as a preliminary step to the development of risk management recommendations to be undertaken in the Phase 2 NARAP. The objective of this NARAP is to improve capacities of the parties to reduce exposure to dioxins, furans, and hexachlorobenzene, to prevent and reduce releases from human sources to the environment, and to promote continuous reduction of releases where feasible. The Phase 1 NARAP will be released for public consultation following internal approvals.
- Assessments of High-Production-Volume Chemicals - Canada is participating in a variety of Organisation for Economic Cooperation and Development (OECD) committees and task forces to develop Screening Information Data Sets for high-production-volume chemicals and to assess the hazards of these chemicals. Member countries are sponsoring initial assessments of the data sets, with Canada sponsoring five. Environment Canada and Health Canada are also part of a pilot project to review the chemical assessment reports that are being generated under the International Council of Chemical Associations initiative to collect data and assess 1000 high-production-volume chemicals by 2004.
- National Environmental Policy - Environment Canada continued its role with the OECD by participating on the new Working Party on National Environmental Policy. In August 2001, Environment Canada published a Guidance Manual for Establishing, Maintaining and Improving Producer Responsibility Organizations in Canada, that provides decision-makers with a handbook containing the necessary tools to identify when and how EPR should be applied to various types of products and packaging. Environment Canada took a leadership role in helping to formulate OECD Council Recommendations for improving the environmental performance of green public procurement for OECD member countries.
- Sustainable Development - Canadian case studies were provided to the OECD on topics related to the eco-efficiency project, aimed at analyzing the relationship between firms, management systems and environmental performance, and on the sustainable construction project, whose objective was to analyze and develop policy instruments for environmentally sustainable buildings. Canada has also helped make progress on better integrating economic and environmental policies in the area of domestic and international tradable permit systems for greenhouse gas emissions.
- Multimedia Models - In October 2001, Canada and the United States co-hosted a workshop in Ottawa of the OECD and the United Nations Environment Programme (UNEP) on the use of multimedia models for estimating overall environmental persistence and long-range transport in the context of assessing POPs and substances that are persistent, bioaccumulative, and toxic. The application of models is an important component of the categorization of the DSL, and this initiative was successful at focusing on the usefulness of multimedia.
5.3 Substances and Activities New to Canada
Substances that are not on the Domestic Substances List (DSL) are considered to be new to Canada. These cannot be manufactured or imported until:
- the Minister has been notified prior to manufacturing or importation of the substance;
- relevant information needed for an assessment of its potential toxicity has been provided by the notifier; and
- the period for assessing the information (as set out in regulations) has expired.
CEPA 1999 requirements apply to all new substances unless other applicable Acts contain the same requirements for notice and assessment and are specifically identified on Schedule 2 of the Act. These provisions mean that CEPA 1999 sets the standard and acts as a safety net for new substances that are not covered under other Acts of Parliament.
During 2001-02, Environment Canada and Health Canada jointly assessed approximately 700 new substances (chemical and polymer) notifications and four notifications for transitional substances. Transitional substances are defined as substances that were manufactured in or imported into Canada between January 1987 and July 1994 (when the New Substances Notification Regulations came into effect). These reviews resulted in the imposition of various kinds of controls on seven new substances and six Significant New Activities notices in 2001-02. These notices require persons who want to import, manufacture or use the substance to provide additional information to the Minister.
Good Laboratory Practice
The Good Laboratory Practice (GLP) Compliance Monitoring Unit is responsible for advising scientific evaluators of new substances notifications on compliance issues related to submitted test data and for performing inspections and audits in Canadian testing facilities. Highlights of activities in 2001-02 included the following:
- collaborated on preparing the report for the OECD mutual joint visits to Canada, the Netherlands, New Zealand, and Australia;
- provided support to the public consultations on revision of theNew Substances Notification Regulations;
- represented Canadian interests on OECD GLP Steering and Working Groups;
- participated in domestic and OECD GLP training courses;
- conducted audits for the Canadian Association of Environmental Analytical Laboratories;
- maintained the Canadian database of OECD GLP inspections; and
- provided information on compliance issues to new substances evaluators.
Consultations on the New Substances Program
When the New Substances Notification Regulationswere promulgated in 1994, a commitment was made by Environment Canada and Health Canada to review them after the first three years of implementation. This was to enable adjustments to be made to the Regulations and to the New Substances Program if necessary. To help fulfil this commitment, a multistakeholder consultative process was established in June 1999, to work towards a common understanding of the New Substances Notification Regulations and the overall program and to provide consensus recommendations for their improvement. Eight meetings were held in 1999-2001. The consultations resulted in 76 consensus recommendations. The final report of the multistakeholder consultations was released in May 2002. The Government Response report and an Action Plan to address the consensus recommendations will be released in early 2003.
In 2001-02, two regulations were being developed under section 89 of CEPA 1999:
- Amendments to the New Substances Notification Regulations - Amendments of Schedules IX and X to the New Substances Notification Regulations were published on June 6, 2001. Amendments to Schedule IX (type of polymers) enhanced its content readability and understanding. Amendments to Schedule X (list of reactants and their Chemical Abstracts Service registry numbers) updated the list of reactants.
- New Substances Fees Regulations - Environment Canada published the proposed New Substances Fees Regulations on June 30, 2001. The regulations were developed as a result of recommendations following the 1995 departmental program review. The regulations allow for a partial cost recovery scheme for the assessment and notification processes.
Scheduling of Other Acts
CEPA 1999 allows for the waiving of its notification and assessment requirements for new substances if they are met by another federal Act. This means that CEPA 1999 acts as a safety net - unless new substances fall under other Acts that are specifically listed in Schedule 2 (chemicals or polymers) or Schedule 4 (products of biotechnology), CEPA 1999 requirements will apply to all new substances.
On August 7, 2001, final orders to add three Acts and Regulations to Schedule 2, and five Acts and Regulations to Schedule 4 were published (see Table 3). The legal provisions that authorize the Schedules came into force on September 13, 2001.
|Schedule 2 (Chemicals and Polymers)||Schedule 4 (Animate Products of Biotechnology)|
|Pest Control Products Actand Pest Control Products Regulations||Pest Control Products Actand Pest Control Products Regulations|
|Feeds Act and Feeds Regulations||Feeds Act and Feeds Regulations|
|Fertilizers Act and Fertilizers Regulations||Fertilizers Act and Fertilizers Regulations|
Seeds Act and Seeds Regulations
Health of Animals Act and Health of Animals Regulations
Interdepartmental action plans have been initiated to develop regulations under the Food and Drugs Act and the Fisheries Act and in certain products under the Health of Animals Act in order to meet CEPA 1999 requirements. In spring 2002, Health Canada and Environment Canada signed an MOU whereby Health Canada will apply the New Substances Notification Regulations and conduct an environmental assessment of substances in products that are regulated under the Food and Drugs Act. During 2001-02, Health Canada assessed ten new substances in products regulated under the Food and Drugs Act. Other such agreements are currently being drafted with Fisheries and Oceans Canada and the Canadian Food Inspection Agency to address transgenic aquatic organisms and livestock animals, respectively.
Key international activities related to new substances in 2001-02 included:
- Four Corners Agreement - In an effort to streamline the new substances notification and assessment schemes in Canada and the United States, Environment Canada is collaborating with the United States Environment Protection Agency and industry in both countries through the Four Corners Agreement, which was first piloted in 1996. This agreement involves the exchange of technical data and assessment information. During 2001-02, four substances were submitted and reviewed under this program. One of these substances was added to the Non-Domestic Substances List, while the three remaining substances were being assessed.
- Canada-Australia Arrangement - During 2001-02, Canada and Australia continued their discussions on developing a formal arrangement between the two countries and started exchanging information to gain greater understanding of their respective New Chemicals programs. The Canada-Australia Arrangement is also in keeping with the OECD Task Force on New Industrial Chemicals and is being viewed as a model for other OECD countries. (The Arrangement was signed by both parties in August 2002.)
- OECD Task Force on New Industrial Chemicals - Canada chairs the OECD Task Force on New Industrial Chemicals, established in 1999-2000. Seven work elements were developed at that time. In 2001-02, progress has been achieved in all seven work elements:
- bilateral/multilateral arrangements;
- standardized notification form;
- standardized formats for assessment reports;
- hazard assessment - promoting the exchange of common elements;
- minimal and no-notification requirements for low-concern or exempt chemicals;
- confidential business information/ proprietary information; and
- OECD Environmental Exposure Assessment Task Force, Emission Scenario Documents - Environment Canada, in cooperation with Health Canada, actively contributes as a member of the OECD Environmental Exposure Assessment Task Force. In 2001-02, work was initiated on the development of two emission scenario documents to describe chemical uses and discharges at pulp and paper and textile mills. They will be included as part of the OECD's effort to share available emission scenario documents and other useful information and tools.
5.4 Export of Substances
The Act allows the Minister to establish an Export Control List containing substances whose export is controlled because their manufacture, import, and/or use in Canada are prohibited or severely restricted or because Canada has accepted, through an international agreement, to control their export. The Act also allows the Minister to make regulations in relation to substances specified on the Export Control List.
The Export Control List Notification Regulationsrequire exporters to provide notice of the proposed exports of substances on the Export Control List and to submit annual reports. In 2001, there were twelve notifications of exports received.
Environment Canada continued development of the Export of Substances under the Rotterdam Convention Regulations to permit Canada to implement the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. The regulations will ensure that chemicals and pesticides subject to the prior informed consent procedure are not exported to parties to the Convention without the importer's prior informed consent.
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