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ARCHIVED - CEPA Annual Report for Period April 2003 to March 2004
- 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 Waste
- 8. Environmental Emergencies
- 9. Government Operations and Federal and Aboriginal Lands
- 10. Enforcement
- 11. Miscellaneous Matters
- Appendix A: Risk Management Measures Proposed or Finalized in 2003-04
- Appendix B: Contacts
- National Library of Canada cataloguing in publication data
5. Controlling Toxic Substances
- 5.1 Existing Substances
- 5.1.1 Risk Assessment
- 5.1.2 Risk Management
- 5.2 New Substances
- 5.2.1 Risk Assessment
- 5.2.2 Risk Management
- 5.2.3 Regulations
- 5.2.4 Additions to the Domestic Substances List
- 5.2.5 Consultation on the New Substances Program
- 5.2.6 International Actions
- 5.3 Export of Substances
CEPA 1999 includes specific requirements for the assessment and management of substances currently existing in commerce or being released to the environment in Canada and substances that are new to Canada.
Determining a substance to be "toxic" under CEPA 1999 is a function of its release or possible release into the environment, the resulting concentrations in environmental media and its inherent toxicity. Section 64 of CEPA 1999 defines a substance as "toxic" if it is entering or may enter the environment in a quantity or concentration or under conditions that:
- have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- constitute or may constitute a danger to the environment on which life depends; or
- constitute or may constitute a danger in Canada to human life or health.
Part 5 sets specific timelines for taking preventive or control action to manage the risks posed by toxic substances, including virtual elimination from the environment for substances meeting certain criteria. CEPA 1999 allows for the setting of conditions and prohibitions on new substances. Part 5 also provides for the development of regulations and interim orders as well as the management of exports of substances.
The three key risk assessment processes conducted under CEPA 1999 are:
- categorization and screening of the Domestic Substances List;
- assessment of the Priority Substances List; and
- review of other jurisdictions' decisions.
Other assessments may be triggered by information provided by other programs, industry and scientific research. CEPA 1999 also allows for the creation of a Virtual Elimination List and information gathering.
The Domestic Substances List includes substances that were in Canadian commerce, between January 1, 1984, and December 31, 1986, or used for manufacturing purposes, or manufactured in or imported into Canada in a quantity of 100 kilograms or more in any calendar year. Currently, there are approximately 23 000 substances on the Domestic Substances List. These substances are referred to as "existing substances." Substances not on the Domestic Substances List are considered to be "new substances" and are subject to the New Substances Program (see Section 5.2).
Results on categorizing substances on the Domestic Substances List include:
- Categorization Decisions by Environment Canada -- The department collected and reviewed available information and produced preliminary categorization decisions for 10 648 organic and 984 inorganic substances on the Domestic Substances List. During the reporting period, interested parties were invited to submit information to help improve or refine these preliminary categorization decisions.
- Categorization for Inherent Toxicity to Humans -- Health Canada refined the approach for the initial categorization of organic substances on the Domestic Substances List for "inherent toxicity to humans" by considering 1352 organic substances and 642 inorganic substances.
- Environment Canada Guidance Manual for the Categorization of Organic and Inorganic Substances on Canada's Domestic Substances List -- Published in September 2003 for public comment, this document provides the rationale and guidance that Environment Canada uses to categorize organic substances, inorganic substances and organic metal salts against the criteria of persistence, bioaccumulation and potential and inherent toxicity to non-human organisms.
- Health Canada Proposal for Priority Setting for Existing Substances on the Domestic Substances List under CEPA 1999: Greatest Potential for Human Exposure -- Released for public comment on January 16, 2004, this document outlines the approach for the initial categorization of the 23 000 substances on the Domestic Substances List for their greatest potential for human exposure.
Environment Canada and Health Canada conducted various screening assessments and refined their screening assessment approaches and processes. Progress with the screening assessments included:
- the continuing assessments of 25 substances, including those representing categories or classes of related chemicals, as well as a variety of persistent, bioaccumulative substances, or substances that pose great potential for human exposure;
- the completion of the first environmental and health screening assessment of polybrominated diphenyl ethers (a notice was published on May 8, 2004, proposing to add seven of these substances to the List of Toxic Substances with the goal of virtual elimination of three of them);
- the commencement of a second screening assessment on tetrabromobisphenol A and two derivative compounds, ethoxylated tetrabromobisphenol A and tetrabromobisphenol A allyl ether;
- Health Canada's review of the basis for decisions of other jurisdictions to prohibit or restrict 16 substances for health reasons identified in preparation for implementation of Section 75 of CEPA 1999; and
- internal reviews of draft screening health assessments on the following compounds (perfluorooctanoic acid and its salts; quinoline; biphenyl; 2-methyl-4,6-dinitrophenol; 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methylphenol]; 1,1-dichloroethylene; ethylene dibromide; hexachloroethane; 4,4'-methylenebis[2-chloro-benzenamine]; acetone; hydrogen sulfide; ethylbenzene; tetrabromobisphenol A and derivatives) by senior staff members of the Existing Substances Division of Health Canada, and externally (quinoline; biphenyl; ethylene dibromide; 2-methyl-4,6- dinitrophenol; 4,4'-methylenebis[2-chloro-benzenamine]; 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methylphenol]) by outside experts.
Updates were completed on six Priority Substances List compounds (aniline, bis(2-chloroethyl) ether, 3,5-dimethylaniline, di-n-octyl phthalate, non-pesticidal organotin compounds, 1,1,2,2-tetrachloroethane) for which data were considered insufficient to conclude whether they were "toxic" under Paragraph 11(c) of the 1988 Canadian Environmental Protection Act. Environment Canada and Health Canada released one follow-up assessment report for public comment and published four final decisions for substances from the first Priority Substances List for which there was originally insufficient information to conclude whether they were "toxic" under the 1988 Canadian Environmental Protection Act. Used crankcase oils were proposed to be considered toxic under CEPA 1999, and four substances (styrene, tetrachloroethane, di-n-octyl phthalate, non-pesticidal organotin compounds) were found not to be toxic under CEPA 1999.
Results in 2003-04 include the following:
- Six substances were added to the List of Toxic Substances: ethylene oxide, formaldehyde, N-nitrosodimethylamine, hexachlorobutadiene, particulate matter containing metals that is released in emissions from copper smelters or refineries, or from both, and particulate matter containing metals that is released in emissions from zinc plants.
- Two substances were proposed to be added to the List of Toxic Substances: 2-butoxyethanol and 2-methoxyethanol.
- One substance was found not to be toxic: 2-ethoxyethanol.
Health Canada continued to work with an Expert Steering Committee to refine design parameters for a study on the neurological effects of aluminum. The department also held discussions with representatives of the primary aluminum industry in Canada on how the study should be carried out.
Health Canada worked with representatives of the American Chemistry Council to finalize the protocol for industry-sponsored studies to address uncertainty concerning the progression of renal lesions in male rats following exposure to ethylene glycol.
When a substance is assessed and found to be CEPA toxic, it is added to the List of Toxic Substances in Schedule 1 of CEPA 1999. By adding substances to Schedule 1 of CEPA 1999, the federal government has the authority to take action, including making regulations or requiring the preparation of pollution prevention plans or environmental emergency plans.
|Substance||Proposed Order adding to Schedule 1|
|Final Order adding to Schedule 1|
|2-methoxyethanol and 2-Butoxyethanol||October 25, 2003||2-methoxyethanol is not commercially produced in Canada.|
2-methoxyethanol is imported for limited use mainly as industrial
coating, chemical intermediate and military applications.2-Butoxyethanol is not commercially produced in Canada, but it is imported for use mainly as a solvent for formulations in paints and coatings, inks and cleaning products. It is also used to a much lesser extent as an additive to hydraulic fluids, and in the chemical processing for plasticizers and other compounds.
|Ethylene oxide||April 27, 2002||June 4, 2003||Use as a process reactant, as a sterilizer of health care materials and heat-sensitive products.|
|Formaldehyde||April 27, 2002||June 4, 2003||Automotive and other fuel combustion, industrial on-site sources, and natural sources (including forest fires).|
|Gaseous ammonia||July 27, 2002||June 2, 2003||Natural sources include waste product of animal, fish and microbial mechanism, whereas anthropogenic sources include industry and agriculture.|
|Hexachlorobutadiene||June 1, 2002||August 13, 2003||No industrial or commercial uses in Canada. It is released as by-product and contaminant from various industries.|
|Nitric oxide and|
|July 27, 2002||June 12, 2003||The main anthropogenic sources are from combustion in transportation, industry and the electric power generating sector. The natural sources are mainly forest fires, lightning and soil microbial activity.|
|N-Nitrosodimethylamine||April 27, 2002||June 4, 2003||There are no industrial or commercial uses of this substance in Canada; released as by-product and contaminant from various industries, and municipal wastewater treatment plants. Major releases have been from the manufacture of pesticides, rubber tires, alkylamines, and dye manufacture.|
|Ozone||July 27, 2002||June 12, 2003||Ozone is produced in the atmosphere from precursors, primarily nitrogen oxides and volatile organic compounds. These precursor gases are emitted from combustion processes often associated with industry and the transportation sector, and from various commercial and industrial processes and solvent use.|
|Particulate matter containing metals that is released in emissions from copper smelters or refineries, or from both||November 2, 2002||August 13, 2003||Copper smelters and refineries.|
|Particulate matter containing metals that is released in emissions from zinc plants||November 2, 2002||August 13, 2003||Zinc plant operations.|
|Sulphur dioxide||July 27, 2002||June 2, 2003||Sulphur dioxide is the main precursor that contributes to the formation of fine particulate matter in the summer months in eastern Canada. Emissions occur from copper and zinc smelters and refineries.|
|Tetrachlorobenzenes and pentachlorobenzene||April 24, 2004||Not produced or used in their pure form in Canada. They may be formed and released to the environment as a result of waste incineration and barrel burning of household waste, dielectric fluids, pesticides, municipal solid waste. Possible sources of release may include dielectric PCB material still in use, some pesticides and a wood preservation chemical.|
|Used crankcase oils||June 21, 2003||New information on exposure and effects from leakage of waste crankcase oil (WCO) from the crankcases of vehicles was found in the literature. Studies on roadway runoff provide a link between release of WCO from vehicles and effects on benthic organisms, which also include changes in the biodiversity of sediment fauna. Various components of WCO are listed on the List of Toxic Substances (Schedule1), including arsenic and its compounds, benzene, cadmium, chromium and its compounds, acidic, sulfidic and soluble inorganic nickel, polycyclic aromatic hydrocarbons (PAHs) and lead.|
|Volatile organic compounds as listed in the Order||July 27, 2002||June 12, 2003||Anthropogenic sources include combustion and evaporation processes associated with transportation, the industrial sector, applications of surface coatings (e.g., paints), general solvent use and other miscellaneous sources.|
CEPA 1999 provides several authorities to request any person to provide or generate data for the purpose of assessing whether a substance is toxic or capable of becoming toxic or for assessing whether to control, or the manner in which to control, a substance. In 2003-04, information-gathering notices were published for five substances in order to assess whether to control them and/or the manner in which to control them:
- methyl bromide (February 14, 2004);
- hexachlorobutadiene in certain chlorinated substances (May 24, 2003);
- submitting samples for the determination of hexachlorobutadiene in certain chlorinated substances (May 24, 2003);
- certain halons (June 21, 2003); and
- dichloromethane (methylene chloride) (February 28, 2004).
CEPA 1999 requires that preventive or control actions be established to manage the risks posed by substances assessed as toxic under the Act within strict legislated timelines. Risk management tools that are substance specific, apply to groups of substances or apply to sector(s) are developed through the Toxics Management Process. Central to the process are the development and implementation of a risk management strategy that communicates what will be done to prevent or control the uses or releases from the sources/sectors of the toxic substance. Under this process, Environment Canada and Health Canada ensure that risk management instruments are developed in a way that provide efficient and effective consultations with industry and public stakeholders and that the obligations to protect the environment and human health set out in CEPA 1999 are met.
A variety of risk management measures are available to risk managers to reduce risk associated with the use and/or release of toxic substances. These risk management measures may be used to control any aspect of the substance's life cycle - from the design and development stage to its manufacture, use, storage, transport and ultimate disposal. They include instruments that are developed pursuant to a specific provision in CEPA 1999, such as regulations, pollution prevention plans, guidelines and codes of practice, and those that are developed outside of CEPA 1999 such as environmental performance agreements (referred to as tools). Under certain conditions, risk management actions can also be applied through other federal acts or provincial and territorial legislation.
Appendix A contains a list of the risk management measures proposed or finalized in 2003-04.
In 2003-04, four final regulations (see Appendix A) were published under Part 5 of CEPA 1999 related to existing substances:
- Prohibition of Certain Toxic Substances Regulations, 2003 (April 9, 2003) -- The regulations feature a schedule, listing toxic substances subject to prohibition for manufacture, use, sale, offer for sale and import. The amendments include the addition of two substances to the Schedule in the regulations (benzidine and its salt (benzidine dihydrochloride) and hexachlorobenzene) and the application of conditions on one of them (hexachlorobenzene).
- Regulations Amending the Benzene in Gasoline Regulations (October 8, 2003) -- The amendments are of a minor technical nature and do not alter the intent of the regulations.
- Regulations Amending the Sulphur in Gasoline Regulations (October 8, 2003) -- The regulations limit the level of sulphur in gasoline to an average of 150 parts per million and further reduce the limit to 30 parts per million starting in 2005. The amendments provide for a more accurate measurement of sulphur at low levels. At the same time, a number of other minor changes were made to update the regulations, clarify some provisions and make the regulations more consistent with other federal fuels regulations.
- Solvent Degreasing Regulations (August 13, 2003) -- These regulations will implement a three-year freeze in the consumption of trichloroethylene and tetrachloroethylene, followed by a 65% reduction in consumption for the subsequent years. The regulations will apply to persons involved in degreasing operations (vapour and cold degreasing) who use more than 1000 kilograms of these solvents during a calendar year.
In 2003-04, two proposed regulations were published:
- Regulations Amending the Benzene in Gasoline Regulations (Miscellaneous Program) (November 22, 2003) -- The regulations correct inconsistencies between French and English versions of the regulations.
- Virtual Elimination List Regulations (August 16, 2003) -- Environment Canada proposed the addition of the first substance to the Virtual Elimination List: hexachlorobutadiene with a 0.06 nanogram per millilitre level of quantification in a chlorinated solvent. Hexachlorobutadiene is incidentally present in certain chlorinated solvents and chemicals such as ferric chloride and may be released to the environment upon their use. Other possible releases could be from hazardous landfill leachates and hazardous waste incineration.
An environmental performance agreement is a voluntary agreement negotiated among parties to achieve specified environmental results. While it is not considered an instrument under CEPA 1999, it is an additional risk management tool that can be used to achieve environmental objectives for toxic substances and other substances of concern.
In 2003-04, one agreement was signed with the Specialty Graphic Imaging Association and participating facilities in Ontario (see Appendix A). Facilities participating in this agreement will develop targets and timelines to achieve verifiable reductions in the use, generation and release of specified priority substances, develop and implement plans to minimize and eliminate volatile organic compounds using pollution prevention activities and best available technology that is economically achievable, and implement an environmental management system.
Substances that are not on the Domestic Substances List 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.
When the assessment process identifies a new substance that may pose a risk to human health or the environment, the Act empowers Environment Canada to intervene by requiring a risk management measure, placing restrictions or prohibiting the substance from import or manufacture in Canada.
When Environment Canada and Health Canada suspect that a significant new activity in relation to a new substance that had been previously assessed and found not to be toxic may result in the substance becoming toxic, a Significant New Activity Notice is issued to ensure that adequate additional information is provided to the Minister by the notifier or any other proponent who wishes to manufacture, import or use the organism 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 the new activities.
CEPA 1999 requirements apply to new substances (chemicals and polymers) that are manufactured or imported unless other applicable Acts provide for notice and assessment and are specifically identified on Schedule 2 of the Act.
During 2003-04, the New Substances Program (composed of Environment Canada and Health Canada officials) received 757 new substance notifications under CEPA 1999. Additionally, the New Substances Notification Regulations under CEPA 1999 currently apply to substances in products regulated under the Food and Drugs Act, which is administered by Health Canada. During 2003-04, Health Canada received 85 submissions for new substances under the Food and Drugs Act, of which 78 were accepted and 7 were withdrawn or rejected due to, among other reasons, the submission of incomplete applications.
Of the 757 substances assessed under the New Substances Program, Environment Canada issued 10 Significant New Activity Notices and 6 conditions related to some of these substances.
The revised New Substances Notification Regulations were published on June 18, 2003 (see Appendix A). These revisions to the chemicals and polymers portion of the regulations were based on the recommendations received during the public consultations (see Section 5.2.5) and are expected to improve and streamline the regulations while not compromising Environment Canada's and Health Canada's abilities to protect human health and the environment.
Substances regulated under the Food and Drugs Act are eligible to be added to the Domestic Substances List provided that the Environment Minister is satisfied that these substances, between 1984 and 1986, were manufactured in or imported into Canada by a person in a quantity of not less than 100 kilograms in any one calendar year or used in Canadian commerce or used for commercial manufacturing purposes in Canada.
Health Canada nominated 1226 substances listed in the Food and Drugs Act for addition to the Domestic Substances List. Of these 1226 substances:
- 2 were already on the Domestic Substances List;
- 623 were added to the Domestic Substances List on February 11, 2004 (these substances will now be subject to the categorization and screening program); and
- 601 submissions required further investigation and data collection by Health Canada.
Three hundred and fifty-five substances regulated under the New Substances Notification Regulations were also added to the Domestic Substances List between April 2003 and March 2004.
Spanning two years, the consultations on the New Substances Program began in June 1999 and resulted in 76 recommendations to amend the New Substances Notification Regulations and the New Substances Program. In November 2003, Environment Canada and Health Canada reported on the progress in implementing the recommendations in the document Consultations on the CEPA New Substances Notification Regulations and New Substances Program (Chemicals and Polymers Portion) - Report on Progress: Implementing the Consultation Recommendations for Period Ending October 2003.
The Four Corners Arrangement was revised in November 2003 and signed in January 2004 by Environment Canada, Health Canada, the United States Environmental Protection Agency, the American Chemical Council and the Industry Coordinating Group from Canada. The overall objective of the revised arrangement is to work towards achieving efficiency of resources for all parties for the introduction of new substances to the North American marketplace, while continuing to protect human health and the environment.
During 2003-04, four substances were submitted and reviewed under this Agreement. Two of these substances were recommended for addition to the Non-Domestic Substances List. The Non-Domestic Substances List contains those substances that, while new to Canada, are already in commerce in the United States. Substances on the Non-Domestic Substances List are still subject to notification requirements in Canada, but face less onerous information requirements under the New Substances Notification Regulations.
The Cooperative Arrangement among the National Industrial Chemicals Notification and Assessment Scheme of Australia, Environment Canada and Health Canada allows both the sharing of information on new industrial chemicals and the harmonizing of national new industrial chemicals schemes.
In 2003-04, 15 notification requests were processed under the Arrangement. Assessment reports on 10 substances were shared with Australia following requests by industry. Canada and Australia continued work on comparing assessment approaches and methodologies for six polymers and three chemicals. A draft report describing "lessons learned" for polymers was completed, and a similar report for chemicals was in progress.
The Organisation for Economic Co-operation and Development (OECD) New Chemicals Task Force was established to manage a work program aimed at improving information and work sharing associated with notification and assessment of new industrial chemicals. A retrospective document in the area of bilateral/ multilateral arrangements was prepared by Environment Canada and Health Canada and presented at the 7th Meeting of the Organisation's Task Force on New Chemicals. This document was presented to senior officials for endorsement in November 2004.
The OECD principles of good laboratory practice set out managerial concepts covering the organization of test facilities and the conditions under which preclinical safety studies are executed. Their purpose is to ensure the generation of high-quality and reliable test data (in vitro and in vivo) related to the safety of chemicals and analytical procedures in the framework of the Mutual Acceptance of Data.
In 2003-04, work on the New Substance Notification Good Laboratory Practice compliance monitoring program included:
- maintaining and updating the OECD Canadian database;
- providing technical advice during the revision of good laboratory practice aspects of the New Substances Notification Regulations;
- representing Environment Canada on the OECD Steering and Working Groups on Good Laboratory Practices; and
- providing information on data quality to new substances evaluators.
The authorities in the Act allow 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, such as the Rotterdam Convention, to control their export. The authorities also allow the Minister to make regulations in relation to substances specified on the Export Control List.
The Export Control List Notification Regulations require exporters to provide notice to the Minister of the Environment of the proposed export of substances on the Export Control List and to submit annual reports. In 2003-04, eight notifications of export were received, and no additional substances were added to the Export Control List (Schedule 3).
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