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ARCHIVED - CEPA Annual Report for Period April 2002 to March 2003
- 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 New to Canada
- 7. Controlling Pollution and Managing Wastes
- 8. Environmental Emergencies
- 9. Government Operations and Federal and Aboriginal Land
- 10. Enforcement
- 11. Miscellaneous Matters
5. Controlling Toxic Substances
- 5.1 Risk Assessments of Existing Substances
- 5.1.1 Categorizing the Domestic Substances List
- 5.1.2 Screening Assessments
- 5.1.3 Priority Substances List Assessments
- 5.1.4 Other Assessments
- 5.2 Management of Toxic Substances
- 5.2.1 Data Collection and Generation
- 5.2.2 Risk Management Strategies
- 5.2.3 Regulations
- 5.2.4 Environmental Performance Agreements
- 5.2.5 Municipal Wastewater Effluents
- 5.2.6 International Actions
- 5.3 Substances New to Canada (Chemicals and Polymers)
- 5.3.1 Risk Assessments
- 5.3.2 Consultations on the New Substances Program
- 5.3.3 Regulations
- 5.3.4 Scheduling of Other Acts
- 5.3.5 International Actions
- 5.4 Export of 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 that they pose to human health or the environment. These substances are on the Domestic Substances List (DSL). Substances that are not on that list are considered to be new and are subject to the New Substances Program.
Risk Assessment of Existing Substances is a joint Environment Canada and Health Canada program driven by strict legislative requirements. Among others, CEPA 1999 requires that the Ministers:
- Categorize substances on the DSL by September 2006. This involves identifying substances, based on available information, that:
- may present, to individuals in Canada, the greatest potential
for exposure; or
- are persistent and/or bioaccumulative, in accordance with the Persistence and Bioaccumulation Regulations, and inherently toxic to humans or nonhuman organisms;
- may present, to individuals in Canada, the greatest potential
- Conduct a screening-level risk assessment for all substances “categorized in” to determine whether or not the substances are CEPA toxic;
- Establish a Priority Substances List, which identifies substances to be assessed on a priority basis;
- Review decisions of other jurisdictions (within Canada or the OECD) with which the Minister has developed procedures to exchange information 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.
Results in 2002-03 included the following:
- Health Canada developed a proposal for the first stage of priority setting for categorization for the greatest potential for human exposure based on information on the Domestic Substances List (DSL) and identified approximately 1250 compounds as priorities for further consideration.
- Health Canada developed an approach for categorization of organic substances on the DSL for inherent toxicity to humans, based on operational familiarity from draft categorization decisions for 1500 organic substances.
- A multistakeholder workshop was held in October 2002 by Environment Canada to address the technical aspects of persistence and bioaccumulation.
- A Draft Guidance Manual entitled DSL Environmental Categorization Guidance Document prepared by Environment Canada for the categorization of organic and inorganic substances on the DSL was posted on the web in June 2003 for a 60-day comment period.
- Ecological toxicity and bioaccumulation data on approximately 900 inorganic substances on the DSL were collected and reviewed by Environment Canada.
- Electronic copies of all the computer-generated estimates and empirical data collected to date for the 12 000 organic substances on the DSL were made available to the public and to stakeholders by Environment Canada.
In 2002-03, accomplishments at Environment Canada included:
- Problem formulations -- a systematic review of available data in order to set priorities -- were completed for all 123 organic substances on the Domestic Substances List (DSL) pilot project list.
In 2002-03, accomplishments at Health Canada included the following:
- Finalizing the format of, and refinement of the approaches for, screening health assessments of existing substances; and
- Developing models for category screening health assessments based upon the internal draft screening health assessments for polybrominated diphenyl ethers and perfluorooctane sulfonate and its precursors.
Updates on the First Priority Substances List
Environment Canada and Health Canada released draft conclusions and follow-up assessment reports for public comment on 13 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:
- Two substances (di-n-octyl phthalate and non-pesticidal organotin compounds) were proposed not to constitute a danger to human health.
- One substance (1,1,2,2-tetrachloroethane) was proposed not to be harmful to the environment and not to constitute a danger to human health.
- Four substances (styrene, 1,2-dichlorobenzene, 1,4-dichlorobenzene, trichlorobenzenes) were proposed not to be harmful to the environment.
- Three substances (tetrachlorobenzenes, pentachlorobenzenes, and used crankcase oils) were proposed to be harmful to the environment. Tetrachlorobenzenes and pentachlorobenzenes were also proposed for virtual elimination, as they were found to meet the persistence and bioaccumulation criteria and are released primarily as a result of human activity.
- Three substances (3,5-dimethylaniline, aniline, and bis(2-chloroethyl ether)) were suspected to constitute a danger in Canada to human health.
- A draft Assessment Report for chlorinated paraffins (medium- and long-chain) was completed.
Updates on the Second Priority Substances List
Results in 2002-03 included the following:
- Five substances on the second Priority Substances List (nonylphenol and its ethoxylates, textile mill effluents, inorganic chloramines, ethylene oxide, ammonia dissolved in water) were added to the List of Toxic Substances.
- Final decisions were published for three substances (ethylene oxide, N-nitrosodimethylamine, and formaldehyde), which concluded that these three substances are toxic under CEPA 1999. Final Orders to add these substances to the List of Toxic Substances were published in the Canada Gazette, Part I, on April 13, 2002.
Progress in 2002-03 on suspended assessments included the following:
- Health Canada worked with an Expert Steering Committee to refine design parameters for a study on the neurological effects of aluminum.
- Health Canada worked with representatives of the American Chemistry Council to develop and refine proposals and protocols for industry sponsored studies to address uncertainty concerning the progression of renal lesions in male rats following exposure to ethylene glycol.
Work continued on the preparation of a guidance document for assessing decisions made by other jurisdictions to ban or restrict substances of concern.
Canada participated 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. Health Canada worked with representatives of the American Chemistry Council to develop and sponsor a Screening Information Data Set Initial Assessment Report on a group of ethylene glycols for the OECD’s highproduction- volume assessment program.
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 on and assess 1000 high-production volume chemicals by 2004.
Substances that are found to meet the definition of toxic under CEPA 1999 are managed throughout their life cycle to minimize the risks that they pose to the environment and human health. Toxic substances that persist in the environment for several months or years, bioaccumulate in the tissue of living organisms, and are predominantly the result of human activity are targeted for virtual elimination. Virtual elimination is the ultimate reduction of the quantity or concentration of the substance in the release below the lowest concentration that can be accurately measured using sensitive but routine sampling and analytical methods.
The Act sets specific timelines for taking preventive or control action to manage the risks posed by toxic substances. Preventive or control instruments for each toxic substance are developed through the Toxics Management Process. The Toxics Management Process is a new, more streamlined approach to controlling substances that meet the criteria for toxic under CEPA 1999. This process ensures that risk management actions are developed in a way that ensures that industry and public stakeholders are effectively consulted and that the obligations to protect the environment and human health set out in CEPA 1999 are met.
Under section 68 of CEPA 1999, the Minister has the authority to collect or generate data for the purpose of assessing whether a substance is toxic or capable of becoming toxic or for the purpose of assessing whether to control, or the manner in which to control, a substance. Under section 71 of CEPA 1999, the Minister has the authority to request information that may be in the person’s possessions or to which the person may reasonably be expected to have access. Section 71 (1) c) provides the Minister with the authority to request that person or persons described in the Notice generate new data through technological and other tests specified in the Notice
In 2002-03, three information-gathering notices (one pursuant to s. 68, and two pursuant to s. 71 (1) b)) were published -- no notices under section 71 (1) c) were published.
- S. 68 notice to anyone engaged in the production, import or use of ozone-depleting substances (ODSs) (2002-06-08);
The Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer agreed to phase out the production and consumption of ODSs. The Fourth Meeting of the Parties decided to allow for possible exemptions to these production/consumption phase-out dates in order to meet the marketplace demand for uses that are considered “essential”. The Parties have established criteria and a procedure to assess nominations for “essential” use exemptions. Canada, as a signatory to the Montreal Protocol, must ensure that the requirements of this international treaty are implemented in Canada. During the reporting period, no information was submitted to EC requesting exemption status.
- S. 71 (1) b) notice with respect to short-, medium-, and long-chain chlorinated paraffins (2002-11-30);
Chlorinated paraffins are used as secondary plasticizers for polyvinyl chloride, as extreme pressure additives in metal machining fluids, and as fire retardants. They are imported into Canada for use mainly as lubricants in the metal working sector. They are also used as flame retardants and/or plasticizers in items including PVC, synthetic rubber, paints and sealants. The information collected is being used to further an ongoing environmental assessment related to chlorinated paraffins, and will be considered in the development of any future management tools.
- S. 71 (1) b) notice with respect to certain hydrochlorofluorocarbons (2003-01-25);
Hydrochlorofluorocarbons (HCFCs), which have measurable, albeit low, ozone depletion potentials, are included in the list of substances controlled by the Montreal Protocol on Substances that Deplete the Ozone Layer. Parties, including Canada, agreed to control their production and their consumption, monitor their use of these substances, monitor their impact on ozone layer depletion, and encourage the production of alternative products and technologies. The information assisted EC in developing a proposal to amend the Ozone-depleting Substances Regulations,1998 in order to help those subject to the regulation more effectively comply with the Montreal Protocol requirements.
Central to the Toxics Management Process is the development of a risk management strategy for toxic substances. Each strategy describes how the risks to human health and the environment posed by the use or release of a particular toxic substance will be addressed. In developing the risk management strategy, Environment Canada identifies the sources that pose the greatest risk to the environment and human health, guided by the science in the risk assessment. A risk management objective is then identified. This objective is usually based on the results achieved from the best available practices, technologies, or techniques and, in some cases, environmental quality objectives are established (see Section 3.4.1).
Once a risk management objective has been set, management measures and instruments to achieve the objective are selected. These 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.
Substances that were being considered for addition and substances that were added to the List of Toxic Substances in 2002-03 are found in Table 2. Risk Management Strategies will be proposed for these substances and will be published in the Canada Gazette for public review.
order adding to schedule 1 - date
order adding to schedule 1 - date
|Ozone and the |
and ozone (gaseous
nitric oxide, nitrogen
[VOCs], as specified
in the Order).
|July 27, 2002||July 2, 2003||Ozone is a gas formed in sunlight and warm stagnant air from reactions involving the precursor gases of nitrogen oxides and volatile organic compounds (VOCs). Fuel combustion processes in the transportation and power generation sectors, releases during the use of solvents, the application of inks and paints and other industrial coatings, the manufacturing of fertilizer in the chemical industry and animal husbandry and fertilizer application in the agricultural sector.|
|Road salts||Dec. 1, 2001||Application as a de-icer on road surfaces.|
|Particulate matter containing metals||Nov. 2, 2002||Aug. 13, 2003||Copper smelters and refineries, and zinc plant operations.|
|Ammonia dissolved in water||Nov. 2, 2002||Jan. 1, 2003||Municipal wastewater treatment plants, agricultural activity, fertilizer production and use, pulp and paper mill operations, mine operations, food processing.|
|Nonylphenol and its ethoxylates||June 23, 2001||Jan. 1, 2003||Industrial and municipal wastewater treatment plant effluents (liquid and sludge), |
fertilizer production and direct discharge, pesticide production.
|Effluents from textile mills using wet processing||June 23, 2001||Jan. 1, 2003||Most wet processing mills in Canada (96%) discharge to municipal wastewater systems, and 99% of these municipal wastewater systems have primary, secondary, or tertiary wastewater treatment prior to release into receiving water. Approximately 70% of municipal wastewater systems in Canada receive secondary or tertiary treatment.|
|Ethylene oxide||April 27, 2002||June 4, 2003||Use as a de-icer, use as a sterilizer of health care materials and heat-sensitive products.|
|Formaldehyde||April 17, 2002||June 4, 2003||Automotive and other fuel combustion, industrial on-site sources, and natural sources (including forest fires).|
|N-Nitrosodimethylamine (NDMA)||April 27, 2002||June 4, 2003||No industrial or commercial uses of NDMA in Canada; released as by-product and contaminant from various industries, municipal wastewater treatment plants, pesticides, rubber tires, alkylamines, and dye manufacture.|
with molecular formula NHnCl(3-n),
where n = 0, 1, 2
|June 23, 2001||Jan. 1, 2003||Sewage treatment plants, industrial and cooling water processes treated with chlorine or chloramines, breaks and leaks in water mains, fire-fighting runoff, stormwater runoff from domestic water supplies treated with these substances.|
|Hexachlorobutadiene||June 1, 2002||Aug. 13, 2003||Used to make rubber compounds. Also used as a solvent and to make lubricants, in gyroscopes, as heat transfer liquid, and as a hydraulic fluid. Mainly released from disposal following industrial uses.|
In 2002-03, risk management strategies were developed for the following seven toxic substances:
- Acrylonitrile (life cycle management) -- The Risk Management Strategy proposed pollution prevention planning as the most effective instrument to reduce releases from synthetic rubber manufacturing facilities. The proposed pollution prevention notice was published in the Canada Gazette, Part I, on May 25, 2002. Environment Canada's objective is to reduce releases of acrylonitrile from major industrial sources to the lowest achievable levels through the application of the best available techniques that are economically achievable.
- Ethylene oxide (life cycle management) -- The Risk Management Strategy proposed guidelines under CEPA 1999 to manage ethylene oxide released from sterilization applications in health care facilities. Application of these guidelines would achieve a 99% reduction of emissions at establishments with no pollution control equipment.
- Hexachlorobutadiene (virtual elimination) -- Completed in fall 2002, the Risk Management Strategy proposed that hexachlorobutadiene be prohibited under the Prohibition of Certain Toxic Substances Regulations, since it meets the criteria for virtual elimination. Hexachlorobutadiene has never been commercially produced in Canada. Formerly, the substance was imported into Canada for use as a solvent, but it is no longer imported. There are no natural sources of hexachlorobutadiene in the environment.
- Road salts (life cycle management) -- Consultations were held on a strategy for reducing releases of road salts to the environment while maintaining road safety. A proposed Code of Practice was developed in consultation with a working group.
- Ammonia dissolved in water, inorganic chloramines, and chlorinated wastewater effluents (life cycle management) -- A series of one-day consultation sessions were held in 13 centres across Canada in 2002 on a proposed Risk Management Strategy. The proposed Risk Management Strategy, addressing ammonia dissolved in water, inorganic chloramines, and chlorinated wastewater effluents, was published in August 2002 on the CEPA Registry. The strategy proposed pollution prevention planning for the owners and operators of selected wastewater systems as an integrated step towards a long-term strategy for managing wastewater effluents. The proposed notice requiring the preparation and implementation of pollution prevention plans was published in Part I of the Canada Gazette on June 7, 2003.
Proposed Risk Management Strategy addressing Ammonia, Inorganic Chloramines and Chlorinated Wastewater Effluents
- Nonylphenol and its ethoxylates (life cycle management) -- Environment Canada began implementing the Risk Management Strategy, which proposed pollution prevention planning. The implementation will result in a 50% reduction by December 2006 and a 95% reduction by December 2009 of these substances, which are found in soap and cleaning products, processing aids used in textile wet processing, and pulp and paper processing aids. A working document as well as related instructions were published on the CEPA Registry in June 2003. The document outlines the proposed pollution prevention planning requirements for products containing nonylphenol and its ethoxylates.
- Textile mills that use wet processing (life cycle management) -- Environment Canada began implementing the Risk Management Strategy, which proposed pollution prevention planning to reduce the use of nonylphenol and its ethoxylates by 97% from textile mills and to lower the toxicity of effluent from these mills. The proposed notice requiring the preparation and implementation of pollution prevention plans was published in the Canada Gazette, Part I, on June 7, 2003.
The status of the development of management tools and instruments for 2002-03 is summarized in Table 3.
Federal Halocarbon Regulations, 2003
|Proposed December 7, 2002|
|Solvent Degreasing Regulations||Proposed December 7, 2002|
|Regulations Amending the Gasoline Regulations||Finalized April 9, 2003|
|Regulations Amending the Sulphur in Gasoline Regulations||Proposed February 1, 2003;|
Finalized October 8, 2003
|Regulations Amending the Benzene in Gasoline Regulations||Proposed February 1, 2003;|
Finalized October 8, 2003
|Off-Road Small Spark-Ignition Engine Emission Regulations||Proposed March 29, 2003|
|On-Road Vehicle and Engine Emission Regulations||Finalized January 1, 2003|
|Export of Substances Under the Rotterdam Convention |
|Finalized August 28, 2002|
|Environmental Emergency Regulations||Proposed August 10, 2002;|
Finalized September 10, 2003
|Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations||Finalized March 12, 2003|
|Living Modified Organisms Regulations||Proposed September 28, 2002|
|New Substances Fees Regulations||Finalized November 6, 2002|
|Regulations Amending the Disposal at Sea Regulations||Proposed February 1, 2003|
|Regulations Amending the New Substances Notification |
|Finalized June 18, 2003|
|Regulations Amending the Export and Import of |
Hazardous Wastes Regulations
|Proposed April 20, 2003|
|Interprovincial Movement of Hazardous Waste |
|Proposed April 20, 2003;|
Finalized August 15, 2003
|Sulphur in Diesel Fuel Regulations||Finalized July 31, 2002|
|POLLUTION PREVENTION PLANS|
Canada Gazette Notice requesting the preparation
and implementation of pollution prevention plans for
|Proposed August 31, 2002|
|Canada Gazette Notice requiring the preparation |
and implementation of pollution prevention plans in
respect of nonylphenol and its ethoxylates used in
the wet processing textile industry and effluents
from textile mills that use wet processing
|Proposed June 7, 2003|
|Canada Gazette Notice requiring the preparation |
and implementation of a pollution prevention plan in
respect of one or more of the following substances:
ammonia dissolved in water; inorganic
chloramines; and chlorinated wastewater effluents
|Proposed June 7, 2003|
|Canada Gazette Notice requesting the |
preparation and implementation of pollution
prevention plans for acrylonitrile
|Proposed May 25, 2002|
|CODES OF PRACTICE|
Reduction of Dichloromethane Emissions from the
Use of Paint Strippers in Commercial Furniture
Refinishing and Other Stripping Applications
|Finalized June 2003|
|Code of Practice for On-Road Heavy-duty |
Vehicle Emission Inspection and Maintenance
|Finalized November 2002|
Guidelines for Volatile Organic Compounds in
|Finalized November 2002|
|ENVIRONMENTAL PERFORMANCE AGREEMENTS|
Environmental Performance Agreement (EPA)
with the Automotive Parts Manufacturers’
|Signed June 3, 2002|
Canada-wide Standards for Dioxins and Furans
from Steel Manufacturing Electric ArcFurnaces
and Iron Sintering Plants
|Endorsed March 2003|
|Administrative Agreement Between the |
Government of Canada and Quebec
Pertaining to the Pulp and Paper Sector.
|Proposed July 27, 2002|
Progress in 2002-03 included:
- Chlorobiphenyls Regulations -- A final round of stakeholder consultations was held in 2002-03 on the proposed amendments to these regulations. These amendments will accelerate the phaseout of use of polychlorinated biphenyls (PCBs), require an earlier phase-out at environmentally sensitive locations, add new provisions on the tracking of PCBs until they are disposed of, and lower the manufacturing control limit.
- Storage of PCB Material Regulations -- A final round of stakeholder consultations was held in 2002-03 on the proposed amendments to these regulations. These amendments will accelerate the destruction of PCBs already in storage, prohibit the storage of PCBs at environmentally sensitive locations, and limit the storage time of PCBs before their disposal.
- Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations -- Final regulations were published in Part II of the Canada Gazette on March 12, 2003. The regulations reduce the use and releases of tetrachloroethylene by requiring newer, more efficient dry cleaning machines, minimizing spills, and managing the collection and disposal of residues and wastewater.
- Solvent Degreasing Regulations -- The proposed regulations were published in Part I of the Canada Gazette on December 7, 2002. The regulations reduce the use and releases of trichloroethylene and tetrachloroethylene into the environment from solvent degreasing facilities.
An Environmental Performance Agreement is a voluntary agreement negotiated among parties to achieve specified environmental results. These agreements are not CEPA instruments but may be used where they are cost-effective, where they support the policy and regulatory framework, where participants have the capacity to implement them, and where they are deemed appropriate. An agreement must consider specific core design criteria in the negotiating process. The Policy Framework for Environmental Performance Agreements provides assurance of transparency and accountability as well as a solid basis for negotiating agreements.
Environment Canada negotiated an Environmental Performance Agreement with the Automotive Parts Manufacturers’ Association. The agreement represents a voluntary commitment by participating companies to reduce releases of volatile organic compounds and carbon dioxide. Companies can also choose to address other toxic substances, depending on their facility operations and business cycles. The Environmental Performance Agreement with Dow Chemical requires the preparation of an environmental management plan, establishment of emission reduction goals, an air monitoring program, and reporting on releases. An Environmental Management Plan was submitted in October with a goal of a 48% reduction in emissions. Data from 2002 indicate that the goal has already been accomplished, but further evaluation is required to determine if this is sustainable.
On January 1, 2003, ammonia dissolved in water, inorganic chloramines, effluents from textile mills that use wet processing, and nonylphenol and its ethoxylates were added to the List of Toxic Substances (Schedule 1) for CEPA 1999 (see Table 2). Chlorinated wastewater effluents were added to the list on March 4, 1999. These substances are primarily discharged to surface waters through municipal wastewater effluents.
Environment Canada, in consultation with the National Advisory Committee (see Section 1.1), developed a proposed instrument for these substances. Two documents were prepared by Environment Canada: A Proposed Risk Management Strategy Addressing Ammonia, Inorganic Chloramines and Chlorinated Wastewater Effluents under CEPA 1999; and Pollution Prevention Planning for Ammonia, Inorganic Chloramines and Chlorinated Wastewater Effluents Working Document.
These documents propose pollution prevention planning requirements for the owners/operators of selected wastewater systems as an integrated step towards a long-term strategy for managing wastewater effluents. The proposed notice requiring the preparation and implementation of pollution prevention plans was published in Part I of the Canada Gazette on June 7, 2003.
Environment Canada hosted a series of one-day consultation sessions in 13 centres across Canada from August 20 to November 4, 2002. The Department also provided information to stakeholders and interested parties and collected feedback on the proposed risk management strategy for ammonia, inorganic chloramines, and chlorinated wastewater effluent.
Many toxic substances that are produced, used, and released into the environment are of global concern. Key international activities in 2002-03 included:
- Green Power -- Together with the Netherlands, Environment Canada co-sponsored a networking seminar on international perspectives on green power development at the national Green Power Trade Show. This event promoted dialogue and facilitated information exchange on wind energy.
- National Environmental Policy -- Environment Canada continued to participate on the new Working Party on National Environmental Policy under the Organisation for Economic Co-operation and Development. In 2003, a book entitledEnvironmentally Sustainable Buildings -- Challenges and Policies was released. Canada was also used as a case study for a forthcoming publication on voluntary approaches, which describes environmental performance agreements as an example of voluntary approaches with industry.
- The Great Lakes Bi-national Toxics Strategy -- Environment Canada’s Ontario Region, the U.S. Environmental Protection Agency, and various stakeholders work together towards the goal of virtual elimination of certain targeted persistent toxic substances resulting from human activities in the Great Lakes basin. Measurements of emissions of various persistent toxic substances were undertaken at Ontario industrial facilities as a voluntary initiative. Environment Canada completed an evaluation of biomedical incinerators in Toronto and Hamilton, a copper smelter in Kidd Creek, a recovery boiler in Red Rock, and a crematorium in Roselawn.
The New Substances Program ensures that no new substances are introduced 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. The program operates under the New Substances Notification Regulations and is jointly administered by Environment Canada and Health Canada.
Chemicals, polymers, and inanimate products of biotechnology that are new to Canada are covered under Part 5 of CEPA 1999. Animate products of biotechnology that are new to Canada are dealt with under Part 6 (see Section 6). Parts 5 and 6 of CEPA 1999 are integral parts of the federal government’s approach to pollution prevention.
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
Environment Canada and Health Canada received 917 new substance notifications in 2002-03. Risk management measures imposed included seven conditions and five Significant New Activity Notices. When a new substance has been assessed and there is a suspicion that it is toxic or capable of becoming toxic, the Minister may prohibit any person from manufacturing or importing the substance, request any person to provide any additional information or submit the results of any testing that is considered necessary, or place restrictions/conditions upon the substance (e.g., on how and where it is used or on storage or disposal methods).
When Environment Canada and Health Canada suspect that there is significant new activity in regards to a substance that has already been assessed, a 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 or import 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 the new activities and take any actions necessary to protect the environment and human health.
During 2002-03, 55 submissions were made to Health Canada of new substances in products regulated under the Food and Drugs Act. Of those, 43 submissions were accepted and were being assessed, and 12 were screened and rejected as incomplete or withdrawn by the notifier.
When the New Substances Notification Regulations were promulgated in 1994, a commitment was made by Environment Canada and Health Canada to review them after the first three years of implementation. This review 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 2001. The government response report to address the consensus recommendations was released in September 2002.
The stakeholders recommended improvements in five areas: Risk Assessments, Regulatory Framework, Transparency, Responsiveness of the Regulations and the New Substances Program in an International Context, and Service Delivery. The recommendations reflect the government’s fundamental goal to protect human health and the environment while enhancing the efficiency and effectiveness of the New Substances Notification Regulations and the New Substances Program. The recommendations will continue to be implemented over the next few years.
In 2002-03, the following regulations were completed or in the process of being developed:
- New Substances Notification Regulations -- As per the recommendations from the multistakeholder consultations, the proposed amendments to the chemicals and polymers portion of the regulations will improve and streamline the regulations, while not compromising the protection of human health and the environment. The revised regulations were published in the Canada Gazette, Part II on June 18, 2003.
- New Substances Fees Regulations -- Section 328 of CEPA 1999 gives the Minister of the Environment and the Minister of Health the authority to make regulations to help recover part or all of the costs involved in processing and assessing new substance notifications. The fees structure was developed as a result of multistakeholder consultations that included representatives from the federal government, the chemical industry, and non-governmental organizations. The fees are projected to recover approximately 20% of the New Substances Program’s total annual costs for providing service. The New Substances Fees Regulations came into effect on January 1, 2003.
CEPA 1999 allows for the waiving of its notification and assessment requirements for new substances (chemicals, polymers, animate and inanimate products of biotechnology) if they are met by another Federal Act. Schedule 2 identifies the other Acts that chemicals and polymers may fall under (see Table 4). These provisions mean that CEPA 1999 sets the standard for notice and assessment and acts as a safety net for new substances that are not regulated by other Acts of Parliament. The legal provisions that authorize the schedules came into force on September 13, 2001.
|Schedule 2 (chemicals and polymers)|
|Pest Control Products Act and Pest Control Products Regulations|
|Feeds Act and Feeds Regulations|
|Fertilizers Act and Fertilizers Regulations|
The Food and Drugs Act is not scheduled under CEPA 1999 at this time. New substances in products regulated under the Food and Drugs Act must therefore be notified under the New Substances Notification Regulations of CEPA 1999. Health Canada held a series of consultation meetings in 2002-03 with stakeholders to explain the development of new regulations for the environmental assessment of Food and Drugs Act products, which would meet the CEPA 1999 requirements. A multistakeholder workshop was held in February 2003 on a Draft Issue Identification Paper.
Key international activities in 2002-03 included:
- Four Corners Arrangement -- The Four Corners Arrangement focused on providing a mechanism to expedite the movement of substances from the U.S. Toxic Substances Control Act (TSCA) Inventory to Canada’s Non-Domestic Substances List (NDSL) before the five-year waiting period elapsed or to identify Canadian data requirements that could be waived based on U.S. assessment of the same new substance.
The Non Domestic Substances List (NDSL), contains those substances that while new to Canada, are already in commerce in the U.S. and appear on the U.S. EPA Toxic Substances Control Act (TSCA) Inventory. NDSL substances are still subject to notification requirements in Canada, but face less onerous information requirements under the New Substances Notification Regulations (NSNR).
The NDSL is updated annually by adding those substances that were introduced to the U.S. TSCA five years prior (e.g., substances added to the TSCA in 1990 were added to the NDSL in 1995). One of the recommendations from the recent New Substances Notification Regulations multistakeholder consultations was to reduce the waiting period for the addition of new TSCA listings to the NDSL from five years to one year and to make changes to the information requirements set out in the notification schedules of the NSNR.
The Signatories and Supporting Partners (Environment Canada, Health Canada, U.S. Environmental Protection Agency, Industry Coordinating Group, and the American Chemical Council) have agreed that it is necessary to change the Agreement into a less formal “Arrangement,” which could have a broader, more global scope and provide greater benefits. Discussions on the Four Corners Agreement resulted in a proposal to revise the Four Corners Arrangement.
The proposed Arrangement aims to achieve efficiencies of resources for all parties with respect to the introduction of new substances to the North American marketplace, while continuing to protect human health and the environment.
During 2002-03, four substances were submitted and reviewed under the original Agreement. Assessments were completed for all four of these substances. None of these substances was added to the NDSL.
- Canada-Australia Arrangement -- A cooperative arrangement between the National Industrial Chemicals Notification and Assessment Scheme of Australia, Environment Canada, and Health Canada was signed in May 2002.
This arrangement is in keeping with wider Organisation for Economic Cooperation and Development (OECD) efforts aimed at learning from each other, enhancing information and work sharing, and harmonizing national new industrial chemicals schemes. The benefits associated with such a bilateral arrangement would be to increase the efficiency of new industrial chemical notification and assessment schemes by providing greater transparency in assessments. It can also lead to a possible reduction in animal testing, a reduction in resources needed for new industrial chemicals work in governments and industry, and a more expedient process of product introduction into the marketplace for some substances.
This arrangement between Australia and Canada will provide a model for the cooperation envisaged with other OECD countries and will be consistent with the initiatives undertaken by the OECD New Chemicals Task Force.
A “lessons learned” report, which compared assessment methodologies, was completed in March 2003. Canada provided assessment reports on six new substances notifications to Australia.
- OECD New Chemicals Task Force -- The 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. Its overall objective is to provide greater transparency and to reduce the resources needed to manage new industrial chemicals programs without compromising the protection of the environment and human health. The New Substances Branch of Environment Canada is closely involved in this international work and chairs the Task Force.
Activities fall within seven Work Elements, including the establishment of bilateral/multilateral agreements, development of a standard notification format, development of a standard format for country assessment reports, acceptance of hazard assessments, the investigation of low-concern and exempt chemicals, the handling of confidential business information, and the feasibility of a global inventory.
- Good Laboratory Practice -- Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD member countries have established criteria for the performance of these studies. The OECD principles of Good Laboratory Practice (GLP) 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 preparations in the framework of the Mutual Acceptance of Data.
In 2002-03, information was provided to CEPA New Substances Notification scientific evaluators on the GLP compliance status of private-sector laboratories in OECD countries that supply testing data to Canada. Work continued on development of the database that stores this information and training Environment Canada staff responsible for validating the quality of the data and carrying out recruitment activities to add GLP testing laboratories to the inspection program. Drafting of a GLP guidance document in support of the new New Substances Notification Regulations was initiated.
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 such as the Rotterdam Convention, 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 Regulations require exporters to provide notice of the proposed export of substances on the Export Control List and to submit annual reports. In 2002, 10 notifications of export were received.
Environment Canada amended the Export Control List (Schedule 3) to add a total of four substances (see Table 5).
|Binapacryl (CAS No. 485-31-4)||August 28, 2002||Pesticides|
|Toxaphene (CAS No. 8001-35-2)||August 28, 2002||Pesticides|
|1,2-Dichloroethane (CAS No. 107-06-2)||August 28, 2002||Pesticides|
|Ethylene oxide (CAS No. 75-21-8)||August 28, 2002||Pesticides|
Environment Canada finalized the Export of Substances Under the Rotterdam Convention Regulations in August 2002. The regulations permit Canada to implement the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. The regulations ensure that certain chemicals and pesticides are not exported to Parties to the Convention unless the importing Party has provided its “prior informed consent” to the export.
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