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ARCHIVED - CEPA Annual Report for Period April 2004 to March 2005
- 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. Compliance Including Enforcement
- 11. Miscellaneous Matters
- Appendix A: Management Measures Proposed or Finalized in 2004-05
- Appendix B: Contacts
- List of Acronyms
- 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 of New Substances
- 5.2.2 Risk Management of New Substances
- 5.2.3 Additions to the Domestic Substances List
- 5.2.4 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.
A substance meets the criteria of section 64 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.
Determining whether a substance meets these criteria and requires management is a function of the substance’s physical, chemical, and biological properties, the nature and extent of current or possible releases, and the potential for the substance to affect the environment or human health.
Part 5 of the Act sets specific timelines for taking preventive or control action to manage the risks posed by substances recommended for addition to Schedule 1, 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.
Environment Canada and Health Canada, through the Existing Substances Program, jointly identify, prioritize, and assess the risks resulting from exposure to existing substances. Existing substances are those listed on the Domestic Substances List and include substances that were in Canadian commerce or used for manufacturing purposes or manufactured in or imported into Canada in a quantity of 100 kilograms or more in any calendar year between January 1, 1984, and December 31, 1986.
Candidate substances for risk assessment are identified through seven main mechanisms under CEPA 1999:
- industry information;
- categorization of the Domestic Substances List;
- provincial or international decisions;
- public nominations;
- new substances notifications;
- emerging science and monitoring; and
- international assessment or data collection.
These seven mechanisms allow Environment Canada and Health Canada to provide a scientifically rigorous, open, and transparent process for identifying and prioritizing candidate substances for their assessment for potential risks within Canada.
During 2004-05, government scientists continued to collect and review information on all 23 000 substances on the Domestic Substances List to identify which of these substances may need additional action.
The categorization exercise is an enormous undertaking -- it has not been attempted by any other government in the world. And yet, all nations face the same challenge. That is why the Government of Canada seeks input from other nations and is freely sharing the information that this exercise generates so that many countries can contribute in the effort to protect our global environment and our collective health from the adverse effects of pollutants.
With the help of many institutions and organizations, the Government of Canada is generating a substantial body of research and robust scientific tools that will assist in future chemical assessments and risk management decisions. The categorization exercise under CEPA 1999 is providing a wealth of additional scientific benefits that will advance our understanding of substances around the world.
Environment Canada and Health Canada have been engaging stakeholders such as industry, environmental groups, and the public, soliciting input for categorization decisions and approaches. Industries play an important role by sharing the information that they have on the chemicals they use and by being innovative in finding ways to manage those chemicals identified as hazardous. Research institutes and universities in Canada and around the world are also involved by filling information gaps and developing tools for efficient assessments of these chemicals. The environmental community is monitoring the process and lending its own experts to the consultation process.
Results under the categorization exercise in 2004-05 include the following:
- At the end of the reporting period, Environment Canada had collected, generated, and reviewed available information and produced preliminary categorization decisions for 19 700 substances on the Domestic Substances List. During the reporting period, interested parties were invited to submit information to help improve or refine information before the final categorization decisions are issued in September 2006.
- 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.
- Health Canada developed simple and complex exposure assessment and hazard identification tools for use in the identification, prioritization, and screening health assessment of existing substances.
- Health Canada released a draft maximal list of about 1900 substances warranting further consideration in categorization and screening health assessment, based upon the criteria of greatest potential for human exposure and inherently toxic to humans. These substances were identified through application of simple exposure assessment and hazard identification tools for some and more complex tools for others. A subgroup of 275 of these substances was identified as having high hazard and the greatest potential for exposure and would likely be high priorities for subsequent screening health risk assessments. Information on both the exposure potential and hazard of the substances on this draft maximal list will also contribute to the prioritization of these existing substances for subsequent screening health assessment.
- Environment Canada throughout the year issues a quarterly CD-ROM that contains:
- background material on the progress of ecological categorization;
- a Guidance Manual for the Categorization of all Substances on Canada's Domestic Substances List;
- category approaches for decisions on data-poor substances;
- spreadsheets containing information on the 23 000 substances on the Domestic Substances List and the preliminary categorization decisions;
- Robust Study Summaries of laboratory studies pivotal to categorization decisions; and
- information submitted by stakeholders to improve categorization decisions.
Environment Canada and Health Canada conducted several screening assessments and refined their screening assessment approaches and processes. Progress on screening assessments during 2004-05 included:
- development of a framework for conducting screening health assessments;
- finalization of draft screening health assessments for public comment on a number of chemicals [2,2'-methylenebis[6-(1,1-dimethylethyl)- 4-methylphenol]; 2-methyl-4,6-dinitrophenol; biphenyl; ethylbenzene; quinoline; 1,1-dichloroethylene; ethylene dibromide; hexachloroethane; and 4,4'-methylenebis(2- chlorobenzenamine)];
- completion of a draft environmental and health screening assessment of PBDEs (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);
- completion of a draft ecological and health screening assessment of PFOS, its salts, and its precursors that contain the C8F17SO2 or C8F17SO3 moiety (a notice was published on October 2, 2004, proposing to add PFOS, its salts, and its precursors to the List of Toxic Substances and that consideration be given to the implementation of virtual elimination for PFOS and its salts);
- continuing assessments of 20 substances, including those representing categories or classes of related chemicals as well as a variety of persistent, bioaccumulative substances or substances that pose greatest potential for human exposure; and
- an ongoing ecological screening assessment on tetrabromobisphenol A and two derivative compounds, ethoxylated tetrabromobisphenol A and tetrabromobisphenol A allyl ether, which are brominated flame retardants used in electronic and communications equipment, building materials, and automobiles.
Environment Canada completed an evaluation of the procedures for the exchange of information with Organisation for Economic Co-operation and Development (OECD) countries for substances that are prohibited or substantially restricted for environmental or health reasons. Following this evaluation, a proposed approach for the exchange of information with OECD jurisdictions was drafted and published for a 60-day public comment period in March 2005.
Under the 1988 Canadian Environmental Protection Act, 44 substances were assessed under the Priority Substances List program. Of the 44 substances, 27 substances were found to meet the requirements of section 11 (CEPA 1988), and 10 were found not to. There has been insufficient information to conclude on the remaining substances.
In 2004-05, the Minister published final decisions for a number of substances (see Table 4), including:
- 1,2-dichlorobenzene, 1,4-dichlorobenzene, and trichlorobenzenes: the Ministers decided to take no further action at this time under CEPA 1999 in respect to the substances, as they were not considered to meet the criteria in section 64 of CEPA 1999; and
- pentachlorobenzene and tetrachlorobenzenes: the Ministers concluded that these substances met the criteria in section 64 and proposed to add these substances to the List of Toxic Substances in Schedule 1 of CEPA 1999 -- these substances were also to be considered as candidates for virtual elimination.
|Recommended for addition to Schedule 1 and candidates for virtual elimination||Pentachlorobenzene|
|No further action recommended||1,2-Dichlorobenzene|
Bis (2-chloroethyl) ether (proposed)
|Ongoing follow-up assessments||Aniline|
Used crankcase oils
Following up on assessments published in 2003-04, the Ministers proposed to take no further action in respect to bis (2-chloroethyl) ether and 3,5-dimethylaniline, as these were not listed on the Domestic Substances List and are therefore "new substances" and subject to the requirements of the New Substances Notification Regulations. Under these regulations, if a person wishes to import or manufacture any of these substances and files a notification with Environment Canada, an assessment will be initiated by Environment Canada and Health Canada to decide if and how the substance will be managed.
As of March 31, 2005, final conclusions had been reached for 23 of the 25 substances on the second Priority Substances List, which was published in 1995.
During 2004-05, assessments concluded that 2-butoxyethanol and 2-methoxyethanol meet the criteria set out under section 64, and they were added to Schedule 1 (see Table 5).
|Recommended for addition to Schedule 1||2-Butoxyethanol|
|No further action recommended||Releases of radionuclides from nuclear facilities (impact on non-human biota)|
|Not meeting the criteria under section 64||Butylbenzylphthalate|
Health Canada's work on aluminum salts and ethylene glycol in 2004-05 included the following:
- Health Canada met with industrial stakeholders to discuss the status of the suspended assessment of aluminum salts and conducted external peer reviews of two industry-submitted draft protocols for studies designed to assess the neurotoxicity of aluminum citrate in rats. Health Canada also organized an expert committee that made further recommendations for modifications to the protocols and participated in meetings of Canadian and European industrial stakeholders to discuss the applicability of the protocols for European regulatory requirements. Work was also initiated on a joint funding arrangement with the U.S. National Institute of Environmental Health Sciences for the conduct of a study of the oral bioavailability and distribution to the central nervous system of aluminum citrate in rats by the University of Kentucky.
- Health Canada was updated on the progress of a study sponsored by the American Chemistry Council on the progression of renal lesions in male rats following exposure to ethylene glycol.
When a substance is assessed and determined to meet the criteria of section 64, one of the measures that the Ministers may propose is its addition to the List of Toxic Substances in Schedule 1 of CEPA 1999. CEPA 1999 gives the federal government the authority to make regulations or require the preparation of pollution prevention plans or environmental emergency plans for substances on Schedule 1.
Table 6 shows activity in 2004-05 to add various substances to Schedule 1.
Proposed Order adding to Schedule 1 - date
Final Order adding to Schedule 1 - date
|2-Methoxyethanol and 2-butoxyethanol||October 25, 2003||March 9, 2005|
2-Methoxyethanol is not commercially produced in Canada but is imported for limited use mainly as an industrial coating, as a chemical intermediate, and in military applications.
2-Butoxyethanol is not commercially produced in Canada but 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.
|Dichlorodiphenyl-trichloroethane (DDT), which has the molecular formula C14H9Cl5||April 3, 2004||March 9, 2005|
DDT was first registered as a pesticide in the 1940s, and although it was never manufactured in Canada, it was widely used in pest control products until the 1960s. In response to increasing environmental and safety concerns, most Canadian uses of DDT were phased out by the mid-1970s, and registration of all uses of DDT was discontinued in 1985, with the understanding that existing stocks would be sold, used, or disposed of by December 31, 1990. Since then, the sale or use of DDT in Canada is a violation of the Pest Control Products Act.
An Environment Canada review of DDT's physical and chemical properties, environmental fate, and toxicity concluded that DDT should be virtually eliminated from the environment.
|Tetrachlorobenzenes and pentachlorobenzene||April 24, 2004||Tetrachlorobenzenes and pentachlorobenzene are not produced or used in their pure form in Canada. They may be formed and released to the environment as a result of municipal solid waste and hazardous waste incineration and barrel burning of household waste, dielectric fluids, pesticides, wood preservative chemicals, magnesium production, and other potential minor sources.|
CEPA 1999 provides several authorities to require any person to provide or generate data for the purposes of assessing a substance or for deciding whether or how to control a substance. In 2004-05, information-gathering notices were published for:
- methyl bromide;
- perfluoroalkyl and fluoroalkyl substances; and
- PFOS, its salts, and its precursors.
As part of the release of a draft maximal list by Health Canada of almost 1900 substances identified from the health-related components of categorization, the department invited the submission of information relevant to priority setting for the health-related components of categorization under CEPA 1999 (see www.hc-sc.gc.ca/ewh-semt/contaminants/existsub/index_e.html).
The release of this draft maximal list during 2004–05 was intended to provide an opportunity for interested parties to submit data to justify reducing the number of substances on the final list to be considered for screening assessment under the Act. Health Canada invited stakeholders to provide information on the identity, use, or toxicity of any of the substances included on the draft maximal list.
Preventive or control instruments for each toxic substance or group of toxic substances are developed through the Toxics Management Process. The risk management actions are developed in a way that ensures that industry and public stakeholders are properly consulted and that the obligations to protect the environment and human health set out in CEPA 1999 are met. The cornerstone of the Toxics Management Process is the development of Risk Management Strategies. A Risk Management Strategy describes how the risks to human health and the environment from a substance will be addressed using a range of measures to control any aspect of the substance's life cycle. Examples of preventive or control instruments under the Act include regulations under Part 5, guidelines and codes of practice under Part 3, pollution prevention plans under Part 4, and environmental emergency plans under Part 8. Measures can also be taken under other federal acts or provincial, territorial, or Aboriginal legislation. Voluntary measures, such as Environmental Performance Agreements, may also be used.
Appendix A contains a list of the risk management measures proposed or finalized in 2004-05.
Provisions under CEPA 1999 support the virtual elimination of the release of substances recommended for addition to Schedule 1 that are persistent, bioaccumulative, present in the environment primarily as a result of human activity, and not naturally occurring.
Under the Act, the Ministers of the Environment and Health are required to establish a Virtual Elimination List for substances that meet the above criteria. For each substance added to the list, the Ministers must specify a level of quantification, which is the lowest concentration at which that substance can be measured using sensitive but routine sampling and analytical methods. The Ministers also must prescribe through regulation a limit on the quantity or concentration of the substance that may be released into the environment (known as the release limit). In addition to the Ministerial regulation authority, the substance may also be controlled by regulations or instruments under the Act approved by the Governor in Council and by other risk management tools.
HCBD is the first substance the Ministers have proposed (August 16, 2003) for addition to the Virtual Elimination List. In response to comments received from stakeholders regarding the level of quantification proposed for HCBD, Environment Canada conducted an interlaboratory study to confirm the method used to determine the level of quantification for the substance. The study, which required several months to complete, determined that the measurement of HCBD at the proposed level of quantification is achievable by other commercial and government laboratories using the same analytical method as that used by Environment Canada.
In 2004-05, the government published four final regulations under Part 5 of CEPA 1999:
- Regulations Amending the Ozone-depleting Substances Regulations, 1998 (finalized December 29, 2004) -- The regulations include a system of consumption allowances for hydrochlorofluorocarbons. The amendments will help stakeholders adapt to the 35% reduction in hydrochlorofluorocarbon consumption without compromising Canada's international commitments under the Montreal Protocol.
- Prohibition of Certain Toxic Substances Regulations, 2005 (registered on February 15, 2005; proposed on April 3, 2004, under Total, Partial or Conditional Prohibition of Certain Toxic Substances Regulations) -- These regulations prohibit the manufacture, use, sale, offer for sale, and import of certain toxic substances. Amendments restructured and replaced the Prohibition of Certain Toxic Substances Regulations, 2003. In addition to providing more targeted regulatory controls and facilitating the addition of new substances, the new regulations:
- identify prohibitions for three additional toxic substances (HCBD, N-nitrosodimethylamine [NDMA], and DDT);
- introduce new notification, reporting, and record-keeping requirements;
- create a permit system for granting temporary exemptions to prohibitions, where it is identified that a transition period will be required to find or implement alternatives;
- more tightly associate the limit established for the incidental presence of certain substances to products or mixtures where their presence has been detected and control decisions have been made; and
- assist Canada in meeting its international obligations under the Stockholm Convention on Persistent Organic Pollutants.
- The Off-Road Compression-Ignition Engine Emission Regulations (published February 23, 2005) -- The regulations address emissions from a wide range of new off-road diesel engines powering industrial, forestry, agricultural, construction, and mining equipment and will apply to engines of the 2006 and later model years.
- Regulations Amending the Benzene in Gasoline Regulations (Miscellaneous Program) (finalized December 1, 2004) -- The regulations correct inconsistencies between French and English versions of the regulations.
In 2004-05, three proposed regulations were published for comment:
- Chromium Electroplating, Chromium Anodizing and Reverse Etching Regulations (proposed November 6, 2004) -- The purpose of the proposed regulations is to protect the environment and the health of Canadians by reducing air emissions of hexavalent chromium compounds from facilities using chromic acid in their chromium electroplating, chromium anodizing, or reverse etching operations.
- Regulations Amending the Vinyl Chloride Release Regulations, 1992 (proposed April 3, 2004) -- The proposed regulations are mostly of an administrative nature; they clarify the current regulations and achieve consistency between the English and French versions of the regulations.
- Regulations Amending the Sulphur in Diesel Fuel Regulations (proposed October 2, 2004) -- The purpose of the proposed regulations is to reduce harmful emissions from diesel- powered engines and equipment used in off-road, rail, and marine applications. The regulations will establish limits for sulphur levels in diesel fuel produced, imported, or sold for these uses.
Extended producer responsibility is an excellent example of how innovative risk management measures are being developed as a result of the work performed under the Toxics Management Process. The concept of extended producer responsibility urges manufacturers to recover and manage their products in an environmentally sound manner when consumers are finished using them. It has already been used to target a broad and growing range of post-consumer products in Canada, including used oil, scrap tires, refrigerants, paints, and pesticides. In March 2004, Environment Canada co-hosted Canada's Third National Workshop on Extended Producer Responsibility and an OECD Experts Workshop on Evaluating the Costs and Benefits of Extended Producer Responsibility. Environment Canada also remains engaged in activities with provinces, territories, industry, and other stakeholders to help foster regional and national approaches that require extended producer responsibility for electronic devices, including computers and televisions.
In 2003, a Memorandum of Understanding was signed between Environment Canada and the Canadian Nuclear Safety Commission, which lays out principles and protocols on matters of mutual interest respecting the environment.
In December 2004, an Annex to the Memorandum of Understanding was developed to manage the risk to the environment associated with radionuclides. Following a Priority Substances List assessment, releases of uranium and uranium compounds contained in effluent from uranium mines and mills were found to meet the criteria of section 64 of CEPA 1999. Under the Nuclear Safety and Control Act, the Commission has the mandate to ensure that the operation of nuclear facilities, such as uranium mines and mills, does not pose unreasonable risks to the environment. The Nuclear Safety and Control Act provides a broad range of regulatory powers respecting environmental protection. Recognizing the mandate of the Commission and to avoid regulatory duplication, the Ministers of the Environment and Health have recommended that they take no further action with respect to radionuclides at this time under CEPA 1999. The Annex to the Memorandum of Understanding sets out a cooperative process to develop risk management measures under the Nuclear Safety and Control Act.
Substances that are not on the Domestic Substances List are considered to be new to Canada. A new substance 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 the Minister of the Environment to intervene by designing a risk management process, placing restrictions on the substance, or prohibiting the substance from import or manufacture in Canada.
When the Ministers of the Environment and Health 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, they can issue a Significant New Activity Notice to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import, or use the substance for activities not specified by the notice. The additional information allows Environment Canada and Health Canada to assess the potential environmental and human health risks associated with 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 2004-05, 794 new substance notifications were received pursuant to the New Substances Notification Regulations. Environment Canada received 689 notifications for substances regulated under CEPA 1999, and Health Canada received 105 notifications for products regulated under the Food and Drugs Act.
Canada Gazette publication date*
|1,1'-(1,2-Ethanediyl)-bis-[pentabromobenzene]||Import the substance for use only as a flame retardant additive in wire and cable coatings for the telecommunications, electrical, power, and automotive industries||October 2, 2004|
|Indanedioxa||Import or manufacture the substance for use only as a fragrance ingredient||September 4, 2004|
|Perfluoroalkyl-hydroxyaminoazetidinium polymer||Importation or manufacture of the substance is prohibited||February 7, 2005|
|Stannane, tetrabutyl||Import the substance for use only as a component of stabilizers for rigid poly(vinyl chloride)||March 19, 2005|
|Stannane, tetraoctyl||Import the substance for use only as a component of stabilizers for rigid poly(vinyl chloride)||March 19, 2005|
|Stannane, chlorotrioctyl||Import the substance for use only as a component of stabilizers for rigid poly(vinyl chloride)||March 19, 2005|
|Phosphoric acid, mixed polyoxyalkylene aryl and alkyl esters||Import the substance for use only as a component of a petroleum gelling agent formulation, intended only for use in fracturing and testing of oil and gas wells and associated pipelines||February 26, 2005|
|2-Propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate||Import or manufacture of the substance is prohibited||July 19, 2004|
|Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethylpoly(difluoromethylene), alkylbranched alcohols and 1-alkanol||Import or manufacture of the substance is prohibited||July 19, 2004|
|2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and unsaturated anhydride, perfluoroalkyl esters, tert-Bu benzenecarboperoxoate-initiated||Import or manufacture of the substance is prohibited||July 19, 2004|
Significant new activity
Canada Gazette publication date*
|1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters (SNAN 13 283)||Any new activity other than importing it for use as a plasticizer in polyurethane adhesives for automotive glass bonding||October 2, 2004|
|Benzeneacetic acid, α-oxo-, 2-(2-hydroxyethoxy)ethyl ester (SNAN 13 029)||Any new activity other than using it as a component of a photoinitiator for use in industrially applied radiation cured coatings||October 9, 2004|
|Benzeneacetic acid, α-oxo-, oxydi-2-1-ethanediyl ester (SNAN 13 028)||Any new activity other than using it as a component of a photoinitiator for use in industrially applied radiation cured coatings||October 9, 2004|
|Siloxanes and silicones, 3-[(2-aminoethyl)amino]-2-methylpropyl Me, di-Me, reaction products with N,N,N-trimethyloxiranemethanaminium chloride (SNAN EAU-135)||Any use in personal care products at final concentrations greater than 4%||November 13, 2004|
|Octanethioic acid, S-[3-(triethoxysilyl)propyl] ester (SNAN 13 247)||Any new activity other than manufacturing, importing, using, or distributing it exclusively as a raw material in industrial operations in the manufacture of cured rubber articles||November 27, 2004|
|Acetamide, N-[5-[bis(2-methoxyethyl)amino]-2-[(5-nitro-2,1-benzisothiazol-3-yl) azo]phenyl]-, (SNAN 9396)||Any new activity other than using it for the dyeing of polyester and modified polyester using batch dyeing techniques||December 18, 2004|
|Oxirane, methyl-, polymer with oxirane, monoalkyl ether, (SNAN 13 475)||Any use as a component in personal care products||January 8, 2005|
|Quaternary amide, polymer with 2-propenoic acid, sodium salt, reaction products with disodium (disulfite) (SNAN 12 881)||Any new activity other than importing it or manufacturing it for use in industrial, commercial, or consumer general purpose cleaners or detergents||September 25, 2004|
|Oxirane, methyl-, polymer with oxirane, monoalkyl ether (SNAN 13 476)||Any new activity other than use as a component in personal care products||January 8, 2005|
|Isooctadecanoic acid, reaction products with tetraethylenepentamine, compounds with di-Bu phosphonate-2,2'-dithiobis[ethanol]alkyl substituted alcohol reaction products, 2,2'-iminobis[ethanol], [N-[3-(C16-18-alkyloxy)propyl]] derivatives and 4(or 5)-methyl-1H-benzotriazol, (SNAN 13 424)||Any new activity other than importing it for use in power transmission fluids||February 26, 2005|
On October 30, 2004, four proposed regulations or regulatory amendments were published in Canada Gazette, Part I:
- New Substances Notification Regulations (Chemicals and Polymers) (proposed October 30, 2004) -- The proposed regulations are the culmination of extensive stakeholder consultation on the chemicals and polymers portion of the existing New Substances Notification Regulations and the New Substances Program. The proposed regulations implement consensus-based recommendations from the new substances notification multistakeholder consultative process. This process used the experience of stakeholders to suggest improvement to the effectiveness and efficiency of the new substances notification and assessment process for chemicals and polymers, while maintaining high standards for the protection of the environment and human health.
- New Substances Notification Regulations (Organisms) (proposed October 30, 2004) -- The purpose of the proposed regulations is to implement part of a new regulatory structure for new substances notification under CEPA 1999. The proposed regulatory structure carves out the provisions related to organisms from the provisions related to chemicals and polymers in the existing New Substances Notification Regulations.
- Regulations Repealing the New Substances Notification Regulations (proposed October 30, 2004) -- These regulations would repeal the existing regulations, which would be replaced with the above-noted, proposed regulations for chemicals and polymers and organisms.
- Regulations Amending the New Substances Fees Regulations (proposed October 30, 2004) -- The proposed regulations are necessary to harmonize theNew Substances Fees Regulations with the proposed New Substances Notification Regulations (Chemicals and Polymers).The pre-publication was followed by a 75-day public review period during which five sets of written comments were received: four submissions from industry and industry associations and one from an environmental group. The proposed regulations received wide support and positive feedback.
Health Canada continued its activities to develop and establish an Environmental Assessment Regulatory Framework for new substances in products regulated under the Food and Drugs Act. These activities included progress towards the development of an Options Analysis Paper and a path forward that included a public release of the paper in 2005-06 and consultations with stakeholders on the options outlined in the paper.
Substances listed under the Food and Drugs Act are eligible to be added to the Domestic Substances List provided that the Minister of the Environment 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.
During the reporting period, 121 substances were added to the Domestic Substances List.
In 2004-05, a strategic plan relating to international regulatory and scientific cooperation was completed. In this strategy, Canada will work with other countries to find common ways of doing business that will improve decision-making about new chemicals and polymers in Canada and internationally while continuing to protect human health and the environment.
The Four Corners Arrangement was revised in November 2003 and signed in January 2004 by Environment Canada, Health Canada, the U.S. Environmental Protection Agency, the American Chemistry 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, by avoiding duplication of efforts associated with assessments through enhanced information and work sharing, without compromising the protection of human health and the environment. Four notifications were received under the Four Corners Arrangement in 2004-05.
The Cooperative Arrangement on New Industrial Chemicals 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 potential alignment of national new industrial chemicals schemes. The arrangement has been renewed and continues to support information exchange in technical, regulatory, and policy areas. Canada has been recognized under the foreign schemes provision of the Australian legislation as a competent authority in new substances.
In 2004-05, 18 notification requests were received under the arrangement. Canada and Australia continue to work on comparing assessment approaches and methodologies for chemicals and polymers.
The OECD New Chemicals Task Force was established to improve information and work sharing associated with notification and assessment of new industrial chemicals.
A Steering Group was formed to lead the implementation of the pilot phase of the Parallel Process, which involves sharing hazard assessments between jurisdictions. The pilot phase is expected to be finalized by the end of 2006. Representatives of the Steering Group include Australia, Canada (Chair), Japan, the United States, and the Business and Industry Advisory Committee. The Steering Group met in March 2005 and presented the outcome of this meeting at the New Chemicals Task Force meeting in April 2005. The Steering Group identified the following tasks:
- development of a hazard assessment template;
- application of Robust Study Summary templates; and
- addressing elements of the Predetermined Set of Information, which would be based on the OECD's Minimum Pre-Marketing Set of Data for new chemicals.
During 2004-05, the New Substances Program also worked with the OECD and the U.S. Environmental Protection Agency, to advance the Mutual Acceptance of Notifications initiative. The duplication of efforts and differences in national notifications and assessment schemes were the motivating factors for the emergence of this initiative. The main objectives of this initiative are to:
- reduce the burden and costs for governments and industry;
- improve efficiency; and
- increase collaboration expertise in order to harmonize assessment approaches among the member countries.
The OECD's principles of good laboratory practice set out managerial concepts covering the organization of test facilities and the conditions under which pre-clinical 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 2004-05, work on the New Substance Notification Good Laboratory Practice compliance monitoring program included:
- providing technical advice during the revision of good laboratory practice aspects of the New Substances Notification Regulations;
- representing Environment Canada on the OECD's Steering and Working Groups on Good Laboratory Practices; and
- providing information on data quality to new substances evaluators.
The revised regulations will require that biotic studies be good laboratory practice-compliant and that all other studies be consistent with the principles of good laboratory practice.
The authorities in the Act allow the Minister to establish an Export Control List containing substances whose export is controlled because their manufacture, import, or use in Canada is prohibited or severely restricted or because Canada has agreed, 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 2004-05, 13 notifications of export were received, and no additional substances were added to the Export Control List.
Canada implements the provisions of the Rotterdam Convention (Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade) through the Export of Substances Under the Rotterdam Convention Regulations. The main purpose of the regulations is to ensure that chemicals and pesticides subject to the Prior Informed Consent (PIC) procedure are not exported to Parties to the Convention, unless the importing Party has provided its "prior informed consent" to the shipment. Canada has also undertaken to ensure that Canadian exporters respect any conditions imposed on the importation of these substances.
Consultations on the proposed addition of tetraethyl lead, tetramethyl lead, and chrysotile asbestos to the PIC procedure were conducted in 2004-05.
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