5. Controlling toxic substances

The Canadian Environmental Protection Act, 1999 (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:

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:

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.

5.1.1.1 Categorization and screening of the Domestic Substances List

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.

Categorization

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:

Screening assessments

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:

5.1.1.2 Decisions of other jurisdictions

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.

www.ec.gc.ca/substances/ese/eng/sect75.cfm

5.1.1.3 First Priority Substances List

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:

Table 4: Status of first Priority Substances List assessments during 2004-05
Status
Substances
Recommended for addition to Schedule 1 and candidates for virtual elimination Pentachlorobenzene
Tetrachlorobenzenes
No further action recommended 1,2-Dichlorobenzene
1,4-Dichlorobenzene
Trichlorobenzenes
Bis (2-chloroethyl) ether (proposed)
3,5-Dimethylaniline (proposed)
Ongoing follow-up assessments Aniline
Chlorinated paraffins
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.

5.1.1.4 Second Priority Substances List

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).

Table 5: Status of second Priority Substances List assessments during 2004-05
Status
Substances
Recommended for addition to Schedule 1 2-Butoxyethanol
2-Methoxyethanol
No further action recommended Releases of radionuclides from nuclear facilities (impact on non-human biota)
Not meeting the criteria under section 64 Butylbenzylphthalate
Carbon disulfide
Chloroform
N,N-Dimethylformamide
Phenol

Health Canada's work on aluminum salts and ethylene glycol in 2004-05 included the following:

5.1.1.5 The addition of substances to Schedule 1 of CEPA 1999

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.

Table 6: Substances added to or being considered for addition to the List of Toxic Substances (Schedule 1) in 2004-05
Substance
Proposed Order adding to Schedule 1 - date
Final Order adding to Schedule 1 - date
Sectors/sources involved
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.
5.1.1.6 Information gathering

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:

Notices

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.

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.

5.1.2.1 Virtual elimination

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.

hexachlorobutadiene (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.

5.1.2.2 Regulations

In 2004-05, the government published four final regulations under Part 5 of CEPA 1999:

In 2004-05, three proposed regulations were published for comment:

Regulations

5.1.2.3 Extended producer responsibility and stewardship

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.

5.1.2.4 Memorandum of Understanding

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.

www.ec.gc.ca/Toxics/docs/substances/RN/EN/mou.cfm

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:

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.

5.2.2.1 Notifications

Of the total 794 notifications received, Environment Canada issued 6 conditions, 4 prohibitions, and 10 Significant New Activity Notices (see Tables 7 and 8).

www.ec.gc.ca/substances/nsb/eng/pub_e.htm

Table 7: Notices of Ministerial Conditions and Prohibitions issued during 2004-05
Substance
Conditions/prohibitions
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

* The publication date informs when the Ministerial Condition and Prohibitions took effect.

Table 8: Significant new activity notices published during 2004-05
Substance
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

* As of this date, the Significant New Activity Notice will only allow importation, manufacture, and use of the substance for the activities proposed in the table.

5.2.2.2 Regulations Regarding New Substances

On October 30, 2004, four proposed regulations or regulatory amendments were published in Canada Gazette, Part I:

Regulations

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.

In Commerce sub-lists of Food and Drugs Act substances

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.

5.2.4.1 Four Corners arrangement

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.

5.2.4.2 Canada-Australia arrangement

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.

5.2.4.3 New Chemicals Task Force

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:

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:

5.2.4.4 Good Laboratory Practice

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:

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.

www.etc-cte.ec.gc.ca/organization/spd_e.html

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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