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ARCHIVED - CEPA Annual Report for Period April 2005 to March 2006

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:

  • 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. The Canadian Environmental Protection Act, 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.

5.1 Existing Substances

5.1.1 Risk Assessment

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 the Canadian Environmental Protection Act, 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 assessment as potential risks within Canada.

5.1.1.1 Categorization and Screening of the Domestic Substances List

During 2005-06, 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 was 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 to 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 the Canadian Environmental Protection Act, 1999 is providing a wealth of additional scientific benefits that will advance our understanding of substances around the world.

During 2005-06 Environment Canada and Health Canada continued to engage stakeholders from industry, environmental groups, and the public, soliciting input for categorization decisions and approaches. Industries play an important role by sharing the information 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 assessment of these chemicals. The environmental community is monitoring the process and lending its own expertise to the consultation process.

Results under the categorization exercise in 2005-06 include the following:

  • Draft Decisions for Ecological Categorization of Substances on the Domestic Substances List (in July 2006)
  • At the end of the reporting period, Environment Canada had collected, generated and reviewed the available information and produced categorization decisions for all the substances on the Domestic Substances List. Draft final categorization decisions were issued in July 2006. The categorization exercise has been completed as mandated.
  • Environment Canada produced CD-ROMs in April 2005, July 2005, October 2005 and January 2006 that contain:
    • background material on the progress of categorization;
    • Guidance Manual for the Ecological Categorization of Organic and Inorganic 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.

The health aspects of the categorization of the Domestic Substances List were completed by the end of fiscal year 2005-06. Documentation associated with completion of the health-related components of Domestic Substances List categorization was produced.

Screening Assessments

Environment Canada and Health Canada conducted several screening assessments to refine their screening assessment approaches and processes. Progress in this area during 2005-06 includes:

  • Screening health assessments for polybrominated diphenyl ethers and perfluorooctane sulfonate were completed and published in the Canada Gazette in early 2006. Draft State of the Science reports on nine substances - hexachloroethane; 4,6-dinitro-o-cresol; phenol, 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methyl- (MBMBP); ethylbenzene, dibromoethane, dichloroethene, quinoline, biphenyl; and 4,4'-Methylenebis(2-chlorobenzenamine) (MBOCA) - were published on the Health Canada Web site.
Table 3: Substances Undergoing Screening Assessments
CAS NumberSubstance Name
534-52-1DNOC
91-22-5Quinoline
119-47-1MBMBP
92-52-4Biphenyl
75-35-4Dichloroethene
67-72-1Hexachloroethane
106-93-41,2,dibromoethane
101-14-4MBOCA
100-41-4Ethylbenzene
67-64-1Acetone
7783-06-4H2S
79-94-7; 25327-89-3; 4162-45-2TBBPA
GroupPFOA and its salts
GroupPolychlorinated naphthalenes
74-85-1Ethene
115-07-11-propene
3194-55-6HBCDD

 

5.1.1.2 Decisions of Other Jurisdictions

The recommended approach for the exchange of information with member countries of the Organisation for Economic Co-operation and Development regarding substances that are prohibited or substantially restricted was issued for public comments.

5.1.1.3 First Priority Substances List

Under the 1988 Canadian Environmental Protection Act, 44 substances were assessed under the program of the first Priority Substances List. Of 44 substances, 27 were found to meet the requirements of section 11 of the original Canadian Environmental Protection Act, and 10 did not. There has been insufficient information to conclude on the remaining substances.

In 2005-06, the follow-up assessment for chlorinated paraffins was published for a 60-day public comment period on June 11, 2005. It was proposed that these substances be added to the List of Toxic Substances with the goal of virtually eliminating short-chain and medium-chain chlorinated paraffins (see Table 4).

In 2005-06 the Minister of Environment also published final orders for pentachlorobenzene and tetrachlorobenzenes. The Ministers of Environment and Health concluded that these substances met the criteria set out in section 64 and have proposed adding these substances to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999. These substances were also to be considered as candidates for virtual elimination.

Work on an assessment of aniline, an "Insufficient to Conclude" substance on the first Priority Substances List, was initiated based on a re-evaluation of the exposure assessment information in the first Priority Substances List assessment.

Table 4: Status of First Priority Substances List Assessments in 2005-06
StatusSubstances
Recommended for addition to Schedule 1Chlorinated paraffins
No further action recommendedUsed crankcase oils
Ongoing follow-up assessmentsAniline

 

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.

Based on information provided by industry, Health Canada initiated a report on ethylene glycol.

Health Canada continued to liaise with industrial stakeholders on the status of the suspended second Priority Substances List assessment of aluminum salts. Discussions were held on options for modifying draft protocols developed by the industrial stakeholders for the neurotoxicity studies required for completion of the second Priority Substance List assessment.

Table 5: Status of Second Priority Substances List Assessments in 2005-06
StatusSubstances
Recommended for addition to Schedule 1None
No further action recommendedReleases of radionuclides from nuclear facilities (impact on non-human biota)

 

5.1.1.5 Addition of Substances to Schedule 1

When a substance is assessed and determined to meet the criteria of section 64, one of the measures the Ministers of Environment and Health may propose is its addition to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999. The Canadian Environmental Protection Act, 1999gives the federal government the authority to make regulations or require the preparation of pollution prevention plans or environmental emergency plans for substances in Schedule 1.

Six greenhouse gases were added to Schedule 1 of the Canadian Environmental Protection Act, 1999.

5.1.1.6 Information Gathering

The Canadian Environmental Protection Act, 1999 provides several authorities to require any person to provide or generate data for the purpose of assessing a substance or for deciding whether or how to control a substance.

Notices

An information-gathering Notice with respect to Selected Substances Identified as Priority for Action was published in the Canada Gazette on March 4, 2006. This notice required companies who manufactured or imported more than 100 kilograms of listed substances to provide information on their activities. Substances covered by this notice have been identified, through categorization of the Domestic Substances List, as potentially hazardous to the environment or human health or as representing the greatest potential for human exposure or as substances of emerging concern and international interest.

Preliminary research has indicated that a high percentage of these substances may no longer be manufactured or imported in Canada. One of the goals of the survey is to identify substances that were not commercially available during the 2005 calendar year. Confirmation of those substances not currently marketed in Canada will allow government to ensure that post-categorization efforts are focused on substances with potential for release into the Canadian environment.

The second major goal is to identify companies whose current activities involve any of these substances for purposes of gathering, where necessary, more detailed information on patterns of use, for example, in order to prioritize future assessment and/or risk management activities. Future detailed data collection regarding these substances will be designed in consideration of the level of activity or sector identified in the responses to the Notice.

The information gathered pursuant to the Notice will be used, along with other data sources, to inform current and future risk assessment and risk management activities conducted under the Canadian Environmental Protection Act, 1999.

An information-gathering Notice with respect to certain hydrofluorocarbons was published on April 16, 2005, with an amendment being published on May 21, 2005.

Health Canada responded to information and inquiries regarding the maximal list of substances that were prioritized for consideration in screening assessment under the Canadian Environmental Protection Act, 1999.

Table 6: Substances Added to or Being Considered for Addition to the List of Toxic Substances (Schedule 1) in 2005-06
SubstanceProposed Order Adding to Schedule 1 - DateFinal Order Adding to Schedule 1 - DateSectors/Sources Involved

Carbon dioxide, which has the molecular formula CO2

Methane, which has the molecular formula CH4

Nitrous oxide, which has the molecular formula N2O

Hydrofluorocarbons that have the molecular formula CnHxF(2n+2-x) in which 0

The following perfluorocarbons: (a)those that have the molecular formula CnF2n+2 in which 04F8

Sulphur hexafluoride, which has the molecular formula SF6

September 3, 2005November 21, 2005Carbon dioxide, methane and nitrous oxide are produced from a wide variety of sectors and sources. The fluoroalkanes are used in a wide range of industrial, commercial and even medical applications, including use as refrigerants, propellants and solvents.
MethaneSeptember 3, 2005November 21, 2005These six substances or groups of substances were included in the Kyoto Protocol because they have significant global warming potentials (GWPs), are long-lived and therefore of global concern. Furthermore, given historical emissions from anthropogenic sources, and the quantity of emissions expected over the next century, they have the potential to contribute substantially to climate change.
Carbon dioxideSeptember 3, 2005November 21, 2005
Nitrous oxideSeptember 3, 2005November 21, 2005
HydrofluorocarbonsSeptember 3, 2005November 21, 2005
Some perfluorocarbons and octafluorocyclobutaneSeptember 3, 2005November 21, 2005
Sulphur hexafluorideSeptember 3, 2005November 21, 2005
Tetrachlorobenzenes and pentachlorobenzeneApril 24, 2004September 21, 2005Tetrachlorobenzenes and pentaclorobenzene 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 productions and other potential minor sources.
Chlorinated paraffinsJune 11, 2005  
Polybrominated diphenyl ethersJuly 1, 2006  
Perfluorooctane sulfonate (PFOS), its salts and its precursors, compounds that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2NJuly 1, 2006  

 

5.1.2 Risk Management

The Canadian Environmental Protection Act, 1999 sets specific timelines for taking preventive or control actions to manage the risks posed by substances on Schedule 1. 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 the Canadian Environmental Protection Act, 1999 are met. The cornerstone of the Toxics Management Process is the development of Risk Management Strategies. Risk Management Strategies detail how the risks to human health and the environment will be addressed using a range of measures to control any aspect of a 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 2005-06.

5.1.2.1 Regulations

In 2005-06, the following final regulation was published under Part 5 of the Canadian Environmental Protection Act, 1999:

  • Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations (finalized June 1, 2005, proposed March 20, 2004). The purpose of these Regulations is to protect Canada's environment and the health of Canadians from the risks posed by the transboundary movement of hazardous wastes and hazardous recyclable materials and to implement Canada's international obligations. The Regulations revoke and replace the former Export and Import of Hazardous Wastes Regulationsadopted in 1992 under the authority of the former Canadian Environmental Protection Act.

In 2005-06, two proposed regulations were published for comment:

  • Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2005 (2-Methoxyethanol, Pentachlorobenzene and Tetrachlorobenzenes) (proposed July 9, 2005). This amendment will add 2-methoxyethanol, pentachlorobenzene and tetrachlorobenzenes to the Prohibited Toxic Substances List in Schedule 2, Parts 1 and 2, of theProhibition of Certain Toxic Substances Regulations, 2005.
  • Regulations Respecting 2-Butoxyethanol (proposed July 9, 2005). The purpose of the proposed Regulations is to protect the health of Canadians by setting limits for the concentration of 2-butoxyethanol in products designed for indoor use. This will reduce human exposure to 2-butoxyethanol present in cleaning, painting and coating products. The proposed concentration limits will apply to products that are manufactured, imported, offered for sale, sold or used in Canada.
5.1.2.2 Greenhouse Gas Notice of Intent

A proposed regulatory framework for Greenhouse Gas emissions from industrial sectors was developed in a Notice of Intent to Regulate, published in the Canada Gazette, Part I, on July 16, 2005.

  • Detailed discussions were undertaken with individual sectors to define emission intensity targets to be set out in sectoral regulations.
  • A draft of the cross-cutting provisions for the proposed regulations was developed and released for consultation.
  • Development of a proposed single-window quantification and reporting system was pursued in collaboration with provinces and stakeholders.
  • A proposed design for the offset crediting system was published and national consultations were conducted.
  • Draft rules and guidance for offset program elements were developed, and drafting of quantification protocols for a number of key project types was initiated in collaboration with provinces and stakeholders.
5.1.2.3 Extended Producer Responsibility and Stewardship

Extended Producer Responsibility is a concept under which producers and brand owners of products are required or in some cases volunteer to take the financial and operational responsibility to recover and manage their products in an environmentally sound manner when consumers are finished using them. It has 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 2006, in Calgary, Environment Canada co-hosted, with Alberta Environment, Canada's 4th National Workshop on Extended Producer Responsibility. Through its leadership of a national committee on electronics waste, Environment Canada also remains engaged in activities with provinces, territories, industry, and other stakeholders to help foster consistent regional and national Extended Producer Responsibility approaches for a variety of electronic devices, including computers and televisions. Environment Canada also participates in the Canadian Council of Ministers of the Environment's Extended Producer Responsibility Task Group, which has a mandate to develop supportive tools and guidance for the application of Extended Producer Responsibility programs across the country.

5.1.2.4 Memoranda of Understanding and Environmental Performance Agreements

An Environmental Performance Agreement is a negotiated agreement with principles and design criteria that are negotiated among parties to achieve specified environmental results. Environmental Performance Agreements are second-generation, voluntary instruments that flow from Environment Canada's experience with Memoranda of Understanding with industrial sectors. The negotiation and implementation of Memoranda of Understanding during the 1990s provided Environment Canada with valuable experience and led to the development of a Policy Framework for Environmental Performance Agreements (June 2001).

Environmental Performance Agreement must consider specified core design criteria in the negotiating process. The Policy Framework provides assurance of transparency and accountability as well as a solid basis for negotiating agreements.

No new agreements were signed in 2005-06 as five were already in place.

  • Environmental Performance Agreement Respecting Refractory Ceramic Fiber. This agreement, signed in 2002 with six companies, applies to environmental emissions monitoring. The data collected under the monitoring program were used by health and environment specialists to better evaluate the risks associated with this substance. Based on the information collected in the 2002 Environmental Performance Agreement, this agreement was re-negotiated in 2004-05 (to be signed in fall 2006) to include additional processors of Refactory Ceramic Fiber, to continue the monitoring program and to implement an industry-wide product stewardship program.
  • Environmental Performance Agreement Respecting the Production and Distribution of 1,2-Dichloroethane.This agreement was signed with two Dow Chemical facilities in 2001 to manage emissions of 1,2-dichloroethane, a toxic substance under the Canadian Environmental Protection Act, 1999. As of 2004 Dow has reported release reductions of over 5,200 kg (37%) from base-year levels. The models and methods used to obtain these results were verified by an independent third-party audit.
  • Environmental Performance Agreement Automotive Parts Manufacturers' Association. This agreement was signed in 2002 by the Automotive Parts Manufacturers' Association, Environment Canada, and Industry Canada and is due to expire in December of 2007. The Environmental Performance Agreement focuses on sector-wide targets to reduce substances like volatile organic compounds, smog precursors and greenhouse gases, metals and substances listed on Schedule 1 of the Canadian Environmental Protection Act, 1999. Currently, there are 38 facilities among five companies participating in the Automotive Parts Manufacturers' Association Environmental Performance Agreement. The Automotive Parts Manufacturers' Association committed to an aggregate 20% reduction per unit of output of volatile organic compounds emissions from the participating Ontario-based companies, and an aggregate 3% reduction in carbon dioxide emissions per unit of output from all participating companies (based on a year 2000 baseline).
  • Environmental Performance Agreement with Specialty Graphic Imaging Association. This agreement was signed in 2003 and it provides an opportunity for screen and digital printers in the Greater Toronto Area to implement activities to reduce releases of volatile organic compounds and other substances of concern. Twelve companies are actively engaged and achieving significant reductions. Technograph completely eliminated the use of methylene chloride; North American Decal decreased solid waste (film, fluorescent lamps, plastics, paper products and skids) sent to landfills by over 11%, despite an increase in sales and in the volume of printing completed; Ellis Studios reduced volatile organic compounds emissions by more than 93% by converting to ultra violet technology. Further, North American Decal is in the process of converting its facility to using ultra violet technology and will soon be realizing significant reductions in volatile organic compounds emissions.
  • Memorandum of Understanding with the Canadian Chemical Producers' Association. This agreement is a renewal of the previous Memorandum of Understanding with the Canadian Chemical Producers' Association. It was signed in 2001 by Health Canada, Industry Canada, Environment Canada, Ontario Ministry of the Environment, Alberta Ministry of the Environment and the Canadian Chemical Producers' Association. The objective of this Memorandum of Understanding is the prevention and reduction of the release of toxic and other chemical substances through voluntary, non-regulatory action by encouraging and publicly recognizing progress made by Canadian Chemical Producers' Association and its member companies. Included in this agreement is an annex committing member companies to reduce their releases volatile organic compounds. This agreement expired in 2005, and is currently being re-negotiated.

5.2 New Substances

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 significant quantities 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 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.

The Canadian Environmental Protection Act, 1999 Part 5 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.

5.2.1 Risk Assessment of New Substances

During 2005-06, 550 new substance notifications were received pursuant to the New Substances Notification Regulations.Environment Canada received 455 notifications for substances regulated under Canadian Environmental Protection Act, 1999 and Health Canada received 95 notifications for products regulated under the Food and Drugs Act.

5.2.1.1 Notifications

Of the total 550 notifications it received, Environment Canada issued two conditions and no prohibitions, rescinded three conditions related to some of these substances (see Table 8), and published 10 Significant New Activity notices (see Table 7).

Table 7: Risk Management of New Substances
Part 5 of CEPA - New Substances Statistics: Significant New Activity (SNAc) Notices Published in 2005-06
Substance NameChemical, Polymer or OrganismActionCanada Gazette Publication Date
Propane, 1,1,1,3,3-pentafluoro-chemicalSNAc4-Jun-05
Clarified oils (petroleum), catalytic cracked, reaction products with cresol and polymethylene polyphenylene isocyanatepolymerSNAc18-Jun-05
Formamide, N-ethenyl-chemicalSNAc25-Jun-05
DifluoromethanechemicalSNAc26-Nov-05
Alkanethioic acid, S-[3-(triethoxysilyl)propyl] ester, reaction products with 2-methyl-alkanediolchemicalSNAc17-Dec-05
Alkanethioic acid, S-[3-(triethoxysilyl)propyl] ester, hydrolysis products with 2-methyl-alkanediolchemicalSNAc17-Dec-05
Silane, triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)-chemicalSNAc28-Jan-06
Propane,
1,1,1,3,3-pentafluoro-,
chemicalRescinded SNAc
New SNAc
18-Feb-06
18-Feb-06
Benzenesulfonic acid, 4-[[4-[(4-hydroxy-2- methylphenyl)azo]phenyl]amino]-3-nitro-, monosodium saltchemicalSNAc11-Mar-06

Table 8: Notices of Ministerial Conditions and Prohibitions in 2005-06
Part 5 of CEPA - New Substances Statistics: Notices of Ministerial Conditions and Prohibitions Issued in 2005-06
Substance NameChemical, Polymer or OrganismActionCanada Gazette Publication Date
Piperidine, 1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6- tetramethyl-ChemicalModification to condition9-Apr-05
Benzene, 1,1ó-(1-methylethylidene)bis[3,5-dibromo-4-(2,3- dibromopropoxy)-ChemicalModification to condition30-Apr-05
Alphatic, aromatic unsaturated bicyclic derivativeChemicalCondition13-Aug-05
Phosphorous acid, mixed 4-isononylphenyl and lauryl and tridecyl triestersChemicalCondition15-Oct-05
DifluoromethaneChemicalRescinded condition26-Nov-05
Propane, 1,1,1,3,3-pentafluoro-ChemicalRescinded two conditions18-Feb-06

 

5.2.1.2 Regulations Regarding New Substances

On September 21, 2005, four proposed regulations or regulatory amendments were published in the Canada Gazette, Part II, and came into force on October 30, 2005:

New Substances Notification Regulations (Chemicals and Polymers) (pre-published on October 30, 2004).The 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 regulations implement consensus-based recommendations from the new substances notification multi-stakeholder 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) (pre-published on October 30, 2004). The purpose of these regulations is to implement part of a new regulatory structure for new substances notifications under the Canadian Environmental Protection Act, 1999. The 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 (pre-published on October 30, 2004). These regulations repealed the existing regulations, which were replaced with the above-noted regulations for chemicals and polymers and organisms.

Regulations Amending the New Substances Fees Regulations (pre-published on October 30, 2004). The amendments harmonize the New Substances Fees Regulationswith the New Substances Notification Regulations (Chemicals and Polymers).

The pre-publication of all these regulations 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.

Health Canada, in collaboration with Environment Canada, developed and released the Options Analysis Paper: An Environmental Assessment Regime for New Substances in Products Regulated under the Food and Drugs Act. The Options Analysis Paper was released in June 2005 and an electronic consultation proceeded with comments from all stakeholders requested for September 2005.

The comments from stakeholders on the options presented in the Options Analysis Paper were analysed to produce the Options Analysis Paper Feedback Analysis Report, which was released in February 2006.

To proceed with the development of appropriate regulations for new substances contained in products regulated under the Food and Drugs Act, Health Canada hosted a multi-stakeholder consultation in March 2006. The major outcome of the consultation was that Health Canada should proceed with developing the regulations under the New Substances Provisions of the Canadian Environmental Protection Act, 1999.

5.2.2 Additions to the Domestic

Substances List 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 no 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, 339 substances were added to the Domestic Substances List.

5.2.3 International Actions

In 2005-06 the New Substances Program continued its international regulatory and scientific cooperation. Canada worked with other countries to find common ways of doing business that will continue to improve decision-making on new chemicals and polymers in Canada and internationally, while protecting human health and the environment. Examples of this are the Organisation for Economic Co-operation and Development New Substances Task Force, Mutual Acceptance of Notifications ongoing project to standardize notification procedures for industry with Organisation for Economic Co-operation and Development countries. A table showing all international areas of cooperation and activities has been designed and made available on the New Substances Web site.

5.2.3.1 Four Corners Arrangement

The Four Corners Arrangement was revised in November 2003 and signed in January 2004 by Environment Canada, Health Canada, the United States Environmental Protection Agency, the American Chemical Council, and the Industry Coordinating Group of Canada. The overall objective of the revised arrangement is to work towards achieving efficiency of resources for all parties related to 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. One notification was received in 2005 under the Four Corners Arrangement. The Arrangement is under review by the New Substances Program to ascertain its benefits with other international activities.

5.2.3.2 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 exchanges 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 2005-06, 14 requests were made to share information with Australia under the Arrangement. Canada and Australia continue to work on comparing assessment approaches and methodologies for chemicals and polymers.

5.2.3.3 New Chemicals Task Force

The Organisation for Economic Co-operation and Development 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 2008. Representatives of the Steering Group include Australia, Canada (Chair), Japan, the United States, and the Business and Industry Advisory Committee to the Organisation for Economic Co-operation and Development.

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.
5.2.3.4 Good Laboratory Practice

The Organisation for Economic Co-operation and Development'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.

The revised regulations require that biotic studies be good-laboratory-practice compliant and that all other studies must be consistent with the principles of good laboratory practice.

5.3 Export of Substances

The authorities in the Act allow the Minister to establish an Export Control List containing substances whose export is controlled because their manufacture, import, and/or use in Canada are prohibited or severely restricted or because Canada has 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.

5.3.1 Export Control List

The Export Control List Notification Regulationsrequire 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 2005-06, 12 notifications of export were received, and no additional substances were added to the Export Control List.

5.3.2 Rotterdam Convention

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 procedure are not exported to parties to the Convention, unless the importing Party has provided its consent prior to the import taking place. Canada has also undertaken to ensure that Canadian exporters respect any conditions imposed on the importation of these substances.

In 2005-06, there were no consultations on the addition of substances to the Prior Informed Consent procedure.