5. Controlling toxic substances

There are currently about 23 000 substances manufactured in, imported into, or used in Canada on a commercial scale that have not been assessed for the risks they pose to human health or the environment. These substances are on the Domestic Substance List (DSL). The DSL distinguishes between substances that are assessed and managed under the Existing Substances Program, and those that are subject to the New Substances Program.

Existing substances are assessed in three ways. First, a screening level assessment must be conducted on all substances identified through categorization of the DSL. Second, the Ministers of Environment and Health are required to establish a Priority Substance List (PSL), which identifies substances to be assessed on a priority basis. Third, the Ministers must review the decisions of other OECD countries to ban or seriously restrict a substance for environmental or health reasons, and determine if the substance meets the definition of toxic under CEPA 1999. Canada is the only country in the world taking such a comprehensive approach to examining all substances in commerce.

The act requires the Ministers to categorize all 23 000 substances listed on the DSL by September 2006, identifying those substances that pose the greatest potential for human exposure in Canada that are persistent, bioaccumulative, and inherently toxic to human and non-human organisms. If a substance meets these criteria, then a screening-level risk assessment is required to determine whether the substance is toxic under the act.

Notable accomplishments in 2001-02 included the following:

In 2001-02, Environment Canada focused on developing tools to conduct screening-level ecological risk assessments, based on lessons learned from the PSL assessments. Work continued on the pilot project involving 123 organic substances. Final results from the pilot project will be used to refine the screening-level risk assessment methodology, the criteria for moving to a more thorough assessment, and the methodology for prioritizing substance assessments.

Health Canada continued to develop and refine the approach and criteria for decision-making for conducting screening-level risk assessments on substances identified through categorization of the DSL, by focusing on screening-level risk assessments on a number of high-production-volume chemicals as well as on specific classes of substances (groups of related substances that have a similar molecular structure) such as the polybrominated diphenyl ethers.

Health Canada continued to develop a screening-level risk assessment on those perfluoroalkyl substances on the DSL that are related to perfluorooctanylsulfonate. A health and environmental screening-level risk assessment on this group of compounds is expected to be released for public comment in 2002-03.

Categorization and screening of substances on the DSL

Figure 5-1 (see long description below)
Long description of Figure 5.1

There were 13 substances on the first Priority Substances List (PSL1) for which there was insufficient information to conclude on "toxicity" to the environment or human health. Seven of these substances required follow-up by Environment Canada, five required follow-up by Health Canada, and one substance required follow-up by both departments. Environment Canada and Health Canada addressed the data gaps for all of these assessments in 2000-01. In addition, chlorinated paraffins, also a PSL1 substance, is being re-evaluated by both Health Canada and Environment Canada. In 2001-02, the draft follow-up reports for 15 substances went through peer review. They will be released for public comment in 2002-03.

Of the 25 substances on the second Priority Substances List (PSL2), published in 1995, risk assessments on 23 subsances were completed by December 2000 within the five-year time frame prescribed under CEPA 1999. In 2001-02, five PSL substances were added to the List of Toxic Substances: PM10, acetaldehyde, acrolein, acrylonitrile, and 1,3-butadiene. Final Ministerial decisions were also published in the Canada Gazette indicating that eight additional PSL substances were determined to be toxic and were proposed to be added to the List of Toxic Substances: ammonia dissolved in water, textile mill effluents, nonylphenol and its ethoxylates, inorganic chloramines, road salts, ethylene oxide, formaldehyde, and n-nitrosodimethylamine. Work is progressing on the final reports for the remaining substances.

Two assessments (ethylene glycol and aluminum salts) were suspended in order to collect necessary data. Health Canada has initiated work with stakeholders and others to collect the necessary data that will permit completion of these assessments with respect to human health impacts.

Assessment of substances on the Priority Substances List

Figure 5-2 (see long description below)
Long description of Figure 5.2

Notices

The act requires that toxic substances be managed to minimize the risks they pose to the environment and human health. The most dangerous toxic substances (those that are found to be persistent, bioaccumulative inherently toxic and primarily the result of human activity) are targeted for virtual elimination.

The act imposes strict timelines for taking preventive or control action to manage the risks posed by toxic substances. For substances that have been determined to be toxic under section 77 (i.e., assessed as a result of the PSL, screening of the DSL, or review of another jurisdiction's decision), two years are allowed to develop a proposed instrument containing preventive or control measures, such as pollution prevention plans, regulations, or certain guidelines.

Once the proposed instrument is published, interested parties have 60 days to comment on the proposal or file a notice of objection and request the establishment of a board of review. The final instrument must be published within 18 months after the publication of the proposed instrument.

The act also imposes requirements for the virtual elimination of releases into the environment of substances that are persistent, bioaccumulative inherently toxic and that result primarily from human activity. Section 65 further requires the Ministers of Environment and Health to specify the level of quantification (LoQ) for each substance whose discharges to the environment are targeted for virtual elimination on a Virtual Elimination List.

The LoQ is the lowest concentration of a substance that can be accurately measured using sensitive but routine sampling and analytical methods. Table 2 summarizes the management tools that were under development in 2001-02. It should be noted that the tools include regulations under Part 5 of the Act as well as other parts of CEPA 1999, such as agreements under Part 2, guidelines and codes of practice under Part 3, P2 plans under Part 4, and regulations under Parts 7, 8, and 9.

Table 2: Management tools under development during 2001-02
Management tool Management tool: regulations Status
Regulations Amendments to the PCB Waste Export Regulations Under development
Regulations Contraventions Regulations (under the federal Contraventions Act) Finalized October 25, 2001
Regulations Disposal at Sea Regulations Finalized August 15, 2001
Regulations Environmental Emergencies Regulations Under development
Regulations Export of Substances under the Rotterdam Convention Under development
Regulations Federal Halocarbon Regulations, 2002 Finalized August 28, 2002
Regulations Federal Hazardous Waste Regulations Instructions given to Justice Canada for the drafting of the proposed regulation - February 2002
Regulations Federal Petroleum Products and Allied Petroleum Products Storage Tank Systems Regulations Under development
Regulations Interprovincial Movement of Hazardous Waste Regulations Under development
Regulations New Substances Fees Regulations Proposed June 30, 2001
Regulations On-Road Vehicle and Engine Emission Regulations Proposed March 30, 2002
Regulations Prescribed Non-hazardous Wastes Regulations Consulted March 2001
Regulations Prohibition of Certain Toxic Substances Regulations, 2001 (benzidine and hexachlorobenzene) Proposed September 29, 2001
Regulations Regulations Amending the Export and Import of Hazardous Wastes Regulations Under development
Regulations Regulations Amending the New Substances Notification Regulations Finalized June 6, 2001
Regulations Regulations Amending the Ozone Depleting Substances Regulations, 1998 Finalized March 13, 2002
Regulations Regulations Respecting the Form and Content of an Application for a Permit for Disposal at Sea Finalized August 15, 2001
Regulations Sulphur in Diesel Fuel Regulations Proposed December 22, 2001
Regulations Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations Proposed August 18, 2001
Pollution prevention plans Acrylonitrile releases from synthetic rubber manufacturing facilities Under development
Pollution prevention plans Dichloromethane from aircraft paint stripping, flexible polyurethane foam blowing, pharmaceutical and chemical intermediates, adhesive formulations, and industrial cleaning Under development
Pollution prevention plans Textile mills effluent and nonyphenol and its ethoxylates from the wet processing textile industry Under development
Pollution prevention plans Nonylphenol and its ethoxylates in manufacture and imported products Under development
Codes of practice Integrated Steel Mills and for Non-Integrated Steel Mills Finalized December 2001
Codes of practice Dichloromethane-based Paint Strippers Consultations held early 2001
Codes of practice ase Metal Smelters and Refineries Proposed March 2002
Environmental quality guidelines CCME water quality guidelines (inorganic fluorides, nonylphenol and its ethoxylates) Under development
Environmental quality guidelines CME sediment quality guidelines (nonylphenol and its ethoxylates) Under development
Environmental quality guidelines CCME soil quality guidelines (dioxins and furans, selenium, nonylphenol and its ethoxylates) Under development
Environmental quality guidelines CCME water quality guidelines (aluminum, mercury, nitrate, phosphorus, methyl tertiary-butyl, sulfolane, diisopropanolamine) Under development
Environmental quality guidelines CCME soil quality guidelines (uranium, sulfolane, diisopropanolamine) Under development
Environmental quality guidelines Environmental Choice Guidelines on Renewable Low-impact Electricity Proposed December 8, 2001
Environmental performance agreements Voluntary Action through the Responsible Program (Canadian Chemical Producers' Association) Finalized February 2002
Environmental performance agreements Refractory Ceramic Fibres (six companies) Finalized February 13, 2002
Environmental performance agreements 1,2-Dichloroethane (Dow Chemicals) Finalized October 26, 2001
Administrative agreeements Quebec Pulp and Paper Administrative Agreement sector Under development
Canada-wide standards Benzene (Phase II) Endorsed September 2001
Canada-wide standards Petroleum Hydrocarbons in Soil Endorsed May 2001
Canada-wide standards Mercury-containing Lamps Endorsed September 2001
Canada-wide standards Mercury in Dental Amalgams Endorsed September 2001
Canada-wide standards Dioxins and Furans from Waste Incineration and Coastal Pulp and Paper Boilers Endorsed May 2001
Canada-wide standards Dioxins and Furans from Iron Sintering Plants and Steel Making Electric Arc Furnaces Proposed September 2001

The following tools for managing PSL1 toxic substances were under development in 2001-02:

The Toxics Management Process is a new, more streamlined approach to controlling substances declared toxic under CEPA 1999. It is the result of a 2001-02 review of Environment Canada's risk management process, and is designed to fulfill the new requirements of CEPA 1999.

The Toxics Management Process deals both with substances identified for virtual elimination and substances slated for life-cycle management. Under the process, risk management strategies that identify a range of management tools, including preventive and control instruments, are developed. The risk management strategies also serve as the basis for public consultations.

The Toxics Management Process is initially being used to manage PSL2 toxic substances and is being further refined to deal with other toxic substances. Highlights of actions taken on the risk management strategies for PSL2 toxic substances slated for life-cycle management in 2001-02 include:

Canada continues to promote actions both domestically and internationally on the virtual elimination of releases of substances under the federal Toxic Substances Management Policy, a leading-edge policy among industrialized countries. The Policy calls for the virtual elimination of releases of toxic substances that are persistent and bioaccumulative and that are present in the environment primarily due to human activity (Track 1 substances) and life-cycle management of other toxic substances and substances of concern (Track 2 substances). Nine of the 12 Track 1 substances were active ingredients in pesticides that are now prohibited in Canada. Environment Canada continues to take action to severely limit the others under CEPA 1999 and other acts or programs.

Under the act, the Ministers of Environment and Health must propose virtual elimination for substances that are toxic under CEPA 1999 and persistent (take a long time to break down), bioaccumulative (collect in living organisms and end up in the food chain), and primarily the result of human activity. The ultimate objective of virtual elimination is to reduce releases to the point where they can no longer be measured (below the Level of Qualification (LoQ)).

Since CEPA 1999 came into force, there have been no final assessments of substances that would trigger its virtual elimination provisions. However, the department is preparing for this eventuality. In 2001-02, Environment Canada initiated the development of an approach to implement the virtual elimination provisions of the act that will also be consistent with the Toxics Substances Management Policy. It will outline the approach to be taken for substances identified for virtual elimination under CEPA 1999 and for the 12 substances identified for virtual elimination under the Toxics Substances Management Policy.

In 2001-02, work was ongoing on the development of level of qualifications for hexachlorobutadiene and chlorobenzenes. These LoQs will be finalized following consultations with stakeholders in concert with consultations on risk management strategies for these substances.

A regulation imposes conditions on an activity related to a substance or limits the concentrations that can be used, released to the environment, or present in a product. In 2001-02, four regulations regarding toxic substances were at various stages of development:

Regulations

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

An EPA must consider specific 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.

In 2001-02, three MOUs or agreements meeting the criteria outlined in the Policy Framework for Environmental Performance Agreements were signed:

Progress reports on agreements respecting environmental performance signed with Dofasco in 1997 and Algoma in 2000, show that these companies are on track in meeting the targets set under the Strategic Options Report for Steel Manufacturing.

EPA design criteria

EPAs must address the following core design criteria:

Many toxic substances that are produced, used, and released into the environment are of global concern. In order to efficiently and effectively address the assessment of risk for existing substances, a concerted international approach has been taken. Key international activities in 2001-02 included:

Substances that are not on the Domestic Substances List (DSL) are considered to be new to Canada. These cannot be manufactured or imported until:

CEPA 1999 requirements apply to all new substances unless other applicable acts contain the same requirements for notice and assessment and are specifically identified on Schedule 2 of the act. These provisions mean that CEPA 1999 sets the standard and acts as a safety net for new substances that are not covered under other acts of Parliament.

During 2001-02, Environment Canada and Health Canada jointly assessed approximately 700 new substances (chemical and polymer) notifications and four notifications for transitional substances. Transitional substances are defined as substances that were manufactured in or imported into Canada between January 1987 and July 1994 (when the New Substances Notification Regulations came into effect). These reviews resulted in the imposition of various kinds of controls on seven new substances and six Significant New Activities notices in 2001-02. These notices require persons who want to import, manufacture or use the substance to provide additional information to the Minister.

The Good Laboratory Practice (GLP) Compliance Monitoring Unit is responsible for advising scientific evaluators of new substances notifications on compliance issues related to submitted test data and for performing inspections and audits in Canadian testing facilities. Highlights of activities in 2001-02 included the following:

When the New Substances Notification Regulationswere promulgated in 1994, a commitment was made by Environment Canada and Health Canada to review them after the first three years of implementation. This was to enable adjustments to be made to the Regulations and to the New Substances Program if necessary. To help fulfil this commitment, a multistakeholder consultative process was established in June 1999, to work towards a common understanding of the New Substances Notification Regulations and the overall program and to provide consensus recommendations for their improvement. Eight meetings were held in 1999-2001. The consultations resulted in 76 consensus recommendations. The final report of the multistakeholder consultations was released in May 2002. The Government Response report and an Action Plan to address the consensus recommendations will be released in early 2003.

In 2001-02, two regulations were being developed under section 89 of CEPA 1999:

Regulations

CEPA 1999 allows for the waiving of its notification and assessment requirements for new substances if they are met by another federal act. This means that CEPA 1999 acts as a safety net - unless new substances fall under other Acts that are specifically listed in Schedule 2 (chemicals or polymers) or Schedule 4 (products of biotechnology), CEPA 1999 requirements will apply to all new substances.

On August 7, 2001, final orders to add three acts and regulations to Schedule 2, and five acts and regulations to Schedule 4 were published (see Table 3). The legal provisions that authorize the Schedules came into force on September 13, 2001.

Table 3: Scheduled acts and regulations
Schedule 2 (chemicals and polymers) Schedule 4 (animate products of biotechnology)
Pest Control Products Actand Pest Control Products Regulations Pest Control Products Actand Pest Control Products Regulations
Feeds Act and Feeds Regulations Feeds Act and Feeds Regulations
Fertilizers Act and Fertilizers Regulations Fertilizers Act and Fertilizers Regulations
Seeds Act
and Seeds Regulations
Health of Animals Act
and Health of Animals Regulations
(veterinary biologics)

Interdepartmental action plans have been initiated to develop regulations under the Food and Drugs Act and the Fisheries Act and in certain products under the Health of Animals Act in order to meet CEPA 1999 requirements. In spring 2002, Health Canada and Environment Canada signed an MOU whereby Health Canada will apply the New Substances Notification Regulations and conduct an environmental assessment of substances in products that are regulated under the Food and Drugs Act. During 2001-02, Health Canada assessed ten new substances in products regulated under the Food and Drugs Act. Other such agreements are currently being drafted with Fisheries and Oceans Canada and the Canadian Food Inspection Agency to address transgenic aquatic organisms and livestock animals, respectively.

Orders

Key international activities related to new substances in 2001-02 included:

The act allows the Minister to establish an Export Control List containing substances whose export is controlled because their manufacture, import, and/or use in Canada are prohibited or severely restricted or because Canada has accepted, through an international agreement, to control their export. The act also allows the Minister to make regulations in relation to substances specified on the Export Control List.

The Export Control List Notification Regulationsrequire exporters to provide notice of the proposed exports of substances on the Export Control List and to submit annual reports. In 2001, there were twelve notifications of exports received.

Export of substances on the Export Control List for 2001

Environment Canada continued development of the Export of Substances under the Rotterdam Convention Regulations to permit Canada to implement the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. The regulations will ensure that chemicals and pesticides subject to the prior informed consent procedure are not exported to parties to the Convention without the importer's prior informed consent.

Regulations

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