Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2024-275

Canada Gazette, Part II, Volume 159, Number 1

Registration
SOR/2024-275 December 16, 2024

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2024-1331 December 16, 2024

Whereas, under subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on June 26, 2021, a copy of the proposed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, under the title Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, under subsection 90(1)footnote c of that Act, the Governor in Council is satisfied that the substance set out in the annexed Order is toxic;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, makes the annexed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 under subsection 90(1)footnote c of the Canadian Environmental Protection Act, 1999 footnote b.

Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999

Amendment

1 Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote b is amended by adding the following in numerical order:

Coming into Force

2 This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

Coal tars and their distillates (or “coal tar substances”) were assessed under the Canadian Environmental Protection Act, 1999 (the Act) on June 26, 2021. Coal tar substances meet the ecological and human health criteria set out in paragraphs 64(a) and 64(c) of the Act. In accordance with subsection 90(1) of the Act, as it read before the coming into force of the Strengthening Environmental Protection for a Healthier Canada Act, which received royal assent on June 13, 2023, the Minister of the Environment and the Minister of Health (the Ministers) recommended that the Governor in Council make an Order adding coal tars and their distillates to Schedule 1 to the Act (the List of Toxic Substances). Under subsection 61(2) of the Strengthening Environmental Protection for a Healthier Canada Act, that recommendation is deemed a recommendation to add coal tars and their distillates to Part 2 of Schedule 1 to the Act.footnote 1

Background

Strengthening Environmental Protection for a Healthier Canada Act

On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act received royal assent. It amended various provisions of the Act, and, for that reason, some provisions referenced throughout this document have since been repealed or replaced and are no longer in force. Particular to additions of substances to Schedule 1 to the Act, it divided Schedule 1 into two parts. Toxic substances added to Part 1 require the Ministers to prioritize the total, partial, or conditional prohibition of activities involved with those substances when managing their risks. Toxic substances added to Part 2 require the Ministers to prioritize pollution prevention actions, which may include total, partial or conditional prohibition, when managing their risks. This Act provides under subsections 60(1), (2) and 61(1), (2), Transitional Provisions to determine whether substances assessed prior to this Act meet the criteria for addition to Part 1 or Part 2 of Schedule 1 to the Act.

Chemicals Management Plan

The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and living organisms that may be harmful to the environment or human health. As part of the CMP, the Ministers assessed coal tar substances under sections 68 and 74 of the Act as it read before the coming into force of the Strengthening Environmental Protection for a Healthier Canada Act.

Coal tar substances: description, production, uses and sources of release and exposure

Description

Coal tars and their distillates do not occur naturally, rather, their presence in the environment is a result of human activity. Coal tars are almost black liquids or semisolids that are heavier than water, slightly alkaline and have a characteristic naphthalene-like odour (like mothballs). They are only slightly soluble in water. Coal tars can be distilled into various fractions referred to as coal tar distillates. Although the absolute chemical composition of coal tars and their distillates is not known, a typical mixture can consist of up to 10 000 chemical compounds and the composition varies greatly, depending on factors of production, such as type of coal, temperatures used and other changes that occur during the distillation process.footnote 2 Coal tars and their distillates are complex mixtures of hydrocarbons (mainly aromatic), phenolics, and heterocyclic oxygen, sulphur and nitrogen-containing compounds that contain a large and variable number of chemical components (some of which are unknown) and, as a result, coal tar substances are considered to be substances of “unknown or variable composition, complex reaction products or biological materials” (or UVCBs) that have no specific chemical formula or structure, compared to “discrete substances” that are represented by a single chemical formula or structure.

Production

In Canada, coal tars are a by-product of coke-making operations in four integrated steel mills located in Ontario. Coal tars are the condensation products obtained by cooling, to approximately ambient temperature, the gas produced in the distillation of coal during its use as feedstock in coke-making operations. Coke is a solid fuel made by heating coal in the absence of air so that the volatile components are driven off. It is used in blast furnaces in the conversion of iron ore to iron, which can be further refined to produce steel. Coal tars produced in Canada are classified as either coal tar (CAS RNfootnote 3 8007-45-2) or high-temperature coal tar (CAS RN 65996-89-6), but not low-temperature coal tar (CAS RN 65996-90-9). This is because the coal tars produced in Canada are from coke-making operations that use temperatures well above 700 degrees Celsius, the threshold between high-temperature and low-temperature coal tars.

High-temperature coal tar is used as a feedstock to produce coal tar distillates at the only coal tar refinery in Canada, also located in Ontario. Coal tar distillates produced in Canada include, but are not limited to, coal tar oils (CAS RN 65996-82-9), coal tar upper distillates (CAS RN 65996-91-0), and high-temperature coal tar pitch (CAS RN 65996-93-2), which is expected to account for about 50% of the total coal tar distilled annually in Canada.footnote 4

Based on the presentation Coal Tar Pitch Markets in Europe & North America (Sutton 2008), an estimated 146 kilotonnesfootnote 5 (kt) of coal tars and 165 kt of coal tar distillates were produced in Canada in 2007.footnote 6 The production of coal tars and coal tar distillates for more recent years were not identified.

Uses

The Department of Health and the Department of the Environment (the Departments) issued a mandatory survey under section 71 of the Actfootnote 14 encompassing coal tars and their distillates (reporting year 2011) to obtain information on the manufacture and import of coal tar distillates in Canada. Industry reported that the manufacture and import of coal tar oils were in the range of 100 kt to 1 000 kt and that imports of coal tar upper distillates were in the range of 1 kt to 100 kt. The reported information is not expected to have changed significantly since 2011. Table 1 shows a summary of a selection of coal tar distillates’ description and uses in Canada.

Table 1: Summary of a selection of coal tar distillates’ description and uses
Common Name Description and use
Coal tar pitch A thick black liquid mainly used in the aluminum industry as a binder for aluminum smelting anodes. It is also used as a base for coatings and paint, in roofing and paving, and as a binder in asphalt products. It may also be used as an adhesive/binder in clay pigeons and briquettes, to strengthen and impregnate refractories for lining industrial furnaces, in pavement sealants, and in epoxy coatings used in industrial applications.
Carbon black A fine black powder mainly used as a reinforcing filler in tires and other rubber products. In plastics, paints and inks, it is used as a colour pigment.
Creosote A dark brown oil used as a wood preservative.
Oils These oils (light oil, carbolic oil, naphthalene oil, wash oil, anthracene oil, base oil, tar acid oil and heavy aromatic oil) are mainly used as feedstocks for industrial processes.
Crude naphthalene A white crystalline solid with a characteristic odour used as a main ingredient in mothballs and as a raw material for chemical manufacture.
Coal tar An active ingredient in veterinary and human drugs, primarily in the form of shampoos to treat skin conditions, such as psoriasis, eczema and seborrheic dermatitis.
Sources of release and exposure

Based on the expected production, manufacture, import and use of coal tar substances in Canada, coal tars and their distillates may be released to the environment (air, water and soil) from industrial activities associated with their production, transportation and storage, as well as during use and disposal of consumer and industrial products that contain them (e.g. coal tar-based pavement and roofing sealants). Increased exposure to releases of coal tar substances to air may occur for those living near the four integrated steel mills and the coal tar refinery, as well as for consumers that use products that contain them. Subsequent deposition of coal tar substances to soil and discharges to water (via the sewer system) from air releases at these industrial facilities can also occur. Coal tar substances may be released to soil and water from the application and use of coal tar-based pavement sealants in residential driveways, commercial parking lots and roofing sealants.

Canadian risk management activities

Federal government

The use of coal tar as an active ingredient in human and veterinary drugs, primarily in the form of shampoos used to treat skin conditions, is listed in Health Canada’s Drug Product Database and thus regulated under the Food and Drugs Act (FDA). Under the FDA, coal tars (crude and refined) are described on the Cosmetic Ingredient Hotlist as prohibited as ingredients in cosmetic products in Canada. The substances are not permitted to be sold as a natural health product, and are not approved for use as food additives.

There are no federal risk management actions in place on coal tar-based sealant consumer products or coal tar refining pertaining to the use or release of coal tars and their distillates. However, the Certain Products Containing Toxic Substances Regulations were proposed on November 18, 2023, to prohibit the manufacture, import and sale of certain coal tar-based sealant products and certain sealant products containing high levels of polycyclic aromatic hydrocarbons (PAHs) to prevent harmful ecological impacts and to help reduce the risk of adverse health impacts. Additionally, at the federal level, there are risk management measures to manage releases of air pollutants from integrated steel mills, such as PAHs and benzene, two major components of coal tar substances. These measures (e.g. Pollution Prevention Planning Notice, Codes of Practice, and Canada-Wide Standard) have resulted in substantial reductions of PAHs and benzene releases to air from integrated steel mills in Canada (e.g. as of 2008, benzene emissions had been reduced approximately 88% from 1995 levels).

Provincial/territorial governments

There are no provincial/territorial risk management actions on coal tar-based sealant consumer products in place pertaining to the prevention or control of releases of coal tar substances from these products. However, there are risk management measures in place in Ontario, where all integrated steel mills and the only coal tar refinery in Canada are located. These measures aim to limit exposure to chemical substances that can affect the environment and human health released from local industrial and commercial facilities, including integrated steel mills and the coal tar refinery. Between 2016 and 2017, the province approved site-specific standards for benzo[a]pyrene (a PAH) and benzene for the four integrated steel mills and the coal tar refinery. These standards are expected to result in significant emission reductions.footnote 7

International risk management activities

The United States (U.S.)

Under the U.S. Toxic Substances Control Act, coal tar and upper distillates of coal tar are subject to a significant new use rule. This requires the filing of a significant new use notification with the Environmental Protection Agency (EPA) prior to manufacturing, importing, or processing any of these chemical substances for use. The required notification provides the EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit, or limit that activity before it occurs.

Additionally, several regulations under the U.S. National Emission Standards for Hazardous Air Pollutants program of the Clean Air Act could also be applicable to the production of coal tar substances. For instance, coke oven batteries use coal to produce coke,footnote 8 and under this program, the standard for coke ovens pushing, quenching and battery stacks seeks to reduce emissions of toxic air pollutants from these coke oven processes. Another example is the equipment leak standard for coal tar refining under the standard for synthetic organic chemical manufacturing industry (PDF).

An increasing number of jurisdictions in the U.S. are controlling or banning the use of coal tar-based pavement sealants. As of early 2018, Texas, Wisconsin, New York, Massachusetts, District of Columbia, Michigan, North Carolina, South Carolina, Washington, California, Kansas, Illinois, Maryland, Minnesota, Connecticut and Missouri had known restrictions on coal tar-based pavement sealers within their boundaries.

The European Union (EU)

High-temperature coal tar pitch is identified as a Substance of Very High Concern in the EU and the European Chemicals Agency recommended the substance for inclusion in Annex XIV of the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation in 2017. This substance is therefore not allowed to be marketed or used after October 2020 unless an authorization or an exemption is granted.

The Classification, Labelling, and Packaging of Substances and Mixtures Regulation classified high temperature coal tar pitch as hazardous to human health under the Carcinogenic category 1A (known to cause that effect in humans), Mutagenic category 1B (suspected to cause that effect in humans), and Reproductive Toxicity category 1B (suspected to cause that effect in humans). These categories trigger labelling requirements such as hazard and precautionary statements.

The Directive for Integrated Pollution Prevention and Control (IPPC Directive 2008/1/EC) sets out guidelines to minimize pollution from various point sources such as emissions from storage tanks and establishes the Best Available Techniques (BAT) reference documents. The IPPC Directive 2008/1/EC is the main EU instrument regulating pollutant emissions from industrial installations and requires that these BAT be the reference in setting permit conditions (European Commission, 2010).footnote 9

Summary of the screening assessment

On June 26, 2021, the Ministers published a screening assessment on coal tars and their distillates on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether coal tars and their distillates meet one or more of the criteria for a toxic substance as set out in section 64 of the Act.

Under section 64 of the Act, a substance is considered toxic if it is entering or may enter the environment in a quantity or concentration, or under conditions that

The Departments collected and considered information from multiple sources (e.g. modelling, literature reviews, internal and external database searches, data from mandatory surveys submitted in response to a survey issued under section 71 of the Act, and, where warranted, data from targeted follow-ups with stakeholders) to inform the screening assessment conclusion. The ecological and human health portions of this assessment have undergone external written peer review/consultation. Comments were received from academics, subject matter experts, the Ontario Ministry of the Environment, and other relevant stakeholders.

The screening assessment on coal tars and their distillates concluded that coal tar substances meet the ecological and human health criteria for a toxic substance as set out in paragraphs 64(a) and (c) of the Act, and thus, have the potential to cause ecological harm and constitute a risk to human health in Canada. Below are the assessment considerations and summaries of the ecological and human health assessments.

Assessment considerations

As UVCBs, coal tars and their distillates are complex mixtures that contain a large and variable number of chemical components (some of which are unknown) that are difficult to measure and have the potential to be harmful to the environment and human health. The approach used to assess these UVCBs was to select representative components for practical reasons, in particular because it was not feasible to characterize all components of these complex UVCBs. Representative components are typically selected based on consideration of their hazard relative to other components; their relative contribution to the overall composition of the UVCB; and their data richness. Ideally, representative components will be high in all of these criteria. Based on the data reported to the National Pollutant Release Inventory (NPRI) from coal tar refining facilities and available information on the chemical composition of coal tar substances, polycyclic aromatic hydrocarbons (PAHs) and benzene components which are expected to be of greatest ecological and health concern, were selected as representative components to assess risks of exposure of Canadians and the environment to coal tars and their distillates.

While high-hazard representative components are selected for quantitative analysis, such as PAHs and benzene in coal tar substances, the assessment and its conclusion are based on the UVCBs as a whole, which includes other chemical components. Other chemical components (e.g. monocyclic aromatic hydrocarbons, phenolics and heterocyclics) were identified in the assessment to have the potential to contribute to the ecological toxicity of coal tar substances. In this context, where the assessment identifies a risk associated with exposure to the representative components (PAHs and benzene), other harmful components of coal tar substances have the potential to contribute to the ecological or human health concern in Canada. While PAHs and benzene are toxic substances listed in Schedule 1 to the Act,footnote 10 due to UVCBs characteristics, it was found appropriate to add coal tars and their distillates to Schedule 1 to the Act in order to address the risks of exposure to coal tar substances. Below is more information about the toxicity of PAHs, benzene, and other components of coal tar substances:

Ecological assessment summary

For the ecological assessment, PAHs were selected as the representative components to assess the potential ecological risk associated with coal tar substances’ release to the environment, which includes other components (e.g. non-PAHs) that have the potential to contribute to the overall ecological risk posed by coal tar substances. The assessment used the data on releases of PAHs from the affected coal tars and their distillates sector and other available information to evaluate ecological risks for three identified exposure scenarios. These scenarios included the deposition of PAHs onto soil from air releases at the coal tar refinery; the releases of PAHs into water from the same refinery; and the releases of PAHs into water from application of coal-tar-based pavement sealants. As part of the evidence presented in the assessment, to determine if these scenarios may pose an ecological risk, predicted environmental concentrations (PEC) were estimated for PAHs, using PAHs releases reported to the NPRI and other available information, such as peer-reviewed literature and databases with information on product usage in Canada. Based on information from the Canadian Environmental Quality Guidelines (i.e. water and soil), the predicted no-effect concentrations (PNEC) of PAHs were also estimated. PEC values greater than PNEC values are an indicator of potential for ecological harm in that environmental compartment (i.e. water, air, soil and sediment).

Based on the PEC and PNEC values for each of the scenarios assessed and other available information, the screening assessment determined that

Given the above information, as well as the potential for other components of coal tar substances (e.g. non-PAHs) to contribute to the ecological toxicity of coal tars and their distillates, the screening assessment concluded that coal tars and their distillates have the potential to cause ecological harm, as per the criteria for a toxic substance set out in paragraph 64(a) of the Act. Coal tar substances did not meet the criteria for a toxic substance set out in paragraph 64(b) of the Act.

Human health assessment summary

For the human health assessment, PAHs and benzene were selected as the representative components to assess the potential human health risks of exposure to coal tar substances releases, which include other chemical components that have the potential to contribute to the overall human health risk posed by coal tars and their distillates. The assessment identified three exposure scenarios as having the potential to pose a risk to human health in Canada.

The first two scenarios considered releases of coal tar substances from processing and/or storage to the air in the vicinity of integrated steel mills and the coal tar refinery. The third scenario examined exposure to coal tar substances from house dust due to the weathering/wearing of coal tar driveway sealants.

The risk associated with long-term inhalation exposure of the general population to evaporative emissions of coal tars from integrated steel mills and the coal tar refinery was characterized by comparing the estimated exposure to benzene and PAHs released to air from these facilities with the estimates of carcinogenic potency for these substances. It was concluded that exposure to benzene by inhalation over the long-term may pose a human health risk to the populations living in the vicinity of these facilities.

The risk associated with exposure to coal tar substances from house dust due to the weathering of coal tar driveway sealants was characterized by estimating the lifetime exposure to PAHs from house dust due to incidental (i.e. non-intentional) ingestion of house dust with the estimate of carcinogenic potency for PAHs. It was concluded that exposure to PAHs associated with the use of coal tar driveway sealants may pose a human health risk. Additionally, it was noted that children aged six months to 11 years old were considered to represent a susceptible subpopulation due to their greater exposure potential and higher susceptibility to the effects of PAHs.

Given the above information, as well as the potential for other components of coal tar substances (e.g. non-PAHs) to contribute to the human health toxicity of coal tars and their distillates, the screening assessment concluded that coal tars and their distillates constitute a risk to human health, as per the criteria for a toxic substance as set out in paragraph 64(c) of the Act.

Objective

The objective of the Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to enable the Ministers to propose risk management measures for a toxic substance under the Act that prioritize pollution prevention actions, which may include prohibitions, when managing potential environmental and human health risks associated with coal tars and their distillates.

Description

The Order adds coal tars and their distillates to Part 2 of Schedule 1 to the Act.

Regulatory development

Consultation

On June 11, 2016, the Ministers published a Notice with a summary of the draft screening assessment of coal tars and their distillates (which included a link to the complete draft assessment) in the Canada Gazette, Part I, for a 60-day public comment period. The Notice also informed of the release of the risk management scope document for coal tar substances to initiate discussions with stakeholders on the development of risk management actions following their addition to Schedule 1 to the Act. During this period, eight industry stakeholders and non-governmental organizations submitted comments. Comments on the draft screening assessment were related to new information and data, as well as on the methodology used to evaluate ecological and human health risk and exposure. A table with a complete summary of public comments and the responses to these comments is available on the Canada.ca (Chemical Substances) website.

New information and data

Stakeholders provided a description of the “Substance Identity” of coal tar-based pavement sealant, and requested the consideration of information on coal tars published by the United States Geological Survey (USGS) and on the site-specific standards (SSS) Ontario approved for integrated steel mills related to the coal tar substances emission reductions. Officials responded that the description of the “Substance Identity” of coal tar-based pavement sealant and the information from the USGS was considered and added to the final screening assessment. Officials also reviewed the information provided on the approved SSS in Ontario for integrated steel mills and determined that their emissions continued to present a potential concern to human health in Canada.

The methodology used to evaluate ecological and human health risk and exposure

While an industry stakeholder and a non-government organization agreed with the ecological and human health toxicity conclusion, one other industry stakeholder challenged the use of the metrics that supported the ecological and human health toxicity conclusions, such as the margin of exposures (MOEs), points of impingement, predicted environmental concentration (PEC) and predicted no-effect concentration (PNEC). The industry stakeholder was of the view that these parameters did not reflect the current exposure to human health and the environment from coal tar and their distillates. Officials responded by modifying the exposure approach used for one of the exposure scenarios and providing evidence-based justifications for the methodologies employed in the assessment, based on multiple studies representing a range of conditions and various products that may be used in Canada, rather than relying on a single study.

Another industry stakeholder suggested that the global approach taken in the draft screening assessment did not accurately reflect the current situation associated with coke-producing facilities in Ontario. Officials responded that the approach used in the assessment to evaluate exposure to emissions from coke-producing facilities in Ontario is appropriate to determine potential ecological and human health risks under section 64 of the Act. Information specific to Canadian facilities was used in the screening assessment when available, including site-specific information for the coke-producing facilities in Ontario provided by the Canadian Steel Producers Association. Data from NPRI databases on releases of PAHs and benzene to air and other environmental media (e.g. water and soil) at coke-producing facilities in Ontario was also considered. Estimation approaches and models were used when specific data was not available.

Some industry stakeholders and non-government organizations proposed various sources of new data and recent studies. These sources were considered and some of them were integrated into the final screening assessment. In addition, a notice for a mandatory section 71 survey was issued on December 1, 2018, in the Canada Gazette, Part I, to inform risk management activities for coal tar substances.

The comments on the draft screening assessment report were considered in the development of the final screening assessment, published on June 26, 2021, but did not change the conclusion that coal tars and their distillates meet the criteria for a toxic substance as set out in paragraphs 64(a) and (c) of the Act. As a result, the Ministers recommended the addition of coal tars and their distillates to Schedule 1 to the Act.

The comments received on the risk management scope document were considered in the development of the risk management approach document. On June 26, 2021, the Ministers published the risk management approach document on the Canada.ca (Chemical Substances) website to continue discussions with stakeholders on the proposed risk management actions for coal tars and their distillates following their addition to Schedule 1 to the Act, such as

Further consultation on risk management actions, including assessment of impacts, would take place during the regulatory development of any proposed risk management actions by the Ministers.

Prepublication in the Canada Gazette, Part I

On June 26, 2021, the proposed Order recommending the addition of coal tars and their distillates to Schedule 1 to the Act was published in the Canada Gazette, Part I, for a 60-day public comment period. During this period, comments from one industry stakeholder were received on the proposed listing order for coal tars and their distillates. The stakeholder was not supportive of adding coal tars and their distillates to Schedule 1 to the Act, indicating that both PAHs and benzene are already listed and that therefore, coal tars and their distillates should not need to be added to Schedule 1 to the Act. Officials responded that coal tars and their distillates are UVCB compounds that include PAHs, benzene, and other components, all of which may contribute to toxicity. The current listings of PAHs and benzene do not suffice to address the ecological and human health risks posed by exposure to coal tar substances. The screening assessment established that adverse effects could not be exclusively attributed to PAHs and benzene present as components in coal tars and their distillates. As a result, it was found appropriate to add coal tars and their distillates to Schedule 1 to the Act.

The stakeholder also requested a review of recent scientific data and additional stakeholder consultations. Through its ongoing prioritization process, the Government of Canada will continue to monitor and review any new scientific data available. This information will inform any future prioritization, risk assessment or risk management activities. Additional details on the prioritization process can be found on the Canada.ca (Chemical Substances) website.

The Departments informed the provincial and territorial governments about all publications through the Canadian Environmental Protection Act’s National Advisory Committeefootnote 11 via a letter and provided them with an opportunity to comment. No comments were received from the Committee.

Modern treaty obligations and Indigenous engagement and consultation

The assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders adding substances to Schedule 1 to the Act do not introduce any new regulatory requirements, and therefore, do not result in any impact on modern treaty rights or obligations. As such, targeted engagement and consultations with Indigenous Peoples were not undertaken. However, the prepublication comment period is an opportunity for Indigenous Peoples to provide feedback on the proposed Order, which was open to all Canadians.

Instrument choice

When a substance meets one or more of the criteria for a toxic substance as set out in section 64 of the Act, the Ministers shall propose one of the following measures:

Toxic substances that pose the highest risk are added to Part 1 of Schedule 1. These are prioritized for total, partial, or conditional prohibition. Other toxic substances are added to Part 2 of Schedule 1 and are prioritized for pollution prevention actions, which may include total, partial or conditional prohibition. Until regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic, or toxic to reproduction are developed, toxic substances that have been found to meet the criteria in the existing Persistence and Bioaccumulation Regulations will be added to Part 1. Should additional criteria be specified in regulation, some substances initially considered for addition to Part 2 of Schedule 1 may instead be considered for addition to Part 1 of Schedule 1. Since the screening assessment did not conclude that coal tar substances meet the criteria set out in the Persistence and Bioaccumulation Regulations, they are being added to Part 2 of Schedule 1 to the Act.

Regulatory analysis

Benefits and costs

The addition of coal tars and their distillates to Part 2 of Schedule 1 to the Act does not on its own, impose any regulatory requirements on businesses and therefore does not result in any incremental compliance costs for stakeholders or enforcement costs for the Government of Canada. The Order grants the Ministers the authority to develop risk management instruments under the Act for coal tars and their distillates. The Government of Canada will consult stakeholders on any future risk management instruments before implementation and will consider their potential impacts.footnote 12

Small business lens

Analysis under the small business lens concluded that the Order will not impact Canadian small businesses, as it does not impose any administrative or compliance costs on businesses.

One-for-one rule

The one-for-one rule does not apply, as the Order does not result in a change in administrative burden imposed on businesses.

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g. the United States Environmental Protection Agency [EPA], European Chemicals Agency, and the Organization of Economic Cooperation and Development), and is party to several international multilateral environmental agreements in the area of chemicals and waste.footnote 13 While the Order will not on its own relate to any international agreements or obligations, it will enable the Ministers to propose risk management measures that may align with actions undertaken by other jurisdictions.

Effects on the environment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed for the CMP, which encompasses orders adding substances to Schedule 1 to the Act. The assessment concluded that the CMP is expected to have a positive effect on the environment and human health.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for the Order.

Implementation, compliance and enforcement, and service standards

As no specific risk management measures are recommended as part of the Order, developing an implementation plan and a compliance and enforcement strategy, as well as establishing service standards, are not necessary at this time.

Contacts

Thomas Kruidenier
Executive Director
Substance Prioritization, Assessment and Coordination Division
Environment and Climate Change Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Email: substances@ec.gc.ca

Andrew Beck
Director
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613‑266‑3591
Email: andrew.beck@hc-sc.gc.ca