Vol. 149, No. 8 — April 22, 2015

Registration

SOR/2015-73 March 30, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-87-04-01 Amending the Domestic Substances List

Whereas the substance set out in the annexed Order is specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of the substance under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and released a proposed risk management approach on November 19, 2011, for a 60-day public comment period, in which one of the risk management objectives is to prevent increases in exposure to the substance;

Whereas the Ministers are satisfied that the substance quinoline is, in any one calendar year, only being manufactured in or imported into Canada by any person in a quantity of more than 100 kg for a limited number of uses;

Whereas the Ministers suspect that the information concerning a significant new activity in relation to the substance may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (see footnote c);

And whereas, pursuant to section 91 of the Canadian Environmental Protection Act, 1999 (see footnote d), a notice of intent to modify the Domestic Substances List (see footnote e) to apply the significant new activity provisions was published in the Canada Gazette, Part I, on November 16, 2013, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the notice;

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote f), makes the annexed Order 2015-87-04-01 Amending the Domestic Substances List.

Gatineau, March 24, 2015

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2015-87-04-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

2. Part 2 of the List is amended by adding the following in numerical order:

Column 1

Substance		 Column 2

Significant new activity for which substance is subject to subsection 81(3) of the Act
91-22-5 S′
  1. Any activity involving, in any one calendar year, more than 100 kg of the substance quinoline in its isolated form, namely, quinoline that is extracted from naturally occurring sources or that is manufactured.
  2. For each proposed significant new activity, the following information must be provided to the Minister at least 180 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    • (a) a description of the proposed significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used;
    • (c) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site;
    • (d) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (f) the information specified in paragraph 11(b) of Schedule 6 to those Regulations;
    • (g) the products and, if known, end-use products that are anticipated to contain the substance, the intended use of those products and the function of the substance in those products;
    • (h) a summary of all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
    • (i) the identification of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the department or agency’s file number and, if any, the outcome of the assessment by the department or agency and the risk management actions in relation to the substance imposed by the department or agency;
    • (j) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on their behalf; and
    • (k) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person authorized to act on their behalf.
  3. The above information will be assessed within 180 days after the day on which it is received by the Minister.

COMING INTO FORCE

3. 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

Quinoline is a naturally occurring substance that is found in coal and coal-derived compounds. Based on a screening assessment carried out by the Government of Canada, it has been determined that this substance poses a risk to human health and the environment. A number of existing risk management actions are in place, and others are being considered, to address potential sources of exposure to quinoline from activities involving coal and coal-derived compounds occurring in Canada.

In addition to being naturally associated with coal and coal-derived compounds such as coal tar and creosote, quinoline can also be extracted from coal tar or synthesized into an isolated form (e.g. neat or technical grade form) and used on its own, as a reactant for a chemical reaction or process, or as a component in other formulations or products. Given the hazardous properties of quinoline, its use in such a way may pose a risk to human health and the environment. At present, there are no known cases of quinoline being used in its isolated form in Canada. If it were to be used this way, however, the Government would need to assess any such proposed new use to determine the potential health or environmental risks.

The Minister of the Environment (the Minister) is therefore applying the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to any activity involving quinoline in its isolated form. (see footnote 2) This will require that the Minister be notified of any significant new activities in Canada involving quinoline in its isolated form or involving mixtures, products or other formulations containing the isolated form of quinoline. (see footnote 3) The Minister will then assess the proposed activities and, if appropriate, implement measures to limit risks to human health and the environment.

Background

Environment Canada and Health Canada conducted a screening assessment to determine whether quinoline is toxic, as defined under section 64 of CEPA 1999. According to the summary of the screening assessment, published in the Canada Gazette, Part I, on November 19, 2011, quinoline is harmful to human health and the environment and meets the criteria set out in paragraphs 64(a) and 64(c) of CEPA 1999. An order adding the substance to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II, on November 21, 2012, to enable the development of risk management instruments to manage the risks associated with quinoline. (see footnote 4)

SNAc provisions of CEPA 1999

Given that quinoline was listed on Part 1 of the Domestic Substances List (DSL), any activities associated with the substance could be conducted by industry or others without any obligation to notify the Government of Canada, unless the substance is subject to other notification requirements in Canada. However, when the Government of Canada is concerned that any significant new activity in relation to a substance may result in an increased risk to human health or the environment, the Minister may impose notification requirements on significant new activities associated with the substance. (see footnote 5)

As it has been concluded that quinoline is harmful to human health and the environment, and that new activities associated with this substance in its isolated form may be a source of concern, on November 16, 2013, the Government of Canada published a notice of intent in the Canada Gazette, Part I, to indicate that the SNAc provisions under CEPA 1999 would be applied to quinoline. (see footnote 6)

Current Canadian industrial activities

Quinoline is naturally associated with coal and coal-derived compounds. These compounds include coal tars and their distillation products. Quinoline has been found in coal tar-based products, such as sealcoats used on parking lots and driveways, and in creosote used as a preservative in the lumber and wood products industries. It has also been detected in a commercial brush-on product containing creosote and two commercial products for use only within wood treatment facilities.

According to information submitted in response to a survey carried out under section 71 of CEPA 1999, more than 20 000 kg of quinoline, primarily as a component of coal tar and coal tar pitch, containing quinoline at a composition of less than 1%, were manufactured in or imported into Canada in 2000. The information received also indicated that quinoline produced in Canada was present as a part of coal tar and coal tar pitch.

Current and potential risk management actions

Quinoline is listed on Schedule 5 of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and on Schedule 1 of the Vessel Pollution and Dangerous Chemicals Regulations. Quinoline is classified under class 6.1 of the Transportation of Dangerous Goods Regulations (toxic by inhalation) and is subject to the Tobacco Reporting Regulations.

Risk management actions on coal-based products are expected to provide co-benefits to address risks associated with the potential release of quinoline, which is naturally present in these substances. For example, coal tars are on the List of Prohibited and Restricted Cosmetic Ingredients (more commonly referred to as the Cosmetic Ingredient Hotlist or simply the Hotlist), an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene the general prohibition found in section 16 of the Food and Drugs Act, or a provision of the Cosmetic Regulations. Coal tar and their distillates are also being assessed under the Petroleum Sector Stream Approach of the Chemicals Management Plan (CMP). Activities associated with coal tar and their distillates could be subject to further risk management actions, if it were deemed necessary by the Minister of the Environment and the Minister of Health.

Several provincial standards have been established which are expected to help to limit the releases of quinoline from contaminated industrial sites. They include the Ontario Interim Provincial Water Quality Objective, and the British Columbia Interim Surface Water Quality Guideline and British Columbia’s Contaminated Sites Regulation. The Canadian Council of Ministers of the Environment (CCME) Canadian Water Quality Guidelines for the Protection of Aquatic Life and the CCME Canadian Soil Quality Guidelines for the Protection of Environmental and Human Health are guidelines that provide a baseline standard for all Canadian jurisdictions when they develop their own regulations, but are not considered control instruments.

There are information gathering tools that are expected to help inform and evaluate the performance of risk management actions associated with the substance. Quinoline is subject to reporting requirements under the National Pollutant Release Inventory, where the threshold was recently changed to increase reporting of unintentionally produced quinoline (e.g. combustion by-product) from facilities in sectors that report for other polycyclic aromatic hydrocarbons (utilities, steel plants, wood preservation facilities, aluminum smelters and waste incinerators). Quinoline is also included in the Chemicals Management Plan Environmental Monitoring and Surveillance Program’s wastewater monitoring activities.

Risk management actions in other jurisdictions

Quinoline has been classified as a toxic substance since 1973 by the International Maritime Organization under the United Nations and is listed in the Dangerous Goods List of the International Maritime Dangerous Goods Code dealing with packaged materials.

In the United States, quinoline is subject to several regulatory instruments. Under the Toxics Release Inventory (TRI), facilities must submit information on disposal or other release of quinoline. (see footnote 7) Under the Clean Air Act of 1990, quinoline is listed as a hazardous air pollutant and is included in the Integrated Urban Strategy. (see footnote 8) Under the Clean Water Act, quinoline is designated as a hazardous substance, which controls release of substances into water. (see footnote 9) And under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), quinoline is listed as a hazardous substance which requires reporting of releases over a specified threshold. (see footnote 10)

In the European Union, quinoline is registered under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), although quinoline is not subject to any restrictions at this time.

Objectives

The objective of the Order is to contribute to the protection of human health and the environment by requiring submission of information on significant new activities associated with the isolated form of quinoline before they are undertaken. The information collected will assist the Government of Canada in assessing the substance in relation to the significant new activity and in determining whether further risk management actions are necessary.

Description

The Order 2015-87-04-01 amending the Domestic Substances List was made by the Minister, pursuant to subsection 87(3) of CEPA 1999, was registered and is now in force. It is therefore mandatory to meet all the requirements of the Order should a person wish to import, manufacture or use the isolated form of quinoline for a significant new activity, as defined in the Order.

The Order deletes quinoline from Part 1 of the DSL by removing the CAS Registry Number 91-22-5 from that Part and adds it to Part 2 of the DSL; and indicates, by the addition of the letter “S′” following the CAS Registry Number, that the substance is subject to the SNAc provisions under CEPA 1999. (see footnote 11)

Applicability of the Order

The Order’s applicability is broad and requires that any person engaging in a significant new activity in relation to the isolated form of quinoline must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 180 days prior to import, manufacture or use of the substance for the significant new activity.

The objective of the Order is to capture activities involving the isolated form of quinoline, when the substance has been extracted from its natural sources or has been synthesized through a chemical reaction or process. If the isolated form of quinoline is present in a mixture, product, or other formulation, the quinoline is still considered to be in its “isolated form” for the purpose of the Order. Hence, the mixture, product or other formulation will still be considered to contain the “isolated form” of quinoline, and related significant new activities will be subject to the Order.

In general, activities with respect to quinoline requiring a SNAN submission include the manufacture, import or use of quinoline in bulk form (also referred to as “neat or technical grade composition”), or when the isolated form is added to or present in a mixture or other product. Significant new activities could include, but are not limited to, quinoline’s extraction from coal tar, its synthesis, importation for a significant new activity, its use as a reactant, for example in the manufacture of dyes or pharmaceuticals, its use as a component of any industrial, commercial, or consumer product such as a detergent, or the import of a product containing the isolated form of quinoline. Additional guidance may be found in the “Compliance” subsection of this document.

Activities not subject to the Order

Activities in relation to quinoline where the substance is present in coal tars and their distillates and the substance is unprocessed, or processed only by manual, gravitational or mechanical means, by dissolution in water, by flotation, or by heating solely to remove water do not require submission of a SNAN. Examples of potential activities excluded from the provisions include the use of coal tar pitch in industrial processes or the use of its distillates, such as creosote, for various purposes. Quinoline, when present incidentally or as an impurity within a distillate of coal tar, is also not notifiable due to exemptions under subsection 81(6) of CEPA 1999.

This Order does not apply to uses of the isolated form of quinoline that are regulated under any Act of Parliament listed in Schedule 2 of CEPA 1999, including, but not limited to, the Pest Control Products Act, the Fertilizers Act and the Feeds Act. It also does not apply to reaction intermediates, impurities, by-products and contaminants, and in some circumstances to items such as, but not limited to, wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be notifiable under the Order. (see footnote 12)

Information to be submitted

The Order sets out the information that must be provided to the Minister 180 days before the day on which the isolated form of quinoline is imported, manufactured or used for a significant new activity. Environment Canada and Health Canada will use the information submitted in the SNAN to conduct human health and environmental assessments within 180 days after the complete information is received.

Information being required in respect of potential new activities associated with quinoline in its isolated form includes details surrounding use and exposure. Some of the information requirements of the Order reference the New Substances Notification Regulations (Chemicals and Polymers), which describe in more detail the specific information being requested. (see footnote 13) Additional guidance on preparing a SNAN can be found in section 4 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Consultation

On November 16, 2013, a notice of intent to amend the DSL was published in the Canada Gazette, Part I, for a 60-day public comment period. During the 60-day public comment period, three submissions from industry stakeholders were received. All comments were considered in finalizing the Order.

Environment Canada also informed the governments of the provinces and territories through the National Advisory Committee of CEPA 1999 (CEPA NAC) of the notice of intent. No comments were received from CEPA NAC.

Below is a summary of the key comments received on quinoline and comments relevant to the overall application of SNAc provisions, as well as the responses to these comments.

“One-for-One” Rule

The Order does not trigger the “One-for-One” Rule. Current activities involving quinoline are not subject to the notification requirement of the Order, and there is no indication that industry’s current activity patterns associated with the substance may change in the future. As a result, no incremental administrative costs are expected to be incurred by businesses.

Small business lens

The small business lens does not apply to this Order, as there are no expected impacts on industry or small businesses based on their current and anticipated practices. Canadian companies that are currently using or importing coal and coal-derived compounds, which contain quinoline as a natural component, are not affected by the Order’s notification requirement, and there is no indication that current industrial activity patterns associated with the substance will change in the future.

Rationale

The screening assessment determined that quinoline meets one or more criteria of section 64 of CEPA 1999. The assessment concluded that quinoline is harmful to human health, as it may cause cancer, and that it is harmful to the environment, as a consequence of its high toxicity to organisms in aquatic ecosystems. Quinoline has been added to Schedule 1 of CEPA 1999.

A number of existing risk management actions are in place, and others are being considered, to address potential sources of exposure to quinoline in coal and coal-derived compounds. However, given the hazardous properties of quinoline, when it is extracted from coal tar or synthesized into an isolated form and used on its own, as a reactant for a chemical reaction, or process or as a component in other formulations or products, it may pose a risk to human health and the environment. Therefore, the Minister determined that any activity involving quinoline in its isolated form, as well as any activity involving mixtures, products or other formulations containing the isolated form of quinoline, be subject to the SNAc provisions of CEPA 1999.

Because quinoline was previously listed on Part 1 of the DSL, activities involving the substance did not require notification to the Minister unless it was subject to other notification requirements under CEPA 1999 or any other federal statute. Amending the DSL to apply the SNAc provisions to quinoline allows the Minister to be informed of significant new activities involving the substance in its isolated form prior to the activity being undertaken. The submitted information will assist the Government of Canada in conducting both health and environmental assessments and, where necessary, to take appropriate risk management actions in relation to those activities. As a result, the Minister has determined that applying the SNAc provisions to quinoline is the preferred option.

The Order contributes to the protection of human health and the environment by requiring industry to submit information on any proposed significant new activity associated with the use of quinoline in its isolated form, and by allowing the health and environmental assessments of the substance in relation to any of the proposed significant new activities prior to their introduction in Canada.

Based on their current business practices, Canadian companies that are currently using or importing coal and coal-derived compounds, which contain quinoline as a natural component, will not be impacted as a result of the Order. Should significant new activities involving the isolated form of the substance occur, costs would be incurred by industry for generating data and other information to be supplied to the Minister. However, it is not expected that current industrial activity patterns would change in the future. As a result, the Order is not expected to impact industry.

In the event that a notification is submitted, the Government of Canada would incur the costs for processing the information in relation to the SNAc and for conducting health and environmental assessments. It is assumed that these costs are unlikely to be incurred, given that no significant new activities involving quinoline in its isolated form are expected. The Government of Canada will incur costs for conducting compliance promotion and enforcement activities associated with the Order. Annual compliance promotion and enforcement costs are expected to be negligible.

Implementation, enforcement and service standards

Compliance

When assessing whether or not a particular SNAc applies, a person is expected to make use of information in their possession or to which they ought to have access. The phrase “to which they ought to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product, are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDS). Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to SNAc provisions due to public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that quinoline is toxic under CEPA 1999, the person in possession of or who has knowledge of the information, and is involved in activities with the substance is obligated, under section 70 of CEPA 1999, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999, provides more detail on this subject. (see footnote 14)

Any person who transfers the physical possession or control of quinoline in its isolated form should notify all persons to whom the physical possession or control is transferred of the obligation to comply with the Order, including the obligation to notify the Minister of any significant new activity and to provide all the required information outlined in the Order.

A pre-notification consultation (PNC) is available for notifiers who wish to consult with the Program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

Where a person has questions concerning his or her obligations to comply with this Order or believes they may be out of compliance, or would like to request a PNC, he or she is encouraged to contact the Substances Management Information Line. (see footnote 15) The Program will work with the person to help him or her comply with the Order.

Implementation

The compliance promotion activities that will be conducted as part of the implementation of the Order include developing and distributing promotional material, responding to inquiries from stakeholders, and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.

Enforcement

The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy (the Policy) implemented under CEPA 1999. (see footnote 16) The Policy also sets out the range of possible responses to violations, including warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for cost recovery.

When an enforcement officer discovers an alleged violation following an inspection or an investigation, the officer will choose the appropriate enforcement action based on the following factors:

Service standards

The Government of Canada will assess all information submitted as part of a SNAN and will communicate the result to the notifier 180 days after the required information is received.

Contacts

Greg Carreau
Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
Fax: 819-938-3231
Email: substances@ec.gc.ca

Michael Donohue
Manager
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@hc-sc.gc.ca