ARCHIVED — Vol. 145, No. 51 — December 17, 2011
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
Canadian Environmental Protection Act, 1999
Department of the Environment and Department of Health
(This statement is not part of the Order.)
Issue and objectives
Canadians depend on chemical substances that are used in hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can negatively affect our health and environment when released in a certain quantity or concentration in the environment. Scientific assessment of the impact of human and environmental exposure to quinoline has determined that this substance has or may have an immediate or long-term harmful effect on the environment or its biological diversity and constitutes or may constitute a danger to human health or to the environment as per the criteria set out under paragraphs 64(a) and 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act).
The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the proposed Order), made under subsection 90(1) of CEPA 1999, is to add quinoline, Chemical Abstracts Service Registry No. (see footnote 1) 91-22-5, to the List of Toxic Substances in Schedule 1 of CEPA 1999, as per the recommendation of the screening assessment.
This addition enables the Minister of the Environment and the Minister of Health (the Ministers) to develop proposed regulations or instruments to manage human health and environmental risks posed by this substance under CEPA 1999. The Ministers may, however, choose to develop instruments outside of the purview of CEPA 1999 to manage these risks.
Description and rationale
Approximately 23 000 substances (often referred to as “existing” substances) were reported to be in use in Canada between January 1, 1984, and December 31, 1986. These substances are found on the Domestic Substances List (DSL), but many of these have never been assessed as to whether they meet any of the toxicity criteria set out in section 64 of CEPA 1999. Section 73 of CEPA 1999 requires that substances on the DSL be “categorized” to determine which of them pose the greatest potential for exposure to the general population as well as those that are persistent or bioaccumulative and inherently toxic to human beings or non-human organisms. Pursuant to section 74 of CEPA 1999, substances that have met the categorization criteria must undergo an assessment to determine whether they meet any of the criteria set out in section 64.
Prior to the categorization exercise, a pilot project for screening assessments was initiated by Environment Canada and Health Canada. The Pilot Project (see footnote 2) initially identified 123 substances that were anticipated to be persistent and/or bioaccumulative and inherently toxic to human and non-human organisms and/or to have a high potential for exposure (not including workplace exposures) to the general population of Canada. Quinoline was selected as one of the 123 substances for the Screening Assessment Pilot Project.
The Ministers completed the categorization exercise in September 2006. Of the approximately 23 000 substances on the DSL, about 4 300 were identified as needing further attention. The categorization exercise confirmed quinoline to be a high priority for assessment because it was categorized as persistent and inherently toxic to non-human organisms, and may present “the greatest potential for exposure” to the public.
The screening assessment (see footnote 3) for quinoline was conducted in order to assess whether the substance meets the criteria set out in section 64 of CEPA 1999 — that is to say, whether the substance 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.
When a substance is found to meet one or more of the criteria set out in section 64, a recommendation can be made that the substance be added to Schedule 1 of CEPA 1999.
The addition of a substance onto Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet their obligations under section 91 of CEPA 1999 (to propose a regulation or other regulatory instruments within two years and to finalize the instrument 18 months later). The Act enables the development of risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health. These instruments can be developed for any aspect of the substance’s life cycle from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. A proposed risk management approach document, which provides an indication of where the Government will focus its risk management activities, has been prepared for quinoline and is available on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/ challenge-defi/quinoline-quinoleine-eng.php.
The draft screening assessment for quinoline was published on the Chemical Substances Web site indicated above, and the statement recommending its addition to Schedule 1 was published in the Canada Gazette, Part Ⅰ, on July 31, 2010, for a 60-day public comment period.
The substance description, assessment summary and conclusions are presented below.
Substance description and assessment summary
Quinoline is naturally present in coal and coal-derived compounds and may be formed as a trace pollutant during incomplete combustion of nitrogen-containing substances. Based on a survey conducted under section 71 of CEPA 1999, one or more companies in Canada reported the manufacture or import of quinoline in excess of 20 000 kg in the year 2000, in the form of mixtures which contained quinoline at a composition of less than 1%.
Quinoline is a component of coal tar-based products, such as sealcoats used on parking lots and driveways and creosote used as a preservative in the lumber and wood industries. Quinoline was also identified as being used as a component in fragrance mixtures.
According to the National Pollutant Release Inventory, in the year 2009, 390 kg of quinoline were released on-site to air, 82 tonnes were transferred off-site as waste for incineration and 578 kg were transferred off-site for landfill disposal. No release to water was reported. Potential sources of quinoline release to water include discharges of creosote, coal tar and associated contaminated groundwater from contaminated sites at former coal gasification plants (or gasworks) and former and existing steel plants equipped with coke ovens, coal tar distillation facilities, wood impregnation plants and aluminum smelters. Quinoline may be emitted to the environment from sources such as automobile exhaust and tobacco smoke as quinoline may be formed during the incomplete combustion of nitrogen-containing substances.
Quinoline has a low potential to bioaccumulate but is expected to be persistent in air during wintertime. Although quinoline is not persistent in surface waters, field evidence suggests that quinoline is not easily degraded by micro-organisms living in deep soil and groundwater, and hence is expected to be persistent in these media. Estimated dissolved quinoline concentrations in water were significantly above the predicted no-effect concentration of 3.4 µg/L calculated for fish. Based on the calculated risk quotients, quinoline has the potential to cause harmful effects to groundwater micro-organisms, organisms living at the sediment-water interface and early life stages of fish found on spawning grounds near contaminated sites.
Exposure of the general population in Canada to quinoline, mainly through air inhalation, is expected to be low. Canadians are exposed to quinoline from incomplete combustion of nitrogen-containing substances (e.g. tobacco, petroleum and coal) and from the use of consumer products containing quinoline.
On the basis of the empirical evidences that increased incidences of unusual tumours were observed in multiple strains of rats and mice exposed to quinoline orally, the critical effect for the characterization of risk of quinoline to human health is considered to be carcinogenicity. The United States Environmental Protection Agency (EPA) had previously drawn the same conclusion. In addition, in experimental studies, quinoline exhibited effects causing damage to DNA and altering cell reproduction and regeneration. Therefore, although the mode of induction of tumours of quinoline has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction of quinoline or its metabolites with genetic materials, for which there may be a probability of harm at any level of exposure.
On the basis of ecological hazard and reported releases of quinoline, it is concluded that this substance is entering 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 as per criteria set out under paragraph 64(a) of CEPA 1999.
On the basis of the carcinogenicity of quinoline, for which there may be a probability of harm at any level of exposure, it is concluded that quinoline is a substance that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as per criteria set out under paragraph 64(c) of CEPA 1999.
It is therefore concluded that quinoline meets one or more criteria under section 64 of CEPA 1999. Quinoline is thus proposed for addition to Schedule 1 of CEPA 1999. Additionally, quinoline meets the criteria for persistence but not for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.
The final screening assessment report and the proposed risk management approach document may be obtained from the Chemical Substances Web site at www. chemicalsubstanceschimiques.gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), firstname.lastname@example.org (email).
The following measures can be taken after an assessment is conducted under CEPA 1999:
- adding the substance to the Priority Substances List for further assessment (when additional information is required to determine if a substance meets the criteria in section 64 or not);
- taking no further action in respect of the substance; or
- recommending that the substance be added to the List of Toxic Substances in Schedule 1 and, where applicable, the implementation of virtual elimination.
It has been concluded in the final screening assessment that quinoline is entering 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 as set out in paragraph 64(a) of CEPA 1999. Also, it was concluded that quinoline is entering, or may enter, the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999. Adding quinoline to Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.
Benefits and costs
This addition enables the Ministers to develop proposed regulations or instruments to manage risks posed by this substance under CEPA 1999. These include instruments such as pollution prevention plans, guidelines or codes of practice. The Ministers may, however, choose to develop instruments outside of the purview of the Act to help protect human health and the environment. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.
On July 31, 2010, the Ministers published a summary of the scientific assessments for quinoline in the Canada Gazette, Part Ⅰ, for a 60-day public comment period. The risk management scope document was also released on the same date, outlining the preliminary options being examined for the management of quinoline. No comments were received during the 60-day public comment period.
Environment Canada and Health Canada also informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessment report, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.
Implementation, enforcement and service standards
The proposed Order would add quinoline to Schedule 1 of CEPA 1999, thereby allowing the Ministers to meet their obligation to publish a proposed regulation or other management instruments within 24 months after the publication of the final screening assessment, which will be fall 2013. Also, the risk management instruments will be finalized within 18 months after the publication of the proposal, which will be spring 2015. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for quinoline.
Acting Executive Director
Program Development and Engagement Division
Substances Management Information Line
Telephone: 1-800-567-1999 (toll free in Canada)
Telephone: 819-953-7156 (outside of Canada)
Risk Management Bureau
Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-953-7155 or by email to email@example.com.
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, December 8, 2011
Assistant Clerk of the Privy Council
ORDER ADDING A TOXIC SUBSTANCE TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 4) is amended by adding the following:
Quinoline, which has the molecular formula C9H7N
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Information on the Pilot Project can be viewed at www.chemicalsubstanceschimiques.gc.ca/about-apropos/assess-eval/projet-pilot-project/index-eng.php.
This screening assessment is an update of the State of the Science Report, which was conducted in 2005 and published on Health Canada’s Web site (www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/quinoline-quinoleine/quinoline-eng.pdf) on January 30, 2006. The State of the Science Report has been peer reviewed and all comments were taken into consideration in finalizing the State of the Science Report.
S.C. 1999, c. 33
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33