PROPOSED RISK MANAGEMENT APPROACH

for

Quinoline

Chemical Abstracts Service Registry Number (CAS RN): 91-22-5

Environment Canada Health Canada

November 2011

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Table of Contents

1. ISSUE 3

1.1 PILOT PROJECT BACKGROUND 3 1.2 FINAL SCREENING ASSESSMENT REPORT CONCLUSION FOR QUINOLINE 4 1.3 PROPOSED MEASURE 4

2. BACKGROUND 5 2.1 SUBSTANCE INFORMATION 5

3. WHY WE NEED ACTION 6 3.1 CHARACTERIZATION OF RISK 6

4. CURRENT USES AND INDUSTRIAL SECTORS 7

5. PRESENCE IN THE CANADIAN ENVIRONMENT AND EXPOSURE SOURCES 8 5.1 RELEASES TO THE ENVIRONMENT 8 5.2 EXPOSURE SOURCES 9

6. OVERVIEW OF EXISTING ACTIONS 10 6.1 EXISTING CANADIAN RISK MANAGEMENT 10 6.2 EXISTING INTERNATIONAL RISK MANAGEMENT 11

7. CONSIDERATIONS 12 7.1 ALTERNATIVE CHEMICALS OR SUBSTITUTES 12 7.2 ALTERNATIVE TECHNOLOGIES AND/OR TECHNIQUES 12 7.3 SOCIO-ECONOMIC CONSIDERATIONS 12 7.4 CHILDREN’S EXPOSURE 12

8. PROPOSED OBJECTIVES 13 8.1 ENVIRONMENTAL AND HUMAN HEALTH OBJECTIVES 13 8.2 RISK MANAGEMENT OBJECTIVES 13

9. PROPOSED RISK MANAGEMENT 13 9.1 PROPOSED RISK MANAGEMENT INSTRUMENT AND INFORMATION GATHERING ACTIVITIES 13 9.2 IMPLEMENTATION PLAN 14

10. CONSULTATION APPROACH 14

11. NEXT STEPS / PROPOSED TIMELINE 15

12. REFERENCES 16

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This proposed risk management approach document builds on the previously released risk management scope document for quinoline, and outlines the proposed control actions for this substance. Stakeholders are invited to submit comments on the content of this proposed risk management approach or provide other information that would help to inform decision making. Following this consultation period, the Government of Canada will initiate the development of the specific risk management instrument(s) and/or regulation(s) where necessary. Comments received on the proposed risk management approach will be taken into consideration in developing the instrument(s) and/or regulation(s). Consultation will also take place as individual instrument(s) and/or regulation(s) are developed.

SUMMARY OF PROPOSED RISK MANAGEMENT

1. The Government of Canada plans to implement Significant New Activity provisions under CEPA 1999 to this substance. This would require that any proposed new manufacture, import or use be subject to further assessment, and would determine if the new activity requires further risk management consideration.

Note: This summary is an abridged list of the instruments and tools proposed to risk manage this substance. Please see section 9 of this document for a complete explanation of risk management.

1. ISSUE

1.1 Pilot Project Background

The substance quinoline, Chemical Abstract Service Registry Number (CAS RN)1 91-22-5, was identified in a pilot project list of 123 substances for screening assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) on the basis of 1) its potential persistence in the environment and inherent toxicity to non human organisms; and 2) its anticipated high potential for human exposure. CEPA 1999 requires the Minister of the Environment and the Minister of Health (the Ministers) to categorize all substances on the Domestic Substances List (DSL). Further to this activity, the Act requires the Ministers to conduct screening assessments of substances that meet the categorization criteria to determine whether these substances meet one or more of the criteria set out in section 64 of the Act.2

1 CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information 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 of Canada 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. 2 A determination of whether one or more of the criteria of section 64 are met and whether risk management may be required is based upon an assessment of potential risks to the environment and/or to human health associated with exposures in the general environment. For humans, this includes, but is not limited to, exposures from ambient and indoor air, drinking water, foodstuffs and the use of consumer products. A conclusion under CEPA 1999 is not relevant to nor does it preclude an assessment against the hazard criteria specified in the Workplace Hazardous Materials Information System [WHMIS] Controlled Products Regulations for products intended for workplace use.

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1.2 Final Screening Assessment Report Conclusion for Quinoline

A notice summarizing the scientific considerations of the final screening assessment report was published for quinoline by Environment Canada and Health Canada in the Canada Gazette, Part I, on November 19, 2011, under subsection 77(6) of CEPA 1999. On the basis of ecological hazard and estimated releases of quinoline, the final screening assessment report concluded 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. Additionally quinoline meets the criteria for persistence but not for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations (Canada 2011). On the basis of the carcinogenicity of quinoline, together with potential for general population exposure, the final screening assessment report also 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 (Canada 2011). Based on available information for environmental and human health considerations, it is concluded that quinoline meets one or more of the criteria set out in section 64 of CEPA 1999 (Canada 2011). For further information on the final screening assessment report conclusion for quinoline, refer to the final screening assessment report, available from http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/other_chem-autres_sub-eng.php.

1.3 Proposed Measure

As a result of a screening assessment of a substance under section 74 of CEPA 1999, the substance may be found to meet one or more of the criteria under section 64 of CEPA 1999. The Ministers can propose to take no further action with respect to the substance, add the substance to the Priority Substances List (PSL) for further assessment, or recommend the addition of the substance to the List of Toxic Substances in Schedule 1 of the Act. Under certain circumstances, the Ministers must make a specific proposal to recommend the implementation of virtual elimination. In this case, the Ministers proposed to recommend the addition of quinoline to the List of Toxic Substances in Schedule 1. As a result, the Ministers will develop a regulation or instrument respecting preventive or control actions to protect the health of Canadians and the environment from the potential effects of exposure to this substance. Quinoline is not subject to the virtual elimination provisions under CEPA 1999 and will be managed using a lifecycle approach, to prevent or minimize its release into the environment.

Proposed Risk Management Approach for Quinoline Government of Canada

2. BACKGROUND

2.1 Substance Information

Quinoline is an organic base that belongs to the group of nitrogen heterocycles or aza-arenes. Table 1 presents other names, trade names, chemical groupings, the chemical formula, the chemical structure and the molecular mass for quinoline. Table 1. Identity of Quinoline CAS RN 91-22-5 DSL name Quinoline

NCI names Benzo[b]pyridine (ECL) Quinoline (AICS, ASIA-PAC, EINECS, ENCS, NZIoC, PICCS, SWISS, TSCA)

Other names 1-Azanaphthalene, 1-Benzazine, 1-Benzine, Benzopyridine, 2,3-Benzopyridine, Chinoleine, Chinolin, Chinoline, Leucol, Leucoline, Leukol, Quinolin

Chemical group (DSL stream) Discrete organics

Major chemical class or use N-Heterocycles (aza-arenes)

Major chemical subclass Quinolines

Chemical formula C9H7N

Chemical structure

N

quinoline (base)

N

quinolinium ion(conjugated acid)

1

2

3

45

6

7

8 H+

SMILES C12C(CCCC1)NCCC2 Molecular mass 129.16 g/mol

Abbreviations: AICS, Australian Inventory of Chemical Substances; ASIA-PAC, Asia-Pacific Substances Lists; CAS RN, Chemical Abstracts Service Registry Number; DSL, Domestic Substances List; ECL, Korean Existing Chemicals List; EINECS, European Inventory of Existing Commercial Chemical Substances; ENCS, Japanese Existing and New Chemical Substances; NCI, National Chemical Inventories; NZIoC, New Zealand Inventory of Chemicals; PICCS, Philippine Inventory of Chemicals and Chemical Substances; SMILES, simplified molecular input line entry specification; SWISS, Swiss Giftliste 1 and Inventory of Notified New Substances; TSCA, Toxic Substances Control Act Chemical Substance Inventory. Source: NCI 2006

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3. WHY WE NEED ACTION

3.1 Characterization of Risk

Characterization of Ecological Risk The approach taken in the ecological portion of the screening assessment (Canada 2011) was to examine various supporting information and develop conclusions based on a weight of evidence approach as required under section 76(1) of CEPA 1999. Particular consideration has been given to risk quotient analyses, persistence, inherent toxicity, environmental realism of the exposure scenario used to derive predicted environmental concentrations (PECs) and widespread occurrence in the environment. Endpoint organisms have been selected based on analysis of exposure pathways. For each endpoint organism, a conservative (reasonable worst-case) PEC and a predicted no-effect concentration (PNEC) are determined. The PNEC is arrived at by selecting the lowest critical toxicity value (CTV) for the organism of interest and dividing it by an application factor appropriate for the data point. A risk quotient (PEC/PNEC) is calculated for each of the endpoint organisms in order to contribute to the characterization of ecological risk in Canada. An exposure scenario was designed whereby a contaminated groundwater plume containing quinoline develops from a pure coal tar pool in the soil and eventually comes into contact with surface water. It was based on field observations of coal tar plumes made at abandoned gasworks sites and coke oven sites in Canada. This exposure scenario would be relevant to former and current industrial applications producing or handling coal tar or creosote on-site, including coal tar distillation plants, creosoting plants and roofing felt and tarred paper manufacturing facilities, as well as abandoned gasworks and coke ovens, where storage and disposal of coal tar and creosote have led to a release of these chemical mixtures to the subsurface. Estimated dissolved quinoline concentrations were many times above the PNEC of 3.4 µg/L calculated for fish. Based on the risk quotients calculated in the assessment, quinoline has the potential to cause harmful effects to groundwater microorganisms, organisms living at the sediment–water interface, and early life stages of fish found on spawning grounds. Quinoline is determined to be persistent in accordance with the Persistence and Bioaccumulation Regulations of CEPA 1999 (Canada 2000a), based on observations of its persistence in deep soils, groundwater and air in winter. Available empirical aquatic toxicity data indicate that quinoline may be harmful to aquatic organisms at relatively low concentrations, below 1 mg/L for acute tests and below 0.1 mg/L for chronic tests. In addition, available evidence indicates that quinoline can be biotransformed in fish to an epoxide derivative that can covalently bind to nucleic acids (i.e., form a DNA adduct), resulting in mutagenic effects (Bean et al. 1985). Quinoline has been detected in a variety of media in Canada. For example, it has been detected in agricultural soils and street sediments in Ontario and in bottom sediments of rivers near industrial areas, although not in concentrations exceeding the calculated PNECs. The receiving environment of the modelled exposure scenario is representative of a high proportion of aquatic systems next to sites impacted by coal tar and creosote in Canada. This observation is supported by information contained in inventories of former coal gasification sites and industrial sites

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where coal tar was stored and handled which are available for Quebec, Ontario and other provinces (RDRC 1987; MENVIQ 1988; MOEE 1997). Characterization of Risk to Human Health Evaluation of risk to human health involves consideration of data relevant to estimation of exposure (non-occupational) of the general population, as well as information on health effects. A critical effect for the characterization of risk of quinoline exposure to human health is carcinogenicity, based on the observation of hemangioendotheliomas in multiple strains of rats and mice exposed orally. In addition, quinoline induced hepatoadenomas and carcinomas following intraperitoneal injection and initiated skin tumours following dermal application in mice. Quinoline was also genotoxic and mitogenic in several in vitro and in vivo assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material, for which there may be a probability of harm at any level of exposure (Canada 2011). Exposure of the general population to quinoline is expected to be mainly from air. Comparison of the critical effect level for non-cancer effects (i.e., 25 mg/kg-bw per day) with the upper-bounding estimate of exposure (i.e., 0.03 µg/kg-bw per day) results in a margin of exposure of approximately 5 orders of magnitude (approximately 800 000). If exposure to quinoline through use of consumer products is considered, the margin of exposure would remain in the same range of magnitude. These margins of exposure for non-cancer effects are considered adequate (Canada 2011). On the basis of the carcinogenicity of quinoline, together with potential for general population 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 (Canada 2011). 4. CURRENT USES AND INDUSTRIAL SECTORS

Quinoline is naturally associated with coal and coal-derived compounds such as coal tar and creosote (Canada 2011).

Coal Tar Historically, coal gasification plants were located at most urban centers in Canada to manufacture coal gas from coal. The resulting waste product from this process was coal tar, which was stored and/or disposed of at or near plant facilities. Quinoline is present in coal tar at levels of less than 1% by weight (Canada 2011). Currently, in Canada and elsewhere, coal tar is recovered from coke ovens at integrated steel mills and is used to manufacture coal tar pitch, creosote and naphthalene. Coal tar pitch is used in the production of electrodes in aluminum smelters and is also used as an ingredient in certain consumer and commercial products such as coal tar-based pavement sealants (Canada 2011).

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Creosote Creosote is distilled from coal tar in Canada and is registered in Canada for use as a heavy-duty wood preservative under the Pest Control Products Act (PMRA 2010). Major uses at wood preservation facilities located across Canada include treatment of railway ties, utility poles for export, and pilings and timbers for marine applications (Environment Canada 1999a). Quinoline is present in creosote at levels of less than 1% by weight (Environment Canada 1999b).

Information received from a notice published under section 71 of CEPA, 1999 indicates that more than 20 000 kg of quinoline were manufactured in or imported into Canada in 2000 in materials at concentrations of less than 1.0% (Environment Canada 2001a). Reported activities associated with quinoline included coal tar distillation, coke production and manufacturing of an industrial by-product. It is described in public literature that quinoline may be used as a solvent, chemical intermediate, corrosion inhibitor and in the manufacture of pharmaceuticals, although there is no evidence of these uses in Canada (Finley 1996; HSDB 2009). Industrial applications of quinoline include the manufacture of methine dyes and the production of terpene, as a decarboxylation reagent, as a solvent of polycyclic aromatic hydrocarbons (PAHs) in paint production, as well as being a chemical intermediate and anti-foaming agent in petrochemical manufacturing (Scorecard 2005; HSDB 2009). Quinoline was identified as being used as a component in fragrance mixtures (RIFM 2003). 5. PRESENCE IN THE CANADIAN ENVIRONMENT AND EXPOSURE SOURCES

5.1 Releases to the Environment

Soil, Groundwater, Sediment and Surface Water The final screening assessment report indicated that there is a potential for the release of quinoline at levels that pose a risk to the environment from sites where pure coal tar or creosote had leaked into the subsurface and formed a pool of pure non-aqueous phase liquid in soil. When a pool of coal tar or creosote is present in the subsurface, it is possible that quinoline can dissolve into groundwater and, subsequently, be transported to surface water and sediments at the groundwater-surface water interface (Canada 2011). The presence of pure phase coal tar has been documented at properties where former coal gasification plants operated. Other sites where historic industrial activities resulted in the release of coal tar or creosote include steel plants equipped with coke ovens, coal tar distillate (creosote) facilities, wood preservation facilities, roofing products manufacturing facilities and aluminum smelters. An inventory of sites completed in 1987 identified 150 former coal gasification plants or industrial facilities where coal tar might be found. In the 1980s and 1990s, many of these large industrial sites underwent environmental investigations and were determined to contain pure phase coal tar in soils and within fractures in subsurface bedrock (Canada 2011). The number of sites in Canada where pure coal tar or creosote is still found in the subsurface soils or bedrock is not known, although it is recognized that a significant number have been subject to

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either remediation efforts or monitoring programs. Due to the implementation of a variety of risk management measures for substances that are found in coal tar and creosote, current industrial practices are not considered likely to result in significant release of pure coal tar or creosote. These measures are described in Annex 1. No release of quinoline to water was reported to the National Pollutant Release Inventory (NPRI) for 2009, however, minor releases of other substances associated with coal tar - polycyclic aromatic hydrocarbons (PAHs) - were reported from integrated steel mills (< 20 kg total) and aluminum smelting (< 35 kg total). Coal tar based pavement sealants were identified in the assessment report as a possible source of quinoline to soil and/or sewer as a result of commercial and consumer application. It is estimated that a total of 10 500 ± 50% tonnes of coal tar-based pavement sealants are sold in Canada per year. In a recent study, the quinoline content of two commercial coal-tar based pavement sealants was been measured to be on the order of 0.1% w/w. Quinoline concentrations measured in wet sealants and dried sealants showed that 80-90% of quinoline was released to air within 48 hours of application (Diamond Environmental Group, 2011). The resulting low concentration of quinoline in the cured sealants indicates a low likelihood for these products to release significant amounts of quinoline to water through leaching.

Air Quinoline is formed during incomplete combustion of nitrogen-containing substances (e.g., petroleum, coal) and is dispersed in the environment as a component of suspended particulate matter emitted from sources such as automobile exhaust and petroleum or coal refining facilities. Quinoline has been measured in the atmosphere of urban areas. Industrial atmospheric releases of 390 kg were reported to the National Pollutant Release Inventory (NPRI) in 2009 from manufacturing plants (chemicals and pavement sealants) and from one coal tar distillation facility. An additional 83 tonnes were reported to be disposed of through off-site incineration (82 tonnes) and landfill (<1 tonne) (NPRI 2011).

5.2 Exposure Sources

Environmental Exposures The exposures of environmental concern described in the final screening assessment report for quinoline include exposure of micro-organisms in groundwater, benthic organisms in sediment at groundwater discharge locations and aquatic organisms in surface water in the vicinity of sites where pure phase creosote or coal tar is found in subsurface soils. Because of a paucity of information, exposure scenarios were not developed and characterized for ecological risk for the following potential releases of quinoline to the environment: atmospheric emissions from steel plants equipped with coke ovens and aluminum smelters; emissions to soil and water from industrial facilities currently handling coal tar or creosote; use of coal tar based asphalt sealants and roofing materials; creosote-impregnated wood used in harbour docks; and creosote-impregnated railroad ties and frames used in support walls along

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lake shorelines. Therefore, the risk to the environment due to quinoline releases from these sources is currently not known (Canada 2011). Human Health Exposures The screening assessment report for quinoline indicates that inhalation, in particular inhalation of indoor air, is the primary route of exposure for the general population. Potential sources of indoor air exposure to quinoline include consumer products and combustion. The estimate of exposure from consumer products did not contribute significantly to the estimate of exposure from environmental media, suggesting that consumer products are not the main source of quinoline in indoor air. Several studies identified a strong correlation between indoor air levels of quinoline and cigarette smoke and/or fireplace use, suggesting that combustion sources, principally cigarette smoking within the home, are the main sources of quinoline in the indoor environment (Air Resources Board 1993; Chuang et al. 1991).

6. OVERVIEW OF EXISTING ACTIONS

6.1 Existing Canadian Risk Management

The proposed Risk Management Scope document for quinoline indicated that Environment Canada would conduct a regulatory gap analysis to verify that handling and storage requirements for coal tar and creosote at existing facilities would prevent the release of quinoline to the environment. Results from this analysis suggest that quinoline is not likely being released in quantities of concern from ongoing industrial activities identified in British Columbia, Ontario and Quebec due to the existence of municipal and provincial controls on facilities manufacturing and using coal tar, coal tar pitch and creosote. These measures apply at various points where quinoline could be released to the environment and include requirements for effluent monitoring and quality (PAH limits exist for some facilities), spill containment and spill contingency planning, and disposal of wastes. See Annex 1 for a complete list of these measures. At a federal level, following risk assessments on both PAHs (1994) and “creosote-impregnated waste materials from creosote-contaminated sites” (1993), these substances were added to Schedule 1 of CEPA 1999, and several risk management measures were implemented to reduce environmental releases of PAHs and to prevent the creation of creosote-contaminated sites. It is likely that these initiatives have been (and continue to be) effective at controlling releases of quinoline from these sources. See Annex 1 for a complete list of these measures. Federal measures or requirements in place implicating quinoline directly include the following:

• National Pollutant Release Inventory (NPRI). For facilities with more than 20,000 employees hours (i.e. 10 employees) or undertaking specified activities (such as incineration), releases, disposals and transfers for recycling of quinoline would be required to be reported annually to Environment Canada if the threshold of 10 tonnes at 1% weight concentration (except for by-products and mine tailings), is exceeded. (NPRI 2011).

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• Quinoline is found on Schedule 5 to the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations(Canada 2005).

• Quinoline is listed on Schedule 1 under the Regulations for the Prevention of Pollution from Ships and for Dangerous Chemicals under the Canada Shipping Act (Canada 2007).

• Transport of Dangerous Goods Regulations under the Transportation of Dangerous Goods Act (Canada 2008). Quinoline is classified under class 6.1 (toxic by inhalation). These Regulations establish safety requirements for the transportation of dangerous goods, including means of containment, training, emergency response assistance plans (ERAP), and accidental release and imminent accidental release report requirements.

• The Tobacco Reporting Regulations (Canada 2000b) under the Tobacco Act require reporting emissions of quinoline. Canadians are reminded that they should not smoke. For more information about smoking and how to quit, please visit the Health Concerns - Tobacco section of Health Canada's Web site (http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/index-eng.php) or speak with a doctor.

Several national (i.e., the Canadian Council of Ministers of the Environment – CCME) and provincial water quality standards/guidelines/objectives have been established, including the following:

• CCME Water Quality Guidelines for the Protection of Aquatic Life of 3.4 μg/L (CCME 1999)

• CCME Soil Quality Guidelines - interim remediation criteria for soil (agricultural land use) of 0.1 mg/kg (CCME 1991). The 1991 interim remediation criteria were based on best professional judgement but are considered generally protective of human and environmental health; they are slowly being replaced with more science/risk-based criteria. These guidelines provide a benchmark against which landowners can assess soil data for quinoline when assessing and remediating contaminated sites. They may also be incorporated into existing provincial contaminated site regulations.

• Ontario interim provincial water quality objective of 10 μg/L (MOEE 1994) • The British Columbia Interim Surface Water Quality Guideline of 3.4 μg/L (BC MOE

2006). • British Columbia’s Contaminated Sites Regulation (B.C. Reg. 375/96), Schedule 6

establishes a generic numerical water standard of 34 μg/L for quinoline for the protection of aquatic life (aquatic life guideline multiplied by 10 to account for dilution in the aquifer prior to discharge to surface; BC MOE 1996).

6.2 Existing International Risk Management

International Maritime Organization (UN) • Quinoline is featured in the Dangerous Goods List of the IMDG Code (the International

Maritime Dangerous Goods Code dealing with packaged materials) under UN No. 2656, where it is classified as a toxic substance (Class 6.1) (UN 1973)

United States

• U.S. Toxics Release Inventory (TRI). Facilities must report information on disposal or other releases of quinoline to TRI if they manufacture or process >55,000 kg (25,000 lbs)

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of quinoline or otherwise use >22,000 kg (10,000 lbs) of quinoline in a given year above a 1% minimum concentration limit (US EPA 2011).

• Clean Air Act 1990: Quinoline is on the list of 188 hazardous air pollutants (US 1990). It is also included in the Integrated Urban Strategy, on a priority list of 33 urban air toxics (US EPA 1999).

• Clean Water Act : Quinoline is designated as an hazardous substance under the Act, which controls release of substances into water (US 1972).

• Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA): Quinoline is listed as a hazardous substance which requires spill reporting of releases over 2270 kg (5000 lbs) (US 1980)

European Union REACH

• Quinoline is registered under REACH and is not subject to any restrictions at this time. 7. CONSIDERATIONS

7.1 Alternative Chemicals or Substitutes

Quinoline is naturally associated with coal and coal-derived compounds and therefore cannot be substituted for within these compounds. No substitutes have been identified for intentional uses of quinoline.

7.2 Alternative Technologies and/or Techniques

No information is available on alternative technologies or techniques that would eliminate the use of quinoline in its intentional uses. A variety of industrial practices are used to minimize the release of PAHs from activities involving coal and coal-derived compounds such as steel milling, coal-tar refining and aluminum smelting. These practices are likely to reduce the release of quinoline along with PAHs. The risk management tools (e.g., codes of practice, performance agreements) relevant to PAHs that outline these practices are listed in Annex 1.

7.3 Socio-economic Considerations

Socio-economic factors will be considered in the development of regulations, instrument(s) and/or tool(s) as identified in the Cabinet Directive on Streamlining Regulation (Treasury Board of Canada Secretariat 2007) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action.

7.4 Children’s Exposure

The Government of Canada considered, where available, risk assessment information relevant to children’s exposure to this substance. Given the information considered, it is proposed that no risk management actions to specifically protect children are required for this substance at this time.

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8. PROPOSED OBJECTIVES

8.1 Environmental and Human Health Objectives

An environmental or human health objective is a quantitative or qualitative statement of what should be achieved to address environmental or human health concerns identified during a risk assessment. The proposed environmental objective for quinoline is to minimize releases of the substance to soil and water to levels that are protective of the environment and its biological diversity. The proposed human health objective for quinoline is to minimize human exposure to the greatest extent practicable.

8.2 Risk Management Objectives

A risk management objective is a target expected to be achieved for a given substance by the implementation of risk management regulations, instrument(s) and/or tool(s). As exposures of Canadians to quinoline and existing environmental releases of quinoline are considered to be low under the current use conditions, the proposed environmental and health risk management objective is to prevent increases in exposure. A secondary proposed environmental risk management objective for quinoline is to limit releases from contaminated sites. 9. PROPOSED RISK MANAGEMENT

9.1 Proposed Risk Management Instrument and Information Gathering Activities

As required by the Government of Canada’s Cabinet Directive on Streamlining Regulation3 and criteria identified in the Treasury Board document entitled Assessing, Selecting, and Implementing Instruments for Government Action, the proposed risk management instrument was selected using a consistent approach, and took into consideration the information that was available at the time. In order to achieve the risk management objectives and to work towards achieving the environmental and human health objectives for quinoline, the risk management being considered is the application of Significant New Activity provisions of CEPA 1999 to quinoline. This would require that any proposed new manufacture, import or use be subject to further assessment, and would determine if the new activity requires further risk management consideration. Environment Canada will review existing CCME Canadian Soil Quality Guidelines for quinoline and these guidelines will be updated, where feasible and appropriate. The RM Scope indicated that Environment Canada proposed to consult with provincial and municipal partners to

3 Section 4.4 of the Cabinet Directive on Streamlining Regulation states that “Departments and agencies are to: identify the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures, and justify their application before submitting a regulatory proposal”.

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determine the status of any ongoing or completed remediation programs at former coal gasification and industrial sites, as well as existing or proposed provincial regulatory instruments with respect to the management of contaminated sites that may contain quinoline. This work has been initiated and is ongoing. Quinoline has been determined to meet the emergency hazard criteria as set out in section 200 of CEPA 1999. It is therefore a possible candidate for future addition to the Environmental Emergency Regulations. To assess progress towards meeting the environmental and risk management objectives for quinoline and to provide additional information to verify the results of the regulatory gap analysis, quinoline will be considered for sediment, surface water and/or wastewater monitoring under the Chemicals Management Plan Environmental Monitoring and Surveillance Program. The Government will also consider lowering the reporting threshold for quinoline under the National Pollutant Release Inventory (NPRI). In addition, as part of the Canadian Health Measures Survey, Cycle 2 (2009–2011), approximately 5600 households across the country will have their indoor air sampled for a number of airborne substances, including quinoline. These data will provide national estimates of quinoline concentrations in Canadian households (2010 email from Chemicals Surveillance Bureau, Health Canada to Risk Management Bureau, Health Canada; unreferenced). The Government of Canada is planning an assessment of coal-tar and coal-tar pitch as part of the Petroleum Sector Stream Approach. Because quinoline occurs naturally in coal tar and coal-tar pitch, additional risk management activities affecting quinoline could be proposed under a comprehensive risk management strategy for coal-tar and coal-tar pitch, if determined to be necessary.

9.2 Implementation Plan

The proposed regulation or instrument respecting preventative or control actions in relation to quinoline will be published in the Canada Gazette, Part 1, no later than November 19, 2013, as per the timelines legislated in CEPA 1999. 10. CONSULTATION APPROACH The risk management scope document for quinoline, which summarized the proposed risk management under consideration at that time, was published on July 31, 2010. Industry and other interested stakeholders were invited to submit comments on the risk management scope document during a 60-day comment period. No comments were received on the proposed risk management scope document for quinoline. Consultation for the proposed risk management for quinoline will involve publication of the proposed Risk Management Approach document on November 19, 2011, and a 60-day public comment period.

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The primary stakeholders include

• Coal tar contaminated site landowners • Provincial/territorial and municipal governments • Industrial sectors using coal-tar or creosote products • Non-governmental organizations

11. NEXT STEPS / PROPOSED TIMELINE

Actions Date

Electronic consultation on proposed risk management approach document

November 19, 2011 to January 19, 2012

Response to comments on proposed the risk management approach document

No later than the time of publication of the proposed instrument

Publication of the proposed instrument No later than November 2013

Publication of the final instrument No later than May 2015

Industry and other interested stakeholders are invited to submit comments on the content of this proposed risk management approach or provide other information that would help to inform decision making. Please submit comments or information prior to January 19, 2012 since the risk management of quinoline will be moving forward after this date. During the development of the proposed instrument there will be opportunity for consultation. Comments and information submissions on the proposed risk management approach should be submitted to the address provided below: Chemicals Management Division Gatineau Quebec K1A 0H3 Tel: 1-888-228-0530 / 819-956-9313 Fax: 819-953-7155 Email: Substances@ec.gc.ca

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12. REFERENCES Air Resources Board. 1993. Indoor concentrations of polycyclic aromatic hydrocarbons in California residences. Final report. RTI321U-5038/010-3F. Sacramento (CA): Air Resource Board, [BC MOE 1988] British Columbia Ministry of Environment. Environmental Management Act: Hazardous Waste Regulation B.C. Reg. 63/88. Victoria (BC): Queen’s Printer. February 1988. [BC MOE 1996] British Columbia Ministry of Environment. 1996. Environmental Management Act: Contaminated Sites Regulation B.C. Reg. 375/96. Victoria (BC): Queen’s Printer. December 1996. [BC MOE 2006] British Columbia Ministry of Environment. 2006. A Compendium of Working Water Quality Guidelines for British Columbia Table 1. Available at: http://www.env.gov.bc.ca/wat/wq/BCguidelines/working.html#table1 Bean RM, Dauble DD, Thomas BL, Hanf RW Jr, Chess EK. 1985. Uptake and biotransformation of quinoline by rainbow trout. Aquat Toxicol 7: 221–239. Canada. 1993. Priority Substances List Assessment Report. Creosote-impregnated Waste Materials. Available at: http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/psl1-lsp1/creosote/creosote-eng.pdf Canada. 1994. Priority Substances List Assessment Report. Polycyclic Aromatic Hydrocarbons. Available at: http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/psl1-lsp1/hydrocarb_aromat_polycycl/hydrocarbons-hydrocarbures-eng.pdf Canada. 1999. Canadian Environmental Protection Act, 1999. S.C., 1999, ch. 33. Canada Gazette. Part III, vol. 22, no.3. Ottawa: Queen’s Printer. Available at: http://www.gazette.gc.ca/archives/p3/1999/g3-02203.pdf Canada. 2000a. Canadian Environmental Protection Act: Persistence and Bioaccumulation Regulations, P.C. 2000-348, 23 March 2000, SOR/2000-107. Canada Gazette. Part II, vol. 134, no. 7, p. 607−612. Ottawa: Queen’s Printer. Available at: http://www.gazette.gc.ca/archives/p2/2000/2000-03-29/pdf/g2-13407.pdf Canada. 2000b. Tobacco Act: Tobacco Reporting Regulations, P.C. 2000-1040,19 July 2000, SOR-2000/273. Canada Gazette, Part II, vol. 135, no. 15, p. 1761–1792. Ottawa: Queen’s Printer. Available at: http://www.gazette.gc.ca/archives/p2/2000/2000-07-19/pdf/g2-13415.pdf Canada. 2005. Canadian Environmental Protection Act, 1999: Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations, P.C. 2005-930, 17 May 2005, SOR/2005-149. Canada Gazette. Part II, vol. 139, no. 11, p. 1197–1304. Ottawa: Queen’s Printer. Available at: http://www.gazette.gc.ca/archives/p2/2005/2005-06-01/pdf/g2-13911.pdf Canada. 2007. Canada Shipping Act: Regulations for the Prevention of Pollution from Ships and for Dangerous Chemicals, P.C. 2007-699, 3 May 2007, SOR/2007-86. Canada Gazette. Part II, vol. 141, no. 10, p. 705–768. Ottawa: Queen’s Printer. Available at: http://www.gazette.gc.ca/archives/p2/2007/2007-05-16/pdf/g2-14110.pdf Canada. 2008. Transportation of Dangerous Goods Act: Consolidated Transportation of Dangerous Goods Regulations including Amendment SOR/2008 (Amendment 6). [cited 2008 Feb]. Available at: http://www.tc.gc.ca/tdg Canada. 2011. Dept. of the Environment, Dept. of Health. Screening Assessment Report for Quinoline, Chemical Abstracts Service Registry Number (CAS RN): 91-22-5. Available at: http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/other_chem-autres_sub-eng.php [CCME] Canadian Council of Ministers of the Environment. 1991. Canadian soil quality guidelines for the protection of environmental and human health. Available at: http://www.ccme.ca/assets/pdf/rev_soil_summary_tbl_7.0_e.pdf

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[CCME] Canadian Council of Ministers of the Environment. 1999. Canadian water quality guidelines for the protection of aquatic life. Polycyclic Aromatic Hydrocarbons. Available at: http://ceqg-rcqe.ccme.ca/download/en/201/ Chuang JC, Mack GA, Kuhlman MR, Wilson NK. 1991. Polycyclic aromatic hydrocarbons and their derivatives in indoor and outdoor air in an eight-home study. Atmos Environ 25B(3):369–380. Diamond Environmental Group (University of Toronto). 2011. Reconnaissance Study of Coal Tar Sealcoat Application in Toronto and an Estimate of Related PAH Emissions. Report prepared for Environment Canada. [EHS] Environmental Health Strategies Inc. 2010. Technical and Economical Study of VOCs from Coal-tar Based Pavement Sealants. Toronto (ON). Report prepared for Environment Canada.. Environment Canada. 1999a. Recommendations for the Design and Operation of Wood Preservation Facilities. March 1999. Available from the Inquiry Center at: http://www.ec.gc.ca/Publications/default.asp?lang=En&xml=3DEF25CE-B19D-4BAC-BB7F-B305D0761268 Environment Canada. 1999b. Strategic Options for the Management of Toxic Substances - Wood Preservation Sector. July 1999. Available from the Inquiry Center at : http://www.ec.gc.ca/Publications/default.asp?lang=En&xml=B6EDB2D6-DAEA-415F-BBF3-EC5C689075E9 Environment Canada. 2000. Accelerated Reduction/Elimination of Toxics (ARET) Environmental Leaders 3 Update: Voluntary Action on Toxic Substances. ARET Secretariat (Feb 2000). Available from the Inquiry Centre at enviroinfo@ec.gc.ca. Environment Canada. 2001a. Canadian Environmental Protection Act, 1999: Notice with respect to certain substances on the Domestic Substances List (DSL). November 17, 2001. Canada Gazette. Part I, vol. 135, no. 46, p. 4194–4210. Available at: http://www.gazette.gc.ca/archives/p1/2001/2001-11-17/pdf/g1-13546.pdf Environment Canada. 2001b. Environmental Code of Practice for Integrated Steel Mills – CEPA 1999 Code of Practice. 1st edition. Environmental protection series: EPS 1/MM/7. Minister of Public Works and Government Services Canada. Available at: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=30360F3C-1 Environment Canada. 2004. Recommendations for the Design and Operation of Wood Preservation Facilities -Technical Recommendations Document, Environmental Protection Series: EPS 2/WP/6. Available at: http://www.ec.gc.ca/Publications/default.asp?lang=En&xml=639AD740-F9D5-4C2F-A385-76FE4264DF79 Environment Canada. 2005. Notice requiring the preparation and implementation of pollution prevention plans in respect of inorganic arsenic compounds, hexavalent chromium compounds, polychlorinated dibenzodioxins, polychlorinated dibenzofurans and/or hexachlorobenzene used by wood preservation facilities. May 2005. Canada Gazette. Part I, vol 139, no. 20. Available at: http://www.gazette.gc.ca/archives/p1/2005/2005-05-14/html/notice-avis-eng.html#i12pdf/g1-13920.pdf Environment Canada. 2008a. Environmental Performance Agreement Concerning Atmospheric Emissions of Polycyclic Aromatic Hydrocarbons - Alcoa, Ltd. Available at: http://www.ec.gc.ca/epe-epa/51AF3E52-F5CA-491E-82BD-36D589079765/20080616_Alcoa_EPA_eng.pdf Environment Canada. 2008b. Environmental Performance Agreement Concerning Atmospheric Emissions of Polycyclic Aromatic Hydrocarbons - Rio Tinto Alcan. Available at: http://www.ec.gc.ca/epe-epa/default.asp?lang=En&n=5BE979CD-1 Finley KT. 1996. Quinolines and isoquinolines. In: Kroschwitz JI, Howe-Grand M, editors. Kirk-Othmer encyclopedia of chemical toxicology. 2nd ed. Vol. 20. New York (NY): John Wiley and Sons. p. 768–799. Health Canada. 2008. List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient “Hotlist”). [cited 2008 July 28]. Available at: http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/prohibited-eng.php

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[HSDB] Hazardous Substances Data Bank [database on the Internet]. 2009. Quinoline. Bethesda (MD): National Library of Medicine (US). [revised 2003 Feb 14; cited 2009 Sep]. Available at: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB [MENVIQ 1988] Ministère de l’Environnement du Québec. 1988. Les cokeries au Québec, rapport d’étape juin 1988. Québec (QC): Ministère de l’Environnement du Québec, Direction des Substances dangereuses. 26 p. + annex. [MENVIQ 2011] Ministère de l’Environnement du Québec. 2011. Regulation respecting industrial depollution attestations R.R.Q. c. Q-2, r. 5. Québec (QC). Éditeur officiel du Québec. Available at: http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=3&file=/Q_2/Q2R5_A.htm [MOEE 1990]. Ontario Ministry of the Environment and Energy. 1999. R.R.O. 1990, Regulation 347 General -- Waste Management. Toronto (ON): Queen’s Printer for Ontario. Available at:http://www.e-laws.gov.on.ca/html/source/regs/english/2007/elaws_src_regs_900347r07224_e.htm [MOEE 1994]. Ontario Ministry of the Environment and Energy. 1994. Water Management Policies Guidelines Provincial Water Quality Objectives of the Ministry of Environment and Energy. ISBN 0-7778-8473-9 rev. Toronto (ON): Queen’s Printer for Ontario. Available at: http://www.ene.gov.on.ca/envision/gp/3303e.htm [MOEE, 1995]. Ontario Ministry of the Environment and Energy. 1995. Ontario Regulation 214/95 Effluent Monitoring and Effluent Limits – Iron and Steel Manufacturing Sector. Toronto (ON): Queen's Printer for Ontario. Available from: http://www.e-laws.gov.on.ca/html/regs/english/elaws_regs_950214_e.htm [MOEE, 1997] Ontario Ministry of Environment and Energy. 1997. Coal tar site investigation 1986–1995. Toronto (ON): Ontario Ministry of Environment and Energy. Report No.: PIBS 3482E. 18 p. + annex. [MOEE 2007]. Ontario Ministry of the Environment and Energy. 2007. Ontario Regulation 224/07 Spill Prevention and Contingency Plans. Toronto (ON): Queen’s Printer For Ontario. Available at: http://www.e-laws.gov.on.ca/html/source/regs/english/2007/elaws_src_regs_r07224_e.htm [NPRI] National Pollutant Release Inventory [database on the Internet]. 2011. Gatineau (QC): Environment Canada. Available at: http://www.ec.gc.ca/inrp-npri/ [PMRA 2010] Pest Management Regulatory Agency, Pesticide Product Information Database. Available at: http://pr-rp.hc-sc.gc.ca/pi-ip/index-eng.php [PMRA 2011] Pest Management Regulatory Agency, Re-Evaluation Decision RVD 2011-06 Heavy Duty Wood Preservatives: Creosote, Pentachlorophenol, Chromated Copper Arsenate (CCA) and Ammoniacal Copper Zinc Arsenate (ACZA). June 2011. Available at: http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/rvd2011-06/index-eng.php [RDRC] Resources Development Research Centre. 1987. National overview of abandoned coal gasification works in Canada. Prepared for the Conservation and Protection Service, Environment Canada, by the Resources Development Research Centre, Carleton University, Ottawa, Ontario. 41 p. Contract Report No.: KE145-6-0728. [RIFM] Research Institute for Fragrance Materials, Inc. 2003. Quinoline. In: Monographs with cross reference list [CD ROM]. Hackensack (NJ): Research Institute for Fragrance Materials, Inc. Scorecard [database on the Internet]. 2005. Chemical profile for quinoline (CAS No. 91-22-5). [cited 2009 Mar 17]. Available at: http://www.scorecard.org/chemical-profiles/ Treasury Board of Canada Secretariat. 2007. Cabinet Directive on Streamlining Regulation, section 4.4. http://www.regulation.gc.ca/directive/directive01-eng.asp

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[UN] United Nations. 1973. International Convention for the Prevention of Pollution from Ships (MARPOL). Available at: http://www.imo.org [US, 1972] United States Clean Water Act. 33 U.S.C. §1251 et seq. Available at: http://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE [US, 1980] United States Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. §§ 9601 to 9675. Available at: http://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE [US, 1990] United States Clean Air Amendments of 1990. List of Hazardous Air Pollutants. Available at: http://www.epa.gov/ttn/atw/orig189.html [US EPA] United States Environmental Protection Agency. 1999. National Air Toxics Program: The Integrated Urban Strategy, Notice. July 19, 1999, Federal Register. Available at: http://www.epa.gov/ttn/oarpg/t3/fr_notices/urbanstr.pdf [US EPA] United States Environmental Protection Agency. 2011. Toxics Release Inventory. Available at: http://www.epa.gov/tri/index.htm

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ANNEX 1 – CANADIAN MEASURES PERTAINING TO SUBSTANCES RELATED TO QUINOLINE (E.G., PAHS, CREOSOTE AND COAL TAR)

Federal measures or requirements in place concerning PAHs, creosote and coal tar include the following: • Environmental Code of Practice for Integrated Steel Mills (Environment Canada 2001b).

The Code of Practice recommends targets and schedules for reductions of PAH releases from coke ovens and coke by-product plants.

• Environmental Performance Agreement Concerning Atmospheric Emissions of Polycyclic Aromatic Hydrocarbons - Alcoa, Ltd. The Agreement sets environmental performance objectives for the reduction of atmospheric emissions of PAHs from the use of the Söderberg process at Alcoa’s plant in Baie-Comeau, Quebec. The Agreement also requires the development and the yearly update of an action plan for its Söderberg plant. (Environment Canada 2008a)

• Environmental Performance Agreement Concerning Atmospheric Emissions of Polycyclic Aromatic Hydrocarbons - Rio Tinto Alcan. The Agreement sets environmental performance objectives for the reduction of atmospheric emissions of PAHs from the use of the Söderberg process at Rio Tinto Alcan’s plants in Kitimat, British Columbia; Shawinigan, Quebec and Beauharnois, Quebec. The Agreement also requires the development and the yearly update of an action plan for its Söderberg plants. (Environment Canada 2008b)

• Pest Control Products Act - Creosote, a heavy duty wood preservative, is a mixture of 200-250 identifiable substances. Quinoline accounts for less than 1% of this mixture. A Re-evaluation Decision Document for PMRA's re-evaluation of creosote was published in June 2011. The document recommends continued registration while outlining mitigation measures for environmental and health risk associated with uses regulated under the Pest Control Products Act (PMRA, 2011).

• Recommendations for the design and operation of wood preservation facilities - Technical Recommendations Document (TRD) (Environment Canada 2004) provides recommendations for storage and handling of creosote, site considerations for sensitive ecological areas, spill and fire contingency, emission and site monitoring as well as proper disposal of soils contaminated as a result of creosote spill. The PMRA Creosote decision (PMRA, 2011) requires that all facilities treating with creosote comply with the TRD guidelines by 2013.

• Pollution Prevention Plan (P2 plan) - Notice requiring the preparation and implementation of pollution prevention plans in respect of inorganic arsenic compounds, hexavalent chromium compounds, polychlorinated dibenzodioxins, polychlorinated dibenzofurans and/or hexachlorobenzene used by wood preservation facilities (Environment Canada 2005). Although this P2 plan requirement was not directly connected to quinoline, the plan required certain facilities to develop a plan for implementing best management practices identified in the two previous publications, effectively reducing the creation of creosote contaminated sites.

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• ARET Program (Environment Canada 2000). Pursuant to this voluntary program, reductions in emissions to air of many substances (including PAHs and quinoline) were achieved between 1993 and 2000.

• Coal tar and coal tar dyes (in which quinoline may be present) are listed on the Health Canada Cosmetic Ingredient Hotlist, which is an administrative tool to help manufacturers satisfy the cosmetic safety provisions of section 16 of the Food and Drugs Act. Compliance with the provisions of section 16 are monitored, in part, through the mandatory notification provisions of section 30 of the Cosmetic Regulations of the Food and Drugs Act, which require that all manufacturers and importers provide a list of the cosmetic’s ingredients to Health Canada (Health Canada 2008).

Provincial and municipal measures or requirements in place concerning PAHs, creosote and coal tar include the following:

Ontario

• Ontario Regulation 347 General -- Waste Management – Identifies specific sources of Hazardous Industrial waste that include wastes from coking operations and concentration limits for land disposal of wastes containing residues from coal tar refining, coal or processes using creosote (MOEE, 1990).

• Ontario Regulation 224/07 Spill Prevention and Contingency Plans. – Requires all integrated steel mills and organic chemical manufacturing facilities in Ontario to prepare spill containment and spill contingency plans (MOEE, 2007).

• Ontario Regulation 214/95 Effluent Monitoring and Effluent Limits – Iron and Steel Manufacturing Sector – Sets out effluent monitoring requirements and effluent limits for the Iron and Steel Manufacturing sector. Daily loading limits for two PAHs (benzo(a)pyrene and naphthalene) are established (MOEE, 1995).

Quebec

• Regulation respecting industrial depollution attestations requires sampling for 13 PAHs in effluents. No limits are set, but a fee is charged when annual quantities released are greater than that resulting from 3 times the detection limits (MENVIQ, 2011).

British Columbia

• British Columbia Regulation 63/88 Hazardous Waste Regulation – Hazardous waste includes "waste containing PAH" and waste with leachate results above specified PAH limits (BC MOE, 1988).

Municipal

• Two municipalities identified as receiving wastewater from integrated steel mills and/or coal tar, carbon black and naphthalene refining facilities have PAH limits in their sewer use by-laws ranging from 1 to 5 μg/L.