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Risk Management Scope
Chemical Abstract Service Registry Number (CAS RN):
(PDF Format - 152 KB)
Table of Contents
- Summary of Proposed Risk Management
- 1. Context
- 2. Issue
- 3. Background
- 4. Considerations
- 5. Overview of Existing Risk Management
- 6. Proposed Risk Management
- 7. Next Steps
- 8. References
Summary of Proposed Risk Management
This document outlines the proposed risk management actions for ethylbenzene. In particular, the Government of Canada is considering:
- Activities that would minimize releases of ethylbenzene during the indoor use of lacquers, stains, varnishes and concrete floor sealers which will help to minimize consumer inhalation exposure.
More information is needed on the following to inform risk management decision-making :
- Information on concentration levels, labelling, use and other information regarding the consumer products of interest.
Note: The above summary is an abridged list of actions proposed to manage ethylbenzene and to seek information on identified information gaps and uncertainties. Refer to section 6 of this document for more complete details in this regard.
The substance benzene, ethyl-, Chemical Abstract Service Registry Number (CAS RN)Footnote100-41-4, referred to throughout this document as “ethylbenzene”, was selected for assessment as part of the pilot project to assess substances on the Canadian Domestic Substances List (DSL). The Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health (the Ministers) to categorize substances on the Domestic Substances List(DSL). This categorization exercise was completed in September 2006.
2.1 Draft Screening Assessment Report Conclusion
Health Canada and Environment Canada conducted a joint scientific assessment relevant to the evaluation of ethylbenzene in Canada. A notice summarizing the scientific considerations of the draft screening assessment report was published for ethylbenzene by Environment Canada and Health Canada in the Canada Gazette,Part I, on November 16, 2013, under subsection 77(1) of CEPA 1999. The draft screening assessment report proposes that ethylbenzene is or 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.
The draft screening assessment proposes that ethylbenzene is not 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 or that constitute or may constitute a danger to the environment on which life depends.
Based on the information available, it is proposed that ethylbenzene meets one or more criteria set out in section 64 of CEPA 1999 (Canada 2013).
The draft screening assessment report also proposes that ethylbenzene meets the criteria for persistence and does not meet the criteria for bioaccumulation, as defined in the Persistence and Bioaccumulation Regulations made under CEPA 1999 (Canada 2000).
For further information on the proposed Draft Screening Assessment Report conclusion for ethylbenzene (Please note that based on information received during the public comment period, the proposed conclusions described in this document and in the draft screening assessment report are preliminary and are subject to change).
2.2 Proposed Recommendation under CEPA 1999
As a result of screening assessments conducted under section 74 of CEPA 1999, substances may be found to meet one or more of the criteria under section 64 of CEPA 1999. The ministers can then propose to take no further action with respect to the substances, add the substances to the Priority Substances List (PSL) for further assessment, or recommend the addition of the substances to the List of Toxic Substances in Schedule 1 of the Act. In this case the Ministers propose to recommend addition of ethylbenzene to the List of Toxic Substances in Schedule 1 of the Act.
3.1 Current Uses
Evaluation of risk to human health involves consideration of data relevant to estimation of exposure of the general population, as well as information on health hazards.
Ethylbenzene occurs naturally in the environment in crude oil and as a result of incomplete combustion of natural materials such as during forest fires. Ethylbenzene is used as a surfactant in the hydraulic fracturing industry and also as a component of vehicle and aviation fuels as well as a component of “mixed” xylenes, which are used as solvents in various applications including in paints, stains, concrete floor sealer and automotive cleaners. Ethylbenzene is also synthetically produced and mainly used in the manufacture of styrene. Styrene is then used to manufacture various types of polymers such as polystyrene. Minor applications of the synthetically produced ethylbenzene include use as a solvent and in the production of other chemicals such as diethylbenzene.
3.2 Exposure Sources, Identified Risks and implicated Sectors
The general population of Canada is exposed to ethylbenzene from environmental media (i.e., ambient air, indoor air, drinking water, and soil), food, and during the intermittent use of consumer products.
According to the results from a section 71survey conducted for the year 2000, approximately 1700 kilotonnes of ethylbenzene at a concentration greater than 1% were manufactured in and imported into Canada during that year, mainly by companies in the petrochemical sector.
In 2003, a total of 906 000 tonnes of ethylbenzene was produced. More recent information on ethylbenzene production is not available. Approximately 545 tonnes of ethylbenzene was imported into Canada in 2009, and approximately 51.6 tonnes were exported the same year.
Ethylbenzene is included in the National Pollutant Release Inventory (Environment Canada, 2013), and facilities manufacturing, importing, or otherwise using more than 10 tonnes per year of the substance must report their releases. In 2011, facilities across Canada reported to the NPRI on-site environmental releases totaling approximately 325 tonnes, transfers for disposal totaling 1800 tonnes, and transfers for recycling totaling 541 tonnes.
Ethylbenzene has been detected in ambient and indoor air, drinking water, surface water, groundwater, soil, and biota but not in sediment in Canada. Ethylbenzene was also detected in various food items in the United States. Ethylbenzene was identified in numerous consumer products, building materials, gasoline, and vehicle exhaust as well as in cigarettes and cigarette smoke.
The critical health effects associated with exposure to ethylbenzene are considered to be tumor induction and non-cancer systemic effects, primarily on the auditory system and on the liver, kidney and pituitary glands. Minor developmental effects, hematological effects, effects on endocrine glands (thyroid hyperplasia), and on the central nervous system were observed at higher dose levels and following prolonged exposure periods. Consideration of the available information regarding genotoxicity indicates that ethylbenzene is not likely to be directly genotoxic, and a margin of exposure approach is used to characterize the human health risks associated with ethylbenzene exposure.
The margins of exposure between the upper bound exposure estimates from the use of some consumer products such as stain, varnish, lacquer and concrete floor sealer containing ethylbenzene and the critical exposure levels associated with health effects are considered inadequately protective of human health. The margins of exposure between upper bound conservative exposure estimates from the use of spray paint, liquid paint, paint remover, and caulking and the critical exposure levels associated with health effects are considered adequate to account for uncertainties in the health effects and exposure databases.
The margins of exposure between the upper bound exposure estimates from environmental media (i.e., ambient air, indoor air, including vehicle interior air, drinking water and soil) and from refuelling a vehicle, and the critical exposure levels associated with health effects) are considered adequately protective of human health. Therefore these sources of exposure are not being considered for risk management.
The Government of Canada considered, where available, risk assessment information relevant to children’s exposure to this substance. As part of the Chemicals Management Plan, the Government asked industry and interested stakeholders to submit any information on the substance that may be used to inform risk assessment, risk management and product stewardship.
As the margins of exposure for indoor consumer stains, varnishes, lacquers and concrete floor sealers are considered inadequate these products will be implicated in risk management.
4.1 Alternatives and Alternate Technologies
Alternative technologies and formulations are available for stains, varnishes, lacquers and concrete floor sealers which do not contain ethylbenzene. However they may not provide the same performance qualities as those products which use resins requiring the solvating properties of a xylene/ethylbenzene blend.
4.2 Socio-economic and Technical Considerations
Socio-economic factors will be considered in the selection process for a regulation and/or instrument respecting preventive or control actions, and in the development of the risk management objective(s). Socio-economic factors will also be considered in the development of regulations, instrument(s) and/or tool(s) as identified in the Cabinet Directive on Regulatory Management (TBS 2012a) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action.
5. Overview of Existing Risk Management
5.1 Related Canadian Risk Management Context
Ethylbenzene is listed in the Guidelines for Canadian Drinking Water Quality published by Health Canada (Health Canada 1988). The guideline for ethylbenzene in drinking water has been established at ≤2.4 μg/L, based on aesthetic considerations (e.g., taste, odour) rather than on potential health effects.
Ethylbenzene is reportable under the National Pollutant Release Inventory (NPRI) for facilities manufacturing, importing, or using more than 10 tonnes per year (Environment Canada 2009).
The Controlled Products Regulations, established under the Hazardous Products Act, require ethylbenzene to be disclosed on the Material Safety Data Sheet that must accompany workplace chemicals when it is present at a concentration of 0.1% or greater as specified on the Ingredient Disclosure List (Canada 1988).
5.2 Pertinent International Risk Management Context
US EPA National Primary Drinking Water Regulations list a Maximum Contaminant Level (MCL) of 700 ug/L for ethylbenzene (US EPA 2012).
Ethylbenzene has been identified as an OECD High Production Volume (HPV) chemical (OECD 2005) and as a US HPV chemical (US EPA 2006).
The WHO recommends that the concentration of ethylbenzene in drinking water not exceed 300 μg/L (WHO 1996).
6. Proposed Risk Management
6.1 Proposed Human Health Objective
Proposed human health objectives are quantitative or qualitative statements of what should be achieved to address human health concerns while proposed risk management objectives set quantitative or qualitative targets to be achieved by the implementation of risk management regulations, instrument(s) and/or tool(s) for a given substance or substances.
The proposed human health objective for ethylbenzene is to minimize human exposure via inhalation to the greatest extent practicable during the application of certain consumer products such as lacquers, stains, varnishes and concrete floor sealers.
6.2 Proposed Risk Management Objectives and Action(s)
The proposed risk management objective for ethylbenzene is to reduce human exposure via inhalation to the sources of concern, specifically, indoor use of lacquers, stains, varnishes and concrete floor sealers.
In order to achieve the proposed risk management objective and to work towards achieving the proposed human health objective, the proposed risk management actions being considered for ethylbenzene are to consider a regulatory or non-regulatory initiative that would minimize releases of ethylbenzene from the indoor use of consumer lacquers, stains, varnishes and concrete floor sealers in order to minimize consumer inhalation exposure.
In alignment with the Government of Canada’s Cabinet Directive on Regulatory Management (TBS 2012a) and Red Tape Reduction Action Plan (TBS 2012b), the proposed risk management regulation(s), instrument(s) or tool(s) will be selected using a thorough, consistent and efficient approach and take into consideration the information that has been received through this initiative and other information available at this time.
Following the publication of this Risk Management Scope document, additional information obtained from the public comment period and from other sources will be considered, along with the information presented in this document, in the instrument selection process. The risk management options outlined in this Risk Management Scope document may evolve through consideration of assessments and risk management options published for other substances used in this sector as required in order to ensure effective, coordinated, and consistent risk management decision-making.
6.3 Risk Management Information Gaps
Data needs exist to confirm concentrations of ethylbenzene in Canadian indoor consumer products. Data is needed to provide current information on which products are major sources of ethylbenzene during their use, an important consideration in developing future risk management actions. Although all submitted information will be considered, specific information on the items described below would help to address uncertainties and inform decision-making:
- Maximum concentrations of ethylbenzene (including ethylbenzene fraction of mixed xylenes) in the following consumer products that may be used indoors (including in garages) and are sold in Canada:
- Concrete floor sealer
- Expected future trends for ethylbenzene in consumer products that may be used indoors (in particular in stain, varnish, lacquer and concrete floor sealers) as a result of initiatives, such as the Volatile Organic Compound (VOC) Concentration Limits for Architectural Coatings Regulations.
- The following information on concrete floor sealers:
- Names/lists of products that may be used indoors (including garages and basements)
- Any additional information on the products listed above
Data collection initiatives (such as s.71 surveys or informal data gathering) may be under taken to collect additional information on ethylbenzene to inform risk management decision-making.
7. Next Steps
Industry and other interested stakeholders are invited to submit comments on the content of this Risk Management Scope or other information that would help to inform decision making. Please submit comments prior to April 9, 2014. The Risk Management Approach will be published approximately eleven months after the release of the Risk Management Scope. This will coincide with the publication of the final screening assessment report. At that time, there will be opportunity for further consultation.
Comments and information submissions on the Risk Management Scope should be submitted to the address provided below:
Chemicals Management Division
Gatineau Quebec K1A 0H3
Tel: 1-888-228-0530 / 819-956-9313
|Electronic consultation on the Risk Management Scope||February 8, 2014 to April 9, 2014|
|Publication of responses to public comments on the draft Screening Assessment Report and Risk Management Scope||January 2015|
|Publication of the final Screening Assessment Report||January 2015|
|Publication of the Risk Management Approach||January 2015|
Canada. 1988. Ingredient Disclosure List [Internet]. SOR/88-64. [cited 2013 Sept 19]. Available from: http://www.canlii.org/ca/regu/sor88-64/part274942.html
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 from: http://www.gazette.gc.ca/archives/p3/1999/g3-02203.pdf.
Canada. 2000. Canadian Environmental Protection Act, 1999: Persistence and Bioaccumulation Regulations, P.C. 2000-348, 23 March 2000, SOR/2000-107. Available from: http://www.gazette.gc.ca/archives/p2/2000/2000-03-29/pdf/g2-13407.pdf
Canada. 2011. Dept. of the Environment. Canadian Environmental Protection Act, 1999: Announcement of planned actions to assess and manage, where appropriate, the risks posed by certain substances to the health of Canadians and the environment. Canada Gazette, Part I, vol. 145, no. 41, p. 3125-3129. Available from: http://www.gazette.gc.ca/rp-pr/p1/2011/2011-10-08/html/notice-avis-eng.html#d127
Canada. 2013. Dept. of the Environment, Dept. of Health. Draft Screening Assessment for Ethylbenzene- (CAS RN 100-41-4). Available from: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=FE722725-1
Environment Canada. 2013. National pollutant release inventory [database on the Internet]. Gatineau (QC): Environment Canada. [cited 2013 May 6]. Available from: http://www.ec.gc.ca/inrp-npri/default.asp?lang=en&n=BF14CADF-1
Health Canada. 1988. [modified 1988 Aug]. Guidelines for Canadian drinking water quality – technical documents: toluene, ethylbenzene and the xylenes. [Internet]. Ottawa (ON): Health Canada. [cited 2009 Dec]. Available from: http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/toluene/index-eng.php
OECD] Organisation for Economic Co-operation and Development. 2005. Ethylbenzene. CAS No. 100-41-4. SIDS Initial Assessment Report for SIAM 14, 26–28March 2002. Paris (FR): OECD. Available from: http://www.chem.unep.ch/irptc/sids/OECDSIDS/100414.pdf.
[TBS] Treasury Board of Canada Secretariat. 2012a. Cabinet Directive on Regulatory Management. Available from: http://www.tbs-sct.gc.ca/ri-qr/directive/directive00-eng.asp
[TBS] Treasury Board of Canada Secretariat. 2012b. Red Tape Reduction Action Plan. Available from: http://www.tbs-sct.gc.ca/rtrap-parfa/rtrapr-rparfa-eng.asp
[US EPA] US Environmental Protection Agency. 2006. High Production Volume (HPV) Challenge. Available from: http://www.epa.gov/hpv/pubs/general/hpvchemdata.htm
[US EPA] US Environmental Protection Agency. 2012. Basic Information about Ethylbenzene in Drinking Water [cited 2012 Mar]. Available from: http://water.epa.gov/drink/contaminants/basicinformation/ethylbenzene.cfm
[WHO] World Health Organization. 1996. Guidelines for drinking-water quality. Vol. 2. 2nd ed. [Internet]: Ethylbenzene. Geneva (CH): World Health Organization. [cited 2009 Dec]. Available from: http://www.who.int/water_sanitation_health/dwq/chemicals/ethylbenzene.pdf
- Footnote 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
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