Certain Organic Flame Retardants Substance Grouping
Risk Management Scope
1,4:7,10-Dimethanodibenzo[a,e]cyclooctene, 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro- 1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro- Dechlorane Plus (DP)
Chemical Abstracts Service Registry Number
Environment and Climate Change Canada
(PDF Format - 352 KB)
Table of Contents
- Summary of Proposed Risk Management
- 1. Context
- 2. Issue
- 3. Proposed Risk Management
- 4. Background
- 5. Exposure Sources and Identified Risk(s)
- 6. Risk Management Considerations
- 7. Overview of Existing Risk Management
- 8. Next Steps
- 9. References
Summary of Proposed Risk Management
This document outlines the risk management options under consideration for the substance Dechlorane Plus (DP) from the Certain Organic Flame Retardant Substances Grouping. To achieve the proposed environmental objective of reducing the concentrations of DP in the Canadian environment to the greatest extent practicable, the Government of Canada is considering:
- The implementation of regulatory and/or non-regulatory controls that would restrict the conditions under which DP, and products containing DP, may be manufactured, used and/or imported.
- Exploring additional measures to address potential transboundary sources of DP.
Information on the following items is required to inform risk management decision-making and should be provided (on or before December 7, 2016), to the contact details identified in section 8 of this document:
- Quantity and use of DP by Canadian manufacturers and importers of the substance and products containing the substance
- Changing use patterns and economic impacts
- Chemical and non-chemical alternatives to DP
The risk management options outlined in this Risk Management Scope document may evolve through consideration of assessments and risk management options published for other Chemicals Management Plan (CMP) substances, and in particular other flame retardant substances, as required to ensure effective, coordinated, and consistent risk management decision-making.
Note: The above summary is an abridged list of options under consideration to manage this substance and to seek information on identified information gaps and uncertainties. Refer to section 3 of this document for more complete details in this regard.
The Canadian Environmental Protection Act, 1999(CEPA) (Canada 1999) provides the authority for the Minister of the Environment and the Minister of Health (the Ministers) to conduct assessments to determine if substances are toxic to the environment and/or harmful to human health as set out in paragraph 64 of CEPAFootnote 1,Footnote2, and if so, to manage the associated risks.
As part of the second phase of the CMP, the Ministers plan to assess and manage, where appropriate, the potential health and ecological risks associated with approximately 500 substances, in nine substance groupings (Canada 2011).
The substance 1,4:7,10-Dimethanodibenzo[a,e]cyclooctene, 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro-, Chemical Abstracts Service Registry NumberFootnote 3 13560-89-9, commonly known as Dechlorane Plus® (Dechlorane Plus) and referred to throughout this document as DP, is included in the Certain Organic Flame Retardants Substance Grouping of the Substance Groupings Initiative of the CMP.
2.1 Draft Screening Assessment Conclusions
Health Canada and Environment and Climate Change Canada conducted a joint scientific assessment relevant to the evaluation of DP in Canada. A notice summarizing the scientific considerations of the draft screening assessment for this substance was published in Canada Gazette, Part I, on October 8, 2016 (Canada 2016a).
Based on the information available, the draft screening assessment proposes that DP is toxic under paragraph 64 (a) of CEPA because it 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 (Canada 2016a). The draft screening assessment also proposes that DP is not harmful to human health under paragraph 64 (c) of CEPA because it is not 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 2016a).
The draft screening assessment also proposes to that DP meets the criteria for persistence and meets the criteria for bioaccumulation, as defined in the Persistence and Bioaccumulation Regulations (Canada 2000).
Considering the evidence presented in the draft screening assessment for DP, including the high environmental concentrations of DP in Great Lakes sediments, there is risk of harm to organisms, but not to the broader integrity of the environment from DP (Canada 2016a). This document will focus on the risks of concern (refer to Section 5).
Of note, the proposed risk management options described in this document and the proposed conclusion outlined in the draft screening assessment are preliminary and may be subject to change. For further information on the draft screening assessment for DP, refer to Draft Screening Assessment Certain Organic Flame Retardants Substance Grouping 1,4:7,10-Dimethanodibenzo[a,e]cyclooctene, 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro-Dechlorane Plus (DP).
2.2 Proposed Recommendation Under CEPA
Based on the findings of the draft screening assessment conducted as per CEPA, the Ministers propose to recommend that DP be added to the List of Toxic Substances in Schedule 1 of the CEPAFootnote 4.
The Ministers will take into consideration comments made by stakeholders during the 60-day public comment period on the draft screening assessment and Risk Management Scope document. If the Ministers finalize the recommendation to add DP to Schedule 1, risk management instruments must be proposed and finalized within a set period of time, as outlined in sections 91 and 92 of CEPA (refer to section 8 for publication timelines applicable to this group of substances).
3. Proposed Risk Management
3.1 Proposed Environmental Objectives
Proposed environmental objectives are quantitative or qualitative statements of what should be achieved to address environmental concerns.
The proposed environmental objective for DP is to reduce its concentrations in the Canadian environment to the greatest extent practicable, taking into account social, economic and technical matters (refer to section 6 of this document).
The proposed environmental objective outlined in this document will be refined and further detailed in the Risk Management Approach document that will be published concurrently with the final screening assessment for this substance, or in subsequent risk management documents (e.g. consultation document on proposed instrument)Footnote 5, as the case may be.
3.2 Proposed Risk Management Objective and Options under Consideration
Proposed risk management objectives set quantitative or qualitative targets to be achieved by the implementation of risk management instrument(s) and/or tool(s), including regulations for a given substance or group of substances.
The proposed risk management objective for DP is to achieve the lowest level of release of the substance, which is technically and economically feasible, into the Canadian environment.
In support of the risk management objective, consideration will be given to the implementation of regulatory and non-regulatory controls to minimize releases of DP to the Canadian environment. Consideration will be given to prohibiting the manufacture of DP in Canada. Restrictions on the use and import of DP, including products containing DP, will also be considered. Furthermore, additional measures to prevent the release of DP into the Canadian environment from potential international sources may also be explored. For example, the Government of Canada will explore Canada - United States mechanisms to address the potential risk posed by transboundary sources of DP in the Great Lakes area.
A phased approach to the implementation of controls for this substance may be considered to take into account socio-economic factors such as the transition to alternative substances.
The proposed risk management objective will be refined and further detailed in the Risk Management Approach document that will be published concurrently with the final screening assessment for this substance, or in subsequent risk management documents (e.g. consultation document on proposed instrument), as the case may be.
Following the publication of this Risk Management Scope document, additional information obtained during the public comment period and from other sources will be considered, along with the information presented in this document, in the instrument selection and development process. The risk management options outlined in this document may evolve through the consideration of assessments and risk management options published for other CMP substances to ensure effective, coordinated, and consistent risk management decision-making.
3.3 Risk Management Information Gaps
In order to make informed decisions on the proposed risk management, more information is needed on the following:
1) Quantity and use of DP by Canadian manufacturers and importers of the substance and products containing the substance
- Details on the uses of DP as an additive flame retardant in electrical wiring and cables, automobiles, plastic roofing materials and hard plastic connectors, including:
- The quantity of DP used in these applications;
- The concentration of DP used in these applications;
- Description of the specific uses of DP for these applications; and
- The measures and practices currently implemented by industrial users to minimize the environmental risks and releases.
2) Changing use patterns and economic impacts
- Ongoing and anticipated changes in the use of DP, whether in response to:
- Changes in flammability requirements and/or standards;
- Market forces;
- Shifts to alternative flame retardant substances (please provide commercial name and their function as additive or reactive) and alternate systems and approaches, such as heat resistant polymers that do not require flame retardant additives;
- Global phase-out of other flame retardants including Decabromodiphenyl ether (DecaBDE) commercial mixture; and
- Other reasons (please provide information on these reasons).
- Anticipated economic impacts if the manufacturing, import and/or use of DP is prohibited or restricted in Canada.
3) Chemical and non-chemical alternatives to DP
- Details on alternatives to DP and/or technologies, and their feasibility as applicable to Canadian manufacturers and importers as flame retardants in:
- Various sectors such as: electrical and electronic equipment (e.g. wires and cables coating, appliances, computer and peripheral), automotive, aircraft, and transportation, adhesives and sealants, textiles;
- The production of polymeric systems, such as thermoplastic or thermoset parts and coatings (e.g. plastic and rubber materials); and
- Meeting applicable flammability requirements and standards.
- Information related alternatives, including:
- Description of the specific uses and the necessary performance attributes of the alternative;
- Description of the process and the expected testing and replacement timeline to confirm viability of the alternative and relative costs compared to DP; and
- Whether these alternatives are manufactured in Canada, or abroad, exported and/or imported.
A 60-day public comment period will follow the publication of this document to solicit feedback and information from stakeholders and the public regarding the proposed risk management measures and information gaps for DP.
4.1 General Information on DP
DP is a chlorinated cycloaliphatic flame retardant. The commercial technical product DP is primarily a mixture of syn and anti stereoisomers, typically composed of approximately 25% syn-DP and 75% anti-DP (Canada 2016a.
4.2 Current Uses and Identified Sectors
DP is used as an additiveFootnote 6 flame retardant in multiple sectors where it may have various applications, including electrical and electronic equipment (i.e. wire and cable), automobiles, plastic roofing materials, hard plastic connectors as well as polymeric systems (i.e. thermoplastic and thermosets parts and coatings).
In Canada, DP is listed on the Domestic Substances List(DSL).
Based on a survey conducted under section 71 of CEPA, the total quantity of DP imported into Canada in 2011 was in the range of 1 to 10 tonnes for use as an additive flame retardant in formulation, products and/or manufactured items. Also, DP was not identified as being manufactured in Canada in 2011. According to the DSLInventory Update conducted for the year 2008, DP was found to be imported into Canada by a number of companies in similar quantities (same order of magnitude range) as reported in 2011 (Canada 2013; Canada 2016a).
Currently, there are two known producers of DP in the world, which are located in the United States and China. According to the available literature, the worldwide annual production volume for DP has been estimated at approximately 4 500 to 5 000 tonnes (Canada 2016a). The U.S. production was estimated between 450 to 4 500 tonnes from 1986-2006 (Niagara Falls, NY) and for China between 300 to 1 000 tonnes in 2003-2005 (Huai’an, Jiangsu) (Canada 2016a).
The information that was collected on these uses and sectors is reviewed and presented in detail in the draft screening assessment. The sections below provide a summary of the uses and sectors where the potential for ecological risk was identified in the draft screening assessment of the substance.
5. Exposure Sources and Identified Risks
Because DP is expected to be persistent in water, soil and sediment and is predicted to have moderate to high bioaccumulation potential, all releases of this substance may potentially pose a risk to the environment.
Releases of DP to the Canadian environment, due to the substance’s use as a flame retardant, are expected to be diffuse with some point sources.
DP is expected to be released primarily from industrial sources to wastewater (a pathway to surface water and the soil environment) and may undergo some migration from consumer or commercial products to the atmosphere as a non-reactive flame retardant. Releases from consumer and commercial products are expected to be limited, geographically disperse and spread out over the duration of the service life and end-of-life of these products. DP is very likely highly removed by adsorption to biosolids (sludge) in wastewater treatment systems and can be applied to agricultural soils during biosolids amendment.
Once released into the environment, DP will be found mainly in sediment and soil, where it may persist for long periods of time. Based on measurements in remote regions and modelling results, DP, via sorption to particles, also has potential for long range transport and deposition in remote areas.
DP has been measured in the Canadian environment, as well as globally, with the highest concentrations found close to urban or industrial areas. Within Canada, many studies have measured relatively high DP concentrations in media in the Great Lakes region, particularly in the vicinity of the Niagara River and Lake Ontario, downstream of an American DP manufacturing facility. In Canada, DP has been measured in various environmental media such as air, soil, water, sediment, as well as biota.
Industrial scenarios were developed to provide estimates of exposure, based on available site information including potential quantities used. The scenarios cover a range of known DP industrial activities that could occur in Canada, and include: manufacturing of wires and cables, automobile manufacturing, and manufacturing of hard plastic connectors. These scenarios involved industrial effluents release to water resulting in DP partitioning to sediment, and partitioning to wastewater treatment biosolids followed by their application to soil. Risk quotient analysis was performed for sediment and soil organisms, and wildlife. Results of these analyses do not show that DP posed a risk to organisms based on current use levels in Canada. However, at least one soil scenario for biosolid application to soil suggests predicted environmental concentrations of DP may approach a level that could result in possibility of risk to soil organisms (i.e. risk quotient = 0.79).
Furthermore, several studies have reported DP sediment concentrations in the Great Lakes region that exceed the predicted environmental concentrations for sediment developed from industrial scenarios based on quantities in use in Canada. This suggests that DP exposure in specific areas of Canada could be underestimated and precaution is warranted. Preliminary risk quotient analysis, based on upper range values for these reported DP sediment concentrations, indicates risk to sediment-dwelling organisms (i.e. risk quotient greater than 1). It should be noted that DP is a High Production Volume substance in the USA. Past and/or present environmental transport of DP from the northern USA, in particular manufacturing near the Great Lakes, may therefore contribute to DP exposure in Canada.
Also, DP has been detected in household dust and wastewater treatment system biosolids indicating that the substance can be released from products (e.g. via volatilization and particulates from abrasion). A coarse scenario for the diffuse release of DP from commercial and consumer products in Canada was developed for releases over the service life of products. While there are uncertainties and limited information characterizing potential releases from products, the scenario suggests that significant release of DP from commercial and consumer products is unlikely. However, the scenario result is considered to be highly uncertain.
6. Risk Management Considerations
6.1 Alternatives and Alternate Technologies
Flame retardant substances are generally used to meet performance-based flammability requirements. These requirements do not specify that chemical flame retardants need to be used; rather they may require a product or component to pass a laboratory test such as a cigarette smoulder or open flame ignition test (UL 2014; ASTM 2014; Canada 1980; California 2013). Using chemical flame retardants in their products is one means through which companies can achieve flammability requirements for their products. Alternate technologies as well as non-chemical-based alternatives, such as nano-technologies and barrier materials, may also be used to replace the use of flame retardant substances in various applications.
Where chemical flame retardants are concerned, a number of factors come into play in determining whether one flame retardant is a good alternative to another. Different flame retardants are appropriate for application to different materials and for different end uses. Their physical and chemical properties affect their ability to meet flammability requirements as well as the uses in which they can be effective. Flame retardant properties such as pH, viscosity, the ability to mix evenly and stability in exothermic reactions can impact the quality of end products such as foams. Cost is also a factor in decision-making regarding alternative flame retardants (Eastern Research Group 2015).
Substances in the OFR Grouping may be used as alternatives for each other as well as in place of other "legacy" flame retardants that have been prohibited or are subject to risk management measures in Canada, in other jurisdictions or globally.
Leading candidates for substituting DP are expected to be various brominated flame retardants. Due to similar applications and performance in high impact polysterene (HIPS), acrylonitrile-butadiene-styrene (ABS), polyesters, and epoxies, potential alternatives for DP include: decabromodiphenyl ether (decaBDE) and decabromodiphenyl ethane (DBDPE). Potential substitutes for these substances could also be alternatives to DP (ChemInfo 2012).
DP is currently marketed as an alternative/replacement for the commercial mixture Decabromodiphenyl ether (DecaBDE), due to its compatibility within the same products and applications (Canada 2016a; US EPA 2014a).
However, decaBDE has been assessed as toxic in Canada and its manufacture is prohibited under the Polybrominated Diphenyl Ethers Regulations which came into force on June 19, 2008 (Canada 2008d). Furthermore, Environment and Climate Change Canada has proposed additional controls on decaBDE which would extend the prohibition to use, import, sale and offer for sale of the substance (Canada 2015b). As a result, the commercial mixture DecaBDE would be prohibited.
DBDPE is included in the Certain Organic Flame Retardants Substance Grouping and is proposed to be toxic to the environment and risk management measures are being considered for the substance (Canada 2016b). Please refer to Risk Management Scope for DBDPE for additional information on options under consideration.
6.2 Socio-Economic and Technical Considerations
There is little information available about the current state of industry transition to alternative substances. Therefore, socio-economic factors will be considered in the development of the risk management objective(s). Socio-economic factors will also be considered in the selection and development of regulations, instrument(s) and/or tool(s) respecting preventative or control actions, 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 (TBS 2007).
7. Overview of Existing Risk Management
7.1 Related Canadian Risk Management Context
Currently, DP is not subject to any substance-specific risk management in Canada, and is listed under the DSL under CEPA.
7.2 Pertinent International Risk Management Context
7.2.1 United States
22.214.171.124 Federal Level
In the United States, DP is listed under the Toxic Substances Control Act inventory under CAS Number 13560-89-9.
DP is listed as a High Production Volume (HPV) Chemical under the HPV Challenge Program (US EPA 2014). Under this initiative, DP manufacturers and processors are "challenged" to publish data on the health and environmental effects of chemicals that are produced or imported in the United States in quantities of 450 tonnes or more per year (Canada 2016a).
126.96.36.199 State Level
In the State of New York, DP is subject to water quality standards under the Environmental Conservation Law. The principal organic contaminant standard for DP concentration in groundwater is 5 ug/L (NY DEC 1999).
DP has not been subject to the risk assessment process under the European Chemical Bureau and no known restrictions exist for DP in Europe.
8. Next Steps
8.1 Public Comment Period
Industry and other interested stakeholders are invited to submit comments on the content of this Risk Management Scope that would help to inform decision-making, and in particular information related to the information gaps identified in Section 3.3. Please submit additional information and comments prior to December 7, 2016. The Risk Management Approach document, which will outline and seek input on the proposed risk management instrument(s), will be published at the same time as the final screening assessment. At that time, there will be further opportunity for consultation.
Comments and information submissions on the Risk Management Scope should be submitted to the address provided below:
Environment and Climate Change Canada
Chemicals Management Division
Gatineau Quebec K1A 0H3
Tel: 1-888-228-0530 | 819-956-9313
Companies who have an interest in DP are encouraged to identify themselves as stakeholders. Stakeholders will be informed of future decisions regarding DP and may be contacted for further information.
Following the public comment period on the Risk Management Approach document, the Government of Canada will initiate the development of the specific risk management instrument(s), where necessary. Comments received on the Risk Management Approach document will be taken into consideration in the selection or development of these instrument(s). Consultation will also take place as instrument(s) are developed.
8.2 Timing of Actions
|Electronic consultation on the Risk Management Scope||October 8, 2016 to December 7, 2016|
|Submission of additional studies or information on DP||on or before December 7, 2016|
|Publication of responses to public comments on the draft screening assessment and Risk Management Scope||No later than the time of publication of the final SAR|
|Publication of the final screening assessment and, if required, the Risk Management Approach document||Expected to be Fall 2017|
|Publication of responses to public comments on the Risk Management Approach, if applicable and if required, the proposed instrument(s)||24-months from the publication of the final screening assessment|
|Consultation on the proposed instrument(s), if required||60-day public comment period starting upon publication of each proposed instrument|
|Publication of the final instrument(s), if required||18-months from the publication of each proposed instrument|
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