Canada Gazette, Part I, Volume 153, Number 26: Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
June 29, 2019
Canadian Environmental Protection Act, 1999
Department of the Environment
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
The Minister of the Environment and the Minister of Health (the ministers) have conducted screening assessments of 10 organic flame retardants to determine if the substances could pose a risk to the environment or human health in Canada. Two of the substances met the ecological toxicity criterion in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). The substances are
- Benzene, 1,1′-(1,2-ethanediyl)bis[2,3,4,5,6-pentabromo-, also known as decabromodiphenyl ethane (DBDPE); footnote 1 and
- 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-, also known as Dechlorane Plus (DP). footnote 2
As a result, the ministers are recommending to the Governor in Council to propose the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 for the addition of DBDPE and DP to the List of Toxic Substances in Schedule 1 of CEPA.
The Chemicals Management Plan (CMP) is a federal program launched in 2006 to assess and manage chemical substances that may be harmful to human health or the environment. The 10 organic flame retardants, which include DBDPE and DP, were identified as priorities for assessment for the second phase of the CMP. In addition to DBDPE and DP, 8 other organic flame retardants were assessed as part of the Certain Flame Retardants Grouping initiative under the second phase of the CMP: ATE, EBTBP, TBB, TBPH, TCP, TCPP, TDCPP and melamine. footnote 3
Concurrently with the final screening assessments for DBDPE and DP, four other final reports covering a total of five substances have been published, which found those substances unlikely to pose a risk to the environment or human health. New information received in April 2018 affected the screening assessments of three of the organic flame retardants in this grouping (TCPP, TDCPP and melamine). These substances are currently being further evaluated and their revised assessments will be available at a later time.
DBDPE and DP description, uses and sources of release
The two substances are not known to naturally occur in the environment. Based on the responses to a mandatory survey conducted under section 71 of CEPA and considering data from new substances notifications for DBDPE, in 2011, the two substances were not reported to be manufactured in Canada, but they were reported to be imported into the country within the following quantity ranges:
- DBDPE: 1 000 000 kilograms (kg) to 10 000 000 kg; and
- DP: 1 000 kg to 10 000 kg.
The two substances are used as additive flame retardants in multiple sectors and in many applications. These substances are used in materials to slow the ignition and spread of fire.
DBDPE has been used as a flame retardant since the early 1990s and has recently become more in demand as an alternative to commercial decabromodiphenyl ether (DecaBDE). DBDPE is used in many applications such as plastic and rubber materials; electrical and electronics; automotive, aircraft, and transportation; and adhesives and sealants. It is also used in basic organic chemical manufacturing.
Globally, sources of exposure to DBDPE are primarily from waste streams or effluents from manufacturing and processing plants using DBDPE as an additive flame retardant, and from releases from products available to consumers or commercial products over their service life and at end-of-life stages.
DP is imported to Canada for use as an additive flame retardant in several applications. Known international uses of DP include flame retardant applications such as wire and cable jacketing, electronics, appliances, automobiles, hard plastic connectors, and plastic roofing materials. DP has been produced for at least 40 years, although not in Canada, and is currently marketed as an alternative or replacement for decabromodiphenyl ether (DecaBDE).
Globally, DP release to the environment is most likely to occur during manufacturing, formulation or industrial use. Releases to the environment are expected to occur primarily through wastewater, with some release to water directly from industrial sites. Additive use of DP in products suggests diffuse emissions may occur from consumer or commercial products, and although there are uncertainties, the rate is assumed to be low in comparison to industrial point sources during incorporation of DP into products. Overall, releases from products are expected to be geographically dispersed and spread out over the duration of the service life and end-of-life of these products.
Existing risk management measures in Canada and in other jurisdictions
In Canada, DBDPE is not listed on the Domestic Substances List (DSL) and is thus subject to the New Substances Notification Regulations (Chemicals and Polymers) pursuant to CEPA. Under these Regulations, 11 ministerial conditions have been imposed on DBDPE to limit imports of the substance for use only as a flame retardant additive in thermoplastic parts, thermoplastic coatings, thermoset parts and thermoset coatings. The ministerial conditions restrict import of the substance for certain applications and place restrictions on handling and disposal of the substance in industrial settings. footnote 4
In the United States, DBDPE is listed as a new chemical under the Toxic Substances Control Act (TSCA) inventory. Individuals and firms are required to submit a significant new use notice to the U.S. Environmental Protection Agency (EPA) at least 90 days before manufacturing or processing DBDPE for that use. Moreover, it is a chemical subject to the export notification requirements under section 12(b) of the TSCA. footnote 5
In Europe, DBDPE was identified in 2012 for immediate evaluation as part of the Community Rolling Action Plan (CoRAP) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations. To support the evaluation, additional information from industry was requested for submission, due to concerns with DBDPE and its potential transformation products, which were suspected of being persistent, bioaccumulative, and inherently toxic. The timeline for completion of this work, including an update to the European REACH dossier for DBDPE, was January 2019. The data from the studies has not yet been uploaded to the dossier under REACH and a decision on the substance under CoRAP has not been made.
DBDPE is listed as a high production volume chemical under the Organisation for Economic Co-operation and Development (OECD) Cooperative Chemicals Assessment Programme. Under the OECD, “Member countries shall cooperatively investigate high production volume (HPV) chemicals in order to identify those which are potentially hazardous to the environment and/or to the health of the general public or workers”. footnote 6
DP is listed on the DSL under CEPA but is not subject to any substance-specific risk management in Canada.
In the United States, DP is listed under the TSCA and as a high production volume (HPV) chemical under the HPV Challenge Program. Manufacturers and processors of DP are “challenged” to publish data on the health and environmental effects of the chemicals produced or imported in the United States.
In January 2018, the European Chemicals Agency (ECHA) added DP to the Candidate List of substances of very high concern (SVHC) for Authorisation, in accordance with Article 59(10) of the REACH regulation. This means that ECHA will eventually assess DP to determine whether it should be included on the Authorization List. If added to the Authorization List, there will be a prohibition on placing DP on the market or using it after a given date, unless an authorization is granted for a specific use or the use is exempted.
Summary of screening assessments
The ministers conducted screening assessments of DBDPE and DP to determine if these substances meet one or more of the criteria of toxicity described in section 64 of CEPA. This involves determining whether substances are entering or may enter the environment in a quantity or concentration or under conditions that
- (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life depends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
Ecological assessment summary
High import volumes of DBDPE into Canada, along with information on its uses, indicate the potential for widespread release into the Canadian environment. DBDPE release to the environment is most likely to occur during industrial processing activities. Releases to the environment are expected to occur primarily through wastewater, with some releases to water directly from industrial sites. Releases from products available to consumers are also expected to occur, be geographically dispersed and spread out over the service life and end-of-life stages. Once released into the environment, DBDPE is found mainly in sediment and soil, where it may persist for long periods of time, resulting in DBDPE build-up as seen by rapid doubling times in sediment in the Great Lakes.
Empirical data indicate that DBDPE may accumulate to some degree in the tissues of biota footnote 7 (low to moderate bioaccumulation potential). Based on soil chronic toxicity testing, DBDPE has the potential, at high concentrations, to cause reproductive effects in earthworms as well as affect plant survival and growth. Furthermore, considering a comparable substance, decaBDE, as well as DBDPE transformation product studies and model predictions, there is concern that upon transformation, there is a potential for the formation of persistent, bioaccumulative and hazardous substances, which can be considered comparable to lower brominated polybrominated diphenyl ethers (PBDEs) that are currently listed in Schedule 1 of CEPA. The screening assessment concluded that DBDPE presents a risk of ecological harm, but not to the broader integrity of the environment. Therefore, it is proposed to conclude that DBDPE meets the environmental toxicity criterion under paragraph 64(a) of CEPA. However, the substance does not meet the criterion under paragraph 64(b) of CEPA.
The screening assessment also concluded that DBDPE meets the criteria for persistence but does not meet the criteria for bioaccumulation, as defined in the Persistence and Bioaccumulation Regulations made under CEPA; however, upon transformation, DBDPE may contribute to the formation of persistent, bioaccumulative and inherently toxic substances, such as lower brominated diphenyl ethanes, in the environment.
DP releases to the environment are most likely to occur during industrial processing activities. Releases to the environment are expected to occur primarily through wastewater, with some release to water directly from industrial sites. Releases from products available to consumers are also expected to occur, be geographically dispersed and spread out over the service life and end-of-life stages. Based on measurements of DP in air and biota in remote regions and modelling results, DP also has the potential for long-range transport and deposition in remote areas. DP is expected to be persistent in water, soil and sediment. Published bioaccumulation and biomagnification studies, as well as widespread measurements of DP in biota, indicate that DP may be highly bioaccumulative and may biomagnify in organisms and food webs.
Due to a lack of soil and sediment ecotoxicity data for DP, chronic toxicity data for two analogous substances footnote 8 were evaluated and results suggest that DP can cause effects at low concentrations in sediment and soil organisms. Results from risk quotient analyses, integrating conservative estimates of DP exposure from industrial and wastewater release with toxicity information, indicate that DP could represent a risk to sediment-dwelling organisms. In addition, at least one soil exposure scenario suggests that predicted environmental concentrations of DP approach a level that could result in risk to soil organisms. Although DP is imported in low quantities, certain Canadian regions are experiencing high environmental concentrations of the substance, potentially due to proximity to U.S. manufacturing sources in the Great Lakes region. The screening assessment concluded that DP presents a risk of ecological harm in Canada, but not to the broader integrity of the environment. Thus, it is proposed to conclude that DP meets the environmental toxicity criterion under paragraph 64(a) of CEPA. However, the substance does not meet the criterion under paragraph 64(b) of CEPA.
The screening assessment also concluded that DP meets the criteria for persistence and for bioaccumulation, as defined in the Persistence and Bioaccumulation Regulations made under CEPA.
Human health assessment summary
No classifications of the health effects of DBDPE by national or international regulatory agencies, or chronic or carcinogenicity studies using DBDPE, were identified. On the basis of the available information regarding genotoxicity, DBDPE is not considered genotoxic. The U.K. Environment Agency assessed DBDPE in 2007 and indicated that the absence of signs of carcinogenicity from repeated-dose studies, such as the lack of proliferative changes and the lack of genotoxicity in the available data, would suggest that DBDPE is unlikely to be carcinogenic. No adverse effects were observed in 90-day studies in laboratory animals. In two separate developmental toxicity studies, no effects were observed in laboratory animals exposed to DBDPE via the oral route.
Canadians are potentially exposed to DBDPE from the environment. However, in experimental studies, animals have been exposed to levels that are more than one million times greater than what humans are estimated to be exposed to through environmental media, with no significant health effects observed in the animals. Therefore, the risk to the Canadian general population is considered to be low.
Consumer products, specifically children’s toys, were identified as a potential source of exposure of young children to DBDPE. However, the estimated level of DBDPE that young children could be exposed to from mouthing hard plastic toys is more than one million times less than the highest levels used in oral studies involving laboratory animals at which no adverse health effects were observed. The risk to the Canadian general population from exposure to DBDPE from consumer products, specifically from children’s toys, is therefore considered to be low.
Based on this information, the screening assessment concluded that the substance does not meet the human health toxicity criterion as defined in paragraph 64(c) of CEPA.
No classifications of the health effects of DP by national or international regulatory agencies were identified. Results for the genotoxicity database were all negative, indicating that DP is not likely to be genotoxic.
The Canadian general population can be exposed to DP from environmental media (e.g. air, water, dust), food and breast milk. Based on the low potential of DP to cause harm to human health and on the current levels of exposure, the screening assessment concluded that the substance does not meet the human health toxicity criterion as defined in paragraph 64(c) of CEPA.
On May 11, 2019, the final screening assessments for DBDPE and DP were published on the Canada.ca (Chemical Substances) website. Based on the results of the final screening assessment, the ministers concluded that DBDPE and DP meet the ecological criterion for a toxic substance as set under paragraph 64(a) of CEPA, and have therefore recommended these two substances for addition to Schedule 1 of CEPA. footnote 9
The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to enable the Minister of the Environment (the Minister) to propose risk management measures under CEPA that may be deemed necessary to manage potential ecological risks associated with DBDPE and DP.
The proposed Order would add DBDPE and DP to Schedule 1 of CEPA.
The “One-for-One” Rule does not apply, as the proposed Order would not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business.
The draft screening assessment was subject to external written peer review and/or consultation. On October 8, 2016, the ministers published a summary of the draft screening assessments for 10 organic flame retardants in the Canada Gazette, Part I, for a 60-day public comment period. During the 60-day public comment period, comments were received from industry as well as health and academic stakeholders, and these comments were considered during the development of the final screening assessments. A table summarizing the complete set of comments received and the responses to these comments is available on the Canada.ca (Chemical Substances) website. The key comments and responses are summarized below.
Overview of public comments and responses
Non-governmental organizations have commented that, given the complexities and uncertainties involved in assessing flame retardants, the goal should be chemical elimination or product redesign with non-flammable materials, rather than continued usage of flame retardants at lower levels or use of potentially unsuitable substitutes. Officials responded that current assessment activities in the third phase of the CMP will build on the information supporting informed substitution for organic flame retardant substances. The information will also be considered when choosing the best option to manage the substances when risk management actions are being developed.
Comments by substances
Industry stakeholders were concerned that decaBDE (an analogue) was used as a read-across source of information for DBDPE, arguing that the two substances are too different for this purpose. Officials responded that decaBDE is considered to have a high degree of chemical similarity to DBDPE. The two substances have similar physical and chemical properties; therefore, certain decaBDE physical–chemical properties are used to supplement the DBDPE dataset. Furthermore, the structural similarity of the substances is sufficient to identify concerns for DBDPE transformation products, as were identified for decaBDE.
No comments were received on DP.
As previously mentioned, new information received in April 2018 had implications for three of the organic flame retardants in the grouping (TCPP, TDCPP and melamine). These substances are undergoing further evaluation, and their revised draft screening assessments will be published in a notice of intent in the Canada Gazette, Part I, at a later date.
Based on the review of the data submitted by industry and collected and generated by the ministers as part of the screening assessment process, it was determined that DBDPE and DP are being released in the Canadian environment in quantities or at concentrations that may be harmful to non-human organisms. DBDPE and DP may be taken up by aquatic, soil and sediment-dwelling organisms, and it has been demonstrated that these substances cause harm at very low concentrations in terms of survival, growth, or reproduction. Therefore, DBDPE and DP were determined to have the potential to cause ecological harm, as they meet the ecological toxicity criterion under paragraph 64(a) of CEPA.
One of the following measures must be proposed after a screening assessment is conducted under CEPA:
- 1. taking no further action with respect to the substance;
- 2. adding the substance to the Priority Substances List for further assessment; or
- 3. recommending that the substances be added to the List of Toxic Substances in Schedule 1 of CEPA, and where applicable, recommending the implementation of virtual elimination.
Based on the available evidence, which includes data received from industry and the conclusions of the screening assessment, the ministers have determined that options 1 and 2 are not appropriate to manage the ecological risks associated with DBDPE and DP in Canada. Therefore, option 3, which recommends that the substances be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option proposed by the ministers. footnote 10
The proposed addition of DBDPE and DP to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or the industry, since the proposed Order would not impose any compliance requirements on stakeholders. Accordingly, there would be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the proposed Order would enable the Minister to propose risk management measures under CEPA, should such measures be deemed necessary to manage potential ecological risks associated with the substances.
The ministers have considered socio-economic factors and will consult with the public and other stakeholders during the development of any risk management proposals under CEPA for the two substances.
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment (SEA) was completed under the CMP. The detailed analysis that was completed as part of the SEA indicated that the CMP will have a positive effect on the environment and human health.
Implementation, enforcement and service standards
The proposed Order would add DBDPE and DP to Schedule 1 of CEPA, thereby enabling the Minister to propose risk management measures respecting preventive or control actions under CEPA. Developing an implementation plan and an enforcement strategy and establishing service standards are only considered necessary when a specific risk management approach is proposed. As the proposed Order does not include a specific risk management proposal, there is no requirement for implementation, enforcement or service standards.
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Risk Management Bureau
Department of Health
PROPOSED REGULATORY TEXT
Notice is given, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, or by email to firstname.lastname@example.org.
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, June 13, 2019
Assistant Clerk of the Privy Council
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 11 is amended by adding the following in numerical order:
- 152Benzene, 1,1’-(1,2-ethanediyl) bis [2,3,4,5,6- pentabromo-, which has the molecular formula C14H4Br10
- 1531,4:7,10-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-, which has the molecular formula C18H12Cl12
Coming into Force
2 This Order comes into force on the day on which it is registered.