Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2019-198
Canada Gazette, Part II, Volume 153, Number 13
SOR/2019-198 June 10, 2019
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2019-757 June 9, 2019
Whereas, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on October 15, 2011, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;
And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substance set out in the annexed Order is a toxic substance;
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 1 is amended by adding the following in numerical order:
N,N′-mixed phenyl and tolyl derivatives of 1,4-benzenediamine
Coming into Force
2 This Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
The Government of Canada (the Government) completed a screening assessment on 1,4-benzenediamine, N,N′-mixed phenyl and tolyl derivatives, hereafter referred to as “BENPAT,” footnote 2 to assess whether the substance may pose a risk to human health or the environment in Canada. The screening assessment concluded that BENPAT meets the environmental criterion for toxic as defined in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). As a result, the Government is adding BENPAT to the List of Toxic Substances in Schedule 1 of CEPA. footnote 3
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. Under the CMP, BENPAT was identified as a high priority for ecological risk assessment, as available information suggested that the substance was persistent, footnote 4 bioaccumulative footnote 5 and inherently toxic to aquatic organisms. Available information did not identify BENPAT as a high priority for human health risk assessment.
Substance description and sources of release
BENPAT is not naturally produced in the environment. It consists of a mixture of mainly three different components footnote 6 and is known to be used as an additive in rubber products, including tires and hoses, to prevent degradation and increase durability. While it was not reported to be manufactured in Canada, between 1 000 000 and 10 000 000 kg of BENPAT were imported into the country in 2006. The annual amount of BENPAT entering Canada in 2018 is expected to remain within this range, as there are currently no control measures under CEPA for the substance and stakeholders have continued to express an interest in using BENPAT to manufacture tires in Canada (see the “Consultation” section). Furthermore, considering the stability of the tire manufacturing sector footnote 7 and the fact that any transition away from BENPAT is anticipated to take several years, BENPAT is expected to continue to be used to manufacture millions of tires in Canada annually. BENPAT is released into the environment as a result of tire manufacturing (industrial release) and, to a much lesser extent, as a result of consumer uses of tires.
Existing and international risk management measures
In Canada, BENPAT contained in tires is expected to be managed in an environmentally responsible manner at the end of its service life. All Canadian provinces and Yukon Territory have extended producer responsibility (EPR) or product stewardship programs in place for managing end-of-life tires. The EPR is an environmental policy approach in which the producer’s responsibility for reducing environmental impact and managing the product is extended across the whole life cycle, from selection to end-of-life.
BENPAT is on the high production volume (HPV) lists of the following organizations: the United States Environmental Protection Agency (US EPA),8 the European Commission’s Joint Research Centre, and the Organisation for Economic Co-operation and Development.
In Europe, BENPAT was evaluated in 2005 by the European Chemicals Agency (ECHA) Persistence Bioaccumulation Toxicity (PBT) Working Group and found to be bioaccumulative, toxic, but not persistent according to criteria under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) legislation. footnote 9 Subsequently, in 2013, BENPAT was added to the Community Rolling Action Plan under REACH for evaluation based on environmental concerns, suspected PBT status, wide dispersive and consumer use, and aggregated tonnage. The ongoing evaluation found BENPAT bioaccumulative, and additional degradation studies were requested from industry registrants to evaluate its persistence. This request was appealed under the ECHA Board of Appeal (BoA). In 2017, the BoA annulled some of the test demands, but ruled that one degradation study be performed; the deadline for generating data is 2020.
Scientific assessment summary
An assessment of BENPAT was conducted by the Government to determine if the substance meets one or more of the criteria for a toxic substance set out in section 64 of CEPA. Specifically, this involved determining whether the substance is 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.
The ecological and human health components of the assessment have undergone external written peer review and consultation by Canadian and international experts and from academia and stakeholders. The assessment concluded that BENPAT meets the criterion for a toxic substance under paragraph 64(a) but not (b) or (c) of CEPA. footnote 10
Ecological assessment summary
BENPAT is a substance of unknown or variable composition, complex reaction products, or biological materials (UVCB). UVCBs are typically multicomponent substances that cannot be represented by a unique chemical structure or molecular formula. For the purpose of this assessment, BENPAT was represented by three key components.
Based on experimental degradation data as well as their physical and chemical properties, components of BENPAT are not expected to degrade quickly in water, soil or sediment in the environment. Components of BENPAT also have the potential to accumulate in organisms to a significant extent. The screening assessment concluded that these components, and thus BENPAT, meet the persistence criteria, but not the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for BENPAT indicate that the substance has the potential to cause harm to aquatic organisms.
For this screening assessment, the realistic worst-case scenarios selected to determine BENPAT’s potential to cause ecological harm were associated with discharge of the substance into the aquatic environment from industrial operations. In the release scenarios considered, the predicted environmental concentration in water (PEC) was above the predicted no-effect concentration (PNEC) footnote 11 calculated for algae, indicating potential for ecological harm. Based on the information available, the screening assessment concluded that BENPAT poses an ecological risk to aquatic organisms near sources of industrial release. Therefore, it is concluded that BENPAT meets the criterion under paragraph 64(a). It does not meet the criterion under paragraph 64(b) of CEPA, as the substance does not constitute a danger to the broader integrity of the environment.
Human health assessment summary
Chronic toxicity studies for BENPAT and an analogue indicated no evidence of carcinogenicity footnote 12 in experimental animals and available information also indicated that BENPAT is not likely genotoxic. footnote 13 Considering this information, the characterization of risk to human health was based on non-cancer effects of BENPAT.
The commercial uses for BENPAT in rubber products, identified in literature searches and in responses to a notice issued under section 71 of CEPA, are not expected to result in exposure levels of concern for the general population of Canada. Incidental dermal contact with rubber products containing BENPAT is not expected to result in dermal exposure levels that could pose a concern to human health. As a result, the screening assessment concluded that BENPAT does not meet the criterion under paragraph 64(c) of CEPA, as activities associated with the substance do not pose a human health concern in Canada.
In September 2011, the final screening assessment report for BENPAT was published on the Canada.ca (Chemical Substances) website. On October 15, 2011, the proposed Order recommending the addition of BENPAT to Schedule 1 of CEPA was published in the Canada Gazette, Part I. footnote 14, footnote 15
The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to propose risk management measures for toxic substances under CEPA to manage environmental risks associated with BENPAT.
The Order adds N,N′-mixed phenyl and tolyl derivatives of 1,4-benzenediamine (i.e. BENPAT) to Schedule 1 of CEPA (the List of Toxic Substances).
The “One-for-One” Rule does not apply, as the Order will not impose any administrative burden on businesses.
Small business lens
The small business lens does not apply, as the Order will not impose any compliance or administrative costs on small businesses.
On October 2, 2010, the Government published a summary of the scientific assessment for BENPAT (PDF) (B) in the Canada Gazette, Part I, for a 60-day public comment period. During the 60-day public comment period, comments were received from five industry and non-governmental organization stakeholders on the screening assessment report for BENPAT, and these were considered in developing the final screening assessment for the substance, which was published in September 2011. These comments, however, did not change the conclusion that BENPAT meets the ecological criterion for toxic under paragraph 64(a) of CEPA. A table summarizing the complete set of comments received and the Government’s responses is available on the Canada.ca (Chemical Substances) website.
On October 15, 2011, the proposed Order recommending the addition of BENPAT to Schedule 1 of CEPA was published in the Canada Gazette, Part I, for a 60-day public comment period, which included a summary of the comments received on the draft screening assessment for BENPAT and the Government’s responses to these comments. During the 60-day public comment period for the proposed Order, three sets of comments were submitted by non-governmental organizations and two by citizens. Additionally, a notice of objection was filed by one company, under subsection 332(2) of CEPA, regarding the proposed addition of BENPAT to Schedule 1 of CEPA and requesting the establishment of a board of review pursuant to section 333 of CEPA to inquire into the nature and extent of the danger posed by BENPAT.
The comments submitted by the three non-governmental organizations and two citizens were supportive of the proposed Order recommending the addition of BENPAT to Schedule 1 of CEPA. With respect to the notice of objection, the company provided information and new studies that had been completed after the release of the final scientific assessment report for BENPAT. In general, these studies challenge some aspects of the ecological assessment such as the Government’s persistence designation of BENPAT. The Government reviewed and evaluated the new information provided by the company, in context with all available information. Upon this evaluation, it was considered that the information provided did not impact the scientific assessment. In addition, the Government maintained that the critical review of available studies, models used and assumptions employed in exposure scenarios were based on sound scientific judgment, employed the best available science, and took into account present-day uncertainties regarding releases of BENPAT into the environment. As a result, the Minister of Environment refused to establish a board of review. Subsequently, the company made an application for judicial review in the Federal Court and then in the Federal Court of Appeal, requesting that the Court direct the Minister to either establish a board of review or reconsider the decision to add BENPAT to the List of Toxic Substances in Schedule 1 of CEPA. In July 2017, the Federal Court of Appeal rendered its decision to uphold the Minister’s decision and on that basis denied the company’s judicial review application.
The delay between the publication of the proposed Order in the Canada Gazette, Part I, and the publication of the final Order in the Canada Gazette, Part II, is a result of the decision by the Government to wait for the judicial review proceedings to conclude.
Prior to these publications, the Government had informed the governments of the provinces and territories, through the CEPA National Advisory Committee (NAC), of the release of these documents and of the related public comment period. No comments were received from the CEPA NAC. footnote 16
BENPAT is known to be used as an additive in rubber products, including tires and hoses, to prevent degradation and increase durability. The quantities of BENPAT imported into Canada, along with the known uses of this substance, indicate that it could be released into the Canadian environment. Based on available data, components of BENPAT are not expected to degrade quickly in the environment and they also have the potential to accumulate in organisms. The screening assessment concluded that BENPAT meets the persistence criteria, but not the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity values indicate that this substance is highly hazardous to aquatic organisms. A comparison of PECs associated with industrial discharge of BENPAT into the aquatic environment to the PNEC indicates that the substance poses an ecological risk to aquatic organisms near areas adjacent to sources of industrial release. As a result, the screening assessment concluded that BENPAT meets the environmental criterion under paragraph 64(a) of CEPA. One of the following measures must be proposed after an 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 substance 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 and the conclusions of the screening assessment, the Government determined that choosing option 1 or 2 is not appropriate to manage the potential ecological risk associated with releases of BENPAT into the environment in Canada. Therefore, option 3, which recommends that BENPAT be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option selected by the Government. footnote 17
The addition of BENPAT to Schedule 1 of CEPA will not result in any incremental impacts (benefits or costs) on the public or industry, since the Order will not impose any compliance requirements on stakeholders. Accordingly, there will be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the Order enables risk management measures for toxic substances under CEPA to be proposed to manage potential ecological risks associated with BENPAT.
The Government has considered socio-economic factors and will consult with the public and other stakeholders during the development of risk management proposals for a toxic substance under CEPA for BENPAT.
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 Order adds BENPAT to Schedule 1 of CEPA, thereby enabling risk management measures respecting preventive or control actions for toxic substances under CEPA to be proposed. 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 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