Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2020-218
Canada Gazette, Part II, Volume 154, Number 22
SOR/2020-218 October 6, 2020
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2020-770 October 2, 2020
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 December 9, 2017, a copy of the proposed Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999, in the annexed form, 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(2) of that Act, the Governor in Council is satisfied that the inclusion of the substance, set out in the annexed Order, on the List of Toxic Substances in Schedule 1 to that Act is no longer necessary;
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(2) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999.
Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Item 110 of Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 1 is repealed.
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 substance benzenamine, N-phenyl-, reaction product with styrene and 2,4,4-trimethylpentene (CAS RN footnote 2 68921-45-9; hereby referred to as “BNST”) had previously been added to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA or the Act) in 2011. However, new available information indicates that BNST has a lower potential to cause ecological harm in Canada than previous available information had indicated. Therefore, the Governor in Council, on the advice of the Minister of the Environment and the Minister of Health (the ministers) is making an order to delete BNST from the List of Toxic Substances in Schedule 1 of the Act.
The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and micro-organisms that may be harmful to the environment or to human health. The ministers assessed 14 substituted diphenylamine (SDPA) substances (including BNST) in accordance with section 74 of CEPA, under the Substituted Diphenylamine Substance Grouping of the Substance Groupings Initiative, as part of the CMP.
Description, uses, and sources of release of the 14 SDPA substances
SDPA substances do not occur naturally in the environment. Mandatory surveys issued under section 71 of CEPA for the reporting year 2011 indicated that between one million and 10 million kilograms (kg) of SDPA substances were imported into the country, and over 10 million kg of SDPA substances were manufactured in Canada, the majority of which (over 90%) were exported.
SDPA substances are used as antioxidants to prevent the degradation of the materials into which they are added. At least 96% of the SDPA substances in Canada are used as antioxidants in the blending of lubricants such as engine, compressor, turbine, and aviation oils. Other uses include SDPA substances as an additive in plastic, foam, rubber, and adhesives.
Releases of SDPA substances into the environment are expected to occur into water and soil from industrial activity (e.g. manufacturing of SDPAs and SDPA use in product manufacturing). Releases into the environment from consumer use of plastic, foam, and rubber products are expected to be minimal, geographically dispersed, and to extend over the duration of the service life and end of life of these products. For lubricants and engine oils, releases can occur through leaks, spills, and improper disposal of the products containing the substances. However, the overall amount released from these sources is considered minor in comparison to quantities predicted to be released during use or from manufacturing.
Summary of the screening assessment on the 14 SDPA substances
In December 2017, the ministers published a screening assessment on 14 SDPA substances on the Canada.ca (Chemical substances) website. The screening assessment was conducted to determine whether these substances meet one or more of the criteria for a toxic substance as set out in section 64 of CEPA (i.e. to determine if these substances could pose a risk to the environment or to human health in Canada).
Under section 64 of CEPA, a substance is considered toxic if it 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 Department of the Environment and the Department of Health (the departments) generated and collected information from environmental sampling, modelling, literature reviews, database searches, and mandatory surveys issued under section 71 of CEPA to inform the screening assessment conclusion that the 14 SDPA substances do not meet any of the criteria for a toxic substance as set out in section 64 of CEPA and therefore, do not constitute a risk to the environment or to human health in Canada.
Summary of the ecological assessment
Available information on concentrations of the 14 SDPA substances in the environment in Canada (i.e. in water, sediments, and biota, as well as in wastewater and biosolids) was used to support the assessment of potential ecological risks. Tissue concentrations for fish near a manufacturing site showed low levels of SDPA concentrations, with many samples being below the detection limits.
The measured concentrations, as well as estimated concentrations in other organisms (i.e. shrew, earthworm, and fish), showed a low potential for harm when compared to the thresholds at which SDPA substances could have an effect. The lower concentration of chemical components associated with the 14 SDPA substances found in non-human organisms suggests that releases of these substances to the environment in Canada do not result in exposure levels of concern. Therefore, the 14 SDPA substances do not meet the criteria under paragraph 64(a) or 64(b) of CEPA.
Summary of the human health assessment
Based on the data associated with the 14 SDPA substances, critical health effects appear to be most correlated with the liver and the kidney at higher levels of exposure to these substances. Analysis of the information received from mandatory surveys issued under section 71 of CEPA determined that the activities or uses of SDPA substances that could pose a concern to human health in Canada were associated with automotive lubricants used by consumers (such as in motor oil and transmission fluid change) and some foam products.
An estimate of dermal exposure to SDPA substances was generated from consumers using automotive lubricants, and an estimate of oral exposure was generated by modelling a scenario of an infant and a toddler exposing their mouth to a couch cushion manufactured with foam. footnote 3 The assessment concluded that current exposure levels from these scenarios and other uses of the 14 SDPA substances in Canada do not pose a risk to human health and, therefore, these substances do not meet the criterion under paragraph 64(c) of CEPA.
Previous addition of BNST to Schedule 1 of CEPA
In 2006, BNST was identified as a high priority for assessment under the CMP’s Challenge Initiative, as the substance was suspected to be persistent, bioaccumulative, and inherently toxic to non-human organisms, and was reported to be manufactured or imported into Canada in vast quantities. While releases of BNST were suspected to pose an ecological risk in Canada, potential risks to human health from exposure to BNST were not considered a high priority for assessment. footnote 4 The other 13 SDPA substances did not meet the criteria for priority assessment under the Challenge Initiative and were subsequently assessed at a later date.
Summary of the 2009 screening assessment on BNST
In 2009, a screening assessment on BNST found that the substance does not degrade quickly in the environment (is persistent), may accumulate in the tissues of living organisms in the food chain (is bioaccumulative), may be moderately to highly hazardous to aquatic organisms (is inherently toxic), and was used in Canada in dispersive uses, suggesting that significant quantities of the substance could be released to the environment.
Based on information that was available at the time, including information from computer-based models, mandatory surveys issued under section 71 of CEPA, Statistics Canada reports, manufacturers’ websites, technical databases, and other relevant peer-reviewed documents, the 2009 screening assessment concluded that BNST met the environmental criterion for a toxic substance under paragraph 64(a) of CEPA. As a result of this screening assessment conclusion, the ministers added BNST to the List of Toxic Substances in Schedule 1 of CEPA in 2011.
Risk management measures under CEPA previously applied to BNST
Virtual elimination is defined in subsection 65(1) of CEPA as the reduction of the quantity or concentration of a toxic substance in the release into the environment to below a certain level specified by the ministers (i.e. the lowest levels of the substance that can be accurately measured using sensitive but routine sampling and analytical methods). footnote 5 In accordance with subsection 77(4) of CEPA, the implementation of virtual elimination is applicable if
- the substance met one of the criteria for a toxic substance in section 64 of CEPA;
- the substance was found to be persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations;
- the presence of the substance in the environment resulted primarily from human activity; and
- the substance was not a naturally occurring inorganic substance or radionuclide.
Based on information that was available at the time, the implementation of virtual elimination applied to BNST. To meet the environmental objective of achieving the lowest possible concentration of BNST in the environment, the manufacture, use, sale, offer for sale, and import of BNST (and products containing BNST) were prohibited in Canada under the Prohibition of Certain Toxic Substances Regulations, 2012, with exemptions for limited additional uses and a permit scheme to allow for certain uses, which expired on March 14, 2018.
New available information on SDPA substances and subsequent updates to risk management measures under CEPA previously applied to BNST
In 2017, the ministers assessed BNST alongside 13 other SDPA substances, because these substances share some of the same chemical components and have potential uses as alternatives for one another. While the overall use of SDPA substances in lubricants is not expected to have decreased since the section 71 surveys issued for reporting year 2011, it is estimated that the use of BNST in lubricants since the section 71 surveys issued for reporting year 2006 has decreased by more than 99%. The vast estimated reduction in the use of BNST in lubricants, coupled with the steady overall use of SDPA substances in the same products, suggests a greater availability of SDPA substances (with similar chemical and physical properties to BNST) that industry may have used to replace the substance as an additive in lubricants.
Recent concentrations of SDPA substances measured in the environment, including concentrations of chemical components found in BNST, indicate that SDPA substances have a lower potential to cause ecological harm in Canada than previously available information had indicated. As a result of new available information, the 2017 screening assessment concluded that BNST and the other 13 SDPA substances are not considered toxic under CEPA, and that BNST does not meet the criteria for virtual elimination set out in subsection 77(4) of CEPA. Consequently, the prohibitions respecting BNST were repealed under the Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012, published on December 13, 2017.
The objective of the Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to delete BNST from the List of Toxic Substances in Schedule 1 of CEPA. As a result, BNST is no longer able to become subject to risk management measures for a toxic substance implemented under the Act.
The Order deletes benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST) from the List of Toxic Substances in Schedule 1 of CEPA.
On December 10, 2016, the ministers published a summary of the draft screening assessment for the 14 SDPA substances in the Canada Gazette, Part I, which was followed by a 60-day public comment period. The draft screening assessment proposed to conclude that none of the 14 SDPA substances are harmful to the environment or human health in Canada. During the 60-day public comment period, a total of seven submissions from the chemical industry, automotive industry, oil and gas sector, non-governmental organizations and other governments were received. A table summarizing the complete set of comments received on the draft screening assessment report and the departments’ responses to these comments is available on the Canada.ca (Chemical substances) website.
The majority of stakeholder submissions on the draft screening assessment supported the assessment conclusion for the 14 SDPA substances. Five of the seven submissions commended the ministers on the process of reassessing substances. Members of a national industry association lauded this as an example of the dutiful revisiting of past assessments when appropriate. However, one stakeholder expressed concerns about the scientific process and data validity from the methods used to extract the substances from the samples used in the assessment, as well as the reversal of bioaccumulation findings associated with BNST. The departments responded that assessing substances under the CMP is based on the best available information, estimation methods, including application of read-across methodology (which is filling data gaps by applying data from better-known substances to other substances that are chemically similar), and international guidelines and tools that utilize both modelling and empirical data.
The estimation methods are based on conservative assumptions, and the results are peer-reviewed by technical experts. Although certain measured environmental concentrations had uncertainties due to methodological limitations, complementary sampling was also carried out, which supported the reversal of bioaccumulation findings. The complementary sampling confirmed that SDPA concentration levels accumulated in fish, including chemical compounds found in BNST, were not indicative of harm.
The comments received on the draft screening assessment report were considered during the development of the final screening assessment report for the 14 SDPA substances, but did not change the assessment conclusion that these substances do not pose an ecological or human health risk in Canada, as per the criteria set out in section 64 of CEPA. The final screening assessment report for the 14 SDPA substances was published on the Canada.ca (Chemical substances) website in December 2017.
The proposed Order recommending the deletion of BNST from the List of Toxic Substances in Schedule 1 of CEPA was published in December 2017 in the Canada Gazette, Part I, to launch a 60-day public comment period. One submission was received on the proposed Order from an industry association, indicating support of the proposal to delete BNST from the List of Toxic Substances in Schedule 1 of CEPA.
The departments informed the provincial and territorial governments about all publications through the CEPA National Advisory Committee (CEPA NAC) footnote 6 via a letter, and provided them with an opportunity to comment. No comments were received from CEPA NAC.
Modern treaty obligations and Indigenous engagement and consultation
The assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders deleting substances from the List of Toxic Substances in Schedule 1 of CEPA do not impose any regulatory or administrative burdens; therefore, they do not result in any impact on modern treaty rights or obligations. The assessment also concluded that the making of an order under section 90 of the Act does not require specific engagement and consultation with Indigenous peoples.
An order is the only available instrument to delete a substance from the List of Toxic Substances in Schedule 1 of CEPA.
Benefits and costs
The deletion of BNST from the List of Toxic Substances in Schedule 1 of CEPA has no impacts (benefits or costs). The Order addresses the screening assessment conclusion on the 14 SDPA substances, which determined that they do not meet any of the criteria for a toxic substance as set out in section 64 of CEPA. At the time of its deletion, BNST is not subject to any risk management measures for a toxic substance issued under the Act.
Small business lens
The assessment of the small business lens concluded that the Order does not have an impact on small businesses, as it does not impose any administrative or compliance costs on businesses.
The assessment of the one-for-one rule concluded that the rule does not apply to the Order, as there is no impact on industry.
Regulatory cooperation and alignment
Canada is engaged in several international bilateral and multilateral agreements related to chemicals and their management, footnote 7 and the CMP is administered in cooperation and alignment with these agreements.
In addition, the Order aligns with risk management activities associated with SDPA substances conducted in other jurisdictions. In the United States, BNST was part of the United States Environmental Protection Agency (EPA) High Production Volume Challenge Program (the Program), which required companies to provide, and make public, basic hazard information on the substance. The 2009 United States EPA Screening-level Hazard Characterization (SDPA category) outlined screening-level indicators of potential hazards (toxicity) for humans and the environment. No regulatory decisions were made regarding the SDPA category resulting from the Program. In Europe, the assessment of SDPA substances under the European Union Registration, Evaluation, Authorization and Restriction of Chemicals Regulation is still at its early stages, and seeks to clarify the potential for SDPA substances to be persistent, bioaccumulative, and toxic. In Europe, there are currently no control measures in place for SDPA substances. In Australia, BNST remains a priority for environmental assessment; however, there are currently no control measures in place for the substance.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment (archived) was completed for the CMP, which encompasses orders deleting substances from the List of Toxic Substances in Schedule 1 of CEPA. The assessment concluded that the CMP is expected to have a positive effect on the environment and on human health.
Gender-based analysis plus
The gender-based analysis plus (GBA+) assessment concluded that the Order does not affect sociodemographic groups based on factors such as gender, sex, age, language, education, geography, culture, ethnicity, income, ability, sexual orientation, or gender identity.
Implementation, compliance and enforcement, and service standards
As a result of the Order, BNST is no longer able to become subject to risk management instruments for a toxic substance under CEPA. It is not necessary to develop an implementation plan and a compliance and enforcement strategy, nor is it necessary to establish service standards, as these elements would only be associated with proposals for such instruments.
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