Canada Gazette, Part I, Volume 151, Number 49: Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999
December 9, 2017
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 Government of Canada (the Government) has completed a screening assessment of 14 substituted diphenylamines (SDPA) substances to determine if they could pose a risk to the environment or human health in Canada. The assessment determined that the substances do not constitute a risk as they are not entering the environment in a quantity or concentration or under conditions that could have harmful effects on the environment or human health in Canada. The assessment thus concluded that the 14 SDPA substances do not meet any of the toxicity criteria under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA or the Act). (see footnote 1)
One of the 14 substances is benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST). In an earlier assessment, published in 2009, BNST was found to meet the environmental criterion under paragraph 64(a) of CEPA, and was added to the List of Toxic Substances, in Schedule 1 of the Act, in 2011. Recent measured environmental concentrations for SDPA substances, which included concentrations of chemical components also found in BNST, show that they have a lower potential to cause ecological harm in Canada than previously available information had indicated.
As a result of the assessment conclusion for the 14 SDPA substances, under paragraph 90(2)(a) of the Act, the Government is therefore recommending that BNST be deleted from the List of Toxic Substances in Schedule 1 of CEPA.
The Chemicals Management Plan (CMP) (see footnote 2) is a federal program that aims to assess and manage chemical substances in Canada. A key element in the CMP is the Challenge (see footnote 3) initiative in which approximately 200 chemical substances were identified as high priorities for assessment as they presented the greatest potential for exposure to individuals in Canada; or were persistent, bioaccumulative and inherently toxic to human beings or to non-human organisms. BNST had met the persistent, bioaccumulative and inherent toxicity criteria to non-human organisms and was assessed under the Challenge initiative to determine if releases of BNST posed an ecological risk in Canada. BNST was not, however, considered to be a high priority for assessment of potential risks to human health. (see footnote 4) As the remaining SDPA substances did not meet the criteria to be assessed under the Challenge initiative, they were assessed at a later time.
BNST was originally added to Schedule 1 of CEPA because the 2009 BNST assessment had found that the substance does not degrade quickly in the environment (it was found to be persistent), may accumulate in the tissues of living organisms in the food chain (it was found to be bioaccumulative) and may be moderately to highly hazardous to aquatic organisms. Furthermore, based on a survey conducted under section 71 of the Act, in 2006, the quantity manufactured and imported into Canada along with the dispersive uses of BNST indicated that significant quantities of the substance could be released to the environment.
The 2009 assessment conducted on BNST was based on the best information available at the time. This information came from a variety of sources, including computer-based models and regulatory surveys conducted under section 71 of CEPA, Statistics Canada, manufacturers' websites, technical databases and other relevant peer-reviewed documents. During the consultation process, which included two 60-day public comment periods (following the publication of the draft screening assessment and the proposed Order recommending the addition of BNST to Schedule 1 of the Act), stakeholders submitted information and comments that were considered in finalizing the BNST assessment, but did not contradict the assessment conclusion indicating that BNST releases to the environment had the potential for ecological harm. As a result, the assessment concluded that BNST met the environmental criterion under paragraph 64(a) of the Act, and it was subsequently added to Schedule 1 of CEPA.
In addition, BNST met the criteria for virtual elimination (VE), as defined under subsection 77(4) of CEPA, since
- BNST met one of the criteria in section 64 of CEPA,
- BNST was found to be persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations, (see footnote 5)
- the presence of BNST in the environment resulted primarily from human activity, and
- BNST was not a naturally occurring radionuclide or a naturally occurring inorganic substance. (see footnote 6)
Under CEPA, VE is the reduction of the quantity or concentration of a toxic substance in releases to the environment to below a “level of quantification” (see footnote 7) specified by the Minister of Health and the Minister of the Environment (the ministers). To meet the environmental objective of achieving the lowest possible concentration of BNST in the environment, BNST was prohibited under the Prohibition of Certain Toxic Substances Regulations, 2012 (the Prohibition Regulations).
Description of SDPA substances (including BNST)
The other SDPA substances were identified as priorities for assessment based on their chemical similarity and potential use as alternatives for each other, which included their potential use as alternatives to BNST following its prohibition.
SDPA substances, including BNST, are used as antioxidants to prevent the degradation of the materials into which they are added. In Canada, SPDA substances are mainly used in lubricants and may be used as an additive in plastic, foam and rubber. Releases of SDPAs are expected to occur to water and soil from consumer use and industrial activity. Releases to the environment from consumer use of plastic, foam, and rubber products are expected to be minimal, geographically dispersed, and 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.
A notice issued under section 71 of CEPA for the reporting year 2011 indicated that between 1 million kilograms and 10 million kilograms of SDPA substances were imported and over 10 million kilograms of SDPA substances were manufactured in Canada, the majority of which (over 90%) was exported. At least 96% of SDPA substances in Canada are used in lubricants. It is estimated that since 2006, the use of BNST in lubricants has decreased by more than 99%. The estimated reduction is attributed in part to the Prohibition Regulations and availability of other SDPA substances with similar chemical and physical properties to BNST that industry may have used to replace the substance as an additive in lubricants. It is assumed that the demand for SDPA substances has stayed relatively constant since 2006, and therefore, it is assumed that the total quantity of SDPA substances used in Canada today are fairly similar than before the prohibition regime.
Summary of the screening assessment of the 14 SDPA substances
The Government conducted a screening assessment on 14 SDPA substances, which includes BNST, to determine if these substances would meet one or more of the criteria for a toxic substance as described in section 64 of CEPA. Specifically, 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.
Human health assessment
Based on the data associated with the 14 SDPA substances, critical health effects appear to be targeted to the liver, and the kidney, at higher levels of exposure to the substances. Analysis of the information received 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 from a scenario of mouthing by an infant and toddler of a couch cushion manufactured with foam. (see footnote 8)
The assessment concluded that current exposure levels from these scenarios and other uses of the 14 SDPA substances, including BNST, in Canada do not pose a risk to human health and the substances therefore do not meet the criterion under paragraph 64(c) of CEPA. (see footnote 9)
The screening assessment for SDPA substances determined the potential ecological risks associated with releases of 14 SDPA substances, including BNST, to the environment. Available information on concentrations of SDPA substances in the environment in Canada (i.e. 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 concentration, with many being below the detection limits. The measured concentrations as well as estimated concentrations in other organisms (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 SDPA substances, including BNST, 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 assessment concluded that the 14 SDPA substances do not pose an ecological risk, as the substances are 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. Therefore, the 14 SDPA substances, including BNST, do not meet the criteria under paragraph 64(a) or 64(b) of CEPA. (see footnote 10)
International risk management activities
BNST was part of the United States Environmental Protection Agency (U.S. EPA) High Production Volume (HPV) Challenge Program (the Program), which required companies to provide and make public basic hazard information on the chemical. The U.S. EPA Screening-level Hazard Characterization (SDPA category), released in 2009, outlines screening-level indicators of potential hazards (toxicity) for humans and the environment, which are aligned with Canada's SDPA assessment toxicity findings. No regulatory decisions were made on the SDPA category, including BNST, as part of the Program.
In Europe, the SDPA substances, including BNST assessment process, under the European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation, is still at its early stages and seeks to clarify the potential for SDPA substances, including BNST, to be persistent, bioaccumulative, and toxic. There are currently no control measures in place for SDPA substances, including BNST.
In Australia, BNST remains a priority for environmental assessment; however, there are currently no control measures in place for BNST.
Publication and conclusions
On December 9, 2017, the final screening assessment for 14 SDPAs, including BNST, was published on the Canada.ca (Chemical Substances) website. Based on the results of the final screening assessment, it was concluded that these 14 SDPAs do not meet any of the criteria under section 64 of CEPA, and the ministers therefore propose to recommend that BNST be deleted from Schedule 1 of CEPA. (see footnote 11)
The objective of the proposed Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) would be to repeal the listing of BNST in Schedule 1 of CEPA.
The proposed Order would delete BNST from Schedule 1 of the Act.
The “One-for-One” Rule would not apply, as the proposed Order would not impose any administrative burden on business.
Small business lens
The small business lens would not apply, as the proposed Order would not impose any compliance or administrative costs on small business.
On December 10, 2016, the ministers published a summary of the draft screening assessment for 14 SDPA substances in the Canada Gazette, Part I, for a 60-day public comment period. The draft screening assessment proposed to conclude that none of the 14 SDPA substances considered in the assessment are harmful to the environment or human health in Canada. This proposed conclusion applied to BNST, which is one of the 14 SDPA substances assessed.
During the 60-day public comment period, a total of seven submissions from the chemicals industry, automotive industry, oil and gas sector, non-governmental organizations as well as other governments were received on the draft screening assessment. These comments were considered during the development of the final screening assessment report for the 14 SDPA substances. A table summarizing the complete set of comments received and the Government's responses is available on the Canada.ca (Chemical Substances) website. (see footnote 12)
Overview of public comments and responses
The majority of submissions supported the conclusion of the assessment on the 14 SDPA substances, including BNST. Five of the seven submissions commended the Government on the process of reassessing substances. It was stated that this is an example of the Government revisiting past decisions when appropriate.
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. Government officials responded that assessing substances under the CMP is based on the best available information and 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 use 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 submitted to the Department of the Environment had uncertainties due to methodological limitations, the Department of the Environment also carried out complementary sampling that supported the reversal of bioaccumulation findings by, for example, confirming that SDPA concentration levels accumulated in fish were not indicative of harm — these concentrations included chemical components found in BNST.
The Government conducted a screening assessment of 14 SDPA substances, including BNST, to determine if they could pose a risk to the environment or human health in Canada. The assessment concluded that the substances do not constitute an environmental or human health risk in Canada as defined in section 64 of CEPA. One of these substances was BNST, which was assessed under the Challenge initiative in 2009, since available information at the time identified the substance as presenting high ecological risk. BNST was subsequently added to the list of Toxic Substances in Schedule 1 of CEPA, in 2011. In 2012, BNST was prohibited under the Prohibition Regulations.
It is estimated that since 2006, the use of BNST in lubricants has decreased by more than 99%. The estimated reduction is attributed in part to the Prohibition Regulations and the availability of other SDPA substances with similar chemical and physical properties to BNST that industry may have used to replace the substance as an additive in lubricants. It is assumed that the demand for SDPA substances has stayed relatively constant since 2006; therefore, it is assumed that the total quantity of SDPA substances used in Canada today is fairly similar to before the prohibition regime.
Recent measured environmental concentrations for SDPA substances, which included concentrations of chemical components also found in BNST, show that they have a lower potential to cause ecological harm in Canada than previously available information had indicated. The sampling for measured environmental concentrations dates from before the prohibition regime was in place for BNST. This information showed that SDPA substances have a low potential to accumulate and cause harm to aquatic and terrestrial organisms. The SDPA assessment therefore determined that none of the 14 SDPA substances, including BNST, meet the human health or environmental toxicity criteria as defined in section 64 of CEPA. As a result, the Government is recommending under paragraph 90(2)(a) of the Act that BNST be deleted from the List to Toxic Substances in Schedule 1 of CEPA.
The proposed deletion of BNST from Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or 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.
Implementation, enforcement and service standards
The proposed Order would delete BNST from Schedule 1 of CEPA. An implementation plan and enforcement strategy is not required for the deletion of substances from Schedule 1 of CEPA.
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) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see 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(2) of that Act, proposes to make the annexed Order Amending 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 (fax: 819-938-5212; email: 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, November 23, 2017
Assistant Clerk of the Privy Council
Order Amending Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Item 110 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 13) is repealed.
Coming into Force
2 This Order comes into force on the day on which it is registered.