Order 2020-87-23-01 Amending the Domestic Substances List: SOR/2020-172
Canada Gazette, Part II, Volume 154, Number 17
SOR/2020-172 July 29, 2020
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the substance set out in the annexed Order is specified on the Domestic Substances List footnote a;
Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of the substance under section 74 of the Canadian Environmental Protection Act, 1999 footnote b;
And whereas the Ministers suspect that the information concerning a significant new activity in relation to the substance may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of that Act;
Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order 2020-87-23-01 Amending the Domestic Substances List.
Gatineau, July 24, 2020
Minister of the Environment
Order 2020-87-23-01 Amending the Domestic Substances List
1 Part 1 of the Domestic Substances List footnote 1 is amended by deleting the following:
2 Part 2 of the List is amended by adding the following in numerical order:
Coming into Force
3 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, 4,4′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis- (CAS RN footnote 2 13080-86-9, hereafter referred to as “BAPP”) has properties of concern that could pose a risk to the environment in Canada if exposure levels to the substance were to increase due to certain new activities. In order to address this concern, the Minister of the Environment (the Minister) is amending the Domestic Substances List (DSL) in accordance with subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA) to apply the significant new activity (SNAc) provisions of CEPA to BAPP.
The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and living organisms that may be harmful to the environment or human health. The Minister of the Environment and the Minister of Health (the ministers) assessed BAPP in accordance with section 74 of CEPA as part of the CMP.
Description, uses, and sources of release
BAPP does not occur naturally in the environment. BAPP has low solubility in water, negligible volatility, and a tendency to partition to particles because of its hydrophobic nature. For these reasons, the substance is mainly expected to be found in sediments and soil relative to other environmental media, and is not expected to be subject to long-range atmospheric transport.
Mandatory surveys were issued pursuant to section 71 of CEPA for the reporting years 2006 and 2010. For the reporting year 2006, BAPP was not reported to be manufactured above the reporting threshold of 100 kg per year, though 250 kg were reported to be imported into the country, by a single company, in an adhesive bonding primer for aerospace applications. For the reporting year 2010, the same company identified an increase in the use quantity of BAPP to 500 kg.
In Canada, BAPP is used as an additive in corrosion-inhibiting primer used in an epoxy adhesive bonding system in the aeronautic industry. Internationally, the substance has been identified for use as an organic intermediate in the chemical synthesis of polyester-type materials (where it acts as a solidifying agent), as an organic dyestuff pigment intermediate, and as a reagent (a substance added to a system to test if a chemical reaction occurs) for high-performance polymer research.
Based on assessed patterns of industrial uses, BAPP may be released into the environment through industrial processes as well as through waste disposal via incineration, landfills, and wastewater. While BAPP was found to have the potential for release into the environment, quantities released are estimated to be low, given current use patterns.
Summary of the screening assessment for BAPP
In October 2017, the ministers published a screening assessment for BAPP on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether the substance meets one or more of the criteria for a toxic substance as set out in section 64 of CEPA (i.e. to determine if the substance could pose a risk to the environment or human health).
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 multiple sources, such as modelling, literature reviews, database searches, and mandatory surveys issued under section 71 of CEPA, to inform the screening assessment conclusion that BAPP does not meet any of the criteria for a toxic substance set out in section 64 of CEPA. However, the assessment also determined that BAPP has properties of environmental concern that could pose a risk in Canada if exposure levels to the substance were to increase due to certain new activities.
Summary of the ecological and human health assessments
The ecological risks of BAPP were characterized using modelled data. BAPP is not expected to degrade quickly in the environment. The substance persists in water, soil, and sediments, and has the potential to accumulate in organisms and to biomagnify through food chains. Modelled acute and chronic aquatic toxicity values indicate that BAPP is highly hazardous to aquatic organisms. Despite this hazard, given the small amount of BAPP that is currently imported into Canada, its use patterns, and its handling and disposal practices, ecological exposure to the substance is expected to be very low.
The human health risks of BAPP were characterized using modelled data, which indicated potential for the substance to act as a genotoxicant (a substance that may damage genetic material in cells) and a carcinogen (a substance that may cause cancer). Despite this potential hazard, general population exposure to the substance through environmental media, food, and products available to consumers is expected to be null to negligible.
In order to address potential environmental concerns relating to the use of BAPP in certain new activities, the Minister is applying the SNAc provisions of CEPA to BAPP.
Summary of the SNAc provisions of CEPA
Under CEPA, activities associated with any substance listed on the DSL can be carried out without an obligation for any person (individual or corporation) to notify the Minister of such activities. However, if a substance has been assessed and available information suggests that there may be a risk to the environment or human health from the use of the substance in certain new activities in Canada, the Minister may apply the SNAc provisions of CEPA to the substance. footnote 3 These provisions establish a requirement for any person (individual or corporation) considering a significant new activity in relation to a substance subject to the SNAc provisions to provide the required information as part of a notification to the Minister. Upon receipt of the complete information, an assessment of the substance relating to the proposed significant new activity is conducted before the activity is undertaken in Canada.
The objective of Order 2020-87-23-01 Amending the Domestic Substance List (the Order) is to contribute to the protection of human health and the environment by applying the SNAc provisions of CEPA to BAPP. The Order requires that the Minister be notified of any significant new activity involving BAPP, and presented with the required information, so that further risk assessment of the substance relating to the proposed significant new activity is conducted before the activity is undertaken in Canada and, if necessary, risk management measures are implemented.
Pursuant to subsection 87(3) of CEPA, the Order applies subsection 81(3) of CEPA (i.e. the SNAc provisions) to BAPP.
Applicability and reporting requirements
The Order requires any person (individual or corporation) wishing to engage in a significant new activity in relation to BAPP to submit a significant new activity notification (SNAN) to the Minister. The SNAN must contain all of the information prescribed in the Order, and must be submitted at least 90 days prior to the import, manufacture, or use of the substance for the proposed significant new activity. footnote 4 The ministers will use the information submitted in the SNAN and other available information to conduct environmental and human health assessments and, if necessary, implement risk-management measures before the activity is undertaken in Canada.
Below is a summary of the notification requirements for BAPP. For specific details, please see the regulatory text of the Order.
Activities subject to notification requirements
The notification requirements apply to
- any activity involving BAPP (including the use of the substance as a research and development substance, a site-limited intermediate substance, or an export-only substance) footnote 5 in which the total volume of the substance involved in the activity in one calendar year is
- greater than 10 000 kg, if the substance is used in a spray booth equipped with filters to capture overspray in industrial settings; or
- greater than 1 000 kg, if the substance is used in any other activity.
Activities not subject to notification requirements
The notification requirements do not apply to
- any use of the substance that is regulated under the acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act, and the Feeds Act, as these uses are already subject to risk management measures; and
- any use of the substance that is exempt or excluded from notification requirements under CEPA (i.e. as a transient reaction intermediate, an impurity, contaminant, a partially unreacted material or an incidental reaction product, or, under certain circumstances, in mixtures, manufactured items, wastes, or substances carried through Canada). footnote 6
Below is a summary of the information requirements for the notification of a proposed significant new activity involving BAPP. For specific details, please see the regulatory text of the Order.
The Order requires the following information:
- a description of the proposed significant new activity;
- relevant information in schedules 4, 5, and 6 of the New Substances Notification Regulations (Chemicals and Polymers);
- a description of the product that contains the substance, the intended use of that product, and the function of the substance within that product;
- the data and report from a chronic toxicity study in respect of the substance; and
- other information in respect of the substance, including additional details surrounding use, and exposure information.
On October 28, 2017, the Minister published a notice of intent (NOI) to apply the SNAc provisions of CEPA to BAPP in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received during this period.
The departments informed the provincial and territorial governments about the Order through the CEPA National Advisory Council (CEPA NAC) footnote 7 via a letter, and provided them with an opportunity to comment. No comments were received from the CEPA NAC.
Modern treaty obligations and Indigenous engagement and consultation
An assessment of modern treaty implications made in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders amending the DSL do not result in any impact on modern treaty rights or obligations. It was also concluded that the making of an order under sections 87 or 112 of CEPA does not require specific engagement and consultation with Indigenous peoples.
For a substance that is not found to meet the criteria for a toxic substance as set out in section 64 of CEPA, but that has properties of concern for which certain increases in exposure could result in a risk to the environment or human health, several follow-up actions are available to the ministers. Such actions include, but are not limited to applying the SNAc provisions of CEPA, conducting biomonitoring (for humans), conducting environmental monitoring (for air, water, sediment, wastewater, soil, or wildlife), issuing voluntary surveys or mandatory surveys under section 71 of CEPA, requiring facilities to report to the National Pollutant Release Inventory, and conducting consumer-product testing.
Among the options for follow-up actions, applying the SNAc provisions of CEPA will be considered when
- there are no or limited uses of the substance in Canada, but there is a suspicion that a significant new activity could pose risk;
- the current uses of the substance in Canada present no or limited risk, but there is a suspicion that a significant new activity could pose risk; or
- the current uses of the substance in Canada are adequately managed, but there is a suspicion that a significant new activity could pose risk. footnote 8
The screening assessment informed the determination that applying the SNAc provisions of CEPA is the most appropriate follow-up action for BAPP, since current activities involving the substance do not pose a risk to the environment or human health, but the substance has properties of concern that could result in a risk if exposure levels were to increase due to certain new activities.
Benefits and costs
The Order contributes to the protection of the environment and human health by requiring that potential significant new activities involving BAPP undergo an assessment to determine if the proposed activity could pose a risk to the environment or human health before the activity is undertaken and that, if necessary, risk management measures would be implemented.
The SNAc provisions of CEPA do not target activities involving BAPP that have been previously identified and assessed in the screening assessment and would only target significant new activities involving the substance, should any person (individual or corporation) choose to pursue such an activity. In the event that any person (individual or corporation) wishes to use, import, or manufacture BAPP for a significant new activity, they would be required to submit a SNAN to the Minister containing the complete information referred to in the Order.
While there is no notification fee associated with submitting a SNAN to the Minister in response to the Order, the notifier may incur costs associated with generating data and supplying the required information. Similarly, in the event that a SNAN is received, the departments would incur costs for processing the information and conducting assessments of the substance relating to the proposed significant new activity. The Department of the Environment will incur negligible costs for conducting compliance promotion and enforcement activities associated with the Order.
Small business lens
The assessment of the small business lens concluded that the Order has no impact on small businesses, as it does not impose any administrative or compliance costs on businesses related to current activity.
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 related to current activity.
Regulatory cooperation and alignment
Canada is engaged in several bilateral and multilateral agreements with other countries related to chemical substances, living organisms, and their respective management, footnote 9 and the CMP is administered in cooperation and alignment with these agreements.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed for the CMP, which encompasses orders amending the DSL. The assessment concluded that the CMP is expected to have a positive impact on the environment and human health.
Gender-based analysis plus
The gender-based analysis plus (GBA+) assessment concluded that the Order does not affect socio-demographic groups based on factors such as gender, sex, age, language, education, geography, culture, ethnicity, income, ability, sexual orientation, or gender identity.
Implementation, compliance, enforcement, and service standards
The Order comes into force on the day it is registered. Compliance promotion activities conducted as part of implementation of the Order will include developing and distributing promotional material, responding to inquiries from stakeholders, and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.
When assessing whether or not a substance is subject to SNAc provisions, a person (individual or corporation) is expected to make use of information in their possession, or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information, and the relevant safety data sheet (SDS).
Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the SDS mainly serve to protect the health of workers in the workplace from specific hazards of chemical products, and may not include all the information on these hazards. Therefore, an SDS may not list all product ingredients or substances that may be subject to an order. Anyone requiring more detailed information on product composition is encouraged to contact their supplier.
If any information becomes available that reasonably supports the conclusion that a substance subject to SNAc provisions is toxic or capable of becoming toxic under section 64 of CEPA, the person (individual or corporation) who is in possession of, or has knowledge of the information, and who is involved in activities with the substance, is obligated under section 70 of CEPA to provide that information to the Minister without delay.
A company can submit a SNAN on behalf of its clients. In cases where a person receives possession and control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN. footnote 10
Any person (individual or corporation) who transfers the physical possession or control of a substance subject to an order should notify that individual or corporation of their obligation to comply with that order, including the obligation to notify the Minister of any significant new activity and to provide all the required information specified in that order.
A pre-notification consultation (PNC) is recommended for notifiers who wish to consult during the planning or preparation of a SNAN, to discuss any questions or concerns they have about the prescribed information and test plans. Where a person (individual or corporation) has questions concerning their obligations to comply with an order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to contact the Substances Management Information Line. footnote 11
The Order is made under the authority of CEPA, which is enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act. In instances of non-compliance, consideration is given to the following factors when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement. Suspected violations under CEPA can be reported to the Department of the Environment’s Enforcement Branch by email at firstname.lastname@example.org.
In the event that a SNAN is submitted to the Minister in relation to BAPP, the ministers will assess the information after the complete information is received, within the prescribed timelines set out in the Order.
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
Telephone: 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada)
Risk Management Bureau
Department of Health