Order 2019-87-24-01 Amending the Domestic Substances List: SOR/2020-153
Canada Gazette, Part II, Volume 154, Number 15
SOR/2020-153 June 30, 2020
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the substance set out in the annexed Order is specified on the Domestic Substances List footnote a;
And whereas the Minister of the Environment and the Minister of Health 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 the Canadian Environmental Protection Act, 1999 footnote b;
Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order 2019-87-24-01 Amending the Domestic Substances List.
Gatineau, June 22, 2020
Minister of the Environment
Order 2019-87-24-01 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:
1 The use of the substance acetamide, N-(4-ethoxyphenyl)- in the manufacture of any of the following products such that the substance is present in the product in a concentration equal to or greater than 0.1% by weight:
2 Any activity involving the use of the substance acetamide, N-(4-ethoxyphenyl)- in a quantity greater than 10 kg in a calendar year in any of the following products, if the product contains the substance at a concentration equal to or greater than 0.1% by weight:
3 Despite sections 1 and 2, a use of the substance is not a significant new activity if the substance is used
4 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the significant new activity begins:
5 The information referred to in section 4 is to be assessed within 90 days after the day on which it is received by the Minister.
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 Department of the Environment and the Department of Health (the Departments) conducted a screening assessment on acetamide, N-(4-ethoxyphenyl)-, hereinafter referred to as “phenacetin,” footnote 2 to determine whether the substance poses a risk to human health or the environment in Canada, as per the criteria for a toxic substance set out in Part 5, section 64, of the Canadian Environmental Protection Act, 1999 (CEPA). It was concluded that the identified current activities/uses of phenacetin in Canada do not result in exposure levels that could pose an undue risk to human health. Based on the outcome of the Ecological Risk Classification of organic substances (ERC) approach, phenacetin is considered unlikely to be causing ecological harm. As a result, phenacetin did not meet any of the criteria in section 64 of CEPA.
The assessment also determined that phenacetin has a health effect of concern due to its potential to cause cancer, and that increased exposure from its use in consumer products and cosmetics that were not identified or assessed in the screening assessment could pose a risk in Canada. In order to address this concern, the Minister of the Environment (the Minister) is applying the significant new activity (SNAc) provisions of CEPA to phenacetin.
The Chemicals Management Plan (CMP) is a federal program that assesses chemical substances and micro-organisms to determine if they pose or may pose a risk to human health or the environment in Canada. If a risk is identified, risk management activities may be undertaken. Phenacetin was assessed under the CMP to determine whether the substance could pose a risk to human health or the environment in Canada.
Under section 64 of CEPA, a substance is considered toxic if it is entering or may enter the environment in a quantity, 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.
Summary of the screening assessment for phenacetin
The screening assessment for phenacetin includes consideration of information on chemical properties, environmental fate, hazards, uses, and exposure, including additional information submitted by stakeholders. Relevant data were identified, and targeted literature searches were conducted up to March 2016. Additional information was collected from internal databases of Department of Health programs up to October 2017. Empirical data from key studies, as well as some results from models were used to reach the conclusions. When available and relevant, information presented in assessments from other jurisdictions was considered. The human health components of this assessment underwent external review. The ecological portion of the assessment was based on the ERC approach document, which was subject to an external review. The assessment was subject to a 60-day public comment period, following the publication of the summary of the draft screening assessment for phenacetin in the Canada Gazette, Part I, on April 15, 2017.
The screening assessment found that phenacetin did not meet any of the environmental or human health criteria for a toxic substance under section 64 of CEPA. Below is a summary of the ecological and human health assessment components of the screening assessment.
Summary of the ecological assessment
The ecological risk of phenacetin was characterized using the ERC approach. The ERC is a risk-based approach that employs multiple metrics for both hazard and exposure based on weighted consideration of multiple lines of evidence for determining risk classification. Based on low hazard and low exposure classifications according to ERC for phenacetin, this substance was classified as having a low potential for ecological risk and thus did not meet any of the ecological criteria under paragraph 64(a) or (b) of CEPA.
Summary of the human health assessment
Phenacetin had a long history of use as an analgesic and antipyretic before being withdrawn from the market for these applications in 1973, due to indications of nephropathy (kidney disease or damage) and increased risk of certain cancers in chronic, heavy users. While phenacetin is still present on the Prescription Drug List in Canada, there are currently no marketed prescription drug products in Canada that contain the substance.
Based on information gathered from mandatory surveys issued under section 71 of CEPA for the 2008 calendar year, there were no reports of manufacture or imports of phenacetin in Canada above the reporting threshold of 100 kg per year, though there were reports of imports in quantities below or equal to this threshold. Phenacetin was reported to be used in Canada as a laboratory substance and in medical devices. In addition, based on notifications submitted under the Cosmetic Regulations of the Food and Drugs Act, phenacetin is present in certain cosmetic products as a stabilizer for hydrogen peroxide. Product categories notified include hair bleaches, hair colouring preparations, hair shampoos (colouring), and permanent waves. The assessment concluded that exposure to phenacetin from these products is not a human health concern in Canada, and thus phenacetin did not meet the human health criterion for a toxic substance under paragraph 64(c) of CEPA. It was also determined that increased exposure to phenacetin from its use in other cosmetic products that were not identified or assessed in the screening assessment for the substance could pose a risk. In order to address this concern, the Minister is applying the SNAc provisions of CEPA to phenacetin.
Summary of SNAc provisions of CEPA
Under CEPA, activities associated with substances listed on the Domestic Substances List (DSL) can be carried out without an obligation for any person (individual or corporation) to notify the Minister of such activities. However, when available information suggests that there may be a risk to human health or the environment from the use of a substance for a new activity 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 any of the substances 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 shall be conducted before the new activity can be undertaken in Canada.
Publications and conclusions
In June 2018, the Departments published the Final Screening Assessment for Phenacetin on the Government of Canada (Chemical Substances) website, concluding that phenacetin does not meet any of the environmental or human health criteria for a toxic substance under section 64 of CEPA. On July 28, 2018, the Minister published a notice of intent (NOI) to apply the SNAc provisions of CEPA to phenacetin in the Canada Gazette, Part I, for a 60-day public comment period.
The objective of Order 2019-87-24-01 Amending the Domestic Substances List is to contribute to the protection of human health and the environment in Canada by applying the SNAc provisions of CEPA to phenacetin. The Order requires that the Minister be notified of any significant new activity involving the substance so that an assessment is conducted. If necessary, risk management measures are implemented, before the activity can be undertaken in Canada.
This Order applies the SNAc provisions of CEPA to phenacetin. The Order requires any person (individual or corporation) wishing to engage in a significant new activity in relation to the substance to submit a significant new activity notification (SNAN) footnote 4 to the Minister, containing all of the information prescribed in the Order at least 90 days prior to the import, manufacture or use of the substance for the significant new activity. footnote 5 The Departments will use the information submitted in the SNAN, and other available information, to conduct human health and ecological assessments.
Summary of notification requirements
Below is a summary of the notification requirements for phenacetin. For specific details, please see the regulatory text in the Order.
Activities subject to notification requirements
This Order applies to any consumer product to which the Canada Consumer Product Safety Act applies, or to any cosmetic (other than hair colour products) within the meaning of section 2 of the Food and Drugs Act that
- uses phenacetin in the manufacture of the product, if the concentration of phenacetin in the product is greater than 0.1% by weight; or
- uses phenacetin in any other activity involving the product (i.e. other than the manufacture of one of these products), if the concentration of phenacetin in the product is greater than 0.1% by weight, and the total quantity of the substance used in the product is greater than 10 kg in one calendar year.
Activities not subject to notification requirements
The Order does 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;
- any use of the substance that is exempt or excluded from notification requirements under CEPA (i.e. as a transient reaction intermediate, an impurity, a contaminant, a partially unreacted material or an incidental reaction product, and, under certain circumstances, in mixtures, manufactured items, wastes or substances carried through Canada); footnote 6 and
- any use of the substance as a research and development substance, site-limited intermediate substance, or export-only substance, as no exposure of concern to the general population is expected from these activities. footnote 7
Summary of information requirements
Below is a summary of the information requirements for the notification of a proposed significant new activity involving phenacetin. For specific details, please see the regulatory text in the Order.
The Order requires
- a description of the proposed significant new activity;
- relevant information in schedules 4 and 5 of the New Substances Notification Regulations (Chemicals and Polymers);
- a description of the consumer product or cosmetic that contains the substance, the intended use of that consumer product or cosmetic and the function of the substance within that consumer product or cosmetic; and
- other information in respect of the substances, including additional details surrounding their use, and exposure information.
On July 28, 2018, the NOI to amend the DSL to apply the SNAc provisions of CEPA to phenacetin was published in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received.
The Departments also informed the provincial and territorial governments about the Order through the National Advisory Committee of CEPA (CEPA NAC) footnote 8 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
In accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications must be conducted. The assessment that orders amending the DSL does not result in impacts on modern treaty rights or obligations. Further, these orders do not require specific engagement and consultation with Indigenous peoples.
For a substance that is not found to meet the criteria set out in section 64 of CEPA, but that has properties of concern for which any increase in exposure could result in a risk to the environment or human health, several follow-up actions are available to the ministers. Such actions could 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 or mandatory surveys under section 71 of CEPA, requiring facilities to report to the National Pollutant Release Inventory, or 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 9
The screening assessment informed the decision that applying the SNAc provisions of CEPA is the most appropriate follow-up action for phenacetin, 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.
Benefits and costs
The Order contributes to the protection of human health and the environment by ensuring that future activities that could pose a risk to Canadians or the environment would not be undertaken before undergoing an assessment, and that, if necessary, risk management measures would be implemented.
The Order is not expected to have a significant impact on industry, governments or Canadian consumers. The SNAc provisions of CEPA do not apply to activities involving phenacetin that have been previously identified and assessed in the risk assessment, and only apply to significant new activities involving the substance. In the event that any person (individual or corporation) wishes to use, import or manufacture phenacetin for a significant new activity, the information referred to in the Order will need to be submitted at least 90 days before the day on which the substance is imported, manufactured, or used for a significant new activity.
There is no notification fee associated with submitting a SNAN to the Minister in response to the Order. However, costs associated with generating data and supplying other information could be incurred by the notifier. Similarly, the Departments will incur costs for processing the information and conducting assessments. The Department of the Environment (the Department) 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 new administrative or compliance costs on small businesses related to current activity.
The assessment of the one-for-one rule concluded that the rule does not apply to the Order, as it does not impose any new administrative or compliance costs on industry related to current activity.
Regulatory cooperation and alignment
Canada is engaged in several bilateral and multilateral agreements related to chemicals and their management, footnote 10 and the CMP is administered in cooperation and alignment with these agreements.
Strategic environmental assessment
A strategic environmental assessment (SEA) is not required for orders amending the DSL. However, in accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals (PDF), a SEA for the CMP as a whole was completed, concluding that the CMP will 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 that it is registered. Compliance promotion activities conducted as part of the 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 the 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 for 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 goal of the SDS is 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. Any person requiring more detailed information on product composition is encouraged to contact their supplier.
If any information becomes available that reasonably supports the conclusion that the substance 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. For example, 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 11
Any person (individual or corporation) who transfers the physical possession or control of a substance subject to an order to another should notify that individual or corporation of their obligation to comply with the order, including the obligation to notify the Minister of any significant new activity and to provide all the required information specified in the 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 12
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, 1999. 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 Enforcement Branch by email at email@example.com.
In the event that a SNAN is submitted to the Minister in relation to phenacetin, the Department 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:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Risk Management Bureau
Department of Health