Order 2020-87-23-01 Amending the Domestic Substances List: SOR/2020-172

Canada Gazette, Part II, Volume 154, Number 17

Registration

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

Jonathan Wilkinson
Minister of the Environment

Order 2020-87-23-01 Amending the Domestic Substances List

Amendments

1 Part 1 of the Domestic Substances List footnote 1 is amended by deleting the following:

13080-86-9

2 Part 2 of the List is amended by adding the following in numerical order:

Column 1

Substance

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

13080-86-9 S′
  • 1 Any activity involving, in any one calendar year, more than 1 000 kg of the substance benzenamine, 4,4′-[(1methylethylidene)bis(4,1-phenyleneoxy)]bis-.
  • 2 Despite section 1, the use of less than 10 000 kg of the substance in any one calendar year is not a significant new activity if the substance is applied in a spray booth, or an area that is enclosed or designed to capture overspray, and wastes are collected at the site of application.
  • 3 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:
    • (a) a description of the significant new activity in relation to the substance, including a statement as to whether the activity involves an industrial or commercial use of the substance or whether the substance will be used in a consumer product;
    • (b) the anticipated annual quantity of the substance to be used;
    • (c) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site;
    • (d) if the substance will be used in a product, a description of the product, its intended use and the function of the substance in the product;
    • (e) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (f) the information specified in paragraphs 2(d) to (f), 3(e) and (f), 8(a), (b), (f) and (g) and 10(d) of Schedule 5 to those Regulations;
    • (g) the information specified in paragraph 11(b) of Schedule 6 to those Regulations;
    • (h) a flow diagram of the overall process and the steps involved in the significant new activity that result or may result in the entry or release of the substance into the environment, including the use of holding tanks and distillation towers, if applicable;
    • (i) a description of each of the steps referred to in paragraph (h), the quantities and concentrations that are or may be released at each step, the physical form of the substance for each location where the substance will or may be released and, if applicable, the anticipated frequency, duration and rate of release;
    • (j) a description of the waste management practices to be implemented to prevent or minimize the release of the substance at the facility, if any, where the significant new activity will be conducted, including
      • (i) the quantity of the substance, in effluents and emissions, that is anticipated to be released into the environment, including average and peak concentrations,
      • (ii) if the substance is anticipated to be released into a municipal wastewater system, the name and address of the municipal wastewater treatment facility, the name of the receiving water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released at that location per day, expressed in kilograms,
      • (iii) if the substance is anticipated to be released directly into surface waters, the name of the receiving water and the location of the point of release, as well as the total quantity the substance that is anticipated to be released at that location per day, expressed in kilograms, and
      • (iv) if waste containing the substance is anticipated to be treated on-site, a description of the treatment system, the total quantity of the substance that is anticipated to be released per year, expressed in kilograms, the percentage of the substance to be removed from the waste, the name of the receiving water and the location of the point of release;
    • (k) a description of the degree to which the significant new activity will disperse the substance or, if the substance will not be dispersed, a description of how it will be contained or consumed;
    • (l) a description of the methods to be used by the person proposing the significant new activity to destroy or dispose of the substance, including
      • (i) the total quantity of the substance to be destroyed or disposed of by each method per year, expressed in kilograms,
      • (ii) a description of the types of waste that will contain the substance, the anticipated quantity of each type of waste to be produced per year, expressed in kilograms, the classification of the waste under provincial law and the site of disposal of the waste, and
      • (iii) a description of the methods to be used to treat and dispose of containers that have been used for the substance’s transportation and storage;
    • (m) the data and report from a chronic toxicity study in respect of the substance conducted in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Test No. 234: Fish Sexual Development Test, that is current at the time the study is conducted, using Japanese medaka or zebrafish and a minimum of five test concentrations to ensure a reliable no-observed-effect concentration and effect concentration;
    • (n) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance;
    • (o) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
    • (p) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and
    • (q) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.
  • 4 The study described in paragraph 3(m) must be conducted in conformity with the practices described in the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, that are current at the time the study is conducted.
  • 5 The information provided under section 3 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.)

Issues

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.

Background

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

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.

Objective

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.

Description

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.

Notification requirements

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

Activities not subject to notification requirements

The notification requirements do not apply to

Information requirements

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:

Regulatory development

Consultation

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.

Instrument choice

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

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.

Regulatory analysis

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.

One-for-one rule

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

Implementation

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.

Compliance

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

Enforcement

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 ec.enviroinfo.ec@canada.ca.

Service standards

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.

Contacts

Andrea Raper
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Gatineau, Quebec
K1A 0H3

Substances Management Information Line:
Telephone: 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada)
Fax: 819‑938‑5212
Email: eccc.substances.eccc@canada.ca

Andrew Beck
Director
Risk Management Bureau
Department of Health
Ottawa, Ontario
K1A 0K9
Phone: 613‑948‑2585
Fax: 613‑952‑8857
Email: andrew.beck@canada.ca