Vol. 147, No. 18 — August 28, 2013

Registration

SOR/2013-152 August 16, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2013-87-08-01 Amending the Domestic Substances List

Whereas the substances set out in the annexed Order are specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under sections 68 and 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and have released proposed risk management approaches on March 6, 2010, for a 60-day public comment period, in which the risk management objective is to prevent increases in exposure to these substances;

Whereas the Ministers are satisfied that the substances methanone, bis[4-(dimethylamino)phenyl]- and oxirane, (butoxymethyl)- are, in any one calendar year, not being manufactured in Canada by any person in a quantity of more than 100 kg and are only being imported into Canada by any person in that quantity for a limited number of uses;

Whereas the Ministers suspect that the information concerning a significant new activity in relation to any of those substances 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 (see footnote c);

And whereas, pursuant to section 91 of the Canadian Environmental Protection Act, 1999 (see footnote d), a notice of intent to amend the Domestic Substances List to apply the significant new activity provisions was published in the Canada Gazette, Part I, on March 3, 2012, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the notice;

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote e), makes the annexed Order 2013-87-08-01 Amending the Domestic Substances List.

Gatineau, August 12, 2013

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2013-87-08-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

90-94-8

2426-08-6

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

90-94-8 S′
  1. Any activity involving, in any one calendar year, the use of more than a total of 100 kg of the substance methanone, bis[4-(dimethylamino)phenyl]-, other than its use
    • (a) as a processing aid in the manufacture of abrasive grinding tools;
    • (b) as a component of dyes at a concentration of less than or equal to 5% by weight;
    • (c) as a component of pigments at a concentration of less than or equal to 5% by weight;
    • (d) as a component of inks at a concentration of less than or equal to 3% by weight; or
    • (e) in the manufacture of electronics and circuit boards.
  2. For each proposed significant new activity, the following information must be provided to the Minister at least 180 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    • (a) a description of the significant new activity in relation to the substance;
    • (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) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (f) the information specified in item 11 of Schedule 6 to those Regulations;
    • (g) a summary of 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 have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
    • (h) the identification of every other government agency, either outside or within Canada, that has been notified of the significant new activity by the person proposing it and, if known, the agency’s file number and the outcome of the assessment and, if any, the risk management actions in relation to the substance imposed by the agency;
    • (i) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity or, if any, the person authorized to act on behalf of that person; and
    • (j) a certification stating 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 authorized to act on their behalf.
  3. The above information will be assessed within 180 days after the day on which it is received by the Minister.

2426-08-6 S′
  1. Any activity involving, in any one calendar year, the use of more than a total of 100 kg of the substance oxirane, (butoxymethyl)- in the manufacture of a consumer product — as defined in section 2 of the Canada Consumer Product Safety Act —, including any of its components, where the substance is in its uncured or not dried form.
  2. For each proposed significant new activity, the following information must be provided to the Minister at least 180 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    • (a) a description of the significant new activity in relation to the substance;
    • (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) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (f) the information specified in item 11 of Schedule 6 to those Regulations;
    • (g) a summary of 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 have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
    • (h) the identification of every other government agency, either outside or within Canada, that has been notified of the significant new activity by the person proposing it and, if known, the agency’s file number and the outcome of the assessment and, if any, the risk management actions in relation to the substance imposed by the agency;
    • (i) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity or, if any, the person authorized to act on behalf of that person; and
    • (j) a certification stating 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 authorized to act on their behalf.
  3. The above information will be assessed within 180 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.)

Issue

Screening assessments have been conducted on methanone, bis[4-(dimethylamino)phenyl]- (hereafter referred to as Michler’s ketone) and oxirane, (butoxymethyl)-, also known as n-butyl glycidyl ether (hereafter referred to as n-BGE). (see footnote 2) The screening assessments concluded that the two substances constitute or may constitute a danger in Canada to human life or health as they may cause cancer. However, current activities associated with the two substances are not expected to pose undue risk to human health as the nature of current activities related to the two substances results in low exposure to Canadians. Given the hazard profile of the two substances, should new activities associated with them commence, they may pose a risk to human health.

Background

On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to assess and manage chemical substances that may be harmful to human health or the environment. A key element of the CMP is the Challenge initiative, which collected information on the properties and uses of the approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each. The two substances subject to this Order, Michler’s ketone and n-BGE, are among the 14 chemicals that were included in batch seven of the Challenge.

Health Canada and Environment Canada conducted screening assessments to determine whether any of the substances in batch seven are toxic as defined under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). According to the summary of the screening assessments, published in the Canada Gazette, Part I, on March 6, 2010, Michler’s ketone and n-BGE constitute or may constitute a danger in Canada to human life or health and meet the criteria as set out in paragraph 64(c) of CEPA 1999. (see footnote 3) This conclusion was based on Michler’s ketone’s carcinogenicity and n-BGE’s carcinogenicity and genotoxicity. An order adding the two substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II, on December 21, 2011, to enable the development of risk management instruments to manage potential risks associated with the two substances. (see footnote 4)

Significant New Activity (SNAc) provisions of CEPA 1999

Given that the two substances are listed on the Domestic Substances List (DSL), activities associated with them can be conducted by industry without obligation to notify the Government of Canada unless they are subject to other notification requirements. When the Government of Canada is concerned that significant new activities in relation to a substance may result in an increased risk to human health or the environment, the Minister of the Environment (the Minister) may impose notification requirements on significant new activities associated with the substance. (see footnote 5) As Michler’s ketone and n-BGE have been determined to constitute a danger in Canada to human life or health, new activities involving them may be a source of potential concern. Therefore, the Minister published a notice of intent in the Canada Gazette, Part I, on March 3, 2012, to inform stakeholders of the Minister’s intent to apply the SNAc provisions of CEPA 1999 to the two substances.

Current industry activities for the two substances
Michler’s ketone

The substance is found as a residue in paper colourants, such as dyes, pigments, stains, and inks, at low concentration. Also, it has been found as a residual in pen inks. In addition, the substance has been applied in the electronics manufacturing industry as a process chemical for circuit board manufacturing and as a component of a processing aid used during the manufacturing of abrasive tools, for example, for grinding, polishing and drilling.

According to submissions to a survey made under section 71 of CEPA 1999 and voluntary submissions to the Challenge questionnaire, Michler’s ketone was not manufactured in quantities above the reporting threshold of 100 kg in Canada during the 2006 calendar year. In the same year, approximately 800 kg of this substance were reported to be imported into Canada, while between 1 000 and 10 000 kg of this substance were reported to be used in Canada. (see footnote 6)

n-BGE

The current use of n-BGE in Canada is in the formulation of epoxy resins, which have applications in coatings, adhesives, binders, sealants, resins and fillers. (see footnote 7) It is used as a solvent in some industrial paints, and was reported to be imported as an impurity in a preservative for paint.

According to submissions to a survey made under section 71 of CEPA 1999, n-BGE was not manufactured in Canada in 2006 in quantities above 100 kg. In the same year, between 10 000 and 100 000 kg of this substance were reported to be imported into Canada, and between 1 000 and 10 000 kg of the substance were reported to be used in Canada. (see footnote 8)

Risk management actions in Canada

Michler’s ketone is listed on Health Canada’s Cosmetic Ingredient Hotlist. (see footnote 9) Its application in food packaging is subject to the Food and Drug Regulations. Also, the substance is subject to reporting requirements under the National Pollutant Release Inventory.

The substance n-BGE is on the Ontario Jurisdictional Screening Level (JSL) List, which was developed to provide an additional screening tool for managing local air quality in Ontario. (see footnote 10) The substance is also subject to the Controlled Products Regulations established under the Hazardous Products Act which requires the disclosure of the substance on a material safety data sheet when it is present at a workplace in products at a concentration of 0.1% or greater. Recognizing the high hazard nature of n-BGE, additional analysis will be done on domestic industrial activity (for example, possible activities could include monitoring, surveillance, follow-up or industry contact) to determine what, if any, further risk management is needed.

Risk management actions in other jurisdictions

Michler’s ketone is subject to various risk management actions in other jurisdictions. The states of New Jersey and California have prescribed limits for the use of this substance. The U.S. Environmental Protection Agency considers this substance as a hazardous air pollutant and the substance is subject to reporting requirements. In the European Union (EU) and New Zealand, Michler’s ketone is prohibited in cosmetics and personal care products. (see footnote 11)

The substance n-BGE is subject to air quality standards in several U.S. states (e.g. the states of Washington, Michigan and Texas). The EU has prohibited n-BGE in cosmetic products. (see footnote 12) Additionally, the Swedish Chemicals Agency (KEMI) classifies n-BGE as a priority risk reduction substance.

Objectives

The objective of the Order is to contribute to the protection of human health by collecting information on significant new activities associated with the two substances before they are undertaken. The information collected will assist the Government of Canada in assessing the two substances associated with the new activities and in determining whether further risk management actions on these substances is necessary.

Description

The Order deletes the two substances from Part 1 of the DSL by removing their Chemical Abstracts Service (CAS) Registry Numbers, adds them to Part 2 of the DSL, and indicates, by the addition of the letter S′ following the CAS Registry Numbers, that the two substances are subject to the SNAc provisions under CEPA 1999.

The Order requires any person intending to import, use or manufacture Michler’s ketone above the reporting threshold of 100 kg in any calendar year to provide the required information to the Minister 180 days in advance, unless the activity is permitted under the Order. Any person that intends to use n-BGE above 100 kg in any calendar year for the manufacture of a consumer product, where n-BGE would be present in the uncured form, is required to provide the prescribed information to the Minister 180 days in advance of the intended activity. The Order outlines the information to be provided to the Minister.

Environment Canada and Health Canada will use the submitted information to conduct environmental and human health assessments within 180 days after it is received and will determine if such a significant new activity requires further risk management considerations. Activities which are of low concern are exempted from the notification requirements. These exemptions are described in the Order.

The Order complements the existing risk management actions, and will assist in managing potential risks associated with significant new activities involving the two substances.

The Order comes into force on the day on which it is registered.

Consultation

On March 3, 2012, a notice of intent to amend the Domestic Substances List was published in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 13) During the 60-day public comment period, two submissions, one from an industry stakeholder and another from an industry association, were received on the notice of intent requiring clarification as to whether the wording for the exclusion of the epoxy resin containing n-BGE also indicated that imports of epoxy resin containing n-BGE were excluded from the notification requirements. The comments were considered in developing the Order. In addition, it was determined that the cured form of the epoxy resin containing n-BGE is not suspected to be a concern to consumers; however, there may be risks associated with consumer use of the uncured resin. Therefore, the wording was modified to clarify that activities involving uncured (or not dried) n-BGE in consumer products constitute the significant new activity targeted for reporting.

No comments were received on the notice of intent with respect to Michler’s ketone. However, concentration thresholds were included in the definition of a significant new activity to better meet the risk management approach.

The National Advisory Committee of CEPA 1999 was given the opportunity to advise the Minister of Health and the Minister of Environment (the ministers) on the notice of intent. No comments were received.

“One-for-One” Rule

The Order does not trigger the “One-for-One” Rule. Current activities involving the two substances are excluded from the Order and there is no indication that new activities associated with the two substances may occur in the future. Therefore, no incremental administrative costs are expected to be incurred by businesses.

Small business lens

The small business lens does not apply to this Order as there are no expected impacts on industry or small businesses based on their current and anticipated practices. Canadian companies that are currently conducting activities associated with the two substances are not captured by the Order and there is no indication that new activities associated with the two substances will occur in the future.

Rationale

The screening assessments found that the two substances may constitute a danger to human life or health. Both substances have been added to Schedule 1 of CEPA 1999. This addition enables the Minister to propose and publish in the Canada Gazette risk management instruments for the two substances.

Current activities associated with the two substances are not expected to pose undue risk to human health as the nature of current activities related to the two substances or the controls in place result in low exposure to Canadians. The two substances are listed on Part 1 of the DSL, indicating that activities involving them do not require notification to the Minister unless they are subject to other notification requirements under CEPA 1999 or any other federal statute.Given the hazardous properties of the two substances, significant new activities associated with them may pose undue risk to human health. Therefore, maintaining the status quo as a risk management option has been rejected.

Modifying the DSL to apply the SNAc provisions allows the Government to be informed of significant new activities involving the two substances. The submitted information will assist the Government of Canada in conducting both health and environmental assessments and will also allow the ministers to take appropriate risk management actions in relation to those activities. As a result, the Minister has determined that applying the SNAc provisions to the two substances is the preferred option.

The Order contributes to the protection of human health by enabling the assessment of the substances in relation to the significant new activities prior to their introduction. The permitted activities, as indicated in the Order, are expected to result in a low to negligible exposure of Canadians to the substances. Therefore, the Order allows these activities to continue while ensuring that the Government is notified of any significant new activities that could pose a risk.

Based on their current business practices, companies that are conducting the permitted activities associated with the two substances will not be impacted as a result of the Order. Should significant new activities involving the substances occur, costs would be incurred by industry for generating data and other information to be supplied to the Minister. However, it is not expected that new activities associated with the substances will occur in the future and industry did not provide any indications to the contrary following the publication of the notice of intent. Consequently, the Order is not expected to impact industry.

In the event a notification is submitted, the Government of Canada will incur the costs for processing the information in relation to the SNAc and for conducting health and environmental assessments. It is assumed that these costs are unlikely to be incurred given that no significant new activities involving the substances are expected. The Government of Canada will incur costs for conducting compliance promotion activities. Annual costs associated with these promotion activities are expected to be low. Enforcement activities for cases of non-compliance will be conducted on a referral basis only. Therefore, enforcement costs are expected to be negligible.

Although it is not possible to quantify the benefits and costs, the overall impact of the Order is expected to be positive.

Implementation, enforcement and service standards

Implementation

The Order comes into force on the day on which it is registered. The compliance promotion activities to be 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.

Enforcement

The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy implemented under CEPA 1999. The Compliance and Enforcement Policy sets out the range of possible responses to violations, including warnings, directions,environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.

When an enforcement officer discovers an alleged violation following an inspection or an investigation, the officer will choose the appropriate enforcement action based on the following factors:

Service standards

The Department will assess all information submitted as part of SNAc notification and will communicate the result to the notifier 180 days after the information is received.

Contacts