Vol. 148, No. 6 — March 12, 2014

Registration

SOR/2014-30 February 26, 2014

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2014-87-01-01 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 section 68 or 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and on September 18, 2010 released, for a 60-day public comment period, proposed risk management approaches in which the risk management objective is to prevent increases in exposure to those substances;

Whereas the Ministers are satisfied that the substance Benzene, 1,2-dimethoxy-4-(2-propenyl)- is not being manufactured in or imported into Canada by any person in a quantity of more than 100 kg in any one calendar year;

Whereas the Ministers are satisfied that the substances Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- and Bromic acid, potassium salt 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 (see footnote e) to apply the significant new activity provisions was published in the Canada Gazette, Part I, on September 15, 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 f), makes the annexed Order 2014-87-01-01 Amending the Domestic Substances List.

Gatineau, February 20, 2014

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2014-87-01-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

93-15-2

7328-97-4

7758-01-2

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

93-15-2 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Benzene, 1,2-dimethoxy-4-(2-propenyl)- in its isolated form — when the substance is extracted from its naturally occurring sources or manufactured — in a consumer product as defined in section 2 of the Canada Consumer Product Safety Act, other than an activity regulated under the Pest Control Products Act.
  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 products and, if known, end-use products that are anticipated to contain the substance, the intended use of those products and the function of the substance in those products;
    • (f) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (g) the information specified in item 11 of Schedule 6 to those Regulations;
    • (h) 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;
    • (i) the identification of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the department or agency’s file number and, if any, the outcome of the assessment by the department or agency and the risk management actions in relation to the substance imposed by the department or agency;
    • (j) the name, civic and postal addresses, telephone number, and, if any, the fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on their behalf; and
    • (k) 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 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.

7328-97-4 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis-, in its uncured or undried form, in a consumer product as defined in section 2 of the Canada Consumer Product Safety Act, other than an activity involving its use in an epoxy-based paint, epoxy-based coating or epoxy-based adhesive.
  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 products and, if known, end-use products that are anticipated to contain the substance, the intended use of those products and the function of the substance in those products;
    • (f) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (g) the information specified in item 11 of Schedule 6 to those Regulations;
    • (h) 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;
    • (i) the identification of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the department or agency’s file number and, if any, the outcome of the assessment by the department or agency and the risk management actions in relation to the substance imposed by the department or agency;
    • (j) the name, civic and postal addresses, telephone number, and, if any, the fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on their behalf; and
    • (k) 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 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.

7758-01-2 S′

  1. In relation to the substance Bromic acid, potassium salt
    • (a) any activity involving, in any one calendar year, more than 100 kg of the substance, in a consumer product as defined in section 2 of the Canada Consumer Product Safety Act; or
    • (b) any industrial or commercial activity involving, in any one calendar year, more than 1000 kg of the substance, other than an activity involving its use as
      • (i) an oxidizer in flour milling for export,
      • (ii) a component of an industrial or commercial cleaning product, or
      • (iii) a component of an industrial or commercial paint or coating.
  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 the applicable quantity set out in paragraph 1(a) or (b) 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 products and, if known, end-use products that are anticipated to contain the substance, the intended use of those products and the function of the substance in those products;
    • (f) the information specified in paragraphs 2(d) to (f) and 8(a) to (g) of Schedule 5 to those Regulations;
    • (g) the information specified in item 11 of Schedule 6 to those Regulations;
    • (h) 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;
    • (i) the identification of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the department or agency’s file number and, if any, the outcome of the assessment by the department or agency and the risk management actions in relation to the substance imposed by the department or agency;
    • (j) the name, civic and postal addresses, telephone number, and, if any, the fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on their behalf; and
    • (k) 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 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.)

Issues

Screening assessments for three substances were conducted to determine whether the substances have the potential to be harmful to human health or the environment. The screening assessments concluded that all three substances are harmful to human health based on their carcinogenicity. The substances are

Current activities associated with the three substances are being managed through existing measures, will be managed through proposed measures, or are of minimal exposure concern. However, given the hazardous properties of the three substances, they may pose a risk to human health should new activities associated with them commence. Therefore, the Minister of the Environment (the Minister) is applying the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to these substances. (see footnote 2)

Background

On December 8, 2006, the Chemicals Management Plan (CMP) was launched 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 high priority chemicals were divided into 12 batches of 10 to 20 chemicals each. The 3 substances mentioned above are among the 17 chemicals that were included in batch 9 of the Challenge.

Environment Canada and Health Canada conducted screening assessments to determine whether any of the substances in batch nine are toxic as defined under section 64 of CEPA 1999. According to the summary of the screening assessments, published in the Canada Gazette, Part I, on September 18, 2010, methyl eugenol, TGOPE and potassium bromate are harmful to human health and meet the criterion as set out in paragraph 64(c) of CEPA 1999. An order adding substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II, on October 24, 2012, to enable the development of risk management instruments to manage the risks associated with these substances. (see footnote 3)

SNAc provisions of CEPA 1999

Given that the three substances are listed on the Domestic Substances List (DSL), activities associated with them can be conducted by industry or others without obligation to notify the Government of Canada, unless the substances are subject to other notification requirements. When the Government of Canada is concerned that any significant new activity in relation to a substance may result in an increased risk to human health or the environment, the Minister may impose notification requirements on significant new activities associated with the substance.As it has been concluded that the three substances are harmful to human health, significant new activities involving them may be a source of concern. Therefore, a notice of intent to apply the SNAc provisions of CEPA 1999 to substances was published in the Canada Gazette, Part I, on September 15, 2012. (see footnote 4)

SNAc provisions do not apply to a substance that is manufactured or imported for a use that is regulated under the Pest Control Products Act, the Fertilizers Act or the Feeds Act, which are listed in Schedule 2 of CEPA 1999. In addition, SNAc provisions do not apply, in some circumstances, to transient reaction intermediates, to impurities, or to substances that undergo chemical reactions. Finally, as described in section 3 of CEPA 1999, SNAc provisions do not apply, in some circumstances, to wastes, mixtures or manufactured items. (see footnote 5)

Current industry activities and risk management actions
Methyl eugenol

Methyl eugenol is a naturally occurring substance found in the essential oils of several plant species, including culinary herbs, citronella, basil and the tea tree. The substance can be used as a component in flavouring ingredients that can be added to certain foods. (see footnote 6) The substance may also be a component of certain fragrances present in pest control products at a low concentration. Citronella oil, which may contain methyl eugenol, is a pest control ingredient in some commercially available personal insect repellent lotions and sprays applied to the skin.

According to submissions to a survey made under section 71 of CEPA 1999, the substance was not manufactured, imported or used in Canada during the 2006 calendar year above the reporting thresholds.

In Canada, methyl eugenol is listed on Health Canada’s Cosmetic Ingredient Hotlist and the maximum concentration of the substance in cosmetics is restricted. Certain therapeutic products, which may contain methyl eugenol, are regulated under the Natural Health Products Regulations. The listing of methyl eugenol in the Natural Health Products Ingredients Database has been updated from a restricted substance to a substance that is no longer authorized for use in natural health products. Health Canada’s reevaluation of personal use citronella oil-based insect repellents requires that companies submit safety data to support the long-term use of insect repellents containing methyl eugenol. If the companies do not submit this information then Health Canada will not renew the license of those companies to produce these products, and these products will be gradually phased out as the licenses expire.

In the United States (U.S.), methyl eugenol was affirmed as GRAS (Generally Recognized as Safe) by the Food and Drug Administration as a food additive, and was registered as a pesticide active ingredient by the U.S. Environmental Protection Agency. In the European Union (EU), the addition of methyl eugenol to foods is prohibited; the concentration of methyl eugenol in some processed foods is restricted; the use of the substance as a pure chemical in cosmetics is not permitted; and the substance as a component of plant extracts in cosmetics is subject to concentrations requirements. (see footnote 7) In Australia, methyl eugenol is permitted in drugs at concentrations of 1% or less.

TGOPE

The substance is used in paint, coating and adhesive manufacturing. It is also found in an adhesive product that may have commercial uses.

According to information submitted in response to surveys made under section 71 of CEPA 1999, TGOPE was not manufactured in Canada in quantities above the reporting threshold of 100 kg in 2005 or 2006. However, between 1 000 and 10 000 kg of the substance were imported in 2006.

There are no risk management measures applying to TGOPE in Canada and the exposure of the general population in Canada to that substance is expected to be low to negligible. No risk management measures were found applying to TGOPE in other jurisdictions.

Potassium bromate

The substance is predominantly used in industrial and commercial applications. It was reported being used as an oxidizer in milling of flour for export. The entire final product is exported to the United States. (see footnote 8)

According to information submitted in response to a survey made under section 71 of CEPA 1999, the substance was not manufactured in quantities above the reporting threshold in Canada in 2006. However, less than 1 000 kg of the substance were imported into Canada in the same year.

In Canada, this substance is subject to the requirements set out in section 28.3 of the Cosmetic Regulations and is listed on Health Canada’s Cosmetic Ingredient Hotlist. It is not permitted to be used as a food additive in foods offered for sale in Canada under the Food and Drug Regulations. Bromate is listed in the Guidelines for Canadian Drinking Water Quality. (see footnote 9) Also, potassium bromate is captured by section 4, of the Food and Drugs Act, which prohibits the sale of any article of food containing poisonous or harmful substances. The substance is subject to reporting requirements under the National Pollutant Release Inventory.

In the United States, potassium bromate is subject to Title 16 (Part 1700), Title 21 (Part 136, Part 137 and Part 172) and Title 40 (Part 172) of the Code of Federal Regulations (CFR). (see footnote 10) Bromate is subject to Title 21 (Part 165) and Title 40 (Part 141) of the CFR. In EU, potassium bromate is prohibited in cosmetics and is subject to labelling and packaging requirements as described in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. The use of potassium bromate as a flour improver has been prohibited in England, Wales and Scotland since the 1990s. In addition, a guideline concentration for bromate is listed in the World Health Organization Guidelines for Drinking-water Quality.

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 three substances before such activities are undertaken. The information collected will assist the Government of Canada in assessing the substances in relation to the significant new activities and in determining whether further risk management activities are necessary.

Description

The Order deletes the three substances from Part 1 of the DSL by removing their CAS Registry Numbers; adds them to Part 2 of the DSL; and indicates, by addition of the letter “S′” following the CAS Registry Numbers, that the three substances are subject to the SNAc provisions under CEPA 1999.

The Order requires any person that intends to use methyl eugenol in its isolated form (when the substance is synthesized or extracted on its own from its naturally occurring sources) or TGOPE (in its uncured or undried form), above 100 kg in any calendar year for the manufacture of a consumer product, other than for exempted activities, to provide the required information to the Minister 180 days in advance of the intended activity.

The Order requires any person that intends to use potassium bromate (above 100 kg in any calendar year) in a consumer product, or intends to conduct industrial or commercial activity involving potassium bromate (above 1 000 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. The Order outlines the information to be provided to the Minister.

Environment Canada and Health Canada will use the submitted information to conduct human health and environmental assessments within 180 days after the information is received. Current activities that are being managed and are anticipated to be of minimal concern are exempt from the notification requirements. These exemptions are described in the Order.

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

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

Consultation

On September 15, 2012, a notice of intent to amend the DSL was published in the Canada Gazette, Part I, for a 60-day public comment period.

Environment Canada and Health Canada also informed the governments of the provinces and territories through the National Advisory Committee of CEPA 1999 (CEPA NAC) of the notice of intent. No comments were received from CEPA NAC.

During the 60-day public comment period, one submission from an industry association was received on methyl eugenol. The submission questioned whether the SNAc provisions would apply to methyl eugenol as a component of essential oils.

The Government of Canada responded that the SNAc provisions are not intended to target naturally occurring methyl eugenol but only its isolated form. The definition of a significant new activity for methyl eugenol has been rewritten to better reflect this.

There was no submission on TGOPE or potassium bromate.

“One-for-One” Rule

The Order does not trigger the “One-for-One” Rule. Current activities involving the three substances are not subject to the notification requirement of the Order, and there is no indication that industry’s current activity patterns associated with the three substances may change 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 using or importing the substances are not captured by the Order’s notification requirement, and there is no indication that current industrial activity patterns associated with the three substances will change in the future.

Rationale

The screening assessments determined that the three substances have the potential to be harmful to human health as they may cause cancer. The three substances have been added to Schedule 1 of CEPA 1999.

Current activities associated with the three substances are being managed through existing measures, will be managed through proposed measures, or are of minimal exposure concern. However, given the hazardous properties of the three substances, significant new activities associated with them may pose a risk to human health.

The three substances were listed on Part 1 of the DSL, indicating that activities involving them did not require notification to the Minister, unless they were subject to other notification requirements under CEPA 1999 or any other federal statute. Modifying the DSL to apply the SNAc provisions allows the Minister to be notified of significant new activities involving the three substances. The submitted information will assist the Government of Canada in conducting both health and environmental assessments and, where necessary, in taking appropriate risk management actions in relation to those activities. As a result, the Minister of the Environment and the Minister of Health have determined that applying the SNAc provisions to the three substances is the preferred option.

The Order contributes to the protection of human health and the environment by assessing proposed significant new activities associated with the three substances prior to their introduction. The permitted activities, as set out in the Order, are expected to result in low environmental exposure or low-to-negligible exposure of Canadians to the substances, and are therefore of minimal concern. Therefore, the Order allows these activities to continue while ensuring that the Government is notified of any significant new activities in order to determine whether they could pose a risk.

Based on their current business practices, companies currently conducting activities associated with the three 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 current industrial activity patterns would change in the future. As a result, the Order is not expected to impact industry.

In the event that 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 was not possible to quantitatively estimate 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 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 apply the Compliance and Enforcement Policy implemented under CEPA 1999. This 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 cost recovery.

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

Service standards

Environment Canada and Health Canada will assess all information submitted as part of SNAc notification and will communicate the result to the notifier within 180 days after the information is received.

Contacts

Greg Carreau
Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca

Michael Donohue
Manager
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@hc-sc.gc.ca