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Registration

SOR/2012-144 July 5, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-87-07-01 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 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

Whereas the Ministers are satisfied that in any one calendar year the substances Thiourea, Phenol, 2,4,6-tris(1,1-dimethylethyl)-, Pigment Red 104 and C.I. Pigment Yellow 34 are only being manufactured in or imported into Canada by any person in a quantity of more than 100 kg for a limited number of uses;

Whereas the Ministers are satisfied that the substance Oxirane, chloromethyl- 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;

And whereas the Ministers suspect that the information concerning a significant new activity in relation to any of those substances may contribute to determine 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);

Therefore, the Minister of the Environment, pursuant to subsections 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2012-87-07-01 Amending the Domestic Substances List.

Gatineau, June 27, 2012

PETER KENT
Minister of the Environment

ORDER 2012-87-07-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

62-56-6

106-89-8

732-26-3

1344-37-2

12656-85-8

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

62-56-6 S′

1. Any activity involving, in any one calendar year, more than 100 kg of the substance Thiourea, other than an activity related to its use

(a) as a reactant in non-ferrous metal refining, except in aluminum refining;

(b) as a metal finishing solution or etching treatment in the manufacture of printed circuit boards;

(c) as an accelerant in rubber production;

(d) as a reducing agent in the production of thiourea dioxide, or as a chemical intermediate in an industrial facility, where release to the environment is managed;

(e) in corrosion inhibitors, anti-oxidants or anti-scaling agents in a concentration of less than 10% by weight;

(f) in a metal polish, including silver polish, in a concentration of less than 7% by weight; or

(g) in a metal cleaner in a concentration of less than 0.5% by weight.

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 for the significant new activity;

(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 paragraphs 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 concerning 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 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 the person has notified of the significant new activity in relation to the substance 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, the fax number and email address of the person proposing the significant new activity and, 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 a 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.

106-89-8 S′

1. Any activity involving, in any one calendar year, more than 100 kg of the substance Oxirane, chloromethyl-.

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 for the significant new activity;

(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 paragraphs 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 concerning 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 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 the person has notified of the significant new activity in relation to the substance 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 the fax number and email address of the person proposing the significant new activity and, 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 a 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.

732-26-3 S′

1. Any activity involving, in any one calendar year, more than 100 kg of the substance Phenol, 2,4,6-tris(1,1-dimethylethyl)-, other than an activity related to its use as an antioxidant in fuels or lubricants.

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 proposed significant new activity in relation to the substance;

(b) the anticipated annual quantity of the substance to be used for the significant new activity;

(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 paragraphs 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 concerning 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 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 the person has notified of the significant new activity in relation to the substance 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, the fax number and email address of the person proposing the significant new activity and, 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 a 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.

1344-37-2 S′

1. Any activity involving, in any one calendar year, more than 100 kg of the substance C.I. Pigment Yellow 34, other than an activity related to its use

(a) as a component of plastics that are used in commercial or industrial applications or that are to be exported for sale;

(b) as a component of paints or coatings in industrial or commercial applications;

(c) as a component of commercial printing inks; or

(d) as a component of decals in industrial or commercial applications.

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 proposed significant new activity in relation to the substance;

(b) the anticipated annual quantity of the substance to be used for the significant new activity;

(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 paragraphs 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 concerning 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 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 the person has notified of the significant new activity in relation to the substance 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, the fax number and email address of the person proposing the significant new activity and, 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 a 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.

12656-85-8 S′

1. Any activity involving, in any one calendar year, more than 100 kg of the substance C.I. Pigment Red 104, other than an activity related to its use

(a) as a component of plastics that are used in commercial or industrial applications or that are to be exported for sale;

(b) as a component of paints or coatings in industrial or commercial applications

(c) as a component of commercial printing inks; or

(d) as a component of decals in industrial or commercial applications.

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 for the significant new activity;

(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 paragraphs 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 concerning 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 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 the person has notified of the significant new activity in relation to the substance 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, the fax number and email address of the person proposing the significant new activity and, 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 a 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.)

1. Background

On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to manage chemicals that are 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 approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each. The five substances that are the subject of this Order (hereafter “the five substances”) are among the 17 chemicals that were included in the second batch of the Challenge and are listed below:

  • Thiourea (Chemical Abstracts Service [CAS] Registry No. 62-56-6);
  • Oxirane, chloromethyl- (CAS Registry No. 106-89-8), hereafter referred to as “epichlorohydrin”;
  • C.I. Pigment Yellow 34 (CAS Registry No. 1344-37-2);
  • C.I. Pigment Red 104 (CAS Registry No. 12656-85-8); and
  • Phenol, 2,4,6-tris(1,1-dimethylethyl)- (CAS Registry No. 732-26-3), hereafter referred to as “2,4,6-TTBP”.

Health Canada and Environment Canada conducted screening assessments to determine whether any of the substances in the second batch are harmful to the environment or human health as defined under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), that is, whether they are entering or may enter the environment in a quantity or concentration or under conditions that

  • (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;

  • (b) constitute or may constitute a danger to the environment on which life depends; or

  • (c) constitute or may constitute a danger in Canada to human life or health.

The screening assessments were published in the Canada Gazette, Part Ⅰ, on January 31, 2009. They concluded that thiourea, epichlorohydrin, C.I. Pigment Yellow 34, and C.I. Pigment Red 104 meet the criteria set out in paragraph 64(c) of CEPA 1999, and that 2,4,6-TTBP meets the criteria set out in paragraph 64(a) of CEPA 1999. Furthermore, 2,4,6-TTBP meets the criteria for virtual elimination. Therefore, an order adding the five substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part Ⅱ, on February 16, 2011. (see footnote 2)

On January 22, 2011, the Minister of Environment (Minister) published a Notice of Intent in the Canada Gazette, Part Ⅰ, proposing to amend the Domestic Substances List (DSL) to ensure that the Significant New Activity (SNAc) provisions of CEPA 1999 are applied to the five substances.

Current industry activities for the five substances

Thiourea is mainly used in metal finishing solutions and in etching treatments for printed circuit boards. It is also used as a chemical intermediate, as a reducing agent in the production of thiourea dioxide, as a reactant in the copper refinery industry, and as an accelerant in rubber production. According to information submitted in response to a survey published under section 71 of CEPA 1999, no Canadian companies reported manufacturing the substance in a quantity greater than or equal to the 100 kg threshold in 2006. However, between 10 000 and 100 000 kg of the substance was imported into Canada in the same reporting year.

Epichlorohydrin is used as an intermediate in the production of a wide variety of substances, but mainly used in the production of epoxy resins. Epoxy resins are used in protective coatings including those used for lining food and beverage containers, and are also used in structural applications such as circuit board laminates, semiconductor encapsulants, and structural composites. The substance was not reported to be manufactured or imported by any company in Canada above the 100 kg reporting threshold in 2006. However, it is likely being imported in small quantities below the reporting threshold as a residual monomer in products containing epoxy resins or other resins made using the substance.

C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are used in plastic formulation for commercial applications and export; commercial, non-consumer paints and coatings; and a very limited number of commercial printing inks or coatings used for plastics and certain outdoor applications such as commercial identification decals. Both these substances were reported to be manufactured in and imported into Canada in 2006. Canadian use of these substances ranged between 1 000 000 and 10 000 000 kg for C.I. Pigment Yellow 34 and between 100 000 and 1 000 000 kg for C.I. Pigment Red 104.

The substance 2,4,6-TTBP is used in Canada as an antioxidant in fuels. It was also reported as present in some antioxidants added to lubricants. Antioxidants are added to stabilize fuels and prevent the formation of engine-fouling residues. The substance is not manufactured in pure form, but is an unintended co-product formed during the process used to make other antioxidants. The maximum concentration of 2,4,6-TTBP found in fuels and lubricants is estimated to be about 0.1%. It is not manufactured in Canada and is imported through Canadian distributors from a small number of U.S. manufacturers/blenders as a component of antioxidants containing the substance. It is estimated that the total quantity of 2,4,6-TTBP imported into Canada in 2006 was below 20 tonnes. However, a decreasing trend in the quantity of this substance in commerce between 1986 and 2007 has been observed.

Current management actions in Canada

Thiourea is subject to a variety of regulations, such as the Consumer Chemicals and Containers Regulations, 2001 and the Controlled Products Regulations established under the Hazardous Products Act. It is on the Cosmetic Ingredients Hotlist under the Food and Drugs Act. It is also subject to reporting under the National Pollutant Release Inventory (NPRI).

Epichlorohydrin is subject to

  • the Environmental Emergency Regulations and the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations under CEPA 1999;
  • the Consumer Chemicals and Containers Regulations, 2001 and the Controlled Products Regulations established under the Hazardous Products Act;
  • the Regulations for the Prevention of Pollution from Ships and for Dangerous Chemicals under the Canada Shipping Act;
  • Division 16 (Food Additives) of the Food and Drug Regulations; and
  • reporting under the NPRI.

As epichlorohydrin-containing polymers can be used in drinking water treatment, Canada currently has voluntary health-based standards for additives that limit the amount of epichlorohydrin residual that can be present in finished drinking water. (see footnote 3)

C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are subject to the Surface Coating Materials Regulations, the Consumer Chemicals and Containers Regulations, 2001, and the Controlled Products Regulations established under the Hazardous Products Act. They are also subject to provincial and municipal regulations or bylaws regarding levels of acceptable releases of lead or chromium. They are also on the Cosmetic Ingredients Hotlist under the Food and Drugs Act.

The substance 2,4,6-TTBP is required to be labelled pursuant to the Transportation of Dangerous Goods Regulations. Also, fuels that may contain 2,4,6-TTBP as an additive are managed through various existing regulations, codes of practice, guidelines, and best industry practices in place in Canada. These include the Environmental Emergency Regulations under CEPA 1999, under which gasoline is listed and the addition of diesel is being proposed; (see footnote 4) the storage tank requirements for fuel products in the Environmental Code of Practice for Aboveground and Underground Storage Tank Systems Containing Petroleum and Allied Petroleum Products (CCME, 2003); and the transportation requirements for fuel products in the Transportation of Dangerous Goods Act.

Risk management actions in other jurisdictions

In the U.S., thiourea is not permitted in food for human consumption and has been listed as a hazardous constituent of waste in the Resource Conservation and Recovery Act. It is also listed on the Superfund Amendments and Reauthorization Act.

The use of epichlorohydrin in cosmetics and certain hair dyes has been prohibited by the European Commission Directives 2004/83/EC and 2007/54/EC. Both the U.S. and the United Kingdom have set a maximum concentration for the substance in drinking water and regulate its use in materials which come into contact with food. The World Health Organization also has a provisional guideline for the substance in drinking water.

The United States Consumer Product Safety Commission prohibits the sale of residential paint containing greater than 600 parts per million (p.p.m.) of lead. Furthermore, new United States consumer safety legislation sets specific lead limits in toys intended for children 12 years and under, as well as further reduces the total lead limit in surface coatings, such as paints.

Importation, manufacture and use of 2,4,6-TTBP is prohibited in Japan. Other countries have included the substance on lists for assessment/evaluation purposes. This substance has been identified as a high production volume (HPV) chemical under the United States Environmental Protection Agency (EPA) HPV Challenge Program and is included on the Organisation for Economic Co-operation and Development’s list of HPV chemicals. The U.S. EPA has identified a group of substances, which includes 2,4,6-TTBP, for further assessment under the Toxic Substances Control Act (TSCA). This group of substances, known as the TSCA Work Plan Chemicals, will be used to help focus activities over the next several years. This substance is also included on the Oslo-Paris Commission’s list of chemicals for priority action, but is considered a low production volume chemical.

2. Issue

Scientific assessments conducted on the five substances concluded that thiourea, epichlorohydrin, C.I. Pigment Yellow 34, and C.I. Pigment Red 104 pose risks to human health due to carcinogenicity and other non-cancer effects. Furthermore, it was also concluded that 2,4,6-TTBP poses a risk to the environment on the basis of high acute aquatic toxicity. As a result, the five substances have been added to Schedule 1 of CEPA 1999.

Current activities associated with the four substances constituting a danger to human health are being controlled through existing measures and result in low to negligible exposure. For 2,4,6-TTBP, in addition to existing risk management, a measure is being proposed to further prevent its accidental release to the environment. (see footnote 5) However, significant new activities in relation to the five substances may result in increased risks to the environment and human health.

3. Objectives

The objective of the Order 2012-87-07-01 Amending the Domestic Substances List (the Order) is to collect information on new or increased activities, allowing the government to determine whether further risk management activities on the five substances are required.

4. Description

The Order deletes the five substances from Part 1 of the DSL, by removing their 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 five substances are subject to the SNAc provisions of CEPA 1999.

The Order requires any person that intends to manufacture, use or import any of the five substances above the threshold of 100 kg to provide a notice to the Minister 180 days in advance of the start of the activity or of the import or use of the substance, unless the activity is exempted. The Order outlines the information requirements, including a description of the new activity.

The submitted information will be assessed by Environment Canada and Health Canada within 180 days after it is received, to assess the potential environmental and human health risks associated with a new or increased activity and to determine if such a new or increased activity requires further risk management actions.

Activities which are deemed to be of low concern or adequately managed by existing or planned risk management actions are exempted 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 new or increased uses of the five substances.

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

5. Consultation

On January 22, 2011, a Notice of intent to amend the Domestic Substances List (see footnote 6) was published for a 60-day public comment period in the Canada Gazette, Part Ⅰ. A Consultation Document on the proposed risk management for 2,4,6-TTBP was also published in January 2011 (including discussion of the intent to apply SNAc provisions to 2,4,6-TTBP).

The National Advisory Committee of CEPA 1999 (CEPA NAC) was given the opportunity to advise the Minister of Environment and the Minister of Health (ministers) on the scientific evidence in support of the screening assessment conclusions, as well as on the Notice of Intent. No comments were received from CEPA NAC.

Two submissions from industry and one submission from a non-governmental organization (NGO) were received on the Notice of Intent and the Consultation Document for 2,4,6-TTBP in relation to the SNAc proposal. (see footnote 7) All comments were considered in developing the final Order. Below is a summary of the comments received on the Notice of Intent for the five substances and the Consultation Document for 2,4,6-TTBP, as well as responses to them. The comments received and the complete responses are available on the Chemical Substances Web site. (see footnote 8)

Two stakeholders supported the use of the SNAc provisions to manage C.I. Pigment Yellow 34 and C.I. Pigment Red 104.

  • One industry stakeholder commented that sufficient time should be given to prepare for and meet requirements when SNAc provisions are implemented.

Response: Industry stakeholders were made aware of the intention to apply the SNAc provisions though publication of the Notice of Intent. A 60-day period was provided to industry stakeholders to comment on the proposed SNAc provisions. The period of time between the publication of the Notice of Intent and the publication of the DSL amendments Order should allow industry sufficient time to adequately prepare.

  • One NGO commented that the application of the SNAc provisions is not an appropriate measure to achieve virtual elimination of 2,4,6-TTBP and that a measure to prohibit the use and import of 2,4,6-TTBP may be more appropriate.

Response: The SNAc provisions are not intended to achieve virtual elimination of 2,4,6-TTBP, but to complement the additional proposed risk management actions for existing uses of the substance. The application of the SNAc provisions will enable the Government of Canada to assess any new use that could result in releases to the environment. In combination with the additional proposed risk management measures to prevent accidental releases to the environment, these actions are expected to be the most effective way to prevent risks from these substances and move towards virtual elimination of releases to the environment.

  • One industry stakeholder commented that a small volume of 2,4,6-TTBP is also present in some lubricant antioxidants, a use not previously reported.

Response: Similar to the use of 2,4,6-TTBP in fuel antioxidants, 2,4,6-TTBP is an unintentional co-product formed during the process used to make other antioxidants used in lubricants. For completeness, the proposed SNAc provisions have been modified to exclude reporting for the use of 2,4,6-TTBP as an antioxidant in both fuels and lubricants.

6. Rationale

The screening assessments found that among the five substances, four are potentially harmful to human health and one is potentially harmful to the environment. The five substances were added to Schedule 1 of CEPA 1999 in February 2011. Section 92 of CEPA 1999 requires the Minister to propose and publish control instruments in the Canada Gazette in relation to substances listed on Schedule 1 of CEPA 1999.

The five substances either are currently being managed or have proposed risk management for risks associated with their current activities. However, given that the five substances are listed on Part 1 of the DSL, they could be used for any other activities and in any quantity without a requirement to report to the Minister. Given the hazardous nature of these substances, increased or new activities without government review may pose a risk to the environment or 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 increased or new activities pertaining to the five substances. The submitted information will assist the government in conducting risk assessments in relation to these activities and determining the potential for the substances to impact the environment and health of Canadians. This would allow the ministers to take appropriate risk management actions in relation to these potential risks. For these reasons, the Government has determined that applying the SNAc provisions to the five substances is the preferred option.

The Order contributes to the protection of the environment and human health by limiting manufacture, import and new use of the five substances until the new activity patterns and use quantities of the substances are evaluated. The permitted activities, as set out in the Order, are expected to result in a low to negligible exposure to the five substances or are the subject of other risk management measures. Therefore, the Order allows these activities to continue while ensuring any increased or new activity is reported. Information submitted as per the requirements of the Order will allow the Government to evaluate the potential harm to human health and the environment and ensure that future activities do not significantly increase the risk to human health or the environment.

Companies that manufacture, use, or import the five substances at or above the specified threshold for a new activity will incur costs associated with generating data and with supplying other information as required by the Order. As the cost for generating data is determined on a case by case basis, providing an estimate of the cost to industry to meet the notification requirements is not possible.

However, based on consultations and comments received from the Notice of Intent, companies are either exempted from the Order or not currently using the substances above the threshold. Furthermore, no stakeholders have expressed intentions to manufacture, use or import the substances above the threshold in the future. Therefore, it is not expected that their current activity patterns and use quantities will change significantly in the future. Therefore, the Order is not expected to have any impact on industry, including small businesses.

In the event of notification, the Government will incur costs for processing the information in relation to the SNAc and for assessing potential health and environmental risks. However, these costs are not expected to be significant and will be covered under current funding from the Chemicals Management Plan. Furthermore, the Government will incur costs to ensure compliance with the Order by conducting compliance promotion and enforcement activities. Annual incremental costs for inspections, investigations and measures to deal with alleged violations would be expected to be low, but cannot be accurately estimated given the lack of information regarding potential future uses. Compliance promotion activities will be delivered concurrently with other departmental activities to encourage compliance with the Order. The costs associated with these activities are routine governmental administrative costs and are not considered incremental.

In conclusion, although it was not possible to quantitatively estimate the benefits and costs, the overall impact of the Order is expected to be positive.

7. Implementation and enforcement

Implementation

The Order will come 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:

  • Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of CEPA 1999.
  • Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with CEPA 1999, willingness to co-operate with enforcement officers, and evidence of corrective action already taken.
  • Consistency: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce CEPA 1999.

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.

8. Contacts

Greg Carreau
Acting 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

Markes Cormier
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: markes.cormier@hc-sc.gc.ca

Footnote a
SOR/94-311

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 1999, c. 33

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

Footnote 2
http://canadagazette.gc.ca/rp-pr/p2/2011/2011-02-16/html/sor-dors25-eng.html

Footnote 3
National Sanitation Foundation Standard 60/61

Footnote 4
For more information on proposed risk management for 2,4,6-TTBP, please refer to www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=4941F836-1.

Footnote 5
For more information on the proposed risk management for 2,4,6-TTBP, please refer to www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=4941F836-1.

Footnote 6
http://canadagazette.gc.ca/rp-pr/p1/2011/2011-01-22/html/notice-avis-eng.html#d103

Footnote 7
www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=4941F836-1

Footnote 8
www.chemicalsubstances.gc.ca/challenge/batch-2/index-eng.php