ARCHIVED — Vol. 147, No. 11 — May 22, 2013

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Registration

SOR/2013-97 May 10, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-87-06-02 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);

Whereas the Ministers are satisfied that those substances are 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 a significant new activity in relation to any of those substances may result in the substance 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 subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2012-87-06-02 Amending the Domestic Substances List.

Gatineau, May 6, 2013

PETER KENT
Minister of the Environment

ORDER 2012-87-06-02 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

  • 55-18-5
  • 59-88-1
  • 60-35-5
  • 62-50-0
  • 62-55-5
  • 66-27-3
  • 75-25-2
  • 76-01-7
  • 78-88-6
  • 79-00-5
  • 79-16-3
  • 94-58-6
  • 96-09-3
  • 96-18-4
  • 100-63-0
  • 101-61-1
  • 106-87-6
  • 110-88-3
  • 115-28-6
  • 116-14-3
  • 122-60-1
  • 123-39-7
  • 123-73-9
  • 131-18-0
  • 131-52-2
  • 135-20-6
  • 136-35-6
  • 141-90-2
  • 331-39-5
  • 492-80-8
  • 569-61-9
  • 591-78-6
  • 593-60-2
  • 606-20-2
  • 615-28-1
  • 823-40-5
  • 1120-71-4
  • 1694-09-3
  • 3296-90-0
  • 4170-30-3
  • 10034-93-2
  • 10046-00-1
  • 13463-39-3
  • 13840-56-7
  • 15545-48-9
  • 24602-86-6
  • 25321-14-6
  • 25376-45-8
  • 26447-14-3
  • 39156-41-7
  • 55290-64-7
  • 103122-66-3

2. Part 2 of the List is amended by adding the following after the substance “Group A*”:


Column 1


Substance

Column 2

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

Group B
(see footnote 2)

  1. Any activity involving, in any one calendar year, more than 100 kg of any Group B substance, other than an activity related to

    • (a) its use as a drug;
    • (b) its use as a component of a drug; or
    • (c) its use in the manufacture of a drug as defined in the Food and Drugs Act.
  2. For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the 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 in relation to the significant new activity;
    • (c) if known, the three sites in Canada where the greatest quantity of the substance, in relation to the significant new activity, is anticipated to be used or processed and the estimated quantity by site;
    • (d) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) 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;
    • (f) the identification of every other government agency, either outside or within Canada, that the person proposing the significant new activity has notified of 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;
    • (g) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on behalf of that person; and
    • (h) 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 90 days after the day on which it is received by the Minister.

COMING INTO FORCE

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Background

Based on information obtained through the categorization process as required by the Canadian Environmental Protection Act, 1999 (CEPA 1999), 53 chemical substances of which 52 are listed in the Order 2012-87-06-02 Amending the Domestic Substances List (the Order) (see footnote 3) had been identified as posing a high hazard to human health based on carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. (see footnote 4) Furthermore, 15 of the 52 substances were determined to meet the categorization criteria for persistence or bioaccumulation, and inherent toxicity to human or non-human organisms. (see footnote 5) Therefore, the 52 substances were identified as priorities for further assessment. These 52 substances are subject to this Order.

To establish whether certain substances were being manufactured in or imported into Canada, two notices were published under the authority of section 71 of CEPA 1999 in 2006 and 2009. The results from the two surveys revealed no reports of industrial activities (import or manufacture) of the 52 substances above the reporting threshold of 100 kg for the reporting years of 2005 and 2008. Therefore, these substances are considered to be “not in commerce” in Canada at the reporting threshold.

To identify direct exposure potential to the general population, information searches for releases and sources of the 52 substances in relevant databases were conducted up to the year 2010. No information was found indicating that current uses or releases of the 52 substances exceed the reporting threshold in Canada. Therefore, the likelihood of exposure to these substances in Canada resulting from commercial activity is low, hence the potential risks to human health or the environment are considered to be low.

Health Canada and Environment Canada conducted a screening assessment for the 52 substances to determine whether they are harmful to the environment or human health as defined under section 64 of CEPA 1999. (see footnote 6) Based on available information, it was concluded in the final screening assessment that the 52 substances did not meet any of the criteria in section 64 of CEPA 1999 due to the low probability of exposure since they are considered “not in commerce.” The final screening assessment on the 52 substances was published on the Chemical Substances Web site along with a notice that was published in the Canada Gazette, Part I. (see footnote 7)

Significant new activity (SNAc) provisions of CEPA 1999

Given that the 52 substances are listed on the Domestic Substances List (DSL), new activities associated with these substances in Canada can be conducted by industry without any obligation to notify the Government of Canada. When the Government of Canada is concerned that any significant new activity in relation to a substance may result in harmful effects to human health or the environment, the Minister of the Environment (Minister) may impose notification requirements upon the new activity.

Given the potential high hazard to human health of all 52 substances, there is concern that new activities associated with the 52 substances could lead to the substances meeting the criteria set out in section 64 of CEPA 1999. Therefore, the Minister published a Notice of Intent on July 2, 2011, in the Canada Gazette, Part I, to indicate his intention to apply the SNAc provisions of CEPA 1999 to 53 substances. However, the Order lists only 52 substances since the substance thiophanate-methyl (Chemical Abstracts Service [CAS] Registry Number 23564-05-8), which was included in the notice of intent, has been removed from the Order.

Issues and objectives

According to the conclusion of the screening assessment, the 52 substances do not currently pose a risk to the environment or human health because it was determined that the substances are considered to be currently not in commerce above the reporting threshold in Canada. However, new activities involving the 52 substances, which have not been identified or assessed under CEPA 1999, could increase the potential for exposure and may lead to these substances meeting the criteria set out in section 64 of CEPA 1999 due to the potential high hazard to human health.

Given these concerns, SNAc provisions under CEPA 1999 are implemented to require that any new activities in Canada associated with the 52 substances in quantities above the 100 kg threshold be reported, so that the Government can undertake ecological and human health risk assessments to determine if these activities pose an increased risk to human or environmental health.

The objective of the Order is to contribute to the protection of human health and the environment by collecting information on significant new activities associated with the 52 substances before such activities are undertaken. To achieve this, the Order subjects the 52 substances to the SNAc provisions of CEPA 1999, requiring notification to the Minister prior to any new activities associated with the substances.

Description

The Order deletes the 52 substances from Part 1 of the DSL by removing their Chemical Abstract Service (CAS) Registry Numbers, and adds them to Part 2 of the DSL. The addition of the letter S′ following their CAS Registry Numbers indicates that the 52 substances are subject to the SNAc provisions set out in subsection 81(3) of CEPA 1999.

The SNAc provisions require any person that intends to start any significant new activity related to one of these 52 substances to provide, 90 days in advance, a notice to the Minister. The Order defines the new activity and outlines the details of the information requirements such as a description of the new activity, quantity and sites of the substance to be used for the new activity, and information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).

The submitted information will allow Environment Canada and Health Canada to assess the potential environmental and human health risks associated with the new activity in relation to any of the 52 substances within 90 days after it is received.

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

Consultation

On July 2, 2011, a notice of intent to amend the DSLwas published to propose that the SNAc provisionsof CEPA 1999 be applied to the 52 substances and another substance. (see footnote 8) The notice announcing the publication of the draft screening assessment report on the Chemical Substances Web site was also published on that day in the Canada Gazette, Part I, for a 60-day public comment period.

One submission was received from an industry stakeholder in support of the application of the SNAc provisions to manage the 52 substances.

Environment Canada and Health Canada have also informed the governments of the provinces and territories through the National Advisory Committee under CEPA 1999 (CEPA NAC) about the Order via a letter, with an opportunity to comment. There were no comments from CEPA NAC.

“One-for-One” Rule

The “One-for-One” Rule does not apply to the Order as there is no expected administrative burden on industry. There are no Canadian companies that reported using the 52 substances above the threshold. Furthermore, there is no indication that industry’s current activity pattern associated with these substances may change in the future.

Small business lens

The small business lens does not apply to the Order as there are no expected impacts on industry or small business. There are currently no activities involving the 52 substances above the reporting threshold and no indication that industry’s current activity pattern associated with these substances may change in the future.

Rationale

Since no information was found indicating that current activities associated with the 52 substances exceed the reporting threshold in Canada, it was determined that the substances are “not in commerce” in Canada. However, given the potential high hazard of the 52 substances, significant new activities may increase exposure and may pose potential risks to human health. Therefore, the new activities associated with the 52 substances which have not been assessed may lead to these substances meeting the criteria set out in section 64 of CEPA 1999.

As the 52 substances are currently not in commerce above the reporting threshold, it is assumed that there are no current risks associated with the 52 substances. However, since the 52 substances are currently listed on Part 1 of the DSL, they could be used for any activity and in any quantity without any requirement to report to the Minister. Given the hazardous nature of these substances, future activities that have not been assessed may pose a risk to human health and the environment and the risks associated with these activities would not be managed appropriately. Therefore, maintaining the status quo has been rejected.

Applying SNAc provisions allows the Government to be informed of new activities associated with the 52 substances. The submitted information will assist the Government in conducting a risk assessment in relation to these activities and the potential for these substances to impact the environment and health of Canadians. Therefore, applying SNAc provisions to the 52 substances is the preferred option.

The Order contributes to the protection of human health and the environment by ensuring that no activities above the defined threshold in relation to any of the 52 substances can occur without notification to the Minister. This allows for the evaluation of the potential human and environmental risks associated with these new activities prior to the 52 substances being used commercially in Canada.

As the 52 substances are currently not in commerce in Canada, the Order is not expected to have any negative impact on industry. Should a new activity with the 52 substances occur above the specified threshold, costs associated with supplying information as required by the Order would be incurred. However, it is not possible at this time to accurately estimate the occurrence of any future activities. As a result, providing a total estimate of the cost to industry to meet the notification requirements is not possible at this time.

In the event of notification of a new activity, the Government will incur costs for processing the information in relation to the SNAc and for assessing potential health and environmental risks. The Government will also incur costs related to compliance promotion and enforcement activities. Annual costs associated with these activities are expected to be low, but cannot be accurately estimated given the lack of information regarding potential future activities.

In conclusion, although it was not possible to quantitatively estimate the benefits, they are expected to exceed the costs in the long term.

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 alleged 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. (see footnote 9)

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 Government will assess all information submitted as part of SNAc notification and will communicate the result to the notifier 90 days after the complete 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
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@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
    Group B: 55-18-5 S′, 59-88-1 S′, 60-35-5 S′, 62-50-0 S′, 62-55-5 S′, 66-27-3 S′, 75-25-2 S′, 76-01-7 S′, 78-88-6 S′, 79-00-5 S′, 79-16-3 S′, 94-58-6 S′, 96-09-3 S′, 96-18-4 S′, 100-63-0 S′, 101-61-1 S′, 106-87-6 S′, 110-88-3 S′, 115-28-6 S′, 116-14-3 S′, 122-60-1 S′, 123-39-7 S′,  123-73-9 S′, 131-18-0 S′, 131-52-2 S′, 135-20-6 S′, 136-35-6 S′, 141-90-2 S′, 331-39-5 S′, 492-80-8 S′, 569-61-9 S′, 591-78-6 S′, 593-60-2 S′, 606-20-2 S′, 615-28-1 S′, 823-40-5 S′, 1120-71-4 S′, 1694-09-3 S′, 3296-90-0 S′, 4170-30-3 S′, 10034-93-2 S′, 10046-00-1 S′, 13463-39-3 S′, 13840-56-7 S′, 15545-48-9 S′, 24602-86-6 S′, 25321-14-6 S′, 25376-45-8 S′, 26447-14-3 S′, 39156-41-7 S′, 55290-64-7 S′, 103122-66-3 S′.
  • Footnote 3
    Following the receipt of additional information, substance thiophanate-methyl (Chemical Abstracts Service [CAS] Registry Number 23564-05-8), which was proposed for inclusion in the significant new activity (SNAc) at the Notice of Intent stage, was removed from the Order. The Domestic Substances List listing for this substance will not be amended at this time. Additional action may be taken on this substance at a later date and in concert with other, similar substances, following additional risk assessment.
  • Footnote 4
    The classification for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity was completed by other national or international agencies, such as the International Agency for Research on Cancer, U.S. National Toxicology Program, or U.S. Environmental Protection Agency.
  • Footnote 5
    The 15 substances are listed in Appendices A and B of the final screening assessment report.
  • Footnote 6
    A substance is toxic under section 64 of CEPA 1999 if it is 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.
  • Footnote 7
    The final screening assessment report can be found at www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/nics53-eng.php.
  • Footnote 8
    See footnote 1 for the reason why the Order includes 52 substances when the Notice of Intent published in July 2011 included 53 substances.
  • Footnote 9
    A copy of the Policy may be obtained from the following Web site: www.ec.gc.ca/CEPARegistry/documents/policies/candepolicy/toc.cfm.