ARCHIVED — Order 2010-87-05-01 Amending the Domestic Substances List

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Vol. 144, No. 23 — November 10, 2010

Registration

SOR/2010-246 November 1, 2010

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substance set out in the annexed Order is 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 the substance under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and have published the final decision on the screening assessment under subsection 77(6) of that Act on March 7, 2009 in the Canada Gazette, Part I;

Whereas the Ministers are satisfied that the substance, in any one calendar year, is not being manufactured in Canada by any person in a quantity of more than 100 kg and is only being imported into Canada in that quantity for a limited number of industrial uses;

And whereas the Ministers suspect that a significant new activity in relation to the substance 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), hereby makes the annexed Order 2010-87-05-01 Amending the Domestic Substances List.

Ottawa, October 28, 2010

JIM PRENTICE
Minister of the Environment

ORDER 2010-87-05-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

111-15-9

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

Column 1


Substance

Column 2

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

111-15-9 S′

1. Any activity involving, in any one calendar year, more than 100 kg of Ethanol, 2-ethoxy-, acetate (2-ethoxyethanol acetate, 2-EEA), other than its use in an industrial setting as a solvent, paint, coating or cleaning solution.

 

2. For each 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 a calendar year:

 

(a) a description of the proposed significant new activity in relation to the substance;

 

(b) the information specified in items 2 to 9 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);

 

(c) the information specified in paragraphs 2(d) to (f) and item 8 of Schedule 5 to those Regulations; and

 

(d) the information specified in items 7 to 11 of Schedule 6 to those Regulations.

 

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.)

Issue and objectives

The purpose of Order 2010-87-05-01 Amending the Domestic Substances List (the Order), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) is to delete a substance from Part 1 of the Domestic Substances List (the List) and add it to Part 2 of the List and to indicate that this substance is subject to subsection 81(3) of CEPA 1999. The substance subject to the Order is Ethanol, 2-ethoxy-, acetate also known as 2-Ethoxyethanol acetate (2-EEA), Chemical Abstract Service (CAS) Registry Number 111-15-9.

Description and rationale

On August 23, 2008, a notice entitled Publication after screening assessment of a substance — Ethanol, 2-ethoxy-, acetate (2-Ethoxyethanol Acetate, 2-EEA), CAS No. 111-15-9 — Specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999] was published in the Canada Gazette, Part I, for a 60-day public comment period. In addition, the draft screening assessment report on 2-EEA was also released on the Government of Canada’s Chemical Substances Web site, www.chemicalsubstances.gc.ca. This publication was made in the context of the Chemicals Management Plan announced by the Government of Canada on December 8, 2006.

2-EEA was identified for assessment as it was found to pose a high hazard to human health on the basis of reproductive and developmental toxicity based on other international agencies classification. Additionally, results from a notice issued under paragraph 71(1)(b) of CEPA 1999 in February 2008 revealed no manufacture of 2-EEA above the reporting threshold of 100 kg in 2006. 2-EEA was reported to be imported in the range of 10 000–100 000 kg in 2006 to be used in limited/specialized activities. Therefore, exposure to 2-EEA via consumer products is not expected to be significant.

The Ministers of the Environment and of Health finalized the screening assessment on 2-EEA and published in the Canada Gazette, Part I, on March 7, 2009, a notice entitled: Publication of final decision on the screening assessment of a substance — Ethanol, 2-ethoxy-, acetate (2-ethoxyethanol acetate; 2-EEA), CAS No. 111-15-9 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999).

The screening assessment was conducted to determine whether the substance met the toxicity criteria under section 64 of CEPA 1999. Under that provision a substance is toxic 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.

The conclusion of the screening assessment is that 2-EEA is currently not entering or likely to enter the environment in a quantity or concentration or under conditions that result in 2-EEA meeting any of the criteria set out in section 64 of CEPA 1999.

However, given the hazardous properties of the substance, there is a concern that new activities involving the substance which have not been identified or assessed under CEPA 1999 could lead to the substance meeting the criteria set out in section 64 of the Act. Therefore, it was recommended that the substance be subject to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that any new use of the substance in quantities exceeding 100 kg per year is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act. A notice entitled Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies to Ethanol, 2-ethoxy-, acetate (2-ethoxyethanol acetate, 2-EEA) was published in the Canada Gazette, Part I, on March 7, 2009.

Based on this recommendation, the Order deletes 2-EEA from Part 1 of the Domestic Substances List and adds it to Part 2 of the List and indicates that this substance is subject to subsection 81(3) of CEPA 1999.

Authority

The Order is made under subsection 87(3) of CEPA 1999. This modification to the List will trigger the application of subsection 81(3) of the Act with respect to the substance that is the object of the amendment.

Subsection 81(3) of CEPA 1999 requires persons to provide the prescribed information to the Minister of the Environment for significant new activities in relation to a substance listed on the Domestic Substances List.

Upon the adoption of the Order, subsection 81(3) of the Act will require any person that intends to use, import or manufacture the substance in a quantity exceeding 100 kg in a calendar year for use other than its use in an industrial setting as a solvent, paint, coating or cleaning solution, to provide the following information to the Minister, at least 90 days prior to the commencement of the proposed new activity:

(a) a description of the proposed significant new activity in relation to the substance; and

(b) the information specified in items 2 to 9 to Schedule 4 of the New Substances Notification Regulations (Chemicals and Polymers), sub-items 2(d), (e) and (f), and item 8 to Schedule 5 of those Regulations and items 7 to 11 of Schedule 6 of those Regulations.

The above information will be assessed within 90 days after it is received by the Minister of the Environment.

Benefits and costs

The amendment to the Domestic Substances List will allow notification for risk assessment with respect to any new activity in relation with this substance. This will allow for the making of informed decisions, and manage appropriately the risks associated with this substance prior to the commencement of the new activity.

The substance is principally used in solvents, paints, coatings and cleaning solution for industrial applications. The total quantity imported into Canada in 2006 was reported to be in the range of 10 000–100 000 kg. There is currently no evidence of manufacture of 2-EEA in Canadian commerce above an annual threshold of 100 kg. Also, there is currently no evidence of import or use of the substance in Canadian commerce in excess of 100 kg threshold other than its use in an industrial setting as a solvent, paint, coating or cleaning solution. Hence, incremental costs to the public, industry or governments associated with this Order are not expected.

In the event, however, that a person wishes to use, import or manufacture this substance for activities other than its use in an industrial setting as a solvent, paint, coating or cleaning solution in a quantity above the prescribed threshold, the required information specified above needs to be provided. That person may incur a one-time cost of up to $179 000 per substance ($2004). This amount can be reduced by using surrogate data (test results from a similar substance or obtained from modeling, for example). In addition, the interested party can request a waiver of these requirements under subsection 81(8) of CEPA 1999.

Assumptions on the magnitude of the use of the substance and the size of the industry for a new use are not feasible. Hence, a total cost expected to be incurred by that industry in the event of significant new activities cannot be estimated at this time.

There would likely be cost to the government associated with assessing the information provided by the regulatees as per section 83 of CEPA 1999. These costs cannot be estimated at this time.

Consultation

On March 7, 2009, a Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies to 2-EEA and a proposed summary of the screening assessment conducted under section 74 were published for a 60-day public comment period in the Canada Gazette, Part I.

Environment Canada has also informed the governments of the provinces and territories through the CEPA National Advisory Committee (CEPA NAC) via a letter, with an opportunity to comment. No concerns were received from CEPA NAC.

A summary of comments received on the draft screening assessment report and the notice of intent and Environment Canada’s responses is available from the Chemical Substances Web site: www.chemicalsubstances.gc.ca.

One submission was received from an industry stakeholder during the public comment period on the draft screening assessment report and on the risk management scope document.

The enquiry was on the applicability of the Significant New Activity provision to impurities, since 2-EEA is present as an impurity in Ethanol, 2-butoxy-, acetate also known as ethylene glycol monobutyl ether acetate (CAS Registry No. 112-07-2) which is used as a solvent in the formulation of printing inks for graphic films in commercial graphics applications.

Environment Canada clarified that paragraph 81(6)(c) of CEPA 1999 specifies that the Significant New Activity provisions do not apply to impurities.

Implementation, enforcement and service standards

Since the Order is made under CEPA 1999, enforcement officers will, if and when verifying compliance with the requirements set out in the Order, apply the guiding principles set out in the Compliance and Enforcement Policy implemented under the Act. The 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 contravention to CEPA 1999). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.

When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, 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 the Act.
  • 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 the Act, 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 the Act.

Since this Order deletes the substance from Part 1 and adds it to Part 2 of the Domestic Substances List, developing an implementation plan, a compliance strategy or establishing a service standard are not considered necessary.

Contact

David Morin
Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 1-800-567-1999 (within Canada); 819-953-7156 (outside Canada)
Fax: 819-953-7155
Email: substances@ec.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