Vol. 143, No. 19 — September 16, 2009

Registration

SOR/2009-254 August 31, 2009

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2009-87-05-04 Amending the Domestic Substances List

Whereas the substance set out in this 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 are satisfied that the substance is persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations (see footnote c) and is inherently toxic to non-human organisms;

Whereas the Ministers are satisfied that the substance 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 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 d);

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote e), hereby makes the annexed Order 2009-87-05-04 Amending the Domestic Substances List.

Ottawa, August 18, 2009

JIM PRENTICE
Minister of the Environment

ORDER 2009-87-05-04 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

6232-56-0

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
6232-56-0 S′	Any activity involving, in any one calendar year, more than 100 kg of the substance ethanol, 2-[[4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]methylamino]-.
	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; and (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
	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 the Order 2009-87-05-04 Amending the Domestic Substances List (the Order), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 is to delete one substance currently listed on Part 1 of the Domestic Substances List (the List hereafter), and add it to Part 2 of the List and to indicate, by the addition of the letter S’ following the substance identification number, that this substance is subject to the prohibition contained in subsection 81(3) of the Canadian Environmental Protection Act, 1999. The substance subject to the order is Ethanol, 2-[[4-[(2, 6-dichloro-4-nitrophenyl)azo] phenyl]methylamino]- (Disperse Orange 5; CAS Registry Number 6232-56-0).

Description and rationale

On February 21, 2009, 19 Notices relating to the release of draft screening assessments for the 19 substances in Batch 5 of the Challenge as well as the draft screening assessments were published in the Canada Gazette, Part I, Vol. 143, No. 8, for a 60-day public comment period. In addition, the draft screening assessments were also released on the chemical substance Web site. These publications were made in the context of the Chemicals Management Plan announced by the Government of Canada on December 8, 2006. The screening assessments found that Disperse Orange 5 met the ecological categorization criteria for persistence, bioaccumulation and inherent toxicity to non-human organisms. Additionally, results from notices issued under paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 in March 2006 and February 2008 revealed no reports of industrial activities (import or manufacture) with respect to Disperse Orange 5 above the reporting threshold of 100 kg per year for the specified reporting years of 2005 and 2006. This substance is hence deemed not in commerce.

Because of the hazardous persistence, bioaccumulation and inherent toxicity properties of the substance 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 Disperse Orange 5 was published in the Canada Gazette on February 21, 2009. It was proposed that the Significant New Activity provisions of the Act be applied so that any new use, manufacture or import of this substance in quantities greater that 100 kg per year is notified to the Minister of the Environment and undergoes ecological and human health risk assessments, prior to the substance being introduced into Canada.

The Ministers of the Environment and of Health have finalized the screening assessment on this substance and have published in the Canada Gazette, Part I, on August 22, 2009, the Final Decision on the Screening Assessment of a substance on the Domestic Substances List (in accordance with subsection 77(6) of the Canadian Environmental Protection Act, 1999).

The screening assessment was conducted to determine whether the substance meets the criteria under section 64 of the Canadian Environmental Protection Act, 1999; whereas 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 screening assessment has identified no commercial activity with this substance, nor any other information indicating that the substance is entering or likely to be entering the environment. It has been concluded that it does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999. The final assessment report can be found at www. chemicalsubstances.gc.ca.

Authority

As mentioned above, the Order is made under subsection 87(3) of the Canadian Environmental Protection Act, 1999. This modification to the List will trigger the application of subsection 81(3) of the Act with respect to the substances that are the object of the amendment.

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 to provide the following information 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 description of the proposed significant new activity in relation to the substance; and
• the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).

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

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

Alternatives

Since the substance is listed on Part 1 of the Domestic Substances List, it could be re-introduced in the Canadian market for any activity and in any quantity without any requirement to report to the Minister of the Environment. As this substance has been determined to possess hazardous properties, therefore, the option of not moving the substance to Part 2 of the Domestic Substances List to make it subject to the significant new activities provisions of the Canadian Environmental Protection Act, 1999 has been rejected.

Benefits and costs

Benefits

The amendment of the Domestic Substances List will allow for risk assessment of any new activity in relation with this substance. This will allow for the making of informed decisions, and appropriate management of the risks associated with this substance.

Costs

There is currently no evidence of the presence of this substance in Canadian commerce above an annual threshold of 100 kg. Therefore, 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 any of these substances in a quantity above the prescribed threshold, they would be required to provide the required information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers). 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 the Canadian Environmental Protection Act, 1999.

As this substance is not in commerce, a reasonable assumption of the magnitude of its use and the size of the industry is not feasible. Hence, a total cost expected to be incurred by the 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 February 21, 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 toDisperse Orange 5 and a proposed summary of the screening assessment under subsection 77(1) 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) about the Order via a letter, with an opportunity to comment. No concerns were received from CEPA NAC.

A total of 14 submissions on the draft screening assessment report and the notice of intent were received from three industry stakeholders; seven industry associations and three non-governmental organizations. All comments received during the public comment period were considered and taken into account when finalizing the Order and the final screening assessment report.

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/.

Comments from non governmental organizations stated that the use of the SNAc provision would not be sufficient to protect the Canadian environment and recommended the substance be determined as “toxic” under section 64 of CEPA 1999.

Environment Canada indicated that SNAc provisions are used for substances which are likely to pose a threat to the Canadian environment if they are used and released in Canada given a certain quantity or concentration. Since Disperse Orange 5 is not currently being imported into or used in Canada, no environmental release is expected. Hence, the substance does not currently meet the criteria of section 64 of CEPA 1999. The SNAc ensures that any proposed future imports of Disperse Orange 5 are subject to assessment under the New Substances Notification Regulations.

Implementation, enforcement and service standards

Since the Order is made under the Canadian Environmental Protection Act, 1999, enforcement officers will, if and when verifying compliance with the requirements pursuant to section 6 of the New Substances Notification Regulations (Chemicals and Polymers) set out in the Order, apply the guiding principles set out in the Compliance and Enforcement Policy implemented under the Act. The Policy also 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 the Canadian Environmental Protection Act, 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

Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-4936
Email: Existing.substances.existantes@ec.gc.ca

Footnote a
SOR/94-311

Footnote b
S.C. 1999, c. 33

Footnote c
SOR/2000-107

Footnote d
S.C. 1999, c. 33

Footnote e
S.C. 1999, c. 33

Footnote 1
SOR/94-311

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).