Vol. 143, No. 17 — August 19, 2009

Registration

SOR/2009-237 August 4, 2009

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2009-87-05-03 Amending the Domestic Substances List

Whereas the substances set out in this 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 these substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and are satisfied that these substances are persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations (see footnote c) and are inherently toxic to non-human organisms;

Whereas the Ministers are satisfied that none of these substances are 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 these substances may result in the substances 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 2009-87-05-03 Amending the Domestic Substances List.

Ottawa, July 27, 2009

JIM PRENTICE
Minister of the Environment

ORDER 2009-87-05-03 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

1154-59-2

1176-74-5

64325-78-6

68443-10-7

70776-86-2

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
1154-59-2 S′	Any activity involving, in a calendar year, more than 100 kg of the substance Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-.
	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.
1176-74-5 S′	Any activity involving, in a calendar year, more than 100 kg of the substance Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl) (3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester.
	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.
64325-78-6 S′	Any activity involving, in a calendar year, more than 100 kg of the substance Adenosine, N-benzoyl-5′-O-[bis(4-methoxyphenyl) phenylmethyl]-2′-deoxy-.
	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.
68443-10-7 S′	Any activity involving, in a calendar year, more than 100 kg of the substance Amines, C18-22-tert-alkyl, ethoxylated.
	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.
70776-86-2 S′	Any activity involving, in a calendar year, more than 100 kg of the substance 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4αβ,10aα)]-.
	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 Amending the Domestic Substances List (the Order), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 is to delete five substances currently listed on the Domestic Substances List from Part 1 of the List and add them to Part 2 of the List and to indicate, by the addition of the letter S′ following the substances identification number, that these substances are subject to the Significant New Activity provisions specified under subsection 81(3) of the Canadian Environmental Protection Act, 1999. The substances subject to the Order are

• Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy- (CAS No 1154-59-2);
• Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester (CAS No 1176-74-5);
• Adenosine, N-benzoyl-5-O-[bis(4-methoxyphenyl)phenylmethyl]-2-deoxy- (CAS No. 64325-78-6);
• Amines, C_18-22-tert-alkyl, ethoxylated (CAS No 68443-10-7); and
• 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl7-(1-methylethyl)-1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4αβ,10aα)]- (CAS No 70776-86-2)

Description and rationale

On January 24, 2009, 13 notices relating to the release of draft screening assessments for the 18 substances in Batch 4 of the Challenge as well as the draft screening assessments were published in the Canada Gazette, Part I, Vol. 143, No. 4, for a 60-day public comment period. In addition, the draft screening assessments were also released on the chemical substances 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 these five substances meet the ecological categorization criteria for persistence, bioaccumulation and inherent toxicity (PBiT) 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 November 2007 revealed no reports of industrial activities (import or manufacture) with respect to these substances above the reporting threshold of 100 kg per year for the specified reporting years of 2005 and 2006. These substances are hence deemed not in commerce.

Because of the hazardous PBiT properties of the five substances 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 Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-; Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester; Adenosine, N-benzoyl-5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxy-; Amines, C18-22-tert-alkyl, ethoxylated; and 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4αβ,10aα)]- ] was also published in the Canada Gazette on January 24, 2009. It was proposed that the Significant New Activity provisions of the Act be applied so that any new use, manufacture or import of these five substances in quantities greater that 100 kg per year is notified and undergoes ecological and human health risk assessments, prior to these substances being introduced into Canada.

The Ministers of the Environment and of Health have finalized the screening assessment on these five substances and have published in the Canada Gazette, Part I, on August 1st, 2009, the Final Decision on the Screening Assessment of 5 substances on the Domestic Substances List (Subsection 77(6) of the Canadian Environmental Protection Act, 1999).

The screening assessment was conducted to determine whether the substances meet the toxicity 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 these substances, nor any other information indicating that the substances are entering or likely to be entering the environment. It has been concluded that the substances do 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.

Subsection 81(3) of the Act requires any person that intends to use, import or manufacture any of the five substances in a quantity exceeding 100 kg in a calendar year to provide the following information to the Minister, at least 90 days prior to the commencement of the proposed new activity:

• 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 five substances are listed on Part 1 of the Domestic Substances List, they 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 these substances have been determined to possess hazardous properties, therefore, the option of not listing these substances to Part 2 of the Domestic Substances List to make them subject to the significant new activities provisions of the Canadian Environmental Protection Act, 1999 has been rejected.

Benefits and costs

Benefits

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

Costs

There is currently no evidence of the presence of these substances 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 these substances are not in commerce, a reasonable assumption of the magnitude of their 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 January 24, 2009, a Notice of intent to amend the Domestic Substances List under subsection 87(3) ofthe Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies to Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-; Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene) methyl]-, ethyl ester; Adenosine, N-benzoyl-5'-O-[bis(4-methoxyphenyl)phenylmethyl]-2'-deoxy-; Amines, C18-22-tert-alkyl, ethoxylated; and 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octa hydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenyl]methyl] (3-oxo-3-phenylpropyl)amino]-,[1R-(1α,4αβ,10aα)]-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.

One submission was received from two non governmental organisations, on the notice of intent to amend the Domestic Substances List. All comments were considered in developing the final screening assessments.

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

Non-governmental organisations expressed the view that substances categorized as persistent, bioaccumulative and inherently toxic for which the quantities in commerce are below the threshold of 100 kg/year, should be designated as “toxic” under section 64 of CEPA and added to the Prohibition of Certain Toxic Substances Regulations, 2005 to ensure that no future use, manufacture, import or sale of these substances is permitted in Canada. Non-governmental organisations argued that this would be in keeping with the precautionary principle.

Environment Canada indicated that the threshold of 100 kg/ year is consistent with the threshold for notification under the New Substances program and clarified that, to be designated as toxic, the substances must pose a potential risk to the environment or human health. However, the amendment to the Domestic Substances List will allow for risk assessment of any new activity should these substances be manufactured, imported and used above the threshold. This will allow making informed decisions, and managing appropriately the risks associated with any of these five substances.

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 five substances from Part 1 and adds them 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:
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