Vol. 143, No. 11 — May 27, 2009

Registration

SOR/2009-135 May 6, 2009

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2009-87-02-01 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 those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b), have published a summary of the results of this process under subsection 77(6) of that Act on January 31, 2009 in the Canada Gazette, Part I, and are satisfied that those 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 neither of those substances is being manufactured in or imported into Canada 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 those 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 2009-87-02-01 Amending the Domestic Substances List.

Ottawa, April 29, 2009

JIM PRENTICE
Minister of the Environment

ORDER 2009-87-02-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

70161-19-2
83006-67-1

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
70161-19-2 S′	Any activity involving, in any one calendar year, more than 100 kg of the substance specified in column 1.
	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.
83006-67-1 S′	Any activity involving, in any one calendar year, more than 100 kg of the substance specified in column 1.
	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 2009-87-02-01 Amending the Domestic Substances List (the Order) is to delete two substances, currently listed on the Domestic Substances List, from Part 1 and to add them to Part 2 of that List and to indicate, by the addition of the letter “S′ ” following the substances identification number, that these substances will be subject to the Significant New Activity provisions specified under subsection 81(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). The substances subject to the Order are:

• Benzenesulfonic acid, [(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)bis(imino-4,1-phenyleneoxy)]bis-, disodium salt (Acid Green 40:1), Chemical Abstracts Service (CAS) Registry Number 70161-19-2, and
• Benzenesulfonic acid, 2,2 -[(9,10-dihydro-5,8-dihydroxy-9,10-dioxo-1,4-anthracenediyl)diimino]bis[5-(1,1-dimethylethyl)-, disodium salt (ADIBSS), CAS Number 83006-67-1.

A person who intends to use, manufacture or import any of these substances for a significant new activity in quantities exceeding 100 kg per year must provide the Minister of the Environment the prescribed information prior to the use, manufacture or import.

Description and rationale

On May 24, 2008, 16 notices relating to the release of draft screening assessments for the 17 substances in batch 2 of the Challenge as well as the draft screening assessments were published in the Canada Gazette, Part I, Vol. 142, Nos. 16, 20 and 21 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 under the Chemical Management Plan announced by the Government of Canada on December 8, 2006. The screening assessments for Acid Green 40:1 and ADIBSS found these substances to 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 CEPA 1999 in March 2006 and May 2007 revealed no reports of industrial activities (import or manufacture) with respect to these two substances above the reporting threshold of 100 kg per year for the specified reporting years of 2005 and 2006. These two substances are hence deemed not in commerce. Thus, the proposed conclusion was that the two substances do not meet the criteria set out in section 64 of CEPA 1999.

Because of the hazardous PBiT properties of Acid Green 40:1 and ADIBSS 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 Benzenesulfonic acid, [(9,10-dihydro-9, 10-dioxo-1,4-anthracenediyl) bis(imino-4,1-phenyleneoxy)]bis-, disodium salt and Benzenesulfonic acid, 2,2′ -[(9,10-dihydro-5, 8-dihydroxy-9,10-dioxo-1,4-anthracenediyl)diimino]bis[5-(1,1-dimethylethyl)-, disodium salt was also published in the Canada Gazette, on May 24, 2008. It was proposed that the Significant New Activity provisions of the Act be applied to ensure that any new use, manufacture or import of these 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 Acid Green 40:1 and ADIBSS and have published in the Canada Gazette, Part I, on January 31, 2009, the Final Decision on the Screening Assessment of two substances on the Domestic Substances List [Subsection 77(6) of the Canadian Environmental Protection Act, 1999]. The conclusion of the screening assessment is that the two substances are currently not entering, or likely to enter, the environment as a result of commercial activity. Therefore, it is concluded that they do not meet any of the criteria set out in section 64 of CEPA 1999 (www.chemicalsubstances.gc.ca).

Authority

Subsection 81(3) of CEPA 1999 requires persons to provide prescribed information to the Minister of the Environment for significant new activities in relation to a substance listed on the Domestic Substances List. A significant new activity includes, as outlined in section 80 of CEPA 1999, any activity that result or may result in

(a) the entry or release of the substance into the environment in a quantity or concentration that, in the Minister’s opinion, is significantly greater than the quantity or concentration of the substance that previously entered or was released into the environment; or

(b) the entry or release of the substance into the environment or the exposure or potential exposure of the environment to the substance in a manner and circumstances that, in the Minister’s opinion, are significantly different from the manner and circumstances in which the substance previously entered or was released into the environment or of any previous exposure or potential exposure of the environment to the substance.

The Order requires any person who intends to use, import or manufacture any of the two substances in a quantity exceeding 100 kilograms 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.

In addition, the Order deletes the two substances from Part 1 of the Domestic Substances List and adds them to Part 2 (see footnote 2) of this List. Part 2 of the Domestic Substances List contains chemical substances that are subject to significant new activity requirements. The letter “S′ ” (see footnote 3) is added to each substance identification number to indicate that subsection 81(3) applies to them.

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

Alternatives

Because Acid Green 40:1 and ADIBSS are listed on Part 1 of the Domestic Substances List, they could be re-introduced in Canadian market for any activity and in any quantity without any requirement to report to the Minister of the Environment. The Minister has determined that given the hazardous properties of these substances, the alternative of not amending the Domestic Substances List to indicate that the Significant New Activity provisions of CEPA 1999 apply to them is not acceptable. Therefore, the option of not listing these substances in Part 2 of the Domestic Substances List to make them subject to the Significant New Activity provisions of the Act 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 these substances. This will allow the government to make informed decisions, and manage appropriately the risks associated with these 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 meet the requirements of section 2 of the Order and 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 dollars). 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 costs to the government associated with assessing the information provided by the regulatees as per section 83 of CEPA 1999. Furthermore, there might be costs associated with enforcement activities to verify compliance with this Order. These costs cannot be estimated at this time.

Consultation

On May 24, 2008, 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 Benzenesulfonic acid, [(9,10-dihydro-9, 10-dioxo-1,4-anthracenediyl) bis(imino-4,1-phenyleneoxy)]bis-, disodium salt and Benzenesulfonic acid, 2,2′ -[(9,10-dihydro5,8-dihydroxy-9,10-dioxo-1,4-anthracenediyl)diimino]bis[5-(1,1-dimethylethyl)-, disodium salt and a summary of the draft screening assessment under subsection 77(1) were published for a 60-day public comment period in the Canada Gazette, Part I. No comments were received on any of these publications.

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.

Implementation, enforcement and service standards

Since the Order will be made under the CEPA 1999, enforcement officers will, if and when verifying compliance with 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 CEPA 1999 violation). 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.

Contacts

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

Grant Hogg
Acting Director
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-952-9477
Fax: 613-952-8857
Email: Grant_Hogg@hc-sc.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

Footnote 2
The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214) published in the Canada Gazette, Part II, on July 4, 2001, establishes the structure of the list whereby substances are listed by categories based on certain criteria in corresponding parts and sets out the conditions to apply relevant indicators to a substance’s name. For more information, please visit: http://canadagazette.gc.ca/archives/p2/2001/2001-07-04/html/sor-dors214-eng.html.

Footnote 3
Some substances listed on the Domestic Substances List with the indicator “S” or “S′ ” may require notification in advance of their manufacture, import or use for a significant new activity. As well substances with the indicator “P” require notification in advance of their manufacture or import if they are in a form that no longer meets the reduced regulatory requirement criteria as defined in the New Substances Notification Regulations (Chemicals and Polymers).

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).