Source: http://canadagazette.gc.ca/rp-pr/p2/2009/2009-03-18/html/sor-dors82-eng.html
Timestamp: 2014-09-18 21:43:30
Document Index: 692537262

Matched Legal Cases: ['art 2', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2']

ARCHIVED — Canada Gazette – Order 2009-87-01-01 Amending the Domestic Substances List
ARCHIVED — March 18, 2009
ARCHIVED — Order 2009-87-01-01 Amending the Domestic Substances List
Vol. 143, No. 6 — March 18, 2009 Registration
SOR/2009-82 March 5, 2009
Whereas the Ministers of the Environment and 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 that assessment under subsection 77(6) of that Act on March 7, 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, during a calendar year, being manufactured in or imported into Canada in a quantity of more than 100 kg;
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 2009-87-01-01 Amending the Domestic Substances List.
ORDER 2009-87-01-01 AMENDING THE DOMESTIC SUBSTANCES LIST
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 4395-65-7 S’
Any activity involving, in a calendar year, more than 100 kg of 9,10-Anthracenedione, 1-amino-4-(phenylamino).
60352-98-9 S’
Any activity involving, in a calendar year, more than 100 kg of 1-Propanaminium, 3-[[4-[(2,4-dimethylphenyl) amino]-9, 10-dihydro-9,10-dioxo-1-anthracenyl]amino]-N,N,N-trimethyl-, methylsulfate.
74336-60-0 S’
Any activity involving, in a calendar year, more than 100 kg of 9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl9-oxopyrazolo[5,1-b]quinazolin-3-yl)azo]-.
The purpose of the Order Amending the Domestic Substances List (the Order) is to delete three 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 9,10-Anthracenedione, 1-amino-4-(phenylamino); 1-Propanaminium, 3-[[4-[(2,4-dimethylphenyl)amino]-9,10-dihydro9,10-dioxo-1-anthracenyl]amino]-N,N,N-trimethyl-, methylsulfate; and 9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl9oxopyrazolo[5,1-b]quinazolin-3-yl)azo]-. 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 August 23, 2008, 17 notices relating to the release of draft screening assessments for the 19 substances in Batch 3 of the Challenge as well as the draft screening assessments were published in the Canada Gazette, Part I, Vol. 142, No. 34, 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 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 the CEPA 1999 in March 2006 and May 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. Thus, the proposed conclusion was that the three substances do not meet the criteria set out in section 64 of CEPA 1999.
Because of the hazardous PBiT properties of these 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 9,10-Anthracenedione, 1-amino-4-(phenylamino); 1-Propanaminium, 3-[[4-[(2,4-dimethylphenyl)amino]-9,10-dihydro-9,10-dioxo1-anthracenyl]amino]-N,N,N-trimethyl-, methylsulfate; and 9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl 9-oxopyrazolo[5,1-b]quinazolin-3-yl)azo] was also published on August 23, 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 these three substances and have published in the Canada Gazette, Part I, on March 7, 2009, the Final Decision on the Screening Assessment of three 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 three 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 (http://www.chemicalsubstances.gc.ca).
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
(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 Ministers’ 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 three 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).
In addition, the Order deletes the three substances from Part I of the Domestic Substances List and adds them to Part 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’ “ is added to each substance identification number to indicate that subsection 81(3) applies to them.
Because 9,10-Anthracenedione, 1-Propanaminium and 9,10-Anthracenedione are listed on Part I 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. 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
The amendment to 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 appropriately manage the risks associated with these substances.
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 CEPA 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.
On August 23, 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 are 9,10-Anthracenedione, 1-amino-4-(phenylamino); 1-Propanaminium, 3-[[4-[(2,4-dimethylphenyl) amino]-9,10-dihydro-9,10-dioxo-1-anthracenyl]amino]-N,N,N-trimethyl-, methylsulfate; and 9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl9-oxopyrazolo[5,1-b]quinazolin-3-yl)azo]- 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. 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 is made under CEPA 1999, enforcement officers will, if and when verifying compliance with the Order, apply 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 CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.