Vol. 145, No. 19 — September 14, 2011
SOR/2011-175 September 2, 2011
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
ARCHIVED — Order 2011-66-04-01 Amending the Domestic Substances List
Whereas the substances set out in the annexed 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 each of those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);
And whereas the Ministers are satisfied that those substances meet the reduced regulatory requirement polymer criteria;
Therefore, the Minister of the Environment, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), hereby makes the annexed Order 2011-66-04-01 Amending the Domestic Substances List.
Gatineau, September 1, 2011
Minister of the Environment
ORDER 2011-66-04-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. (1) Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:
(2) Part 1 of the List is amended by adding the following in numerical order:
COMING INTO FORCE
2. 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 2011-66-04-01 Amending the Domestic Substances List (the Order), made under subsection 66(1) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) is to establish with more precision the identity of two substances listed in Part 1 of the Domestic Substances List (the List) by adding the letter “P” to their Chemical Abstracts Service (CAS) registry number. This addition indicates that these substances are Reduced Regulatory Requirement Polymers as defined in the New Substances Notification Regulations (Chemicals and Polymers). The substances subject to the Order are
- Siloxanes and Silicones, Me 3,3,3-trifluoropropyl, Me vinyl, hydroxyl- terminated (CAS Registry No. 68952-02-3); and
- Siloxanes and Silicones, di-Me, hydrogen-terminated (CAS Registry No. 70900-21-9).
Description and rationale
On October 2, 2010, 11 notices relating to the release of draft screening assessments for the 16 substances in Batch 11 of the Challenge were published in the Canada Gazette, Part Ⅰ, Vol. 144, No. 40, and the draft screening assessments were released for a 60-day public comment period 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.
The two substances subject to the Order were identified for assessment as they were found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms. Additionally, results from a notice issued under paragraph 71(1)(b) of CEPA 1999 in March 2006 revealed that the two substances were being manufactured and imported for commercial purposes in Canada above the reporting threshold of 100 kg per year for the specified reporting year of 2006.
The Minister of the Environment and the Minister of Health have finalized the screening assessments on these substances and have published a summary of the final screening assessments in the Canada Gazette, Part Ⅰ, on September 3, 2011. In addition, the final screening assessments were released on the Chemical Substances Web site.
The screening assessments were conducted to determine whether the substances met the criteria under section 64 of CEPA 1999. Pursuant to this 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 assessments is that the two substances do not meet any of the criteria set out in section 64 of CEPA 1999. However, given that these substances can exist as other forms which have not been assessed, and the potentially hazardous, persistence and inherent toxicity properties associated with low molecular weight polymers, it is necessary to clarify that these substances are Reduced Regulatory Requirements Polymers as defined in the New Substances Notification Regulations (Chemicals and Polymers).
The Order modifies the Domestic Substances List by adding “P” to the CAS number of two substances listed above (CAS Nos. 68952-02-3 and 70900-21-9) on Part 1. This addition indicates that these substances are Reduced Regulatory Requirement Polymers.
The Order will come into force on the day on which it is registered.
Benefits and costs
The amendments to the List will require the submission of relevant information if anyone manufactures or imports the polymers in Canada in a form that no longer meets the Reduced Regulatory Requirement Polymer criteria. Should other forms of these polymers, not meeting these criteria, be introduced to the Canadian market, those polymers would be considered new to Canada and subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers).
The amendment of the Domestic Substances List will require the communication of information that will allow for risk assessment with respect to any form of these polymers that does not meet the Reduced Regulatory Requirement criteria. This will allow for the making of informed decisions, and appropriately manage the risks associated with any of these new substances prior to the introduction to the Canadian market.
There is currently no evidence of the presence of other forms of substances not meeting the Reduced Regulatory Requirement criteria in Canadian commerce above an annual threshold of 100 kg. Therefore, incremental costs to the public, industry or governments associated with this Order are estimated to be negligible.
In the event, however, that a person wishes to use another form of these substances that does not meet the Reduced Regulatory Requirement criteria in an annual quantity exceeding 100 kg, the information required in the New Substances Notification Regulations (Chemicals and Polymers) will need to be provided before the quantity imported or manufactured exceeds 100 kg. That person may incur a one-time cost of up to $179,000 per substance (2004 dollars) to produce this information. This amount can be reduced by using surrogate data (test results from a similar substance or obtained from modeling, for example). In addition, the person can request a waiver of these requirements under subsection 81(8) of CEPA 1999.
As other forms of the substances not meeting the Reduced Regulatory Requirement criteria 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 notification requirements 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. These costs cannot be estimated at this time.
On October 2, 2010, a Notice of intent to amend the Domestic Substances List under subsection 66(1) of the Canadian Environmental Protection Act, 1999 was published to indicate that two substances are Reduced Regulatory Requirement Polymers as defined in the New Substances Notification Regulations (Chemicals and Polymers). A proposed summary of the screening assessments under subsection 77(1) was also published on the same date for a 60-day public comment period in the Canada Gazette, Part Ⅰ. No comments were received.
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 comments 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 its requirements set out in this 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 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 modifies the identity of two substances listed on Part 1 of the Domestic Substances List, developing a new compliance strategy and establishing a service standard are not considered necessary.
Acting Executive Director
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
819-953-7156 (outside of Canada)
S.C. 1999, c. 33
S.C. 1999, c. 33