Vol. 145, No. 3 — February 2, 2011
SOR/2011-2 January 12, 2011
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
ARCHIVED — Order 2010-87-12-01 Amending the Domestic Substances List
Whereas the substance set out in the annexed 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);
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 c);
Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote d), hereby makes the annexed Order 2010-87-12-01 Amending the Domestic Substances List.
Gatineau, January 7, 2011
Minister of the Environment
ORDER 2010-87-12-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:
2. Part 2 of the List is amended by adding the following in numerical order:
1. Any activity involving, in any one calendar year, more than 100 kg of the substance Resin acids and Rosin acids, fumarated, barium salts.
2. For each significant new activity, 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 any one 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).
3. 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 (CEPA 1999), is to delete one substance currently listed on Part 1 of the Domestic Substances List (the List) and add it to Part 2 of the List and to indicate that this substance is subject to subsection 81(3) of the Canadian Environmental Protection Act, 1999. The substance subject to the Order is resin acids and rosin acids, fumarated, barium salts (Chemical Abstract Service [CAS] Registry Number [RN] (see footnote 2) 124751-15-1).
Description and rationale
On June 26, 2010, seven Notices relating to the release of draft screening assessments for the 12 (see footnote 3) substances in Batch 10 of the Challenge were published in the Canada Gazette, Part I, Vol. 144, No. 26, for a 60-day public comment period. In addition, the draft screening assessments were also released on Environment Canada’s 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. For one hazardous substance, results from the notice issued under paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 in June 2009 revealed no reports of industrial activities (manufacture or import) with respect to this substance above the reporting threshold of 100 kg per year for the specified reporting year of 2006. This substance is hence deemed not in commerce.
Because of the hazardous persistence, bioaccumulation and inherent toxicity properties of this 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 resin acids and rosin acids, fumarated, barium salts was published in the Canada Gazette, Part I, on June 26, 2010. It was proposed that the Significant New Activity provisions of the Act be applied so that any new use of this substance is notified and undergoes ecological and human health risk assessments, prior to this substance being commercially introduced into Canada.
The Minister of the Environment and the Minister of Health have finalized the screening assessment on this substance and published in the Canada Gazette, Part I, on January 15, 2011, the Final Decision on the Screening Assessment of one substance on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999).
The screening assessment was conducted to determine whether the substance met the toxicity criteria under section 64 of the Canadian Environmental Protection Act, 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 assessment is that the substance does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999. The final screening assessment report can be found at www.chemical substances.gc.ca.
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 substance that is the object of the amendment.
Subsection 81(3) of the Act requires any person that intends to use, import or manufacture this substance 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 Order provides that this information will be assessed within 90 days after it is received by the Minister of the Environment.
Benefits and costs
The amendment of the Domestic Substances List will allow for conducting a risk assessment with respect to any new activity in relation to this substance. This will allow for the making of informed decisions, and appropriately managing the risks associated with this substance prior to the commencement of the new activity.
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 this substance in a quantity above the prescribed threshold, the required information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers) needs to be provided. 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.
On June 26, 2010, 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 one substance was published. A proposed summary of the screening assessment under subsection 77(1) was 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. There were no comments from CEPA NAC.
One submission was received from a non-governmental organization (NGO), on the notice of intent to amend the Domestic Substances List. The comments from this submission were considered in developing the final screening assessment.
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/.
The NGO submitted five comments:
- Concerns were raised that there is not enough public engagement in reviewing the assessments for a substance following a notification of significant new activity made pursuant to the Order.
The New Substances Program has initiated the development of a process for periodic review of its assessment reports by groups outside the New Substances Program. Although the process is still being developed, it is the Government’s intention for the public to have access to assessment reports when processing Significant New Activity Notifications.
- The commenter indicated that the threshold of 100 kg for submitting under SNAc is too high and does not require accountability by all users of the targeted substance.
The 100 kg per year threshold specified in the section 71 notice, and used to determine whether a substance is imported into or manufactured in Canada, is based on the lowest threshold that triggers notifications under the New Substances Program. The new substances regulatory framework has been subject to extensive multistakeholder consultations where it was recognized that the CEPA 1999 definition of toxic is not based on “hazard” assessments. CEPA 1999 defines toxic in terms of both intrinsic properties and exposure potential. The New Substances Notification Regulations were therefore structured around a set of volume-triggered tiered testing requirements, thus incorporating the notion of exposure by requiring more extensive assessments for larger exposure potential. Stakeholders not subject to the section 71 Notice (i.e. that fall below the reporting threshold) are strongly encouraged to inform the Government of Canada of their activities relating to substances by responding to the Challenge Questionnaire. When such information is received, it is considered in the risk assessment and, if applicable, in the development of the risk management approach.
- It was expressed by this NGO that Environment Canada does not define this chemical as toxic under CEPA 1999, despite evidence of the inherent hazard of this chemical which perpetuates the on-going use of this chemical unless evidence of harm is presented.
CEPA 1999 defines toxic in terms of both intrinsic properties and exposure potential. This substance had no report of import, use or manufacture for the year 2006; the potential for exposure is already very low; therefore, it does not meet the criteria set out in section 64 of CEPA 1999. The application of the Significant New Activity provisions under CEPA 1999 would require that any proposed new manufacture, import or use involving more than 100 kg in a year be subject to further assessment, and would determine if further risk management is required with respect to the substance. The SNAc provisions will be used to identify any new activity in relation to this substance that may result in their meeting the criteria set out under section 64.
- The NGO also expressed the opinion that there is an inadequate framework to consider impacts to vulnerable populations (e.g. developing fetuses and children, workers, indigenous communities including Inuit communities and First Nations, people of low income and people with chemical sensitivities).
As in the Challenge, an assessment following a notification would include various conservative exposure scenarios considered to be protective of both the general and vulnerable populations in Canada and would incorporate specific exposure estimates for Canadians of different ages. If information was available that suggested a specific sub-population would be particularly vulnerable, this information would be considered in the assessment. Hazard information obtained from occupational settings, in particular data from epidemiological investigations, would be considered in the assessments, when available. The information developed through the Chemicals Management Plan may be used to inform decisions concerning additional actions to minimize exposure to workers.
- Finally, it was also expressed that there is limited opportunity in the approach to require the submission of toxicity data on critical hazard endpoints including endocrine disruption and neurodevelopmental toxicity.
If a Significant New Activity notification is submitted, the onus would be on the notifier to submit new reliable/credible information that indicates that it is not harmful to human health or the environment. If the information in the Significant New Activity Notification is insufficient, paragraph 84(1)(c) of CEPA 1999 enables the Minister of the Environment, under certain conditions, to request additional information to determine whether the substance is harmful to human health or the environment or capable of becoming harmful. After a submission of new information, the assessment process is resumed and appropriate risk management measures can be taken, if necessary.
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 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 one substance from Part 1 and adds it to Part 2 of the Domestic Substances List, developing an implementation plan or a compliance strategy or establishing a service standard are not considered necessary.
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
S.C. 1999, c. 33
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
An additional substance, Cobalt sulfate (CAS RN 10393-49-4), was added to the Notice with respect to Batch 10 Challenge substances and was assessed concurrently with other Batch 10 substances.