Vol. 147, No. 3 — January 30, 2013
Registration
SOR/2013-5 January 17, 2013
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2013-87-01-01 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 68 or 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);
Whereas the Ministers are satisfied that the substances sulfuric acid, diethyl ester and sulfuric acid, dimethyl ester are not being manufactured in Canada by any person in a quantity of more than 100 kg in any one calendar year and are only being imported into Canada by any person in that quantity for a limited number of uses;
Whereas the Ministers are satisfied that the substance ethanol, 2-chloro-, phosphate 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 the information concerning a significant new activity in relation to any of those substances may contribute to determining the circumstances in which the substance is toxic or capable of 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), makes the annexed Order 2013-87-01-01 Amending the Domestic Substances List.
Gatineau, January 11, 2013
PETER KENT
Minister of the Environment
ORDER 2013-87-01-01 AMENDING THE DOMESTIC SUBSTANCES LIST
AMENDMENTS
1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:
-
64-67-5
-
77-78-1
-
115-96-8
2. Part 2 of the List is amended by adding the following in numerical order:
| Column 1 |
Column 2 |
|---|---|
64-67-5 S′ |
|
77-78-1 S′ |
|
115-96-8 S′ |
|
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.)
Background
On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to assess and manage chemical substances that may be harmful to human health or the environment. A key element of the CMP is the Challenge initiative, which collected information on the properties and uses of the approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each. The three substances subject to this Order (hereafter “the three substances”) are among the 37 chemicals that were included in batches four and five of the Challenge and are listed below:
- Sulfuric acid, diethyl ester (Chemical Abstracts Service [CAS] Registry No. 64-67-5), hereafter referred to as “diethyl sulfate”;
- Sulfuric acid, dimethyl ester (CAS Registry No. 77-78-1), hereafter referred to as “dimethyl sulfate”; and
- Ethanol, 2-chloro-, phosphate (3:1) [CAS Registry No. 115-96-8], hereafter referred to as “TCEP.”
Health Canada and Environment Canada conducted screening assessments to determine whether any of the substances in batches four and five are harmful to the environment or human health as defined in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). (see footnote 2) The summaries of the screening assessments for the substances from batches four and five were published in the Canada Gazette, Part I, on August 1, 2009, and August 22, 2009, respectively. They concluded that diethyl sulfate and dimethyl sulfate meet the criteria set out in paragraph 64(c) of CEPA 1999 based on their carcinogenic effects, while TCEP meets the criteria set out in paragraph 64(c) of CEPA 1999 based on its carcinogenic and non-cancer effects. Two orders adding the three substances to Schedule 1 of CEPA 1999 were published in the Canada Gazette, Part II, on March 2, 2011, to enable the development of risk management instruments to manage risks associated with the three substances. (see footnote 3)
Significant New Activity (SNAc) provisions of CEPA 1999
Given that the three substances are listed on the Domestic Substances List (DSL), new activities associated with them can currently be conducted by industry without an obligation to notify the Government of Canada. When the Government of Canada is concerned that any significant new activity in relation to a substance may result in harmful effects to human health or the environment, the Minister of the Environment (Minister) may impose notification requirements upon the new activity. (see footnote 4) As the three substances have been determined to be harmful to human health, new activities associated with the three substances that have not been assessed are of potential concern. Therefore, the Minister published a Notice of intent in the Canada Gazette, Part I, on July 30, 2011, to inform stakeholders of the Minister’s intent to apply the SNAc provisions of CEPA 1999 to the three substances.
Current industry activities for the three substances
Diethyl sulfate is a synthetic organic chemical used as a processing aid in the manufacture of abrasive grinding tools and as a chemical intermediate in the paper industry in Canada. According to a survey published under section 71 of CEPA 1999 (section 71 survey), no Canadian companies reported manufacturing this substance in a quantity greater than or equal to the 100 kg threshold in 2006. However, approximately 1 000 kg of the substance were imported into Canada in the same reporting year.
Dimethyl sulfate is a synthetic chemical mainly used as an intermediate in the manufacture of pharmaceuticals in Canada. According to the section 71 survey, no Canadian companies reported manufacturing this substance in a quantity greater than or equal to the 100 kg threshold for the 2006 calendar year, though importation of approximately 1 000 kg was reported that year.
The substance TCEP has been used in a variety of industrial and commercial applications as a flame retardant in polyurethane foams, adhesives and coatings, and as a plasticizer in thermoplastic resins in Canada. According to the section 71 survey, no Canadian companies reported manufacturing TCEP in a quantity greater than or equal to the 100 kg reporting threshold in 2006. However, between 100 000 kg and 1 000 000 kg of TCEP were imported into Canada in the same reporting year. Subsequent information gathered from stakeholders who reported under section 71 survey indicated that both import and use of TCEP has ceased since 2010.
Current management actions in Canada
Diethyl sulfate is subject to the Consumer Chemicals and Containers Regulations, 2001, established under the Canada Consumer Product Safety Act,the Controlled Products Regulations established under the Hazardous Products Act, and the Vessel Pollution and Dangerous Chemicals Regulations under the Canada Shipping Act. In addition, the substance is subject to reporting requirements under the National Pollution Release Inventory and is also listed on Health Canada’s Cosmetic Ingredient Hotlist.
Dimethyl sulfate is subject to the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations. The substance is also subject to the same risk management actions noted above for diethyl sulfate.
Regulations were proposed under the Canada Consumer Product Safety Act to prohibit the import, manufacture, advertisement and sale of products intended for children under three years of age that are made in whole, or in part from foam that contains TCEP. (see footnote 5) The Province of British Columbia has TCEP standards for rural, urban and industrial soil levels, including a standard for drinking water.
Risk management actions in other jurisdictions
Diethyl sulfate and dimethyl sulfate are subject to various risk management actions internationally. In the United States, the two substances are subject to the Clean Air Act, under which they are listed as hazardous air pollutants. They are also listed as toxic substances under the California Safe Drinking Water and Toxic Enforcement Act.In the European Union (EU) and New Zealand, the presence of the two substances in cosmetics is prohibited. In Sweden, the two substances have been classified as phase-out substances, whereby the use of the two substances must be phased out of all products within a certain timeline. In Australia, there are regulations in place to prevent releases of the two substances from ships. Finally, occupational exposure limits and ambient air quality guidelines are applied by various international jurisdictions for dimethyl sulfate.
The substance TCEP is managed by various risk management actions across several jurisdictions. In the United States, TCEP is in the chemical inventory of the Toxic Substances Control Act, and has been identified as a high production volume chemical. In Australia, a standard for levels of TCEP in recycled water supplied for drinking purposes has been set up in the 2005 Schedule 3B Queensland Consolidated Regulations in the State of Queensland. In Europe, TCEP has been added to the Registration, Evaluation, authorization and Restriction of Chemicals (REACH) authorization list. (see footnote 6) Furthermore, the Scientific Committee on Health and Environmental Risks of the European Union concluded that the use of TCEP in toys for children should be avoided. TCEP is also listed on the environmental hazard list of the Nordic Council of Ministers.
Issues and objectives
The scientific assessments conducted by Health Canada and Environment Canada found that the three substances have the potential to cause cancer at any level of exposure and TCEP may cause certain non-cancer effects (e.g. impaired fertility). Therefore, it is concluded that the three substances may pose risks to human life or health and they have been added to Schedule 1 of CEPA 1999.
Current activities associated with the three substances are limited and those activities that could pose a danger to human health are being managed through existing measures or will be managed through proposed instruments. However, significant new activities in relation to the three substances that have not been assessed may result in increased risks to human health or the environment.
The objective of the Order is to contribute to the protection of human health by collecting information on significant new activities before they are undertaken. This will allow the Government of Canada to determine whether further risk management activities on the three substances are necessary.
Description
The Order deletes the three substances from Part 1 of the DSL, by removing their CAS registry numbers, adds them to Part 2 of the DSL, and indicates, by the addition of the letter S′ following the CAS registry numbers, that the three substances are subject to the SNAc provisions of CEPA 1999.
Any person that intends to import, use, or manufacture any of the three substances in quantities above 100 kg and in the manner(s) identified in the Order, is required to provide a notice to the Minister at least 180 days in advance of the intended use.
The submitted information will be assessed by Environment Canada and Health Canada within 180 days after it is received to assess the potential environmental and human health risks associated with a new or increased activity and to determine if such a new or increased activity requires further risk management actions.
Activities which are determined to be adequately managed by existing or anticipated risk management actions or are of low concern are exempted from the notification requirements. These exemptions are described in the Order.
The Order complements the existing risk management actions and will assist in managing potential risks associated with new or increased activities of the three substances.
The Order comes into force on the day on which it is registered.
Consultation
On July 30, 2011, a Notice of intent to amend the Domestic Substances List was published for a 60-day public comment period in the Canada Gazette, Part I. (see footnote 7)
The National Advisory Committee of CEPA 1999 (CEPA NAC) was given the opportunity to advise the ministers on the Notice of intent. No comments were received from CEPA NAC.
One submission from an industry stakeholder was received on the Notice of intent. All comments from this submission were considered in developing the Order. Below is a summary of the key comment received on the Notice of intent, as well as the response to it.
- The industry stakeholder commented that the current usage of diethyl sulfate in the paper industry should not be considered a significant new activity as the uses of diethyl sulfate in certain chemical reactions as a chemical intermediate had already been established.
Response: The use of the substance as a chemical intermediate is expressly excluded from the significant new activities being added in the Order. Therefore, using the substance as a chemical intermediate in the manufacture of paper products is not considered a significant new activity.
“One-for-One” Rule
The “One-for-One” Rule is not applicable to the Order. Current activities involving the three substances are exempted by the Order and there is no indication that industry’s current activity pattern associated with the three substances may change in the future. Therefore, no incremental administrative costs are expected to be incurred by businesses.
Small business lens
The small business lens does not apply to this Order as there are no expected impacts on industry or small business. Canadian companies are currently either using the substances below the threshold, or are not captured by the Order and there was no indication that current industrial activity patterns associated with the three substances will change in the future.
Rationale
The screening assessments found that the three substances have the potential to be harmful to human health, and had been added to Schedule 1 of CEPA 1999. For these substances, section 92 of CEPA 1999 requires the Minister to propose and publish in the Canada Gazette control instruments in relation to substances listed onto Schedule 1 of CEPA 1999.
Current activities associated with the three substances are limited and are either being managed by existing risk management actions or will be managed by proposed risk management actions. However, as the three substances are listed on Part 1 of the DSL, activities involving the three substances do not currently require notification and reporting to the Minister. Given the hazardous nature of these substances, future activities that have not been assessed may pose a risk to human health or the environment and may need to be managed, if appropriate. Therefore, maintaining the status quo as a risk management option has been rejected.
Modifying the DSL to apply the SNAc provisions allows the government to be informed of increased or new activities of the three substances. The submitted information will assist the Government of Canada in conducting risk assessments in relation to these activities and determining the potential for the substances to impact the environment and health of Canadians. This would allow the ministers to take appropriate risk management actions in relation to those risks. For these reasons, the ministers have determined that applying the SNAc provisions to the three substances is the preferred option.
The Order contributes to the protection of the environment and human health by restricting the manufacture, import and new use of the three substances until the new activity patterns of the substances are evaluated. The permitted activities, as set out in the Order, are expected to result in minimal exposure to the three substances. Therefore, the Order allows these activities to continue while ensuring significant new activities, as defined in the Order, are notified.
Should activities associated with the three substances occur at or above the specified threshold, costs for generating data and other information to be supplied to the Minister would be incurred unless the activity is exempted from the Order. As the cost for generating data is determined on a case-by-case basis, providing an estimate of the cost to industry to meet the notification requirements is not possible.
However, through consultations and comments received from the Notice of intent, it is expected that the Order will not impact industry. Companies are currently either using the substances below the threshold, or are not captured by the Order. There was no indication that their current activity patterns and activity quantities will change in the future.
In the event of notification, the Government of Canada will incur costs for processing the information in relation to the SNAc and for assessing potential health and environmental risks. Furthermore, the Government of Canada will incur costs to confirm compliance with the Order by conducting compliance promotion and enforcement activities. Annual costs associated with these activities are expected to be low, but cannot be accurately estimated given the lack of information regarding potential future activities.
In conclusion, although it was not possible to quantitatively estimate the benefits and costs, the overall impact of the Order is expected to be positive.
Implementation, enforcement and service standards
Implementation
The Order will come into force on the day on which it is registered. The compliance promotion activities to be conducted as part of the implementation of the Order will include developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.
Enforcement
The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy implemented under CEPA 1999. The Compliance and Enforcement 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 an enforcement officer discovers an alleged violation following an inspection or an investigation, 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 CEPA 1999.
- 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 CEPA 1999, 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 CEPA 1999.
Service standards
The Department will assess all information submitted as part of SNAc notification and will communicate the result to the notifier 180 days after the information is received.
Contacts
-
Greg Carreau
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca -
Michael Donohue
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@hc-sc.gc.ca
- Footnote a
SOR/94-311 - Footnote b
S.C. 1999, c. 33 - Footnote c
S.C. 1999, c. 33 - Footnote d
S.C. 1999, c. 33 - Footnote 1
SOR/94-311 - Footnote 2
Criteria set out under section 64 of CEPA 1999 are whethera substance 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.
- Footnote 3
The orders adding the three substances to Schedule 1 of CEPA 1999 can be found at http://canadagazette.gc.ca/rp-pr/p2/2011/2011-03-02/html/index-eng.html. - Footnote 4
As set out in section 80 of CEPA 1999, a significant new activity includes, in respect of a substance, any activity that results in or may result in (a) the entry or release of the substance into the environment in a quantity or concentration that is significantly greater than the quantity or concentration of the substance that previously entered or was released in to 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 are significantly different from the manner and circumstances in which the substance previously entered or was released in the environment or potential exposure of the environment to the substance. - Footnote 5
The Regulations amending Schedule 2 to the Canada Consumer Product Safety Act with respect to TCEP (Batch 5) were published in the Canada Gazette on November 10, 2012: www.gazette.gc.ca/rp-pr/p1/2012/2012-11-10/html/reg2-eng.html. - Footnote 6
According to REACH, the substances of very high concern on the authorization list will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization. - Footnote 7
www.gazette.gc.ca/rp-pr/p1/2011/2011-04-02/html/notice-avis-eng.html#d110