Vol. 146, No. 21 — October 10, 2012
SOR/2012-175 September 20, 2012
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2012-87-06-01 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 substance ethanol, 2-methoxy-, acetate 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;
Whereas the Ministers are satisfied that the substance ethanol, 2-(2-methoxyethoxy)- is not being manufactured in Canada by any person in a quantity of more than 100 kg in any one calendar year and is 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 2-naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- is only being manufactured in or imported into Canada by any person in a quantity of more than 100 kg in any one calendar year for a limited number of uses;
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 2012-87-06-01 Amending the Domestic Substances List.
Gatineau, September 19, 2012
Minister of the Environment
ORDER 2012-87-06-01 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:
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.)
On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to manage chemicals that are 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 that are the subject of this Order (hereafter “the three substances”) are among the 18 chemicals that were included in batch three of the Challenge and are listed below:
- Ethanol, 2-methoxy-, acetate (Chemical Abstracts Service [CAS] Registry No. 110-49-6), hereafter referred to as “2-MEA”;
- Ethanol, 2-(2-methoxyethoxy)- (CAS Registry No. 111-77-3), hereafter referred to as “DEGME”; and
- 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- (CAS Registry No. 2425-85-6), hereafter referred to as “Pigment Red 3.”
Health Canada and Environment Canada conducted screening assessments to determine whether any of the substances in batch three meet any of the criteria specified under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). (see footnote 2) The summaries of screening assessments were published in the Canada Gazette, Part Ⅰ, on March 7, 2009. The screening assessments concluded that the three substances meet the criteria set out in paragraph 64(c) of CEPA 1999; that is, they are potentially harmful to human health. An order adding the three substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part Ⅱ, on February 16, 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 be conducted by industry without an obligation to notify the Government of Canada. When the Government of Canada is concerned that a significant new activity in relation to a substance may result in this substance becoming harmful to human health or the environment, the Minister of the Environment (Minister) may impose notification requirements upon the new activity. (see footnote 4) The Minister of the Environment and the Minister of Health (ministers) will assess the submitted information to determine whether the proposed new activity may result in the substance being harmful or capable of becoming harmful to human health or the environment. Amending the DSL to apply the SNAc provisions of CEPA 1999 to a substance will complement existing risk management measures and ensure that future activities are subject to further assessment.
To inform stakeholders of the Minister’s intent to apply the SNAc provisions of CEPA 1999, the Minister published on April 2, 2011, a Notice of Intent in the Canada Gazette, Part Ⅰ, proposing to amend the DSL to ensure that the SNAc provisions of CEPA 1999 are applied to the three substances.
Current industry activities for the three substances
There are currently no known activities involving 2-MEA in Canada. According to the information received from a survey published pursuant to section 71 of CEPA 1999 (section 71 survey), 2-MEA was not manufactured in or imported into Canada in a quantity greater than the reporting threshold of 100 kg in 2006. However, some importation below the threshold was reported for the same reporting year. Activities associated with 2-MEA have been phased out in recent years.
DEGME is mainly used as an additive in aviation fuel (though releases from this source are estimated to be low), an additive in diesel fuel and biodiesel, and a formulant in pest control products for various applications, particularly in the pulp and paper industry. It is used in floor finishes, in various cleaners and degreasers, in paints and paint removers, and in some hairsprays, skin creams and cleansers, and is a fragrance ingredient. In addition, this substance may be used as a solvent in the manufacture of inks and metal can end coatings used in food contact applications. Historically, it has been used in cleaners used in the food industry. According to a section 71 survey, no Canadian companies reported manufacturing the substance in a quantity greater than or equal to the 100 kg threshold in 2006. However, between 1 000 000 and 10 000 000 kg of the substance were imported into Canada in the same reporting year.
Pigment Red 3 is currently used in paints for both interior and exterior applications, including anti-rust proofing, in plastics, printing inks, textiles and polyurethane coatings. Industrial applications include manufactured or imported industrial paints for use on metal tools or equipment, plastic compounding, plastic coloration and the manufacture of industrial printing inks. There are also limited uses of this substance in cosmetic products. According to a section 71 survey, one company manufactured the substance in a quantity ranging from 100 000 to 1 000 000 kg in 2006. However, of that quantity, all but 30 000 to 50 000 kg were exported. Furthermore, seven companies imported a total of 10 000 to 100 000 kg into Canada and nine companies used approximately 40 000 kg in Canada.
Current management actions in Canada
The three substances are all listed on Health Canada’s Cosmetic Ingredient Hotlist, which is an administrative tool to communicate to manufacturers and others that certain substances, when used in a cosmetic, may cause injury to the health of the user in contravention of section 16 of the Food and Drugs Act.
The substance 2-MEA is subject to reporting under the National Pollutant Release Inventory. Furthermore, Pigment Red 3 and DEGME are both on List 2 of the Pest Control Products Act (PCPA) List of Formulants, a list of formulants potentially of concern with high priority for reassessment. (see footnote 5)
Products containing DEGME are subject to the Consumer Chemicals and Containers Regulations, 2001 established under the Canada Consumer Product Safety Act. These Regulations require that chemical products be classified against criteria based on short-term exposure situations, with the results determining the appropriate product labelling and packaging requirements. Also, as a volatile organic compound, applicable products containing DEGME may be impacted by the Volatile Organic Compound (VOC) Concentration Limits for Architectural Coatings Regulations and the Volatile Organic Compound (VOC) Concentration Limits for Automotive Refinishing Products Regulations. In Ontario, there are guidelines for the maximum level of DEGME in the air, such as point of impingement guidelines and ambient air quality criteria. In addition, a concentration limit on DEGME in surface coating materials has been proposed by Health Canada for consultation. (see footnote 6)
Risk management actions in other international jurisdictions
In the European Union, the use of 2-MEA in cosmetic products is prohibited, while in the United States, this substance is subject to the New Source Performance Standard and National Emission Standard for Hazardous Air Pollutants under the Clean Air Act; and the Significant New Use Rule under the Toxic Substances Control Act (TSCA).
In the European Union, DEGME is prohibited in cosmetics, and a maximum concentration of 0.1% DEGME is allowed in consumer paints, paint strippers, cleaning agents, self-shining emulsions or floor sealants. (see footnote 7) (see footnote 8) The Netherlands has established maximum permissible limits for total intake of DEGME in food and water, and drinking water. In the United States, DEGME is listed as an inert ingredient in non-food-use pesticides under the U.S. Federal Insecticide, Fungicide and Rodenticide Act as well as on the TSCA Inventory. As a VOC, DEGME may be subject to the US EPA National Volatile Organic Compound Emission Standards for Consumer and Commercial Products under the Clean Air Act, the Ozone Transport Commission Model Rule, and the California Air Resources Board regulations prescribing VOC content limits for antiperspirants, deodorants and consumer products.
Use of Pigment Red 3 is prohibited in cosmetics in the United States. In Europe, the substance is allowed exclusively in cosmetic products intended to have only brief contact with the skin. (see footnote 9)
On the basis of developmental and reproductive effects for 2-MEA and DEGME, combined with the potential for general population exposure, the scientific assessment concluded that these two substances were harmful to human health. Based on carcinogenicity of Pigment Red 3, combined with the potential for general population exposure, the scientific assessment concluded that this substance was harmful to human health. As a result, the three substances were added to Schedule 1 of CEPA 1999.
Current activities associated with the three substances that could pose a risk to human health are either phased out or being managed through existing measures, resulting in low exposure. An additional measure is also being proposed for DEGME, as discussed earlier. However, significant new activities in relation to the three substances may result in increased risks to the environment and human health and should therefore undergo assessment.
The objective of the Order is to contribute to the protection of human health and the environment by collecting information on significant new activities associated with the three substances. This will allow the Government of Canada to determine whether further risk management measures on the three substances are necessary.
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.
The Order requires any person that intends to import/use/ manufacture any of the three substances above the threshold of 100 kg per year to provide a notice to the Minister 180 days in advance, unless the activity is exempted. The Order outlines the information requirements, including a description of the new activities.
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 consideration.
Activities which were 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 uses of the three substances.
The Order comes into force on the day on which it is registered.
On April 2, 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 10)
The National Advisory Committee of CEPA 1999 (CEPA NAC) was given the opportunity to advise the Minister of Environment and the Minister of Health (ministers) on the scientific evidence in support of the screening assessment conclusions, as well as on the Notice of Intent. No comments were received from CEPA NAC.
Three submissions from industry stakeholders and one submission from an industry association were received on the Notice of Intent. Among them, one industry stakeholder strongly supports the use of the SNAc provisions. All comments were considered in developing the final Order. Below is a summary of the views raised on the Notice of Intent for the three substances, as well as responses to them.
- One industry stakeholder recommended that the provisions of SNAcs be aligned with the New Substances Notification Regulations (NSNR) to facilitate stakeholders’ response.
Response: The use of the SNAc provisions under CEPA 1999 for substances placed on Schedule 1 has been aligned with the NSNR as much as possible, while still maintaining an ability to tailor the SNAc Order to the substances in question. When identifying the information required to assess a Significant New Activity Notification, the reference to the Schedules of the NSNR is intended to provide predictability to industry.
- One industry stakeholder commented that the logic and criteria used by government for granting exemptions are not explained sufficiently.
Response: The Government was made aware of the various activities undertaken with substances through the section 71 survey submissions for each of the batches in the Challenge, as well as through additional stakeholder engagement, research studies, and public comments received during the 60-day comment period on the Notice of Intent to apply the SNAc provisions. Where activities will be adequately managed through existing or planned actions, or they pose a low concern to human health or the environment, an exemption can be made for these known activities to ensure the SNAc provisions do not impede the activities.
- One industry stakeholder commented that notification of use of Pigment Red 3 in new cosmetic or children’s products is a sound risk management approach if there is no unnecessary disruption of commerce for the commercial paint, plastic and ink industries.
Response: The exclusions provided for Pigment Red 3 were developed in recognition of the current uses of the substance which are considered to be adequately managed through existing or planned actions, or otherwise pose a low concern to human health or the environment. Therefore, any new activity is required to be reported to the Government for assessment and potential additional risk management.
- One industry stakeholder and one industry association commented that the definition of “enamel” to be used in the Order should be clarified when determining the exclusions of existing activities in the SNAc Order.
Response: The Government was made aware of the various activities undertaken with substances through the section 71 survey submissions for each of the batches in the Challenge, as well as through additional stakeholder engagement and studies. The definition of “enamel” as outlined by the ASTM D16-11 “Standard Terminology for Paint, Related Coatings, Materials and Applications” is adequate to identify the enamels which are excluded from the definition of a significant new activity. (see footnote 11)
The screening assessments found that the three substances constitute or may constitute a danger to human health. As a result, the three substances were added to Schedule 1 of CEPA 1999. Section 92 of CEPA 1999 requires the Minister to propose and publish in the Canada Gazette preventive or control instruments in relation to substances listed onto Schedule 1 of CEPA 1999.
The three substances are either currently being managed or intended to be managed for risks associated with their existing activities. However, as the three substances are listed on Part 1 of the DSL, activities involving the three substances do not require notification and reporting to the Minister. Given the hazardous nature of these substances, future uses without government review may pose a risk to human health and the environment. If future activities are not assessed, the risks associated with these activities cannot be managed appropriately. 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 uses 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 the 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 best option.
The Order contributes to the protection of the environment and human health by restricting manufacture, import and new use of the three substances until the new activity patterns are evaluated. The permitted activities, as set out in the Order, are subject to other planned actions or are expected to result in a low exposure to the three substances. Therefore, the Order allows these activities to continue while ensuring any increased or new activities are reported.
Companies that are currently using or importing the three substances below the specified threshold will not be impacted as a result of the Order. Should non-exempted 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. 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, companies either are currently manufacturing, using, or importing the substances below the threshold, or are not captured by the Order. Nor was there an indication that their current activity patterns and activity quantities will change in the future. Therefore, the Order is not expected to impact industry, including small business.
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 ensure 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.
7. Implementation, enforcement and service standards
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.
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 cost 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.
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.
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)
Risk Management Bureau
S.C. 1999, c. 33
S.C. 1999, c. 33
S.C. 1999, c. 33
Criteria set out under section 64 of CEPA 1999 are to determine whether a 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 envi-ronment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life de-pends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
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 of 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.
A formulant is any component of a pest control product that is added intentionally to the product and that is not an active ingredient.
A consultation document on this proposed regulatory action was published for public comment in 2011: www.hc-sc.gc.ca/cps-spc/legislation/consultation/_2011degme/index-eng.php.
DEGME is on Annex I of the Directive 76/769/EEC.
The concentration limit is as per Decision 1348/2008/EC.
This prohibition is as per Council Directive 76/768/EEC, Annex IV, PartI.
The Notice of Intent can be found at http://gazette.gc.ca/rp-pr/p1/2011/2011-04-02/html/notice-avis-eng.html#d110.