Vol. 145, No. 26 — December 21, 2011
SOR/2011-293 December 8, 2011
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2011-87-12-01 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 an assessment of each of those substances under either section 68 or 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);
Whereas the Ministers are satisfied that those substances are not being manufactured for commercial purposes 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 in that quantity 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 determine 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), hereby makes the annexed Order 2011-87-12-01 Amending the Domestic Substances List.
Gatineau, December 5, 2011
Minister of the Environment
ORDER 2011-87-12-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. Part 1 of the Domestic Substance 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.)
Issue and objectives
Scientific assessments conducted on four substances concluded that there is a probability of harm to human life or health at any level of exposure to these substances as they are found to be potentially carcinogenic to humans. The substances are
- Oxirane, methyl- (Chemical Abstracts Service Registry Number [CAS RN] 75-56-9), also known as Propylene Oxide and hereafter referred to as “methyloxirane”;
- Oxirane, ethyl (CAS RN 106-88-7), hereafter referred to as “ethyloxirane”;
- 1,2- benzenediol (CAS RN 120-80-9), hereafter referred to as “catechol”; and
- 1,4- benzenediol (CAS RN 123-31-9), hereafter referred to as “hydroquinone.”
The current uses associated with these substances (hereafter “the four substances”) are either being appropriately controlled through other statutes or are not of concern. However, significant new activities in relation to the four substances in the future may result in increased risks to human health or life. Therefore, the Order 2011-87-12-01 Amending the Domestic Substances List (the Order), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act) deletes the four substances currently listed on Part 1 of the Domestic Substances List (DSL), adds them to Part 2 of the DSL, and indicates the significant new activities (SNAcs) to which subsection 81(3) of CEPA 1999 applies with respect to these substances.
The Order prescribed the threshold quantities or concentration of the four substances used in specified applications over which notification shall be made to the Minister of the Environment (the Minister). In addition, any new use or activity beside those identified in the Order must be notified and the prescribed information submitted. The additional information that will be reported to Environment Canada will allow the assessment of the potential human health risks associated with any new activities before they are undertaken.
Description and rationale
Description of the Order
The Order deletes the substances methyloxirane, ethyloxirane, catechol and hydroquinone from Part 1 of the DSL, by deleting 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 four substances are subject to the SNAc provisions specified under subsection 81(3) of CEPA 1999.
Subsection 81(3) of CEPA 1999 prohibits any person to use, import or manufacture a substance for a significant new activity unless they provide the prescribed information to the Minister on the substance for which this subsection applies. With respect to the four substances, the complete list of prescribed information is described in the Order.
For any significant new activity, the Order requires the following information be provided to the Minister, at least 180 days prior to the commencement of the proposed new activity:
- (a) a description of the proposed significant new activity in relation to the substance;
- (b) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
- (c) the information specified in paragraphs 2(d) to (f), items 8 and 9 of Schedule 5 to those Regulations; and
- (d) the information specified in item 11 of Schedule 6 to those Regulations.
The submitted information will be assessed within 180 days after it is received by the Minister.
The Order is made under subsection 87(3) of CEPA 1999 and comes into force on the day on which it is registered.
In September 2006, a categorization exercise of the substances in the DSL was completed which resulted in the identification of approximately 4 300 chemicals needing further attention. Of these 4 300 chemicals, approximately 200 of them were identified as high priorities for action. Thus, information on their properties and use has been collected according to the “Challenge” initiative, which is a key element of the Chemicals Management Plan (see footnote 2) (the CMP) that was launched on December 8, 2006. These 200 high priority chemicals were divided into 12 batches of 10 to 20 chemicals each and were targeted for screening assessments. The four substances were among the 15 chemicals that were included in the first batch of the Challenge (Batch 1).
In 2007 and 2008, Health Canada and Environment Canada conducted screening assessments to determine whether any of the Batch 1 substances are toxic, as defined under section 64 of CEPA 1999. The screening assessments were finalized and published in the Canada Gazette, Part Ⅰ, on July 5, 2008.
With regard to the four substances, it is found that there is a probability of harm to human health at any level of exposure. The screening assessments concluded that the four substances may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Therefore, the four substances meet the criteria set out under paragraph 64(c) of CEPA 1999. An order adding these four substances to Schedule 1 of CEPA 1999 was published in Canada Gazette, Part Ⅱ, on May 12, 2010. (see footnote 3)
As the current uses associated with the four substances are either appropriately controlled through other statutes or are not of concern due to their current use patterns, future increases through the expansion of use are the main concern for risk management to protect human health and the environment. On July 3, 2010, the Minister published a Notice of Intent in the Canada Gazette, Part Ⅰ, to amend the DSL to propose that subsection 81(3) of the Act apply to the four substances. Under these provisions, industry would be required to notify the Minister of any proposed new manufacture, import or use of these substances in quantities greater than 100 kg per year, other than for those uses specifically excluded in the Order. Based on these notifications, Environment Canada and Health Canada would conduct further risk assessment and would determine the need for further risk management consideration. Comments received on the Notice of Intent were taken into account when developing the Order.
Current industry activities for the four substances
Methyloxirane is used mainly as a monomer in polymer production of polyether polyols. It may also be used in the manufacture of propylene glycol, as a starch-modifying agent in food, in potential food contact applications, resins, ink, and synthetic lubricants and in the automotive industry as a detergent additive and corrosion inhibitor in motor fuels, gasket removers, cleaners, petroleum defoamers, fuel additives and adhesives. This substance is also found in paint stripper. It is used for fumigation of dried fruit products and as a fumigant for bulk quantities of several food products such as cocoa, spices, processed nutmeats, starch and gum in the United States. It is also used as a stabilizer in benzyl chloride. Under information reported pursuant to section 71 of CEPA 1999 with respect to methyloxirane, no Canadian companies reported manufacturing this substance in a quantity greater than or equal to 100 kg in 2006. Canadian companies reported importing methyloxirane in a quantity greater than 10 000 000 kg for the 2006 calendar year. However, industrial use patterns have changed after a chemical company’s closure of its polyol plant which resulted in a reduction of imports by 99.9% since 2006.
Ethyloxirane is used principally as a stabilizer in industrial solvents that in turn are primarily used for vapour degreasing and ultrasonic and cleaning solvents. It is also used for secondary cleaning in the semiconductor industry, in the manufacture of automobile coatings, and in the production of other chemicals. According to information gathered under section 71 of CEPA 1999, ethyloxirane was reported to be imported into Canada in 2006 in a total quantity in the range of 10 000 to 100 000 kg.
Catechol is used as a component in photographic developer and in various applications (e.g. laboratory reagent, antioxidant in electroplating baths) that would not result in exposure to the general population. Under information reported pursuant to section 71 of CEPA 1999, the total quantity of catechol that was manufactured in or imported into Canada in 2006 ranged between 1 000 000 and 10 000 000 kg.
Hydroquinone is used in Canada as a polymerization inhibitor in unsaturated polyester and methylmethacrylate resin monomers; as a stabilizer in colourants and various types of industrial and consumer adhesives, thread lockers and thread sealants; as an additive to heat shrink tubing, restorative paste, bonding tape, film tape and liquid bandages; as a performance additive in sheetfed printing and heatset inks; and as a reducing agent in photographic developer. Based on information reported pursuant to section 71 of CEPA 1999, the total quantity of hydroquinone imported into Canada in 2006 was between 100 000 kg and 1 000 000 kg. No Canadian companies manufactured this substance in a quantity above 100 kg in Canada in 2006.
Current management actions in Canada
Methyloxirane and catechol are subject to the Controlled Products Regulations and the Hazardous Products Act, requiring ingredients on the Ingredient Disclosure List to be disclosed on the Material Safety Data Sheet; the Consumer Chemicals and Containers Regulations, 2001 established under the Canada Consumer Products Safety Act, requiring that products be classified against criteria based on short-term exposure situations, with the results determining the appropriate product labelling and packaging requirements; the Food and Drugs Act and Food and Drug Regulations with the objective of precluding human exposure in finished foods. In addition, catechol is on the Cosmetics Ingredients Hotlist and is subject to the Tobacco Reporting Regulations. Methyloxirane is also subject to the Environmental Emergency Regulations under CEPA 1999, requiring the development and testing of environmental emergency plans.
Ethyloxirane is subject to the Pest Control Products Act indicating that it is no longer used as a formulant in pesticides in Canada; it appears on the Cosmetic Ingredient Hotlist. In addition, the Province of British Columbia has established guidelines for the substance concentration at industrial, residential and agricultural sites as well as drinking water standards.
Hydroquinone is subject to the Food and Drug Regulations and the Natural Health Products Regulations under the Food and Drugs Act, when used in drugs or natural health products, respectively; the Controlled Products Regulations and the Hazardous Products Act, requiring ingredients on the Ingredient Disclosure List to be disclosed on the Material Safety Data Sheet; the Consumer Chemicals and Containers Regulations, 2001 established under the Canada Consumer Products Safety Act, requiring products to be classified against criteria based on short-term exposure situations, with the results determining the appropriate product labelling and packaging requirements; it appears on the Cosmetic Ingredient Hotlist and the Tobacco Reporting Regulations and is subject to the Pest Management Regulatory Agency (PMRA) List of Formulants.
Risk management actions in other jurisdictions
Various U.S. states have set 24-hour ambient air quality criteria guidelines for methyloxirane ranging from 6 to 30 µg/m3. Austria has an occupational daily average (8-hour) guideline of 6 mg/m3 in place.
Few countries appear to have guidelines in place for ethyloxirane. Under the National Model Regulations for the Control of Workplace Hazardous Substances, Australia has set occupational concentration cut-off levels associated with various health end-points ranging from 1% to 25%, at and above which ethyloxirane is classified as a hazardous substance. The United States also have various reporting requirements regarding ethyloxirane.
There are currently no international risk management measures in place for catechol and hydroquinone. However, the U.S. FDA has proposed a ban on over-the-counter sales of skin-lightening products containing hydroquinone. The intention is to restrict them only to prescription use under medical supervision. The rule was published for public comments on December 26, 2006. Additional studies have been underway since late 2009 to better assess the risk of hydroquinone to humans from over-the-counter skin-lightening products containing the substance.
The screening assessments found that methyloxirane, ethyloxirane, catechol and hydroquinone have the potential to be carcinogenic. These substances were added onto Schedule 1 of CEPA 1999. Section 92 of the Act requires the Minister to propose and publish in the Canada Gazette a control instrument in relation to a substance listed onto Schedule 1.
Furthermore, the four substances are currently listed on Part 1 of the DSL. If no further risk management activities are undertaken, these substances could be used for any activity and in any quantity without any requirement to report to the Minister. Given the toxic nature of these substances, allowing widespread future use without government review would pose a risk to human health.
For these reasons, maintaining the status quo has been rejected.
Given that these substances may pose a risk at any level of exposure, developing a regulation prohibiting any manufacture, import or use of these substances was considered. The current uses associated with these substances either are being appropriately controlled through other statutes or are not of concern. However, new or significant uses of the four substances in the future may result in increased risks to human health or life. Considering that current use pattern combined with current risk management with regard to these substances lowers the concerns adequately, a prohibition would unduly create economic losses for producers and importers of these substances as well as end users of products containing these substances.
Another approach examined would be to prohibit all future uses, while providing an exemption for current ones. This would prevent widespread use of these substances in the future, without imposing any costs on current manufacturers and importers of these substances or products containing them. The risk management objective in the case of the four substances is to limit new uses or increased volumes of current uses until an assessment is conducted on use patterns and potential increased exposure of the Canadian population. Prohibition of a substance with exemption may not be appropriate and would not allow data collection and assessment of the new usages or increased usage of current levels of the substance.
For these reasons, regulations did not present themselves as efficient control measures and they were not considered any further.
Modifying the DSL to apply SNAc provisions allows the Government to be informed of increased or new uses of the substances. The submitted information will assist the Government in conducting risk assessment in relation to these uses and the potential for the substances to impact the environment and health of Canadians. The design of the Order minimizes impacts on industry by allowing prescribed uses and provides the flexibility to take appropriate risk management action towards future uses or changes in the use patterns if they are found to pose a risk to human health or the environment.
For these reasons, the Government has determined that applying SNAc provisions to the four substances is the preferred option for managing the health risks that they pose.
Benefits and costs
Amending the DSL to apply the relevant SNAc provisions to the four substances has several benefits.
The Order contributes to the protection of human health by limiting manufacture, import and new use of substances until the expected new use patterns and use quantities of the substance are evaluated. The permitted uses, as set out in the Order, are not of concern to human health or the environment. Therefore, the Order allows these uses to continue while ensuring any increased or new use is notified. Information submitted as per the requirements of the Order will allow the Government to evaluate the potential harm to human health and the environment and ensure that future uses do not significantly increase the risk to human health or the environment.
The Order provides flexibility to both industry and the Government. Subject to the requirements of the Order and assessment results, industry may be able to use these substances in new applications and supply their products on the market provided it does not unduly increase the risk to human health or the environment. It is therefore expected that economic and social benefits can be realized in the future while still being protective to human health and the environment. Due to lack of information regarding potential future uses these benefits cannot be estimated.
Persons that are currently using or importing for use any of the four substances at or below the specified thresholds will not incur any cost as a result of the Order. Thus, the Order will have no negative impact on these businesses. However, in the event that a person wishes to use, import or manufacture any of the four substances for a new use or for an existing use in quantities above the prescribed thresholds, the information referred to in the Order will need to be provided and that person will incur the associated notification cost. Given that the effort to provide the information is administrative in nature, the associated cost is expected to be negligible for that person. It is not possible to make reliable assumptions of future decisions of current users, nor is it possible to accurately estimate the level of future uses and associated notifications. As a result, providing a total estimate of cost to industry to meet the notification requirements was not possible.
Additionally, the requirement that information be submitted to Government 180 days before any new activity commences may result in lost opportunities or costs to some companies beyond the administrative costs of submitting the required information. For example, if new products containing any of these substances are ready or nearly ready to go into commerce at the time the Order is published, the company will have to delay marketing of the product, submit the required information to the Minister and wait for a decision. This 180-day waiting period will likely result in lost revenue for the company. While delaying the launch of a new product for 6 months would not necessarily result in large financial loses in all cases, the losses could be significant in some situations. So, the impact of delaying to buy or sell materials and final products containing these substances may be non-trivial to industry if such a delay results in a financial loss or a market share loss relative to international competitors who are not subject to the same time restrictions. Since it is not possible to predict what, if any, new activities may be proposed in the short term, it is not currently possible to estimate the impact (opportunity costs) that may result from the 180-day waiting requirement under this instrument.
In the event of notification, the Government will incur costs for processing the information in relation to the SNAc and for assessing potential health and environmental risks. These costs are not expected to be significant and will be covered as part of the basic operating expenses of Environment Canada and Health Canada.
Furthermore, the Government will incur costs to ensure compliance with the Order by conducting compliance promotion and enforcement activities. With respect to incremental enforcement costs, a one-time amount of $53,000 would be required for training of enforcement officers. Annual costs for inspections, investigations, measures to deal with alleged violations and prosecutions would be expected to be low, but cannot be accurately estimated given the lack of information regarding potential future uses. Compliance promotion activities would also be conducted to encourage the targeted community to comply with the Order. Compliance promotion activities could include mailing out of the Order, developing and distributing promotional materials (such as a fact sheet and Web material), attendance and presentations at trade association conferences or workshops and responding to and tracking inquiries. The associated incremental cost is estimated at $25,000 for the first year of implementation of the Order, with an additional annual budget of $6,000 for subsequent years. It should be noted that the intensity and level of effort associated with compliance promotion and enforcement activities may change when compliance analyses are completed or if unforeseen challenges with respect to compliance arise.
In conclusion, the Order will not lead to any incremental cost to current users or importers of the four substances if the current use pattern is maintained. However, industry may incur a small cost to notify increase or new uses. The Government will incur negligible cost to raise awareness and ensure compliance with the Order. On the other hand, the Order will ensure the health of Canadians is protected by preventing exposure to these substances and ensure appropriate government interventions. Although it was not possible to quantitatively estimate the benefits, they are expected to exceed the costs.
On July 3, 2010, a Notice of intent to amend the Domestic Substances List under subsection 87(3) of the CEPA 1999 to indicate that subsection 81(3) of the Act applies to methyloxirane, ethyloxirane, catechol and hydroquinone was published for a 60-day public comment period in the Canada Gazette, Part Ⅰ.
Several comments were received from industry on the Notice of intent. The comments received pertained to two of the listed substances — methyloxirane and hydroquinone. All comments were considered in developing the final Order.
The CEPA National Advisory Committee (NAC) was given the opportunity to advise the Ministers on the scientific evidence supporting the declaration of these substances as being harmful to human health or life, as well as on the Notice of intent. No comments were received from CEPA NAC.
Below is a summary of the key comments received on the Notice of Intent, as well as their responses. The comments received on the Notice of Intent and the complete responses to them are available on the Chemical Substances Web site: www. chemicalsubstances.gc.ca/challenge/batch-1/index-eng.php.
- One industry stakeholder commented that it is not clear if the intent or structure of the SNAc is to be applied to incidental, contamination or residual presence of a substance because the proposed exceptions listed are for intentional uses with one unintentional use.
Response: Paragraph 81(6)(c) of the SNAc provisions in CEPA 1999 states that these provisions do not apply to impurities, contaminants and partially unreacted materials, the formation of which is related to the preparation of a substance. An otherwise unintentional generation of a substance may be excluded from the application of a SNAc because it has been assessed.
- One industry stakeholder commented that data requirements for each substance in the Notice may need to be reviewed for appropriateness, and it should be clarified whether industries may request a waiver if the new activity is such that industries are unable to generate certain data as outlined in the data requirement portion of the SNAc.
Response: The data requests have been tailored to meet the needs of risk assessments should a notification of a SNAc be received. Due to the informational history in existence for these substances, the data requirements for the SNAcs were designed to specifically outline the new activity and allow the Government to determine if the exposure scenario increases the risk to human health or the environment.
If stakeholders have questions regarding the data requirements for a specific significant new activity that they wish to propose, then stakeholders are invited to contact Environment Canada for further advice regarding specific requirements for the case in question.
- One industry stakeholder commented that industries need a confirmation as to whether they are able to import products in the future if an activity not currently in commerce in Canada is described as a new activity in the Order.
Response: The SNAcs apply to the manufacture, use and import of a substance. If the products intended for import have the substance in them, they may be subject to the SNAc provisions and may require notification. If the import of the substance for use has not been assessed for risk by the Government, the stakeholder responsible for this use will need to submit the required data 180 days before the commencement of the activity. The Government will then assess whether the new activity increases the risk of exposure to the substance and if risk management is necessary.
- One industry stakeholder requested that a line be added to the Order which excludes research and development using these substances from notification requirements.
Response: Exclusions from a SNAc notice are considered on a case-by-case basis to tailor the instrument to the specific substance and exposure scenarios in question. Research and development activities are captured under “any activity” in this SNAc notice. Due to the toxicity of these substances, further assessment of potential risks from any new activity is needed to ensure protection of human health and the environment.
- One industry stakeholder indicated an additional existing use of methyloxirane as a stabilizer in benzyl chloride.
Response: The information provided indicates that the use of methyloxirane as a stabilizer in benzyl chloride should be deemed an existing activity. Furthermore, this activity has been reviewed and is not expected to be a significant contributor to the releases of or exposure to methyloxirane. This activity has been added to the SNAc Order as an exclusion.
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 the Act. The Compliance and Enforcement 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 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 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.
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
Information on the Chemical Management Plan can be viewed at www.chemicalsubstanceschimiques.gc.ca/index-eng.php.