Vol. 148, No. 2 — January 15, 2014
Registration
SOR/2013-258 December 24, 2013
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2013-87-11-01 Amending the Domestic Substances List
Whereas the substances set out in the annexed Order are specified on the Domestic Substances List (see footnote a);
Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and on July 31, 2010 released, for a 60-day public comment period, proposed risk management approaches in which the risk management objective is to prevent increases in exposure to those substances, and a consultation document on changes to the proposed risk management approach for Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1- methylpropyl)- was published on December 21, 2011 by Environment Canada in which the risk management objective is to minimize releases of this substance to water and soil to the greatest extent practicable;
Whereas the Ministers are satisfied that the substances Propane, 2-nitro-, Benzene, 1-methyl-2-nitro-, Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- and Methylium, [4(dimethylamino)phenyl]bis[4-(ethylamino)-3-methylphenyl]-, acetate are, in any one calendar year, not being manufactured in Canada by any person in a quantity of more than 100 kg and are only being imported into Canada by any person in that quantity for a limited number of uses;
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);
And whereas, pursuant to section 91 of the Canadian Environmental Protection Act, 1999 (see footnote d), a notice of intent to amend the Domestic Substances List (see footnote e) to apply the significant new activity provisions was published in the Canada Gazette, Part I, on July 28, 2012, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the notice;
Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote f), makes the annexed Order 2013-87-11-01 Amending the Domestic Substances List.
Gatineau, December 16, 2013
LEONA AGLUKKAQ
Minister of the Environment
ORDER 2013-87-11-01 AMENDING THE DOMESTIC SUBSTANCES LIST
AMENDMENTS
1. Part 1 of the Domestic Substance List (see footnote 1) is amended by deleting the following:
- 79-46-9
- 88-72-2
- 17540-75-9
- 72102-55-7
2. Part 2 of the List is amended by adding the following in numerical order:
| Column 1 |
Column 2 |
|---|---|
79-46-9 S′ |
|
88-72-2 S′ |
|
17540-75-9 S′ |
|
72102-55-7 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.)
Issues
Screening assessments for four substances were conducted to determine if they have the potential to be harmful to human health or the environment. The substances are
- Propane, 2-nitro- (Chemical Abstracts Service [CAS] Registry No. 79-46-9), hereafter referred to as “2-nitropropane”;
- Benzene, 1-methyl-2-nitro- (CAS Registry No. 88-72-2), hereafter referred to as “2-nitrotoluene”;
- Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- (CAS Registry No. 17540-75-9), hereafter referred to as “DTBSBP”; and
- Methylium, [4- dimethylamino) phenyl] bis [4-(ethylamino)-3-methylphenyl]-, acetate (CAS Registry No. 72102-55-7), hereafter referred to as “MAPBAP acetate.”
The screening assessments concluded that 2-nitropropane and 2-nitrotoluene are harmful to human health based on their carcinogenicity, and that DTBSBP and MAPBAP acetate may have harmful effects on the environment as they could pose risks to aquatic organisms. MAPBAP acetate was concluded to be harmful to the environment; however, potential human health concerns were also identified.
Current activities associated with the four substances are being managed through existing measures, will be managed through proposed measures, or are of minimal exposure concern. While current activities are not expected to pose undue risks to human health or the environment, given the hazardous properties of these four substances, new or increased activities may pose a risk to human health or the environment. Therefore, the Minister of the Environment (the Minister) is applying the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to these substances. (see footnote 2)
Background
On December 8, 2006, the Chemicals Management Plan (CMP) was launched 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 approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each. The 4 substances, 2-nitropropane, 2-nitrotoluene, DTBSBP and MAPBAP acetate, are among the 14 chemicals that were included in batch eight of the Challenge.
Environment Canada and Health Canada conducted screening assessments to determine whether any of the substances in batch eight are toxic as defined under section 64 of CEPA 1999. According to the summary of the screening assessments, published in the Canada Gazette, Part I, on July 31, 2010, 2-nitropropane and 2-nitrotoluene constitute a danger to human health and meet the criteria as set out in paragraph 64(c) of CEPA 1999, while DTBSBP and MAPBAP acetate may have an immediate or long-term harmful effect on the environment and meet the criteria as set out in paragraph 64(a) of CEPA 1999. (see footnote 3) An order adding the four substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II, on March 28, 2012, to enable the development of risk management instruments to manage the risks associated with the four substances. (see footnote 4)
SNAc provisions of CEPA 1999
Given that the four substances are listed on the Domestic Substances List (DSL), activities associated with them can be conducted by industry without obligation to notify the Government of Canada unless they are subject to other notification requirements. When the Government of Canada is concerned that any significant new activity in relation to a substance may result in an increased risk to human health or the environment, the Minister may impose notification requirements on significant new activities associated with the substance. As it has been concluded that the four substances are harmful to human health or the environment, new or increased activities involving them may be a source of concern. Therefore, the previous minister published a notice of intent in the Canada Gazette, Part I, on July 28, 2012, to inform stakeholders of his intent to apply the SNAc provisions of CEPA 1999 to the four substances.
SNAc provisions do not apply to a substance that is manufactured or imported for a use regulated under the Pest Control Products Act, the Fertilizers Act, or the Feeds Act, which are listed in Schedule 2 of CEPA 1999. Also, as described in paragraphs 81(6)(b) and (c) of CEPA 1999, the SNAc provisions do not apply, in some circumstances, to a substance’s transient reaction intermediates, impurities, or when it undergoes a chemical reaction. Finally, as described in section 3 of CEPA 1999, SNAc provisions do not apply in some circumstances to wastes, mixtures or manufactured items. (see footnote 5)
Current industry activities and risk management actions
2-nitropropane
The substance is used in industrial adhesives and is present in certain materials destined for hazardous waste disposal, in which case human exposure is not expected. Although 2-nitropropane is permitted for use in processing vegetable oils intended for human consumption, this use has not been reported in Canada.
According to submissions to a survey made under section 71 of CEPA 1999, 2-nitropropane was not manufactured in a quantity greater than 100 kg (the minimum threshold for reporting) during the 2006 calendar year, but between 100 and 1 000 kg of the substance were imported into Canada.
In Canada, 2-nitropropane is subject to the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations under CEPA 1999. The substance is also managed by Division 23 of the Food and Drug Regulations, which controls the safety of all materials used for packaging foods. Health Canada is in the process of removing it from the List of Permitted Carrier or Extraction Solvents. Once the substance is de-listed, its addition in vegetable oils for sale in Canada will no longer be permitted. The substance is also subject to reporting requirements under the National Pollutant Release Inventory.
Internationally, 2-nitropropane is prohibited in cosmetic products in the European Union (EU). In the United States (U.S.), the substance is listed by the U.S. Food and Drug Administration as a food contact substance, which is subject to section 175.105, Title 21 of the Code of Federal Regulations. The Joint Food and Agriculture Organization of the United Nations and the World Health Organization (FAO/WHO) Expert Committee on Food Additives have not accepted this substance as a solvent in the production of fats and oils since 1989.
2-nitrotoluene
The majority of 2-nitrotoluene currently used in Canada is for the manufacturing of explosives.
According to submissions to a section 71 survey, this substance was not manufactured in a quantity greater than 100 kg during the 2006 calendar year, but between 100 and 1 000 kg of the substance were imported and used in Canada.
In Canada, 2-nitrotoluene is listed on Schedule 1 of the Vessel Pollution and Dangerous Chemicals Regulations as part of the Canada Shipping Act, 2001 and on Schedule 1 of the Transportation of Dangerous Goods Regulations. In British Columbia, the substance is listed on Schedule 10 and Schedule 11 of the Contaminated Sites Regulations, which require that quantities and concentrations of the substance for industrial and commercial uses meet certain environmental standards. In Ontario, the substance is on the Jurisdictional Screening Level (JSL) List, developed to provide an additional screening tool for managing local air quality in Ontario.
Internationally, 2-nitrotoluene is prohibited in cosmetic products in the EU. In the United States, the substance is subject to reporting requirements under part 302 of the Comprehensive Environmental Response, Compensation, and Liability Act. Also, the substance is subject to the Texas Risk Reduction Program and was added to the list of chemicals known to cause cancer or birth defects or other reproductive harm published annually under the Safe Drinking Water and Toxic Enforcement Act of 1986 by the State of California.
DTBSBP
DTBSBP was reported to be used in plastics product manufacturing (primarily urethane and other foam products, except polystyrene). However, this use was discontinued in March 2012. DTBSBP was also reported as being used in brake fluid at low concentrations as an antioxidant/corrosion inhibitor. However, work by industry is underway to phase out the importation of DTBSBP for use in brake fluids. Two confidential uses of DTBSBP in Canada were reported. One use was reported in quantities below 100 kg per year. The other confidential use was reported in quantities above 100 kg per year, but this use has been discontinued according to information available to Environment Canada after 2006.
According to submissions to section 71 surveys, DTBSBP was not manufactured in a quantity greater than 100 kg in 2005 and 2006 calendar years. However, between 1 000 and 100 000 kg of the substance were imported into Canada in 2005. Approximately 17 000 kg of the substance were imported into Canada in 2006.
In Canada, there are no existing control measures related specifically to DTBSBP. The substance, however, is captured at both the federal and provincial/territorial levels by existing risk management measures related to the management of hazardous and non-hazardous wastes and recyclable materials, including used oils, where DTBSBP may be found. In addition, the Government of Canada will continue to monitor the complete phase-out of the importation of DTBSBP for use in brake fluids.
Internationally, in the U.S., DTBSBP is included in the Toxic Substances Control Act inventory and has been identified as a High Production Volume (HPV) chemical under the Environmental Protection Agency’s HPV Challenge Program. Also, the substance is listed as a food contact substance subject to the Code of Federal Regulations, Title 21, section 175.105. In the EU, DTBSBP is considered hazardous as per the Safety Data Sheets Directive, and there is no authorized use in plant protection products. The substance is also included on the Oslo-Paris (OSPAR) Commission’s List of Substances of Possible Concern. (see footnote 6)
MAPBAP acetate
The substance is used as a dye, mainly in the production of wood, pulp or paper products.
According to submissions to section 71 surveys, MAPBAP acetate was not manufactured in a quantity greater than 100 kg for the 2005 and 2006 calendar years. However, between 10 000 and 100 000 kg of the substance were imported into Canada in 2005. In 2006, between 10 000 to 100 000 kg of the substance were imported into and used in Canada. In March 2012, an additional use was identified as an industrial dye for professionally applied polyurethane insulation.
In Canada, the proposed Guidelines for the Reduction of Dyes Released from Pulp and Paper Mills under CEPA 1999, which were published in the Canada Gazette, Part I, on July 14, 2012, will target the reduction of the levels of MAPBAP acetate released from pulp and paper mills. In addition, the Pulp and Paper Effluent Regulations under the Fisheries Act, which require wastewater treatment, may provide a co-benefit in removing MAPBAP acetate from effluent.
In the United States, MAPBAP acetate is listed in the U.S. Environmental Protection Agency’s “Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products” and in the Toxic Substances Control Act chemical inventory. In New Zealand, the substance is listed in the New Zealand Inventory of Chemicals. The inventory states that MAPBAP acetate may be used as a component in a product covered by a group standard but it is not approved for use as an individual chemical.
Objectives
The objective of the Order is to contribute to the protection of the environment and human health by collecting information on significant new activities associated with the four substances before they are undertaken. The information collected will assist the Government of Canada in further assessing the potential human or environmental risks associated with the substances and in determining whether additional risk management activities may be necessary.
Description
The Order deletes the four 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 four substances are subject to the SNAc provisions of CEPA 1999.
The Order requires any person intending to import, use, or manufacture any of the four substances above the threshold of 100 kg in any calendar year to provide a notification to the Minister of the Environment 180 days in advance, unless the activity is exempted from the notification requirements of the Order. The Order outlines the information to be provided to the Minister.
Following the publication of the notice of intent and upon consideration of new information, definitions of significant new activities for 2-nitropropane and MAPBAP acetate were modified to clarify that the exclusions apply to industrial applications when the substances are not used in consumer products, as defined in section 2 of the Canada Consumer Product Safety Act.
This Order does not constitute an endorsement from the Government of Canada of the substances to which it relates, the activities involving the substances, or an exemption from any other act or regulation in force in Canada to which those substances may be subject.
Environment Canada and Health Canada will use the submitted information to conduct human health and environmental assessments within 180 days after it is received. Activities that are anticipated to be of minimal concern are exempt from the notification requirements. These exemptions are described in the Order.
The Order complements the existing and proposed risk management actions and will assist in managing potential risks associated with significant new activities involving the four substances.
The Order comes into force on the day on which it is registered.
Consultation
On July 28, 2012, a notice of intent to amend the DSL was published in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 7) During the 60-day public comment period, one submission from an industry stakeholder was received. The submission requested that the use of DTBSBP in plastic products manufacturing (primarily urethane and other foam products, except polystyrene) be exempted from the notification requirements of the Order. Information received from follow-up communication with the stakeholder revealed that this stakeholder is no longer importing DTBSBP into Canada for this use, and that an exemption for plastic products manufacturing would not be required. As a result, Environment Canada determined that an exemption for the importation of DTBSBP for the manufacturing of plastic products into Canada was not justified.
No comments were received for 2-nitropropane and 2nitrotoluene after the publication of the notice of intent.
Also, in March 2012, one industry stakeholder submitted information following consultation on another risk management action for MAPBAP acetate, indicating that the substance is also used as an industrial dye for professionally applied polyurethane foam insulation, a usage that had not previously been assessed by the Government of Canada. This activity was evaluated by the Government of Canada and it was determined that no risk management action was warranted for this activity at this time. Therefore, this activity is excluded from the reporting requirement of the Order.
The National Advisory Committee to CEPA 1999 was given the opportunity to advise the Minister of Health and the Minister of Environment on the notice of intent. No comments were received.
“One-for-One” Rule
The Order does not trigger the “One-for-One” Rule. Current activities involving the four substances are exempted from the notification requirement of the Order and there is no indication that industry’s current activity patterns associated with the four 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 businesses based on their current and anticipated practices. Canadian companies that are currently using or importing the substances are not captured by the Order’s notification requirements and there is no indication that current industrial activity patterns associated with the four substances will change in the future.
Rationale
The screening assessments determined that the four substances are toxic as defined under section 64 of CEPA 1999. The four substances have been added to Schedule 1 of CEPA 1999, which enables the Minister to propose and publish preventive or control instruments in relation to these substances in the Canada Gazette.
Current activities associated with the four substances are being managed through existing measures, will be managed through proposed measures, or are of minimal exposure concern. The four substances are listed on Part 1 of the DSL, indicating that activities involving them do not require notification to the Minister, unless they are subject to other notification requirements under CEPA 1999 or any other federal statute. Given the hazardous properties of the four substances, significant new activities associated with their use may pose a risk to human health or the environment.
The Government of Canada considered a regulation to prohibit or limit the conditions under which DTBSBP may be imported, manufactured or used as one of the potential measures. However, in light of the proactive and ongoing reduction/replacement or discontinued use of DTBSBP in certain applications by industry, the limited release potential of DTBSBP in the environment, and existing measures in place for the management of hazardous and non-hazardous wastes and recyclable materials, including used oil, where DTBSBP may be found, a prohibition regulation was deemed unnecessary and was no longer considered.
Modifying the DSL to apply the SNAc provisions allows the Minister to be informed of significant new activities involving the four substances. The submitted information will assist the Government of Canada in conducting both health and environmental assessments and will also allow the Ministers to take appropriate risk management actions in relation to those activities. As a result, the Minister of the Environment and Minister of Health (the Ministers) have determined that applying the SNAc provisions to the four substances is the preferred option.
The Order contributes to the protection of human health and the environment by assessing proposed significant new activities in relation to the four substances prior to their introduction. The exempted activities, as set out in the Order, are expected to result in low environmental exposure, low to negligible exposure of Canadians to the substances, or are subject to planned risk management actions and are therefore of minimal concern. As a result, the Order allows these activities to continue while ensuring that the Government is notified of any significant new activities.
Based on their current business practices, companies currently conducting activities associated with any of the four substances will not be impacted as a result of the Order. Should significant new activities involving the substances occur, costs would be incurred by industry for generating data and other information to be supplied to the Minister. However, it is not expected that current industrial activity patterns would change in the future. Therefore, the Order is not expected to impact industry.
In the event a notification is submitted, the Government of Canada will incur the costs for processing the information in relation to the SNAc and for conducting health and environmental assessments. It is assumed that these costs are unlikely to be incurred given that no significant new activities involving the substances are expected. The Government of Canada will incur costs for conducting compliance promotion activities. Annual costs associated with these promotion activities are expected to be low. Enforcement activities for cases toward non-compliance will be conducted on a referral basis only. As a result, enforcement costs are expected to be negligible.
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 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 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 cooperate 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
Environment Canada and Health Canada will assess all information submitted as part of SNAc notification and will communicate the result to the notifier within 180 days after the information is received.
Contacts
Greg Carreau
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
Manager
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 e
SOR/94-311 - Footnote f
S.C. 1999, c. 33 - Footnote 1
SOR/94-311 - Footnote 2
The definition of significant new activities can be found in section 80 of CEPA 1999: www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=24374285-1&offset=6&toc=show. - Footnote 3
The final screening assessments for all batch eight substances can be found at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-8/index-eng.php. - Footnote 4
The order adding the four substances to Schedule 1 of CEPA 1999 can be found at www.gazette.gc.ca/rp-pr/p2/2012/2012-03-28/pdf/g2-14607.pdf. - Footnote 5
For additional information, please see the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers, found on Environment Canada’s Web site. - Footnote 6
The OSPAR Commission publishes the List of Substances of Possible Concern to make its decisions transparent as to which substances are classified as chemicals for priority action and to provide an opportunity for any errors or omissions in the data on which those decisions were based to be corrected. - Footnote 7
The notice of intent can be found at www.gazette.gc.ca/rp-pr/p1/2012/2012-07-28/pdf/g1-14630.pdf (pages 2169 to 2173).