Vol. 148, No. 6 — March 12, 2014
Registration
SOR/2014-31 February 26, 2014
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2014-87-01-02 Amending the Domestic Substances List
Whereas the substance set out in the annexed Order is specified on the Domestic Substances List (see footnote a);
Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of that substance under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and on September 18, 2010 released, for a 60-day public comment period, a proposed risk management approach in which the risk management objective is to prevent increases in exposure to the substance and reduce industrial emissions of particulate matter which may contain the substance;
Whereas the Ministers are satisfied that in any one calendar year the substance Vanadium pentoxide is only being manufactured in or imported into Canada by any person in a quantity of more than 100 kg 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 modify the Domestic Substances List (see footnote e) to apply the significant new activity provisions was published in the Canada Gazette, Part I, on September 15, 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 2014-87-01-02 Amending the Domestic Substances List.
Gatineau, February 20, 2014
LEONA AGLUKKAQ
Minister of the Environment
ORDER 2014-87-01-02 AMENDING THE DOMESTIC SUBSTANCES LIST
AMENDMENTS
1. Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:
1314-62-1
2. Part 2 of the List is amended by adding the following in numerical order:
Column 1 |
Column 2 |
---|---|
1314-62-1 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
A screening assessment was conducted for vanadium pentoxide (Chemical Abstracts Service [CAS] Registry No. 1314-62-1) to determine whether the substance has the potential to be harmful to human health or the environment. The screening assessment concluded that the substance is harmful to human health based on its carcinogenicity.
Although vanadium pentoxide is harmful to human health, there are a number of initiatives in place and in development that are expected to help address the main exposure source of concern to vanadium pentoxide. However, given the hazardous properties of vanadium pentoxide, any new uses or sources of exposure to this substance might present a risk to human health. 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 the substance. (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 the approximately 200 high priority chemical substances. These high priority chemicals were divided into 12 batches of 10 to 20 chemicals each. Vanadium pentoxide is among the 17 chemicals that were included in batch 9 of the Challenge.
Environment Canada and Health Canada conducted screening assessments to determine whether any of the substances in batch nine are toxic as defined under section 64 of CEPA 1999. According to the summary of the screening assessment, published in the Canada Gazette, Part I, on September 18, 2010, vanadium pentoxide is harmful to human health and meets the criterion set out in paragraph 64(c) of CEPA 1999. An order adding substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part II, on October 24, 2012, to enable the development of risk management instruments to manage the risks associated with the substance. (see footnote 3)
SNAc provisions of CEPA 1999
Given that vanadium pentoxide is listed on the Domestic Substances List (DSL), activities associated with the substance can be conducted by industry or others without obligation to notify the Government of Canada unless the substance is 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 vanadium pentoxide is harmful to human health, significant new activities involving it may be a source of concern. Therefore, a notice of intent to apply the SNAc provisions of CEPA 1999 to substances was published in the Canada Gazette, Part I, on September 15, 2012. (see footnote 4)
SNAc provisions do not apply to a substance that is manufactured or imported for a use that is regulated under the Pest Control Products Act, the Fertilizers Act or the Feeds Act, which are listed in Schedule 2 of CEPA 1999. In addition, SNAc provisions do not apply, in some circumstances, to transient reaction intermediates, to impurities or to substances that undergo chemical reactions. 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
The major use of vanadium pentoxide in Canada is in the production of ferrovanadium alloys for the manufacture of hardened steel, such as in mechanical tools, bicycle parts and surgical instruments. It is also used widely as a catalyst in industrial applications, as an anti-corrosive, in chemical fertilizer manufacturing, or as an oxidizing agent. Vanadium is found in fossil fuels, such as coal and oil. The combustion of such fossil fuels leads to the formation of incidentally released by-products that contain vanadium pentoxide, including solid residues, soot and fly ash (the main source of exposure to vanadium pentoxide).
According to information submitted in response to a survey of industry carried out under section 71 of CEPA 1999, between 1 000 000 and 10 000 000 kg of vanadium pentoxide were incidentally produced in Canada in the 2006 reporting year. In the same year, between 100 000 and 1 000 000 kg of vanadium pentoxide were reported as being imported into Canada, and between 1 000 000 and 10 000 000 kg of the substance were reported as being used in Canada.
Current and proposed risk management actions
In Canada, the substance is not permitted for use in natural health products. It is subject to the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and is listed on Schedule 1 of the Vessel Pollution and Dangerous Chemicals Regulations. Vanadium and its compounds, except when in alloys, are subject to the reporting requirement under the National Pollutant Release Inventory (NPRI). Vanadium in ambient air has been monitored through the National Air Pollution Surveillance Network since 2009. In addition, vanadium pentoxide is being considered for addition to the Environmental Emergency Regulations under CEPA 1999.
There is evidence suggesting that Canadian emissions of vanadium pentoxide have been significantly reduced in recent years. Reporting to the NPRI indicates that total vanadium releases have declined by 75% between 2006 and 2011. Although vanadium pentoxide is not explicitly reported to the NPRI, it is believed that the reduction in total vanadium releases is correlated with a significant reduction in vanadium pentoxide.
In addition, a number of current regulations, as well as certain control instruments in development, are expected to help reduce vanadium pentoxide emissions. The recent federal Reduction of Carbon Dioxide Emissions from Coal-Fired Generation of Electricity Regulations require the gradual conversion of existing coal-fired electrical plants to cleaner alternatives. These regulations should result in vanadium pentoxide emission reductions from the electrical power sector (one of the major industrial emission sources) as facilities are converted or replaced. Under the new federal-provincial Air Quality Management System, the federal government plans to introduce a number of industrial regulations and other emission control measures to reduce emissions of fine particulate matter (PM). Given that vanadium pentoxide may be released as one of the components of PM from some of the targeted industrial sectors, the Government expects that these PM control measures may help reduce vanadium pentoxide as well.
At the provincial level, Nova Scotia, Ontario and Alberta have requirements to limit emissions of nitrogen oxides, sulfur dioxide and mercury in the electricity sector. In addition, Ontario is to phase out inefficient coal-fired electric power generation plants by the end of 2014. All of these actions are expected to have cobenefits that reduce emissions of metal compounds, including vanadium pentoxide, and PM.
The Government of Canada will continue using NPRI data to determine the effectiveness of current and proposed measures associated with this substance.
Risk management actions in other jurisdictions
In the United States, vanadium pentoxide is subject to regulation under the Identification and Listing of Hazardous Waste, the Emergency Planning and Notification, and the Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities. In the European Union and New Zealand, vanadium pentoxide is prohibited in cosmetic products.
Objectives
The objective of the Order is to contribute to the protection of human health by collecting information on significant new activities associated with vanadium pentoxide before they are undertaken. The information collected will assist the Government of Canada in assessing the substance in relation to the significant new activities and in determining whether further risk management activities are necessary.
Description
The Order deletes the substance from Part 1 of the DSL by removing its CAS Registry Number; adds the substance to Part 2 of the DSL; and indicates, by addition of the letter “S′” following the CAS Registry Number, that the substance is subject to the SNAc provisions under CEPA 1999.
The Order requires any person intending to import, use or manufacture vanadium pentoxide, above the reporting threshold of 100 kg in any calendar year, to provide the required information to the Minister 180 days in advance, unless the activity is permitted under the Order. The Order outlines the information to be provided to the Minister.
Environment Canada and Health Canada will use the submitted information to conduct human health and environmental assessments within 180 days after it is received. Current activities that are of minimal concern are exempt from the notification requirements. These exemptions are described in the Order.
The Order complements the existing and proposed initiatives and will assist in managing potential risks associated with significant new activities involving the substance.
The Order comes into force on the day on which it is registered.
Consultation
On September 15, 2012, a notice of intent to amend the DSL was published in the Canada Gazette, Part I, for a 60-day public comment period.
Environment Canada and Health Canada also informed the governments of the provinces and territories through the National Advisory Committee of CEPA 1999 (CEPA NAC) of the notice of intent. No comments were received from CEPA NAC.
During the 60-day public comment period, four submissions from industry stakeholders and industry associations were received on the notice of intent for vanadium pentoxide. All comments were considered in finalizing the Order.
Below is a summary of the key comments as well as the responses to them.
- An industry stakeholder and an industry association requested the planned future use of vanadium pentoxide as an intermediate in the production of bismuth vanadate pigments be exempted from the notification requirement.
Response: Based on information submitted by the stakeholder noting that there would be negligible to no release of vanadium pentoxide, an exposure of concern was not identified by Health Canada. Therefore, this activity is excluded from the notification requirement of the Order. Should new information indicate that the manufacture of bismuth vanadate pigments may cause concern, Environment Canada and Health Canada may re-evaluate the activity and impose risk management measures if necessary. - Two industry stakeholders commented that the wording in the notice of intent did not accurately reflect the maximum concentration of vanadium pentoxide that could be present in catalytic applications. The concentration indicated in the notice of intent is too low and should be either corrected or removed.
Response: The limits proposed in the notice of intent were based on information received through the section 71 survey for batch nine. The exclusions regarding catalyst use have been simplified in the Order. - Industry associations requested clarification as to whether a change in the type of combustion fuel would trigger obligations in the SNAc.
Response: SNAc orders do not apply to “substances produced when a substance undergoes a chemical reaction that is incidental to the use to which the substance is put” as stated in paragraph 81(6)(d) of CEPA 1999. As the production of vanadium pentoxide through the combustion of fossil fuel is incidental manufacturing, the Order will not be applicable to it regardless of a change of fuel.
“One-for-One” Rule
The Order does not trigger the “One-for-One” Rule. Current activities involving the substance are not subject to the notification requirement of the Order, and there is no indication that industry’s current activity patterns associated with the substance 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 substance are not captured by the Order’s notification requirement, and there is no indication that current industrial activity patterns associated with the substance will change in the future.
Rationale
The screening assessment determined that vanadium pentoxide has the potential to be harmful to human health, as it may cause cancer. The substance has been added to Schedule 1 of CEPA 1999.
Although vanadium pentoxide is harmful to human health, there are a number of initiatives in place and in development that are expected to help address the main exposure source of concern to this substance. As a result, additional regulatory measures to address the current uses of or exposure to vanadium pentoxide are not required at this time. However, given the hazardous properties of the substance, it may pose a risk to human health should significant new activities associated with it commence.
Because vanadium pentoxide was listed on Part 1 of the DSL, activities involving it did not require notification to the Minister unless it was subject to other notification requirements under CEPA 1999 or any other federal statute. Modifying the DSL to apply the SNAc provisions allows the Minister to be informed of significant new activities involving the substance. The submitted information will assist the Government of Canada in conducting both health and environmental assessments and, where necessary, to take appropriate risk management actions in relation to those activities. As a result, the Minister of the Environment and the Minister of Health have determined that applying the SNAc provisions to vanadium pentoxide is the preferred option.
The Order contributes to the protection of human health and the environment by assessing the substance in relation to proposed significant new activities prior to their introduction. The activities excluded from the definition of a significant new activity, as set out in the Order, are 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 in order to determine whether they could pose a risk.
Based on their current business practices, companies conducting activities associated with the substance will not be impacted as a result of the Order. Should significant new activities involving the substance 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 that 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 of 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 comes into force on the day on which it is registered. The compliance promotion activities to be conducted as part of the Order’s implementation include developing and distributing promotional material, responding to inquiries from stakeholders, and undertaking activities to raise industry stakeholders’ awareness of the Order’s requirements.
Enforcement
The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers apply the Compliance and Enforcement Policy implemented under CEPA 1999. This 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 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 at www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=24374285-1&offset=6&toc=show. - Footnote 3
The order can be found at: www.gazette.gc.ca/rp-pr/p2/2012/2012-10-24/pdf/g2-14622.pdf, p. 2361. - Footnote 4
The notice of intent can be found at: www.gazette.gc.ca/rp-pr/p1/2012/2012-09-15/pdf/g1-14637.pdf (pages 2650 to 2654). A separate order will apply the SNAc provisions to three other substances that were included in the same notice of intent. - Footnote 5
For additional information, please see the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers at http://publications.gc.ca/collections/Collection/En84-25-2005E.pdf.