Vol. 148, No. 6 — March 12, 2014
SOR/2014-30 February 26, 2014
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2014-87-01-01 Amending the Domestic Substances List
Whereas the substances set out in the annexed Order are specified on the Domestic Substances List (see footnote a);
Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under section 68 or 74 of the Canadian Environmental Protection Act, 1999 (see footnote b) and on September 18, 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;
Whereas the Ministers are satisfied that the substance Benzene, 1,2-dimethoxy-4-(2-propenyl)- 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 substances Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- and Bromic acid, potassium salt 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 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 2014-87-01-01 Amending the Domestic Substances List.
Gatineau, February 20, 2014
Minister of the Environment
ORDER 2014-87-01-01 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.)
Screening assessments for three substances were conducted to determine whether the substances have the potential to be harmful to human health or the environment. The screening assessments concluded that all three substances are harmful to human health based on their carcinogenicity. The substances are
- Benzene, 1,2-dimethoxy-4-(2-propenyl)- (Chemical Abstracts Service [CAS] Registry No. 93-15-2), hereafter referred to as “methyl eugenol”;
- Oxirane, 2,2′,2″2″′-[1,2-ethanediylidenetetrakis(4,1phenyleneoxymethylene)]tetrakis- (CAS Registry No. 7328-97-4), hereafter referred to as “TGOPE”; and
- Bromic acid, potassium salt (CAS Registry No. 7758-01-2), hereafter referred to as “potassium bromate.”
Current activities associated with the three substances are being managed through existing measures, will be managed through proposed measures, or are of minimal exposure concern. However, given the hazardous properties of the three substances, they may pose a risk to human health should new activities associated with them commence. 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)
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. The 3 substances mentioned above are 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 assessments, published in the Canada Gazette, Part I, on September 18, 2010, methyl eugenol, TGOPE and potassium bromate are harmful to human health and meet the criterion as 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 these substances. (see footnote 3)
SNAc provisions of CEPA 1999
Given that the three substances are listed on the Domestic Substances List (DSL), activities associated with them can be conducted by industry or others without obligation to notify the Government of Canada, unless the substances 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 three substances are harmful to human health, significant new activities involving them 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 and risk management actions
Methyl eugenol is a naturally occurring substance found in the essential oils of several plant species, including culinary herbs, citronella, basil and the tea tree. The substance can be used as a component in flavouring ingredients that can be added to certain foods. (see footnote 6) The substance may also be a component of certain fragrances present in pest control products at a low concentration. Citronella oil, which may contain methyl eugenol, is a pest control ingredient in some commercially available personal insect repellent lotions and sprays applied to the skin.
According to submissions to a survey made under section 71 of CEPA 1999, the substance was not manufactured, imported or used in Canada during the 2006 calendar year above the reporting thresholds.
In Canada, methyl eugenol is listed on Health Canada’s Cosmetic Ingredient Hotlist and the maximum concentration of the substance in cosmetics is restricted. Certain therapeutic products, which may contain methyl eugenol, are regulated under the Natural Health Products Regulations. The listing of methyl eugenol in the Natural Health Products Ingredients Database has been updated from a restricted substance to a substance that is no longer authorized for use in natural health products. Health Canada’s reevaluation of personal use citronella oil-based insect repellents requires that companies submit safety data to support the long-term use of insect repellents containing methyl eugenol. If the companies do not submit this information then Health Canada will not renew the license of those companies to produce these products, and these products will be gradually phased out as the licenses expire.
In the United States (U.S.), methyl eugenol was affirmed as GRAS (Generally Recognized as Safe) by the Food and Drug Administration as a food additive, and was registered as a pesticide active ingredient by the U.S. Environmental Protection Agency. In the European Union (EU), the addition of methyl eugenol to foods is prohibited; the concentration of methyl eugenol in some processed foods is restricted; the use of the substance as a pure chemical in cosmetics is not permitted; and the substance as a component of plant extracts in cosmetics is subject to concentrations requirements. (see footnote 7) In Australia, methyl eugenol is permitted in drugs at concentrations of 1% or less.
The substance is used in paint, coating and adhesive manufacturing. It is also found in an adhesive product that may have commercial uses.
According to information submitted in response to surveys made under section 71 of CEPA 1999, TGOPE was not manufactured in Canada in quantities above the reporting threshold of 100 kg in 2005 or 2006. However, between 1 000 and 10 000 kg of the substance were imported in 2006.
There are no risk management measures applying to TGOPE in Canada and the exposure of the general population in Canada to that substance is expected to be low to negligible. No risk management measures were found applying to TGOPE in other jurisdictions.
The substance is predominantly used in industrial and commercial applications. It was reported being used as an oxidizer in milling of flour for export. The entire final product is exported to the United States. (see footnote 8)
According to information submitted in response to a survey made under section 71 of CEPA 1999, the substance was not manufactured in quantities above the reporting threshold in Canada in 2006. However, less than 1 000 kg of the substance were imported into Canada in the same year.
In Canada, this substance is subject to the requirements set out in section 28.3 of the Cosmetic Regulations and is listed on Health Canada’s Cosmetic Ingredient Hotlist. It is not permitted to be used as a food additive in foods offered for sale in Canada under the Food and Drug Regulations. Bromate is listed in the Guidelines for Canadian Drinking Water Quality. (see footnote 9) Also, potassium bromate is captured by section 4, of the Food and Drugs Act, which prohibits the sale of any article of food containing poisonous or harmful substances. The substance is subject to reporting requirements under the National Pollutant Release Inventory.
In the United States, potassium bromate is subject to Title 16 (Part 1700), Title 21 (Part 136, Part 137 and Part 172) and Title 40 (Part 172) of the Code of Federal Regulations (CFR). (see footnote 10) Bromate is subject to Title 21 (Part 165) and Title 40 (Part 141) of the CFR. In EU, potassium bromate is prohibited in cosmetics and is subject to labelling and packaging requirements as described in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. The use of potassium bromate as a flour improver has been prohibited in England, Wales and Scotland since the 1990s. In addition, a guideline concentration for bromate is listed in the World Health Organization Guidelines for Drinking-water Quality.
The objective of the Order is to contribute to the protection of human health by collecting information on significant new activities associated with the three substances before such activities are undertaken. The information collected will assist the Government of Canada in assessing the substances in relation to the significant new activities and in determining whether further risk management activities 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 addition of the letter “S′” following the CAS Registry Numbers, that the three substances are subject to the SNAc provisions under CEPA 1999.
The Order requires any person that intends to use methyl eugenol in its isolated form (when the substance is synthesized or extracted on its own from its naturally occurring sources) or TGOPE (in its uncured or undried form), above 100 kg in any calendar year for the manufacture of a consumer product, other than for exempted activities, to provide the required information to the Minister 180 days in advance of the intended activity.
The Order requires any person that intends to use potassium bromate (above 100 kg in any calendar year) in a consumer product, or intends to conduct industrial or commercial activity involving potassium bromate (above 1 000 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 the information is received. Current activities that are being managed and 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 three substances.
The Order comes into force on the day on which it is registered.
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, one submission from an industry association was received on methyl eugenol. The submission questioned whether the SNAc provisions would apply to methyl eugenol as a component of essential oils.
The Government of Canada responded that the SNAc provisions are not intended to target naturally occurring methyl eugenol but only its isolated form. The definition of a significant new activity for methyl eugenol has been rewritten to better reflect this.
There was no submission on TGOPE or potassium bromate.
The Order does not trigger the “One-for-One” Rule. Current activities involving the three substances are not subject to the notification requirement of the Order, and there is no indication that industry’s current activity patterns associated with the three substances may change in the future. Therefore, no incremental administrative costs are expected to be incurred by businesses.
Small business lens
The small business lens does not apply to this Order, as there are no expected impacts on industry or small 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 requirement, and there is no indication that current industrial activity patterns associated with the three substances will change in the future.
The screening assessments determined that the three substances have the potential to be harmful to human health as they may cause cancer. The three substances have been added to Schedule 1 of CEPA 1999.
Current activities associated with the three substances are being managed through existing measures, will be managed through proposed measures, or are of minimal exposure concern. However, given the hazardous properties of the three substances, significant new activities associated with them may pose a risk to human health.
The three substances were listed on Part 1 of the DSL, indicating that activities involving them did not require notification to the Minister, unless they were 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 notified of significant new activities involving the three substances. The submitted information will assist the Government of Canada in conducting both health and environmental assessments and, where necessary, in taking 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 the three substances is the preferred option.
The Order contributes to the protection of human health and the environment by assessing proposed significant new activities associated with the three substances prior to their introduction. The permitted activities, as set out in the Order, are expected to result in low environmental exposure or low-to-negligible exposure of Canadians to the substances, and are therefore of minimal concern. Therefore, 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 currently conducting activities associated with the three 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. As a result, 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. Therefore, 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
The Order comes 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 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 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.
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.
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
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
- Footnote a
- Footnote b
S.C. 1999, c. 33
- Footnote c
S.C. 1999, c. 33
- Footnote d
S.C. 1999, c. 33
- Footnote e
- Footnote f
S.C. 1999, c. 33
- Footnote 1
- 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 adding the substance to Schedule 1 of CEPA 1999 can be found at gazette.gc.ca/rp-pr/p2/2012/2012-10-24/pdf/g2-14622.pdf#page=47.
- 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 vanadium pentoxide, another substance that was 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.
- Footnote 6
This refers to those foods that do not have a standard of identity and composition in the Food and Drug Regulations and to those foods that have a standard of identity and composition that allows for the addition of flavours.
- Footnote 7
The permitted concentrations are as follows: 0.01% in fine fragrances, 0.004% in eau de toilette, 0.002% in a fragrance cream, 0.0002% in other leave-on products and oral hygiene products, and 0.001% in rinse-off products.
- Footnote 8
The United States Code of Federal Regulations permits potassium bromate to be used in various flours and in the malting of barley.
- Footnote 9
It should be noted that the drinking water guidelines for bromate apply to any source of bromate, which includes potassium bromate.
- Footnote 10
Details can be found from the risk management approach at www.ec.gc.ca/ese-ees/default.asp?lang=En&n=D1613C58-1.