Vol. 146, No. 22 — October 24, 2012
SOR/2012-219 October 5, 2012
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2012-1331 October 4, 2012
Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part Ⅰ, on October 30, 2010, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;
And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), hereby makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following in numerical order:
121. Benzene, 1,2-dimethoxy-4-(2-propenyl)-, which has the molecular formula C11H14O2
122. Vanadium pentoxide, which has the molecular formula V2O5
123. Oxirane, 2,2′,2″,2″′-[1,2-ethanediylidenetetrakis (4,1-phenyleneoxymethylene)]tetrakis-, which has the molecular formula C38H38O8
124. Bromic acid, potassium salt, which has the molecular formula KBrO3
COMING INTO FORCE
2. 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.)
Canadians depend on chemical substances that are used in the manufacture of hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can have detrimental effects on human health or the environment when released in the environment. To manage risks associated with such chemicals, the Government of Canada announced the Chemicals Management Plan (CMP) on December 8, 2006. A key element of the CMP is the Challenge initiative, which collected information on the properties and uses of the approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each.
The four substances (hereafter referred to as the four substances) that are the subject of this Order are among the 17 chemicals that were included in Batch 9 of the Challenge and are listed below:
- Vanadium pentoxide (Chemical Abstracts Service [CAS] Registry No. 1314-62-1);
- Bromic acid, potassium salt (CAS Registry No. 7758-01-2), hereafter referred to as “potassium bromate”;
- Oxirane, 2,2′,2″,2′″-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis- (CAS Registry No. 7328-97-4), hereafter referred to as “TGOPE”; and
- Benzene, 1,2-dimethoxy-4-(2-propenyl)-, (CAS Registry No. 93-15-2), hereafter referred to as “methyl eugenol.”
Screening assessments were conducted to determine the potential for the 17 substances from Batch 9 to harm human health and the environment.
To facilitate the screening assessments, information for each substance within the Challenge initiative, such as quantities imported, manufactured or used in Canada, was collected from industry stakeholders via mandatory surveys issued under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Affected parties were required to submit this information to better inform decision making, including determining whether these substances meet one or more of the criteria set out in section 64 of CEPA 1999, that is, whether they are entering or may enter the environment in a quantity or concentration or under conditions that
- (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life depends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
Based on the information received through the Challenge and other available information, draft screening assessments were conducted in order to assess whether the four substances met the criteria of section 64 of CEPA 1999. The draft screening assessments were peer-reviewed and additional advice was also sought, as appropriate, through the Challenge Advisory Panel. (see footnote 2) The draft screening assessments were then published on the Chemical Substances Web site along with notices published in the Canada Gazette, Part Ⅰ, on March 20, 2010, that signalled the intent of the Minister of the Environment and the Minister of Health (the ministers) with regard to further risk management. (see footnote 3)
After considering public comments and new available information, final screening assessment reports were published on the Chemical Substances Web site along with notices that were published in the Canada Gazette, Part Ⅰ, on September 18, 2010.
Screening assessment conclusions
Based principally on the weight-of-evidence-based assessment of international and other national agencies (e.g. European Commission, U.S. National Toxicology Program, and International Agency for Research on Cancer), the final screening assessments concluded that these four substances met the criteria set out in paragraph 64(c) of CEPA 1999, on the basis of carcinogenicity for which there may be a probability of harm at any level of exposure. Therefore, an order adding the four substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part Ⅰ, on October 30, 2010. (see footnote 4)
Based on the information received, none of the four substances is harmful to the environment as defined under paragraphs 64(a) and 64(b) of CEPA 1999.
The final screening assessments, the proposed risk management approach documents, and the responses to comments received on the four substances may be obtained from the Chemical Substances Web site or from the Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), or by email at email@example.com.
Vanadium pentoxide is an industrial chemical and also occurs naturally in the environment. It is also produced as a by-product upon combustion of certain fossil fuels. It is used primarily in Canada in the manufacture of ferrovanadium and as a catalyst in the production of sulphuric acid. According to information submitted in response to a survey published under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act), between 1 000 000 kg and 10 000 000 kg of the substance were manufactured in Canada in the 2006 reporting year, and between 100 000 kg and 1 000 000 kg were imported during the same year.
The main route of exposure of the general population is expected to be through inhalation of air containing vanadium pentoxide formed from combustion of certain fossil fuels. Exposure to vanadium pentoxide may also occur due to its natural presence in foods and soil.
Potassium bromate is an industrial chemical that is used predominantly in industrial and commercial applications, such as an oxidizing reagent in laboratories or in the dyeing of textiles. According to information submitted in response to a survey published under section 71 of CEPA 1999, less than 1 000 kg of this substance were imported into Canada in 2006. No Canadian companies reported manufacturing it in the same year.
About 20 kg of the substance were released primarily to air from industrial emissions according to the 2007 data from National Pollutant Release Inventory, and less than 10 kg were transferred to an offsite waste disposal facility. Exposure of the general population through environmental media (e.g. drinking water), food and consumer products is expected to be negligible. Since 1994, this substance is no longer permitted to be used as an additive in foods offered for sale in Canada.
The substance TGOPE is an industrial chemical. It is an adhesive or binding agent. It is primarily used in Canada in the manufacture of paints, coatings designed for industrial use, and certain consumer epoxy-patch adhesives. According to information submitted in response to a survey published under section 71 of CEPA 1999, this substance was not manufactured in Canada in 2006, but between 1 000 kg and 10 000 kg of the substance were imported into Canada in the same year. Exposure of the general population is expected to be negligible from environmental sources and low from consumer products (e.g. certain epoxy adhesives).
Methyl eugenol is a naturally occurring substance found in the essential oils of plants, including various herbs. These oils are extracted for use as fragrance ingredients and softeners in personal care products and cosmetics and as a flavour ingredient in food and beverages. According to information submitted in response to a survey published under section 71 of CEPA 1999, methyl eugenol was not manufactured in Canada in 2006, and less than 100 kg were imported into Canada in the same year. Canadians may be exposed to low levels of methyl eugenol from certain types of essential oils found in personal care products, cosmetics and citronella oil personal insect repellents. Canadians may also be exposed to methyl eugenol in plant essential oils or parts such as leaves, stems and seeds that naturally contain methyl eugenol and can be used as flavouring ingredients in foods.
According to the conclusions of the screening assessments, as summarized above, the four substances may constitute a danger in Canada to human life or health at any level of exposure on the basis of their carcinogenicity and genotoxicity.
Given the assessment conclusion, action should be taken to ensure that control measures are available to the ministers to appropriately manage the risks posed by the four substances.
The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to enable the ministers to develop risk management instruments under CEPA 1999 to manage human health risks posed by the four substances.
The Order adds the four substances to Schedule 1 of CEPA 1999 (the List of Toxic Substances).
The Minister of the Environment is required under section 91 of CEPA 1999 to publish in the Canada Gazette a proposed instrument that establishes preventive or control actions within two years of publishing a statement under paragraph 77(6)(b) of CEPA 1999 indicating that the measure the ministers propose to take, as confirmed or amended, is a recommendation that the substance be added to Schedule 1 of CEPA 1999. Section 92 of the Act then requires that that instrument be finalized and published within 18 months following the publication in the Canada Gazette, Part Ⅰ.
On March 20, 2010, the ministers published a summary of the scientific assessments for the four substances of Batch 9 in the Canada Gazette, Part Ⅰ, for a 60-day public comment period. Risk management scope documents were also released on the same date, outlining the preliminary options being examined for the management of the four substances proposed to meet one or more of the criteria under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessment reports on the four substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.
During the 60-day public comment period, a total of nine submissions were received from three environmental non-governmental organisations (ENGOs), two industry associations, and four industry stakeholders (including one chemical manufacturer) on the draft screening assessment report and proposed risk management scope for vanadium pentoxide. All comments were considered in developing the final assessment and risk management approach. No comments were received on the screening assessment reports for potassium bromate, TGOPE or methyl eugenol.
Below is a summary of comments received on the screening assessment of vanadium pentoxide, as well as responses to these comments. In cases where comments have been made concerning whether or not a substance meets one of the criteria of section 64 of the Act due to lack of information or uncertainty, the Government has indicated that it will proceed to take precautionary action to protect the health of Canadians and their environment. The complete responses to comments received may be obtained at the Web site, address or fax number or email address listed above.
- One chemical industry association commented that exposure of the general population to vanadium pentoxide is highly unlikely. There is no evidence of exposure in Canada to the substance that constitutes a risk to the health of Canadians as a result of its inhalation.
Response: The final screening assessment concludes that vanadium pentoxide is carcinogenic. General population exposure to vanadium pentoxide was estimated based on available information. The general population of Canada is expected to be exposed to low levels of vanadium pentoxide from inhalation of air containing vanadium pentoxide formed from combustion of certain fossil fuels. The releases of vanadium pentoxide into the Canadian environment are mainly atmospheric emissions from various industrial activities.
- One chemical industry association suggested that vanadium pentoxide was not genotoxic and was only reported to cause cancer in one poorly conducted U.S. National Toxicology Program study in mice, by non-DNA reactive mechanism(s). The commenter provided one new animal bioassay (an experiment to measure the effects of a substance on a living organism) and several scientific discussion papers to support this position.
Response: For the health effects characterization, all available and relevant data on vanadium pentoxide were considered, including conclusions of U.S. National Toxicology Program and International Agency for Research on Cancer (IARC). A weight-of-evidence approach was taken when characterizing risk. In the absence of a fully elucidated mode of action, i.e. the mechanism by which the substance can produce harmful effects upon a living organism, and with only one animal cancer bioassay available, it cannot be precluded that tumours observed in experimental animals result from direct interaction with genetic material and are relevant to humans.
- One chemical industry association suggested that vanadium pentoxide should not have been classified as being of “greatest potential for exposure” to Canadians and thus should not have been assessed under the Challenge.
Response: The determination of “greatest potential for exposure” (GPE) for this substance refers to the results of the prioritization process for existing chemicals (categorization) which the Government of Canada completed in 2006. This determination was based on information collected during the compilation of the Domestic Substances List in the mid-1980s. It is important to note that when Health Canada and Environment Canada characterize exposure for use in screening assessments, current use patterns are determined using all available sources of information, including Section 71 submissions. This approach has been applied for vanadium pentoxide in the current assessment.
Furthermore, vanadium pentoxide was identified as a priority for assessment based on hazard classifications of other organizations.
- An industry stakeholder commented that based on evidence published in scientific literature, it is incorrect to assume that all releases of “vanadium” are converted to and released as “vanadium pentoxide” from the combustion of wood, bark and oil in industrial boilers.
Response: The Government of Canada recognized that it is an overestimation to assume that all releases of vanadium from these sources are vanadium pentoxide. As noted in the screening assessment report, this value was used as a worst-case scenario for the ecological exposure assessment. Since no risks were identified for ecological receptors, further refinement was not undertaken.
Comments received following publication of the proposed Order in the Canada Gazette, Part Ⅰ
On October 30, 2010, the ministers published a proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 in the Canada Gazette, Part Ⅰ.
During the 60-day public comment period, two industry associations filed notices of objection under subsection 332(2) of the Act and requested that a board of review be constituted pursuant to section 333 of CEPA 1999 regarding the proposed addition of vanadium pentoxide to Schedule 1 of CEPA 1999. No other comments were received.
The information provided in the notices of objection was reviewed by Health Canada and Environment Canada. It was determined that none of the information provided supports a change in the conclusion of the assessment that vanadium pentoxide is harmful to human health. Therefore, the ministers decided not to establish a board of review.
Below is a summary of comments from the notices of objection as well as responses to these comments.
- An industry association commented that the assessment is not based on the best available data and scientific knowledge regarding the chemical properties of vanadium, and specifically vanadium pentoxide. The industry association commented that the assessment relies on unsupported conclusions, ignores available data, makes overly precautionary assumptions, and results in the development of unreasonable exposure scenarios.
Response: Health Canada clarified that all available and relevant data on vanadium and vanadium pentoxide were considered in reaching the conclusions of the assessment. This included information provided by stakeholders as well as results of literature searches. No new scientific data that would support a change in the assessment conclusion that vanadium pentoxide is harmful to human health was provided along with the notices of objection. Due to the uncertainties associated with the exposure dataset for vanadium pentoxide (lack of data on speciated vanadium in environmental media and food), the screening assessment incorporated conservative assumptions, in accordance with the application of precaution, as required by CEPA 1999. This is consistent with the approach taken for all other metal compounds in the Challenge program assessed to date.
- An industry association commented that while marked differences in the carcinogenic response between rats and mice are apparent, the reasons for this and the relevance of the difference to human exposures have not been determined. As a result, the relevance of the effects of vanadium pentoxide for human health is unknown.
Response: The final screening assessment recognizes that there is uncertainty regarding interspecies differences. However, the treatment related effect is considered to be toxicologically significant. In the absence of a fully elucidated mode of action, it cannot be precluded that tumours observed in experimental animals result from direct interaction with genetic material and are relevant to humans.
- The two commenters argued that they do not support the conclusions of the assessment report, specifically that there is a probability of harm at any level of exposure, and they were unclear on why such an extrapolation of reference material was used in the assessment.
Response: In assessing potential for carcinogenicity of vanadium pentoxide, Health Canada reviewed all available and relevant data, including the conclusions of U.S. National Toxicology Program, the California Environmental Protection Agency and IARC.
Consistent with the ministers’ Notice of Intent (December 9, 2006), Health Canada considers that evidence of carcinogenicity (i.e. classification by one or more international/ national agencies), in the absence of a fully elucidated mode of action analysis, is sufficient to propose a conclusion that there is a probability of harm at any level of exposure and that the criterion in paragraph 64(c) of CEPA 1999 is met. The application of a precautionary approach is required under CEPA 1999.
- An industry association commented that the evidence provided in the draft screening assessment is not based on a sound and reasonable exposure scenario, and there is little reasonable evidence of the exposure conclusions reached by the draft risk assessment.
Response: Due to uncertainties associated with the exposure dataset for vanadium pentoxide, the screening assessment used conservative assumptions, in accordance with the application of a precautionary approach as required by CEPA 1999. No data were found, or provided by stakeholders, on speciated vanadium levels in environmental media or in food. Consequently, for the purpose of this screening assessment, exposure to vanadium pentoxide was estimated from levels of total vanadium in these sources. As noted earlier, worst-case exposure scenarios based on conservative assumptions did not identify ecological risks, hence there was no need to refine them.
As described in the “Background” section, the four substances are used in various applications in Canada and these uses result in general population exposure to these substances. Furthermore, the screening assessments concluded that the four substances are carcinogenic. Given these concerns, the screening assessments conclude that the four substances meet the criteria set out in paragraph 64(c) of CEPA 1999.
Three measures can be taken after an assessment is conducted under CEPA 1999:
- adding the substance to the Priority Substances List for further assessment (when additional information is required to determine if a substance meets the criteria in section 64 or not);
- taking no further action in respect of the substance; or
- recommending that the substance be added to Schedule 1 of CEPA 1999 and, where applicable, recommending the implementation of virtual elimination.
Adding the four substances onto Schedule 1 of CEPA 1999 enables the ministers to develop risk management instruments under the Act to control the risks posed by them, and is therefore the preferred option among the three alternatives.
A proposed Order adding four substances to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part Ⅰ, on October 30, 2010. Two industry associations filed notices of objection under subsection 332(2) of the Act and requested that a board of review be constituted pursuant to section 333 of CEPA 1999 regarding the proposed addition of vanadium pentoxide to Schedule 1 of CEPA 1999. No other comments were received.
The addition of four substances to Schedule 1 of CEPA 1999 does not result in any incremental costs or benefits for the public or incremental compliance or administrative burden upon industry and small businesses. The ministers will assess costs and benefits and consult with the public and other stakeholders during the development of risk management proposals for these substances.
7. Implementation, enforcement and service standards
Adding the four substances to Schedule 1 to CEPA 1999 enables the ministers to develop risk management instruments under CEPA 1999 to manage human health risks posed by the four substances. The ministers are required to publish proposed risk management instruments no later than September 18, 2012, and finalize them no later than March 18, 2014. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary as no specific risk management proposals are made with this Order. An appropriate assessment of implementation, compliance and enforcement has been undertaken during the development of proposed risk management instrument(s) respecting preventive or control actions for these substances.
Program Development and Engagement Division
Science and Risk Assessment Directorate
Science and Technology Branch
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
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
S.C. 1999, c. 33
S.C. 1999, c. 33
The Panel, made up of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to the Government on the application of precaution and weight of evidence to screening assessment in the Challenge.
The Chemical Substances Web site can be found at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php.