Vol. 146, No. 7 — March 28, 2012
SOR/2012-40 March 8, 2012
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2012-260 March 8, 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 2, 2010, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the form set out in the annexed Order, 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:
116. Propane, 2-nitro-, which has the molecular formula C3H7NO2
117. Benzene, 1-methyl-2-nitro-, which has the molecular formula C7H7NO2
118. Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)-, which has the molecular formula C18H30O
119. Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)3-methylphenyl]-, acetate, which has the molecular formula C27H34N3.C2H3O2
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.)
Issue and objectives
Canadians depend on chemical substances that are used in the manufacturing of hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can have detrimental effects on the environment and/or human health when released in a certain quantity or concentration or under certain conditions in the environment. Scientific assessments of the impact of human and environmental exposure have determined that a number of these substances constitute or may constitute a danger to human health or to the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).
The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the Order), made under subsection 90(1) of CEPA 1999, is to add the following substances to the List of Toxic Substances in Schedule 1 of CEPA 1999, as per the recommendation of the screening assessment report:
- Propane, 2-nitro- (Chemical Abstracts Service [CAS] (see footnote 2) Registry No. 79-46-9), hereafter referred to as “2-nitropropane”;
- Benzene, 1-methyl-2-nitro- (CAS No. 88-72-2), hereafter referred to as “2-nitrotoluene”;
- Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- (CAS No. 17540-75-9), hereafter referred to as “DTBSBP”; and
- Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)-3-methylphenyl]-, acetate (CAS No. 72102-55-7), hereafter referred to as “MAPBAP acetate.”
This addition enables the Minister of the Environment and the Minister of Health (the Ministers) to develop proposed regulations or instruments to manage human health and environmental risks posed by these substances under CEPA 1999. The Ministers may, however, choose to develop instruments outside of the purview of CEPA 1999 to manage these risks.
Description and rationale
Approximately 23 000 substances (often referred to as “existing” substances) were in use in Canada between January 1, 1984, and December 31, 1986. These substances are found on the Domestic Substances List (DSL), but many of them have never been assessed as to whether they meet any of the criteria set out in section 64 of CEPA 1999. Section 73 of CEPA 1999 requires that substances on the DSL be categorized to determine which of them pose the greatest potential for exposure to the general population. Categorization also determines which of these substances are persistent or bioaccumulative in accordance with the regulations and inherently toxic to human beings or to non-human organisms. Pursuant to section 74 of CEPA 1999, substances that were flagged during the categorization process must undergo an assessment to determine whether they meet any of the criteria set out in section 64. Assessments may also be published under section 68 of CEPA 1999 for substances identified as high priorities for action, but that do not meet the categorization criteria set out under section 73 of CEPA 1999.
The Ministers completed the categorization exercise in September 2006. Of the approximately 23 000 substances on the DSL, about 4 300 were identified as needing further attention.
As a result of categorization, the Chemicals Management Plan (the Plan) was launched on December 8, 2006, with the objective of enhancing the protection against hazardous chemicals.
A key element of the Plan is the collection of information on the properties and uses of the approximately 200 substances identified as high priorities for action. This includes substances
- that were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and that are known to be in commerce, or of commercial interest, in Canada; these substances are considered to be high priorities for assessment of ecological risk; and/or
- that were found either to meet the categorization criteria for greatest potential for exposure to Canadians or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity; these substances are considered to be high priorities for assessment of risk to human health.
This information is being used to make decisions regarding the best approaches to be taken in order to protect Canadians and their environment from the risks these substances might pose. This information-gathering initiative is known as the “Challenge.”
To facilitate the process, Environment Canada and Health Canada have organized the approximately 200 substances into 12 batches of approximately 15 substances. A batch is released every three months, and stakeholders are required to report information such as quantities imported, manufactured or used in Canada via a mandatory survey issued under section 71 of CEPA 1999. Affected parties are required to submit this information to better inform decision making, including determining whether a substance meets one or more of the criteria set out in section 64 of CEPA 1999 — that is to say, whether the substance is entering or may enter the environment in a quantity or concentration or under conditions that
- have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- constitute or may constitute a danger to the environment on which life depends; or
- constitute or may constitute a danger in Canada to human life or health.
Based on the information received and other available information, screening assessments are conducted in order to assess whether substances meet one or more of the criteria of section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. 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 assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-8/index-eng.php along with notices that are published in the Canada Gazette, Part Ⅰ, that signal the Ministers’ intent with regard to further risk management.
The Minister of the Environment is required under section 91 of CEPA 1999 to publish in the Canada Gazette a proposed regulation or other instrument establishing 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 the List of Toxic Substances in Schedule 1 of CEPA 1999. Section 92 then requires that the regulation or other instrument be finalized within 18 months following the publication in the Canada Gazette, Part Ⅰ.
The addition of substances onto Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet the obligations. CEPA 1999 enables the development of risk management instruments (such as regulations, guidelines and codes of practice) to protect the environment and human health. These instruments can be developed for any aspect of the substance’s life cycle from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. Proposed Risk Management Approach documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 8 substances and are available on the Chemical Substances Web site listed above.
Substance descriptions, assessment summaries and conclusions for Batch 8 substances
Propane, 2-nitro-, also known as “2-nitropropane,” is an industrial chemical used as a solvent and chemical intermediate. As a solvent, it may be used in inks, paints, adhesives, varnishes, polymers and synthetic materials. Additionally, 2-nitropropane may be used as an intermediate in the synthesis of pharmaceuticals, dyes and insecticides. Although the substance may be used in the production of printing inks for flexible food packaging, no use in food packaging applications has been reported in Canada for at least 10 years. The substance 2-nitropropane is permitted for use in the processing of vegetable oils; however, available information (provided by stakeholders to Health Canada, 2009) has indicated that it is not used in vegetable oil processing in North America. Also, its use as a food-processing solvent is discouraged internationally. Nonetheless, to account for the possibility that 2-nitropropane may be present in vegetable oils imported into Canada, an assessment of the potential exposure from vegetable fats and oils was conducted.
The substance 2-nitropropane was not manufactured in Canada above the 100 kg threshold, while between 100 kg and 1 000 kg were imported into Canada in 2006. The most significant sources of potential exposure to 2-nitropropane are likely to include inhalation of cigarette smoke and possibly the ingestion of vegetable oil, which may contain residual concentrations of this substance. Based on weight-of-evidence-based assessments of international and other national agencies (International Agency for Research on Cancer, European Commission, U.S. National Toxicology Program), the critical effect for the characterization of risks to human health from exposure to 2-nitropropane is carcinogenicity. Increased incidence of liver tumours in experimental animals was reported in various studies and the substance has also demonstrated clear evidence of genotoxicity in rats.
The substance 2-nitrotoluene is an industrial chemical primarily limited to industrial applications in closed systems in the explosives-manufacturing industry in Canada. Other known uses internationally include the production of pesticides and pharmaceutical products, which could be imported into Canada. No manufacturing was reported in Canada, while between 100 kg and 1 000 kg of the substance were imported into Canada in 2006. The general population is not likely to be exposed to 2-nitrotoluene through environmental media nor in food or beverages and consumer products. The substance 2-nitrotoluene has been classified on the basis of carcinogenicity by other national and international agencies (International Agency for Research on Cancer, European Commission, U.S. National Toxicology Program). Although information on the potential carcinogenicity of 2-nitrotoluene in humans is very limited, increased incidence of tumours was reported in experimental animals. Exposure has also been associated with non-cancer effects, including developmental and reproductive effects as well as effects in the lungs, liver, spleen, bone marrow and the hematopoietic system. The substance 2-nitrotoluene was also genotoxic in essays in exposed rodents.
The substance DTBSBP is not naturally produced in the environment and is used in Canada and elsewhere as an antioxidant and stabilizer in plastics such as polyvinyl chloride (PVC) and polyurethane foam, as well as in brake fluids, ink resins and mineral/vegetable oils used in industrial applications. However, it is no longer used in Canada in PVC. It is also used as an antioxidant in the petrochemical sector. While the substance was not manufactured in Canada, between 10 000 kg and 100 000 kg of DTBSBP were imported into Canada in 2006, for use mainly in plastics manufacturing and in brake fluids. The quantity of DTBSBP imported into Canada, along with the potentially dispersive uses of this substance, indicates that it may be released into the Canadian environment. In terms of assessment activities in other countries, it was sponsored under the U.S. High Production Volume Program as part of the class “Alkylphenols,” and the U.S. Environmental Protection Agency (EPA) completed a hazard assessment in 2007. The substance DTBSBP is also currently being sponsored by Japan for a Screening Information Data Set (SIDS) under the Organisation for Economic Co-operation and Development (OECD) High Production Volume Program. Empirical and modelled data for DTBSBP and empirical data for close structural analogues indicate that DTBSBP is expected to be persistent in water, soil and sediments. Modelled and analogue data show that DTBSBP has the potential to accumulate in organisms and may biomagnify in food chains. The substance has been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, modelled data and empirical data for close structural analogue 2,4,6-tri-tert-butylphenol indicate that the substance is potentially highly hazardous to aquatic organisms.
The substance MAPBAP acetate is not naturally occurring in the environment and is used in Canada and elsewhere as a cationic dye mainly in the production of paper products (newsprint). While the substance was not manufactured in Canada, between 10 001 kg and 100 000 kg of MAPBAP acetate were imported into Canada in 2006. The quantity of MAPBAP acetate imported into Canada, along with the known uses of this substance, indicates that it could be released into the Canadian environment. Although no releases of MAPBAP acetate were reported in response to a survey under section 71 of CEPA 1999, releases to the environment could occur given the substance’s current use as a paper dye. The substance was not assessed by the European Union or the United States. Since there is no experimental data for the persistence and bioaccumulation potential of MAPBAP acetate, modelled data was used for persistence. MAPBAP acetate is expected to be persistent in the environment, but is not expected to bioaccumulate, under the criteria set out in the Persistence and Bioaccumulation Regulations. In addition, available data indicate that MAPBAP acetate is potentially highly hazardous to aquatic organisms.
Final assessment conclusions
The final screening assessments for the eighth batch of the Challenge concluded that 4 of the 14 substances meet one or more of the criteria set out in section 64 of CEPA 1999.
On the basis of the carcinogenicity potential for which there is a probability of harm at any level of exposure, as well as the potential for other harmful effects, it is concluded that 2-nitropropane and 2-nitrotoluene may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999.
Based on the information available, it is concluded that DTBSBP and MAPBAP acetate are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity as set out in paragraph 64(a) of CEPA 1999. The substances 2-nitropropane, 2-nitrotoluene, DTBSBP and MAPBAP acetate are thus proposed for addition to Schedule 1 of CEPA 1999.
In addition, the presence of DTBSBP in the environment results primarily from human activity, and the available data regarding persistence and bioaccumulation indicate that the substance meets the criteria set out in the Persistence and Bioaccumulation Regulations, made under CEPA 1999. The substance thus meets the criteria for implementation of virtual elimination of releases to the environment as defined under subsection 77(4).
The final screening assessment reports, the proposed risk management approach documents and the complete responses to comments received on Batch 8 substances were published on July 31, 2010, and may be obtained from the Chemical Substances Web site listed above, or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), or by email at Existing.Substances. Existantes@ec.gc.ca.
The following 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 the List of Toxic Substances in Schedule 1, and where applicable, recommending the implementation of virtual elimination.
It has been concluded in the final screening assessment reports that 2-nitropropane and 2-nitrotoluene are entering, or may enter, the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999.
It has also been concluded that DTBSBP and MAPBAP acetate are entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity as set out in paragraph 64(a) of CEPA 1999.
Adding these substances onto Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.
In addition, the presence of DTBSBP in the environment results primarily from human activity, and the available data indicate that the substance is persistent and bioaccumulative, as set out in the Persistence and Bioaccumulation Regulations. Consequently, the Ministers will follow the process specified in CEPA 1999 for substances that meet the criteria for virtual elimination of releases to the environment.
Benefits and costs
This addition enables the Ministers to develop proposed regulations or instruments to manage risks posed by these substances under CEPA 1999. These include instruments such as pollution prevention plans, guidelines or codes of practice. The Ministers may, however, choose to develop instruments outside of the purview of the Act to help protect human health and the environment. The Ministers will undertake an assessment of the potential impacts, including an economic analysis, and consult with the public and other stakeholders during the development of these risk management proposals.
On January 30, 2010, the Ministers published a summary of the scientific assessments for 14 substances of Batch 8 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 be toxic 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 14 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 10 submissions were received from 4 industry stakeholders and 4 non-governmental organizations, on the scientific assessment and risk management scope documents for the Batch 8 substances proposed to be added to Schedule 1 of CEPA 1999. All comments were considered in developing the final screening assessments. Comments received on the risk management scope regarding the substances were considered when developing the proposed risk management approach documents, which are also subject to a 60-day public comment period.
Below is a summary of some key comments specific to the assessments’ conclusions for toxicity and the departments’ responses to them. In cases where comments have been made concerning whether or not a substance meets the criteria of section 64 of CEPA 1999 due to the lack of information or uncertainty, the Government errs on the side of precaution to protect the health of Canadians and their environment. The complete responses to comments are available on the Government of Canada’s Chemical Substances Web site, or at the address, fax number or email address listed above.
Summary of general comments and responses
- A chemical manufacturer commented that screening assessments represent a summary of critical information and do not represent a review of all available data. This opens the door to valid challenges to the assessment and/or the risk-management actions.
Response: Screening assessments are based on the information currently available for the determination of the critical health and ecological effects. Health Canada and Environment Canada scientists examine lines of evidence from industry submissions (voluntary or under section 71 of CEPA 1999), available scientific data from a range of sources including published scientific journals, as well as other international reviews, and seek additional scientific advice and review from experts when proposing conclusions. Health Canada is aware of the context and regulatory implications of using weight-of-evidence evaluations of hazard done by other international agencies. Assessments are also subject to a 60-day public comment period, which additionally provides an opportunity to all stakeholders to provide comments or additional data or information. These comments are taken into consideration in finalizing the assessments. Should the science evolve and new findings or certainties arise at a later date, the assessments may be revisited as appropriate.
- An industry manufacturer requested an explanation for why the new POPs (persistent organic pollutants) screening model from the Organisation for Economic Co-operation and Development (OECD) is used.
Response: The persistent organic pollutants (POPs) screening model is a tool for predicting the long-range transport potential (LRTP) of a chemical and has been used since 2006. The tool has the ability to predict how much of a chemical can end up in a targeted region in addition to the transport potential. This feature is unique to the tool. Another important feature is that the tool is able to compare the substance in question with known POPs and determine whether it has POP-like characteristics. Because of these features, the tool provides an additional line of evidence with respect to LRTP in the assessment.
- An industry manufacturer questioned why risk quotients were not calculated for persistent and bioaccumulative substances.
Response: It is generally acknowledged that when risks for persistent and bioaccumulative substances are estimated using standard methods, the risks may be underestimated since food consumption is usually the primary route of exposure to persistent and bioaccumulative substances — especially for top predators. Predicted no-effect concentrations (PNECs) may underestimate effect thresholds if the food pathway is not considered in key toxicity studies. Although conservative approaches (e.g. additional assessment or uncertainty factors) may be used to address these shortcomings, there are significant uncertainties associated with resulting risk estimates.
Evidence that a substance is both persistent and bioaccumulative provides a significant indication of its potential to be harmful to the environment. This evidence, when taken together with other information such as evidence of toxicity to laboratory or other organisms and evidence of potential for release into the environment, is sufficient to conclude that the substance may meet the criteria set out in paragraph 64(a) of CEPA 1999. A risk quotient is not calculated in these cases.
- An environmental non-governmental organization (ENGO) commented that the citing of confidential business information (CBI) on use and volume of chemicals should be reviewed with an aim to reducing claims for CBI. Stakeholders are not able to appropriately comment on the assessments without access to that information. CBI restrictions should be reconsidered by the government when there are public health and environmental impacts.
Response: The Ministers continually work with stakeholders to ensure that information can be presented in the most transparent manner possible, in a way that also respects requests for confidentiality.
Summary of key comments on health priority substances
One ENGO suggested that there is insufficient information on environmental releases, and that research and monitoring is needed to determine the concentration of 2-nitropropane in environmental media and consumer products.
Response: The screening assessment is based on the information available, which suggests that the exposure of the general population is expected to be low. Canadian importers and manufacturers are required to disclose releases to air, land and water as part of the section 71 survey. With respect to the concentrations estimated for environmental media, the information available on various elements (e.g. low import volume, absence of reported releases) supports the conclusion that the exposure for the population from environmental media is likely to be negligible. The assumptions used in the assessment were considered to be appropriately conservative and to provide sufficient evidence for a decision.
One ENGO commented that the assessment does not take into consideration vulnerable populations.
Response: The screening assessment for 2-nitrotoluene is a science-based assessment of the available data. Taking into account the industrial use of 2-nitrotoluene in Canada, exposure to all populations, including vulnerable populations, is not expected.
One environmental NGO indicated that there is concern that all uses of 2-nitrotoluene in Canada are not known and that concentrations in the environment and in imported consumer goods are underestimated or unknown. There was also concern about the limited information available on releases to the Canadian environment and disposal.
Response: The assessment is based on the information available, which suggests that the exposure of the general population is expected to be low. These concerns were raised during the screening assessment process. As a result, all possible worldwide uses of 2-nitrotoluene were considered for their potential use in Canada. No additional information was available. The information presented on releases was based on information provided by industry and obtained in the literature. Use trends (worldwide and in Canada) indicate that the use of 2-nitrotoluene has decreased. Therefore, the majority of information in the literature was based on historical use. There was no disposal information reported, potentially due to limited and low use of 2-nitrotoluene in industrial settings.
Summary of key comments on ecological priority substances
One chemical manufacturer commented that the estimates and model assumptions for releases of DTBSBP (e.g. wastewater emissions) are extremely high and are not realistic.
Response: The releases estimated for DTBSBP represent realistic worst-case scenarios (i.e. maximum potential releases). Most assumptions for environmental releases were taken from emission scenario documents issued by the OECD. However, the release estimates did not affect the ecological conclusions of this screening assessment.
One chemical manufacturer provided new information on the physical properties of the substance, as well as details on the import, uses and releases of the substance, and existing management practices.
Response: Environment Canada and Health Canada scientists have taken this new information into consideration in completing the final assessment.
Comments received following publication of the proposed Order in the Canada Gazette, Part Ⅰ
On October 2, 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. No comments were received during the 60-day public comment period.
Implementation, enforcement and service standards
The Order adds the four above-mentioned substances to Schedule 1 to CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other instruments no later than July 31, 2012, and finalize them no later than January 31, 2014. Developing an implementation plan or a compliance strategy or establishing service standards are not considered necessary if no specific risk management proposals are made. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of proposed regulations or control instrument(s) respecting preventive or control actions for these substances.
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
Risk Management Bureau
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
S.C. 1999, c. 33
S.C. 1999, c. 33
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.