ARCHIVED — Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
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Vol. 145, No. 4 — February 16, 2011
SOR/2011-26 February 4, 2011
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2011-62 February 3, 2011
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 May 16, 2009, 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 proposed 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:
104. Ethanol, 2-methoxy-, acetate, which has the molecular formula C5H10O3
105. 1-Propanol, 2-methoxy-, which has the molecular formula C4H10O2
106. 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]-, which has the molecular formula C17H13N3O3
107. Ethanol, 2-(2-methoxyethoxy)-, which has the molecular formula C5H12O3
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.
(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 negatively affect human health and the environment when released to the environment in a certain quantity or concentration or under certain conditions. 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 and/or the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999, also referred to as “the Act”).
The Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the Order), made pursuant to subsection 90(1) of CEPA 1999, adds the following substances to the List of Toxic Substances in Schedule 1 of CEPA 1999:
- Ethanol, 2-methoxy-, acetate (Chemical Abstracts Service Registry Number [CAS RN] 110-49-6), hereafter referred to as “2-MEA,”
- Ethanol, 2-(2-methoxyethoxy)- (CAS RN 111-77-3), hereafter referred to as “DEGME,”
- 1-Propanol, 2-methoxy- (CAS RN 1589-47-5), hereafter referred to as “2-methoxypropanol,” and
- 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- (CAS RN 2425-85-6), hereafter referred to as “Pigment Red 3.”
This addition enables the Minister to develop a proposed regulation or instrument to manage human health risk posed by these substances under CEPA 1999. The Ministers may also choose to develop non-regulatory instruments 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 the Act required 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 the Act, 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 the Act for substances identified as high priorities for action, but that do not meet the categorization criteria set out under section 73 of the Act.
The Minister of the Environment and the Minister of Health (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, and approximately 200 of these were identified as high priorities for action.
As a result of categorization, the Chemicals Management Plan was launched on December 8, 2006, with the objective of enhancing 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 of 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-3/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 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 instrument be finalized and published within 18 months following publication in the Canada Gazette, Part I.
The addition of these substances to Schedule 1 of CEPA 1999 allows the Ministers to develop risk management regulatory instruments in order to meet these obligations. The Act enables the development of risk management instruments (such as regulations, guidelines or 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 3 substances and are available on the Chemical Substances Web site listed above.
The final screening assessments for the third batch of the Challenge comprising 19 substances were published on the Chemical Substances Web site (www.chemicalsubstanceschimiques.gc.ca/ challenge-defi/batch-lot-3/index-eng.php) on March 7, 2009, and the statements recommending addition to Schedule 1 were published in the Canada Gazette, Part I, on May 16, 2009.
It was concluded that four of the 19 substances assessed in Batch 3 meet the criterion set out in paragraph 64(c) of the Act, as they constitute or may constitute a danger to human life or health.
A summary of the assessments and conclusions and an overview of the public comments received during the public comment period on the draft screening assessment reports and the risk management scope documents for the substances are available from the Chemical Substances Web site, at www. chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-3/ index-eng.php.
Substance descriptions, assessment summaries and conclusions for Batch 3 substances listed in Schedule 1
2-MEA is an industrial chemical. It is used primarily as a solvent in industrial paints and coatings, varnishes and lacquers or as components of industrial adhesives, gums, resins, waxes and oils. It is not manufactured in Canada, though it is imported below the 100 kg threshold and used below the 1 000 kg threshold (whether alone, in a mixture, in a product or manufactured item). (see footnote 2) Industrial releases are low, and based on the most recent data, 2-MEA is not expected to be found in consumer products. For these reasons, exposures to the general population of Canada to this substance are believed to be negligible. 2-MEA was assessed as a high priority for human health risk. The screening assessment concluded that 2-MEA had a similar intrinsic hazard potential as its parent alcohol, 2-ME (2-methoxyethanol [CAS RN 109-86-4], which is already listed on Schedule 1 of CEPA 1999). The toxicity of 2-ME was therefore considered in the risk characterization of 2-MEA. The most significant health effects included developmental and reproductive toxicity (may cause harm to the developing fetus and impairment of fertility). This assessment is based on available information from toxicological studies (European Commission, 2007 and International Programme on Chemical Safety, 1990) in experimental animals and epidemiological investigations in occupationally exposed populations for 2-MEA and its ethanol analogue, 2-ME.
DEGME is an industrial chemical which may also be found in some consumer products. It is used in various applications and products, including as an additive in jet fuel, as a solvent in paints, paint removers, floor care products, brake fluids, sealers and caulkings and in a very small number of skin creams and cleansers. Based on the most recent data available from 2006, it was not manufactured in Canada above the 100 kg reporting threshold, but 1 000 000 to 10 000 000 kg was imported into Canada. DEGME was assessed as a high priority for human health risk. The screening assessment has determined that it can cause harm to the developing fetus. This assessment is based principally on consideration of the available relevant data and studies (including peer-reviewed journal articles and international reports) and on the weight-of-evidence-based classification of DEGME by the European Commission as a Category 3 substance (possible risk of harm) which in turn is based on an assessment prepared by the European Union (European Union Risk Assessment Report 2000, European Chemical Substances Information System 2007).
2-Methoxypropanol is a by-product in the manufacture of propylene glycol monoethylether, a solvent used in various products including paint remover, polyurethane varnish and concrete primer. It may also be found as an impurity in industrial and consumer paints, and in some cosmetic products such as nail enamel, nail polish remover, hair conditioners and hair dyes. Based on the most recent data available from 2006, 2-methoxypropanol was not manufactured commercially in Canada above the reporting threshold of 100 kg, but between 100 000 and 1 000 000 kg of the substance were imported into Canada in the 2006 reporting year. 2-Methoxypropanol was assessed as a high priority for human health risk. The assessment has determined that it can cause harm to the developing fetus. This assessment is based principally on the weight-of-evidence-based classification of 2-methoxypropanol by the European Commission (European Commission 1997 and 1998; European Chemicals Bureau 2004; European Chemical Substances Information System 2007) as Category 2 for developmental toxicity (clear evidence of a specific effect on either fertility or developmental hazard), and consideration of available relevant data for the substance (including peer-reviewed journal articles and international reports) as well as for related chemicals.
Pigment Red 3 is a man-made red pigment used mainly for paints. It has also been found to be used in minimal amounts in some cosmetics, including nail polish, skin cleanser and bath soap. Based on the most recent data from 2006, Pigment Red 3 is currently produced in Canada and is used in products that are sold in Canada. The total amount in use for 2006 was approximately 40 000 kg and between 10 000 and 100 000 kg was imported into Canada. While Pigment Red 3 was initially assessed as a high priority for ecological assessment, it was concluded that it 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. The assessment has determined that it can cause cancer in laboratory animals, based on consideration of relevant available information, including a weight-of-evidence-based assessment by the International Agency for Research on Cancer, an international authority on cancer research. Exposure-related tumours were also observed at multiple places in experimental animals. The confidence in the characterization of exposure to this substance is low as the concentrations of the substances in environmental media could not be quantified in Canada or elsewhere, leading to uncertainty in the exposure assessment. Based on the properties and uses of the substances, there is confidence that actual environmental exposure levels are low. However, for a small population of Canadians, there is uncertainty regarding possible exposure to higher concentrations, but this could not be quantified.
Final assessment conclusions
On the basis of the carcinogenicity for which there is a possibility of harm at any level of exposure, it is concluded that Pigment Red 3 is entering or 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.
On the basis of the potential inadequacy of the margins between estimated exposure during use of some consumer products and critical effect levels for developmental toxicity, it is concluded that 2-methoxypropanol and DEGME be considered substances that are entering or 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.
Based principally on the non-distinguishable intrinsic hazard potential between 2-ME and 2-MEA on a wide range of health effects, including reproductive and developmental endpoints for which there may be a probability of harm at any level of exposure, it is recommended that the conclusion on 2-ME under paragraph 64(c) of CEPA 1999 (Environment Canada and Health Canada 2002) be expanded and applied to its acetate moiety, 2-MEA. Therefore, it is concluded that 2-MEA should be considered a substance that is entering or 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.
These four substances are thus added to Schedule 1 of CEPA 1999.
Based on the information received, none of these substances were found to be entering or have the possibility of 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. Nor was it found that they constitute or may constitute a danger to the environment on which life depends as defined under section 64 of CEPA 1999.
The final screening assessments for all substances, the risk management approach documents and the complete responses to comments received on Batch 3 substances were published on March 7, 2009, and may be obtained from the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3; 819-953-7155 (fax); or by email at Substances@ec.gc.ca.
The following measures can be taken after a screening assessment is conducted under CEPA 1999:
- adding the substance to the Priority Substances List for further assessment (when additional information is required to determine whether or not a substance meets the criteria in section 64);
- 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 assessments that 2-MEA, DEGME, 2-methoxypropanol and Pigment Red 3 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 defined under paragraph 64(c) of CEPA 1999. Adding these substances to Schedule 1, which will enable the development of proposed regulations or other risk management instruments, is therefore the best option.
Benefits and costs
Adding these substances to Schedule 1 enables the Ministers to develop a proposed regulation or instrument to manage human health risks posed by these substances. The Ministers may also choose to develop non-regulatory instruments to manage these risks. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.
On August 23, 2008, the Ministers published for a 60-day public comment period in the Canada Gazette, Part I, a draft summary of the scientific screening assessments for the 19 substances in Batch 3. Risk management scope documents outlining the preliminary options being examined for the management of these substances were also released on the same date for substances proposed to be considered as meeting the criteria set out under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada had 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 19 substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.
During this 60-day public comment period, a total of 15 submissions were received from industry stakeholders, industry associations, non-governmental organizations, research centers and a foreign government on the scientific assessment and risk management scope documents. All comments were considered in developing the final screening assessments. Comments received on the risk management scope documents regarding the substances were also considered when developing the proposed risk management approach documents. The latter were also subject to a 60-day public comment period.
Below is a summary of some key comments specific to the screening assessment conclusions for toxicity and the responses of Health Canada and Environment Canada (the departments) to them. In cases where comments have been made concerning whether or not a substance meets one or more of the criteria of section 64 of the Act that indicate a 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 public comments are available via the Government of Canada’s Chemical Substances website, address, fax number or email mentioned above.
A number of environmental non-governmental organizations (NGOs) suggested that risk assessments should consider more information relating to exposure variables within Canada, including all routes, durations, levels and variables of exposure (e.g. waste disposal, occupational) that may impact health effects.
Response: The Ministers strive to take into consideration all potential releases to the Canadian environment during the assessment process. Information from a variety of sources (section 71 data, published scientific reports, etc.) is used to identify sources of exposure to a substance. Assessment of risk then focuses on those sources that are most likely to be of concern. Potential exposure of the general population, including different age groups, is examined. Uncertainties in exposure characterization and assumptions used in deriving exposure estimates are considered. Further investigation on disposal methods for the sewage sludge (e.g. land application, landfill) or through incinerators can be added to the assessment when relevant and available. In only a very limited number of cases is sufficient information available to estimate the quantity of the substance released. Occupational exposure is largely a provincial mandate and is therefore beyond the scope of screening assessments conducted under the Chemicals Management Plan. However, hazard information obtained from occupational settings is considered in the assessments as appropriate.
Summary of substance-specific comments
One industry stakeholder commented that the model selected for estimating exposure to DEGME from consumer products was inappropriate and that the default inputs used in the modeling were too conservative.
Response: In order to have as full a spectrum of information as possible, the exposure model selected by the departments includes both dermal exposure (i.e. contact with skin) and inhalation exposure (i.e. exposure from breathing air). Exposure of the public was estimated using the maximum concentrations of DEGME in products based on information available from literature searches or data submitted by industry, with a preference for Canadian-specific data when available. The departments’ scientists also make efforts to determine reasonable product concentration values, which is acceptable within the context of a screening assessment.
One industry stakeholder indicated that there is no alternative to the use of DEGME as an additive in jet fuel (its main use) and that it is also found in a large number of consumer products in Canada. The stakeholder suggested that the Government of Canada should conclusively determine that an unacceptable risk is present before concluding that the chemical may cause harm to human health or the environment.
Response: The screening assessment examined multiple sources of exposure to the general public. The assessment included indirect exposures from environmental media (including releases from the use of jet fuel) and direct exposures from the use of consumer products. While it was determined that exposure to the public from the use of DEGME does not pose a concern for human health, it was determined that there is a risk to human health based on its uses in consumer products. Also, it was determined in the assessment that DEGME may have developmental and reproductive effects at any level of exposure.
One industry stakeholder commented that the default values used in the model to estimate exposure to 2-methoxypropanol were too conservative.
Response: To protect the health of Canadians, the default assumptions in the exposure model help to predict a conservative potential exposure to the general population. In determining the scenario for exposure to 2-methoxypropanol, Government of Canada scientists included information specific to Canadian personal care products that was obtained from a proprietary database maintained by Health Canada (the Cosmetic Notification System). Additional product-specific information obtained from the survey of industry under section 71 of CEPA 1999 was also used in the exposure scenario. Health Canada and Environment Canada scientists also make efforts to determine reasonable product concentration values, which is acceptable within the context of a screening assessment. Furthermore, the models were re-run to verify the exposure outcomes and this resulted in the same conclusion as previously reported.
Pigment Red 3
Environmental NGOs were generally supportive of the conclusion of the assessment, that Pigment Red 3 be considered harmful to human health. Some NGOs commented that there is a need for further information (e.g. monitoring, data on product use, consideration of international uses of similar products) to determine the extent of the environmental releases and human exposures.
Response: Information from a variety of sources (section 71 data, published scientific reports, etc.) was used to identify sources of exposure and to prepare the assessment for Pigment Red 3, and the data from these sources were sufficient for deriving the conclusion that the substance be considered harmful to human health. That being said, the Ministers strive to take into consideration all potential sources of information. These potential sources will be considered when setting priorities for future monitoring work.
Comments received following publication of the proposed Order in the Canada Gazette , Part I
On May 16, 2009, 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, for a 60-day public comment period. Below is a summary of comments received and responses relevant to the proposed addition of the above mentioned substances to the List of Toxic Substances in Schedule 1 of CEPA 1999. No comments were received for 2-MEA and 2-methoxypropanol. Nor were comments received from the CEPA NAC.
A foreign government commented that the European Commission had classified DEGME as a Category 3 toxicant (with hazardous risks) using a weight-of-evidence-based approach, but that the organization does not list Category 3 substances as substances of very high concern. Also, the decision to add DEGME to Schedule 1 of CEPA exceeds the necessary legal purpose of protecting human health, and plays a limited role in achieving the purpose of environment and health protection. This decision, based on insufficient scientific and technical information, would certainly result in unnecessary obstacles to international trade.
Response: Due to the uncertainties associated with some parameters used for exposure scenarios caused by information gaps, and the nature of the health effects associated with exposure to this substance, the screening assessment used conservative assumptions, in accordance with the precautionary approach mandated under CEPA 1999. The exposure scenarios indicated that the margins of exposure of the general Canadian population to DEGME in consumer products may not be adequately protective of human health. The potential for harmful effects of DEGME cannot be dismissed and the application of precaution is warranted. Thus, Health Canada’s assessment indicates that there is reasonable evidence to suggest cause for concern and justification for the addition of DEGME to Schedule 1 of CEPA 1999. As the addition to Schedule 1 reflects the state of the science and is not a risk management measure, it is not expected to have a direct and noticeable impact on international trade. Impacts on international trade will be assessed during the risk management phase, which includes a process involving consultations with partners and potentially affected stakeholders on a range of risk management options and their expected related impacts, including impact on trade.
Pigment Red 3
One industry association indicated that the decision to add Pigment Red 3 to Schedule 1 should be delayed pending resolution of the questions on dermal absorption. The industry association also indicated that there was not sufficient evidence to support the conclusions of the assessment and that the conclusions overstate the potential risks posed by this substance.
Response: The dermal absorption value does not impact the conclusion that Pigment Red 3 should be considered as harmful to human health, as this conclusion is based on the risk of carcinogenicity at any level of exposure. Also, as required under CEPA 1999, Health Canada applies precaution and weight of evidence in its scientific decision making. Despite the uncertainty in some elements of the assessment of this substance, the available information indicates potential concern for human health and that there is enough evidence to support the addition of Pigment Red 3 to Schedule 1 of CEPA.
The industry association also stated that the analogue used in the assessment for the estimated dermal absorption does not represent a good surrogate for the structure and characteristics of Pigment Red 3.
Response: The screening assessment for Pigment Red 3 used the monoazoanalogue 1-phenylazo-2-naphthalenol (CAS RN 842-07-9) also known as “Sudan 1” to estimate dermal absorption. In a public comment, a different diazo analogue, “Sudan 3” (CAS RN 85-86-9), also known as D&C Red 17, was suggested to be used instead of Sudan 1. Based on molecular size and physicochemical properties, it was determined that Sudan 1 was a better analogue for this substance.
Implementation, enforcement and service standards
The Order adds the four above-mentioned substances to Schedule 1 of CEPA 1999, thereby allowing the Ministers to publish proposed regulations or instruments no later than March 7, 2011, and finalize them no later than September 7, 2012. Developing an implementation plan or a compliance strategy or establishing service standards is not considered necessary without any specific risk management proposals. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for these substances.
Program Development and Engagement Division
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
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.
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