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Vol. 137, No. 43 — October 25, 2003 Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999Statutory Authority Canadian Environmental Protection Act, 1999 Sponsoring Departments Department of the Environment and Department of Health REGULATORY IMPACT Description The purpose of this initiative is to propose the addition of 2-methoxyethanol and 2-butoxyethanol to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). A scientific assessment conducted indicates that these substances are 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. Therefore, it is recommended that these substances be proposed for addition to the List of Toxic Substances in Schedule 1 of CEPA 1999. The full Assessment Report may be obtained from the Priority Substances List Assessment Report Web Page at www.ec.gc.ca/ substances/ese/eng/psap/final/main.cfm, or from the Inquiry Centre, Environment Canada, Hull, Quebec K1A 0H3, 1-800-668-6767. Authority Subsection 76(1) of CEPA 1999 requires the Minister of the Environment and the Minister of Health to compile a list, to be known as the Priority Substances List (PSL), which may be amended from time to time, and which identifies substances (including chemicals, groups of chemicals, effluents and wastes) that may be harmful to the environment or constitute a danger to human health. The Act also requires both Ministers to assess these substances to determine whether they are toxic or capable of becoming toxic as defined under section 64 of the Act. A substance is determined to be "toxic" if it 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. Assessment of Substances on the Priority Substances List The responsibility for assessing priority substances is shared by Environment Canada and Health Canada. The assessment process includes examining potential effects on humans and other organisms, as well as determining the entry of the substance into the environment, the environmental fate of the substance and the resulting exposure. Upon completion of the scientific assessment for each substance, a draft Assessment Report is prepared and made available to the public. In addition, the Ministers must publish the following in the Canada Gazette: — a summary of the scientific results of the assessment; and — a statement as to whether they propose to recommend that the substance be added to the List of Toxic Substances in Schedule 1; or, that no further action be taken in respect of the substance. The notice in the Canada Gazette provides for a 60-day public comment period during which interested parties can file written comments on the recommendations the Ministers propose to take, and their scientific basis. After taking into consideration any comments received, the Ministers may, if they deem it appropriate, make revisions to the draft Assessment Report. The Ministers must then publish in the Canada Gazette their final decision as to whether they propose to recommend that the substance be added to the List of Toxic Substances in Schedule 1, or whether they recommend that no further action be taken in respect of the substance. A copy of the final report of the assessment is also made available to the public. If the Ministers' final decision is to propose that the substance be added to the List of Toxic Substances in Schedule 1, they must also recommend to the Governor in Council that the substance be added to the List. Once the Ministers' final decision is made public, the Government must publish within two years, in the Canada Gazette, Part I, a proposed regulation or instrument respecting preventive or control actions. 2-Methoxyethanol 2-methoxyethanol is not commercially produced in Canada. It is imported for use mainly in the production of other chemicals and as a solvent in industrial processes, including small uses in electronics and pharmaceutical manufacturing. It is also used as a solvent in a number of consumer products, including paints, paint thinners and cleaning products. Though data on effects in humans are not available, based on a relatively extensive database in experimental animals, 2-methoxyethanol is associated with a wide range of adverse effects on health, including those considered to be severe and irreversible (e.g. effects on the developing fetus), with some occurring at relatively low levels of exposure. Due to reported declining use of the compound in recent years as it is replaced with less hazardous compounds, exposure of the general population through environmental media is expected to be low; any exposure would likely be due to emissions to air from facilities where it might still be used, and from consumer products that still contain the substance. Quantitative worst-case estimates of human exposure in the general environment in Canada are much lower than levels of exposure that have induced developmental toxicity in experimental animals. However, it cannot be confidently concluded that, based on worst-case estimates, exposure of humans to the substance in consumer products wouldn't approach levels of exposure which have induced toxic effects in experimental animals. Principally on the basis of its high health hazard potential, 2-methoxyethanol 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. Therefore, 2-methoxyethanol is considered to be "toxic" as defined under section 64 of CEPA 1999. 2-Butoxyethanol 2-Butoxyethanol is not commercially produced in Canada, but it is imported for use mainly as a solvent for formulations in paints and coatings, inks and cleaning products. 2-Butoxyethanol is also used to a much lesser extent as an additive to hydraulic fluids, and in the chemical processing for plasticizers and other compounds. Most reported environmental releases are to the atmosphere, with some minor releases to water. However, the exposure route of concern for this substance is not through the environment but their presence in consumer products. Available data indicate that inhalation of 2-butoxyethanol in air is an important route of exposure for humans, with estimated exposure through use of consumer products containing the substance (such as cleaning agents) being considerable. Based largely on the results of studies in experimental animals, exposure to 2-butoxyethanol in air causes effects on the blood associated with the destruction of red blood cells. Since concentrations of 2-butoxyethanol in ambient air in Canada are low, it is believed that there is little likelihood that ambient levels would induce such effects in the general population. However, exposure to 2-butoxyethanol during use of some consumer products containing the substance could potentially be higher than a level that would be considered protective for these effects in humans. 2-Butoxyethanol is considered to 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. Therefore, 2-butoxyethanol is considered to be "toxic" as defined in section 64 of CEPA 1999. Alternatives The Assessment Report concludes that 2-methoxyethanol and 2-butoxyethanol are considered to 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. Consequently, the Ministers have determined that the alternative of taking no further action is not acceptable for these substances. When the Ministers publish their Final Decision of an Assessment Report and indicate that they propose to recommend a substance for addition to Schedule 1, they must publish within two years a proposed regulation or instrument respecting preventive or control actions for the substance. Benefits and Costs The addition of 2-methoxyethanol and 2-butoxyethanol to the List of Toxic Substances will enable the taking of preventive or control actions to ensure the protection of human health. The decision to amend the List of Toxic Substances in Schedule 1 of CEPA 1999 is based solely on a science assessment. The Government will undertake an appropriate assessment of the potential impacts of a range of possible instruments during the risk management phase. Consultation A notice concerning the assessment of this priority substance under CEPA 1999 was published in the Canada Gazette, Part I, as follows:
The notice was posted on Environment Canada's "The Green Lane" Web site and on the CEPA Registry Web pages. The above notice offered interested parties the opportunity to comment, within 60 days, on the draft Priority Substances Assessment Report and the Ministers' proposal to have 2-methoxyethanol and 2-butoxyethanol added to the List of Toxic Substances in Schedule 1 of CEPA 1999. Comments, most of which were technical in nature, were received from industrial stakeholders during the 60-day public comment period. There were no concerns raised with respect to the addition of 2-methoxyethanol to Schedule 1, the List of Toxic Substances, while objections were raised by industrial stakeholders concerning the addition of 2-butoxyethanol. These objections related principally to concern about the estimates of exposure included in the health-related sections of the Assessment Report. The submitted technical comments of the industrial stakeholders were carefully considered, the text of the draft Assessment Report revised as documented in the response to comments, and the document additionally peer-reviewed. The final revisions did not impact on the proposed conclusion of "toxic" under CEPA 1999. The public comments and responses on the draft Assessment Report may be obtained from the Priority Substances List Assessment Report Page (www.ec.gc.ca/substances/ese/eng/psap/ final/main.cfm). Industrial stakeholders also submitted additional data related to health effects well after the cut-off date for consideration of data for the PSL assessment. Preliminary review of these data indicate that they are unlikely to impact upon the conclusion of "toxic" under CEPA 1999, and industrial stakeholders have been informed of this outcome in correspondence and in meetings. The CEPA National Advisory Committee has been given an opportunity to advise the Ministers on the scientific evidence supporting the declaration of these substances as toxic and their proposal to have them added to the List of Toxic Substances in Schedule 1. Compliance and Enforcement There are no compliance or enforcement requirements associated with the List of Toxic Substances in Schedule 1 itself. Bette E. Meek, Manager, Existing Substances Division, Environmental Health Centre, Health Canada, Tunney's Pasture, Ottawa, Ontario K1A 0L2, (613) 957-3129 (Telephone), bette_ meek@hc-sc.gc.ca (Electronic mail); and Céline Labossière, Policy Manager, Regulatory and Economic Analysis Branch, Environment Canada, Gatineau, Quebec K1A 0H3, (819) 997-2377 (Telephone), celine.labossiere@ec.gc.ca (Electronic mail). Notice is hereby given, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 (see footnote a), that the Governor in Council, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999. Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Janet Beauvais, Director, Existing Substances Branch, Toxics Pollution Prevention Directorate, Environmental Protection Service, Department of the Environment, Ottawa, Ontario K1A 0H3. A person who provides information to the Minister may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, October 23, 2003
EILEEN BOYD
ORDER ADDING TOXIC SUBSTANCES AMENDMENT 1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following: 2-butoxyethanol, which has the molecular formula C6H14O2 2-methoxyethanol, which has the molecular formula C3H8O2 COMING INTO FORCE 2. This Order comes into force on the day on which it is registered. [43-1-o] S.C. 1999, c. 33 S.C. 1999, c. 33 |
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