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Vol. 140, No. 24 — June 17, 2006 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 (This statement is not part of either the proposed Order or the proposed Regulations.) Description Purpose The purpose of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to add the following substances (hereinafter referred to as the four new fluorotelomer-based substances) to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Act): Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethyl-poly(difluoromethylene), C16-20-branched alcohols and 1-octadecanol 2-propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5-furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate-initiated 2-propen-1-ol, reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine Adding the four fluorotelomer-based substances to Schedule 1 enables the making of regulations in respect of these substances under the Act. The purpose of the proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2005 (Four New Fluorotelomer-based Substances) [hereinafter referred to as the proposed Regulations] is twofold. First, the proposed Regulations will add a new part to Schedule 1 to the Prohibition of Certain Toxic Substances Regulations, 2005 (hereinafter referred to as the 2005 Regulations). The 2005 Regulations prohibit the manufacture, use, sale, offer for sale and import of the toxic substances listed in Schedules 1 and 2 to the Regulations. Schedule 1 lists prohibited toxic substances subject to total prohibitions, with the exception of incidental presence. Schedule 2 includes toxic substances that are subject to prohibitions related to concentration or use. The new part in Schedule 1, entitled "Prohibited toxic substances unless present in manufactured items," will allow for excluding from the prohibitions certain manufactured items where the prohibited substances are present. Second, the proposed Regulations will add the aforementioned four new fluorotelomer-based substances to the new part in Schedule 1 to the 2005 Regulations. The proposed Regulations will maintain the prohibition imposed through three Notices of Ministerial Prohibitions published in Part I of the Canada Gazette on July 17, 2004, under the authority of subsection 84(5) of the Act and a fourth one published on February 5, 2005. The proposed Regulations will replace these four notices, upon entry into force. In essence, the proposed Regulations will prohibit the manufacture, use, sale, offer for sale and importation of the four new fluorotelomer-based substances. This prohibition will not apply to the four new fluorotelomer-based substances when present in certain manufactured items. Assessment of the four new fluorotelomer-based substances The Act requires, under the new substances notification and assessment regime established under sections 80 to 89, that no new substance be introduced into Canadian commerce without first being assessed to determine if it could pose a risk to Canadians or the environment. The Act empowers the Minister of the Environment to intervene quickly when this assessment leads to a suspicion that a new substance meets any of the criteria set out in section 64 of the Act, including prohibiting the substance. However, a prohibition imposed by the Minister on a substance expires after two years, unless a proposal to regulate the substance is published in the Canada Gazette. In 2004, the four new fluorotelomer-based substances were assessed by Environment Canada and Health Canada after notifications were received from companies wishing to market these substances in Canada. According to the notifications submitted, these substances could be used in stain and water repellents for materials such as paper, fabric, leather and carpets, as well as stone and tile; in sizing agents (to resist the spreading and penetration of liquids) for packaging and paper products; and in leveling agents (to provide an even surface) in coatings. Based on the results of the assessments, the Minister of the Environment prohibited the importation and manufacture of the four new fluorotelomer-based substances. These prohibitions will expire on June 23, 2006, for three of the substances, and on January 17, 2007, for the fourth one, unless regulations are proposed in respect of these substances. The assessments of the four new fluorotelomer-based substances were based upon information submitted by the notifiers, scientific literature, and information otherwise available to the Minister of the Environment and the Minister of Health at the time. The assessments indicated that the four new fluorotelomer-based substances are ultimately sources of perfluorinated carboxylic acids (PFCAs) through the release of precursors. PFCA precursors can be released from fluorotelomer-based substances in two ways:
Figure 1 shows the transformations leading to the formation of PFCAs. Figure 1: Formation of PFCAs
The PFCAs formed from fluorotelomer-based substances contain a range of carbon chain lengths. Evidence indicates certain PFCA precursors are volatile and subject to long-range transport via the atmosphere. PFCAs themselves may be subject to long-range transport via oceanic currents. Increasing the carbon chain length of PFCAs tends to increase their bioaccumulation in fish and clearance time in certain mammals. Monitoring data show the widespread presence of low levels of PFCAs in wildlife, and based on archived tissue samples, increasing concentrations in certain species over time. Field studies have also shown evidence of biomagnification, meaning higher concentrations are found in organisms at higher levels of the food chain. Based on bioconcentration factors and biomonitoring studies, longer carbon chain length PFCAs (≥ 9 carbons) are considered bioaccumulative, meaning they collect in living organisms. PFCAs are considered environmentally persistent, as they may degrade in the environment at only extremely slow rates. According to available data with experimental animals, including data on similar substances, the four new fluorotelomer-based substances themselves are expected to show low potential for irritating the skin or the eyes, low toxicity following short-term exposure by the oral route, and low potential to adversely affect reproduction or offspring development. However, due to the presence of certain unreacted PFCA precursors, long-term repeated exposure to these substances could result in adverse effects on the thyroid, liver, and kidney. The hazard evaluation of the PFCAs, which are the ultimate degradation products from the four new fluorotelomer-based substances, is based on available data, principally on perfluorooctanoic acid (PFOA), the 8 carbon PFCA. The acute and chronic hazard profile for aquatic organisms is low to moderate. For mammalian species, PFOA and its salts were found to cause cancer in rats and adverse effects on the immune system in mice. In addition, PFOA and its salts can display reproductive or developmental toxicity in rodents at moderate levels of exposure, and moderate to high systemic toxicity in rodents and monkeys following long-term exposure by the oral route. It has been assumed for these assessments that despite the absence of robust toxicity datasets for longer chain PFCAs, these substances are reasonably expected to be of greater concern than PFOA, as a result of their known slower clearance rates—rate at which a substance is eliminated or biodegraded in an organism—and higher potential to bioaccumulate. The assessments do not attribute the environmental presence of PFCAs solely to the four new fluorotelomer-based substances, nor do they preclude contribution from other substances or international sources. However, if introduced into Canadian commerce, the four new fluorotelomer-based substances would constitute new sources of PFCAs. Since the completion of the assessments in 2004, there have been over 100 relevant publications in peer-reviewed journals and numerous presentations made at conferences. At the beginning of 2006, this information was reviewed in order to account for findings of the current science and to update the original new substances assessment conclusions. Key information supports the conclusion that fluorotelomer-based substances used in household products could be continually releasing PFCA precursors. Fluorotelomer-based monomers, which are used to manufacture substances for treating consumer products, have been shown to biodegrade, releasing PFCA precursors. Two studies of indoor air have shown the presence of PFCA precursors associated with dust particles, which suggests sources such as treated carpets or textiles. In addition, PFCA precursors were measured at levels up to 3.8% in a study of several industrial and consumer products containing fluorotelomer-based substances, including certain surfactants, carpet protector products and windshield wiper fluid. Recent studies continue to report levels of PFCAs in a variety of environmental media that directly impact human exposure, such as indoor air, dust, food and drinking water. Biomonitoring clearly demonstrates that the longer chain length PFCAs (≥C9) are accumulating in a wide variety of freshwater and marine animals in Canada and other regions of North America and Europe. In addition, further evidence is available demonstrating that PFCAs are capable of biomagnification and the concentrations in certain biota are increasing over time. The recently available ecotoxicity studies provide further support for the low-to-moderate acute toxicity for PFCAs; however, there is now evidence to suggest long-term multigenerational effects and the potential for decreased biodiversity in aquatic ecosystems. The presence of PFOA and other polyfluorinated substances in human blood has been confirmed globally. Detection of PFOA in seminal plasma, breast milk and umbilical cord blood raises new concerns regarding routes of exposure and potential effects. Recently reviewed information is supportive of the original human health assessment conclusions. For example, the species-dependent rates of elimination of PFOA are better established. Gene expression experiments have now implicated PFOA in affecting the metabolism of lipids and fatty acids. Deliberations of the Science Advisory Board PFOA Review Panel of the United States Environmental Protection Agency (U.S. EPA) have, at present, led to a recommended classification of PFOA as "likely to be carcinogenic" to humans. As well, a recent study suggests mixtures of PFCAs are more toxic than PFOA alone. Based on these considerations, the Minister of the Environment and the Minister of Health conclude that the four new fluorotelomer-based substances 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 and may constitute a danger in Canada to human life or health. Therefore, the Ministers conclude that these substances meet the criteria set out in paragraphs 64(a) and 64(c) of the Act. The assessment reports and the document updating these assessments may be obtained from the New Substances Division, Environment Canada, Gatineau, Quebec K1A 0H3, 1-800-567-1999. Context for the proposed Regulations The four new fluorotelomer-based substances belong to the larger class of fluorochemicals referred to as polyfluorinated alkyl compounds, which includes several substances already in commerce in Canada that are also potential sources of PFCAs. Environment Canada and Health Canada have developed an Action Plan to address the assessment and management of all PFCAs and their precursors. The Action Plan contains the following main elements:
The proposed Regulations address the first element of the Action Plan, by prohibiting the introduction into Canada of the four new fluorotelomer-based substances. A copy of the Action Plan may be obtained from the following Web site: www.ec.gc.ca/TOXICS/EN/detail.cfm?par_substance ID=199∥_actn=s1 or from the officials identified at the end of this document. A notice summarizing the proposed Action Plan is being published, concurrently with the publication of the proposed Regulations, in the Canada Gazette, Part I. Other countries have also indicated concerns over PFCAs and continue to discuss research needs, as well as monitoring, risk assessment and risk reduction activities. While working under a different regulatory framework, the U.S. EPA uses the same approach of stopping the entry into commerce of new sources of PFCAs. As well, in January 2006, the U.S. EPA invited all manufacturers of similar substances already in U.S. commerce to work toward essentially eliminating emissions of certain PFCAs and their precursors from manufactured facilities and as residuals in commercial products. Measures included in the Canadian Action Plan to address sources of PFCAs already in Canadian commerce are consistent with U.S. EPA actions. Alternatives Proposed Order Status Quo The assessment of alternatives for managing the risk posed by the four fluorotelomer-based substances indicated that regulations are the instrument that would most effectively continue the prohibitions imposed through the four Notices of Ministerial Prohibitions. Since regulations can only be made under the Act with respect to substances specified on Schedule 1 to the Act, the alternative of not listing the four new fluorotelomer-based substances on Schedule 1 is not viable. Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 The addition of the four fluorotelomer-based substances to Schedule 1 to the Act enables the making of regulations in respect of these substances to ensure the protection of human health and of the environment. Proposed Regulations Status Quo Taking no action at this time would mean the possible introduction of the four new fluorotelomer-based substances into Canada once the ministerial prohibitions imposed on these substances would expire. This would result in new sources of PFCAs in the Canadian environment. The persistent and bioaccumulative nature of long chain PFCAs warrants the taking of action to prevent new sources of PFCAs from entering into Canada. Pollution prevention plans Pollution prevention plans are better suited for environmental management than for addressing the import and manufacture of the four new fluorotelomer-based substances. Because these substances are currently not in use in Canada, it would also be difficult to capture all potential importers, manufacturers and users of these substances. Market-based instruments Market-based instruments like tradable permits and deposit-refund systems cannot ensure that the substances would not be imported or manufactured in Canada. This type of instrument can generally be used as a step towards phasing out occurring substances, and as a means to implement extended producer responsibility programs. Voluntary instruments Voluntary instruments such as codes of practices and guidelines would not achieve the necessary shift in behaviour by the targeted sectors. These instruments would not address the prohibition on the import, manufacture and use of the four new fluorotelomer-based substances; rather they would target limiting the release of the substances from industrial sources or defining best industrial practices. Other voluntary tools like Environmental Performance Agreements present some limitations in this case. In particular, it would be difficult to determine who would be a party to such an agreement when there is no import/manufacture. Signing an agreement with the notifiers might not capture all the targeted parties, thus creating the risk of import and/or manufacture of the substances. Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2005 (Four New Fluorotelomer-based Substances) The proposed Regulations were identified as the instrument that would most effectively continue the prohibitions imposed through the four Notices of Ministerial Prohibitions. The proposed Regulations would apply equally to everyone, thus providing for a level playing field. They would also provide the authority to enforce its provisions. Benefits and costs Proposed Order The decision to add the four new fluorotelomer-based substances to Schedule 1 to the Act is based primarily on scientific assessments. An assessment of the potential impacts of risk management measures was carried out for the proposed Regulations. Proposed Regulations The proposed Regulations will prevent the introduction of a new source of PFCAs in Canada, hence protecting human health and the environment. Even though the four new fluorotelomer-based substances represent a small portion of the environmental sources of PFCAs, the proposed Regulations are a first step towards developing more comprehensive risk management measures for PFCAs and their precursor substances. Industry will not be able to introduce the regulated substances into Canada. Thus, industry will not have the opportunity to use these substances in a number of applications. The availability of other fluorotelomer-based substances as well as hydrocarbon-based and silicone-based polymer with similar properties indicates that this lost opportunity will likely result in negligible, if any, incremental costs to the Canadian industry. The number of companies involved with these substances is relatively small. Therefore, Government costs associated with promoting compliance and enforcing the proposed Regulations are expected to be minimal. The proposed Regulations have been identified as a first step towards a more comprehensive approach for dealing with PFCAs and their precursors. The potential benefits and costs of additional measures for addressing the risks posed by PFCAs and their precursors will be assessed as new measures are developed. Consultation Proposed Order and Regulations A multi-stakeholder consultation meeting was held in Ottawa, in February 2006, involving representatives from industry, academia, environmental non-governmental organizations (ENGOs) and governmental organizations. In addition, informal discussions also took place with the same stakeholders throughout the risk assessment and management process. The proposed risk management strategy for the four new fluorotelomer-based substances, as well as the proposed Action Plan for PFCAs and their precursors, were distributed to interested stakeholders for comments and posted on Environment Canada's Web site. As previously mentioned, the Action Plan outlines how the proposed Regulations fit within the suite of actions intended to address the class of similar substances already in commerce in Canada. Overall, stakeholders agreed on the need to take action on the four new fluorotelomer-based substances. However, they expressed some concerns. ENGOs were concerned about what was perceived as a lack of harmonization between the proposed Regulations and the actions proposed for similar substances already in Canadian commerce. They were of the opinion that the proposed Regulations represented only one of several important and necessary steps to reduce the impacts of exposure from perfluorinated substances to the environment and human health, and that an overall objective of elimination for similar substances already in Canadian commerce was needed. Industry stakeholders argued that it is not essential to maintain the prohibition for the four new fluorotelomer-based substances. They suggested that it would be sufficient to include the four new fluorotelomer-based substances in the proposed plan for addressing fluorotelomer-based substances already in Canadian commerce. In particular, they were concerned that adding these substances to Schedule 1 to the Act could negatively impact the market perception of the whole class of similar substances. The proposed Regulations are consistent with the preventive approach that is the basis of the Act and the New Substances Program of Environment Canada and Health Canada. The intent of the New Substances Program is to ensure that no new substance is introduced into Canada before an assessment is made. If a substance has the potential to pose a risk to the environment or to human health, control measures are put in place before they are introduced into the Canadian marketplace. The ability to act early is an essential component of the federal management of toxic substances. Risk management actions imposed at an early stage of a substance's life cycle are arguably more cost-effective than actions taken after a substance has become "entrenched" in the economy. Similar substances already in Canadian commerce will be addressed as a separate step under the Action Plan. In addition, other countries are also starting to take action, and alternatives with a more favourable environmental profile are becoming available. Some stakeholders were also concerned that imported manufactured items treated with the four new fluorotelomer-based substances were not included under the scope of the proposed Regulations, as they would also be a source of PFCAs. Environment Canada and Health Canada agree that this is an important aspect to consider. However, at the present time, controlling the import of manufactured items containing the four new fluorotelomer-based substances is not practical. In particular, it would be difficult to identify the substances in manufactured items (e.g. some items have the substances sprayed on them), as there are difficulties associated with sampling and testing. This issue will be considered as part of our next steps towards the management of PFCAs and their precursors. Compliance and enforcement Proposed Order There are no compliance or enforcement requirements associated with Schedule 1 itself. Proposed Regulations As the proposed Regulations will be promulgated under the Act, enforcement officers will, when verifying compliance with the Regulations, apply the Compliance and Enforcement Policy implemented under the Act. The Policy outlines measures designed to promote compliance and consultation on the development of Regulations. A copy of the Policy may be obtained from the following Web site: www.ec.gc.ca/CEPARegistry/documents/policies/candepolicy/toc.cfm. When verifying compliance with these Regulations, enforcement officers will abide by the Compliance and Enforcement Policy, which also sets out the range of possible responses to violations, including warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a violation under the Act). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery. When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, the officer will choose the appropriate enforcement action based on the following factors:
Josée Portugais, Head, Controls Development Unit, Chemicals Sector Division, Environment Canada, 351 Saint-Joseph Boulevard, 12th Floor, Gatineau, Quebec K1A 0H3, (819) 953-6984 (telephone), (819) 994-0007 (fax), josee.portugais@ec.gc.ca (email); or Céline Labossière, Policy Manager, Impact Analysis and Instrument Choice Division, Environment Canada, 10 Wellington Street, 24th Floor, Gatineau, Quebec K1A 0H3, (819) 997-2377 (telephone), (819) 997-2769 (fax), celine.labossiere@ec.gc.ca (email). Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council proposes, pursuant to subsection 90(1) of that Act, 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 sent to the Director General, Pollution Prevention, Environmental Stewardship, Department of the Environment, Ottawa, Ontario K1A 0H3. A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, June 8, 2006
DIANE LABELLE ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999 AMENDMENT 1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following: Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethyl-poly(difluoromethylene), C16-20-branched alcohols and 1-octadecanol 2-propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5-furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate-initiated 2-propen-1-ol reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine COMING INTO FORCE 2. This Order comes into force on the day on which it is registered. [24-1-o] S.C. 2004, c. 15, s. 31 S.C. 1999, c. 33 S.C. 1999, c. 33 |
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