Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE
April 1, 2017
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues As part of the Chemicals Management Plan, (see footnote 1) the Government of Canada (the Government) has completed screening assessments (see footnote 2) of 358 substances within the Aromatic Azo Benzidine-based Substance Grouping (see footnote 3) to assess whether they may pose a danger to human health or the ... (Click for more)
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Published on April 2, 2017
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues As part of the Chemicals Management Plan, (see footnote 1) the Government of Canada (the Government) has completed screening assessments (see footnote 2) of 358 substances within the Aromatic Azo Benzidine-based Substance Grouping (see footnote 3) to assess whether they may pose a danger to human health or the environment. One of the substances assessed was acetamide, N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]-, which according to a section 71 survey under the Canadian Environmental Protection Act, 1999 (CEPA) is primarily used in textile dyeing in Canada. For this specific use, the substance is known as Disperse Yellow 3. It is also known as Solvent Yellow 77. (see footnote 4) Based on the information available, including estimated releases of Disperse Yellow 3 to the aquatic environment, the screening assessment concluded that Disperse Yellow 3 met the environmental criterion for a toxic substance as defined in paragraph 64(a) of CEPA. Therefore, the Government is proposing to add the substance to the List of Toxic Substances in Schedule 1 of CEPA. Background On December 8, 2006, the Chemicals Management Plan was launched by the Government of Canada to assess and manage chemical substances that may be harmful to human health or the environment. One of the initiatives under the Chemicals Management Plan is the Substance Groupings Initiative (see footnote 5) in which the Minister of Health and the Minister of the Environment (the ministers) assess and, where appropriate, manage the potential health and ecological risks associated with approximately 500 substances. To facilitate the screening assessment process, these substances were divided into nine groups based on similar chemical properties and other key similarities. One of these groups, which consists of 358 aromatic azo and benzidine-based substances, was further divided into 10 assessment subgroups. Disperse Yellow 3 was in the “Certain Azo Solvent Dyes” subgroup, while disperse dye-type (e.g. dyeing of textiles) uses of this substance were covered in the “Certain Azo Disperse Dyes” subgroup. (see footnote 6) Substance description Based on information submitted under section 71 of CEPA, this substance was reported to be imported into Canada for its application as a disperse dye in a quantity between 100 and 1 000 kg in 2009, but it was not reported to be manufactured in Canada. Disperse Yellow 3 is primarily used in textile facilities for the dyeing of polyester, polyester blends, nylon, cellulose fibres and acrylics in Canada. Disperse Yellow 3 does not dissolve readily in water and is often in the form of crystals of varying sizes. These properties make it difficult to uniformly distribute the dye in water and can result in uneven dyeing. In order to improve the dyeing process, the substance is finely ground, usually in the presence of a dispersing agent, and then sold as a paste, or spray dried and sold as a powder to customers who use the final product in textile dyeing. Based on the information obtained in section 71 surveys in 2006 and 2009, fewer than four facilities were identified to use Disperse Yellow 3 in the formulation of textile chemicals. Aquatic releases from textile chemicals formulation were estimated based on the daily quantities of azo disperse dyes used. Other parameters considered included emission factor to wastewater, wastewater treatment removal, wastewater flow and receiving water dilution. A total of 38 textile dyeing facilities reported using azo disperse dyes in 2005, 2006, 2008, and 2010 according to section 71 surveys. These facilities were located in three provinces (Ontario, Quebec and Nova Scotia). There are two principal processes that contribute to the potential release of disperse dyes from these facilities, via wastewater, to the aquatic environment: the cleaning of the dye tank following the preparation of the dye bath, and the draining of the dye bath after the dyeing process is complete. Of the total disperse dye that may be released to the environment, approximately 90% originates from the draining of the dye bath following the dyeing process. While some dyeing facilities have on-site wastewater treatment, the presence and type of treatment for each facility varies. As a conservative approximation, it was assumed that azo disperse dyes were released to the sewer system without being removed by on-site wastewater treatment. Screening assessment summary The Government conducted screening assessments for the Aromatic Azo Benzidine-based Substance Grouping, which includes Disperse Yellow 3, to determine if these substances would meet one or more of the criteria for a toxic substance as described in section 64 of CEPA. Specifically, this involves determining whether substances are entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health. Human health assessment Due to the properties of the Aromatic Azo and Benzidine-based Substance Grouping, which includes Disperse Yellow 3, carcinogenicity was generally considered the effect most critical to human health. Therefore, the potential risk to human health for these substances was evaluated by examining their hazard potential, including carcinogenicity, compared to the current level of exposure of the general population of Canada. Disperse Yellow 3 was identified in the screening assessment as having the potential to cause cancer based on evidence of increased tumours in rats and mice from a study by the United States National Toxicology Program. (see footnote 7) In addition, this substance was classified as a Category 2 carcinogen in the European Union. (see footnote 8) Although Disperse Yellow 3 has the potential to pose a risk to human health, the estimated current exposure levels in Canada, which included dermal exposure of the general population (from the dye in textile clothing and leather products), and oral exposure of infants (from mouthing of textiles) to this substance, were sufficiently lower than the estimated level of exposure at which critical health effects would occur. Therefore, the screening assessment concluded that Disperse Yellow 3 does not meet the criterion under paragraph 64(c) of CEPA. (see footnote 9) Environmental assessment Releases of Disperse Yellow 3 to the environment may occur during the dye formulation using the substance or its use in textile dyeing. The substance, when released to the environment, is expected to remain for a long time in water, sediment and soil. The aquatic concentration of Disperse Yellow 3 in the environment was estimated for textile dye formulation and textile dyeing. For textile dye formulation, the aquatic concentration of Disperse Yellow 3 was estimated to be 0.011 milligrams per litre (mg/L) downstream of textile dye formulation facilities. The estimated range of aquatic concentrations derived for textile dyeing facilities was 0.00012 to 0.11 mg/L downstream of textile dyeing facilities. Toxicity tests using fish, crustaceans, and bacteria showed that fish and aquatic invertebrates experienced adverse effects when exposed to azo disperse dyes. Peer-reviewed aquatic toxicity studies were used to estimate a predicted no-effect concentration (PNEC) for Disperse Yellow 3 of 0.0023 mg/L. The PNEC represents a concentration at or below which no critical impacts on organisms’ survival, reproduction, and growth would occur. Given the estimates of aquatic concentrations between 0.00012 mg/L and 0.11 mg/L, this analysis resulted in predicted aquatic concentrations of Disperse Yellow 3 that are 4.7 times greater than the PNEC for textile dye formulation, and aquatic concentrations between 0.05 and 47 times the PNEC for textile dyeing. Therefore, environmental concentrations of Disperse Yellow 3 from textile dye formulation and from textile dyeing may cause harm to aquatic organisms. (see footnote 10) Based on the information available, including estimated releases of Disperse Yellow 3 to the aquatic environment when used in textile dye formulation and textile dyeing, the screening assessment concluded that Disperse Yellow 3 met the environmental criterion for a toxic substance as defined in paragraph 64(a) of CEPA. However, the substance does not meet the criterion under paragraph 64(b) of CEPA. Assessment publication and conclusions On March 11, 2017, the final screening assessment for Certain Azo Disperse Dyes, including Disperse Yellow 3, was published on the Government of Canada’s Chemical Substances website. Based on the results of the final screening assessment, the ministers have concluded that the substance meets the environmental criterion for a toxic substance, as set out under paragraph 64(a) of CEPA, and have therefore recommended the addition of the substance to Schedule 1 of CEPA. (see footnote 11) Objectives The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Minister of the Environment (the Minister) to propose risk management activities under CEPA to manage potential ecological risks associated with Disperse Yellow 3, should such activities be deemed necessary. Description The proposed Order would add acetamide, N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]-, which has the molecular formula C15H15N3O2, to Schedule 1 of CEPA. “One-for-One” Rule The “One-for-One” Rule does not apply, as the proposed Order would not impose any administrative burden on business. Small business lens The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business. Consultation On November 2, 2013, the Government of Canada published the draft Screening Assessment for Certain Azo Disperse Dyes, where this substance was assessed as a disperse dye (known as Disperse Yellow 3), and the draft Screening Assessment for Certain Azo Solvent Dyes, where this substance was assessed as a solvent dye (known as Solvent Yellow 77). (see footnote 12) All publications were subject to a 60-day public comment period. During the 60-day public comment period, there were no comments received pertaining specifically to Disperse Yellow 3. However, comments were received on the disperse dyes and solvent dyes screening assessments in general. (see footnote 13) These included suggestions that only the azo disperse dyes that are in commerce should be found toxic. In addition, a toxicity study was provided that suggests that azo disperse dye substances with large molecular weight (see footnote 14) may not be as hazardous to aquatic organisms as azo disperse dyes with small molecular weight. (see footnote 15) In response, the Government re-evaluated the original proposed conclusion for these substances to conclude that only the smaller azo disperse dyes found to be in commerce posed a risk to the environment. Since Disperse Yellow 3 was the only substance meeting these characteristics, it was concluded that only this substance is toxic. Follow-up on other substances with properties similar to Disperse Yellow 3, which are not reported to be in commerce in Canada or are not included in the Aromatic Azo Benzidine-based Substance Grouping, is being considered, including the use of Significant New Activity (SNAc) provisions, following consultation with stakeholders. Prior to these publications, the Department of the Environment and the Department of Health informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of these documents and of the related public comment period aforementioned. No comments were received from the CEPA NAC. (see footnote 16) Rationale Based on the submitted and available information, in Canada, Disperse Yellow 3 can be released in quantities and in concentrations that may be harmful to the aquatic environment (via publicly owned wastewater systems) as a result of its use in the chemical formulation of dyes or in the dyeing of synthetic textiles. Toxicity information indicates that this substance may be harmful to aquatic organisms and that it may remain for a long time in water, sediment and soil. Therefore, the screening assessment concluded that the use of Disperse Yellow 3 has the potential to cause ecological harm in Canada, and that the substance meets the criterion under paragraph 64(a) of CEPA. Once a final screening assessment under section 74 is published, subsection 77(2) of CEPA requires that one of following measures be proposed: 1. taking no further action with respect to the substance; 2. adding the substance to the Priority Substances List for further assessment; or 3. recommending that the substance be added to the List of Toxic Substances in Schedule 1 and, where applicable under subsection 77(4), recommending the implementation of virtual elimination. Based on the available scientific evidence summarized in this document, the data received from industry regarding the use of Disperse Yellow 3 in Canada, and the conclusions of the peer-reviewed scientific human health and ecological assessments, the Government has determined that taking no further action or adding the substance to the Priority Substances List for further assessment were not appropriate to address the potential for harm to aquatic organisms from current use of Disperse Yellow 3 in Canada. Of the three options required under CEPA, the addition of the substance to Schedule 1 of CEPA is therefore the preferred option. (see footnote 17) The proposed addition of the substance to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or industry, since the proposed Order would not impose any compliance requirement on stakeholders. Accordingly, there would be no compliance or administrative burden imposed on businesses, including small businesses. Rather, the proposed Order is an enabling instrument that allows the Minister to propose risk management activities under CEPA, should they be deemed necessary. If the Minister determines that risk management for Disperse Yellow 3 is required, the Minister will assess the costs and benefits, if required, and consult with the public and other stakeholders during the development of any risk management instrument. In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. More information on this assessment is available at the following address: http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php. Implementation, enforcement and service standards The proposed Order recommends to add the substance to Schedule 1 of CEPA. The final order would allow the development and publication of regulations or instruments under CEPA, if such actions are deemed necessary. Since developing an implementation plan or an enforcement strategy, or establishing service standards are only considered necessary when there is a specific risk management proposal, these measures are not necessary for this proposed Order. Contacts Greg Carreau Program Development and Engagement Division Department of the Environment Gatineau, Quebec K1A 0H3 Substances Management Information Line: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Michael Donohue Risk Management Bureau Department of Health Ottawa, Ontario K1A 0K9 Telephone: 613-957-8166 Fax: 613-952-8857 Email: [email protected] PROPOSED REGULATORY TEXT Notice is given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance 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 by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212 or by email to [email protected] 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, March 23, 2017 Jurica & #268;apkun Assistant Clerk of the Privy Council Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 Amendment 1 Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 18) is amended by adding the following: Acetamide, N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]-, which has the molecular formula C15H15N3O2 Coming into Force 2 This Order comes into force on the day on which it is registered. [13-1-o] Footnote 1 For more information on the Chemicals Management Plan, please visit http://www.chemicalsubstanceschimiques.gc.ca/index-eng.php. Footnote 2 A screening assessment looks at the hazardous properties of the chemical substance and the ways people and the environment are exposed to the hazard. Screening assessments can vary in complexity. Footnote 3 For more information on the Aromatic Azo and Benzidine-based Substance Grouping, please visit http://chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/dyes-colorants-eng.php. Footnote 4 When used in solvent dye applications such as in lacquers and varnishes, printing inks, stains, cosmetics, waxes, and plastics. Footnote 5 For more information on the Substance Groupings Initiative, please visit http://chemicalsubstanceschimiques.gc.ca/group/index-eng.php. Footnote 6 For more information on these subgroups, please visit the Chemical Substances website at http://chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/dyes-colorants-eng.php. Footnote 7 National Toxicology Program (United States). 1982b. Carcinogenesis Bioassay of Disperse Yellow 3 (CAS No. 2832-40-8) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park (NC): U.S. Department of Health & Human Services, National Toxicology Program - Technical Report Series No. 222. Footnote 8 The European Union’s classification of carcinogens consists of three categories: 1. substances known to be carcinogenic to humans; 2. substances which should be regarded as if they are carcinogenic to humans; and 3. substances which cause concern (due to possible carcinogenic effects) for humans but for which the available information is not adequate for making a satisfactory assessment. Footnote 9 For more information on the health assessment for this substance as a disperse dye (Disperse Yellow 3) and as a solvent dye (Solvent Yellow 77), please visit the Chemical Substances website at http://chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/dyes-colorants-eng.php. Footnote 10 For more information on the environmental assessment associated with Disperse Yellow 3, please see the final screening assessment at http://chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/dyes-colorants-eng.php. Footnote 11 The final screening assessment and other related publications can be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3; 819-938-5212 (fax); or by email at [email protected] Footnote 12 On the same date, the Risk Management Scope document, outlining the preliminary options being examined by the Government of Canada for the management of azo disperse dyes, including Disperse Yellow 3, was published on the Chemical Substances website. Footnote 13 For more information on the public comments and responses to these comments, please visit the Chemical Substances website at http://www.chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/dyes-colorants-eng.php#a3. Footnote 14 Azo disperse dyes larger than 360 grams per mole. Footnote 15 Azo disperse dyes smaller than 360 grams per mole. Footnote 16 Section 6 of the Canadian Environmental Protection Act, 1999 provides that the CEPA National Advisory Committee (NAC) be the main intergovernmental forum for the purpose of enabling national action and avoiding duplication in regulatory activity among governments within Canada. This Committee has a representative for the Department of the Environment and for the Department of Health, a representative of each of the provinces and territories, as well as up to six representatives of Aboriginal governments. Footnote 17 The implementation of virtual elimination is not applicable for this substance. Footnote 18 S.C. 1999, c. 33 Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33
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