Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2018-129
Canada Gazette, Part II, Volume 152, Number 14
June 22, 2018
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2018-845 June 21, 2018
Whereas, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on April 1, 2017, a copy of the proposed Order Adding a Toxic Substance 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 substance set out in the annexed Order is a toxic substance;
Therefore, Her 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 footnote b, makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 1 is amended by adding the following in numerical order:
- 141 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.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
As part of the Chemicals Management Plan, footnote 2 the Government of Canada (the Government) completed screening assessments footnote 3 of 358 Aromatic Azo Benzidine-based substances footnote 4 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]-, also known as Disperse Yellow 3 or Solvent Yellow 77. footnote 5, footnote 6
The screening assessment concluded that Disperse Yellow 3 met the environmental criterion for a toxic substance as defined in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government is adding the substance to the List of Toxic Substances in Schedule 1 of CEPA.
On December 8, 2006, the Chemicals Management Plan (CMP) was launched by the Government of Canada to assess and manage chemical substances that may be harmful to human health or the environment. Disperse Yellow 3 was assessed under the CMP.
Substance description and sources of release
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. During a typical dyeing process, the dye bath is prepared, which involves the addition of the dye and a dispersing agent to hot water.
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. Fewer than four facilities were identified to use Disperse Yellow 3 in the formulation of textile chemicals in 2006 and 2009. 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.
The ecological and human health components of the assessment have undergone external written peer review or consultation by Canadian and international experts selected from government organizations, academia and stakeholders. The assessment concluded that Disperse Yellow 3 meets the criterion for a toxic substance under paragraphs 64(a) but not (b) or (c) of CEPA. Below, please find summaries of the ecological and human health components of the assessment for Disperse Yellow 3.
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. footnote 7 In addition, this substance was classified as a Category 2 carcinogen in the European Union. 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. footnote 9
Releases of Disperse Yellow 3 to the environment may occur during the textile dye formulation or its use in textile dyeing through wastewater releases. The substance, when released to the environment, is expected to remain for a long time in water, sediment and soil.
The predicted environmental concentration (PEC) of Disperse Yellow 3 in the aquatic environment downstream of textile dye formulation and textile dyeing facilities was estimated. 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. The PNEC represents a concentration at or below which no critical impacts on organisms’ survival, reproduction, and growth would occur. There is a potential for ecological harm when the PEC results show that the concentration in the water would be higher than the PNEC, as in the case of Disperse Yellow 3.
Given this information, 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 as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends. footnote 10
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 therefore recommend the addition of Disperse Yellow 3 to Schedule 1 of CEPA. footnote 11
The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to propose risk management activities under CEPA to manage potential ecological risks associated with Disperse Yellow 3.
The Order adds acetamide, N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]-, which has the molecular formula C15H15N3O2, to Schedule 1 of CEPA.
The “One-for-One” Rule does not apply, as the Order does not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the Order does not impose any compliance or administrative costs on small business.
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). 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. 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 footnote 14 may not be as hazardous to aquatic organisms as azo disperse dyes with small molecular weight. footnote 15 In response, the Government re-evaluated the originally proposed conclusion for these substances to conclude that only the smaller molecular weight 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 application of the Significant New Activity (SNAc) provisions, following consultation with stakeholders.
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. The proposed order and Regulatory Impact Analysis Statement were published on April 1, 2017, for a 60-day public comment period. No comments were received on the proposed order.
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. footnote 16
Based on the submitted and available information, 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 in Canada. 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 the Ministers propose one of the following measures:
- taking no further action with respect to the substance;
- adding the substance to the Priority Substances List for further assessment; or
- 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. footnote 17
The addition of the substance to Schedule 1 of CEPA does not result in any incremental impacts (benefits or costs) on the public or industry, since the Order does not impose any compliance requirement on stakeholders. Accordingly, there is no compliance or administrative burden imposed on businesses, including small businesses. Rather, the Order is an enabling instrument that allows the Minister to propose risk management activities under CEPA. The proposed risk management approach was published in March 2017. footnote 18
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 (SEA) was completed under the CMP. The detailed analysis that was completed as part of the SEA indicated that the CMP will have a positive effect on the environment and human health. footnote 19, footnote 20
Implementation, enforcement and service standards
The Order recommends adding the substance to Schedule 1 of CEPA and allows for 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 Order.
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