Canada Gazette, Part I, Volume 150, Number 22: GOVERNMENT NOTICES

May 28, 2016

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Federal Environmental Quality Guidelines for certain substances

Whereas the Minister of the Environment is required to issue environmental quality guidelines for the purpose of carrying out the Minister's mandate respecting preserving the quality of the environment;

Whereas the guidelines relate to the environment pursuant to paragraph 54(2)(a) of the Canadian Environmental Protection Act, 1999;

Whereas the Minister of the Environment has offered to consult provincial and territorial governments and the members of the National Advisory Committee who are representatives of indigenous governments in accordance with subsection 54(3) of the Act;

And whereas at least 60 days have elapsed following the day on which the Minister offered to consult in accordance with subsection 54(3) of the Act,

Now, therefore, the Minister of the Environment, pursuant to subsections 54(1) and 54(4) of the Act, gives notice of the Federal Environmental Quality Guidelines (FEQGs) for certain substances listed in the Annex hereby. These Guidelines are available on the Chemical Substances Web site at www.chemicalsubstances.gc.ca.

Inquiries concerning the Guidelines may be directed to the National Guidelines and Standards Office, Science and Risk Assessment Directorate, Environment Canada, 351 Saint-Joseph Boulevard, 6th Floor, Gatineau, Quebec K1A 0H3, 1-800-567-1999 (toll free in Canada), 819-938-5212 (fax), or by email to EC.RQE-EQG.EC@canada.ca.

CATHERINE McKENNA
Minister of the Environment

ANNEX

Federal Environmental Quality Guidelines (FEQGs) have been issued for the following substances or groups of substances:

chlorinated alkanes
hexabromocyclododecane
tetrabromobisphenol A
vanadium

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice with respect to the Code of Practice to Reduce Fugitive Emissions of Total Particulate Matter and Volatile Organic Compounds from the Iron, Steel and Ilmenite Sector and with respect to the Code of Practice to Reduce Emissions of Fine Particulate Matter (PM_2.5) from the Primary Aluminum Sector

Whereas on May 28, 2016, the Minister of the Environment issues, under subsection 54(1) of the Canadian Environmental Protection Act, 1999, the Code of Practice to Reduce Fugitive Emissions of Total Particulate Matter and Volatile Organic Compounds from the Iron, Steel and Ilmenite Sector and the Code of Practice to Reduce Emissions of Fine Particulate Matter (PM_2.5) from the Primary Aluminum Sector.

Notice is hereby given that the Minister of the Environment has made available the following codes of practice issued under subsection 54(1) of that Act:

Code of Practice to Reduce Fugitive Emissions of Total Particulate Matter and Volatile Organic Compounds from the Iron, Steel and Ilmenite Sector
Code of Practice to Reduce Emissions of Fine Particulate Matter (PM_2.5) from the Primary Aluminum Sector

Electronic copies of these codes of practice may be downloaded from the Internet at the following addresses: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=A4BFECB4-1 (steel) and http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=BF9A6F9A-1 (aluminium). Paper copies are available from Environment Canada's Inquiry Centre at 1-800-668-6767.

VIRGINIA POTER
Director General
Industrial Sectors, Chemicals and Waste Directorate

On behalf of the Minister of the Environment

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a living organism — Candida utilis strain ATCC (see footnote 1) 9950 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Candida utilis strain ATCC 9950 is a living organism that has been added to the Domestic Substances List under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on this living organism pursuant to paragraph 74(b) of the Act is annexed hereby;

Whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given under section 77 of the Act that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Candida Utilis Strain ATCC 9950

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Candida utilis (C. utilis) ATCC 9950.

C. utilis ATCC 9950 is a yeast that has characteristics in common with other strains of the species C. utilis. C. utilis can adapt to varying conditions and thrives in soil and water. Multiple potential uses of C. utilis in consumer, industrial, commercial and agricultural sectors exist. These include production of food, natural health products, feeds, biochemicals used in cosmetics and therapeutic drugs, bioremediation and wastewater treatment.

C. utilis has an established history of use as a feed supplement in aquaculture, swine, poultry, and livestock diets, yet only two incidents of infection in vertebrates have been attributed to C. utilis. In both cases, the affected animals had pre-existing conditions and the infections were effectively treated with antifungals. No reports in the literature showed significant effects of C. utilis in terrestrial or aquatic plants or invertebrates. Certain strains of C. utilis have anti-algal, antibacterial and anti-fungal properties, which allow its use as a biocontrol agent against pest micro-organisms.

Although C. utilis has also been extensively used in the food industry, the incidence of human infection with C. utilis is exceedingly low. There have been no reported human infections attributed specifically to the Domestic Substances List (DSL) strain C. utilis ATCC 9950; however, some strains of C. utilis can act as opportunistic pathogens in susceptible individuals, particularly those who have a weakened immune system or underlying medical conditions.

This assessment considers the aforementioned characteristics of C. utilis ATCC 9950 with respect to environmental and human health effects associated with consumer and commercial product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. A conclusion under CEPA on this living organism has no bearing on and does not preclude assessments, authorized under the Food and Drugs Act, of products produced by or containing C. utilis ATCC 9950. C. utilis ATCC 9950 was nominated to the DSL because of its use in the food industry. To update information on current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA (section 71 notice) as published in the Canada Gazette, Part I, on October 3, 2009. Information submitted in response to the notice indicates that C. utilis ATCC 9950 was imported into Canada in 2008 for use in food production and processing. No uses related to consumer products were reported in Canada.

Considering all available lines of evidence presented in this Screening Assessment, there is low risk of harm to organisms and the broader integrity of the environment from C. utilis ATCC 9950. It is concluded that C. utilis ATCC 9950 does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is not 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 or that constitute or may constitute a danger to the environment on which life depends.

Based on the information presented in this Screening Assessment, it is concluded that C. utilis ATCC 9950 does not meet the criteria under paragraph 64(c) of CEPA as it is not 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.

Conclusion

It is concluded that C. utilis ATCC 9950 does not meet any of the criteria set out under section 64 of CEPA.

The Screening Assessment for this living organism is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a living organism — Pseudomonas sp. ATCC (see footnote 2) 13867 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Pseudomonas sp. ATCC 13867 is a living organism that has been added to the Domestic Substances List under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on this living organism pursuant to paragraph 74(b) of the Act is annexed hereby;

Whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given under section 77 of the Act that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Pseudomonas sp. ATCC 13867

Pseudomonas sp. ATCC 13867 belongs to a group of strains that are currently without a validated species name. Prior to 1982, the species was referred to as Pseudomonas denitrificans before that name was officially rejected. For the purposes of this assessment, the name “Pseudomonas sp. ATCC 13867” will be used when information pertains specifically to this strain.

Pseudomonas sp. ATCC 13867 is a bacterium that can proliferate in soil and water. It has properties that make it of potential use in the production of vitamin B₁₂, coenzyme Q, other biochemicals and biofuels, as well as in denitrification products for use in soil improvement, in treatment of activated sludge and wastewater and oil degradation.

No adverse effects in terrestrial or aquatic plants, invertebrates or vertebrates or infections in humans have been attributed to Pseudomonas sp. ATCC 13867 or its close relatives.

This assessment considers the aforementioned characteristics of Pseudomonas sp. ATCC 13867 with respect to environmental and human health effects associated with consumer and commercial product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey (section 71 notice) under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009. Information submitted in response to the section 71 notice indicates that Pseudomonas sp. ATCC 13867 was not imported into or manufactured in Canada in 2008.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from Pseudomonas sp. ATCC 13867. It is concluded that Pseudomonas sp. ATCC 13867 does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not 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 or that constitute or may constitute a danger to the environment on which life depends.

Based on the information presented in this Screening Assessment, it is concluded that Pseudomonas sp. ATCC 13867 does not meet the criteria under paragraph 64(c) of CEPA, as it is not 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.

Conclusion

It is concluded that Pseudomonas sp. ATCC 13867 does not meet any of the criteria set out in section 64 of CEPA.

The Screening Assessment for this living organism is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — Carbamic acid, ethyl ester (ethyl carbamate), CAS RN (see footnote 3) 51-79-6 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas carbamic acid, ethyl ester is a substance on the Domestic Substances List;

Whereas a summary of the Screening Assessment conducted on the substance pursuant to paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999 is annexed hereby;

Whereas it is concluded that the substance meets the criterion set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 and constitutes or may constitute a danger in Canada to human life or health;

Whereas, pursuant to paragraph 2(1)(m) of the Canadian Environmental Protection Act, 1999, the Government of Canada, in the administration of the Act, shall ensure, having regard to the Constitution and the laws of Canada, and to the extent that is reasonably possible, that all areas of federal regulation for the protection of the environment and human health are addressed in a complementary manner in order to avoid duplication and to provide effective and comprehensive protection;

And whereas risk management actions are being considered under the Food and Drugs Act to control the presence of carbamic acid, ethyl ester in alcoholic beverages,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action under the Canadian Environmental Protection Act, 1999 on carbamic acid, ethyl ester at this time.

Notice is furthermore given that the Minister of Health is releasing a proposed risk management approach document for this substance on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca) to continue discussions with stakeholders on the manner in which Health Canada intends to implement preventive or control actions in relation to the substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of Health written comments on the proposed risk management approach document. More information regarding the proposed risk management approach may be obtained from the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-938-5212(fax), eccc.substances.eccc@canada.ca (email).

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Carbamic Acid, Ethyl Ester (Ethyl Carbamate)

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on carbamic acid, ethyl ester, hereinafter referred to as ethyl carbamate, Chemical Abstracts Service Registry Number (CAS RN) 51-79-6. This substance is part of the Internationally Classified Substance Grouping, which includes substances that were prioritized for screening assessment because they were classified by certain international agencies as potentially of concern for human health.

Ethyl carbamate is a by-product of the fermentation process and has been detected in many types of fermented foods and beverages. It is also a constituent of tobacco plants and is present in mainstream tobacco smoke.

Based on information obtained from stakeholder consultation in 2012–2013, no single company has been identified as having imported or used ethyl carbamate above the reporting threshold of 100 kg per year in Canada. In Canada and internationally, the current uses of ethyl carbamate are limited to medical laboratory research.

Ethyl carbamate has high water solubility, a very low octanol–water partition coefficient, and moderate vapour pressure. If released to the environment, the substance is not expected to significantly partition into air. Based on a low Henry's Law constant, the majority of ethyl carbamate is expected to reside in water and soil. Partitioning to sediments is expected to be limited; however, given that the substance is highly water soluble, it could be found in pore water.

Ethyl carbamate demonstrated low toxicity to aquatic organisms; however, some genetic and biochemical effects have been observed in worms and frogs. Considering the low quantity of ethyl carbamate in commerce in Canada and its limited uses, environmental releases of this substance are not expected to be significant. Therefore, environmental exposure of organisms is considered to be negligible, and ethyl carbamate is not expected to pose a risk to organisms in Canada.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from ethyl carbamate. It is concluded that ethyl carbamate does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is not 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 or that constitute or may constitute a danger to the environment on which life depends.

The critical effect for characterization of risk to human health associated with exposure to ethyl carbamate is carcinogenicity; ethyl carbamate is a multisite carcinogen in animal studies. The margins of exposure between upper-bounding estimates of dietary exposure for adults from alcohol consumption and the critical effect level for cancer are potentially inadequate to address uncertainties in the health effects and exposure databases. Corresponding margins of exposure for the general population, excluding alcohol consumption, are considered adequate to address uncertainties in the health effects and exposure databases.

Based on the information presented in this Screening Assessment, it is concluded that ethyl carbamate meets the criteria under paragraph 64(c) of CEPA as it is 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.

Overall conclusion

It is concluded that ethyl carbamate meets one or more of the criteria set out in section 64 of CEPA.

The Screening Assessment for ethyl carbamate and the proposed risk management approach document are available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

EXPLANATORY NOTE

Decision on the Final Screening Assessment of Ethyl Carbamate

The ministers propose to take no further action under the Canadian Environmental Protection Act, 1999 (CEPA) on ethyl carbamate at this time in recognition of the fact that the only source of concern is its presence in certain alcoholic beverages. Ethyl carbamate is not intentionally added to food and beverages, but is a natural fermentation by-product. Risk management actions are currently in place and others are being proposed under the Food and Drugs Act to reduce human exposure to ethyl carbamate from alcoholic beverages. Therefore, the ministers are satisfied that the Food and Drugs Act is a more appropriate federal statute to manage the potential risks posed by ethyl carbamate.

Ethyl carbamate will be added to the Non-Statutory List on the CEPA Environmental Registry, which is the list of substances that have been assessed and found to meet at least one of the criteria set out in section 64 of CEPA but that have not been added to Schedule 1 of the Act. This list is available at http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D74AD69-1.

For more information on the assessment and risk management of carbamic acid, ethyl ester, a substance in the Internationally Classified Substance grouping, please consult www.chemicalsubstances.gc.ca or contact the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-938-5212 (fax), eccc.substances.eccc@ec.gc.ca (email).

DAVID MORIN
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

VIRGINIA POTER
Director General
Industrial Sectors, Chemicals and Waste Directorate

On behalf of the Minister of the Environment

JOHN COOPER
Acting Director General
Safe Environments Directorate

On behalf of the Minister of Health

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — Ethanol, 2-[(2-aminoethyl)amino]- (AEEA), CAS RN (see footnote 4) 111-41-1 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas ethanol, 2-[(2-aminoethyl)amino]- is a substance on the Domestic Substances List;

Whereas a summary of the Screening Assessment conducted on the substance pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;

Whereas it is concluded that the substance does not meet any of the criteria set out in section 64 of the Act;

And whereas the Minister of the Environment is considering amending the Domestic Substances List, under subsection 87(3) of the Act, to indicate that the significant new activities provision under subsection 81(3) thereof applies with respect to this substance,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on this substance at this time.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Ethanol, 2-[(2-aminoethyl)amino]-

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of ethanol, 2-[(2-aminoethyl)amino]-, hereinafter referred to as AEEA. The Chemical Abstracts Service Registry Number (CAS RN) of AEEA is 111-41-1. This substance is part of the Internationally Classified Substance Grouping, which includes substances that were prioritized for screening assessment because they were classified by certain international agencies as potentially of concern for human health.

AEEA does not occur naturally in the environment. In Canada, AEEA is imported both as a pure substance and as a component of products. In 2008, a quantity lower than the reporting threshold of 100 kg of AEEA was manufactured in Canada, and more than 500 000 kg of AEEA were imported into Canada. In 2011, AEEA was not manufactured in Canada, and between 100 000 and 500 000 kg of AEEA were imported into Canada in the same year. AEEA can be used as a chemical intermediate, a component of adhesives and sealants used in asphalt paving or patching, a curing agent for epoxy resins, in building products with mainly commercial applications, a component in super glue, and a component of corrosion inhibitors and lubricant additives. As a chemical intermediate, AEEA is used to manufacture surfactants that in turn have applications as industrial detergents and in consumer products such as cosmetics. AEEA is used as a component in food-packaging adhesives and inks with no direct contact with food, and as a component of an agent used in the paper manufacturing process. AEEA is also used as a component in additives for closed recirculating cooling systems where the water treated will not come into direct contact with food.

AEEA is characterized by a moderate vapour pressure, a very low Henry's Law constant, and very low log K_oc and log K_ow values. AEEA is miscible in water. Monitoring data on AEEA in the Canadian environment have not been identified.

AEEA has a short half-life in air, and it is not expected to be present in the atmosphere. AEEA is readily biodegradable in water and it is not expected to remain in soil or sediments for prolonged periods of time. Based on the available empirical and modelled evidence, AEEA is expected to have a limited persistence in air, water, soil and sediments.

AEEA has a low bioaccumulation potential, as evidenced by very low empirical and modelled bioconcentration and bioaccumulation values for fish.

Several studies have been conducted on AEEA to identify ecotoxicological effects of the substance on aquatic organisms, including micro-organisms, crustaceans and fish. The results of these studies indicated that AEEA has a low to moderate potential to cause acute toxic effects in exposed organisms. Longer-term ecotoxicological studies on AEEA were not available. It was noted that at higher exposure concentrations, AEEA increased the alkalinity of the aqueous test solutions, and this may have contributed to additional toxic effects to exposed organisms. The effects of AEEA on soil and sediment organisms have not been studied; however, such effects are not expected to be greater than those determined in aquatic species.

AEEA is imported as a minor component in products or mixtures that are used in industrial, commercial or consumer applications. Many of these products undergo curing. The potential for AEEA releases into the environment from these cured products as well as from AEEA applications in asphalt cement is not expected to be significant. AEEA can also be a minor constituent of imported solid products in building materials, but with very limited potential for releases. The main source of release of AEEA is expected to be industrial use of the pure substance as a chemical intermediate. AEEA is assumed to be chemically converted during industrial processes, and it is expected that it no longer exists in its parent form. The only quantitative scenario considered was based on disposal of unreacted residual AEEA from the cleaning of empty transport and processing containers. Based on this scenario, and using conservative assumptions, exposure to organisms in the environment would be below levels expected to cause harm.

Considering all available lines of evidence presented in this Screening Assessment, there is low risk of harm to organisms and the broader integrity of the environment from AEEA. It is concluded that AEEA does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is not 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, or that constitute or may constitute a danger to the environment on which life depends.

Critical effects for characterization of risk to human health for AEEA are developmental and reproductive effects in animal studies.

There were no reports of AEEA in environmental media identified for Canada. Exposure of the general population to AEEA from environmental media is not expected, given that it is not manufactured in Canada and its use is limited to a few industrial applications. Canadians are also not expected to be exposed to AEEA through food consumption or the use of consumer products. Accordingly, the risk to human health is considered to be low.

Based on the information presented in this Screening Assessment, it is concluded that AEEA does not meet the criteria under paragraph 64(c) of CEPA as it is not 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.

Overall conclusion

It is concluded that AEEA does not meet any of the criteria set out in section 64 of CEPA.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, AEEA is recognized to have effects of concern based on its potential developmental and reproductive toxicity. There may be a concern for human health if exposures to the general population of Canada to AEEA were to increase, for example, through an increased presence in products available to consumers. Options for monitoring changes in uses of AEEA have been assessed and application of the Significant New Activity provisions to AEEA will be proposed. Stakeholders will have an opportunity to comment on the Notice of Intent.

The Screening Assessment for this substance is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of four cresol substances specified on the Domestic Substances List — phenol, methyl-, CAS RN (see footnote 5) 1319-77-3 (subsection 77(6) of the Canadian Environmental Protection Act, 1999) and phenol, 2-methyl-, CAS RN 95-48-7, phenol, 3-methyl-, CAS RN 108-39-4, and phenol, 4-methyl-, CAS RN 106-44-5 (section 68 of the Canadian Environmental Protection Act, 1999)

Whereas phenol, methyl- is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on the four cresol substances, pursuant to paragraphs 68(b) and 68(c) of the Act for phenol, 2-methyl-; phenol, 3-methyl-; and phenol, 4-methyl- and section 74 of the Act for phenol, methyl-, is annexed hereby;

And whereas it is concluded that the substances do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on phenol, 2-methyl-; phenol, 3-methyl-; and phenol, 4-methyl- at this time, and

Notice is further given that the ministers propose to take no further action on phenol, methyl- at this time under section 77 of the Act.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Cresol (Phenol, methyl-) Substances

CAS RNs and Domestic Substances List (DSL) names for substances in the cresols subgroup
CAS RN	DSL name	Common name
95-48-7*	Phenol, 2-methyl-	o-cresol
108-39-4*	Phenol, 3-methyl-	m-cresol
106-44-5*	Phenol, 4-methyl-	p-cresol
1319-77-3	Phenol, methyl-	Mixed cresols

* This substance was not identified under subsection 73(1) of CEPA, but was included in this assessment because it was considered a priority based on other human health concerns.

These substances are part of the Internationally Classified Substance Grouping, which includes substances that were prioritized for screening assessment because they were classified by certain international agencies as potentially of concern for human health.

Manufacture of cresols in the 2011 calendar year was in the range of 100 000 to 1 000 000 kg, while imports were in the range of 10 000 to 100 000 kg, according to surveys under section 71 of CEPA. Much of the manufacturing activity was associated with the incidental production of cresols during processing of other materials.

Cresols are widespread in nature, occurring naturally in plants and as natural components of crude oil, coal tar and brown cresylic-type mixtures. In addition, they can be produced endogenously by many organisms, such as mammals and micro-organisms. Cresols occur naturally in a variety of foods and beverages, but levels in foods are generally low. They are also natural products of incomplete combustion, and may be produced and released from natural fires associated with lightning, spontaneous combustion, and volcanic activity.

Cresols are organic substances with a variety of industrial and consumer applications. They are used as intermediates in the production of antioxidants, resins and plasticizers, pesticides, dyes, deodorizing and odour-enhancing compounds, fragrances, pharmaceuticals and other chemicals (e.g. photographic developers, explosives). Cresols are also used as industrial cleaners and solvents, synthetic food flavours, preservatives in drugs, and fragrances in pest control products.

Based on certain assumptions and reported use patterns, cresols are expected to be released primarily to air, with releases also occurring to surface waters and soil. The chemical properties of high water solubility, moderate vapour pressure, and low to moderate sorption potential indicate that, when released into the environment, cresols can be expected to distribute into air, water or soil, depending upon the compartment of release. Cresols have been detected in all environmental media, including air, surface and ground waters, sediment, soil and biota. However, given the extensive natural presence of these substances in the environment, their occurrence in a medium cannot always be linked with anthropogenic activities.

High aerobic biodegradation rates and low bioaccumulation potential reduce the exposure potential of cresols to organisms. While cresols demonstrate low to moderate toxicity in laboratory testing, a number of aquatic and terrestrial species have demonstrated a capacity to effectively metabolize and excrete these substances, thereby reducing the potential for adverse effects. Cresols may have the potential to contribute to adverse ecosystem effects through rapid depletion of dissolved oxygen under conditions of large-scale release into waters with limited oxygen exchange. Quantitative analyses based on empirical and modelled toxicity and environmental concentration data were conducted for air, soil, surface waters and sediment; these predicted that the highest environmental concentrations of cresols originating from industrial sources will be much less than experimentally determined no-effect levels.

Monitoring data indicate that levels of cresols in the Canadian environment are generally low. However, cresols were present at very high concentrations in a limited number of sediment samples, and it is possible that organisms residing in the vicinity of these sampling locations may be adversely impacted by the presence of cresols. These sites are likely influenced by production of cresols from endogenous sources and/or associated with areas of known historical industrial contamination. Corresponding aqueous concentrations of cresols at a number of these sites in the Canadian environment were below detection limits despite the high sediment concentrations detected at these sites and the high water solubility of cresols, which places further weight on the likely contribution of endogenous production within the surface sediment.

Considered together, these factors reduce the overall level of concern for cresols in the Canadian environment. Considering all available lines of evidence presented in this screening assessment, there is low risk of harm to organisms or the broader integrity of the environment from these substances. It is concluded that o-, m- and p-cresol and mixed cresols do not meet the criteria under paragraph 64(a) or (b) of CEPA as they are not 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 or that constitute or may constitute a danger to the environment on which life depends.

It is expected that exposure to cresols from their naturally occurring presence in a variety of foods and beverages represents the primary sources of total intake for the Canadian population. For the human health assessment, the risk characterization for cresols focuses on the incremental exposure from anthropogenic sources, i.e. through inhalation of air in the vicinity of pulp and paper mills.

Carcinogenicity is a potential critical effect for cresols, although tumours occurred only at high oral doses in animal studies. Limited inhalation studies in animals exposed to o- and/or p-cresol resulted in adverse effects on the respiratory tract, blood and liver. Margins of exposure between effect levels in animal studies and estimates of inhalation exposure to individuals in the vicinity of industrial sites were considered adequate to address uncertainties in the health effects and exposure databases.

Based on the adequacy of the margins between estimates of exposure and critical effect levels in experimental animals, it is concluded that o-, m- and p-cresol and mixed cresols do not meet the criteria under paragraph 64(c) of CEPA as they are not 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.

Conclusion

It is concluded that cresols do not meet any of the criteria set out in section 64 of CEPA.

The Screening Assessment for cresol (phenol, methyl-) substances is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[22-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of 16 aromatic amines specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas 3 of the 16 aromatic amines identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on 13 aromatic amines pursuant to paragraphs 68(b) and (c) of the Act and on the remaining 3 aromatic amines pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that the 16 aromatic amines do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action under section 77 of the Act on 13 aromatic amines at this time.

Notice is further given that the ministers propose to take no further action on the remaining 3 aromatic amines at this time.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Aromatic Amines

Pursuant to sections 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on 16 aromatic amines. These substances are being assessed as part of the Government of Canada's Chemicals Management Plan (CMP). They were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of CEPA and/or were considered as a priority based on other human health concerns.

The Chemical Abstracts Service Registry Number (CAS RN), (see footnote 6) Domestic Substances List (DSL) names and common names of the 16 substances in the aromatic amines assessment are presented in the following table.

Identity of the 16 aromatic amines
CAS RN	DSL name	Common name used in this assessment
88-53-9^a	Benzenesulfonic acid, 2-amino-5-chloro-4-methyl-	Red Lake C Amine
90-04-0^{a, b}	Benzenamine, 2-methoxy-	o-Anisidine
91-59-8^{a, b}	2-Naphthalenamine	2-Naphthylamine
95-51-2	Benzenamine, 2-chloro-	2-Chloroaniline
95-53-4^{a, b}	Benzenamine, 2-methyl-	o-Toluidine
95-76-1	Benzenamine, 3,4-dichloro-	3,4-Dichloroaniline
95-80-7^{a, b}	1,3-Benzenediamine, 4-methyl-	2,4-Diaminotoluene
100-01-6^a	Benzenamine, 4-nitro-	4-Nitroaniline
106-47-8^{a, b}	Benzenamine, 4-chloro-	4-Chloroaniline
106-49-0^a	Benzenamine, 4-methyl-	p-Toluidine
108-45-2	1,3-Benzenediamine	1,3-Diaminobenzene
123-30-8^a	Phenol, 4-amino-	p-Aminophenol
156-43-4^a	Benzenamine, 4-ethoxy-	p-Phenetidine
540-23-8^a	Benzenamine, 4-methyl-, hydrochloride	p-Toluidine hydrochloride
541-69-5^a	1,3-Benzenediamine, dihydrochloride	1,3-Diaminobenzene dihydrochloride
615-05-4^{a, b}	1,3-Benzenediamine, 4-methoxy-	2,4-Diaminoanisole

^a This substance was not identified under subsection 73(1) of CEPA but was included in this assessment as it was considered as a priority based on other human health concerns.

^b Denotes that the aromatic amine is part of the 22 aromatic amines listed in Appendix 8 of Regulation (EC) No. 1907/2006 (EU 22).

Global, anthropogenic sources of aromatic amines include biomass and fossil fuel combustion, chemical synthesis, coal gasification plants, aluminum smelting, wastewater treatment plants, drinking water plants, refineries and production facilities, dye houses and chemical factories. The 16 aromatic amines considered in this assessment are industrial chemicals primarily used as chemical intermediates in the synthesis of pigments, dyes, pesticides, drugs and rubber products, as well as in laboratory chemicals.

No manufacturing activity of any of the 16 aromatic amines in Canada was reported above the 100 kg/year threshold, according to recent surveys under section 71 of CEPA. Seven of the aromatic amines have been reported as being imported into Canada above the 100 kg/year survey reporting threshold. An additional two aromatic amines were reported as being imported into Canada below the 100 kg/year reporting threshold.

Environment

The 16 aromatic amines are soluble in water. In terms of potential releases to water, sediment and soil, taking into consideration the physical and chemical properties of these substances, aromatic amines will bind to dissolved organic matter, particulate matter and sediment over time; however, water is considered the primary route of exposure.

Available experimental and modelled data regarding the abiotic and biotic degradation of the 16 aromatic amines indicate that these substances are persistent in water, sediment and soil. Information on the log octanol–water partition coefficients and fish bioconcentration factors indicates that these substances are not likely to bioconcentrate or bioaccumulate in aquatic organisms.

There is a wide range of acute and chronic aquatic toxicity data for the aromatic amines (median effective concentrations [EC₅₀] or median lethal concentrations [LC₅₀]: 0.0004–418 mg/L). The toxicity of substituted aniline compounds is dependent on their mode of action, the type of substituents (chloro-, methyl-, etc.), the number of substituents (mono-, di-, etc.) and their position (ortho-, meta-, para-). Aquatic invertebrates (Daphnia) were more sensitive than other organisms to aromatic amines. Limited toxicity data were available for terrestrial and sediment-dwelling organisms.

Aquatic exposure scenarios were developed to represent the potential major environmental releases due to industrial and consumer activities involving the aromatic amines. Predicted environmental concentrations were calculated for the aquatic environment for those section 71–identified substances released from tire manufacturing, tire wear, personal care and cosmetics formulation and consumer use of personal care products and cosmetics. The probability that the predicted environmental concentration of aromatic amines would exceed the substances' predicted no-effect concentration was low (~5% or less) for all four scenarios, meaning that a low risk of adverse effects to aquatic organisms is expected as a result of these industrial and consumer activities, respectively.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from the 16 aromatic amines. It is concluded that these aromatic amines do not meet the criteria under paragraph 64(a) or 64(b) of CEPA, as they are not 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 or that constitute or may constitute a danger to the environment on which life depends.

Human health

This human health assessment focuses on substances that are reported above the reporting threshold of 100 kg/year in the recent surveys conducted under section 71 of CEPA or for which available information indicates potential exposure to the general population of Canada. Potential exposure of the general population of Canada was characterized for 9 of the 16 substances included in this assessment: 2-naphthylamine, o-toluidine, 2,4-diaminotoluene, 4-chloroaniline, 3,4-dichloroaniline, o-anisidine, p-aminophenol, 1,3-diaminobenzene and Red Lake C Amine. Exposure of the general population in Canada to one or more of the 9 aromatic amines from the use of certain consumer products, such as cooking utensils, textiles and cosmetics, was estimated. No robust Canadian data on concentrations of these 9 aromatic amines in environmental media were identified. With the exception of p-aminophenol, section 71 data indicate low volumes of use of these 9 aromatic amines in Canada; therefore, exposures from environmental media are generally not expected for these substances. Environmental media are not considered a significant source of exposure of p-aminophenol, considering the direct exposure from use of this substance in cosmetic products.

Exposures were not expected for the remaining seven aromatic amines; this includes those not reported under section 71 and those with no other information identified to indicate exposure.

Carcinogenicity was considered to be the health effect of concern for six of the nine aromatic amines for which exposure was characterized. 2-Naphthylamine, o-toluidine, 2,4-diaminotoluene, 4-chloroaniline and o-anisidine are classified as known or possible human carcinogens by the International Agency for Research on Cancer (Group 1 or 2B) and the European Union (Category 1A or 1B). Carcinogenicity was not identified as an endpoint of concern for p-aminophenol, 1,3-diaminobenzene or Red Lake C Amine; therefore, critical non-cancer health effect levels were selected for risk characterization.

Four substances (2-naphthylamine, 2,4-diaminotoluene, 4-chloroaniline and o-anisidine) were detected in some imported textile and leather products in a study conducted by Health Canada in 2012. Margins between estimates of exposure of the general population from dermal contact with textiles as well as mouthing of textiles by infants and critical effect levels are considered adequate to address uncertainties in the health effects and exposure databases.

Available information indicates that residual o-toluidine, 2,4-diaminotoluene, o-anisidine, 4-chloroaniline and 1,3-diaminobenzene may migrate to foods being prepared with polyamide cooking utensils. Margins between the estimated daily oral exposure from use of polyamide cooking utensils and critical effect levels are considered adequate to address uncertainties in the health effects and exposure databases.

Exposures to p-aminophenol, 1,3-diaminobenzene, 4-chloroaniline and Red Lake C Amine were identified from the use of certain cosmetic products. The margins between exposure estimates and critical effect levels for each of these substances were considered adequate to address uncertainties in the health effects and exposure databases.

o-Toluidine was identified at low levels in breast milk from a small sample of Canadian women. The margin between the estimated daily intake of o-toluidine for non-formula-fed infants via breast milk and the critical effect level is considered adequate and does not indicate a concern at these low levels of exposure.

For the remaining seven aromatic amines (2,4-diaminoanisole, 2-chloroaniline, p-toluidine, p-toluidine hydrochloride, 4-nitroaniline, p-phenetidine and 1,3-diaminobenzene dihydrochloride), no information was identified to indicate that there is current exposure to the general population of Canada; therefore, risk to human health from these substances is not expected.

Some of the aromatic amines in this assessment have effects of concern based on potential carcinogenicity. While available information does not indicate a risk to human health for Canadians at current levels of exposure, there may be a concern if exposure were to increase.

Based on the information presented in this Screening Assessment, it is concluded that the aromatic amines evaluated in this assessment do not meet the criteria under paragraph 64(c) of CEPA, as they are not 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.

Overall conclusion

It is concluded that the aromatic amines evaluated in this assessment do not meet any of the criteria set out in section 64 of CEPA.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances in this assessment are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposure to the general population of Canada to these substances were to increase in products available to consumers such as textiles, cosmetics and food.

Options on how best to monitor changes in the use profile of these substances are being investigated. Stakeholders will have the opportunity to provide feedback on a consultation document, describing potential options for information gathering or preventative actions, to be published once assessments for all of the aromatic azo and benzidine-based substances are completed.

The Screening Assessment is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[22-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of 22 azo solvent dyes specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas 17 of the 22 azo solvent dyes identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas five of the substances, Solvent Red 3 (CAS RN (see footnote 7) 6535-42-8), Solvent Red 4 (CAS RN 2653-64-7), Solvent Yellow 18 (CAS RN 6407-78-9), CAS RN 73528-78-6 and CAS RN 85392-21-8, are currently subject to the Significant New Activity provisions under subsection 81(3) of the Act;

Whereas a summary of the Screening Assessment conducted on 5 azo solvent dyes pursuant to paragraphs 68(b) and (c), and pursuant to section 74 of the Act for the 17 remaining azo solvent dyes is annexed hereby;

Whereas the Publication of final decision after screening assessment of a substance — 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-(Solvent Red 23), CAS No. 85-86-9 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) was published in the Canada Gazette, Part I, on September 10, 2011;

Whereas the final decision that Solvent Red 23 meets one or more of the criteria set out in section 64 of the Act remains unchanged;

Whereas the final conclusion under section 64 of the Act for Solvent Yellow 77 (CAS RN 2832-40-8, also known as Disperse Yellow 3) is deferred to the final Screening Assessment of certain azo disperse dyes that will be published at a later date;

And whereas it is concluded that the remaining 20 azo solvent dyes do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on five substances at this time,

Notice is further given that the ministers propose to take no further action on the remaining 15 azo solvent dyes at this time under section 77 of the Act, and

Notice is further given that, pursuant to subsection 87(3) of the Act, the Minister of the Environment intends to amend the Domestic Substances List such that Solvent Red 3 (CAS RN 6535-42-8), Solvent Red 4 (CAS RN 2653-64-7), Solvent Yellow 18 (CAS RN 6407-78-9), CAS RN 73528-78-6 and CAS RN 85392-21-8 are no longer subject to the Significant New Activity provisions under subsection 81(3) of the Act.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Azo Solvent Dyes

Pursuant to sections 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on 22 azo solvent dyes. These substances are being assessed as part of Canada's Chemicals Management Plan (CMP). They were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of CEPA and/or were considered as a priority based on other human health concerns.

The Chemical Abstracts Service Registry Number (CAS RN), Domestic Substances List (DSL) name, and Colour Index (C.I.) name or common name of the 22 substances are presented in the following table.

Identity of the 22 azo solvent dyes in the aromatic azo and benzidine-based substances
CAS RN	DSL name	Colour Index name or common name
60-09-3^a	Benzenamine, 4-(phenylazo)-	Solvent Yellow 1 or p-Aminoazobenzene
60-11-7^a	Benzenamine, N,N-dimethyl-4-(phenylazo)-	Solvent Yellow 2
85-83-6^a	2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-	Solvent Red 24 or Sudan IV
85-86-9^b	2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-	Solvent Red 23 or Sudan III
97-56-3^a	Benzenamine, 2-methyl-4-[(2-methylphenyl)azo]-	Solvent Yellow 3
101-75-7	Benzenamine, N-phenyl-4-(phenylazo)-	4-Anilinoazobenzene
103-33-3^a	Diazene, diphenyl-	Azobenzene
495-54-5	1,3-Benzenediamine, 4-(phenylazo)-	Solvent Orange 3
842-07-9	2-Naphthalenol, 1-(phenylazo)-	Solvent Yellow 14 or Sudan I
1229-55-6^b	2-Naphthalenol, 1-[(2-methoxyphenyl)azo]-	Solvent Red 1
2646-17-5	2-Naphthalenol, 1-[(2-methylphenyl)azo]-	Solvent Orange 2 or Oil Orange SS
2653-64-7	2-Naphthalenol, 1-(1-naphthalenylazo)-	Solvent Red 4
2832-40-8	Acetamide, N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]-	Solvent Yellow 77^c
3118-97-6^b	2-Naphthalenol, 1-[(2,4-dimethylphenyl)azo]-	Solvent Orange 7 or Sudan II
5290-62-0	1-Naphthalenol, 4-[(4-nitrophenyl)azo]-	Magneson II
6368-72-5	2-Naphthalenamine, N-ethyl-1-[[4-(phenylazo)phenyl]azo]-	Solvent Red 19
6407-78-9^b	3H-Pyrazol-3-one, 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-	Solvent Yellow 18
6535-42-8^b	1-Naphthalenol, 4-[(4-ethoxyphenyl)azo]-	Solvent Red 3
21519-06-2	3H-Pyrazol-3-one, 2,4-dihydro-2-(3-hydroxyphenyl)-5-methyl-4-[[4-(phenylazo)phenyl]azo]-	N/A
73507-36-5	2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-, compounds with N,N'-bis (mixed Ph and tolyl and xylyl)guanidine monohydrochloride-	N/A
73528-78-6	3-Pyridinecarbonitrile, 5-[[4-[(2,6-dichloro-4-nitrophenyl)azo]-2,5-dimethoxyphenyl]azo]-2,6-bis[(2-methoxyethyl)amino]-4-methyl-	N/A
85392-21-8	3-Pyridinecarbonitrile, 5-[[2-chloro-4-(phenylazo)phenyl]azo]-2,6-bis[(3-methoxypropyl)amino]-4-methyl-	N/A

Abbreviations: N/A, not available
^a This substance was not identified under subsection 73(1) of CEPA but was included in this assessment as it was considered as a priority based on other human health concerns.

^b This substance was previously assessed and concluded on under the CMP.
^c Solvent Yellow 77 is also known as Disperse Yellow 3. The ecological assessment and the section 64 of CEPA conclusions of this substance are deferred to the azo disperse dyes assessment while the human health assessment for this substance is included in this assessment of azo solvent dyes.

Assessments to determine whether five of the azo solvent dyes (Solvent Red 1, Solvent Red 3, Solvent Red 23, Solvent Yellow 18 and Solvent Orange 7) met one or more criteria under section 64 of CEPA were previously conducted under the CMP. Among them, one substance (Solvent Red 23) was concluded to meet the criteria set out in paragraph 64(c) of CEPA. As outlined in the notice of intent for the Aromatic Azo and Benzidine-based Substance Grouping, (see footnote 8) it was recognized that assessments and conclusions pertaining to some of the substances in this assessment may be subsequently updated as part of the current assessment. Specifically, significant new information has been identified to inform the ecological assessment of the azo solvent dyes substances and the assessments for the five substances have been updated accordingly. Similarly, significant new information pertaining to human health has been identified for three of the five substances (Solvent Red 1, Solvent Red 3 and Solvent Yellow 18) and the human health risk assessments for these three substances have been updated.

Solvent Yellow 77 (CAS RN 2832-40-8), also known as Disperse Yellow 3, is included in the azo solvent dyes assessment, which was established based on the similarity in physical-chemical properties of these substances. However, due to the use of Solvent Yellow 77 in textile dye formulation and textile dyeing reported under section 71 of CEPA, the ecological assessment for this substance is deferred to the azo disperse dyes assessment. However, the human health assessment for this substance, including exposure from its use as a textile dye, is part of the assessment of azo solvent dyes. The section 64 conclusions of CEPA for this substance will be included in the azo disperse dyes assessment.

Azo solvent dyes are not expected to occur naturally in the environment. None of the 22 azo solvent dyes were reported to be manufactured in Canada based on recent surveys conducted under section 71 of CEPA; however, 5 of these substances were reported to be imported into Canada above reporting thresholds (during 2005 or 2008). Some of these substances were also identified as being used in products available to consumers in the Canadian marketplace. No measured concentrations in the Canadian environment have been identified for any of these substances.

Environment

Azo solvent dyes are generally hydrophobic substances that are sparingly soluble in water, with some monoazo substances having experimental water solubilities slightly above 1 mg/L. Given the import and use of five azo solvent dyes in Canada above reporting thresholds, potential releases to the aquatic environment and to the terrestrial environment (via municipal wastewater sludge) have been estimated. When considering potential releases to water, sediment, and soil as well as the physical and chemical properties of these substances, it is expected that the azo solvent dyes may remain in the water column up to their apparent water solubility limit, and may also ultimately partition to suspended solids, sediments or soil particles. Available experimental and modelled data regarding the abiotic and biotic degradation of the azo solvent dyes indicate that these substances tend to persist in water, sediment and soil. In anaerobic environments (i.e. anoxic layers of sediments), there is the potential for these substances to degrade to aromatic amines as a result of cleavage of the azo bond under anaerobic or reducing conditions.

Although there are limited experimental data available, information on the log octanol–water partition coefficients (K_ow) and fish bioconcentration factors (BCFs) indicates that these substances are not likely to bioconcentrate or bioaccumulate in aquatic organisms. These results were substantiated with modelled data that considered metabolism.

All of the structurally related azo solvent dyes (with the exception of CAS RN 73507-36-5) are expected to have a common mode of action with respect to ecotoxicity (based on the reactivity of the amine, aniline, or phenolic functional groups); thus, the toxicity information for aquatic, sediment- and soil-dwelling organisms was applied to all of these 21 structurally related substances. Toxicity information for these substances indicates that they are hazardous to aquatic organisms at low concentrations. Sediment-dwelling organisms may also be adversely affected, although the available toxicological data are preliminary. Toxicity information for CAS RN 73507-36-5 indicates that it would not be harmful to aquatic organisms at low concentrations.

Aquatic exposure analyses were focused on scenarios representing potential major environmental releases due to industrial activities involving azo solvent dyes that may result in high levels of exposure to aquatic organisms. Predicted environmental concentrations (PECs) were calculated for the aquatic environment for those substances identified in industrial formulation activities. The PECs did not exceed the predicted no-effect concentration (PNEC) for water.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from 21 of the 22 azo solvent dyes. For the remaining substance, Solvent Yellow 77 (Disperse Yellow 3), the ecological risk is being addressed in the assessment of azo disperse dyes. It is concluded that these 21 azo solvent dyes do not meet the criteria under paragraph 64(a) or 64(b) of CEPA, as they are not 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, or that constitute or may constitute a danger to the environment on which life depends.

Human health

With respect to human health, this Screening Assessment addresses 20 of 22 azo solvent dyes, including substances previously assessed for which significant new information has become available. The remaining two substances, Solvent Orange 7 and Solvent Red 23, were previously assessed and conclusions were drawn for these substances under the CMP. As significant new information relevant to the health assessment was not identified for these two substances, the previous conclusions on human health for these substances have not been updated. However, information on Solvent Orange 7 and Solvent Red 23 was considered to support a read-across approach for the Sudan dyes subset in the health assessment.

For the health assessment, the azo solvent dyes were evaluated as part of one of three health subsets: “Azobenzene and its derivatives,” “Sudan dyes” and “miscellaneous substances.” Based on the empirical data identified, the critical health effects associated with exposure to Azobenzene and its derivatives (i.e. Azobenzene, p-Aminoazobenzene, Solvent Yellow 2, Solvent Orange 3, Solvent Yellow 3 and Solvent Yellow 77) are considered to be carcinogenicity and genotoxicity. In addition, Azobenzene, p-Aminoazobenzene, Solvent Yellow 2 and Solvent Yellow 77 are considered to have haematological effects. For the Sudan dyes (i.e. Sudan I, Oil Orange SS, Solvent Red 1 and Sudan IV), based on the empirical data identified and from read-across data, these substances are considered to have carcinogenic and genotoxic potential as well as potential for causing haematological effects. For the miscellaneous substances (i.e. Solvent Red 3, Solvent Yellow 18, Solvent Red 19, 4-Anilinoazobenzene, Solvent Red 4, Magneson II, CAS RN 21519-06-2, CAS RN 73507-36-5, CAS RN 73528-78-6 and CAS RN 85392-21-8), only limited empirical data were identified; hence, their critical health effects cannot be conclusively determined.

Exposure for the general population of Canada to the 20 azo solvent dyes through environmental media and food is not expected; therefore, risk to human health from these exposure sources is not expected.

Seven azo solvent dyes (Solvent Orange 3, Solvent Yellow 77, Sudan I, Solvent Red 1, Sudan IV, Solvent Red 3 and Solvent Yellow 18) were identified to be used in certain products available to consumers in the Canadian marketplace. Margins between the exposure estimates for Solvent Orange 3, Solvent Yellow 77, Sudan I, Solvent Red 1 and Solvent Red 3 from use of products (shoe polish, textiles, leather, writing ink and cosmetics) containing these substances and the critical health effects levels were considered adequate to address uncertainties in the health effects and exposure databases. Based on available health effects data, Solvent Yellow 18 was not identified as having high hazard potential. Therefore, risk to human health from use of cosmetics containing this dye is considered to be low. Risk to young children who may incidentally ingest paper products containing Solvent Yellow 77 is expected to be low, as available information indicates that acute toxicity is not a health concern for this substance. In addition, exposure to Sudan IV used as a dye in food packaging material is not expected to be significant; therefore, risk to human health from this application is considered to be low.

For the remaining 13 azo solvent dyes, no uses of these substances in products available to consumers in the Canadian marketplace were identified. Therefore, based on available information for exposure in Canada, the risk to human health is not expected for these 13 azo solvent dyes.

Some of the azo solvent dyes in this assessment have effects of concern based on potential carcinogenicity. While available information does not indicate a risk to human health for Canadians at current levels of exposure, there may be a concern if exposures were to increase.

Based on the information presented in this Screening Assessment, it is concluded that the 19 azo solvent dyes evaluated in this assessment for human health do not meet the criteria under paragraph 64(c) of CEPA, as they are not 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. In addition, there are no updates to the conclusions made with respect to paragraph 64(c) for Solvent Red 23 and Solvent Orange 7, previously assessed by the Government of Canada. The conclusion with respect to paragraph 64(c) of CEPA for Solvent Yellow 77 (Disperse Yellow 3) is summarized in the azo disperse dyes assessment.

Overall conclusion

It is concluded that the azo solvent dyes evaluated in this assessment do not meet any of the criteria set out in section 64 of CEPA.

While it was determined that CAS RN 2832-40-8 (Solvent Yellow 77 [Disperse Yellow 3]) did not pose a risk to human health, the conclusions made with respect to section 64 of CEPA for this substance are included in the azo disperse dyes assessment.

The conclusion previously made under the Challenge Initiative that Solvent Red 23 meets the criteria set out in paragraph 64(c) of CEPA remains unchanged.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances in this assessment are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers, such as textiles, cosmetics and food.

Options on how best to monitor changes in the use profile of these substances are being investigated. Stakeholders will have the opportunity to provide feedback on a consultation document describing potential options for information gathering or preventive actions, which will be published once assessments for all of the aromatic azo and benzidine-based substances are completed.

Two solvent dyes, Solvent Red 3 and Solvent Yellow 18, were previously assessed under the Challenge Initiative of the CMP and have had the significant new activity (SNAc) provisions of CEPA applied. For Solvent Red 3, the SNAc provisions of CEPA were applied as a result of the previous assessment, which indicated that the substance, which was not in commerce in Canada, had potential health concerns as a member of the class of azo substances, some members of which are known or suspected carcinogens. For Solvent Yellow 18, the SNAc provisions of CEPA were applied as a result of the previous assessment, which indicated that the substance, which was not in commerce in Canada, had effects of concern based on potential health concerns as a member of the class of azo substances, and in addition, it was considered to have ecological concerns based on being persistent, bioaccumulative and inherently toxic to non-human organisms (PBiT). The current Screening Assessment no longer identifies these two substances as having human health effects of concern based on potential carcinogenicity, and also no longer identifies ecological concerns for Solvent Yellow 18. As the original human health or ecological concerns identified to support the application of the SNAc provisions have changed based on the current Screening Assessment, it is consequently proposed to rescind the SNAc provisions for these two substances.

A further three substances included in the assessment, Solvent Red 4, CAS RN 73528-78-6 and CAS RN 85392-21-8, were previously assessed in April 2008 in an assessment of 145 PBiT substances. Following that assessment, the SNAc provisions were applied because the assessment indicated that these substances, which were not in commerce in Canada, were persistent, bioaccumulative and inherently toxic. The current Screening Assessment now concludes that these three substances are not bioaccumulative. As the original ecological concern identified to support the application of the SNAc provisions has changed for these three substances based on the current Screening Assessment, it is consequently proposed to rescind the SNAc provisions for these three substances.

Should stakeholders have new information or a commercial interest in any of these substances, they are encouraged to contact the program or request a pre-notification consultation or to submit the new information through the Substances Management Information Line: substances@ec.gc.ca (email), 1-800-567-1999 (toll-free in Canada), 819-938-3232 (outside of Canada).

The Screening Assessment for these substances is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[22-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of 33 azo basic dyes specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas 29 of the 33 azo basic dyes identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on 4 azo basic dyes pursuant to paragraphs 68(b) and (c) of the Act and on the remaining 29 azo basic dyes pursuant to section 74 of the Act is annexed hereby;

Whereas the substance CAS RN (see footnote 9) 59709-10-3 is currently subject to the Significant New Activity provisions under subsection 81(3) of the Act;

And whereas it is concluded that these 33 azo basic dyes do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on four azo basic dyes at this time,

Notice is further given that the ministers propose to take no further action under section 77 of the Act on the remaining 29 azo basic dyes at this time, and

Notice is further given that, pursuant to subsection 87(3) of the Act, the Minister of the Environment intends to amend the Domestic Substances List such that CAS RN 59709-10-3 is no longer subject to the Significant New Activity provisions under subsection 81(3) of the Act.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Azo Basic Dyes

Pursuant to sections 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on 33 azo basic dyes. These substances were assessed as part of the Government of Canada's Chemicals Management Plan (CMP). They were identified as priorities for action as they met categorization criteria under subsection 73(1) of CEPA and/or were considered as a priority based on other human health concerns.

An assessment to determine whether one basic dye (NDTHPM) met one or more criteria under section 64 of CEPA was previously conducted under the CMP and the substance was concluded not to meet the criteria under section 64 of CEPA. The Chemical Abstracts Service Registry Number (CAS RN) (see footnote 10), Domestic Substances List (DSL) name and Colour Index (C.I.) or generic name (if applicable) of the 33 azo basic dyes are presented in the following table.

Table S1: Identity of 33 azo basic dyes in the aromatic azo and benzidine-based substances
CAS RN	Domestic Substances List name	Colour Index name or generic name
136-40-3^a	2,6-Pyridinediamine, 3-(phenylazo)-, monohydrochloride	Phenazopyridine hydrochloride
532-82-1^a	1,3-Benzenediamine, 4-(phenylazo)-, monohydrochloride	Basic Orange 2
2869-83-2	Phenazinium, 3-(diethylamino)-7-[[4-(dimethylamino)phenyl]azo]-5-phenyl-, chloride	N/A
4608-12-2	Phenazinium, 3-(dimethylamino)-7-[[4-(dimethylamino)phenyl]azo]-5-phenyl-, chloride	N/A
4618-88-6	Phenazinium, 3-amino-7-[[4-(dimethylamino)phenyl]azo]-5-phenyl-, chloride	N/A
10114-58-6	1,3-Benzenediamine, 4,4′-[1,3-phenylenebis(azo)]bis-, dihydrochloride	Basic Brown 1
10189-42-1	Pyridinium, 1-[2-[[4-[[2,6-dichloro-4-[(dimethylamino)sulfonyl]phenyl]azo]phenyl]ethylamino]ethyl]-, chloride	N/A
14408-20-9	Pyridinium, 1-[2-[[4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]-, chloride	N/A
14970-39-9	1H-1,2,4-Triazolium, 5-[[4-(diethylamino)phenyl]azo]-1,4-dimethyl-, trichlorozincate(1−)	N/A
23408-72-2	Benzothiazolium, 2-[[4-(dimethylamino)phenyl]azo]-3-ethyl-6-methoxy-, trichlorozincate(1−)	N/A
29508-48-3	1H-Pyrazolium, 1,5-dimethyl-3-[(2-methyl-1H-indol-3-yl)azo]-2-phenyl-, methyl sulfate	N/A
36986-04-6	Pyridinium, 1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]-, chloride	N/A
52769-39-8	1H-1,2,4-Triazolium, dimethyl-3-[[4-[methyl(phenylmethyl)amino]phenyl]azo]-, trichlorozincate(1−)	N/A
59709-10-3	Pyridinium, 1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]-, acetate	N/A
63589-49-1	1H-Pyrazolium, 2-cyclohexyl-3-[[4-(diethylamino)phenyl]azo]-1-methyl-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
63681-54-9	Benzenesulfonic acid, dodecyl-, compd. with 4-(phenylazo)-1,3-benzenediamine (1:1)	N/A
65150-98-3	Thiazolium, 2-[[4-(diethylamino)phenyl]azo]-3-methyl-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
68929-07-7	Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-5-methoxy-3-methyl-, methyl sulfate (salt)	N/A
68936-17-4	1H-Imidazolium, 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
69852-41-1	Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
71032-95-6	2-Naphthalenesulfonic acid, 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-(phenylazo)phenyl]azo]-, monoacetate (salt)	NDTHPM
72361-40-1	Pyridinium, 1-[2-[[4-[(2-bromo-4,6-dinitrophenyl)azo]-3-methylphenyl]ethylamino]ethyl]-, chloride	N/A
72379-36-3	1H-1,2,4-Triazolium, 5-[[4-[ethyl(phenylmethyl)amino]phenyl]azo]-1,4-dimethyl-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
72379-37-4	1H-1,2,4-Triazolium, 3-[[4-[ethyl(phenylmethyl)amino]phenyl]azo]-1,2-dimethyl-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
74744-63-1	1H-1,2,4-Triazolium, 3,3′(or 5,5′)-[1,2-ethanediylbis[(ethylimino)-4,1-phenyleneazo]]bis[1,4-dimethyl-, (T-4)-tetrachlorozincate(2-) (1:1)	N/A
75199-20-1	1,3′-Bipyridinium, 1′,2′-dihydro-6′-hydroxy-3,4′-dimethyl-2′-oxo-5′-[[4-(phenylazo)phenyl]azo]-, chloride	N/A
75660-25-2^a	1,3-Benzenediamine, 4-(phenylazo)-, monoacetate	N/A
79234-33-6^a	1,3-Benzenediamine, 4-(phenylazo)-, acetate	N/A
83969-13-5	1,3,4-Thiadiazolium, 5-[bis(1-methylethyl)amino]-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-, sulfate (2:1)	N/A
85114-37-0	1H-1,2,4-Triazolium, 1,4-dimethyl-3(or 5)-[[4-[methyl(phenylmethyl)amino]phenyl]azo]-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
85480-88-2	Benzothiazolium, 3-(3-amino-3-oxopropyl)-2-[(1-ethyl-2-phenyl-1H-indol-3-yl)azo]-, (T-4)-tetrachlorozincate(2−) (2:1)	N/A
93783-70-1	1,3,4-Thiadiazolium, 5-[bis(1-methylethyl)amino]-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-, trichlorozincate(1−)	N/A
125329-01-3	Propanoic acid, 2-hydroxy-, compd. with 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-(phenylazo)phenyl]azo]-2-naphthalenesulfonic acid (1:1)	N/A

Abbreviations: CAS RN, Chemical Abstracts Service Registry Number; N/A, not applicable
^a This substance was not identified under subsection 73(1) of CEPA but was included in this assessment as it was considered as a priority based on other human health concerns.

The 33 azo basic dyes are not expected to occur naturally in the environment. No manufacturing activity of any of the 33 azo basic dyes in Canada was reported above the 100 kg/year threshold, according to recent surveys under section 71 of CEPA. Six substances have been reported as being imported into Canada above the 100 kg/year survey reporting threshold.

Environment

Azo basic dyes have moderate to high water solubility (0.1–340 g/L). Azo basic dyes are expected to settle out of the water column to bed sediments or wastewater sludge. Modelled biodegradation data for azo basic dyes predict that these substances would biodegrade slowly in water under aerobic conditions. In sediment and soil, biodegradation is also expected to be slow under aerobic conditions and fast under anaerobic conditions. Azo basic dyes may degrade and transform to certain aromatic amines if they reach anaerobic environments.

Azo basic dyes are not expected to bioaccumulate, given their physical and chemical properties (i.e. low log octanol–water partition coefficients, ionized at relevant environmental pH, moderate molar weights, relatively large cross-sectional diameters and moderate to high water solubilities).

Azo basic dyes were divided into seven ecological subsets, and the critical toxicity value for the most sensitive ecological subset was derived from the most sensitive valid experimental value. Most substances had median lethal concentrations (LC₅₀values) that ranged between 0.3 and 13 mg/L for aquatic organisms. Based on the experimental and read-across data and the low critical toxicity values for each subset, it is concluded that azo basic dyes may be expected to be hazardous to aquatic organisms at moderate concentrations (i.e. LC₅₀ < 10 mg/L). Based on limited empirical soil toxicity data, azo basic dyes are not expected to cause harm to soil-dwelling organisms at low concentrations.

Given that the water column is the major environmental compartment for the presence of azo basic dyes, aquatic exposure analyses were focused on scenarios representing potential major environmental releases due to industrial activities that may result in high levels of exposure of aquatic organisms. Predicted environmental concentrations were calculated for the aquatic environment for those substances used in chemical formulation, paper dyeing, textile dyeing and pharmaceutical production processes. The predicted environmental concentrations were derived in the form of probabilistic distributions due to the variability and uncertainty in several contributing variables. The probability that the predicted environmental concentrations of azo basic dyes exceeded the predicted no-effect concentration was very low in all four scenarios.

Considering all available lines of evidence presented in this Screening Assessment, there is low risk of harm to organisms and the broader integrity of the environment from the 33 azo basic dyes evaluated in this assessment. It is concluded that these azo basic dyes do not meet the criteria under paragraph 64(a) or 64(b) of CEPA, as they are not 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 or that constitute or may constitute a danger to the environment on which life depends.

Human health

With respect to human health, the current Screening Assessment addresses 32 of 33 azo basic dyes. The remaining substance, NDTHPM, was previously assessed and a conclusion was published under the CMP. As no significant new information was identified for NDTHPM, the human health risk assessment for this substance has not been updated.

Exposure of the general population of Canada to the azo basic dyes substances from environmental media is not considered to be a significant source of exposure; therefore, risk to humans is considered low from environmental media.

Of the 32 azo basic dyes included in the human health assessment, 12 substances have been identified as being available in certain products (paper products, textiles, drugs and cosmetics) in Canada based on available information. For 2 of these 12 substances (phenazopyridine hydrochloride and CAS RN 63681-54-9), although uses were reported under section 71, based on available information, exposure to the general population is not expected for these substances. Therefore, 10 of these 12 substances were considered to have potential exposure to the general population (Basic Orange 2, Basic Brown 1, CAS RNs 14408-20-9, 36986-04-6, 52769-39-8, 59709-10-3, 68929-07-7, 69852-41-1, 75660-25-2, 93783-70-1) and risk was characterized for these substances.

The margins between the estimate of dermal exposure to Basic Orange 2 in hair dye and the short-term critical health effect in rats are considered adequate to address uncertainties in the exposure and health effects databases. The margin of exposure derived for Basic Orange 2 for combined incidental oral and dermal exposure to toddlers through pen ink and the oral short-term effect level in rats is considered adequate to address uncertainties in the exposure and health effects databases.

Use of CAS RN 75660-25-2, CAS RN 52769-39-8, and Basic Brown 1 in paper products may result in potential exposure; however, the risk to human health is considered to be low for this use.

Exposure to CAS RNs 14408-20-9, 36986-04-6, 59709-10-3, 68929-07-7, 69852-41-1 and 93783-70-1 may occur through dermal and oral contact with textiles as well as oral ingestion of paper. No health effects data were identified for azo basic dyes, nor were appropriate analogues identified. There were also no indications of effects of concern for those azo cleavage products for which data was available. In the absence of suitable toxicity data for the above-mentioned substances, health effect levels from phenazopyridine hydrochloride have been applied as a conservative approach, resulting in margins of exposure that are adequate to address uncertainties in the exposure and health effects databases. Therefore, for dermal exposure to textiles and incidental ingestion of textiles or paper containing these substances, the risk to human health is considered to be low.

For the remaining 20 of the 32 azo basic dyes included in the human health assessment, available information did not identify sources of current exposure for the general population of Canada; therefore, risk to human health is not expected for these substances.

Some of the azo basic dyes in this assessment have effects of concern based on potential carcinogenicity. While available information does not indicate a risk to human health for Canadians at current levels of exposure, there may be a concern if exposures were to increase.

Based on the information presented in this Screening Assessment, it is concluded that the azo basic dyes evaluated in this assessment do not meet the criteria under paragraph 64(c) of CEPA, as they are not 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. In addition, there are no updates to the assessment and conclusion made with respect to paragraph 64(c) for NDTHPM, previously considered by the Government of Canada.

Overall conclusion

It is concluded that the 33 azo basic dyes evaluated in this assessment do not meet any of the criteria set out in section 64 of CEPA.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances in this assessment are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers such as textiles, cosmetics and food.

The current screening assessment concludes that the potential ecological concern identified in the previous assessment of CAS RN 59709-10-3 with respect to new uses as described in the Screening Assessment of 145 persistent, bioaccumulative and inherently toxic substances, published in April 2008, has changed. The current screening assessment concludes that this substance is no longer of concern to the environment, nor considered as having effects of concern. Consequently, amendments to the Domestic Substances List, indicating that the Significant New Activity provisions under subsection 81(3) of the Act no longer apply to this substance, are being considered.

The Screening Assessment is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[22-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of 33 monoazo pigments specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas 25 of the 33 monoazo pigments identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas four of the substances, NANPAP (CAS RN (see footnote 11) 85005-63-6), NAPNPA (CAS RN 94199-57-2), Pigment Red 251 (CAS RN 74336-60-0) and Pigment Yellow 60 (CAS RN 6407-74-5), are currently subject to the Significant New Activity provisions under subsection 81(3) of the Act;

Whereas a summary of the Screening Assessment conducted on eight monoazo pigments pursuant to paragraphs 68(b) and (c) and pursuant to section 74 of the Act for the remaining 25 monoazo pigments is annexed hereby;

Whereas the Publication of final decision on the screening assessment of a substance — 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- (Pigment Red 3), CAS No. 2425-85-6 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) was published in the Canada Gazette, Part I, on March 7, 2009;

Whereas the final decision that Pigment Red 3 meets one or more of the criteria set out in section 64 of the Act remains unchanged;

Whereas Pigment Red 3 was added to Schedule 1 to the Canadian Environmental Protection Act, 1999 on February 16, 2011, by his Excellency the Governor in Council on the recommendation of the Minister of the Environment and the Minister of Health (the ministers);

And whereas it is concluded that the remaining 32 monoazo pigments do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers propose to take no further action on eight monoazo pigments at this time,

Notice is further given that the ministers propose to take no further action on the remaining 24 monoazo pigments at this time under section 77 of the Act, and

Notice is further given that, pursuant to subsection 87(3) of the Act, the Minister of the Environment intends to amend the Domestic Substances List such that NANPAP (CAS RN 85005-63-6), NAPNPA (CAS RN 94199-57-2), Pigment Red 251 (CAS RN 74336-60-0) and Pigment Yellow 60 (CAS RN 6407-74-5) are no longer subject to the Significant New Activity provisions under subsection 81(3) of the Act.

CATHERINE McKENNA
Minister of the Environment

JANE PHILPOTT
Minister of Health

ANNEX

Summary of the Screening Assessment of Monoazo Pigments

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of 33 monoazo pigments. These substances are being assessed as part of the Government of Canada's Chemicals Management Plan (CMP). They were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of CEPA and/or were considered as a priority based on other human health concerns.

The Chemical Abstracts Service Registry Number (CAS RN), Domestic Substances List (DSL) name, Colour Index (C.I.) name or acronym of the 33 substances are presented in the following table.

Identity of the 33 monoazo pigments
CAS RN	DSL name	Colour Index name (Colour Index number)	Chemical acronym
1103-38-4	1-Naphthalenesulfonic acid, 2-[(2-hydroxy-1-naphthalenyl)azo]-, barium salt (2:1)	Pigment Red 49:1 (C.I. 15630:1)	PR49:1
2425-85-6^a	2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]-	Pigment Red 3 (C.I. 12120)	PR3
2512-29-0^b	Butanamide, 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenyl-	Pigment Yellow 1 (C.I. 11680)	PY1
2786-76-7	2-Naphthalenecarboxamide, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxy-	Pigment Red 170 (C.I. 12475)	PR170
2814-77-9^a	2-Naphthalenol, 1-[(2-chloro-4-nitrophenyl)azo]-	Pigment Red 4 (C.I. 12085)	PR4
3468-63-1^a	2-Naphthalenol, 1-[(2,4-dinitrophenyl)azo]-	Pigment Orange 5 (C.I. 12075)	PO5
5160-02-1	Benzenesulfonic acid, 5-chloro-2-[(2-hydroxy-1-naphthalenyl)azo]-4-methyl-, barium salt (2:1)	Pigment Red 53:1 (C.I. 15585:1)	PR53:1
6372-81-2	Benzoic acid, 2-[(2-hydroxy-1-naphthalenyl)azo]-, barium salt (2:1)	Pigment Red 50:1 (C.I. 15500:1)	PR50:1
6407-74-5^a	3H-Pyrazol-3-one, 4-[(2-chlorophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-	Pigment Yellow 60 (C.I. 12705)	PY60
6410-09-9^a	2-Naphthalenol, 1-[(2-nitrophenyl)azo]-	Pigment Orange 2 (C.I. 12060)	PO2
6410-13-5^a	2-Naphthalenol, 1-[(4-chloro-2-nitrophenyl)azo]-	Pigment Red 6 (C.I. 12090)	PR6
6410-41-9^a	2-Naphthalenecarboxamide, N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulfonyl]-2-methoxyphenyl]azo]-3-hydroxy-	Pigment Red 5 (C.I. 12490)	PR5
6417-83-0^b	2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-, calcium salt (1:1)	Pigment Red 63:1 (C.I. 15880:1)	PR63:1
6486-23-3^b	Butanamide, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxo-	Pigment Yellow 3 (C.I. 11710)	PY3
6535-46-2^b	2-Naphthalenecarboxamide, 3-hydroxy-N-(2-methylphenyl)-4-[(2,4,5-trichlorophenyl)azo]-	Pigment Red 112 (C.I. 12370)	PR112
7023-61-2^b	2-Naphthalenecarboxylic acid, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-, calcium salt (1:1)	Pigment Red 48:2 (C.I. 15865:2)	PR48:2
12236-62-3^b	Butanamide, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-	Pigment Orange 36 (C.I. 11780)	PO36
12236-64-5^a	2-Naphthalenecarboxamide, N-[4-(acetylam no)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxy-	Pigment Orange 38 (C.I. 12367)	PO38
12238-31-2	Pigment Red 52:2	Pigment Red 52:2 (C.I. 15860:2)	PR52:2
13515-40-7^b	Butanamide, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxo-	Pigment Yellow 73 (C.I. 11738)	PY73
13824-00-5	2-Naphthalenecarboxamide, 3-hydroxy-N-(4-methoxyphenyl)-4-[(4-methylphenyl)azo]-	Not available	NAPMPA
16403-84-2	2-Naphthalenecarboxamide, 4-[[5-(aminocarbonyl)-2-methylphenyl]azo]-3-hydroxy-N-phenyl-	Pigment Red 268 (C.I. 12316)	PR268
17852-99-2^b	2-Naphthalenecarboxylic acid, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-, calcium salt (1:1)	Pigment Red 52:1 (C.I. 15860:1)	PR52:1
17947-32-9	2-Naphthalenecarboxamide, 3-hydroxy-N-(4-methoxyphenyl)-4-(phenylazo)-	Not available	NAPPA
36968-27-1	2-Naphthalenecarboxamide, 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)-	Pigment Red 266 (C.I. 12474)	PR266
43035-18-3^a	Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]-, calcium salt (2:1)	Pigment Red 247:1 (C.I. 15915)	PR247:1
49744-28-7	2-Naphthalenol, 1-[(4-methoxy-2-nitrophenyl)azo]-	Not available	NONPA
59487-23-9^a	2-Naphthalenecarboxamide, 4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxy-	Pigment Red 187 (C.I. 12486)	PR187
71832-83-2	2-Naphthalenecarboxylic acid, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-, magnesium salt (1:1)	Pigment Red 48:5 (C.I. 15865:5)	PR48:5
74336-60-0^a	9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl-9-oxopyrazolo[5,1-b]quinazolin-3-yl)azo]-	Pigment Red 251 (C.I. 12925)	PR251
83249-60-9	1-Naphthalenesulfonic acid, 2-[(2-hydroxy-6-sulfo-1-naphthalenyl)azo]-, calcium salt (1:1)	Not available	NSNAC
85005-63-6	2-Naphthalenecarboxamide, 4-[(2,4-dinitrophenyl)azo]-3-hydroxy-N-phenyl-	Not available	NANPAP
94199-57-2	2-Naphthalenecarboxamide, N-(2-ethoxyphenyl)-3-hydroxy-4-[(2-nitrophenyl)azo]-	Not available	NAPNPA

^a This substance was previously assessed and concluded on under the CMP.

^b This substance was not identified under subsection 73(1) of CEPA but was included in this assessment as it was considered as a priority based on other human health concerns.

Assessments to determine whether 11 of the monoazo pigments (PR3, PR4, PR5, PR6, PR187, PR247:1, PR251, PO2, PO5, PO38 and PY60) met one or more criteria under section 64 of CEPA were previously conducted under the CMP. Among them, one substance (Pigment Red 3) was concluded to meet the criteria as set out in paragraph 64(c) of CEPA. As outlined in the notice of intent for the aromatic azo and benzidine-based substance grouping, (see footnote 12) it was recognized that assessments and conclusions pertaining to some of the substances may be subsequently updated as part of the current assessment. Specifically, significant new information has been identified to inform the ecological assessment of monoazo pigments, and the assessments for the 11 substances have been updated accordingly. Similarly, significant new information pertaining to human health has been identified for 10 of the 11 substances, excluding Pigment Red 3; therefore, the human health risk assessment for these 10 substances has been updated.

These 33 monoazo pigments are not expected to occur naturally in the environment. Twenty-one of the 33 monoazo pigments are reported as being either manufactured in and/or imported into Canada at levels above the reporting threshold of 100 kg/year. Some of the 33 monoazo pigments were also identified as being used in products available to consumers. No measured concentrations in the Canadian environment have been identified for any of these substances.

Environment

The monoazo pigments exist principally as particles in the sub- or low-micron range, and the pigment powder is typically composed of primary particles (i.e. the crystal lattice of a pigment), aggregates, and agglomerates. These 33 monoazo pigments have very low solubility in water (sub- to low-microgram per litre) and low solubility in octanol (below 20 mg/L); because of this, it is proposed that a quotient logarithm of the molar solute concentrations in octanol and water would reasonably represent the octanol–water partition coefficient for these pigments. Physical-chemical properties and the particulate nature of these substances suggest that soil and sediments are expected to be the two major environmental media of concern for the monoazo pigments.

Experimental data indicate that under aerobic conditions, monoazo pigments are expected to be persistent in water, soil, and sediments. Bioavailability of monoazo pigments is expected to be low based on the particulate character of these substances and their low solubility in water. As a result, the potential to bioaccumulate in pelagic organisms is expected to be low, which is confirmed by the results of bioconcentration studies.

Due to the limited bioavailability of monoazo pigments, no effects were found at the concentration of 1 000 mg/kg soil (dry weight) in chronic soil toxicity studies. These pigments also showed “no effect at saturation” in acute and chronic aquatic ecotoxicological studies where solvents were not used. The results of these studies allowed for a conclusion that monoazo pigments are not expected to be harmful to aquatic and soil-dwelling organisms at low (environmentally relevant) concentrations.

To evaluate potential exposures to monoazo pigments in the environment, predicted environmental concentrations (PECs) were calculated; the industrial release scenario was chosen to evaluate the potential exposure to these substances. Predicted no-effect concentrations (PNECs) for water and soil were calculated based on the experimental critical toxicity values. Calculated risk quotients (PEC/PNEC) were lower than one, indicating that harm to organisms in water and soil is not expected.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from the 33 monoazo pigments evaluated in this assessment. It is concluded that these monoazo pigments do not meet the criteria under paragraph 64(a) or 64(b) of CEPA, as they are not 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 or that constitute or may constitute a danger to the environment on which life depends.

Human health

With respect to human health, this Screening Assessment addresses 32 of 33 substances in the monoazo pigments subgroup, including substances previously assessed for which significant new information has become available. The remaining substance, Pigment Red 3, was previously assessed and conclusions were drawn for this substance under the CMP. As significant new information relevant to the health assessment was not identified for Pigment Red 3, the previous conclusion on human health for this substance has not been updated. However, Pigment Red 3 was considered to support a read-across approach for the β-naphthol pigments subset in the health assessment.

For the health assessment, most of the substances were evaluated as part of structurally related subsets: β-naphthol pigments (PO2, PO5, PR4, PR6 and NONPA), β-naphthol pigment lakes (PR49:1, PR50:1 and PR53:1), BONA pigment lakes (PR48:2, PR48:5, PR52:1, PR52:2 and PR63:1), monoazo yellow pigments (PY1, PY3 and PY73), or naphthol AS pigments (NANPAP, NAPMPA, NAPNPA, NAPPA, PO38, PR5, PR112, PR170, PR187, PR266 and PR268). The remaining five substances (NSNAC, PO36, PR247:1, PR251 and PY60) were evaluated as individual substances.

A range of data availability was identified across the subsets. While a number of health effects studies were identified for the β-naphthol pigments, β-naphthol pigment lakes and BONA pigment lakes, limited health effects studies were identified for the monoazo yellow pigments and naphthol AS pigments. No studies were identified for the other individual monoazo pigments in this assessment.

The β-naphthol pigments and β-naphthol pigment lakes exhibited similar toxicity in repeated-dose animal studies with target organs and systems, including the hematopoetic system, liver and kidney. While the β-naphthol pigments demonstrated mutagenic potential, the β-naphthol pigment lakes were predominantly negative in genotoxicity assays. Evidence for carcinogenicity was observed for both the β-naphthol pigment subset (liver tumours) and the β-naphthol pigment lake subset (liver and spleen tumours). In repeated-dose animal studies, the kidney was identified as the primary target organ for the BONA pigment lakes, while these substances did not generally show the same hemolysis and liver toxicity observed for the β-naphthol pigments and β-naphthol pigment lakes. The BONA pigment lakes were generally negative in genotoxicity assays and, based on results from studies with the analogue PR57:1, did not exhibit carcinogenic potential. The available short-term toxicity data indicate a low hazard potential for the monoazo yellow pigment subset and naphthol AS pigment subset. For the five substances considered individually (NSNAC, PO36, PR247:1, PR251 and PY60), only limited empirical data were identified; hence, their critical health effects cannot be conclusively determined.

Exposure to the 32 monoazo pigments via environmental media is not expected to be a significant source of exposure to the general population of Canada; therefore, the risk to human health from environmental media is considered to be low.

Nineteen monoazo pigments (NONPA, PO5, PO36, PO38, PR4, PR5, PR48:2, PR49:1, PR52:1, PR52:2, PR53:1, PR63:1, PR112, PR170, PR187, PR266, PY1, PY3 and PY73) were identified to be used in certain products available to consumers in the Canadian marketplace (e.g. face paint, finger paint, face mask, lipstick, and natural health products) and the exposure to these substances for the general population of Canada has been characterized. Margins between the estimates of exposures and critical effect levels from animal studies were considered adequate to address uncertainties in the exposure and health effects databases.

For two monoazo pigments (PR247:1 and PR268), limited uses in Canada were identified; however, exposure for the general population of Canada is not expected from these uses. Therefore, the risk to human health is not expected. For the other 11 monoazo pigments (NANPAP, NAPMPA, NAPNPA, NAPPA, NSNAC, PO2, PR6, PR48:5, PR50:1, PR251 and PY60), no uses of these substances in products in the Canadian marketplace were identified. Therefore, based on available information for exposure in Canada, the risk to human health is not expected for these 13 monoazo pigments.

Some of the monoazo pigments in this assessment have effects of concern based on potential carcinogenicity. While available information does not indicate a risk to human health for Canadians at current levels of exposure, there may be a concern if exposures were to increase.

Based on the information presented in this Screening Assessment, it is concluded that the 32 monoazo pigments evaluated in this assessment for human health do not meet the criteria under paragraph 64(c) of CEPA, as they are not 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. In addition, there are no updates to the conclusion made with respect to paragraph 64(c) for Pigment Red 3, previously assessed by the Government of Canada under the Challenge Initiative of the CMP.

Overall conclusion

It is concluded that 32 monoazo pigments evaluated in this assessment do not meet any of the criteria set out in section 64 of CEPA.

The conclusion previously made that Pigment Red 3 meets the criteria set out in paragraph 64(c) of CEPA remains unchanged.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances in this assessment are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers, such as textiles, cosmetics and food.

Options on how best to monitor changes in the use profile of these substances are being investigated. Stakeholders will have the opportunity to provide feedback on a consultation document describing potential options for information gathering or preventive actions, which will be published once assessments for all of the aromatic azo and benzidine-based substances are completed.

Two substances included in the monoazo pigments assessment, Pigment Yellow 60 and Pigment Red 251, were previously assessed under the CMP and have had the significant new activity (SNAc) provisions of CEPA applied. For Pigment Yellow 60, the SNAc provisions of CEPA were applied as a result of the previous assessment. That assessment indicated that the substance, which was not in commerce in Canada, raised potential health concerns as a member of the class of azo substances, some members of which are known or suspected carcinogens, and was persistent, bioaccumulative and inherently toxic (PBiT) to non-human organisms. For Pigment Red 251, the SNAc provisions of CEPA were applied because the previous assessment indicated that the substance, which was not in commerce in Canada, was persistent, bioaccumulative and inherently toxic to non-human organisms. The current Screening Assessment no longer identifies Pigment Yellow 60 as having human health effects of concern based on potential carcinogenicity, and also no longer identifies ecological concerns for these two substances. As the original human health or ecological concerns identified to support the application of the SNAc provisions have changed, based on the current Screening Assessments, it is consequently proposed to rescind the SNAc provisions for these two substances.

A further two substances included in the monoazo pigments assessment, NANPAP and NAPNPA, were previously assessed in April 2008 in an assessment of 145 PBiT substances. Following that assessment, the SNAc provisions were applied because the assessment indicated that these substances, which were not in commerce in Canada, were persistent, bioaccumulative and inherently toxic. The current Screening Assessments now conclude that these two substances are not bioaccumulative. As the original ecological concern identified to support the application of the SNAc provisions has changed, based on the current Screening Assessments, it is consequently proposed to rescind the SNAc provisions for these two substances.

The Screening Assessment for these substances is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[22-1-o]

BANK OF CANADA

Statement of financial position as at April 30, 2016

(Millions of dollars) Unaudited
ASSETS	Amount	Total
Cash and foreign deposits		11.7
Loans and receivables
Securities purchased under resale agreements	7,002.5
Advances to members of the Canadian Payments Association	46.8
Advances to governments	—
Other receivables	6.5
		7,055.8
Investments
Treasury bills of Canada	14,873.2
Government of Canada bonds	78,405.9
Other investments	386.4
		93,665.5
Property and equipment		468.6
Intangible assets		35.7
Other assets		126.9
Total assets		101,364.2

LIABILITIES AND EQUITY	Amount	Total
Bank notes in circulation		74,048.8
Deposits
Government of Canada	24,174.6
Members of the Canadian Payments Association	547.2
Other deposits	1,551.8
		26,273.7
Other liabilities
Securities sold under repurchase agreements	—
Other liabilities	563.4
		563.4
		100,885.9
Equity
Share capital	5.0
Statutory and special reserves	125.0
Available-for-sale reserve	348.3
		478.3
Total Liabilities and Equity		101,364.2

I declare that the foregoing return is correct according to the books of the Bank.

Ottawa, May 16, 2016

Carmen Vierula
Chief Financial Officer and Chief Accountant

I declare that the foregoing return is to the best of my knowledge and belief correct, and shows truly and clearly the financial position of the Bank, as required by section 29 of the Bank of Canada Act.

Ottawa, May 16, 2016

Stephen S. Poloz
Governor

[22-1-o]

Footnotes

Footnote 1
American Type Culture Collection.
Footnote 2
American Type Culture Collection.
Footnote 3
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 4
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 5
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 6
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 7
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 8
Canada. Department of the Environment, Department of Health. 2010. Canadian Environmental Protection Act, 1999: Notice of intent to assess and manage the risks to the health of Canadians and their environment posed by aromatic azo substances which may break down to certain aromatic amines, substances which may break down to certain benzidines, and the corresponding aromatic amines or benzidines. Canada Gazette, Part I, Vol. 144, No. 23, pp. 1402–1405. Available from http://canadagazette.gc.ca/rp-pr/p1/2010/2010-06-05/html/notice-avis-eng.html#d101.
Footnote 9
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 10
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 11
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
Footnote 12
Canada. Department of the Environment, Department of Health. 2010. Canadian Environmental Protection Act, 1999: Notice of intent to assess and manage the risks to the health of Canadians and their environment posed by aromatic azo substances which may break down to certain aromatic amines, substances which may break down to certain benzidines, and the corresponding aromatic amines or benzidines. Canada Gazette, Part I, Vol. 144, No. 23. Available from http://canadagazette.gc.ca/rp-pr/p1/2010/2010-06-05/html/notice-avis-eng.html#d101