Canada Gazette, Part I, Volume 154, Number 42: GOVERNMENT NOTICES

October 17, 2020

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 20497

Ministerial condition
(Paragraph 109(1)(a) of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the living organism Coxsackievirus A21, Kuykendall strain;

And whereas the ministers suspect that the living organism is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),

The Minister of the Environment, pursuant to paragraph 109(1)(a) of the Act, hereby permits the manufacture or import of the living organism in accordance with the conditions of the following annex.

Jacqueline Gonçalves
Acting Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment

ANNEX

Conditions

(Paragraph 109(1)(a) of the Canadian Environmental Protection Act, 1999)

1. The following definitions apply in these ministerial conditions:

  • “Canadian Biosafety Standard” means the document entitled Canadian Biosafety Standard, 2nd Edition, published in 2015, developed by the Public Health Agency of Canada and the Canadian Food Inspection Agency, as amended from time to time;
  • “contained facility” means an enclosed building with walls, floor and ceiling, or an area within such a building, where the containment is in accordance with the physical and operational requirements of a level set out in either the Canadian Biosafety Standard or Appendix K of the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) June 1994, published in the Federal Register by the U.S. Department of Health and Human Services, 59 FR 34472 (July 5, 1994), as amended from time to time, and which are required based on the risk group classification of the living organism;
  • “engineered hazardous waste landfill facility” means a facility that is part of an overall integrated hazardous waste management system where wastes that do not require additional treatment or processing are sent and where hazardous materials are confined or controlled for the duration of their effective contaminating lifespan;
  • “living organism” means the living organism Coxsackievirus A21, Kuykendall strain;
  • “notifier” means the person who has, on August 4, 2020, provided to the Minister of the Environment the prescribed information concerning the living organism, in accordance with subsection 106(1) of the Canadian Environmental Protection Act, 1999; and
  • “waste” means any solid or liquid material generated by a facility for disposal and may include the effluents that result from rinsing equipment or vessels used for the living organism, disposable vessels used for the living organism, any spillage that contains the living organism, the process effluents that contain the living organism, and any residual quantity of the living organism in any equipment or vessel.

2. The notifier may manufacture or import the living organism in accordance with the present ministerial conditions.

3. The present ministerial conditions do not apply in relation to the living organism if a licence has been issued to the notifier under the Human Pathogens and Toxins Act to conduct controlled activities with the living organism.

Restrictions

4. The notifier may only import or manufacture the living organism if the following conditions are met:

  • (a) it is imported to a contained facility which meets the containment level requirements for Risk Group 2 organisms or, if the organism is classified in a different risk group, the containment level for that risk group;
  • (b) it is manufactured in a contained facility which meets the containment level requirements for Risk Group 2 organisms or, if the organism is classified in a different risk group, the containment level for that risk group; and
  • (c) it is not released outside the contained facility.

5. The notifier must ensure that the following conditions are met concerning the living organism:

  • (a) it is transferred to or used in a contained facility which meets the containment level requirements for Risk Group 2 organisms or, if the organism is classified in a different risk group, the containment level for that risk group;
  • (b) it is not administered to patients by inhalation, nebulization, or by another method which would spray or release it into the environment (excluding release into the environment through viral shedding from treated patients);
  • (c) for any other administration method, the area of the body treated with the living organism is covered with a waterproof dressing that covers the entire treated area and the dressing remains in place until staff administering the living organism determines that the dressing can be replaced or removed; and
  • (d) any exposed lesion at the site where the living organism is injected into the patient treated with the living organism is completely covered with a waterproof dressing and the dressing remains in place until staff administering the living organism determines that the dressing can be replaced or removed.

Handling and disposal of the living organism

6. (1) The notifier must not release the living organism or waste into the environment.

(2) The notifier must decontaminate all surfaces that may directly come into contact with the living organism with an effective antiviral agent.

(3) The notifier must decontaminate liquids containing the living organism prior to release to sanitary sewers.

(4) The notifier must handle specimens or samples collected from persons treated with the living organism in accordance with the Canadian Biosafety Standard.

(5) The notifier must collect any waste in their physical possession or under their control in biohazard containers and must destroy or dispose of it in the following manner:

  • (a) incineration in accordance with the laws of the jurisdiction where the incineration facility is located; or
  • (b) disposal in an engineered hazardous waste landfill facility, in accordance with the applicable laws of the jurisdiction where the facility is located, if it cannot be incinerated in accordance with paragraph 6(5)(a).

(6) The notifier must decontaminate in an autoclave all materials that came into contact with the living organism, if the materials are not incinerated in accordance with paragraph 6(5)(a).

Environmental release

7. Where any release of the living organism or waste to the environment occurs, the notifier must immediately take all measures necessary to prevent any further release and to limit the dispersion of any release. Furthermore, the notifier must, as soon as possible in the circumstances, inform the Minister of the Environment by contacting an enforcement officer designated under the Canadian Environmental Protection Act, 1999.

Other requirements

8. The notifier must, prior to transferring the physical possession or control of the living organism or waste to any person,

  • (a) inform the person to whom they transfer the physical possession or control of the living organism or waste, in writing, of the terms of the present ministerial conditions; and
  • (b) obtain, prior to the first transfer of the living organism or waste, written confirmation from this person that they were informed of the terms of the present ministerial conditions and agree to comply with sections 4 to 7 of the present ministerial conditions.

9. The person who signs the written confirmation referred to in paragraph 8(b) must comply with sections 4 to 7 as if these sections referred to this person.

Record-keeping requirements

10. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating

  • (a) the use of the living organism;
  • (b) the quantity of the living organism that the notifier manufactures, imports, purchases, distributes, sells and uses;
  • (c) the risk group classification of the living organism;
  • (d) the containment level of the facility where the living organism was imported, manufactured or used;
  • (e) the method by which the living organism was administered to patients;
  • (f) the method used to cover any lesions at the injection site or treated area of the body of the patient;
  • (g) the name and address of each person to whom the notifier transfers the physical possession or control of the living organism;
  • (h) the name and address of each person in Canada who disposed of the living organism or of waste for the notifier, the method used to do so and the quantities of the living organism or waste shipped to that person; and
  • (i) the written confirmation referred to in para- graph 8(b).

(2) The notifier shall maintain electronic or paper records mentioned in subsection (1) at their principal place of business in Canada, or at the principal place of business in Canada of their representative, for a period of at least five years after they are made.

Coming into force

11. The present ministerial conditions come into force on October 2, 2020.

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of a substance — 1,3,5-triazine-2,4,6-triamine (melamine), CAS RNfootnote 1 108-78-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas melamine is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the updated draft screening assessment conducted on melamine pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that the substance meets one or more 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 recommend to Her Excellency the Governor in Council that this substance be added to Schedule 1 of the Act.

Notice is furthermore given that the ministers have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of risk management actions.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. 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, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, or by email to eccc.substances.eccc@canada.ca. Comments can also be submitted to the Minister of the Environment, using the online reporting system available through Environment and Climate Change Canada’s Single Window.

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.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

Gwen Goodier
Director General
Industrial Sectors, Chemicals and Waste Directorate
On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of melamine

Pursuant to section 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 1,3,5-triazine-2,4,6-triamine (CAS RN 108-78-1), commonly known as melamine, a substance included in the Certain Organic Flame Retardants (OFR) Substance Grouping under Canada’s Chemicals Management Plan, which includes 10 organic substances that have a similar function: application to materials to slow the ignition and spread of fire. Melamine was identified as a priority for assessment as it met the categorization criteria under subsection 73(1) of CEPA. A draft screening assessment for melamine was published in October 2016. Significant new information subsequently became available regarding exposure to products available to consumers, specifically foam products containing flame retardants such as melamine. As a result, the draft assessment was updated and is presented here.

Melamine does not occur naturally in the environment. It is not manufactured in Canada; however, imports of melamine, as a pure substance or blended into products, in the range of 10 to 100 million kilograms were reported for the year 2011. In Canada, melamine has numerous industrial applications; its predominant use is in the manufacture of polyurethane foams and melamine-based resins for application in laminates, plastics, paints and coatings. Globally, melamine is used primarily in the synthesis of melamine–formaldehyde resins for similar applications, and in adhesives and moulding compounds. Due to its high nitrogen content, melamine has also been used globally as a fertilizer. In Canada, sources of environmental exposure to melamine are primarily from waste streams or effluents of manufacturing of melamine-based resins, and, to a lesser degree, from processing plants using melamine to manufacture products with flame retardant properties. Discharges to the environment can be direct or via municipal wastewater treatment systems.

Melamine is a compact and stable molecule characterized by high water solubility, negligible vapour pressure, and low to negligible organic carbon–water and octanol–water partition coefficients. Monitoring of melamine in environmental media has not been conducted in Canada. When released to the environment, melamine is expected to predominantly reside in water and, to a lesser degree, in soil, depending on the compartment of release.

Melamine does not degrade rapidly in the environment; it has a long half-life in air, and has relatively slow biodegradation rates in water and soil. Melamine has a limited potential to bioaccumulate in tissues of organisms. It has very low bioconcentration factors in fish, and residue clearance rates from numerous organisms including mammals, fish and birds are known to be fast.

Based on empirical evidence from short- and long-term studies, melamine has a low toxicity to aquatic and soil-dwelling organisms. As the toxic effects of melamine exposure were more pronounced in long-term studies and those encompassing sensitive life stages, results from these types of studies were generally more informative. In contrast, in the multiple short-term studies, the toxicity limit for melamine could not be defined since the highest concentration tested showed no effects.

It is expected that melamine may be released to the Canadian environment as a result of industrial processing activities. Although melamine can be found in products available for consumer or commercial use, it is expected that release to the environment via this route is minimal. Industrial scenarios, where melamine is released to water, were developed to provide estimates of exposure. Risk quotient analyses, integrating conservative estimates of exposure with toxicity information, were performed for the aquatic compartment. These analyses showed that melamine risk to the environment in Canada is unlikely.

Considering all available lines of evidence presented in this updated draft screening assessment, there is a low risk to the environment from melamine. It is proposed to conclude that melamine 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 main sources of exposure to melamine for the general population in Canada are expected to be from the use of products available to consumers, food and environmental media (water, soil). Biomonitoring data were also available from relevant populations (United States).

Based principally on the weight-of-evidence assessments of international agencies and available information, critical effects associated with exposure to melamine are carcinogenicity and effects on the urinary system. Available information indicates that melamine is not genotoxic. For infants, toddlers and young individuals (up to 18 years old), comparisons between levels associated with critical effects in animal studies and estimates of exposure from lying on foam-containing mattresses or furniture containing melamine are considered to be potentially inadequate to address uncertainties in the health effects and exposure databases. For all other types of exposures (from environmental media and food or from use of products available to consumers of all age groups), comparisons between levels associated with critical effects in animal studies and estimates of exposure were considered adequate to address uncertainties in the health effects and exposure databases.

On the basis of the potential inadequacy of the margins between estimates of exposure and critical effect levels in experimental animals in this updated draft screening assessment, it is proposed to conclude that melamine 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.

Proposed overall conclusion

It is therefore proposed to conclude that melamine meets one or more of the criteria set out in section 64 of CEPA. It is also proposed to conclude that melamine meets the persistence criteria, but not the bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The draft screening assessment and the risk management scope document for this substance are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of a substance — benzenesulfonic acid, 4-methyl- (p-toluenesulfonic acid), CAS RNfootnote 1 104-15-4 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas p-toluenesulfonic acid is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft screening assessment conducted on p-toluenesulfonic acid pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that the substance does 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 this substance at this time under section 77 of the Act.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by email to eccc.substances.eccc@canada.ca or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

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.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of p-toluenesulfonic acid

Pursuant to section 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 benzenesulfonic acid, 4-methyl-, hereinafter referred to as p-toluenesulfonic acid (PTSA). The Chemical Abstracts Service Registry Number (CAS RN) for PTSA is 104-15-4. This substance was identified as a priority for assessment as it met categorization criteria under subsection 73(1) of CEPA.

PTSA does not naturally occur in the environment. According to information submitted in response to a CEPA section 71 survey, 141 600 kg of PTSA were imported into Canada in 2011 and no manufacturing was reported.

The ecological risk of PTSA was characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, the substance is considered unlikely to cause ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to the environment from PTSA. It is proposed to conclude that PTSA 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.

In Canada, PTSA is primarily used in the manufacture of paints and coatings, and of plastic and rubber materials. Exposure of the general population to PTSA is primarily from use of cosmetics (face lotion, permanent hair dye, and hair conditioner), an adhesive for crack repair, and conversion varnish sprays (catalyst-activated coating for interior wood furnishings).

Although PTSA has not been reviewed internationally, hydrotropes, including salts of PTSA, have been reviewed through the Cooperative Chemicals Assessment Programme of the Organisation for Economic Co-operation and Development (OECD). These OECD assessments were used to inform the health effects characterization of PTSA in this screening assessment. On the basis of available health effects information for PTSA and analogues in laboratory studies, the substance was not found to have genotoxic, carcinogenic, reproductive or developmental effects, and no systemic adverse effects were observed in repeated-dose studies with PTSA or its analogues up to the limit dose of 1 000 mg/kg bw/day. Given the low hazard potential of PTSA, estimates of exposure to the general population were not derived as the risk to human health is considered to be low.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that PTSA does not meet criteria under paragraph 64(c) of CEPA as it is not entering the environment in a quantity or concentration under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed overall conclusion

It is proposed to conclude that p-toluenesulfonic acid does not meet any of the criteria set out in section 64 of CEPA.

The draft screening assessment for this substance is available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of six substances in the Triarylmethanes Group specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Malachite Green, Basic Violet 4, and Basic Blue 7 are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on Basic Violet 3, Pigment Blue 61, and Brilliant Blue FCF pursuant to paragraphs 68(b) and (c) of the Act and on Malachite Green, Basic Violet 4, and Basic Blue 7 pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that Pigment Blue 61 and Brilliant Blue FCF do not meet any of the criteria set out in section 64 of the Act,

Notice is further given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on these two substances at this time.

And whereas it is concluded that Basic Violet 3, Malachite Green, Basic Violet 4 and Basic Blue 7 meet one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers propose to recommend to Her Excellency the Governor in Council that these substances be added to Schedule 1 of the Act.

Notice is furthermore given that the ministers are releasing a proposed risk management approach document for Basic Violet 3, Malachite Green, Basic Violet 4 and Basic Blue 7 on the Canada.ca (Chemical Substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to these substances.

Public comment period on the risk management approach

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

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.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX

Summary of the screening assessment of the Triarylmethanes Group

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 six substances referred to collectively under the Chemicals Management Plan as the Triarylmethanes Group. These six substances were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other concerns. A seventh substance was initially included in the group; however, it was determined to be of low concern through other approaches, and the conclusion for this substance is provided in a separate report.footnote 2 Accordingly, this screening assessment addresses the six substances listed in the table below. The six substances addressed in this screening assessment will hereinafter be referred to as the Triarylmethanes Group.

Substances in the Triarylmethanes Group
CAS RN table b1 note a Domestic Substances List name Common name
548-62-9 table b1 note b Methanaminium, N-[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride Basic Violet 3
569-64-2 Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride Malachite Green
1324-76-1 table b1 note b Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- Pigment Blue 61
2390-59-2 Ethanaminium, N-[4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride Basic Violet 4
2390-60-5 Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride Basic Blue 7
3844-45-9 table b1 note b Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, disodium salt Brilliant Blue FCF

Table b1 notes

Table b1 note a

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.

Return to table b1 note a referrer

Table b1 note b

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

Return to table b1 note b referrer

Triarylmethanes are primarily used as colouring agents and do not occur naturally in the environment. They are used as dyes and/or pigments in inks, toners, and colourants, in paper products and manufactured items, and potentially in food packaging materials, for commercial and consumer use. Substances in this group are also used in other products available to consumers, including cosmetics (e.g. body cream, hair products, hair dyes, makeup, perfume), cleaning products, and water treatment products for aquarium fish, as well as in additional industrial and laboratory products. Brilliant Blue FCF is also used in food, natural health products, pest control products, prescription and non-prescription drugs, and a range of additional products available to consumers. According to information submitted for the reporting years of either 2008 or 2011, all six substances were imported into Canada, each in quantities ranging from 1 000 to 100 000 kg, and Brilliant Blue FCF was manufactured in Canada in a quantity ranging from 100 to 1 000 kg.

Substances in the Triarylmethanes Group may be released to the Canadian environment from their use in Canada in paper dyeing and de-inking, as well as from the formulation, manufacture and consumer use of products containing these substances. Releases are expected to the aquatic environment from both diffuse and point sources. Releases of some of these substances to terrestrial environments are also possible. If released to the aquatic environment, Pigment Blue 61 is likely to behave like a particle and settle to bed sediment. The other triarylmethane substances will be charged at environmentally relevant pH and will tend to sorb to dissolved and suspended solids. Therefore, these substances may potentially be transported in the water column or settle to bed sediment. Substances in the Triarylmethanes Group tend to persist in water, sediment and soil. They have a low potential to bioaccumulate in the lipids of aquatic organisms; however, the non-sulfonated dyes (i.e. Basic Violet 3, Malachite Green, Basic Violet 4 and Basic Blue 7) instead may bind to proteins and accumulate in other types of fish tissue.

Experimental acute toxicity data for the non-sulfonated dyes show they have the potential to cause adverse effects to aquatic organisms at low concentrations. Adverse effects in aquatic organisms were observed for Brilliant Blue FCF at relatively higher concentrations, whereas no effects were observed at the solubility limit for Pigment Blue 61. Ecological exposure scenarios were developed for down-the-drain releases from uses of products containing these substances and for releases from industrial sites. Risk quotient analyses were conducted to compare estimated aquatic concentrations to adverse effect concentrations in aquatic organisms for different exposure scenarios. Scenarios for paper dyeing and paper de-inking indicated that the non-sulfonated triarylmethane dyes pose a risk to aquatic organisms, whereas the scenarios for general formulation/product handling and consumer uses did not. Exposure scenarios for Brilliant Blue FCF did not show a risk to aquatic organisms and Pigment Blue 61 is not expected to pose a risk to aquatic organisms as it is expected to behave more like a particle and is not likely to be bioavailable.

Considering all available lines of evidence presented in this screening assessment, there is a risk of harm to the environment from Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7. It is concluded that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 meet the criteria under paragraph 64(a) of CEPA as they are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. However, it is concluded that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 do not meet the criteria under paragraph 64(b) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends. It is also concluded that Pigment Blue 61 and Brilliant Blue FCF 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.

For the general population of Canada, the predominant sources of exposure to dye substances in the Triarylmethanes Group are the use of products available to consumers that contain these substances and from environmental media (e.g. drinking water). Potential oral exposures to Basic Violet 3, Malachite Green, Basic Violet 4, Basic Blue 7 and Brilliant Blue FCF were estimated based on potential levels in drinking water. Potential dermal and oral exposures to Brilliant Blue FCF were derived from the use of natural health products and cosmetics, as well as oral exposures from its use as a food additive. Potential exposures to Malachite Green, Basic Violet 4 and Basic Blue 7 were derived from the use of cosmetics (hair dyes). Potential inhalation exposure to Brilliant Blue FCF from the use of perfume was also characterized. Inhalation exposure to the remaining substances in the Triarylmethanes Group was not considered to be of concern due to their negligible volatility, as well as their potential uses. Given its physical and chemical properties and identified uses, exposure to Pigment Blue 61 for the general population of Canada is not expected.

In laboratory studies, Basic Violet 3 is not observed to cause developmental or reproductive toxicity, but is genotoxic and carcinogenic. On the basis of health effects information for a structurally related substance, the critical health effect for Malachite Green is developmental toxicity. Pigment Blue 61 was not identified as posing a high hazard to human health on the basis of classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Basic Violet 4 and the structurally related substance Basic Blue 7 are not genotoxic. On the basis of health effects information on structurally related substances, Basic Violet 4 and Basic Blue 7 are not considered to be developmental or reproductive toxicants, but may be carcinogenic. Brilliant Blue FCF is poorly absorbed orally and dermally, is not a developmental or reproductive toxicant, is not genotoxic, and is not carcinogenic.

For Basic Violet 3, Basic Violet 4, Basic Blue 7, and Brilliant Blue FCF, comparisons of levels of exposure to the general population and levels at which critical health effects were observed result in margins of exposure considered adequate to address uncertainties in the health effects and exposure databases for both non-cancer and cancer effects. In contrast, similar comparisons of exposure from the use of Malachite Green in hair dye resulted in margins of exposure that are considered potentially inadequate to address uncertainties in the health effects and exposure databases, particularly since the critical health effects were observed at the lowest tested dose.

On the basis of the information presented in this screening assessment, it is concluded that Malachite Green 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. It is also concluded that Basic Violet 3, Pigment Blue 61, Basic Violet 4, Basic Blue 7, and Brilliant Blue FCF 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

Therefore, it is concluded that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 meet one or more of the criteria set out in section 64 of CEPA. It is concluded that Pigment Blue 61 and Brilliant Blue FCF do not meet any of the criteria set out in section 64 of CEPA. It is also concluded that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The screening assessment and the risk management approach document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of results of investigations and recommendations for two substances — 2-propanol, 1-chloro-, phosphate (3:1) [TCPP], CAS RN 13674-84-5, and 2-propanol, 1,3-dichloro-, phosphate (3:1) [TDCPP], CAS RNfootnote 1 13674-87-8 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas a summary of the updated draft screening assessment conducted on TCPP and TDCPP pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;

And whereas it is proposed to conclude that the substances meet one or more 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 recommend to Her Excellency the Governor in Council that these substances be added to Schedule 1 of the Act.

Notice is furthermore given that the ministers have released a risk management scope document for these substances to initiate discussions with stakeholders on the development of risk management actions.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. 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, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, or by email to eccc.substances.eccc@canada.ca. Comments can also be submitted to the Minister of the Environment using the online reporting system available through Environment and Climate Change Canada’s Single Window.

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.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

Gwen Goodier
Director General
Industrial Sectors, Chemicals and Waste Directorate
On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of TCPP and TDCPP

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 2-propanol, 1-chloro-, phosphate (3:1), hereinafter referred to as TCPP, Chemical Abstracts Service Registry Number (CAS RN) 13674-84-5, and of 2-propanol, 1,3-dichloro-, phosphate (3:1), hereinafter referred to as TDCPP, CAS RN 13674-87-8. TCPP and TDCPP are part of the Certain Organic Flame Retardants (OFR) Substance Grouping, which includes 10 organic substances having the following similar function: application to materials to slow the ignition and spread of fire. These two substances were identified as a priority for assessment based on other human health concerns. A draft screening assessment of TCPP and TDCPP was published in October 2016. Significant new information subsequently became available regarding exposure to products available to consumers, specifically foam products containing flame retardants such as TCPP and TDCPP. As a result, the draft assessment was updated and is presented here.

TCPP and TDCPP are discrete organic chemicals that do not occur naturally in the environment. According to information identified from a survey issued under section 71 of CEPA, there is no manufacturing of either TCPP or TDCPP in Canada. Both substances were predominantly imported into Canada as pure substances or in manufactured items. The total import volumes in 2011 ranged from 1 000 000 to 10 000 000 kg of TCPP, and 100 000 to 1 000 000 kg of TDCPP.

TCPP is used as an additive flame retardant for manufacturing of building or construction materials in Canada (e.g. polyurethane spray foam insulation), and is contained in imported products of polyurethane spray foam insulation with the same functional use. TCPP is also imported into Canada in manufactured items containing flexible polyurethane foam (e.g. in upholstered furniture and mattresses) and as a textile waterproofing spray intended for consumer use. Available information indicates the potential for migration of flame retardants from foam objects.

TDCPP is used as an additive flame retardant in the manufacturing of flexible polyurethane foam in Canada (used in manufactured items such as upholstered furniture and mattresses). The substance is imported as a pure substance and in commercial products and products available to consumers with the same functional use.

TCPP is highly soluble in water and has a low octanol–water partition coefficient, while TDCPP possesses moderate water solubility and octanol–water partition coefficient. Both substances have a low vapour pressure and do not dissociate in water. Empirical studies indicate that neither substance is rapidly biodegradable. Both substances are considered to be very stable in water, sediment and soil, but not in air (gas phase). Based on findings from environmental sampling studies, TCPP and TDCPP have been found to be associated with particulates in air where they are considered to be very persistent. Both substances have been detected in air samples over the Arctic areas in Canada and Europe and are considered to have potential for long-range transport when adsorbed to aerosols.

Potential environmental releases of TCPP and TDCPP are from industrial activities (during their blending with a polyol) and from use of commercial products and products available to consumers. Releases from industrial activities are expected to primarily enter water via wastewater treatment systems. Based on physical and chemical properties, TCPP will partition to water, with insignificant amounts partitioning to sediments. On the other hand, TDCPP may be found in both sediment and water to some extent. Unlike TCPP, which is expected to remain predominantly dissolved in effluents, TDCPP, given its greater propensity to adsorb to solids, is likely to be found adsorbed to wastewater treatment system biosolids, which ultimately may be applied to soils. Emissions from manufactured items, commercial products, and products available to consumers are expected to enter the environment through air or dust, and ultimately settle in surface water and soil. However, it is expected that releases to the environment via this route are minimal and diffuse.

As would be expected based on the physical and chemical properties of TCPP and TDCPP, laboratory studies have reported low bioconcentration factors and rapid metabolism for these two substances, indicating that both substances have a limited potential to accumulate in aquatic biota. Significant exposure in higher trophic level organisms through the food chain is not expected for TCPP and TDCPP. Rapid excretion of biotransformation products in the mammalian studies suggests that metabolites are also unlikely to bioaccumulate.

Empirical ecotoxicity data have been identified for both substances. TCPP has demonstrated moderate toxicity to aquatic organisms and terrestrial plants, while TDCPP has shown considerably higher toxicity to aquatic organisms, including effects on the endocrine system in fish. Additional sublethal effects (i.e. neurotoxicity and genetic effects in birds) are also noted in both in vivo and in vitro studies. Data for endpoints from in vitro studies that show linkage to organism-level effects have been considered in the risk assessment for these two substances.

Considering the environmental fate and available toxicity data for these two substances, risk quotient analyses were conducted in the aquatic compartment for TCPP, and in the aquatic, sediment and soil compartments for TDCPP. Outcomes from the risk quotient analyses indicate that the risk associated with exposure of organisms to these two substances due to releases from industrial uses and products available to consumers is low at current predicted levels of release.

Considering all available lines of evidence presented in this updated draft screening assessment, there is low risk of harm to the environment from TCPP or TDCPP. It is therefore proposed to conclude that TCPP and TDCPP 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.

On the basis of available information on concentrations in environmental media and results from a survey under section 71 of CEPA, the general population is expected to be exposed to TCPP and TDCPP from environmental media (air, water, dust), from food and during the use of products available to consumers containing this substance (i.e. in products such as spray foam and waterproofing products, and manufactured items such as foam-containing furniture and mattresses).

On the basis of the available information on health effects of TCPP, the critical effects for characterization of risk to human health are reproductive and developmental effects.

The margin of exposure between estimates of exposure to TCPP from environmental media (air, water, dust) and food (including breast milk) as well as use of spray insulation foam or sealant and waterproofing sprays, and the critical effect levels are considered to be adequate to address uncertainties in the health effects and exposure databases. The margins of exposure between estimates of exposure resulting from prolonged skin contact with certain manufactured items containing TCPP, such as foam-containing upholstered furniture and mattresses, and the critical effect levels are considered potentially inadequate to account for uncertainties in the exposure and health effect databases.

On the basis of available information and classifications by other international regulatory agencies, critical effects for characterization of the risk to human health from exposure to TDCPP are carcinogenicity and non-cancer effects on the kidneys and testes. Tumours were observed in multiple organ sites, including kidney and liver in both sexes, testes (in males) and adrenal gland (in females) in a two-year carcinogenicity study in rats. Results of genotoxicity tests were mixed in vitro and mostly negative in vivo.

The margins of exposure between estimates of exposure to TDCPP from environmental media (air, water, dust) and food (including breast milk), and the critical effect levels for cancer and non-cancer effects are considered to be adequate to address uncertainties in the health effects and exposure databases. The margins of exposure between estimates of exposure resulting from prolonged skin contact with manufactured items containing TDCPP, such as foam-containing upholstered furniture and mattresses, and the critical effect levels for cancer and non-cancer effects are considered potentially inadequate to account for uncertainties in the exposure and health effects databases.

On the basis of the information presented in this updated draft screening assessment, it is proposed to conclude that TCPP and TDCPP meet the criteria under paragraph 64(c) of CEPA, as they are 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.

Proposed overall conclusion

It is therefore proposed to conclude that TCPP and TDCPP meet one or more of the criteria set out in section 64 of CEPA. It is also proposed that TCPP and TDCPP meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The draft screening assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

  • Associate Deputy Head of Shared Services Canada, to be styled Executive Vice-President of Shared Services Canada
    • Perron, Sony, Order in Council 2020-665
  • Associate Deputy Minister of Indigenous Services
    • Gideon, Valerie, Order in Council 2020-667
  • Canada Council for the Arts
    • Member
      • Verna, Gaëtane, Order in Council 2020-734
  • Copyright Board
    • Part-time Chair
      • Martineau, The Hon. Luc, Order in Council 2020-782
  • Court of Appeal of Quebec
    • Puisne Judges
      • Cournoyer, The Hon. Guy, Order in Council 2020-706
      • Lavallée, Sophie, Order in Council 2020-707
  • Court of Queen’s Bench of Alberta
    • Justice
  • Court of Appeal of Alberta
    • Judge ex officio
      • Malik, Ola, Order in Council 2020-794
  • Financial Transactions and Reports Analysis Centre of Canada
    • Director
      • Paquet, Sarah, Order in Council 2020-664
  • Immigration and Refugee Board
    • Full-time members
      • Doherty, Adam, Order in Council 2020-738
      • Farha, Soraya Hinde, Order in Council 2020-744
      • Farrell, Latoya Sylvia, Order in Council 2020-737
      • Khalifa, Reisa, Order in Council 2020-746
      • Ko, Laura Mei Woon, Order in Council 2020-736
      • Ouellet, Daphnée, Order in Council 2020-747
      • Russell, Darren Ted, Order in Council 2020-743
  • Parole Board of Canada
    • Full-time member
      • Goodwin, Kirsten M., Order in Council 2020-686
  • Public Health Agency of Canada
    • President
      • Stewart, Iain, Order in Council 2020-670
  • Shared Services Canada
    • Executive Vice-President
      • Perron, Sony, Order in Council 2020-666
  • Superior Court of Justice of Ontario
    • Judge
  • Court of Appeal for Ontario
    • Judge ex officio
      • Chown, Roger, Order in Council 2020-792
  • Superior Court of Justice of Ontario, Family Court branch
    • Judge
  • Court of Appeal for Ontario
    • Judge ex officio
      • Bruhn, Joanne, Order in Council 2020-793
  • Superior Court of Quebec for the district of Montréal
    • Puisne judges
      • Desfossés, Katheryne Alexandra, Order in Council 2020-715
      • Di Donato, Tiziana, Order in Council 2020-712
      • Pless, Alexander, Order in Council 2020-714
  • Superior Court of Quebec for the district of Québec
    • Puisne Judge
      • Montminy, Marie-Hélène, Order in Council 2020-713
  • Superior Court of Quebec for the districts of Mégantic and Saint-François
    • Puisne Judges
      • Provencher, The Hon. Sylvain, Order in Council 2020-709
      • Villeneuve, The Hon. Claude, Order in Council 2020-710
  • Superior Court of Quebec for the districts of Saint-François and Bedford
    • Puisne Judges
      • Brodeur, The Hon. Johanne, Order in Council 2020-711
      • Dallaire, The Hon. Claude, Order in Council 2020-708
  • Supreme Court of Yukon
    • Chief Justice
      • Duncan, The Hon. Suzanne, Order in Council 2020-705

October 1, 2020

Diane Bélanger
Official Documents Registrar

PRIVY COUNCIL OFFICE

Appointment opportunities

We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.

We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.

The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.

Current opportunities

The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.

Position Organization Closing date
Member Atlantic Pilotage Authority Canada  
President and Chief Executive Officer Atomic Energy of Canada Limited  
Director Business Development Bank of Canada  
Director — Board Risk Committee Chairperson Business Development Bank of Canada  
President and Chief Executive Officer Canada Development Investment Corporation  
Commissioner for Employers Canada Employment Insurance Commission  
Commissioner for Workers Canada Employment Insurance Commission  
President and Chief Executive Officer Canada Lands Company Limited  
President Canada Mortgage and Housing Corporation  
Member (Federal) Canada—Newfoundland and Labrador Offshore Petroleum Board  
President Canadian Commercial Corporation  
Member Canadian Cultural Property Export Review Board  
Commissioner (full-time), Commissioner (part-time) Canadian Energy Regulator  
Director Canadian Energy Regulator  
Chief Commissioner Canadian Grain Commission  
Commissioner Canadian Grain Commission  
Member Canadian Human Rights Tribunal  
Chairperson Canadian International Trade Tribunal  
Chairperson Canadian Museum of History  
Permanent Member Canadian Nuclear Safety Commission  
Executive Director Canadian Race Relations Foundation  
President Canadian Space Agency  
Chairperson Canadian Transportation Agency  
Temporary Member Canadian Transportation Agency  
Chief Administrator Courts Administration Service  
Director Export Development Canada  
Director Farm Credit Canada  
Chairperson Federal Public Sector Labour Relations and Employment Board  
Vice-Chairperson Federal Public Sector Labour Relations and Employment Board  
Chairperson Great Lakes Pilotage Authority Canada  
Director (Federal) Hamilton-Oshawa Port Authority  
Member, Northwest Territories Historic Sites and Monuments Board of Canada  
Assistant Deputy Chairperson Immigration and Refugee Board of Canada  
Member (appointment to roster) International Trade and International Investment Dispute Settlement Bodies  
Chairperson The Jacques Cartier and Champlain Bridges Incorporated  
Chairperson Marine Atlantic Inc.  
Director (Federal) Nanaimo Port Authority  
Secretary National Battlefields Commission  
Member Natural Sciences and Engineering Research Council of Canada  
Taxpayers’ Ombudsman Office of the Taxpayers’ Ombudsman  
Veterans’ Ombudsman Office of the Veterans’ Ombudsman  
Member Payments in Lieu of Taxes Dispute Advisory Panel  
Chairperson Polar Knowledge Canada  
Member Polar Knowledge Canada  
President Polar Knowledge Canada  
Director Public Sector Pension Investment Board  
Commissioner Roosevelt Campobello International Park Commission  
Member Social Sciences and Humanities Research Council of Canada  
President Social Sciences and Humanities Research Council of Canada  
Registrar Supreme Court of Canada  
Member Telefilm Canada  
Chairperson and Member Transportation Appeal Tribunal of Canada  
Member Transportation Appeal Tribunal of Canada  
Vice-Chairperson Transportation Appeal Tribunal of Canada