Canada Gazette, Part I, Volume 152, Number 49: GOVERNMENT NOTICES
December 8, 2018
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Final guideline for Canadian drinking water quality for perfluorooctane sulfonate
Pursuant to subsection 55(3) of the Canadian Environmental Protection Act, 1999, the Minister of Health hereby gives notice of a final guideline for Canadian drinking water quality for perfluorooctane sulfonate. The technical document for this guideline is available on the Water Quality website. The document underwent a public consultation period of 60 days in 2016 and was updated to take into consideration the comments received.
November 29, 2018
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Guideline
The maximum acceptable concentration (MAC) for perfluorooctane sulfonate (PFOS) in drinking water is 0.0006 mg/L (0.6 µg/L). The MAC is based on exposure solely to PFOS.
As the toxicological effects of PFOS and perfluorooctanoic acid (PFOA) are considered to be additive, the sum of the ratios of the detected concentrations to the corresponding MACs for PFOS and PFOA should not exceed 1.
Executive summary
PFOS is a synthetic compound that does not occur naturally in the environment. It is no longer manufactured, imported, sold, offered for sale or used in Canada, but is still found in the environment because of its extremely persistent nature. PFOS was used for water, oil and/or stain resistance on surface and paper-based applications, such as rugs and carpets, fabric and upholstery. It was also used in specialized chemical applications, such as firefighting foams, hydraulic fluids, and carpet spot removers.
The guideline technical document reviews and assesses all identified health risks associated with PFOS in drinking water. It incorporates available studies and approaches and takes into consideration the availability of appropriate analytical methods and treatment technology. Based on this review, the drinking water guideline for PFOS is a maximum acceptable concentration (MAC) of 0.0006 mg/L (0.6 µg/L), based on the general population.
As PFOS and other perfluoroalkyl substances (PFAS) are increasingly being detected in the environment, more scientific studies on their health effects are being conducted in Canada and around the world. Health Canada continues to monitor new research and will work with the provinces and territories to update the guideline, or develop new guidelines or other technical support material, as needed, to reflect significant changes in the weight of evidence.
Health effects
The carcinogenicity of PFOS has not been evaluated by the International Agency for Research on Cancer (IARC). Some cancer effects were observed in humans after exposure to PFOS, but no clear links could be made due to various study limitations. Tumours were observed in the liver, thyroid, and mammary gland of rats following long-term exposure to PFOS. Non-cancer effects occurring at the lowest level of exposure to PFOS in animals include effects on the immune system, liver effects, effects on the thyroid and changes in serum lipid levels.
Cancer and non-cancer endpoints were considered in the derivation of the MAC for PFOS in drinking water. The non-cancer approach, based on liver effects in rats, was used to calculate a MAC that is protective of human health from cancer and non-cancer effects. Because PFOS remains in the human body longer than in does in rats, an approach that accounts for this difference was used in the derivation of the MAC for PFOS in drinking water.
Exposure
Canadians can be exposed to PFOS through its presence in food, consumer products, dust, and drinking water. Exposure is mainly from food and consumer products, however, the proportion of exposure from drinking water can increase in individuals living in areas with contaminated drinking water. Although PFOS is not regularly monitored at water treatment plants in Canada, the analysis has been performed in a few locations. When PFOS is detected in drinking water, it is usually found below 0.001 µg/L.
Analysis and treatment
To date, the United States Environmental Protection Agency (U.S. EPA) has not approved any analytical methods for the analysis of PFOS in drinking water. There are some methods that can be used to measure PFOS in drinking water at levels well below the MAC. However, they require good quality control procedures to get accurate results.
The selection and effectiveness of a treatment strategy for PFOS removal is driven by several factors, including source water chemistry, concentration of PFOS and/or other perfluoroalkyl substances and pre-existing treatment processes. Conventional treatment is not effective for PFOS removal. Other treatment methods are promising, although full-scale studies are limited. Granular activated carbon (GAC) adsorption can achieve treated water concentrations of PFOS below the MAC. However, proper operation of the system is essential to ensure that the performance of GAC is not affected by the presence of natural organic matter in the source water. Membrane filtration techniques (reverse osmosis and nanofiltration) and anion exchange may also be effective. Although there are no residential treatment devices certified to remove PFOS, it is expected that the same treatment technologies would also be effective at the residential scale.
Additivity
The health effects of PFOS and PFOA are similar and well documented. Recent scientific evidence shows that PFOS and PFOA affect the same organ in similar ways. Therefore, when PFOA and PFOS are found together in drinking water, the best approach to protect human health is to consider both chemicals together when comparing concentrations to the guideline values. This is done by adding the ratio of the observed concentration for PFOS to its MAC with the ratio of the observed concentration for PFOA to its MAC; if the result is below or equal to one, then the water is considered safe for drinking. Science currently does not justify the use of this approach for other PFAS.
International considerations
The U.S. EPA has established a non-regulatory lifetime health advisory of 0.07 μg/L for PFOS, based on reproductive/developmental effects. It also specifies that when PFOA co-occurs with PFOS at the same time and location in a drinking water source, the health advisory should be applied to the sum of the concentrations of PFOS and PFOA. The Australia Department of Health has established a health-based drinking water quality value of 0.07 µg/L for use in site investigations, also based on reproductive/developmental effects. It also specifies that when PFOS co-occurs with perfluorohexane sulfonate (PFHxS), the drinking water quality value should be applied to the sum of the concentration of PFOS and PFHxS. The World Health Organization and the European Union have not established a limit for PFOS in drinking water.
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Final guideline for Canadian drinking water quality for perfluorooctanoic acid
Pursuant to subsection 55(3) of the Canadian Environmental Protection Act, 1999, the Minister of Health hereby gives notice of a final guideline for Canadian drinking water quality for perfluorooctanoic acid. The technical document for this guideline is available on the Water Quality website. The document underwent a public consultation period of 60 days in 2016 and was updated to take into consideration the comments received.
November 29, 2018
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Guideline
The maximum acceptable concentration (MAC) for perfluorooctanoic acid (PFOA) in drinking water is 0.0002 mg/L (0.2 µg/L), based on exposure solely to PFOA.
As the toxicological effects of PFOA and perfluorooctane sulfonate (PFOS) are considered to be additive, the sum of the ratios of the detected concentrations to the corresponding MACs for PFOS and PFOA should not exceed 1.
Executive summary
PFOA is a synthetic compound that does not occur naturally in the environment. It is used in the manufacture of stain/water-resistant coatings for various consumer products and in specialized chemical applications, such as firefighting foams, hydraulic fluids and carpet spot removers. Environmental concentrations, therefore potential exposure levels, may be higher in areas near facilities using high amounts of PFOA and near locations with extinguished fires if PFOA-containing firefighting foams were used.
The guideline technical document reviews and assesses all identified health risks associated with PFOA in drinking water. It incorporates available studies and approaches and takes into consideration the availability of appropriate treatment technology. Based on this review, the drinking water guideline for PFOA is a maximum acceptable concentration (MAC) of 0.0002 mg/L (0.2 µg/L), based on the general population.
As PFOA and other perfluoroalkyl substances (PFAS) are increasingly being detected in the environment, more scientific studies on their health effects are being conducted in Canada and around the world. Health Canada continues to monitor new research and will work with the provinces and territories to update the guideline, or develop new guidelines or other technical support material, as needed, to reflect significant changes in the weight of evidence.
Health effects
PFOA and its salts have been classified as possibly carcinogenic to humans (Group 2B) by the International Agency for Research on Cancer (IARC), based on limited epidemiological evidence demonstrating associations between PFOA and testicular and renal cancers, and on limited evidence in laboratory animals. Non-cancer effects occurring at the lowest level of exposure to PFOA in animals include liver effects, reproductive and developmental effects and changes in serum lipid levels.
Cancer and non-cancer endpoints were considered in the derivation of the MAC for PFOA in drinking water. The non-cancer approach, based on liver effects in rats, was used to calculate an MAC that is protective of human health from cancer and non-cancer effects. Because PFOA remains in the human body longer than it does in rats, an approach that accounts for this difference was used in the derivation of the MAC for PFOA in drinking water.
Exposure
Canadians can be exposed to PFOA in food, consumer products, dust, and drinking water. Exposure is mainly from food and consumer products; however, the proportion of exposure from drinking water can increase in individuals living in areas with contaminated drinking water. PFOA is often found with other PFAS, including PFOS. Although PFOA is not regularly monitored at water treatment plants in Canada, the analysis has been performed for a few locations. When PFOA is detected in drinking water, it is usually found at levels below 0.003 µg/L.
Analysis and treatment
To date, the United States Environmental Protection Agency (U.S. EPA) has not approved any methods for the analysis of PFOA in drinking water. There are some methods that can be used to measure PFOA in drinking water at levels well below the MAC.
The selection and effectiveness of a treatment strategy for PFOA removal are driven by several factors, including source water chemistry, concentration of PFOA and/or other PFAS and pre-existing treatment processes. Conventional treatment is not effective for PFOA removal. Other treatment methods are promising, although full-scale studies are limited. Activated carbon adsorption can achieve treated water concentrations of PFOA below the MAC. However, proper operation of the system is essential to ensure that the performance of granular activated carbon (GAC) is not affected by the presence of natural organic matter in the source water. Membrane filtration techniques (reverse osmosis and nanofiltration) and anion exchange may also be effective. Although there are no residential treatment devices certified to remove PFOA, it is expected that the same treatment technologies would also be effective at the residential scale.
Additivity
The health effects of PFOA and PFOS are similar and well documented. Recent scientific evidence shows that PFOS and PFOA affect the same organ in similar ways. Therefore, when PFOS and PFOA are found together in drinking water, the best approach to protect human health is to consider both chemicals together when comparing concentrations to the guideline values. This is done by adding the ratio of the observed concentration for PFOA to its MAC with the ratio of the observed concentration for PFOS to its MAC; if the result is below or equal to one, then the water is considered safe for drinking. Science currently does not justify the use of this approach for other PFAS.
International considerations
The U.S. EPA has established a non-regulatory lifetime health advisory level of 0.07 μg/L for PFOA, based on developmental effects. It also specifies that when PFOA co-occurs with PFOS at the same time and location in a drinking water source, the health advisory should be applied to the sum of the concentrations of PFOS and PFOA. The Australia Department of Health has established a health-based value for drinking water quality of 0.56 µg/L for use in site investigations, also based on reproductive/developmental effects. The World Health Organization and the European Union have not established a limit for PFOA concentration in drinking water.
DEPARTMENT OF INDUSTRY
OFFICE OF THE REGISTRAR GENERAL
| Name and position | Order in Council |
|---|---|
| Court of Queen's Bench of Alberta | |
| Justices | |
| Court of Appeal of Alberta | |
| Judges ex officio | |
| Bercov, Susan L., Q.C. | 2018-1396 |
| Woolley, Alice | 2018-1397 |
| Immigration and Refugee Board | |
| Full-time members | |
| Lee, Monica Elizabeth Pui Wai | 2018-1412 |
| Lefebvre, Jolyane | 2018-1413 |
| Oh, Matthew | 2018-1411 |
| Pinto, Stephanie | 2018-1410 |
| Molgat, Sylvie M. | 2018-1398 |
| Federal Court | |
| Prothonotary | |
| Parole Board of Canada | |
| Full-time members | |
| Dawson, Catherine Jane | 2018-1407 |
| Giles, Rayette S. | 2018-1404 |
| McCorkell, Tammy | 2018-1405 |
| Part-time members | |
| Bercov, Marni Lynn | 2018-1406 |
| Lang, Brian | 2018-1408 |
| Mann-Rempel, Michelle | 2018-1403 |
November 30, 2018
Diane Bélanger
Official Documents Registrar
OFFICE OF THE DIRECTOR OF PUBLIC PROSECUTIONS
DIRECTOR OF PUBLIC PROSECUTIONS ACT
Directive
Whereas HIV is first and foremost a public health issue, and public health authorities' efforts to detect and treat HIV have resulted in significantly improved health outcomes for those living with HIV in Canada, as well as prevention of its onward transmission;
Whereas the Supreme Court of Canada has stated that the criminal law has a role to play in cases involving sexual activity and non-disclosure of HIV where public health interventions have failed and the sexual activity at issue poses a risk of serious harm;
Whereas persons from marginalized backgrounds such as, for example, Indigenous, gay and Black persons, are more likely than others to be living with HIV in Canada such that criminal laws that apply to HIV non-disclosure are likely to disproportionately impact these groups;
Whereas the criminal law applies to persons living with HIV if they are aware of their HIV positive status and that they are infectious, and they fail to disclose, or misrepresent, their HIV status prior to sexual activity that poses a realistic possibility of transmission of HIV;
Whereas the Supreme Court of Canada has clarified that the issue of whether sexual activity poses a realistic possibility of transmission is to be determined on the basis of the most recent medical science on HIV transmission;
Whereas the most recent medical science shows that the risk of HIV transmission through sexual activity is significantly reduced where: the person living with HIV is on treatment; condoms are used; only oral sex is engaged in; the sexual activity is limited to an isolated act; or, the person exposed to HIV, for example as a result of a broken condom, receives post-exposure prophylaxis;
Whereas it is not in the public interest to pursue HIV non-disclosure prosecutions for conduct that medical science shows does not pose a risk of serious harm to others;
Whereas the research, medical science and analysis presented in Justice Canada's 2017 Report on the Criminal Justice System's Response to HIV Non-Disclosure, as well as any future developments in the relevant medical science, should be considered before pursuing a criminal prosecution in HIV non-disclosure cases;
Whereas I have consulted with the Director of Public Prosecutions under subsection 10(2) of the Director of Public Prosecutions Act;
- I direct the Director of Public Prosecutions as follows:
- (a) The Director shall not prosecute HIV non-disclosure cases where the person living with HIV has maintained a suppressed viral load, i.e., under 200 copies per ml of blood, because there is no realistic possibility of transmission.
- (b) The Director shall generally not prosecute HIV non-disclosure cases where the person has not maintained a suppressed viral load but used condoms or engaged only in oral sex or was taking treatment as prescribed, unless other risk factors are present, because there is likely no realistic possibility of transmission.
- (c) The Director shall prosecute HIV non-disclosure cases using non-sexual offences, instead of sexual offences, where non-sexual offences more appropriately reflect the wrongdoing committed, such as cases involving lower levels of blameworthiness.
- (d) The Director shall consider whether public health authorities have provided services to a person living with HIV who has not disclosed their HIV status prior to sexual activity when determining whether it is in the public interest to pursue a prosecution against that person.
Ottawa, November 30, 2018
The Honourable Jody Wilson-Raybould
Attorney General of Canada
OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS
TRUST AND LOAN COMPANIES ACT
Equitable Trust — Letters patent of incorporation
Notice is hereby given of the issuance, pursuant to section 21 of the Trust and Loan Companies Act, of letters patent incorporating Equitable Trust as a trust company under the name, in English, Equitable Trust, and, in French, Fiducie Équitable, effective October 30, 2018.
November 6, 2018
Jeremy Rudin
Superintendent of Financial Institutions
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 |
|---|---|---|
| Chief Administrator | Administrative Tribunals Support Service of Canada | |
| Member | Arbitration Board (Inuvialuit) | January 14, 2019 |
| Chairperson | Asia-Pacific Foundation of Canada | |
| Director | Business Development Bank of Canada | |
| Director | Canada Council for the Arts | |
| Chairperson | Canada Foundation for Sustainable Development Technology | |
| Chairperson | Canada Lands Company Limited | |
| President and Chief Executive Officer | Canada Lands Company Limited | |
| President and Chief Executive Officer | Canada Post Corporation | |
| Chairperson | Canada Science and Technology Museum | |
| Vice-Chairperson | Canada Science and Technology Museum | |
| President and Chief Executive Officer | Canadian Commercial Corporation | |
| Chairperson | Canadian Institutes of Health Research | |
| Vice-Chairperson | Canadian Museum for Human Rights | |
| Vice-Chairperson | Canadian Museum of Immigration at Pier 21 | |
| Vice-Chairperson | Canadian Museum of Nature | |
| Regional Member (Quebec) | Canadian Radio-television and Telecommunications Commission | |
| Chairperson and Member | Canadian Statistics Advisory Council | |
| President (Chief Executive Officer) | Canadian Tourism Commission | |
| Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police | |
| President and Chief Executive Officer | Defense Construction (1951) Limited | |
| President and Chief Executive Officer | Export Development Canada | |
| Chief Executive Officer | The Federal Bridge Corporation Limited | |
| Commissioner | Financial Consumer Agency of Canada | |
| Director | Freshwater Fish Marketing Corporation | |
| Director (Federal) | Hamilton Port Authority | |
| Commissioners and Chairperson | International Joint Commission | |
| Members (appointment to roster) | International Trade and International Investment Dispute Settlement Bodies | |
| Librarian and Archivist of Canada | Library and Archives of Canada | |
| President and Chief Executive Officer | Marine Atlantic Inc. | |
| Chairperson | National Arts Centre Corporation | |
| Vice-Chairperson | National Arts Centre Corporation | |
| Chief Executive Officer | National Capital Commission | |
| Member | National Capital Commission | |
| Government Film Commissioner | National Film Board | |
| Director | National Gallery of Canada | |
| Chairperson | National Research Council of Canada | |
| President | Natural Sciences and Engineering Research Council of Canada | |
| Canadian Ombudsperson | Office of the Canadian Ombudsperson for Responsible Enterprise | |
| Commissioner of Competition | Office of the Commissioner of Competition | |
| Ombudsperson | Office of the Ombudsperson for National Defence and Canadian Forces | |
| Director (Federal) | Oshawa Port Authority | |
| Chairperson | Pacific Pilotage Authority | |
| Member | Patented Medicine Prices Review Board | |
| Vice-Chairperson and Member | Patented Medicine Prices Review Board | |
| Panel Member | Payment in Lieu of Taxes Dispute Advisory Panel | |
| Master of the Mint | Royal Canadian Mint | |
| Chairperson and Vice-Chairperson | Royal Canadian Mounted Police External Review Committee | |
| Principal | Royal Military College of Canada | |
| Director (Federal) | Saguenay Port Authority | |
| Chairperson | Telefilm Canada | |
| Member (Marine and Medical) | Transportation Appeal Tribunal of Canada | |
| President and Chief Executive Officer | VIA Rail Canada Inc. |
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of six substances in the Triarylmethanes Group — specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(1) 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 draft screening assessment conducted on Malachite Green, Basic Violet 4 and Basic Blue 7 pursuant to section 74 of the Act and on Basic Violet 3, Pigment Blue 61 and Brilliant Blue FCF pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;
Whereas it is proposed to conclude 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;
And whereas it is proposed to conclude that Pigment Blue 61 and Brilliant Blue FCF 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 recommend to Her Excellency the Governor in Council that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 be added to Schedule 1 to the Act;
Notice is further given that the ministers propose to take no further action on Pigment Blue 61 and Brilliant Blue FCF at this time;
Notice is furthermore given that the ministers have released a risk management scope document for Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 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 measures the ministers propose to take and on the scientific considerations on the basis of which the measures are 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
Marc D'Iorio
Director General
Industrial Sectors, Chemicals and Waste Directorate
On behalf of the Minister of the Environment
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX I
Summary of the draft screening assessment of six substances in 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 on 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 proposed conclusion for this substance is provided in a separate report footnote 1. 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.
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, and 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 children's arts and crafts materials (e.g. paint markers), cosmetics (e.g. body cream, hair products, hair dyes, makeup, perfume), cleaning products, and water treatment for pet fish, as well as in additional commercial and laboratory products. Specifically, Basic Violet 3 is an active ingredient in drugs for human and veterinary use. Brilliant Blue FCF is also used in food, natural health products, pest control products, prescription and non-prescription drugs and a wide range of additional products available to consumers. All six substances were imported into Canada in quantities for each substance ranging from 1 000 to 100 000 kg while Brilliant Blue FCF was manufactured in Canada in a quantity ranging from 100 to 1000 kg, according to information submitted for the reporting years of either 2008 or 2011.
All substances in the Triarylmethanes Group may be released to the Canadian environment on the basis of their uses in Canada including paper dyeing, de-inking of paper, 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 these substances to terrestrial environments are 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, Basic Violet 4, Malachite Green and Basic Blue 7) instead may bind to proteins and accumulate in other 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 indicate that the non-sulfonated triarylmethanes 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 for aquatic organisms as it is expected to behave more like a particle and would not likely be bioavailable.
Considering all available lines of evidence presented in this draft 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 proposed to conclude 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 proposed to conclude 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 proposed to conclude 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 dermal and/or oral exposures to Malachite Green, Basic Violet 4 and Basic Blue 7 were derived from the use of paint markers (a children's arts and craft product) and/or 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. Exposure to Pigment Blue 61 for the general population of Canada is not expected on the basis of its physical and chemical properties and identified uses.
In laboratory studies, Basic Violet 3 is not observed to cause developmental or reproductive toxicity, but is genotoxic and can increase liver tumours. 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 results 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 to Malachite Green in hair dye and paint markers resulted in inadequate margins of exposure, particularly since the critical health effects were observed at the lowest tested dose.
On the basis of the information presented in this draft screening assessment, it is proposed to conclude 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 proposed to conclude 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.
Proposed conclusion
It is proposed to conclude 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 proposed to conclude 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 proposed to conclude 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 draft screening assessment for the Triarylmethanes Group and the risk management scope document for Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 are available on the Canada.ca (Chemical Substances) website.
ANNEX II
| CAS RN table 1 note a | Domestic Substances List name | Common name |
|---|---|---|
| 548-62-9 table 1 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 |
| 1324-76-1table 1 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 |
| 3844-45-9table 1 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 1 Notes
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of a substance — talc (Mg3H2(SiO3)4) (talc), CAS RN footnote 2 14807-96-6 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas talc 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 talc 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
Marc D'Iorio
Director General
Industrial Sectors, Chemicals and Waste Directorate
On behalf of the Minister of the Environment
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the draft screening assessment of talc
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 talc. The Chemical Abstracts Service Registry Number (CAS RN) for talc is 14807-96-6. This substance is among those substances identified as priorities for assessment, as it met categorization criteria under subsection 73(1) of CEPA.
Talc is a naturally occurring mineral. According to information reported under section 71 of CEPA and publicly available information, in 2011 talc was manufactured in Canada in quantities ranging between 50 and 75 million kilograms, and in 2016, approximately 100 million kilograms of talc were imported. In Canada talc is used in adhesives and sealants; automotive, aircraft, and transportation applications; building and construction materials; ceramics; electrical and electronics; textiles; floor coverings; ink, toner, and colourants; lubricants and greases; oil and natural gas extraction applications; paints and coatings; paper and paper products, mixtures, and manufactured items; plastic and rubber materials; toys, playground, and sporting equipment; and in water treatment. The major uses in Canada align with major global uses of talc. Talc is an ingredient in self-care products and is a permitted food additive. In North America, approximately 3 to 4% of the talc produced and sold is used in cosmetics. High-purity talc is used in cosmetics, while lower-grade talc is used in commercial applications.
The ecological risk of talc was characterized using the Ecological Risk Classification of Inorganic Substances (ERC-I) approach. The ERC-I is a risk-based approach that employs multiple metrics, considering both hazard and exposure in a weight of evidence. Hazard characterization in ERC-I included a survey of past predicted no-effect concentrations (PNECs) and water quality guidelines, or the derivation of new PNEC values when required. Exposure profiling in ERC-I considered two approaches: predictive modelling using a generic near-field exposure model for each substance, and an analysis of measured concentrations collected by federal and provincial water quality monitoring programs. Modelled and measured predicted environment concentrations (PECs) were compared to PNECs, and multiple statistical metrics were computed and compared to decision criteria to classify the potential for causing harm to the environment. The ERC-I identified talc as having a low potential 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 talc. It is proposed to conclude that talc 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.
Talc has been reviewed internationally by other organizations, including the International Agency for Research on Cancer (IARC) and the Danish Environmental Protection Agency. These assessments informed the human health risk assessment.
No critical health effects were identified for the oral or dermal routes of exposure. Therefore, oral exposure to talc resulting from food intake and self-care products is not of concern. Inhalation exposure from industrial and commercial uses of talc was not identified to be of concern for human health given the limited number of sites producing and processing talc in Canada. Rather, the focus of the assessment is on inhalation and perineal exposure to certain self-care products containing cosmetic- or pharmaceutical-grade talc.
With respect to inhalation exposure, non-cancer lung effects were identified as a critical health effect for risk characterization on the basis of United States National Toxicology Program studies conducted with rats and mice exposed to cosmetic-grade talc. There is potential for inhalation exposure to talc powder during the use of certain self-care products (e.g. cosmetics, natural health products, non-prescription drugs formulated as loose powders). Self-care products formulated as pressed powders (e.g. face makeup) are not of concern. Margins of exposure between air concentrations following the use of dry hair shampoo and critical lung effects observed in animal studies are considered adequate to address uncertainties in the health effects and exposure databases. Margins of exposure between air concentrations following the use of loose powders (e.g. body powder, baby powder, face powder, foot powder) and critical lung effect levels observed in animal studies are considered potentially inadequate to address uncertainties in the health effects and exposure databases.
The meta-analyses of the available human studies in the peer-reviewed literature indicate a consistent and statistically significant positive association between perineal exposure to talc and ovarian cancer. Further, available data are indicative of a causal effect. Given that there is potential for perineal exposure to talc from the use of various self-care products (e.g. body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, bath bombs), a potential concern for human health has been identified.
Based on the available information, it is proposed that there is potential for harm to human health in Canada at current levels of exposure. Therefore, on the basis of the information presented in this draft screening assessment, it is proposed to conclude that talc meets the criterion 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 proposed to conclude that talc meets one or more of the criteria set out in section 64 of CEPA.
It is proposed to conclude that talc 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.