Canada Gazette, Part I, Volume 155, Number 17: GOVERNMENT NOTICES

April 24, 2021

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 20614

Ministerial condition

(Paragraph 84(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 substance phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and 4,4′-methylenebis[cyclohexanamine], Chemical Abstracts Service Registry Number 38294-67-6;

And whereas the ministers suspect that the substance 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 84(1)(a) of the Act, hereby permits the manufacture or import of the substance subject to the conditions of the following annex.

Marc D'Iorio
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment

ANNEX

Conditions

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

1. The following definitions apply in these ministerial conditions:

“notifier” means the person who has, on November 20, 2020, provided to the Minister of the Environment the prescribed information concerning the substance, in accordance with subsection 81(1) of the Canadian Environmental Protection Act, 1999; and

“substance” means phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and 4,4′-methylenebis[cyclohexanamine], Chemical Abstracts Service Registry Number 38294-67-6.

2. The notifier may manufacture or import the substance subject to the present ministerial conditions.

Restrictions

3. The notifier must not use the substance to manufacture a consumer product to which the Canada Consumer Product Safety Act applies.

4. The notifier must not import the substance if it is present in a consumer product to which the Canada Consumer Product Safety Act applies.

Other requirements

5. The notifier shall, prior to transferring the physical possession or control of the substance to any person

6. The person who signs the written confirmation referred to in subsection 5(2) must comply with section 3 as if this section referred to this person.

Record-keeping requirements

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

(2) The notifier shall maintain the 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

8. The present ministerial conditions come into force on April 14, 2021.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999)

Whereas, any person who proposes to import or manufacture a living organism that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 106(1) of the Canadian Environmental Protection Act, 1999; and

Whereas, a person may, pursuant to subsection 106(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 106(1) of the Canadian Environmental Protection Act, 1999 to be waived.

Therefore, notice is hereby given, pursuant to subsection 106(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information in accordance with the following annex pursuant to subsection 106(8) of that Act.

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement Division
On behalf of the Minister of the Environment

ANNEX

Waiver of information requirements

(Subsection 106(9) of the Canadian Environmental Protection Act, 1999)
Person to whom a waiver was granted Information concerning a living organism in relation to which a waiver was granted
AstraZeneca Canada Inc. Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
Data from tests of antibiotic susceptibility
Canadienzyme Inc. Data from tests of antibiotic susceptibility (7) table 1 note 1
Cross Cancer Institute Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
Data from tests of antibiotic susceptibility
Janssen Inc. Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
Data from tests of antibiotic susceptibility
Turnstone Biologics, Inc. Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed

Table 1 note(s)

Table 1 note 1

The number in brackets indicates the number of times that the information requirement in the second column was waived for the person.

Return to table 1 note 1 referrer

EXPLANATORY NOTE

The decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year an average of 500 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999 and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.

For more information, please see the waivers webpage on the New Substances website.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)

Whereas any person who proposes to import or manufacture a substance that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 81(1) of the Canadian Environmental Protection Act, 1999; and

Whereas a person may, pursuant to subsection 81(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 81(1) of the Canadian Environmental Protection Act, 1999 to be waived;

Therefore, notice is hereby given, pursuant to subsection 81(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information pursuant to subsection 81(8) of that Act and in accordance with the following annex.

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement Division
On behalf of the Minister of the Environment

ANNEX

Waiver of information requirements

(Subsection 81(9) of the Canadian Environmental Protection Act, 1999)
Person to whom a waiver was granted Information concerning a substance in relation to which a waiver was granted
BASF Canada Inc. Data in respect of hydrolysis rate as a function of pH
Brenntag Canada Inc. Data in respect of vapour pressure
Canadian General-Tower Ltd. Data from an in vivo mammalian mutagenicity test for chromosomal aberrations or gene mutations
INEOS Oligomers USA LLC Data in respect of hydrolysis rate as a function of pH
INVISTA (Canada) Company Data from an in vivo mammalian mutagenicity test for chromosomal aberrations or gene mutations (4) table 2 note 1
Lubrizol Canada Limited Data in respect of hydrolysis rate as a function of pH
Sumitomo Chemical Advanced Technologies LLC Data in respect of number average molecular weight (Mn)
Data in respect of maximum concentrations, expressed in percentage, of all residual constituents having a molecular weight less than 500 daltons and of all residual constituents having a molecular weight less than 1 000 daltons

Table 2 note(s)

Table 2 note 1

The number in brackets indicates the number of times that the information requirement in the second column was waived for the person.

Return to table 2 note 1 referrer

EXPLANATORY NOTE

The decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year, an average of 500 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999 and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.

For more information, please see the waivers webpage on the New Substances website.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2021-87-04-02 Amending the Non-domestic Substances List

Whereas, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999 footnote a, the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances List footnote b;

Therefore, the Minister of the Environment, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2021-87-04-02 Amending the Non-domestic Substances List.

Gatineau, April 7, 2021

Jonathan Wilkinson
Minister of the Environment

Order 2021-87-04-02 Amending the Non-domestic Substances List

Amendment

1 Part I of the Non-domestic Substances List footnote 1 is amended by deleting the following:

Coming into Force

2 This Order comes into force on the day on which Order 2021-87-04-01 Amending the Domestic Substances List comes into force.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to address the broad class of per- and polyfluoroalkyl substances

The Government of Canada intends to move forward with activities to address the broad class of per- and polyfluoroalkyl substances (PFAS) because scientific evidence to date indicates the PFAS used to replace regulated PFOS, footnote 2 PFOA, footnote 3 and long-chain PFCAs (LC-PFCAs) footnote 4 may also be associated with environmental and/or human health effects.

Substance-specific information is lacking for most PFAS that are currently used, including those that have been used to replace restricted PFAS. The large number of PFAS that are commercially available and their diverse chemical structures, combined with the lack of data on the hazards and properties of the individual substances, renders a traditional substance-by-substance assessment and management approach impractical. This has been recognized in publications prepared by a number of scientists following international meetings regarding PFAS, including the Zurich Statement, which recommends a grouping approach for this class of substances. Considering PFAS as a class of chemicals would better address situations where exposure occurs to multiple PFAS at the same time. This will allow the Government of Canada to consider cumulative effects, and to prevent regrettable substitutions.

Planned actions

In 2021, the Government of Canada will

In addition, within the next two years, the Government of Canada will publish a State of PFAS Report, which will summarize relevant information on the class of PFAS.

Stakeholder engagement is an important step to advance Canada's efforts. Stakeholders and interested parties will have opportunities to provide input to help inform Government of Canada activities related to addressing PFAS as a class. As a first step, stakeholders are invited to provide initial feedback on the intent to address PFAS as a class, including any challenges or opportunities they foresee. Contact information is provided below.

Rationale for action

In recent years, a growing number of jurisdictions, including in the United States, Australia, New Zealand, and the European Union, are addressing or are proposing to address PFAS as a class, including restricting specific uses in some jurisdictions. Often these actions relate to foams used to fight fuel fires, or to restricting non-essential uses where alternatives exist.

The Stockholm Convention on Persistent Organic Pollutants (POPs) requires its 184 Parties to eliminate or severely restrict PFOS and PFOA and advises against the use of other PFAS in firefighting foams. This recommendation was aimed at avoiding regrettable substitutions because they recognized that other PFAS could have similar hazard profiles and properties, potentially resulting in similar contamination of drinking water and the surrounding environment.

Background

Per- and polyfluoroalkyl substances (PFAS) are a broad group of over 4 700 human-made substances that contain linked carbon and fluorine atoms. Because of their unique properties, they are used in a wide range of products, such as surfactants, lubricants, and repellents (for dirt, water, and grease). PFAS can also be found in other products as diverse as firefighting foams, textiles (e.g. carpets, furniture, and clothing), cosmetics, and in food packaging materials. PFAS are not manufactured in Canada but enter through importation, within products or manufactured items.

Well-studied PFAS have demonstrated the following characteristics:

Globally, PFAS have been found in the environment in close proximity to, and downstream from, point sources, such as manufacturing plants and sites where firefighting foams have been released (e.g. airports, military bases, and fuel storage areas). In Canada, a major point source of PFAS contamination is the use of firefighting foams to extinguish fuel fires or in the conduct of firefighting training and testing activities. PFAS can also be released to the environment during consumer use and disposal of PFAS-containing manufactured items; therefore, landfills and wastewater treatment facilities are potential sources of PFAS release.

Existing risk management measures and other activities in Canada for certain PFAS

The Government of Canada evaluated the risks of PFOS, PFOA, and LC-PFCAs, and published the findings in screening assessment reports in 2006 and 2012. These substances were found to be toxic to the environment, and added to the List of Toxic Substances under Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). As a result, measures to manage risks from these substances were put in place. In response to risk management measures taken over the past decade by the Government of Canada and other international jurisdictions, industry has shifted from using PFOS, PFOA and LC-PFCAs to using other PFAS as substitutes. The large majority of the 4 700 PFAS, as identified by the Organisation for Economic Co-operation and Development, have not been assessed and are not being managed globally.

In Canada, risk management actions for PFOS have been in place since 2008. Since 2016, the manufacture, use, sale, offer for sale or import of PFOS, PFOA, LC-PFCAs, and products that contain them have been prohibited, with a limited number of exemptions (e.g. manufactured items containing PFOA or LC-PFCAs) under the Prohibition of Certain Toxic Substances Regulations, 2012. In 2018, a consultation document was published outlining a proposal to further restrict these substances by removing all current exemptions. The proposed regulations are targeted for publication in the spring of 2021.

The Government of Canada conducts regular monitoring and surveillance of certain PFAS. For example, over the past decade, concentrations of certain PFAS in the blood of Canadians have been measured to establish baseline concentrations, track trends over time, and allow for comparisons with subpopulations. PFAS will continue to be monitored over time and reflect exposures from all sources, including air, dust, water, products, and food.

The federal government develops environmental quality guidelines to protect human health and the environment. Since 2018, the Guidelines for Canadian Drinking Water Quality for PFOS and PFOA, screening values for 9 other PFAS in drinking water, and Canadian soil screening values for 11 PFAS (including PFOS and PFOA) have been made available. Federal Environmental Quality Guidelines for PFOS in surface water, fish tissue, wildlife diet, and bird eggs also help assess the significance of PFOS concentrations in the environment, including contaminated sites.

Contact information

Stakeholders are invited to submit relevant information or indicate their interest in being engaged in future discussions by emailing eccc.substances.eccc@canada.ca. Stakeholders are also invited to subscribe to the Chemicals Management Plan subscription service to be kept informed of future information sessions and/or consultations.

Aimee Zweig
Acting Director General
Industrial Sectors and Chemicals Directorate
Environment and Climate Change Canada

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
Environment and Climate Change Canada

David Morin
Director General
Safe Environments Directorate
Health Canada

DEPARTMENT OF HEALTH

HAZARDOUS MATERIALS INFORMATION REVIEW ACT

Filing of claims for exemption

A supplier can file a claim for exemption under the Hazardous Materials Information Review Act (HMIRA) with Health Canada from having to disclose information under the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR) that they consider to be confidential business information (CBI) on a safety data sheet (SDS) or label associated with a hazardous product.

An employer can also file a claim for exemption under the HMIRA with Health Canada from having to disclose information under the Canada Labour Code or the provisions of the Accord Act that they consider to be CBI on an SDS or label associated with a hazardous product.

Notice is hereby given of the filing of claims for exemption under the HMIRA listed in the table below.

Claims for exemption
Claimant Product identifier Subject of the claim for exemption Registry numbert
Nalco Canada ULC 3D TRASAR™ 3DT270 C.i. of one ingredient 03404147
Canadian Energy Services LP WRXSOL-NANO-SSSL C.i. and C. of four ingredients 03404330
Nalco Canada ULC 3DT306 C.i. of two ingredients 03404423
Solenis LLC Pergasol™ C YELLOW 97 L NA C.i. and C. of one ingredient 03404783
ChampionX Canada ULC FLOW13110A C.i. and C. of two ingredients 03405048
Sea Foam International, Inc. Sea Foam Marine Pro C.i. and C. of two ingredients 03405462
Sea Foam International, Inc. Sea Foam High Mileage C.i. and C. of two ingredients 03405463
Erthos Inc. Erthos™ EcoResin 005 (ECR 005) C.i. and C. of three ingredients 03405524
SUEZ Water Technologies & Solutions Canada PROSWEET S1830 C.i. and C. of three ingredients 03405833
ChampionX Canada ULC ACPC19360A C.i. and C. of two ingredients 03406918
ChampionX Canada ULC CORR18663A C.i. and C. of six ingredients 03406919

Note: C.i. = chemical identity and C. = concentration

Lynn Berndt-Weis
Director
Workplace Hazardous Materials Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

April 12, 2021

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.

Governor in Council appointment opportunities
Position Organization Closing date
Member Atlantic Pilotage Authority Canada  
Commissioner British Columbia Treaty Commission  
Director Business Development Bank of Canada  
President and Chief Executive Officer Business Development Bank of Canada  
President and Chief Executive Officer Canada Development Investment Corporation  
Commissioner for Employers Canada Employment Insurance Commission  
Director Canada Infrastructure Bank  
President and Chief Executive Officer Canada Lands Company Limited  
Director Canada Mortgage and Housing Corporation  
Chairperson Canada-Nova Scotia Offshore Petroleum Board  
Member of the Board of Directors Canada Post  
Member Canadian Cultural Property Export Review Board  
Chairperson Canadian Dairy Commission  
Chief Executive Officer Canadian Dairy Commission  
Director Canadian Energy Regulator  
Federal Housing Advocate Canadian Human Rights Commission  
Chairperson Canadian Human Rights Tribunal  
Member Canadian Human Rights Tribunal  
Member Canadian Institutes of Health Research  
Chairperson Canadian Museum of History  
Director Canadian Museum of History  
Director Canadian Race Relations Foundation  
Chairperson Canadian Transportation Agency  
Temporary Member Canadian Transportation Agency  
Chairperson Destination Canada  
Director Destination Canada  
Director Farm Credit Canada  
Vice-Chairperson Federal Public Sector Labour Relations and Employment Board  
Director Freshwater Fish Marketing Corporation  
Member Great Lakes Pilotage Authority Canada  
Director
(Federal)
Hamilton-Oshawa Port Authority  
Member, Yukon Historic Sites and Monuments Board of Canada  
Governor International Development Research Centre  
Member
(appointment to roster)
International Trade and International Investment Dispute Settlement Bodies  
Chairperson Laurentian Pilotage Authority Canada  
Director Marine Atlantic Inc.  
Chairperson Military Police Complaints Commission of Canada  
Member Military Police Complaints Commission of Canada  
Member National Arts Centre Corporation  
Member National Seniors Council  
Commissioner and Director Office of the Commissioner of Indigenous Languages  
Superintendent Office of the Superintendent of Financial Institutions Canada  
Member Payments in Lieu of Taxes Dispute Advisory Panel  
Director Public Sector Pension Investment Board of Canada  
Commissioner Roosevelt Campobello International Park Commission  
Chairperson Standards Council of Canada  
Registrar Supreme Court of Canada  
Director
(Federal)
Toronto Port Authority  
Chairperson and Member Transportation Appeal Tribunal of Canada  
Vice-Chairperson Transportation Appeal Tribunal of Canada  
Director
(Federal)
Trois-Rivières Port Authority  

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — talc (Mg3H2(SiO3)4), CAS RNfootnote 5 14807-96-6 — specified on the Domestic Substances List (subsection 77(6) 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 screening assessment conducted on talc pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded 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 His Excellency the Administrator in Council that this substance be added to Schedule 1 of the Act;

Notice is furthermore given that the ministers are releasing a proposed risk management approach document for talc 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 the substance.

Public comment period on the proposed 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 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 talc

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. 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 was imported into Canada. 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; inks, toners, 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 equipment and sporting equipment; and in water treatment. The major uses in Canada align with major global uses of talc. Talc is a permitted food additive and is an ingredient in self-care products. In North America, approximately 2% to 4% of the talc produced and sold is used in cosmetics. High-purity talc is used in self-care products, including 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), 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 characterization in ERC-I included a survey of published 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 environmental 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. Based on the outcome of the ERC-I analysis, talc is considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from talc. It is concluded 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 via the oral or dermal routes of exposure. Therefore, oral exposure to talc resulting from food intake and oral and dermal exposure from the use of self-care products are not of concern. Inhalation exposure via ambient air for the general population 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 (e.g. inflammation, impaired lung function, fibrosis) 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 for inhalation exposure. Margins of exposure between air concentrations following the use of dry hair shampoo and foot powder 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 body powder, baby powder, and loose face powder and critical lung effect levels observed in animal studies are considered potentially inadequate to address uncertainties in the health effects and exposure databases.

With regard to perineal exposure, 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. The available data are indicative of a causal effect. Given that there is potential for perineal exposure to talc from the use of certain self-care products (e.g. body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, bath bombs, bubble bath), a potential concern for human health has been identified.

Considering all the information presented in this screening assessment, it is concluded that talc meets the criteria under paragraph 64(c) of CEPA, as it is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Overall conclusion

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

Talc has been determined to 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 this substance are available on the Canada.ca (Chemical Substances) website.