Canada Gazette, Part I, Volume 155, Number 21: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
May 22, 2021
Canadian Environmental Protection Act, 1999
Department of the Environment
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
The substance talc, which has the molecular formula Mg3H2(SiO3)4 (CAS RN footnote 1 14807-96-6), meets the human health criterion for a toxic substance as set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA or the Act). In accordance with paragraph 77(2)(c) of CEPA, the Minister of the Environment and the Minister of Health (the ministers) are recommending to the Administrator in Council to make an order adding talc to the List of Toxic Substances in Schedule 1 to the Act under subsection 90(1) of the Act.
The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and micro-organisms that may be harmful to the environment or human health. The ministers assessed talc in accordance with section 74 of CEPA as part of the CMP.
Description, uses, and sources of release
Talc is one of the softest naturally occurring minerals. The pure mineral is made up of magnesium, hydrogen, silicon, and oxygen. The term “talc” refers to both the pure mineral and a wide variety of soft, talc-containing rocks that are mined and used for a variety of applications. Relatively pure talc ore is also referred to as steatite, and soapstone refers to impure, massive talc rock. Commercially exploited talc contains 20% to 99% of the pure mineral and can be categorized into different grades (e.g. pharmaceutical or cosmetic grade).
Talc is found in most provinces of Canada, with major deposits located in Ontario, Quebec, British Columbia, and Newfoundland and Labrador. Currently, there is only one producing mine and concentrator facility footnote 2 in Canada, which is located in Ontario. In 2019, China was the largest producer of talc, followed by India and Brazil. Based on the responses to a mandatory survey under section 71 of CEPA, between 50 000 tonnes and 75 000 tonnes of talc were manufactured in Canada in 2011. footnote 3 According to the Canadian International Merchandise Trade Database, approximately 100 000 tonnes of natural steatite and talc (crushed or powdered) and 4 700 tonnes of natural steatite and talc (not crushed, not powdered) were imported into Canada in 2016.
The Department of the Environment and the Department of Health (the departments) also gathered information about the usage of talc in Canada from voluntary stakeholder engagement and the websites of talc producers. In Canada, talc is used in adhesives and sealants; automotive, aircraft, and transportation applications; building and construction materials (e.g. wood and engineered wood); ceramics; electrical and electronics; textiles; floor coverings; inks, toner, and colourants; lubricants and greases; oil and natural gas extraction applications; paints and coatings; paper and paper products, mixtures, or manufactured items; plastic and rubber materials; toys, playground equipment and sporting equipment; and in water treatment. Talc is also a formulant in pest control products registered in Canada.
In addition, in Canada talc is a permitted food additive for limited uses in a small number of foods. It may be present in food packaging materials and in incidental additives footnote 4 used in food processing establishments. Talc is present in approximately 10 000 self-care products. footnote 5 This is based on approximately 7 750 cosmetics, 2 100 natural health products and 150 non-prescription drugs. In addition, talc is present as a non-medicinal ingredient in approximately 1 550 marketed or approved non-over-the-counter human and veterinary drug products in Canada.
Current risk management activities
In Canada, cosmetics, natural health products and non-prescription drugs all require disclosure of the ingredients (medicinal and non-medicinal) on the product label. The Cosmetic Ingredient Hotlist footnote 6 currently lists cautionary statements for cosmetics containing talc in powder form intended to be used on infants and children. Talc is listed in the Natural Health Products Ingredients Database (NHPID) to indicate that this ingredient must be used in accordance with the restrictions described in the Cosmetic Ingredient Hotlist footnote 7 when included in topical natural health products, as well as those described in the Department of Health's Diaper Rash Products monograph. The NHPID also includes entries for talc used in homeopathic medicines and in traditional Chinese medicines. Talc is included on the Department of Health's List of Permitted Food Additives with Other Accepted Uses. The use of talc as a colourant in drugs is subject to the provisions of the Food and Drug Regulations.
The United States and the European Union allow the use of talc in cosmetics. The European Union requires a warning statement for cosmetics similar to that in Canada. In Europe, talc is an approved food additive and is also used in food packaging materials. In the United States, talc is “generally recognized as safe” for specified food uses in food packaging.
Summary of the screening assessment
The ministers published a screening assessment of talc on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether the substance meets one or more of the criteria for a toxic substance as set out in section 64 of CEPA (i.e. to determine if the substance could pose a risk to the environment or human health in Canada).
Under section 64 of CEPA, a substance is considered toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that
- (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life depends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
The departments collected and considered information from multiple sources (including literature reviews, internal and external database searches, modelling, data from a mandatory survey issued under section 71 of CEPA, and, where warranted, data from targeted follow-ups with stakeholders) to inform the screening assessment conclusion. The screening assessment has undergone external peer review and consultation with academics and other relevant stakeholders.
The screening assessment concluded that talc meets the criterion set out in paragraph 64(c) of CEPA and constitutes a risk to human health in Canada. Below are summaries of the ecological and human health assessments.
Summary of the ecological assessment
The ecological risk of talc was characterized using the ecological risk classification of inorganic substances (ERC-I) approach, which is a risk-based approach that employs multiple metrics that consider both hazard and exposure in a weight of evidence. Its purpose was to classify a set of inorganic substances as either warranting further evaluation of their potential to cause harm to the environment or as having a low likelihood to cause ecological harm. Using the ERC-I approach, talc was characterized as being of low ecological concern and therefore unlikely to cause harm to the Canadian environment at levels of exposure considered in the assessment. The screening assessment concluded that talc does not meet the criteria set out in paragraph 64(a) or (b) of CEPA. It has also been determined that talc meets the persistence but not the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations made under CEPA.
Summary of the human health assessment
The human health risks of talc were characterized (i.e. identified and described for the purposes of the assessment) based on non-cancer lung effects and ovarian cancer. Based on the results of the human health assessment, it was determined that inhalation and female perineal (genital) exposure to talc from the use of certain self-care products represent a potential concern for human health. This was based on an assessment of risks following inhalation and perineal (genital) exposure. The assessment found no critical health effects from oral and dermal exposure to talc.
The assessment identified the potential for non-cancer lung effects (e.g. inflammation, impaired lung function, fibrosis) following inhalation exposure to respirable talc particles. Margins of exposure (MOEs) associated with baby powder, body powder, face powder, foot powder and dry hair shampoo were estimated. These MOEs were derived by comparing the estimated air concentration following the use of self-care products containing talc and levels at which critical lung effects were observed in an animal study. Based on these MOEs, the assessment determined that the inhalation of talc from the use of baby powder, body powder and loose face powder poses a potential risk to human health. The assessment also identified ovarian cancer as a critical health effect for the perineal (genital) route of 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 and bubble bath). Analyses of the available human studies in the peer-reviewed literature indicate a consistent and statistically significant positive association between perineal (genital) exposure to talc and ovarian cancer.
Based on the available lines of evidence, the screening assessment concluded 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.
The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to add talc to the List of Toxic Substances in Schedule 1 to CEPA, which would enable the ministers to propose risk management measures for the toxic substance under CEPA to manage potential human health risks associated with the substance.
The proposed Order would add talc, which has the molecular formula Mg3H2(SiO3)4, to the List of Toxic Substances in Schedule 1 to CEPA.
On December 8, 2018, the ministers published a notice with a summary of the draft screening assessment on talc (which included a link to the draft assessment) in the Canada Gazette, Part I, for a 60-day public comment period. Over 100 comments were received from various stakeholders, including 9 from the cosmetics, consumer products and mining industries and/or their industry associations, 3 from non-governmental organizations (NGOs), and 5 from private individuals that provided unique scientific analysis. The remainder of the comments were from 90 private individuals. The majority of these individuals (87 in total) participated in one of two letter-writing campaigns and submitted one of two verbatim letters as comments. All these comments were considered in the development of the final screening assessment report, but they did not change the conclusion that talc meets the criterion set out in paragraph 64(c) of CEPA. A table summarizing the complete set of comments received and the response to these comments is available on the Canada.ca (Chemical Substances) website.
Many comments from NGOs and private individuals indicated that they agreed with the assessment conclusion on perineal (genital) exposure to talc and the associated risk of ovarian cancer. While several comments received from industry stakeholders indicated agreement with the assessment conclusions in regard to the ecological risks and human health risks associated with oral and dermal exposures, several industry stakeholders expressed concern with the overall approach used to assess the potential human health risks of talc from inhalation and perineal (genital) exposure.
More specifically, they disagreed with the methodology used to assess the inhalation and perineal (genital) exposure scenarios and on the characterization of the resulting health effects. It was also noted by those stakeholders that the assessment lacked transparency and sufficient details concerning the methods and evidence considered. Industry stakeholders requested additional clarification for the scenarios considered, as well as data and studies selected or omitted in the assessment. They also criticized certain references that were cited and the overreliance on unpublished data. Government officials responded that the screening assessment for talc was based on the best and most relevant available science and applied both weight-of-evidence and precaution, and explained that only key references were cited, which is consistent with either application under the CMP.
A significant amount of information was submitted by industry stakeholders during the public comment period, including several reviews and analyses of the scientific literature, documents originally submitted to the United States Food and Drug Administration, and documents related to litigation cases in the United States. All the information received was reviewed and considered when updating the screening assessment. As a result, additional information was added to the screening assessment in consideration of these comments to enhance transparency with respect to the data, approach and assumptions used in the assessment. Overall, it resulted in the addition of approximately 80 citations, primarily peer-reviewed journal citations, and scientific reports. These comments and additional information did not change the conclusion.
In regard to comments addressing the management of risks posed by talc, government officials would address them during the development of risk management measures, which would also be subject to their own consultation process. Two industry stakeholders voiced that it is not recommended that the Government of Canada proceed with the listing of talc to Schedule 1 to the Act, while one voiced that it is premature for the Government to consider risk management for the substance. Government officials responded that the listing is warranted as talc was determined to pose a risk to human health and that stakeholders will have further opportunity to provide input during the consultation period on the risk management approach.
Several industry stakeholders voiced concern with how the Government of Canada has already begun communicating the potential human health risk through the Department of Health social media channels (Twitter) and the “Do it for a Healthy Home” website prior to finalizing the screening assessment. It was also noted that information shared through media releases and communication products should be thoroughly reviewed and released in conjunction with the final screening assessment. Government officials responded that the Department of Health provides information so Canadians can have the latest information to make decisions about their health.
The departments informed the provincial and territorial governments about the publication of the draft screening assessment and risk management scope through the CEPA National Advisory Committee (CEPA NAC) footnote 8 via a letter and provided them with an opportunity to comment during the 2018 60-day public comment period noted above. No comments were received by CEPA NAC.
Modern treaty obligations and Indigenous engagement and consultation
An assessment of modern treaty implications was conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation. It was concluded that orders adding substances to Schedule 1 to CEPA do not introduce any new regulatory requirements, and therefore, do not result in any impact on modern treaty rights or obligations. Hence, specific engagement and consultations with Indigenous peoples were not undertaken. However, the prepublication comment period is an opportunity for Indigenous peoples to provide feedback on the proposed Order, which is open to all Canadians, in the event that the ministers propose risk management measures for talc.
When a substance meets one or more of the criteria set out in section 64 of CEPA, the ministers shall propose one of the following options under subsection 77(2) of CEPA:
- (a) taking no further action with respect to the substance;
- (b) unless the substance is already on the Priority Substances List, footnote 9 adding the substance to the Priority Substances List; or
- (c) recommending that the substance be added to the List of Toxic Substances in Schedule 1 to CEPA, and, where applicable, recommending the implementation of virtual elimination footnote 10 under subsection 65(3) of CEPA.
When proposing option C, the ministers shall recommend the implementation of virtual elimination if the substance was assessed under section 74 of CEPA and, as set out in subsection 77(4) of CEPA, the ministers are satisfied that
- the substance met one of the criteria for a toxic substance as set out in section 64 of CEPA;
- the substance was found to be persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations;
- the presence of the substance in the environment resulted primarily from human activity; and
- the substance was not a naturally occurring inorganic substance or radionuclide.
The implementation of virtual elimination does not apply to talc, as the substance is a naturally occurring inorganic substance. Furthermore, talc is persistent but not bioaccumulative. Based on the available evidence, the ministers determined that taking no further action, or adding the substance to the Priority Substances List (option A or option B) is not appropriate since these options do not address the potential human health risks associated with talc in Canada. Therefore, the ministers are recommending to the Administrator in Council to add talc to the List of Toxic Substances in Schedule 1 to CEPA (option C). An order is the only available instrument to implement this recommendation.
Benefits and costs
The addition of talc to Schedule 1 to CEPA would not, on its own, impose any regulatory requirements on businesses, and therefore, would not result in any incremental compliance costs for stakeholders or enforcement costs for the Government of Canada. The proposed Order would grant the ministers the authority to develop risk management measures under CEPA for this substance. If pursued, these measures could result in incremental costs for stakeholders and the Government of Canada. In the event that the ministers propose risk management measures for talc in products available to consumers (i.e. cosmetics, natural health products, and non-prescription drugs), the departments would assess their benefits and costs, and would conduct consultations with stakeholders, the public, and other interested parties during the development of such measures.
Small business lens
The small business lens analysis concluded that the proposed Order would have no associated impacts on small businesses, as it would not impose any administrative or compliance costs on businesses. In the event that the ministers propose risk management measures for talc, the departments would assess any associated impact on small businesses during the development of such measures.
The one-for-one rule does not apply as there is no incremental change in administrative burden imposed on businesses. In the event that the ministers propose risk management measures for talc, the departments would assess any associated administrative burden during the development of such measures.
Regulatory cooperation and alignment
Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g. the United States Environmental Protection Agency, the European Chemicals Agency, and the Organisation for Economic Co-operation and Development), and is party to several international multilateral environmental agreements in the area of chemicals and waste. footnote 11
While the proposed Order would not, on its own, relate to any international agreements or obligations, any risk management measures to be implemented following the addition of talc to Schedule 1 to CEPA could result in a regulatory misalignment with the United States and the European Union as there are currently no restrictions or prohibitions to talc in those jurisdictions. Any potential regulatory misalignment would therefore be assessed by the departments during the development of any risk management measures.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a (ARCHIVED) Strategic Environmental Assessment of the Chemicals Management Plan was completed, inclusive of orders adding substances to the List of Toxic Substances in Schedule 1 to CEPA. The assessment concluded that the CMP is expected to have a positive effect on the environment and human health.
Gender-based analysis plus
The gender-based analysis plus concluded that the proposed Order would not affect socio-demographic groups based on factors such as gender, sex, age, language, education, geography, culture, ethnicity, income, ability, sexual orientation, or gender identity, as it would not introduce any new regulatory requirements.
Implementation, compliance and enforcement, and service standards
As no specific risk management measures are recommended as part of the proposed Order, developing an implementation plan and a compliance and enforcement strategy, as well as establishing service standards, are not necessary at this time. In the event that the ministers propose risk management measures for talc, the departments would assess these elements during the development of such measures.
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Risk Management Bureau
PROPOSED REGULATORY TEXT
Notice is given, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b that the Administrator in Council, on the recommendation of the Minister of Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices 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 (email: firstname.lastname@example.org; Single Window: https://ec.ss.ec.gc.ca/).
A person who provides information to the Minister of the Environment may submit the information with a request for confidentiality under section 313 of that Act.
Ottawa, May 13, 2021
Assistant Clerk of the Privy Council
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote b is amended by adding the following in numerical order:
- 164 Talc, which has the molecular formula Mg3H2(SiO3)4
Coming into Force
2 This Order comes into force on the day on which it is registered.