Canada Gazette, Part I, Volume 157, Number 13: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
April 1, 2023
Canadian Environmental Protection Act, 1999
Department of the Environment
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
An assessment, conducted by government officials on phenol, 4-chloro-3-methyl- (CAS RNfootnote 1 59-50-7; hereafter referred to as chlorocresol) as part of the Government of Canada’s Chemicals Management Plan (CMP), concluded that the substance meets the human health criterion set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA or the Act). In accordance with subsection 90(1) of CEPA, the Minister of the Environment and the Minister of Health (the ministers) are recommending that the Governor in Council make an order adding chlorocresol to Schedule 1 to the Act (the List of Toxic Substances).
The CMP is a federal program that assesses and manages chemical substances and living organisms that may be harmful to the environment or human health. The ministers assessed chlorocresol in accordance with section 74 of CEPA as part of the CMP.
Description, uses, and sources of release
Chlorocresol does not occur naturally in the environment. The Department of the Environment and the Department of Health (the departments) issued a mandatory survey under section 71 of CEPAfootnote 2 encompassing chlorocresol (reporting year 2011). Information reported by industry indicated that chlorocresol was not manufactured in Canada above the reporting threshold of 100 kg in the 2011 calendar year, but was imported to Canada in the range of 100 kg to 1 000 kg in the same period for use as a concrete admixture.
Chlorocresol is also used in Canada as an ingredient in certain cosmetics such as body moisturizer creams and lotions, and as a non-medicinal ingredient in a limited number of natural health products and non-prescription drugs used to treat temporary skin irritations. Chlorocresol is a registered active ingredient in pest control products in Canada. Chlorocresol may also be used in Canada as a component in incidental additives (lubricants) used in food processing facilities where exposure from food is considered to be negligible.
Chlorocresol is not detected in environmental media in Canada, such as drinking water and indoor air, at levels that would result in significant exposure to the general population. In addition, chlorocresol was not detected, or was detected at very low concentrations, in sludge from wastewater treatment systems.
Current risk management activities
In Canada, chlorocresol is listed in the Natural Health Products Ingredients Database with a non-medicinal role, for topical use only up to 0.2%, and as a preservative antimicrobial, and is in the Licensed Natural Health Products Database as being present as a non-medicinal ingredient in a limited number of natural health products used to treat temporary skin irritations. Chlorocresol is also a medicinal ingredient in a registered veterinary drug.
As an incidental additive, chlorocresol is subject to the Food and Drug Act, which stipulates: “No person shall sell an article of food that has in or on it any poisonous or harmful substance.”
Chlorocresol is an active ingredient in certain pest control products registered for material preservative uses under the authority of the Pest Control Products Act.
The use of chlorocresol in defoaming agents for use in coatings in the manufacture of paper and paperboard and in animal glue is regulated under the United States Food and Drug Administration (U.S. FDA) Code of Federal Regulations Title 21, Indirect Additives used in Food Contact Substances. Chlorocresol is also listed in the U.S. FDA Inventory of Effective Food Contact Substance Notifications for use as an antimicrobial preservative in lubricants with incidental food contact. Chlorocresol is a registered active ingredient for pesticides by the United States Environmental Protection Agency (U.S. EPA).
The European Commission has chlorocresol listed as an active pesticide substance. The ingredient is not to be used in products applied on mucous membranes, and is restricted to a maximum concentration of 0.2% in ready-for-use preparations or in other cosmetic products.
In Japan, chlorocresol is restricted to a maximum amount of 0.50 g/100 g in all types of cosmetics as per Japan’s Standards for Cosmetics.
Summary of the screening assessment
On May 22, 2021, the ministers published a screening assessment on chlorocresol on the Canada.ca (Chemical Substances) website. The screening assessment was conducted to determine whether the substance met one or more of the criteria 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 (e.g. literature reviews, internal and external database searches, modelling, data gathered from mandatory surveys issued pursuant to section 71 of CEPA, and, where warranted, data from targeted follow-ups with stakeholders) to inform the screening assessment conclusion. The ecological and human health portions of the screening assessment have undergone external peer review or been the subject of consultation with academics and other relevant stakeholders.
The screening assessment concluded that chlorocresol meets the criterion set out in paragraph 64(c) of CEPA; therefore, it 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 risks of chlorocresol were characterized using the ecological risk classification of organic substances (ERC) approach, which is a risk-based approach that identifies, weighs, and combines multiple metrics of hazard and exposure for organisms in aquatic and terrestrial environments, to identify substances either as warranting further evaluation of their potential to cause harm, or as having a low likelihood to cause harm. On the basis of its low hazard and low exposure classifications according to information considered under ERC, chlorocresol was classified as having a low potential for ecological risk; therefore, it is unlikely to result in concerns for the environment in Canada.
Considering all available lines of evidence presented in the screening assessment, there is a low risk of harm to the environment from chlorocresol. The screening assessment concluded that chlorocresol does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.
The screening assessment also determined that chlorocresol does not meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.
Summary of the human health assessment
Chlorocresol is not a naturally occurring substance. Exposure of the general population to chlorocresol is expected as a result of the substance being present in cosmetics, natural health products, and non-prescription drugs. The critical health effect for chlorocresol was identified as decreased adrenal gland weights in a chronic exposure study. Margins of exposure (MOEs) between the critical effect level and estimates of exposure to certain body lotions are considered potentially inadequate to address uncertainties in the health effects and exposure databases.
With respect to short-term dermal exposure to chlorocresol from the use of topical natural health products or non-prescription drugs, the MOEs between the critical effect level and estimates of exposure are considered adequate to address uncertainties in the health effects and exposure databases.
Considering all the information presented in the screening assessment, it is concluded that chlorocresol 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. Therefore, it is concluded that chlorocresol meets one or more of the criteria set out in section 64 of CEPA.
The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to enable the ministers to propose risk management instruments for a toxic substance under CEPA to manage potential environmental and human health risks associated with the substance.
The proposed Order would add chlorocresol to Schedule 1 to CEPA (the List of Toxic Substances).
On July 27, 2019, the ministers published a notice with a summary of the draft screening assessment of chlorocresol (which included a link to the complete draft screening assessment) in the Canada Gazette, Part I, for a 60-day public comment period. The notice also served to inform stakeholders of the release of the risk management scope for chlorocresol to initiate discussions with stakeholders on the development of the risk management actions following its addition to the List of Toxic Substances in Schedule 1 to CEPA. In total, three comments were received from various stakeholders, including two from industry stakeholders and one from an individual. A table summarizing the complete set of comments received and the response to these comments is available on the Canada.ca (Chemical Substances) website.
A comment was submitted that suggested the Government of Canada incorporate occupational exposure standards in the screening assessment. Officials noted that screening assessments conducted under CEPA focus solely on the risk of exposure to the general population rather than risks of exposure in the workplace. Another comment submitted by a stakeholder suggested that the conclusion about toxicity of the substance in the screening assessment should only apply to certain products containing chlorocresol. In response, officials noted that a conclusion about toxicity under CEPA is applicable to a substance as a whole, as defined in the Act. However, any proposed risk management measure may address uses of the substance, including the use of the substance in specific products. The proposed risk management for chlorocresol will focus on cosmetics, as that is the source of concern for Canadians. Officials acknowledged the information provided by all of the stakeholders. These comments were considered in the development of the final screening assessment, but did not change the conclusion that chlorocresol met the criterion set out under paragraph 64(c) of CEPA.
In regard to comments about the management of risks posed by chlorocresol, officials would address them during the development of risk management measures, which would also be subject to their own consultation process. Stakeholders requested that the Government of Canada place a limit on the quantity of chlorocresol in cosmetics in lieu of a ban. Government of Canada officials responded that a consistent instrument-selection process that includes environmental, health and socio-economic considerations is followed to select the most appropriate instrument (or mix of instruments) to manage risks associated with a toxic substance.
Modern treaty obligations and Indigenous engagement and consultation
An assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders adding substances to Schedule 1 to CEPA do not introduce any new regulatory requirements and do not result in any impact on modern treaty rights or obligations. Therefore, specific engagement and consultations with Indigenous Peoples were not undertaken. However, the prepublication consultation period, which is open to all Canadians, is an opportunity for Indigenous Peoples to provide feedback on the proposed Order.
When a substance meets the definition of “toxic substance” as set out in section 64 of CEPA, the ministers may propose one of the following measures:
- (a) taking no further action in respect to the substance;
- (b) unless the substance is already on the Priority Substances List,footnote 3 adding the substance to the Priority Substances List; or
- (c) recommending that the substance be added to Schedule 1 to CEPA, and, where applicable, recommending the implementation of virtual elimination.footnote 4
When proposing Option C, the ministers shall recommend the implementation of virtual eliminationfootnote 5 if the ministers are satisfied that
- the substance meets at least one of the criteria for a toxic substance as set out in section 64 of CEPA;
- the substance is persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations;
- the presence of the substance in the environment results primarily from human activity; and
- the substance is not a naturally occurring inorganic substance or radionuclide.
The duty to implement virtual elimination does not apply to chlorocresol as the substance was found not to be persistent or bioaccumulative. Based on the available evidence, the ministers determined that it is not appropriate to manage the potential ecological risks associated with chlorocresol by taking no further action or adding the substance to the Priority Substances List (Option A or Option B). Therefore, the ministers are recommending that chlorocresol be added to Schedule 1 to CEPA (Option C). An order is the only available instrument to implement this recommendation.
Benefits and costs
The addition of chlorocresol to Schedule 1 to CEPA would not 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 instruments under CEPA for chlorocresol. The Government of Canada would consult stakeholders on any future risk management instruments before implementation and would consider their potential impacts.footnote 6
Small business lens
Analysis under the small business lens concluded that the proposed Order would not impact Canadian small businesses, as it would not impose any administrative or compliance costs on businesses.
The one-for-one rule does not apply as the proposed Order would not result in a change in the administrative burden imposed on businesses.
Regulatory cooperation and alignment
Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g. the U.S. EPA, European Chemicals Agency, and the Organisation of Economic Co-operation and Development). While the proposed Order would not on its own relate to any international agreements or obligations, it would enable the ministers to propose risk management measures that may align with actions undertaken by other jurisdictions.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed for the CMP, inclusive of orders adding substances to 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
No gender-based analysis plus impacts have been identified for this proposal.
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, is not necessary at this time.
Acting Executive Director
Program Development and Engagement Division
Environment and Climate Change Canada
Substances Management Information Line:
Telephone: 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 Governor in Council, on the recommendation of the Minister of the 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; Environment and Climate Change Canada’s Single Window: https://ec.ss.ec.gc.ca/).
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, March 24, 2023
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:
- 165 Phenol, 4-chloro-3-methyl-, which has the molecular formula C7H7CIO
Coming into Force
2 This Order comes into force on the day on which it is registered.
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