Canada Gazette, Part I, Volume 157, Number 7: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
February 18, 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.)
Government officials conducted an assessment as part of the Chemicals Management Plan of tall oil (CAS RNfootnote 1 8002-26-4). Crude tall oil and distilled tall oil share the same CAS RN. Specifically on the basis of risk presented by crude tall oil (also known as CTO), the assessment concluded that CTO meets the ecological criterion set out in paragraph 64(a) 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 to the Governor in Council to make an order adding CTO to Schedule 1 to the Act (the List of Toxic Substances).
The Chemicals Management Plan (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 tall oil in accordance with section 74 of CEPA as part of the CMP.
In 1994, a substance was added to the Domestic Substances List (DSL)footnote 2 under the name “tall oil.” This substance may refer to both CTO and distilled tall oil (DTO). Although the distinction between these two substances was not made during the original DSL nomination, and the two substances share a common CAS RN, a distinction between these two substances was made, where possible, in the final screening assessment. Tall oil, identified with CAS RN 8002-26-4, is part of the Resins and Rosins Group under the CMP. Fourteen substances were prioritized for assessment and were grouped as the Resins and Rosins Group, most of them derived from CTO. Under the screening assessment of the Resins and Rosins Group, 12 of the 14 substances were assessed and 2 were identified as being of low concern through other approaches. Only tall oil (specifically on the basis of risk presented by environmental releases of CTO from manufacturing and associated activities) was found to meet at least one criterion under section 64 of CEPA.
Description, uses, and sources of release
CTO has a very complex composition, with a large range of components. The substance is a dark oily liquid made of 26% to 42% of resin acids (represented in the screening assessment by abietic acid, isopimaric acid, and dehydroabietic acid), 36% to 48% of fatty acids (represented by linoleic acid), and 10% to 38% of neutral compounds (represented by β-sitosterol, abietinol, and abietinal). As the nature and proportions of the various components have a certain degree of uncertainty and variability, CTO is considered to be a substance of “unknown or variable composition, complex reaction products or biological material” (or UVCB) rather than a discrete chemical that is represented by a single component. The substance is a co-productfootnote 3 of kraft pulping of coniferous wood, which is a major industry in Canada. Certain components found in CTO may also be naturally occurring in terrestrial environments (e.g. plants and soil) and aquatic environments (e.g. lakes and streams).
The Department of the Environment issued a mandatory survey pursuant to section 71 of CEPAfootnote 4 for CTO in 2012. Information reported by industry under that survey indicated that CTO was manufactured (as a co-product of the kraft pulping of coniferous wood) in the range of 10 000 tonnes to 100 000 tonnes and imported into Canada in the range of 10 tonnes to 100 tonnes for the reporting year 2011. A recent survey led by the National Council for Air and Stream Improvement found that there were five companies or facilities importing CTO and four companies or facilities manufacturing CTO in Canada.
CTO is typically burned in a recovery boiler or used as a feedstock for refining into various downstream products, including tall-oil pitch, rosin and DTO. These downstream products were part of the screening assessment for the Resins and Rosins Group. CTO refining is not known to currently occur in Canada, but downstream products of CTO are imported into Canada. CTO that is imported into Canada may have various industrial applications, including use as a raw material for oil and gas drilling applications. The major sources of emissions for CTO relate to the manufacturing and associated activities for CTO in Canada. Despite recovery measures in place, CTO may be released to water from kraft pulping and other facilities manufacturing CTO in Canada, such as through their day-to-day operations and spills.
Releases of concern occur primarily in surface water where certain components that tend to adsorb to organic carbon rather than dissolve in water may partition into sediments. The likelihood of CTO being released to soil in Canada is low, given that the use of biosolids from pulp and paper mills (the largest sources of release of CTO) is not a common practice. Releases to air or transfers to air from other environmental media are also not considered significant for CTO based on the evaluation of the physical-chemical properties of the representative chemicals and considering the major industrial uses and volumes used.
Current risk management activities
The Canadian pulp and paper sector is subject to multiple risk management instruments,footnote 5 but none is specific to CTO. The Pulp and Paper Effluent Regulations, under the Fisheries Act, currently set regulatory limits on mill effluent for suspended solids, biochemical oxygen demand, and acute lethality.
The United States and the European Union have risk management measures in place for pulp and paper mills, but not specifically to address releases of CTO in pulp and paper effluents. In the United States, tall oil has active commercial status under the Toxic Substances Control Act Inventory. It is listed on the U.S. High Production Volume Challenge Program List, under the High Production Volume Program / Voluntary Children’s Chemical Evaluation Program, and under the Federal Insecticide, Fungicide, and Rodenticide Act as an inert ingredient authorized for food and non-food uses. In the European Union, tall oil is registered under the European Union’s Registration, Evaluation, and Authorization of Chemicals.
Summary of the screening assessment
In July 2022, the ministers published the screening assessment of the Resins and Rosins Group on the Canada.ca (Chemical Substances) website.footnote 6 The screening assessment was conducted to determine whether these substances meet one or more of the criteria for a toxic substance as set out in section 64 of CEPA.
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 Department of the Environment and the Department of 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 this assessment have undergone external peer review and consultation with academics.
The screening assessment concluded that tall oil, specifically CTO, meets the ecological criterion for a toxic substance as set out in paragraph 64(a) of CEPA, and thus constitutes a risk to the environment in Canada. Below are summaries of the ecological and human health assessments.
Summary of the ecological assessment
CTO has a very complex composition, with a large range and diversity of components and subclasses of components, including highly biodegradable subclasses such as fatty acids. However, a significant proportion (44%) of the subclasses of components shows moderate to high persistence, including resin acids, alcohols, aldehydes, and plant sterols (i.e. phytosterols). CTO representative chemicals for these subclasses of components show low to moderate bioconcentration, while other components representing close to 20% of CTO exhibit a high, but uncertain, bioaccumulation potential. Representative components of CTO also occur via natural processes (e.g. from the decomposition of vegetation), likely resulting in near-continuous background presence in many aquatic environments. For that reason, elevated persistence and bioaccumulation potential for these components was interpreted with some reduced weight compared to chemicals that do not occur naturally.
Major scenarios considered in the exposure analysis of CTO include co-production at kraft pulp mills and other facilities and various industrial applications of CTO, including use as a raw material for oil and gas drilling applications. A weight-of-evidence approach was used to determine if these scenarios posed an ecological risk. Risk quotients were calculated as the ratio between predicted environmental concentrations (PECs) and predicted no-effect concentrations (PNECs) for these substances (PEC divided by PNEC) based on the representative chemicals of the subclasses of components. When PEC values are greater than PNEC values, there is a potential for ecological harm. PNECs were derived from modelled and empirical data available for representative chemical components of CTO. Under the scenario where CTO is co-produced at kraft pulp mills and other facilities, PECs were derived for each representative chemical of the subclass of components of CTO in the receiving waters by estimating the amount of each representative chemical released to the wastewater treatment effluent, the effluent volume and the receiving water’s dilution of effluent from kraft pulping mills in Canada. The resulting risk quotient was indicative of an elevated risk potential to aquatic organisms. The same analysis of the various industrial uses of CTO was not indicative of potential harm to the environment.
The screening assessment concluded that tall oil, specifically CTO, meets the ecological criterion for a toxic substance as set out in paragraph 64(a) of CEPA, as it is 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. The assessment did not conclude on the persistence and bioaccumulation of CTO because components of CTO also occur naturally, and near continuous background environmental exposure is therefore likely.
Summary of the human health assessment
On the basis of classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity, or reproductive toxicity, CTO was not identified as posing a high hazard to human health. Hazard studies conducted on the Resins and Rosins Group substances that were assessed demonstrate no evidence of carcinogenicity or genotoxicity in experimental animals or cell lines. There are a limited number of health effect studies for CTO specifically.
Available information indicates that tall oil may be used in a variety of products available to consumers in Canada. However, information submitted to the departments by industry suggests that consumer products are made solely with DTO, which translates to no expected exposure of Canadians to CTO from consumer products.
The screening assessment concluded that the risk to the general population from CTO is low, and therefore not a concern. As a result, CTO does not meet the human health criterion for a toxic substance as set out in paragraph 64(c) of CEPA.
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 crude tall oil to Schedule 1 to CEPA. This would enable the ministers to propose risk management instruments for a toxic substance under CEPA to manage potential environmental risks associated with the substance.
The proposed Order would add crude tall oil to Schedule 1 to CEPA (List of Toxic Substances).
On June 22, 2019, the ministers published a notice with the summary of the draft screening assessment of 12 substances of the Resins and Rosins Group, including CTO, in the Canada Gazette, Part I, for a 60-day public comment period. The notice also advised of the publication of a risk management scope document for CTO to initiate discussions with stakeholders on the development of risk management actions for CTO, following its addition to Schedule 1 to CEPA. During this period, comments were received from five stakeholders on the draft screening assessment, and from four stakeholders on the risk management scope document. A table summarizing the complete set of comments received and the response to these comments is available on the Canada.ca (Chemical substances) website.
Industry stakeholders submitted comments indicating that the screening assessment needed to better distinguish between CTO and DTO. The departments agreed that they are distinct substances, and the screening assessment was updated to further distinguish between CTO and DTO where possible. Stakeholders also commented that the methodology used to calculate the risk to the environment and human health was deficient, in that it based the conclusion on the assessment of representative components of CTO, rather than on the whole substance; the departments responded that a weight-of-evidence approach was taken in the assessment, where relevant data respecting physical, chemical, and other properties of CTO were weighed accordingly to calculate risk. Stakeholders also submitted new data or additional information on the manufacturing process, new and existing uses, and environmental releases of CTO in Canada. The departments acknowledged the information provided by all of the stakeholders and incorporated it into the screening assessment, where applicable. These comments were considered in the development of the final screening assessment report, but did not change the conclusion that tall oil, specifically on the basis of risk presented by CTO, meets the criterion for a toxic substance as set out in paragraph 64(a) of CEPA.
Some of the comments received pertained to the management of the ecological risk posed by CTO. The departments considered these comments during the development of the Risk Management Approach document for CTO. Comments derived from public, partner, and stakeholder consultations will continue to be considered during the development of any risk management instrument associated with CTO.
The departments informed the provincial and territorial governments about all publications through the CEPA National Advisory Committeefootnote 7 via a letter, and provided them with an opportunity to comment. No comments were received from the Committee.
Modern treaty obligations and Indigenous engagement and consultations
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 therefore, 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 comment period is an opportunity for Indigenous Peoples to provide feedback on the proposed Order, which is open to all Canadians.
When a substance meets one or more of the criteria for a 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 of the substance;
- (b) unless the substance is already on the Priority Substances List, 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 eliminationfootnote 8 under subsection 65(3) of CEPA.
When proposing option (c), the ministers shall recommend the implementation of virtual elimination under subsection 65(3) of CEPA if the substance was assessed under section 74 of CEPA and, as set out in subsection 77(4) of CEPA, if 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 duty to implement virtual elimination does not apply to CTO, as the substance was not found to be persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations. Based on the available evidence, the ministers determined that it is not appropriate to manage the potential ecological risks associated with the substance 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 CTO 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 CTO to Schedule 1 to CEPA would not on its own impose any regulatory requirements on businesses; therefore, it 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 these substances. The Government of Canada would consult stakeholders on any future risk management instruments before implementation and would consider their potential impacts.footnote 9
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. Environmental Protection Agency, the European Chemicals Agency, and the Organisation for 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 (GBA+) 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:
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, February 3, 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:
- 168Crude tall oil
Coming into Force
2 This Order comes into force on the day on which it is registered.
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