Canada Regulatory News

On February 5, 2024, the Canadian Food Inspection Agency (CFIA) notified the World Trade Organization (WTO) of an interim standard for per- and polyfluoroalkyl substances (PFAS) in municipal biosolids...

On February 5, 2024, the Canadian Food Inspection Agency (CFIA) notified the World Trade Organization (WTO) of an interim standard for per- and polyfluoroalkyl substances (PFAS) in municipal biosolids imported or sold in Canada as fertilizers. The deadline for comments is April 5, 2024. 

Background Information 

Per- and polyfluoroalkyl substances (PFAS) have become a major concern due to their persistence and potential adverse effects on human health and the environment. Commonly found a variety of products and industrial processes, the substances have the potential to contaminate soil, air, water, and even municipal biosolids (the product of wastewater treatment processes). In response to this threat, the Canadian Food Inspection Agency (CFIA) is taking action by proposing an interim standard to reduce PFAS contamination in municipal biosolids imported or sold as fertilizers. This initiative is part of the Government of Canada's broader efforts to reduce human and environmental exposure to PFAS throughout their lifecycle, from production to disposal. 

Purpose of the Consultation 

The CFIA has launched a consultation to gather input from Canadians, including producers, farmers, and the general public, on the implementation of the interim standard for PFAS in biosolids. 

Proposed Risk Management Approach 

Under CFIA’s proposed interim standard biosolids marketed as commercial fertilizer must meet a standard of less than 50 parts per billion (ppb) of perfluorooctane sulfonate (PFOS), which serves as an indicator of PFAS contamination. To import or sell biosolids as fertilizer in Canada, applicants will need to meet the following requirements: 

1. Certificate of Analysis (CoA): Applicants must provide a CoA for PFOS as an indicator, dated within the last six months. This document must confirm that the concentration of PFOS in the biosolids is less than 50 ppb based on dry weight. Testing must be performed at least every six months to account for potential variations in inputs and treatment. The CoA provided at the time of import or domestic inspection should have a sampling date within the previous six months. CFIA will provide a list of accredited laboratories for guidance. 

2. Attestation Form: A template attestation form provided by the CFIA must be completed and signed by the responsible party. This form is used to certify to the validity of the CoA. 

These requirements apply to all biosolids products that are represented as fertilizers, including those that are exempt from registration, and those that are required to be registered as defined in the List of Primary Fertilizer and Supplement Materials. 

Scientific Basis: 

To determine the most appropriate risk management approach, the CFIA conducted a thorough review of the scientific literature on PFAS, with a particular focus on their impact on agriculture. This review also considered assessments conducted by other regulatory bodies, both domestic and international, including Environment and Climate Change Canada, Health Canada, the U.S. Environmental Protection Agency, the European Chemical Agency, and the European Environment Agency. In addition, the CFIA collected data on PFAS levels in soils and other matrices and investigated the beneficial uses of biosolids. 

Results and Conclusion: 

An analysis of the data revealed that the majority (92%) of domestic biosolids had PFOS concentrations below 50 ppb, indicating a relatively low level of contamination. CFIA was inspired by the Michigan Department of the Environment, Great Lakes, and Energy, which implemented a similar interim strategy in March 2021 with considerable success in reducing PFAS contamination levels in biosolids. 

The CFIA is commited to ongoing collaboration with federal and provincial partners and stakeholders to monitor scientific developments related to PFAS, actions taken in other jurisdictions, and contamination levels in biosolids. The interim approach will be reviewed after one year to ensure its continued effectiveness in protecting human health and the environment. 

In accordance with the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada is actively engaged in the comprehensive evaluation of substances to assess their potential risks to...

In accordance with the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada is actively engaged in the comprehensive evaluation of substances to assess their potential risks to human health and the environment. This process involves a thorough examination of both the intrinsic hazardous properties of the substances and the extent of their exposure to humans and the environment. 

Focus on four substituted phenols 

As part of this ongoing effort, the government is currently focusing on a group of 15 substances in the substituted phenols group. Four substances in this group, CAS RNs 118-82-1, 128-37-0, 36443-68-2, and 61788-44-1, have been identified as potential sources of environmental concern. These four substances have the potential to cause adverse effects to organisms if released into the environment. 

To address these concerns, the Government of Canada is considering a range of regulatory and non-regulatory options for industrial formulation activities involving these substances. The objective is to minimize their release into the environment and thereby reduce potential harm. 

Safety of remaining substances 

It is important to note that the remaining 11 substances in the group have not been found to pose harm to the environment. The ecological hazard and exposure potential of these substances has been assessed using the Ecological Risk Classification of Organic Substances (ERC) approach. 

While some substances within this group may be associated with health effects, the assessment does not indicate any harm to human health when exposure levels are taken into account. These substances, which are used as antioxidants, can come into contact with humans through various routes, such as drinking water, food, food packaging, and consumer products, including cosmetics. 

Ongoing commitment and future actions 

The Government of Canada remains committed to its role in assessing and managing the risks associated with various substances under CEPA to protect both the environment and public health. Further actions and risk management strategies will be developed as deemed necessary to mitigate potential harm from these substances. 

Canada's health and environment ministries, namely Health Canada (HC) and Environment and Climate Change Canada (ECCC), are actively seeking public input as they embark on the development of a com...

Canada's health and environment ministries, namely Health Canada (HC) and Environment and Climate Change Canada (ECCC), are actively seeking public input as they embark on the development of a comprehensive strategy to reduce the use of vertebrate animal testing in the assessments of chemicals. HC and ECCC are responsible for assessing and managing a wide range of health and environmental risks, including those posed by chemicals, under the Canadian Environmental Protection Act (CEPA). CEPA is the primary legislative framework governing pollution prevention in Canada and provides the legal foundation for a range of federal environmental and health protection initiatives. 

Background 

The process of prioritizing and assessing chemical risks largely relies on data derived from toxicity tests conducted on vertebrate animals to evaluate potential adverse effects. Nonetheless, these studies using experimental vertebrate animals are not only costly and time-consuming but may also have limited biological relevance, in addition to ethical concerns related to animal welfare. In light of these challenges, New Approach Methods (NAMs) have emerged as a promising alternative to traditional vertebrate animal-based approaches for chemical toxicity testing and risk assessment. 

NAMs are broadly defined as any technology, methodology, approach, or combination thereof that can replace, reduce, or refine animal toxicity testing, potentially leading to faster and more effective prioritization and assessment of chemicals. These methods cover a wide range of possibilities, including the use of computer-based models, modernized whole organism assays, assays using biological molecules, cells, tissues, or organs, as well as exposure prediction techniques. 

As part of their ongoing commitment to integrate NAMs into regulatory programs under CEPA, the HC and ECCC are working diligently to develop and standardize of NAMs. Simultaneously, they are actively establishing frameworks and tools to facilitate the ongoing evaluation and incorporation of non-animal data and alternative approaches in prioritization and risk assessment.  

These scientific advances are in line with the efforts by various regulatory authorities around the world, such as those in the United States, Australia, and the European Union, which are increasingly emphasizing modern approaches to minimize the use of vertebrate animals in toxicity testing. These efforts include strategies and research programs designed to accelerate the development and implementation of NAMs for regulatory decision-making. 

The current initiative involves the formulation of a comprehensive strategy to guide the future efforts of the HC and ECCC in their quest to minimize the reliance on vertebrate animal testing under CEPA for the assessment of potential risks to human health and the environment. Although initially developed within the context of CEPA, this strategy has the potential for broader applicability to other Government of Canada regulatory programs, where relevant and feasible. Canada intends to collaborate closely with national and international partners in the development, standardization, and implementation of fit-for-purpose NAMs. Furthermore, building scientific confidence and garnering acceptance of NAMs within the Government of Canada and among external stakeholders is considered critical to the successful advancement and timely adoption of alternative methods and strategies for regulatory testing and assessment.  

This strategy responds to CEPA's commitment outlined in the Plan of Chemicals Management Priorities, which underscores the inclusion of activities and initiatives to promote the development and timely integration of scientifically justified alternative methods and strategies to replace, reduce, or refine the use of vertebrate animals in chemical testing. 

Key elements 

Key elements proposed to be addressed in this strategy include: 

1. Identifying and prioritizing the requirements for NAMs within chemical regulatory programs under CEPA. 

2. Promoting research and data generation for NAMs to support method development, standardization, and translational research. 

3. To promote harmonization, collaboration, communication, and engagement. 

4. Implement NAMs to reduce reliance on vertebrate animal toxicity testing in chemical regulatory programs under CEPA. 

Deadline 

This strategy, which is expected to be published alongside the Plan of Chemicals Management Priorities by June 2025, is an important step towards a more sustainable and ethical approach to chemical assessment. Comments on the animal testing notice are encouraged and should be submitted by January 29, 2024, providing a valuable opportunity for public input into this transformative endeavor. 

On 18 November 2023, in a significant move to safeguard both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This ini...

On 18 November 2023, in a significant move to safeguard both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This initiative is part of the broader Chemicals Management Plan (CMP), which aims to evaluate and reduce risks posed to the environment and human health by potentially harmful chemical substances. 

Upgraded Management of Harmful Chemicals 

Under the Canadian Environmental Protection Act (CEPA), substances that are considered toxic to the environment or human health are subject to strict regulations. The CMP, backed by CEPA, empowers the Governor in Council to enact regulations to reduce the risks associated with these toxic substances. 

Focus on Coal Tars and Distillates 

The proposed regulations focus on coal tars and their distillates. These substances, which consist of complex mixtures of hydrocarbon and other chemicals, are essential for the production of various materials like creosote, crude naphthalene, and coal tar pitch and oils. They are also used in certain veterinary and human pharmaceuticals. 

Key Objectives of the New Regulations 

The primary goal of these new regulations is to ban the manufacture, import, and sale of specific coal tar-based sealant products and sealants containing Polycyclic Aromatic Hydrocarbons (PAH) levels exceeding 1,000 ppm. This action is a proactive measure to prevent ecological damage and reduce health risks associated with these toxic substances in Canada. 

Implementation Timeline and Exceptions 

By 1 January 2025, the regulations will prohibit the manufacture and import of certain sealant products containing coal tar and PAHs above the 1,000-ppm threshold. Excemptions include products manufactured for export only or in transit through Canada, and those manufactured under a specific permit. The ban covers pavement and roofing sealant products and, for coal tars, includes industrial-use sealants on various materials. 

The sale and offer of these products will be prohibited by 30 June 2025, with certain temporary exemptions. In particular, coal tar-based industrial sealants will be exempt until 1 January 2028. 

Integration of 2-BE Regulations 

The new regulations will also incorporate the existing 2-BE Regulations to improve their consistency with the current legislative draft. The 2-BE Regulations set the limits on the amount concentration of 2-butoxyethanol (2-BE) contained in cleaning, painting and coating products designed for indoor use. However, the core permitting and record-keeping requirements under the 2-BE Regulations will remain unchanged. 

Enforcement Measures 

Enforcement of these regulations, under CEPA's Compliance and Enforcement Policy, will be stringent to ensure compliance to the new standards. This move reflects Canada's commitment to a healthier environment and public safety, emphasizing the government's proactive approach to chemicals management. 

On 18 November, in a significant move to protect both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This groundbrea...

On 18 November, in a significant move to protect both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This groundbreaking initiative is part of the broader Chemicals Management Plan (CMP), which aims to evaluate and reduce  risks posed to the environment and human health by potentially harmful chemical substances. 

Upgraded Management of Harmful Chemicals 

Under the Canadian Environmental Protection Act (CEPA), substances that are considered toxic to the environment or human health are subject to strict regulations. The CMP, backed by CEPA, gives the Governor in Council the authority to enact regulations to reduce the risks associated with these toxic substances. 

Focus on Coal Tars and their Distillates 

The proposed regulations particularly focus on coal tars and their distillates. These substances, which consist of  complex mixtures of hydrocarbon and other chemicals, are essential for the production of various materials like creosote, crude naphthalene, and coal tar pitch and oils. They are also used in certain veterinary and human pharmaceuticals. 

Key Objectives of the New Regulations 

The primary goal of these new regulations is to ban the manufacture, import, and sale of specific coal tar-based sealant products and sealants containing Polycyclic Aromatic Hydrocarbons (PAH) above 1,000 ppm. This is a proactive measure to prevent ecological damage and reduce health risks associated with these toxic substances in Canada. 

Implementation Timeline and Exceptions 

By January 1, 2025, the regulations will prohibit the manufacture and import of certain sealant products containing coal tars and PAHs above the 1,000 ppm threshold. Exemptions include products manufactured for export only or in transit through Canada, and those manufactured under a specific permit. The ban extends to pavement and roofing sealant products and, for coal tars, includes industrially applied sealants on various materials. 

The sale and offer of these products will be prohibited by June 30, 2025, with certain temporary exemptions. Notably, coal tar-based industrial sealants will be exempt until January 1, 2028. 

Integration of 2-BE Regulations 

The new regulations will also incorporate the existing 2-Butoxyethanol Regulations (2-BE Regulations), to improve their consistency with the current legislative draft. However, the core requirements for permitting and record-keeping under the 2-BE Regulations will remain unchanged. 

Enforcement Measures 

Enforcement of these regulations, under CEPA's Compliance and Enforcement Policy, will be stringent to ensure compliance with the new standards. This move reflects Canada's commitment to a healthier environment and public safety and underscores the government's proactive approach to chemicals management. 

The Canadian Environmental Protection Act, 1999 (CEPA), under its vigilant section 68, recently underwent a comprehensive assessment by the Environment Ministry and the Health Ministry. This review fo...

The Canadian Environmental Protection Act, 1999 (CEPA), under its vigilant section 68, recently underwent a comprehensive assessment by the Environment Ministry and the Health Ministry. This review focused on a group of 13 substances, known collectively as the Titanium-containing Substances Group. The aim was to determine their potential environmental and health impacts. This article discusses the findings of this assessment and what they mean for Canada. 

What are these Titanium-containing Substances? 

Titanium, a naturally occurring metal, forms the core of these 13 evaluated substances. They range from well-known compounds such as titanium dioxide (TiO2), used in a variety of consumer products, to more complex chemicals such as titanium tetrachloride and tetrahydroxytitanium. The 13 chemicals are listed in the table below. 

Assessment Methods and Key Findings: 

The inter-ministerial team employed the Ecological Risk Classification of Inorganic Substances (ERC-I) method, which focuses on both hazard and exposure levels, to assess ecological risks. This innovative approach combined predictive models, water quality data, and various statistical metrics. The conclusion? These 13 substances are unlikely to cause significant  damage to the ecosystem. 

Human Health and Exposure 

The assessment extended beyond ecological impacts, to explore potential health risks to Canadians. The main sources of human exposure to these substances include air, water, food, and consumer products. Notably, food emerged as a major source of titanium exposure for the general population. Intriguingly, titanium was barely detectable in blood samples from the Canadian population, suggesting minimal health risks at current exposure levels. 

Specific Risks and Safety Thresholds 

Going deeper, the study identified a no-observed-adverse-effects level (NOAEL) for systemic exposure to titanium, taking into account various health endpoints. Moreover, for inhalation exposure, the study identified non-cancerous respiratory effects as the primary concern but deemed these to be unlikely at current exposure levels in the general population. 

Conclusion 

Encouragingly, this comprehensive study suggests that the 13 substances in the Titanium-containing Substances Group do not meet the CEPA criteria for being environmentally or health hazardous under current conditions. This conclusion represents a critical step in the understanding and management of these substances in Canada, ensuring a balance between use and safety. 

Health Canada has extended the comment period for stakeholders to provide feedback on the proposed disclosure requirements for hazardous substances found in household chemical products such as cleaner...

Health Canada has extended the comment period for stakeholders to provide feedback on the proposed disclosure requirements for hazardous substances found in household chemical products such as cleaners and lubricants. This pre-consultation is open for public comment until October 20, 2023.This initiative is part of Health Canada's ongoing efforts to improve consumer safety by introducing new requirements for chemical products under the Canadian Consumer Product Safety Act (CCPSA). 

The primary aim of this proposal is to protect the well-being of Canadians by implementing a comprehensive hazard classification and information disclosure framework for Hazardous Household and Health-Related Chemicals (HHHOCs). In conjunction with this, additional protective measures, such as prohibitions, restrictions, and child-resistant container requirements, will be considered. This approach will ensure that consumers are well informed about the presence of HHHOCs in household chemical products and are provided with essential precautionary information, including safe use instructions and first aid guidelines on the associated risks. 

Background  

A wide range of consumer chemical products, including household cleaning products, adhesives, and lubricants, are readily available to the Canadian public. The Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the CCPSA play a crucial role in protecting Canadians from acute human health and physical hazards associated with consumer chemical products. These regulations accomplish this through various means, such as prohibiting dangerous consumer chemical products, imposing restrictions, requiring information disclosure, and specifying container standards. The specific requirements for consumer chemical products are determined through scientific assessments of the hazards associated with the substances contained in the products, evaluated against the classification criteria established in the regulations. 

As of now, the CCCR, 2001 address acute human health and physical hazards, which include: 

1. Acute toxicity, which includes lethal or serious, non-lethal effects. 

2. Corrosivity, which covers chemical burns and eye damage. 

3. Flammability, which covers chemicals that can catch fire. 

4. Pressurized containers, which can explode if heated or punctured. 

5. Quick skin-bonding adhesives, adhesives that bond skin rapidly. 

However, there is a need to reduce the risks associated with Hazardous Household and Health-Related Chemicals (HHHOCs), which can cause adverse health effects from long-term or intermediate exposure. The current CCCR, 2001, lacks requirements to address the following HHHOCs: 

1. Carcinogenicity, associated with the induction of cancer. 

2. Germ cell mutagenicity, which involves heritable gene mutations. 

3. Reproductive toxicity, which includes adverse effects on sexual function, fertility, or developmental toxicity in the offspring. 

4. Specific target organ toxicity, resulting in adverse effects in target organs after single or repeated exposure. 

5. Respiratory or skin sensitization, resulting in allergic reactions or hypersensitivity. 

Requirements for consumer chemical products 

The proposed requirements for consumer chemical products under the CCPSA include: 

1. Classification criteria for HHHOCs, in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

2. Information disclosure requirements for HHHOCs, based on the GHS labelling elements, including hazard symbols, signal words (e.g., "Danger" or "Warning"), hazard statements (e.g., "May cause cancer"), precautionary statements (e.g., instructions for safe use and first aid), and ingredient disclosure requirements. 

3. Additional protective measures, such as prohibitions, restrictions, or child-resistant container requirements, as deemed necessary. 

It is important to note that the existing requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001), including classification criteria, prohibitions, information disclosure requirements, and container specifications, will remain in force under this proposed regulation. 

Deadline 

To implement these proposed requirements, Health Canada is exploring various regulatory options, such as amending the CCCR, 2001, or introducing a new regulation under the CCPSA. This pre-consultation period is open for public comment until October 20, 2023.