On April 13, the Government of Canada introduced Bill C-28: Strengthening Environmental Protection for a Healthier Canada Act, which proposes to amend the Canadian Environmental Protection Act, 1999 (CEPA) and the Food and Drugs Act (FDA). The proposed amendments would be the first significant reform to CEPA in decades and would facilitate significant changes to Canada’s chemicals management program, including a new environmental assessment regime for FDA-regulated drugs.
While the proposed amendments retain CEPA’s core risk management framework for new and existing substances, there are several notable aspects of Bill C-28 that, if passed, will fundamentally alter how chemical substances, and specifically drugs, are assessed for environmental risk.
Right to a Healthy Environment and Cumulative Effects: The preamble to CEPA will be amended to recognize that every Canadian has the right to a healthy environment. An implementation framework will be developed setting out how that right will be considered when administering CEPA. The government would be required to exercise its powers in a manner that minimizes risks to vulnerable populations, which may include those living/working in areas with higher pollution levels. When conducting and interpreting risk assessments, the government would be required to consider the potential cumulative effects from exposure to the substance in combination with exposure to other substances.
Higher-Risk Toxics: The CEPA amendments would create a new regime for controlling certain CEPA-toxic substances that pose the most significant risks. Under this regime, priority would be given to prohibiting related activities, including substances being phased out or prohibiting new uses. The criteria for higher-risk substances would be set out in new regulations and will likely consider persistence, bioaccumulation, carcinogenicity, mutagenicity, and reproductive toxicity. The current Schedule 1 (List of Toxic Substances), will be bifurcated into two parts: higher-risk toxics and all other toxics.
Substitution Watch List: In a move toward greater informed substitution, a “Watch List” will be developed listing the substances determined to be capable of becoming toxic under CEPA. The intention behind the Watch List is to assist manufacturers, importers and Canadian consumers in making informed substitutions when replacing a regulated substance with an alternative.
Increased Transparency: Canadians will have the means to formally request that a chemical be assessed. Federal regulators will be required to consider and respond to such requests. When a substance is found to be CEPA toxic, the government will also be required to communicate anticipated timelines for completing all associated risk management actions. Additionally, industry will be required to provide a rationale in support of any requests for confidentiality of business information. The government will also establish circumstances where the names of masked substances or living organisms may be disclosed.
New Environmental Assessment Regime for Drugs: The proposed amendments to the FDA are a move towards consolidating the notification, risk assessment and risk management of drug products and active pharmaceutical ingredients (APIs). Currently, APIs are assessed for environmental impact under the New Substances Notification Regulations (Chemicals and Polymers) under CEPA. However, CEPA was designed to assess industrial chemicals, has high volume thresholds for new substances and many new APIs are not being assessed for environmental risk.
The FDA amendments will permit the development of a CEPA-equivalent assessment regime under the FDA so that environmental risk assessments can be completed alongside safety, efficacy, and quality assessments. The proposed FDA amendments include provisions related to:
- creating new regulations to assess and manage environmental risks
- prohibiting the sale of a drug unless an assessment of environmental risks has been conducted in accordance with the regulations (e.g., creating regulations prescribing the data required for environmental risk assessment and the ability to waive prescribed requirements)
- amending labels, imposing terms and conditions, and requesting additional information/tests and recalls if a serious environmental risk is identified
- disclosing confidential business information to other government departments and/or other governments for the purpose of managing an environmental risk.
Health Canada is proposing that environmental risk assessments will not impede access to new drugs, including the issuance of a Notice of Compliance (i.e., market approval). Exemptions for drugs accessed through the Special Access Program, Extraordinary Use New Drug Submission pathway, and other emergency access pathways for life-saving drugs are also anticipated.
Other FDA products (e.g., foods, cosmetics) are not expected to be captured under any new environmental regulations. However, the government is further considering reviewing biotechnology products that fall under the New Substances Notification Regulations (Organisms), to allow for assessing risks posed by new living organisms prior to their introduction into the Canadian marketplace.
Health Canada is targeting consultation for development of environmental assessment regulations under the FDA in fall 2021, but the provisions are not expected to be in force until 2026/2027.
Labelling and Information for Consumers: Over the next year, the government will consult stakeholders on mandatory labelling requirements to enhance the availability of information on chemicals in products. These consultations will focus on digital data to support regulatory compliance, informed consumer decision making, and sustainability. Initial consultations are expected in fall 2021 to focus on cosmetics, cleaning products and flame retardants in upholstered furniture, with regulatory changes planned for 2022.
Cosmetic Labelling Changes: The government has also proposed requiring that cosmetic labels begin declaring the use of specific fragrance allergens, outside of the term “parfum.” This aligns with EU requirements in place since 2005. Health Canada will consider e-labelling to address challenges with labelling requirements on small packages. Other Cosmetic Regulations amendments will bolster Health Canada’s ability to conduct risk assessments and support enforcement.
Consultations on the cosmetic labelling changes will begin in spring 2021 with regulatory changes planned for 2022.
The authors wish to thank Ceviel Alizadeh-Najmi, articling student, for her help in preparing this legal update.