Last Updated on July 6, 2021 by Ithos Global Regulatory Team
Canada is in the process of renewing and updating the country’s Environmental Protection Act (CEPA-99).
The act states that “the Government of Canada is proposing to recognize that every individual in Canada has a right to a healthy environment … and the Act be … balanced with relevant factors, such as social, health, economic and scientific considerations.”
The amendments to the original CEPA bill are effectively outlined in bill C-28, the “Strengthening Environmental Protection for a Healthier Canada Act”.
Industry is favorable to the changes and feels that the changes were well thought out, considered stakeholder input and is a balanced, risk-based approach. Vulnerable subpopulations and indigenous peoples, as is the general Canadian approach to legislative action, are considered.
Other perspectives in the revision are legitimization of the Revised In Commerce list, a non-animal testing approach, a revision of nomenclature, eliminate designation of CEPA-Toxic to more appropriate language, and how the precautionary principle is applied, including the ability to Act if there is a lack of information.
Bill C-28 also proposes to amend the FDA to incorporate the regulation of environmental risks associated with foods, drugs, cosmetics and devices in addition to the assessment of the safety, efficacy and quality of drugs. This is anticipated to result in a more streamlined and strengthened environmental risk assessment process as well as better risk management of drugs.