Environmental Assessment of Pharmaceuticals in Canada: A Regulatory Perspective
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Andrew Beck, BSc, D Ecotox Health Canada, New Substances Assessment and Control Bureau, Environmental Assessment Unit Ottawa, Ontario, Canada
Key Words Pharmaceuticals; Environment; Assessment; Regulations; CEPA Correspondence Address Andrew Beck, New Substances Assessment and Control Bureau, Health Canada, 123 Slater Street, PL:3505A, Ottawa, ON, K1A 0K9, Canada (e-mail: [email protected]).
Environmental Assessment of Pharmaceuticals in Canada: A Regulatory Perspective
INTRODUCTION The Canadian Environmental Protection Act (CEPA) has been a cornerstone of the government of Canada’s environmental legislation for almost 20 years. Jointly administered by the minister of environment and minister of health, CEPA serves to protect both the Canadian environment and the health of Canadians (1). In accordance with this mandate, one of CEPA’s key objectives is the prevention and management of risks posed by harmful substances. CEPA provides the legislative framework to carry out necessary functions such as information gathering, risk assessment, risk management, implementation of remedial measures, and compliance and enforcement for any new or existing substance in Canada. In order to make the distinction between new and existing substances, CEPA gives the minister of environment authority to maintain the Domestic Substances List (DSL), which identifies substances already in use in Canada. If the substance is not included on the DSL, it is considered “new” and is subject to the New Substance Notification Regulations (NSNR) of CEPA. The intention of these regulations is to implement a preventive approach to new substances management by requiring data on the substance before it can be manufactured or imported into Canada (2). Based on these data, Health Canada and Environment Canada con-
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The development of environmental assessment regulations for pharmaceuticals and personal care products is currently under way in Canada. This article provides a brief summary of this initiative including background information on the federal legislation driving the process, activities that have taken place to date and the next steps toward a new regulatory framework. The article also outlines how environmental assessments of new substances in pharmaceuticals and personal care products are currently being conducted and how pharmaceuticals and personal care products currently in Canadian commerce are being addressed.
duct an assessment and determine the risk of the substance to human health and the environment, whether controls may be warranted to mitigate risk, or whether additional information is required. The New Substances Notification process can ultimately result in addition of a substance to the DSL. CEPA could be considered a “safety net” in that it captures many of the substances not screened for environmental impacts under other federal acts or regulations. CEPA endeavors, however, to avoid legislative duplication by recognizing other federal acts and regulations that provide equivalent protection to the environment an
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