This is a report on Health Canada's achievements under the Canadian Environmental Protection Act of 1999 (CEPA 1999). According to CEPA 1999, Section 343, the Act must be reviewed every five years by one or both Houses of Parliament. In support of Parliamentary Review, the Minister of the Environment must table a formal submission to Parliament in advance of the Committee's work. As Environment Canada's partner, Health Canada (HC) has requested this report to assist the Ministers in preparing their submissions. The quantitative data covered in this report are for the period April 1, 2000 to March 31, 2005. The qualitative data relate to a similar period; however, they also take into consideration some developments shortly before and after.
The key questions addressed in this report are described below:
The report findings are based on recent studies of HC's CEPA program and relevant HC organizations conducted by different parties, including BearingPoint 1. These other studies' reports were based themselves on the following tasks: (1) Review of existing HC documents; (2) Review of CEPA outputs captured in HC's Program Management Reporting System (PMRS); (3) Interviews with HC managers to directly obtain data on expenditures, activities, outputs, achievements, issues and opportunities for improvement.
The Canadian Environmental Protection Act 1999 (CEPA 1999) is the cornerstone of environmental protection in Canada. Its aim is to:
CEPA mandates that EC and HC assess the risks that different substances pose to the environment and to human health and apply controls to mitigate the identified risks. Under CEPA, a substance is defined as "any distinguishable kind of organic or inorganic matter, whether animate or inanimate". This includes:
Substances regulated by CEPA are classified into of one of three classes:
Responsibility for CEPA is shared between Environment Canada (EC) and Health Canada (HC). The Minister of Environment through EC is responsible for all non-human ecosystem issues and overall administration of CEPA. The Minister of Health through HC advises on all human health evaluations. In addition, the Minister of Health has taken on the responsibility of conducting non-human risk assessments for new substances in products subject to the Food and Drugs Act, through a Memorandum of Understanding with Environment Canada. The legislation imposes on each Minister stringent requirements and deadlines for action on toxic substances, consultation, public accountability and transparency.
Among other notable features, CEPA requires that all substances new to Canada be assessed to determine whether the substance is toxic. The New Substances Notification Regulations (NSN regulations) under CEPA set out information requirements that manufacturers and importers must submit pre-manufacture or pre-import for substances that are new to Canada. Health Canada has established a New Substances Assessment and Control Bureau (NSACB) and Environment Canada has established a New Substances Branch (NSB) to support their responsibilities under CEPA regarding new substances. The NSACB is physically located in Ottawa, ON while the NSB is located in Gatineau, QC. These two organizations together represent the New Substances Program (NS Program) in the delivery of service to a wide range of stakeholder groups with significantly different needs.
Health Canada delivers its CEPA responsibilities in a decentralized fashion. The Healthy Environments and Consumer Safety Branch (HECSB) acts as the department's primary delivery agent 3 for its responsibilities under CEPA, through two distinct and separate programmes - the Safe Environments Program (SEP) and the Product Safety Programme (PSP):
The Environmental Contaminants Bureau (ECB), the Environmental Health Science Bureau (EHSB), and the Water Quality & Health Bureau (WQHB) carry out CEPA activities and program management.
Exhibit 3.1 depicts the logic model (of October 2004) developed by HC to delineate CEPA activities, outputs and outcomes. Please note in the exhibit that Stakeholders include industry, other government departments (e.g.Industry Canada), and the public of Canada.
Exhibit 3.2 shows the main Branches, Programmes, Bureaux, and Divisions responsible for CEPA within Health Canada.
Within SEP, the Environmental Contaminants Bureau (ECB) performs all risk assessment and risk management activities for existing substances, while the Environmental Health Science Bureau (EHSB) is responsible for carrying out a large part of CEPA-related research and surveillance.
SEP Environmental Contaminants Bureau. The organizations within SEP's ECB that carry out the bulk of CEPA activities are:
SEP Environmental Health Science Bureau (EHSB). The EHSB is responsible for additional scientific support to inform risk assessment and risk management activities. Mandatory research under CEPA, including the investigation of endocrine disrupting substances, is also carried out by the EHSB.
The Product Safety Programme. The Bureau within PSP responsible for CEPA is the New Substances Assessment and Control Bureau. The NSACB is responsible for the assessment of the risk to human health (direct and indirect) posed by new substances, or those not presently in commerce, and the management of these risks. The Bureau is also responsible for assessing the risks posed to environmental species by new substances in products subject to the Food and Drugs Act.
The Health Products and Food Branch. While most CEPA responsibilities are undertaken within the HECS Branch, the HPFB is responsible for co-ordinating activities related to risk assessment of new and existing substances in products regulated under the Food and Drugs Act. Overall, the Office of International and Regulatory Affairs (ORIA) is responsible for meeting the legislative requirements for environmental impact assessment under CEPA through the development of appropriate environmental assessment regulations for substances in products regulated under the Food and Drugs Act; development and implementation of a collaborative scientific research agenda to support the development of the regulations; and the development and implementation of best practices for the management and disposal of these substances. ORIA has an agreement with PSP to support their assessment efforts.
The Safe Environments Programme's responsibility is to categorize and screen these substances as follows:
The Product Safety Programme's role is to assess all New Substances so they can be put onto the DSL and made commercially available in Canada. These assessments have to be done within distinct timeframes (typically 5 to 90 days depending on the class of substance and volume of substance to be produced/sold/imported annually). If the New Substances group cannot meet the timeline the substance is eligible to be added to the DSL. Also, if the most comprehensive information package has been submitted, manufacture or import can start.
Within the NSACB there is also an Environmental Assessment Unit (EAU) that is responsible for the assessment of the risk to human health and to the environment posed by new substances regulated under the Food & Drugs Act. This unit was established quite recently, in response to the determination that the FDA does not have "CEPA equivalency" (see 3.2.6). There is some support from the HECS regional organization re: education, outreach
CEPA 1999 will apply to every new substance unless the Governor in Council is convinced that a given statute or regulation provides "CEPA Equivalent" protection to the environment. Environment Canada and industry would like all statutes and regulations (e.g. Food and Drugs Act) to be "CEPA Equivalent" for operational efficiency. The FDA has not been declared CEPA Equivalent. As a result, new substances in products regulated by the FDA must also undergo an assessment under CEPA until such time as amendments or legislative changes are made that would require the assessments to be done under the purview of the Food and Drugs Act.
2. Some material is adapted from Canadian Environmental Protection Act, 1999 (CEPA 1999) Health Canada - Safe Environment Programme Operational Review. Centre for Public Management, October 2002 Draft.
3.The Healthy Products and Food Branch (HPFB) has some limited responsibility in delivering HC's CEPA mandate in that its Office of Regulatory and International Affairs (ORIA) is tasked with developing environmental assessment regulation that are CEPA Equivalent for substances regulated under the F&DA.
4. The DSL is an inventory comprising some 23,000 chemicals and biological agents that were considered to be in commerce in Canada between January 1984 and December 1986. The list was initially established under CEPA-1988. Roughly 1,700 additional substances from the food and drugs sectors were nominated for addition to the DSL since then.