Report on Health Canada's Achievements (2000-2004) Under the Canadian Environmental Protection Act of 1999 (CEPA 1999) in Support of Parliamentary Review

1.0 Introduction

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.

2.0 Scope and Methodology

2.1 Scope

The key questions addressed in this report are described below:

1. Achievements - What has HC been able to accomplish with respect to its responsibilities under CEPA?
2. Operating Practices and Work Flows - What is the ability of HC's operating practices and workflows to meet stakeholder and public expectations and legislative deadlines?
3. Results-Based Achievements and Value for Money - How does HC rate on the concept of Value for Money?
4. Way Forward - Suggested path forward, including opportunities for improvement.

2.2 Methodology

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.

3.0 CEPA and Health Canada

3.1 Overview of CEPA 1999

3.1.1 CEPA Goals

The Canadian Environmental Protection Act 1999 (CEPA 1999) is the cornerstone of environmental protection in Canada. Its aim is to:

• Protect human health and biological diversity
• Contribute to sustainable development through pollution prevention
• Effectively assess and manage risks posed by "CEPA toxic" substances and pollutants
• Incorporate the precautionary principle from the 1992 Rio Declaration on Environment
• Virtually eliminate the release of man-made toxic substances that present the greatest risk to Canadians and their ecosystems
• Provide an environmental "safety net" i.e. CEPA will apply unless "CEPA Equivalency" [see below] of other statutes or regulations has been recognized.

3.1.2 Substances Under CEPA Review

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:

• Any matter capable of being dispersed in the environment;
• Any element or free radical;
• Any combination of elements;
• Complex combinations that could not be formed by simply combining individual components;
• Any mixture that is a combination of substances;
• Any manufactured item; and
• Any animate matter in effluents, emissions or wastes

Substances regulated by CEPA are classified into of one of three classes:

• Existing Substances: These are substances in Canadian commerce between 1984 - 1986 that have been placed on the Domestic Substances List (DSL). Presently there are 23,000+ substances listed on the DSL with no restriction on their use in commerce.
• New Substances: These are defined as any substance not presently listed on the DSL, but that can become eligible for addition to the DSL.
• Transitional Substances: These are substances entering Canadian commerce after 1986, but before the promulgation of the New Substances Notification Regulations in 1994. Transitional substances are not on the DSL but may be "in commerce" in Canada..

3.1.3 Delivery of CEPA Overall

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.

3.2 CEPA and Health Canada

3.2.1 Delivery of CEPA by Health Canada²

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):

• Safe Environments Program - Under SEP, the Environmental Contaminants Bureau (ECB) is responsible for the assessment of the risk to human health posed by existing substances, or those presently in commerce, and the management of these risks. Existing substances are defined as substances presently on the Domestic Substances List (DSL)⁴. Substances placed on the DSL are essentially those that have been in Canadian commerce between 1984-1986. There is also an "In Commerce List" (ICL), which is a group of substances that were in commerce in Canada between 1986 and Sept. 1999 but are not on the DSL.

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.

• Product Safety Programme - Under PSP, 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. New substances are defined as those not presently on the DSL. Assessments are done to determine whether these new substances pose a risk, in which case further action is required for risk management and control.

3.2.2 CEPA Logic Model and Activities

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.

3.2.3 Roles and Responsibilities

Exhibit 3.2 shows the main Branches, Programmes, Bureaux, and Divisions responsible for CEPA within Health Canada.

Exhibit 3.2
Health Canada and the eight CEPA organizations

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:

• Existing Substances Division (ExSD) - Responsible for the assessment of potential risks to human health posed by existing substances in Canada. Responsibilities include: the categorization of all substances on the DSL, with respect to their inherent toxicity to humans or greatest potential for human exposure in Canada, conducting screening assessments, conducting Priority Substance List (PSL) assessments, and reviewing decisions of other jurisdictions that specifically prohibit or substantially restrict the use of a substance for environmental or health reasons.
• Management of Toxic Substances Division (MTSD) - Responsible for risk management of existing substances determined to be "CEPA toxic". The Division is responsible for aiding Environment Canada in developing risk management strategies and implementing control instruments for substances that have been found to be CEPA toxic as per Section 64 of the Act.
• Strategic Science and Operations Division (SSOD) - Responsible for the overall HC CEPA program. It is responsible for providing both intradepartmental and interdepartmental operational support for HC CEPA activities. The Division is also responsible for the management of CEPA Regulatory Affairs within HC. The Division provides monitoring, evaluation and reporting of HC CEPA activities within a Quality Assurance (QA) framework.
• Air Health Effects Division (AHED) - Responsible for the research, risk assessment and development of policies, positions, programs and regulatory options to manage the risk of health hazards associated with indoor and outdoor air pollutants, including emissions from fuels
• Water Quality and Health Bureau (WQHB) - Responsible for the assessment of exposure and impact on human health of selected contaminants in tap and groundwater, in order to establish national drinking water quality guidelines.

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.

3.2.4 Description of The Safe Environments Programme

The Safe Environments Programme's responsibility is to categorize and screen these substances as follows:

• By September 2006, categorize the more than 23,000 substances ⁵ on the CEPA DSL. The purpose of categorization is to identify DSL substances that pose the greatest potential for exposure to the general population in Canada, as well as to identify those persistent or bioaccumulative substances considered "inherently toxic" to humans.
• For substances meeting the criteria above, screening assessments are then conducted. There is no mandated time line, but there is significant public expectation for timely action and potential imposition of mandatory deadlines in upcoming CEPA renewal. Where a more in-depth analysis of risks is warranted, the substance is then added to the PSL.
• Within the mandated 5-year time limit, carry out Priority Substance assessments to determine if the existing substance is "CEPA toxic";
• For a substance concluded to be "CEPA toxic", develop and pre-publish in the Canada Gazette the proposed regulatory or similar control measure within 24 months and finalize the measure within the following 18 months (timelines are new, less than half previous average time taken to identify control measure);
• Fulfil legislated requirement for research on hormone disrupting substances;
• Determine the role of substances in illnesses and health problems;
• Provide health advice to Environment Canada for some of its responsibilities under CEPA, e.g. human health impacts of ambient air pollutants, including emissions from fuels.
• Make publicly available the basis and outcome of assessment decisions.

3.2.5 Description of The Product Safety Programme

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

3.2.6 CEPA Equivalency

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.