ARCHIVED - CEPA - Annual Report for the Period April 1993 to March 1994

While CEPA's general intent and the joint achievements of Environment Canada and Health Canada have been fully described elsewhere in this report, the following section summarizes Health Canada's major achievements under CEPA during the past year. Most of the work has been undertaken by the staff of the Environmental Health Directorate of the Health Protection Branch.

Health Canada is jointly responsible with Environment Canada for assessing and managing the risks to human health from toxic substances. CEPA includes detailed provisions for dealing with potential health risks from existing and new substances, as well as from hazardous wastes.

Environmental Quality (CEPA Part I)

Section 8 of CEPA, which deals with ensuring the quality of the environment, gives the Minister of the Environment responsibility for formulating environmental quality objectives, guidelines and codes of practice. The Minister of Health has similar authority to preserve and improve public health under Section 9.

As part of this mandate, Environment Canada and Health Canada are working together to develop National Ambient Air Quality Objectives for a number of air pollutants. As part of the Federal-Provincial Working Group on Air Quality Objectives and Guidelines, work has been undertaken to develop a more consistent approach to setting objectives.

The current objectives for carbon monoxide, nitrogen dioxide, fine particulate matter and ground-level ozone are being revised. Through the auspices of the Canada-U.S. Air Quality Agreement, information on these substances has been exchanged at a technical level and common management strategies are being developed.

Draft versions of new objectives for gaseous fluorides and reduced sulphur compounds have also been completed.

Regulating Toxic Substances (CEPA Part II )

Priority Substances

Health Canada has made a major contribution to the Priority Substances Assessment Program of CEPA (Sections 12 and 13). In 1993-94, the Department completed human health risk assessments for 11 of the 44 substances on the first Priority Substances List (PSL1), as follows:

• dichloromethane;
• styrene;
• bis(2-ethylhexyl phthalate);
• mineral fibres;
• 1,2 dichloroethane;
• chromium and its compounds;
• aniline;
• inorganic fluorides;
• cadmium and its compounds;
• polycyclic aromatic hydrocarbons; and
• nickel and its compounds.

In addition, Health Canada drafted sections on the human health-related aspects of waste crankcase oils and 1,1,1-trichloroethane.

Prior to April 1993, Health Canada had completed health assessments for 28 substances on the Priority Substances List (PSL1) and contributions for an additional three. Therefore, Health Canada had fulfilled its responsibilities for assessment before the February 1994 legislated deadline.

Assessment reports for 18 substances were printed in 1993-94 and are included in the publications list. In addition, a paper outlining the basis for determining "toxic" to human health under CEPA was finalized for printing.

In preparation for the second Priority Substances List (PSL2), Health Canada screened the remaining 463 of approximately 590 candidate chemicals for consideration in the revision of the priority list. With Environment Canada, the Department also completed a consultation document on PSL2 that has been circulated to approximately 600 stakeholders and will be revised according to their responses.

Collecting Information

In carrying out the provisions of CEPA Section 17, Environment Canada forwards all information it has collected concerning potential adverse health effects to Health Canada for assessment. Health Canada has received a total of 417 such submissions to date, most of them dealing with hazard data obtained from toxicological studies.

In 1993-94, the Environmental Health Directorate established an electronic database for tracking the review of these submissions. The Directorate also implemented a system for classifying submissions. This enables the allocation of resources to the submission reviews with the highest priority and approximates a time frame for the reviews to be completed.

In consultation with Environment Canada, Health Canada finalized guidelines for submitting information. These guidelines have now been distributed.

New Substances

Under sections 25 to 32 of CEPA (substances new to Canada), Health Canada and Environment Canada are jointly responsible for the assessment and control of new substances that are either imported into or manufactured in Canada. The work of the two departments is concentrated in two main areas: regulations for reporting chemicals and polymers, and regulations for biotechnology products.

Chemicals and Polymers

Health Canada has made major contributions to the following activities with Environment Canada:

• providing advice on changes to the New Substances Notification Regulations following their publication in the Canada Gazette Part I in May 1993;
• preparing supporting materials for the publication of the New Substances Notification Regulations in the Canada Gazette Part II in April 1994;
• completing a guidance manual to assist Health Canada staff in their assessment of new chemicals and polymers;
• developing processes for responding to notifications so that a reply is sent to the notifier within the assessment period; and
• preparing communications materials for information sessions on the New Substances Notification Regulations that were presented to industry.

Biotechnology Products (Organisms)

The Environmental Health Directorate has continued to work with Environment Canada to develop notification regulations for new biotechnology products. Health Canada staff participated in the organization of the second meeting of a multi-stakeholder consultative committee on these regulations held in July 1993.

At this meeting, the committee reviewed and accepted in principle the data requirements proposed for human health assessment of micro-organisms used in environmental and industrial applications. In addition, the committee accepted information requirements for biochemicals and biopolymers, and incorporated specific notification requirements for nucleic acids in the proposed regulations.

Industry and environmental groups also indicated a need to review the notification guidelines that will explain the information requirements for biotechnology products in detail. In response, Health Canada completed the first draft of notification guidelines for health-related information on micro-organisms and made substantial progress on establishing the criteria for judging and evaluating data. In particular, work proceeded on establishing criteria for identification of micro-organisms, description and evaluation of genetic constructs, description of containment practices, and evaluation of micro-organism exposure.

Managing Toxic Substances

Control of Toxic Substances

Under Section 34 of CEPA, both the Minister of Health and the Minister of the Environment have the authority to establish wide-ranging controls for toxic substances. The particular responsibility of the Minister of Health, however, is to protect the health of the Canadian public.

During 1993-94, the Environmental Health Directorate of Health Canada collaborated with Environment Canada to develop a risk management framework for toxic substances. Health Canada's objective was to ensure that risk-management options for substances with identified health concerns receive appropriate attention within the Environment Canada strategic options process. This input included a priority ranking based on health considerations for 17 substances found to be "toxic" under CEPA during the PSL1 risk assessment program. As a result of this ranking, Health Canada has given arsenic, cadmium, benzene and trichloroethylene a high priority for risk management. Because a number of CEPA toxic substances occur in the emissions associated with certain industrial sectors, risk management for these substances will be developed primarily on a sectoral basis. Discussions with members of the petroleum-refining industry, for example, will contribute to controls over benzene.

In addition, Health Canada completed a report recommending health-based general guidance principles to be applied to the development and implementation of controls under CEPA.

Fuels

In accordance with sections 46 and 47 of CEPA (prohibition and regulation of fuels), as well as with the monitoring provisions of the Act, Health Canada continued to assess the health implications associated with using methylcyclopentadienyl manganese tricarbonyl (MMT) as an octane enhancer in Canadian gasoline. A health-risk assessment is nearing completion.

Other Activities

Research Activities

Under Section 15 of CEPA (information gathering), a number of research activities have continued in the laboratories of the Environmental Health Directorate. The research has included a wide range of projects, including the development of assay methods for determining the harmful effects of potentially toxic substances. In addition, studies have been completed that improve understanding of how toxic substances act on the human body. A list of publications is appended.

Communications

To communicate the outcome of the PSL1 assessments, Health Canada published Assessment Reports, Departmental Issues Papers and papers in peer-reviewed scientific journals, and prepared draft Environmental Health Criteria documents for the International Programme on Chemical Safety. In addition, Health Canada produced a document outlining how substances are determined "toxic" under CEPA. Versions of this document for both the scientific community and the general public were made available. A full list of Health Canada publications related to CEPA can be found in Appendix A.