Health Canada's contributions under CEPA

While the Canadian Environmental Protection Act (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 (HPB).

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, including products of biotechnology, as well as from hazardous wastes.

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 work together to develop National Ambient Air Quality Objectives for a number of air pollutants. A draft protocol for the development of assessments and the setting of objectives was developed by the Federal-Provincial Working Group on Air Quality Objectives and Guidelines. Work towards finalizing the protocol is continuing.

An assessment document for fine particulates was drafted and is undergoing final revision, to be followed by the derivation of a new objective(s). Assessments of carbon monoxide, nitrogen dioxide, and ground level ozone are nearing completion. 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.

Work continued towards finalizing new objectives for gaseous fluorides and reduced sulphur compounds.

Health Canada has continued to contribute to the Priority Substances Assessment Program of CEPA (sections 12 and 13). In 1994-95, the Approach Paper "Human Health Risk Assessment for Priority Substances" was completed and released. Following the completion of assessments of the first Priority Substances List (PSL) in 1993/94, the final three assessment reports, and health-related supporting documentation on eight compounds, were released early in 1994-95.

Thirty-five manuscripts on the health-related assessments completed for compounds on the first PSL were published in a special edition of the Journal of Environmental Science and Health. Draft Environmental Health Criteria Documents were prepared for the International Programme on Chemical Safety for six of the substances included on the first PSL. Preparation of a booklet for publication of reference values for protection of human health in the general environment for compounds included on PSL I was initiated.

Various aspects related to assessment of exposure and effects including fugacity modelling, uncertainty analysis, uncertainty factors and benchmark doses, were evaluated with respect to their relevance and usefulness to the approach adopted to assessment of "toxic" under sub-section 11(c) of CEPA for Priority Substances.

In collaboration with other government departments, the list of candidate substances to be submitted by the federal government to the Ministers' Advisory Panel which will develop the second PSL was finalized. In collaboration with Environment Canada, Health Canada officials are providing the Secretariat for the Advisory Panel, for which two meetings were held in 1994/95.

Background dossiers on substances which are candidates for inclusion on PSL II were prepared for use by the panel preparing that list.

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 460 submissions as of March 31, 1995, most of them dealing with hazard data obtained from toxicological studies. In 1994/95, 45 new submissions were received.

The Environmental Health Directorate reviewed the toxicological data on 445 section 17 submissions in 1994/95, and provided advice to Environment Canada on the hazard associated with most of these substances, thereby eliminating the backlog of section 17 submissions.

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

The New Substances Notification Regulations for chemicals and polymers came into force on July 1, 1994. Approximately 5,000 transitional substances, first used between 1987 and June 1994, were notified by November 1994. Assessment procedures were established for the health hazard and human exposure evaluation for various categories of notification. Administrative procedures were established within Health Canada for dealing with this large number of notifications.

Health Canada collaborated with Environment Canada in implementing effective communications, including electronic communications, between the two departments in order to exchange information and decisions quickly.

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 and meeting of the Expert Working Group on CEPA New Substances Notification Regulations held in December 1994. Subsequent to the meeting, a formal draft of the regulations for biotechnology products was prepared for publication in Canada Gazette Part 1.

In support of this work, Health Canada has prepared guidelines describing the information needed in order to conduct health assessments and, with Environment Canada, has incorporated this information into a Notification Guideline. In addition, Health Canada has been developing approaches for assessing this information. Contract research is ongoing on pathogenicity testing of Pseudomonas, indicator testing of microbial consortia, and monitoring of endotoxin.

Staff of the Environmental Health Directorate worked with Environment Canada to develop criteria for the listing of certain biochemicals (proteins) on the Domestic Substances List (DSL) and assisted in the preparation of the Regulatory Impact Analysis Statement (RIAS) for the draft biotechnology regulations.

Under section 43 of CEPA, both the Minister of Health and the Minister of the Environment have the authority to establish wide-ranging controls in order to manage the risks of toxic substances. The particular responsibility of the Minister of Health, however, is to protect the health of the Canadian public by ensuring that exposure to potentially harmful environmental contaminants is kept within acceptable limits.

Health Canada's risk management activities have centred around the development of risk management options (control options) for those substances that were declared "toxic" for reasons of human health under section 11(c) of CEPA. Control options for "toxic" substances are being developed within the framework of the Strategic Options Process, a multi stakeholder consultations process which will make recommendations for action to the Ministers of the Environment and Health within a 12 to 18 month time frame.

A number of multi stakeholder meetings (so-called Issues Tables) were initiated during 1994-95 for consideration of control options. Health Canada participated in the following meetings where control options for single substances or for toxic substances released from a particular industrial sector were considered:

Single-substance approach

• Benzidine
• 3,3'-dichlorobenzidine
• Refractory ceramic fibres
• Short-chain chlorinated paraffins

Sectoral approach

• Wood preservation sector (asenic, polycyclic aromatic hydrocarbons (PAHs), hexachlorobenzene (HCB), chromium, creosote impregnated wastes)
• Dry cleaning sector (tetrachloroethylene)
• Degreasing sector (tetrachloroethylene and trichloroethylene)

Participation in the above Issues Tables has involved collecting, compiling and further developing technical information critical to the decision-making process, e.g. linkage of sources and levels of exposure, in order to supplement that found in the assessment reports. Considerable effort has also been expended in developing a consistent and coherent Health Canada position in preparation for negotiations at the multi stakeholder meetings. Other essential input to the risk management process has included reviewing previous and current risk management activities, both in Canada and the international community, ongoing consultations with other stakeholders and a detailed examination of the technical feasibility as well as of socio-economic considerations associated with the implementation of various control options.

During 1994-95, staff of the Environmental Health Directorate of Health Canada participated with Environment Canada in the development of a number of policy matters that have an impact on risk management activities of the federal government. These initiatives include the development of a federal framework for the risk management of toxic substances (the Toxic Substances Management Policy), as well as policy documents concerned with pollution prevention, sustainable development and the greening of government.

In accordance with sections 46 and 47 of CEPA (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 was completed, and indicated that the combustion products of MMT do not represent an added health risk to the Canadian population. MMT is expected to be controlled under other legislation.

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.

Studies on the systemic effects of selected PSL I substances have been completed. These include substances for which data were "insufficient to assess" (di-n-octyl phthalate) and others with identified data gaps (chlorinated paraffins and di-2-ethylhexylphthalate). Subchronic studies are in progress on chemicals which are candidates for future PSLs, including acridine and benzothiophene.

A battery of in vitro screening methods are currently in use to evaluate environmental chemicals for adverse effects on endocrine and reproductive function. Novel biomarkers of effect have been incorporated into single generation reproductive toxicity studies and are being used to identify potential hazards to human reproduction from these compounds. An in vitro biomarker for the detection of potential tumour promoting activity of chemicals was developed, that will assist in understanding the mechanism of action of carcinogens.

Research continued on the validation of a transgenic mouse gene mutation assay, which appears to improve substantially the ability to conduct in vivo mutagenicity tests under the CEPA New Substance Notification Regulations. Molecular methodology was developed for the quantization of human and environmental exposure to microbial biotechnology products.

Two contract reports were completed, one on the occurrence of tri- and tetrachloroethylene in smaller community drinking water systems supplied from ground water sources, and one on transformation products of tetrachloroethylene in ground water.

Health Canada has continued to contribute to the Organisation for Economic Co-operation and Development (OECD) guideline development, in order to move toward international harmonization of testing and assessment of chemicals and biotechnology products.

Health Canada continued to communicate the outcome of the PSL I assessments, by publishing 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 paper for the public, outlining Health Canada's approach to biotechnology products was published. A full list of Health Canada publications related to CEPA can be found in Appendix A.