ARCHIVED - CEPA Annual Report for the Period April 1994 to March 1995

• The Priority Substances List
• The Priority Substances List II
  • Collecting Information
  • Confidentiality Requests
  • Disclosing Information
• The Domestic Substances List
• The Non-domestic Substances List
• New Substances
  • Confidential Business Information
• Good Laboratory Practice
• Creating Regulations
  • Strategic Options Process
  • Regulatory Review
  • Recently Developed Regulations and Amendments
  • Ozone-depleting Substances Regulations
• Release of Toxic Substances
  • Recovery of Reasonable Costs
  • Export and Import of Hazardous Wastes
  • The Basel Convention

Part II of CEPA focuses on reducing the risks posed by new and existing substances. In order to distinguish new substances from existing ones and to prescribe reporting requirements for new substances, Environment Canada has developed two major inventories:

• the Domestic Substances List, an inventory of all chemicals known to be in use in Canada during 1984-86; and
• the Non-domestic Substances List, an inventory of substances not in use in Canada from 1984-86 but used elsewhere.

Part II of CEPA also requires the establishment of the Priority Substances List (PSL), a list of substances considered most important for assessment.

The Priority Substances List

The first Priority Substances List (PSL) was published in February 1989 by the Ministers of the Environment and of Health. The assessment of these substances to determine whether or not they are toxic or capable of becoming toxic, as defined under section 11 of CEPA, was completed within the five year time frame.

According to CEPA, a substance is toxic if it is entering or may enter the environment in a quantity, or concentration, or under conditions

• having or that may have an immediate or long-term harmful effect on the environment;
• constituting or that may constitute a danger to the environment on which human life depends; or
• constituting or that may constitute a danger in Canada to human life or health.

A new PSL is under preparation.

The Priority Substances List II

In 1994, following extensive consultation, Environment Canada and Health Canada published a revised proposal for developing PSL II using an open, science-based process to select substances. The proposal suggested a process for substance nomination, criteria for screening candidate substances, and considerations for a Ministerial Expert Advisory Panel that would recommend a new list.

In December 1994 the Ministers of Environment and of Health appointed the Expert Advisory Panel for PSL II. The multi-stakeholder Panel represents labour, health and environmental groups, academia, industry and the provincial, territorial and federal governments. The Panel held two meetings in 1995. Panel members have developed networks within their constituencies to advise them on substance nominations and other related issues. Two additional Panel meetings have been scheduled and the Panel's aim is to provide the Ministers with its final recommendation by the end of September 1995.

Under the Priority Substances Assessment Program, the Government is developing a guidance manual to provide evaluators with a consistent approach for assessing the ecological risks of substances on PSL II. The manual will address the most recent scientific advances in the field of ecological risk assessment and is being developed in consultation with other government departments, industry representatives and scientific experts and stakeholders from outside the program. A multi-stakeholder workshop was held in January 1995 that led to the resolution of some critical scientific issues. An initial draft of the manual is scheduled to be completed in July 1995. The guidance manual is expected to be finalized by November 1995.

Collecting Information

Sections 15 through 18 of CEPA allow the federal government to collect data and samples concerning the production, application and importation of substances.

National Pollutant Release Inventory

In 1994 Environment Canada received and compiled reports filed with the National Pollutant Release Inventory (NPRI) by 1,466 facilities across Canada. For 1993, the first reporting year for the NPRI, a total of 5,248 substance reports were filed and overall releases were 227,683 tonnes. Facilities had until June 1, 1994 to file their reports with Environment Canada.

The National Pollutant Release Inventory published its first annual summary report in March 1995. The annual summary reflects 1993 releases and transfers. The information is available on Internet at www2.ec.gc.ca/pdb/npri/

On February 26, 1994, a notice was published in the Canada Gazette requiring facilities to report their releases and transfers in waste for the 1994 reporting year, the second reporting year for the NPRI. This information will also be made public through the publication of an annual summary in early 1996 and through Internet access.

A notice was published on February 18, 1995 in the Canada Gazette requiring facilities to report for 1995. A change was made to the reporting criteria used in previous years so that facilities that release large quantities at low concentrations would be required to report. Changes were also made to the list of substances in order to better capture substances of concern.

Confidentiality Requests

In some circumstances, a person may submit a written request for confidentiality when providing information on toxic substances (section 19). Section 20 provides for the non-disclosure of information that has been submitted with a request for confidentiality. Such requests are subject to certain terms and conditions.

Disclosing Information

Information collected under CEPA may be disclosed if it consists of

• general data on uses of a substance;
• occupational exposure studies;
• recommended methods for disposal and elimination of a substance;
• toxicological, clinical and ecological studies of a substance;
• safe handling precautions;
• physical and chemical data that do not reveal the identity of a substance;
• safety measures to be taken in case of accidents involving a substance;
• health and safety data;
• tests performed under CEPA; or
• test methods and results of product or environmental testing when carried out by, or on behalf of, a government institution, unless it was done for a fee as a service to other than a federal government institution.

In 1994/95 Environment Canada received 20 requests pursuant to the Access to Information Act for information related to CEPA. Requests were received on the following subjects:

• PCB storage sites in Quebec;
• Pulp and Paper Effluent Chlorinated Dioxin and Furan Regulations;
• Quebec/Canada Administrative agreement under s. 98 of CEPA;
• Federal Mobile PCB Treatment and Destruction Regulations (SOR/90-5);
• PCB Waste Export Regulations (SOR/90-453);
• Treatment and disposal of hazardous waste on federal lands; and
• Environmental compliance of properties.

Environment Canada released in whole or in part in seven requests with documents being excluded in one request. The requested information did not exist in eight requests and one request was abandoned. The department treated two requests informally.

Environmental Compliance Requests

Of the 20 CEPA related requests received in 1994/95, 12 concerned the environmental compliance status of properties. Compliance with respect to CEPA, and all other Acts administered by Environment Canada was included in the search. Information did not exist in eight requests, documents were located in three requests and one request was abandoned.

National Pollutant Release Inventory

More the 130 companies indicated that the information that they were providing to the 1993 NPRI was confidential.

As permitted under paragraph 20(2)(a) of CEPA [information may be disclosed if it consists of general data on uses of a substance] and section 20(3) of CEPA [Environment Canada can deal with a request under the Access to Information Act], the companies which claimed confidentiality were asked to support their claim for confidentiality using criteria in section 20 of the Access to Information Act.

Of the 43 responses received, 26 reconsidered their position and consented to disclosure, 17 requested confidentiality.

Four claims of confidentiality were accepted; the remainder were rejected and the companies were advised of their right to a review of this decision by the Federal Court of Canada. One company filed an application pursuant to section 44 of the Access to Information Act with the Federal Court of Canada.

The Domestic Substances List

The Domestic Substances List is an inventory of more than 21,000 substances manufactured in or imported into Canada on a commercial scale between 1984 and 1986. Environment Canada published the first list in the January 1991 edition of the Canada Gazette Part I. In May 1994, it published a revised list in the Canada Gazette Part II, incorporating deletions, additions and corrections to the 1991 publication. Another amendment for the Domestic Substances List is scheduled for the Fall of 1995.

Environment Canada uses the Domestic Substances List as its sole basis for determining whether a substance is "new" to Canada. It relies on the list when deciding whether substances require notification or assessment before they are manufactured in Canada or are imported into the country. Substances on this list are exempt from CEPA's New Substances provisions, as they are considered to be "in use" in Canada. However, existing substances that could cause adverse environmental or health effects could be nominated for Priority Substances List assessments.

Environment Canada has developed eligibility criteria for incorporation of living organisms on the Domestic Substances List and, together with Health Canada and the affected industry, has established naming rules for incorporation of biochemicals and biopolymers on the Domestic Substances List. Environment Canada is advising Canadian manufacturers and importers of these developments and will request nominations of micro-organisms and products of organisms such as enzymes for entry on the Domestic Substances List. A provisional list of micro-organisms and products of organisms nominated for inclusion on the Domestic Substances List is under review and a final list will be published in fall 1995.

The Non-domestic Substances List

There are 41,000 substances on the Non-domestic Substances List known to be commercially available around the world, but not on the Canadian market.

This list recognizes substances that are not on the Domestic Substances List but are not new to world commerce. The Government requires less detailed information about these substances than about substances new to Canada.

Environment Canada chose the United States' 1985 Toxic Substances Control Act Inventory as a basis for this list. It deleted all substances on Canada's Domestic Substances List from the non-confidential portion of the U.S. inventory to produce the Non-domestic Substances List.

The list appeared, along with the Domestic Substances List, in the Canada Gazette Part I on January 26, 1991. Environment Canada is currently updating the Non-domestic Substances List from the Toxic Substances Control Act Inventory additions of 1985 to 1990. Revisions to the Non-domestic Substances List are expected to be published in the Canada Gazette in fall 1995.

New Substances

Notification and assessment is required before substances not on the Domestic Substances List can be manufactured in or imported into Canada. The New Substances Notification Regulations prescribe the information required from manufacturers and importers for this notification.

New Substances Notification Regulations: Chemicals and Polymers

The New Substances Notification Regulations for chemicals and polymers were published in the Canada Gazette Part II in April 1994 and came into effect July 1, 1994.

The effective date of these regulations marked the beginning of CEPA's New Substances Notification Program. The regulations require manufacturers and importers to supply specified information on new commercial substances, including chemical identity; toxicological and environmental effects data; manufacturing, processing and use data; and the volumes proposed for manufacture and import. Substances on the Non-domestic Substances List, however, have fewer notification requirements than other new substances.

New substances are divided into categories, such as site-limited intermediates, export only, and research and development substances. The characteristics of each category and any anticipated concerns determine the nature of the information required about new substances. The Government may require additional information or testing, impose controls, or ban the manufacture or importation of a substance if it suspects the substance is toxic. The Departments of Environment and Health are currently reviewing 5,500 transitional substances and are expecting 500 new substances notification for 1995/1996.

New Substances Notification Regulations: Biotechnology

Draft new substance notification regulations for biotechnology products have been developed following multi-stakeholder consultations in December 1992, July 1993 and December 1994. The draft regulations address micro-organisms and plants and substances produced by organisms. A draft Regulatory Impact Analysis Statement for the New Substance Notification Regulations dealing with biotechnology products has been prepared based on the assessment of the impacts associated with the regulations. The regulations form part of a package of regulatory amendments, developed by Environment Canada, Health Canada and Agriculture and Agri-Food Canada, that addresses the regulation of biotechnology substances and are collectively referred to as the "federal framework for regulating biotechnology". The draft regulations are targeted for publication in Canada Gazette Part I in fall 1995, and in Canada Gazette Part II in spring 1996. Regulations are proposed to come into effect in summer 1996.

Confidential Business Information

Regulations have been developed for confidential business information submissions and for masking chemical names published on the Domestic Substances List and the Non-domestic Substances List for reasons of confidentiality. The Masked Names Regulations were published in the Canada Gazette Part II on April 6, 1994.

Good Laboratory Practice

Environment Canada has formed a Good Laboratory Practice (GLP) Compliance Monitoring Unit in response to Organisation for Economic Co-operation and Development (OECD) Council decisions on the mutual acceptance of data and on GLP requirements for tests involving the health and safety evaluation of chemicals and requirements in the New Substances Notification Regulations of 1994. This Unit is inspecting domestic laboratories which supply test data for new substances notifications, determining the compliance status of foreign laboratories which supply similar data, and participating in ongoing OECD activities on the development and use of GLP in member countries.

During 1994, the Unit participated in: a workshop on GLP in Canada; an OECD training course for GLP inspectors; OECD working groups on the harmonization of inspection reports and on the application of GLP to computer systems; preparation of an Annex on GLP in a new Canadian Standards Association standard for environmental testing laboratories; and in bilateral discussions with the European Union and the US Food and Drug Administration on the mutual recognition of GLP programs. During 1995, work will continue on public consultation on the development of a Canadian GLP program, the development of international bilateral agreements on the mutual recognition of GLP programs, and an OECD initiative to update its Principles of Good Laboratory Practice.

Creating Regulations

Regulations can be developed under various parts of CEPA. Before they have the force of law, CEPA regulations pass through many stages to allow time for public comment and close examination of implications. For hazards requiring immediate action, however, the Government may issue interim orders and temporarily by-pass the public consultation system. Interim orders have the force and effect of regulations.

Regulations typically begin with an assessment report that establishes a scientific basis for control. The Government considers a number of options before pursuing regulations, but where regulations are the preferred course of action, draft versions are developed and sent to a Cabinet committee following public consultation.

Proposed regulations appear in the Canada Gazette Part I with a Regulatory Impact Analysis Statement (RIAS) summarizing the purpose of the regulations, alternatives, benefits and costs, consultation, and enforcement and compliance. Following a 60-day period set aside for public comment, the government finalizes the proposed regulations. After regulations are registered, they are in force and are published in the Canada Gazette Part II.

Throughout the decision-making process for all environmental protection initiatives, the government's approach to regulation takes socio-economic issues into account. This includes

• developing socio-economic background studies;
• assessing the effectiveness of alternative instruments for achieving environmental protection objectives; and
• evaluating and quantifying the costs and benefits of the selected instruments.

These considerations provide for more informed decision making and improve the quality of RIAS.

Strategic Options Process

Consultative working groups were established to identify and evaluate options regarding the best way to address the problems caused by the substances declared toxic under CEPA. Stakeholders invited to participate in the consultations include other federal departments, provinces, industry and ENGOs.

Two approaches have been used to address the toxic substances:

1. Substance Approach: when a substance is released to the environment during the use of a commercial product (ie: solvent "x" in paint, as an example); and
2. Sector Approach: when a substance is released to the environment due to an industrial operation (benzene during steel manufacturing, for example).

During 1994-95, three substance and three sector working groups started their deliberations (PSL-1 table: Items #2 and #4). Original time lines, to deliver recommendations to Ministers of Environment and of Health, were expected to be between 12 and 18 months. These time lines were requested to be compressed as shown in the table.

During 1995-96, four sector working groups listed under Item #5 are expected to start their deliberations, with compressed time lines as shown.

For the purpose of accelerating the deliverables, Environment Canada will prepare control options reports for four additional substances (Item #3) without using the formal consultative process described above.

Five substances, listed in the table (Item #1), are directly regulated without the use of the formal consultative process described above. One of the substances, an ozone-depleting substance (ODS), will be phased-out under the Montreal Protocol with Bis(chloroethyl) ether and Bis(chloromethyl) methyl ether being phased-out as a preventative measure since they are not in Canadian use, production or commerce. Dioxins/furans from the pulp and paper sector will continue to be regulated under the existing framework.

The chlorinated municipal effluent compound of chlorinated wastewater effluents is now being addressed through a proposed strategy on municipal effluents.

PAHs and inorganic fluorides are mainly released from aluminum smelting operations. This sector is in majority located in the province of Quebec. The Quebec Ministry of Environment is currently in the process of amending its air regulations in a way that is expected to reduce the release of these two substances. Environment Canada is supporting Quebec's efforts in this domain.

Regulatory Review

In November 1994, Environment Canada released the Regulatory Review Final Report, in accordance with Treasury Board's government-wide review of regulations. The review covered 25 CEPA regulations. The final report includes Environment Canada`s conclusions and recommendations of its review of regulations. Action plans for implementing the recommendations of the review of CEPA regulations are included in the final report.

* ODS = Ozone Depleting Substances

Recently Developed Regulations and Amendments

Thirty-two regulations, which include amendments, are currently in place under CEPA. Over the past year, the department brought eight new and/or amended regulations into force and continued work on several other regulatory initiatives. The Government also introduced an Omnibus Amendment Order during the year. It allows departments to make minor, non-contentious amendments with no policy implications through a streamlined process. Through the use of this Order, amendments to five other regulations were made.

Note: In addition, there have been a number of minor modifications to CEPA regulations which have been dealt with through the Omnibus Amendment Order.

CEPA Omnibus Amendment Order, 1993

The Omnibus Amendment Order allows departments to clean up various regulations requiring minor changes or corrections without following the normal lengthy regulatory process. Under the Omnibus Amendment Order published in the Canada Gazette Part II in June 15, 1994, the following regulations under CEPA were amended:

• Asbestos Mines and Mills Release Regulations;
• Chlor-Alkali Mercury Release Regulations;
• PCB Waste Export Regulations;
• Pulp and Paper Mill Defoamer and Wood Chip Regulations; and
• Secondary Lead Smelter Release Regulations.

CEPA New Substances Notification Regulations

The CEPA New Substances Notification Regulations were published in Canada Gazette Part II on April 6, 1994 and came into effect on July 1, 1994. These regulations will ensure that new chemical and polymeric substances are thoroughly evaluated for potential adverse impacts on the Canadian environment and human health before any significant manufacture in or importation into Canada takes place. (See page 23 - New Substances Notification Regulations: Chemicals and Polymers).

Ozone-Depleting Substances Regulations

Regulations on Ozone-depleting Substances

Canada, as a party to the Montreal Protocol on Substances that Deplete the Ozone Layer, must take the necessary measures to implement the requirements of this international treaty. In some cases, the Canadian government is also committed to supplementary domestic measures.

In 1994, Environment Canada published two regulations under CEPA to fulfil its international and domestic commitments.

The Ozone-depleting Substances Regulations came in force on June 2, 1994. These regulations control the import, manufacture and export of ozone-depleting substances. Among other things, they establish the phase-out dates for the manufacture and import of new halons (July 1, 1994), carbon tetrachloride (January 1, 1995) and CFCs and methyl chloroform (January 1, 1996). In addition, these regulations prohibit the use or sale of an ozone-depleting substance that would have been illegally imported or manufactured after its phase-out date.

The Ozone-depleting Substances Regulations also establish requirements for obtaining permits for the import and export of used, recovered, recycled and reclaimed ozone-depleting substances.

These regulations were amended on December 6, 1994 to include controls on methyl bromide. Starting on January 1, 1995, methyl bromide imports were frozen to 1991 level. The amendments also require a 25 percent reduction of methyl bromide imports by 1998.

The Ozone-depleting Substances Products Regulations which had been promulgated on August 28, 1990 (as Ozone-depleting Substances Regulations No. 3) were amended on June 2, 1994. These regulations prohibit the manufacture, import, sale and offer for sale of pressurized containers that contains 10 kilograms or less of CFCs. Products which are affected by this prohibition include cans of refrigerant (less than 10 kilograms). They also prohibit the importation of certain products containing ozone-depleting substances from countries that are not Parties to the Montreal Protocol.

Domestic Regulations to Support International Commitments

Environment Canada, authorized by CEPA, regulates the production, import and export of ozone-depleting substances, including CFCs, halons, methyl chloroform, carbon tetrachloride, hydrobromofluorocarbons (HBFCs) and methyl bromide, as well as certain products containing CFCs.

The federal government is amending its regulations to reflect its current domestic and international commitments. The following is a short description of the current contents of these regulations.

Ozone-Depleting Substances Regulations

The amalgamated and amended Ozone-depleting Substances Regulations came into force in June 1994. They were amended in December 1994 to include methyl bromide. These regulations control the import, manufacture, use, sale and export of bulk ozone-depleting substances. They reflect the commitments Canada has made regarding production and consumption of ozone-depleting substances. Note that consumption is equal to the amount of a substance produced domestically plus the amount imported, less the amount exported.

Canada has made the following commitments:

• CFCs:
  • 75 percent reduction by January 1, 1994
  • 100 percent elimination by January 1, 1996
• halons:
  • 100 percent elimination by January 1, 1994
• carbon tetrachloride:
  • 100 percent elimination by January 1, 1995
• methyl chloroform:
  • 50 percent reduction by January 1, 1994
  • 85 percent reduction by January 1, 1995
  • 100 percent elimination by January 1, 1996
• hydrobromofluorocarbons (HBFCs):
  • 100 percent elimination by January 1, 1996
• methyl bromide:
  • freeze at 1991 level by January 1, 1995
  • 25 percent reduction by January 1, 1998

These regulations prohibit the use or sale of a controlled substance that was illegally imported or manufactured after its phase-out date. They also establish requirements for obtaining permits for the import and export of used, recovered, recycled and reclaimed ozone-depleting substances.

Ozone-depleting Substances Products Regulations

The Ozone-depleting Substances Regulations No. 3 (Products) were amended and became the Ozone-depleting Substances Products Regulations in June 1994. These regulations prohibit the manufacture, import, sale and offer for sale of

• plastic foam packaging material or containers in which any CFC has been used as a foaming agent; and
• pressurized containers that contain 10 kilograms or less of CFCs. Products affected by this prohibition include aerosols, cans of refrigerant (less than 10 kilograms), novelty products and fog horns.

Health care products are exempted from these regulations. The regulations also prohibit the import of certain products containing ozone-depleting substances from non-parties to the Montreal Protocol as required by the Protocol.

The development of strategic options reports for HCFCs was completed in February 1995. Consultations on control options took place in October 1994 and February 1995 for HCFCs. Amendments to incorporate controls on HCFCs into the existing regulations are being prepared.

Release of Toxic Substances

Sections 36 through 38 of CEPA address the dangers posed by the release of toxic substances into the ecosystem. CEPA provides for reporting and precautionary measures, including the notification of inspectors and of any member of the public who may be adversely affected by the impending threat.

Recovery of Reasonable Costs

When the Department must step in to control the release of toxic substances, CEPA makes provisions for the recovery of costs. Under sections 39, 60 and 77, when polluters fail to take preventive measures to correct their contravention of a CEPA regulation or interim order, the federal government may take action and reclaim expenses. In 1994-95, Environment Canada was not required to invoke these sections.

Export and Import of Hazardous Wastes

According to section 43 of CEPA, "hazardous waste" is a waste dangerous good within the meaning of the Transportation of Dangerous Goods Act and Regulations, or any substance included on Environment Canada's list of hazardous wastes requiring an export or import notification. This section gives the Minister of the Environment authority to:

• determine which hazardous wastes require import and export notification;
• decide which hazardous waste authorities importers and exporters must notify; and
• regulate the contents of the notification and conditions under which a person may import or export a hazardous waste.

The Export and Import of Hazardous Waste Regulations (EIHWR) pursuant to sections 43 to 45 of CEPA came into force in November 1992. They regulate the transboundary movement of hazardous wastes, destined for disposal or recycling, in and out of Canada. They also allow Canada to meet its international obligations to control the transboundary movement of hazardous wastes.

An amendment to these regulations was published in the Canada Gazette Part II on July 13, 1994. Among other changes, the amendment allows the electronic transmission of the notification of import through an electronic data interchange (EDI) system.

Environment Canada and Revenue Canada (Customs) have a Memorandum of Understanding for the implementation of the EIHWR. In 1994, Customs put into place procedures to be used by custom officers dealing with the import and export of hazardous wastes.

During 1994, a study was undertaken to review the needs of the Hazardous Waste Management Division (HWMD), and to develop a plan that will allow for the implementation of various information management systems (both computerized and manual) currently used for tracking and controlling transboundry movements of hazardous wastes, under the EIHWR. This plan is to provide the flexibility to allow the incorporation of new developments in information management technology and to identify a long range vision of information management within HWMD to better implement the EIHWR. The recommendation for a new client-server system is being implemented. The computerized hazardous waste tracking system is expected to be in ful l operation by the end of 1997. In the meantime, the existing computerized database has been upgraded to include operating features required to accommodate new needs.

The Basel Convention

When the Export and Import of Hazardous Waste Regulations were introduced in Canada in November 1992, the Basel Convention on the Transboundary Movements of Hazardous Wastes and their Disposal came into force in this country. The Convention aims to:

• ensure the prior informed consent of the receiving country prior to shipment;
• ensure that hazardous waste is disposed of in the country of generation, wherever possible;
• prohibit export of hazardous waste to countries lacking the legal, administrative and technical capacity to manage and dispose of it safely;
• forbid exports to countries that have banned the imports; and
• promote technology transfer, information exchange and harmonized standards, guidelines and codes.

The Basel Convention also supports the continued application of bilateral and multilateral agreements that promote environmentally sound management of hazardous wastes. Canada is party to two such agreements: the Canada-United States Agreement on the Transboundry Movement of Hazardous Wastes, which governs Canadian hazardous waste shipments to and from the United States, and the Organization for Economic Cooperation and Development (OECD) Council Act concerning the control of transfrontier movements of wastes destined for recycling operations.

In March 1994, Canada attended the second meeting of the parties to the Basel Convention. This meeting resulted in 28 decisions. One decision called for a ban on the export of hazardous wastes for final disposal from OECD countries to non-OECD countries. It also calls for a phase-out of such exports destined for recycling/recovery operations by December 31, 1997.