Part 5: Controlling Toxic Substances (Sections 64 to 103)

• Definition of "Toxic" (Section 64)
• Substance Assessment - Existing Substances (Sections 66 - 79)
• Substance Assessment - New Substances (Sections 80 - 89)
• Management of Toxic Substances
• Virtual Elimination
• Virtual Elimination Definition (Section 65)
• Preventive or Control Measures (Sections 90 - 93)
• Interim Orders (Section 94)
• Release of Toxic Substances (Sections 95 - 99)
• Export of Substances (Sections 100 - 103)

These sections provide authority to assess substances to determine if they are toxic, and to manage them to prevent pollution that could harm the environment or human health.

To be determined toxic under CEPA 1999, substances must enter the environment in amounts that have or may have an immediate or long-term harmful effect on the environment or human health. The Act takes a risk-based approach to decision-making that takes into account the entry of substances into the environment, exposure conditions and inherent toxicity.

The Minister is required to maintain the Domestic Substances List, a list of the approximately 23,000 substances currently in use in Canada. This List allows for a distinction to be made between existing substances and those that are new to Canada. Substances on the Domestic Substances List will be assessed under one of the three following tracks (see Figure A):

1. Priority Substances (Section 76)

• under CEPA 1988, 44 substances were assessed under the first Priority Substances List (PSL) and 25 are being assessed under the second PSL.
• Ministers have five years to complete PSL assessments.

2. Categorization of the Domestic Substances List (Section 73)

• Within seven years of Royal Assent3, all 23,000 substances must be categorized for their potential for exposure to Canadians, or for their inherent toxicity and persistence or bioaccumulation. "Pesistence" means that a substance takes a long time to break down. "Bioaccumulation" means that a substance collects in the tissue of living organisms.
• Substances of concern will undergo a further "screening" assessment to determine toxicity and, if required, a more comprehensive PSL assessment.

3. Review Decisions of other OECD countries, Canadian Provinces and Territories (Section 75)

• The Ministers are obliged to review these decisions to ban or substantially restrict substances for environmental or health reasons to determine if they are toxic within the Canadian context.
• If the substance is of concern , but there is insufficient evidence to declare it toxic, it can be placed on the PSL for further assessment.

Sections 68, 70 and 71 provide authority to gather information to assess whether a substance is toxic. This includes the authority to require sampling, testing and the generation of new data.

Following an assessment, Ministers must propose one of the three following measures:

1. take no further action;
2. add the substance to the Priority Substances List unless it is already on the List; or
3. recommend that the substance be added to the List of Toxic Substances and, where applicable, propose it for virtual elimination.

All proposals will undergo a 60-day public comment period where interested parties may bring forward additional scientific evidence to support or refute the Ministers' decision. After taking into account any information provided during this 60-day period, Ministers are required to publish their final decision. If option 3 (above) is chosen the Ministers may, at the same time, make a recommendation to the Governor in Council that the substance be added to the List of Toxic Substances. If a substance has been declared toxic and the Ministers have declared their intention to recommend adding the substance to the List of Toxic Substances, the Ministers must, at the same time, recommend that the Governor in Council add it to the List.

Substances that are not on the Domestic Substances List are considered to be new substances. These cannot be manufactured or imported until:

• the Minister has been notified;
• relevant information needed for an assessment has been provided by the applicant;
• the prescribed fee has been paid; and
• the period for assessing the information (ashset out in regulations) has expired.

In certain circumstances, manufacturers and importers must also report "significant new activities" involving already approved substances so that they can be re-evaluated.

The Minister has the ability to waive some or all of the information requirements for new substances or significant new activities involving a substance if:

• such information is not needed to assess a substance;
• the substance can be contained in a way that protects the environment and human health; or
• it is not practical or feasible to obtain the test data.

This is intended to prevent the unnecessary gathering of information. These waivers do not remove the Ministers' responsibility to determine that a new substance is safe. All waivers must be published in the Canada Gazette and the Environmental Registry.

The requirements for notification and assessment in CEPA 1999 do not apply if the new substance is manufactured or imported for a use that is regulated under another Act of Parliament that requires notice and assessment. The Governor in Council is responsible for determining that another Act meets these requirements and for placing it on Schedule 2 of CEPA 1999. Proposals to schedule an Act must undergo a 60-day public comment period.

The 1995 federal Toxic Substances Management Policy sets out two tracks for the management of toxic substances: virtual elimination and life-cycle management (see Figure B).

Experience has shown that even extremely small releases of certain substances (such as PCBs and DDT) to the environment can create problems that are extremely costly or impossible to correct. This is particularly true of substances that are:

• toxic as defined under CEPA;
• primarily the result of human activity;
• persistent - take a long time to break down; and
• bioaccumulative - collect in living organisms and end up in the food chain.

Under CEPA 1999 the Ministers must propose virtual elimination for substances that meet these criteria. Regulations under Section 73 set out the criteria for persistence and bioaccumulation.

• Section 65(1) defines virtual elimination as the release of a substance to the environment below the level of quantification (LOQ);
• the LOQ is defined in Section 65.1 as the lowest concentration of a substance that can be accurately measured using sensitive but routinely available measurement technology;
• Section 65(2) requires the Ministers of the Environment and Health to specify the LOQ for each substance on the Virtual Elimination List (this is not a regulatory release limit);
• Section 65(3) requires consideration of environmental or health risks and relevant social, economic and technical matters before the Ministers of the Environment and Health set enforceable release limits.

In other words, the ultimate objective of virtual elimination is to reduce releases to the point where they can no longer be measured. At the same time, there may be relevant social, economic or technical factors that make it impossible to reach virtual elimination immediately. In these instances, the Ministers can set a release limit above the level of quantification, or set out a phased approach with ever-decreasing limits until the LOQ is reached.

CEPA 1999 provides the regulatory authority to achieve both the virtual elimination of a substance and life-cycle management to minimize releases to the environment. In the case of virtual elimination, companies will be required to prepare "virtual elimination plans" to achieve the regulatory release limit set under subsection 65(3).

Manufacture and import of new substances found to be toxic can be prohibited or subjected to conditions specified by the Ministers. After two years, the Governor in Council must publish a notice of proposed regulations for these substances.

For existing substances (such as those on the Domestic Substances List) found to be toxic, the Minister of the Environment has two years to develop preventive or control measures. These measures can include voluntary arrangements, economic instruments, and requirements for pollution prevention planning or regulations. Once proposed, the Minister has a further 18 months to finalize the measures. Regulations are made by the Governor in Council on the recommendation of both Ministers.

The National Advisory Committee must be provided with an opportunity to provide advice on any proposed regulations made under section 93. Proposed regulations also undergo a 60-day public comment period.

CEPA 1999 cannot be used to regulate an aspect of a substance that is regulated under another Act in a manner that provides, in the opinion of the Governor-in-Council, sufficient protection to the environment and human health.

CEPA 1999 authorizes the Minister to issue "interim orders" on a substance when immediate action is needed to deal with a significant danger to the environment or human health. An interim order has the same legal force as a regulation made under section 93.

When making an interim order, the Minister must consult all affected provincial, territorial and aboriginal governments within 24 hours to determine if they are prepared to take sufficient action to deal with the significant danger. The Minister must also consult with other federal ministers to determine if any action can be taken under any other Act of Parliament. An interim order ceases to be in force unless it is approved by the Governor in Council within 14 days. Interim orders can remain in force for two years, but within 90 days the Ministers must publish in the Canada Gazette their intention to recommend regulations to deal with the substance.

Individuals are obliged to report any releases of toxic substances that contravene a regulation. Whistleblower protection is available to any employee who makes a voluntary report of a release.

These sections provide authority to control the export of substances regulated under CEPA 1999 or another Act of Parliament. Substances fall into three categories:

1. Prohibited substances;
2. Substances whose export is subject to an international agreement that requires the notification or consent of the receiving country; and
3. Restricted substances.

Prohibited substances can be exported only if they are to be destroyed. The Governor in Council may make regulations for all three categories of substances, including:

• prohibitions on export;
• the type of information to be provided to the Minister;
• the type of information to accompany an export; and
• conditions under which an export may be made.

Details concerning these exports must be published in the Environmental Registry. These provisions allow Canada to meet its commitments under the Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade.

3 CEPA 1999 received Royal Assent on September 14, 1999