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ARCHIVED - Scoping The Issues: Preparation for the Parliamentary Review of the Canadian Environmental Protection Act, 1999


Section 3: Effective Decision-Making

3.1 Overview and Key Objectives

Effective environmental decision-making is:

  • predicated on pollution prevention;
  • timely and precautionary;
  • transparent and reflective of public perspectives and values;
  • coherent: reflecting shared responsibilities and clear accountabilities across jurisdictions and enabling governments to speak with one voice; and
  • informed by sound science.

This Section addresses each of these features, other than sound science, which is addressed in Section 4. This Section also discusses issues related to Aboriginal participation in environmental decision making and some of the issues related to environmental management on federal and Aboriginal lands. Each of these sets of issues goes to the heart of effective, coherent decision making.

3.2 Pollution Prevention

What CEPA 1999 Does

CEPA 1999 defines pollution prevention as "the use of processes, practices, materials, products, substances or energy that avoid or minimize the creation of pollutants and waste and reduce the overall risk to the environment or human health". Many methods of environmental protection focus on managing pollution and waste after they have been created. Pollution prevention avoids or minimizes creating the pollutants and waste in the first place.

CEPA 1999 includes many provisions designed to position pollution prevention as the priority approach for protecting the environment and human health. Section 2 of the Act requires the Government of Canada to administer CEPA 1999 in a manner that promotes and reinforces enforceable pollution prevention approaches. Part 3 requires the Minister to conduct research and studies related to pollution prevention, and to establish an information clearing house respecting pollution prevention. Part 4 gives the Minister of the Environment the authority to require the preparation and implementation of pollution prevention plans for specific substances that are on the List of Toxic Substances (Schedule 1 of the Act). Part 4 also commits the Minister of the Environment to develop and consult on guidelines respecting the circumstances under which pollution prevention planning is appropriate. Part 5 (s. 90) states that in developing proposed regulations or instruments respecting preventive or control actions in relation to substances specified on the List of Toxic Substances in Schedule 1, the Ministers shall give priority to pollution prevention actions.

The New Substances provisions in Parts 5 and 6 of CEPA1999 are a critical element in promoting pollution prevention. They require that no new substances (i.e., chemicals, polymers and inanimate and animate products of biotechnology) are introduced into the Canadian marketplace before the proponent provides the necessary information to enable the government to determine whether or not the substances are toxic or capable of becoming toxic to the environment or human health. The risks associated with new substances that are determined to be, or suspected of being, toxic or capable of becoming toxic may be managed, as necessary, through the imposition of handling or use conditions or the prohibition of their import or manufacture. CEPA 1999 also establishes a mechanism to require that a designated substance that has previously been assessed as a new substance must undergo further review if a significant new use is proposed.

CEPA 1999 sets a federal benchmark for the notification and assessment of new substances. There are currently five Acts and related regulations listed under CEPA 1999 that the Governor in Council has declared as meeting the CEPA 1999 environmental and health protection benchmarks with respect to new substances. New substances regulated under those five listed Acts are not subject to CEPA 1999's controls on manufacture and import. However, all other new substances, including new substances that are regulated under other Acts that are not listed in either Schedule 2 or 4 of CEPA 1999 are subject to CEPA 1999 and must be notified in accordance with the Act and the New Substances Notification (NSN) Regulations.

Part 7 allows the Minister, subject to certain conditions and Cabinet approval, to require pollution prevention plans from Canadian sources of international air and water pollution. Part 9 of the Act provides that the Governor in Council may, on the recommendation of the Minister, make regulations respecting pollution prevention and pollution prevention plans relating to, among other things, federal departments and facilities. Part 10 authorizes a judge to require anyone in violation of CEPA1999 to prepare and implement a pollution prevention plan. Under Part 10, pollution prevention plans may be considered as part of an environmental protection alternative measure (EPAM).

The disposal at sea provisions in CEPA 1999 are also premised on pollution prevention. They require permit applicants to assess alternatives to disposal at sea and the suitability of the material proposed for disposal. If the assessment reveals opportunities for waste prevention at source, the Act requires applicants to formulate and implement a waste prevention strategy. Part 8 of CEPA 1999 provides authority to require environmental emergency plans for various substances. An environmental emergency plan describes a facility's preparations and procedures for preventing and responding to an environmental emergency.

The positioning of pollution prevention as the priority approach for protecting the environment and human health is an important new concept incorporated into CEPA 1999 and includes a specific part on pollution prevention planning (Part 4). Environment Canada and Health Canada have therefore devoted considerable resources to developing, consulting on and implementing a variety of policies, "How-To" manuals, on- line tutorials, success stories, sector specific training sessions, notices, codes of practices and guidelines to ensure consistent and comprehensive understanding of pollution prevention principles and practices as well as the legal requirements in the Act. These educational initiatives address pollution prevention across all sectors of society, including industry, businesses, communities, individuals, and governments. The Pollution Prevention Planning Handbook (which includes a model plan) and the Guidelines for the Implementation of the Pollution Prevention Planning Provisions of Part 4 of the Canadian Environmental Protection Act, 1999 are two examples of efforts to promote pollution prevention. Environment Canada's National Office of Pollution Prevention maintains a website that provides public access to all of these initiatives.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

  • Implementing pollution prevention

Environment Canada and Health Canada recognize that a great deal of effort has been devoted to the "why" and "how" of pollution prevention. An important challenge is to ensure that the departments now use the pollution prevention authorities in CEPA 1999 as effectively and appropriately as possible for managing toxic substances. In addition, attaining the goal of the highest levels of environmental quality as a means to enhance the well-being of Canadians, preserve our natural environment and advance our long- term economic competitiveness will require going beyond legislation and using non- legislative incentives to encourage and enable organizations throughout Canada to implement pollution prevention more broadly as a core aspect of their ongoing operations.

Q. What are your views on this issue?

  • Keeping-clean-areas-clean

The Canadian Council of Ministers of the Environment (CCME) Canada-wide Standard for Particulate Matter and Ozone, the Canada-wide Acid Rain Strategy for Post-2000 and the federal Clean Air Agenda include the concept of keeping-clean-areas-clean. The concept of keeping-clean-areas-clean is to promote programs in areas where air quality or acid deposition are below these agreed upon standards, by encouraging pollution prevention, best management practices and best available technology.

Q. Should CEPA 1999 provide support for the objective of keeping-clean-areas-clean? If so, how?

3.3 Precautionary Principle

What CEPA 1999 Does

The Precautionary Principle is an important concept of science-based decision making that applies throughout CEPA 1999. Section 2 requires the Government of Canada, in the administration of the Act, to apply the precautionary principle such that"... where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to preventenvironmental degradation." In addition, the Act requires the Ministers to apply the Precautionary Principle when "conducting and interpreting the results" of a screening assessment, a review of a decision of another jurisdiction, or a Priority Substances List (PSL) assessment of whether a substance is "toxic or capable of becoming toxic".

The federal government released its Framework for the Application of Precaution in Science-Based Decision Making About Risk in July 2003. The Framework outlines guiding principles for application of precaution and for precautionary measures in areas of federal regulatory activity in order to describe and strengthen existing practice. Multistakeholder consultations were held on a draft of the federal Framework document along with a draft Guidance Document from Environment Canada and Health Canada soliciting advice on the operationalization of the precautionary principle under CEPA 1999. Environment Canada and Health Canada are currently finalizing their Guidance Document for operationalizing the Precautionary Principle in decision making under the Act.

The main challenge with respect to implementing the precautionary principle is to understand and provide useful guidance regarding the operational implications of the precautionary principle on a case-by-case basis. The precautionary principle relates to the degree of scientific certainty required to justify taking action to address a risk of serious or irreversible harm. CEPA 1999 requires the development and application of science and information to support a range of decisions, and as such all of the key decisions made under the Act are grounded on a sound scientific basis. At the same time, however, almost no decisions made on issues as complex as those related to the environment and health can reflect absolute certainty. The implications of the precautionary principle on an operational basis will therefore vary from case-to-case, reflecting both the degree of scientific certainty and the seriousness or irreversibility of the potential damage as well as other considerations.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

  • Vulnerable populations

CEPA 1999 does not explicitly require that impacts on children and other susceptible groups be taken into consideration in the risk assessment and management process. In practice, human health risk assessment and management procedures, to the extent possible, currently consider available scientific information on the exposure of the substance on the most affected population group(s), including children and other vulnerable populations. The Pest Control Products Act (given Royal Assent in 2002, but not yet in force) requires the Minister of Health, in evaluating the health and environmental risks of a pest control product and in determining whether those risks are acceptable, to apply appropriate margins of safety to take into account, among other relevant factors, the different sensitivities to pest control products of major identifiable subgroups, including pregnant women, infants, children, women and seniors. As is the case with other decisions under the Act, where there is less than full scientific certainty, the precautionary principle can help inform decisions on actions to protect susceptible populations.

Q. Does work under CEPA 1999 adequately consider the precautionary principle and the most vulnerable populations?

3.4 Transparency And Public Participation

What CEPA 1999 Does

CEPA 1999 includes numerous provisions that encourage and support transparency in decision making processes, access to information and public participation. These include:

  • the requirement to share information regarding decisions made or proposed under CEPA 1999 on the Environmental Registry,
  • the obligation to prepare and publish the National Pollutant Release Inventory (NPRI);
  • the right to request that the Minister investigate an alleged violation of the Act,
  • citizen right-to-sue provisions; and
  • enhanced whistle-blower protection.

CEPA 1999 also provides formal opportunities for public participation during the risk management stage. In most cases, the departments arrange some form of public consultations regarding the development of risk management strategies and measures. Specific provisions in the Act that support transparency and participation in the risk management process include:

  • the right to request the addition of a substance to the Priority Substances List;
  • the requirement to publish in Part I of the Canada Gazette, for 60-day public comment period, summaries of the assessment conclusions and the proposed measure (no further action, addition to the PSL, addition to the List of Toxic Substances);
  • the right to comment on the scientific basis for the draft scientific assessment reports;
  • the requirement to provide a 60 day public comment period on a proposed order adding a substance to the List of Toxic Substances; and
  • the right to file a notice of objection and to request a Board of Review regarding a decision or a proposed regulation or order (e.g., orders adding a toxic substance to the List of Toxic Substances), or instrument (e.g., administrative or equivalency agreements).

The Act also requires the Ministers to establish the CEPA Environmental Registry. In 2003-04, the Internet-based Registry received approximately 25 000 visitors per month.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

Environment Canada and Health Canada have a strong commitment to communication and consultation regarding decisions taken under CEPA 1999.

Q. Does CEPA 1999 adequately enable effective transparency, access to information and opportunities for public participation?

  • CEPA Environmental Registry

Environment Canada recognizes that an ongoing challenge will be to ensure that the Registry remains as accessible and user friendly as possible while the amount of information in it continues to grow.

Q. Are there improvements needed to the CEPA Environmental Registry to facilitate better access to information and informed participation in decisions related to CEPA 1999?

  • Mandatory review period

Section 343 of the Act requires a parliamentary review of "the provisions and operation" of the Act every five years. More recent federal legislation requires reviews every seven years (Pest Control Products Act (given Royal Assent in 2002, but not yet in force) and the Canadian Environmental Assessment Act (as amended in 2003). In choosing a review cycle, Parliament must balance the need to keep legislation current with evolving trends in policy against the disruption they cause to program delivery, the strain on time management and human and financial resources for all parties involved in the review process, and the need to allow enough time to pass to have adequate implementation experience to review the Act effectively.

Q. Should the Parliamentary review of the Act be increased from every five years to every seven years?

3.5 Coherence Within And Among Governments

Under the Minister of Environment's goal for a competitive economy anchored by a sustainable environment, environmental management would be delivered in a coherent, integrated manner, within and among governance structures. Coherence would be based on shared outcomes, agreement on how the outcomes are to be achieved and clear accountabilities across jurisdictions. To achieve the agreed-to outcomes, governments can determine the optimal mix of policy instruments, from the full range of their authorities. Clear accountabilities and timeframes for achieving outcomes are particularly important if there are varying means of implementation.

In Canada, coherence is needed both across government environmental policies and among environmental, health and economic policies. It can enable governments to speak with one voice.

In addition, government policies should encourage and enable the private sector to integrate environmental and human health considerations into short- term and long-term decisions. A coherent approach requires collaboration among relevant jurisdictions and regulatory bodies in order to streamline regulations and policies to effectively achieve outcomes.

The permanent, multistakeholder sector sustainability tables being considered by the department are one possible mechanism for implementing a more coherent environmental and health protection agenda that is better integrated with a competitiveness agenda.

As an integral component of the Canadian environmental management regime, CEPA 1999 provides the scientific basis and knowledge for helping to set environmental and health outcomes and assessing what action needs to be taken. The Act also authorizes a range of risk management measures to help address a number of environmental and health protection issues, particularly where it is important to take a nationally consistent approach to protect the environment and health of Canadians. It also enables reporting and tracking progress towards achievement of those outcomes.

In order to ensure national environmental sustainability, a healthy population and economic competitiveness, it is important to be able to address issues identified for action under CEPA 1999 in a coherent, integrated manner. The following section examines issues related to:

  • promoting national coherence and
  • promoting coherence among federal laws.

3.5.1 Promoting National Coherence

A) Federal/Provincial Coherence in Managing Toxic Substances
What CEPA 1999 Does

Under CEPA 1999, once the Ministers have conducted a risk assessment of an existing substance under the Priority Substances List (PSL), a screening level risk assessment or a review of a decision by another jurisdiction, they must propose one of three measures:

  • They may add the substance to the PSL. Typically, they will do this if they decide that there is a need for a more comprehensive risk assessment.
  • They may recommend that the Governor in Council (the federal Cabinet) add the substance to the List of Toxic Substances (Schedule 1), and, if applicable, to the Virtual Elimination List. They will typically add the substance to Schedule 1, if they determine that the substance meets the criteria for "toxic" under the Act and that regulatory or pollution prevention or environmental emergency planning risk management measures should be taken under CEPA 1999.
  • They may propose no further action. They will typically do this if they determine that the substance is not "toxic." They also may propose no further action if they determine that the substance is toxic but that actions being taken or about to be taken outside of the Act are sufficient to manage the risks in a timely manner.

For substances that the Ministers of Environment and Health propose to add to the List of Toxic Substances based on a screening level risk assessment, a review of a foreign decision or a PSL assessment, the Minister of the Environment must propose a preventive or control regulation or instrument1 authorized under CEPA 1999 within two years of the Ministers' publication of their statement indicating this proposed recommendation. The Act then requires a final regulation or instrument within a subsequent eighteen months. A regulation developed under CEPA 1999 must apply throughout Canada. The only exception is that some regulations may apply to a part or parts of Canada for human health or environmental reasons, such as may be the case for sensitive ecosystems.

In many cases, it is necessary to address the use or release of a substance from more than one sector. This may entail the development of multiple risk management measures, including more than one instrument authorized under CEPA 1999 and/or actions taken outside of the Act.

If jurisdictions work more systematically together on national long term outcomes, using the best situated authorities to achieve these outcomes, the Ministers may in the future make more use of federal authorities other than CEPA 1999, or provincial or territorial regimes to reduce risks. This is what is envisioned in association with the mechanism of the sector sustainability tables.

CEPA 1999 provides considerable flexibility to accommodate the proposed mechanism of sector sustainability tables and it explicitly recognizes the importance of demonstrating national leadership in establishing environmental standards and ecosystem objectives. The risk assessment work done under CEPA 1999 informs the development of long term outcomes. CEPA 1999 is well-situated to address risks where national consistency is required. Furthermore, it may be similarly well-situated to provide the regulatory backstop envisioned for long term outcomes.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

When a substance is identified as toxic, it is important to ensure timely, efficient and effective risk management. While CEPA 1999 provides the framework for identifying substances or releases that pose risks to the environment or health, it may not always be the most efficient or effective tool to manage those risks. Where the Ministers use risk management options in addition to, or as alternatives to those available in CEPA 1999 they must remain confident that the approach will be transparent and that they can monitor that the risks are being effectively managed within the expected timeframe.

In some cases, where Ministers have chosen to rely on actions taken under authorities other than CEPA 1999, but that risks are not being managed from some sources or geographical areas within the expected timeframe, they will want to act expeditiously and in a focused manner to reduce these risks.

Q. If Ministers choose the route of no further action under CEPA 1999 (i.e. a non-CEPA measure is pursued), should conditions be put in place to ensure effective accountability for protection of the environment and human health?

Q. If a non-CEPA 1999 measure is pursued, should CEPA 1999 play a backstop role? If so, how can this be done efficiently?

B) Coherence among Federal/Provincial/Territorial/Aboriginal Authorities
What CEPA 1999 Does

Part 1 of the Act requires the Minister to establish an intergovernmental National Advisory Committee (NAC), consisting of representation from federal, provincial, territorial and Aboriginal governments. The Committee advises the Ministers on decisions taken under the Act, to enable national action, cooperative action and for the purpose of avoiding duplication in regulatory activity among governments. The NAC also serves as the single window into provincial and territorial governments and representatives of Aboriginal governments on offers to consult under CEPA 1999. The Act also requires that the Minister of the Environment offer to consult with the provinces, territories and representatives of Aboriginal governments for various decisions.

CEPA 1999 also allows for action by other levels of government though administrative and equivalency agreements. It authorizes the Minister to sign administrative agreements with provincial, territorial and Aboriginal governments or with an Aboriginal people. These are work-sharing arrangements that can cover any matter related to the administration of the Act, including inspections, investigations, information gathering, monitoring, and reporting of collected data. These agreements do not release the federal government from any of its responsibilities under the law, nor do they delegate legislative power from one government to another. To date, the Minister has entered into several administrative agreements.

The effect of equivalency agreements is that a CEPA 1999 regulation no longer applies in a province, a territory or an area under the jurisdiction of an Aboriginal government that has equivalent requirements. Equivalency agreements are possible with provincial, territorial and Aboriginal governments for CEPA 1999 regulations dealing with issues including toxic substances, international air or international water pollution, and environmental emergencies. Equivalency agreements with respect to regulations made under Part 9 may also be entered into with Aboriginal governments, such as those under the First Nations Land Management Act. To date, the Minister has entered into one equivalency agreement.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

In supporting federal-provincial-territorial-Aboriginal government cooperation, it is important for CEPA 1999 to:

  • establish an efficient mechanism for entering into cooperative agreements;
  • ensure that there is transparency and clear accountability; and,
  • create an effective process for making adjustments, as appropriate.
  • Administrative and equivalency agreements

Two possible limitations have been identified with respect to the administrative and equivalency agreement provisions. First, one of the reasons that only one equivalency agreement has been developed is that often laws from different jurisdictions that appear at first blush to be equivalent are in fact quite different. Even where the subject matter of the laws are the same, the specific activities/behaviours regulated, the targeted regulated communities, anticipated outcomes, and legal consequences for breaches of the law might be very different. For this reason, there have been more administrative agreements (which are akin to work-sharing) than equivalency agreements.

Second, the Act requires that all equivalency and administrative agreements terminate five years after coming into force. A 5-year lifespan may not always be commensurate with the time and effort required to negotiate these agreements. In addition, these agreements are particularly useful to support arrangements regarding Canada-wide Standards made under the Canadian Council of Ministers of the Environment (CCME). Some of the Canada-wide Standards include a 10-year time frame for achieving identified targets. The 5-year expiry date for CEPA 1999 agreements is mismatched with these 10-year time frames.

Environment Canada and Health Canada regard administrative and equivalency Agreements as important mechanisms for enhancing the efficiency of the overall Canadian environmental management regime. As such, the subject matter, scope and timeframe of these agreements can vary markedly.

Q. Should CEPA 1999 provide the flexibility to tailor administrative and equivalency agreements to appropriate circumstances?

C) Coherence with Aboriginal Peoples in Policy and Instrument Development
What CEPA 1999 Does

In addition to including representatives of "Aboriginal Governments" on the CEPA NAC, when consulting on CEPA 1999 policies and practices, Environment Canada has usually adopted an issue-by-issue approach to its engagement of all sectors of society, including Aboriginal people.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

Recognizing that CEPA NAC is a forum for enhancing intergovernmental cooperation, it may not be the best or only mechanism to hear and respond to the full range of Aboriginal interests on CEPA 1999. This may be particularly significant with respect to the regulatory gap on Aboriginal Lands (see 3.6, below) given that the Aboriginal members of NAC are from "Aboriginal governments" as defined in CEPA1999,2 and therefore are not representatives of all Aboriginal people affected by the regulatory gap.

Through other fora, Environment Canada has been working to improve Aboriginal engagement on specific issues (e.g., comprehensive Aboriginal input on proposed Petroleum Storage Tank Regulations). From this experience the department has learned that there are many other factors that must be taken into consideration to enhance Aboriginal participation. In particular, the diversity of Aboriginal interests relative to the department's capacity to effectively engage the number of interested Aboriginal groups must be considered.

Q. What are your views on this issue?

3.5.2 Promoting Coherence Among Federal Laws And Policies

What CEPA 1999 Does

The Preamble in CEPA 1999 emphasizes the need to encourage cooperation within the federal government regarding environmental protection. Section 2 of the Act (the administrative duties) also includes the obligation on the Government of Canada to

"ensure, to the extent that is reasonably possible, that all areas of federal regulation for the protection of the environment and human health are addressed in a complementary manner in order to avoid duplication and to provide effective and comprehensive protection".

For some issues, CEPA 1999 explicitly establishes a federal benchmark. For new substances, for example, it allows for substances regulated for uses under other federal Acts and regulations to be exempt from the CEPA 1999 notification and assessment requirements if the other Act and regulation provide for equivalent notification and assessment of risks to the environment and human health. For control of toxic substances, Part 5 of CEPA 1999 requires that regulations not be made if the regulation would control an aspect of the substance that is regulated under another Act of Parliament, as long as the control under that other Act provides sufficient protection to the environment and human health. A similar type of clause appears in Part 8 of the Act, governing environmental emergencies.

To control air emissions from the transportation sector, CEPA 1999 brought together the authority to regulate more coherently fuels and emissions from engines. Part 7 of CEPA 1999 provides for regulation of emissions from vehicles and engines other than those in large ships, rail and aircraft. Transport Canada has maintained authority to regulate various aspects of the ships, rail and aircraft sectors, including environmental matters, to provide a "one-window" approach for them. Transport Canada also works to provide coherence with international requirements for these sectors operating within a global context. For example, Transport Canada is currently amending regulations to reduce sulphur content of fuel for ships, which is an area that CEPA 1999 has already regulated for other engine uses.

Should CEPA 1999 be implemented differently? Should the Act be Changed?
  • Managing toxics associated with products

It is anticipated that in the future there will be an increased demand to manage the risks from toxic substances arising from the use of a product or from the end-of-life treatment or disposal of that product. In some cases, a product may contain a toxic substance that is released during the use, treatment or disposal of the product (e.g., mercury in light switches). In other cases, the use of a product may lead to the creation and release of a toxic substance. An example of this type of product is a woodstove, whose use typically releases particulate matter. CEPA 1999, as do other federal Acts, contains various authorities relevant to the management of toxic substances and products. While CEPA 1999 allows individual users of these products to be regulated, it may be more efficient, under some circumstances, to regulate the product at the point of manufacture as is done with motor vehicles and other types of combustion engines, or at the point of sale. Environment Canada and Health Canada are exploring the various complex issues raised by the challenge of managing toxics in and released from various products, including the scope of other relevant federal authorities and their implications for the appropriate role of CEPA 1999 in addressing toxics and products. The departments are interested in ensuring that no gaps exist within the federal regime for dealing with toxic substances in or released from products.

Q. What are your views on this issue?

Q. How should CEPA 1999 interface with other federal authorities for the management of products?

  • Biotechnology

The 1993 Federal Framework for the Regulation of Biotechnology, as updated by the 1998 Canadian Biotechnology Strategy, is intended to ensure that the benefits of biotechnology products and processes are realized in a way that protects health, safety and the environment. The 1993 Framework resulted from an agreement among federal regulatory departments and agencies on principles for an efficient and effective approach to regulating biotechnology products. The 1993 Framework recognizes that federal departments and agencies with expertise and experience related to specific classes of products will take primary responsibility for the regulation of new living organisms that fall within their sector.

CEPA 1999 was designed to strengthen this horizontal approach to regulating biotechnology products by establishing the Act as the federal benchmark for the notification and assessment of environmental and health risks and for regulating biotechnology products not regulated for uses under another federal law. Part 6 establishes a notification and assessment process for living organisms that are new animate products of biotechnology. This process mirrors the provisions in Part 5 respecting new substances that are chemicals or polymers.

Several external expert committees, including the Royal Society of Canada, the External Advisory Committee on Smart Regulations (EACSR) and the Canadian Biotechnology Advisory Committee (CBAC) have identified a growing need for a more comprehensive and coherent federal regulatory framework for the biotechnology sector. In particular, the EACSR recommended that the federal government identify, prioritize and address legislative gaps impacting biotechnology.

There are currently five statutes and related regulations listed in Schedule 4 of CEPA 1999, which the Governor in Council has declared meet the CEPA 1999 benchmarks with respect to living organisms. These include four Acts and their regulations administered by the Canadian Food Inspection Agency (the Fertilizers Act, the Seeds Act, the Health of Animals Act and the Feeds Act) and the Pest Control Products Act and its regulations (administered by the Pest Management Regulatory Agency).

All remaining substances fall under CEPA 1999. Regulations are in various stages of development with respect to products related to animals, fish and pharmaceuticals. In the meantime, Environment Canada and Health Canada are responsible for the health and environmental assessments of these products.

The key regulatory departments and agencies have been working closely to meet the challenges in fulfilling the goals and principles of the 1993 Framework within the constraints of their respective legislation and mandates:

  • Environment Canada and Health Canada are finalizing a Letter of Understanding with the Canadian Food Inspection Agency (CFIA) regarding the regulatory oversight of livestock that are products of biotechnology.
  • CFIA, Environment Canada and Health Canada have developed a draft notification guidance document for biotechnology derived livestock that is modeled on the New Substances Notification Regulations.3
  • In 2004, Fisheries and Oceans Canada, Environment Canada and Health Canada concluded a Memorandum of Understanding (MOU), which explains how they will work together on the assessment of environmental and indirect human health effects of aquatic organisms with novel traits under CEPA 1999. Work to implement the MOU includes the development of regulations under the Fisheries Act that can be listed under CEPA 1999.
  • Regulatory departments and agencies are also considering how the regulatory framework may be adapted to address other rapidly emerging technologies, such as biobased molecular production systems (which use plants and animals for the production of pharmaceuticals and other products).

The management of biotechnology is an important and complex issue that has many dimensions - such as horizontal governance - outside of the scope of CEPA 1999.

Q. In the context of a federal strategy to build on existing legislation, is the residual role that CEPA 1999 serves adequate for assessing and managing current products of biotechnology?

Q. Is the Act adequate for assessing and managing emerging developments of biotechnology?

  • Remedial measures for animate products of biotechnology

The Act provides the Minister with the authority to take remedial measures for toxic substances under Part 5, nutrients and fuels. This allows the Minister to direct, among other things, that public notice be given by a manufacturer, processor, importer, retailer or distributor that a substance or product presents a danger to the environment or human life or health. These authorities can also be used to direct that the manufacturer, processor, importer, retailer or distributor accept return of the substance or product or reimburse the purchase price to the purchaser. The Act does not provide similar authority under Part 6 for remedial measures with respect to "animate products of biotechnology".

Q. Should CEPA 1999 authorize remedial measures with respect to animate products of biotechnology?

3.6 Federal Operations and Federal and Aboriginal Lands

What CEPA 1999 Does

Under Canada's Constitution, provincial environmental laws do not generally apply to activities of the federal Crown (e.g., federal government departments, agencies, Crown Corporations) or on federal and Aboriginal land. This means that federal activities and activities on federal and Aboriginal lands are, for the most part, not subject to the provincial, territorial and municipal regulations or permit systems on a wide range of issues (e.g., resource extraction and management, environmental protection, health and safety). This leaves a "regulatory gap". It is important, however, to note that other parts of CEPA 1999 and their respective regulations apply on all lands in Canada, including federal and Aboriginal lands.

Part 9 of CEPA 1999 was put in place to address some aspects of this regulatory gap. In particular, Part 9 provides the authority to address only those environmental protection matters falling within the purpose of the Act and the scope of the enabling authorities established within Part 9. Thus, Part 9 authorizes nationally-applied regulations and other measures to manage many, but not all, of the environmental protection risks on federal and Aboriginal lands, as defined under CEPA 1999 that would otherwise be addressed by provincial and territorial legislation.

Over the past decade, the Government of Canada has adopted policies (such as the 1992 Federal Code of Environmental Stewardship and the 1995 Guide to Green Governmentand Directions on Greening Government Operations) to address environmental performance of its operations. These policies, however, do not address private third party activity on federal and Aboriginal lands.

Mention should also be made that the environmental regulatory regime on lands north of 60° is quite different than lands south of 60°. In the Northwest Territories and Nunavut, the federal government continues to play a provincial-like role as manager of lands and resources. The situation in these two territories is to be contrasted with that in the Yukon where devolution of provincial-like jurisdiction over land and resources to the Yukon Territorial Government has taken place.

Should CEPA 1999 be implemented differently? Should the Act be Changed?

Despite ongoing efforts, there remain significant environmental protection regulatory gaps with respect to Aboriginal lands and to a lesser extent on federal lands and federal operations and works and undertakings. These gaps have various significant implications.

Importantly, the gap on many Aboriginal lands and federal lands extends beyond the environmental protection ambit of Part 9 of CEPA 1999 to encompass the full range of environmental management issues, such as potable water and resource management. In particular, the resulting regulatory uncertainty is a disincentive to investment and sustainable economic growth on Aboriginal lands.

The range of municipal services, commercial and industrial activities on reserves mirrors that found off-reserve, only at a much smaller scale. The Government of Canada is committed to increasing sustainable economic activity by investing in the capacity of Aboriginal communities. The goal is to build stronger Aboriginal economies, leading to greater economic independence. This commitment is being limited, in part, by the regulatory gap. The External Advisory Committee on Smart Regulations observed that the regulatory uncertainty on reserves is a disincentive to investment and sustainable economic growth in First Nation communities.

Addressing the gap on Aboriginal land involves difficult political, economic and legal considerations, many of which extend well beyond the scope of Part 9 of CEPA 1999. Therefore, any discussions on the use of Part 9 to address the environmental protection regulatory gap on Aboriginal land must also take into account the intentions of the federal government to address the broader environmental management regulatory gap, the interests of Aboriginal people, and the need to respect Aboriginal and treaty rights. .n addition, solutions to address this gap must recognize the role and responsibilities Band Councils have over public works and commercial activity on reserves.

Considerations such as administrative efficiency and the desire to ensure a "level playing field" for public works and commercial and industrial activities suggest that, in some cases, the appropriate way to address the regulatory gap would be for the federal government to use federal legislation to incorporate by reference relevant provincial laws and regulations. Doing this through CEPA 1999 would require changes to the Act. At present, varying provincial environmental protection laws cannot be incorporated in regulations under Part 9 of CEPA 1999 due to the requirement in Section 330(3) that all regulations developed under Part 9 apply uniformly throughout Canada. This means that private sector activities on federal and Aboriginal land operating under a Part 9 regulation may have different standards and processes to follow than their peers engaged in the exact same activities in the same province but outside of federal and Aboriginal lands.

It is important to recognize that enabling the incorporation of provincial laws under CEPA 1999 would only address the environmental protection part of what is effectively a much broader regulatory gap. It is equally important to remember that even with incorporation of provincial laws, regulations made under other parts of CEPA 1999 and other federal Acts would continue to apply.

The regulatory gaps with respect to federal activities and lands and with respect to Aboriginal lands presents ongoing challenges whose resolution requires considering a wide range of factors, some of which are well outside of the scope of CEPA 1999.

Q. What are your views on this issue?


1 For further explanation of what constitutes a preventive or control regulation or instrument under CEPA 1999 see the factsheet on Identifying Risk Management Tools for Toxic Substances Under CEPA1999

2 CEPA 1999 defines "Aboriginal government" as a governing body that is established by an agreement between the government of Canada and Aboriginal people and that is empowered to enact laws respecting the environment or respecting the registration of vehicles or engines (Part 7 of CEPA 1999).

3 This draft document entitled "Notification Guidelines for the Environmental Assessment of Biotechnology - Derived Livestock Animals" is posted on CFIA's website.

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