Section 5: Sound science and research

Sound science is the basis for risk assessment and management decision making in the Canadian Environmental Protection Act (CEPA 1999). The capacity to develop shared priorities based on science is also essential for developing and delivering a shared environmental and health protection agenda.

In addition to establishing risk assessment requirements for new and existing substances, CEPA 1999 mandates certain types of scientific research and enables a wide range of other research.

Ideally, these processes would:

• provide a sound scientific basis of information to enable appropriate decisions;
• be leveraged domestically through a coordinated system of shared scientific and research activities within government, the private sector and civil society; and
• be linked to international efforts, enabling Canada to contribute to and benefit from scientific and other research occurring throughout the world on issues of interest to Canada.

The principle that science informs decision-making in CEPA 1999 is guided by several provisions in the preamble and administrative duties detailed in the Act. The preamble and administrative duties recognize the integral role of research and monitoring, as well as the role of traditional Aboriginal knowledge, the need to take an "ecosystem approach" and the requirement to apply a "weight of evidence approach" and the precautionary principle to guide science-based decision-making related to assessing and managing risks to the environment and human health. Numerous other provisions in the Act require and enable the generation and use of information and knowledge to promote better decision-making.

Scientific and technological research and development underpin virtually all aspects of CEPA 1999. The Act requires both the Minister of the Environment and the Minister of Health to conduct research on hormone disrupting substances. The Act authorizes research by the Minister of Environment on vehicle and engine emissions and requires research and studies related to pollution prevention, the effects of pollution on environmental quality, and to provide advisory and technical services and information related to that research. The Act also requires the Minister of Health to conduct and publish research and studies relating to the role of substances in illnesses or in health problems.

Risk management options and instruments under CEPA 1999 range broadly in nature: from guidelines and codes of practice to regulations that virtually eliminate releases of persistent and bioaccumulative toxic substances. Correspondingly, the nature of scientific and technological research and development required to support risk management is varied - from helping to identify the appropriate toxic substances and sources of those substances to manage, to pollution abatement technology development and testing, to the development and use of precise chemical and biological testing methods and sampling techniques for confirming and enforcing compliance with regulations and other risk management measures.

Environmental and health sciences are complex fields requiring the capacity to detect and understand trends over time, as well as to address emerging issues. Managing this capacity presents a challenge since it requires developing and retaining a variety of high-calibre scientists with the necessary expertise and up-to-date facilities. The effective generation and use of environmental and health research requires sustained investments. To this end, it is important to enable the government to strengthen its science and technology research partnerships and networks, and to strengthen the ability to set priorities collectively.

Q. How may current resources and capacity be used to further develop and coordinate scientific and research partnerships and activities, in order to advance scientific objectives which support decision-making under CEPA 1999?

Traditionally, Aboriginal peoples have been closely connected to the land, both spiritually and through hunting, fishing and harvesting activities. CEPA 1999 requires the Government of Canada to recognize the role of traditional Aboriginal knowledge in the process of making decisions relating to the protection of the environment and human health.

Environment Canada and Health Canada understand the importance and value of accounting for traditional Aboriginal knowledge. Traditional Aboriginal knowledge has been helpful in monitoring environmental change and in detecting trends, and the departments continue to explore the potential role of traditional aboriginal knowledge in assessing risks to the environment and human health.

Q. How can Environment Canada and Health Canada most effectively include traditional aboriginal knowledge in their decision-making processes?

The significant expansion in commercial activities over the past century has been accompanied and supported by the development and use of a wide range of chemicals and other substances. The global production of chemicals increased 400-fold from 1930 to 2000. For the most part, this increased development and use of chemicals and other substances proceeded without systematic analysis of the risks to humans and the environment. By the early 1990s most developed countries, including Canada, had put in place legal structures to assess and manage the potential risks posed by new substances before they were introduced into the environment. Nevertheless, the legacy of chemicals that are currently in use but which entered commerce before systematic notification and assessment safeguards were introduced, must still be addressed.

The 1988 CEPA established legal definitions and consequences for existing and new substances. Among other things, the 1988 CEPA created the Domestic Substances List (DSL). The DSL includes substances that were, between 1984 and 1986 in Canadian commerce, or used for manufacturing purposes, or manufactured in or imported into Canada in a quantity of 100 kg or more in a calendar year. Any substance that is not on the DSL is a new substance and must be assessed in accordance with the Act and the New Substance Notification Regulations, prior to importation into or manufacture in Canada. In general, once a substance has been assessed under the New Substance Notification Regulations and becomes eligible for use in Canada, it is added to the DSL.

The DSL currently includes the approximately 23,000 substances from the original DSL ("existing substances") and about 2,000 that have been added to the list following their assessment under CEPA 1999 as new substances.

For the majority of the 23,000 existing substances on the DSL that have not undergone a risk assessment, there is very little data that is publicly available. This lack of publicly available information about many of the substances in current use and about their potential impacts on the environment and human health has been a cause for concern. This challenge is compounded by the limited number of qualified scientists, and the resources required from government and industry to address the volume of existing substances needing review.

These challenges are not unique to Canada, and Canada must continue to work within a global context in order to accumulate and access the data necessary to assess and manage this legacy systematically and efficiently. Canadian industry is a relatively minor player in worldwide chemical production, producing approximately two percent of the global total. The European Union, with the world's largest chemical industry, has 100,000 existing substances on their inventory, and the United States has an inventory of 82,000 substances. While these figures are not directly comparable, most of the substances on the Canadian DSL are on the European Union and the American inventories. As we share the same legacy and challenges, this represents a great opportunity to work together.

Under CEPA 1999, the departments of Environment and Health have made important strategic shifts in their approaches to assessing the risks from existing substances. The main approach required by CEPA 1988 was the Priority Substances List (PSL). The first PSL, established in 1989, comprised 44 substances or mixtures; the second PSL, established in 1995, included 25 other substances or mixtures. Both lists were compiled from substances nominated through stakeholder consultations.

Risk assessments of substances on the PSL have been quite comprehensive and rigorous, and no other country has produced 67 assessment decisions on 550 substances during the past 15 years. Nonetheless, the PSL has been found to be a time- and resource-intensive mechanism.

While the PSL remains available for conducting detailed assessments, CEPA 1999 also provides for a number of other pathways for identifying risks from existing substances. These paths are designed to enable more rapid, but still transparent and scientifically rigorous approaches for identifying substances that pose a risk to human health or the environment.

One of the important new paths under CEPA 1999 is the requirement that the Ministers review any decision by another government in Canada or of a national or state-level government of an Organisation for Economic Co-operation and Development (OECD) country to prohibit or substantially restrict a substance for environmental or human health reasons. The review must determine whether the substance is toxic or capable of becoming toxic, as defined by CEPA 1999.

The most extensive risk assessment pathway introduced under CEPA 1999, and the one that presents the most ongoing challenges, is the requirement to categorize and screen existing substances. The 23,000 "existing substances" on the DSL represent the Canadian dimensions of the global legacy of substances that have not yet been assessed to determine their potential impact on the environment and human health. CEPA 1999 requires that the Ministers of the Environment and Health, by September 2006, categorize these substances, together with approximately 1,200 other substances already reviewed for health impacts under the Food and Drugs Act.

Categorization involves the identification of those existing substances that meet the following criteria:

• are inherently toxic, and either persistent in the environment (take a long time to break down) or bioaccumulate (collect in living organisms and aggregate as they move up the food chain), or
• may present to individuals in Canada the greatest potential for exposure.

Substances that do not meet these categorization criteria require no further action under this program at this time (i.e. unless new knowledge in the future identifies a concern).

Categorization is essentially a preliminary step towards identifying priorities for risk assessment. In many cases, categorization of specific substances must rely on readily available information or the use of statistical probability analysis and theoretical modeling.

Substances that meet the specified categorization criteria must undergo a screening risk assessment. A screening assessment involves an analysis to determine whether the substance is toxic or capable of becoming toxic as defined in CEPA 1999 (see Figure 2). These risk assessments consider both the hazard posed by a substance, together with the likelihood that sufficient exposure to a person, organism or the environment will occur such that a risk can be anticipated.

The Ministers also may recommend the addition to the List of Toxic Substances of any substance they are satisfied meets the definition of "toxic", regardless of whether the substance has followed one of the above risk assessment paths. The Ministers may, for example, rely on a risk assessment conducted under the auspices of the Canadian Council for Ministers of Environment or an international assessment that has relevance to the Canadian context.

Risk assessment for a substance involves the application of a weight of evidence approach and the precautionary principle and ends when the Ministers have sufficient evidence to conclude whether or not it is "toxic" as defined by the Act.

Figure 2 - Definition of "toxic" under CEPA 1999

Priority Substances List (PSL): Of the 69 substances on PSL 1 and PSL 2, 46 have been found toxic, 21 not toxic and two assessments (ethylene glycol and aluminum salts) have been suspended in order to collect necessary data. This represents approximately 550 substances of the 23,000 on the DSL.

Decisions of other jurisdictions: In order to develop procedures to exchange information under s.75, Health Canada and Environment Canada have reviewed the basis for about 80 decisions by other jurisdictions to prohibit or restrict substances, including 16 substances prohibited or restricted for health reasons.

Screening assessments: The departments have launched a pilot project for 123 substances that require screening assessments because they meet the categorization criteria. This pilot will develop and test screening assessment procedures for individual substances as well as groups of related compounds. In 2004, the departments released for comment draft screening assessments on a group of 7 Polybromodiphenyl ethers and on perfluorooctane sulfonate, its salts and its precursors (PFOs) (which represents almost 60 substances).

Categorization: The departments are confident that they will complete the categorization process by the 2006 deadline. Implementing the requirement has involved considerable planning including consultation with stakeholders, other jurisdictions and international agencies. To date Environment Canada has developed and is seeking input on preliminary categorization decisions on 15,000 substances on the DSL, which include organic and inorganic substances, polymers and UVCBs (Unknown or Variable Composition Complex Reaction Products or Biological Materials). In 2004, Health Canada and Environment Canada released for comment proposed approaches to categorize substances against the criteria of greatest potential for human exposure, persistence, bioaccumulation and inherent toxicity. Health Canada has also refined the approach for categorizing the "inherent toxicity to humans" of the 1352 organic compounds and 642 inorganic compounds on the DSL that Environment Canada has identified as having persistent or bioacccumulative characteristics but as not inherently toxic to the environment.

Additional information can be found on the Chemical Substances portal.

It is important to ensure that thorough and timely risk assessments are conducted on substances as they are identified by the categorization and other processes as being of potential concern.

It is expected that the DSL categorization process will identify a significant number of substances that will require a further risk assessment. This highlights the need for an additional priority setting process following categorization to determine which risk assessments to conduct first.

A major challenge in conducting the risk assessments is the lack of complete datasets on hazard properties, uses, releases, exposure levels and human and environmental impacts for the majority of the DSL substances. While industry has unpublished data on some of the substances, the cost and workload associated with either providing data or filling the information gaps, both to government and to industry could be substantial. Consequently, international cooperation is critical to ensuring that risk assessments are carried out in the most efficient manner possible. While Canada's goal is to be among the leaders internationally, it cannot proceed entirely on its own. Hence, Canada shares the challenge with other countries to review the thousands of unassessed substances in use globally.

It is, therefore, imperative that the departments continue to work cooperatively with Canadians, industry in Canada and abroad, other governments and international organizations. Foreign sources of data will be particularly useful; it will be very important to continue to collaborate with the United States High Production Volume Challenge Program, the High Production Volume Programme of the International Council of Chemical Associations (ICCA), the OECD Chemicals Programme and the International Programme on Chemical Safety of the World Health Organization.

Canada is the only country with a legislative requirement to categorize and do further risk assessment of all existing substances. The European Union has recognized the significant challenges to deal with existing substances. It is proposing to address these issues over the next two decades through its REACH (Registration, Evaluation and Authorization of Chemicals) initiative. Although still under discussion, REACH contemplates an European Union (EU)-wide approach to identifying the risks from both existing and new substances. Environment Canada and Health Canada officials are in contact with their EU counterparts to help minimize duplication and maximize opportunities for collaboration.

Given the challenges listed above, Environment Canada and Health Canada plan to continue to:

• use the tools provided by CEPA 1999 in the most efficient manner possible;
• identify opportunities and methodologies for grouping substances together by class or sector for risk assessment; and
• seek collaborative opportunities to improve databases and reduce resource requirements and timelines for assessments of existing substances.

Q. What are your views on this issue?

The new substances provisions of CEPA 1999 are an integral part of the government's approach to pollution prevention because they help identify and manage environmental and human health risks before they occur. The New Substances Program was created under the 1988 CEPA. The regulations for notifying new chemicals and polymers came into force in 1994 and the regulations for notifying new biotechnology products came into force in 1997.

CEPA 1999 requires the notification and risk assessment of any "new" substance (i.e. not on the Domestic Substance List) prior to its import or manufacture. The Program processes and evaluates approximately 800 new substance notifications per year, taking the appropriate risk management actions within the prescribed timeframes. Prior to the promulgation of the New Substances Notification Regulations (NSNR) (Chemicals and Polymers portion) in 1994, Environment Canada and Health Canada committed to review the regulations after three years of implementation. To fulfil this commitment, the departments established a multistakeholder consultative process in 1999. The consultations resulted in recommendations for improving the NSNR and the New Substances Program, which have been implemented or are in the process of being implemented. Environment Canada and Health Canada are targeting Spring 2005 for implementation of the amended NSNR.

• New substances

In order for the new substances program to operate as efficiently as possible, the departments are continuously seeking ways to maximize the effectiveness of their inter- jurisdictional cooperation and information sharing arrangements (for example, access to and use of another jurisdiction's assessments to assist Canadian regulators in their assessments). The New Substances Notification Regulations allow reduced notification requirements for new chemical or polymer substances already approved in certain other jurisdictions. The departments have been very active within the Organisation for Economic Co-operation and Development (OECD) concerning the notification and risk assessment of new chemicals, and they continue to seek ways to reduce the burden to government and industry while maintaining environmental and human health protection when a new substance is being introduced into Canada, following introduction into another country.

Q. Does the Act provide adequate authority to support inter-jurisdictional cooperation in the implementation of the New Substances Program?

• Updating the Domestic Substances List (DSL)

New substances under CEPA 1999 are considered to be those substances that are not on the Domestic Substances List (DSL). The DSL consists of substances that were in commercial use in the mid-1980s. Some of the substances on the DSL may no longer be in commercial use. Nonetheless, CEPA 1999 does not provide the Minister the authority to remove any of the originating substances from the DSL because they are no longer in use in Canada. Removing substances not in commerce from the DSL would mean that any renewed or increased use of the substance in the future would trigger the new substances notification and assessment regime. Furthermore, because CEPA 1999 allows for the Minister to restrict approval of new substances to specific uses, an updated DSL list would provide for a case-by-case risk management response that accounts both for the properties of the substance and for its intended use(s).

If these substances remain on the DSL, Environment Canada and Health Canada are required to include them in the categorization process and to then conduct a screening risk assessment on any of them that meet the categorization criteria - even if the substance is not presently in use in Canada. This problem applies in particular to the substances categorized as persistent and/or bioaccumulative and inherently toxic. It is likely that the departments will categorize a number of substances on the DSL with these characteristics (therefore requiring a risk assessment), but which are no longer in use in Canada.

It may be more appropriate to require that the DSL be updated to remove a substance if it is no longer in commerce or its quantity in use falls below specified thresholds. The United States has an authority to require industry to submit information on the quantity and use of a substance, which is used to update their inventory of substances. Some have suggested that Canada should have a similar authority.

Q. Should CEPA 1999: provide the authority to remove any of the original substances from the DSL if information determines that the is no longer used in Canada; and fl clarify the authority for the submission of information regarding current use patterns and quantities in use of substances on the DSL?