Information Gathering for Risk Assessments
Information gathering is an essential component in risk assessment for making science-based decisions for concluding whether a substance is toxic or capable of becoming toxic, as defined under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Information gathering typically starts well in advance of the publication of draft assessments. It involves collecting information on a substance or group of substances from a variety of published and unpublished sources, stakeholders and various databases. In addition, information on analogues (other substances that are structurally similar and/or functionally similar to the substance being assessed) and data generated using modelling approaches may also be used to address data needs and/or support a weight of evidence.
Sources of information
Environment and Climate Change Canada (ECCC) and Health Canada (HC) collect scientific data (for example, toxicological studies) and commercial activity information (for example, substance use and quantities) from a variety of sources and mechanisms, which may include:
- Publicly available information: An extensive literature search is conducted to collect critical studies published in peer reviewed scientific journals on exposure and hazard of substances, as well as obtaining information through sources such as databases, trade journals, and safety data sheets.
- Industry stakeholders and associations: Information may be gathered by working in collaboration with stakeholders and associations. A single submission of data can be provided on behalf of multiple submitters, such as an association submitting information on behalf of their members, a supplier submitting on behalf of their customers, or an industry consortium sharing information that is jointly owned by multiple companies. Information is collected from industry stakeholders and associations through information gathering initiatives, such as:
- Domestic Substances List Inventory Updates: Through the mandatory information gathering provisions under CEPA 1999, the Government of Canada (GC) obtains updated information on the commercial status of substances.
- Voluntary information gathering approaches: Information can be gathered through direct follow up with those known to be engaged with the substances, or the use of voluntary questionnaires. Voluntary information gathering approaches are typically considered before mandatory information gathering activities are undertaken.
- Mandatory information gathering provisions under CEPA 1999: Several sections of CEPA 1999, such as sections 46, 70 and 71, allow the GC to collect information from industry and other individuals regarding their activities with substances, as well as other available toxicological information that inform the assessment. Under the Chemicals Management Plan (CMP), the GC has used these authorities under CEPA 1999, along with broader approaches and stakeholder engagement, to collect information on the commercial status of existing substances and certain other information required for risk assessments. Section 71 may also be used to require the generation of data, such as toxicological tests. Section 70 puts the onus on industry to provide information in their possession that reasonably supports the conclusion that a substance is toxic or capable of becoming toxic as defined under section 64 of CEPA 1999.
- New substances provisions under CEPA: For substances that are new to Canada, industry is required to provide specific information to the New Substances Program as required by the New Substances Notification Regulations under CEPA 1999.
- ECCC and HC research, monitoring & surveillance activities: The GC invests in research, monitoring and surveillance, including biomonitoring, to provide essential information about chemical exposures and their effects on human health and the environment. This internally generated information can fill data needs in risk assessments.
- Information submitted to the GC under other statutes: Information on substances is also available through other programs within ECCC and HC, or through other provincial/territorial government departments. Some programs have their own respective databases that provide pertinent information on substances if they have specific uses in sectors that are regulated by HC, such as pesticides, food additives, cosmetic products, or medical ingredients. For example, the National Pollutant Release Inventory is a database for tracking releases, disposals, and transfers for recycling of specific substances.
- Other government departments/agencies: Other federal departments such as Natural Resources Canada, the Canadian Border Services Agency and Statistics Canada may also contribute data for risk assessments. For example, the Canadian Health Measures Survey (CMHS) prepared by Statistics Canada is a source for information relevant to the health of Canadians.
- Other regulatory jurisdictions: Information is also available in other jurisdictions that could be shared through agreements. For example, the United States Environmental Protection Agency, the European Chemicals Agency, and the National Industrial Chemicals Notification and Assessment Scheme, can often provide information that informs risk assessment.
How the information is used for risk assessment
The GC carefully reviews scientific information collected for its quality and relevance to the Canadian context in order to determine critical information for risk assessment. To determine the quality of a study, certain aspects such as the methodology, reproducibility, as well as experimental/modelling conditions are reviewed to determine how the data should be considered. For the information related to exposure assessment, Canadian studies are typically given more weight than studies conducted in other countries. For example, the measured concentrations of a substance reported in Canadian environmental media (air, water, soil, sediment) would always be considered before a similar study conducted in a foreign country when the quality of the studies is considered equivalent.
In some, instances information submitted under CEPA 1999 to support risk assessments may be identified as confidential business information (CBI). CBI is considered in risk assessment decision-making but is protected in public documents in order to maintain confidentiality. CBI should only be claimed for information that is truly confidential, to allow for increased transparency in public documents.