Identification of Risk Assessment Priorities (IRAP): results of the 2016 review

Environment and Climate Change Canada
Health Canada

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Table of contents

• Background
• Scope of 2016 review
• Acquisition
• Evaluation
• Results and action
• References
• Appendicies
  • Appendix A. substances identified as priorities for risk assessment
  • Appendix B. substances identified for data gathering and/or international activity

Background

Under Canada's Chemicals Management Plan (CMP), Environment and Climate Change Canada (ECCC) and Health Canada (HC), in addition to addressing substances already identified as priorities for assessment, have continued to develop approaches to incorporate new scientific knowledge and increase collaboration with other regulatory and international agencies. One of the formal approaches developed by ECCC and HC is a cyclical process known as the Identification of Risk Assessment Priorities, or IRAP. As part of this approach, both departments compile new information on substances, evaluate this information, and then subsequently determine if further action on the substance(s) may be warranted. This approach is described in the document titled "Approach for identification of chemicals and polymers as risk assessment priorities under Part 5 of the Canadian Environmental Protection Act, 1999 (CEPA 1999)" (Environment Canada, Health Canada 2014). This initiative supports ongoing priority setting by identifying additional potential priorities for risk assessment in a transparent manner. In the approach document, the process for identifying additional priorities is described in three steps. These three steps are briefly described below.

• Acquisition refers to the active and passive collection of information relevant to the potential health and ecological risks of substances.
• Evaluation refers to the triage of substances for which new information has been received. This evaluation requires expert judgment, and consideration of the different types of information that may be available for any given substance.
• Action refers to the type of activity that will be undertaken on the substances identified as candidates for further work. These actions could include assessment, risk management, data collection, research and monitoring, generation of new data, etc.

Prior to the application of this approach in the current 2016 review cycle, the results of the 2015 IRAP prioritization exercise were published (ECCC, HC 2015). Fundamentally, the approach was applied in the same manner in both the 2015 and the current 2016 IRAP prioritization exercises; instances where differences between the two review cycles exist (e.g., broadening of the scope of review) are highlighted within this report. This report describes the manner in which the approach was applied in the 2016 IRAP review, and the results.

Scope of 2016 review

The scope of each review cycle includes the identification of the range of substances and the type of information that will be considered (the latter is outlined in more detail under the Acquisition section). It was recognized at the outset of the development of the Approach for Identification of Risk Assessment Priorities that the scope of the various IRAP review cycles could change with future iterations. The change in scope cycles can occur for various reasons, including timing (e.g., the length of time since a substance was last assessed) and types or sources of information not previously considered (e.g., emerging concern from toxicological endpoints or product uses). Future iterations of the IRAP approach will continue to evolve to incorporate these changes and advancements to ensure the main goals of the Approach for Identification of Risk Assessment Priorities, which are to incorporate new scientific knowledge and increase collaboration with other regulatory and international agencies, as well as identify emerging issues of concern, are achieved.
Specifically, the scope of the 2016 review focused on identifying sources of new information that would constitute indicators of hazard and/or exposure for the following types of substances:

• Substances on Canada's Domestic Substances List (DSL) that have not recently been (i.e., within the last 5 years), and are not or currently being, assessed under the CMP, or those substances already scheduled to be assessed under the CMP.
• Previously assessed substances on the DSL depending on the time elapsed since data/information on the substance was last reviewed (e.g., substances concluded as non-toxic in Phase 1 of the CMP).
• Substances that had been reviewed and assigned an outcome of data gathering or international activity in the 2015 review cycle.
• Substances that were not on the DSL may have been considered; particularly in situations where new information regarding possible emerging concerns was brought forward by CMP program staff.
• Substances identified as potentially requiring review pursuant to section 75 of CEPA.

Focusing on these sources of new information supported efficient decision-making, while still being comprehensive and scientifically sound.

Acquisition

While not an exhaustive list of the sources of information consulted, the following are illustrative of sources utilized in the 2016 review:

• Hazard classifications from agencies such as:
  • International Agency for Research on Cancer (IARC)
  • National Toxicology Program (NTP)
  • United States Environmental Protections Agency (US EPA)
  • European Chemicals Agency (ECHA)
• Classifications from the Global Harmonised System (GHS) obtained, for example, from ECHA's Harmonised Classification and Labelling information
• International lists of restricted and/or prohibited substances, or other lists of international priorities, such as:
  • Substances of Very High Concern (SVHC) and Authorization list from ECHA
  • US EPA Action Plans and US EPA Toxic Substances Control Act (TSCA) work plan
  • Community Rolling Action Plan (CoRAP) from ECHA
• Data obtained under section 71 of CEPA (e.g., DSL Inventory Update surveys)
• Data submitted under section 70 of CEPA
• Notifications to Health Canada concerning substances used in cosmetics
• Canadian and international Material Safety Data Sheets (MSDS)/Substance Data Sheets (SDS)
• US EPA Chemical and Product Categories (CPCat)
• Non-confidential data reported under the US EPA Chemical Data Reporting (CDR) Rule
• Available Canadian and international biomonitoring, environmental monitoring and surveillance data
• Substances identified as potentially requiring review pursuant to requirements of section 75 of CEPA (e.g., substances implicated by pertinent international conventions/agreements (e.g., Stockholm/Rotterdam conventions, Export notifications from other jurisdictions)
• Emergent technologies and sources of data (e.g., high-throughput screening (HTS), in silico quantitative and qualitative methodologies)

After reviewing the pertinent sources of information, the process identified a list of approximately 6000 substances that had one or more types of information that required further evaluation under the approach. This is a significantly larger number of substances than were identified at this step in the 2015 IRAP review due to a number of factors, including, but not limited to:

• Expansion of the scope of the review (e.g., inclusion of some previously assessed substances)
• Growth and expansion in the volume of data from sources used as indicators of hazard/exposure (e.g., ECHA GHS classifications, updates to international lists and/or priorities)
• New information brought forward internally

Evaluation

The guiding principles and considerations involved in the evaluation process are described in the Approach for Identification of Risk Assessment Priorities (Environment Canada, Health Canada 2014).

The process applied under this approach supported a triaging of the approximately 6000 substances to separate those that are unlikely to require further work based on information available at this time, from those that represent potential new priorities for assessment, or which require further information and data to determine this. The outcomes of this exercise are discussed in the following section.

Results and action

This IRAP review cycle identified slightly over 3% of the 6000 substances as having sufficient indicators of hazard and/or exposure to merit further activity, including: i) additional data gathering, ii) prioritization for risk assessment, and iii) monitoring of ongoing international activity. The outcomes, and the relative proportions of evaluated substances that fall within each, are shown in Figure 1.

Long description for figure 1

Pie chart: No current evidence for further consideration (97%) and other [3.4% = Data gathering (2.2%), Risk assessment (0.2%) International work (0.2%)and Data Gathering and International Activity (0.8%)]

As Figure 1 illustrates, for the majority of substances (~97%) evaluated within the 2016 IRAP review, it was determined that there was not a sufficient basis for further consideration at this time. Consistent with how the IRAP approach was implemented in the 2015 review, this group of 6000 substances also includes those where a hazard may have been identified, but the uses and exposures were not relevant in the current Canadian context (e.g., pesticide uses are addressed under the Pest Control Products Act, not under CEPA). Although these substances were found to have no current evidence for further consideration under the 2016 IRAP review, they will continue to be part of future IRAP review cycles.

While the majority of substances within the 2016 IRAP review were determined to have no basis for further consideration, the remaining 3.4% of substances were identified as candidates for further work/consideration. A breakdown of the specific outcomes for these substances, and a description of what actions these outcomes represent, is provided below.

A total of 10 substances (0.2%) were identified as candidates for risk assessment via this review. They had been identified as being of low concern in the Rapid Screening of Substances of Lower Concern initiative (Environment Canada, Health Canada 2013) in part because they were in commerce in low quantities (maximum use in Canada of 1000 kg per year based on 1986 data). However, notifications received from Phase 2 of the DSL Inventory Update (IU) under section 71 (Environment Canada 2013) indicated that these substances are now in commerce at significantly higher quantities, meriting further consideration of their potential risk. Eight of the 10 substances align with activities on polymers under the third phase of the CMP (CMP3) (i.e., polymer approach), and have therefore been included in CMP3 plans. The remaining two substances do not align with planned CMP3 assessments and will be considered for assessment at a later date. The 10 substances are listed in Appendix A, along with the rationale for their recommended addition to the CMP risk assessment plan.

The need for additional data has been identified for 184 (3%) substances (see Appendix B). This includes 51 substances that are also subject to international activities. Similar to the 2015 IRAP review, these substances were seen as having relevant hazard and/or exposure indicators, but require further data gathering to determine whether they could be priorities for risk assessment under CEPA. The most common scenario under the data gathering outcome is when there is an indicator of hazard, yet the commercial status in Canada is uncertain. The options available for data gathering include, but are not limited to, upcoming DSL Inventory Updates, and may also include initiatives such as targeted surveys and research or monitoring activities.

Lastly, 14 substances (0.2%), plus the above-mentioned 51 substances, were identified as currently being subject to international activities (see Appendix B). This outcome captures 65 substances that have been prioritized internationally by other organizations, for which assessment work and/or data gathering is ongoing or planned. Current information on commercial activity in Canada is available for these 14 substances (e.g., were included in previous section 71 surveys). As a consequence, it was determined that further gathering of this type of information was not required. Outcomes of these international activities will inform what, if any, actions are required in future review cycles.

References

[ECCC, HC] Environment and Climate Change Canada, Health Canada. 2015. Identification of risk assessment priorities: results of the 2015 review. Ottawa (ON): ECCC, HC.

[ECCC, HC] Environment and Climate Change Canada, Health Canada. 2016. List of substances in the next phase of the Chemicals Management Plan (CMP) and two-year rolling risk assessment publication plan. Gatineau (QC): ECCC.

[ECHA] European Chemicals Agency. [updated 2016 Jan 14]. Substance information: triisobutylphosphine sulphide. Helsinki (FI): ECHA. [accessed 2016 Sep 15].

Environment Canada. 2013. DSL Inventory Update data collected under the Canadian Environmental Protection Act, 1999, section 71: Notice with respect to certain substances on the Domestic Substances List. Data prepared by: Environment Canada, Health Canada; Existing Substances Program.

Environment Canada, Health Canada. 2013. Rapid screening of substances of lower concern: results of the screening assessment. Ottawa (ON): Environment Canada, Health Canada.

Environment Canada, Health Canada. 2014. Approach for identification of chemicals and polymers as risk assessment priorities under Part 5 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Ottawa (ON): Environment Canada, Health Canada.

Appendices

Appendix A. substances identified as priorities for risk assessment

Appendix B. substances identified for data gathering and/or international activity

Date modified:

2017-06-16