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Integrated Framework for the Health-Related Components of Categorization of the Domestic Substances List Under CEPA 1999: Questions & Answers

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Table of Contents

• List of Acronyms
• What is an existing substance under CEPA 1999?
• How are existing substances selected for consideration under CEPA 1999?
• What is categorization?
• What is the role of the Minister of Health in categorization under CEPA 1999?
• How does this proposal contribute to Health Canada's responsibility for categorization under CEPA 1999?
• How does this proposal relate to an earlier one on "greatest potential for exposure" released by Health Canada in the autumn of 2003?
• By what process have these proposals been developed?
• What aspects of human exposure does Health Canada consider under CEPA 1999?
• What potential effects on human health does Health Canada consider under CEPA 1999?
• How does Health Canada identify relevant information on existing substances for consideration in priority setting and assessment of individual existing substances?
• Why are so many tools necessary to fulfil the Minister of Health's responsibilities related to categorization of the Domestic Substances List under CEPA 1999? What are the benefits of this additional workload?
• What are each of the tools, their strengths and limitations and differences between them?
• How do each of the tools contribute in defining priorities?
• How have persistence and bioaccumulation been taken into account in development of the integrated framework and draft maximal list?
• How has it been ensured that the approach (i.e., integrated framework) has identified highest priorities and is protective of human health?
• How is information on individual substances identified for consideration in the simple and complex exposure and hazard tools?
• What is the draft maximal list? What do the designations of high, moderate and low probability/likelihood on the maximal list mean? What does inclusion of a substance on the maximal list mean?
• How was the draft maximal list developed?
• What will happen to the draft maximal list between now and the deadline for categorization of September 13, 2006? Which of the subsets are additionally being considered through application of tools, and which tools are being applied?
• What does exclusion of a substance from the maximal list (i.e., setting aside from further consideration in categorization) mean?
• What information would be helpful in additionally defining priorities, and how and by what date is it to be submitted?
• Why has it been suggested that information on risk management options or practices be considered for 301 substances identified in categorization?
• Why are 388 substances being identified as priorities for consideration of persistence and bioaccumulation?
• How do these priorities (i.e., the draft maximal list) relate to those being identified by Environment Canada on the basis of persistence, bioaccumulation and designation as "inherently toxic" to non-human organisms?
• What will happen post-2006 for substances that continue to be added to the DSL for which information available prior to the deadline of September 13, 2006, precludes their meaningful consideration?
• What happens if new information becomes available after September 2006? Can decisions on categorization be changed?
• How have substances added to the DSL as a result of scheduling of the Food and Drugs Act been considered in the development of the draft maximal list?
• How were high- and low-hazard substance lists in the simple hazard tool selected?
• What happens to the results of categorization if the lists that Health Canada used as the basis for the simple hazard tool are updated?
• How were endpoints in the complex hazard tool selected?
• How are reproductive toxicity (including endocrine disruption), immunotoxicity and neurotoxicity taken into account in priority setting through the application of either the simple hazard tool or the complex hazard tool?
• How are data versus predictive methods weighted in priority setting for hazard?
• What are the predictive tools used in the complex hazard tool? How has reliability of output been ensured?
• What is the basis for the quantitative criteria for hazard in the complex hazard tool?
• What are the sources of the regulatory/reference values used in the complex hazard tool?
• What is a "sentinel product" in the complex exposure tool? How is exposure through multiple products taken into account?
• How are impacts of exposures to multiple chemicals being taken into account in priority setting and assessment?
• How are potentially sensitive subgroups (e.g., children, women of child-bearing age) accounted for in the proposed integrated framework?
• How will the order of screening assessments for substances remaining as priorities following the categorization deadline be determined? What are the expected timelines for completion of screening assessments on various priorities?
• Has assessment work been completed on the approximately 1200 substances from the health draft maximal list now considered as either high or moderate health priorities for further action?
• What are the next steps for the approximately 700 substances from the draft health maximal list that are now considered to not require further work for human health at this time?
• How are data gaps addressed in priority setting for categorization?
• Is there a minimum data set for making categorization decisions? Are substances set aside if no relevant information is identified? Are data (e.g., environmental monitoring and biomonitoring data) being generated to support categorization efforts?