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Risk Assessment/Management

Comparative Analysis of Regulatory Frameworks for Risk Management of Nanomaterials

Existing domestic statutes have provided a firm foundation for the regulation and oversight of a wide range of industrial chemicals/substances, and jurisdictions around the world have concluded that for the most part, existing regulatory authorities for industrial chemicals are applicable to nanomaterials.[1]  Even though nanomaterials are not specifically named in any of the current regulations, the definitions of a ‘chemical’ or a ‘substance’ under these legislative tools are considered broad enough to include them.  Recently however, specific advisory notes or notification procedures have been issued by agencies within Canada, the US, the European Commission (EC) and several other countries to make it clearer how, when, and which nanomaterials should be notified/registered. 

Although neither the Canadian New Substances Program nor the US New Chemicals Program have developed regulations specific to nanomaterials, reviewing the regulatory frameworks for pre-market assessment of chemicals in both jurisdictions does provide the RCC with an analysis of the current regulatory environment overseeing nanomaterials.  

A comparative analysis of regulatory frameworks under CEPA 1999 and TSCA was completed by reviewing and analyzing the two countries’ respective legislations and regulations, policies and material definitions. This provided regulatory context to the analysis of risk assessment and risk management approaches used by the Canada/US Programs, as well as an understanding of the regulatory requirements, policies and regulatory options available in Canada and the US.  In addition, a scan of regulatory tools, policies and definitions for nanomaterials in other jurisdictions (including Australia, members of the European Union and Japan) was completed.  A copy of the entire report can be found in Appendix A.

Although there are statutory differences surrounding pre-market notification requirements, information packages, assessment timelines, and target populations of interest between the Canadian and US Programs, it was found that the overarching principles for the risk assessment/risk management of nanomaterials are consistent[2],[3]

The following conclusions/observations were noted with respect to the pre-market notification of industrial chemicals and nanomaterials in the Canada/US Programs:

  • Canada and the US share more commonalities in their approaches to the management of ‘new’ chemicals and nanomaterials than they do differences.  Both countries have the capacity to issue reporting requirements, request additional information/testing, impose conditions of use or prohibitions if a ‘new’ substance is deemed to pose an unacceptable risk to health or the environment. 
  • Both Canada and the US provide notification exemptions and/or exclusions which are carefully defined and described in legislation and regulations, and are further explained in guidance documents.
  • While both countries require industry to notify their substances/nanomaterials prior to import or manufacture within their jurisdictions, the regulations under CEPA 1999 have volume triggers ranging from ≥ 100 kg/calendar year to ≥ 50,000 kg/calendar year, while TSCA has no such triggers.
  • In both countries, notifiers and evaluators are bound by timelines for new substance notifications, although those timelines are different.  Assessment periods in Canada for chemicals can be very short, ranging from 5 to 75 days.  In the US, all assessment periods are 90 days unless the assessment is for a chemical for which an exemption is requested (assessment periods are then either 30 days or 45 days). Assessment periods can be extended under both CEPA 1999 and TSCA if additional time/information is needed based on a concern to humans or the environment.  
  • The required information packages for new substances differ significantly between Canada and the US. In Canada, the identification of the substance and test data needed to evaluate hazard for the human health and the environment are prescribed in a tier-like fashion by quantity of chemical intended to be imported or manufactured. In the US, under TSCA, there are pre-market notification requirements to provide all known information; however, more detailed information is requested by the EPA only after an initial screening if it considers that there is cause for concern for human health, including specific concerns related to worker health, or for the environment.  Both Canada and the US have indicated to their industry partners a desire to receive early notification of nanomaterials and as much information as possible on the characterization and properties of these substances.
  • Both programs apply conservative assumptions about dispersal, persistence, and bioaccumulation of nanomaterials in their evaluations when there is little suitable test data available for exposure, hazard and/or risk assessment.
  • Both programs apply significant new use type provisions for notified substances about which they have concern for impacts on health and the environment (that is, permit the current use but require additional information and assessment if the use were to change).
  • International cooperation and harmonization, to the extent to which legislation permits, is also seen by both countries as a necessary and desirable objective.  

[1] OECD. 2011. Regulated Nanomaterials: 2006-2009. ENV/JM/MONO(2011)52

[2] “Policy Statement on Health Canada's Working Definition for Nanomaterial”, located at (accessed on December 9, 2013).

[3] ‟Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials", (accessed on December 9, 2013).