Resultant Changes to Regulatory Approaches
Stakeholders can expect pragmatic changes in regulatory approaches within Canada and the US based on the outcomes of the five Work Elements. These include a consistent policy approach for nanomaterials based on shared policy principles and consistent use of the nanomaterial classification scheme to:
- identify data needs (short-term);
- support the use of analogue/read-across information (That is, identification of a chemical analogue to the nanomaterial in question and allocation of known characteristics from that analogue to the new nanomaterial) for risk assessment (medium to long-term);
- consistently use data submitted to support risk assessments based on the framework for human health information and common assumptions for ecological fate and effects; and,
- deploy use information to characterise exposures in risk assessments and focus information requests for new activities.
Stakeholders should expect these changes to be implemented as the two countries continue to dialogue and undertake implementation activities.
Advantages of Regular Engagement
The RCC Nanotechnology Initiative enhanced the level of collaboration between the Canada/US Programs at both the working and senior management levels. Stakeholder engagement throughout this collaboration ensured that the work remained both relevant and beneficial to the regulated community. A government/stakeholder technical team was established which included key industry, government, non-government and academic partners which provided expertise and facilitated outreach to relevant groups to support delivery of the RCC Work Plan Elements. Both government and stakeholders found this process very useful; the technical team will continue to actively assist implementation of the approaches developed.
The RCC Nanotechnology Joint Initiative’s success was predicated on the ability of the Canada- and US-based counterparts’ abilities to address challenges. One significant challenge was the sharing of confidential business information (CBI), which must generally be safeguarded to protect industry’s competitive advantages. Ideally, open sharing of all CBI between the two programs would have led to more informed improvements to the regulatory processes of nanomaterials; however, due to the nature of each country’s regulatory framework, neither country was able to share CBI. As an alternative to a broader study, both countries sought permission to conduct a case study within Work Element 3 on a single nanomaterial that both jurisdictions had previously assessed in order to analyse and compare risk assessment and risk management approaches to support the RCC process.
A Path Forward for Harmonization
Although implementing the RCC approaches developed within the five Work Elements will improve regulatory harmonization, all stakeholders agree that a joint submission process would be optimal. In that scenario, a company would submit a substance for assessment to both jurisdictions at the same time; ensuing risk assessment conclusions would be delivered simultaneously. A joint submission process would, however, require significant regulatory changes which are not being considered at this time. As an alternative to regulatory changes, and as an incremental step forward, at the January 2014 RCC Nanotechnology Results Workshop, a proposal was brought forth by industry to conduct joint pre-notification/notice consultations (PNCs). PNCs are used by submitters as an informal tool to discuss regulatory requirements. Both Canada and the US have been involved with many PNCs associated with nanomaterials and conducting them jointly would improve collaboration, alignment and consistency. The two governments are relying on industry stakeholders to inform their partners of this mechanism and to consider jointly submitting PNC requests; industry support – and the joint submissions initiative’s success - will be measured by the number of joint PNC submissions that are actually made.
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