Work Element Outcomes
Work Element 1, “Principles”, of the Nanotechnology Work Plan focused on the development of shared policy principles between Canada and the US to guide the regulatory oversight of nanotechnology across government departments and agencies. Canada reviewed the policy principles that had been developed by the US (click here for report), amended them to ensure they were applicable within the Canadian regulatory landscape and, in 2014, adopted them as Government of Canada policy principles. These policy principles promote scientific integrity with the flexibility to take into account new knowledge, consistency in risk assessments and risk management, awareness of potential benefits and potential costs of regulations, openness and transparency in decision-making, communication with stakeholders, and coordinated activities including domestic and international research.
Within Work Element 2, “Priority-Setting”, a classification scheme for nanomaterials was developed to assist in the Canada/US Programs’ regulatory processes. This classification scheme is based on similarities in chemical composition (e.g., considering carbon nanotubes and titanium dioxide nanoparticles as different classes). It is designed to identify which types of nanomaterials the Canada/US Programs typically assess using nano-relevant information, and provide a framework upon which information from one nanomaterial can be used to assess another - similar - nanomaterial (analogue/read-across). As noted by stakeholders, this classification scheme is a first step; additional work is needed in order to apply it in a regulatory setting. Applying analogue/read-across information in a regulatory setting will be the main task moving forward under this work area. In addition, research is still needed to validate identified classes and further refine them for specific regulatory needs by, for example, identifying toxicological modes of action for each class. This classification scheme will also be discussed internationally under the OECD (e.g., at the WPMN Expert workshop on categories in fall 2014) and subsequently refined.
Work Element 3, “Risk Assessment/Management”, focused on comparing the two countries’ risk assessment processes and identifying common best practices. To achieve this, the two countries undertook a comparative analysis of their respective legislative and regulatory frameworks and identified areas of commonalities and differences and shared tools (such as models) used in risk assessments for nanomaterials. Further, to better identify the specific similarities and differences in their respective risk assessments, a joint Canada/US case-study was done to compare a risk assessment that had been completed on the same nanomaterial in each country. Multi-walled carbon nanotubes were chosen for the case-study after consultation with stakeholders, using jointly-developed criteria to determine the best candidate. Outcomes of these activities indicated that both countries conduct risk assessments in a similar manner; most variances stem from differences in their respective legislative and regulatory frameworks. To increase alignment, both countries developed a flow chart to provide consistency on how human exposures are identified and on the types of human health information needed by the Canada/US Programs. In addition, common assumptions for evaluating ecological fate and effects were developed to help the two countries consider releases to the environment in a consistent manner and to apply OECD guidance. To validate these approaches, both countries are considering additional case studies.
Work Element 4, “Commercial Information”, was aimed at increasing knowledge of commercial uses of nanomaterials in Canada and the US. This uses knowledge is critical for regulators as it supports better informed exposure scenarios in risk assessment, as well as better use of control measures. In addition, existing databases on commercial uses lack sufficient validation to be used for regulatory purposes. With active collaboration from industry and other government departments, a table was developed which identified nanomaterials and their associated uses in Canada and the US. Through this work paints, coatings, and composites were identified as the largest uses of nanomaterials in Canada and the US. Moving forward, both countries are analysing the use information in the context of the classification scheme developed under Work Element 2 to determine what can be learned about nanomaterial composition, function, and type of uses. The different types of uses also provide information into the types of generic release scenarios needed for nanomaterials in order to evaluate releases from industrial sites. In addition, Canada and the US are considering how to supplement use information with information on the quantity of nanomaterials being used, which is key to improving certainty in exposure assessments.
Work Element 5, “Regulatory Cooperation in Areas of Emerging Technologies”, identified lessons learned from the RCC Nanotechnology Work Plan and considered how to apply those lessons to other emerging technologies. A framework was developed to promote regulatory alignment between Canada and the US for other emerging technologies. RCC contracted academic experts to complete this project; the ensuing framework includes early identification of priorities, engagement at different working and management levels between the two countries, and the development of appropriate expertise to adequately ensure the safety of emerging technologies while also fostering innovation.
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