Multi-sector workshop on innovative regulation: Challenges and benefits of harmonising the licensing process for emerging technologies

Multi-Sector regulation workshop, December 2020

While regulatory frameworks vary across industrial sectors and countries, they all share a common goal: to ensure that a particular technology can benefit society while the risks of using that technology are maintained at the lowest acceptable levels. Therefore, despite having different legal frameworks and safety standards, regulators from different sectors and countries can learn from each other by exchanging best practices, especially to address innovative technologies.

In this context, the NEA organised a virtual workshop in collaboration with the Canadian Nuclear Safety Commission (CNSC) on 14-18 December 2020 to discuss the best regulatory practices that the nuclear sector can adopt from non-nuclear sectors when licensing new and innovative technologies. The workshop provided a forum for regulators and stakeholders from different sectors to exchange experiences of standardisation, design review, licensing and reporting systems, and international co-operation.

NEA Director-General William D. Magwood, IV delivered opening remarks, followed by a keynote address by CNSC President and Chief Executive Officer Rumina Velshi.

“Nuclear regulators today are faced with new technologies, such as micro reactors and mobile reactors,” said NEA Director-General Magwood during his opening remarks to the audience of experts from nuclear, aerospace, pharma, and other sectors. “While we are dealing with different technologies, different industries and different terminologies across industries, regulators are dealing with very similar core issues.”

CNSC President and CEO Velshi underlined the importance of international co-operation during her keynote address. “Since many regulators share common goals of safety at all times and being at a state of readiness to regulate innovative technologies, it makes sense to collaborate as much as possible and make best use of our limited resources with human information or technology,” she noted.

The five-day workshop brought together high-level experts from regulatory bodies, international organisations and industry representatives from a wide range of sectors. The participants exchanged insights on harmonised, efficient, and effective regulatory processes within the context of innovation. They focused particularly on the following key challenges:

1) How to set clear regulatory requirements for safety that are risk-informed and reflect an understanding of the actual risks posed by the technologies but that also allow room for and encourage innovation and technical advancement.

On setting regulatory requirements that are risk-informed and that also allow for innovation and advancements, participants stressed the need for a performance- or objective-based regulatory approach that provides a flexible framework.

2) How to leverage lessons learnt and operational experience on harmonisation from other high reliability sectors, such as aviation, transportation and medical technologies.

Workshop participants suggested that there are some good universal regulatory best practices to consider. Those include i) staying focused on objectives, ii) strong international collaboration, and iii) leveraging industry best practices to consult stakeholders on developing standards.

3) How to correctly balance between harmonisation and national regulator’s sovereignty

Participants suggested that the nuclear sector could make progress in balancing harmonisation and sovereignty by regulating using a risk-informed approach without compromising safety and by involving technical experts from various fields in the development of harmonised standards and requirements.

4) How to embark on this journey while ensuring public trust in the regulators, as well as in their processes and decisions.

On ensuring public trust, participants agreed that regulators need to maintain their independence and objectivity and that they should avoid being seen as too close to the industry. Stakeholder engagement should start early and be continued throughout the regulatory process. Stakeholder engagement should also reflect diversity; consultation with a large variety of audiences is essential to i) building relationships, ii) ensuring different perspectives are considered, and iii) earning the public’s confidence.

“One thing I hear today that particularly resonated with me is the need for adaptive processes and approaches to regulation that rely more on trial and error, rapid feedback loops and a more responsive iterative approach,” Velshi noted during her closing remarks. “In other words, the need for regulators to prioritise agility. That is something we have embraced at the CNSC and I know some of my other regulator colleagues have done so as well.”

The workshop concluded with a poll through which participants were able to express their views on the similarities between nuclear safety regulation and the regulation of other high reliability sectors, such as the air transportation, chemical, medical and radioactive material transport sectors. According to the poll results, most participants found the air transportation sector to be the most similar to the nuclear sector.

“Nuclear is different; nuclear is not the same as pharma, it is not the same as aviation,” Director-General Magwood noted in his closing remarks. “But there are lessons to be learnt. And the purpose of this workshop was to see where they might be some things we can pull into the nuclear sector and advance our discussion about harmonisation and innovation.”

A summary report of the workshop and its outcomes is in preparation. The report will identify actions that could be taken by policy makers, regulators, industry and intergovernmental organisations in order to advance nuclear regulatory harmonisation and innovation.

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