The pace of innovation in the Life Sciences field is accelerating, and the regulatory oversight of the resulting products and technologies needs to evolve and adapt accordingly.

Using gene editing techniques as an example, from the first applications of CRISPR-based methodologies just a few years ago to the present day, the generation of novel applications, editing tools, methodologies, and products has been faster than ever.

Also, the demand for bio-based solutions in agriculture, food production, and the environment is growing everywhere and will keep growing, and specific criteria for biosafety assessments will be required.

Progressive and adaptive criteria for biosafety assessments require a collaborative effort across disciplines, risk assessment experts, and institutions around the globe to enable fit-for-purpose regulations that promote the safe implementation of innovations and their accessibility to society.

It is timely to compile a set of publications in one issue, which provides an overview of different aspects of the current challenges to adapt biosafety considerations for innovative biotechnological applications.

The main goal of this Research Topic is to provide a contextual, technical, and conceptual base to build upon when considering the evolution and future direction of biosafety regulations.

In this context, revisiting the scientific rationale for assessing gene technologies (particularly transgenics) in the light of current knowledge and experience is of interest as we advance. In particular, biologicals seem an appropriate case to discuss fit for purpose and adaptive criteria, as it is one of the fields that will be expected to grow the most in the near future, with diverse applications in agriculture, novel foods, the environment, and others.

The need for clear and harmonized definitions and language is also vital in achieving modern, transparent, and sustainable regulatory frameworks, which determine the feasibility of many R&D projects reaching the market (especially public sector and small companies).

Other aspects to be featured in this Research Topic, like the role of regulatory cooperation, experimentation (“sandboxes”) and harmonization, and the societal acceptance factor, are also critical aspects to consider when discussing the future of biosafety regulations.

Areas to be covered in this Research Topic may include, but are not limited to:
• Biosafety revisited: Are current criteria fit for purpose? What makes sense and what does not from the current risk science perspective?
• GMOs: where to focus going forward (over 30 years of experiences/learnings, case studies, process vs product?
• Biologicals: (applications in agriculture, food, environment, etc.) - they are not plants, not chemicals…how should a “GM” microbe be defined? Is there a consensus?
• Emerging and re-emerging discussions on innovative technologies
• Synthetic biology
• Molecular Farming
• Clear language: words matter (definitions and concepts in regulatory guidelines and normative interpretation)
• The role of regulatory diplomacy in achieving global progressive regulations
• Gene Editing: global harmonization and international trade, is it possible?
• Adaptive regulations – Regulatory sandboxes – collaborative working models - the role of AI
• The commercialization challenges of including societal-economic implications-
• Acceptance/perception of innovations, impact on regulatory frameworks

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Frontiers in Bioengineering and Biotechnology

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