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Safety Precautions and Operating Procedures in an ABSL-4 Laboratory: 3. Aerobiology

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Responsible Learning About Risks Arising from Emerging Biotechnologies.

Britte Bouchaut¹, Lotte Asveld²

¹Department of Biotechnology, Section of Biotechnology and Society, Delft University of Technology, Van der Maasweg 9, 2629 HZ, Delft, The Netherlands. B.F.H.J.Bouchaut@tudelft.nl.

Science and Engineering Ethics

|March 29, 2021

Summary

The Safe-by-Design (SbD) approach enables responsible learning about uncertain risks from new biotechnologies. Its full potential requires regulatory flexibility, co-responsibility, and stakeholder openness for effective risk management.

Keywords:

Forward-looking responsibility GMO regulation Precautionary principle Risk management Safe-by-design

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Area of Science:

Biotechnology
Risk Assessment
Regulatory Science

Background:

Genetic engineering, including CRISPR-Cas, advances biotechnology but poses uncertain risks.
The European Union's Precautionary Principle guides risk management for health and environmental safety amid uncertainty.
Assessing consequences of novel biotechnologies is challenging due to non-compliance with established risk assessment norms.

Purpose of the Study:

To explore the Safe-by-Design (SbD) approach as a framework for responsible learning in biotechnology.
To identify critical conditions for enabling a controlled learning environment to address uncertain risks.
To argue for the necessity of specific conditions for the effective implementation of SbD.

Main Methods:

Conceptual analysis of the Safe-by-Design (SbD) approach.
Examination of the Precautionary Principle in the context of emerging biotechnologies.
Argumentative framework based on identified necessary conditions for responsible learning.

Main Results:

The Safe-by-Design (SbD) approach can facilitate responsible learning about unknown risks in biotechnology.
Three essential conditions are identified: regulatory flexibility, co-responsibility between researchers and regulators, and openness to all stakeholders.
The absence of any of these conditions hinders the full potential of SbD and responsible learning.

Conclusions:

Implementing Safe-by-Design (SbD) effectively requires a supportive ecosystem.
Regulatory flexibility, co-responsibility, and stakeholder engagement are crucial for managing uncertain risks in biotechnology.
Failure to meet these conditions may leave policies lagging behind technological advancements and their potential risks.