Biosafety and Biosecurity in Containment: A Regulatory Overview

Abstract

When biosafety for contained use is addressed in international fora and discussions, often the topic is limited to working with genetically modified organisms (GMOs) in facilities such as laboratories, animal facilities, and greenhouses. However, the scope of biosafety in containment encompasses many other types of biological materials, such as human, animal and plant pathogens, nucleic acids, proteins, human samples, animals or plants, or by-products thereof, and overlaps often with the topic of biosecurity. This is also reflected in the regulations that apply for activities with biological materials in contained facilities. The common denominator of these regulations is the focus on protection of people and environment, while applying the key principles of risk assessment and risk management. This review provides an overview of regulatory frameworks for biosafety and biosecurity in containment around the globe, as well as points out overlap with other regulatory frameworks, such as the Nagoya Protocol, or Plant and Animal Health regulations.

Implementation of Bio-Risk Management System in a National Clinical and Medical Referral Centre Laboratories

“…All laboratories handling clinical and environmental specimens should meet a basic standard or requirement in order to achieve a good implementation of bio-risk management, involving the knowledge of the current biosafety level, the availability of protocols regarding the chain of guardianship, risk identification, and guidelines in safe handling of biological agents [23]. Various tools and guidelines on biosafety and biosecurity have been established and used as global assessment tools, such as WHO bio-risk management (2006), Centre for Disease Control and prevention (CDC) guidelines for safe work practices in human and animal medical diagnostic laboratories (2012), and the Canadian Biosafety Standard (2015) [21]. Recently, ISO has proposed a standard for bio-risk management for laboratories and other related organisation under ISO 35001:2019.…”

“…The tool also includes several aspects to be assessed, such as the context of organisation, leadership, support, planning, operation, performance evaluation and improvement [20]. Hence, this study aims to identify the gap between bio-risk management system implementation and requirements in the ISO 35001:2019 at a national referral laboratory centre [21]. The National Clinical and Medical Referral Centre Laboratories in Indonesia have a potential of daily exposure to dangerous biological materials during sampling activities in the laboratory.…”

Biosecurity in an age of open science

“…However, some life science research has the potential to be misused. Misuse risks can be classified into biosafety risks, concerning accidental exposure and release, and biosecurity risks, concerning deliberate misuse [ 3 ]. As biotechnology grows more powerful and accessible [ 4 ], risks from accidental or deliberate misuse of research may increase.…”

Evaluation of infectious risk among biomedical agents in Morocco

“…It is about principles, containment technologies and practices, which are implemented to prevent unintentional exposure to pathogens and toxins or their accidental release. 1,2 The risk of infection among biomedical technicians and engineers (BMTE), as well as healthcare personnel, is a major public health problem, particularly in developing countries. 3 The risk of acquiring an infection is influenced by many variables.…”