In addition to biosecurity requirements and standards outlined in laws and executive policies, there are several overarching principles and strategies set forth to demonstrate the principles and objectives of the United States Government towards biosecurity and safeguarding the nation against the misuse of biological materials. These documents do not focus on the individual tenets of biosecurity – physical, information (cyber), or personnel reliability – but rather they address more than one of these disciplines under a biorisk management approach.
There are biosecurity publications that are internationally recognized as good practice and may or may not be enforced standards in other countries. In the United States, they may be used as references to demonstrate international efforts to share voluntary standards to promote safe and secure laboratory practices. These efforts, as well as training developed by U.S. Government agencies, have contributed to a national understanding about the importance of securing facilities which possess or use biological agents (e.g., conducting research with these assets).
There are also advisory groups and task forces that issue reports on the status of current biosecurity efforts or make recommendations for future improvements. The following descriptions are brief summaries of the applicable voluntary guidance, recommendations, and training, with links to the full references and points of contact for further information, if applicable.
U.S. Government Policy on Oversight of Life Sciences Dual Use Research of Concern
This policy establishes regular review of U.S. Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be Dual Use Research of Concern (DURC) in order to mitigate risks as appropriate and collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. More information on DURC.
United States Government Policy for Institutional Oversight of Life Sciences DURC
The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication of DURC. More information on DURC.
Department of Health and Human Services Framework on H5N1 DURC Research
In February 2013, HHS developed a Framework for Guiding Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets to guide funding decisions on proposals for research anticipated to generate HPAI H5N1 viruses that are transmissible by respiratory droplets among mammals. The new Framework outlines a robust review process that takes into account the scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures pertinent to the proposed research.
White House National Strategy for Countering Biological Threats
Advances within the life sciences hold extraordinary potential for beneficial progress, but they also can empower those who would use biological agents or toxins for ill purposes. Addressing these unique challenges requires a comprehensive approach that recognizes the importance of reducing threats from outbreaks of infectious diseases whether natural, accidental, or deliberate in nature. This Strategy articulates a vision of shared commitment wherein the United States Government works with domestic and international partners to advance the health security of all people. It recognizes that the life sciences require tailored approaches to mitigate the potential for misuse with minimal impacts on beneficial use and establishes a series of mutually reinforcing activities to address specific threats as they arise.
CDC Laboratory Biosecurity Training
This training describes key principles for securing biological agents and toxins in research laboratories and biomedical facilities where loss, theft, release, or intentional misuse of the agent or toxin might have significant public health or economic consequences. This training defines the term biosecurity, delineates differences and similarities between biosafety and biosecurity, and describes components of a laboratory biosecurity program. Successful biosecurity programs should have full support from all levels of management, be site-specific, and be based on an understanding of facility assets and needs. Identifying which agents and infrastructure that need to be protected is an individual organization’s management decision. Biosecurity programs should apply corresponding security measures by using a graded approach to reduce risk to an acceptable level.
Report of the Defense Science Board Task Force on Department of Defense Biological Safety and Security Program
The Defense Science Board Task Force on the Department of Defense Biological Safety and Security Program issued a report in May 2009 examining the biological safety, security, and personnel reliability programs of DoD’s biological labs in comparison to similar operations in academia, industry, and the federal government. The task force found that the safety and security of the DoD facilities assessed were as good or better than comparably sized government, industry, and academic facilities. However, the task force did make recommendations to further improve security and safety, as the single overarching finding was that a determined adversary cannot be prevented from obtaining very dangerous biological materials intended for nefarious purposes, whether from a DoD laboratory or from another source.
U.S. Department of Defense Manual 6055.18-M: Safety Standards for Microbiological and Biomedical Laboratories
This Manual prescribes the technical safety requirements and the requirement of a biological safety plan for all BSL-2 and higher DoD biomedical and biological research settings, microbiology teaching laboratories, veterinary reference laboratories, and nonclinical facilities that use, handle, transport, transfer, store, or dispose of infectious agents and toxins. Enclosure 4 describes in detail the biological safety program that must be in place at DoD laboratories, based on the biosafety level. Enclosure 4 also includes commissioning criteria and laboratory safety inspection checklists. Other enclosures include key biosafety practices, safety equipment, and PPE requirements.
CEN CWA 15793: Laboratory Biorisk Management Standard (expired)
This laboratory biorisk management standard is based on a management system approach. The management system approach enables an organization to effectively identify, monitor, and control the laboratory biosafety and biosecurity aspects of its activities. The requirements of this standard are performance based, generic, and are intended to be applicable to all organizations handling biological agents or toxins, regardless of the type or quantity of biological agents handled. This standard takes a risk-based approach, but it does not employ biological agent risk classification or laboratory safety/containment levels, although such approaches can be entirely compatible with this approach.
OECD Best Practice Guidelines on Biosecurity for Biological Resource Centres
Endorsed by the Organization for Economic Cooperation and Development (OECD) member countries, these best practices are provided to support governments in the recognition of Biological Resource Centers, and describe the methods and protocols for secure maintenance and provision of biological materials. Biological Resource Centers “consist of service providers and repositories of the living cells, genomes of organisms, and information relating to heredity and the functions of biological systems” (OECD, 2001 ).They are designed to secure all types of biological materials in proportion to the risk they present. This guide consists of an approach consisting of two key components: performing a risk assessment of the various biological materials held in collections and recommended risk management practices to reduce the risk of their loss or theft.
WHO Biorisk Management: Laboratory Biosecurity Guidance
In recent years, several countries have developed and implemented laboratory biosecurity legislation to regulate the possession, use, and access to biological materials. Despite the advances of some countries, in many other countries and for many laboratories, guidance or specific requirements for the appropriate handling and storage of valuable biological materials (VBM) do not yet exist. Valuable Biological Materials are “biological materials that require (according to their owners, users, custodians, caretakers or regulators) administrative oversight, control, accountability, and specific protective and monitoring measures in laboratories to protect their economic and historical (archival) value, and/or the population from their potential to cause harm” (WHO). Within a comprehensive biorisk management approach, this document aims to define and guide the reader in the field of laboratory biosecurity. It is addressed to laboratories wishing to handle and store VBM, and discusses the legal framework within countries holding and supporting such laboratories.
WHO: Laboratory Biorisk Management: Strategic Framework for Action 2012–2016
This document presents a strategic framework, aimed at the development of sustainable global, regional, and national plans relating to laboratory biorisk management. Under the International Health Regulations (IHR ) , all State Parties have made a legally binding commitment to assess, develop, and maintain their national core capacities for surveillance, assessment, and response. Laboratory services are essential to identify and confirm the agents involved in important public health events, including those which may cause public health emergencies of international concern (PHEIC). The management of laboratory biorisk is addressed through the implementation of appropriate biosafety and laboratory biosecurity measures. At present, there is no overarching framework or global strategy in this area to provide strategic direction to ensure that investments are planned and implemented appropriately to meet these needs. This plan sets out a basis and rationale for WHO’s role in supporting the measures and mechanisms required to move towards the objective of supporting safe and secure environments in and around every laboratory in the world.
WHO: Laboratory Quality Management System
This handbook is intended to provide a comprehensive reference on the Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for the quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. The laboratory is responsible for assuring safety and security, for containment of any infectious materials, for dealing appropriately with waste management, and for following all regulations for the transport of dangerous goods.
WHO: Responsible Life Sciences Research for Global Health Security
The purpose of this guidance is to inform WHO Member States about the risks posed by laboratory accidents or the potential deliberate misuse of life sciences research and to propose measures to minimize these risks within the context of promoting and harnessing the power of the life sciences to improve health for all people. Although the issues addressed in this document can potentially interest quite a lar¬ge audience, the proposed measures and the self-assessment questionnaire are of a public health nature. Health researchers, laboratory managers, and research institutions are therefore the primary audience of this guidance. Laboratory biosecurity, which is not only com¬plementary to good biosafety practices, but also an integral part of an overall laboratory biorisk man¬agement system, addresses the safekeeping of all valuable biological materials (VBM), which include not only pathogens and toxins, but all biological materi-als which are scientifically, historically, or economically important.
U.S. Department of Agriculture/Office of Inspector General's Reviews
U.S. Department of Health and Human Services/Office of Inspector General's Reviews
U.S. Government Accountability Office (GAO)'s Reviews