Biosafety and Biosecurity Policy (2024)

Dual Use Research of Concern

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

Watchthe video“Dual Use Research: A Dialogue”

Research Involving Enhanced Potential Pandemic Pathogens (ePPP)

The U.S. Government and the Department of Health and Human Services define enhanced potential pandemic pathogen(ePPP) research as research that may be reasonably anticipated to create, transfer or use potential pandemic pathogens resulting from the enhancement of a pathogen’s transmissibility and/or virulence in humans.

ePPP research can help us prepare for the next pandemic, for example by informing public health and preparedness efforts including surveillance and the development of vaccines and medical countermeasures. However, such research requires strict oversight and may only be conducted with appropriate biosafety and biosecurity measures.

The HHSFramework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework)was established in 2017 to guide HHS funding decisions on proposed ePPP research and aims to preserve the benefits of life sciences research involving ePPPs while minimizing potential biosafety and biosecurity risks. The HHS P3CO Framework is responsive to and in accordance with theRecommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversightissued by the White House Office of Science and Technology Policy following a three-year, public deliberative process.

Department of Health and Human Services P3CO Framework

Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens

U.S. Government Policy on Enhanced PPP Research

Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

TheNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules(NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

  • NIH Guidelines – April 2024 (PDF) (Printer friendly for duplex printing)
  • NIH Guidelines – April 2024 (HTML)

Incident Reporting

The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses” be reported to OSP within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).

  • Incident Reporting FAQs – December 2023
  • Incident Reporting Template – April 2019

*Incident reports may be released to the public in full. Please note that incident reports should not include personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in the report. If it is necessary to include such information, please clearly mark it as such so that it can be considered for redaction in accordance with Freedom of Information Act exemptions.*

IBC RMS and Registration Information

The Institutional Biosafety Committee Registration Management System (IBC-RMS) supports the online submission of IBC registrations and annual registration updates. IBC-RMS users can access the system to keep track of their institution’s registration status, view IBCs currently registered with OSP, and access important compliance guidance relating to the NIH Guidelines. The IBC-RMS also allows users to send policy questions directly to OSP through the Web interface.

  • Institutional Biosafety Committee Registration Management System (IBC-RMS)

IBC Self-Assessment Tool

  • IBC Self-Assessment Tool – April 2024

Investigator Brochure

  • Investigator Responsibilities under theNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules– October 2021

Links to Other Biosafety Resources

Additional Resources

Biosafety and Biosecurity Policy (2024)

FAQs

What is biosafety and biosecurity summary? ›

Whereas biosafety aims at protecting public health and environment from accidental exposure to biological agents, biosecurity deals with the prevention of misuse through loss, theft, diversion or intentional release of pathogens, toxins and any other biological materials.

What are the 8 pillars of biosecurity? ›

  • Biosecurity awareness.
  • Personnel reliability.
  • Transport security.
  • Information security.
  • Accountability for materials.
  • Emergency response.
  • Physical security.

What is the conflict between biosafety and biosecurity? ›

Biosafety provides policies and practices to prevent the unintentional or accidental release of specific biological agents and toxins, whereas biosecurity provides policies and practices to prevent the intentional or negligent release of biological materials or the acquisition of knowledge, tools, or techniques that ...

Do you think that biosafety and biosecurity in the laboratory is important? ›

Biosafety and biosecurity ensures that risks associated with research or development of harmful biological agents are minimized, thus protecting the health of humans and animals involved in such activities. This is important to prevent infection or exposure that could endanger their life and health.

What is the main goal of biosafety? ›

The basic objective of a biosafety program is the containment of potentially harmful biological agents. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.

What is biosafety in your own words? ›

Biosafety is a framework that describes the use of specific practices, training, safety equipment, and specially designed buildings to protect the worker, community, and environment from an accidental exposure or unintentional release of infectious agents and toxins.

What are the 3 principles of biosecurity? ›

These three components come under three guiding principles of biosecurity, which are: bio-exclusion – the prevention of outside agents from entering a farm or other facility and spreading among the animal population; bio-management – the way in which disease spread is prevented within the farm or facility including the ...

What are the 4 levels of biosecurity? ›

The four biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4, with BSL-4 being the highest (maximum) level of containment. There are additional specific rules and designations for animal research (ABSL), agricultural research (BSL-Ag), and other types of research.

What are the 3 biosecurity essentials? ›

Biosecurity has three major components: Isolation, Traffic Control, Sanitation.

What are two types of biosecurity? ›

  • Primary biosecurity: the prevention of pathogen spread between farms.
  • Secondary biosecurity: prevention of pathogen spread within a farm.
  • Tertiary biosecurity: measures that increase the resistance or immunity of the animals against pathogens.

What is another word for biosafety? ›

Biosafety, Biosecurity, and Biorisk Management are three terms that are often used interchangeably but in fact they have different meanings and implications.

What is an example of biosecurity? ›

Biosecurity examples: Biosecurity measures include quarantining new animals, disinfecting equipment and vehicles, and restricting access to agricultural fields. Biosecurity measures in microbiology labs include the implementation of biosafety levels and the routine sterilisation of lab equipment.

What are the biosafety policies? ›

Biosafety guidelines are a set of policies, rules, and procedures necessary to observe by personnel working in various facilities handling microbiological agents such as bacteria, viruses, parasites, fungi, prions, and other related agents and microbiological products.

What is the most important aspect of biosecurity? ›

In domesticated animal farming, maintaining the animals' sterility and ensuring the production of safe food are the two main objectives of biosecurity (Roberts, 2015).

What are biosecurity risks? ›

A biosecurity risk is anything that could increase the impacts of pests, diseases, weeds or contaminants on the economy, environment or community. The risk may not directly impact you and your property, but may impact someone else. By law, you must still take steps to address these risks.

What is the summary of biosecurity? ›

“Biosecurity is the management of risks to the economy, the environment, and the community, of pests and diseases entering, emerging, establishing or spreading.” Biosecurity is a holistic term that includes policies and regulations to protect humans, food, agriculture, and the environment from potential biological ...

What is the biosecurity Act summary? ›

The BIOSECURE Act has two core areas of focus: First, the legislation would prohibit federal agencies from directly procuring services from or funding (by federal loan or grant) a “biotechnology equipment or service” from a “biotechnology company of concern” (defined below).

What is biosecurity in your own words? ›

Biosecurity is defined as the strategic approach to analyzing and managing risks to human heath, animal and plant life and the associated risks to the environment. It is based on recognition that hazards have the potential to be deliberately or accidentally misused resulting in harm.

What are the pillars of biosafety and biosecurity? ›

A biosecurity program rests upon five pillars: inventory process, physical security, a personal reliability program, transport programs, and information security processes. A biosecurity program must have an overall program management that supports the five pillars.

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