IM OSQI 2026-01 USGS Biosafety Program and USGS Institutional Biosafety Committee
U.S. GEOLOGICAL SURVEY DIRECTIVE
INSTRUCTIONAL MEMORANDUM
Issuance Number: OSQI 2026-01
Subject: USGS Biosafety Program and USGS Institutional Biosafety Committee
Issuance Date: May 1, 2026
Expiration Date: Retain until superseded or cancelled.
Responsible Office: Office of Science Quality and Integrity
Instruction: This is a new Survey Manual (SM) Instructional Memorandum (IM).
Approving Official: /s/ William (Bill) Cunningham
Acting Director, Office of Science Quality and Integrity
1. Purpose and Scope.
The USGS is committed to the safe and responsible execution of science activities involving biohazards. This directive establishes and outlines the essential functions for the U.S. Geological Survey (USGS) Biosafety Program and the USGS Institutional Biosafety Committee (IBC), both of which support the mission of the USGS in maintaining credibility, ensuring public trust, and fostering a culture that prioritizes safety and accountability.
This directive applies to USGS science activities (including those in the laboratory or field) involving the handling, collection, detection, transport, storage, manipulation, or characterization of biohazards, whether intentional or incidental. This directive applies to all personnel performing work for or supporting USGS scientific activities, including employees, volunteers, external partners, emeriti, contractors, and students (further referred to as “USGS personnel”).
2. Authority.
A. Executive Orders.
(1) Executive Order 14292, Improving the Safety and Security of Biological Research (Effective May 5, 2025)
(2) Executive Order 14303, Restoring Gold Standard Science (Effective May 23, 2025)
B. Occupational Safety and Health Administration Labor Standards.
(1) 29. C.F.R. Part 1904, Recording and Reporting Occupational Injuries and Illnesses
(2) 29 C.F.R. Part 1910, Occupational Safety and Health Standards
(a) Subpart I – Personal Protective Equipment
(b) Subpart J – General Environmental Controls
(c) 29 C.F.R. Part 1910.1030, Bloodborne Pathogens
(d) 29 C.F.R. Part 1910.1450, Occupational exposure to hazardous chemicals in laboratories
(3) 29 C.F.R. Part 1960, Basic Program Elements for Federal Employee Occupational Safety and Health Programs and Related Matters
C. Select Agents and Toxins, Plants, and Imports.
(1) 7 C.F.R. Part 330, Federal Plant Pest Regulations; General; Plant Pests, Biological Control Organisms, and Associated Articles; Garbage
(2) 7 C.F.R. Part 331, Possession, Use, and Transfer of Select Agents and Toxins (Agriculture)
(3) 9 C.F.R. Part 121, Possession, Use, and Transfer of Select Agents and Toxins (Animal and Animal Products)
(4) 42 C.F.R. Part 71.54, Foreign Quarantine, Centers for Disease Control (CDC) Import Regulations for Infectious Biological Agents, Infectious Substances, and Vectors)
(5) 42 C.F.R. Part 73, Select Agents and Toxins (Public Health)
D. Animal Care and Use.
(1) 50 C.F.R 16, Injurious Wildlife (provisions of the Lacey Act)
(2) Title 9, Animal Welfare Act (AWA) Public Law 89-544 and its Regulations (AWAR)
3. References.
A. SM Part 502, Fundamental Science Practices
B. SM 445.1, Occupational Safety and Health Policy and Responsibilities
C. SM 431.1, Records Management Roles and Responsibilities
E. Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
G. United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential
4. Definitions. The definitions provided below are specific to their use within this directive.
A. Biohazard (biological hazard) – Biological material that poses a threat to the health of living organisms (e.g., humans, animals, insects, plants) or the environment. Biohazards can include pathogens, prions, tissues, infected animals, venomous wildlife, parasites, biological toxins, and recombinant or synthetic nucleic acid molecules. Biohazards can be found in the environment, in organisms, or in samples collected from these sources.
B. Biosafety – The application of safety precautions that reduce an individual’s risk of exposure to a potential biohazard and limit contamination of the work environment and, ultimately, the community.
C. Biosafety Level (BSL) – A designation assigned to a laboratory space based on the risk associated with work involving a biohazard. These designations, ranging from BSL-1 (lowest risk) to BSL-4 (highest risk), specify the laboratory practices, safety equipment, and facility design necessary to protect people (e.g., laboratory personnel, other personnel working in the facility, the public) and the environment. USGS will adhere to the BSL requirements and designations as defined by industry standards, including the latest edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), to ensure consistent and compliant laboratory operations.
D. Gene Drive Modified Organisms – Organisms that have been genetically modified to pass on a specific gene or trait to most or all their offspring.
E. Institutional Review Entity – As defined by the 2012 Federal Dual Use Research of Concern Policy, a committee established to assess proposed scientific research that may fall under the definition of Dual Use Research of Concern or Pathogens with Enhanced Pandemic Potential.
F. Pathogens – Microorganisms, such as bacteria, viruses, fungi, that cause disease in humans, animals, or the environment.
G. Recombinant and Synthetic Nucleic Acid Molecules – As defined by the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or molecules that result from the replication of those described in (a) or (b) above.
H. Risk Groups – Classification system which defines the hazard level of biohazards from 1 (lowest) to 4 (highest), based on their ability to cause disease and the severity of disease in healthy humans or animals.
I. Science Activities – As defined in 305 DM 3, activities that employ the scientific method for inventorying, monitoring, experimenting, studying, researching, and modeling.
5. Policy.
A. The USGS Biosafety Program establishes biosafety practices and procedures relevant to USGS science, personnel, and facilities to support the safety of USGS personnel, the public, and the environment in accordance with industry standards, including the latest edition of the BMBL. Science activities that include intentional or incidental work or contact with biohazards must follow established biosafety practices and procedures for safe execution. Biosafety practices and procedures focus on mitigation measures to reduce the risk of accidental exposures to biohazards, minimize the risk of contamination, and safeguard against unintended release of biohazards into the environment.
The following Biosafety Program essential functions are necessary for ensuring awareness of biohazards and appropriate biosafety practices for all USGS science activities:
(1) Collaboration – Promote collaboration with USGS personnel, both scientists and safety professionals, to integrate biosafety principles into science activities, strengthen overall safety practices, and ensure alignment with USGS science objectives.
(2) Training, Tools, and Guidance – Deliver biosafety training to USGS personnel that aligns with applicable guidelines, regulations, and standards to raise awareness and provide knowledge of safe work practices. Provide proactive biosafety support through guidance documents, tools, and templates that help USGS personnel recognize and address biohazards in laboratory and field settings.
(3) Biosafety Level Designation – Designate biosafety levels (BSL) for each laboratory space. USGS will adhere to the BSL requirements and designations as defined by industry standards, including the latest edition of the BMBL, to ensure consistent, compliant, and safe laboratory operations.
(4) Consultation– Provide biosafety-related consultations to promote safe practices. This includes responding to requests with tailored feedback and practical guidance and may involve advice or participation for investigating adverse safety events, conducting inspections or assessments, engaging in facility design reviews, and other activities requiring biosafety expertise.
B. The USGS IBC will review and approve science activities involving recombinant or synthetic nucleic acid molecules, gene drive modified organisms, prions, risk group 3 and risk group 4 biohazards, or other biohazards that pose a significant risk to humans, animals, or the environment (as determined by the USGS IBC). The USGS IBC performs the following essential functions:
(1) Registration and Reporting – Maintain registration as the singular USGS IBC with the National Institutes of Health (NIH) Office of Science Policy in accordance with the NIH Guidelines. The USGS IBC reports incidents involving recombinant or synthetic nucleic acid molecules and gene drive modified organisms as required.
(2) Review and Approval – Manages the evaluation of biological risks associated with proposed science activities submitted to the USGS IBC, ensuring that safety measures—such as engineering controls, work practices, and personal protective equipment—are appropriate for the work to be conducted. The USGS IBC must review and approve the proposed work and provide written notification to the personnel responsible before science activities may begin.
(3) Compliance –Functions as the Institutional Review Entity (IRE) as it relates to Executive Order 14292 and the 2024 United States Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential, as needed. The USGS IBC ensures USGS personnel are aware of the relevant policies, and reviews, approves, and reports projects in accordance with the applicable Executive Order, federal policy, or regulations.
6. Responsibilities – Specific responsibilities for the effective operation of the USGS Biosafety Program and USGS IBC are as follows:
A. USGS Director and Deputy Directors. The Director and Deputy Directors, in coordination with other members of the Executive Leadership Team (ELT), jointly ensure the USGS Biosafety Program and USGS IBC supports the mission of the Bureau. As part of this coordination, they demonstrate the organization’s commitment through provision of resources and support.
B. Associate Directors, Regional Directors. Provide management for the processes in their chain of command. They collaborate with one another, Science Center Directors (or equivalent), and the Office of Science Quality and Integrity to ensure science activities are conducted according to this directive and applicable regulations. They ensure adequate resources are available to support compliance with current regulations and directives, and that biosafety issues identified within their areas are addressed appropriately and effectively.
C. Science Centers and Center Directors. Science Centers remain responsible for implementing biosafety measures within their organizational purview. As such, Science Center Directors (or equivalent), supervisors, and any designated center staff and contractors under their direction will ensure their laboratory infrastructure is appropriately maintained and laboratory and field work is conducted and monitored in accordance with the requirements of this directive. Science Center Directors (or designees) collaborate with the USGS IBC to ensure projects involving applicable biohazards are appropriately identified and reviewed. They will also work with the USGS IBC to ensure they have the appropriate level of information to make informed decisions. Science Center Directors (or designees) will work with the USGS IBC to identify subject matter experts to serve as USGS IBC members either as appointed members or ad-hoc representatives. Finally, Science Center leadership will maintain a non-punitive reporting culture by encouraging staff to report adverse safety events, hazardous situations, and other safety-related concerns without fear of reprisal.
D. Office of Science Quality and Integrity (OSQI). OSQI maintains biosafety-related directives and procedures that support USGS science activities. OSQI ensures sufficient staffing and funding are provided for effective administration and oversight of the USGS Biosafety Program and USGS IBC.
E. USGS Safety Professionals (e.g., Regional Safety Managers, Full Time Safety Managers, Collateral Duty Safety Program Coordinators, and other personnel with safety-related duties). Safety Professionals partner with OSQI to incorporate relevant aspects of the USGS Biosafety Program and USGS IBC into their respective areas of responsibilities. Safety Professionals work with chain of command leadership (e.g., Science Center Directors) to review and recommend applicable safety and biosafety policies and assist with determining when protocols must be submitted for IBC review. Safety Professionals notify the USGS Biosafety Program of relevant biosafety related issues, concerns, and adverse safety events.
F. USGS Institutional Biosafety Committee (IBC). The USGS IBC is responsible for reviewing, approving, withholding approval, or suspending science activities involving recombinant or synthetic nucleic acid molecules, gene drive modified organisms, prions, risk group 3 and risk group 4 biohazards, or other biohazards that pose a significant risk to humans, animals, or the environment. It also ensures that appropriate risk management and mitigation measures are in place. The USGS IBC provides guidance to scientists and Science Center (or equivalent) leadership to support compliance with the review process.
G. Biosafety Senior Scientist. The Bureau Biosafety Senior Scientist leads the USGS Biosafety Program. The Bureau Biosafety Senior Scientist collaborates closely with Occupational Safety and Health Management Branch (OSHMB), Regional Safety Managers, the Biorisk Management Coordinator, and other biosafety and safety professionals across the USGS to foster a collaborative safety culture. The Bureau Biosafety Senior Scientist also supports the USGS IBC as the point of contact for USGS biosafety-related questions and examines biosafety concerns as needed. On behalf of the USGS Biosafety Program, the Bureau Biosafety Senior Scientist assigns BSL designations to USGS laboratory spaces.
H. Biorisk Management Coordinator. The Biorisk Management Coordinator is responsible for directing, coordinating, and ensuring the functions of the USGS IBC are performed and any reporting obligations of the USGS IBC are fulfilled. The coordinator serves as the liaison with Science Center (or equivalent) leadership regarding the risk assessment process. The coordinator maintains awareness of external guidance, policy, and regulations that could affect USGS science and advises on changes required to internal programs or directives. The coordinator maintains a collaborative relationship with the Biosafety Program and consults on program functions, where applicable.
I. USGS Personnel. USGS personnel are responsible for complying with this directive, as applicable, and promptly reporting adverse safety events, hazardous conditions, or biosafety concerns through established reporting mechanisms.