Notice2026-18646
Draft NIH Biosafety Policy for Research Involving Biohazards
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 14, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
As the world's largest public funder of biomedical research, the National Institutes of Health (NIH) is committed to ensuring that gold-standard science is conducted under gold-standard biosafety conditions. To achieve this goal, NIH is proposing a new policy that modernizes and strengthens biosafety practices to ensure that oversight keeps pace with evolving risks. NIH is requesting public input on a new, comprehensive biosafety policy proposal that, when finalized, will replace the current NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (https://osp.od.nih.gov/wp-content/ uploads/NIH_Guidelines.pdf).
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 176 (Monday, September 14, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 176 (Monday, September 14, 2026)]
[Notices]
[Pages 58132-58139]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18646]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft NIH Biosafety Policy for Research Involving Biohazards
AGENCY: National Institutes of Health, HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: As the world's largest public funder of biomedical research,
the National Institutes of Health (NIH) is committed to ensuring that
gold-standard science is conducted under gold-standard biosafety
conditions. To achieve this goal, NIH is proposing a new policy that
modernizes and strengthens biosafety practices to ensure that oversight
keeps pace with evolving risks. NIH is requesting public input on a
new, comprehensive biosafety policy proposal that, when finalized, will
replace the current NIH Guidelines for Research Involving Recombinant
or Synthetic Nucleic Acid Molecules (<a href="https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf">https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf</a>).
DATES: To ensure consideration, comments must be submitted on or before
October 19, 2026.
ADDRESSES: Comments must be submitted electronically to: <a href="https://osp.od.nih.gov/comment-form-draft-nih-biosafety-policy-for-research-involving-biohazards/">https://osp.od.nih.gov/comment-form-draft-nih-biosafety-policy-for-research-involving-biohazards/</a>.
Comments are voluntary and may be submitted anonymously. You may
also voluntarily include your name and contact information with your
response. Other than your name and contact information, please do not
include in the response any 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 your response. After the NIH Office of Science Policy (OSP)
has finished reviewing the responses, the responses may be posted to
the OSP website without redaction.
FOR FURTHER INFORMATION CONTACT: Cari Young, Sc.M., Director of the
Biosafety, Biosecurity, and Emerging Biotechnology Policy Division,
Office of Science Policy, (301) 496-9838 or <a href="/cdn-cgi/l/email-protection#3360505a565d5056635c5f5a504a735c571d5d5a5b1d545c45"><span class="__cf_email__" data-cfemail="2774444e4249444277484b4e445e67484309494e4f09404851">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
Nearly 50 years ago, NIH introduced the foundational Guidelines for
Research Involving Recombinant DNA Molecules (<a href="https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf">https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf</a>), which established the biosafety
framework for much of today's research enterprise. However, the
increasingly multi-disciplinary, cross-sector, and global nature of
modern science calls for a paradigm shift and, on September 9, 2025,
NIH announced (<a href="https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight">https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight</a>) it
was beginning a process to modernize and strengthen the oversight of
biosafety, to ensure that it is transparent, adaptive, and accountable.
To inform the initial policy proposal, NIH undertook an intensive
community outreach and engagement effort (<a href="https://osp.od.nih.gov/table-of-biosafety-engagements-modernizing-and-strengthening-biosafety-oversight/">https://osp.od.nih.gov/table-of-biosafety-engagements-modernizing-and-strengthening-biosafety-oversight/</a>), hearing from researchers, biosafety professionals, members
of the public, and more. Comments were solicited through six regional
listening sessions, smaller engagements with groups throughout the
United States, and an on-demand portal to receive individual comments
for the duration of the community engagement effort.
The feedback received to date has informed a new policy proposal
that expands the scope of the NIH Guidelines to all biohazards while
removing red tape for low-risk research. As part of this modernization,
NIH also seeks to strengthen the role of Institutional Biosafety
Committees (IBCs) and reinforce consistency with Institutional Review
Boards and Institutional Animal Care and Use Committees, which serve as
three foundational pillars of institutional oversight of biomedical
research.
Through this draft policy, NIH aims to augment public safety,
transparency, and accountability in its stewardship of the biomedical
research enterprise. NIH recognizes that resources and guidance will be
required to achieve successful implementation of a modernized biosafety
policy. Thus, NIH intends to provide additional supplemental materials
for the community through implementation resources. These materials
will include information about IBC functions, as well as content drawn
from existing information, such as biosafety considerations for
research with gene drive modified organisms (<a href="https://osp.od.nih.gov/wp-content/uploads/2024/03/gdmo-reference.pdf">https://osp.od.nih.gov/wp-content/uploads/2024/03/gdmo-reference.pdf</a>), Risk Group (RG)
classifications (currently articulated in Appendix B of the NIH
Guidelines); and additional information about requirements for
containment practices, occupational health plans, and training for
research with RG3 influenza viruses (currently articulated in Section
III-D-7 and Appendix G-II-C-5 of the NIH Guidelines).
Draft NIH Biosafety Policy for Research Involving Biohazards
Scope and Applicability
Section I. Purpose
As the world's largest public funder of biomedical research, NIH is
committed to ensuring that gold-standard science is conducted under
gold-standard biosafety conditions. The purpose of the NIH Biosafety
Policy for Research Involving Biohazards (the Policy) is to achieve
this goal by setting forth requirements for federal and local
institutional oversight of biomedical research involving biohazards,
and to help ensure the safe, responsible, and secure conduct of such
research.
Section II. Scope
The NIH Biosafety Policy covers all biomedical research, in
laboratory settings, involving biohazards.
For the purpose of the scope of this Policy, research involving
biohazards is defined as research involving known or potential risk to
human health and any of the following:
1. Wild-type biological agents (i.e., bacteria, viruses, fungi, or
parasites) that cause disease in humans;
2. Cells, viruses, or organisms, other than plants, that have been
genetically modified;
3. Toxins, prions, and other self-aggregating proteins; or
4. Cells or organisms, other than plants, containing 1, 2, or 3
above.
This Policy applies to research supported in whole or in part by
NIH, regardless of NIH funding level or funding mechanism, including
the NIH Intramural Research Program. This Policy is applicable to all
competing award applications, competitive revisions, proposals for
contracts, and other funding agreements (e.g., Other Transactions,
Cooperative Agreements) on or after [effective date will be 6 months
from publication of the final Policy], and all existing awards and
agreements as of that date. This Policy is applicable to all intramural
research projects conducted on or after [effective date will be 6
months from publication of final Policy], including on-going or new
studies. This Policy is also applicable to non-NIH funded research that
is conducted on or after [effective
[[Page 58133]]
date will be 6 months from publication of final Policy] at an
institution that receives any NIH funding.
Based on risk, different categories of research will require
different levels of oversight as described in Section IV.
Any research subject to this Policy that is also under the
regulation or purview of another federal agency may proceed under the
oversight of the other federal agency once approvals or other
applicable clearances have been obtained.
Compliance and Enforcement
All institutions conducting NIH-supported research will be required
to comply with this Policy, which will be included in the applicable
terms and conditions of the award or agreement and included in
applicable NIH intramural policies and procedures. As a term and
condition for NIH funding, institutions shall ensure that any research
conducted at or sponsored by the institution, irrespective of the
source of funding, shall comply with this Policy, as specified in
applicable terms and conditions of the award or agreement.
Failure to comply may provide a basis for enforcement actions,
including, but not limited to, additional special terms and conditions,
or termination, consistent with applicable grant regulations;
applicable NIH policies and procedures, including NIH intramural
policies and procedures; the Federal Acquisition Regulations; and/or
other authorities, as appropriate. Enforcement actions may affect
future funding decisions for the recipient institution, as authorized
in the NIH Grants Policy Statement (GPS). In cases where NIH proposes
to suspend, limit, or terminate financial assistance because of
noncompliance with the Policy, applicable HHS and Public Health Service
procedures shall govern.
Voluntary Compliance
This Policy outlines fundamental biosafety principles and practices
that serve as a foundation for biomedical research. The Policy may
serve globally as a model framework for biosafety oversight, and
entities not otherwise subject are encouraged to follow the Policy
principles and implement commensurate oversight procedures to enable
safe, responsible, and secure research regardless of funding source.
General Definitions
The following terms, which are used throughout the NIH Biosafety
Policy, are defined as follows:
Biological agent: Bacteria, viruses, fungi or parasites that cause
human disease.
Biomedical research: Research on a topic that is within the mission
of the NIH (<a href="https://www.nih.gov/about-nih/mission-goals">https://www.nih.gov/about-nih/mission-goals</a>), including
applicability to: research supported by NIH, and non-NIH funded
research that is conducted at an institution that receives any NIH
funding.
Biosafety Assurance: Documentation from an institution, through the
Authorized Organizational Representative (AOR), assuring institutional
compliance with this Policy.
Emerging agent or organism: An agent or organism newly identified
in nature.
Gene drive: Technology whereby a particular heritable element
biases inheritance in its favor, resulting in the heritable element
becoming more prevalent than predicted by Mendelian laws of inheritance
in a population over successive generations.
Genetic modification:
<bullet> The introduction into cells, organisms, or viruses of
nucleic acid molecules that meet any of the following criteria:
[cir] Possess biological properties that enable introduction of
stable alterations (e.g., mutations, insertions, or deletions) into the
genome (e.g., cis elements involved in integration, gene editing); or
[cir] Have the potential for one or more cycles of replication in a
cell; or
[cir] Can be transcribed or translated; or
<bullet> The introduction into cells, organisms, or viruses of
stable alterations into the genome by passaging, reassortment, chemical
or radiological means.
Institutional Biosafety Committee (IBC): A committee that meets the
requirements for membership, and reviews, approves, and oversees
projects in accordance with the responsibilities defined in Section
III-B.
Laboratory research: Research conducted within Biosafety Level/
Animal Biosafety Level (BSL/ABSL) 1-4 containment facilities, including
spaces such as vivarium, core facilities, or clinical settings. It does
not include the deliberate release of a biohazard outside of
biocontainment, such as field release research.
National Biosafety Data and Safety Analysis Center: A Federally
Funded Research and Development Center (FFRDC) established under this
policy to independently aggregate, de-identify, and analyze laboratory
biosafety incident data, near-misses, and anomalies for the purpose of
advancing the metascience of biosafety.
NIH-supported research: All research funded in whole or in part by
NIH. This includes research conducted by the NIH intramural research
program, and funded or conducted by extramural grants, contracts, other
transactions, or other funding agreements, regardless of NIH funding
level or funding mechanism.
Novel agent or organism: An agent or organism not existing in
nature, deliberately designed, and possibly derived from multiple,
different natural or synthetic sources (e.g., chimeras, or organisms
generated by synthetic biology in conjunction with artificial
intelligence).
Prions and self-aggregating proteins: Misfolded forms of proteins
that can self-propagate and cause neurodegenerative disease in humans
or animals.
Toxin: A protein or peptide produced by living organisms that
causes harm in humans.
Wild type: Naturally occurring organisms, cells, or viruses without
deliberately introduced genetic modifications.
Zoonotic: An agent reasonably suspected of transmission from
animals to humans with the potential to cause human disease.
Section III. Roles and Responsibilities
Section III-A Responsibilities of the Institution
An institution conducting or sponsoring research subject to the NIH
Biosafety Policy is responsible for ensuring that such research is
conducted in full compliance with the Policy as a term and condition of
NIH funding. No research subject to this Policy may be conducted until
the institution conducting the research has provided a written
Biosafety Assurance through the Authorized Organizational
Representative (AOR) (<a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.1.2_recipient_staff.htm">https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.1.2_recipient_staff.htm</a>) that has been approved by
NIH, setting forth compliance with this Policy. Assurances are approved
by NIH for a period of up to four years. Assurance submissions will
include:
<bullet> Lines of authority and responsibility for administering
the program and ensuring compliance with this Policy; to include
contact information for relevant staff such as the IBC Contact, IBC
Chair, and Biological Safety Officer (BSO) if applicable.
<bullet> To the maximum extent possible, weblinks to publicly-
posted institutional biosafety procedures(including but not limited to
documentation detailing the IBC roles,
[[Page 58134]]
responsibilities, authorities, and processes for how biosafety risks
are managed), a continuously updated IBC roster, IBC meeting minutes,
incident reports, synopses of relevant staff trainings provided, and
contact information for the IBC Contact, IBC Chair, and BSO (if
applicable); information regarding whether the institution conducts
research in a BSL3/ABSL-3 or BSL4/ABSL-4 laboratory, research with
GDMOs, has a BSO, receives NIH funding, and/or has an externally
administered IBC.
<bullet> Other pertinent information requested by NIH.
The institution must maintain all IBC records in accordance with
Section 8.4.2 of the NIH GPS, which requires recipients of awards to
maintain appropriate documentation in accordance with record retention
requirements in 2 CFR 200.334, which states ``the recipient and
subrecipient must retain all Federal award records for three years from
the date of submission of their final financial report.'' In addition,
IBC meeting minutes and incident reports must be publicly posted for a
minimum of five years. Records may need to be retained for longer
durations in accordance with other requirements of the NIH GPS as
applicable. When incident reports or meeting minutes contain records
related to awards, they must be maintained for at least as long as
stated in this requirement and must be made available to the public
during this time if requested.
Incident reports may contain records related to multiple protocols
which may be in different stages of the grant cycle.
The institution is responsible for ensuring appropriate training
regarding laboratory safety and implementation for the IBC Chair and
members, the BSO and other containment experts (when applicable),
Principal Investigators (PI), and laboratory staff.
The institution may be required to establish and maintain an
occupational health and safety program (OHSP) based on other
regulations and policies. If an OHSP is required under those
regulations and policies, or if it is needed based on research
conducted, it should be maintained as part of the overall biosafety
program. The role of the OHSP to support biosafety will depend on the
facility, research activities, and biohazards involved.
Section III-B Responsibilities of the Institutional Biosafety Committee
(IBC)
The institution shall establish an IBC to meet the criteria
outlined in this Policy. Additional responsibilities may be added, as
needed by the institution, whose responsibilities need not be
restricted to research within the scope of the Policy. The IBC must
meet the following minimum requirements.
IBC Membership
The IBC must have at least five members who have appropriate
expertise, experience, and the capability to assess research involving
biohazards and identify any potential risk to institutional personnel,
public health, or the environment, and to determine the appropriate
biosafety, and biosecurity measures, when appropriate, to mitigate
those risks. The IBC should include individuals with expertise in
biological safety and physical containment, and include, or have
available on an ad hoc basis, individuals knowledgeable in
institutional commitments and policies, applicable law, security,
standards of professional conduct and practice, community attitudes,
and the environment, as appropriate.
The following individuals must be appointed as voting members:
<bullet> A BSO, when the institution conducts research at BSL-3,
BSL-4 or research involving GDMOs.
<bullet> At least one member with expertise in animal containment
principles, when the institution conducts research, subject to the
Policy, in animals that are of a size or have growth requirements that
preclude housing in primary containment isolators, or an equivalent
means of primary containment, including but not limited to agricultural
animals and other animal species.
<bullet> At least one member with adequate expertise in ecological
or environmental risk assessment, when reviewing and approving research
involving GDMOs. Ad hoc consultants may be used if necessary.
<bullet> At least two members who are not affiliated with the
institution, other than their membership on the IBC, to represent the
interest of the surrounding community with respect to health and
protection of the environment.
The institution should appoint other individuals to the IBC, as
needed for the types of research conducted at the institution, or use
ad hoc consultants, as appropriate.
IBC Functions
The IBC, or its delegate as applicable, is responsible for:
<bullet> Reviewing research for compliance with the Policy as
specified in Section IV ``Categories of Oversight for Research Based on
Risk'' and approving, as warranted, research that meets the
requirements of the Policy. This review shall include: (1) independent
risk assessment (see Section V ``Risk Assessment and Mitigation for
Research Involving Biohazards'') of the biocontainment levels required
for the proposed research; (2) assessment of the facilities,
procedures, practices, training, and expertise of personnel involved in
the research; (3) in cases of research involving human research
participants, the assessment should focus on biosafety issues (e.g.,
product administration, shedding). IBC oversight may conclude after the
last participant is administered the final dose of product. However,
IBCs may choose to establish other endpoints for oversight, based on
their biosafety assessment of the proposed research.
[cir] No member of the IBC may be involved in the review or
approval of a project in which they are or expect to be engaged, or in
which they have a direct financial or any other conflict of interest,
except to provide information requested by the IBC to facilitate their
review. Such members can be counted for purposes of establishing a
voting quorum for the meeting even if they recuse themselves from the
final determination related to the project.
[cir] When possible and consistent with protection of privacy,
proprietary interests, and national security concerns, the institution
is encouraged to be maximally transparent and open its IBC meetings to
the public.
<bullet> Taking IBC meeting minutes and approving them no later
than their next convened meeting. The IBC must post the approved
minutes on a public-facing web page on the website of the institution,
using the required meeting minutes template. Minutes should be posted
immediately after approval and once all appropriate and allowable
redactions have been made.
<bullet> Notifying the PI when the research is approved, including
the required biocontainment level, any biosafety requirements, or any
other conditions specified as part of the approval. Approval should be
granted for a period not to exceed three years, at which time a de novo
registration submission and review is required. During the approval
period, any changes to the approved research that have potential impact
on the original biosafety assessment must be reviewed and approved by
the IBC, or its delegate, before such research is conducted.
<bullet> Lowering containment levels for certain experiments
conducted at BSL-2, as specified in Section IV ``Categories of
Oversight for Research Based on Risk.''
<bullet> Petitioning NIH for determination of the minimum
biocontainment level for emerging, novel, or zoonotic biological agents
for which the RG
[[Page 58135]]
classification or containment level is not available in the BMBL
(<a href="https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf">https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf</a>). The IBC may not approve such research until authorized by NIH
and any other applicable Federal, State, or local entities.
<bullet> Petitioning NIH to determine the appropriate
biocontainment level for research involving emerging, novel, or
zoonotic biological agents, or to lower the minimum containment for
research involving RG3 and RG4 agents that have not previously been
approved by NIH. Initial requests should be submitted to NIH by the IBC
Chair or BSO and include a full description of:
[cir] The agent and specific modifications to the agent (e.g.,
attenuation);
[cir] The biological system(s) and experimental manipulations that
will be employed, such as:
[ssquf] All biological reagents (e.g., plasmids, cell lines,
prokaryotic hosts) that will be used in the experiment(s), and
[ssquf] Types of experiments to be performed (e.g., tissue culture,
animal work).
[cir] The IBC's risk assessment of the proposed research activities
and the proposed BSLs at which each of these operations will occur,
along with any special practices or procedures;
[cir] Supporting documentation such as published or investigator-
generated data demonstrating the attenuation or loss of function of the
agent that the IBC reviewed as part of its risk assessment; and
[cir] Other pertinent information.
The IBC may not approve the lowering of biocontainment for such
research until authorized by NIH and any other applicable Federal,
State or local entities.
<bullet> Periodically reviewing approved research conducted at the
institution, to ensure compliance with the conditions established in
the IBC approval and with the Policy. This responsibility may be
delegated to the BSO or other staff, as appropriate.
<bullet> Adopting plans which include emergency response for
handling accidental spills, personnel contamination, post-exposure
response, loss of containment, or release of biohazards, waste
disposal, or other incidents involving research covered under the
Policy.
<bullet> Reviewing incidents that occur during the conduct of
research subject to the Policy, to ensure the appropriate response
occurred, and to determine if additional biosafety measures are
warranted to mitigate the risk of future similar incidents.
<bullet> Reporting certain incidents to NIH that pose a significant
risk to human health, using the required incident reporting template.
Such incidents require immediate notification to NIH (within 24 hours
or as soon as the institution becomes aware of the incident), followed
by a full report once all information is gathered (no later than 30
days). This includes incidents that involve:
[cir] A confirmed or potential laboratory-acquired infection (LAI);
[cir] Any loss of containment/release that has the potential for
community risk;
[cir] Any incident at BSL-3/ABSL-3 or BSL-4/ABSL-4, including:
[ssquf] Potential exposures involving a personal injury, and/or
when medical treatment is sought after the incident to address the
possibility of a LAI;
[ssquf] Potential releases involving facility and/or equipment
failures, even when redundant systems were functioning properly, to
address the possibility of risk to personnel and the community and
prevent future occurrences;
[ssquf] Biological agent inventory and security issues that may
have public health consequences.
[cir] Any incidents involving exposures at BSL-2/ABSL-2 that
require agent-specific treatment beyond basic first aid; and
[cir] Any compliance violations at any BSL/ABSL, such as failure to
obtain or maintain IBC approval, or failure to obtain NIH approval for
lowering biocontainment for research, when required.
If treatment is provided to an exposed individual due to the
potential presence of adventitious agents (e.g., non-human primate
Herpes B or blood borne pathogen prophylaxis) and not agent(s)
deliberately involved in the research, no report is required unless a
LAI results from the exposure, in which case the incident must be
reported to NIH.
<bullet> Reviewing certain lower-risk incidents described below
that do not require reporting to NIH. Such incidents must be reported
to and addressed by the IBC. The IBC should determine whether the
appropriate response occurred, and if additional biosafety measures are
warranted to mitigate the risk of future similar incidents. Such
incidents include:
[cir] Any incident involving research subject to the policy with an
animal that is housed at BSL-1/ABSL-1 or BSL-2/ABSL-2 (e.g., bite,
scratch, escape or improper disposition)
[cir] Any incident at BSL-1/ABSL-1 or BSL-2/ABSL-2 that does not
involve agent-specific medical treatment when first aid is
administered.
Minor spills of low-risk agents, that do not involve a breach of
containment and that were properly cleaned and decontaminated,
generally do not need to be reported.
<bullet> Posting all incident reports on a public-facing web page
on the website of the institution, using the required incident
reporting template. Final incident reports should be posted within 30
days of NIH's final response (when reportable to NIH) or IBC/
institutional review and finalization (when not reportable to NIH) and
once all appropriate and allowable redactions have been made. For
incidents reportable to NIH, NIH's final response must be posted along
with the final incident report.
<bullet> Performing other functions as may be delegated to the IBC
by the institution.
Biological Safety Officer (BSO)
A BSO must be appointed when the institution conducts research
subject to the Policy i) at BSL-3 or 4, or ii) involving GDMOs.
The BSO's duties include but are not limited to:
<bullet> Conducting periodic inspections to ensure that laboratory
biocontainment facilities and equipment are functioning properly,
biosafety standards are rigorously followed, and IBC approval
conditions for the conduct of research are being followed.
<bullet> Reporting to the IBC and the institution any significant
problems, violations of the Policy, or any significant research-related
incidents of which the BSO becomes aware.
<bullet> Responding to and investigating research-related incidents
occurring during the conduct of research subject to the Policy.
<bullet> Providing technical advice to research personnel and the
IBC.
If an institution does not designate a BSO, the institution must
assign another official to take on these responsibilities.
Section III-C Responsibilities of the Principal Investigator
The responsibilities of the PI include:
<bullet> Ensuring no research within the scope of this Policy is
conducted until approved by the IBC, or IBC delegate, and has met all
other requirements of the Policy.
<bullet> Reporting any incidents occurring during the conduct of
research subject to the Policy (See incident reporting requirements in
Section III-B for further details).
<bullet> Ensuring all laboratory personnel under their supervision
understand the
[[Page 58136]]
requirements of the Policy and have received adequate biosafety
training for the research they will be conducting.
<bullet> Adhering to all IBC-approved plans including emergency
response for handling accidental spills, personnel contamination, post-
exposure response, loss of containment or release of biohazards, waste
disposal, or other incidents involving research covered under the
Policy.
<bullet> Making an initial risk assessment to determine a risk
mitigation strategy, including levels of physical containment and other
biosafety practices as appropriate for the safe conduct of the proposed
research.
<bullet> Selecting appropriate biocontainment facilities and
equipment, and biosafety practices and procedures for the safe conduct
of proposed research.
<bullet> Submitting the initial research protocol and any
subsequent changes that may alter the biorisk assessment of the
research to be conducted, to the IBC and NIH (as appropriate), for
review and approval.
<bullet> Making available to all laboratory personnel the protocols
that describe all biohazards and the biosafety precautions to be taken.
<bullet> Coordinating and/or providing appropriate training on the
Policy and biosafety requirements applicable to the research being
conducted for all research personnel under their supervision.
<bullet> Informing the laboratory staff of the reasons and
provisions for any occupational health or exposure response procedures,
advised or required.
<bullet> Supervising the performance of laboratory staff to ensure
that the required safety practices and techniques are employed and
correcting any errors.
<bullet> Ensuring the integrity, maintenance, and correct
functioning of facilities, physical containment equipment, and personal
protective equipment.
Institutions are further authorized and encouraged to submit
voluntary, confidential reports regarding near-misses, secondary
failures, or procedural issues to the National Biosafety Data and
Safety Analysis Center (NBDSAC). The NIH shall not utilize the
voluntarily submitted data for enforcement or action on funding,
provided the incident did not result in an environmental release or a
LAI. All data maintained within the NBDSAC repository must be de-
identified to protect individual and institutional privacy, but
institutions have flexibility in what scientific information they
choose to share.
Section III-D Responsibilities of the National Institutes of Health
NIH is responsible for:
<bullet> Promulgating requirements and guidance necessary to
implement the NIH Biosafety Policy.
<bullet> Determining the appropriate containment level for
emerging, novel, or zoonotic biological agents for which the RG
classification or containment level is not available in the BMBL.
<bullet> Determining the appropriate containment level for research
involving wild type or genetically modified RG3 or RG4 biological
agents (e.g., experiments with attenuated or replication-defective
constructs) for initial requests to lower containment.
<bullet> Publishing approved determinations of appropriate lower
containment for research involving wild type or genetically modified
RG3 or RG4 biological agents.
<bullet> Reviewing requests for lowering containment levels in a
timely manner and revising the risk classification of biological agents
in conjunction with other Federal agencies as applicable.
<bullet> Interpreting this Policy for cases in which the Policy
does not specifically assign containment levels.
<bullet> Requesting and negotiating, approving or disapproving, and
as necessary, restricting or withdrawing approval of Assurances.
<bullet> Reviewing and responding in a timely manner to reports of
incidents subject to the Policy, that require reporting to NIH.
<bullet> Verifying the institutional response to incidents subject
to the Policy is appropriate, and when applicable, indicating when
additional action is required by the institution.
<bullet> Generating and publishing an Annual Incident Summary
Report that allows for trends to be identified, promote transparency,
and to provide assurance that NIH is aware of and has oversight of
incidents occurring at our grantee institutions.
<bullet> Conducting outreach and education on biosafety and the
requirements of the Policy.
Section IV Categories of Oversight for Research Based on Risk
The scope of biohazards defined in the Policy is broad; however,
different categories of research will require different levels of
oversight based on risk. Certain research associated with higher levels
of risk or uncertainty must be reviewed and approved at the Federal
level by NIH. This research also must be reviewed and approved by the
IBC, who may require additional biosafety provisions based upon its
risk assessment of the research and local knowledge of facilities
features and personnel capacities. Other research must be reviewed and
approved by the IBC or delegated for review and approval by an
individual or sub-group of the IBC for research of lower risk.
Section IV-1 Research That Requires NIH and IBC Approval Before
Initiation
Review and approval for determination of appropriate containment
and biosafety practices and procedures must be obtained from NIH for
higher risk research including:
<bullet> Research involving emerging, novel, or zoonotic agents for
which the RG classification or a recommendation for minimum containment
level is not available in the BMBL.
<bullet> Initial requests for NIH to lower containment for research
involving wild type or genetically modified RG3 or RG4 biological
agents (e.g., experiments with attenuated or replication-defective
constructs).
<bullet> Initial requests for NIH to lower containment below BSL-2
for research involving GDMOs.
Initiation of research may proceed after approvals from both NIH
and the IBC. The IBC may stipulate higher containment or additional
biosafety precautions.
Section IV-2 Research That Requires IBC Review and Approval Before
Initiation
For initial submissions of research within the scope of the policy,
and not otherwise specified in other sections, review and approval must
be obtained from the IBC before initiation. This would include:
<bullet> Research involving RG3 or RG4 wild-type biological agents.
<bullet> Research involving genetically modified cells, viruses, or
organisms, other than plants (e.g., certain vectors, replicons, gene
drive modified biological agents, GDMOs).
<bullet> Research involving toxins listed as Select Agents (<a href="https://www.selectagents.gov/sat/list.htm">https://www.selectagents.gov/sat/list.htm</a>), prions, or other self-aggregating
proteins.
<bullet> Research with primary cells that may be contaminated by
adventitious agents.
<bullet> Research with wild type or genetically modified RG2
biological agents for which lower containment is requested, or research
with wild type or genetically modified RG3 or RG4 biological agents
that NIH has previously approved to be conducted at lower containment.
<bullet> Clinical research involving deliberate administration to
one or more
[[Page 58137]]
human research participants of the following biohazards:
[cir] Products that are capable of shedding, replicating, or
integrating.
[cir] Products that require higher risk manipulations (e.g.,
aerosolization, bladder infusions).
[cir] RG2 or higher wild type biological agents (e.g., challenge
experiments for medical countermeasures).
Clinical research cannot be initiated until IBC, and all other
applicable institutional and regulatory authorization(s) and approvals
have been obtained.
The deliberate transfer of a clinical product, that would otherwise
fall under the scope of this Policy, into one human research
participant conducted under a Food and Drug Administration (FDA)
regulated individual patient expanded access Investigational New Drug
(IND), or protocol, including for emergency use, is not research
subject to this Policy and does not need to be submitted to an IBC for
review and approval.
Section IV-3 Research That Requires Review and Approval Before
Initiation and May Be Delegated to an Individual or Subgroup of IBC
Members
Review and approval must be obtained before initiation from an
individual or a subgroup of IBC members for minor amendments to
previously IBC approved submissions or for research including:
<bullet> Research involving RG2 wild type biological agents.
<bullet> Research with genetically modified RG1 biological agents
[Note: Experiments involving RG1 wild-type biological agents are not
subject to this Policy].
<bullet> Research conducted with transgenic organisms at BSL-1/
ABSL-1.
<bullet> Research with plasmids or replication-incompetent, non-
integrating viral vectors expressing reporter or low-risk transgenes.
<bullet> Research with well-characterized cell lines.
<bullet> Research with biological toxin proteins not on the Select
Agent list.
Individuals or a subgroup of IBC members conducting delegated
reviews may elevate review and approval to the full IBC as necessary.
The IBC must be notified of all approvals granted by delegated review
when granted, and the approval must be reported in full to the IBC at
its next scheduled meeting for inclusion in the minutes.
Section V. Risk Assessment and Mitigation for Research Involving
Biohazards
Investigators and IBCs must conduct a comprehensive risk assessment
prior to initiating research involving biohazards. Conducting a risk
assessment is required as a key part of the responsibilities of
investigators and IBCs to provide for the safe conduct of the research.
A risk assessment is essential to identify the likelihood of an
accidental exposure to, or release of, a biohazard during the conduct
of research, and the potential severity of harm to research personnel,
the public, or the environment. Based on the risk assessment, an
appropriate risk mitigation strategy must be developed to lower the
risks associated with the research to an acceptable level.
A risk assessment is a multistep process that involves
consideration of:
<bullet> The characteristics of the biohazard.
<bullet> Manipulations of the biohazard.
<bullet> Genetic modifications, if any.
All of these steps are critical to assessing the risks associated
with constructing or handling the biohazard. The risks are addressed in
the risk mitigation strategy through determination of appropriate
physical and biological containment, laboratory safety procedures and
practices, personal protective equipment, and training.
Based on the specific research to be conducted, the factors to
consider in the risk assessment will differ. The considerations for
risk assessment in this document are harmonized with the BMBL, and the
BMBL should serve as a primary handbook for conducting risk
assessments. Additional requirements and considerations specific to
NIH-supported research, including genetic modification of agents or
organisms and manipulations, are presented here.
Section V-A. Requirements and Considerations for Risk Assessment of the
Characteristics of the Biohazard
The first step of risk assessment must be to understand the risks
associated with the types of biohazards involved in the research. The
characteristics of wild-type bacteria, viruses, fungi, or parasites
must be evaluated for their ability to cause disease in humans,
population impact, and the availability of countermeasures for that
disease. Certain transgenic animals or GDMOs present different risks
and may also impact populations or the environment. Risks associated
with handling cells or tissues in vitro culture may vary depending on
whether the research involves a well-established cell line, or primary
cells, or tissues that may harbor adventitious agents, which may carry
additional risks. Work with many proteins presents risks more akin to
chemical hazards because they are incapable of replicating. Prions, and
other proteins that aggregate, are capable of spreading and causing
neurodegenerative diseases. Risks associated with toxins may differ
depending on the potency, amounts used, and whether they are in a form
allowing intracellular access (e.g., toxin single subunit or
holoenzyme).
Biological agents that cause disease in humans are classified into
four RGs based on pathogen characteristics and population impacts.
Pathogen characteristics include severity of illness, case fatality
rate, route of exposure, infectious dose, rate of transmission, and
environmental prevalence and stability. Population impacts include
status of immunity in humans, availability of preventive or therapeutic
countermeasures, vulnerable individuals or groups within populations,
and burden on health care systems.
Representative genera and species of bacteria, viruses, fungal and
parasitic agents are classified into RGs based on the potential effect
on a healthy human adult; however, some individuals may have increased
susceptibility, due to preexisting conditions, prescribed medications,
compromised immunity, pregnancy, or breast feeding (which may increase
exposure of infants to some biological agents), among other factors.
Absence of agent specification in the list of RG2- RG4 does not imply
automatic or implicit classification as RG1. A risk assessment must be
conducted based on the known and potential properties of the agents not
listed and their relationship to agents that are listed. Special
attention should be given to novel, emerging, or zoonotic agents (Refer
to Section IV-1 of this Policy ``Research That Requires NIH and IBC
Approval Before Initiation'').
Additional resources can be found in the agent summary statements
and minimum BSL recommendations in the BMBL. The BMBL also provides
information regarding prions and some agents that infect animals. The
Federal Select Agent Program (<a href="https://www.selectagents.gov/index.htm">https://www.selectagents.gov/index.htm</a>)
oversees the possession, use, and transfer of Select Agents and Toxins,
which pose a threat to the public and animal or plant health. All
entities must follow the requirements laid out in the Select Agent
Regulations (<a href="https://www.selectagents.gov/regulations/index.htm">https://www.selectagents.gov/regulations/index.htm</a>).
Section V-B. Requirements and Considerations for Risk Assessment for
Genetically Modified Biological Agents, Cells, or Organisms
The starting point for risk assessment must be based on the risks
associated
[[Page 58138]]
with the parent agent, cell, or organism; but those risks may be
affected by changes due to genetic modifications, which must also be
assessed. Changes to agent pathogenicity, transmissibility, host or
tissue range, etc., may increase risks compared to the parent. Genetic
modifications may be used to create attenuated or replication-defective
agents with less risk than the parent. Modifications may affect
toxicity, physiological activity, or allergenicity. The source and
function of the nucleic acid sequence altered, introduced, or deleted
in a genetically modified biohazard affects risk (e.g., modifications
to RG 2-4 agents versus introduction of RG 2-4 sequence into non-
pathogenic prokaryotes or lower eukaryotes).
Research involving GDMOs requires risk assessments that incorporate
a broader scope of considerations because of greater uncertainty of the
technology and potential uncertainty of the impact of the newly
modified organism or biological agent. Specific attention must be paid
to risks of an unintended release from the laboratory and the potential
impact on humans, other populations of organisms, and the environment.
Section V-C. Requirements and Considerations for Risk Assessment for
Synthetic Biological Agents or Emerging Technologies
As synthetic biology and other uses of emerging technologies move
forward, it may become easier to develop an organism containing genetic
sequences from multiple sources such that the parent agent may not be
obvious when examined out of context. In such cases, the risk
assessment must include at least three levels of analysis:
<bullet> The first involves the RG, if available, of the source(s)
of the sequences.
<bullet> The second involves an assessment of the functions that
may be encoded by these sequences (e.g., virulence or
transmissibility).
<bullet> The third involves the probability of any synergistic
effects of the genetic sequences.
Investigators and IBCs must consider the highest RG classification
of all agents that are the source of sequences included in the
construct, the percentage of the genome contributed by each parent
agent, and the predicted function or intended purpose of each
contributing sequence. The initial assumption should be that all
sequences will function as they did in the original host context.
The combination of certain sequences in a new biological context
may result in an organism whose risk profile could be higher than that
of the contributing organisms or sequences. The synergistic function of
these sequences may be one of the key attributes to consider in
deciding whether a higher containment level is warranted, at least
until further assessments can be carried out. During risk assessment,
it must be considered that there could be potentially new or
unpredictable biosafety risks associated with an organism formed
through combination of sequences from a number of organisms or due to
the synergistic effect of combining transgenes that results in a new
phenotype.
Section V-D. Requirements and Considerations for Risk Assessment of
Manipulations of Biohazards
Manipulations of the biohazard must also be considered as they may
alter the risks of personnel exposure or release to the environment.
Different manipulations may introduce different levels of risk (e.g.,
use of sharps, generation of aerosols, tissue culture, animal
procedures, large culture volumes). For work with biological agents,
investigators and IBCs must assess whether handling could result in an
exposure through possible routes of transmission (e.g., inoculation,
animal bite, aerosolization of respiratory viruses, etc.).
Section V-E. Risk Mitigation Strategies and Laboratory Containment
Informed by the risk assessment, investigators and IBCs must
develop a risk mitigation strategy to help minimize the identified
risks of exposure or release of the biohazard. Combinations of
mitigation measures to be applied include:
<bullet> Physical containment through facility design (e.g.,
ventilation, decontamination systems, laboratory configuration) and
primary barriers such as biosafety cabinets.
<bullet> Biological containment based on the design of the agent or
organism, with consideration of the potential for and probability of
off-target effects.
<bullet> Safety equipment and personal protective equipment (PPE).
<bullet> Standard and special practices, procedures, and training.
Four BSLs based on these combinations are described in the BMBL.
The BMBL provides the elements for each BSL with protections that
increase as the risks associated with the research increase. The BMBL
also provides criteria for the animal biosafety level (ABSL) required
for work with animals, including in loose housing or open pens. The
agent summary sections of the BMBL include some recommendations for the
minimum BSL for work with known wild-type agents, toxins, or prions
using certain standard procedures. However, investigators and IBCs must
conduct a risk assessment for each specific experiment. While both RGs
and BSLs/ABSLs have four classification categories (RG1-RG4), these
concepts are related but not equivalent. RGs describe the biological
properties of the agent, and depending on the work proposed, the
appropriate BSL/ABSL used to safely handle the agent may be lower or
higher. For instance, while research with an RG3 agent often may be
conducted at BSL-3, the research may be conducted at a lower or higher
level of laboratory containment based on a thorough consideration of
how the agent is going to be manipulated, and if applicable, what
genetic modifications are applied to the agent. Also, depending on the
specific research to be conducted, the BSL may be combined with
enhancements (e.g., work with a respiratory virus in a BSL-2 laboratory
may require additional respiratory PPE).
Certain research is required to be conducted at a minimum BSL.
<bullet> Research involving GDMOs must be conducted at a minimum of
BSL-2 containment.
<bullet> Experiments with influenza viruses (e.g., reassortants,
generation by reverse genetics of chimeric viruses with reassorted
segments, introduction of specific mutations) must be conducted at the
BSL containment corresponding to the RG of the virus that was the
source of the majority of segments in the virus (e.g., experiments with
viruses containing a majority of segments from a RG3 virus must be
conducted at BSL-3).
<bullet> Experiments with influenza viruses containing genes or
segments from 1918-1919 H1N1 (1918 H1N1), human H2N2 (1957-1968) and
highly pathogenic avian influenza H5N1 strains within the Goose/
Guangdong/96-like H5 lineage (HPAI H5N1), including, but not limited
to, strains of HPAI H5N1 virus that are transmissible among mammals by
respiratory droplets, as demonstrated in an appropriate animal model or
clinically in humans, must be conducted at BSL-3 enhanced containment
and an occupational health plan is required.
Clinical research involving handling and administration of
potentially biohazardous materials to research participants is most
often conducted in clinical settings that do not conform to laboratory
BSLs. However, precautions to protect personnel must include the use of
universal precautions such as
[[Page 58139]]
gloves, and eye and respiratory protection.
In addition to physical containment, biological or environmental
risk mitigation strategies may be applicable for certain biohazards.
Biological containment may involve genetically modified biohazards that
have been altered to decrease risks by limiting infectivity or
replication in specific hosts, or dissemination and survival in the
environment outside the laboratory. Environmental containment
strategies may include conducting research in a geographically isolated
area, an environment in which biohazard organisms are not able to
survive (e.g., tropical organism in an arctic climate) or a genetically
isolated environment (e.g., an area with no native organisms that could
mate with non-native laboratory organisms).
Request for Input
NIH seeks public input on its Draft NIH Biosafety Policy for
Research Involving Biohazards, which, when finalized, will supersede
the NIH Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules. Respondents are free to address any or all of
the topics listed or any other relevant topics for NIH to consider.
Respondents should not feel compelled to address all items. NIH will
consider all comments received. Comments are welcome on all aspects of
the draft policy, including the scope, risk assessment, categories of
oversight based on risk, roles and responsibilities, IBC functions, and
procedures. NIH is also seeking comments on draft incident reporting
and IBC meeting minute templates which can be found here (<a href="https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2">https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2</a>.
NIH also seeks comments on specific topics listed below:
<bullet> Scope of research covered by the new policy, including the
definition of biohazards for the purpose of oversight and any
inadvertent gaps in oversight that should be addressed.
<bullet> Structure of tiered oversight (i.e., Federal,
institutional, and investigator), including appropriateness in terms of
calibration to risk, accountability measures, transparency, and
streamlining of administrative burden, etc.
<bullet> Continued utility of Risk Groups (RGs) as a baseline for
risk assessment, particularly when agents are being genetically
modified, versus use of Biosafety Levels (BSL) outlined in the
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
(<a href="https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf">https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf</a>).
<bullet> Effectiveness of compliance and enforcement mechanisms for
ensuring biosafety, including strategies for encouraging voluntary
compliance for research not subject to the policy (e.g., at non-NIH
funded institutions), and addressing any biosecurity challenges.
<bullet> Feedback on the implementation resources and areas in
which additional guidance would be beneficial.
This notice is being published in accordance with a statement made
by the NIH Director found here (<a href="https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight">https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight</a>).
Dated: September 8, 2026.
Matthew Memoli,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2026-18646 Filed 9-11-26; 8:45 am]
BILLING CODE 4167-05-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 14, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.