I. PURPOSE

The United States Government (“USG”) recognizes that research involving biological agents and toxins is essential to the scientific advances that underpin improvements in the health and safety of the public, agricultural crops and other plants, animals, and the environment. While this research provides enormous benefits to society, there are risks associated with certain subsets of this work that require heightened biosafety and biosecurity practices, including appropriate risk assessment and risk mitigation strategies. The USG has existing statutes, regulations, policies, and guidelines that address potential biosafety and biosecurity risks, including those associated with research oversight and management. Together, these authorities, policies, and guidelines provide a foundation for ensuring that scientific research is conducted safely and securely.

In 2024, USG issued a new policy for the Oversight of Dual Use Research of Concern and Pathogen with Enhanced Pandemic Potential (DURC-P3CO) (the “2024 USG Policy”), which combined and modified three previous policies: (1) 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern; (2) 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern; and (3) 2017 Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversite.

The purpose of this policy is to ensure institutional compliance with federal oversight for conducting and managing research with Biological Agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security and/or national security at New York Medical College (“NYMC”) and Touro University (“TU”).

II. SCOPE

This policy applies to all individuals performing research at NYMC or TU campuses overseen by the NYMC IBC and IRE regardless of the source of funding.

III. DEFINITIONS

A.  Biological Agents are any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), infectious material, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious material, capable of causing (i) death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; (ii) deterioration of food, water, equipment, supplies, or material of any kind; or (iii) deleterious alteration of the environment. 

B.  Biosafety is the application of practices, controls, and containment infrastructure that reduces the risk of unintentional exposure to, contamination with, release of, or harm from pathogens, toxins, and other associated biological materials. 

C.  Biosecurity is the application of security measures designed to prevent the loss, theft, misuse, diversion, unauthorized possession or material introduction, or intentional release of pathogens, toxins, biological materials, and related information and/or technology. 

D. Category 1 Research

1.  Category 1 Research meets all of the following criteria:

a.  It involves one of the agents listed D.2 below; 
b.  It is Reasonably Anticipated to result, or does result, in one of the experimental outcomes in D.3
below; and
c.  Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC as specified in Section 4.1.3 of the 2024 USG Policy. 

2.  Biological Agents under the scope of Category 1 Research are:

a.  All Select Agents and Toxins listed in 9 CFR 121.3–121.4, 42 CFR 73.3–73.4, and 7 CFR 331.3 and regulated by the United States Department of Agriculture and/or the Department of Health and Human Services.
b.  All Risk Group 3 (“RG3”) or Risk Group 4 (“RG4”) pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules - Classification of Human Etiologic Agents on the Basis of Hazard.
c.   All agents recommended to be handled at BSL3 or BSL4 in the current edition of Biosafety in Microbiological and Biomedical Laboratories.
d.  Agents added during future federal guidance.

3.  Research is considered within the scope of Category 1 Research if the experimental outcomes with the agent in question can be Reasonably Anticipated to do any of the following:

a.  Increase transmissibility of a pathogen within or between host species;
b.  Increase the virulence of a pathogen or convey virulence to a non-pathogen;
c.   Increase the toxicity of a known toxin or produce a novel toxin;
d.   Increase the stability of a pathogen or toxin in the environment, or increase the ability to  disseminate a pathogen or toxin;
e.   Alter the host range or tropism of a pathogen or toxin;
f.    Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
g.   Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions; 
h.   Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against the pathogen or toxin; or 
i.   Enhance the susceptibility of a host population to a pathogen or toxin.

4.  Research that meets the definition of both Category 1 and Category 2 Research must be treated as Category 2 Research.

E.  Category 2 Research

1.  Category 2 research meets the following three criteria:

a.  It involves, or is Reasonably Anticipated to result in, PPP;
b.  It is Reasonably Anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in E.2 below; and
c.  The research can be Reasonably Anticipated to result in the development, use, or transfer of a pathogen with PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.

2.  Research is considered within the scope of Category 2 if the experimental outcomes with the agent in question can be Reasonably Anticipated to do any of the following:

a.  Enhance transmissibility of the pathogens in humans; or
b.  Enhance the virulence of the pathogens in humans; or
c.   Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection; or
d.  Generate, use, reconstitute or transfer an eradicated or extinct PPP or a previously identified PEPP.

F.  Dual Use Research is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes. 

G.  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 misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. 

H.  Federal Funding Agency is a federal department, agency, institute, center, or office that funds or sponsors intramural or extramural research at research institutions in the United States or internationally, with Biological Agents or toxins where the research is within Category 1 or Category 2 under this Policy. 

I.   Institutional Biosafety Committee (IBC) reviews all research involving recombinant or synthetic nucleic molecules. The IBC reviews and approves all projects and is responsible for ensuring compliance in accordance with the National Institutes of Health Guidelines. The IBC of NYMC also reviews all projects involving the use of infectious agent(s) (e.g. bacteria, viruses, parasites, fungi, protozoa, prions, etc.) that require biosafety level 2 containment (BSL2) or above.  

J.   Institutional Contact for Dual Use Research (ICDUR) is the official designated by the research institution to serve as an internal resource for application of this Policy as well as the liaison between the institution and the relevant Federal Funding Agency.   NYMC and TU have designated the Biosafety Officer/Director of the Department of EHS as the ICDUR.

K.  Institutional Review Entity (IRE) is the subcommittee of the IBC established by the research institution to execute the institutional oversight responsibilities, particularly for that research which has a higher risk potential, including potential Dual Use Research and research involving PPPs.

L.  Life Sciences is the study or use of living organisms, viruses, or their products, including all disciplines, methodologies, and applications of biology including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques. 

M. Pathogen with Pandemic Potential (PPP) is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.

N.  Pathogen with Enhanced Pandemic Potential (PEPP) is a type of PPP resulting from experiments that enhance a pathogen’s transmissibility10 or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential. 

O.  Principal investigator (PI) is the senior/key person seeking or receiving federal research and development funding (i.e., extramural funding). There may be more than one PI on a research grant or project. 

P.   Reasonably Anticipated describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood. It does not require high confidence that the outcome will definitely occur but excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.

Q.   Select Agents and Toxins are Biological Agents and toxins that have the potential to pose a severe threat to public health and safety, as well as to animal and plant health or products.

IV. POLICY

All individuals involved in research on the NYMC or TU campuses with Biological Agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security and/or national security must comply with appropriate identification, notification and management steps in compliance with 2024 USG Policy and as further described in the procedures herein. These procedures apply to both federally and non-federally funded research.

All responsibilities of the PI and the College, including IRE, are described in explicit detail in the 2024 USG Policy in Section 5.1 and 5.2.  All PIs working with pathogens at NYMC and associated TU campuses must review the 2024 USG Policy and be aware of their responsibilities, according to USG guidelines. All work with recombinant or synthetic nucleic molecules or infectious agents that require BSL2 containment or above requires submission of a protocol for review.

V. PROCEDURES

A.    Each PI must make the initial assessment as to whether their proposed or ongoing research falls with the scope of Category 1 or Category 2 Research.

1. 1. 1. All work with potential pathogens requiring BSL2 or higher containment must be registered with the IBC. The IBC application has a checklist that helps PIs to determine if their research might reasonably fall withing such research categories.
      2. As of May 2025, when a PI submits a research proposal for federal funding, they must include notification that the research may fall within the scope of Category 1 or Category 2 Research. 

B.    After NYMC has been contacted by the organization providing the funding, the IRE will convene and review the PI’s initial assessment and confirm whether the proposed or ongoing research is within the scope of Category 1 or Category Research. Alternatively, a PI may contact the IBC chair, EHS, the Institutional Biosafety Officer, or ORA to indicate that their research may constitute research under Category 1 or Category 2.

C.    If the IRE determines that the research falls under the 2024 USG Policy:

1. 1. 1. The ICDUR will promptly notify the PI and the funding organization/agency.
      2. The PI, IRE, and the IBC will conduct risk-benefit assessments and develop a draft risk mitigation plan for the conduct and communication of research and submit these to the funding agency within 90 calendar days.
      3. Mitigation plans must be specific to the type of work being performed after a comprehensive risk-benefit analysis is carried out by the IBC.
      4. PIs and IRE must also evaluate Category 1 and Category 2 research for potential DURC risks as outlined in USG Policy for Oversight of DURC and PEPP 2024, Section 4.
      5. The research, risk-benefit analysis, and the mitigation plan must be submitted to the Federal Funding Agency (for Category 1 Research) or the Federal Funding Agency’s department-level review entity (for Category 2 Research). For non-Federally Funded Research, the ICDUR will contact the NIH to determine if they will accept submission for oversight of the research. If the NIH declines oversight, the NYMC IBC & IRE will maintain the same oversight as Federally Funded Research and will generate the same reports and keep them on file.
      6. The ICDUR will serve as an internal resource regarding oversight of Category 1 or Category 2 Research and serve as the liaison between the institution and the Federal Funding Agency.
      7. The Federal Funding Agency or appropriate department-level review entity will review the research proposal, risk-benefit analysis, and mitigation plan, and make recommendations.
      8. The specific research associated with Category 1 or Category 2 Research will not be conducted until it is approved by the relevant Federal Funding Agency.
      9. It is generally understood that this will occur as part of the Just in Time (JIT) process for federal grant funding.

D.  If during on-going research, it is determined that the research may fall under Category 1 or Category 2 of the policy that was not previously classified as such, then all research must stop and the PI shall contact the IBC and IRE, and conduct the required assessments described above. The ICDUR will contact the funding agency to update the classification of the protocol.

E. Some of the crucial responsibilities of the PI, as stated in the 2024 USG policy, section 5.1) are:

1. 1. 1. Assess their research at the proposal stage, and continuously throughout the research lifecycle, to identify whether there is research Reasonably Anticipated to be within scope of Category 1 or Category 2 Research.
      2. Following identification of potential Category 1 or Category 2 Research, notify the Federal Funding Agency and the IBC, refer the research to an appropriate IRE, and be prepared to develop a risk-benefit assessment and a risk mitigation plan.
      3. Work with the IRE to assess the risks and benefits of the proposed research and submit the risk-benefit assessments and draft risk mitigation plan for Category 1 or Category 2 research to the Federal Funding Agency for review and approval when appropriate.
      4. Provide annual progress reports for Category 1 Research and semiannual progress reports for Category 2 Research, and as requested by the Federal Funding Agency (e.g., as part of terms and conditions of award or risk mitigation plans), for review, evaluation, assessment, and, where necessary, clarification or confirmation.

F. Guidance and Strategies for Drafting Risk Mitigation Plans can be found in the document “IMPLEMENTATION GUIDANCE for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, May 2024” (Implementation Guidance) section F. This document and the 2024 USG DURC-P3CO policy can be found on the Mentor IBC Website.

VI. EFFECTIVE DATE

This policy is effective immediately. 

VII. POLICY MANAGEMENT

Executive Stakeholder: Vice President for Research
Oversight Office: Environmental, Health and Safety