Biological Materials Research

The Institutional Biosafety Committee (IBC) reviews all activities that involve recombinant DNA and/or pathogenic substances and conducts yearly inspections of laboratories where such activities are conducted. Biosafety containment practices protect the faculty, staff, students, volunteers and visitors from exposure to infectious agents, biological toxins, Select Agents/Toxins and rDNA and prevent the release of biohazards into the environment.

IBC review and approval is required prior to using the following biohazardous agents:

• Recombinant DNA (rDNA), as defined by the NIH Guidelines, section 8.2. Some protocols may be exempt under section 1.7 (PDF); however these protocols still require review and approval by the IBC Chair.
• Any microorganism (including but not limited to bacteria, viruses, fungi, rickettsia, protozoa, or parasites) or infectious substance, or naturally occurring, bioengineered or synthesized component of any such microorganism or infectious substance that is capable of causing death, disease or other biological malfunction in a human, an animal, or a plant.
• Select Biological Agents and Toxins, High Consequence Livestock Pathogens and Restricted Plant Pathogens, as per 42 CFR 73, CFR121 and 7 CFR 331.
• Any biological toxin: a toxic material or product of plants, animals, or microorganism (including but not limited to bacteria, viruses, fungi, rickettsia, or protozoa), or infectious substance, or recombinant or synthesized molecule (whatever the origin and method of production).
• Any human blood or body fluid.
• Cell lines, tissues, bodily fluids, feces, or other biologics derived from human or non-human primates.
• The definition also includes projects involving known biohazards that do not appear to fall into one of the above criteria (e.g. prions or cell lines, known to be infected with viruses). If in doubt as to whether a material constitutes a potential biohazard, the NIU Biological Safety Officer should be consulted.

Although federal regulations allow exemptions for some types of rDNA and other agents, the principal investigator (PI) must submit an application for all projects using rDNA and biohazardous materials, agents and toxins so that the IBC is aware of the activities and can verify that they are exempt.

The White House Office of Science and Technology Policy (OSTP) released the Framework for Nucleic Acid Synthesis Screening on April 29, 2024, and it took effect on April 29, 2025. This Framework establishes requirements – as a condition of receiving U.S. governmental life sciences research funding – that synthetic nucleic acids, and benchtop devices capable of synthesizing them, are only procured from providers and manufacturers that comply with the requirements of the Framework.

These screening requirements build on the recommendations in the 2024 HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids. Both documents are focused on preventing access to synthetic genetic materials containing Sequences of Concern (SOC)s by individuals without a legitimate need for them.

SOCs are defined as a nucleotide or amino acid sequence that is a Best Match to a sequence of federally regulated agents (Biological Select Agents and Toxins) or the Commerce Control List, except when the sequence is also found in an unregulated organism or toxin.  This includes sequences known to contribute to pathogenicity or toxicity.

Researchers should consult with their funding agencies and Institutional Biosafety Committee (IBC) to determine which providers and manufacturers have made attestations available regarding their compliance with the Framework. The framework is part of a larger effort to strengthen biosecurity measures and reduce the risks of misuse of synthetic nucleic acids.

Beginning April 26, 2025, all providers and manufacturers of synthetic nucleic acids must adhere to the following:

• Write a statement attesting to the adherence to the new policy, posted publicly
• Screen purchase orders (PO)to identify SOCs
• Screen customers to verify legitimacy
• Report potentially illegitimate POs
• Retain records of POs for a minimum of three years
• Take steps to ensure cybersecurity and informational security

The framework applies to all synthetic nucleic acids (RNA and DNA) and whole organism genomes. At a minimum, DNA or RNA of 200 nucleotides or longer should be screened. Beginning October  2026, the screening window will be decreased to 50 nucleotides.

If you are synthesizing nucleic acid sequences at NIU or procuring them, please contact the Office of Research Compliance, Integrity and Safety (ORCIS) to identify what steps you need to take to remain compliant with these new regulations.

Contact ORCIS if you have questions on how these new regulations impact your research at researchcompliance@niu.edu

Resources:

• Department of Energy  Framework for Nucleic Acid Synthesis Screening (February 2026)
• NIH Requirements Regarding Procurement of Synthetic Nucleic Acids (NA) and Benchtop NA Synthesis Equipment NOT-OD-25-012

As a principal investigator,

I certify that the following training and information is provided for all laboratory personnel:

• The biosafety containment level requirements are posted in the laboratory.
• All investigative staff members are informed orally about the policies and procedures concerning handling and disposing of recombinant DNA molecules and organisms as required, based on the appropriate biosafety containment level.
• All investigative staff who have not taken microbiology and recombinant DNA courses are given appropriate instructions and must participate in laboratory demonstrations of the procedures for properly handling and disposing of recombinant DNA/organism-contaminated waste and laboratory materials.

I certify that the following laboratory environment safeguards are enforced at all time:

• Access to biohazard areas is restricted.
• Lab benches are disinfected before and after every experiment.
• Mouth pipetting is prohibited; mechanical pipettes are provided.
• Surgical gloves are required whenever lab personnel are working with biohazardous materials.
• Laminar flow cabinets are used according to the criteria specified by the CDC and the NIH in their publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.
• Safety glasses used according to the criteria specified by the Occupational Safety and Health Administration (OSHA).
• Syringes, needles, broken glass and all other sharps are disposed of according to the procedures prescribed by the CDC and the NIH in their publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition.

I certify that the appropriate containment and disposal safeguards are enforced at all times:

• Disposable materials that are contaminated with the recombinant or infectious material are put into a biohazard bag and autoclaved.
• Non-disposable materials that are contaminated with recombinant or infectious materials are inactivated by autoclaving or cleaning with bleach.

I certify that the information provided in my protocol submission form is accurate; and any protocol changes, including the DNA being cloned, the vector, the host organism, or any other toxic or infectious agents, will be submitted to the IBC for approval prior to initiation.

I further certify that I have read and will comply with all relevant publications, including but not limited to the NIU Institutional Biosafety Committee Policy (PDF), the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition and the Department of Health and Human Services National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules or Synthetic Nucleic Acid Molecules.

Regardless of the source of your funding, non-compliance with NIU biosafety policy may lead to suspension, limitation, or termination of all NIH funding to NIU. Specifically, non-compliance with the NIH Guidelines can result in:

• Suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant DNA research at NIU, or
• A requirement of prior NIH approval of any or all recombinant DNA projects at NIU.

Last updated 2/1/2026

Scott Grayburn, Ph.D., Chair
Director, Molecular Core Lab Department of Biological Sciences, NIU
815-753-0638
sgrayburn@niu.edu
Plant Molecular Pathogen Expert Member

Shicheng Chen, Ph.D.
Assistant Professor
Medical Laboratory Sciences, NIU
815-753-6554
schen1@niu.edu
Faculty Biological/Recombinant DNA Expert Member

Michelle Dummer, MT
Laboratory Manager
Beloit Health System
608-364-5133
mdummer@beloithealthsystem.org
Non-affiliated, Community Health Science Member

Andrew Iverson, Ph.D.
Professor
Harper College
847-925-6388
a.iverson@harpercollege.edu
Non-affiliated, Plant and Microbiology Expert Member

Ben Kastler, MSEd., LAT, ATC
Associate Athletic Trainer
Athletics, NIU
815-753-1624
bkastler@niu.edu
Health Safety Member

Patrick McCarthy, M.S.
Research Technologist
Department of Biological Sciences, NIU
815-753-7843
pmccarthy@niu.edu
Microbiology Expert Member

Linda Srygler, M.S.
Laboratory Safety Specialist
Office of Research Compliance, Integrity and Safety, NIU
815-753-9251
lyates@niu.edu
Biological Safety Officer, IBC Coordinator

April 17, 2025