The use of certain biological materials in research are regulated by multiple Federal, State, and local regulations. These regulations are put in to place to ensure the safe and legal use of these materials in order to minimize the risk to the researcher, Cornell, and the greater community. Cornell manages the use of these materials in research through a variety of different mechanisms most of which involve review of the proposed research activity by a Cornell committee.
Regulated Biological materials most often include the use of recombinant or synthetic nucleic acids (r/sNA) to generate transgenic or genetically modified organisms, the use of infectious agents (bacteria, fungi, virus, parasite, prion), biological toxins, and/or human derived materials (cell lines and tissues), in research activities.
The committees include the Institutional Biosafety Committee (IBC), the Human Embryonic Stem Cell Research Oversight Committee (ESCRO), and the Dual Use Research of Concern (DURC) committee. Additional approvals from outside regulatory agencies may also be needed in order to conduct research, such as the Federal Select Agents (FSA) program, the USDA APHIS Biotechnology Regulatory Services (BRS) or Plant Protection and Quarantine (PPQ), and various New York state agencies.
Institutional Biosafety Committee (IBC)
The Institutional Biosafety Committee (IBC) is a university committee mandated by Federal granting regulations to oversee the safe and responsible use of certain biological materials in research. The committee, in conjunction with EHS Biosafety, reviews applications known as Memorandum of Understanding and Agreement (MUA). The IBC committee has an electronic MUA submission system known as eMUA and reviews MUA applications at their monthly meetings. To get started with an IBC application, learn more about what needs IBC approval, find helpful guidance material, or if you have any questions you can reach out to the IBC office staff or reach out to the trusted advisor for assistance.
Cornell University coordinates research involving risk group 3 infectious agents under Biosafety Level 3 (BSL3) containment in collaboration with multiple groups across campus. The coordination involves shared information and processes between the IBC, BSL-3/ABSL-3 Operations group, and the BSL-3/ABSL-3 Strategy and Planning group. The IBC is responsible for the review and approval of research involving RG3 agents in BSL3 conditions. The operations group oversees BSL3 facility training and operation, while the strategy and planning group coordinates the activities and allocation of space within BSL3 facilities. For further information about BSL3 research and training please see the BSL3 written program or contact the Cornell Biosafety Officer Joshua Turse firstname.lastname@example.org. To inquire about space availability and cost for use of the facility please reach out to the College of Veterinary Medicine Associate Dean for Research and Graduate Education, Robert Weiss.
Research with Select Agents and Toxins
Research involving Select Agents and Toxins must be approved by the Federal Select Agent Program (FSAP) before the agent can be acquired and research conducted on it. For information about Cornell’s Select Agent Program please visit EHS Biosafety Select Agents and Toxins or contact the University Responsible Official for Select Agents Josh Turse email@example.com.
Dual Use Research of Concern (DURC)
Research involving any of the 15 agents designated as Dual Use Research of Concern, must go through an additional review by the Institutional Review Entity (IRE) to determine if the research qualifies as DURC. In the event the research is classified as DURC, a risk assessment will be performed and communicated to the NIH or funding agency as applicable for approval. All DURC agents are also Select Agents or toxins so the DURC process may coincide with the FSAP process. After the DURC and FSAP processes have been completed, the IBC will then conduct their review as required by Federal regulation. Further information about DURC and the DURC process.
Research with Human Embryonic Stem Cells
Research involving human embryonic stem cells (hESC), human embryos, or the derivatives of these materials must be reviewed and approved by the Cornell human Embryonic Stem Cell Research Oversight Committee (ESCRO). The committee looks at the ethics and the adherence to policy of the proposed research to determine if the research is allowable under the regulations for research with human embryonic stem cells or tissues. Registration with the ESCRO is required for all work with human embryonic stem cells. For further information or questions please reach out to Michael Betteken.
Research requiring a USDA APHIS permit
USDA APHIS BRS Permits: Research involving the importation, interstate movement, or environmental release (outdoor field trials) of certain organisms(plants, insects, and microbes) that may pose a plant pest risk require a USDA APHIS BRS permit to conduct. These permits can be applied for through the USDA APHIS eFile system and are required in order to conduct work that involves the use of genetically modified plants or insects outside of a laboratory, growth chamber, or greenhouse. A USDA APHIS Permit may also be required to receive a shipment of a transgenic modified plant or insect. As part of the IBC process, the USDA APHIS BRS permit must be attached to the IBC application. Certain transgenic plants are exempt for these regulations. Please see the USDA website on exemptions for further details.
USDA APHIS PPQ 526 Permits: Research involving the importation, interstate movement, possession, and/or release into the environment of plant pathogenic bacteria, viruses, fungi, mycoplasmas, and nematodes require a PPQ 526 permit. These permits can be applied for through the USDA eFile system. As part of the IBC process, work with certain plant pathogens will require an approved USDA APHIS PPQ permit to be uploaded to the IBC application before approval for the work can be issued. Please note that plant pathogens isolated in the state of New York (unless being shipped to you from out of state) and certain pathogens do not require PPQ permits.
For questions about USDA APHIS BRS or PPQ permits please reach out to Michael Betteken.
Research involving Hemp
Under the Farm Bill of 2018 research activities which result in the production of hemp require a license through the NY State Hemp Licensing program. For information about how to register to produce hemp for research under the Cornell hemp growing license please visit the Cornell Hemp Program or reach out to Michael Betteken.
About Environment, Health and Safety (EHS)
Research Safety, part of Environment, Health and Safety, is staffed by a team of Biological Safety, Chemical and Laboratory Safety, and Radiation Safety professionals who have the expertise to assist researchers mitigate and manage the risks associated with their research and meet regulatory and compliance requirements. See the Research Safety page for more information.
|Biological Materials requiring Committee Approvals||Approvals needed||Trusted Advisor||Contact for more information|
|All r/sNA modified cells/organisms||IBC||Michael Bettekenfirstname.lastname@example.org|
|RG2/BSL2 infectious agents||IBC||Michael Bettekenemail@example.com|
|RG3/BSL3 infectious agents||IBC, BSL3 program||Joshua Tursefirstname.lastname@example.org|
|Human cell lines||IBC||Michael Bettekenemail@example.com|
|Human (blood, tissues, fluids)||IBC, IRB||Michael Bettekenfirstname.lastname@example.org|
|Transgenic/GMO plants||IBC||Michael Bettekenemail@example.com|
|Transgenic animals||IBC, IACUC||Michael Bettekenfirstname.lastname@example.org|
|Biological Toxins||IBC||Michael Bettekenemail@example.com|
|Select Agents and Toxins||FSAP, IBC||Joshua Tursefirstname.lastname@example.org|
|Human embryonic stem cells (hESCs)||IBC, IRB, ESCRO, IACUC||Michael Bettekenemail@example.com|
|Field release of GMO plants||IBC, USDA BRS||Michael Bettekenfirstname.lastname@example.org|
|Plant pathogens||IBC, USDA PPQ||Michael Bettekenemail@example.com|
|Dual Use Research of Concern||FSAP, DURC, IBC||Joshua Tursefirstname.lastname@example.org|
|Hemp||NY state||Michael Bettekenemail@example.com|