All U.S. institutions and individuals that possess, use, or transfer select agents and toxins are required to adhere to 42 CFR Part 73 (Federal Select Agent Program Regulations).
This policy also extends to research involving the select agents and toxins identified in the HHS and USDA Select Agents and Toxins List of the Federal Select Agent Program as posing a severe threat to human and/or animal health, plant health, or animal and plant products.
These regulations establish requirements regarding registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications.
NIH has established a policy for the use of NIH funds for research involving select agents. NIAID is implementing this policy using the Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts, which are included in any grant, cooperative agreement, or contract in which select agents are or will be used. The terms and conditions of award are in the accompanying document.
Awards to U.S. Institutions. Awards to U.S. institutions for research involving select agents will contain a Term of Award requiring registration with the Centers for Disease Control and Prevention (CDC) of HHS or Animal and Plant Health Inspection Service (APHIS) of USDA, depending on the agent, prior to using NIH funds for such research.
Awards to non-U.S. (Foreign) Institutions. Awards to non-U.S. institutions for research involving select agents will contain a Term of Award requiring U.S. review and approval of safety and security measures and practices prior to use of NIH funds for such research. An NIH-chaired committee of U.S. federal employees (including representatives of NIH grants and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73.
Toward this end, awardee institutions must be willing to provide key information delineating any laws, regulations, policies, and procedures applicable to the institution for the safe and secure possession, use, and transfer of select agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations, and policies.
For security risk assessments, awardee institutions must be willing to provide the names of all individuals who will have access to the select agents and procedures for ensuring that only approved and appropriate individuals have access to select agents that are the subject of the NIH award.
Awards to U.S. Institutions with Foreign Components. Awards to U.S. institutions with non-U.S. components for research involving select agents will contain a Term of Award (or a Special Contract Requirements Clause under Section H in the case of contract awards) requiring U.S. review and approval of safety and security measures and practices prior to use of NIH funds for such research.
An NIH-chaired committee of U.S. federal employees (including representatives of NIH grants and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will assess the policies and procedures for comparability to the U.S. requirements described in the Federal Select Agent Program Regulations.
Toward this end, the U.S. awardee institution must be willing to provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of select agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations and policies.
For security risk assessments, awardee institutions must be willing to provide the names of all individuals at the foreign institution who will have access to the select agents and procedures for ensuring that only approved/appropriate individuals have access to select agents that are the subject of the NIH award.
More information
If your research involves select agents, find more information at Research Using Select Agents.