Division of Regulatory Science and Compliance: Enforcement of Select Agent and Toxin Regulations

To ensure that organizations that work with select agents or toxins are complying with the requirements of the select agent regulations, the Federal Select Agent Program inspects these organizations using standardized checklists to make sure they have the appropriate measures in place to prevent the unauthorized access, theft, loss, or release of select agents.

During these inspections, if there are violations of the select agent regulations, the Federal Select Agent Program can use the following enforcement actions:

  • Administrative actions: Federal Select Agent Program can decide to suspend or revoke a registered entity’s certificate of registration. Also, DSAT can deny an entity’s application to possess, use, or transfer select agents;
  • Referrals to HHS-Office of Inspector General (HHS-OIG) or APHIS-Investigative and Enforcement Services (APHIS-IES): Depending on the authority, violations of the select agent regulations are referred to HHS-OIG or APHIS-IES.  Civil monetary penalties can be levied (up to $250,000 for an individual for each violation and up to $500,000 for an entity for each violation) or criminal enforcement (imprisonment for up to five years, a fine, or both).
  • Referral to FBI: Federal Select Agent Program can refer possible violations involving criminal negligence or suspicious activities or people.

For more information about Federal Select Agent Program enforcement, visit: SelectAgents.gov FAQ page.

The Federal Select Agent website provides applicable regulations, guidance documents, frequently asked questions, links to guidelines, and other helpful information. All Select Agent forms can be downloaded at this website.