Responsible Official Resource Manual:
Compliance with the Select Agent Regulations
The RO is responsible for ensuring the following specific items and duties occur to maintain compliance with the select agent regulations:
- Develop and implement a site-specific security plan external icondesigned according to a site-specific risk assessment that provides graded protection in accordance with the risk of the select agents and toxins for which the entity is
- Develop and implement an agent-specific, site-specific biosafety plan external iconcommensurate with the risk of the select agents and toxins, and the use and disposal of the agents or toxins, for which the entity is registered. The plan should contain sufficient information and documentation to describe biosafety and containment procedures.
- Develop and implement a site-specific incident response plan external iconcommensurate with the hazards of the select agents and toxins for which the entity is registered. Describe the entity’s response procedures for the theft, loss, or release of a select agent and toxin, inventory discrepancies, security breaches, natural disasters, and other
- Review the security, biosafety, and incident response plans at least annually and revise them as necessary, including after any drill or exercise, and after any
- Conduct site-specific drills or exercises external iconat least annually to validate or test the effectiveness of the security, biosafety, and incident response plans. Document drills and exercises to include how the plans were tested and evaluated, any identified problems and corrective actions taken, and the list of
- Provide information and training external iconon incident response, biosafety, and security to each individual with access approval prior to him or her having access to select agents and toxins. Provide refresher training annually. This training must be
- Provide risk-based training to individuals escorted into registered space on incident response, biosafety and security prior to entering registered This training must be documented.
- Ensure coordination and communication with the entity’s biosafety and security officials to assess potential personnel security issues for Tier 1
- Review and maintain the entity’s pre-access and ongoing suitability assessments external iconfor individuals with access to Tier 1
- Ensure the entity has an active insider threat awareness training program if they have Tier 1
- Ensure that annual inspections are conducted and documented for each laboratory and storage area where select agents and toxins are stored or used. Correct any discrepancies, and document the corrections
- Ensure that individuals are provided the contact information for the HHS OIG Hotline external iconand the USDA OIG external iconHotline external iconso that they may anonymously report any safety or security concerns related to select agents and
- Ensure that an investigation is conducted to determine the reason for any failure of a validated inactivation procedure external iconor any failure to remove viable select agent from material. If the entity is unable to determine the cause as a deviation from a validated inactivation procedure or a viable select agent removal procedure, or receives a report of any inactivation failure after the movement of material to another location, the RO must report the inactivation or viable agent removal procedure failure to
Federal Select Agent Program Notification
The RO submits reports and requests by utilizing eFSAP, FSAP’s secure information system. eFSAP is used to submit select agent program information via a two-way portal that is accessible by both FSAP and the regulated community.
Purpose of Form
|APHIS/CDC Form 1||Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins||
|APHIS/CDC Form 2||Request to Transfer Select Agents and Toxins||
|APHIS/CDC Form 3||Report of a Release/Loss/Theft||
Immediate reporting: https://www.selectagents.gov/efsap/using/form3/quickref-in.htmexternal icon
|APHIS/CDC Form 4||Reporting the Identification of a Select Agent or Toxin||
||https://www.selectagents.gov/efsap-external icon tools-form4.htmlexternal icon
Non-form notification via eFSAP:
- If there is any failure of a validated inactivation procedure or failure to remove a select agent from material, the RO must investigate the cause. If unable to identify the cause as a deviation from a validated procedure, the RO must report the failure to FSAP immediately by telephone or
- If the RO receives a report of inactivation failure after material has been transferred to another location, the RO must report the failure to FSAP immediately through eFSAP, telephone, or email.