Severity Spectrum of Inspection Departures and Enforcement Actions

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The Federal Select Agent Program (FSAP) has developed a spreadsheet that outlines categories of inspection regulatory departures grouped according to the level of severity, as well as related enforcement options that may be applied.  The intention of this information is to provide awareness of how FSAP considers the severity of inspection findings and provide visibility to the application of enforcement options to these findings.  Example violations are grouped into a three-tier risk scoring system in the categories of low, moderate, and serious severity levels.

Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities.  Please note that this is not meant to be an all-inclusive list of possible departures, but is meant to convey, at a large scale, how FSAP views risk.

Federal Select Agent Program (FSAP) Severity Spectrum of Regulatory Departures

General Considerations:

Severity Spectrum: Departures from the select agent and toxin regulations are communicated through an inspection report. Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities. The intention of this document is to provide awareness of how FSAP considers severity of inspection findings and provide visibility to the application of enforcement options to these findings.

Serious: Departures that are an immediate threat to human, plant, or animal health, animal or plant products, and/or security of biological select agents and toxins (BSAT) and those that indicate a need for systemic improvements. In selected cases, an Immediate Action Report will be submitted within 10 days from the Monday following the last day of the inspection. Required corrective action may include ceasing work or addressing departures within a shortened period of time. Other departures will be reported in the routine inspection report submitted within 30 days from the Monday following the last day of the inspection.

Moderate: Departures that have the potential to be a threat to human, plant, or animal health, animal or plant products, and/or security of BSAT. If not corrected, such departures will likely impact the safety of humans, animals, and/or plants, animal or plant products, and/or security of BSAT and increase the risk of more serious departures.  A routine inspection report will be submitted within 30 days from the Monday following the last day of the inspection.

Low: Departures that are unlikely to pose an immediate threat to human, plant, or animal health, animal or plant products, and/or security of BSAT but are not consistent with safe and secure standards of practice. If not corrected, such departures degrade the culture of safety and security. Repetition of departures may be considered more serious and lead to enforcement actions. A routine inspection report will be submitted within 30 days from the Monday following the last day of the inspection.

Federal Select Agent Program (FSAP) Enforcement Options

Revocation: An entity’s registration will be revoked if the FSAP determines that an entity is unwilling or unable to meet the requirements of the select agent and toxin regulations such that the entity presents a threat to the safety of humans, animals, plants, animal products or plant products; and/or the security of BSAT cannot be maintained even in a storage only capacity. Refer to Section 8 of the select agent and toxin regulations.

Suspension: An entity may be suspended if any regulatory departure presents an imminent danger to the safety of humans, animals, and/or plants, animal or plant products, and/or the security of BSAT. Suspension for such regulatory departures is applied entity-wide, is communicated through a “cease and desist letter,” and is not voluntary. Suspended entities must not conduct activities with select agents and toxins, but will be allowed to securely store to prevent theft, loss, or release of the select agents and toxins in their possession. All suspensions are referred to external agencies for further investigation (see below for more details). Refer to Section 8 of the select agent and toxin regulations.

Immediate action: A limited suspension action for a serious regulatory departure that presents a danger to the safety of humans, animals, and/or plants, animal or plant products, and/or the security of BSAT that can be mitigated with an immediate stoppage of the activity or an immediate change in entity work and/or security practices. This order is communicated through an “immediate action letter” that specifies conditions that must be met within a defined period of time. An immediate action order may include a partial suspension of an entity to possess, use, or transfer BSAT specific to certain agents/toxins, of the activities of a principal investigator, and/or the use of a registered area.

Corrective Action Plan (CAP): Multiple serious, moderate, and/or repeated regulatory departures indicate a systemic failure to comply with the requirements of the select agent and toxin regulations. An entity must fully resolve the departures within 30 days from receipt of the inspection report; or the entity may develop and implement a CAP to resolve the regulatory departures according to a timeline specified by the FSAP. As a part of the CAP program, an entity must submit progress reports in accordance with the timeline documenting actions it has taken to correct regulatory departures. The availability to participate in the CAP program is communicated through an “opportunity to show cause” letter and is voluntary.

Increased Monitoring: Some specific regulatory departures or a history of repeated regulatory departures may indicate an entity is having difficulty complying with the requirements of the select agent and toxin regulations. The FSAP closely monitors implementation of corrective actions and may conduct additional onsite inspections.

Referrals: There are two types of referrals for civil penalties: (1) DSAT may make a referral to the HHS OIG with a recommendation that the HHS OIG seek civil penalties; and (2) AgSAS may make a referral to the APHIS IES with a recommendation that APHIS seek civil penalties. Either DSAT or AgSAS may make a referral to the FBI when DSAT or AgSAS has reason to believe that there has been a violation of Federal criminal law. FSAP may make a referral to another Federal Department or Agency when the FSAP has reason to believe that a regulation under the jurisdiction of that Department or Agency has been violated.

Note: the following examples are not a complete list of departures in these categories. Some of the examples describe multiple regulatory departures that individually may represent the level severity or trigger the enforcement action.

The Federal Select Agent Program (FSAP) has developed a spreadsheet that outlines categories of inspection regulatory departures grouped according to the level of severity, as well as related enforcement options that may be applied.  The intention of this information is to provide awareness of how FSAP considers the severity of inspection findings and provide visibility to the application of enforcement options to these findings.  Example violations are grouped into a three-tier risk scoring system in the categories of low, moderate, and serious severity levels.

Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities.  Please note that this is not meant to be an all-inclusive list of possible departures, but is meant to convey, at a large scale, how FSAP views risk.

Federal Select Agent Program (FSAP) Severity Spectrum of Regulatory Departures

General Considerations:

Severity Spectrum: Departures from the select agent and toxin regulations are communicated through an inspection report. Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities. The intention of this document is to provide awareness of how FSAP considers severity of inspection findings and provide visibility to the application of enforcement options to these findings.

Serious: Departures that are an immediate threat to human, plant, or animal health, animal or plant products, and/or security of biological select agents and toxins (BSAT) and those that indicate a need for systemic improvements. In selected cases, an Immediate Action Report will be submitted within 10 days from the Monday following the last day of the inspection. Required corrective action may include ceasing work or addressing departures within a shortened period of time. Other departures will be reported in the routine inspection report submitted within 30 days from the Monday following the last day of the inspection.

Moderate: Departures that have the potential to be a threat to human, plant, or animal health, animal or plant products, and/or security of BSAT. If not corrected, such departures will likely impact the safety of humans, animals, and/or plants, animal or plant products, and/or security of BSAT and increase the risk of more serious departures.  A routine inspection report will be submitted within 30 days from the Monday following the last day of the inspection.

Low: Departures that are unlikely to pose an immediate threat to human, plant, or animal health, animal or plant products, and/or security of BSAT but are not consistent with safe and secure standards of practice. If not corrected, such departures degrade the culture of safety and security. Repetition of departures may be considered more serious and lead to enforcement actions. A routine inspection report will be submitted within 30 days from the Monday following the last day of the inspection.

Federal Select Agent Program (FSAP) Enforcement Options

Revocation: An entity’s registration will be revoked if the FSAP determines that an entity is unwilling or unable to meet the requirements of the select agent and toxin regulations such that the entity presents a threat to the safety of humans, animals, plants, animal products or plant products; and/or the security of BSAT cannot be maintained even in a storage only capacity. Refer to Section 8 of the select agent and toxin regulations.

Suspension: An entity may be suspended if any regulatory departure presents an imminent danger to the safety of humans, animals, and/or plants, animal or plant products, and/or the security of BSAT. Suspension for such regulatory departures is applied entity-wide, is communicated through a “cease and desist letter,” and is not voluntary. Suspended entities must not conduct activities with select agents and toxins, but will be allowed to securely store to prevent theft, loss, or release of the select agents and toxins in their possession. All suspensions are referred to external agencies for further investigation (see below for more details). Refer to Section 8 of the select agent and toxin regulations.

Immediate action: A limited suspension action for a serious regulatory departure that presents a danger to the safety of humans, animals, and/or plants, animal or plant products, and/or the security of BSAT that can be mitigated with an immediate stoppage of the activity or an immediate change in entity work and/or security practices. This order is communicated through an “immediate action letter” that specifies conditions that must be met within a defined period of time. An immediate action order may include a partial suspension of an entity to possess, use, or transfer BSAT specific to certain agents/toxins, of the activities of a principal investigator, and/or the use of a registered area.

Corrective Action Plan (CAP): Multiple serious, moderate, and/or repeated regulatory departures indicate a systemic failure to comply with the requirements of the select agent and toxin regulations. An entity must fully resolve the departures within 30 days from receipt of the inspection report; or the entity may develop and implement a CAP to resolve the regulatory departures according to a timeline specified by the FSAP. As a part of the CAP program, an entity must submit progress reports in accordance with the timeline documenting actions it has taken to correct regulatory departures. The availability to participate in the CAP program is communicated through an “opportunity to show cause” letter and is voluntary.

Increased Monitoring: Some specific regulatory departures or a history of repeated regulatory departures may indicate an entity is having difficulty complying with the requirements of the select agent and toxin regulations. The FSAP closely monitors implementation of corrective actions and may conduct additional onsite inspections.

Referrals: There are two types of referrals for civil penalties: (1) DSAT may make a referral to the HHS OIG with a recommendation that the HHS OIG seek civil penalties; and (2) AgSAS may make a referral to the APHIS IES with a recommendation that APHIS seek civil penalties. Either DSAT or AgSAS may make a referral to the FBI when DSAT or AgSAS has reason to believe that there has been a violation of Federal criminal law. FSAP may make a referral to another Federal Department or Agency when the FSAP has reason to believe that a regulation under the jurisdiction of that Department or Agency has been violated.

Note: the following examples are not a complete list of departures in these categories. Some of the examples describe multiple regulatory departures that individually may represent the level severity or trigger the enforcement action.