Severity Spectrum of Inspection Departures and Enforcement Actions

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) DASAT may make a referral to the APHIS IES with a recommendation that APHIS seek civil penalties. Either DSAT or DASAT may make a referral to the FBI when DSAT or DASAT 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.

Severity

Regulation

Examples of Departures

Severity

Serious Departure

Regulation

Registration, Section 7

Examples of Departures

Discovery of BSAT in unregistered space and/or possession of BSAT without approval. The entity conducts work with BSAT that is not described on APHIS/CDC Form 1. Possession of Tier 1 BSAT at non-Tier 1 entity and requirements of section 11(f) are not in place.

Severity

Serious Departure

Regulation

Responsible Official, Section 9

Examples of Departures

Failure of entity and RO to ensure compliance with the select agent and toxin regulations, resulting in widespread departures. Failure of entity to provide adequate authority to an RO to act on behalf of the entity. Failure to report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification.

Severity

Serious Departure

Regulation

Security, Section 11

Examples of Departures

Evidence that an entity allowed a non-SRA approved person access to BSAT. Security breach that has the potential to result in theft or loss of BSAT. Failure to implement Tier 1 requirements, such as a suitability program for personnel with access to Tier 1 BSAT, three physical security barriers to Tier 1 BSAT, and/or functional Intrusion Detection System (IDS).

Severity

Serious Departure

Regulation

Biosafety, Section 12

Examples of Departures

Release that has the potential to result in a laboratory-acquired infection in humans without identification of root cause and/or releases or repeated incidents to which the entity has failed to take adequate corrective action(s) to prevent further containment breaches. Failure to adhere to validated inactivation method. Systemic failure to implement the Occupational Health Plan for Tier 1 BSAT, SARS-CoV, or Reconstructed 1918 influenza virus. The facility is inadequate for BSAT work conducted (refer to specific examples in immediate action category)

Severity

Serious Departure

Regulation

Restricted Experiments, Section 13

Examples of Departures

Conducting a restricted experiment, or possession of a product of a restricted experiment, without prior approval

Severity

Serious Departure

Regulation

Training, Section 15

Examples of Departures

Systemic failure to provide refresher training to FSAP-approved individuals or training to visitors on a consistent basis

Severity

Serious Departure

Regulation

Transfers, Section 16

Examples of Departures

Transfer of a select agent or regulated quantities of select toxin to another entity without APHIS/CDC Form 2 authorization

Severity

Serious Departure

Regulation

Records, Section 17

Examples of Departures

BSAT inventory is inaccurate to a degree that material accountability is not possible. Entity does not have a system to ensure that records and databases are accurate and their authenticity can be verified, to the extent that it cannot be determined if there has been a theft or loss of BSAT. Systemic failure to provide records required by section 17 upon request.

Severity

Serious Departure

Regulation

Inspections, Section 18

Examples of Departures

Entity does not allow FSAP inspectors access to any site at which select agent and toxins activities are conducted.
Entity does not allow FSAP inspectors access to and copying of entity select agent and toxin records.

Severity

Moderate Departure

Regulation

Registration,
Section 7

Examples of Departures

Principal investigator designated on the APHIS/CDC Form 1 does not provide scientific/technical oversight of BSAT activities. Entity does not report accurate and/or current information for BSAT strains/serotypes on APHIS/CDC Form 1.

Severity

Moderate Departure

Regulation

Responsible Official, Section 9

Examples of Departures

Annual inspections by the registered entity are not conducted.

Severity

Moderate Departure

Regulation

Security, Section 11

Examples of Departures

Entity fails to provide graded protection to BSAT (e.g., laboratory has false ceiling that can be overcome without the use of special tools). A complete inventory audit of BSAT is not conducted upon departure of a principal investigator.

Severity

 Moderate Departure

Regulation

Biosafety, Section 12

Examples of Departures

PPE donning/doffing procedures are not followed. The biosafety plan lacks provisions for intentionally or accidentally infected animals/arthropods/plants. The entity works with avian influenza virus but has not developed a written personnel quarantine policy. Centrifuges do not have adequate safety cups or sealed rotors for BSAT work.

Severity

 Moderate Departure

Regulation

Incident Response, Section 14

Examples of Departures

The incident response plan lacks provisions for intentionally or accidentally infected animals/arthropods/plants. The plan has not been coordinated with local responders. The plan does not contain evacuation procedures.

Severity

Moderate Departure

Regulation

Training, Section 15

Examples of Departures

Annual insider threat awareness training is not provided by an entity with Tier 1 BSAT. Refresher training was not provided after the entity significantly amended its plans

Severity

Moderate Departure

Regulation

Transfers,
Section 16

Examples of Departures

Due diligence is not conducted prior to transfers of excluded amounts of select toxin

Severity

Moderate Departure

Regulation

Records, Section 17

Examples of Departures

Visitor entry records do not document name of the escort. BSAT inventory record is missing multiple requirements (i.e., lacks source, strain, date of acquisition). Animal/plant/arthropod accounting is incomplete (i.e., lacks number, species, location, or final disposition).

Severity

Low Departure

Regulation

Registration, Section 7

Examples of Departures

Information is not described accurately on the APHIS/CDC Form 1 (i.e. inaccurate administrative information, security or laboratory features, etc.).

Severity

Low Departure

Regulation

Responsible Official, Section 9

Examples of Departures

Annual inspections conducted by the registered entity were incomplete, such as the entity conducted a biosafety inspection but did not assess other requirements of the Select Agent and Toxin Regulations.

Severity

Low Departure

Regulation

Security, Section 11

Examples of Departures

Shipping and receiving procedures are not described in plan. Plan does not contain sufficient information on physical security, inventory control or information security systems. A BSAT intra-entity transfer protocol is not developed. Annual review of plan is not performed. Annual drills or exercises are not conducted.

Severity

Low Departure

Regulation

Biosafety, Section 12

Examples of Departures

Signage posted for registered areas containing BSAT is inadequate. Durable leak proof containers are not used for transport of BSAT waste. Annual review of plan not performed. Annual drills or exercises not conducted.

Severity

Low Departure

Regulation

Incident Response, Section 14

Examples of Departures

Plan does not contain name(s) of personnel as required by section 14(d). The plan does not fully describe incident response procedure(s). Annual review of plan is not performed. Annual drills or exercises are not conducted.

Severity

Low Departure

Regulation

Training, Section 15

Examples of Departures

Training for visitors does not include all select agent and toxin regulatory requirements, such as security, biosafety, and/or incident response training.

Severity

Low Departure

Regulation

Records, Section 17

Examples of Departures

The entity’s list of Security Risk Assessment (SRA)-approved personnel is not current or accurate. The BSAT inventory record contains transcriptional errors.

Enforcement Action

Regulation

Examples of Departures

Enforcement Action

None

Regulation

Select Agents and Toxins Regulations

Examples of Departures

Inspection report with no departures cited—no further action required by entity

Enforcement Action

Action Required

Regulation

Select Agents and Toxins Regulations

Examples of Departures

Inspection report with departures cited—corrective action required by entity

Enforcement Action

Increased Monitoring

Regulation

Select Agents and Toxins Regulations

Examples of Departures

Refer to FSAP increased monitoring definition

Enforcement Action

Corrective Action Plan

Regulation

Select Agents and Toxins Regulations

Examples of Departures

Refer to FSAP Corrective Action Plan (CAP) definition

Enforcement Action

Regulation

Examples of Departures

Enforcement Action

Immediate Action

Regulation

Registration, Section 7

Examples of Departures

Manipulating BSAT in unregistered areas by a single registered principal investigator

Enforcement Action

Immediate Action

Regulation

Registration, Section 7

Examples of Departures

Use of select toxin under the control of registered principal investigator in unregistered areas and/or by personnel without FSAP approval

Enforcement Action

Immediate Action

Regulation

Security, Section 11

Examples of Departures

Non FSAP-approved personnel control access to registered areas and have access to BSAT

Enforcement Action

Immediate Action

Regulation

Security, Section 11

Examples of Departures

Three physical security barriers are not in place to safeguard Tier 1 BSAT

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 12

Examples of Departures

A room/suite is not adequate for the work being conducted and an alternate registered laboratory is not available

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 12

Examples of Departures

Laboratory does not meet the facility criteria for the designated biosafety level, such as inward airflow for BSL-3

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 12

Examples of Departures

BSC certification record, or cabinet airflow observations, do not confirm that the cabinet maintains primary containment

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 12

Examples of Departures

Decontamination systems such as autoclave or effluent decontamination system (EDS) are currently inoperable

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 12

Examples of Departures

Laboratory exhaust HEPA filters failed certification and room exhaust HEPA filtration is required for the agent in use

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 12

Examples of Departures

Use of aerosol generating equipment outside of primary containment

Enforcement Action

Immediate Action

Regulation

Restricted Experiments, Section 13

Examples of Departures

Conducting a denied restricted experiment or possession of a product of a denied restricted experiment

Enforcement Action

Immediate Action

Regulation

Biosafety, Section 17

Examples of Departures

BSAT inventory records are inaccurate to a degree that material accountability is not possible

Enforcement Action

Suspension

Regulation

Registration, Section 7

Examples of Departures

Working with BSAT in unregistered space by more than one registered principal investigator and/or unregistered individuals

Enforcement Action

Suspension

Regulation

Registration, Section 8

Examples of Departures

Any departure from the select agent regulations that is considered a present danger to human, plant, or animal health, animal or plant products and/or security of BSAT. Refer to Section 8 of the Select Agent and Toxin Regulations.

Enforcement Action

Suspension

Regulation

Responsible Official, Section 9

Examples of Departures

Entity does not have an RO. The suspension is in effect until such time that a new RO is approved

Enforcement Action

Suspension

Regulation

Security, Section 11

Examples of Departures

Evidence that entity allowed a restricted person access and use of BSAT

Enforcement Action

Suspension

Regulation

Security, Section 11

Examples of Departures

Security breach is of such high risk that theft or loss is imminent – continuation of work puts BSAT in jeopardy

Enforcement Action

Suspension

Regulation

Security, Section 12

Examples of Departures

Release that results in laboratory-acquired infection of humans or accidental infection of animals/plants

Enforcement Action

Suspension

Regulation

Security, Section 12

Examples of Departures

Release that leaves secondary containment and jeopardizes public health, animals or plants, and/or animal or plant products

Enforcement Action

Suspension

Regulation

Security, Section 12

Examples of Departures

Systemic failure to implement biosafety and containment procedures commensurate with the risk of BSAT such that continued failure jeopardizes the safety of humans/animals/plants inside and outside of the laboratory

Enforcement Action

Suspension

Regulation

Security, Section 12

Examples of Departures

Failure to adhere to validated inactivation method and product(s) transferred outside of entity, with potential exposures to humans/animals/plants

Enforcement Action

Suspension

Regulation

Transfers, Section 16

Examples of Departures

Transfer of select agent or regulated quantities of select toxin without APHIS/CDC Form 2 authorization in multiple cases

Enforcement Action

Suspension

Regulation

Records, Section 17

Examples of Departures

Systemic failure to create, maintain, and produce BSAT records required by the select agent and toxin regulations

Enforcement Action

Suspension

Regulation

Inspections, Section 18

Examples of Departures

Failure to allow inspection in the absence of a reasonable justification

Enforcement Action

Suspension

Regulation

Select Agents and Toxins Regulations

Examples of Departures

Failure to adhere to a CAP agreement may result in suspension until such time that all departures are resolved

Enforcement Action

Revocation

Regulation

Registration, Section 7

Examples of Departures

False registration (e.g., entity is not located at address provided on APHIS/CDC Form 1)

Enforcement Action

Revocation

Regulation

Registration, Section 8

Examples of Departures

Any departure from the select agent regulations that is considered a present danger to human, plant, or animal health, animal or plant products and/or security of BSAT and which the entity is unwilling or unable to resolve. Refer to Section 8 of the Select Agent and Toxin Regulations.

Enforcement Action

Revocation

Regulation

Security, Section 11

Examples of Departures

Security breach is of such high risk that theft or loss is imminent- continuation of storage of BSAT is in jeopardy.

Enforcement Action

Revocation

Regulation

Transfers, Section 16

Examples of Departures

Recurrent shipping of BSAT without APHIS/CDC Form 2 to unregistered entity

Referral

Statute

Examples

Referral

FBI

Statute

18 USC 175b(c)

Examples

The knowing possession of a select agent or toxin by a unregistered individual or entity

Referral

FBI

Statute

18 USC 175b(b)

Examples

The knowing transfer of a select agent or toxin to an unregistered individual or entity

Referral

FBI

Statute

18 USC 175b(a)

Examples

The knowing possession of a select agent or toxin by a “restricted person.”

Referral

FBI

Statute

18 USC 175b(a)

Examples

The knowing transport of a select agent or toxin by a “restricted person.”

Referral

FBI

Statute

18 USC 1001

Examples

Knowing submitting a false or fraudulent document to the FSAP.

Referral

FBI

Statute

Title 18

Examples

Evidence of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select agents or toxins

Referral

HHS OIG and/or APHIS IES

Statute

Select Agents and Toxins Regulations

Examples

Registered individual or entity issued a suspension. FSAP will refer regulatory departures resulting in a “cease and desist” letter that present an imminent danger to the safety of humans, animals, and/or plants, animal or plant products, and/or the security of BSAT.  FSAP may refer regulatory departures that result from an immediate action letter and a partial suspension of BSAT activities.

Referral

HHS OIG and/or APHIS IES

Statute

Select Agents and Toxins Regulations

Examples

Failure to address regulatory departures cited in a “show cause” letter that resulted in a CAP agreement may result in referral.

Referral

HHS OIG and/or APHIS IES

Statute

Select Agents and Toxins Regulations

Examples

Any departure from the select agent and toxin regulations or the submission of documentation of a corrective action that is associated with the entity’s knowing submission of false information to FSAP. (Note: The knowing submission of a false or fraudulent document to the FSAP may also result in a referral to the FBI).

Referral

HHS OIG and/or APHIS IES

Statute

Select Agents and Toxins Regulations

Examples

Continued failure to adequately resolve repeated inspection departures (i.e., specific observations noted repeatedly on follow-up inspections) that demonstrate a registered entity’s failure to maintain institutional integrity.

Referral

HHS OIG and/or APHIS IES

Statute

Select Agents and Toxins Regulations

Examples

Any departure from the select agent regulations that is considered a present danger to human, plant, or animal health, animal or plant products and/or security of BSAT.

Page last reviewed: October 15, 2020, 12:00 PM