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FEDERAL SELECT AGENT PROGRAM
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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
report 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) DRSC 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 DRSC or AgSAS may make a
referral to the FBI when DRSC 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.

Severity

Severity

Severity

Regulation

Regulation

Regulation

Examples of Departures

Examples of Departures

Examples of Departures

Serious Departure

Severity

Serious Departure

Registration, Section 7

Regulation

Registration, Section 7

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.

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.

Serious Departure

Severity

Serious Departure

Responsible Official, Section 9

Regulation

Responsible Official, Section 9

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.

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.

Serious Departure

Severity

Serious Departure

Security, Section 11

Regulation

Security, Section 11

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).

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).

Serious Departure

Severity

Serious Departure

Biosafety, Section 12

Regulation

Biosafety, Section 12

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)

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)

Serious Departure

Severity

Serious Departure

Restricted Experiments, Section 13

Regulation

Restricted Experiments, Section 13

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

Examples of Departures

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

Serious Departure

Severity

Serious Departure

Training, Section 15

Regulation

Training, Section 15

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

Examples of Departures

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

Serious Departure

Severity

Serious Departure

Transfers, Section 16

Regulation

Transfers, Section 16

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

Examples of Departures

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

Serious Departure

Severity

Serious Departure

Records, Section 17

Regulation

Records, Section 17

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.

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.

Serious Departure

Severity

Serious Departure

Inspections, Section 18

Regulation

Inspections, Section 18

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.

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.

Moderate Departure

Severity

Moderate Departure

Registration,
Section 7

Regulation

Registration,
Section 7

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.

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.

Moderate Departure

Severity

Moderate Departure

Responsible Official, Section 9

Regulation

Responsible Official, Section 9

Annual inspections by the registered entity are not conducted.

Examples of Departures

Annual inspections by the registered entity are not conducted.

Moderate Departure

Severity

Moderate Departure

Security, Section 11

Regulation

Security, Section 11

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.

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.

 Moderate Departure

Severity

 Moderate Departure

Biosafety, Section 12

Regulation

Biosafety, Section 12

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.

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.

 Moderate Departure

Severity

 Moderate Departure

Incident Response, Section 14

Regulation

Incident Response, Section 14

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.

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.

Moderate Departure

Severity

Moderate Departure

Training, Section 15

Regulation

Training, Section 15

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

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

Moderate Departure

Severity

Moderate Departure

Transfers,
Section 16

Regulation

Transfers,
Section 16

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

Examples of Departures

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

Moderate Departure

Severity

Moderate Departure

Records, Section 17

Regulation

Records, Section 17

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).

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).

Low Departure

Severity

Low Departure

Registration, Section 7

Regulation

Registration, Section 7

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

Examples of Departures

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

Low Departure

Severity

Low Departure

Responsible Official, Section 9

Regulation

Responsible Official, Section 9

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.

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.

Low Departure

Severity

Low Departure

Security, Section 11

Regulation

Security, Section 11

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.

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.

Low Departure

Severity

Low Departure

Biosafety, Section 12

Regulation

Biosafety, Section 12

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.

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.

Low Departure

Severity

Low Departure

Incident Response, Section 14

Regulation

Incident Response, Section 14

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.

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.

Low Departure

Severity

Low Departure

Training, Section 15

Regulation

Training, Section 15

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

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.

Low Departure

Severity

Low Departure

Records, Section 17

Regulation

Records, Section 17

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

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

Enforcement Action

Enforcement Action

Regulation

Regulation

Regulation

Examples of Departures

Examples of Departures

Examples of Departures

None

Enforcement Action

None

Select Agents and Toxins Regulations

Regulation

Select Agents and Toxins Regulations

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

Examples of Departures

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

Action Required

Enforcement Action

Action Required

Select Agents and Toxins Regulations

Regulation

Select Agents and Toxins Regulations

Inspection report with departures cited—corrective action required by entity

Examples of Departures

Inspection report with departures cited—corrective action required by entity

Increased Monitoring

Enforcement Action

Increased Monitoring

Select Agents and Toxins Regulations

Regulation

Select Agents and Toxins Regulations

Refer to FSAP increased monitoring definition

Examples of Departures

Refer to FSAP increased monitoring definition

Corrective Action Plan

Enforcement Action

Corrective Action Plan

Select Agents and Toxins Regulations

Regulation

Select Agents and Toxins Regulations

Refer to FSAP Corrective Action Plan (CAP) definition

Examples of Departures

Refer to FSAP Corrective Action Plan (CAP) definition

Enforcement Action

Enforcement Action

Enforcement Action

Regulation

Regulation

Regulation

Examples of Departures

Examples of Departures

Examples of Departures

Immediate Action

Enforcement Action

Immediate Action

Registration, Section 7

Regulation

Registration, Section 7

Manipulating BSAT in unregistered areas by a single registered principal
investigator

Examples of Departures

Manipulating BSAT in unregistered areas by a single registered principal
investigator

Immediate Action

Enforcement Action

Immediate Action

Registration, Section 7

Regulation

Registration, Section 7

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Security, Section 11

Regulation

Security, Section 11

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Security, Section 11

Regulation

Security, Section 11

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 12

Regulation

Biosafety, Section 12

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 12

Regulation

Biosafety, Section 12

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 12

Regulation

Biosafety, Section 12

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 12

Regulation

Biosafety, Section 12

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 12

Regulation

Biosafety, Section 12

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 12

Regulation

Biosafety, Section 12

Use of aerosol generating equipment outside of primary containment

Examples of Departures

Use of aerosol generating equipment outside of primary containment

Immediate Action

Enforcement Action

Immediate Action

Restricted Experiments, Section 13

Regulation

Restricted Experiments, Section 13

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

Examples of Departures

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

Immediate Action

Enforcement Action

Immediate Action

Biosafety, Section 17

Regulation

Biosafety, Section 17

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Registration, Section 7

Regulation

Registration, Section 7

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Registration, Section 8

Regulation

Registration, Section 8

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.

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.

Suspension

Enforcement Action

Suspension

Responsible Official, Section 9

Regulation

Responsible Official, Section 9

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Security, Section 11

Regulation

Security, Section 11

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Security, Section 11

Regulation

Security, Section 11

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Security, Section 12

Regulation

Security, Section 12

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Security, Section 12

Regulation

Security, Section 12

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Security, Section 12

Regulation

Security, Section 12

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

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

Suspension

Enforcement Action

Suspension

Security, Section 12

Regulation

Security, Section 12

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Transfers, Section 16

Regulation

Transfers, Section 16

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Records, Section 17

Regulation

Records, Section 17

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

Examples of Departures

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

Suspension

Enforcement Action

Suspension

Inspections, Section 18

Regulation

Inspections, Section 18

Failure to allow inspection in the absence of a reasonable justification

Examples of Departures

Failure to allow inspection in the absence of a reasonable justification

Suspension

Enforcement Action

Suspension

Select Agents and Toxins Regulations

Regulation

Select Agents and Toxins Regulations

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

Examples of Departures

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

Revocation

Enforcement Action

Revocation

Registration, Section 7

Regulation

Registration, Section 7

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

Examples of Departures

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

Revocation

Enforcement Action

Revocation

Registration, Section 8

Regulation

Registration, Section 8

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.

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.

Revocation

Enforcement Action

Revocation

Security, Section 11

Regulation

Security, Section 11

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

Examples of Departures

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

Revocation

Enforcement Action

Revocation

Transfers, Section 16

Regulation

Transfers, Section 16

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

Examples of Departures

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

Referral

Referral

Referral

Statute

Statute

Statute

Examples

Examples

Examples

FBI

Referral

FBI

18 USC 175b(c)

Statute

18 USC 175b(c)

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

Examples

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

FBI

Referral

FBI

18 USC 175b(b)

Statute

18 USC 175b(b)

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

Examples

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

FBI

Referral

FBI

18 USC 175b(a)

Statute

18 USC 175b(a)

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

Examples

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

FBI

Referral

FBI

18 USC 175b(a)

Statute

18 USC 175b(a)

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

Examples

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

FBI

Referral

FBI

18 USC 1001

Statute

18 USC 1001

Knowing submitting a false or fraudulent document to the FSAP.

Examples

Knowing submitting a false or fraudulent document to the FSAP.

FBI

Referral

FBI

Title 18

Statute

Title 18

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

Examples

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

HHS OIG and/or APHIS IES

Referral

HHS OIG and/or APHIS IES

Select Agents and Toxins Regulations

Statute

Select Agents and Toxins Regulations

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.

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.

HHS OIG and/or APHIS IES

Referral

HHS OIG and/or APHIS IES

Select Agents and Toxins Regulations

Statute

Select Agents and Toxins Regulations

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

Examples

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

HHS OIG and/or APHIS IES

Referral

HHS OIG and/or APHIS IES

Select Agents and Toxins Regulations

Statute

Select Agents and Toxins Regulations

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).

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).

HHS OIG and/or APHIS IES

Referral

HHS OIG and/or APHIS IES

Select Agents and Toxins Regulations

Statute

Select Agents and Toxins Regulations

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.

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.

HHS OIG and/or APHIS IES

Referral

HHS OIG and/or APHIS IES

Select Agents and Toxins Regulations

Statute

Select Agents and Toxins Regulations

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.

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.


Last Reviewed: May 6, 2024, 12:00 PM
Source: Division of Regulatory Science and Compliance



Centers for Disease Control and Prevention
Division of Regulatory Science and Compliance
1600 Clifton Road, NE, Mailstop H21-4
Atlanta, GA 30329

Telephone: 404-718-2000
404-488-7100 (after hours)
Fax: 404-718-2096
Email: LRSAT@cdc.gov

Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737

Telephone: 301-851-2070
Fax: 301-734-3652
Email: DASAT@usda.gov


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