FAQ: Outbreaks

No, specimens are not subject to the Federal select agent regulations until identified (i.e., confirmed) as containing Ebola virus, a select agent. For a potential rule out or confirmation of Ebola virus, CDC’s Viral Special Pathogens Branch (VSPB) is available 24/7 for consultations regarding suspected Viral Hemorrhagic Fever cases by calling the CDC Emergency Operations Center at 770-488-7100 and requesting VSPB’s on-call epidemiologist or by e-mailing spather@cdc.gov. Once a specimen is confirmed by CDC’s VSPB to contain Ebola virus, the identification of the select agent must be reported to Division of Select Agents and Toxins (DSAT) immediately by telephone (404-718-2000), Email (CDCForm4@cdc.gov), or through eFSAP information system and an APHIS/CDC Form 4 must be sent to DSAT within seven days of the identification.

The select agent regulations do not apply until the specimen that has tested presumptively positive (such as by a non-CDC laboratory using molecular methods) has been identified as containing Ebola virus by CDC’s VSPB. For a potential rule out or confirmation of Ebola virus, CDC’s Viral Special Pathogens Branch (VSPB) is available 24/7 for consultations regarding suspected Viral Hemorrhagic Fever cases by calling the CDC Emergency Operations Center at 770-488-7100 and requesting VSPB’s on-call epidemiologist or by e-mailing spather@cdc.gov.

Any specimens that are confirmed to contain Ebola virus, a select agent, must be reported to DSAT immediately by telephone (404-718-2000), Email (CDCForm4@cdc.gov), or through eFSAP information system and an APHIS/CDC Form 4  must be sent to DSAT within seven days of the initial report.

Yes. If Ebola virus is confirmed, any diagnostic or clinical specimens (e.g., blood, urine, tissue, and other body fluids) from the patient would be select agent material covered by the select agent regulations. In accordance with the select agent regulations, all select agent material must be destroyed, decontaminated, or transferred to a registered select agent facility within seven days of notification that Ebola virus was identified. Waste generated during patient care provided by a health care provider (e.g., blood collected for routine patient care) that is decontaminated or transferred for destruction in compliance with State and Federal regulations within seven days of the conclusion of patient care is not subject to the regulations.

After the patient has been determined to no longer be infected with Ebola virus, specimens taken or waste generated are not subject to the select agent regulations.

Yes, FSAP must approve any transfer requests of specimens identified to contain Ebola virus.

No, a transfer authorization from the Federal Select Agent Program is not needed to transfer a diagnostic specimen presumptively containing Ebola virus.

Yes. The confirmation of Ebola virus must be reported immediately to DSAT and an APHIS/CDC Form 4 must be sent within seven days of the initial report.  For reporting the identification of the Ebola virus from the clinical sample, only one APHIS/CDC Form 4 should be completed for each patient.

Any person or entity, including any clinical or diagnostic laboratory, that identifies an HHS select agent or toxin, such as Mpox, clade unidentified, contained in a specimen or sample presented for diagnosis or verification is required to report this identification by submitting an APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin) to the Federal Select Agent Program (FSAP).

More information on reporting Mpox virus identifications can be found at SA Grams.

An APHIS/CDC Form 1 (Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins) is required if you would like to register with the FSAP.  Registration is required if an entity or individual intends to possess, use or transfer select agents and toxins.  For example, if a diagnostics laboratory would like to retain samples that have been identified as Mpox virus, clade undetermined, without destroying the select agent via inactivation, registration using an APHIS/CDC Form 1 would be required.

Conversely, if a diagnostics laboratory does not retain any identified HHS select agent material, the Diagnostic Specimen Exemption may apply.  The regulations provide that clinical or diagnostic laboratories or other entities that possess, use or transfer an HHS select agent contained in a specimen presented for diagnosis or verification will be exempt from the requirements of the regulations for such agent – and therefore, do not have to register with FSAP – if the entity,

1. reports the identification of the agent to FSAP using an APHIS/CDC Form 4 and other authorities as required by law,
2. secures the select agent after identification, and
3. transfers or destroys the material in accordance with 42 CFR 73.5(a).*

Therefore, if a diagnostic laboratory meets the criteria for the Diagnostic Specimen Exemption, which includes submitting an APHIS/CDC Form 4, there would be no need to register with FSAP by submitting an APHIS/CDC Form 1.

*Please note on 10/4/2022, in accordance with the HHS Select Agent and Toxin Regulations, 42 C.F.R. § 73.5 (a)(4)(iii), DSAT has authorized less stringent Form 4 reporting requirements for the identification of Mpox virus due to the 2022 Mpox Outbreak. More information can be found at SA Grams.

An entity that isn’t registered with the Federal Select Agent Program (FSAP), can use a recognized sterilization or inactivation process to destroy the HHS select agent and keep the remaining inactivated material.

More information regarding additional requirements, including reporting identification and securing the select agent or toxin prior to destruction or transfer can be found at SA Grams.

An entity registered with FSAP that wants to retain inactivated material as a non-select agent, must inactivate the material by using a validated inactivation procedure that is confirmed through a viability testing protocol. See § 73.3(d)(4). If the registered entity transfers inactivated material, a certificate of inactivation must be included in accordance with §73.17(a)(8)(vii). More information can be found at Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use.

Yes, FSAP must approve any transfer requests of specimens identified to contain Mpox virus, clade undetermined or Congo Basin clade (Clade I) prior to transfer.

If the specimen has been identified to contain non-variola orthopoxvirus or Mpox virus, West African clade (Clade II), no transfer authorization from FSAP is required.

If the agent identified in wastewater is Mpox virus, clade undetermined or Congo Basin clade (Clade I) then the select agent regulations apply. If the agent identified in wastewater is non-variola orthopoxvirus or Mpox virus, West African clade (Clade II) the select agent regulations do not apply.

Yes. The laboratory identified Mpox virus, clade undetermined and is required to complete and submit an APHIS/CDC Form 4A-AB (Report of the Identification of a Select Agent or Toxin) to FSAP.

No. Non-variola orthopoxvirus is not a select agent and West African clade (Clade II) Mpox virus is excluded from the select agent regulatory requirements.

If a select agent is identified in a diagnostic sample, clinical/diagnostic laboratories not registered with the Federal Select Agent Program (FSAP) for Mpox virus should use a validated decontamination process before disposing of the samples.

Entities registered with FSAP to possess Mpox virus must use a validated decontamination process in accordance with their respective biosafety plan.

A validated method is a method that has been shown to render materials safe to handle (i.e., safe in the context of being reasonably free from a risk of disease transmission). The validation of methods for disinfection, decontamination, or destruction of select agent waste does not have to occur in-house since this material is not for future use. Further, validation does not have to be performed on select agents but can be performed on surrogates. However, entities must use the concentrations and conditions prescribed by manufacturers, the Biosafety in Microbiological and Biomedical Laboratories, 6^th ed., or other government regulations, such as those promulgated by the Environmental Protection Agency.