FAQ: Outbreaks

No, specimens are not subject to the Select Agent Regulations until the sample is identified as containing Ebolavirus, a select agent.

Any specimens identified to contain Ebolavirus, a select agent, must be reported to DRSC 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 DRSC within seven days of the initial report.

No, a transfer authorization from the Federal Select Agent Program is not needed to transfer a diagnostic specimen potentially containing Ebolavirus.

Public health departments can contact CDC’s Viral Special Pathogens Branch (VSPB) 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.

Yes. If a patient is infected with Ebolavirus, 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 Ebolavirus 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 Ebolavirus, specimens taken, or waste generated from care of the patient are not subject to the select agent regulations.

Yes, FSAP must approve any transfer requests of specimens identified to contain Ebolavirus prior to the transfer.

Yes. The identification of Ebolavirus must be reported immediately to DRSC by telephone (404-718-2000), email (CDCForm4@cdc.gov), or through the eFSAP information system, and an APHIS/CDC Form 4 must be sent within seven days of the initial report. For reporting the identification of the Ebolavirus from the clinical sample, only one APHIS/CDC Form 4 should be completed for each patient.

Monkeypox virus is a select agent. If monkeypox virus clade undetermined or Clade I is identified in a clinical or diagnostic specimen, the material is a select agent and the select agent and toxin regulations apply; however, an exemption may apply. Exemption provisions for clinical or diagnostic specimens can be found at FAQ/reporting.

If non-variola orthopoxvirus or monkeypox virus Clade II is identified in a clinical or diagnostic specimen, the material is not a select agent and the select agent and toxin regulations do not apply.

When a clinical or diagnostic laboratory not registered with FSAP identifies a specimen as being or containing monkeypox virus Clade I or clade undetermined, the laboratory is exempt from the registration requirements of the select agent and toxin regulations if:

1. Within seven calendar days of identifying monkeypox virus Clade I or clade undetermined, a report is made by telephone, facsimile, or email to CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law. The report must be followed by submission of the “Report of the Identification of a Select Agent or Toxin” form (APHIS/CDC Form 4) also within seven calendar days of identification.
2. Before transfer or destruction of the specimen, the identified select agent is secured against theft, loss, or release, and any theft, loss, or release is reported using an APHIS/CDC Form 3.
3. Unless directed otherwise by FSAP, within seven calendar days after identification of monkeypox virus Clade I or clade undetermined, the specimen is either transferred in accordance with the select agent and toxin regulations (42 CFR 73.16) (which requires prior approval by FSAP) or destroyed on-site by a recognized sterilization or inactivation process.
4. The laboratory maintains a copy of the APHIS/CDC Form 4, Report of the Identification of a Select Agent or Toxin, for a period of three years. 42 CFR 73.5

NOTE: It is a violation of federal law for an individual or entity that is not registered with FSAP to retain a diagnostic, verification, or proficiency sample that has been identified as being or containing monkeypox virus Clade I or clade undetermined, even if it is being retained as a positive control or reference sample.

Yes, the Federal Select Agent Program (FSAP) must provide prior approval for any transfers of specimens or samples identified as being or containing monkeypox virus, clade undetermined or Clade I. An APHIS/CDC Form 2 (Request to Transfer Select Agents and Toxins) is used to request authorization to transfer a select agent or toxin.

If the specimen or sample is identified as being or containing non-variola orthopoxvirus (NVO) or monkeypox virus Clade II, then transfer authorization from FSAP is not required.

Performing surveillance assays that detect nucleic acids from monkeypox virus clade undetermined or Clade I in a wastewater sample without further analysis or assessment is not considered an identification of a select agent in the wastewater sample and therefore, the sample would not be subject to the select agent and toxin regulations (including select agent identification reporting requirements).

If further analysis or assessment, such as culturing monkeypox virus from the wastewater sample, identifies monkeypox virus clade undetermined or Clade I, the sample is subject to the select agent and toxin regulations and the laboratory is required to submit a completed APHIS/CDC Form 4A-AB (Report of the Identification of a Select Agent or Toxin) to FSAP.

All laboratories working with wastewater surveillance samples should consider the biosafety risks associated with these samples. CDC’s Biosafety Laboratory Guidance for Handling and Processing Mpox Specimens includes specific recommendations for wastewater surveillance testing.

If monkeypox virus clade undetermined or Clade I is identified in a diagnostic specimen, a clinical/diagnostic laboratory not registered with the FSAP for monkeypox virus must either transfer the specimen in accordance with 42 CFR § 73.16 to an entity registered with FSAP to possess monkeypox virus, or destroy the identified select agent on-site by a recognized sterilization or inactivation process.

CDC’s Biosafety Laboratory Guidance for Handling and Processing Mpox Specimens includes recommendations for the decontamination of monkeypox virus.

No, specimens are not subject to the Select Agent Regulations until the sample is identified as containing Marburg virus, a select agent.

Any specimens identified to contain Marburg virus, a select agent, must be reported to DRSC 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 DRSC within seven days of the initial report.

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

Public health departments can contact CDC’s Viral Special Pathogens Branch (VSPB) 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.

Yes. If a patient is infected with Marburg virus, 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 Marburg 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 Marburg virus, specimens taken, or waste generated from care of the patient are not subject to the select agent regulations.

Yes, FSAP must approve any transfer requests of specimens identified to contain Marburg virus prior to the transfer.

Yes. The identification of Marburg virus must be reported immediately to DRSC by telephone (404-718-2000), email (CDCForm4@cdc.gov), or through the eFSAP information system, and an APHIS/CDC Form 4 must be sent within seven days of the initial report. For reporting the identification of the Marburg virus from the clinical sample, only one APHIS/CDC Form 4 should be completed for each patient.