FAQ:
Report of Identification of Select Agent or Toxin

Clinical/Diagnostic Identification (Form 4A)

Any person or entity, including any clinical or diagnostic laboratory, having identified a select agent or toxin contained in a specimen or sample presented for diagnosis or verification is required by the select agent regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) to report this identification by submitting a completed and signed APHIS/CDC Form 4A to either DASAT or DRSC.

Proficiency Testing Identification (Form 4B)

Any person or entity, including any clinical or diagnostic laboratory, having identified a select agent or toxin contained in a specimen or sample presented for proficiency testing is required by the select agent regulations to report this identification by submitting a completed and signed APHIS/CDC Form 4B to either DASAT or DRSC.

Federal Law Enforcement Seizure (Form 4C)

A Federal law enforcement agency that seizes a select agent or toxin is required by the select agent regulations to report this seizure by submitting a completed and signed APHIS/CDC Form 4C to either DASAT or DRSC.

Anyone that possesses a select agent or toxin that is contained in a diagnostic or verification specimen or sample is exempt from the requirements of the select agent regulations for that specific select agent or toxin if you do the following:

• Unless directed otherwise by DASAT or DRSC, within seven (7) calendar days after identification of the select agent or toxin, either transfer the select agent or toxin in accordance with section 16 of the select agent regulations (requires prior approval by DASAT or DRSC) or destroy the specimen on-site by a recognized sterilization or inactivation process.
• Before transfer or destruction, secure the select agent or toxin to prevent theft, loss, or release.
• Immediately report the identification of specific select agents and toxins listed in the regulations (See immediate notification list).
• Maintain copies of all APHIS/CDC Form 4A reports for a period of (3) three years.

Anyone that possesses a select agent or toxin that is contained in a specimen used as a part of proficiency testing is also exempt from the requirements of the select agent regulations only for that specific specimen and only if you do the following:

• Unless directed otherwise by DASAT or DRSC, within ninety (90) days of receipt of the sample or specimen used for proficiency testing, either transfer the select agent or toxin in accordance with section 16 of the select agent regulations (includes prior approval by AgSAS or DRSC) or destroy the specimen on-site by a recognized sterilization or inactivation process.
• Before transfer or destruction, secure the select agent or toxin to prevent theft, loss, or release.
• Send an APHIS/CDC Form 4B to the DASAT or DRSC within ninety (90) days of receipt of the proficiency testing sample or specimen. Note: The ninety (90) days starts from the date you receive the proficiency test and not from the date you identify the select agent.
• The entity maintains a completed APHIS/CDC Form 4B for a period of three years.

NOTE: The retention of a diagnostic, verification, or proficiency sample which has been identified as positive for a select agent by an individual or entity that is not registered with either DASAT or DRSC is a violation of Federal law. Such possession would include the retention of a select agent or toxin which had been identified from a diagnostic, verification, or proficiency specimen as a positive control or reference sample.

No, the laboratory is not registered to possess a Tier 1 select agent or toxin.

Yes. If an original food sample and clinical sample submitted to laboratories for diagnosis or verification purposes is identified or verified as a select agent or toxin, it must be reported using APHIS/CDC Form 4. For example, an original food sample could be a container of potato salad or juice. An original clinical sample could be serum or stool from a patient. See the Select Toxin Guidance for more detail.

Each entity in possession of a sample containing identified select agent or toxin is required to complete and submit separate APHIS/CDC Form 4 for each location/sample provider.

Yes. Select the checkbox for each method of disposition used for the identified select agent or toxin.

• Transferred – Indicate the name of entity where the sample was sent, and the date of the transfer noted on the APHIS/CDC Form 2.
• Destroyed – Indicate method of destruction and date destroyed.
• Retained – Indicate the Principal Investigator (PI) (from the dropdown menu of PIs approved to possess the identified select agent and toxin).

Regardless of the amount identified, clinical and diagnostic laboratories that identify a select toxin contained in a sample presented for diagnosis or verification must report the identification of the toxin using APHIS/CDC Form 4.

Yes. In accordance with Section 9(c) of the select agent regulations, the Responsible Official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification. The registered entity does have the option of adding the identified or verified select agent or toxin to their registration.

You would complete APHIS/CDC Form 4A reporting the identification of a select agent or toxin from a clinical/diagnostic specimen (Section A: Reference Laboratory Information and Section B: Select Agent or Toxin Identified from Clinical/Diagnostic Specimen(s)) within seven calendar days of identification of a select agent or toxin as a result of diagnosis or verification.

The following are acceptable sample types to be used:

• Human Clinical/Diagnostic sample – a sample (not the isolate) that was directly derived from an individual human (e.g., blood, sputum, tissue).
• Human Isolate – a purified culture obtained from a specimen or sample taken from a human (e.g., slant, plate, etc.).
• Animal Clinical/Diagnostic sample – a sample (not the isolate) that was directly derived from an individual animal or insect (e.g., blood, sputum, tissue).
• Animal Isolate – a purified culture obtained from a specimen or sample taken from an animal (e.g., slant, plate, etc.).
• Plant Diagnostic sample – a sample (not the isolate) that was directly derived from an individual plant or group of plants (e.g., sap (xylem or phloem), tissue, seed or other fruiting body, other plant part(s), etc.).
• Plant Isolate – a purified culture or purified material obtained from a sample taken from a plant (e.g., slant, plate, DNA, RNA, etc.).
• Environmental sample – a sample that was not directly derived from a human, animal, or plant (e.g., water sample, soil sample, air sample).
• Food Sample – a sample that was directly derived from a food source, food container or food by-product (e.g., can of soup, beans, milk).

After the identification, the non-registered laboratory has within seven calendar day to either:

1. Destroy the specimens (diagnostic specimen containing the select agent). If the choice is to destroy the select agent or toxin, the date and method of destruction must be indicated on the APHIS/CDC Form 4A;
2. Transfer the specimens (diagnostic specimen containing the select agent) to an entity registered for the select agent(s) or toxin(s). Prior to the transfer, pre-approval must be obtained by submitting APHIS/CDC Form 2 (“Request to Transfer of Select Agents or Toxins”) to DASAT or DRSC.

If the laboratory is registered with FSAP for the identified select agent(s) and toxin(s), the laboratory may retain the isolate that contains the select agent. Note: The registered laboratory must still account for the new addition in its records in accord with the select agent regulations.

In Section B9 of the APHIS/CDC Form 4A, the entity should check “retained” and list the name of the person that took responsibility of the material.

Yes, APHIS/CDC Form 2 would be required to request prior authorization for the transfer of the identified select agent(s) or toxin(s).

Yes. The sample provider needs to complete section C and D to report the possession of the specimen and if work with the specimen was performed.

No. However, once a select agent is identified, the possession of that select agent or toxin in a diagnostic or verification specimen or sample is only exempt from the select agent regulation requirements if the laboratory does the following:

1. Unless directed otherwise by DASAT or DRSC, within seven (7) calendar days after identification of the select agent or toxin, either transfer the select agent or toxin in accordance with Section 16 of the select agent regulations (requires prior approval by DASAT or DRSC) or destroy the specimen on-site by a recognized sterilization or inactivation process.
2. Before transfer or destruction, secure the select agent or toxin to prevent theft, loss, or release.
3. Immediately report the identification of specific select agents and toxins listed in the regulations (See immediate notification list).
4. Maintain copies of all APHIS/CDC Form 4A reports for a period of (3) three years.

The test or procedure used to determine whether a select agent or toxin is contained in a specimen presented for diagnosis or verification will depend on the select agent or toxin, and whether the agent is identified at the genus or the genus/species level. A particular test or procedure used by an accredited laboratory, and/or disease program approved laboratory, and/or reference laboratory will have a recognized capability to make either a tentative or positive identification depending on the exactness of the identification needed. In some cases an agent may need to be cultured for confirmatory test purposes and may also require specific disease program testing requirements. The Federal Select Agent Program (FSAP) does not consider a test result identifying the presence of antibodies to select agent antigen(s) in a sample as positive identification of the select agent. FSAP does not define which tests or procedures constitute positive identification of a select agent or toxin.

No. A select agent or toxin that is contained in a specimen for proficiency testing may be transferred without prior authorization from DASAT or DRSC provided that, at least seven (7) calendar days prior to the transfer, the sponsor/sender provides information to DASAT or DRSC the select agent or toxin to be transferred and the name and address of the recipient.

You would complete APHIS/CDC Form 4B Reporting the identification of a select agent or toxin: Proficiency testing report within ninety (90) days of receipt.  Identification of a toxin in a proficiency sample must be reported.

Yes, as long as the entity fulfills all of the requirements outlined in Sections 5 and 6 of the select agent regulations regarding a select agent or toxin that is contained in a sample presented for proficiency testing.

Yes, regardless of the amount identified, a registered entity or a clinical or diagnostic laboratory is required to report the identification of a select toxin contained in a sample presented for proficiency testing using APHIS/CDC Form 4.

No. Any excluded attenuated strain of a select agent or toxin found here is excluded from the requirements of select agent regulations, including the reporting requirements set forth in Sections 5 and 6 of the regulations.

Log into eFSAP and click on Form 4. Click Create Form 4A – Sections A&B. For an immediate notification you must provide the following:

• Select Agent or Toxin identified from the dropdown menu (Section B, Field 1)
• Date of the identification (Section B, Field 2)
• Whether any of the samples containing the select agent or toxin may have led to an unintentional release and/or exposure (Section B, Field 9)
• Click Immediate Notification. You will need to fill out the complete Form 4A – Sections A&B within 7 days of identifying a select agent or toxin. See the Form 4 Quick Reference Guides for more information.

The electronic documentation in eFSAP acts as the record required by the select agent regulations. If there is no electronic documentation within eFSAP, it is your responsibility to ensure a record is available for 3 years.