Report of Identification of Select
Agent or Toxin FAQ's

General

  1. What is the purpose of the APHIS/CDC Form 4A, 4B, and 4C?
    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 AgSAS or DSAT.

    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 AgSAS or DSAT.

    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 AgSAS or DSAT.

  2. Our entity is a diagnostic/clinical laboratory whose activities involving select agents and toxins are limited to diagnosis, verification, and proficiency testing. Do we meet the exemption provisions of select agent regulations?

    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 AgSAS or DSAT, 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 AgSAS or DSAT) 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 AgSAS or DSAT, 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 DSAT) 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 AgSAS or DSAT 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 AgSAS or DSAT 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.

  3. Is there any guidance available to address the day-to-day operations of diagnostic laboratories in human, animal, and plant diagnostic laboratories?

    Recommendations from a CDC-convened, Biosafety Blue Ribbon Panel were published in the Morbidity and Mortality Weekly Report entitled “Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories.” Additional information on this topic can be found in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories manual and the NIH Guidelines for Research Involving Recombinant DNA Molecules. Additional reference information for plant diagnostic labs may be found at the Center for Environmental and Regulatory Information Systems.

  4. If our diagnostic laboratory is not registered to possess a Tier 1 select agent or toxin, may we receive identified Tier 1 select agents and toxin to destroy it or for any other purpose?

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

  5. Is a select toxin identified in an original food sample or clinical sample as a result of diagnosis or verification required to be reported on APHIS/CDC Form 4?

    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.

  6. Is waste generated during the delivery of care for a patient diagnosed with an illness or condition associated with a select agent subject to select agent regulations?

    It depends. Waste generated during the care of a patient diagnosed with a condition associated with a select agent is not subject to select agent regulations if it is decontaminated or transferred for destruction according to state and federal regulations within seven calendar days of the conclusion of care.


Diagnosis and Verification

  1. Is any amount of a select toxin identified as a result of diagnosis or verification required to be reported on APHIS/CDC Form 4?

    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.

  2. Is a registered entity required to report select agents or toxins identified from clinical/diagnostic specimens?

    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.

  3. What Form do I complete if I have identified a select agent or toxin in a clinical sample?

    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.

  4. When completing the APHIS/CDC Form 4A, what should I list under sample type(s) received/provided?

    Under the APHIS/CDC Form 4A block B5 and APHIS/CDC Form 4A block D4 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 (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).

  5. How long may a non-registered laboratory keep a diagnostic specimen of a presumptive select agent sent to a reference laboratory for confirmation?

    A diagnostic specimen may be kept by the sending non-registered laboratory until the identification of a select agent or toxin. After the identification, the non-registered laboratory must 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 AgSAS or DSAT.

  6. If a patient produces multiple specimens, do I need to submit a separate APHIS/CDC Form 4A for each sample?

    No. You would complete one 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). This information would be listed in Section B and should include the number and type of samples received (e.g., tissue, fluid, urine, etc.), the ZIP code of the patient’s residence and if additional samples are anticipated.

  7. After identification, is a laboratory able to retain the isolate that contains a select agent?

    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.

  8. How would the registered entity note on the APHIS/CDC Form 4A that it retains the sample?

    In Section B7 of the APHIS/CDC Form 4A, the entity should check “retained” and list the name of the person that took responsibility of the material.

  9. Is the APHIS/CDC Form 2 required to transfer select agents or toxins identified from clinical/diagnostic specimens being sent for susceptibility testing?

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

  10. Our laboratory is not registered to possess Tier 1 select agents and toxin and we have identified a Tier 1 select agent through diagnosis and verification testing. Do we meet the exemption provisions of the select agent regulations?

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

  11. Does the sample provider need to fill in section C and D of the APHIS/CDC Form 4 if the sample provider provided the entire specimen to the reference laboratory and did not work on the specimen?

    No. The reference laboratory would complete sections A and B of the APHIS/CDC Form 4 and indicate that the entire specimen was submitted by sample provider and no work was performed by sample provider.

  12. Is a select agent that can only be identified at the Genus level as a result of diagnosis or verification required to be reported on APHIS/CDC Form 4A?

    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 AgSAS or DSAT, 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 AgSAS or DSAT) 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.
  13. A registered public health laboratory frequently identifies Francisella tularensis and Yersinia pestis presented in diagnostic samples, but the laboratory is not registered for these agents.  After the agent is identified and an APHIS/CDC Form 4 is submitted, the registered entity destroys all materials within 7 days except for fixed slides that are located in an unregistered laboratory.  With regard to the select agents identified in this scenario, does the registered entity fall under the clinical diagnostic exemption found Section 73.5 (destroy by recognize inactivation process) or is the entity subject to the inactivation requirements found in Section 73.3 (validated inactivation procedure)?

    In order to exclude an agent (for which it is registered) from the requirement of the select agent and toxin regulations, a registered clinical or diagnostic laboratory is required to use an in-house validated inactivation procedure [following the requirements found in Section 3(d)(4) or 4(d)(4)].  To exclude an agent for which it is not registered but has identified in a diagnostic or verification sample, a registered clinical or diagnostic laboratory is allowed to “destroy” the agent on-site by a recognized sterilization or inactivation process as outlined in Section 5(a)(3) or 6(a)(3).

  14. What test or procedure determines whether a select agent or toxin is contained in a specimen presented for diagnosis or verification?

    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 define which tests or procedures constitute positive identification of a select agent or toxin.


Proficiency Testing

  1. Does the sender/sponsor need an APHIS/CDC Form 2 when sending a specimen for proficiency testing that contains 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 AgSAS or DSAT provided that, at least seven (7) calendar days prior to the transfer, the sponsor/sender provides information to AgSAS or DSAT the select agent or toxin to be transferred and the name and address of the recipient.

  2. What section do I complete if I have identified a select agent or toxin in a proficiency test?

    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.

  3. Our laboratory is not registered to possess Tier 1 select agents and toxin and we have identified a Tier 1 select agent through proficiency testing. Do we meet the exemption provisions of Select Agent Regulations?

    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.

  4. As part of a proficiency test, I identified a select toxin but in an amount below the threshold listed in 42 CFR Section 3. Must I still report the identification using an APHIS/CDC Form 4?

    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.

  5. As part of a proficiency test, I identified an excluded attenuated strain of a select agent. Must I still report the identification on APHIS/CDC Form 4?

    No. Any excluded attenuated strain of a select agent or toxin found at https://www.selectagents.gov/SelectAgentsandToxinsExclusions.html is excluded from the requirements of select agent regulations, including the reporting requirements set forth in Sections 5 and 6 of the regulations.


eFSAP Submission

  1. What are the fields that need to be completed for a Form 4 Immediate Notification?

    Log into eFSAP and click on Form 4. Click Create Form 4. 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 4 within 7 days of identifying a select agent or toxin. See the Form 4 Quick Reference Guides for more information.

  2. Can I select more than one method of disposition in the APHIS/CDC Form 4?

    Yes. Select each method of disposition (Field 8) using the checkboxes as applicable to the situation.

    • Transferred – Indicate to whom the sample was sent and the date of the transfer.
    • Destroyed – Indicate method of destruction and date destroyed.
    • Retained – Indicate the Principal Investigator (PI) (from the dropdown menu of PIs approved to possess select agent and toxin).

    Note: The “Retained” selection is not available for agents that you are not authorized by FSAP to possess.


  3. Will entities be required to maintain hard copy printouts of the Form 4 for identifications of select agents or toxins documented in eFSAP?

    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.


  4. What are the deadlines regarding submitting an APHIS/CDC Form 4?

    You must submit a completed APHIS/CDC Form 4A within 7 calendar days after identification of a select agent or toxin contained in a specimen presented for diagnosis or verification.


  5. A sample provider not registered with FSAP submitted a diagnostic sample containing a suspected select agent to a reference laboratory for identification. How will the sample provider know whether to complete APHIS/CDC Form 4?

    FSAP will send an email with a link to the APHIS/CDC Form 4 to the sample provider. Once the sample provider completes the information, they mail, fax, or email it back to FSAP.