FAQ: APHIS/CDC Form 3

The immediate notification can be sent via phone, email, or directly through eFSAP. Complete APHIS/CDC Form 3 in eFSAP within 7 days of the incident. If initial notification is made using eFSAP (APHIS/CDC Form-3), then the date of your immediate notification will appear in APHIS/CDC Form 3 Section B within eFSAP.

Please see the Form 3 Immediate Notification Quick Reference Guide for detailed instructions.

When you start an APHIS/CDC Form 3, you can save it as a draft without clicking Submit.  Log into eFSAP and click on Form 3. Click Create Form 3. After you have started filling out the form, you can click Save Draft at the bottom of the page to save the APHIS/CDC Form 3 as a draft without submitting it to FSAP for review.

To make edits or add more details, open the existing immediate notification, enter the information, and then click Save Update to save as an updated notification. Note that clicking the Close button will NOT update the notification or save the information. When sufficient details are available, click Initiate Submit to submit the complete Form 3 from the existing notification. A complete Form 3 must be submitted within 7 calendar days upon discovery of the theft, loss, or release of a select agent or toxin.

If the Form 3 was submitted in eFSAP, the form acts as the record required by the select agent regulations.  If a paper/pdf Form 3 was submitted, and is not accessible to the entity via eFSAP, it is the entity’s responsibility to maintain the form in its records.

At this time, an NRE must submit a report of theft, loss, or release of a select agent or toxin via email, fax, or mail.

An entity or individual registered for the excluded select toxin involved in the incident:
Yes, if you are registered for the select toxin, an APHIS/CDC Form 3, Report of Theft, Loss, or Release must be submitted. An entity registered to possess, use, or transfer a toxin must comply with the select agent and toxin regulations regardless of the amount of the toxin currently in its possession [42 CFR § 73.7(b)].

An entity or individual not registered for the excluded select toxin involved in the incident:
No, the toxin is excluded from the select agent and toxin regulatory requirements and an APHIS/CDC Form 3, Report of Theft, Loss, or Release, does not need to be submitted.

If an individual or entity detects a known or suspected violation of Federal law or is aware of suspicious activity related to a listed toxin, it must be reported to CDC/DRSC at 404-718-2000 or LRSAT@CDC.gov.

However, first entities should report the incident to the Federal Bureau of Investigation (FBI) Weapons of Mass Destruction Coordinator. To locate the nearest Federal Bureau of Investigation Weapons of Mass Destruction Coordinator, refer to the list of FBI Field Offices.

Then, the report sent to CDC/DRSC should include the following information: 1) Name of facility where the concern was identified, 2) Name of individual reporting the concern, 3) Brief summary of situation, and 4) Evidence and confirmation that this was reported to law enforcement.

See also Permissible Toxin Amounts