Aphis/cdc Form 3 Incident Form To Report Potential Theft, Loss, Release,

REPORT OF A RELEASE/LOSS/THEFT
OF A SELECT AGENT OR TOXIN
APHIS/CDC FORM 3

FORM APPROVED
OMB NO. 0920-0576
EXP DATE: 01/31/2024

Detailed instructions are available at http://www.selectagents.gov/form3.html.
This report must be signed and submitted to either DASAT or DRSC:
Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
4700 River Road Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
FAX: (301) 734-3652
Email: [email protected]

Centers for Disease Control and Prevention
Division of Regulatory Science and Compliance
1600 Clifton Road NE, Mailstop H21-4
Atlanta, GA 30329
FAX: (404) 471-8375
Email: [email protected]

Submit completed form only once by either eFSAP, fax, or email

SECTION A – ENTITY INFORMATION
1. Name of Entity:
2. Physical Address (NOT a post office box):

3. City:

4. State:

5. Zip Code:

{Select}
6. Name of Responsible Official or Laboratory Supervisor:

7. Name of Principal Investigator:

8. Telephone Number of Responsible Official:

9. Email address of Responsible Official:

SECTION B – INCIDENT INFORMATION
1. Date and Time of
Incident: __________

2. Date of Immediate
Notification to CDC or
APHIS:___________

5. Name of Select Agent or Toxin:
{Select}

3. Type of notification to CDC or APHIS:
 E-mail  Fax  Telephone  eFSAP
6. Strain designation of Select Agent or Toxin:
 Recombinant Agent
 Unknown

{Select}

{Select}

8. Type of Incident:
Release/ Potential Exposure (After completing Section B. Go
to Section C)
Loss (After completing Section B. Go to Section D)
Theft (After completing Section B. Go to Section E)
Note: Please complete Appendix 1, event timeline, to
provide details on the theft/loss/release incident
11. Is this incident associated with an APHIS/CDC Form 2 (Transfer):
Yes, APHIS/CDC Form 2 transfer #: _________________
No

4. Location of Incident (bldg., room,
equipment, etc.): _____________
7. Quantity (Unit (vial, plates, etc.)):

 Recombinant Agent
 Unknown
 Recombinant Agent
 Unknown
9. Severity of the incident:
10. What Biosafety Level did the incident
Negligible
occur?
Low
BSL2
 ABSL2
Moderate
BSL3
 ABSL3
High
BSL4
 ABSL4
ACL 2
 ABSL3Ag
ACL 3
 Storage area
ACL 4
 Other________
12. Is this incident associated with an APHIS/CDC Form 4 (Identification):
Yes, APHIS/CDC Form 4 clinical ID#: _____________________
No

SECTION C- REPORT OF RELEASE
1. Type of Potential Exposure/Release
(choose all that apply):
Animal bite/scratch
PPE failure
Spill
Needle stick/Sharps
Inactivation failure

Equipment/mechanical failure
Package damaged in transit (complete B-11)
Decontamination failure
Unintended exposure of animal or plants
Work performed on an open bench
Other: ___________________________________

2a. If yes, (choose all that apply)
Release outside primary containment (e.g., biosafety
cabinet)
Release beyond secondary containment barrier (e.g.,
laboratory)
Release outside all containment barriers of the facility
2b. Did the release pose a threat to animal or plant health, or animal
or plant products, or a public health threat?
No
Yes

3. What PPE was worn at the time of the
incident (choose all that apply)?
Hand Protection (e.g., gloves)
Head Protectors/Covers
Body Protection (e.g.,labcoat)
Eye/Face Protection (e.g.,goggles, face
shield)

2. Was there a release outside containment
barriers?
Yes
No

Foot Protection (e.g., booties, shoe covers)
Respiratory Protection (e.g.,PAPR, N95):
Type __________
Other: ____________________________

3a. Number of individuals wearing the above described PPE?
5. Did the release result in a laboratory acquired infection or
an infection/outbreak in agriculture or in the environment?
Yes
No
Not currently known

6. Was medical surveillance and/or treatment provided to
potentially exposed individuals?
Yes
No

4. Did the release result in potential exposure(s)?
No
Yes

4a. If yes, how many individuals/animals/plants were exposed?
____________________________________
4b. Of the number in 4a, how many individuals were laboratory
staff: ___________________________________

6a. If yes, what medical surveillance and/or treatment was provided to individuals? (choose all
that apply)
None
Signs and symptoms information provided
Physical evaluation
Fever/symptom watch
Serology screening
Antibiotics or other prophylaxis
Other: _____________
6b. Total number of individuals medical surveillance and/or treatment provided to: _________

7a. . Has an internal investigation been initiated to lessen the likelihood of recurrences of incident involving the select agents and toxins at this entity?
No
Yes (If yes, please provide additional details below)
Describe the internal investigation initiated following the incident (if any), and any root cause(s) identified.

7b. What corrective actions have been initiated to lessen the likelihood of recurrence of incident involving the select agents and toxins at this entity?
(choose all that apply)
Retraining on existing policy/
New/modified policy
New training developed
New/updated SOP
SOP New PPE provided
New equipment provided
Equipment repair
Review/revise risk assessment
Audit/remove faulty PPE
Audit/remove faulty equipment
None
Other:______________________________________
Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false
statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of the select agent
regulations may result in civil or criminal penalties, including imprisonment. of 7 CFR Part 331, 9 CFR Part 121, or 42 CFR Part 73.
Signature of Respondent: ________________________________________________ Title: ______________________________________________
Typed or printed name of Respondent: ______________________________________ Date: ______________________________________________

SECTION D - REPORT OF LOSS
1. Type of Loss: (choose all that apply)
Inventory/Recordkeeping error
Sample lost/discarded at entity
Sample lost in transit (complete B-11)
Other:

2. Has Local Law Enforcement been
Notified: (If yes, complete D3-D5)
Yes
No

3. Local Law Enforcement Agency:

4. Local Law Enforcement Agent Name (First MI Last Name):

5. Local Law Enforcement Contact Information (phone/email):

6. Was the FBI Notified:
(If yes, complete D7-D8)
Yes
No

7. FBI Agent Name (First MI Last Name):

8. FBI Agent Contact Information (phone/email):

9. Was the lost select agent
or toxin material found?
Yes
No

10. How long was the select agent or toxin 11. Prior to this incident, provide the date 12. Was there a potential exposure:
material missing?
Yes/Unknown at this time (go to
of the last inventory/audit performed:
Date recovered:___________________
Section C)
No
Duration of loss (hours/days): ________

Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false
statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of the select agent
regulations may result in civil or criminal penalties, including imprisonment. of 7 CFR Part 331, 9 CFR Part 121, or 42 CFR Part 73.
Signature of Respondent: ________________________________________________ Title: ______________________________________________
Typed or printed name of Respondent: ______________________________________ Date: ______________________________________________

SECTION E – REPORT OF THEFT
1. Type of Theft:(choose all that
apply)
Forced Entry
Insider/Insider assisted access
Unauthorized access

2. Has Local Law Enforcement been Notified:
(If yes, complete sections E3-E5)
Yes
No

4. Local Law Enforcement Agent Name (First MI and Last name):

3. Local Law Enforcement Agency:

5. Local Law Enforcement Contact Information (phone/email):

6. Has the FBI been Notified: (If yes,
7. FBI Agent Name: (First M. Last Name):
8. FBI Agent Contact Information (phone/email):
complete E7-E8):
Yes
No
9. Was the stolen select agent or toxin material recovered:
10. Was there a potential exposure:
Yes; Date of Recovery: ____________________
Yes/Unknown at this time (go to Section C)
No
No
Certification: I hereby certify that the information contained on this form is true and correct to the best of my knowledge. I understand that if I knowingly provide a false
statement on any part of this form, or its attachments, I may be subject to criminal fines and/or imprisonment. I further understand that violations of the select agent
regulations may result in civil or criminal penalties, including imprisonment. of 7 CFR Part 331, 9 CFR Part 121, or 42 CFR Part 73.
Signature of Respondent: ________________________________________________ Title: ______________________________________________
Typed or printed name of Respondent: ______________________________________ Date: ______________________________________________
Public reporting burden: Public reporting burden of providing this information is estimated to average 1 hour per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor,
and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D74,
Atlanta, Georgia 30329; ATTN: PRA (0920-0576).

APPENDIX 1
EVENTS TIMELINE
Provide a detailed summary of events, including a timeline of what occurred. Do not include personal identifiable information (PII).