Incident Notification and Reporting APHIS/CDC Form 3 (Th

INCIDENT NOTIFICATION AND REPORTING
APHIS/CDC FORM 3

FORM APPROVED OMB
NO.0579-0213 OMB NO.
0920-0576 EXP DATE
12/31/2018

(THEFT/LOSS/RELEASE)

INSTRUCTIONS
Answer all items completely and type or print in ink. Detailed instructions are available at
http://www.selectagents.gov/form3.html. This report must be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agriculture Select Agent Services
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 Select Agents and Toxins
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30329
FAX: (404) 471-8375
Email: [email protected]

Accession Number:

(For Program Use ONLY)

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

SECTION A – ENTITY INFORMATION
1. Name of Entity:

2. Entity Registration/ NRE Number (if applicable):

3. Physical Address (NOT a post office box):

4. City:

5. State:

7. Name of Responsible Official or Laboratory Supervisor:

8. Name of Principal Investigator:

9. Telephone Number:

11. Email address:

10. Fax Number:

6. Zip Code:

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

2. Date of Immediate
Notification:

3. Type of Immediate Notification :
Email
Fax
Telephone

5. Name of Select Agent or Toxin:

4. Location of Incident (bldg., room, equipment, etc.):

6. Strain designation of Select Agent or
Toxin:

9. Severity of the incident:

8. Type of Incident:


Theft (After completing Section B. Go to Section C)

Loss (After completing Section B. Go to Section D)



Release/ Potential Exposure


(After completing Section B. Go to Section E)
Note: Please complete Appendix A, event timeline, to
provide details on the theft/loss/release incident. 

None



Negligible
Low
Moderate
High



7. Quantity
(Unit (vial, plates, etc.))

10. What Biosafety Level did the incident
occur?
BSL2

ABSL2

BSL3

ABSL3

BSL4

ABSL4

ACL 2

BSL3 Ag

ACL 3

NIHBL2

ACL 4

NIHBL3

NIHBL2N

NIHBL4

NIHBL3N

NIHBL4N

NIHBL2-LS

NIHBL4-LS

NIHBL3-LS

PPQ Agent

11. Is this incident associated with an APHIS/CDC Form 2 (Transfer):

12. Is this incident associated with an APHIS/CDC Form 4 (Identification):

Yes (Fill out Appendix B, if incident occurred during transfer.)

Yes

No

No

APHIS/CDC Form 2 transfer #: _________________________________

APHIS/CDC Form 4 clinical ID#: ________________________________________

SECTION C – REPORT OF THEFT
1. Type of Theft:
Forced Entry
Insider/Insiderassisted access

2. Has Local Law Enforcement been
Notified:

3. Local Law Enforcement Agency:

(If yes, complete sections C3-C5)
Yes

No

Unauthorized access
4. Local Law Enforcement Agent Name:
First:

MI:

6. Has the FBI been Notified:
(If yes, fill out #s C7-8):

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

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

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

Yes
No
9. Was the stolen BSAT material recovered:
Yes
No

10. Was there a potential exposure: (If yes, go to section E- Q: 5-11)
Yes
No
Unsure

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. 7 CFR 331, 9 CFR 121, 42 CFR 73.
Signature of Respondent: _________________________________________________

Title: ____________________________________

Typed or printed name of Respondent: _______________________________________

Date: ____________________________________

SECTION D- REPORT OF LOSS
1. Type of Loss:

2. Has Local Law Enforcement been
Notified: (If yes, fill out #s D3-D5)
Yes

Inventory/Recordkeeping error
Sample lost/discarded at entity

3. Local Law Enforcement Agency:

No

Sample lost in transit (Go to Appendix B to enter add’l info)
Other:_________________________________________
4. Local Law Enforcement Agent Name:

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

First: M: Last:
6. Was the FBI Notified:
(If yes, fill out #s D7-D8)
Yes

7. FBI Agent Name:

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

First: M: Last:

No
9. Was the lost BSAT material
found?

10. How long was the BSAT
material missing?

Yes

Date recovered:

No

Duration of loss (hrs/days):

11. Give the date of the last
inventory/audit performed, which
meets the FSAP regulatory
requirement:

12. Was there a potential exposure:
(If yes, complete Section E- Q: 5-11)
Yes
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. 7 CFR 331, 9 CFR 121, 42 CFR 73.
Signature of Respondent: _________________________________________________

Title: ____________________________________

Typed or printed name of Respondent: _______________________________________

Date: ____________________________________

SECTION E- REPORT OF RELEASE
1. Type of Potential Exposure/Release (choose all that apply):

2. Was there a release outside containment barriers?
(choose all that apply)

Animal bite/scratch

Equipment/mechanical failure

PPE failure

Package damaged in transit (fill out Appendix B)

Spill

Unintended Animal Infection

Needle stick/Sharps

Unintended Plant Pathogen Release

Decontamination failure

Work performed on an open bench

Inactivation failure

Other__________________________________________

Release outside primary containment (e.g., biosafety
cabinet, leaking storage vial within storage unit)
Release beyond secondary containment (e.g.,
laboratory)
Release outside all containment barriers of the facility
(e.g., resulting in possible agricultural/environmental/public
health threat)

3. What PPE was worn at the time of the incident (choose all that apply)?

4. Did the release result in potential exposure(s)?

Hand Protection (gloves)

Foot Protection (e.g., booties, shoe covers)

Head Protectors/Covers

Eye/Face Protection (e.g., goggles, face shield)

Body Protection

Respiratory Protection: Type___________________

Other:_____________________________________________________________
5. Did the release result in a laboratory acquired infection or
an infection/outbreak in agriculture or in the environment?

Yes
If yes, how many individuals/animals/plants were exposed?
___________
No

6. Has medical surveillance been initiated?
Yes

Yes

7. Has prophylaxis or treatment been
provided?
Yes

No

No

No

Not currently known
8. Has an internal investigation been initiated to lessen the likelihood of recurrences of incident involving the select agents and toxins at this entity?
Yes (If yes, please provide additional details.)

No

9. Other than a potential for occupational illness, what other hazards have been identified as a result of this incident?

10. Provide a brief summary of how the laboratory and work surfaces were decontaminated after the incident.

11. Provide a brief summary of the medical surveillance conducted (do not provide names or confidential information).

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. 7 CFR 331, 9 CFR 121, 42 CFR 73.
Signature of Respondent: _________________________________________________

Title: ____________________________________

Typed or printed name of Respondent: _______________________________________

Date: ____________________________________

APPENDIX A
EVENTS TIMELINE
Provide a detailed summary of events, including a timeline of what occurred.

Save and continue on next page

APPENDIX B
IF THE INCIDENT OCCURRED DURING TRANSFER, COMPLETE SECTIONS A AND B OF FORM 3 AND PROVIDE THE
FOLLOWING INFORMATION (INCLUDE A COPY OF THE RELEVANT APHIS/CDC FORM 2)
1. Transfer authorization number from APHIS/CDC Form 2:

2. Date Shipped:

3. Name of Carrier:

4. Airway bill number, bill of lading number, tracking number:

5. Package Description (size, shape, description of packaging including number and type of inner packages; attach additional sheets as necessary):

6. Package with select agents and toxins received by requestor:
No

Yes

If yes, date of receipt: ____________

7. Package with select agents and toxins appears to have been opened or damaged
during shipment:
No

8. Sender was contacted regarding incident:
No

Yes

Yes

If yes, include explanation in box 5 above.

9. Carrier/courier was contacted regarding incident:
No

Yes

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. 7 CFR 331, 9 CFR 121, 42 CFR 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).