Notification of Theft, Loss or Release

FORM APPROVED
OMB NO. 0579-0213
OMB NO. 0920-0576
EXP DATE 10/31/2014

REPORT OF THEFT, LOSS, OR RELEASE OF SELECT AGENTS
AND TOXINS (APHIS/CDC FORM 3)
INSTRUCTIONS

Detailed instructions are available at http://www.selectagents.gov/TLRForm.html. Answer all items completely and type or
print in ink. This report must be signed and submitted to either APHIS or CDC:
Animal and Plant Health Inspection Service
Agricultural Select Agent Program
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 30333
FAX: (404) 718-2096
Email: [email protected]

Accession Number:

(For Program Use ONLY)

Submit completed form only once by either email, fax, or mail
SECTION 1 – TO BE COMPLETED BY ALL ENTITIES
2. Date of Immediate Notification:
3. Type of Immediate Notification:

1. Date of Incident:

Email
Fax
Telephone
5. Entity registration number (For select agent registered entities
only):

4. Name of Entity (entities registered with CDC or APHIS) or
Name of Hospital or Laboratory (non-registered entities):
6. Physical Address:

7. City:

8. State:

9. Zip Code:

10. Responsible Official (registered) or Name of Laboratory Supervisor (non-registered):
11. Telephone #:

12. Fax #:

14a: Type of Incident (Human Health):

13. Email address:
15. Did the release result in a potential exposure?

Theft
Loss
Release
Lab Acquired Infection
14b: Type of Incident (Animal and Plant Health):

No

Yes

N/A (If Yes , explain in Blocks 28 or 30)

If yes, has medical surveillance been initiated?
Unintended Animal Infection
14c: Transfer:

Unintended Plant Agent Release
No

Transfer incident (complete Sections 1 and 2 and Appendix B)
16. Time incident occurred:
17. Location of incident (building and room #):

19. Biosafety level:
BSL2
BSL3
ABSL2
ABSL3
PPQ Agent

BSL4
ABSL4
BSL3 Ag

22. Name of Select Agent or Toxin

20. Date of last inventory (for reporting loss
only):

Yes

N/A (If Yes , explain in Blocks 28 or 30)

18. Location of incident within room (e.g., freezer, incubator,
centrifuge):
21. Name of Principal Investigator:

SECTION 2 – TO BE COMPLETED BY ALL ENTITIES
23. Characterization of Agent
(e. g. strain, ATCC #)

24. Quantity / Amount

A
B
C

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25. Provide a detailed summary of events including a timeline of what occurred. Whenever possible, conduct a risk assessment of the event and determine if the
root cause can be identified. State specifically what personal protective equipment was worn and what, if any, medical surveillance was provided or planned. If
incident involves a non-human primate, please state species.

Block 25. Continued: (Use Appendix A for continuation, if necessary)
SECTION 3 – TO BE COMPLETED BY ALL ENTITIES ONLY FOR RELEASE
OF SELECT AGENTS AND TOXINS OR OCCUPATIONAL EXPOSURE
26. An internal review of laboratory procedures and policies has been initiated to lessen the likelihood of recurrences of theft, loss or release of select agents and
toxins at this entity.
No

Yes

If yes, please provide additional details.

27. What were the hazards posed to humans by the extent of the release or occupational exposure?

28. What is the estimated extent of the release or exposure in relation to the proximity of susceptible humans, animals and plants?

29. Provide a brief summary of how the laboratory and work surfaces were decontaminated after the release.

30. In select agents and toxins posing a risk to humans, please state how many laboratorians were potentially exposed and provide a brief summary of the
medical surveillance provided (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 Signed: _________________ ____________

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APPENDIX A
ADDITIONAL SHEET FOR CONTINUATION OF INFORMATION
Continue Form 3 comments here. State which block from the Form 3 the continuation is from.
(Example: The following statement is a continuation of block 25:)

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APPENDIX A
ADDITIONAL SHEET FOR CONTINUATION OF INFORMATION

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APPENDIX B
IF THE INCIDENT OCCURRED DURING TRANSFER, COMPLETE SECTIONS 1 AND 2 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:

7. Package with select agents and toxins appears to have been opened:

No
Yes If yes, date of receipt:
8. Sender was contacted regarding incident:

No
Yes If yes, include explanation in box 5 above.
9. Carrier/courier was contacted regarding incident:

No

Yes

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 Signed: ______________________________

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 30333;
ATTN: PRA (0920-0576).

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