Notification of Theft, Loss, or Release

Incident Form to Report Potential Theft, Loss, Release, or OCCUPatIONAL EXPOSURE (APHIS/CDC Form 3)

FORM APPROVED OMB NO.0579-0213 OMB NO. 0920-0576 EXP DATE 11/30/2015

INSTRUCTIONS

Detailed instructions are available at http://www.selectagents.gov/form3.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 Agriculture Select Agent Services4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 Riverdale, MD 20737 FAX: (301) 734-3652 Email: [email protected]

Accession Number: (For Program Use ONLY) 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]

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

SECTION 1 – TO BE COMPLETED BY ALL ENTITIES

1. Date of Incident:

2. Date of Immediate Notification:

3. Type of Immediate Notification: Email Fax Telephone

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

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

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 #:

13. Email address:

14a: Type of Incident: Theft Loss Release Unintended Animal Infection Unintended Plant Agent Release Other

15. Did the release result in a potential exposure? No Yes N/A (If Yes , explain in Blocks 28 or 30) Did the release result in a laboratory-acquired Infection? No Yes N/A (If Yes , explain in Blocks 28 or 30) If yes, has medical surveillance been initiated? No Yes N/A (If Yes , explain in Blocks 28 or 30)

14b: Transfer: Transfer incident (complete Sections 1 and 2 and Appendix B)

16. Time incident occurred:

17. Location of incident (building and room #):

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

19. Biosafety level:

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

21. Name of Principal Investigator:

BSL2 ABSL2 PPQ Agent

BSL3 ABSL3

BSL4 ABSL4 BSL3 Ag

SECTION 2 – TO BE COMPLETED BY ALL ENTITIES

22. Name of Select Agent or Toxin

23. Characterization of Agent (e. g. strain, ATCC #)

24. Quantity / Amount

A

B

C

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. For discovery of select agents and toxins in unregistered locations, include your entity’s plan of action to assure no future discoveries, how discovered agents were found and disposition of the discovered agents, inventory reconciliation and assurance that the discovered material was safeguarded against unauthorized access, theft, loss, or release. 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: ____________________________________

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:)

Save and continue on next page (Form automatically defaults to a blank page for continuation)

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: No Yes If yes, date of receipt:	7. Package with select agents and toxins appears to have been opened: No Yes If yes, include explanation in box 5 above.
8. Sender was contacted regarding incident: No Yes	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).