Notification of Theft, Loss or Release

reporting OF THEFT, LOSS, OR RELEASE OF SELECT AGENTS AND TOXINS (APHIS/CDC Form 3)

FORM APPROVED OMB NO. 0579-0213 OMB NO. 0920-0576 EXP DATE XX/XX/XXXX

Read guidance instructions at http://www.selectagents.gov/TLRForm.html before completing this form. Answer all items completely and type or print in ink. The form must be signed and submitted to either APHIS or CDC by email attachment, fax, or mail.

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 E-mail: Agricultural.Select.Agent.Program@aphis.usda.gov

C Accession Number: (For Program use ONLY) enters for Disease Control and Prevention Division of Select Agents and Toxins 1600 Clifton Road NE, Mailstop A46 Atlanta, GA 30333 FAX: (404) 718-2096 Email: Form3@cdc.gov

	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 (human health): Theft Loss Release Laboratory acquired infection											15. Did the release result in a potential exposure? No Yes N/A ( If N/A, explain in Blocks 28 or 31) If yes, has medical surveillance been initiated? No Yes N/A ( If N/A, explain in Blocks 28 or 31)
	14b: Type of incident (animal and plant health): Unintended animal infection Unintended plant agent release
	14c: 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 (PI):
	BSL2 ABSL2 PPQ Agent			BSL3 ABSL3		BSL4 ABSL4 BSL3 Ag
	SECTION 2 – TO BE COMPLETED BY ALL ENTITIES
	23. Name of select agent or toxin							24. Characterization of agent (e. g., strain, ATCC #)						25. Quantity or amount
	A
	B
	C
	26. 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.
					reporting OF THEFT, LOSS, OR RELEASE OF SELECT AGENTS AND TOXINS (APHIS/CDC Form 3)

Block 26. Continued: (Use Appendix A for continuation, if necessary)

SECTION 3 – TO BE COMPLETED ONLY FOR RELEASE OF SELECT AGENTS AND TOXINS OR OCCUPATIONAL EXPOSURE

27. An internal review of laboratory procedures and policies has been initiated to lessen the likelihood of recurrences of a release of select agents and toxins at this entity.

No Yes If yes, please provide additional details.

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

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

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

31. 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).

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 7 CFR 331, 9 CFR 121, or 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Respondent: _____________________________________________________ Title: _________________________________

Typed or printed name of Respondent: ___________________________________________ Date signed: __________________________

Public reporting burden: Public reporting burden of this collection of 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 D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0576).

reporting OF THEFT, LOSS, OR RELEASE OF SELECT AGENTS AND TOXINS (APHIS/CDC Form 3)

FORM APPROVED OMB NO. 0579-0213 OMB NO. 0920-0576 EXP DATE XX/XX/XXXX

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 E-mail: Agricultural.Select.Agent.Program@aphis.usda.gov

C Accession Number: (For Program use ONLY) enters for Disease Control and Prevention Division of Select Agents and Toxins 1600 Clifton Road NE, Mailstop A46 Atlanta, GA 30333 FAX: (404) 718-2096 Email: Form3@cdc.gov

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 26.)

reporting OF THEFT, LOSS, OR RELEASE OF SELECT AGENTS AND TOXINS (APHIS/CDC Form 3)

FORM APPROVED OMB NO. 0579-0213 OMB NO. 0920-0576 EXP DATE XX/XX/XXXX

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 E-mail: Agricultural.Select.Agent.Program@aphis.usda.gov

C Accession Number: (For Program use ONLY) enters for Disease Control and Prevention Division of Select Agents and Toxins 1600 Clifton Road NE, Mailstop A46 Atlanta, GA 30333 FAX: (404) 718-2096 Email: Form3@cdc.gov

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 Block 5 above.
8. Sender was contacted regarding incident: No Yes	9. Carrier/courier was contacted regarding incident: No Yes

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 7 CFR 331, 9 CFR 121, or 42 CFR 73 may result in civil or criminal penalties, including imprisonment.

Signature of Respondent: _____________________________________________________ Title: _________________________________

Typed or printed name of Respondent: ___________________________________________ Date signed: __________________________