Attachment 3c - Original Notification of Theft, Loss or Release Form

GUIDANCE DOCUMENT FOR REPORT 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 12/31/2008

INTRODUCTION
The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (7 CFR 331, 9 CFR
121, and 42 CFR 73), which implement the provisions of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Public Law 107-188) setting forth the requirements for possession, use, and transfer of select agents
and toxins. The select agents and toxins identified in the final rules have the potential to pose a severe threat to public health
and safety, to animal and plant health, or to animal and plant products. Responsibility for providing guidance on this form was
designated to the Centers for Disease Control and Prevention (CDC) by the HHS Secretary and to the Animal and Plant Health
Inspection Service (APHIS) by the USDA Secretary. In order to minimize the reporting burden to the public, APHIS and CDC
have developed a common reporting form for this data collection.
An entity is required by regulation (7 CFR 331.19, 9 CFR 121.19, and 42 CFR 73.19) to notify APHIS (telephone: 301-734-5960,
facsimile: 301-734-3652, e-mail: [email protected]) or CDC (telephone: 404-718-2000,
facsimile: 404-718-2096, or e-mail: [email protected]) immediately upon discovery of a theft (unauthorized removal of select agent
or toxin), loss (failure to account for select agent or toxin), or release (occupational exposure or release of an agent or toxin
outside of the primary barriers of the biocontainment area) of a select agent and toxin. In addition, clinical or diagnostic
laboratories and other entities that possess, use or transfer a select agent or toxin contained in a specimen presented for
diagnosis, verification, or proficiency testing must immediately report upon discovery of a theft, loss, or release of select agent or
toxin. After the initial reporting, this form (APHIS/CDC Form 3) must be sent to APHIS or CDC within 7 calendar days after the
discovery of theft, loss, or release of select agents or toxins.
For theft or loss of select agents or toxins, the entity must notify the appropriate local, state, or federal law enforcement
agencies. For release of select agents or toxins, the entity should notify the appropriate local, state, and federal health
agencies.
PURPOSE
This form is to be used by the RO or facility director to report the theft, loss, or release of select agents or toxins. A copy of the
completed form and attachments must be maintained by the entity for three years.
INSTRUCTIONS
1.

Immediately notify APHIS or CDC via telephone, fax, or e-mail and appropriate local, state, or federal law enforcement
agencies (theft or loss) or appropriate local, state, and federal health agencies (release).

2.

The RO or facility director must complete, sign and date this form. For registered entities, the information provided for this
form should match the information submitted for the entity’s certificate of registration.
A. For reporting of a theft or loss, complete sections 1 and 2. Thefts or losses must be reported even if the select agent or
toxin is subsequently recovered or the responsible parties are identified. For reporting a theft or loss that occurred during
transfer, complete sections 1, 2, and 3 and include a copy of the approved APHIS/CDC Form 2, “Request to Transfer
Select Agents and Toxins.”
B. For reporting a release, complete sections 1, 2, and 4. For reporting a release that occurred during transfer, complete
all sections and include a copy of the approved APHIS/CDC Form 2, “Request to Transfer Select Agents and Toxins.”

3.

The RO or facility director faxes or mails the form to APHIS or CDC within 7 calendar days of the theft, loss, or release.

OBTAINING EXTRA COPIES OF THIS FORM
Additional copies of this form are available on APHIS website (http://www.aphis.usda.gov/programs/ag_selectagent/index.html)
or CDC website (http://www.cdc.gov/od/sap) or by contacting APHIS at (301) 734-5960 or CDC at (404) 718-2000.

REPORT 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 12/31/2008

Read all instructions carefully before completing the report. Answer all items completely and type or print in ink. The 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

1. Entity name:

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

SECTION 1 – TO BE COMPLETED BY ALL ENTITIES
2. Entity registration number (if applicable):

3. Entity address (NOT a post office address):
7. Responsible Official (RO) or facility director
First:
MI:
Last:
11. RO or facility director address (NOT a post office address):

4. City:
8. Telephone:
12. City:

5. State:
9. FAX:

6. Zip Code:

10. E-mail:
13. State:

14. Zip Code:

15. Type of incident:
16. Immediate notification provided to:
17. Date of immediate notification:
18. Type of immediate notification:
Theft
Loss
Release
APHIS
CDC
E-mail
Fax
Telephone
19. An internal review of laboratory procedures and policies has been initiated to prevent recurrences of loss of select agents and toxins at this entity:
No
Yes (If yes, please provide additional details in an attachment.)
SECTION 2 – TO BE COMPLETED BY ALL ENTITIES
LIST OF SELECT AGENTS AND TOXINS LOST, STOLEN OR RELEASED (attach additional sheets if necessary)
23. Form
24. Vol or wt
26.
21. Characterization of
22. Number
25. Total
20. Select agents and/or toxins:
(powder/liquid/ per vial (e.g.,
Concentration/vial
agent:
of vials:
quantity:
slant):
ml, mg, ng):
(e.g., 108 pfu/ml):
A
B
C
D
27. Date and time of incident:

28. Date of last inventory:

29. Name of principal investigator for laboratory with select agents and toxins
First:
MI:
Last:
30. Location of incident (building and room #): 31. Location of incident (within room (e.g., freezer, incubator)): 32. Biosafety level of laboratory where
incident occurred:
33. Name and telephone number of agencies or local authorities
34. Symbols or markings on vials (if any):
35. Agent was recovered (theft/loss):
No
Yes
notified:
36. Provide a summary of actions taken:
Called ambulance
Called fire department
Closed laboratory doors
Closed building
Consulted MSDS or chemical database
Called police department (case #)
Other (explain):
37. Provide a detailed summary of events (attach additional sheets if necessary):

SECTION 3 – IF THE INCIDENT OCCURRED DURING TRANSFER PROVIDE THE FOLLOWING INFORMATION
38. APHIS authorization number from transfer form:

39. CDC authorization number from transfer form:

40. Name of carrier:

41. Airway bill number/bill of lading number/tracking number:

42. Package description (size, shape, description of packaging including number and type of inner packages; attach additional sheets if necessary):
SENDER INFORMATION
43. Name of person:

a. First:

44. Name of entity:
45. APHIS/CDC registration
number:
46. PHS/USDA import permit
number:
47. Date shipped:
48. Telephone:

MI:

Last:

RECIPIENT INFORMATION
b. First:

MI:

Last:

a.
a. APHIS:

b. CDC:

b.
c. APHIS:

d. CDC:

a. PHS:

b. USDA:

c. PHS:

d. USDA:

a.

b.

a.

b.

49. FAX:

a.
50. Package with select agents and toxins received by requestor:
No
Yes

b.
51. Package with select agents and toxins appears to have been opened:
No
Yes (If Yes, explain)

52. Sender was contacted regarding incident:

53. Carrier/courier was contacted regarding incident:

No

Yes

No

Yes

SECTION 4 – TO BE COMPLETED ONLY FOR RELEASE OF SELECT
AGENTS AND TOXINS
54. Hazards posed by release:

55. Exposures:

No

No

Yes (If Yes, explain. Use an attachment if necessary.)

Yes (If Yes, provide number of persons, animals, and plants exposed. Attach additional sheets if necessary.)

56. Area was decontaminated:

No

57. Medical treatment was provided:

Yes (If Yes, explain. Use an attachment if necessary.)

No

Yes (If Yes, explain. Use an attachment if necessary.)

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, and 42 CFR 73 may result in civil or criminal penalties, including imprisonment.
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 D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0576).
APHIS/CDC FORM 3 (12/31/2008)