Background Information and Registration Instructions

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Select Agent Registration
Washington University in St. Louis
Background Information and Registration Instructions
On June 12, 2002, the President signed the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002. This legislation requires that all persons in possession of any ``Select
Agent'' notify the Secretary of the Department of Health and Human Services (DHHS) by September
10, 2002. This legislation also requires all persons in possession of any ``High Consequence
Livestock Pathogen or Toxin'' notify the Secretary of the U.S. Department of Agriculture (USDA) by
October 8, 2002.
On August 6, 2002, the CDC published in the Federal Register lists of Select Agents and High
Consequence Livestock Pathogens or Toxins. The lists appear on the attached form.
If you, or members of your department, possess stocks of any of the agents listed below
(including vaccine strains, recombinant organisms, nucleic acid or genetic elements**) it is
imperative that your possession of these agents be registered with the appropriate Federal
agency. To facilitate this registration process, please complete the attached registration form
and send it to the Office of Biological and Chemical Safety, EH&S, Campus Box 8229; we will
register on your behalf agents possessed collectively by WU with the CDC and USDA. Please
contact Joe Kanabrocki or Tracy Richards, Office of Biological and Chemical Safety, Environmental
Health and Safety Office, as soon as possible at 362-6816 with any questions or for assistance in
fulfilling this registration requirement.
** Definitions of Categories of Microorganisms
1. Viable: Capable of replication on its own, in cell culture, or in an appropriate host.
2. Recombinant organism, nucleic acid, or genetic elements from agent include any of the following:
 Nonviable agents.
 Full-length nucleic acid from any of the viruses on the list. For Variola major virus (Smallpox),
any segment that exceed 100 nucleotides in length.
 Natural or synthetic nucleic acids from bacteria, fungi, or viruses on the list that encode for
either a functional toxin or virulence factor sufficient to cause disease, or natural or synthetic
nucleic acid that encodes for a functional toxin of any of the toxins listed, if: (1) expressed in
vivo; (2) in an expression vector or host chromosome; or (3) in a carrier plasmid.
3. Altered USDA or FDA approved vaccine strains: Vaccine strains that have been modified from
their original licensed, approved, or registered forms.
Select Agent Registration
Washington University in St. Louis, School of Medicine, Environmental Health and Safety
Institutional Biological and Chemical Safety Committee(IBC)/Office of Biological and
Chemical Safety(OBCS)
Return completed form to OBCS, Environmental Health and Safety Office, WUSM Campus Box
8229;
fax to 362-6786; or e-mail to esafety@msnotes.wustl.edu
I.
CORE REGISTRATION INFORMATION
Name of Principal
Investigator (PI):
Job Title:
Office Phone:
Department:
Division:
Campus Box :
Email Address:
Lab Phone:
Fax:
Name of Co-PI(s):
II.
RESEARCH FACILITIES
Location:
Where are Select Agents manipulated or stored? Please describe security measures (e.g. locked
refrigerator/freezer, lab locked when personnel absent, etc.)
Building Name
III.
Room
Number
Security Measures
LABORATORY PERSONNEL
List personnel with authorized access to Select Agents; include lab personnel (investigators and students)
and support staff.
Last name/First name
Signature of Principal Investigator
Job Title
Phone number
Date
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PLEASE CHECK ALL AGENTS WHICH ARE USED OR STORED IN YOUR LABORATORY
 NO AGENTS USED IN MY LABORATORY




Select Agents
(CDC)
Crimean-Congo
Haemorrhagic Fever Virus
Ebola Viruses
Lassa Fever Virus
Marburg Virus
 Rickettsia Prowazekii
 Rickettsia Rickettsii
 South American




Haemorrhagic Fever Viruses
Tick-Borne Encephalitis
Complex Viruses
Variola Major Virus (Smallpox
Virus)
Viruses Causing Hantavirus
Pulmonary Syndrome
Yellow Fever Virus

Overlap Agents
(CDC and USDA)
Bacillus Anthracis
 Brucella Abortus
 Brucella Melitensis
 Brucella Suis
 African Swine Fever Virus
 Akabane Virus
 Avian Influenza Virus (Highly
 Burkholderia (Pseudomonas)
 Blue Tongue Virus (Exotic)


Mallei
Burkholderia (Pseudomonas)
Pseudomallei
Clostridium Botulinum
 Bovine Spongiform

Encephalopathy Agent
Camel Pox Virus
 Classical Swine Fever Virus
 Coxiella Burnetii
 Cowdria Ruminantium
 Eastern Equine Encephalitis
 Foot And Mouth Disease
Virus
 Equine Morbillivirus (Hendra
Virus)
 Francisella Tularensis
 Rift Valley Fever Virus
 Venezuelan Equine
 Diacetoxyscirpenol
 Ricin
 Aflatoxins
 Botulinum Toxins
Encephalitis Virus
 Clostridium Perfringens
Epsilon Toxin
 Tetrodotoxin
Pathogenic)
 Coccidioides Immitis
 Yersinia Pestis
 Abrin
 Conotoxins
 Saxitoxin
High Consequence Livestock
Pathogens Or Toxins (USDA)
 African Horse Sickness Virus
(Heartwater)
Virus
 Goat Pox Virus
 Japanese Encephalitis Virus
 Lumpy Skin Disease Virus
 Malignant Catarrhal Fever
 Menangle Virus
 Mycoplasma Capricolum/M.F
38/M.Mycoides Capri
(Contagious Caprine
Pleuropneumonia Agent)
 Mycoplasma Mycoides
 Shigatoxin

 Staphylococcal Enterotoxin
 T-2 Toxin






Mycoides
(Contagious Bovine
Pleuropneumonia Agent)
Newcastle Disease Virus
(Exotic)
Nipah Virus
Peste Des Petits Ruminants
Rinderpest Virus
Sheep Pox Virus
Swine Vesicular Disease
Virus
Vesicular Stomatitis Virus
EXEMPTIONS:
1. VIRUSES: Vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP-12,
Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D) are exempt.
2. TOXINS: Toxins for medical use, inactivated for use as vaccines, or toxin preparations for biomedical
research use at an LD50 for vertebrates of more than 100 nanograms per kilogram body weight are exempt.
National standard toxins required for biologic potency testing as described in 9 CFR Part 113 are exempt.
533567314
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