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 533567314 2 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 3