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Biological Agents and Materials that Require Oversight

  1. Select Agents and Toxins
    Possession of select agents and toxins is regulated by the Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture (USDA). Their registration requires substantial paperwork and federal involvement. Agents may be brought to campus only after compliance with all select agent registration requirements and with prior approval of the CDC and/or USDA. More information is available at Contact DES at (301) 405-3975 immediately if you currently possess or plan to acquire any of the select agents listed below.

    1. HHS Select Agents and Toxins

      • Abrin (100 mg)
      • Botulinum neurotoxins Brucella abortus
      • Botulinum neurotoxin producing species of Clostridium
      • Cercopithecine herpesvirus 1 (Herpes B virus)
      • Clostridium perfringens epsilon toxin
      • Coccidioides posadasii/Coccidioides immitis
      • Conotoxins (100 mg)
      • Coxiella burnetii
      • Crimean-Congo haemorrhagic fever virus
      • Diacetoxyscirpenol (1000 mg)
      • Eastern Equine Encephalitis virus
      • Ebola viruses
      • Francisella tularensis
      • Lassa fever virus
      • Marburg virus
      • Monkeypox virus
      • Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 Influenza virus)
      • Ricin (100 mg)
      • Rickettsia prowazekii
      • Rickettsia rickettsii
      • Saxitoxin (100 mg)
      • Shiga-like ribosome inactivating proteins (100 mg)
      • South American Haemorrhagic Fever viruses
        • Flexal
        • Guanarito
        • Junin
        • Machupo
        • Sabia
      • Staphylococcal enterotoxins
      • T-2 toxin
      • Tetrodotoxin (100 mg)
      • Tick-borne encephalitis complex (flavi) viruses
        • Central European tick-borne encephalitis
        • Far Eastern tick-borne encephalitis
        • Kyasanur Forest disease
        • Omsk Hemorrhagic Fever
        • Russian Spring and Summer encephalitis
      • Variola major virus (Smallpox virus)
      • Variola minor virus (Alastrim)
      • Yersinia pestis
    2. HHS Select Agents/ USDA High Consequence Livestock Pathogens (Overlap Agents)

      • Bacillus anthracis
      • Brucella abortus
      • Brucella melitensis
      • Brucella suis
      • Burkholderia mallei (formerly Pseudomonas mallei)
      • Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
      • Hendra virus
      • Nipah Virus
      • Rift Valley fever virus
      • Venezuelan Equine Encephalitis virus
    3. USDA High Consequence Livestock Pathogens And Toxins

      • African horse sickness virus
      • African swine fever virus
      • Akabane virus
      • Avian influenza virus (highly pathogenic)
      • Bluetongue virus (Exotic)
      • Bovine spongiform encephalopathy agent
      • Camel pox virus
      • Classical swine fever virus
      • Ehrlichia ruminantium (Heartwater)
      • Foot and mouth disease virus
      • Goat pox virus
      • Japanese encephalitis virus
      • Lumpy skin disease virus
      • Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1)
      • Menangle virus
      • Mycoplasma capricolum subspecies capripneumoniae (contagious caprine pleuropneumonia)
      • Mycoplasma mycoides subspecies mycoides small colony (MmmSC) (contagious bovine pleuropneumonia)
      • Peste des petits ruminants virus
      • Rinderpest virus
      • Sheep pox virus
      • Swine vesicular disease virus
      • Vesicular stomatitis virus (Exotic): Indiana subtypes VSV-IN2, VSV-IN3
      • Virulent Newcastle disease virus (A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral pathogenicity index in day-old chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus)
    4. Listed Plant Pathogens

      • Peronosclerospora philippinensis (Peronosclerospora sacchari)
      • Phoma glycinicola (formerly Pyrenochaeta glycines)
      • Ralstonia solanacearum race 3, biovar 2
      • Rathayibacter toxicus
      • Sclerophthora rayssiae var zeae
      • Synchytrium endobioticum
      • Xanthomonas oryzae pv. oryzicola
      • Xylella fastidiosa (citrus variegated chlorosis strain)

  2. Recombinant DNA molecules
    All recombinant DNA materials are required to be registered at Recombinant DNA molecules that will not be propagated or introduced into live organisms are exempt from registration.

    1. Recombinant DNA involving human pathogens
      Any recombinant DNA construct that makes use of a Risk Group 2, Risk Group 3, or Risk Group 4 microbial pathogen as a host or vector requires registration and approval by the Institutional Biosafety Committee (IBC) prior to initiation of experiments. For more information about risk groups and current listings, see ABSA website.Generally, the biological materials that will fall into this category are recombinant animal virus vectors, including those that are commercially available. This includes retrovirus, adenovirus, herpesvirus, and poxvirus vectors, with or without inserted nucleic acids.

    2. Recombinant DNA molecules containing toxin genes
      Recombinant DNA constructs that contain genes encoding any toxin with an LD50 of less than 100 nanograms / kilogram of body weight require approval by the IBC and the National Institutes of Health prior to initiation of any experiments using such constructs. Additionally, rDNA constructs that contain genes encoding any of the select agent toxins are subject to the select agent regulations (see #1 above).

    3. Non-rodent transgenic animals
      Federal regulations require transgenic animals other than rodents to be registered with the IBC, which will establish the appropriate containment level for such research.

  3. Human pathogens
    All human pathogens are required to be registered at before work is begun.

  4. Microorganisms that require permits to import or transport
    Most human and animal pathogens require a permit from CDC or USDA for import into the US. Animal pathogens also require a permit for transport within the US.

  5. Microorganisms and toxins that require export license
    Many microorganisms and toxins require a license from the Department of Commerce to ship to destinations outside the U.S. If biological materials are being shipped outside the U.S., contact DES at (301) 405-3975 for assistance.
Revised April 2005
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Phone 301.405.3960