Biological Agents and Materials that Require Oversight

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Biological Agents and Materials that Require Oversight

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 http://www.des.umd.edu. 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)
  - Conotoxins (100 mg)
  - Crimean-Congo haemorrhagic fever virus
  - Coccidioides posadasii
  - Diacetoxyscirpenol (1000 mg)
  - Ebola viruses
  - Cercopithecine herpesvirus 1 (Herpes B virus)
  - 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
  - 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
  - Botulinum neurotoxin (0.5 mg)
  - Botulinum neurotoxin producing species of Clostridium
  - Brucella abortus
  - Brucella melitensis
  - Brucella suis
  - Burkholderia mallei (formerly Pseudomonas mallei)
  - Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
  - Clostridium perfringens epsilon toxin (100 mg)
  - Coccidioides immitis
  - Coxiella burnetii
  - Eastern Equine Encephalitis virus
  - Francisella tularensis
  - Hendra virus
  - Nipah Virus
  - Rift Valley fever virus
  - Shigatoxin (100 mg)
  - Staphylococcal enterotoxins (5.0 mg)
  - T-2 toxin (1000 mg)
  - 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
  - Cowdria 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/ M.F38/M. mycoides Capri (contagious caprine pleuropneumonia)
  - Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia)
  - Newcastle disease virus (velogenic)
  - Peste des petits ruminants virus
  - Rinderpest virus
  - Sheep pox virus
  - Swine vesicular disease virus
  - Vesicular stomatitis virus (Exotic)
4. Listed Plant Pathogens
  - Candidatus Liberobacter africanus
  - Candidatus Liberobacter asiaticus
  - Peronosclerospora philippinensis
  - Ralstonia solanacearum race 3, biovar 2
  - Schlerophthora rayssiae var zeae
  - Synchytrium endobioticum
  - Xanthomonas oryzae pv. oryzicola
  - Xylella fastidiosa (citrus variegated chlorosis strain)
Recombinant DNA molecules
All recombinant DNA materials are required to be registered at https://des.umd.edu/research/login.cfm. 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 web site.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.
Human pathogens
All human pathogens are required to be registered at https://des.umd.edu/research/login.cfm before work is begun.
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.
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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Biological Agents and Materials that Require Oversight

HHS Select Agents and Toxins

HHS Select Agents/ USDA High Consequence Livestock Pathogens (Overlap Agents)

USDA High Consequence Livestock Pathogens And Toxins

Listed Plant Pathogens