What is a 'select agent'? The Anti-terrorism and Effective Death Penalty Act was passed in 1996 and built upon the Biological Weapons Anti-terrorism Act (1989) and other earlier anti-terrorism legislation. This legislation directed the Department of Health and Human Services to develop and maintain a list of biological agents that could pose a severe threat to the public health and safety, and to regulate the transfer of such agents while maintaining the availability of these agents for research, education, and other legitimate purposes. In response to this legislation, the CDC developed a list of 31 infectious agents and 12 biological toxins with additional provisions for recombinant organisms and drug resistant organisms and exemptions for research quantities and vaccine strains of organisms. This list of organisms provided below is referred to as the select agent list. 

In December of 2002, the Department of Health and Human Services (DHHS) / Centers for Disease Control and Prevention (CDC) and the U.S. Department of Argriculture (USDA) published the interim final rules which establish new stricter regulations for the possession, use and transfer of select biological agents and toxins that could pose a threat to human, animal and plant health and safety. 

The CDC has developed regulations on the transfer and transport of these select agents. They also require that facilities receiving these agents be registered with the federal government, that they fulfill the proper biosafety level requirements for handling, containment, and disposal, and that a person at the facility be responsible for the oversight of the transfer of such agents.

Researchers must register the laboratory with the CDC prior to purchasing or receiving any select agent.  Contact the Office of Research Services for more information. 
William Pugh, Director, Regulatory Compliance for Laboratory Programs 
(773) 834-4765 wpugh@delphi.bsd.uchicago.edu.

New Select Agent Regulation
New Select Agent Regulation 42 CFR 73

HHS NON-OVERLAP SELECT AGENTS AND TOXINS AGENTS AND TOXINS Crimean-Congo haemorrhagic fever virus Coccidioides posadasii  Ebola viruses Cercopithecine herpesvirus 1 (Herpes B virus)  Lassa fever virus  Marburg virus Monkeypox virus  Rickettsia prowazekii  Rickettsia rickettsii  South American haemorrhagic fever viruses Junin  Machupo Sabia Flexal  Guanarito Tick-borne encephalitis complex (flavi) viruses  Central European Tick-borne encephalitis Far Eastern Tick-borne encephalitis Russian Spring and Summer encephalitis Kyasanur Forest disease Omsk Hemorrhagic fever  Variola major virus (Smallpox virus)  Variola minor virus (Alastrim) Yersinia pestis  Abrin* Conotoxins*  Diacetoxyscirpenol*  Ricin* Saxitoxin* Shiga-like ribosome inactivating proteins* Tetrodotoxin*  HIGH CONSEQUENCE LIVESTOCK PATHOGENS AND TOXINS/ SELECT AGENTS (OVERLAP AGENTS)  Bacillus anthracis  Brucella abortus Brucella melitensis Brucella suis  Burkholderia mallei (formerly Pseudomonas mallei) Burkholderia pseudomallei (formerlyPseudomonas pseudomallei) Botulinum neurotoxin producing species of Clostridium Coccidioides immitis Coxiella burnetii Eastern Equine Encephalitis virus Hendra virus Francisella tularensis Nipah Virus Rift Valley fever virus Venezuelan Equine Encephalitis virus Botulinum neurotoxin* Clostridium perfringens epsilon toxin* Shigatoxin* Staphylococcal enterotoxins* T-2 toxin* USDA HIGH CONSEQUENCE LIVESTOCK PATHOGENS AND TOXINS (NON-OVERLAP AGENTS AND TOXINS) Akabane virus  African swine fever virus  African horse sickness virus Avian influenza virus (highly pathogenic) Blue tongue virus (Exotic) Bovine spongiform encephalopathy agent Camel pox virus Classical swine fever virus Cowdria ruminantium (Heartwater) Foot and mouth disease virus Goat pox virus Lumpy skin disease virus Japanese encephalitis virus Malignant catarrhal fever virus (Exotic) Menangle virus Mycoplasma capricolum/M.F38/M. mycoides capri Mycoplasma mycoides mycoides Newcastle disease virus (VVND) Peste Des Petits Ruminants virus Rinderpest virus Sheep pox virus Swine vesicular disease virus Vesicular stomatitis virus (Exotic) LISTED PLANT PATHOGENS Liberobacter africanus Liberobacter asiaticus Peronosclerospora philippinensis Phakopsora pachyrhizi Plum Pox Potyvirus Ralstonia solanacearum race 3, biovar 2 Schlerophthora rayssiae var zeae Synchytrium endobioticum Xanthomonas oryzae Xylella fastidiosa (citrus variegated chlorosis strain) *Toxins are regulated based on potency and quantity.  Entities that do not at any time have more than the following aggregate amounts (in the purified form or in combinations of pure and impure forms) under the control of a principal investigator are excluded from requirements of the regulation:

Links

CDC Select Agent 42CFR73

Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents

Agricultural Bioterrorism Protection Act of 2002 Biological Agents and Toxins; Possession