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Select Agents, Toxins and Vaccines: NEW REGULATIONS

To: __________@LISTSERV.MED.CORNELL.EDU

Please read carefully, the following applies to all laboratories, clinical practices and other areas where Biological Agents (including Vaccines) may be used and stored. A response must be received from every principal investigator and clinical physician even if you do not have these agents.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) became effective with the President's signature on June 12, 2002. Organizations are now required to certify possession of specific Biological Agents to the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) by September 10, 2002.

Previous requirements to report to the CDC were only for the transfer of agents. Additionally, previously exempt select agents (i.e. USDA or FDA approved vaccines) are now included in the notification requirement. Also included is nucleic acid or genetic elements from the agent.

The new list of agents is to be determined by both the CDC and USDA. A draft notification form has been published, that lists proposed agents (see below). A final list should be issued by July 26, 2002.

If you have not already done so, prepare for registration by surveying your laboratory and/or clinical practice for the Draft List of Agents , which follows. In all likelihood the list will not change due to mandated time constraints.

Once the final form is published, Environmental Health and Safety (EHS) will distribute inventory forms to each laboratory and clinical practice. All areas must complete a form either indicating which agents are present or that no agents are present. Due to time constraints, please do not wait for the forms to begin inventorying.

Principal investigators and clinical physicians should review all areas for the presence of agents. Department administrators should investigate unclaimed materials and pay particular attention to archival collections where no principal investigator is responsible.

Specifically, please do the following:
* review all areas for any form of the agents listed below.
* notify EHS as soon as possible if you discover these agents in any form.
* once EHS issues the final inventory form, complete the form indicating which agents are present or that no agents are present. By December, 2002 the CDC and USDA must promulgate regulations to indicate how these materials are to be handled. At this point, we are unsure what will happen but will keep you informed as additional materials are received.

The Office of Inspector General of the U.S. Department of Health and Human Services has begun inspecting areas where agents are likely to be located. Additionally, USDA has indicated a similar inspection process will begin soon.

Please feel free to contact me if you have any questions about this process. Thank you for your assistance with this matter.

Sincerely,

__________, Director of Environmental Health and Safety
Weill Cornell Medical College

Draft List of Agents
(use as checklist for inventories until final list is released)

HHS SELECT AGENTS
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
Yersinia pestis
Abrin
Conotixins
Diacetoxyscirpenol
Ricin
Saxitoxin
Tetrodotoxin

USDA-HHS OVERLAP AGENTS
Bacillus anthracis
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia (Pseudomonas) Mallei
Burkholderia (Pseudomonas) Pseudomallei
Clostridium botulinum
Coccidioides immitis
Coxiella burnettii
Eastern Equine Encephalitis Virus
Equine Morbillivirus (Hendra Virus)Nipah Virus
Francisella tularensis
Rift Valley Fever Virus
Venezuelan Equine Encephalitis Virus
Aflatoxins
Botulinum Toxins
Clostridium perfiringens Epsilon Toxin
Shigatoxin
Staphylococcal Enterotoxin
T-2 Toxin

USDA HIGH CONSEQUENCE OF LIVESTOCK PATHOGENS AND TOXINS
African Horse Sickness Virus
African Swine Fever
Akabane Virus
Avian Influenza Virus (Highly pathogenic)
Blue Tongue Virus (exotic)
Bovine Spongiform Encepalopathy agent
Camel Pox Virus
Classical Swine Fever
Cowdria ruminantium (Heartwater)
Foot and Mouth Disease Virus
Goat Pox Virus
Japanese Encephalitis Virus
Lumpy Skin Disease Virus
Malignant catarrhal Fever
Menangle Virus
Mycoplasma capricolumm F.38/M.M ycoides Capri Contagious caprine Pleuropneumonia Agent)
Mycoplasma mycoides mycoides (Contagious Bovine Pleuropneumonia Agent)
Newcastle Disease Virus (Exotic)
Peste Des Petits Ruminants
Rinderpest Virus
Sheep Pox
Swine Vesicular Disease Virus
Vesicular Stomatitis Virus