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Possession, Use, and Transfer of Select Agents And Toxins

Introduction

Select agents are microorganisms and toxins that have potential for use by terrorists. The Public Health Security and Preparedness and Response Act of 2002 restricts their possession and use, and requires the University to collect and maintain information on the location and use on campus of any select agents or toxins. Please contact the Biological Safety Officer immediately if you currently possess or plan to acquire any of the listed agents and have not yet reported the fact. Failure to provide notice may result in civil and criminal liability for individuals researchers and/or the University.

Applicable University Policy

It is University of Maryland policy to comply with all federal regulations.

Applicable Regulations

42 CFR Part 73 - Possession, Use, and Transfer of Select Agents and Toxins; Final Rule, March 18, 2005

9 CFR Part 121 and 7 CFR Part 331 - Agricultural Bioterrorism Protection Act of 2002, Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule, March 18, 2005

Summary of Requirements

• Entities possessing select agents must appoint a Responsible Official (RO). An Alternate Responsible Official (ARO) may also be appointed.
• Entities possessing select agents must register with either the Centers for Disease Control and Prevention (CDC) or United States Department of Agriculture/ Animal and Plant Health Inspection Service (USDA/APHIS), depending on the agents possessed;
• Individuals with a legitimate need to work with select agents must undergo a Department of Justice security risk assessment;
• Only approved individuals may have access to select agents;
• Non-approved individuals must be escorted by an approved person at all times while in the laboratory;
• The facility must develop and implement a Biosafety and Security Plan;
• Security systems and procedures must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the threat posed by the agent or toxin;
• Agents may only be transferred to registered entities;
• Either the CDC or USDA/APHIS must approve all transfers of agents prior to the transfer.

Training

• The RO must provide training in biosafety, containment, and security procedures to individuals with access to agents;
• The RO must provide annual refresher training.
• Visitors must be informed of the security requirements and procedures.

Reporting

• Suspected loss or theft of select agents must be reported to the US Department of Agriculture or CDC immediately upon discovery;
• Changes in circumstances must be reported by the RO to the agency that issued the certificate of registration.

Inspections

• Prior to issuing a certificate of registration, APHIS or CDC may inspect and evaluate a facility;
• The RO must inspect the facility at least annually.

Recordkeeping

The RO must keep records including:

• The Biosafety and Security Plan;
• Current list of individuals with access to agents;
• Training records for individuals with access to agents;
• Accurate and current inventory records;
• Permits and transfer documents (APHIS 2041);
• Security records (e.g., transactions from automated access control systems, testing and maintenance of security systems, visitor logs);
• Biosafety, containment, and security incident reports;

All records must be kept for 3 years.

Written Program

A Biosafety and Security Plan is required for each entity possessing select agents or toxins. The University has prepared a Biosafety and Security Plan for its laboratories possessing select agents and toxins

University Resources

Written 5/03
Revised 4/05

Select Agents and Toxins

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

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

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)

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)

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