Select Agent Program

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In the United States, concern over biological warfare, bioterrorism and even laboratory accidents with especially hazardous materials led to the creation of the Select Agent Program. This program, principally under the authority of the Centers for Disease Control but with participation from the United States Department of Agriculture (USDA) when plant and animal pathogens are concerned, defines "select" organisms and toxins. It certifies and registers all laboratories and other entities in the United States of America that possess, use, or transfer agents listed under the program.

While scientifically based, the first purpose of this list is to establish legal controls. The CDC Bioterrorism Agents-Disease list overlaps with the Select Agent Program list, but deals with emerging diseases and other agents considered of concern.

See the "Agents" tab for the current list of agents.

Exceptionally hazardous agents

Some agents are considered to have exceptional risk, and any laboratory, not already registered to handle them, and a laboratory encounters them must immediately inform CDC or CDC by telephone, electronic mail, or facsimile: Category A select agents requires immediate notification to APHIS or CDC via facsimile, e-mail, or telephone:

Agents in biological hazard category A Other agents requiring immediate notification
Ebola virus and Marburg virus Bacillus anthracis
Lassa fever virus Botulinum neurotoxins
South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito) Brucella melitensis
Variola minor (Alastrim) Francisella tularensis
Variola major virus (Smallpox) Hendra virus
Yersinia pestis (plague) Nipah virus
Rift Valley fever virus
Venezuelan equine encephalitis virus

Biosafety principles

Some principles of working safely with high-risk biological agents have the interest of the World Health Organization as well as specific countries. The WHO maintains a list of what are generally termed Biosafety Level 4 laboratories worldwide, although the levels came out of a U.S. sponsored consensus conference. A U.S. technical reference on biosafety are widely used.[1]

In the U.S., there are legal requirements for registration with the U.S. Department of Health and Human Services (HHS) or Agriculture (USDA) if they possess, use, or transfer biological agents or toxins (i.e. select agents and toxins) that could pose a severe threat to public health and safety; to animal or plant health; or animal or plant products. In addition to ensuring that laboratories safely handle these select agents and toxins, the Acts also require increased safeguards and security measures for these agents, including controlling access, screening entities and personnel (i.e., security risk assessments) and establishing a comprehensive and detailed national database of registered entities. The Act also imposes criminal and civil penalties for the inappropriate use of select agents and toxins.

Technical authority for developing procedures was delegated to the Centers for Disease Control's the Division of Select Agents and Toxins (DSAT) in the Coordinating Office of Terrorism Preparedness and Emergency Response.

Defining Select Agents

Definitions have both legal[2] and scientific aspects. Situations may arise where a new agent may need, on an expedited basis, to be added to the lists.

There is another list of agents and toxins that has the potential to pose a severe threat to animal or plant health, or to animal or plant products. [3], under the jurisdiction of the USDA Animal and Plant Health Inspection Service (APHIS).

Overlap agents, such as Bacillus anthracis (anthrax) and Francisella tularensis (tularemia), are threats both to humans and to animals.

Basis for listing

The "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (the Act) requires the HHS Secretary by regulation to establish and maintain a list of each biological agent and toxin that has the potential to pose a severe threat to public health and safety. In determining whether to include an agent in the list the Act requires that the following criteria be considered:

  • 1. the effect on human health of exposure to the agent or toxin;
  • 2. the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;
  • 3. the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and
  • 4. any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate.

An inter-agency workgroup, now known as the Intragovernmental Select Agents and Toxins Advisory Committee (ISATTAC), assists the CDC DSAT in implementing the provisions of the program. It makes recommendations on reviews of requests:

  • 1. for the exclusion of attenuated strains
  • 2. to conduct restricted experiments
  • 3. addition or deletion of agents or toxins to the select agent list.

Special case: attenuated agents

The laws and regulation for the Select Agent Program allow the exclusion of attenuated strains of select agents which, after review by subject matter experts, are not considered a significant danger, when handled under appropriate safety conditions. [4]

Special case: genetic information

As an example of an urgent need to add an agent, or even a form of information, came when the genetic coding of the variants to the influenzavirus, which made the 1918 influenza pandemic so deadly, were published.[5]

ISATTAC advised the CDC DSAT that this agent should be added to the HHS list of select agents and toxins. The HHS then requested an expedited clearance of an Interim final rule to add "replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments" to the list of HHS select agents and toxins. Supplemental biosafety guidance was published. [6]

Personnel security

The program does not deal only with the technical aspects of security, but also requires security clearance, called a Security Risk Assessment (SRA) of Responsible Officials (RO). With exceptions for governmental organizations, the RO, alternate RO, "any individual who owns or controls the entity and all individuals with access to select agents" must have an approved SRA. The Federal Bureau of Investigation administers SRAs.

If an individual from an unaccredited facility, who visits a covered organization and will have access to agents, must first have an approved SRA. The accredited facility will administer obtaining the SRA for the visitor.

Ownership is defined differently for businesses and academic institution. The basic rules are that the individual is a corporate officer, trustee, board member. Business owners are proprietors, partners, or individuals who control 50 percent or more of the voting cases. In both cases, the individual must have some type of managerial authority toward the agents or those who handle them.

Exceptions for virulent organisms

There are some conditions under which an unaccredited laboratory may work with a Select Agent.

Clinical or diagnostic exemption

If a clinical or diagnostic laboratory identify a Select Agent in a specimen they received, with no warning that it contained such an agent, they are not in violation of the Select Agent programs as long as they follow procedures for this exception condition. If they received it for proficiency testing, they have 90 days to destroy the agent or to apply for Program registration for it, and 7 days to do so if they received the agent in a diagnostic specimen. [7] Before destruction or registration, they must appropriately safeguard the organism. They must immediately report it to the appropriate Federal authorities (CDC, APHIS, or both), and other agencies as specified by Federal, State, or local laws.

Public health emergency

If the Secretary of Health and Human Services determines that a person or entity needs to participate in response to a domestic or foreign public health emergency, an exemption may be granted for 30 days, with one extension.

References

  1. Centers for Disease Control (1999), Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th Edition
  2. CDC regulation found in Part 73 of Title 42, Code of Federal Regulations (Possession, Use, and Transfer of Select Agents and Toxins)
  3. Part 331, Title 7, Code of Federal Regulations (Plants) and Part 121, Title 9, Code of Federal Regulations (Animals)
  4. Centers for Disease Control, Notification of Exclusion
  5. "Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus", Science (no. 5745): 77 - 80, 7 October 2005:, DOI:10.1126/science.1119392
  6. Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza Viruses
  7. Constella Group, Procedures to Follow Upon the Identification of a Select Agent or Toxin from Clinical/Diagnostic Specimens