Bio-Buzz Words and CDC’s Select Agents Program

By Christopher Chadwick, MS, Specialist, Public Health Preparedness and Response, APHL

In the bio world, scientists throw around several words that tend to confuse people: biosafety, biosecurity, biodefense and bioterrorism.   What do these buzz words mean?

Bioterrorism and biodefense are probably the terms with the most straightforward definitions.

  • Bioterrorism: the unlawful or threatened use of certain microbes or toxins (“BT agents”) to harm or scare people
  • Biodefense: the measures taken to prevent, detect, respond to and recover from harm or damage caused by BT agents.  Biodefense measures include surveillance systems or networks for detection, such as the Laboratory Response Network (LRN), and medical countermeasures for response and recovery, such as vaccines and antimicrobials.

The laboratories are vital in the detection and characterization of potential BT agents, but what protects the laboratories and the laboratorians from exposure to the agents or from accidentally releasing them to the public? Biosafety and biosecurity!

  • Biosafety: the policies, practices, safeguards, and equipment that protect laboratorians, the environment, and the public from the accidental exposure to BT agents. Essential to biosafety is the Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidance document, a voluntary guide to standard practices, safety equipment, facility structure (e.g., biosafety levels 1-4).
  • Biosecurity: the protection, control and accountability for agents to prevent misuse or intentional release.

CDC’s Select Agent Program

Chris Chadwick's Halloween pumpkin -- yes, he *really* made this

Recently, biosecurity has been a hot topic among the laboratories with the release of the final rule of the Select Agents Regulation by the Department of Health and Human Services Centers for Disease Control and Prevention. The Select Agents Regulation, more formally known as the Rules for Possession, Use, and Transfer of Select Agents and Toxins or 42 CFR Part 73, provides biosecurity guidance on a specific list of agents and toxins, including the popular BT agents anthrax, botulism, plague and smallpox, in order to implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

On October 5, 2012, the final rule was published with a variety of revisions that were met with support and criticism by the public health laboratory community. The most notable revision is the establishment of 11 Tier 1 agents that pose the greatest risk of misuse and potential for mass casualties (e.g., anthrax, botulism, Ebola). With this new designation, laboratories that handle these agents must develop additional facility safeguards and personnel reliability to ensure biosecurity, thus putting a financial burden on the laboratories. Physical safeguards include establishing an intrusion detection system and three security barriers that would delay someone attempting to reach the agents, while IT safeguards include additional information security to protect against viruses and spyware that may compromise confidential records.

Revisions to the actual list of select agents include the addition of the SARS, Lujo, and Chapere viruses; the removal of 11 agents and toxins; and the retention of Bacillus anthracis (aka, anthrax) Pasteur strain (but not as a Tier 1 agent). Public health labs were quite happy to learn that LRN member laboratories can use exempt attenuated strains of some agents for proficiency tests and that Coccidioides immitis, a soil fungus endemic in the southwestern United States, was removed from the list.

The revisions to the Select Agents Regulation are a great reminder that biosecurity and biosafety efforts are always changing in the laboratory. Technologies are shifting, the workforce is evolving, and new infectious diseases are emerging so these efforts to maintain biosecurity and biosafety are becoming even more important. With that, in the spirit of Halloween, the Public Health Laboratory Division at the Minnesota Department of Health says: Don’t Be a Zombie, Follow Safe Laboratory Practices!

 

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