Oversight of the safety and security of biological agents
Manual of best practices
The Centers for Disease Control and Prevention (CDC) publishes an advisory document called Biosafety in Microbiological and Biomedical Laboratories (BMBL) (pdf). It recommends “best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.” Compliance with these practices is mandatory.
It is also important to understand and follow additional government guidelines and standards.
Human, animal, plant, and other
Work with pathogens and infectious agents includes (but is not limited to) the following:
- Experiments using human or animal pathogens (classed and listed in guidelines) as host-vector systems
- Experiments in which DNA or RNA from human or animal pathogens (see NIH Guidelines for a list) is cloned in nonpathogenic prokaryotic or lower eukaryotic host-vector systems
- Experiments involving the use of infectious animal or plant DNA or RNA viruses of the defective animal or plant DNA or RNA viruses in the presence of helper virus in tissue culture systems
U.S. Department of Labor Occupational Safety and Health Administration (OSHA) regulations aim to minimize risk of exposure to blood-borne pathogens when employees handle human blood and human-derived material, including cells.
This set of regulations is known as the Blood-borne Pathogens Standard.
Training for handling blood-borne pathogens
An online training program offered by the WSU Office of Environmental Health and Safety and the Office of Research Assurances provides a general understanding of blood-borne pathogens, their common modes of transmission, and methods of preventing exposure.
About the Blood-borne Pathogens (BBP) Standard
The standard applies to workplaces where employees perform tasks that involve contact with or exposure to the following:
- Human blood
- Specific body fluids
- Other human-derived materials considered to be a risk for blood-borne pathogens
BBP risk materials
Employees with occupational exposure to the following risk materials must receive initial and annual training in exposure control. They must also be offered hepatitis B vaccination free of charge.
Human body fluids
- Vaginal secretions
- Cerebrospinal fluid
- Synovial fluid
- Pleural fluid
- Pericardial fluid
- Peritoneal fluid
- Amniotic fluid
- Saliva in dental settings
- Any body fluid that is visibly contaminated with blood
- All body fluids in situations where it is difficult or impossible to differentiate between body fluids
Any unfixed human tissue or organ
- Other than intact skin
- The source of the tissue or organ may be living or dead
HIV-containing cultures and culture media
Including the following:
- Cell or tissue cultures
- Organ cultures
- HIV or HBV- containing culture media or other solutions
- Human cell/tissue/organ cultures not shown to be free of blood-borne pathogens
Experimental animals infected with human blood-borne pathogens
Blood, organs, or other tissues from these animals
For further information about the BBP standard as it applies to research or diagnostic labs, please contact the WSU biosafety officer responsible for control of blood-borne pathogen exposure.
Select agents & toxins
The federal government oversees the possession, use, and transfer of select biological agents and toxins that could pose a severe threat to public, animal, or plant health or to animal or plant products.
Jointly run by the Centers for Disease Control and the U.S. Department of Agriculture Animal and Plant Health Inspection Services, the regulatory arm is known as the Federal Select Agent Program.
References from the Federal Select Agent Program
WSU and the Federal Select Agent Program
WSU has been a registered entity with the Federal Select Agent Program since 2003. All inquiries about working with Select Agents at WSU should be directed to the WSU biosafety officer or the Director of the Office of Research Assurances.
Timeline of federal regulations
April 15, 1997
“The Antiterrorism and Effective Death Penalty Act of 1996” (Section 511 of Public Law 104-132)
This law was enacted due to the threat of the illegitimate use of infectious agents and the potential serious adverse consequences for human health and safety.
Select Agents Final Rule (42CFR, Part 72, “Additional Requirements for Facilities Transferring or Receiving Select Agents”)
Enacted in response to the Antiterrorism and Effective Death Penalty Act of 1996, and became effective on the same day. The Department of Health and Human Services (HHS) published the rule, which created a framework to track the access, use, and transfer select agents. Washington State University (WSU) was registered with the Centers for Disease Control and Prevention (CDC) to transfer or receive select agents in compliance with the rule.
October 26, 2001
“United and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of 2001” Act (USA PATRIOT Act)
When signed into law, the PATRIOT Act did the following:
- Criminalized the possession of select agents that had no legitimate purpose
- Banned the possession of select agents by “restricted persons”
- Required the Secretary of the Department of Health and Human Services to establish additional standards and procedures to govern the possession, use, and transfer of select agents
June 12, 2002
“Public Health Security and Bioterrorism Preparedness Act of 2002” (Public Law 107-188)
Signed into law to strengthen and enhance the USA PATRIOT Act of 2001. This law required that the United States improve its ability to prevent, prepare for, and respond to bioterrorism and other public health emergencies. It necessitates that individuals possessing, using, or transferring agents or toxins deemed a threat to public, animal or plant health, or to animal or plant products, notify either the Secretary of the Department of Health and Human Services or the Secretary of the Department of Agriculture (USDA).
February 11, 2003
“Possession, Use, and Transfer of Select Agents and Toxins” (42CFR Part 73)
“Possession, Use, and Transfer of Biological Agents and Toxins” (7CFR Part 331 and 9 CFR Part 121)
These rules went into effect to meet the requirements of the “Public Health Security and Bioterrorism Preparedness Act of 2002.”
- The U.S. Department of Health and Human Services authorized Centers for Disease Control and Prevention (CDC) to develop and administer rules governing the possession, use, and transfer of select agents and toxins.
- USDA authorized the Animal and Plant Health Inspection Service (APHIS) to develop and administer rules governing the possession, use, and transfer biological agents and toxins.
Because some agents and toxins are common to both lists (termed “overlap agents and toxins”) the CDC and APHIS collaborated to produce these new rules.