Biological Safety

Biological safety is the use of various controls present in the laboratory to contain dangerous pathogens to protect laboratory workers, and the environment both inside and outside of the laboratory. To successfully provide the most protection possible, each facility must do a risk assessment, where staffs consider the pathogens that may be present; the procedures that may lead to exposure; laboratory design; training and experience; and laboratory policies and procedures. Risk can never be eliminated but can be mitigated to the lowest degree possible with a safety culture that involves all employees.

There are several documents available, free of charge, to assist laboratories with Biorisk management.

The  Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th edition was published in 2020 and is considered the "gold standard" in the United States. Not only does it thoroughly explain the concepts of biosafety and biosecurity; but it also breaks down pathogen risks, laboratory design and biological safety cabinets (BSC), and includes (Appendix N) for clinical laboratories.

The  Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories explains the concept of risk assessments and walks the reader through the various sections of the clinical laboratory, pointing out the risks specific to those sections.

The Guidelines for Biosafety Laboratory Competency outlines the four skill domains (potential hazards, hazard controls, administrative controls, and emergency preparedness and response) as well as the skills needed for entry level, midlevel, and senior level staffs  to be considered competent in various laboratory settings.

When processing cultures, laboratorians should be aware of  trigger points (i.e. slow-growing organisms, especially from a sterile source) and move work to a biological safety cabinet (BSC). Pathogen-specific information, including characteristics, laboratorian-specific risks, and disinfection can be found on the  Pathogen Safety Data Sheets (Government of Canada, Public Health)

For questions concerning biosafety and (after notification to local public health) to report an accidental exposure or release of a pathogen, please  email Crystal Fortune  or call 406-444-0930.

Packaging and Shipping

 An important aspect of containment is proper packaging and shipping of infectious substances, which is outlined in the United States Department of Transportation Hazardous Materials Regulations

MTPHL will host Packaging and Shipping Infectious Substances online and in-person in 2024. The next session will be held from in person from 8:30 to 4:30 MT on May 22nd (registration link) at the Cogswell Building, Conference Room C207, 1400 East Broadway in Helena. The course registration, resources, examination, and P.A.C.E. credits will all be on the CDC Train website.  Click here for the in-person course brochure for more information, including the registration code.

Anyone involved in any part of the process of sample transport should be trained according to 49 CFR 172.704, and must follow all appropriate regulations, guidelines, and manufacturer's instructions for the packaging used. Recurrent training is required every three years by DOT (i.e., courier transport) and every two years by some accreditation agencies and the International Air Transport Association (IATA), which issues guidance for transport by air (i.e., transport by UPS and FedEx Express). Please remember that training is separate from certification, which is described in 49 CFR 172.704 (d) recordkeeping.

The complete IATA Dangerous Goods Regulations (DGR) manual or a smaller Infectious Substances Shipping Regulations manual are available for purchase on the IATA website.There are also many free resources available you can use as references to ensure you are transporting samples properly. Some of these are listed below:

United States Department of Transportation (DOT) " Transporting Infectious Substances Overview" and  Transporting Infectious Substances Safely

World Health Organization " Guidance on regulations for the Transport of Infectious Substances"

Transport of samples classified as Category A should be packaged accordingly, regardless of mode of transport. You can find the DOT's packaging requirements in 49 CFR 173.196. Additional guidance can be found in IATA Packing Instruction 620. 

  IATA Packing Instruction 650, which applies to transport of cultures by the courier, and transport of UN 3373, Biological substance, Category B. You can also find information on air transport of dry ice and on completing a Shipper's Declaration on the IATA page for Dangerous Goods Documentation

CDC's UN 2814 Infectious substance, Category A and UN 3373 Biological substance, Category B schematic

 Please contact Crystal Fortune, (406) 444-0930, or by email for questions concerning training and safe transport of infectious substances.