When shipping a biological material its classification determines how it must be packaged and handled.
|
Category |
Feature |
|
Infectious Substance, Category A |
exposure can result in death or permanent disability to humans and/or animals |
|
Infectious Substance, Category B |
exposure can cause illness for humans and/or animals but not death or permanent disability |
|
Diagnostic Specimen |
human or animal samples being shipped for diagnostic or investigational purposes AND does not meet exclusions |
|
Biological Product |
products derived from living organisms such as vaccines or diagnostic reagents AND does not meet exclusions |
|
Genetically-modified Organism |
micro-organism or organism altered by genetic engineering and not found naturally AND does not meet exclusions |
|
Unregulated Biological Materials |
biological materials not meeting any of the above criteria AND not affected by other regulations |
To be classified as an infectious substance the material must be able to cause disease following exposure with a reasonable certainty.
Exclusions for classification as a diagnostic specimen:
(1) a live animal
(2) a material that may contain a serious contagious disease AND there is no effective treatment for the disease (in which case handled as an infectious substance)
Exclusions for classification as genetically-modified organism:
(1) infectious substance
(2) other danger to humans, animals or the environment
(3) animals unless exempted
Exclusions for biological products:
(1) for use by medical professionals
(2) infectious substance
(3) separate regulations
Specialty: Clinical Laboratory
