Specific Risk Material, definition

ORM (Other Regulated Material) Under U.S. Department of Transportation regulations, an Other Regulated Material (ORM) is a material that (a) May pose an unreasonable risk to healdi and safety or property when transported in commerce and (b) Does not meet any of the definitions of the other hazard classes specified in subchapter C of the regulation or (c) Has been reclassified an ORM (specifically or permissively). 

Any pharmaceutical product needs to be thoroughly and completely defined and characterized by adequate analytical methods. This includes all starting materials, the production process, purified bulk materials, the formulated vaccine, and any excipient, adjuvant, or other constituent of the vaccine and may well mean that in total a set of 100 or more analytical methods must be applied. Table 1 explains how essential starting materials of a DNA vaccine need to be tested and characterized, mainly in order to provide sufficient information for appropriate risk and safety evaluations and also for a proper and reproducible specification or definition of the product. For safety reasons, any unintended byproduct that could be expressed by the... 

There are currently 15 key federal laws related to the control and regulation of hazardous and toxic materials. A summary of these laws, their regulatory objectives, and primary responsible federal agencies is shown in Table 3.1. In addition there are many more state laws and regulations, often with more stringent requirements than their federal counterparts. It is important to review these state and federal regulations as part of the risk assessment process. The various laws and regulations provide specific definitions, specific lists of toxic and hazardous materials, requirements for compliance, and methods and standards for compliance. 

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