The Research and Special Programs Administration (RSPA), an agency of the U.S. Department of Transportation (DOT), amended the Hazardous Material Regulations (HMR) relating to transportation requirements for infectious substances, including regulated medical waste (Division 6.2 materials). The rule applies to offerors and transporters of Division 6.2 materials, as well as manufacturers of packagings for these materials.
As amended, the revised requirements:
Adopted classification criteria for Division 6.2 material (infectious substances) based on risk groups developed by the World Health Organization (WHO). WHO defines four risk groups for infectious substances based on pathogenecity, mode and ease of transmission, degree of risk to individuals and communities, and reversibility of the disease through prevention and treatment. Unless an exception is authorized, all Risk Group 2, 3, and 4 infectious substances must be transported in specification triple packaging authorized under the HMR. Risk Group 1 infectious substances are excepted (not regulated by the HMR) unless they meet the definition of another hazard class.
Revised the current packaging requirements for Division 6.2 materials for consistency with international standards.
Eliminated the HMR exception for diagnostic specimens and adopted provisions applicable to their transportation--i.e. now regulated. Risk Group 4 diagnostic specimens must be classified as Division 6.2 materials UN2814 or UN2900. All other diagnostic specimens can be packaged in non-specification packages meeting minimum performance criteria. These provisions, spelled out in 49 CFR 173.199, except these diagnostic specimens from all HMR requirements (e.g., shipping papers, performance packaging, label marking, formal training, etc.) but incident reporting when shipped by air. Waste diagnostic specimens must be transported as Regulated Medical Waste. Diagnostic specimens transported by a private or contract carrier in a motor vehicle used exclusively for that purpose are completely excepted from the HMR.
Modified the current HMR exception for biological products limiting the exception to biological products licensed for use under Food and Drug Administration or U.S. Department of Agriculture rules.
Added new bulk packaging options for the transportation of Regulated Medical Waste based on provisions of current DOT exemptions. Risk Group 4 Medical Waste must be classified as Division 6.2 materials UN2814 or UN2900.
Created a DOT regulated biohazard marking design. Added new hazard communication requirements for bulk shipments of Regulated Medical Waste, effective October 1, 2003.
Revised the design of the infectious substances label to include the toll free phone number for the Center and Disease and Control.
Made miscellaneous related changes and provided miscellaneous exceptions.
Regulated Medical Waste transported by private or contract carrier in non-bulk packages that conform to the provisions of 49 CFR 173.197 is excepted from the HMR requirements.
The DOT requirements for infectious substances are in addition to OSHA's bloodborne pathogens requirements and state medical waste requirements.
The final rule is effective February 14, 2003. Voluntary compliance authorized as of September 16, 2002. If you are effected by the HMR changes, you should carefully review the Federal Register notices and take appropriate action.
More info: Federal Register of August 14, Aug. 27, and Sept. 11, 2002.
Definitions Related to Diagnostic Specimens and Medical Waste
Provisions Related to Diagnostic Specimens
Biohazard Marking for Bulk shipment of Regulated Waste
Revised of Infectious Substances Label
