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Interpretation Response #15-0020 ([South Carolina Department of Health and Environmental Control Bureau of Laboratories] [Mr. Brian Gootee])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: South Carolina Department of Health and Environmental Control Bureau of Laboratories

Individual Name: Mr. Brian Gootee

Location State: SC Country: US

View the Interpretation Document

Response text:

December 8, 2015

Mr. Brian Gootee
Safety Officer
South Carolina Department of Health and Environmental Control
Bureau of Laboratories
8231 Parklane Road
Columbia, SC  29223

Reference No. 15-0020

Dear Mr. Gootee:

This is in response to your January 27, 2015 e-mail requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of cultures classified as Division 6.2, Category A infectious substances.  In your letter, you propose to transport the cultures as simulated patient specimens to hospitals within your state to assess their ability to identify biological agents.  You ask if these simulated patient specimens must be transported as Category A materials or if they can be transported as Category B.

In accordance with § 173.134(a)(1) of the HMR, if a material is known or reasonably expected to contain a pathogen, or other infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs, it must be classified as a Category A infectious substance.  There is no exemption to this requirement based on the intended purpose of transportation (e.g., a simulation exercise etc.).  

However, shipping a simulated patient specimen for proficiency testing does not require identification of the organism on the shipping paper.  When a material is described on a shipping paper by one of the proper shipping names identified by the letter “G” in column (1) of the § 172.101 Table, the technical name of the hazardous material must be entered in parentheses in association with the basic description (see § 172.203(k).  Both of the identification numbers associated with Category A infectious substances, “UN 2814” and “UN 2900,” require the use of technical names.  The definition of a “technical name” as specified in § 171.8 states that “[g]eneric descriptions are authorized for use as technical names provided they readily identify the general chemical group, or microbiological group” and that “[f]or proficiency testing only, generic microbiological descriptions such as bacteria, microbacteria, fungus, and viral samples may be used.”  

Therefore, a simulated patient specimen classified as a Category A infectious substance may be shipped for the purpose of proficiency testing using a generic technical name that readily identifies the microbiological group, without identifying the specific organism.

I hope this satisfies your request.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.134(a)(1), 172.203(k), 171.8

Regulation Sections

Section Subject
171.8 Definitions and abbreviations
172.203 Additional description requirements
173.134 Class 6, Division 6.2-Definitions and exceptions