South Carolina Department of Health and Environmental Control Bureau of Laboratories — Hazardous Materials Safety Interpretation

Page 1J.S. Department 1200 New Jersey Avenue, SE of Transportation Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration DEC O 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 "Igleneric descriptions are authorized for use as technical names provided they readily identify the general chemical group, or microbiological group" and that "[flor proficiency testing only, generic microbiological descriptions such as bacteria, microbacteria, fungus, and viral samples may be used."#

Page 2Therefore, 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, rosta T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3- Babich $173.134(6)3, 173.134 (a)s.. Deputions Dodd, Alice (PHMSA) 15-0020 Sent: From: Ciccarone, Michael CTR (PHMSA) Wednesday, January 28, 2015 10:08 AM To: Hazmat Interps Subject: FW: Interpretation Letter Request Shante/Alice, Please submit this for a formal letter of interpretation. Thanks, Mike From: Gootee, Brian [mailto:Gooteebe@dhec.sc.gov] To: PHMSA HM InfoCenter Sent: Tuesday, January 27, 2015 5:02 PM Subject: Interpretation Letter Request We are a Laboratory Response Network (LRN) lab required to access the hospitals within our state for their readiness and ability to identify biological agents. We would like to provide a Proficiency Test exercise to access their abilities. This would require sending the sentinel labs within our state simulated patient specimens and asking them to identify the organism. The organisms provided would be select agent exempt strains on culture media. Some of these organisms would normally be considered Category A as cultures only. 173.134(a)3 and 173.134 (a)4 do not address simulated patient specimens. Sending these Category A would require identifying the organism on the shipper's declaration and defeat the purpose of the simulated patient specimen being unknown to the sentinel lab. Can these simulated patient specimens be sent Category B. Thank you. No. select Brian Gootee, MPH Safety Officer Acint staias Responsible Official for Select Agents South Carolina Department of Health and Environmental Control (DHEC) tower Risk Bureau of, Laboratories 8231 Parklane Road Columbia, SC 29223 803-896-0956 office 803-767-8110 cell 803-896-0983 fax gooteebe@dhec.sc.gov#