{"operation":"document","citation":"15-0020","title":"South Carolina Department of Health and Environmental Control Bureau of Laboratories — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2015-12-08","effective_on":null,"summary":"15-0020 response to South Carolina Department of Health and Environmental Control Bureau of Laboratories concerning 171.8, 172.203, 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0020.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0020.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0020","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/150020.pdf","body":"<<<PAGE 1>>>\n\nJ.S. Department\n1200 New Jersey Avenue, SE\nof Transportation\nWashington, D.C. 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration\nDEC O 8 2015\nMr. Brian Gootee\nSafety Officer\nSouth Carolina Department of Health and Environmental Control\nBureau of Laboratories\n8231 Parklane Road\nColumbia, SC 29223\nReference No. 15-0020\nDear Mr. Gootee:\nThis is in response to your January 27, 2015 e-mail requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of\ncultures classified as Division 6.2, Category A infectious substances. In your letter, you\npropose to transport the cultures as simulated patient specimens to hospitals within your state\nto assess their ability to identify biological agents. You ask if these simulated patient\nspecimens must be transported as Category A materials or if they can be transported as\nCategory B.\nIn accordance with § 173.134(a)(1) of the HMR, if a material is known or reasonably\nexpected to contain a pathogen, or other infectious substance in a form capable of causing\npermanent disability or life-threatening or fatal disease in otherwise healthy humans or\nanimals when exposure to it occurs, it must be classified as a Category A infectious substance.\nThere is no exemption to this requirement based on the intended purpose of transportation\n(e.g., a simulation exercise etc.).\nHowever, shipping a simulated patient specimen for proficiency testing does not require\nidentification of the organism on the shipping paper. When a material is described on a\nshipping paper by one of the proper shipping names identified by the letter \"G\" in column (1)\nof the § 172.101 Table, the technical name of the hazardous material must be entered in\nparentheses in association with the basic description (see § 172.203(k). Both of the\nidentification numbers associated with Category A infectious substances, \"UN 2814\" and\n\"UN 2900,\" require the use of technical names. The definition of a \"technical name\" as\nspecified in § 171.8 states that \"Igleneric descriptions are authorized for use as technical\nnames provided they readily identify the general chemical group, or microbiological group\"\nand that \"[flor proficiency testing only, generic microbiological descriptions such as bacteria,\nmicrobacteria, fungus, and viral samples may be used.\"\n\n<<<PAGE 2>>>\n\nTherefore, a simulated patient specimen classified as a Category A infectious substance may\nbe shipped for the purpose of proficiency testing using a generic technical name that readily\nidentifies the microbiological group, without identifying the specific organism.\nI hope this satisfies your request.\nSincerely,\nrosta\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\n-\nBabich\n$173.134(6)3, 173.134 (a)s..\nDeputions\nDodd, Alice (PHMSA)\n15-0020\nSent:\nFrom:\nCiccarone, Michael CTR (PHMSA)\nWednesday, January 28, 2015 10:08 AM\nTo:\nHazmat Interps\nSubject:\nFW: Interpretation Letter Request\nShante/Alice,\nPlease submit this for a formal letter of interpretation.\nThanks,\nMike\nFrom: Gootee, Brian [mailto:Gooteebe@dhec.sc.gov]\nTo: PHMSA HM InfoCenter\nSent: Tuesday, January 27, 2015 5:02 PM\nSubject: Interpretation Letter Request\nWe are a Laboratory Response Network (LRN) lab required to access the hospitals within our state for their\nreadiness and ability to identify biological agents. We would like to provide a Proficiency Test exercise to\naccess their abilities. This would require sending the sentinel labs within our state simulated patient\nspecimens and asking them to identify the organism. The organisms provided would be select agent exempt\nstrains on culture media. Some of these organisms would normally be considered Category A as cultures only.\n173.134(a)3 and 173.134 (a)4 do not address simulated patient specimens. Sending these Category A would\nrequire identifying the organism on the shipper's declaration and defeat the purpose of the simulated patient\nspecimen being unknown to the sentinel lab. Can these simulated patient specimens be sent Category B.\nThank you.\nNo. select\nBrian Gootee, MPH\nSafety Officer\nAcint staias\nResponsible Official for Select Agents\nSouth Carolina Department of Health and Environmental Control (DHEC)\ntower Risk\nBureau of, Laboratories\n8231 Parklane Road\nColumbia, SC 29223\n803-896-0956 office\n803-767-8110 cell\n803-896-0983 fax\ngooteebe@dhec.sc.gov","truncated":false,"body_characters":4431}