{"operation":"document","citation":"09-0065","title":"ACM Global Central Laboratory — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-10-30","effective_on":null,"summary":"09-0065 response to ACM Global Central Laboratory concerning 173.134, 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0065.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0065.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0065","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090065.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Ave, SE\nWashington, D.C. 20590\nPipeline and Hazardous Materials\nSafety Administration\nOCT 30 2009\nMs. Lisa Fotheringham\nDirector, Clinical Trials Support Operations\nACM Global Central Laboratory\n160 Elmgrove Park\nRochester, NY 14624\nReference No. 09-0065\nDear Ms. Fotheringham:\nThis is in response to your March 15, 2009 letter concerning how to class and mark patient\nmedical specimens under the Hazardous Materials Regulations (HMR; 49 CFR Part 171-180).\nAccording to your letter, some ofthe samples are analyzed as part of a clinical study and\nsome will be offered for transportation by aircraft. We have paraphrased your questions and\nanswered them in the order you provided.\nQl. In a clinical study for diabetes, human immunodeficiency virus (HIV) testing is needed at\nthe screening visit only to determine inclusion/exclusion criteria for a patient prior to entry\ninto the study. Screening specimens obtained from this study's patients are being sent by\naircraft for HIV testing. Should these specimens be classed and marked as a Category B\ninfectious substance, utilize packaging prescribed in § 173.199, and be marked with the\n\"UN 3373\" identification number as prescribed in § 173.199(a)(5)?\nA 1. Yes. A human or animal specimen transported for routine testing to determine whether or\nnot the sample contains an infectious substance is subject to the HMR and must be transported\nas a \"UN 3373, Biological substance, Category B\" infectious substance in accordance with\nthe requirements prescribed in § 173.199. Please note, for liquid Category B shipments by\naircraft, (1) the primary receptacle or the secondary packaging must be capable of\nwithstanding without leakage an internal pressure producing a pressure differential ofnot less\nthan 95 kPa (0.95 bar, 14 psi); (2) the maximum quantity contained in each primary\nreceptacle, including any material used to stabilize or prevent degradation ofthe sample, may\nnot exceed 1 L (34 ounces)~ and (3) the maximum quantity contained in each outer packaging,\nincluding any material used to stabilize or prevent degradation ofthe samples, may not exceed\n4 L (l gallon). This outer packaging limitation does not include the weight of ice, dry ice, or\nliquid nitrogen when used to maintain the integrity ofthe material. See § 173 . 199(b )( 4) and\n(b)(5). Most domestic air carriers prefer shippers use the international requirements for\ntransporting hazardous materials by aircraft that are prescribed in the International Civil\nAviation Organization (ICAO) Technical Instructions for the Safe Transport ofDangerous\nGoods by Air, so your company should be aware ofthese requirements as well. Under the\n\n<<<PAGE 2>>>\n\nprovisions of §§ 171.22-171.24, the HMR give shippers and carriers the option of preparing\nshipments of hazardous materials offered or intended for transportation by aircraft in\nconformance with these instructions.\nQ2. For specimens obtained from patients in a clinical study where the required patients are\nfrom a high-risk patient population (i.e., history of HIV or hepatitis), should specimens being\nsent by aircraft for testing always be sent as a Category B infectious substance in packagings\nprescribed in § 173.199 and marked with the \"UN 3373\" identification number as prescribed\nin § 173. 1 99(a)(5), or would this be a violation of § I 72.303(a), which prohibits marking a\npackage as containing a hazardous material unless it contains the identified material or its\nresidue?\nA2. See answer AI. Human or animal specimens transported for routine testing to determine\nwhether or not the samples contain an infectious substance are subject to the HMR. Note that\nthe definition for a Division 6.2 material is a material that is known or reasonably expected to\ncontain a pathogen. Therefore, marking a package containing a specimen that you reasonably\nexpect contains a pathogen with the UN 3373 identification number would not be a violation\nof the prohibited marking requirements prescribed in § 172.303(a). In addition, the HMR\npermit materials for which the hazard class is uncertain and must be determined by testing to\nbe assigned a tentative proper shipping name, hazard class, identification number, and\npacking group, if applicable, by the shipper based on his or her tentative determination, and\ntransported for testing in conformance with § 172.101 (c)( 11). Thus, marking the package as\nmeeting the Division 6.2 hazardous class in this instance would not violate § 173.199 or\n§ 172.303(a).\nQ3. In accordance with § 173.134(a)(3) and (a)(4), do diagnostic cultures for Herpes B need\nto be treated as a Category A infectious substance?\nA3. No. Under § 173.134(a)(3), a \"culture,\" defined as an infectious substance containing a\npathogen that has been intentionally propagated, does not include a \"patient specimen,\" as\ndefined in § 173. 134(a)(3), that is collected directly from humans or animals and transported\nfor research, diagnosis, investigational activities, or disease treatment or prevention.\nQ4. For batched shipments containing numerous different patient specimens shipped from a\nstorage laboratory facility to another laboratory facility with no knowledge ofthe patients\nfrom whom the specimens were obtained, is it a violation of § 172.303(a) to mark these\npackages as a UN 3373 Category B infectious substance?\nA4. See answer A2. If you tentatively determine that the patient specimens meet the\ndefinition in § 173.134(a)(1)(ii) for a Category B infectious substance, the specimens must be\npackaged in conformance with the requirements prescribed in § 173.199, and the proper\nshipping name \"Biological substances, Category B\" must be marked on the outside ofthe\npackage along with the \"UN 3373\" diamond-shaped mark in letters that are at least 6 mm\n(0.24 inches) high. See § 173.199(a)(5).\n2\n\n<<<PAGE 3>>>\n\nQ5. Ifthe personnel shipping the package from a clinical site have no direct knowledge of\nwhether or not the specimens contain pathogens, is it a violation of § 172.303(a) to mark these\npackages as a UN 3373 Category B infectious substance?\nA5. No. See answers A2 and A4.\nQ6. Does the decision to mark a package as a Category B infectious substance or as an\nexempt human specimen need to be made on an individual specimen or shipment basis, or\nmay it be made for a clinical study where the study sponsor medical personnel provide the\nprofessional judgment based on the included patient population?\nA6. The classification decision for these samples may be made on an individual specimen,\nshipment, or study-wide basis with the professional medical judgment of the person\ndetermining the hazard classification and his or her knowledge of the hazards contained in the\nspecimens. It is the shipper's responsibility to class and describe a hazardous material (see\n§ 173.22). The employees determining the hazard class ofthese specimens are considered\nhazmat employees, as defined in § 171.8, and must be trained and tested by their hazmat\nemployers in accordance with Subpart H of Part 172, and receive in-depth security training, if\napplicable, in accordance with Subpart I ofPart 172.\nI hope this satisfies your request.\nSincerely,\n!=ZlOo/~\nDirector, Office of Hazardous\nMaterials Standards\n3\n\n<<<PAGE 4>>>\n\ntdW/O()SO 1/1\nts 1'72 ·303\nE3r73· t'3tt\nMar/lln!)\nMarch 15, 2009 OQ-OOb 6\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration\n1200 New Jersey Avenue, SE, PHH-50\nWashington, DC 0590-0001\nTo Whom It May Concern:\nI am writing to request written clarification regarding the following shipping situations:\n1. 2. 3. 4. 5. 6. In a clinical study for Diabetes, HIV testing is needed at the Screening Visit only to\ndetermine inclusion/exclusion criteria for a patient prior to entry into the study. Screening\nspecimens obtained from this study's patients are being sent via air for HIV testing. Should\nthese specimens be marked as Category B utilizing packaging marked UN 3373, or is this a\nviolation of 49 CFR, 172.303 (a)?\nFor specimens obtained from patients in a clinical study where the required patients are from\na high risk patient population (i.e. history of HIV or Hepatitis), should specimens being sent\nvia air always be sent as Category B utilizing the packaging marked UN 3373, or is this a\nviolation of 49 CFR, 172.303 (a)?\nIn accordance with 49 CFR 173.134( a)(3 and 4), do diagnostic cultures for Herpes B need to\nbe treated as Category A Biologicals?\nFor batched shipments containing numerous different patients' specimens shipped from a\nstorage laboratory facility to another laboratory facility with no knowledge of the patients\nfrom whom the specimens were obtained, is it in violation of 49 CFR, 172.303 (a) to mark\nthese Category B, UN 3373?\nIfthe personnel shipping the package from a clinical site have no direct knowledge of\nwhether or not the specimens contain pathogens, is it in violation of 49 CFR, 172.303 (a) to\nmark these Category B, UN 3373?\nDoes the decision to mark a package as a Category B biological or an Exempt human\nspecimen need to be made on an individual specimen or shipment basis, or can it be made for\na clinical study where the study sponsor medical personnel provides the professional\njudgment based on the included patient population?\nThank you for the opportunity to submit this request for interpretation and I look forward to your\nresponse. I can be reached at 585-429-1961.\nRegards,\nLisa Fotheringham\nDirector, Clinical Trials Support Operations\nACM Global Central Laboratory\nUS: 160 Elmgrove Park' Rochester, New York 14624 tel: 1 8005255227 fax: 5854291917\nEurope: Aviator Court' Clifton Moorgate, York, Y030 4UZ, UK tel: +44 (0) 1904699400 fax: +44 (0) 1904699401","truncated":false,"body_characters":9724}