{"operation":"document","citation":"09-0102","title":"Inmark, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-05-05","effective_on":null,"summary":"09-0102 response to Inmark, Inc. concerning 173.196, 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0102.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0102.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0102","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2009/090102.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave.. SE\nWashington, DC 20590\nMr. Junius Johnson\nRegulatory Compliance Manager\nInrnark, Inc.\n675 Hartman Road, Suite 100\nAustell, GA 30168\nMAY 5 2009\nReference No. 09-01 02\nDear Mr. Johnson:\nThis is in response to your April 29, and April 30,2009 e-mails asking for clarification of the\nclassification and packaging requirements for the swine flu virus under the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 1 7 1 - 1 80). Specifically, you ask if the swine flu\nvirus must be classed as a Category A infectious substance during a pandemic. You also ask\nif a specimen, regardless of whether or not it is infectious, must be classed as a Category A\ninfectious substance if it is collected fiom a region where a pandemic is occurring.\nBased on information we received from the Centers for Disease Control and Prevention\n(CDC) and the World Health Organization (WHO), it is our understanding that human and\nanimal specimen samples known or suspected of containing the swine flu virus or a Category\nB infectious substance must be transported under the proper shipping description \"UN 3373,\nBiological substance, Category B, 6.2.\" Such samples must be transported in conformance\nwith the requirements prescribed in § 173.199 of the HMR. Cultures of the swine flu virus,\ncultures of certain other Category B infectious substances, and Category A infectious\nsubstances must be transported under the shipping description \"UN 2814, Infectious\nsubstances, affecting humans, 6.2,\" or \"UN 2900, Infectious substances, affecting animals,\n6.2,\" as appropriate. Swine flu cultures must be transported in conformance with the\nrequirements prescribed in 8 173.196.\nNote that for purposes of the HMR a culture is defined as an infectious substance containing\na pathogen that has been intentionally propagated. The term does not include patient\nspecimens collected directly from humans or animals and transported for diagnosis, research,\nor investigational purposes. Please see the definitions in 8 173.1 34.\nI hope this satisfies your request. Please feel free to contact me if you have questions or\nneed additional information.\nSincerely,\nSusan Gorsky d\nRegulations Officer\nOffice of Hazardous Materials Standards\n\n<<>>\n\nPage 1 of 1\nDrakeford, Carolyn CPHM\n. -\" .... . -\" . .\nFrom: Edmonson, Eileen \nSent: Thursday, April 30, 2009 6:37 PM\nTo: Drakeford, Carolyn \nSubject: Please give this letter a reference no. & assign it to me\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Wednesday, April 29, 2009 5:15 PM\nTo: Gorsky, Susan \nCc: Willke, Ted ; Frank Orvino\nSubject: Classification of human biologic samples during a pandemic\nSusan,\nThanks for your help in addressing this immediate concern to the transport of clinical samples during a pandemic.\nWe are getting calls from pharmaceutical companies and laboratories concerned about human samples coming\nout of Central America (Mexico to be specific) as the Swine Flu worsens there. Sources are now saying that if a\npandemic is declared, then all biologics coming out of the area would be classified as Infectious Substance,\nCategory A (UN2814). I need something in writing to provide guidance to clinics and carriers on what is the\ncurrent classification for human body fluids with Swine Flu (currently they are classified as Biological Substance,\nCategory B (UN3373)) and if this classification changes when a pandemic is declared. More importantly, would\nall biologic samples from a region (known infected or not known to be infected) change if a pandemic is declared\nin a region?\nThanks for your help during this global outbreak,\nJay\nJunius Johnson,\nRegulatory Compliance Manager\nlnmark Inc.\nAustell, GA 30168\ndirect: 770.373.3356 i fax: 770.373.3357\n. . ~ . i n m a r k i n c . c o m www.inmarkinc.com\n\n<<>>\n\nPage 1 of 1\nDrakeford, Carolyn \nFrom: Edmonson, Eileen \nSent: Thursday, April 30, 2009 6.37 PM\nTo : Drakeford, Carolyn cPHMSA>\nSubject: Please give this letter a reference no. & assign it to me\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Thursday, April 30, 2009 10:29 AM\nTo: Gorsky, Susan \nCc: Willke, Ted ; Frank Orvino\nSubject: RE: Classification of human biologic samples during a pandemic\nGood Morning Susan,\nThanks for getting back to me so quickly with this. Having something in writing from you will go a long way in\nsecuring that clinical trial samples continue to move in a timely manner during this crisis.\nThere are numerous clinical and safety samples that move from hospitals to labs every day which have nothing to\ndo with swine flu. However, the concern is that since they are coming from a region where the flu is present then\nthey may now be stopped or reclassified as a Category A and the patient's lives could be put in jeopardy from the\ndelay.\nThanks for your help,\nJay\nJunius Johnson,\nRegulatory Compliance Manager\nlnmark Inc.\nAustell, GA 30168\ndirect: 770.373.3356 1 fax: 770.373.3357\nj.ayi@n.m.a_rk/l?_c.com w-,h_nma.rki.n.c..co.m\nFrom: susan.gorsky@dot.gov [mailto:susan.gorsky@dot.gov]\nSent: Thursday, April 30, 2009 7:50 AM\nTo: Jay Johnson\nCc: Ted.Willke@dot.gov; Frank Orvino\nSubject: RE: Classification of human biologic samples during a pandemic\nJay,\nIt is our understanding, based on information forwarded from IATA, that the World Health Organization is advising\nhealth authorities to ship specimens taken from humans or animals that are suspected to contain the swine flu\nvirus under the shipping description \"UN 3373, Biological Substance, Category B, 6.2.\" Such samples must be\ntransported in accordance with the requirements in 5 173.199 of the HMR. WHO advises health authorities to\nship cultures of the swine flu virus under the shipping description \"UN 2814, Infectious substances affecting\nhumans, 6.2.\" Swine flu cultures must be transported in accordance with the requirements in 5 173.196. We plan\nto confirm this information with CDC this morning and to ask if CDC expects this transportation advice to change if\na pandemic is declared. I will let you know what CDC tells us. Once we hear from CDC, I can put this information\nin a formal letter if that would be helpful.\nSusan","truncated":false,"body_characters":6279}