{"operation":"document","citation":"99-0037","title":"Allegheny Airlines, Inc — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-03-24","effective_on":null,"summary":"99-0037 response to Allegheny Airlines, Inc concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0037.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0037.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0037","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990037.pdf","body":"<<<PAGE 1>>>\n\nU.S.Department\nof Transportation\n100 Seventh Street, S.\nVashinaton. D.C. 2059\nSpecial Programs\nResearch and\nAdministration\nMAR 2 4 1999\nMr. Wayne S. Lester\nReference No. 99-0037\nManager, Safety Programs\nAllegheny Airlines, Inc.\n1000 Rosedale Avenue\nMiddletown, PA 17057\nDear Mr. Lester:\nThis is in response to your recent letter concerning differences in the text accompanying the\nETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label in our DOT Chart 10 (1994) and\nDOT Chart 11 (1998), entitled \"Hazardous Materials Marking, Labeling & Placarding\nGuides.\" You asked if placing this label on a package in transportation indicates the package\n. contains a Division 6.2 (infectious substance) hazardous material.\nThe answer is yes. Under 49 CFR 173.134(a)(1) of the DOT Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180), a material meeting the definition of an etiologic agent in 42 CFR\n72.3 of the Department of Health and Human Services, Centers for Disease Control and\nPrevention (CDC) regulations also meets the definition of an infectious substance under the\nHMR. The ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label, depicted in 42 CFR\n72.3(d)(1), is required by CDC to be displayed on the outside of a package containing an etiologic\nagent. Such a package is also required to display the INFECTIOUS SUBSTANCE label depicted\nin 49 CFR 172.432, unless otherwise excepted. For example, under § 173.134(b), an etiologic\nagent that is a biological product or a diagnostic specimen is not subject to any of the\nrequirements in the HMR.\nYou also stated that sometimes your company is offered packages of donor organs for transport\nthat display the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label but do not display\nthe INFECTIOUS SUBSTANCE label. You asked if these shipments are subject to the HMR.\nShipment of a donor organ is not subject to the HMR unless the item as packaged contains a\nmaterial that is otherwise subject to regulation, such as \"Carbon dioxide, solid\" (dry ice). For\nquestions concerning the display of the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL\nlabel on such packages, I suggest you contact Jonathan Y. Richmond, PhD., Director, Office of\nHealth and Safety, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta,\nGA 30333, (404) 639-2453.\n\n<<<PAGE 2>>>\n\n\"\"\n•\nMack\n1240 NI\nAllegheny\n99-0037\nAirlines, Inc.\nWayne S. Lester\nMgr. Safety Programs\nMr. Edward Mazzullo\nDirector OHMS\n400 7h Street, SW\nU.S. Department of Transportation\nWashington, DC 20590\nRe:\nDOT Chart 10 Confusion\nDear Mr. Mazzullo:\nI am writing to ask for a written clarification on a placard, which appears in the DOT\nChart 10.\nI am told that there is a new DOT Chart 11 available and I have ordered these\ncharts, but in the meantime I need your assistance.\nThe DOT Chart 10 (dated February 1994) shows two labels under Class 6, Division 6.2.\nOne is the Infectious Substance label and the other is a Biomedical Material label.\n• The\nBiomedical Material label is the one giving our company trouble.\nOur Flight Training Department instructs our pilots on the carriage of hazardous\nmaterials using the DOT Chart 10. Because the Biomedical Material label appears on the\nchart with the Infectious Substance label, our pilots believe this label to be a hazardous\nmaterials label. We have explained that this is an OSHA label and the mere appearance\nof the Biomedical Material label (or the Biohazard label) on a package does not indicate\nthat the package is a hazardous material. This has not swayed the opinion of our flight\ncrews and they continue to reject the shipment of donor organs simply because of the\nBiomedical Material label. We have reviewed 49 CFR 173.134, where the regulation\ntalks about exceptions, however this does not satisfy our Flight Training Department\nconcerning the appearance of the Biomedical Material label on the DOT Chart 10\nIt would help us greatly if we could receive written confirmation from the DOT\nindicating that, although the Biomedical Material label does appear on the DOT Chart 10,\nthis label appearing by itself on a package does not constitute a hazardous material\nPlease reply to the attention of: Wayne Lester, Manager of Safety Programs, Allegheny\nAirlines, Inc., 1000 Rosedale Ave., Middletown, PA, 17057.\nYour help in dealing with this matter is greatly appreciated\nSincerely,\nNavne S. Leste\n\n<<<PAGE 3>>>\n\nInterpretation Letters\nRequester\nWayne S. Lester\nDate Received: 2/9/99\nCompany\nAllegheny Airlines, Inc.\nTracking Number: 99-0037\nPhone\n717-948-5411\nRevision Date: 2/9/99\nDate Assigned 2/9/99\nDate of Letter 2/9/99\nStaff\nMack\nFirst Draft Due: 3/2/99\nSection\n1240NI\nFirst Draft Date:\nSubject\nLabeling\nConcurrence\nStatus\nStatus Date\nSign Date\nSignor\nHBPE\nCopy to Docket\nCopy to DHM-60\nComment\nsir Alley deceit cornermat\nma normat\nconstitutte\nonuper.\n- Danororgans bood\nmail\nproducts-not\ninfections\nItut comes form lab it well\nhave osHA maro\n14 141 45°\n\n<<<PAGE 4>>>\n\nTELEPHONIC CONVERSATION RECORD\nSpecialist Placing Call: Eileen Mack\nROUTING\nDate of Call: 2/23/99, 9:45 a.m.\nSYMBOL\nINT\nPerson (s) Contacted: (1) Jerry Davis, Consumer\nSafety Officer; (2) Mary Ganikos, PhD., Chief,\nPublic and Professional Education Branch,\nTheir Organization: (1)Office of Compliance, Center\nfor Biologics Evaluation and Research, Food and\nDrug Administration, 1401 Rockville Pike, Suite 400\nSouth, Rockville, MD, 20852, (301) 827-6220, (2)\nDivision of Transplantation, Health Resources and\nServices Administration (HRSA), 5600 Fishers Lane,\nRockville, MD, 20857, (301) 443-7577\nDate of Incoming Letter: Re: Letter from Wayne\nLester, Allegheny Airlines, Inc., 100 Rosedale,\nAve., Middletown, PA 17057, (717) 948-5411, No date\n(Received 2/9/99)\nSpecific Subject (including section #'s and key\nwords): Are donor organs biological products? Does\nany agency within the Department of Health and\nHuman Services regulate the transport of donor\norgans?\nSummary: While preparing the response to Mr. Lester's letter on\nwhether donor organs with the ETIOLOGIC AGENTS--BIOMEDICAL\nMATERIAL label are regulated by DOT in transportation, the\nquestion came up as to whether donor organs were excepted from\nregulation as a biological product. Mr. Davis said the answer is\nno and that the FDA does not regulate donor organs. He referred\nme the HRSA. I spoke to Dr. Ganikos, who explained her agency was\nconcerned with organ procurement and information outreach but had\nno regulations regarding how they are to be transported. On\n2/22/98, I placed a call to Dr. Jonathan Richmond, Centers for\nDisease Control and Prevention, to learn if CDC has any\nregulations regarding donor organs. I am awaiting his response.\nComments for Further Action: Revise the draft to refer Mr. Lester\nto Jonathan Richmond and Jerry Davis. Include the recent phone\nreport. Forward the draft for concurrence and signature.\nSpecialist Signature:\nGiler Mack\nDate: 2/23/99\n\n<<<PAGE 5>>>\n\nTELEPHONIC CONVERSATION RECORD\nSpecialist Placing Call: Eileen Mack\nROUTING\nDate of Call: 2/18/99, 3:45 p.m.\nSYMBOL INT\nPerson (s) Contacted: Wayne Lester, Manager,\nSafety Programs\nTheir Organization: Allegheny Airlines, Inc.,\n1000 Rosedale Ave., Middletown, PA 17057,\n(717) 948-1910\nDate of Incoming Letter: No date (Received\n2/9/99)\nSpecific Subject (including section #'s and\nkey words): Is placing the ETIOLOGIC AGENTS-\nBIOMEDICAL MATERIAL label on a package an\nindication that this package contains a\nDivision 6.2 (infectious substance) material?\nSummary: Mr. Lester says Allegheny does not carry hazardous\nmaterials. They move company mail and donor organs.\nOccasionally, donor organs come in with the ETIOLOGIC\nAGENTS--BIOMEDICAL MATERIAL label and the pilots refuse to\ncarry them.\nWhen they consult the DOT Charts 10 and 11,\nshippers and carriers are confused as to whether the\nETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label belongs to OSHA\nor CDC and if the item is infectious or not. DOT Chart 10\nsays the label is from CDC's regulations. DOT Chart 11 says\nthe label is from OSHA's.\nI informed Mr. Lester that if the\nETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label is used, the\nitem is infectious. I also explained that the reference in\nDOT Chart 11 to OSHA regulations is incorrect. I explained\nthat OSHA's symbol is a trefoil with the words BIOHAZARD\nwritten underneath it. I also explained that it is used\nto\nexpress\nOSHA's universal precautions\nregulations, which\nprovide relief for materials containing human blood only\nwhen it is known they do not contain a blood borne pathogen.\nComments for Further Action: Forward the draft for\nconcurrence and signature.\nThe incoming letter is not\ndated, do not include a letter date in response.\nSpecialist Signature:\nGiler 6. Mack\nDate: 2/18/99\n\n<<<PAGE 6>>>\n\nDOT CHART 10\nTransportation\nU.S. Department of\nHazardous Materials Marking,\nResearch and\nSpecial Programs\nAdministration\nLabeling & Placarding Guide\nlerkeral mgulations\nRefer to 49 CFR, Part 172:\nMarking - Subpart D\nLabeling - Subpart E\nPlacarding - Subpart F\nEmergency Response - Subpart G\nNOTE:\n\n<<<PAGE 7>>>\n\nHazardous Materials Warning Labels\nCLASS 1\nExplosive\n1.1\nCLASS 1\nExplosive\n1.2\n1.4\nCLASS 1 Explosive\n1.5\nCLASS 1\nExplosive\n1.8\nCLASS 2\nDivision\n2.1\nCLASS 2\nDivision\n2.2\nCLASS 2\nDivision\n2.2\n1.3\nFLANIIABLE GAS\n< NON-FLAMILIABLE GAS?\nOXYGEN\n*Include appropriste\ncompatiblilty group latter.\ndivision number and\n*Include appropriate\ncompatiblilty group letter.\n*Include appropriate\ncompatibillty group letter.\n*Include appropriale\ncompatibillty group letter.\nFlammable gas\nNon-flammable gas\nOxygen\nCLASS 2\nDivision\n2.3\nCLASS 3\nCLASS 4\nCLASS 4\nDivision\n4.2\nCLASS 4\nDivision\n4.3\nCLASS 5\nDivision\n5.1\nCLASS 5\nDivision\n5.2\nPOISON GAS\n•FLAMMABLE LIQUID\nDANGEROUS\nOXIDIZER\nORGANIC PEROXIDE\nPoison gas\nFlammable liquid\nFlammable solld\nSpontansously Combuslible\nDangerous when wet\nOxidizer\nOrganic peroxide\nCLASS 6\nDivision\n6.1\nCLASS 6\nDivision\n6.1\nCLASS 6\nDivision\n6.2\nCLASS 7\nCLASS 7\n\"\nCLASS 7\nIlI\nPOISON\nHARMFUL\nSTOW AWAY\nINFECTOUS SUBSTANCE\nRADIOACTIVE I\nRADIOACTIVE II\nRADIOACTIYEMI\nPolson-Packing Group I and Il\nPolson-Packing III\nInfectious substance\nagent label may apply.\n42 CFR 72.3 Etiological\nCLASS 8\nCLASS 9\nSUBSIDIARY RISK LABELS\nFOR AIRCRAFT\nExplosive\nFlammable liquid\nFlammable gas\nCargo Aircraft Only\nCORROSIVE\nFlammable solid\nOxidizer\nCorrosive\nEMPTY\nPolson\nSpontaneously Combustible\nDangerous when wet\nMASTERIKED\nlabel (see Section 172.402).\nThe class number may not be displayed on a subsidiary\nCorrosive\nTRANSITION-2001\nTRANSITION-2001\nTRANSITION-2001\nTRANSITION-2001\nEmpty\nTRANSITION-2001\nTRANSITION-2001\nTRANSITION-2001\nCHLORINE\nFLAMMABLE SOLID\nIRRITANT\nINNER PACKAGES\nHAZARDOUS MATERIALS PACKAGE MARKINGS\nPRESCRIBED\nCOMPLY WITH\nCONSUMER COMMODITY\nSPECIFICATIONS\nDAPOKA\ni car hao bees\nORM-D\n§173.25(a)(4)\nMARINE POLLUTANT\nvita\n$172.322\nits or poison lesto, sia\nINHALATION\n§172.316(a)\nHAZARD\nCONSUMER COMMODITY\n11 11\nHOT\nORM-D-AIR\n§173.9\n$172.313(a)\n§172.312(a)\n$172.325\n§172.316(a)(1)\nKeep a copy of the DOT Emergency Response Guidebook handy!\n\n<<<PAGE 8>>>\n\nnazaraons Malerais Varking,\nSpecial Programs\nAdministration\nLabeling & Placarding Guide\n100\nregulati\nfeeleral\nRefer to 49 CFR, Part 172:\nMarking - Subpart D\nLabeling - Subpart E\nPlacarding - Subpart F\nEmergency Response - Subpart G\nNOTE:\n\n<<<PAGE 9>>>\n\nHazardous Materials Warning Labels\nCLASS 1\nExplosive\n1.1\nCLASS 1\nExplosiva\n55\n1.4\nCLASS 1\nExplosive\n1.5\nCLASS 1\nExplosive\n1.6\nCLASS 2\nDivision\n2.1\nCLASS 2\nDivision\n2.2\nCLASS 2\nDivision\n2.2\nFLAMMABLE GAS\nNON-FLAMMABLE GAS\nOXYGEN\ndivision number and\n*Include appropriate\ncompatibilty group letter.\n*Include appropriate\ncompatibllty group letter.\n*Include appropriate\ncompatiblty group letter.\n*Include appropriate\ncompatibility group letter.\nFlammable gas\nNon-flammable gas\nDxygen\nCLASS 2\nDivision\n2.3\nCLASS 3\nCLASS 4\nDivision\n4.1\nCLASS 4\nDivision\n4.2\nCLASS 4\nDivision\n4.3\nCLASS 5\nDivision\n5.1\nCLASS 5\nDivision\n5.2\nINHALATION\nHAZARD\nFLAMMABLE LIQUID\nDANGEROUS ™\nOXIDIZER\nORGANIC PEROXIDE\n2\n3\nPolson gas\nFlammable liquid\nFlammable solid\nSpontaneously Combustible\nDangerous when wet\nOxidizer\nOrganic peroxide\nCLASS 6\nDivision\n6.1\nCLASS 6\nDivision\n6.1\nCLASS 6\nDivision\n6.1\nCLASS 6\nDivision\n6.2\nCLASS 7\nCLASS 7\nINHALATION\nHAZARD\nPOISON\nHARMFUL\nNFECTIOUS SUBSTANCE\nHONCHCAL\nMATERIAL\nTOW AWA\nRADIOACTIVE T\nRADIOACTIVEN\nPOISON\nonly, Zone A or B.\nPoison-Inhalation Hazard\nmore of PG I or I!, other than\nPlacard 454 kg (1,001 ibs) or\n29 CFR 1910.1030 BIOHAZARD\nmarking may be used for\nZone A or B, inhalation hazard.\nPoison-PG III\nInfectious substance\nRagulated Medical Waste\nSUBSIDIARY RISK LABELS\n(RhW).\nRadioactive WHITE-I\nRadioactive YELLOW-II\nCLASS 7\nCLASS 8\nCLASS 9\nFOR AIRCRAFT\nFlammable gas\nExplosive\nFlammable solld\nFlammable guid\nRADIOACTIVE MI\nCORROSIVE\nOxidizer\nCorrosiva\nEMPTY\nMATERIE\nPoison\nDangerous when wet\nSpontaneously Combustible\nCargo Aircraft Only\nRadioactive YELLOW-HII\nTRANSITION-2001\nCorrosive\nTRANSITION-2001\nMiscellaneous\nhe class number may not be displayed on a subsidia\nTRANSITION-2001\nbel (see Section 172.402\nTRANSITION-2001\nTRANSITION 2001\nEmpty-Radloactive\nTRANSITION-2001\nFLAMMABLE SOLID\nIRRITANT\nHAZARDOUS MATERIALS MARKINGS\nINNER PACKAGES\nPRESCRIBED\nCOMPLY WITH\nCONSUMER COMMODITY\nSPECIFICATIONS\nDANGER\nORM-D\n§173.25(a)(4)\nMARINE POLLUTANT\n§172.322\nINHALATION\n§172.316(a)\nPIES ON\nHAZARD\nCONSUMER COMMODITY\n11 11\nHOT\nDO NOT ENTER\nORM-D-AIR\n$172.302(g) and §173.9\n§172.312(a)\n§172.325\n8172.313(a)\n§172.316(a)(1)\nKeep a copy of the North American Emergency Respons\n\n<<<PAGE 10>>>\n\n- Bloodbonie pathogens. - 1910.1030\n• '\n•\nhttp://www.osha-slc.gov/OshStd_data/1910_1030.html\nOSHA\nDacupatist Satcty is Health Administration\n15. Orparturot of Laloes\nOSHA Regulations (Standards - 29 CFR)\nBloodborne pathogens. - 1910.1030\n• OSHA Regulations (Standards - 29 CFR) - Table of Contents\n• Standard Title: Bloodborne pathogens.\n• Standard Number: 1910.1030\n• SubPart Number: Z\n• SubPart Title: Toxic and Hazardous Substances\nInterpretation(s)\n(a)\ninfectious materials as defined by paragraph (b) of this section.\nScope and Application. This section applies to all occupational exposure to blood or other potentially\n(b)\nDefinitions. For purposes of this section, the following shall apply:\n\"signated representatives the Assistant Secretary of Labor for Occupational Safety and Health, or\n\"Blood\" means human blood, human blood components, and products made from human blood.\ncause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV)\n\"Bloodborne Pathogens\" means pathogenic microorganisms that are present in human blood and can\nand human immunodeficiency virus (HIV).\n\"Clinical Laboratory\" means a workplace where diagnostic or other screening procedures are\nperformed on blood or other potentially infectious materials.\n\"Contaminated\" means the presence or the reasonably anticipated presence of blood or other\npotentially infectious materials on an item or surface.\n\"Contaminated Laundry\" means laundry which has been soiled with blood or other potentially\ninfectious materials or may contain sharps.\n\"Contaminated Sharps\" means any contaminated object that can penetrate the skin including, but not\nlimited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.\n\"Decontamination\" means the use of physical or chemical means to remove, inactivate, or destroy\ntransmitting infectious particles and the surface or item is rendered safe for handling, use, or\nbloodborne pathogens on a surface or item to the point where they are no longer capable of\ndisposal.\n1 of 25\n2/17/1999 8:39 AM\n\n<<<PAGE 11>>>\n\nhttp://www.osha-slc.gov/OshStd_gif/10ZBHSC.gif\nBIOHAZARD\n1 of 1\n2/17/1999 8:39 AM","truncated":false,"body_characters":15600}