{"operation":"document","citation":"PHMSA Guidance, Transporting Infectious Substances Safely","title":"Transporting Infectious Substances Safely","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2022-06-10","effective_on":"2022-06-10","summary":"Transporting Infectious Substances Safely Document Transporting-Infectious-Substances-Safely-Phh50-0186-0622.pdf (1.34 MB) This brochure describes the USDOT regulations for the classification criteria and packaging requirements for the transportation of infectious substances, 49 CFR, Parts 171-180. Issued Date: Friday, June 10, 2022","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-guidance-transporting-infectious-substances-safely-0a34ac90.json","markdown":"https://regulus.evalyn.ai/document/phmsa-guidance-transporting-infectious-substances-safely-0a34ac90.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-guidance-transporting-infectious-substances-safely-0a34ac90","source_url":"https://www.phmsa.dot.gov/training/hazmat/transporting-infectious-substances-safely","body":"Transporting Infectious Substances Safely\n\nDocument\n\n Transporting-Infectious-Substances-Safely-Phh50-0186-0622.pdf (1.34 MB)\n\n        This brochure describes the USDOT regulations for the classification criteria and packaging requirements for the transportation of infectious substances, 49 CFR, Parts 171-180.\n\n          Issued Date: Friday, June 10, 2022\n\n<<<PAGE 1>>>\n\nTRANSPORTING INFECTIOUS\nSUBSTANCES SAFELY\nWWW.PHMSA.DOT.GOV\n\n<<<PAGE 2>>>\n\nNOTICE\nThis publication was prepared as a training aid in the proper use\nof the Hazardous Materials Regulations (HMR) and should not\nbe used to determine compliance with 49 CFR, Parts 100-185.\nThis guidance does not have the force and effect of law\nand is not meant to bind the regulated entities in any way.\n\n<<<PAGE 3>>>\n\nTABLE OF CONTENTS\nINTRODUCTION\nCLASSIFICATION SYSTEM\nCATEGORY A AND CATEGORY B\nCLASSIFICATION PROCESS\nCLASSIFICATION SCENARIOS\nREQUIREMENTS FOR SHIPMENTS\nPACKING, MARKING AND LABELING OF\nCATEGORY A INFECTIOUS SUBSTANCES\nPACKING AND MARKING OF\nCATEGORY B INFECTIOUS SUBSTANCES\nREGULATED MEDICAL WASTE\nPACKING, MARKING AND LABELING\nCLASSIFICATION SCENARIO\nPRIVATE OR CONTRACT CARRIERS\nEXCEPTIONS\nEXCEPTIONS FOR CERTAIN AIR SHIPMENTS\nMATERIALS OF TRADE\nOTHER EXCEPTIONS\nOTHER REQUIREMENTS\nCARRIAGE BY AIRCRAFT\nINCIDENT REPORTING\nTRAINING REQUIREMENTS\nSECURITY PLANS\nEXAMPLES OF CATEGORY A: UN2814,\nINFECTIOUS SUBSTANCES AFFECTING HUMANS\nEXAMPLES OF CATEGORY A: UN2900,\nINFECTIOUS SUBSTANCES AFFECTING ANIMALS\nDEFINITIONS\n3\n3\n4\n5\n6\n8\n10\n12\n13\n13\n14\n14\n14\n15\n15\n15\n15\n16\n18\n20\n\n<<<PAGE 4>>>\n\n\n\n<<<PAGE 5>>>\n\nINTRODUCTION\nWHY ARE INFECTIOUS SUBSTANCES REGULATED IN\nTRANSPORTATION?\nAn infectious substance is regulated as a hazardous material under\nthe U.S. Department of Transportation (DOT) Hazardous Materials\nRegulations (HMR), 49 CFR Parts 171-180. The HMR apply to any\nmaterial DOT determines is capable of posing an unreasonable risk\nto health, safety, and property when transported in commerce. An\ninfectious substance must conform to all applicable HMR requirements\nwhen transported or offered for transportation by air, highway, rail,\nor water.\nThe Pipeline and Hazardous Materials Safety Administration (PHMSA)\nupdated these requirements in a final rule on June 1, 2006. In that\nfinal rule, the HMR established a two-tiered classification system for\ninfectious substances—Category A and Category B.\nCLASSIFICATION SYSTEM\nThe classification criteria and packaging requirements for the\ntransportation of infectious substances are consistent with international\nstandards. The harmonization of these standards ensure an acceptable\nlevel of safety for transporting infectious substances and facilitate their\ndomestic and international transportation.\nThe Category A and Category B classifications are based on criteria\ndeveloped by the UN Committee of Experts working with the World\nHealth Organization (WHO), the U.S. Centers for Disease Control and\nPrevention (CDC), medical professionals, microbiologists, transportation\nprofessionals, and packaging technical experts. They are consistent with\nthe requirements contained in the United Nations Recommendations\nfor the Transport of Dangerous Goods (UN Recommendations), the\nInternational Civil Aviation Organization Technical Instructions\nfor the Safe Transport of Dangerous Goods by Air (ICAO Technical\nInstructions), and the International Maritime Organization (IMO)\nInternational Maritime Dangerous Goods (IMDG) Code.\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n3\n\n<<<PAGE 6>>>\n\nCATEGORY A AND CATEGORY B\nDIVISION 6.2 INFECTIOUS SUBSTANCE\nA Division 6.2 infectious substance is a material known or reasonably\nexpected to contain a pathogen. A pathogen is a micro-organism\n(including bacteria, viruses, rickettsia, parasites, fungi) or other agent,\nsuch as a proteinaceous infectious particle (prion), that can cause\ndisease in humans or animals.\nCATEGORY A\nCategory A classifies an infectious substance as in a form capable of\ncausing permanent disability or life-threatening or fatal disease in\notherwise healthy humans or animals when exposure to it occurs. An\nexposure occurs when an infectious substance is released outside of its\nprotective packaging, which may result in physical contact with humans\nor animals. Classification must be based on the known medical history\nor symptoms of the source patient or animal, endemic local conditions,\nor professional judgment concerning the individual circumstances of\nthe source human or animal. Category A poses a higher health risk than\nCategory B.\nPROPER SHIPPING NAMES AND IDENTIFICATION NUMBERS:\nUN2814, Infectious substances, affecting humans\nUN2900, Infectious substances, affecting animals\nCATEGORY B\nCategory B classifies an infectious substance as not in a form generally\ncapable of causing permanent disability or life-threatening or fatal\ndisease in otherwise healthy humans or animals when exposure to it\noccurs. This includes infectious substances transported for diagnostic or\ninvestigational purposes.\nPROPER SHIPPING NAME AND IDENTIFICATION NUMBER:\nUN3373, Biological substances, Category B\nFor information on Regulated Medical Waste see page 12.\nDivision 6.2 materials that are excepted from the regulations can be found in §173.134(b).\n4\n\n<<<PAGE 7>>>\n\nCLASSIFICATION PROCESS\nSUBSTANCE FOR CLASSIFICATION\nSection 173.134(b) of the HMR contains a list of scenario-based\nexceptions in which some materials are not subject to the requirements\nfor Division 6.2 infectious substances. If a material meets all the\nconditions of any scenario, it is not regulated.\nThe flowchart below provides a process that can be helpful when\ndetermining if a material is infectious and/or eligible for any exceptions\nfrom the requirements. It is important to first determine if the material\nis known or reasonably expected to contain an infectious pathogen. If it\ndoes not contain an infectious pathogen, it is not regulated. However, a\nmaterial that meets the definition of a Category A infectious substance\nwill not be eligible for any exceptions.\nAlways review §173.134(b) to carefully determine if a material meets\nany of the conditional exceptions. The classification scenarios on the\nfollowing pages provide examples of possible ways to move through a\nclassification process.\nIs the material known or reasonably expected to contain an infectious pathogen?\nNO\nYES\nDoes it meet the definition of a Category A infectious substance?\nNO YES\nDoes it meet any of the conditions listed in §173.134(b)?\nYES NO\nNot subject to the\nrequirements of\nDivision 6.2 materials\nUN3373, Biological\nSubstances, Category B\nUN2814,\nInfectious Substances,\naffecting humans; or\nUN2900,\nInfectious Substances,\naffecting animals\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n5\n\n<<<PAGE 8>>>\n\nCLASSIFICATION SCENARIOS\nSCENARIO 1\nAPPROPRIATE CLASSIFICATION\nUN2814, Infectious Substances, affecting humans\nA blood sample known or\nreasonably suspected to contain\nEBOLA VIRUS\nDoes it meet the definition of\na Category A substance?\nYES\nUN2814, Infectious\nSubstances, affecting humans\nSCENARIO 2\nAPPROPRIATE CLASSIFICATION\nUN2900, Infectious Substances, affecting animals\nA culture of\nFOOT AND MOUTH DISEASE\nDoes it meet the definition of\na Category A substance?\nYES\nUN2900, Infectious\nSubstances, affecting animals\n6\n\n<<<PAGE 9>>>\n\nSCENARIO 3\nAPPROPRIATE CLASSIFICATION\nUN3373, Biological Substances, Category B\nA blood sample taken from a\npatient known or suspected to\nhave a Category B pathogen,\nsuch as HEPATITIS B or HIV\nDoes it meet the definition of\na Category A substance?\nNO\nIs it a patient sample transported by private or contract carrier\nin a motor vehicle used exclusively for these materials?\n(See §173.134(b)(10))\nYES\nNO\nNot subject to the requirements of\nDivision 6.2 materials\nUN3373, Biological Substances,\nCategory B\nSCENARIO 4\nAPPROPRIATE CLASSIFICATION\nNot subject to the Hazardous Materials Regulations\nA BLOOD SAMPLE\ncollected for routine testing\nDoes it meet the requirements\nof §173.134(b)(11)?\nYES\nNot subject to the requirements\nof Division 6.2 materials\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n7\n\n<<<PAGE 10>>>\n\nREQUIREMENTS FOR SHIPMENTS\nPACKING, MARKING AND LABELING OF\nCATEGORY A INFECTIOUS SUBSTANCES\nRequirements for packagings of Category A infectious substances are\nfound in §173.196, and must:\n•\nmeet the test standards of §178.609.\n•\nbe a triple packaging consisting of:\n-\n\u0003 primary leakproof receptacle,\n-\n\u0003 leakproof secondary packaging, and\n-\n\u0003 rigid outer packaging.\n•\nbe marked with a UN package certification mark on the outer\npackaging in conformance with §178.503(f).\nSAMPLE OF UN PACKAGE CERTIFICATION MARK\nInfectious Substance\nDivision\nSymbol United Nations\nPackage Code\nYear of\nManufacture\nu\nn\n4G/CLASS 6.2/06\nUSA/0000\nCountry\nTest Facility's/ Manufacturer's Code\nINFECTIOUS SUBSTANCE LABEL\n8\n\n<<<PAGE 11>>>\n\nDIAGRAM OF CATEGORY A PACKAGE\nLeak Proof Primary Receptacle\n(Glass, Metal, or Plastic) Infectious Substance\nAbsorbent Packing Material\n(For Liquids)\nLeakproof Secondary\nPackaging\nCap\nList of Contents\nRigid Outer Packaging\nInfectious Substance\nLabel\nProper Shipping Name\nand UN Number\nu\nn\n4G / CLAS USA/0000\nS 6.2/ 1 6\nUN Package\nCertification Mark\nShipper or\nConsignee\nCertification\nCROSS SECTION OF CLOSED PACKAGE\nLeakproof\nSecondary\nPackaging\nRigid Outer\nPackaging\nClosure Requires\nPositive Means\nof Ensuring\nLeakproof Seal\nInfectious\nSubstance\nAbsorbent\nPacking Material\nNotes: At least one surface of the outer packaging must have a minimum dimension of\n100 mm x 100 mm (3.9 inches). For liquid shipments by aircraft, the primary receptacle\nor the secondary packaging must be capable of withstanding without leakage an internal\npressure producing a pressure differential of not less than 95 kPa. If multiple fragile\nprimary receptacles are placed in a single secondary packaging, they must be either\nindividually wrapped or separated to prevent contact. Follow the package manufacturer’s\nclosure instructions.\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n9\n\n<<<PAGE 12>>>\n\nPACKING AND MARKING OF\nCATEGORY B INFECTIOUS SUBSTANCES\nCategory B infectious substances are excepted from all other\nrequirements of the HMR when transported in accordance with the\nrequirements of §173.199.\nPacking of Category B infectious substances requires marking the outer\npackage, adjacent to proper shipping name, with “Biological substances,\nCategory B\" and the UN3373 package marking.\nUN3373 PACKAGE MARKING\nThe proper shipping names “Clinical Specimen” and “Diagnostic\nSpecimen” were previously authorized until December 31, 2006. Since\nJanuary 1, 2007, only the proper shipping name “Biological substances,\nCategory B” is authorized for use.\nSection 173.199 has additional requirements and limitations for\nhazardous materials in other hazard classes, such as dry ice and\nflammable liquids. Refer to §173.199 for all requirements when shipping\nCategory B infectious substances.\n10\n\n<<<PAGE 13>>>\n\nDIAGRAM OF CATEGORY B PACKAGE\nPrimary Receptacle\nLeakproof or Siftproof\nSecondary Packaging\nLeakproof or Siftproof\n(e.g. Sealed Plastic Bag)\nInfectious Substance\nAbsorbent Packing\nMaterial (For Liquids)\nRigid Outer\nPackaging\nBiological\nSu bstanc e\nCategory B*\nUN 337 3\nPackage Marking\nName and Telephone\nNumber of a Person\nResponsible.\n(This Information\nMay Instead be Provided\non a Written Document\nSuch as an Air Waybill)\nCROSS SECTION OF CLOSED PACKAGE\nRigid Outer\nPackaging\nCushioning\nMaterial\nPrimary Receptacle\nLeakproof or Siftproof\nSecondary Packaging\nLeakproof or Siftproof\n(e.g. Sealed Plastic Bag\nor Other Intermediate\nPackaging)\nAbsorbent\nMaterial\nNotes: At least one surface of the outer packaging must have a minimum dimension of\n100 mm x 100 mm (3.9 inches). For liquid shipments by aircraft, the primary receptacle\nor the secondary packaging must be capable of withstanding without leakage an internal\npressure producing a pressure differential of not less than 95 kPa. If multiple fragile\nprimary receptacles are placed in a single secondary packaging, they must be either\nindividually wrapped or separated to prevent contact. Follow the package manufacturer’s\nclosure instructions.\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n11\n\n<<<PAGE 14>>>\n\nREGULATED MEDICAL WASTE\nPACKING, MARKING AND LABELING\nPackaging requirements for regulated medical waste, including detailed\ninner packaging requirements for each type, can be found in §173.197\nand must be marked and labeled in one of the following methods:\n•\nNon-bulk Packagings (<119 gallons) – UN standard packaging\nconforming to the requirements of Part 178 of the HMR at the\nPacking Group II performance level.\n- Non-bulk packages must be marked and labeled with the\nUN ID number, proper shipping name, infectious substance\nlabel, and consignee's or consignor's name and address.\n•\nLarge Packagings (>119 gallons) – Constructed, tested, and\nmarked in accordance with subparts P and Q of Part 178.\n- Large packages must be marked with the UN ID number and\nBIOHAZARD marking conforming to 29 CFR 1910.1030.\n•\nNon-specification Bulk Packaging (>119 gallons) – includes\nwheeled carts or other bulk outer packaging.\n- Bulk packages must be marked with the UN ID number and\nBIOHAZARD marking conforming to 29 CFR 1910.1030.\nPROPER SHIPPING NAMES AND IDENTIFICATION NUMBERS:\nUN3291, Regulated medical waste, n.o.s.\nClinical waste, unspecified, n.o.s.\n(BIO) Medical waste, n.o.s.\nBiomedical waste, n.o.s.\nMedical waste, n.o.s.\n12\n\n<<<PAGE 15>>>\n\nCLASSIFICATION SCENARIO\nA waste material that contains a Category A infectious substance must\nbe classified as a Category A infectious substance. The flowchart below\nprovides a process to determine if a material is a regulated medical\nwaste or a Category A infectious substance.\nDoes the waste, or reusable material derived from the medical treatment of an animal\nor human, contain a Category A infectious substance?\nYES NO\nUN2814, Infectious substances, affecting\nhumans; or\nUN2900, Infectious substances, affecting\nanimals\nUN3291, Regulated medical waste, n.o.s.;\nClinical waste, unspecified, n.o.s.;\n(BIO) Medical waste, n.o.s.;\nBiomedical waste, n.o.s.; or\nMedical waste, n.o.s.\nBIOHAZARD MARKING\nPRIVATE OR CONTRACT CARRIERS\nRegulated medical waste transported by a private or contract carrier in\na motor vehicle is excepted from:\n•\nthe requirement for an “INFECTIOUS SUBSTANCE” label if the\nouter packaging is marked with a “BIOHAZARD” marking in\naccordance with 29 CFR 1910.1030;\n•\nthe specific packaging requirements of §173.197, if packaged in\na rigid non-bulk packaging conforming to the general packaging\nrequirements of §173.24 and 29 CFR 1910.1030, provided the\nmaterial does not include a waste concentrated stock culture of an\ninfectious substance. Sharps containers must be securely closed to\nprevent leaks or punctures.\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n13\n\n<<<PAGE 16>>>\n\nEXCEPTIONS\nEXCEPTIONS FOR CERTAIN AIR SHIPMENTS\nAccording to §6.3.2.3.8 of the ICAO Technical Instructions, specimen\npackages marked as “Exempt human specimen” or “Exempt animal\nspecimen” are not regulated under the HMR. In the United States, the\nmark “Exempt Human/Animal Specimen” is an indication that there is\nno infectious substance in the package. Packages bearing these marks\nmay be accepted by an air carrier that has made a business decision not to\naccept hazardous materials.\nMATERIALS OF TRADE\nA Division 6.2 material, other than a Category A infectious substance, is\neligible for the Materials of Trade exception when it complies with §173.6\nand it contains human or animal samples (including, but not limited to,\nsecreta, excreta, blood and its components, tissue and tissue fluids, and\nbody parts) being transported for research, diagnosis, investigational\nactivities, or disease treatment or prevention, or it is a biological product\nor regulated medical waste is eligible for materials of trade exceptions.\nSection 173.6 of the HMR describes the packaging and transport\nrequirements for this exception. Note that there are specific quantity\nlimitations and transport must meet the definition of material of trade in\n§171.8.\nOTHER EXCEPTIONS\nSection 173.134 identifies exceptions for infectious substances and\nregulated medical wastes not specifically outlined in this guide. In\naddition, if a DOT special permit is required (DOT-SP) you must follow\nall requirements described in the permit.\n14\n\n<<<PAGE 17>>>\n\nOTHER REQUIREMENTS\nCARRIAGE BY AIRCRAFT\nSection 175.630 contains special requirements for Division 6.1 (poisonous)\nmaterials and Division 6.2 (infectious substances) materials. Paragraph\n(c) requires the inspection of each package, overpack, pallet, or unit load\ndevice containing a 6.2 material for signs of leakage. If evidence of leakage\nis found, the cargo compartment hold where the 6.2 material was stowed\nis required to be disinfected by any means that makes the release of the\n6.2 material ineffective at transmitting disease.\nINCIDENT REPORTING\nYou must report any release of an infectious substance (Category A or B)\nin any mode of transportation to the Department of Transportation. See\n§171.15 for telephone reporting requirements and §171.16 for written\nreport requirements.\nTRAINING REQUIREMENTS\nEmployees involved in the packaging and transport of infectious\nsubstances are subject to the training requirements of the HMR. These\nrequirements vary but are found in §172.704 and include:\n•\nGeneral awareness/familiarization training;\n•\nFunction-specific training;\n•\nSafety training;\n•\nSecurity awareness training; and\n•\nIn-depth security training (if subject to security plan requirements).\nEmployees involved in the packaging and transport of Category B\ninfectious substances are required to be trained on the requirements in\n§173.199. Employees who perform these tasks for excepted infectious\nsubstances, such as Materials of Trade or those listed in §173.134(b) and\n(c), are required to be trained on the applicable requirements of each\nexception.\nSECURITY PLANS\nPersons who offer for transportation or transport select agents and toxins\nregulated by the Centers for Disease Control and Prevention (CDC)\nunder 42 CFR Part 73 or the US Department of Agriculture under 9 CFR\nPart 121 must develop and implement security plans in accordance with\n§172.800 through §172.804.\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n15\n\n<<<PAGE 18>>>\n\nEXAMPLES OF CATEGORY A: UN2814,\nINFECTIOUS SUBSTANCES AFFECTING\nHUMANS\nMICRO-ORGANISM\nBacillus anthracis (cultures only)\nBrucella abortus (cultures only)\nBrucella melitensis (cultures only)\nBrucella suis (cultures only)\nBurkholderia mallei—Pseudomonas mallei—Glanders (cultures only)\nBurkholderia pseudomallei—Pseudomonas pseudomallei (cultures only)\nChlamydia psittaci—avian strains (cultures only)\nClostridium botulinum (cultures only)\nCoccidioides immitis (cultures only)\nCoxiella burnetti (cultures only)\nCrimean-Congo hemorrhagic fever virus\nDengue virus (cultures only)\nEastern equine encephalitis virus (cultures only)\nEscherichia coli, verotoxigenic (cultures only)\nEbola virus\nFlexal virus\nFrancisella tularensis (cultures only)\nGuanarito virus\nHantaan virus\nHantaviruses causing hemorrhagic fever with renal syndrome\nHendra virus\nHerpes B virus (cultures only)\nHuman immunodeficiency virus (cultures only)\n16\n\n<<<PAGE 19>>>\n\nHighly pathogenic avian influenza virus (cultures only)\nJapanese Encephalitis virus (cultures only)\nJunin virus\nKyasanur forest disease virus\nLassa virus\nMachupo virus\nMarburg virus\nMonkeypox virus (Clade I cultures only)\nMycobacterium tuberculosis (cultures only)\nNipah virus\nOmsk hemorrhagic fever virus\nPoliovirus (cultures only)\nRabies and other lyssaviruses (cultures only)\nRickettsia prowazekii (cultures only)\nRickettsia rickettsia (cultures only)\nRift Valley fever virus (cultures only)\nRussian spring-summer encephalitis virus (cultures only)\nSabia virus\nShigella dysenteriae type I (cultures only)\nTick-borne encephalitis virus (cultures only)\nVariola virus\nVenezuelan equine encephalitis virus (cultures only)\nVesicular stomatitis virus (cultures only)\nWest Nile virus (cultures only)\nYellow fever virus (cultures only)\nYersinia pestis (cultures only)\nPHMSA | PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION\n17\n\n<<<PAGE 20>>>\n\nEXAMPLES OF CATEGORY A: UN2900,\nINFECTIOUS SUBSTANCES AFFECTING\nANIMALS\nMICRO-ORGANISM\nAfrican swine fever virus (cultures only)\nAvian paramyxovirus Type 1—Velogenic Newcastle disease virus\n(cultures only)\nClassical swine fever virus (cultures only)\nFoot and mouth disease virus (cultures only)\nLumpy skin disease virus (cultures only)\nMycoplasma mycoides—Contagious bovine pleuropneumonia\n(cultures only)\nPeste des petits ruminants virus (cultures only)\nRinderpest virus (cultures only)\nSheep-pox virus (cultures only)\nGoatpox virus (cultures only)\nSwine vesicular disease virus (cultures only)\nThese examples are provided as guidance only. For more information, refer to the\nWorld Health Organization (WHO) guidance on regulations for the transport of infectious\nsubstances 2019–2020 (WHO/WHE/CPI/2019.20).\n18\n\n<<<PAGE 21>>>\n\n\n\n<<<PAGE 22>>>\n\nDEFINITIONS\nBIOLOGICAL PRODUCT\nA virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood\ncomponent or derivative, allergenic product, or analogous product, or\narsphenamine or derivative of arsphenamine (or any other trivalent\narsenic compound) applicable to the prevention, treatment, or cure of a\ndisease or condition of human beings or animals.\nCULTURE\nAn infectious substance containing a pathogen that is intentionally\npropagated. Culture does not include a human or animal patient\nspecimen as defined below.\nPATIENT SPECIMEN\nHuman or animal materials collected directly from humans or animals\nand transported for research, diagnosis, investigational activities, or\ndisease treatment or prevention. Patient specimen includes excreta,\nsecreta, blood and its components, tissue and tissue swabs, body parts,\nand specimens in transport media (e.g., transwabs, culture media, and\nblood culture bottles).\nREGULATED MEDICAL WASTE\nRegulated medical waste or clinical waste or (bio) medical waste\nmeans a waste or reusable material derived from the medical treatment\nof an animal or human, which includes diagnosis and immunization, or\nfrom biomedical research, which includes the production and testing of\nbiological products. Regulated medical waste or clinical waste or (bio)\nmedical waste containing a Category A infectious substance must be\nclassed as an infectious substance, and assigned to UN2814 or UN2900.\nA complete list of infectious substance definitions can be found in the HMR in §173.134(a).\n20\n\n<<<PAGE 23>>>\n\n\n\n<<<PAGE 24>>>\n\nFor additional information contact:\nThe Hazardous Materials Info Center\n1-800-HMR-4922\n(1-800-467-4922)\nEmail: infocntr@dot.gov\nhttps://www.phmsa.dot.gov\nPipeline and Hazardous Materials Safety Administration\nOutreach, Engagement, and Grants Division\nEast Building, 2nd Floor\n1200 New Jersey Ave., SE\nWashington, DC 20590\nEmail: training@dot.gov\n202-366-4900\n202-366-7342 (Fax)\ncheckthebox.dot.gov\nPHH50-0186-0622","truncated":false,"body_characters":23086}