{"operation":"document","citation":"17-0063","title":"Morton Plant Mease Health Care, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2017-11-14","effective_on":null,"summary":"17-0063 response to Morton Plant Mease Health Care, Inc. concerning 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-17-0063.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-17-0063.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-17-0063","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/56241/170063.pdf","body":"<<<PAGE 1>>>\n\nSite Management Coordinator\nMorton Plant Mease Health Care Inc.\n455 Pinellas Street, Suite 212B\nClearwater, FL 33756\nReference No. 17-0063\nDear Ms. Schelle:\nThis letter is in response to your June 8, 2017, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to Category B infectious\nsubstances. You ask if interpretation letter (Reference No. 09-0011) and the training\nrequirements it describes for transporting Category B infectious substances in accordance with\n§ 173.199 remain valid.\nThe answer is yes, interpretation letter (Reference No. 09-0011) remains valid. Further, based on\na cursory review of the training module you provided, it is the opinion of this Office that the\ncontent sufficiently covers the provisions in § 173.199. Employees who are trained in and\nfamiliar with the requirements of § 173.199 are excepted from all other training requirements of\nthe HMR when Category B infectious substances are offered for transportation or transported in\ncommerce under the provisions of § 173.199. Please note, this letter does not act as certification\nof your training module nor does this Office certify training required by § 173.199(e).\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nespite\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nPlease submit this as a letter of interpretation. Ms. Schelle spoke with Eamonn.\nPlease let me know if you have any questions.\nThanks,\nJordan\nFrom: Schelle, Beth E. [mailto:Beth.Schelle@baycare.org]\nSent: Thursday, June 08, 2017 10:55 AM\nTo: INFOCNTR (PHMSA) < INFOCNTR.INFOCNTR@dot.gov>\nCc: Schelle, Beth E. < Beth.Schelle@baycare.org>\nSubject: Request for Formal Written Response\nTO: U.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration -\nPlease review attached items that include prior communications between DOT PHMSA and ACRP.\nAfterwards, please confirm that the response from DOT still remains current and applicable for the training\nrequirements required for Category B infectious substances transportation.\nThank you!\nBeth\nBeth Schelle RN, BSN, CCRC\nSite Management Coordinator\nCardiovascular Research Dept.\nMorton Plant Mease Health Care Inc.\n455 Pinellas Street, Suite 212 B\nPhone: 727-462-2152\nClearwater, FL 33756\nFax: 727-298-6376\nBeth.Schelle@baycare.org\nConfidential: This electronic message and all contents contain information\nfrom BayCare Health System which may be privileged, confidential or otherwise\nprotected from disclosure. The information is intended to be for the addressee\nonly. If you are not the addressee, any disclosure, copy, distribution or use\n1\n\n<<<PAGE 3>>>\n\n\n\n<<<PAGE 4>>>\n\nMr. David Vulcano\nChair, ACRP Board of Trustees\nAssociation of Clinical Research Professionals\n500 Montgomery Street, Suite 800\nAlexandria, VA 22314\nReference No. 09-0011\nDear Mr. Vulcano:\nThis is in response to your January 7, 2009 letter concerning the training requirements for\nhazmat employees who prepare and package only Category B infectious substances (Division\n6.2) in conformance with § 173.199 of the Hazardous Materials Regulations (HMR; 49 CFR\nParts 171-180). You ask if the HMR excepts these employees from all other training\nrequirements under the HMR if they are trained to carry out the provisions of this section.\nThe answer is yes. Employees trained to know and carry out the requirements prescribed in\n§ 173.199 for Category B infectious substances are excepted from all other training\nrequirements under the HMR when preparing and offering these materials for transportation\nin commerce. See § 173.199(a) and (e).\nYou also ask if the learning objectives and methods your association is considering (i.e., a\npaper-based self-training module, a post test, recurring 3-year training, and a record keeping\nsystem) to satisfy the training requirements in § 173.199 are sufficient and/or correct. It is the\nopinion of this Office that the training scenario you present is sufficient as long as all of the\nprovisions of §173.199 are covered. Section 173.199 stipulates that persons who offer and\ntransport these packages in commerce must be knowledgeable about the requirements of this\nsection. See § 173.199(e).\nI hope this information satisfies your request.\nSincerely,\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 5>>>\n\nPackaging \"Biological Specimens, Category B\"\nTraining Module Pertaining To The Requirements Set Forth In\n49CFR173.199 and 49CFR173.217\nVersion: July 24, 2009\nNOTE: THIS MODULE IS NOT CERTIFICATION TO PACKAGE CATEGORY A Infectious\nSubstances. If you desire such certification, please contact your HazMat Officer.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 6>>>\n\nbe a cata cata da caps ta a fan nasable q unproper\npackaging and transportation may result in the need for resampling, thus inconveniencing human\nsubjects and putting them at additional, unnecessary risk because of this likely preventable\nfailure.\nThrough the normal course of transportation, packages are likely subject to extreme temperature\nshifts, changes in humidity and pressure, shocks and vibrations from loading, unloading and\naccidental drops. Any of these can compromise the integrity of the package and/or the safety of\nthose around it if the package is breached. The completed package must be designed,\nconstructed, maintained, filled, its contents limited, and closed so that under conditions normally\nencountered in transportation, including removal from a pallet or overpack for subsequent\nhandling, there will be no release of hazardous material into the environment. The regulations\nare clear that it is the shipper's responsibility, not the courier's or the recipient's, to assure that\nthe contents are properly packaged to meet this objective.\nThe learning objectives of this module are to teach you...\n1) You will be able to define the common terminology used surrounding the practice of\npackaging and shipping biological specimens.\n2) You be able to differentiate between Category A and Category B Infectious Substances.\n3) You will demonstrate knowledge that the training received in this module is only\nadequate for the packaging and shipping of Category B Infectious Substances and that\nshould you desire to pack or ship Category A Infectious Substances, you require\nadditional training outside the scope of the module\n4) You will recall the non-bulk packaging requirements for Category B Infectious\nSubstances (as detailed in 49CFR199(a)-(d) or IATA Packing Instructions #650)\n5) You will recall the requirements of non-bulk packaging of dry ice (as detailed in\n49CFR 173.217 or IATA Packing Instructions #904).\nCommon Terminology\nAlthough we follow OSHA's Universal Precautions and assume all bodily fluids are infectious,\nfor shipping purposes, the classification of an \"Infectious Substance\" takes on a whole different\nmeaning. An \"Infectious Substance\" classification in the transportation world means that the\nsubstance has crossed the line from unregulated or minimally regulated materials into Hazardous\nMaterials (or \"HazMat\" for short) when shipped over the US highways or airways.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n2}\n\n<<<PAGE 7>>>\n\nLUOU\nSubstances, Affecting Humans\" (a.k.a. \"Category A). The other classification is \"UN3373\nBiological Specimens, Category B\" (a.k.a \"Category B\"). Unlike Category A, a Category B\nspecimen is exempted from many HazMat packaging and documentation regulations. Although\nthe regulations for Category B are less strict, they still need to be followed to protect your safety\nand the safety of the general public while the specimen is in transit. They also provide a\nmechanism for avoiding delays in shipment as well as help the sample arrive at the destination\nlab intact and undamaged so that tests can be run promptly giving good diagnostic information\nwithout the need to redraw the sample.\nThe following are definitions of the commonly used terminology in this discipline:\nBiological Substance, Category B: The official categorization title of Category B Infectious\nSubstances. This term replaces \"Clinical Specimen\" and \"Diagnostic Specimen\" on the HatMat\ntable effective January 1, 2007. The UN identifier for this classification on the HazMat table is\nUN3373. [DOT 49CFR172.101]\nCategory A Infectious Substance: An infectious substance in a form capable of causing\npermanent disability or life-threatening or fatal disease in otherwise healthy humans or animals\nwhen exposure to it occurs. An exposure occurs when an infectious substance is released outside\nof its protective packaging, resulting in physical contact with humans or animals. A Category A\ninfectious substance must be assigned to identification number UN 2814 or UN 2900, as\nappropriate. Assignment to UN 2814 or UN 2900 must be based on the known medical history or\nsymptoms of the source patient or animal, endemic local conditions, or professional judgment\nconcerning the individual circumstances of the source human or animal. [DOT\n49CFR 173.134(a)(1)(i), 72 FR 55692, Oct. 1, 2007]\nCategory B Infectious Substance: An infectious substance that is not in a form generally\ncapable of causing permanent disability or life-threatening or fatal disease in otherwise healthy\nhumans or animals when exposure to it occurs. This includes Category B infectious substances\ntransported for diagnostic or investigational purposes. A Category B infectious substance must\nbe described as \"Biological substance, Category B\" and assigned identification number UN\n3373. This does not include regulated medical waste, which must be assigned identification\nnumber UN 3291. [DOT 49CFR 173. 134(a)(1)(ii), 72 FR 55692, Oct. 1, 2007]\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n3 }\n\n<<<PAGE 8>>>\n\ntAA: The Federal Aviation Administration. The element of the U.S. DOT with primary\nresponsibility for the safety of civil aviation.\nHazardous Materials. Materials that the Secretary of Transportation has determined to be\nhazardous.\nHazMat: Shorthand for \"Hazardous Materials\"\nHazMat Table: The alphabetical list of hazardous materials located at 49CFR 172.101 indicating\ntheir proper shipping name, United Nations identification number, classifications, packaging\ninstructions, labeling instructions and other information required to ship. This table harmonizes\nwith the ICAO table.\nIATA: International Air Transport Association. IATA is the trade association of the world's\ninternational airline industry. Originally founded in 1919, it now groups together nearly 270\nairlines, including the world's largest. These airlines fly over 95 percent of all international\nscheduled air traffic.\nICAO: The International Civil Aviation Organization. A specialized agency of the United\nNations designed to bring safe, secure and sustainable development of civil aviation through\ncooperation amongst its member States. Most countries are part of ICAO and have harmonized\nregulations with ICAO standards.\nInfectious Substance: (a.k.a. Class 6.2 Infectious Substance) means a material known or\nreasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria,\nviruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle\n(prion), that can cause disease in humans or animals. An infectious substance must be assigned\nthe identification number UN 2814, UN 2900, UN 3373, or UN 3291 as appropriate.\nSpecimen (or Patient Specimen): Human or animal material collected directly from humans or\nanimals and transported for research, diagnosis, investigational activities, or disease treatment or\nprevention. Patient specimen includes excreta, secreta, blood and its components, tissue and\ntissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and\nblood culture bottles). (DOT 49CFR 173.134(a)(4)).\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 9>>>\n\nBISUOLI\nTable 1: Examples of Category A (i.e. UN2814 Infectious Substance Affecting Humans)\nBacillus anthracis (cultures only)\nJunin virus\nBrucella abortus (cultures only)\nKyasanur forest disease virus\nBrucella melitensis (cultures only)\nLassa virus\nBrucella suis (cultures only)\nMachupo virus\nBurkholderia mallei—Pseudomonas mallei_\nMarburg virus\nGlanders\n(cultures only)\nBurkholderia pseudomallei-Pseudomonas\nMonkeypox virus\npseudomallei\n(cultures only)\nChlamydia psittaci —avian strains (cultures\nMycobacterium tuberculosis (cultures only)\nonly)\nClostridium botulinum (cultures only)\nNipah virus\nCoccidioides immitis (cultures only)\nOmsk hemorrhagic fever virus\nCoxiella burnetti (cultures only)\nPoliovirus (cultures only)\nCrimean-Congo hemorrhagic fever virus\nRabies and other lyssaviruses (cultures only)\nDengue virus (cultures only)\nRickettsia prowazekii (cultures only)\nEastern equine encephalitis virus (cultures\nRickettsia rickettsia (cultures only)\nonly)\nEscherichia coli, verotoxigenic (cultures only)\nRift Valley fever virus (cultures only)\nEbola virus\nRussian spring-summer encephalitis virus\n(cultures only)\nFlexal virus\nSabia virus\nFrancisella tularensis (cultures only)\nGuanarito virus\nShigella dysenteriae type I (cultures only)\nHantaan virus\nTick-borne encephalitis virus (cultures only)\nHantaviruses causing hemorrhagic fever with\nVariola virus\nrenal syndrome\nHendra virus\nVenezuelan equine encephalitis virus (cultures\nonly)\nHerpes B virus (cultures only)\nVesicular stomatitis virus (cultures only)\nHuman immunodeficiency virus (cultures\nWest Nile virus (cultures only)\nonly)\nHighly pathogenic avian influenza virus\nYellow fever virus (cultures only)\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 10>>>\n\nOtherwise, you are not authorized under law to package a Category A specimens for shipment.\nTo package Category B specimens requires the person who offers or transports a Category B\ninfectious substance to \"know about\" the requirements of the regulations under\n49CFR173.199, all of which are contained in this module.\nGeneral Packaging Instructions for Biological Specimens, Category B (i.c. UN 3373)\nAll Category B infectious substance must be packaged in a \"Triple Packaging\" consisting of a\nprimary receptacle, a secondary packaging, and a rigid outer packaging (a.k.a. the tertiary\ncontainer). These packaging requirements are set forth in the DOT regulations (49CFR173.199)\nwhich harmonize with the IATA Standards (Packing Instructions #650). The requirements are:\n1. Primary receptacles (sealed test-tubes being the most common) must be leakproof if\nshipping liquids (i.e. blood) or siftproof if shipping solids (i.e. swab). You should always\nassure that any seals (i.e. rubber stoppers) are secure and if using a screwtop, the\nscrewtop should be reinforced with tape.\n2.\nPrimary receptacles must be packed in secondary packaging (sealed plastic bags being\nthe most common) in such a way that, under normal conditions of transport, they cannot\nbreak, be punctured, or leak their contents into the secondary packaging. Note that the\nsecondary packaging must also be leakproof if shipping liquids (i.e. blood) or siftproof if\nshipping solids (i.e. swab).\na. When packaging liquids, absorbent material must be placed between the primary\nreceptacle and secondary packaging. The absorbent material must be of sufficient\nquantity to absorb the entire contents of all of the primary receptacles and not\ncompromise the integrity of the cushioning material or the outer packaging.\nb. If several fragile primary receptacles are placed in a single secondary packaging,\nthey must be either individually wrapped or separated to prevent contact between\nthem. The wrapping or separation mechanism may also be the absorbent material\nrequired for liquids if it is capable of absorbing the entire contents of all of the\nprimary receptacles as indicated above.\nc. If residual liquid may be present in the primary receptacle during transportation\nOR if the solid material may become liquid during transportation (i.e. frozen\nspecimens), the solid must be packaged as if it were a liquid.\n3. Secondary packaging must be secured in rigid outer packaging (fiberboard boxes being\nthe most common) with suitable cushioning material such that any leakage of the\ncontents will not impair the protective properties of the cushioning material or the outer\npackaging.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 11>>>\n\nFigure 1: UN3373 Label\nThe width of the line must be at least 2 mm (0.08 inches) and the letters and numbers\n\"Biological substances, Category B\" must be marked on the outer packaging adjacent to\nthe diamond-shaped mark in letters that are at least 6mm (0.24 inches) high.\n5. When packages are placed in an overpack (such as in placing a package into a fourth\ncontainer or combining several packages into one box), all package markings required\nmust be either clearly visible (i.e. through a clear plastic window) or reproduced on the\noutside of the overpack.\n6. The name and telephone number of a person who is either knowledgeable about the\nmaterial being shipped and has comprehensive emergency response and incident\nmitigation information for the material, or has immediate access to a person who\npossesses such knowledge and information, must be included on a written document\n(such as an air waybill or bill of lading) or on the outer packaging.\n7. A packaging containing inner packagings of Category B infectious substances may not\ncontain other hazardous materials except:\na. Refrigerants, such as dry ice or liquid nitrogen, as authorized under paragraph (d)\nof this section;\nb. Anticoagulants used to stabilize blood or plasma; or\nc. Small quantities of Class 3, Class 8, Class 9, or other materials in Packing Groups\nIl and III (as classified on the HazMat table) used to stabilize or prevent\ndegradation of the sample (such as preservatives), provided the quantity of such\nmaterials does not exceed 30 mL (1 ounce) or 30 g (1 ounce) in each inner\npackaging.\n8. For shipments by aircraft, there are some size and weight limitations\na.\nFor liquids, the maximum quantity contained in each primary receptacle,\nincluding any material used to stabilize or prevent degradation of the sample, may\nnot exceed 1 L (34 ounces), and the maximum quantity contained in each outer\npackaging, including any material used to stabilize or prevent degradation of the\nsamples, may not exceed 4 L (1 gallon). The outer packaging limitation does not\ninclude ice, dry ice, or liquid nitrogen when used to maintain the integrity of the\npounds), including any material used to stabilize or prevent degradation of the\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 12>>>\n\nLeakproof or Siftproof\nLeakproof or Siftproof\nSecondary Packaging\n(e.g. Sealed Plastic Bag)\nRigid Outer Packaging\nCategory B•\nSignial\nPackage Mark\nUN3373\nperson responsible. (This information\nName and telephone number of a\nmay instead be provided on a written\ndocument such as an air waybil)\nFigure 2: A properly packaged package\nWhile most organizations who ship do not manufacture the materials used to ship, it is important\nto note that you cannot use just any materials. Manufacturers must pass certain quality control\nparameters in their products as defined in 49CFR 178.609 entitled \"Test requirements for\npackagings for infectious substances\". This section requires exposing the packaging to things\nsuch as extremes in temperature, \"drop tests\" by dropping the boxes from heights at least 1.2\nmeters and pressure tests producing a pressure differential of not less than 95 kPa (0.95 bar, 14\npsi) to assure that the primary receptacles remain intact and not separated from the absorbent\nmaterial. Additionally, there are certain size restrictions (such as at least one surface of the outer\npackaging must have a minimum dimension of 100mm by 100 mm or 3.9 inches). While most\nindividuals rely on the quality control of the manufacturer to assure their materials meet these\nspecifications, it is important to note that if your packaging materials seem damaged in any way,\nthis may have compromised the system so that it will not meet the specifications. As the shipper,\nnot the manufacturer, is ultimately responsible to assure the integrity of the system, you should\nnot use any packaging materials that seem damaged or compromised in any way.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 13>>>\n\n1. Carbon dioxide, solid (dry ice), when offered for transportation or transported by aircraft\nor water, must be packed in packagings designed and constructed to permit the release of\ncarbon dioxide gas to prevent a build-up of pressure that could rupture the packaging.\nFiberboard boxes and styrofoam chests suffice for this provided they are not subsequently\nsealed \"airtight\".\na. Dry ice is placed between the secondary receptacle and the rigid outer packaging.\nIt is not placed within the primary container or the secondary receptacle as the\ndissipation of the dry ice will build pressure In these sealed containers potentially\ncausing rupture in these leakproof or siftproof protective containers.\n2. When offered or transported by aircraft, in quantities not exceeding 2.3 kg (5 pounds) per\npackage and used as a refrigerant for the contents of the package, the package must be\nmarked ''Carbon dioxide, sold\" or \"Dry ice\", marked with the name of the contents being\ncooled (such as your UN3373 label) and marked with the net weight of the dry ice or an\nindication the net weight is 2.3 kg (5 pounds) or less.\n3.\nFor each shipment by air exceeding 2.3 kg (5 Ibs) per package, advance arrangements\nmust be made between the shipper and each carrier.\nFrom time to time, you will be presented with outer packages that have the \"Class 9\" HazMat\ndiamond shaped label preprinted on as in the figure below.\nOr\ng\n•, UN IBAS, Wete\net 3: mation ries of Cote, a a b tensedfis a mabel (let) ad one with aditional dry ice\nin the fashion on the right.\nWhile UN1845 Carbon Dioxide, Solid is classified as a Class 9 Hazmat (Class 9 is\n\"Miscellaneous Hazardous Materials\"), the HazMat Table indicates that dry ice does not need\nthe diamond label that is usually required of other Class 9 material because of its low degree of\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 14>>>\n\nworkers follow \"Universal Precautions\" which assumes that all bodily fluids are treated as if\nthey were infectious and that precautions should be taken when handling bodily fluids for\nany reason (processing, drawing, cleaning spills etc). For more information on Universal\nPrecautions, see an Infection Control specialist. As an example of some of the few items a\ngood Universal Precautions plan should have, the United States Centers for Disease Control\nadvocate things like:\n1. All health-care workers should routinely use appropriate barrier precautions to prevent\nskin and mucous-membrane exposure when contact with blood or other body fluids of\nany patient is anticipated. Gloves should be worn for touching blood and body fluids,\nmucous membranes, or non-intact skin of all patients, for handling items or surfaces\nsoiled with blood or body fluids, and for performing venipuncture and other vascular\naccess procedures. Gloves should be changed after contact with each patient. Masks and\nprotective eyewear or face shields should be worn during procedures that are likely to\ngenerate droplets of blood or other body fluids to prevent exposure of mucous\nmembranes of the mouth, nose, and eyes. Gowns or aprons should be worn during\nprocedures that are likely to generate splashes of blood or other body fluids.\n2. Hands and other skin surfaces should be washed immediately and thoroughly if\ncontaminated with blood or other body fluids. Hands should be washed immediately after\ngloves are removed.\n3. All health-care workers should take precautions to prevent injuries caused by needles,\nscalpels, and other sharp instruments or devices during procedures; when cleaning used\ninstruments; during disposal of used needles; and when handling sharp instruments after\nprocedures. To prevent needlestick injuries, needles should not be recapped, purposely\nbent or broken by hand, removed from disposable syringes, or otherwise manipulated by\nhand. After they are used, disposable syringes and needles, scalpel blades, and other\nsharp items should be placed in puncture-resistant containers for disposal; the puncture-\nresistant containers should be located as close as practical to the use area. Large-bore\nreusable needles should be placed in a puncture-resistant container for transport to the\nreprocessing area.\nDry ice is also potentially harmful in two ways. The most common injury associated with\ndry ice is frost bite which can occur within seconds of direct contact (dry ice is less than -78\ndegrees Centigrade). Only handle dry ice with heavy insulated gloves. Eye protection is also\nrecommended when handling dry ice. Never play with dry ice or use it to cool or freeze\nfood. Should you have direct contact with dry ice, seek medical attention. Accidental eye\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n\n<<<PAGE 15>>>\n\nShould any or te warning signs\nappear, you should immediately move to a well ventilated area and breathe normally until\nsymptoms subside, then move the dry ice to a better ventilated area.\nNever store dry ice in airtight containers. Breathable styrofoam chests in secure areas are\nideal, especially when labeled with cautionary labels such as \"Caution: Dry Ice\" or \"Dry Ice:\nDo Not Touch\". When transporting dry ice in your personal vehicle, place it in the trunk or\ntrunk bed and not in the car cabin. Obtain dry ice in the size that you will need- never try to\nsaw dry ice or break it with a hammer. Follow all regulations when disposing of dry ice\n(such as not dumping in public areas or disposing of it in toilets or sinks). Also, never store\ndry ice in poorly ventilated areas. You should keep a Material Safety Data Sheet (MSDS) for\ndry ice in an appropriate and easily accessible location. You may obtain an MSDS for dry\nice online or from your dry ice vendor.\nFinal Notes And Additional Resources\nIt is the shipper's responsibility to assure that a package containing Category B infectious\nSubstances and/or dry ice is properly packaged, marked and labeled for delivery. The US\nDepartment of Transportation can assign civil penalties up to $50,000 for violations pertaining to\ninadequate training or packaging of hazardous materials.\nWhile a \"HazMat Shipper's Declaration\" you would learn about in a certification course is not\nrequired for Category B Infectious Substances or dry ice, private couriers may require their own\npaperwork. Be sure you are aware of your courier's requirements of shipping Category B\nInfectious Substances and dry ice to better assure that they can deliver your specimens with the\nmost care and in the timeliest manner.\nShould you desire more information or to obtain full HazMat certification for Category A\nInfectious Substances or other hazardous materials, please contact the national DOT office or\nyour local DOT office.\nThe following resources may be of interest to those who want to learn more about shipping\nInfectious Substances (both Category A and Category B) as well as dry ice.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n11)\n\n<<<PAGE 16>>>\n\nfectious%20Substances%20Safely.pdf)\n• IATA Guidance Document \"Infectious Substances\"\nhttp://www.iata.org/nr/rdonlyres/9c7e382b-2536-47ce-84b4-\n9a883ecfa040/0/guidance_doc62dgr_50.pdf)\n• IATA Infectious Substances & Shipping Guidelines\n(http://www.iata.org/ps/publications/infectious-substances.htm)\n• Emergency Response Guidebook: Guide 120- Inert Gasses\n(http://www.phmsa.dot.gov/hazmat/library/erg)\n• Emergency Response Guidebook: Guide 158- Infectious Substances\n(http://www.phmsa.dot.gov/hazmat/library/erg)\nWhat To Do With This Module\nAccording to U.S. DOT regulation, a person must be knowledge of the requirements of the\nregulations, specifically the regulations of 49CFR 173.199. Having employees read the module\nand take the sample Post-Test below is one mechanism you can do to assure they have the\nknowledge. It is recommended that you keep a copy of this module and their Post Test in their\npersonnel file. Additionally, as regulations change, it is recommended that you review the\nregulations at least annually and update training as appropriate. Due to knowledge drift, it is also\nrecommended that a person review this module every three years even in the absence of change\nof regulations.\nThe DOT confirmed through a Request For Guidance or Interpretation (a formal process of the\nDOT) that the objectives in this module are sufficient to meet their requirements. A copy of the\nrequest and DOT's response is available in the ACRP Resource Library.\nAbout The Author\nDavid Vulcano, LCSW, MBA, CIP, RAC is the AVP of Clinical Research at Hospital\nCorporation of America (HCA). Among other leadership roles, he is also the current Chair of\nthe Board of Trustees for the Association of Clinical Research Professionals (ACRP). Mr.\nVulcano is a frequent speaker and publisher of information pertaining to the clinical research\nindustry. David is a trainer for packaging Category B Infectious Substances as well as able to\ncertify individuals for packaging Category A Infectious Substances.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n12)\n\n<<<PAGE 17>>>\n\na. Category A Infectious Substances\nb. Category B Infectious Substances\nc. Dry Ice\nd. All of the above\ne. B and C Only\n2) Fill In the blank: The\n_ is responsible for assuring the integrity of the packaging\nof Category B Infectious Substances.\na. shipper\nb. packaging manufacturer\nc. courier\nd. recipient\ne. All of the above\n3) Which of the following is not listed as a Category A Infectious Substance?\na. Ebola virus\nb. Hepatitis C\nMarburg virus\nd. Human immunodeficiency virus (cultures only)\ne. Rabies and other lyssaviruses (cultures only)\n4) Which of the following is NOT true about packing liquids?\na. Both the primary receptacles AND the secondary packaging need to be leakproof.\nb. Enough absorbent material is needed to absorb the entire contents of all primary\nreceptacles should be placed between the primary receptacle and secondary\npackaging\nc. More than one primary receptacle can be placed in a secondary packaging\nprovided they are individually wrapped or otherwise padded to prevent contact.\nd. The system of having a primary receptacle inside a secondary package which is\ninside a rigid outer package is commonly referred to as the \"Triple Packing\"\ne. There is no need to double-check the containers or tightly seal caps as the\nabsorbent material will absorb any spill from leaking caps.\n5) Which if the following is true when shipping dry ice?\na. Liquid specimens that are shipped frozen on dry ice do not need absorbent\nmaterial as they will be in solid form (i.e. frozen) throughout the shipment.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n13)\n\n<<<PAGE 18>>>\n\n6) Which of the following is NOT true about your safety?\na. You should follow \"Universal Precautions\" when handling bodily fluid\nb. Dry ice can cause frost bite within seconds of contacting skin.\nc. Barrier precautions (such as rubber gloves and protective eyewear) are important\nsafety gear.\nd. Proper hand washing is an essential part of preventing the spread of infection.\ne.\nFrostbite can be treated by running the affected area under hot water and keeping\nit warm by rubbing it afterwards.\n7) You are shipping blood specimens at ambient temperature to a central lab to perform\nroutine diagnostic tests to see if an individual qualifies for a clinical trial. You have no\nreasonable belief that the blood contains any Category A pathogens. Which of the\nfollowing would be an appropriate label and markings?\nUN3373\nDIAGNOSTIC\nSPECIMEN\nBIOLOGICAL\nSUBSTANCE,\na.\nd.\nCATEGORY B\nINFECTIOUS SUBSTANCE\nIN CASE OF DAMAGE OR LEAKAGE\nPUBUC HEALTH ALTHORITY\nMAEDIATELY HOTEFY\nNOTRY CE\nb.\ne.\nC.\nPackaging \"Biological Specimens, Category B\"\nVersion: July 24, 2009\n14)","truncated":false,"body_characters":32314}