FEDERAL REGISTER - .GUIDE TO CHANGES EFFECTIVE OCTOBER 1, 2006 FEDERAL REGISTER Hazardous Materials:

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  • GUIDE TO CHANGESEFFECTIVE OCTOBER 1, 2006

    FEDERAL REGISTERHazardous Materials: InfectiousSubstances; Harmonization With theUnited Nations Recommendations

    U.S. Department

    of Transportation

    Pipeline and

    Hazardous Materials

    Safety Administration

  • Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . 02

    Why Are Infectious Substances Regulated in Transportation?. . . . . . . . . . . . . . . . . . . . 03

    New Transportation Requirements forInfectious Substances . . . . . . . . . . . . . . . . . 03

    Changes to HMR; 49 CFR Parts 171, 172, 173, and 175 . . . . . . . . . . . . . . . . . . . . . . . 03

    New Classification System . . . . . . . . . . . . . . . . 04

    Category A and Category B . . . . . . . . . . . . . . . 06

    New and Revised Definitions . . . . . . . . . . . . . . . 08

    Classification Process . . . . . . . . . . . . . . . . . . . . 10

    Examples of Category A Infectious Substances:UN2814, Infectious Substances Affecting Humans. . . . . . . . . . . . . . . . . . . . . . . . . . . 12

    Examples of Category A Infectious Substances:UN2900, Infectious Substances Affecting Animals Only . . . . . . . . . . . . . . . . . . . . . . . 14

    Table of Contents

  • Classification Scenarios . . . . . . . . . . . . . . . . . . 16

    General Information. . . . . . . . . . . . . . . . . . . . . 18

    Part 172Hazardous Materials Table Changes . . . . 20

    Part 172Special Provisions, Hazardous MaterialsCommunications Changes . . . . . . . . . . . . . . . . . . . 22

    Part 172Security Plans . . . . . . . . . . . . . . . . . . 24

    Part 173General Requirements for Shipments and Packagings Changes . . . . . . . . . 26

    Packing and Labeling of Category A . . . . . . . 28

    Packing and Marking of Category B . . . . . . . 30

    Part 175Carriage by Aircraft Changes . . . . . . . 32

    Where to Learn More . . . . . . . . . . . . . . back cover

    1TRANSPORTING INFECTIOUS SUBSTANCES SAFELY

  • Introduction

  • Final rule effective October 1, 2006

    Voluntary compliance beginning July 2, 2006

    3

    WHY ARE INFECTIOUS SUBSTANCES REGULATED IN TRANSPORTATION? An infectious substance is regulated as a hazardousmaterial under the U.S. Department of Transportations(DOTs) Hazardous Materials Regulations (HMR; 49 CFRParts 171-180). The HMR apply to any material DOTdetermines is capable of posing an unreasonable riskto health, safety, and property when transported incommerce. An infectious substance must conform to allapplicable HMR requirements when offered for trans-portation or transported by air, highway, rail, or water.

    NEW TRANSPORTATION REQUIREMENTS FORINFECTIOUS SUBSTANCESDOTs Pipeline and Hazardous Materials SafetyAdministration (PHMSA) published a final rule on June1, 2006, revising the requirements in the HMR appli-cable to the transportation of infectious substances.The new requirements are effective October 1, 2006.

    CHANGES UNDER THE NEW RULE APPLY TOPARTS 171, 172, 173, AND 175 OF THE HMR New classification system

    New and revised definitions Revised marking requirements Revised packaging requirements New shipping paper requirements New security plan requirements New carriage by aircraft requirements

  • 4

    New Classification S

  • New classification criteria and packaging requirementsare now consistent with international standards andhelp clarify existing requirements to promote compli-ance. These revisions will ensure an acceptable level of safety for the transportation of infectious substancesand facilitate domestic and international transportation.

    The new classifications are based on criteria developedby the UN Committee of Experts working with theWorld Health Organization (WHO), the U.S. Centers forDisease Control and Prevention (CDC), medical profes-sionals, microbiologists, transportation professionals,and packaging technical experts. They are consistentwith the requirements contained in the 13th and 14theditions of the United Nations Recommendations for theTransport of Dangerous Goods (UN Recommendations),the 2005-2006 edition of the International CivilAviation Organization Technical Instructions for theSafe Transport of Dangerous Goods by Air (ICAOTechnical Instructions), and the International MaritimeOrganization (IMO) Dangerous Goods Code.

    The new HMR requirements establish a two-tieredclassification system for infectious substancesCategory A and Category B.

    Regulations arenow consistentwith internationalstandards

    5TRANSPORTING INFECTIOUS SUBSTANCES SAFELY

    n System

  • DIVISION 6.2 (INFECTIOUS SUBSTANCE): Amaterial known or reasonably expected to contain apathogen. A pathogen is a micro-organism (includingbacteria, viruses, rickettsiae, parasites, fungi) or otheragent, such as a proteinaceous infectious particle(prion), that can cause disease in humans or animals.

    CATEGORY A: An infectious substance in a formcapable of causing permanent disability or life-threatening or fatal disease in otherwise healthyhumans or animals when exposure to it occurs. Anexposure occurs when an infectious substance isreleased outside of its protective packaging, resultingin physical contact with humans or animals.Classification must be based on the known medicalhistory or symptoms of the source patient or animal,endemic local conditions, or professional judgmentconcerning the individual circumstances of the sourcehuman or animal. Category A poses a higher degreeof risk than Category B.

    Infectious substances, affecting animals,UN2900

    Infectious substances, affecting humans,UN2814

    Proper shippingnames and

    identificationnumbers

    Category A and Category B

  • CATEGORY B: An infectious substance not in a formgenerally capable of causing permanent disability orlife-threatening or fatal disease in otherwise healthyhumans or animals when exposure to it occurs. Thisincludes Category B infectious substances transportedfor diagnostic or investigational purposes.

    PROPER SHIPPING NAME AND IDENTIFICATIONNUMBER:Biological substance, Category B, UN3373

    (The proper shipping names Diagnostic Specimen orClinical Specimen may be used in place of Biologicalsubstance, Category B until January 1, 2007.)

    New classificationsystem:Category Aand Category B

    7TRANSPORTING INFECTIOUS SUBSTANCES SAFELY

  • 8

    Part 173General Requirements for Shipmentsand PackagingsIn addition to Category A and Category B, there areother new and revised definitions in 173.134.

    BIOLOGICAL PRODUCT: A virus, therapeuticserum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent arseniccompound) applicable to the prevention, treatment,or cure of a disease or condition of human beings or animals.

    New and Revised Definitions

  • New definitionsDivision 6.2InfectiousSubstance(173.134)

    9TRANSPORTING INFECTIOUS SUBSTANCES SAFELY

    CULTURE: An infectious substance containing apathogen that is intentionally propagated. Culturedoes not include a human or animal patient specimenas defined below.

    PATIENT SPECIMEN: Human or animal materialscollected directly from humans or animals and trans-ported for research, diagnosis, investigational activi-ties, or disease treatment or prevention. Patientspecimen includes excreta, secreta, blood and itscomponents, tissue and tissue swabs, body parts,and specimens in transport media (e.g., transwabs,culture media, and blood culture bottles).

    EXCEPTIONS: A complete listing of materialsexcepted from regulation as Division 6.2 materialsunder the HMR is found in 173.134(b).

  • Classification Process

    10

  • 11TRANSPORTING INFECTIOUS SUBSTANCES SAFELY

  • MICRO-ORGANISM

    Bacillus anthracis (cultures only)Brucella abortus (cultures only)Brucella melitensis (cultures only)Brucella suis (cultures only)Burkholderia malleiPseudomonas malleiGlanders

    (cultures only)Burkholderia pseudomalleiPseudomonas pseudomallei

    (cultures only)Chlamydia psittaciavian strains (cultures only)Clostridium botulinum (cultures only)Coccidioides immitis (cultures only) Coxiella burnetti (cultures only)Crimean-Congo hemorrhagic fever virusDengue virus (cultures only)Eastern equine encephalitis virus (cultures only)Escherichia coli, verotoxigenic (cultures only) Ebola virusFlexal virusFrancisella tularensis (cultures only)Guanarito virusHantaan virusHantaviruses causing hemorrhagic fever with renal syndromeHendra virusHerpes B virus (cultures only)Human immunodeficiency virus (cultures only)Highly pathogenic avian influenza virus (cultures only)

    Examples ofCategory A

    infectious substances

    12

    Examples of Category A Infectious SUN2814, Infectious Substances Affecting

  • Japanese Encephalitis virus (cultures only)Junin virusKyasanur forest disease virusLassa virusMachupo virusMarburg virusMonkeypox virusMycobacterium tuberculosis (cultures only)Nipah virusOmsk hemorrhagic fever virusPoliovirus (cultures only)Rabies and other lyssaviruses (cultures only)Rickettsia prowazekii (cultures only)Rickettsia rickettsia (cultures only)Rift Valley fever virus (cultures only)Russian spring-summer encephalitis virus (cultures only)Sabia virusShigella dysenteriae type I (cultures only)Tick-borne encephalitis virus (cultures only)Variola virusVenezuelan equine encephalitis virus (cultures only)Vesicular stomatitis virus (cultures only)West Nile virus (cultures only)Yellow fever virus (cultures only)Yersinia pestis (cultures only)

    List provided asguidance only

    List is NOT all inclusive

    13TRANSPORTING INFECTIOUS SUBSTANCES SAFELY

    s Substances:g Humans