Subject: Ebola Waste Management - UPDATE

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1 A"SAFE"AND"CLEAN"SOLUTION"FOR"YOUR"MEDICAL"WASTE"STREAM"" October 15, 2014 Subject: Ebola Waste Management - UPDATE Dear Valued Customer: Many of our customers have been asking about procedures and requirements for the handling and disposal of Ebola contaminated waste. As you know from news reports, Federal agencies (CDC & USDOT-PHMSA) have been continuously updating their instructions and recommended procedures regarding Ebola contaminated waste. MedAssure is staying on top of this situation will keep you advised. Yesterday, the CDC issued an update entitled Ebola Medical Waste Management. This document, attached, is intended to provide hospitals and healthcare providers with key information about the safe handling and disposal of medical waste generated from the care of persons diagnosed with or suspected of having Ebola virus disease (EVD). Onsite Autoclaving: Waste generators with onsite autoclaves can process the Ebola contaminated waste. After autoclaving, it can be transported as regulated medical waste (RMW). MedAssure can collect this waste along with other RMW. However, we ask that generators label containers with this waste as Treated Ebola Waste (TEW). Normal DOT packaging rules and procedures will apply per DOT 6.2 Category B Regulated Medical Waste. Offsite Transportation & Disposal: A few days ago, the USDOT-PHMSA revised its terms and conditions for the packaging and transport of Ebola contaminated waste offsite for treatment. See the attached document labeled DOT/CDC Temporary Packaging & Transportation Procedures for Ebola Contaminated Medical Waste for information. For the moment, DOT-PHMSA will issue incident specific permits for Ebola medical contaminated waste on a case-by-case basis and for short time only. 149YELLOWBROOKROADP) FARMINGDALE.NJ07727F) info@medassureservices.com

2 Ebola Waste Management UPDATE October 15, 2014 Page 2 of 2 In the meantime, if you encounter an Ebola patient, we will work with you, state and federal agencies to develop an action plan to manage your waste safely. The Emergency Special Permit for offsite transport will require an estimate of waste to be generated and number of containers. The logistics and timing of pick-ups will need to be established under the special permit conditions. Recently, OSHA issued a factsheet on Cleaning and Decontamination of Ebola on Surfaces - Guidance for Workers and Employers in Non-Healthcare/ Non- Laboratory Settings. Workers tasked with cleaning surfaces that may be contaminated with Ebola virus, the virus that causes Ebola hemorrhagic fever (EHF), must be protected from exposure. Employers are responsible for ensuring that workers are protected from exposure to Ebola and that workers are not exposed to harmful levels of chemicals used for cleaning and disinfection. As you can imagine, Federal direction on the matter is still evolving. MedAssure will keep you informed as new information becomes available. We share your concerns about being prepared and establishing plans for safety management waste disposal in case of an occurrence. If you have any questions or further needs for information, please call me directly at or by joed@medassureservices.com. Sincerely, Joe Delloiacovo Executive Vice President Attachments: Ebola Medical Waste Management CDC Temporary Packaging & Transportation Procedures for Ebola Contaminated Medical Waste - USDOT-PHMSA Cleaning and Decontamination of Ebola on Surfaces - OSHA

3 Ebola Medical Waste Management Purpose This document is intended to provide hospitals and healthcare providers with key information about the safe handling and disposal of medical waste generated from the care of persons diagnosed with or suspected of having Ebola virus disease (EVD). Medical waste generated in the care of patients with known or suspected EVD is subject to procedures set forth by local, state and federal regulations. Basic principles for spills of blood and other potentially infectious materials are outlined in the U.S. Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen standard, 29 CFR See ( Medical waste contaminated with Ebola virus is a Category A infectious substance regulated as a hazardous material under the U.S. Department of Transportation s (DOT s) Hazardous Materials Regulations (HMR; 49 CFR, Parts ). The HMR apply to any material DOT determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. For off-site commercial transport of Ebola-associated medical waste, strict compliance with the HMR is required. For more information on the HMR requirements see ( If a person requires a variance to the HMR, that person must apply for a special permit under 49 CFR DOT may grant a special permit if the applicant can demonstrate that an alternative packaging will achieve a safety level that is (1) at least equal to the safety level required under the HMR, or (2) consistent with the public interest if a required safety level does not exist. See ( The HMR contains federal requirements for transporting hazardous materials in commerce. For Ebola-associated medical waste transported by local, state or federal officials, contact DOT s Pipeline and Hazardous Materials Safety Administration (PHMSA). See ( Ebola-associated medical waste inactivated (e.g., autoclaved) or incinerated may be transported as regulated medical waste. Ebola-associated medical waste inactivated or incinerated is no longer considered a Category A infectious substance. 1

4 The inactivation or incineration of Ebola-associated medical waste within a hospital system may be subject to state, local and OSHA regulations. Onsite inactivation Ebola-associated medical waste can be inactivated through the use of appropriate autoclaves. Other methods of inactivation (e.g., chemical inactivation) have not been standardized and would need to consider worker safety issues, as well as the potential for triggering other federal safety regulations. Onsite incineration Ebola-associated medical waste can be incinerated. The products of incineration can be transported and disposed of in accordance with standard protocols for hospital waste disposal. Ebola-associated waste disposal is subject to state and local regulations. Ebola-associated waste that has been appropriately inactivated or incinerated is no longer infectious. See ( Relevant CDC guidance is available at: For questions on CDC guidance, please contact CDC-INFO ( ). Relevant DOT guidance is available at ( For questions on DOT guidance or the HMR requirements, please contact DOT s Pipeline and Hazardous Materials Safety Administration s (PHMSA s) Hazardous Materials Information Center at , 9:00 am-5:00 pm Eastern Standard Time. Relevant OSHA guidance is available at ( For questions on OSHA guidance, please contact OSHA (6742). 1 The HMR applies to interstate, intrastate, and foreign commerce. Page last reviewed: October 11, 2014 Page last updated: October 11, 2014 Content source: Centers for Disease Control and Prevention (/index.htm) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) (/ncezid/index.html) Division of High-Consequence Pathogens and Pathology (DHCPP) (/ncezid/dhcpp/index.html)

5 Division of High-Consequence Pathogens and Pathology (DHCPP) (/ncezid/dhcpp/index.html) Viral Special Pathogens Branch (VSPB) (/ncezid/dhcpp/vspb/index.html)

6 DOT/CDC& &Temporary&Packaging&&& 1.INTRODUCTION: TheUSDepartmentofTransportation(USDOT),PipelineandHazardous MaterialsSafetyAdministration(PHMSA),andtheCentersforDiseaseControl andprevention(cdc),aremeetingtoestablishrequirementsforregulatingthe packaging,transportanddisposalofebolacontaminatedmedicalwaste. EbolaisaCategoryAInfectiousSubstanceand,underDOTJPHMSAregulations, requiresspecialpackagingandtransportation.medicalwastehaulersareonly permittedtotransportcategoryb RegulatedMedicalWaste.ThePHMSA packagingregulationsforcategoryainfectioussubstancesisnotwrittenfor EbolaorotherSelectAgentmedicalwaste. Forthemoment,DOTJPHMSAwillissueincidentspecificpermitsforEbola medicalcontaminatedwasteonacase#by#case(basis(and(for(short(time(only. Thesepermitscanbeappliedforonceanemergencycaseoccurs. ThedocumentcontainsthecurrentDOTJPHMSAtermsandconditionsfor generatorsandtransportersdealingwithebolacontaminatedmedicalwaste. Note,thiscouldchangeatanymomentasmoreislearnedduringcrisis. 2.PURPOSEANDLIMITATION: a.anemergencyspecialpermitauthorizesthetransportationincommerceof certainebolacontaminatedmedicalwasteforautoclavingorincineration.this specialpermitprovidesnorelieffromthehazardousmaterialsregulations (HMR)otherthanasspecificallystatedherein.Themostrecentrevision supersedesallpreviousrevisions. b.thesafetyanalysesperformedindevelopmentofthisspecialpermitonly consideredthehazardsandrisksassociatedwithtransportationincommerce. Thesafetyanalysesdidnotconsiderthehazardsandrisksassociatedwith consumeruse,useasacomponentofatransportvehicleorotherdevice,or otherusesnotassociatedwithtransportationincommerce. Page(1(of(9

7 DOT/CDC& &Temporary&Packaging&&& 3.PERMITEXPIRATION:60DAYSFROMDATEOFISSUANCE. NOTE:TheindustryishopingforDOT/PHMSApermitstobegovernedby thesametimeduringasusdotdiv.6.2 InfectiousWasteCategoryB permits. 4.REGULATORYSYSTEMAFFECTED:49CFRParts106,107and171J REGULATIONSFROMWHICHEXEMPTED:49CFR (a)inthat alternativepackagingisauthorized. 6.HAZARDOUSMATERIALS(49CFR ): Hazardous Materials Description Proper shipping name Hazard Class/ Division Identification Number Packing Group Infectious substances, affecting humans 6.2 UN2814 N/A 7.SAFETYCONTROLMEASURES: a.limitationsonsolidmaterialsthathavebeen CONTAMINATEDWITHTHEEBOLAVIRUS: (1)Thisspecialpermitauthorizesthetransportationincommerceofmaterials thathavebeencontaminatedwithoraresuspectedtohavebeen contaminatedwiththeebolavirusinthepackagingsystemdescribedbelow. (2)Innerpackagingsmustbeplacedintotheouterpackagingsinsucha mannerastominimizetheriskofdamagetothepackagings. Page(2(of(9

8 DOT/CDC& &Temporary&Packaging&&& b.packaging Theprescribedpackagingsareasdescribed below: (1)Acombinationpackagingsconsistingofthesecomponents: (i)outerpackaging:a95gallonun1h2drumtestedand certifiedtothepgiilevelforsolids.thedrummust becertifiedwithamaximumgrossmassof300kgor greater. (ii)innerpackagingsystem:theinnerpackagingsystem isacombinationpackageconsistingofthefollowing components: (A)A55gallonUN1H2drumtestedandcertified tothepgiilevelforsolidscontainingnomore than100kgofmaterial (B)Threeinnerplasticfilmbagswhichmeetthe requirementsbelow: (I)Aminimumfilmthicknessof1.5mils(0.0015inch);and, (II)Ismarkedandcertifiedbyitsmanufacturerashavingpassed: (1)ThetestsprescribedfortearresistanceinASTMD1922, StandardTestMethodforPropagationTearResistanceof PlasticFilmandThinSheetingbyPendulumMethod.Thefilm bagmustmeetatearingresistanceof480gramsinboththe parallelandperpendicularplaneswithrespecttothe lengthofthebag;and (2)ThetestsprescribedforimpactresistanceinASTMD1709, StandardTestMethodsforImpactResistanceofPlasticFilmby thefreejfallingdartmethod.thefilmbagmustmeetan impactresistanceof165grams. (III)Eachplasticfilmbagmustbesealedandsecurelyclosedwith tapetopreventthereleaseofanymaterialfromthebagif inverted. (IV)AllpackagingsmustbecompatiblewiththeEPAJregistered disinfectantthatisrecommendedbythecentersfordisease ControlandPreventionforuseasadisinfectantfortheEbolavirus. Page(3(of(9

9 DOT/CDC& &Temporary&Packaging&&& (C)AllUNStandardinnerandouterpackagingsmustbeclosedin accordancewiththemanufacturers instructions. (2)AmaximumofeightUN1H2drumsmeetingtherequirementsof paragraph7.b.(1)(ii)(a)abovecontainingthewastefromtheentertainment centernotpackagedinthespecifiedinnerfilmbagsmaybetransported whenpackagedinthe95gallonun1h2drums. (3)Amaximumofsevenpackagescontainingitemssuchasatelevision, metalchairsandboxspringthatcannotbeplacedininnerfilmbagsandin the55gallonun1h2drummaybetransportedwhendisinfectedand packagedasfollows: (i)decontaminatetheitemwithbleachinaccordancewithcenters fordiseasecontrolguidance.thenwipewithaminimumof3% hydrogenperoxidesolution. (ii)enclosetheiteminacommercialkingsizedmattressbagand securelysealallseamswithtapetoensurenomaterialcanescape. DisinfecttheoutersurfaceofeachbagwithanEPAJregistered disinfectantthatisrecommendedbythecentersfordiseasecontrol andpreventionforuseasadisinfectantfortheebolaviruspriorto insertingintothenextbag.repeatthisprocessforthreebags. (iii)placethebagsontoa6milpolyethylenesheetandcompletely enclosetheitem.securelysealallseamswithtapesomaterial cannotescapeanddisinfecttheoutersurfaceofthesheetwithan EPAJregistereddisinfectantthatisrecommendedbytheCentersfor DiseaseControlandPreventionforuseasadisinfectantfortheEbola virus.repeatthisprocesswithasecondsheet. (iv)ifpracticable,placethewrappeditemintothe95gallonun1h2 druminaccordancewiththeapplicableprovisionsonthisspecial permit. c.operationalcontrols (1)Onlyvehiclesoperatedbyanauthorizedtransportermaybeusedto transportmaterialsundertheseterms.transportationmayonlybefrom [SiteSpecificGeneratorLocation]oranotherlocationwithinthesame Page(4(of(9

10 DOT/CDC& &Temporary&Packaging&&& StateasdirectedbyStateorlocalauthorities,afternotifyingPHMSA,and thentransportedtothenearestappropriatedisposalfacilityavailableatthe timethematerialisofferedfortransportationwithoutadditionalloadingof thevehicle. (2)Priortoplacementofthewastematerialintheprimaryinnerpackaging thewastematerialmustbetreatedwithadisinfectantthatisrecommended bythecentersfordiseasecontrolandpreventionforuseasadisinfectant fortheebolavirus. (3)Aftertheprimaryinnerpackagingissealed,theexteriorsurfaceofthat innerpackagingmustbetreatedwithadisinfectantthatisrecommendedby thecentersfordiseasecontrolandpreventionforuseasadisinfectantor theebolavirus. (4)Priortoloadingintotheouterpackaging,theprimaryinnerpackaging mustbeplacedintoasecondaryplasticbagmeetingtherequirements specifiedinparagraphs7.b.(2)(i),(ii),(iii)and(iv).afterthesecondplasticbag issealed,theexteriorsurfacemustbetreatedwiththedisinfectantthatis recommendedbythecentersfordiseasecontrolandpreventionforuseasa disinfectantortheebolavirus. 5)Thesealedprimaryandsecondaryinnerpackagingsmustthenbeplaced intoathirdplasticfilmbagmeetingtherequirementsspecifiedinparagraphs 7.b.(2)(ii)(A),(B)and(C)ofthispermit.Afterthethirdplasticfilmbagis sealed,theexteriorsurfacemustbetreatedwithanepajregistered disinfectantthatisrecommendedbythecentersfordiseasecontroland PreventionforuseasadisinfectantfortheEbolavirus. (6)Thesealedplasticfilmbagsarethenplacedintothe55gallon UNIH2drum. (7)Thesealed55gallonUN1H2drummustbetreatedwithanEPAJ registereddisinfectantthatisrecommendedbythecentersfordisease ControlandPreventionforuseasadisinfectantfortheEbolavirusbefore Page(5(of(9

11 DOT/CDC& &Temporary&Packaging&&& beingplacedintotheouter95gallonun1h2drum. (8)Theouter95gallonUN1H2drummustremainclosedexceptwhenbeing filledwithinnerpackagingscontainingthematerialauthorizedbythisspecial permit. (9)Theexteriorofthe95gallonsalvagedrummustbetreatedwithanEPAJ registereddisinfectantthatisrecommendedbythecentersfordisease ControlandPreventionforuseasadisinfectantfortheEbolaviruspriorto loadinginthetransportvehicle. (10)Beforeloadingthepackageintoatransportvehicle,thegranteemust ensurethatthepackageisclosedandsealedtopreventthereleaseofany materialduringtransportation. (11)Loadingandunloadingthevehiclemustbeperformedusingmanual meanstothemaximumextentpracticable.forktrucksorothermechanicals meansmaynotbeusedforloadingorunloadingthevehicleunlessnoother optionexists. (12)Whileintransportation,thedoorsonthemotorvehiclebeingusedto transportthematerialauthorizedbythisspecialpermitmustbeclosedand lockedexceptwhenthevehicleisbeingloadedorunloaded. (13)Priortotransportation,thecarriermustperformanexternalvisual inspectionofthetransportvehicletodeterminethatitisclosedandfreeof leakage. (14)Thecarriermayonlytransportthevehicleloadedwiththematerialtoa finaldestinationthatisauthorizedbyapplicablelawsfortreatmentor disposalofsuchmaterials,withoutunnecessarydelayfromthetimethe carrier'smotorvehicleleavesthesiteoforigin. Page(6(of(9

12 DOT/CDC& &Temporary&Packaging&&& (15)Thecarriermusthaveawrittenspillresponseplanthatincludes provisionsforthedecontaminationofspilledmaterialsandforpersonal protectiveequipmenttobecarriedonthevehicleandusedtoprotectits employeesfromcontactwithinfectiousmaterialsinanyform. (16)Thecarriermustrespondtoanyreleaseorsuspectedreleasefroma packagethatoccursduringtransportation.theresponsemustinclude completeremovalofanyspilledmaterialanddecontaminationoftherelease site,vehiclesurfacesandexternalsurfacesofthepackageinvolved. (17)Eachmotorvehicleusedunderthetermsofthispermitmustbe decontaminatedinaccordancewithapplicablefederal,stateandlocallaws. (18)Eachcommercialmotorvehicleanddriverinvolvedinthisoperation mustbemadeavailableforacvsalevelihazardousmaterialsinspection priortotransport.shouldanyviolationsofthecvsanorthamerican StandardOutJofJServiceCriteria(2014edition)bediscoveredduringthe inspection,theviolation(s)mustbecorrectedpriortotransportinghazardous materialsunderthisspecialpermit. 8.SPECIALPROVISIONS:Acurrentcopyofthisspecialpermitmustbe maintainedateachmedicalortreatmentfacilitywherethepackageisoffered fortransportation. 9.MODESOFTRANSPORTATIONAUTHORIZED:MotorVehicle. 10.MODALREQUIREMENTS:Acurrentcopyofthisspecialpermitmustbe carriedaboardeachmotorvehicleusedtotransportpackagescoveredbythis specialpermit.thecarriershallusehazardousmaterialsrouteswhere designatedandpracticable. 11.COMPLIANCE:Failurebyapersontocomplywithanyofthefollowingmay resultinsuspensionorrevocationofthisspecialpermitandpenalties prescribedbythefederalhazardousmaterialstransportationlaw,49u.s.c. 5101etseq: Page(7(of(9

13 DOT/CDC& &Temporary&Packaging&&& oalltermsandconditionsprescribedinthisspecialpermitandthe HazardousMaterialsRegulations,49CFRParts171J180. opersonsoperatingunderthetermsofthisspecialpermitmust complywiththesecurityplanrequirementinsubpartiofpart172of thehmr,whenapplicable. oregistrationrequiredby etseq.,whenapplicable. Each"Hazmatemployee",asdefinedin 171.8,whoperformsafunction subjecttothisspecialpermitmustreceivetrainingontherequirementsand conditionsofthisspecialpermitinadditiontothetrainingrequiredby through Nopersonmayuseorapplythisspecialpermit,includingdisplayofits number,whenthisspecialpermithasexpiredorisotherwisenolongerin effect. Title49oftheUnitedStatesCode,Section5117(a)(2)nowauthorizesa specialpermit(formallyan exemption )tobegranteduptotwoyearsfor newspecialpermitsanduptofouryearsforrenewals. 12.REPORTINGREQUIREMENTS:Shipmentsoroperationsconductedunderthis specialpermitaresubjecttothehazardousmaterialsincidentreporting requirementsspecifiedin49cfr JImmediatenoticeofcertain hazardousmaterialsincidentsand171.16jdetailedhazardousmaterials incidentreports.inaddition,thegrantee(s)ofthisspecialpermitmustnotify theassociateadministratorhazardousmaterialssafety,inwriting,ofany incidentinvolvingapackage,shipmentoroperationconductedunderterms ofthisspecialpermit. JJJJJJJJJJJ These&terms&and&conditions&require&no&special&resources&or&expertize&beyond& those&commonly&performed&for&normal&regulated&medical&waste,&other&than&the& multiple&liner&requirements&and&packaging&details.& & Page(8(of(9

14 DOT/CDC& &Temporary&Packaging&&& Should&you&have&an&Ebola&incident,&notify&MedAssure&immediately,&so& preparations&can&be&made&to&manage&your&waste&according&to&these&rules.& & If&you&have&any&questions,&please&contact&Joe&Delloiacovo&at&MedAssure:& Direct&Office&Line:&732Q228Q8681& 149(Yellowbrook(Rd. Farmingdale,(NJ(07727( Page(9(of(9

15 FactSheet Cleaning and Decontamination of Ebola on Surfaces Guidance for Workers and Employers in Non-Healthcare/ Non-Laboratory Settings Workers tasked with cleaning surfaces that may be contaminated with Ebola virus, the virus that causes Ebola hemorrhagic fever (EHF), must be protected from exposure. Employers are responsible for ensuring that workers are protected from exposure to Ebola and that workers are not exposed to harmful levels of chemicals used for cleaning and disinfection. Guidelines for cleaning and disinfection Use appropriate protective equipment

16 Disinfectants for Ebola virus Guidelines for waste disposal Use appropriate respiratory protection Follow applicable OSHA standards Occupational Safety

17 and Health Act Assistance for Employers Additional OSHA resources DTSEM FS /2014