2 Course Content Background information Infectious substances Category A: classification, packaging, labeling and documentationCategory B classification, packaging, labeling and documentationExempt human specimensClass 9 shippingDry Ice
3 Dangerous Goods, Definition: Materials or substances having hazardous properties which, if uncontrolled, are capable of posing a risk to health, safety, property or the environment.
4 If you don’t value life, other reasons for concern: Civil penalty for individual up to $50,000 for each violationCriminal penalty for individual up to $500,000 and/or imprisonment up to 5 yearsPenalties double if there is serious injury or deathIn addition to the individual, the institution may be charged
5 Regulatory Authorities UN International Civil Aviation Organization (ICAO)International Air Transport Association (IATA)Department of Transportation (DOT)/Federal Aviation Administration (FAA)United States Post Office (USPS)Individual Air Carriers (FedEx, Alaska Airlines)
6 Regulations IATA Dangerous Goods Regulations Department of Transportation 49 CFRDomestic Mail Manual – Publication 52
7 IATA Dangerous Goods Regulations Key PointsBased on UN ModelIn general, are the most restrictiveDOT will acceptPost Office will accept
8 Training Requirements Anyone who handles, offers for transport, or transports dangerous goods must be trained to perform the duties required by their employer.Three areas of training are required;General Awareness/Familiarization Training – Training designed to provide familiarity with the general requirements of dangerous goods regulationsFunction Specific Training – Training that specifically addresses the functions the employee performs: for example, preparing and offering a shipment of infectious substances and the use of dry ice in transportSafety Training – Training that instructs the employee of hazards associated with dangerous goods as well as safe handling and emergency response procedures – OSHA Blood Borne Pathogen (BBP) standard (29 CFR ) may be used to meet DOT requirements
9 Employer Certification Requirements TestingDemonstrationOralWrittenCertificate of TrainingEmployer must have for each employeeTrainee’s nameDate of examDescription of training materials used to meet training requirementsName and address of trainerTest ScoreSpecific topics for which the employee is traineeCertificate Validity2 years for IATA3 years for DOTAs needed
11 Shipper’s Responsibilities ClassifyIdentifySelect proper packagingPackingMark and labelDocumentMake arrangements
12 Operator’s Responsibilities Must detect errorsUse acceptance checklistEnsure safe loading, storage, and transportInspect for damage or leaksReport any problems to the proper authorities
13 Receiver’s Responsibilities Help obtain import permits, if neededInspect package for damage or leaksVerify itemized list of contentsReport back to shipperReport leaking packages to appropriate authority
15 Classes of Dangerous Goods Nine classes of dangerous goods (class indicates type of hazard not degree)Class 6 Toxic and Infectious SubstancesDivision 6.2 Infectious SubstancesClass 9 MiscellaneousDry Ice
16 Infectious Substances A material known or reasonably expected to contain a pathogenPathogen – a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion), that can cause disease in humans or animalsInfectious substances come in 2 forms:Cultures – an infectious substance containing a pathogen that is intentionally propagatedPatient Specimens – human or animal material collected directly form humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and it components, tissue and tissue swabs, body parts, and specimens in transport media.Infectious substances have multiple categories:Category A – An infectious substance in a form capable of causingPermanent disabilityLife threatening or fatal to otherwise healthy humans or animalsOccurs upon exposureCategory B – An infectious substance that is not in a form generally capable of causingLife threatening or fatal to other wise healthy humans or animalsExempt Human Specimens – Specimens that do not, or are not likely to contain an infectious substance, are not subject to the regulations if the specimen is packed in a manner that prevents leakage
17 Examples of Category A Substances Bacillus anthracis (cultures only) Dengue virus (cultures only)Coccidioides immitis (cultures only) Rabies virus (cultures only)Lassa virus Hepatitis B virus (cultures only)Shigella dysenteriae type 1 (cultures only) Yersinia pestis (cultures only)Examples of Category B SubstancesStaphylococcus aureus Escherichia coli, verotoxigenic,Cryptococcus neoformans Streptococcus pneumoniaeRabies virus Streptococcus pyogenesHepatitis B virus Stenotrophomonas maltophiliaExamples of Exempt Human SpecimensBlood or urine specimens for cholesterolUrine screening for drugs or alcoholBiopsies to detect cancerSpecimens for antibody detection
18 Non-Regulated Materials Unless the following meet the criteria for inclusion in another class or division, are not subject to the regulations:Substances with a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the so it cannot case disease when exposure to it occursMicro-organisms that do not cause disease in humans or animalsSubstances that have been treated so that the pathogens have been neutralized or deactivatedFoodstuffs and environmental samples, such as water or a sample of dust or mold which would not be considered a significant source of infectionDried blood spots or specimens for fecal occult blood detection placed on absorbent filter paper or other material and blood, blood components, tissues or organs collected for the purpose of transfusion or transplantation
20 Using the Dangerous Goods List Name (Proper Shipping Name)UN No.Class or divisionSubsidiary riskHazard LabelsSpecial provisionsUN packing groupBiological substance, Category B33736.2NoneInfectious substance, affecting humans2814InfectiousA A140Infectious substance, affecting animals, only2900Dry ice18459MiscellaneousA A151 No longer III
21 Proper Shipping Name UN Numbers Hazard Labels Special Provisions All dangerous goods must be assigned a proper shipping nameProper shipping names must be spelled exactly as they appear on the list of dangerous goodsUN NumbersEach proper shipping name is assigned a UN numberThe UN number can be used to identify the dangerous goodThe UN number is useful when English is not the native languageThe UN number appears alongside the proper shipping nameHazard LabelsHazard labels indicate the class or division of dangerous goodsSpecial ProvisionsSpecial provisions give detailed information in the handling of packages containing the specific dangerous good
22 Special Provisions A 48 The completed package does not require testing Shipments involving body parts, organs or whole bodies infected with a Category A Infectious substances may exceed the quantity limits for Passenger or Cargo aircraftA140The proper shipping name for Category A Infectious substances must be supplemented with the technical name (scientific name) on the Shipper’s Declaration for Dangerous goods. The technical name is not recommended to be marked on the outside of the package. If the technical name is not known or if the specimen is proficiency testing, the technical name “suspected Category A Infectious substance” must be included.A151Quantity limits for dry ice do not apply when dry ice is used as a refrigerant in pallets.
23 Proper PackagingDangerous goods need to be packed in such a way that the specimen is protected against leakage or spillage during transportQuantity Limits and Packing InstructionsPassenger AircraftCargo AircraftName (Proper Shipping Name)UN No.Class or divisionSubsidiary riskHazard LabelsSpecial provisionsExcepted QuantityPacking instructionMax net quantity per packageBiological substance, Category B33736.2NoneEO6501 L primary 4 L or 4 kgInfectious substance, affecting humans2814InfectiousA A14062050 ml or g4 L or 4 kgInfectious substance, affecting animals, only2900Dry ice18459MiscellaneousA A151954200 kg
24 Proper Packaging Continued Triple packaging required for:Category ACategory BExempt human specimenUN specific packaging required for Category AManufacturer’s test packaging systems and copies of these reports must be shown to the inspectors upon request
25 Comparison Chart of Sample Handling & Packaging StepBiological Substance, Cat.B (UN3373) PI650Solid CO2/Dry Ice PI954Infectious Substance (UN2814 or UN2900) PI6201Place sample in a leakproof primary receptacle or vial. Vial caps must be sealed with tape, paraffin, parafilm. The volume must be 1L or less.If shipped by ground--not regulated, else it must be put in a container that allows the release of pressure and prevents rupture.Prepare a Dangerous Goods (DG) Declaration. Packaging must be UN certified. Place sample in a leakproof primary receptacle or vial. Vial caps must be sealed with tape , paraffin, parafilm.2Sample vial is then placed in a leakproof secondary packaging. Examples of secondary packaging are: plastic canister, sealed plastic bag, sealed styrofoam, screw cap can. Total volume of samples must be 4L or less. Primary or secondary package must be able to withstand and internal pressure of 95 kPa and a temperature range of -400to 550C.Place the dry ice outside the secondary packaging.Sample vial is then placed in a leakproof secondary packaging. Examples of secondary packaging are: plastic canister, sealed plastic bag, sealed styrofoam, screw cap can. Either primary receptacle or secondary must be able to withstand an internal pressure of 95kPa and a temperature range of -400to 550C.3Place absorbent material between primary receptacle and secondary packaging. Examples of absorbent material are: cellulose wadding, cotton balls, paper towels, commercial absorbent packets. Cushioning is required if multiple primary containers are present.Mark the net weight of the solid dry ice on the outside of the package in kilograms.Place absorbent material between primary receptacle and secondary packaging. Examples of absorbent material are: cellulose wadding, cotton balls, paper towels, commercial absorbent packets. Multiple primary receptacles must be cushioned.4Place the above in an outer packaging. Examples are corrugated cardboard box, wood box, rigid plastic cooler, rigid plastic box. Side of box must not be less than 100 mm. Entire package must be able to pass drop test of 1.2 meters.For infectious substances (column on right): •Declare the dry ice on the Dangerous Goods (DG) label with complete shipping name and UN ID# UN1845. •Use a Class 9 Miscellaneous DG label.Place the above in an outer rigid packaging. Examples are corrugated cardboard box, rigid plastic cooler, rigid plastic box. The smallest external dimension must be at least 100mm. Outer packaging must bear the UN specification mark.5Enclose an itemized list of contents between the secondary packaging and outer packaging.N/A6If air waybill is used, under Nature and Quantity of goods write Biological Substance, cat. B UN3373. Write the Name and Telephone number of person responsible for shipment on outside of package or airway bill.Write the Name and Telephone number of person responsible for shipment on outside of package. Write shipper and consignee information on outside of package. Orientation labels should be on opposing sides.7Place a UN3373 diamond shaped sticker on outside of box. Orientation labels should be on opposing sides.Class 9 Miscellaneous Hazard label. Class 9 Proper Shipping Name, UN Number and quantity label on the outside of the package.Place: 1. Proper shipping Name and UN no. label on the outside of the package. 2.The division 6.2 Hazard Label on the outside of the package. 3. complete dangerous goods form.
26 Packaging for Exempt Human Specimens The following is required for shipping exempt human specimens:Triple packaging consisting ofLeakproof primary receptacleLeakproof secondary packagingOuter packaging must be strong enough to safely contain contents throughout the trasport.minimum size for outer package is 100mm on one surfaceAbsorbent material must be placed between the primary and secondary packagingMultiple primary receptacles must be cushionedPrimary receptacles must be secured with positive means (tape, paraffin, parafilm)
27 Miscellaneous General Packaging Rules Reuse is allowed if outer shipper is in good conditionOther dangerous goods cannot be packed with infectious substances except for:Preservatives & transport media < 30 ml per primary receptacleDry ice
28 Packaging Consideration for Refrigerants Types of refrigerants that may be used:Dry iceGel packs or phase change material (PCM) packsLiquid nitrogenWet iceAll refrigerants are to be placed outside the secondary packagingIf wet ice is used, it must be placed in a leakproof containerDry ice must never be placed inside a sealed primary receptacle or sealed secondary packaging due to the risk of explosion. The packaging must permit the safe release of carbon dioxide gas.If liquid nitrogen is used, the liquid nitrogen must be absorbed in porous material such that there is no free standing liquid nitrogen – “dry shipper.” Other special conditions apply when shipping with liquid nitrogen where there is free standing liquid nitrogen in the package.No shipper’s declaration is required if dry ice is used to refrigerate category B substances.
29 Marking and LabelingShipping information requiredShipper informationConsignee InformationName and telephone number of responsible personAppropriate hazard labelsAppropriate handling labels
31 Handling LabelsOrientation label for liquid dangerous goodsNEW (1/1/2013)OLDCargo aircraft only – Required when primary container of Category A is > 50 ml
32 Example of a Category A Shipment Without Dry Ice Infectious substances, affecting humansUN2814 ( )ShipperConsigneeResponsible PersonName & telephone No.UN
33 Example of a Category A Shipment With Dry Ice Infectious substances, affecting humansUN2814 ( )mlsShipperConsigneeResponsible PersonName & telephone No.UN
34 Example of a Category B Shipment Without Dry Ice ShipperConsigneePerson ResponsibleTelephone No.
35 Example of Category B Shipment With Dry Ice ShipperConsigneePerson ResponsibleTelephone No.
36 Example of Exempt Patient Specimen Without Dry Ice ShipperConsignee
37 OverpacksEach package placed into an overpack must be individually marked, labeled and addressed as if it were being shipped independently. Once packages are placed in the overpack, the marks, labels and other information has to be reproduced on the overpack.ShipperConsigneePerson ResponsibleTelephone No.OVERPACK
38 Shipper’s Declaration A document called the “Shipper’s Declaration for Dangerous Goods” must accompany every Category A package.At least 3 copies must be must be preparedThe shipper keeps one copyThe carrier takes 2 and delivers one to the consigneeThe shipper must keep the Shipper’s Declaration at least 2 years and include the date of acceptance by the initial carrierA Shipper’s Declaration is not required for dry ice UN 1845 unless it is used as a refrigerant for dangerous goods which require a Shipper’s Declaration
39 FedEx Requirements for Shipper’s Declaration FedEx requires all Shipper’s Declarations to be prepared using only the following methodsFedEx approved vendor software applicationPreapproved shipper proprietary software, orFedEx Express Automated Shipping Solutions that have dangerous goods error checks
42 Emergency Response for Infectious Substances Any person responsible for carriage or receipt of packages containing infectious substances who becomes aware of damage to or leakage from such a package, must:Avoid handling the package unless wearing appropriate PPEInform the appropriate local Public Health authorityNotify the shipper and the consignee and person responsibleIn case of incidents involving Category A Infectious substances, call the 24-hour emergency response number indicated on the Shipper’s DeclarationKeep unauthorized personnel awayDo not allow clean-up of the spill or disposal of the material except under the supervision of an expert
43 Incident ReportingAnyone who is in contact with a dangerous good when an incident occurs must report the incident to the appropriate authorities in accordance with the authority’s requirements. The following information needs to be relayed:Name of reporterName and address of person represented by reporterPhone number where reported can be contactedDate, time, location of incidentThe extent of injury, if any;Class or division, proper shipping name and quantity of hazardous materials involved, if such information is available; andType of incident and nature of hazardous material involvement and whether a continuing danger to life exists at the scene.Telephone reporting is required whenever:A hazardous material has been directly involved in:The death of a personA person receiving an injury required hospitalizationThe general public is evacuated for one hour or more;A major transportation artery or facility was closed or shut down for one hour or more; orThe operational flight pattern or routine of an aircraft was altered;Fire, breakage, spillage, or suspected contamination occurs involving an infectious substance other than a regulated medical waste;A situation exists of such a nature that, in the judgment of the person in possession of the hazardous material, it should be reported to the CDC even though it does not meet the above criteria
44 Detailed Incident Reports 49CFREach person in physical possession of a hazardous material at the time that any of the following incidents occurs during transportation (including loading, unloading, and temporary storage) must submit a Hazardous Materials Incident Report on DOT Form F within 30 days of discovery of the incident.Examples of incidents requiring detailed incident reportsAny of the immediate reporting incidentsAn unintentional release of hazardous materialAn undeclared hazardous material is discoveredOnline copies of the report are available at: https://hazmatonline.phmsa.dot.gov/incident/An incident report must be retained for 2 years at the reporter’s place of business. The report must be updated within the first year if:A death occurs from injury caused by the hazardous materialThere was a misidentification of the hazardous materialAdditional damage, loss or related cost was incurred and not know at the time of the incident
45 Security Awareness Training Any company or institution who handles or transports dangerous goods should train any staff in contact with the dangerous goods concerning the potential security risks associated with the dangerous goods.Dangerous goods should only be offered to operators that have been appropriately identified.This training should include all aspects of security risks including:Nature of the risksRecognition of risksPractices used to reduce risksProcedures for a security breachSecurity training must be in accordance with a national security plan or equivalent level of trainingInitial training for hazmat employees should occur within 90 days after employmentRecurrent training should be performed whenever there are changes to the security protocols or at least every 2 years and the employer must retain records of security trainingThe following are suggested areas for security awareness and best practices:Restrict access to dangerous goods only to trained and qualified staffEscort visitors and other unauthorized personnelRecord entry into sensitive areas and the purpose of the visitRecord the identity of the escort and the times of entry and exitEnsure that doors and cabinets are locked when staff is not presentMonitor area remotely when staff is not in the areaProtect the chain of custody by using tamper-evident methods as it relates to your packageCreate an audit trail for specimensConsider using serialized packaging
46 Security PlanAny shipper or operator who handles and/or transports Category A infectious substances should adopt a security plan to guard against potential incidents.The security plan must include an assessment of transportation security risks for shipments of hazardous materials, including site-specific or location-specific risks associated with facilities where the hazardous materials are prepared for transportation, stored, or unloaded incidental to movement, and appropriate measures to address the assessed risks.At a minimum, the security plan must include:Measures to confirm information provided by job applicants hired for positions that involve access to and handling of the hazardous materials covered by the planMeasures to address the assessed security risks of shipments of dangerous goods covered by the security plan enroute from origin to destination, including shipments stored incidental to movement.Identification by job title of the senior management official responsible for overall development and implementation of the security plan.Security duties for each position or department that is responsible for implementing the plan or a portion of the plan and the process of notifying employees when specific elements of the security plan must be implemented.A plan for training dangerous goods employees in accordance with the regulations.
47 Security Plan, Continued The security plan must include:Transportation security risk assessmentBe in writingBe reviewed annually and revised/updated as necessaryBe available to employees who are responsible for implementing it and be consistent with personnel security clearance or background investigation restrictions and a demonstrated need to knowNotification of employees when the plan is updated or revisedBe available to appropriate officials when requested
48 References IATA Dangerous “Goods Regulations, 52 Edition, Canada, 2011 SafTPak, Compliance Training Reference Manual for the Safe Transport of Division 6.2 Infectious Substances, Biological Specimens, Dry Ice and Related materials, Edmonton, Alberta, 2011Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations, 49CFR