Alabama Department of Public HealthBureau of Clinical Laboratories

Jeannine Parker, Trainer

ObjectivesReview additions and changes to the IATA and DOT

regulations.Review how to classify, mark, label, and document

Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814).

Review the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens.

Review the exceptions to the regulations and list when they can be used.

General PhilosophyBefore any package of dangerous goods is offered for air

transport, the shipper must comply with certain requirements:Information must be provided so you can carry out your

responsibilities as a shipperOne must ensure that the article is not prohibited from air

transportBefore packaging and shipping, all relevant personnel must have

received training in accordance with their responsibilitiesAll dangerous goods are packed in compliance with the

regulations

Training CurriculaGeneral Familiarization

Familiar with the general provisions of the regulationsFunction Specific Training

Detailed training in the requirements applicable to the function for which that person is responsible

Safety TrainingHazards presented by dangerous goods, safe handling, and

emergency response proceduresOSHA Training may substitute for this training

Function Specific TrainingThis training is for Packaging and Shipping of Infectious

SubstancesNot gasolineNot oilNot explosivesNot gases

Just Infectious Substances

Safety Training

IncludesSafe handling HazardsEmergency response in the event of an incident

Security TrainingAwareness of security risks associated with dangerous

goods transportation

Training IATA 1.5 Training Requirements

1.5.0.2 Personnel identified in the categories specified… must be trained or training must be verified prior to the person performing any duty specified…

1.5.0.3 Recurrent training must be provided within 24 months of previous training to ensure knowledge is current.

1.5.0.4 A test must be provided following dangerous goods training to verify understanding of the regulations.

Training, cont’dWho needs to be trained?

Any persons who: Packages a hazardous material

6.2 materials Dry ice

Prepares materials or documentation Classifies, documents a 6.2 material Transports a hazardous material

Courier in a motor vehicle (exceptions) Air plane Vessel

Training, cont’dEmployer’s Responsibilities

Provide training or verify employee was trainedTest was given and passedDocument the training

Hazmat Safety Security

Certify employee trained

Training, cont’dRecordkeeping

Record of Training Employee name Most recent date trained Description of training Description of training materials/where kept Name and address of trainer

Record of training kept as long as employed

Regulators/RegulationsUnited Nations

UN Committee of Experts (UNCOE) writes the UN Recommendations on the Transport of Dangerous Goods Model Regulations.

International Civil Aviation Organization (ICAO)the specialized agency of the United Nations whose

mandate is to ensure the safe, efficient and orderly evolution of international civil aviation. They are responsible for the Technical Instructions for the Safe Transport of Dangerous Goods by Air .

Regulators/RegulationsInternational Air Transport Association (IATA)

Promulgates the Dangerous Goods Regulation (DGR), based on the Technical Instructions from ICAO, and is printed every January.

IATA is organized in a two-tier format Trade Association (technical, legal, financial, traffic services and

most agency matters) Tariff Coordination (passenger fares, cargo rates, and related

conditions and charges)

Regulators/RegulationsUS Department of Transportation (DOT)

Regulates any hazardous material traveling on the roadways, waterways, and railways of the US

Promulgates regulations to the Code of Federal Regulations (CFR) CFR Title 49 (specific for DOT)

US Postal Service (USPS)Regulates all mailPromulgates US Postal Regulations

Shipper’s Responsibilities

You are ultimately responsible for the package from

beginning to end

What are your Responsibilities?

ClassifyIdentifyPackMark & LabelDocument (if required)

IATA Dangerous Goods RegulationApplicability – applicable to any dangerous good that will

travel by airLimitations – Forbidden/Hidden Dangerous Goods as well as

Exceptions for small quantities (none for Infectious Substances) and Limited Quantity Exceptions (no provisions for Infectious Substances), USG-01 Variation: comply with DOT regulations

Classification – Classifying the hazardous material Identification – Identifying the material as per Proper Shipping

Name and related Technical NamePacking – selecting the proper packaging and using it

according to manufacturer's instructions

DOT RegulationsCFR Title 49 Transportation Parts 100-185 comprise the Hazardous Materials

Regulations (HMR)Governs the shipment of all dangerous goods that transit

through the US by any mode (rail, air, road, sea, etc.)HMR based on the UN Model Regulations

ClassificationSo, just what are dangerous goods?IATA says:

“Articles or substances which are capable of posing a risk to health, safety, property, or the environment and which are shown in the list of dangerous goods in these regulations or which are classified according to these regulations”

IATA DGR 1.0

ClassificationDOT says:

“a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and has been designated as hazardous under section 5130 of Federal Hazardous Materials Transportation Law (49 U.S.C. 5130).” 49 CFR 105.5

How do you Classify your Substance?

Definition of an Infectious SubstanceSubstances which are known or are reasonably expected to

contain pathogens. Pathogens are micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals.

IATA 3.6.2.1.1

9 Hazard Classes1Explosives2Gasses3Flammable liquids4Flammable solids5Oxidizing

substances

6Toxic/Infectious7Radioactive8Corrosive9Miscellaneous

Class 6 Toxic and Infectious SubstancesClass 6 is divided into two Divisions

6.1- Toxins/Poisons6.2- Infectious Substances

Division 6.2 is divided into two categoriesCategory A Infectious SubstancesCategory B Biological Substances

Other Recognized CategoriesHuman Exempt

Specimens with minimal likelihood of a pathogenGenetically modified organisms and micro-organisms

(GMOs) Pathogenic GMO must be designated Category A or BNon-pathogenic GMO

Medical or clinical wastes

DefinitionsCategory A – assigned UN 2814

An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.

Proper Shipping NameInfectious substance, affecting humans

(Technical Name)

DefinitionsCategory B – assigned UN 3373

An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373.

Proper Shipping Name is Biological Substance, Category B

Some Other DefinitionsPatient Specimen

are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue swabs, body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention.

IATA 3.6.2.1.4

Definitions

CulturesAre the result of a process by which pathogens are

intentionally propagated. This definition does not include patient specimens as defined in 3.6.2.1.4.

IATA 3.6.2.1.3

Category A UN 2814

An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.

Proper Shipping NameInfectious substance, affecting humans

(Technical Name)

Table 3.6.D

Table 3.6.D is not exhaustive. Infectious substances which do not appear in the Table but do meet the criteria for inclusion, must be assigned Category A.

Category BUN 3373

An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373.

Proper Shipping Name is Biological Substance, Category B

Exempt Human Specimen Category“Patient specimens for which there is minimal likelihood

that pathogens are present are not subject to these regulations if the specimen is packed in a packaging which will prevent any leakage and which is marker with the words “Exempt Human Specimen” or “Exempt Animal Specimen”, as appropriate. The packaging must meet the following conditions:

Exempt Human SpecimensThe packaging must consist of three components:

A leak-proof primary receptacleA leak-proof secondary packagingAn outer packaging of adequate strength for its capacity,

mass, and intended use, and with at least one surface having minimum dimensions of 100 mm X 100 mm

Exempt Human SpecimensFor liquids, absorbent material in sufficient quantity to

absorb the entire contents must be placed between the primary receptacles and the secondary packaging, so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material

When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them.

Non-Regulated MaterialSubstances which do not contain infectious substances or

substances which are unlikely to cause disease in humans or animals

Substances which contain micro-organisms which are non-pathogenic to humans or animals

Substances in a form that any present pathogens have been neutralized or inactivated such that they not longer pose a threat

Non-Regulated MaterialEnvironmental samples (including food and water

samples) which are not considered to pose a significant risk of infection

Dried blood spots collected by applying a drop of blood onto absorbent material, or fecal occult blood screening tests and blood or blood components which have been collected for the purpose of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation.

DOT Motor Vehicle Exception“A Division 6.2 material, other than Category A Infectious

Substance, contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or a biological product, when such materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport such materials. Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination.” 49 CFR 173.143(b)(10)

Dry Ice UN 1845Class 9 Miscellaneous

Packing Group III – low danger Three packing groups, from high (PG I) to low danger

Packing Groups so not apply to Infectious SubstancesPacking Instruction 954

Package must allow for the release of gas (CO2) Proper shipping name and weight in kilograms must appear on

the package

IdentificationAssigning a Proper Shipping Name to a Dangerous GoodProper Shipping Name (PSN) for 6.2 Category A :

Infectious Substance, affecting humans Assigning a four digit ID number by the UN

UN 2814 (Cat A)UN 3373 (Cat B)UN 2900 (animals)UN 1845 (dry ice)Some DGs require a Technical Name, listed in parentheses,

after the PSN (Suspect Category A, Infectious Substance)

Proper Packaging6.2 Packaging must

Be TestedMeet regulatory specificationsBe certifiedUsed as a unitBe marked with appropriate certification markings

Proper PackagingTriple packaging concept

Primary receptacles must be leak-proofSecondary packaging must be leak-proof and meet the

regulation for pressure differentialOuter packaging must meet the regulations for

Leakage Sturdiness Rigidness markings

Proper PackagingLeak-proof Primary Receptacle

Blood tubesUrine transport tubesMedia slantsMetal-crimped glass vialsMust be cushioned if more than one primary in a secondary

packageLiquid contents primaries must have sufficient absorbent

material to absorb the entire contents if the primary breaks during transport

Must have a positive means of securing the top, i.e., parafilm or tape

Proper PackagingSecondary Packaging

Must be leak-proofMust be able to contain the contents of the primaries

Either Primary or Secondary must be able to withstand an internal pressure differential of 95 kPa in a temperature range of -40°C to 55°C.

Proper PackagingOuter Package

Must meet the design type testing requirements Drop test of 9 m Puncture test of steel rod, weighing 7 kg, dropped from 1 m w/ intent to

rupture primary Water spray of 5 cm/hr for one hour before the drop test

Must be rigid and of adequate strength for its capacity, weight, and intended use

Must bear the UN Specification Mark4G/Class 6.2/02USA/+AX1852

Must be labeled properly

UN

Proper PackagingEntire UN certified 6.2 package must be used as an entire

unitNo substitutions of secondary packagingShould not add or cover up the 6.2 labelName and telephone number of the Responsible Person

must appear on the outer packageSmallest dimensions at least 100 mm X 100 mm (4 inches)

Proper PackagingCategory B

“packaging must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport…Packaging must be constructed and closed so as to prevent any loss of contents….”

Proper PackagingCategory B

Must use the triple packaging conceptPrimaries must be leak-proof cushioned such that breakage cannot occurPrimaries that contain liquid must have sufficient absorbent material to

absorb the entire contents of the primariesPositive means of securing the top, i.e., parafilm or tape

Secondary packaging must be leak-proofSecondary must meet the pressure differential requirement Unit must withstand a drop test of at least 1.2 m

Proper Packaging

Packing Instructions (PI)Category A PI 620

Triple packaging conceptPrimary receptacles must be leak-proofSecondary packaging must be leak-proof and meet the

regulation for pressure differentialItemized List of Contents must be included between

secondary and outer packaging Proper Shipping Name or Suspect Category A Infectious

Substance Number of vials/tubes/etc. included

Packing Instructions (PI)Category A PI 620, cont’d

Outer packaging must meet the regulationsUnit packaging must be used as a unit. Fragile primaries

must have cushioning and/or absorbent material (or both if liquid) and the absorbent material must be sufficient to absorb all the contents of the primaries if they break

Must not pack other materials in with Category A

Category A, 6.2 Packaging

Packing Instructions (PI)Category B PI 650

Triple packaging requiredPrimary receptacles must be leak-proof

Primary receptacle must be packed in secondary packaging …so that they cannot break, be punctured, or leak

Secondary packaging must be leak-proof and meet the regulation for pressure differential Itemized list on contents between primary & secondary

Proper Shipping Name Number of vials/tubes/etc. included

Packing Instructions (PI)Category B PI 650, cont’d

Leakage from a primary cannot compromise the integrity of the cushioning material or the outer package

Fragile primaries must have cushioning and/or absorbent material (or both if liquid) and the absorbent material must be sufficient to absorb all the contents of the primaries if they break

Category B Biological Substance

Dry Ice PI 954 Dry ice must be placed outside the secondary but in the

outer packageSupport other than the dry ice must be provided for the

secondary packagePackaging must be designed and constructed to permit

the release of CO2 gas to prevent a build-up of pressureUse a styrofoam-lined cardboard box for dry ice

shipments

Quantity LimitsCategory A

50 ml/kg quantity limit on passenger airplanes

Category BA single primary receptacle is limited to 1 L

and the entire package must not exceed 4 L

Marking and LabelingPackages are marked and labeled to give information

about the contents, the hazard within, and any special handling requirements.

All markings and labels should be placed so they do not cover any other markings and labels.

Difference between a mark and a label

Marking and LabelingMarking

Name and address of shipper (Phone # is recommended)Name and address of the consignee (Phone # is

recommended)Name and telephone number of the Responsible Person

(required for Cat A and recommended for Cat B)Proper Shipping Name but no technical nameUN ID numberQuantity of DG (required for Cat A and Dry Ice)

Marking and LabelingCategory A Label Category B Marking

Handling LabelsOrientation Labels Cargo Aircraft Only Label

Dry Ice Markings and LabelsDry Ice Hazard Label Dry Ice Marking for Package

Labels and MarkingsCategory A Category B

DocumentationShipper’s Declaration of Dangerous Goods

Air Waybill

DocumentationShipper’s Declaration of Dangerous Goods

Use the correct form in the correct mannerEnsure information is accurate, easy to ID, legible and

durableEnsure form is properly signedEnsure the shipment has been prepared according to the

regulations

DocumentationShipper’s Declaration of Dangerous Goods

Must be in color (red & black, or red on white)Must be in EnglishMust be letter sizeMust produce three copies, FedEx requires four

One for your records Two for carrier’s records One stays with the package

FedEx requires it to be typed or computer-generated, using their software

Under Additional Handling Information, the Responsible Person’s name and telephone number must be included

Air WaybillHandling Information Section

“For Un 3373, it is only necessary to show the text…… and the number of packages.”

Safety TrainingHazards presented by dangerous goods, safe handling, and emergency response procedures

HazardsInhalationIngestionContact

Safe HandlingPPESpill Clean-upDisposal

Emergency Response“Information that can used in the event of an incident..”Emergency Response Guidebook

Security AwarenessSecurity awareness training should address:

Nature of security risks Theft, loss, or release

Recognition of security risks How, when, or where along the chain of transport (or transport

within your facility) can the event occur?Methods to address and reduce the risks identified

How does one secure a package?Actions to be taken in the event of a security breach

Who do you call, what do you do when a breach has been discovered?

Security PlanShould have a written Security PlanPlan should include:

Assessment of transportation security risks Personnel security Unauthorized access En route security

Copies made available to employees and revised and updated as needed

49 CFR Part 172, Subpart I

TESTApply the appropriate,

proper labels and markings to the boxes and complete any required paperwork.