shipping division 6.2 dangerous goods, patient specimens & dry ice august 2012

Shipping Division 6.2 Dangerous Goods,Patient Specimens

& Dry Ice

August 2012

Topics

♦ Category A Infectious substances

♦ Category B Infectious substances

♦ Exempt patient specimens

♦ Genetically modified organisms

♦ Dry ice

♦ Liquid nitrogen dry shippers

♦ Liquid nitrogen wet shippers

♦ Limited and excepted quantities of some dangerous goods

Tulane University - Office of Environmental Health & Safety (OEHS)

Course Outline• Training and testing is mandatory for shippers• Potential liabilities both criminal and civil• This training is designed to meet the training and testing

requirements as set forth in the regulations• Guidance tools including flow charts for interpretation• A series of quizzes to test your progress• A comprehensive final exam• Upon course completion, you will receive a printed

training record/certificate


Course Objectives• Apply dangerous goods regulations correctly• Explain the legal aspects• Explain responsibilities• Identify hazards both visible & hidden• Decide which substances are dangerous goods• Select proper packaging• Properly pack dangerous goods• Mark & label packages• Complete shipping documentation• Accept or reject shipments• Know your employer's responsibilities regarding a security plan


Chapter 1

Regulations

Hazardous Materials Regulations

• Dangerous Goods Regulations• National and international regulatory bodies• Harmonization• Training• Testing, certification and recordkeeping


Dangerous Goods Regulations

• Dangerous goods can cause harm if they are

involved in an accident or incident• Dangerous goods, hazardous materials and

hazmat all mean the same thing• Regulations apply to transport of dangerous goods by air,

rail, road or vessel• International and national guidelines may be different• Differences between regulations can cause problems• Harmonization relieves these problems


International Regulation Bodies

• United Nations Committee of Experts (UNCOE)• UN Recommendations on the Transport of Dangerous Goods Model

Regulations (UN Model Regulations)• International Civil Aviation Organization (ICAO) publishes Technical

Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI)• The UN Economic Commission for Europe (UNECE) publishes the

International Carriage of Dangerous Goods by Rail (RID)• The European Agreement concerning the International Carriage of

Dangerous Goods by Road (ADR)• The International Maritime Dangerous Goods Code published by the

International Maritime Organization (IMO) regulates for the International Convention for the Safety of Life at Sea (SOLAS)

• The Universal Postal Union (UPU) publishes The Letter Post Manual



UNCOEUnited Nations Committee

of Experts

UNECE The UN Economic

Commission for Europe publishes the International

Carriage of Dangerous Goods by Rail (RID)

ICAO International Civil

Aviation Organization publishes Technical

Instructions (ICAO TI)

IATA DGRInternational Civil Aviation

Organization Dangerous Goods Regulations

UPUThe Universal Postal

Union (UPU) publishes The Letter

Post Manual

49 CFRTitle 49 Code of

Federal Regulations

TDGR CanadaTransportation of Dangerous Goods

IATA• Regulations for air transport are more restrictive• Delta Airlines, United Airlines, Air Canada, Air France,

Lufthansa and freight carriers such as Fed Ex, and UPS, etc. are members of IATA

• IATA works with the airlines to improve safety and efficiency in the transportation of dangerous goods

• The IATA DGR is in full compliance with the ICAO TI• IATA dangerous goods regulations apply to anyone who

offers a consignment of dangerous goods to an IATA member airline or air carrier (IATA DGR 1.2.1)

• IATA DGR are the set of guidelines for IATA members• IATA is the most restrictive set of guidelines


National Regulations• The US Department of Transportation (DOT) publishes the Title

49 Transportation of the Code of Federal Regulations (49 CFR)• Parts 100-185 of the 49 CFR or Hazardous Materials Regulations

(HMR) http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl

• The HMR governs shipment of dangerous goods by air, rail, road and sea

• The HMR is in harmony with UN Model Regulations• The HMR recognizes the ICAO TI for air shipments, as long as

US variations are also followed (49 CFR 171.22)


http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/index.tpl

National Regulations

• Violations can result in a civil penalty up to $50,000

• Criminal penalty up to $500,000 and/or 5 years in jail

• Penalties double when the violation results in serious injury or death


TrainingWho needs to be trained?► Anyone who handles, offers for transport or transports

dangerous goods

Who certifies that a dangerous goods employee is trained?

► Employers are responsible for the training of those who handle, offer for transport or transport dangerous goods

What sort of test is required for certification?► Testing may be performance, written and/or verbally based


TrainingThere are four required areas of training

1. General Awareness/Familiarization Training– Provides familiarity with general requirements of

dangerous goods regulations, and enables the employee to recognize and identify hazardous materials

2. Function Specific Training– Training that specifically addresses or is applicable to the

functions the employee performs

• ICAO and IATA use a table to outline some of the specific aspects of the regulations that are required for different positions.


Training

3. Safety Training– Each dangerous goods employee shall receive

safety training in the following three areas:• Emergency response information required by 49

CFR 172.600-172.606• Protection from the risks associated with the

hazardous materials that an employee will be working with

• Accident avoidance


Training

4. Security Awareness Training– Security training for appropriate hazardous

material, including recognizing possible security threats


Recordkeeping• A record of training must be created and maintained for all

dangerous goods employees• The record must be retained for 36 months from the most

recent training completion date (ICAO 1;4.25, IATA 1.5.5.2)• Retained for as long as the employee is employed and 90

days after (49 CFR 172.704(d))• The record of training must include:

– The employee's name; most recent completion date of the employee's training; description, copy, or the location of the training materials used to meet the requirements,; name and address of the organization providing the training; evidence that the employee has been trained and tested.


Testing and Certification

• The final exam at the end of this training will meet the regulatory testing requirement

• The training certificate provided, plus retention of this training material, constitutes a valid "record of training“


For how long is training valid for?• ICAO/IATA require recurrent training every two

years (ICAO 1;4.2.3/IATA 1.5.0.3)

– Recent amendments to recurrent training (ICAO 1;4.2.3 IATA 1.5)

– Recurrent training that is conducted within the final 3 months of the 24-month period will be considered to have been completed on the expiry date of the 24-month period

• DOT requires recurrent training every three years [49 CFR 172.704(c)(2)]


Chapter 1 Review

• The national and international regulatory bodies

• Harmonization of the regulations• Training requirements• Training certificates• Recurrent training requirements


Chapter 2

Introduction to Shipping

Topics to Discuss

• The shipper or consignor• The operator or carrier• The consignee or receiver


Shipper’s Responsibilities• The shipper prepares the shipment• The shippers and operators have

regulated responsibilities• Shipper must be aware of any changes

in the regulations• Shipper's responsibilities include:

– Classification, Identification, Packaging, Marking and Labeling, Documentation, Import/Export Permits, and State and Operator variations


Operator’s Responsibilities

• Operators (carriers) move the shipment• The operator is responsible for the acceptance,

handling, loading, transporting and delivery• Acceptance of a package by an operator transfers

some liability to the operator• Operators are the last line of defense against the

transport of improperly prepared packages• Operators use a checklist to check for errors


Operator’s Responsibilities

• Operator checklist will look for proper:– Documentation, Quantity, Marking and Labeling, Proper

packaging for its intended use, visible leaks or damage

• An operator may refuse a package even if it is packed, labeled and documented correctly.– ICAO 7;(i) Nothing in the regulations should be interpreted

as requiring an operator to transport a particular article or substance, or, as preventing an operator from imposing special requirements on the transport of a particular article or substance. (IATA 9.1.3)


Consignee’s Responsibilities• Inspect packages upon arrival• If a package of Infectious substances is damaged or leaks

during transport, the consignee should report it to the proper authorities (Incident reporting is discussed in Chapter 8)

• Verify that the itemized list of contents is accurate


Chapter 2 Review

• Shipper Responsibilities for:– Classification, Identification, Packaging, Marking and

Labeling, Documentation, Other arrangements

• Operator Responsibilities• Suggestions for the Consignee


Chapter 3Classification


Topics to Discuss

• Dangerous goods• 9 Classes of dangerous goods• Infectious substances• Exemptions• Dry ice


Dangerous Goods• ICAO TI 1;3.2 - dangerous goods " ... 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 instructions (Regulations) or which are classified according to these instructions (Regulations)"(IATA DGR 1.0)

• 49 CFR 105.5 The DOT defines hazardous material as "… 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... The term includes hazardous substances, hazardous wastes, marine pollutants, elevated temperature materials, materials designated as hazardous in the Hazardous Materials Table (see 49 CFR 172.101)


Hidden Dangerous Goods

• Unmarked, improperly packaged hidden dangerous goods have the potential to cause catastrophic problems in air transport

• There are numerous personnel who are specially trained at detecting hidden dangerous goods


Hidden Dangerous Goods

• ICAO 7;6.1/IATA 2.2 maintains a list of common hidden dangerous goods. The list includes:– Dry ice, camping equipment, repair kits, wheel

chairs, diving lights, strike anywhere matches

NOTE: Infectious agents, blood, body fluids, tissues, cultures and other potentially biohazardous materials must NEVER be carried onto an airplane in either checked or carry-on baggage.


Forbidden Dangerous Goods

• All infectious substances are allowed to be transported by air

• Since not all operators accept infectious substances, check if they will accept your shipment


List of Dangerous Goods• Many dangerous goods are listed by their common name; for example,

Ethanol• Proper shipping name• UN number• Both the proper shipping name and UN number are the same in all

regulations• The list is the key to dangerous good regulations• List of Dangerous Goods on blue pages of ICAO TI and IATA DGR• DOT list of hazardous material is found in the 49 CFR section 172.100• Infectious substances are on the List of Dangerous Goods


Classes of Dangerous Goods

• Class 1-Explosives• Class 2-Gases• Class 3-Flammable

Liquids• Class 4-Flammable Solids• Class 5-Oxidizing

Substances & Organic Peroxides

• Class 6-Toxic & Infectious Substances

• Class 7-Radioactive Materials

• Class8-Corrosives• Class 9-Miscellaneous

Dangerous Goods


Classes of Dangerous Goods

• If a dangerous good can be classified under two different classes, the most dangerous class is listed as the primary class and the less dangerous class is listed as the subsidiary risk

• NOTE: The numbers indicate the Class not the degree of danger.

• This training focuses on:– Division 6.2 - Infectious substances– Class 9 - Genetically modified organisms– Class 9 - Dry ice


Classification of Biological Substances

• Category A Infectious substances - high consequence, high containment, life-threatening pathogens

• Category B Infectious substances - moderately hazardous and/or potentially pathogenic substances

• Exempt human/animal specimens - human and animal specimens with minimal likelihood of a pathogen

• Unrestricted biological materials - those that are known to be free of pathogens or are expressly excepted from the regulations

• Genetically modified organisms and micro-organisms - non-pathogenic organisms that are capable of altering animals, plants or microbial substances in a way which is not normally the result of natural reproduction

• Medical or clinical waste - wastes derived from the medical treatment of animals or humans or from bio-research


Key Definitions

• Infectious substances are substances which are known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals. (ICAO 2;6.3.1.1/IATA 3.6.2.1.1)

• Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include patient specimens as defined below. (ICAO2;6.3.1.3 /IATA 3.6.2.1.3)


Key Definitions

• Patient specimens are those collected directly from humans or animals, including but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. (ICAO 2;6.3.1.4/ IATA 3.6.2.1.4)


Key Definitions

Regulations divide infectious substances into two categories, Category A and Category B. However, it is necessary to understand the following definitions before selecting categories:

• Category A: 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. The table of Indicative examples of Category A Infectious substances includes examples which meet this criteria. (ICAO 2;6.3.2.2.1/ IATA 3.6.2.2.2.1)


Key Definitions

• Category B: An infectious substance which does not meet the criteria for inclusion in Category A. (ICAO 6;3.2.2.2/ IATA 3.6.2.2.2.2)


Exempt Patient Specimens

• Patient specimens are those which are

taken directly from a human or animal• Patient specimens for which there is minimal

likelihood that pathogens are present are not subject to these Instructions (Regulations) if the specimen is packed (properly)... and is marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate. (ICAO 6;3.2.3.6 / IATA 3.6.2.2.3.6)


Examples of Exempt patient specimens include:

• Blood or urine tests to monitor: Cholesterol levels, Blood glucose levels, Hormone levels, Prostate specific antigens

• Tests required to monitor organ functions• Tests required for insurance or employment purposes• Pregnancy tests• Cancer biopsies• Antibody detection


The Difference Between Category B Infectious Substances and Exempt

Patient Specimens• In order for a sample to be classified as an Exempt patient

specimen it must fulfill two requirements:– It must be a specimen taken directly from a human or animal.

Cultures from patient specimens are not exempt– Professional judgment has been made to confirm that it does not

contain a pathogen

• If a patient specimen is being transported for non-diagnostic purposes and the source patient is known to be infected with a pathogen then the sample must be classified as a Category A or B Infectious substance as appropriate


Non-Regulated Biological Substances

• Exceptions from the regulations

• A substance is excepted from the regulations if it does not need to be classified or packaged as a dangerous good


Non-Regulated Biological Substances (Exceptions)

• Substances which do not contain infectious substances, or substances which are unlikely to cause disease in humans or animals. (ICAO 6;3.2.3.1 /IATA 3.6.2.2.3.1)

• Substances which contain micro-organisms that are non-pathogenic to humans or animals. (ICAO 6;3.2.3.2 /IATA 3.6.2.2.3.2)

• Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk. (ICAO 6;3.2.3.3 /IATA 3.6.2.2.3.3)


Non-Regulated Biological Substances (Exceptions)

• Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection. (ICAO 6;3.2.3.4 /IATA 3.6.2.2.3.4)

• Dried blood spots collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests and blood or blood components which have been collected for the purposes 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. (ICAO 6;3.2.3.5 / IATA 3.6.2.2.3.5)


Other Biological Material

• ICAO 6;3.3 /IATA 3.6.2.3 Biological products are divided into the following groups:– Those which are manufactured and packaged in accordance with

the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution, and used for personal health care by medical professionals or individuals. Substances in this group are not subject to these Instructions

– Those which do not fall under the above designation and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B


Medical or Clinical Waste• Medical or clinical waste are wastes derived

from the medical treatment of animals or humans or from bio-research. Examples include: waste bandages, waste stocks and cultures, sharps waste, etc.

• Waste containing Category A Infectious substances must be classified as Category A infectious substances

• Waste containing Category B Infectious substances must be classified as Medical or Clinical wastes


Genetically Modified Organisms

• Genetically modified organisms are organisms which have been purposely altered through genetic engineering in a way that does not occur naturally

• Genetically modified micro-organisms that can cause disease in humans or animals (pathogens) must be classified as either Category A or Category B Infectious substances and shipped accordingly

• Non-pathogenic genetically modified organisms that are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction are considered Class 9 Miscellaneous Dangerous Goods


• A sample of a patient's blood containing HIV– Category B

• A sample of a patient's blood suspected to contain Ebola virus– Category A

• A whole kidney being sent for transplantation– Not Regulated

• A culture of Hepatitis B from a sample of a patient's blood– Category A


Review

• List of Dangerous Goods• The nine classes of dangerous goods• Classification of infectious substances• Exemptions to the regulations• Biological products and medical waste• Class 9 Miscellaneous Dangerous goods

– Genetically modified organisms– Dry ice


Chapter 4

Identification


Topics to Discuss

• List of Dangerous Goods• The columns in the List of Dangerous Goods,

including:– Proper shipping names and UN numbers– State and operator variations– Special provisions– Packing groups

• Infectious substance identificationTulane University - Office of Environmental Health & Safety (OEHS)

Proper Shipping Name• A dangerous good must only be assigned one proper shipping

name• The proper shipping name is written in bold faced type.

Portions of the entry not bolded are not considered part of the proper shipping name but are permitted– Use the full name - Abbreviations are NOT allowed; Both singular or

plural forms are accepted. For example: substance or substances - either is correct

• Generic proper shipping names– n.o.s. - not otherwise specified; Flammable liquid, toxic n.o.s.;

Example - a mixture of gasoline and carbon tetrachloride


Technical Names• Technical names must be entered in brackets

immediately following the proper shipping name

• The technical name must be a recognized chemical name or name currently used in scientific and technical handbooks, journals and texts

• Trade names are not acceptable as a technical name


UN Numbers

• Proper shipping names and UN numbers are standard internationally


Special Provisions

• They are found in the List of Dangerous Goods and only apply to the proper shipping name where they are listed– UN 2814 Infectious substances, affecting

humans - special provisions A81 and A140


Packing Groups

• Packing group I - Substances presenting high danger

• Packing group II - Substances presenting medium danger

• Packing group III - Substances presenting low danger

Example - Flammable liquid, toxic n.o.s. can be divided into packing group I, II or III


State and Operator Variations

• ICAO and IATA allow countries (State) and airlines, air carriers, or couriers (Operator) to submit variations to the regulations. If a variation is less restrictive; it is mentioned as information only

• US(G)-United States, CA(G)-Canada, FR(G)-France, FX-FedEx, 5X- United Parcel Service

• Be aware of any variations affecting your shipment– For example, a shipment of dangerous goods being sent from

Mexico City, Mexico to Ottawa, Canada by United Airlines, the shipper must follow all applicable variations for Mexico, United States, Canada and United Airlines.


State and Operator Variation Examples

• ES(G)-01 In domestic transport and in international transport originating in Spain, Spanish shall be used in all markings and on the Shipper's Declaration for Dangerous Goods, in addition to the language required by the States of transit and destination

• CA(G)-05 Infectious substances are not permitted in the mail in Canada

• FX-09 Division 6.2 items classified as Risk Group 4 by the World Health Organization (WHO) will not be accepted for carriage

• AC-01 Advanced arrangements must be made for all shipments of dangerous goods as defined in these regulations


Infectious Substance Identification

• Category A has two proper shipping names– UN 2814 Infectious substance, affecting humans– UN 2900 Infectious substance, affecting animals

• Category B Infectious Substances– UN 3373 Biological substance, Category B


Medical and Clinical WasteUN 3291

• Medical or clinical wastes containing Category A Infectious substances must be assigned to UN 2814 or UN 2900 as appropriate. Medical or clinical wastes containing Infectious substances in Category B must be assigned to UN 3291. (ICAO 2;6.3.5.1 /IATA 3.6.2.5.1

• Medical or clinical wastes that are reasonably believed to have a low probability of containing Infectious substances must be assigned to UN 3291. (ICAO 2;6.3.5.2 /IATA 3.6.2.5.2)

• Decontaminated medical or clinical wastes which previously contained infectious substances are not subject to these Instructions (Regulations) unless they meet the criteria for inclusion in another class. (ICAO 2;6.3.5.2 /IATA 3.6.2.53)


Genetically Modified Organisms & Dry Ice

• UN 3245 Genetically modified organism• UN 3245 Genetically modified micro-organism• NOTE: Genetically modified organisms are not

assigned technical names.• UN 1845 Dry ice• UN 1845 Carbon dioxide, solid


Review

• List of Dangerous Goods– Proper shipping names, UN numbers, Hazard

labels, Special provisions, Packing groups, State and operator variations

• Proper shipping names and UN numbers– Infectious substances, Genetically modified

organisms, Dry ice


Chapter 5Packing


Topics to Discuss

• Quantity limits from the list of Dangerous Goods• Packing instructions• Packing - Packaging – Package• Triple packaging• Detailed instructions for packing:

– Category A Infectious substances– Category B Infectious substances– Exempt patient specimens– Genetically modified organisms

• Refrigerants• Small quantities of dangerous goods• Overpacks


Quantity Limits• Quantity limits are per package, not per consignment• Column 11 in ICAO TI (J in IATA DGR) indicates the

maximum net quantity of dangerous goods per package permitted on a passenger aircraft

• If amount exceeds quantity in column 11 (J) it can only be loaded on a cargo aircraft

• Column 13 in ICAO TI (L in IATA DGR) lists the maximum quantity allowed for cargo aircraft shipments

• For example: Ethanol in packing group II allowed on a passenger aircraft is 5 L and 60 L per package on a cargo aircraft



620

Y341

353 364

954 954

Y342

355 Y343

366

352 Y341

364

361

959 959

620

354365

Packing Instructions• ICAO/IATA both use the same format which

is found in the yellow pages in the ICAO TI and the IATA DGR

• Column 10 and 12 indicate packing instructions.

• For example: 5 L of Ethanol needs to be packed according to Packing Instruction 352



620

Y341

353 364

954 954

Y342

355 Y343

366

352 Y341

364

361

959 959

620

354365

• PACKING - The art and operation by which articles or substances are enveloped in wrappings and/or enclosed in packaging or otherwise secured

• PACKAGING - Receptacles and any other components or materials necessary for the receptacle to perform its containment function and to ensure compliance with the minimum packing requirements of these Instructions (Regulations)

• PACKAGE - The complete product of the packing operation consisting of the packaging and contents prepared for transport


UN Specified Packaging

• Packaging for dangerous goods needs to be strong, durable and able to withstand a reasonable amount of damage without leakage

• Package tests are required for dangerous goods packaging


• "u" over "n" inside a circle• 4G - Type and shape of packaging

– 4 – Box, 5 – Bag, G – Fibreboard, H – Plastic• Y - Packing groups

– X - Packing groups I, II and III; Y - Packing groups II and III; Z - Packing groups III

• 145 - Maximum gross mass• S - Solid dangerous goods or inner packagings• 09-Year of manufacture• US - United States• PACK1-765 – Manufacturer• The example is a fibreboard box, Gross maximum of 145

kilograms, Packing groups II or III, Solid dangerous goods or inner packagings, PACK1, United States, 2009


• NOTE: The UN specification mark for Category A Infectious substances is slightly different than other UN specification marks.

• Packing groups do not apply to infectious substances and the package design tests are different than other dangerous goods. Therefore the UN specification mark contains the words Class 6.2, referencing that the package meets the requirements for infectious substance packaging.


Exceptions for Small Quantities

• Small amount of certain dangerous goods can be shipped as exceptions to the regulations

• Excepted Quantity– Small quantity exceptions allows shipments of some

biological specimens in ethanol or formalin

• NOTE: There are no small quantity exceptions for infectious substances.


Limited Quantity• Many dangerous goods can be safely carried with relaxed standards

for packaging when in small or "limited" amounts• These are referred to as "Limited Quantities" or "LTD QTY". Some

dangerous goods can be carried as limited quantities only under the following conditions:– They are identified as such on the List of Dangerous Goods– The completed package is under the volume or mass limit listed for LTD QTY– They comply with all the appropriate limited quantity packing, marking and

labeling requirements

• For example: Limited quantity of ethanol - up to 1 L, Packing Instruction Y305

• NOTE: There are no limited quantity provisions for: Infectious Substances or Dry Ice


Triple Packaging• A leak-proof primary receptacle (such as a

sealed cryovial, test tube, etc.)• A leak-proof secondary receptacle• Sufficient absorbent to be placed inside the

secondary (if the sample is solid no absorbent is necessary)

• Rigid outer packaging of adequate strength for its capacity, weight and intended use


PI 620- Category A Infectious Substances• Packages must be in good condition and present no hazard• The infectious substance must be packed in triple packaging• Multiple fragile primary receptacle(s) must be wrapped individually• Itemized list of contents placed between the secondary and rigid outer

packaging• Primary or secondary can withstand an internal pressure of 95 kPa and

a temperature range of -40°C to 55°C (-40°F to 130°F)• At least 100 mm (4 inches) in smallest external dimension• IATA adds that the name and telephone number of a person

responsible be marked on the outside of the package• Must have UN specification mark


PI 650- Category B Infectious Substances• Good quality packaging• Sample must be packed in triple packaging• Itemized list of contents between the secondary and outer packaging• Multiple fragile primary receptacle(s) must be wrapped individually• Primary or secondary containers can withstand an internal pressure of

95 kPa and a temperature range of -40°C to 55°C (-40°F to 130°F)• Primary receptacle(s) cannot exceed 1 L and entire package is limited

to 4 L or 4 kg for solid substances.• At least 100 mm (4 inches) in two dimensions• Outer packaging or air waybill marked with the name and telephone

number of a person responsible


Packaging for Exempt Patient Specimens

• The package must consist of three components:– A leakproof primary receptacle– A leakproof secondary receptacle– An outer packaging of adequate strength for its capacity, mass and

intended use and at least one surface having minimum dimensions of 100 x 100 mm

For liquid patient specimens, absorbent material in sufficient quantities to absorb the entire contents. The absorbent material must be placed between the primary and secondary packaging.

Multiple fragile primaries must be wrapped individually


Other Dangerous Goods

• Other dangerous goods must not be sent with infectious substances

• Exception - if the dangerous good is necessary to maintain the viability, stabilizing or preventing degradation or neutralizing the hazards of the infectious substance


PI 959 – Genetically Modified Organisms

• Packing Instruction 959 - Packed according to Packing Instruction 620 without testing or UN specification mark

• Packages must be in good condition and present no hazard• The package must consist of three components:

– Leak-proof primary receptacle(s) (such as a sealed cryovial, test tube, etc.)– Leak-proof secondary packaging– Rigid outer packaging of adequate strength for its capacity, weight and intended use

• There are no package quantity limits for Genetically modified organisms

• NOTE: IATA requires the name and telephone number of a person responsible on the outside of the package.


Refrigerants & Dry Ice• Place refrigerants outside the secondary receptacle• Wet ice is not recommended• Packing Instruction 954 - Secondary receptacle shall be secured within

the outer package to maintain the original position of the inner packages after the dry ice has dissipated

• NEVER PLACE DRY ICE IN A SEALED CONTAINER• The packaging must permit the release of carbon dioxide gas• Allow ventilation for packages containing dry ice• NOTE: Effective Jan 01, 2011, the ICAO/IATA packing instructions

will be changing for dry ice from 904 to 954.• NOTE: There are no regulatory differences between Packing

Instructions 904 and 954.


Liquid Nitrogen

• Liquid Nitrogen Division 2.2 Non-Flammable, non-toxic gas

• There are two options for using liquid nitrogen as a refrigerant: Dry shipper and free standing.

• Dry shipper - liquid nitrogen is fully absorbed in porous material, package design does not allow pressure build-up and no release of liquid nitrogen regardless of orientation

• Free standing liquid nitrogen must be classified as Division 2.2 Dangerous Good UN 1977 Nitrogen, refrigerated liquid


Gel Packs

• Gel packs are not regulated and may be reused


Excepted (Small) Quantities


• Column 9 gives excepted quantity code• The following requirements must be met in the packaging of

excepted quantities:– Inner packagings - Glass, porcelain, stoneware, earthenware, metal or

plastic– The intermediate packagings must contain the contents without

leakage, regardless of orientation– For liquids - Sufficient absorbent material to absorb the entire contents

should leakage occur. The absorbent may also act as cushioning– The intermediate packaging must be secured in strong, rigid outer

packaging (wood, fibreboard, or equally strong material). The package must be of sufficient size to contain all necessary marks

Shipping dangerous goods in excepted quantities

• Applicable to shipments where each inner receptacle contains, in general, no more than 30 ml or 30 g, and each complete package contains, in general, no more than 500 ml or 500 g.

• There are no shipping papers required, the box is a normal inexpensive one that can pass a drop test and stacking test, and there is just one label to be applied to the outside of the box:



353 Y341

355 Y344

364

366

Limited Quantities

• Used when a shipper needs to ship small quantities of dangerous goods which are not permitted, or have exceeded the quantity of, the Excepted quantity provisions.

• Acceptable for some products of some hazardous goods 'Classes' and some 'Packing Groups' that contain very small quantities of dangerous goods.


Shipping dangerous goods in limited quantities

• Applicable to shipments where each inner receptacle contains, in general, no more than 0.5 L or 0.5 kg, and each complete package contains, in general, no more than 1 L or 1 kg.

• The Shipper's Declaration for Dangerous Goods is required. The box may be a normal, inexpensive one that can pass a drop test and stacking test. The box must be marked with the Proper Shipping Name and UN Number. In addition, the box must bear the Dangerous Goods in Limited Quantities label (technically a mark but best purchased from a label printing company):


Limited Quantities• Limited Quantities are found on the List of Dangerous Goods.

The Packing Instructions start with the letter Y• Combination packaging - inner and outer packaging• Packing instructions - maximum quantity limits per inner

container. List of Dangerous Goods - outer package quantity limits

• Limited quantity packages do not need to have the UN specification mark. However they do require a mark indicating that they have successfully passed the required tests.

• Limited quantity or LTD QTY



Y342 354

365

Packing Design Tests

• Includes all aspects of the package - inner and outer packagings

• The package manufacturer will have this information

• There are three main package tests:– Stacking tests– Puncture tests– Drop tests


Overpacks

• Overpack means an enclosure that is used by a single shipper to provide refrigeration, protection or convenience in the handling of a package or to consolidate two or more packages

• NOTE: Any package placed in a overpack must be completely compliant with the required regulations for the substance to be shipped.


Examples of Overpacks• Placed in a protective outer packaging, such as a box or

crate• Placed into an insulated chest and surrounded with gel

packs, dry ice or other refrigerant• Placed or stacked onto a load board such as a pallet and

secured by strapping, shrink wrapping, stretch wrapping or other suitable means

• There are no packing or testing requirements for overpacks• A simple cardboard box could be used as an overpack. If

two packages were taped together, the tape would be considered an overpack


Proper Packaging

• Improper packing voids UN specification mark• If a package is certified with plastic primaries,

glass primaries are not allowed• Do not substitute one manufacturer's secondary

with another manufacturer's outer packaging• NOTE: Once again the shipper will be held

responsible for improperly prepared packages or non-compliant packages.


Common Packing Errors

• Not properly closing/sealing primary and secondary containers

• Not providing enough absorbent or no absorbent at all• Forgetting to include an itemized list of contents• Not reading/following the packaging manufacturer's

instructions provided with the packaging• Using the packaging in a way that has not been tested or

certified (Mixing components from different manufacturers results in a non-tested and non-certified packing design.)

• Exceeding the quantity limits for the package


Reuse of Packages

• ICAO/IATA "Before an empty package which had previously contained an infectious substance is returned to the shipper, or sent elsewhere, it must be thoroughly disinfected or sterilized and any label or marking indicating that it had contained an infectious substance must be removed or obliterated."


Review• Quantity limits from the List of Dangerous Goods• Packing instructions• UN specified packaging• Small quantities of dangerous goods• Triple packaging• Packing Instruction 620 Category A Infectious substances• Packing Instruction 650 Category B Infectious substances• Exempt patient specimens• Packing Instruction 959 Genetically modified organisms• Refrigerants• Packing Instruction 954 Dry ice• Liquid nitrogen• Small quantities of dangerous goods• Overpacks


Chapter 6

Marking and Labeling


Topics to Discuss

• Correct marking and labeling information including:– Hazard labels– Handling labels

• Overpacks


Marks and Labels• Markings and labels must be durable and visible• Each package must display the following information on the outer

packaging:– Complete address of the shipper and consignee– The name and telephone number of a person responsible– Appropriate hazard label(s) for each dangerous good– Proper shipping name for each dangerous good

• NOTE: The technical name for a Category A shipment need not be shown on the package (See special provision A140).

– UN identification number for each dangerous good adjacent to the proper shipping name– Quantity of the dangerous goods ( required for GMOs and dry ice)– NOTE: Required for Category A shipments and LTD QTY.

• Labels are to be placed adjacent to the proper shipping name & UN number

• All marks and labels on one side of packages (size permitting)


Hazard and Handling Labels

• Hazard labels are squares set at an angle of 45 degrees or diamond-on-point

• The dangerous goods class number must be placed at the bottom of the diamond. The division number is not required

• Handling Labels: Direct handling procedures - For example: Orientation arrows


Category A Infectious Substances

• Label name: Infectious substance - Minimum dimensions: 100 × 100 mm (for small packages: 50 × 50 mm) - Number of labels per package: One - Color: Black and white

• The label should also contain the following text:– INFECTIOUS SUBSTANCE In case of damage or

leakage immediately notify a Public Health Authority in U.S.A notify director-CDC, Atlanta GA 1-800-232-0124


Category B Infectious Substances Marking

• Category B substances require a mark rather than a hazard label

• Minimum dimensions: 50 × 50 mm - Line thickness at least 2 mm

• UN3373 must be at least 6 mm in height - Number of marks per package: One - Color: Any contrasting color

• NOTE: The mark fulfills the requirement for the UN number so the package only requires the proper shipping name Biological substances, Category B.


• Exempt patient specimens– Marking of Exempt patient specimen packages as "Exempt

human specimen" or "Exempt animal specimen“

• Hazard label for Class 9 Miscellaneous dangerous goods– Label Name: Miscellaneous hazard label - Minimum

dimensions: 100 × 100 mm (for small packages: 50 × 50 mm) - Number of labels per package: One - Color: Black on white

• Hazard label for free liquid nitrogen– Label name: Non-flammable, non-toxic gas - Minimum

dimensions: 100 x 100 mm - Number of labels per package: One - Color: Green with black or white gas cylinder

– NOTE: Required for both open and closed receptacles.


Package Orientation

• Label name: Orientation label - Minimum dimensions: Standard A7: 74 × 105 mm - Number per package: Two on opposite sides - Color: Black and white or red and white (on a contrasting background)

• NOTE: For infectious substances the orientation arrows are only required when the primary receptacle exceeds 50 mL. If primary containers exceed 50 mL then the closures of the primaries must be oriented with the orientation arrows.


Cargo Aircraft Only Label• Label name: Cargo Aircraft Only -

Minimum dimensions: 120 x 110 mm (for small packages of infectious substances dimensions may be halved) - Color: Black on orange

• NOTE: Until Jan 01, 2009 the CAO label contained the words "Do not load in passenger aircraft". Both labels will be accepted until Jan 01, 2013 at which time only the label with the words "Forbidden on passenger aircraft" will be accepted.


Handling Labels for Free Liquid Nitrogen

• "KEEP UPRIGHT" must be placed in 120° intervals or on all sides

• Mark clearly "DO NOT DROP-HANDLE WITH CARE"


Keys to Marking and Labeling• Try to keep all required marks and labels on one face of the

package• Hazard labels should be placed in the diamond-on-point

orientation• Proper shipping name, UN number and net weight (or

quantity) must be marked adjacent to corresponding hazard label

• Be sure to obliterate, remove, or completely cover any irrelevant marks or labels

• Do not write on or cover any portion of the hazard label within the diamond portion of the label


Marking and Labeling for Excepted Quantities

• This label is an "E" inside a circle. The circle is inside a box of red hatchings. The "E" and circle are also in red

• Under the "E" the class or division of dangerous good is placed to indicate a basic risk

• If the shipper's name and address are not on the package, they are included on the mark under the class or division


Marking and Labeling for Limited Quantities

• Shipper and consignee address• Limited quantity mark• All pertinent hazard labels• UN number

– UN XXXX adjacent to the hazard label– UN number in a diamond-on-point orientation - Line

width: Minimum: 2 mm - Letter size: Minimum 6 mm


Marking and Labeling of Overpacks• Each package in an overpack must be packed, marked, labeled and

addressed individually• NOTE: Each package must be fully compliant with the regulations before

it can be placed in an overpack.• If the marks and labels on the inner packages are not visible they must be

reproduced on the exterior of the overpack• The quantity marked on the overpack is the sum of the packages inside of

the overpack for identical dangerous goods• When labels are reproduced the word "Overpack" must be included• For example, if clear shrink-wrap is used to consolidate several packages

and the marks and labels are visible through the shrink-wrap then further marking and labeling of the overpack shrink-wrap is not necessary


You are shipping 60 mL culture of Hepatitis B virus. What marks and

labels are required?• Infectious substance affecting humans• UN 2814• Cargo aircraft only• 60 mL• Person responsible• Class 6 label• UN specification


You are shipping a 20 mL blood sample obtained directly from a patient who has tested positive for HIV. What marks and

labels are required on the package?• UN 3373 Label• Person responsible ( if not on waybill)• Biological substance, Category B


You are shipping a 3L sample of human blood to test for glucose levels. It has been

determined that the sample does not contain any pathogens. What marks and labels are

required on the package?

• Exempt human specimen


You are shipping a 3L sample of human blood to determine if it contains Herpes B virus.

The sample is being sent with 7 kg of dry ice to keep the sample frozen. What marks and

labels are required on the package?• UN 3373 Label• Person responsible ( if not on waybill)• Biological substance, Category B• UN 1845• Dry Ice 7kg• Class 9 label


You are shipping a tissue sample from a dog to test for cancer. The sample is not

infectious but it is being sent in 60mL of formalin. What marks and labels are required

on the package?• Exempt animal specimen• UN 1198• Formaldehyde solution, flammable 60 mL• Class 3 label• Corrosive label• LTD QTY Label


Review

• Hazard labels• Handling labels• Overpacks


Chapter 7

Documentation


Topics to Discuss

• General Information• Shipping Document• Waybills• Examples


Shipping Documentation

• Dangerous goods shipments require documentation unless otherwise specified

• Shipper must prepare three copies: 1 - Consignor, 2 - Operator, 3 – Consignee

• NOTE: Some carriers may require more than three copies.

• Both the carrier and the shipper must maintain these records for two years


Shipper’s Declaration not needed for:

• UN 3373 Biological substance, Category B• Exempt human specimens• Exempt animal specimens• UN 1845 Dry ice• NOTE: When dry ice is used as a refrigerant for dangerous

goods which require a Shipper's Declaration, the shipper must include dry ice in the declaration.

• Excepted Quantities


Preparing the Shipper's Declaration

• Complete all the information on the form• Ensure that the information on the form is accurate, easy

to identify, legible and durable• Ensure that the information on the form exactly matches the

information on the package– Including addresses, weight, proper shipping name, etc.

• Only trained and certified persons may sign the form• The person who signs the form does not need to be the same as the person

listed in the shipper's address box• Mistakes may be amended by drawing a single line through the incorrect

text, making the change and then signing (full signature, not initials) next to the change. Do not use correction fluid

• The diagonal hatchings printed vertically in the left and right margins must be printed in red ink


Shipper’s Declaration

• If the Shipper’s Declaration is not 100% correct, it is wrong and operators will not accept your shipment.

• Enter the name and address of the shipper. A phone number is not required, but recommended.

• Enter the full name and deliverable address of the consignee. A PO Box is not acceptable.

• Enter the waybill number if it is known. This box may be left blank as the operator may enter or amend as needed.

• The pages section is the number of pages needed to record or list all of the dangerous goods in the consignment, not the number of copies.


Shipper’s Declaration

• Aircraft Limitation-If the package exceeds passenger aircraft limitations, the “Passenger and Cargo Aircraft” section must be crossed out.

• Airport of Departure- Full name of airport of departure (if known)

• Airport of Destination- Full name of airport of destination (if known)

• Shipment Type- cross out “Radioactive”.


Nature and Quantity of Goods• The info should be transferred from the List of Dangerous

Goods• Enter the four digit UN ID Number for each dangerous

good in the consignment. • Enter the Proper Shipping Name,. A technical name in

parenthesis is required by most authorities.• Enter the class and division.• Enter the Packing Group if it is applicable if, not

applicable, leave it blank.


Nature and Quantity of Goods• Enter the total quantity of the consignment. For a single

package, it will be the net weight or volume of the infectious substance and must match the quantity previously marked on the package.

• Type of package refers to the material of the outer packaging. Most infectious substance packages will be fibreboard.


• Enter the Packaging Instruction used. • If you have used a special provision, then the number

must be indicated in the authorization section


• In the additional handling information, enter the name and number of the person responsible for the shipment.

• The 24 hour number must be monitored at all times while the dangerous good is in transportation by a person who is:– Knowledgeable of the hazards and characteristics of the dangerous

goods being transported.– Has comprehensive emergency response and accident information

for the dangerous good or who has immediate access to a person who possesses such knowledge and info.

– The words “Emergency Contact or 24 hour Number” must be written. A name is not required.


• Enter the name and title of the person signing the shipper’s declaration

• Enter the city and date• This person is certifying that all regulations

have been met.


20mL culture of Hepatitis B virus in a fibreboard box?

• UN 2814• Infectious substance affecting humans• (Hepatitis B virus)• 6.2• I fibreboard box x 20mL• 620


5 L shipment of non-pathogenic Genetically modified organism

packed in a fibreboard box?• UN 3245

• Genetically Modified organism


Waybills• This document can be completed by the shipper or the

operator• If the waybill contains information on both dangerous

goods and non-dangerous goods, the dangerous goods must be listed first (ICAO 5;4.2/ IATA 8.2)

• Waybills for dangerous goods shipments must include, in the Handling Information Box, the statements:– "Dangerous Goods per attached Shipper's Declaration" or– "Dangerous Goods per attached DGD" (Dangerous Goods

Document)– "Cargo Aircraft Only" or "CAO" (as applicable)


• If a shipment does not require a Shipper's Declaration, then the nature and quantity of goods section on the waybill must contain:

• UN number• Proper shipping name• Class or division number• Number of packages• Net quantity per package


Review

• General Information• Shipper’s Declaration for Dangerous Goods• Waybills• Need for accurate, neat, legible entries• Shipper’s checklist


Chapter 8

Emergency Response and Security Training


Topics to Discuss

• Emergency Response Guidebook• Reporting of spills or emissions• Response to fire• Incident reporting• General security awareness• Security training• Security plans


Emergency Response Information

• More information is now needed along with the 24 Hour Emergency Response telephone number. Now, you must include the contractor name and customer number.

• Again, besides a 24 Hour Emergency Response number, DOT requires you to provide additional emergency response information in a manner that is available for use when away from the package containing the hazardous material.


Emergency Response Information

• To comply with this requirement, either provide the MSDS for the material along with your shipping paper (DDG) or provide the proper emergency response guide book pages for your material based upon its UN number. In either case, whether you use the MSDS or the ERG pages, the following information must be present:– The basic description and technical name of the hazardous material,

Immediate hazards to health , Risks of fire or explosion, Immediate precautions to be taken in the event of an accident or incident , Immediate methods for handling fires, Initial methods for handling spills or leaks in the absence of fire, Preliminary first aid measures


• If you use the ERG guide book pages to meet the above requirements then you need to indicate the "basic description and technical name of the hazardous material" (its proper shipping name and UN number) on the guide book pages.


Emergency Response Guidebook

• Transport Canada, U.S. DOT, the Secretary of Transport and Communications of Mexico with collaboration from the Centro de Información Química para Emergencias of Argentina have developed an Emergency Response Guidebook

• This book is used by fire fighters, ambulance, police and other emergency services personnel who may be the first to respond to a dangerous goods accident and incident


Emergency Response Procedures

• Avoid handling the package• Handle only while wearing protective clothing• Inspect adjacent packages for contamination and set them

aside• Inform the appropriate public health or veterinary

authority• Provide information on any other countries of transit• Inform the local authorities, the consignor, consignee and

the person responsible• Contact the appropriate national authority


Spills, Leaks or Fires

• Do not touch or walk through the spilled material.• Do not touch damaged containers or spilled materials• Absorb the spill with earth, sand or other non-combustible

material• Cover the damaged package or spilled material with a

damp towel or rag• Keep it wet with liquid bleach or other disinfectant• Small fire - Use a dry chemical, soda ash, lime or sand• Larger fire - Use an extinguishing agent suitable for the

type of surrounding fireTulane University - Office of Environmental Health & Safety (OEHS)

First Aid

• If possible, move the victim to a safe, isolated area• Call emergency medical care if required• Remove contaminated clothing and shoes• Immediately flush the victim's skin or eyes with running

water for at least 20 minutes• Effects of exposure to the substance, be it inhalation,

ingestion or skin contact, may be delayed• The victim may be a source of contamination• Ensure that any medical personnel are made aware of the

material involved so they can take precautionsTulane University - Office of Environmental Health & Safety (OEHS)

Incident Reporting

• ICAO 7;4.4 An operator must report dangerous goods accidents and incidents to the appropriate authorities of the state of the operator and the state in which the accident or incident occurred in accordance with the reporting requirements of those appropriate authorities. (IATA 9.6.1)

• The DOT requirements for incident reporting are found in 49 CFR 171.15 and 171.15


Security Awareness• Dangerous goods have and can cause major incidents with loss

of life, property and environmental damage• Intentional misuse of dangerous goods• Strict security measures are recommended• ICAO 1;5.1.1 International regulations dictate that any

individual who handles dangerous goods should consider security requirements for dangerous goods according to their responsibilities (IATA 1.6.1.1)

• The DOT requires that each hazmat employee must receive training that provides an awareness of security risks associated with hazardous materials transportation and methods designed to enhance transportation security [49 CFR 172.704 (4)]


Security Awareness Training

• ICAO 1; 5.2 The nature of security risks• Recognition of security risks• Methods to address and reduce such risks• Actions to be taken in the event of a security breach (IATA

1.6.2)• Including security plans (if appropriate)


Security Plans

• Category A Infectious substances are High Consequence Dangerous Goods

• This means they have a high potential for misuse in a terrorist incident and which may result in or produce serious consequences such as mass casualties or mass destruction (ICAO 1; 5.3.1 IATA 1.6.3.3)

• Any shipper or operator who handles and/or transports high consequence dangerous goods should adopt a security plan to guard against potential incidents


Tulane UniversityOffice of Environmental Health & Safety (OEHS)

Please contact Kellie C. Mayer(504) 419-1391

[email protected] questions and/or interactive discussion.

Take Quiz

To complete your training, please click on the “take quiz” box above or use this direct test link: https://audubon

.tulane.edu/ehs/enterssn.cfm?testnum=109

mailto:[email protected]

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shipping division 6.2 dangerous goods, patient specimens & dry ice august 2012

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