Transcript Packaging and Shipping of Infectious Substances 2011

Alabama Department of Public Health
Bureau of Clinical Laboratories
Jeannine Parker, Trainer
Objectives
 Review the regulators and their respective regulations,
and their roles within their respective jurisdictions
 Classify, mark, label, and document Division 6.2
Hazardous Materials (Infectious Substances tagged UN
3373 and UN 2814
 Review regulatory requirements for UN 2814 and UN
3373 hazardous materials packaging
 Review Packing Instructions for UN 2814 and UN 3373
hazardous materials
General Philosophy
 Before 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 shipper
 One must ensure that the article is not prohibited from air
transport
General Philosophy
 Before packaging and shipping, all relevant personnel must
have received training in accordance with their
responsibilities
 All dangerous goods are packed in compliance with the
regulations
Training
 This recertification training meets the requirement for
recurring training every two years (IATA) and every three
years (DOT)
 This training is for those people who have been
previously certified
 This training will have a general overview of the
regulations and cover the changes that IATA has instituted
as of January 1, 2011
Regulators/Regulations
 United 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/Regulations
 International 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/Regulations
 US 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 mail
 Promulgates US Postal Regulations
Shipper’s Responsibilities
You are ultimately responsible
for the package from
beginning to end
What are your Responsibilities?
 Classify
 Identify
 Pack
 Mark & Label
 Document (if required)
Classification
 So, 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
Classification
 DOT 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 Substance
 Substances 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 Classes
1Explosives
2Gasses
3Flammable liquids
4Flammable solids
5Oxidizing
substances
6Toxic/Infectious
7Radioactive
8Corrosive
9Miscellaneous
Class 6 Toxic and Infectious
Substances
 Class 6 is divided into two Divisions
 6.1- Toxins/Poisons
 6.2- Infectious Substances
 Division 6.2 is divided into two categories
 Category A Infectious Substances
 Category B Biological Substances
Other Recognized Categories
 Human Exempt
 Specimens with minimal likelihood of a pathogen
 Genetically modified organisms and micro-organisms
(GMOs)
 Pathogenic GMO must be designated Category A or B
 Non-pathogenic GMO
 Medical or clinical wastes
Definitions
 Category 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 Name

Infectious substance, affecting humans
(Technical Name)
Definitions
 Category 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 Definitions
 Patient 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
 Cultures
 Are 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 Name

Infectious 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 B
 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
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 Specimens
 The packaging must consist of three components:
 A leak-proof primary receptacle
 A leak-proof secondary packaging
 An 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 Specimens
 For 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 Material
 Substances 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 Material
 Environmental 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.
Dry Ice UN 1845
 Class 9 Miscellaneous
 Packing Group III – low danger

Three packing groups, from high (PG I) to low danger
 Packing Groups so not apply to Infectious Substances
 Packing Instruction 954


Package must allow for the release of gas (CO2)
Proper shipping name and weight in kilograms must appear on
the package
Identification
 Assigning a Proper Shipping Name to a Dangerous Good
 Proper 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
List of Dangerous Goods
Proper Packaging
 UN 2814 Packaging must
 Be Tested
 Meet regulatory specifications
 Be certified
 Used as a unit
 Be marked with appropriate certification markings
Proper Packaging for UN 2814
 Triple packaging concept
 Primary receptacles must be leak-proof
 Secondary packaging must be leak-proof and meet the
regulation for pressure differential
 Outer packaging must meet the regulations for




Leakage
Sturdiness
Rigidness
markings
Proper Packaging for UN 2814
 Leak-proof Primary Receptacle
 Blood tubes
 Urine transport tubes
 Media slants
 Metal-crimped glass vials
 Must be cushioned if more than one primary in a secondary
package
 Liquid contents primaries must have sufficient absorbent
material to absorb the entire contents if the primary breaks
during transport
Proper Packaging for UN 2814
 Secondary Packaging
 Must be leak-proof
 Must 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 Packaging for UN 2814
 Outer 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 Mark
U
N
4G/Class 6.2/02
USA/+AX1852
 Must be labeled properly
Proper Packaging for UN 2814
 Entire UN certified 6.2 package must be used as an entire
unit
 No substitutions of secondary packaging
 Should not add or cover up the 6.2 label
 Name and telephone number of the Responsible Person
must appear on the outer package
 Smallest dimensions at least 100 mm X 100 mm (4 inches)
Proper Packaging
 Category 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 Packaging
 Category B
 Must use the triple packaging concept
 Primaries must be leak-proof
 cushioned such that breakage cannot occur
 Primaries that contain liquid must have sufficient absorbent material
to absorb the entire contents of the primaries
 Secondary packaging must be leak-proof
 Secondary 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 (CHANGE)
 Triple packaging concept
 Primary receptacles must be leak-proof
 Secondary packaging must be leak-proof and meet the
regulation for pressure differential
 Itemized List of Contents must be included between
secondary and outer packaging


Proper Shipping Name
Number of vials/tubes/etc. included
Packing Instructions (PI)
 Category A PI 620, cont’d
 Outer packaging must meet the regulations
 Unit 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 required
 Primary 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 package
 Support other than the dry ice must be provided for the
secondary package
 Packaging must be designed and constructed to permit
the release of CO2 gas to prevent a build-up of pressure
 Use a styrofoam-lined cardboard box for dry ice
shipments
Quantity Limits
 Category A
 50 ml/kg quantity limit on passenger
airplanes
 Category B
 A single primary receptacle is limited to 1 L
and the entire package must not exceed 4 L
Marking and Labeling
 Packages 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 Labeling
 Marking
 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
 UN ID number
 Quantity of DG (required for Cat A and Dry Ice)
Marking and Labeling
Category A Label
Category B Marking
Handling Labels
Orientation Labels
Cargo Aircraft Only Label
Dry Ice Markings and Labels
Dry Ice Hazard Label
Dry Ice Marking for Package
Labels and Markings
Category A
Category B
Documentation
Shipper’s Declaration of
Dangerous Goods
Air Waybill
Documentation
 Shipper’s Declaration of Dangerous Goods
 Use the correct form in the correct manner
 Ensure information is accurate, easy to ID, legible and
durable
 Ensure form is properly signed
 Ensure the shipment has been prepared according to the
regulations
Documentation
 Shipper’s Declaration of Dangerous Goods
 Must be in color (red & black, or red on white)
 Must be in English
 Must be letter size
 Must produce three copies



One for your records
One for carrier’s records
One stays with the package
 FedEx requires it to be typed or computer-generated
 Under Additional Handling Information, the Responsible
Person’s name and telephone number must be
Air Waybill
 Handling Information Section
 “For Un 3373, it is only necessary to show the text…… and
the number of packages.”
Safety Training
Hazards presented by dangerous goods, safe handling,
and emergency response procedures
 Hazards
 Safe Handling
 Inhalation
 PPE
 Ingestion
 Spill Clean-up
 Contact
 Disposal
Emergency Response
 “Information that can used in the event of an incident..”
 Emergency Response Guidebook
Security Awareness
 Security 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 Plan
 Should have a written Security Plan
 Plan 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
TEST
 Apply the appropriate,
proper labels and
markings to the boxes and
complete any required
paperwork.