shipping infectious substances and biological products by commercial carriers

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Shipping Infectious Substances Shipping Infectious Substances and Biological products by and Biological products by Commercial Carriers Commercial Carriers Summary of Requirements under Summary of Requirements under DOT, IATA and WHO DOT, IATA and WHO Philip G. Hauck, MS,MSHS, CBSP,SM(NRCM) Philip G. Hauck, MS,MSHS, CBSP,SM(NRCM) 4/2009 4/2009

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Shipping Infectious Substances and Biological products by Commercial Carriers Summary of Requirements under DOT, IATA and WHO Philip G. Hauck, MS,MSHS, CBSP,SM(NRCM) 4/2009. Definitions. “WHO GUIDANCE”. Introduction. - PowerPoint PPT Presentation

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Page 1: Shipping Infectious Substances and Biological products by Commercial Carriers

Shipping Infectious Substances and Shipping Infectious Substances and Biological products by Commercial Biological products by Commercial

CarriersCarriers

Summary of Requirements under DOT, Summary of Requirements under DOT, IATA and WHOIATA and WHO

Philip G. Hauck, MS,MSHS, CBSP,SM(NRCM)Philip G. Hauck, MS,MSHS, CBSP,SM(NRCM)

4/20094/2009

Page 2: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

“WHO GUIDANCE”

Page 3: Shipping Infectious Substances and Biological products by Commercial Carriers

IntroductionIntroduction

As of October 1, 2006 The Federal Register announced As of October 1, 2006 The Federal Register announced the Harmonization of the Shipping Regulations with the the Harmonization of the Shipping Regulations with the World Health Organization, ICAO, IATA and the IMO.World Health Organization, ICAO, IATA and the IMO.

Page 4: Shipping Infectious Substances and Biological products by Commercial Carriers

IntroductionIntroduction

New classification criteria and packaging requirementsare now consistent** with international standards andhelp clarify existing requirements to promote compliance.

These revisions will ensure an acceptable levelof safety for the transportation of infectious substancesand facilitate domestic and international transportation.

** There are still variances between WHO, ICAO, IATA and US DOT regs……but Close is Good!!

Page 5: Shipping Infectious Substances and Biological products by Commercial Carriers

IntroductionIntroduction

The new classifications are based on criteria

developed by the UN Committee of Experts working

with the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), medical professionals, microbiologists, transportation

professionals, and packaging technical experts.

Page 6: Shipping Infectious Substances and Biological products by Commercial Carriers

IntroductionIntroductionThey are consistent with the requirements contained in

The 13th and 14th editions of the United NationsRecommendations for the Transport of Dangerous Goods(UN Recommendations),

The 2005-2006 edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions),

The International Maritime Organization (IMO) Dangerous Goods Code.

The new HMR requirements establish a two-tiered classification systemfor infectious substances— Category A and Category B.

Page 7: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Infectious substancesFor the purposes of transport, infectious substances are defined as substances which are known or are reasonably expected to contain pathogens.

Pathogens Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals. The definition is applied to all specimens except those explicitly excluded (see Exclusions – WHO GUIDANCE).

Infectious substances are divided into two categories……

Page 8: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitionsInfectious substance, 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.

Indicative examples of substances that meet these criteria are Hepatitis B virus cultures, Vesicular stomatitis virus cultures

NOTE: An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.

Infectious substances meeting these criteria which cause disease in humans or both in humans and animals shall be assigned to United Nations number UN 2814. Infectious substances which cause disease only in animals shall be assigned to UN 2900.

Page 9: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Dangerous goods are assigned UN numbers and proper shipping names according to their hazard classification and their composition. Proper shipping names are used to clearly identify the dangerous article or substance.

Format: UN - 0123

Page 10: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Assignment to UN 2814 or UN 2900 shall be based on: the known medical history symptoms of the source human or animal endemic local conditions, professional judgment concerning individual

circumstances of the source human or animal.

Page 11: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitionsThe proper shipping name of UN 2814 is:

“INFECTIOUS SUBSTANCE, AFFECTING HUMANS”

The proper shipping name for UN 2900 is:

“INFECTIOUS SUBSTANCE, AFFECTING ANIMALS” only

Infectious substances, including new or emerging pathogens, which do not appear in the Annex 2 table [“WHO GUIDANCE” ] but which meet the same criteria shall be assigned to Category A.

If there is doubt as to whether or not a substance meets the criteria it shall be included in Category A.

You can add descriptors in parenthesis, but the OFFICIAL PROPER SHIPPING NAME MUST BE AS WRITTEN ABOVE!

Page 12: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Infectious substance, Category BAn infectious substance which does not meet the criteria for inclusion in Category A.

Infectious substances in Category B shall be assigned to UN 3373.

Page 13: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

The proper shipping name of UN 3373 is:

“BIOLOGICAL SUBSTANCE, CATEGORY B”

“Diagnostic Specimens”, “Clinical Specimens” were discontinued after January 1, 2007 as proper shipping names – they can be used in parenthesis as descriptors to further characterize a shipment.

You can add descriptors in parenthesis, but the OFFICIAL PROPER SHIPPING NAME MUST BE AS WRITTEN ABOVE!

Page 14: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Cultures Cultures are the result of a process by which pathogens are intentionally propagated. This definition -

does not include human or animal patient specimens as defined below. Cultures may be classified as Category A or Category B, depending on the

microorganism concerned.

Patient specimensThese are human or animal materials, 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.

Page 15: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Biological productsBiological products are those products derived from living organisms which are manufactured anddistributed in accordance with the requirements of appropriate national authorities,

which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease

in humans or animals, or for development, experimental or investigational purposes

related thereto.

They include, but are not limited to, finished or unfinished products such as vaccines.

Page 16: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Genetically modified microorganisms and organismsGenetically modified microorganisms and organisms are microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally.

Those genetically modified microorganisms and organisms that do not meet the definition of an infectious substance but which are capable of altering animals, plants or microbiological substancesin a way not normally the result of natural reproduction shall be assigned to UN 3245 and shipped following Packing Instruction P904 (ICAO/IATA PI913) – this is not considered further in theseguidelines.

Page 17: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Medical or clinical wastesMedical or clinical wastes are wastes derived from the medical treatment of animals or humans or from bio-research. Medical or clinical wastes containing Category A infectious substances shall be assigned to UN 2814 or UN 2900 as appropriate.

Medical or clinical wastes containing Category B infectious substances, or which are reasonably believed to have a low probability of containing infectious substances, shall be assigned to UN 3291 and shipped following Packing Instruction P621(ICAO/IATA PI622) – this is not considered further in these guidelines.

Page 18: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitionsExceptions

Because of the low hazard they present, the following substances of biological origin are exempted from dangerous goods requirements and regulations:

substances that do not contain infectious substances orwill not cause disease in humans or animals

substances containing microorganisms that are notpathogenic to humans or animals

substances in a form in which any pathogens presenthave been neutralized or inactivated such that they no

longer pose a health risk

Page 19: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitionsExceptions

environmental samples (including food and water samples) that are not considered to pose a significant

risk of infection

blood and/or blood components collected and shipped for the purposes of transfusion and/or transplantation

dried blood spots and faecal occult blood screening tests

decontaminated medical or clinical wastes.

Unless patient specimens comply with the following requirements, they must be assigned to UN 2814, UN 2900 or UN 3373, as appropriate.

Page 20: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

Exempt Human / Animal SpecimensHuman or animal specimens (patient specimens) for which there is minimal likelihood that pathogens are present, are not subject to these Regulations if the specimen is transported in a packaging which will prevent any leakage and which is marked with the words “Exempt human specimen” or “Exempt animal specimen”, as appropriate.

Page 21: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

The packaging should consist of three components: (i) a leak-proof primary receptacle(s); (ii) a leak-proof secondary packaging; and (iii) 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 × 100 mm;

For liquids, absorbent material in sufficient quantity to absorb the entire contents should be placed between the primary receptacle(s) 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;

Page 22: Shipping Infectious Substances and Biological products by Commercial Carriers

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

If such a packaging is used it should be marked “Exempt human specimen” or “Exempt animal specimen”, as appropriate.

NOTE: An element of professional judgment is required to determine if a substance is exempt under this definition-known medical history, or knowledge of symptoms, circumstances of the source, whether source is human or animal, and the endemic local conditions at the time the specimen was collected.

Pregnancy tests, PSA evaluations, blood glucose levels, antibody detection, and drug/alcohol screens would qualify as exemptions.

Page 23: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions49 CFR Part 173—General Requirements for Shipmentsand Packagings (US DOT)In addition to Category A and Category B, there areother new and revised definitions in §173.134.

BIOLOGICAL PRODUCT: A virus, therapeuticserum, toxin, antitoxin, vaccine, blood, bloodcomponent or derivative, allergenic product, oranalogous product, or arsphenamine or derivativeof arsphenamine (or any other trivalent arseniccompound) applicable to the prevention, treatment,or cure of a disease or condition of human beingsor animals.

Page 24: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions49 CFR Part 173—General Requirements for Shipmentsand Packagings (US DOT)

CULTURE: An infectious substance containing a pathogen that is intentionallypropagated. Culture does not include a human or animal patient specimenas defined below.

PATIENT SPECIMEN: Human or animal materials collected directly fromhumans or animals and transported for research, diagnosis, investigationalactivities, or disease treatment or prevention. Patient specimen includesexcreta, secreta, blood and its components, tissue and tissue swabs, bodyparts, and specimens in transport media (e.g., transwabs, culture media, andblood culture bottles).

EXCEPTIONS: A complete listing of materials excepted from regulation asDivision 6.2 materials under the HMR is found in §173.134(b).

Page 25: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitionsParagraph D. Exceptions for Certain ShipmentsFederal Register / Vol. 71, No. 106 / June 2, 2006/page 32248. (US DOT):

Specimen packages marked as “Exempt human specimen” or “Exemptanimal specimen” according to the ICAO Technical Instructions are notregulated under the HMR.

In the United States, the mark “Exempt Human/Animal Specimen” isan indication that there is no infectious substance in the package.Packages bearing these marks may be accepted by an air carrier thathas made a business decision not to accept hazardous materials.

Page 26: Shipping Infectious Substances and Biological products by Commercial Carriers

DefinitionsDefinitions

§171.15 and §171.16; Incident reporting.

You must report any release of an infectious Substance (Category A or B) in any mode of transportation to the Department of Transportation. See §171.15 for telephonic and §171.16 for written report requirements.

Page 27: Shipping Infectious Substances and Biological products by Commercial Carriers

Packaging,

Labeling and Documentation

Requirements for infectious substances

in Category A

Page 28: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage PreparationBecause of the differences in the hazards posed by Category A infectious substances (UN 2814 and UN 2900) and Category B infectious substances (UN 3373), there are variations in:

The packaging, The labeling and The documentation requirements for the two categories.

The packaging requirements are determined by UNCETDG and are set out as Packing Instructions P620 (PI602 for ICAO/IATAregulations) and P650, respectively [ reproduced in Annexes 3 and 4,WHO GUIDANCE ].

The requirements are subject to change and regular upgrade by the organizations mentioned throughout the presentation.

Page 29: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

The current packaging requirements are described below.

Shippers of infectious substances (Category A and B) shall ensure that packages are prepared in such a manner that they:

arrive at their destination in good condition and present no hazard to persons or animals during transport.

Page 30: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

Basic triple packaging systemThis system of packaging shall be used for all infectious substances.

It consists of three layers as follows.

Primary receptacle: A primary watertight, leak-proof receptacle containing the specimen. The receptacle is packaged with enough absorbent material to absorb

all fluid in case of breakage.

Secondary packaging: A second durable, watertight, leak-proof packaging to enclose and protect the primary receptacle(s). Several cushioned primary receptacles may be placed in one secondary packaging, but sufficient additional absorbent material shall be used to absorb all fluid in case of breakage.

Page 31: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

Basic triple packaging systemThis system of packaging shall be used for all infectious substances.

It consists of three layers as follows.

Outer packaging: Secondary packagings are placed in outer

shipping packagings with suitable cushioning material. Outer packagings protect their contents from outside influences, such

as physical damage, while in transit.

The smallest overall external dimension shall be 10x10 cm. Each completed package is normally required to be correctly marked, labeled and accompanied with appropriate shipping documents (as applicable).

Page 32: Shipping Infectious Substances and Biological products by Commercial Carriers

Category A: "UN 2814 Infectious Substances affecting Humans " Category A: "UN 2814 Infectious Substances affecting Humans " or "UN 2900 Infectious Substances affecting Animals "or "UN 2900 Infectious Substances affecting Animals "

Page 33: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

Your Outer Package MUST be marked as follows, in the same manner!!Your Outer Package MUST be marked as follows, in the same manner!!

4G/Class 6.2/05/GB/2470

FROM

Dr. A. Xyzee

Mount Sinai School of Medicine

1 Gustave L. Levy Place

New York, N.Y 10029

TO: Dr. Ben Waitin

Xyzeee University

Neverville, No 12345

INFECTIOUS SUBSTANCE

AFFECTING HUMANS

UN 2814 Net Qty 15 mls

Responsible Person

Dr. Xyzeee

212 241 1234 24hr / 7days/wk

u

n

Category A PackagingCategory A Packaging

Arrows on Opposite side, tooArrows on Opposite side, too

Page 34: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

Your Outer Package MUST be marked as follows, in the same manner!!Your Outer Package MUST be marked as follows, in the same manner!!

DRY ICE is also a HAZARDOUS SUBSTANCE, and has to be Marked!!DRY ICE is also a HAZARDOUS SUBSTANCE, and has to be Marked!!

4G/Class 6.2/05/GB/2470

FROM

Dr. A. Xyzee

Mount Sinai School of Medicine

1 Gustave L. Levy Place

New York, N.Y 10029

TO: Dr. Ben Waitin

Xyzeee University

Neverville, No 12345

INFECTIOUS SUBSTANCE

AFFECTING HUMANS

UN 2814 Net Qty 15 mls

Responsible Person

Dr. Xyzeee

212 241 1234 24hr /7days

u

nUN 1845

DRY ICE Net Wt 3 Kg

Category A PackagingCategory A Packaging

Page 35: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage PreparationPackaging

Infectious substances in Category A may only be transported in packaging that meets the United Nations class 6.2 specifications and complies with Packing Instruction P620 (PI602) (see Annex 3; Figure 1, WHO GUIDANCE).

This ensures that strict performance criteria are met; tests for compliance with these criteria include:

a 9-metre drop test, a puncture test and a pressure test.

The outer packaging shall bear the United Nations packaging specification marking (Figure 2), which indicates that the packaging has passed the performance tests to the satisfaction of the competent authority.

Page 36: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

PackagingThe primary receptacle or the secondary packaging shall be capable of withstanding a pressure differential of not less than 95 kPa.

The United Nations packaging specification marking alone does not indicate that a test for this has been undertaken, and packaging users should ask their suppliers whether the completed package meets this requirement [or their catalog information should state that it does].

Page 37: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage PreparationPackaging

There is no comprehensive list of suppliers of packagings that comply with Packing Instruction P620** (PI602 – IATA). However, an Internet search using a suitable international or national search engine usually provides appropriate information, as well as access to national regulations.

Search phrases such as “UN packaging” and “UN infectious substance packaging” produce extensive results.

Carriers and forwarding agents should also be able to supply details of local suppliers or local companies that can provide such information.

**P620 / P605 Package Manufacturers are listed in the IATA DRG’sAppendix F (Packaging)**P620 / P605 Package Manufacturers are listed in the IATA DRG’sAppendix F (Packaging)

Page 38: Shipping Infectious Substances and Biological products by Commercial Carriers

4G/Class 6.2/05/GB/2470

This Mandatory marking comprises: the United Nations packaging symbol (“un” in a circle)

an indication of the type of packaging (in this example a fibreboard box (4G))

an indication that the packaging has been specially tested to ensure that it meets the requirements for Category A infectious substances (Class 6.2)

the last two digits of the year of manufacture (in this example 2005)

u

n

Page 39: Shipping Infectious Substances and Biological products by Commercial Carriers

4G/Class 6.2/05/GB/2470

This marking comprises: the competent state authority that has authorized the

allocation of the mark (in this example GB, signifying Great Britain)

the manufacturer’s code specified by the competent authority (in this example 2470)

Users shall be provided with clear instructions as to how the package should be filled and prepared for transport.

Must be on all Category A Shipping Boxes!!

u

n

Page 40: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

For surface transport there is no maximum quantity per package.

For air transport the limits per package are as follows: 50 ml or 50 g for passenger aircraft 4 l or 4 kg for cargo aircraft.

Any primary receptacle with a capacity of more than 50 ml shall be oriented in the outer packaging so that the closures are upwards.

Orientation labels (“UP” arrows) shall be affixed to two opposite sides of the outer packaging. check

Page 41: Shipping Infectious Substances and Biological products by Commercial Carriers

PACKAGE MARKINGSPACKAGE MARKINGS

MarkingsPackages are marked to provide:

information about the contents of the package, the nature of the hazard, and the packaging standards applied.

All markings on packages or overpacks shall be placed in such a way that they are clearly visible and not covered by any other label or marking.

Page 42: Shipping Infectious Substances and Biological products by Commercial Carriers

PACKAGE MARKINGSPACKAGE MARKINGS

MarkingsEach package shall display the following information on the outer packaging or the overpack.

the shipper’s (sender’s, consignor’s) name and address

the telephone number of a responsible person, knowledgeable about the shipment

the receiver’s (consignee’s) name and address

the United Nations number followed by the proper shipping name

(UN 2814 “INFECTIOUS SUBSTANCES AFFECTING HUMANS” or

UN 2900 “INFECTIOUS SUBSTANCES AFFECTING ANIMALS”, as appropriate).

Page 43: Shipping Infectious Substances and Biological products by Commercial Carriers

PACKAGE MARKINGSPACKAGE MARKINGS

MarkingTechnical names need not be shown on the

package. temperature storage requirements (optional)

when dry ice or liquid nitrogen is used: the technical name of the refrigerant, the appropriate United Nations number, and the net quantity

Page 44: Shipping Infectious Substances and Biological products by Commercial Carriers

LabelingLabelingLabeling

There are two types of labels: (a) hazard labels in the form of a square set at an angle of 45°

(diamondshaped) are required for most dangerous goods in all classes;

(b) handling labels in various shapes are required, either alone or in addition to hazard labels, for some dangerous goods.

Specific hazard label(s) shall be affixed to the outside of each package for all dangerous goods to be shipped (unless specifically exempted). The hazard labels shown in Figures 3–7( WHO Guidance) are of importance for infectious substances in Category A:

Page 45: Shipping Infectious Substances and Biological products by Commercial Carriers

LabelingLabelingLabel Name: Infectious substance

Minimum dimensions: 100 × 100 mm

(for small packages: 50 × 50 mm)

No. of labels per package: 1

Colour: Black and white

The words “INFECTIOUS SUBSTANCE”

shall be shown.

The statement “In case of damage or leakage

immediately notify a Public Health Authority”

Is required in some countries.

Hazard label for Category A infectious

Substances and for genetically modified

microorganisms and organisms that meet the

definition of an infectious substance, Category A

Page 46: Shipping Infectious Substances and Biological products by Commercial Carriers

LabelingLabelingLabel Name: Miscellaneous

dangerous substances ( Class 9 )

Minimum dimensions: 100 × 100 mm

(for small packages: 50 × 50 mm)

No. of labels per package: 1

Colour: Black and white

UN 1845 for Carbon Dioxide

Hazard label for certain noninfectious genetically

modified microorganisms and organisms (UN 3245)

and for carbon dioxide, solid (dry ice) (UN 1845);

Substances packed in dry ice shall bear this label in

addition to the primary risk label

Page 47: Shipping Infectious Substances and Biological products by Commercial Carriers

LabelingLabelingLabel name: Orientation label

Minimum dimensions: Standard A7: 74 × 105 mm

No. per package: 2 on opposite sides

Colour: Black and white or red and white

The words “THIS SIDE UP” or “THIS END UP”

may also be displayed on the top cover of the

package.

Orientation label to indicate position of closures on the

primary receptacles; for the air transport of quantities

of liquid infectious substances in Category A that

exceed 50ml per primary receptacle, this label shall be

affixed to two opposite sides of the package with the

arrows pointing in the right direction, in addition to the

label shown.

Page 48: Shipping Infectious Substances and Biological products by Commercial Carriers

DocumentationDocumentationThe following shipping documents are required.

To be prepared and signed by the shipper: for air: the shipper’s Declaration for Dangerous Goods

(Figure 8 shows one example)

a packing list / proforma invoice that includes the receiver’s address, the number of packages, detail of contents, weight, value (Note: for international transport, a minimal value shall be indicated, for customs purposes, if the items are supplied free of charge)

an import and/or export permit and/or declaration if required.

To be prepared by the shipper or the shipper’s agent: an air waybill for air transport or equivalent documents for road,

rail and sea journeys.

Page 49: Shipping Infectious Substances and Biological products by Commercial Carriers

DocumentationDocumentation

The following shipping documents are required.

For UN 2814 and UN 2900, an itemized list of contents shall be enclosed between the secondary packaging and the outer packaging.

When the infectious substance to be transported is unknown, but suspected of meeting the criteria for inclusion in Category A and assignment to UN 2814 or UN 2900, the words “suspected Category A infectious substance” shall be shown, in parentheses, following the proper shipping name on the document inside the outer packaging.

Page 50: Shipping Infectious Substances and Biological products by Commercial Carriers

Documentation

Page 51: Shipping Infectious Substances and Biological products by Commercial Carriers

UN 2814 Infectious Substance

affecting Humans

(Dengue Fever Virus)

6.22 50 mlml 602

XXXXXX

Dry Ice 99

III III

20 kg20 kg

All packAll packed in one in one

fiberboard boxfiberboard box

904

Dr. Xyzee

Mount Sinai School of Medicine

One Gustave L Levy Place

New York, NY 10029

Dr. Ben Wayten

Wattsamatta U.

One Long Way

Neverville, NO 12345

JFK

XXXXXX

UN 1845

Page 52: Shipping Infectious Substances and Biological products by Commercial Carriers

Packaging for Category BPackaging for Category B

Packaging, labeling and documentation

requirements for infectious substances

in Category B

Page 53: Shipping Infectious Substances and Biological products by Commercial Carriers

Packaging for Category BPackaging for Category BPackaging

The triple packaging system continues to apply, including for local surface transport.

Testing documents are not required. However it may be possible to find a local authorized supplier, provided that the packaging manufacturer and the shipper can comply fully with the requirements of P650 (see Annex 4; Figure 9 WHO GUIDANCE ).

As for P620, there is no comprehensive list of suppliers of packagings that comply with Packing Instruction P650.

Carriers and forwarding agents should also be able to supply details of local suppliers or local companies that can provide such information. [ VWR and Fisher have these types of packages]

Page 54: Shipping Infectious Substances and Biological products by Commercial Carriers

Category B:Category B: " UN 3373 Biological Substance, Category " UN 3373 Biological Substance, Category

B "; Formerly B "; Formerly Clinical SpecimensClinical Specimens

Page 55: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

Your Outer Package MUST be marked as follows, in the same manner!!Your Outer Package MUST be marked as follows, in the same manner!!

FROM

Dr. A. Xyzee

Mount Sinai School of Medicine

1 Gustave L. Levy Place

New York, N.Y 10029

TO: Dr. Ben Waitin

Wattsamatta University

One Long Way

Neverville, No 12345

BIOLOGICAL SUBSTANCE ,

CATEGORY B

Net Qty 15 mls

Category B Category B PackagingPackaging

UN 3373 Optional Marking

Page 56: Shipping Infectious Substances and Biological products by Commercial Carriers

Packaging for Category BPackaging for Category BPackaging

To ensure correct preparation for transport, packaging manufacturers and subsequent distributors shall provide clear instructions to the consignor orpersons preparing packages (e.g. patients) on how the packaging should be filled and closed.

For surface transport there is no maximum quantity per package.

For air transport: no primary receptacle shall exceed 1 l (for liquids) or the outer

packaging mass limit (for solids) the volume shipped per package shall not exceed 4 l or 4 kg.

These quantities exclude ice, dry ice or liquid nitrogen when used to keep specimens cold.

Page 57: Shipping Infectious Substances and Biological products by Commercial Carriers

Packaging for Category BPackaging for Category B

Packaging

Provided all the requirements of P650 are met, there are no other transport requirements.

P650 incorporates all that is needed to make a shipment for Category B infectious substances.

Page 58: Shipping Infectious Substances and Biological products by Commercial Carriers

Marking for Category BMarking for Category B Each package shall display the following information:

for air: the shipper’s (sender’s, consignor’s) name, address and telephone number

for air: the telephone number of a responsible person, knowledgeable about the shipment

the receiver’s (consignee’s) name, address and telephone number for air:

the proper shipping name (“BIOLOGICAL SUBSTANCE, CATEGORY B”)

temperature storage requirements (optional).

Page 59: Shipping Infectious Substances and Biological products by Commercial Carriers

Marking for Category BMarking for Category B

The marking shown in Figure 10 is used for shipments of Category B infectious substances.

Minimum dimension: the width of the line forming the square shall be at least 2 mm, and the letters and numbers shall be at

east 6 mm high. For air transport, each side of the square shallhave a length of at least 50 mm

Colour: none specified, provided the mark is displayed on theexternal surface of the outer packaging on a background ofcontrasting colour and that it is clearly visible and legible

The words “BIOLOGICAL SUBSTANCE, CATEGORY B” inletters at least 6 mm high shall be displayed adjacent to the mark.

Page 60: Shipping Infectious Substances and Biological products by Commercial Carriers

Marking for Category BMarking for Category B

Marking for infectious substances of Category B and for

genetically modified microorganisms or organisms that

meet the definition of an Infectious Substance, Category B

UN 3373

Page 61: Shipping Infectious Substances and Biological products by Commercial Carriers

Marking for Category BMarking for Category B

For air transport:

When dry ice (solid carbon dioxide) is used (see section on Refrigerants,WHO GUIDANCE), the label shown in next slide shall be applied.

For cryogenic liquids (see section on Refrigerants) the labels shown in Figures 5 and 6 shall also be affixed.

Page 62: Shipping Infectious Substances and Biological products by Commercial Carriers

Marking for Category BMarking for Category BLabel Name: Miscellaneous

dangerous substances ( Class 9 )

Minimum dimensions: 100 × 100 mm

(for small packages: 50 × 50 mm)

No. of labels per package: 1

Colour: Black and white

UN 1845 for Carbon Dioxide

Hazard label for :

“UN 1845 Carbon Dioxide, Solid (dry ice) ;

Substances packed in dry ice shall bear this label in

addition to the primary risk label

Page 63: Shipping Infectious Substances and Biological products by Commercial Carriers

Package PreparationPackage Preparation

Your Outer Package MUST be marked as follows, in the same manner!!Your Outer Package MUST be marked as follows, in the same manner!!

FROM

Dr. A. Xyzee

Mount Sinai School of Medicine

1 Gustave L. Levy Place

New York, N.Y 10029

TO: Dr. Ben Waitin

Wattsamatta University

One Long Way

Neverville, No 12345

BIOLOGICAL SUBSTANCE ,

CATEGORY B

Net Qty 15 mls

Category B PackagingCategory B Packaging

UN 3373Optional Marking

Nt Wt 25 kg

Page 64: Shipping Infectious Substances and Biological products by Commercial Carriers

Documentationfor Category B

DocumentationDangerous goods documentation (including a shipper’s declaration) is not required for Category B infectious substances. The following shipping documents are required.

To be prepared and signed by the shipper (sender, consignor): for international shipments: a packing list / proforma invoice that includes:

the shipper's and the receiver’s address,the number of packages,detail of contents, weight, value (Note: the statement “no commercial value” shall appear if the items are supplied free of charge)

an import and/or export permit and/or declaration if required [PLAN AHEAD!!].

To be prepared by the shipper or the shipper’s agent: an air waybill for air transport equivalent documents for road, rail and sea journeys.

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Flowchart for the classification of infectious substances and patient specimens

Is it known NOT to contain infectious substances?

Have any pathogens present been neutralized or inactivated, so that they no longer pose a health risk?

May it contain microorganisms that are non-pathogenic to humans or animals?

Is it in a form in which any pathogens present have been neutralized or inactivatedsuch that they no longer pose a health risk?

Is it an environmental sample (including food and water sample) that is not considered topose a significant risk of infection?

Is it a dried blood spot? Is it a faecal occult blood screening test? Is it decontaminated medial or clinical waste? Is it for transfusion or transplantation?

Substance for classification

YES NO

or Unknown

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Subject to “exempt

Human or animal

Specimen provisions

Not subject to the

Transport

requirements

For dangerous goods

Unless meeting the

criteria for another

Division or class

“UN 3373 Biological

Substance, Category B”

“UN 2814 Infectious

Substance, affecting

Humans”, or “UN 2900

Infectious Substance,

affecting animals only”

Has an informed professional judgment based on known medical

history, symptoms and individual circumstances of the source, human

or animal, and endemic conditions determined that there is only

minimal likelihood that a pathogen is present?

Does it meet the definition of a

Category A substance?

NO or Unknown

YES NO

or Unknown

NOYes or Unknown

YES

Page 67: Shipping Infectious Substances and Biological products by Commercial Carriers

UN-NumbersUN-Numbers

Common Laboratory Specimens Offered for TransportCommon Laboratory Specimens Offered for TransportMaterials Requiring a Hazardous Materials (Dangerous Goods)Materials Requiring a Hazardous Materials (Dangerous Goods)

DeclarationDeclaration

UN 2814 Infectious substance, affecting humans (Solid or Liquid)UN 2814 Infectious substance, affecting humans (Solid or Liquid)

UN 2900 Infectious substance, affecting animals (Solid or Liquid) UN 2900 Infectious substance, affecting animals (Solid or Liquid)

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UN-NumbersUN-Numbers

Common Laboratory Specimens Offered forCommon Laboratory Specimens Offered forTransportTransportMaterialsMaterials Not Not Requiring a Hazardous MaterialsRequiring a Hazardous Materials(Dangerous Goods) Declaration – Unless combined with(Dangerous Goods) Declaration – Unless combined withanother HRM (next slide)another HRM (next slide)

UN 3373 Biological Substance, Category B UN 3373 Biological Substance, Category B - Diagnostic Specimens- Diagnostic Specimens

- Clinical Specimens - Clinical Specimens

UN 3245 Genetically Modified micro-organisms UN 3245 Genetically Modified micro-organisms Gets a Class 9 Sticker!!Gets a Class 9 Sticker!!

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Carriers / AssociationsCarriers / Associations

International Air Transport AssociationInternational Air Transport Association

http://www.iata.org/whatwedo/cargo/dangerous_goods/indexhtmhttp://www.iata.org/whatwedo/cargo/dangerous_goods/indexhtm

International Maritime Organization http://www.imo.org/ International Maritime Organization http://www.imo.org/

FedExFedEx http://www.fedex.com/us/http://www.fedex.com/us/

DHL (International ONLY)DHL (International ONLY) http://www.dhl.com/splash.html http://www.dhl.com/splash.html

World CourierWorld Courier http://www.worldcourier.com/ http://www.worldcourier.com/

United Parcel Service http://www.ups.com United Parcel Service http://www.ups.com

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REGULATORY AGENCIESREGULATORY AGENCIES

As the name implies, these are enforceable laws, some carrying fines if not complied with by an offeringAs the name implies, these are enforceable laws, some carrying fines if not complied with by an offeringindividual. The following agencies have jurisdiction over biological materials:individual. The following agencies have jurisdiction over biological materials:

US Customs and Border Patrol http://www.cbp.gov/xp/cgov/toolbox/contacts/customer_service.xml

US Department of Agriculture http://www.usda.gov/APHIS http://www.aphis.usda.gov/US Department of Commerce

http://www.bis.doc.gov/licensing/Do_I_NeedAnECCN.html

US Department of Transportation http://www.dot.gov/

US Postal Service http://www.usps.com/US Public Health Service http://www.os.dhhs.gov/

http://www.os.dhhs.gov/phs/Centers for Disease Control http://www.cdc.gov/od/ohs/And Prevention-Health and Safety http://www.cdc.gov/od/eaipp/Food and Drug Administration (FDA) http://www.fda.gov/ World Health Organization http://www.who.int/home-page/ and specifically,

http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2007_2cc.pdf

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UN-NumbersUN-NumbersOther Hazardous Materials Offered along withOther Hazardous Materials Offered along withInfectious Substances or Biological SubstancesInfectious Substances or Biological SubstancesRequiring a Hazardous Materials (DangerousGoods)Requiring a Hazardous Materials (DangerousGoods)Declaration**Declaration**

UN1977 Nitrogen, refrigerated liquid UN1977 Nitrogen, refrigerated liquid (as a cryopreservative) (as a cryopreservative)

UN 1845 Dry Ice /Carbon Dioxide (UN 1845)UN 1845 Dry Ice /Carbon Dioxide (UN 1845) UN 2209 Formaldehyde solution UN 2209 Formaldehyde solution

(aka Formalin, 10%) (aka Formalin, 10%) UN 1170 Ethyl Alcohol solution (Ethanol)UN 1170 Ethyl Alcohol solution (Ethanol) UN 1219 Isopropyl Alcohol (Isopropanol)UN 1219 Isopropyl Alcohol (Isopropanol)

**When Quantities exceed exempted quantity limits**When Quantities exceed exempted quantity limits

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ConclusionConclusion

Be Advised that neither the US Post Office Be Advised that neither the US Post Office or United Parcel Service (UPS) will take or United Parcel Service (UPS) will take Infectious Substances (UN 2810 or UN Infectious Substances (UN 2810 or UN 2900).2900).Other Courier services will take UN 2810 Other Courier services will take UN 2810 and UN 2900 substances provided that the and UN 2900 substances provided that the material is packaged in accordance with material is packaged in accordance with the P620 (PI602-IATA) Packing the P620 (PI602-IATA) Packing requirements.requirements.

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ConclusionConclusion

Remember-Remember-YouYou areare responsible for obtaining ALL Import permits responsible for obtaining ALL Import permits before attempting to import these materialsbefore attempting to import these materials

You are responsibleYou are responsible for obtaining ALL Export licensees before for obtaining ALL Export licensees before attempting to export these materialsattempting to export these materials

Without the proper Declaration of Dangerous Goods, list and Without the proper Declaration of Dangerous Goods, list and quantity of package contents, import / export documents—your quantity of package contents, import / export documents—your shipment can end up sitting in a Customs impound, and end up shipment can end up sitting in a Customs impound, and end up damaged or destroyeddamaged or destroyed

You may subject yourself to a fine by the FAA, US DOT or other You may subject yourself to a fine by the FAA, US DOT or other agency for offering Dangerous Goods for transport improperly.agency for offering Dangerous Goods for transport improperly.

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ConclusionConclusion

If you still have questions, or comments or If you still have questions, or comments or need further assistance please contact the need further assistance please contact the Biosafety Officer at:Biosafety Officer at:

212 241 5169212 241 5169

[email protected]@mssm.edu