ONLINE SELF-STUDY Shipping of Infectious Substances and Other Biomedical Materials Annual Update

ONLINE SELF-STUDYShipping of Infectious Substances and Other Biomedical Materials Annual Update

Regulatory Updates

June 2014 Changes:• New small quantities exception-

De Minimis Quantities• Changes to Dry Ice label

Course Objectives

The purpose of this program is to: ensure the safe handling of hazardous materials using good

sensible practices. recognize hazardous materials and realize there are special

requirements comply with Federal and International regulations

The basic goal for this training is to provide a framework for decisions

Is material to be shipped a dangerous good, genetically modified, biological substance category B, or an exempt human specimen?

Upon completion you will receive certification to ship hazardous materials

Course Objectives

This training will increase your awareness of safety and compliance issues. If you need more information or help with shipping your package you can e-mail the EHS Shipping Specialist. The training will cover the topics listed below. Classification, identification, and packaging are three of the most important topics covered.

Regulatory Oversight Dangerous Goods/Hazardous Materials Training Requirements Shipper’s & Operators’ Responsibilities Classification, Identification Packaging Shipping with dry ice and Overpacks Marking & labeling packages Shipping documentation Emergency Response Laboratory Security Accept or reject shipments by use of checklist

Regulatory Oversight

Federal Regulations:

U.S. Dept. of Transportation (DOT) – 49 CFROther federal requirements: CDC, OSHA, USDA, Department of Commerce, International Traffic and Arms (ITAR) and Toxic Substance Control Act (TSCA)

DOT regulations primarily cover ground transportation. DOT is the organization that has the authority to fine you for violations. Their authority extends well beyond US boundaries. Import permits from the CDC or USDA may be needed if you are importing human etiological organisms or plant or animal pathogens. Department of Commerce licenses may be needed to export organisms, genetic elements, chemicals, technology or other commodities. TSCA Certification may be needed to import or export certain chemicals.

International Regulations (Air shipments)

International Civil Aviation Organization (ICAO)

International Air Transport Association (IATA)

Dangerous Goods Regulations (DGR)

Internationally, the UN Committee of Experts (CoE) develops recommended procedures for the transport of all types of dangerous good except Radioactive material. The International Civil Aviation Organization (ICAO) uses the UN recommendations as the basis for developing the regulations for the safe transport of dangerous goods by air. IATA is the international trade organization that interprets ICAO regulations and provides the Dangerous Goods Regulations (DGR). The IATA regulations are more stringent than DOT. This training program follows the IATA regulations. IATA regulations are minimal requirements - your carrier can be more stringent.

Regulatory Oversight

Fines and Penalties

"Violations contrary to the U.S. Code of Federal Regulations (CFR) 49, if substantiated, may result in the assessment of a civil penalty of up to $37,500 per violation, and deliberate violations may result in criminal prosecution of up to $500,000 and 5 years in prison."

There has been an increase in the number of Federal Aviation Inspections (FAA) in response to the 1996 ValuJet crash, the September 11, 2001 attacks, and the UPS package bomb scare in November 2010.

If you are receiving a HazMat package it is your responsibility to ensure the sender packages it correctly.

Oxygen-generating canister like the ones on board the ValuJet flight 592

Definitions

Infectious Substance - Class 6.2 Definition:

Infectious substances are substances known to contain, or reasonably expected to contain, pathogens.

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

Critical to the infectious substance definition is the ability to cause disease.

Note the reliance on your professional judgment when the words “reasonably expected” are used.

Definitions

The IATA definition for infectious substances leaves out toxins. Toxins are placed in a separate category. They are treated like chemicals.

Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1 and assignment to UN 3172 (for liquids) or UN 3462 (for solids).

Contact EHS if you are shipping toxins as instructions for shipping toxins is not covered in this training module. Please be aware that many toxins (if shipped out of the US) are regulated by the Department of Commerce. There are significant fines associated with exporting toxins without a license

Definitions

Biological products

Those products derived from living organisms which are manufactured and distributed 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.

Patient Specimens

Patient Specimens 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.

Cultures

Laboratory stocks are the result of a process by which pathogens are intentionally propagated in order to generate high concentrations. This increases the risk of infection when exposure to them occurs. An example of this would be a patient sample of TB that has been cultured.

Training Requirements

You must be currently certified to legally ship dangerous goods.

Who needs to be certified?Anyone who

– prepares,– classifies, – packs, – labels, – or offers a dangerous good for transport.

Certification is valid for 2 years. Completing this training one time is not enough. It must be renewed every 2 years to maintain shipping certification.

Classification and Identification of Dangerous Goods

What is a dangerous good?

Any material that the Secretary of Transportation determines poses a risk to health, safety, property, or the environment.

A dangerous good is any article or substance capable of posing a risk to health, safety, property, or the environment (IATA).

A material or substance posing an unreasonable risk to health, safety, and property when transported (DOT).

Classification of Infectious SubstancesInfectious substances are divided into the following

categories, Category A and Category B. The following are the proper shipping names for each category:

Category A Infectious substances, affecting humans, UN 2814 Infectious substances affecting animals, UN 2900

Category B Biological Substances Category B, UN 3373

Classification

Category A Infectious Substances - an infectious substance which is transported in a form that when exposure occurs, is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals. Examples of substances that meet this criteria are located in this table: Table 3.6.D.

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 the Category A criteria which cause disease in humans or both in humans and animals must be assigned to UN 2814 (Infectious substance, affecting humans).

Infectious substances which cause disease only in animals must be assigned to UN 2900 (Infectious substance, affecting animals).

Classification

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

Example: A patient from a foreign country is admitted to the hospital. You think they may have Ebola. You will ship all body fluids as infectious substances (Category A) using all the applicable packaging and paperwork.

Classification

Category B, Biological substance is an infectious substance which does no meet the criteria for inclusion in Category A.

Example: A patient's body fluid infected with mycobacterium tuberculosis. A culture of this same organism would be a Category A infectious substance.

You must use your professional judgment in deciding if an infectious substance is a Category A or Category B infectious substance. Contact EHS if you need assistance determining your classification.

Classification

Infectious substances in category B must be assigned to UN 3373 except those organisms on table 3.6.D - which must be assigned to UN 2814 or UN 2900.

The proper shipping name of UN 3373 is Biological Substance Category B.

Classification

Exemptions

Substances in this group are not subject to these Regulations unless they meet the criteria for inclusion in another class (Example: Ethanol or another hazards to the sample.)

Unregulated ‘Biological Specimens’Patient Specimens

Classification-ExemptionsUnregulated ‘Biological Specimens’

Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to these regulations unless they meet the criteria for inclusion in another class i.e. you add ethanol to the sample.

Substances containing 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 no longer pose a health risk.

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 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 .

Classification of Infectious SubstancesPatient Specimens

Patient specimens for which there is minimal likelihood that pathogens are present are not subject to these Regulations if the specimen is packed to prevent any leakage and is marked with the words "Exempt human specimen" or "Exempt animal specimen”. The package must meet certain packing requirements.

Examples:

The determination of whether a specimen is consider ‘exempt human/animal specimens’ is based on professional judgment. The judgment should be based on the know medical history, symptoms and individual circumstances of the source, and local endemic conditions.

Specimens suspected of being infectious should be shipped as infectious agents. Live animals or infected animal specimens are not considered exempt.

Other Classifications

Biological Products

For the purposes of these Regulations, 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 use for personal health care by medical professionals or individuals. These include but are not limited to finished and unfinished products such as vaccines.

Substances in this group are not subject to these Regulations.

Those which do not fall under paragraph (a) and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B. Substances in this group must be assigned to UN 2814, UN 2900 or UN 3373, as appropriate.

Note: Some licensed biological products may present a biohazard only in certain parts of the world. In that case, competent authorities may require these biological products to be in compliance with local requirements for infectious substances or may impose other restrictions


Genetically modified microorganisms are: Organisms that do not meet the definition of infectious substances but posses genetic material that has been purposely altered through genetic engineering in a way that does not occur naturally.

Assigned UN 3245

UN 3245 label:

These items must be triple packaged (leak proof primary container, leak proof secondary container, strong outer container). Liquids must have sufficient absorbent material to absorb all contents outside of the primary container. Outer containers must have sender and receiver names, addresses, and phone number marked on the box.

UN3245


Infected Animals

A live animal which has been intentionally infected and is known or suspected to contain an infectious substance cannot be transported by air unless the infectious substance contained cannot be consigned by any other means. Infected animals can only be transported by certain carriers. With the shipment there must be a DOT letter of authorization.

In order to receive infected animals you must obtain an import permit from the USDA. Both a DOT letter of authorization and USDA Permit take weeks to obtain.

Identification

This process begins with a correct assessment of the dangerous good and proper classification of it.

Classify this danger against the List of Dangerous Goods in the Dangerous Goods Regulations. Biological Hazards Chemical Hazards

Use the table to identify the proper shipping name, hazard class, labels needed, packing instructions to follow, and quantity limitations.

IdentificationCategory A Infectious Substance

The table from the Dangerous Goods Regulations provides a lot of critical information. The entries for infectious substances are shown here. You will not find a microorganism listed by its scientific/technical name. There are two UN numbers: UN 2814 and UN 2900 for Category A Infectious Substances (Column A). The asterisk beside infectious substances means you must put the technical name (specific name of the organism) on any paperwork. You do not put the technical name on the outside of the package. Column C gives the class or division and Column D gives the hazard label that will be affixed to the package. Columns J and L give the quantity limits per package type.

UN/ ID no.

A

Proper shipping Name/Description

B

Class or Div.

(Sub Risk)

C

Hazard Label(s)

D

PG

E

EQ

F

Passenger and Cargo Aircraft

CargoAircraft Only S.P.

See 4.4

M

ERG Code

N

Ltd QtyPkg Inst

I

Max Net Qty/Pkg

J

Pkg Inst

K

Max Net Qty/Pkg

L

Pkg Inst

G

Max Net Qty/Pkg

H

2814 Infectious substance, affecting humans *(solid)

6.2 Infectious subst.

E0-- --

620 50 g 620 4 kg A81A140

11Y

2814 Infectious substance, affecting humans *(liquid)


E0-- --

620 50 mL 620 4 L A81A140

11Y

2900 Infectious substance, affecting animals *only (solid)


E0-- --

620 50 g 620 4 kg A81A140

11Y

2900 Infectious substance, affecting animals *only (liquid)


E0-- --

620 50 mL 620 4 L A81A140

11Y

Identification

Category A Infectious Substance

This slide shows the packing instruction and maximum quantity per package. The limits are different for passenger and cargo aircraft.

You are only allowed to ship 50mg/g per package on a passenger and cargo aircraft. You are only allowed to ship 50mL (liquid) or 50g (solid) per package on a passenger and cargo aircraft. With the "cargo aircraft only" label you can ship up to 4L (liquid) or 4 kg (solid) on a cargo aircraft only.

Cargo Aircraft Only Label


CargoAircraft Only

Ltd Qty Pkg Inst

I

Max Net

Qty/PkgJ

Pkg Inst

K

Max Net Qty/Pkg

LPkg Inst

GMax Net Qty/Pkg

H

-- --620 50 g 620 4 kg

-- --620 50 mg 620 4 L

-- --620 50 g 620 4 kg

-- --620 50 mL 620 4 L

Identification

Biological Substance, Category B

The UN number 3373 is in Column A.

When shipping biological substances you have to use packing instruction 650 and you can ship up to 4 L per outer package (primary containers cannot exceed 1 L.)

The 4L quantity excludes ice, dry ice or liquid Nitrogen when keeping specimens cold.

UN/ ID no.

A


B

Class or Div.(Sub Risk)

C

Hazard Label(s)

D

PG

E

EQ

F



See 4.4

M

ERG Code

N

Ltd QtyPkg Inst

I

Max Net Qty/Pkg

J

Pkg Inst

K

Max Net Qty/Pkg

L

Pkg Inst

G

Max Net Qty/Pkg

H

3373Biological substance,

Category B 6.2 E0 -- -- --See 650-- --See 650-- 6L

Identification

Dry Ice

Several of these entries for dry ice look alike. The one you want is UN 1845, Class 9. The Packing Instruction when filling out the Dangerous Goods Declaration is 954.

UN/ ID no.

A


B

Class or

Div.(Sub Risk)

C

Hazard Label(s)

D

PG

E

EQ

F



See 4.4

M

ERG Code

N

Ltd Qty Pkg Inst

I

Max Net Qty/Pkg

J

Pkg Inst

K

Max Net Qty/Pkg

L

Pkg Inst

G

Max Net Qty/Pkg

H

1845 Carbon dioxide, solid

9 Miscellaneous E0 -- -- 954 200 kg 954 200 kg A48A151

9L

Identification

Biological Products

There is no UN number in the left hand column for biologicals. It states they are not restricted. You do not need diamond shaped labels and you can ship as much as you want as long as no chemicals or infectious agents are present.

UN/ ID no.

A


B


C

Hazard Label(s)

D

PG

E

EQ

F


CargoAircraft Only

Ltd Qty Pkg Inst

I

Max Net Qty/Pkg

J

Pkg Inst

K

Max Net Qty/Pkg

L

Pkg Inst

G

Max Net Qty/Pkg

H

Biological products +Manufactured and packaged in accordance with the requirements of national governmental health authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals

----NOT RESTRICTED----

Chemical Preservatives

Solutions used to preserve biological samples may be regulated as dangerous goods.

Ethanol, greater than 24% is assigned to UN1170, Class 3, Ethanol, PGII

10% to <25% Formaldehyde is assigned to UN3334, Class 9, Aviation regulated liquid, n.o.s.

Formaldehyde, not less than 25% assigned to UN2209, Class 8, Formaldehyde solution PGIII

Formaldehyde combined with a flammable substance may qualify as UN1198, Class 3 (Sub risk 8), Formaldehyde solution, flammable.

Call EHS for specific packaging and training before shipping chemicals

Packing Groups

Packing groups apply to toxic substances and chemicals but not infectious substances, biological products or Category B biological substances. The packing groups pertain to performance test requirements. They are assigned with regard to the relative degree of danger of the article or substance.

Here is an example of the packing group criteria for class 3 materials (flammable liquids)

The IATA DGR establishes packing group assignments for all applicable classes based on the type of hazard. For example Class 8 materials are assigned packing groups based on corrosivity and Class 6.1 materials are assigned based on toxicity.

Packing Group

Flash Point (closed cup)

Initial Boiling Point

I Less than or equal to 35° C

II Less than 23° C

Greater than 35° CIII

Equal to or greater than 23° C but less than or

equal to 60.5° C

Packing Group Hazard Level

I High Hazard

II Moderate Hazard

III Low Hazard

Packing Groups

The packing group for a material is indicated on the table in the Dangerous Goods Regulations. Here is an example using the listing for Ethanol.

Ethanol has two packing groups listed (column E). The flashpoint of your ethanol solution will determine which packing group and packing instructions to use. Check the SDS for flashpoint information.

UN/ ID no.

A


B


C

Hazard Label(s)

D

PG

E

EQ

F



See 4.4

M

ERG Code

N

Ltd Qty Pkg Inst

I

Max Net Qty/Pkg

J

Pkg Inst

K

Max Net Qty/Pkg

L

Pkg Inst

G

Max Net Qty/Pkg

H

1170 Ethanol 3 Flamm. liquid IIIII

E2E1

Y341Y344

1 L10 L

353355

5 L60 L

364366

60 L220 L

A3A58

A180

3L3L

Dangerous Goods in Excepted Quantities There are 2 provisions in the Dangerous goods regulations that allows small

quantities of some dangerous goods to be shipped as "dangerous goods in excepted quantities” or “dangerous goods in deminis quantities”

This is very useful for small amounts of hazardous chemicals. Check the EQ column (column F) on the Dangerous Goods Table for the material to

find the Excepted Quantity code. Reference table 2.7 to determine the quantity allowed under your item's code. Some materials are not allowed to ship as Excepted Quantities. These will

have an E0 in column F

For the EQ table, click here: table 2.7

UN/ ID no.

A


B

Class or

Div.(Sub Risk)

C

Hazard Label(s)

D

PG

E

EQ

F



See 4.4

M

ERG Code

N

Ltd Qty Pkg Inst

I

Max Net Qty/Pkg

J

Pkg Inst

K

Max Net

Qty/Pkg

L

Pkg Inst

G

Max Net Qty/Pkg

H

2516 Carbon tetrabromide

6.1 Toxic III E1 Y645 10 kg 670 100 kg 677 200 kg 6L

Dangerous Goods in Excepted Quantities

This form can be downloaded at http://ehs.unc.edu/ih/lab/docs/excepted.pdf.

It needs to be printed on a color printer.

In the upper box you will type the Class number(s), with sub risks in parenthesis. This is found in column C of the Dangerous Goods table.

In the lower box you will type either your name and address or the recipient's name and address IF it is not already marked ON the package.

This label along with an address label placed on a strong outer box is what is needed for shipping excepted quantities of chemicals not forbidden for transport.

The material must be in a leak proof primary container. The primary container needs to be taped closed. This primary container must be securely packed in a secondary container with absorbent/cushioning material in such a way that the primary container will not break, puncture, or otherwise release its contents. The secondary container must be securely packed in a strong rigid outer packaging (wood, cardboard, or other equally strong material). Each outer package must be large enough to apply all necessary markings.

Dangerous Goods in Excepted QuantitiesExcepted Quantity Package Test

The complete package must be capable of withstanding the following drop and load tests. This must be demonstrated by testing and appropriately documented using this form.

Excepted Quantity Package Test Verification Form (http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)

For the purposes of testing you will use a substance with similar physical characteristics (mass, grain size, density, etc.) to the item you intend to ship. Fill the primary container to 98% capacity.

Triple package this substance in identical primary, secondary (including absorbent/cushioning), and outer containers to what you intend to use for shipping and perform the following tests:

Dangerous Goods in Excepted QuantitiesDrop Test:

From a height of 1.8 m (5.9 feet), perform each of the following drops onto a rigid, non-resilient flat and horizontal surface:

Flat on the base

Flat on the top

Flat on the longest side

Flat on the shortest side

On a corner

Load Test:

Calculate the mass of identical size and weight packages as your test sample if stacked to a height of 3 m (10 feet). Apply this amount of force to the top surface of your package for 24 hours.

Dangerous Goods in Excepted QuantitiesA successful package test results in no leakage or breakage of the

inner containers and no significant reduction in effectiveness of any of the 3 layers of packaging.

Remember to document this package test using this form (http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)

If you are using packing materials and specimens that you have previously tested and documented you do not need to re-test the package. You may use a copy of the package test verification form from a previous test of the same materials. Make sure you keep a copy of the package test verification form in your shipping records.

Dangerous Goods in Excepted QuantitiesHere is an example of the label for a package containing an

excepted quantity of a Class 3 flammable liquid.

Dangerous Goods in Excepted QuantitiesMany people ship their biological samples in formalin or ethanol to

preserve them. Packing instructions 620 (UN2814 and 2900 Category A infectious substances) and 650 (UN3373 Biological Substances, Category B) allow for a quantity of 30mL or less of dangerous goods in classes 3, 8, or 9 to be packed in each primary receptacle containing infectious substances. This includes commonly used preservatives such as formalin, ethanol, or formaldehyde.

When these small quantities are packed with infectious substances using the packing method for that infectious substance, the excepted quantity label is not required. The infectious substance packaging will be sufficient.

This does not include phenol, which is a class 6 chemical.

Dangerous Goods in Excepted Quantities

Common Name (Proper Shipping Name)

Class or Division (Sub. Risk)

Packing Group

EQ

Ethanol 3 II E2

III E1

Formaldehyde 10% to <25%(Aviation regulated liquid, n.o.s.)

9 III E1

Formaldehyde solution (Formaldehyde, not less than 25% )

8 III E1

Formaldehyde solution, flammable

3(8) III E1

Phenol solution 6.1 II E4

III E1

EQ Values for Chemicals Commonly Shipped in Small Quantities

Dangerous Goods in De Minimis Quantities Dangerous Goods assigned codes E1, E2,

E4 or E5 do not required Excepted Quantity or any hazard labeling provided: The maximum quantity of material per

inner container is 1 ml/1 g or less. The maximum net quantity per packaging

does not exceed 100ml/100g. Excepted Quantity package test must

still be preformed.

Shipping With Formalin

Shipper's Declaration for Dangerous Goods

Many people ship large amounts of formalin to preserve their specimens. Here is an example of the Shippers Declaration for Dangerous Goods when shipping formalin. If you are shipping formalin or any other chemical, you need to call EHS at 919 - 962 - 5507 for more in-depth training.

Packaging and Documentation

Packaging

Selecting Proper Packaging

Selecting the proper packaging is one of the most important functions of the shipper. With proper packaging you ensure the safety of those who may handle or unpack the contents of the package. Proper packaging ensures that the material is not released during transportation.

The shipper is responsible for all aspects of the packing of dangerous goods.

The carrier (FedEx, DHL, UPS, etc.) will not help you package your material.

Packaging

Selecting Proper Packaging

The shipper must comply with the following packing instructions: UN2814 or UN2900 Category A infectious substances use Packing

Instruction 620 pdf UN3373 Category B infectious substances use Packing Instruction

650 pdf UN1845 Dry Ice use Packing Instruction 954 pdf

Biological Substances Category B PackagingCategory B Specifications

These are the minimum packaging requirements for Packing Instruction 650:

The packagings must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport, including trans shipments.

"Packagings must be constructed and closed so as to prevent any loss of contents that might be caused under normal conditions of transport, by vibration or by changes in temperature, humidity or pressure."

The packaging must consist of three components: Primary receptacle(s) Secondary packaging(s) Rigid Outer Packaging

Biological Substance Category B PackagingBiological Substance, Category B Packaging Requirements Primary receptacle(s) must be leakproof and contain

no more than 1L Secondary packaging must be leakproof If multiple fragile receptacles are in a single secondary

package they must be individually wrapped or separated

to prevent contact Sufficient absorbent material must be placed between

the primary and secondary receptacles.

Primary receptacle

Biological Substance Category B PackagingPackaging Materials for Category B Substances

Notes: You do not need special absorbent. Cotton balls or paper towels may be used.

Biological Substance Category B PackagingBiological Substance, Category B Packaging

Requirements

Place Primary Packaging in Secondary Packaging The primary receptacle or the secondary

packaging must be able to withstand, without leakage, an internal pressure test of 95 kPA in the range of -40° C to 55° C. When you are ordering shipping materials make

sure you order primary or secondary containers that meet the 95 kPA.

Examples: Secondary packaging that meets the 95 kPA requirement. Top: tyvek pouches, Bottom: plastic canisters Notice the biohazard symbol on the packaging. It is

an OSHA (not an IATA) requirement when shipping blood or other potentially infectious material.

Biological Substance Category B PackagingBiological Substance, Category B Packaging

Requirement An Itemized list of contents is required. It is place

between the secondary packaging and outer packaging.

Outer packaging must be marked with the following: The name, address and telephone number of a responsible

person. UN 3373 must be marked on the outside of the box

adjacent to the words Biological Substance Category B. Biological Substance Category B hazard label

The completed package must be able to pass a drop test of 1.2 M on all sides.

The biohazard symbol is not required on the outer box.

Make sure your specimens do not move about loosely in the box.

It is useful many times when shipping out of the country to put "For Research Purposes Only" on the outside of the box.

Biological Substance Category B Packaging

Biological Substance Category B PackagingUS Postal Service Label Requirement for Specimens

OSHA "Biohazard Label"

The U.S. Postal Service accepts Biological Substance Category B. You no longer display the Biohazard symbol on the outside. If you are shipping chemicals or blood or other potentially infectious materials using the U.S. postal service please call EHS at 919 - 962 - 5507.

Exempt Human Specimens PackagingPatient Specimens, Packaging Requirements The marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriateThe packaging must consist of three components:

a leak-proof primary receptacle(s); a leak-proof secondary packaging; and 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;

For liquids, absorbent material in sufficient quantity to absorb the entire contents must 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;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

Shipping With Dry Ice

Dry ice is always considered a Dangerous good It must always be declared by marking, labeling, (Class 9) and

documentation. If there are no other dangerous goods in a shipment, a Shipper’s

Declaration is not required (red hatch-mark form). Outer packaging must be marked with the following:

UN 1845 must be marked on the outside of the box adjacent to the words Dry Ice

Class 9 misc. hazard label Weight of dry ice in kgs

Dry ice is never placed in a sealed container. The package must be able to release vapor at all times. The lid of a Styrofoam cooler should not be taped in place. Tape the outer cardboard box. Even when transporting dry ice by ground, basic safety precautions should be followed. Allow ventilation of the cooler and the vehicle. CO2 can build up in a car with the windows rolled up.


Here is an example of the "Special Handling" box of the Air Waybill (FedEx): The proper Shipping Name box should be checked The Class Number 9 (misc) is printed on the form-fill in the amount of dry ice The UN Number UN1845 should be on the form One of the following boxes must be checked Does this shipment contain dangerous goods?

Wet ice or blue ice packs are not considered dangerous goods. Pack both so the package does not leak.

If you are shipping Biological Substances Category B with wet ice, blue ice, dry ice, or at ambient temperatures you need to check the box. "Yes" (Shippers declaration not required). If you are shipping Infectious Substance Category A on dry ice you will check 'yes' (as per attached shipper's Declaration).


Every package containing dry ice must have a Class 9 Miscellaneous hazard label (minimum size 4 in x 4 in):

For a .pdf version of this label go here: http://ehs.unc.edu/ih/lab/docs/dry_ice.pdf

Note: Labels must be weather resistant. If you use the paper label in the link above be sure to completely cover it with clear packing tape when you attach it to the box.


Effective October 1, 2014

Per DOT regulations, Class 9 hazard labels with the horizontal linewill no longer be accepted.

Infectious Substances Category A PackagingPacking Specifications Infectious

Substances (Category A)

Here are the most important requirements for Packing Instruction 620:

watertight primary receptacle watertight secondary packaging

Either the primary or secondary container must be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kPa and temperatures in the range of -40° C to 55° C.

absorbent material, if liquid itemized list of contents between the

secondary and outer container UN certified outer packaging at least 100mm x 100 mm (4 in x 4 in.)

Infectious Substances Category A PackagingUN Certified Packaging There are several requirements for certified packaging. One requirement for

certified packaging is a drop test. A prototype of the package, properly packed with its filled primary and

secondary containers, is dropped from a height of 30 feet on all sides and a corner. It is then subjected to an hour of rainfall and dropped on all sides again. Following the drop test there must be no leakage from the primary receptacles which must remain protected by absorbent in the secondary packaging. Another test to meet UN certified packaging is the puncture test.

The UN certification stamp on the box certifies that the package has been subjected to and passed all required tests. The UN certification stamp looks like this:

The UN Certification Symbol is pre-printed on the tested boxes. Under no circumstances must you write the UN certification mark on the box.

U 4G/CLASS 6.2/07 DK/ N SP-9989-ERIKSSON

Infectious Substances Category A PackagingUN Certified Packaging A UN Certified box is tested with

a primary and secondary container. Do not change out the components of the box. Ship the box the way it was originally tested to ensure its integrity.

Packages are expensive but reusable. When shipping a box back to a collaborator, deface labels (do not tear them off) and mark it as empty.In order to reuse an infectious shipper cut the tape to open - do not tear the tape off the box.

Infectious Substances Category A PackagingFisherbrand Biohazard Mailers

Take care when selecting your packaging. You cannot ship infectious material from Category A in these cardboard tubes. You will notice there are no UN markings. These should only be used when shipping exempt specimens or Category B materials. When shipping Category B materials make sure the mailer you buy meets the 95kPa pressure test.

Infectious Substances Category A PackagingInfectious Substance, Category A

Packaging Requirements Primary containers must be glass, metal or

plastic (leave room for expansion) Maximum net quantity per package-50ml

Secondary packaging must be leakproof If multiple fragile receptacles are in a single

secondary package they must be individually wrapped or separated to prevent contact

Sufficient absorbent material must be placed between the primary and secondary receptacles.

Plastic Primary receptacles capable of withstanding very low temperatures should be used when shipping with liquid nitrogen.

Primary receptacle

Infectious Substances Category A PackagingInfectious Substance, Category A Packaging

Requirements

The primary receptacle or the secondary packaging must be able to withstand, without leakage, an internal pressure test of 95 kPA in the range of -40° C to 55° C. When you are ordering shipping materials

make sure you order primary or secondary containers that meet the 95 kPA.

Examples: Secondary packaging that meets the 95 kPA requirement. Top: tyvek pouches, Bottom: plastic canisters Notice the biohazard symbol on the packaging.

It is an OSHA (not an IATA) requirement when shipping blood or other potentially infectious material.

Infectious Substances Category A PackagingRequirements Place primary packaging in secondary

packaging Put the secondary packaging along with the

itemized list of contents in the support package.

The interior support packaging secures the secondary package as the dry ice dissipates. Contents of your package should not move around inside the package unsecured.

Place insulated container inside UN certified outer packaging with UN Specification marks.

Remember do not tape the lid of the insulated cooler. Tape only the outer box.

Infectious Substances Category A PackagingRequirements

Marking and Labeling of Outer Packaging for Infectious Substances Shipped with Dry Ice

1. Class 6.2, infectious label

2. Dry Ice name and quantity label

3. Class 9, dry ice label

4. UN packaging certification

5. Orientation marks, 2 sides

6. Consignee address and phone number

7. Shipper with phone # of person responsible

8. Proper shipping name, technical name, UN

number and net quantity of infectious substance

Do not use this version of the Class 9 label, effective Oct. 1, 2014.

Use the new version, which has the “In U.S.A. Notify Director-CDC, Atlanta, GA 1-800-232-0124” removed.

Effective October 1, 2014

Per the DOT regulations, the Class 6 Infectious Substance label with the text ‘In U.S.A. Notify Director-CDC, Atlanta, GA 1-800-232-0124’ will no longer be

allowed.

Shipping With Overpacks

Overpacks are large packages capable of containing one or more smaller packages. Many people use the MediPak diagnostic shipper with an inner UN 6.2 infectious shipper box.

Dangerous goods packages within the overpack must be correctly packed, marked, labeled and in proper condition.


The overpack must have on the outside of the box: All necessary marks and labels. If the UN package specification marks are not

visible, a statement that says "Overpack" must

appear on the outside package.

UN Package Specification MarksRequired on inner package of overpack containing infectious substances.


Labeling the Overpacks for Infectious Substances

The overpack must be labeled in the following way: A Division 6.2 Infectious Substance Hazard Label next to the proper shipping

name and UN number (UN 2814) Net quantity of infectious substance adjacent to proper shipping name Package Orientation labels (up arrows) on opposite sides of the overpack if

not pre-printed on the box. A Class 9 label (if Dry Ice is used).

Other dangerous goods must not be packed in the same package as infectious substances unless they are needed for maintaining viability, stabilizing or preventing degradation or neutralizing the hazards of infectious substances. A quantity of 30 mL or less of dangerous goods included in classes 3 (ethanol), 8 (formaldehyde), 9 (formalin) may be packed in each primary receptacle containing infectious substances NO excepted quantity label is needed.

An overpack does not need to be a UN certified package. It can be a strong, recycled box.

An example of a much used overpack is the UN Certified smaller box inside the outer Medifreeze box.

Infectious Substance Documentation Shipper’s Declaration of Dangerous Goods

The document is a sworn statement to the carrier that the shipment has been prepared in accordance with the regulations

As a legal document, the Declaration binds the shipper to its terms and conditions

It is not required for Category B and Exempt shipments (patient specimens, biological products, excepted quantities, de minimus quantities)

Infectious Substance Documentation The Shippers Declaration is required to be kept for 2 years

(domestic) / 5 years (international). All Shippers Declarations must be typed. A typed signature is unacceptable

A signature can be handwritten, stamped or a facsimile A physical address is needed on the paperwork and box -

no P.O. Boxes Only the shipper is authorized to complete and sign the

Shipper’s Declaration for Dangerous Goods The person who signs the DG Declaration must be trained

and certified.

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Infectious Substance Documentation

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Infectious Substance Documentation The shippers declaration will differ based

on how the shipment is packaged, i.e. if shipping with dry ice or using an overpack.

Contact EHS for assistance with completing the shippers declaration of dangerous goods.


Reminders

□ Listing all classes of Dangerous Goods, remember that dry ice is a Class 9 Dangerous Good

□ Include emergency response information.□ When shipping out of the U.S. a commercial invoice is also

required for customs. □ An import permit from the country you are shipping to may also

be needed when shipping.□ A letter of explanation on UNC letterhead will aid your shipment

through customs.


Reminders

A fillable template with instructions for completing it can be found here: http://ehs.unc.edu/ih/lab/generic.shtml

As of January 10, 2011 FedEx will not accept a Dangerous Goods Declaration created using this template (other carriers will). You must use a Dangerous Goods Declaration created using specific FedEx software. Contact EHS for more information on completing Dangerous Goods Declarations for FedEx shipments.

Infectious Substance Documentation24-Hour Emergency Number Chemtrec is UNC-CH’s 24 hour contact number in the event of an

emergency 1-800-424-9300 within the U.S. – when out of the country (703-527-

3887) You must also put your non-emergency number on the shipping papers

(in the to/from section). Not acceptable on shipping papers:

Pager number CDC reporting number

Before shipping you must fax Chemtrec a Safety Data Sheet on your material (Fax number: 1-703-741-6037) or email it to [email protected]. You only fax it once. It is put into their database. Make sure you write UNC-Chapel Hill on the cover page of your fax. If you ship hazardous materials and you do not have an emergency number listed on the paperwork you can be subject to significant fines.

Infectious Substance DocumentationSDS for Emergency Response

Health Canada has a web site that provides safety data sheets on infectious agents. You can find them at the following web site: http://www.phac-aspc.gc.ca/msds-ftss/#p

If you cannot find what you need you can write your own.

Emergency Response and Security Plans

Emergency Response

Damaged Shipment

How do you know that a package contains dangerous goods? Look for the red hatch marks on paperwork, UN # and diamond shaped labels on box.

A damaged package may be crushed or leaking. Do not sign for packages without seeing them Inspect package before signing Do not accept a package that is damaged Packages are the responsibility of the Shipper until accepted

by recipient If the package is damaged or leaking offer assistance in

cleaning up the spill (call EHS). The carrier should be prepared to deal with the spill.

Emergency Response

Emergency Response for Damaged Package or Spill on Campus

In a laboratory setting it is expected that staff are prepared to cope with a spill.

All labs should have an emergency spill kit on hand and train all personnel in appropriate emergency response.

Isolate spill or leak area immediately in all directions. Keep unauthorized personnel away. Obtain identity of substance involved if possible and report spill to

appropriate authorities. Do not touch or walk through spilled material. Do not touch damaged containers or spilled material unless

wearing appropriate protective clothing.

If you need to, call EHS (919 - 962 - 5507) to help with spill clean up.

Emergency Response


Be very careful to avoid contact with broken glass or sharp objects that may cause cuts or abrasions that could significantly increase the risk of exposure.

Damaged packages containing solid CO2 as a refrigerant may produce water or frost from condensation of air. Do not touch this liquid as it could be contaminated by the contents of the package.

Emergency Response


Liquid nitrogen may be present and can cause severe burns.

Absorb spilled materials with earth, sand or other non-combustible material while avoiding direct contact.

Cover damaged package or spilled material with damp towel and keep wet with liquid bleach of other disinfectant

Evaluate potential personal exposure Contact UNC Employee Occupational Health Clinic (919-

966-9119) for post exposure follow-up

Security Plan

If you ship High Consequence dangerous goods you should adopt, implement and comply with a security plan that addresses the elements specified in section 1.6.3.2 of the IATA Dangerous Goods Regulations

High consequence Dangerous Goods are those that have the potential for misuse in a terrorist incident and which may as a result produce serious consequences. They include 1.1, 1.2, 1.3 explosives; 2.3, toxic gases; 6.1 toxins; 6.2 infectious substances; 7 radioactive materials.

Security Plan

Labs need to take specific action in order to provide security against theft of highly hazardous materials, and to ensure compliance with new regulations.

EHS urges each lab/clinic to review and develop procedures to ensure the security of hazardous materials in your area.

Security Plan

Many of you already implement security measures Locking up controlled substances, syringes, and

needles Securing radioactive material

An easy way to increase laboratory security is to lock the lab whenever it is left unattended

Keep records of dangerous good or types of dangerous goods transported

Review how you store your dangerous goods Put in place procedures for reporting and dealing with

security threats, breaches of security, or security incidents

Security Plan

You should control access to areas where hazardous chemicals are used and stored

Lock freezers, refrigerators where biological agents, hazardous chemicals or radioactive materials are stored

Approach anyone you don't recognize who appear to be wandering in lab areas

Assign security responsibility to one employee in your lab. Give them appropriate authority to carry out their responsibilities.

Security Plan

Use a log book to sign highly hazardous materials in and out of secure storage

Take a periodic inventory of highly hazardous chemicals, biological agents/toxins, radioactive material and controlled substances This could be as simple as frequently looking at your

chemical containers to make sure none are missing Track the use and disposal of hazardous materials. Report

any missing inventory to Public Safety or EHS. Know what materials are being ordered and being brought

into the laboratory Consider having all lab staff wear identification badges

Other Regulatory Requirements and Examples

Contact for Packaging Materials inmark, inc.

Atlanta, GA800-646-6275www.inmarkinc.com

SAF-T-PAKEdmonton, Alberto, Canada800-814-7480www.saftpak.com

CARGOpak, Corp.Raleigh, NC800-266-0652www.cargopak.com

Fisher Scientific800-766-7000www.fishersci.com

Contact your carrier for specific information regarding the shipment of Category B and Category A infectious substances.

Other Regulatory Requirements When importing pathogens that affect poultry or livestock a USDA permit is needed from the

Animal and Plant Health Inspection Service (APHIS)

When importing plants, animals, insects, earthworms, soil, etc., you also need an import permit.

For items not needing an APHIS import permit (human cell, culture, serum, blood) a guideline letter is required. The letter will aid your shipment through customs.

Centers for Disease Control & Prevention A permit is required for the importation of certain etiological agents

Select agent transfers require a Form 2 permit. Facilities transferring or receiving select agents must be registered with CDC Each transfer of a select agent must be documented Contact EHS for more information

Department of Commerce licenses are required when exporting specific biological agents, genetic elements of these agents, toxins, certain chemicals and equipment. Contact EHS prior to exporting materials from your lab for an Export Control evaluation.

OSHA – Blood & Bloodborne pathogens training is required if you work with blood, other potentially infectious substances, or human cell culture. (if you have complied with OSHA's BBP you have not complied with shipping regulations)

Shipping overseas can be quite complicated because you need to consider the requirements of the receiving country.

These additional requirements can take up to a month to accomplish - plan your shipment!

Call the EHS Shipping Specialist for help.

Vapor Shipper

Liquid Nitrogen Liquid Nitrogen is a dangerous good that has specific package

requirements: It is a class 2.2 Non-flammable, non-toxic gas assigned to UN

1977 Nitrogen, refrigerated liquid (If packaged with the vapor shipper it is exempt. You do not need a non flammable 2.2 label. Nor do you declare the liquid nitrogen on the shipping papers)

Insulated packagings (vapor shipper) containing refrigerated liquid nitrogen fully absorbed in a porous material and intended for transport, at low temperature are not regulated.

When using a vapor shipper the words "Not Restricted" and the special provision number "A152" must be included in the description of the substance on the airway bill.

A152 must also be typed in the "authorization" column of the Dangerous Goods Declaration.

Vapor Shipper

Follow manufacturers directions to properly prepare vapor shipper. The blue layer is porous. After charging the shipper, pour off the excess liquid nitrogen. They cost from $600 - $5000. Vapor shippers can maintain freezing temperatures for up to three weeks.

If you are shipping infectious substances in a vapor shipper make sure the shipper is IATA/ICAO certified to ship infectious substances.

The 6.2 label and proper shipping name are required on the outside of the shipper when transporting infectious substance.

Examples

Decide whether sample should be shipped as infectious substance or exempt specimen.

Examples

Example #1A patient (from South Africa) is ill with

symptoms of hemorrhagic fever. You are given the task of sending blood samples for confirmation of Ebola to the Centers for Disease Control and Prevention in Atlanta, GA.

Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

Examples

Example #2In a clinical lab you are given a pleural

sample to be tested for M. tuberculosis. You culture it then send it off for confirmation. When sending it off are you going to classify as infectious or diagnostic?


Examples

Example #3Your collaborator sent you the

laboratory strain of Francisella tularensis you wanted the live vaccine strain: you need to send it back to them.


Examples

Example #4Your lab has been told to send off for

investigational purposes spinal fluid taken from a hospital patient. You are asked to send it off to test for several diseases including meningitis.


Examples

Example #5Your lab is conducting a study on the

effect of folic acid and early pregnancy in 120 healthy women. You are required to send off blood, saliva, and fecal material for folic acid level analysis.


Examples

Example #6You are involved in a drug study on

campus that involves 50 research subjects. Seven of those patients are positive for having syphilis. The other 43 people are healthy adults. How will you send this shipment?


Summary

Compliance with the hazardous materials shipping regulation is not easy.

Work out the details Don't hesitate to ask for assistance-call FedEx, Airborne,

UPS, etc. Call EHS (919 - 962 - 5507) Protect yourself, your coworkers, the public Hazard communication is fundamental (labeling, labeling,

labeling)

In order to receive credit for this training, you must complete the post-test

Documents

ONLINE SELF-STUDY Shipping of Infectious Substances and Other Biomedical Materials Annual Update