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Shipping Biological
Material Policy
2015-04-20
University of Kansas Medical Center (KUMC) Environment, Health & Safety (EHS)
3901 Rainbow Blvd., MS 3032 - Kansas City, KS 66160 - (913) 588-1081 - ehs@kumc.edu - www.kumc.edu
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Shipping Biological
Material Policy
Table of Contents
Section I:
Purpose
Section II:
Definitions
Air Waybill
Cultures
Dangerous Good
Etiological Agents
Excepted Quantity Limits
HazMat Employee
Infectious Substances
Overpack
Patient Specimens
Section III:
Regulations
Department of Transportation (DOT)
United States Postal Office (USPS)
International Civil Aviation Organization (ICAO)
Occupational Safety & Health Administration (OSHA)
International Air Transport Association (IATA)
Center for Disease Control & Prevention (CDC)
Environmental Protection Agency (EPA)
United Stated Department of Agriculture (USDA)
Consumer Product Services Commission (CPSC)
Department of Commerce (DOC)
Census Bureau
US Department of Interior, Fish & Wildlife Services (USFWS)
Section IV:
Responsibilities
Shippers Responsibilities
Operators Responsibilities
Receivers Responsibilities
2015-04-20
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Shipping Biological
Material Policy
Section V:
Personnel Training
General Awareness/Familiarization
Function-Specific Training
Safety Training
Security Training
Section VI:
Shipping Procedures
Shipping Risk Assessment
Material Transfer Agreement
Export Controls
Classification Flow Charts
Personnel Training
Packaging & Labeling
Package Shipped
Shipment Confirmation
Section VII:
Shipment Types
Category A Infectious Substances
Category B Biological Substances
Exempt Patient Specimens
Exclusive Motor Vehicle Exception
Biological Products
Genetically Modified Organisms (or Micro-Organisms)
Purified Toxins
Regulated Medical Waste (RMW)
Non-Regulated Materials
Section VIII:
Special Considerations
Carbon Dioxide (Dry-ice)
Liquid Nitrogen
Formalin & Formaldehyde
Appendix:
Shipment Risk Assessment
2015-04-20
University of Kansas Medical Center (KUMC) Environment, Health & Safety (EHS)
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Shipping Biological
Material Policy
SECTION I
PURPOSE
This policy informs individuals of the correct process involved in the shipping or receiving of
biological specimens on The University of Kansas Medical Center (KUMC). This policy will assist
the user in complying with all federal, state and local regulations as well as industry standards.
Additionally, this document describes how packages are properly prepared in such a manner
that materials are appropriately contained during transport.
Although the federal laws pertaining to shipments will be cited throughout this document, they
can be viewed electronically and printed by visiting the Electronic Code of Federal Regulations
website (www.ecfr.gov).
Due to varying regulations, guidelines and industry standards, all shipments will be assessed on
a case-by-case basis and therefor, each shipment will be considered unique. The nature of
transport, hazards involved, shipping/receiving location and corresponding regulations will all
be considered through a proper risk assessment (attached to this document).
Please note that the more lead-time you allow for the EHS office to review documents the more
likely your shipment will be processed in a timely manner.
Shipping hazardous materials can have serious consequences (monetary, criminal and life
threatening), therefore, individuals are strongly encouraged to contact the Environment,
Health & Safety office (8-1081, ehs@kumc.edu) if they have any questions or concerns. The
EHS office can assist researchers in satisfying the appropriate regulations at the same time
avoiding occupational exposures.
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Shipping Biological
Material Policy
SECTION II
DEFINITIONS
Air Waybill
A document with sender and recipient information, tracking number, and package details filled
out by the shipper or the carrier for air shipments.
Cultures
Flasks or media containing a pathogen isolated and/or intentionally propagated. Note: cultures
cannot be classified as “exempt specimens”.
Dangerous Good
Also known as HazMat Materials (denoted by the DOT), are articles or substances capable of
posing a risk to health, safety, property or the environment when transported in commerce off
private property by means of motor vehicle, railcar, ship or aircraft. There are 9 Classes of
hazards per the DOT with some Classes further subdivided into Divisions. This policy will
primarily discuss Class 6, Division 6.2 (49 CFR 173.134).
Class 1 – Explosives
Class 2 – Compressed Gases
Class 3 – Flammable and Combustible Liquids
Class 4 – Flammable Solids
Class 5 – Oxidizers and Organic Peroxides
Class 6 – Division 6.1 Poisonous/Toxic Materials
Class 6 – Division 6.2 Infectious Substances
Class 7 – Radioactive Materials
Class 8 – Corrosive Materials
Class 9 – Miscellaneous Hazardous Materials
Etiological Agents
See “infectious substance”.
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Shipping Biological
Material Policy
HazMat Employee
A HazMat employee is defined as anyone who affects the transport of hazardous materials in
commerce. All HazMat employees must be trained and most must be certified. You are a
HazMat employee if your employer asks you to do any of the following tasks:
o
o
o
o
o
o
o
Prepare a shipping paper (e.g. a shipper’s declaration form or air waybill)
Sign a shipper’s declaration form
Classify Division 6.2 materials
Select packaging for Division 6.2 materials
Pack hazardous materials for transport
Label or mark a package that contains hazardous materials
Transport hazardous materials in commerce
Infectious Substances
Often referred to as etiological agents or pathogens, they are substances which are known or
are reasonably expected to contain pathogenic microorganisms and/or microbial toxins that
cause disease in humans or animals. Pathogens may be in the form of bacteria, toxins, viruses,
fungi, rickettsiae, protozoans, parasites or prions. For the purposes of shipment regulations,
infectious substances will be divided into two categories (Cultures and Patient Specimens).
Overpack
As defined in the DOT Hazardous Materials Regulations (49CFR171.8), an Overpack is an
enclosure that is used by a single consignor to provide protection or convenience in handling of
a package or to consolidate two or more packages of hazardous materials.
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Shipping Biological
Material Policy
Patient Specimens
Material collected directly from humans or animals for research, diagnoses, investigational or
disease treatment/prevention purposes (diagnostic purposes). Patient specimens are described
as having minimal likelihood of pathogens being present.
Examples include: blood, urine, secreta, excreta, urine, tissue, tissue swabs and body parts.
Unless tests confirm the specimen to be free of pathogens, KUMC shall follow OSHA’s
recommendations to use “universal precautions” in regards to patient specimens by treating all
specimens as containing bloodborne pathogens.
Universal Precautions
As defined by OSHA, Universal Precautions is an approach to infection control to treat all
human blood and certain human body fluids as if they were known to be infectious for HIV, HBV
and other bloodborne pathogens.
The Bloodborne Pathogen Standard 29 CFR
1910.1030(d)(1) requires:
1. Employees to observe Universal Precautions to prevent contact with blood or other
potentially infectious materials (OPIM).
2. Under circumstances in which differentiation between body fluid types is difficult or
impossible, all body fluids shall be considered potentially infectious materials.
3. Treat all blood and other potentially infectious materials with appropriate precautions
such as:
 Use gloves, masks, and gowns if blood or OPIM exposure is anticipated.
 Use engineering and work practice controls to limit exposure.
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Shipping Biological
Material Policy
SECTION III
REGULATIONS
The shipping of biological material may involve multiple regulatory entities. Note: all shipments
are required to adhere to all regulations that the vehicle travels during transit (e.g. a shipment
going from Mexico City, Mexico to Ontario, Canada by UPS must adhere to variations for
Mexico, United States, Canada and UPS). There are five main entities that regulate the
transportation of hazardous materials.
1. Department of Transportation (DOT)
The DOT regulates transportation by air, road, rail or sea (except by US mail). A branch
within the DOT known as the Pipeline and Hazardous Materials Safety Administration
(PHMSA) publishes and updates the Federal Hazardous Materials Regulations (HMR)
(Title 49 CFR 171-180) every October 1st or whenever necessary.
2. United States Postal Service (USPS)
The USPS has regulatory authority for hazardous materials sent by US mail. The
regulations for Category B substances are published in the USPS Domestic Mail Manual
(DMM) 601.10.7.4 and the regulations for exempt human or animal specimens are
published in the USPS Domestic Mail Manual (DMM) 601.10.17.9. USPS does not
transport Category A materials.
3. International Civil Aviation Organization (ICAO)
ICAO, within the United Nations, publishes and updates the Technical Instructions for
the Safe Transport of Dangerous Goods by Air (ICAO TI) every 2 years. All international
flights are subject to the ICAO Technical Instructions.
4. Occupational Safety & Health Administration (OSHA)
OSHA regulates the safe handling of human products known or not known to be
infected with pathogens within the workplace through the Bloodborne Pathogen
Standard (BBP) 29 CFR 1910.1030.
5. International Air Transport Association (IATA)
IATA is an international trade organization that regulates and sets the standards for the
shipping of dangerous goods through air. IATA publishes the Dangerous Goods
Regulations (DGR) annually that corresponds (and exceeds requirements) to that of the
DOT and ICAO regulations, which is why most entities choose to ship materials following
IATA regulations – to be in compliant with all regulating bodies.
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Shipping Biological
Material Policy
OTHER MISCELLANEOUS REGULATORS
Centers for Disease Control & Prevention (CDC)
The CDC within the US Department of Health and Human Services (HHS) regulates the
possession, use and transfer of Select Agents & Toxins through the Select Agent Regulations 42
CFR 73 and the importation of infectious biological agents, infectious substances and vectors of
human disease via the Etiological Agent Permit Program (EAIPP) (Foreign Quarantine; Import
Regulations for Infectious Biological Agents, Infectious Substances, and Vectors 42 CFR 71).
A. CDC Permit Exemptions:
a. Diagnostic specimens, animals or animal products which there is no evidence the
material contains infectious agents or is rendered sterile (except bat & nonhuman primate specimens).
b. Materials containing nucleic acids that cannot produce infectious forms of any
infectious biological agent and is accompanied by an importation certification
statement confirming that the material is not known to contain or suspected of
containing an infectious biological agent.
c. Products cleared, approved, licensed or otherwise authorized under any of the
following laws:
 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301)
 Section 351 of the Public Health Service Act (42 U.S.C. 262) S
 Virus-Serum-Toxin Act (21 U.S.C. 151-159)
Environmental Protection Agency (EPA) & the Kansas Department of Health & Environment
(KDHE)
The federal EPA and the state KDHE regulates specific hazardous materials as they may impact
the community and environment, including specific regulations for environmental cleanup and
the handling/disposal of hazardous waste materials.
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United States Department of Agriculture (USDA)
The USDA through the Animal & Plant Health Inspection Service (APHIS) requires permits for
infectious agents of livestock and biological materials associated with the
importation/exportation of animal products (Title 9 CFR 1-199 Animals and Animal Products) as
well as the shipment of Select Agents & Toxins affecting animals (7 CFR 331 APHIS Possession,
Use and Transfer of Select Agents & Toxins - Plants) & (9 CFR 121 USDA Possession, Use and
Transfer of Select Agents & Toxins - Animals).
Examples under USDA requirements include: live animals, semen, embryos and materials
derived from animals or exposed to animal-source materials such as animal tissues, blood, cells
or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes,
microorganisms including bacteria, viruses, protozoa and fungi.
Consumer Product Services Commission (CPSC)
The CPSC regulates hazardous materials that may be used in products sold for household and
other consumer uses.
Department of Commerce (DOC)
The export of a wide variety of etiologic agents of human, plant and animal diseases may
require a DOC license. The DOC can be contact through the DOC Bureau of Export
Administration (202-482-4811).
Census Bureau
If the value of any single item on your commercial invoice is over $2,500 or if a DOC license is
required, an export declaration must be filed with the US Census Bureau.
U.S. Department of Interior, Fish & Wildlife Services (USFWS)
U.S. Fish and Wildlife Service permits are required for certain live animals, including bats (1800-344-WILD).
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Shipping Biological
Material Policy
SECTION IV
RESPONSIBILITIES
Shippers (consignor) Responsibilities
Shippers are responsible for the preparation of dangerous goods. The shipper can also be held
liable and subject to fines and other penalties. Shippers must:
1. Classification of the dangerous goods
2. Properly package, mark and label the dangerous goods
3. Arrange legal requirements
4. Document the shipment
5. Be appropriately trained
Operators (courier) Responsibilities
The operator is also the courier of the shipment and deals with the acceptance, handling,
loading, transport and delivery of the dangerous goods. The operator may reject any package
that they feel is improperly labeled, marked or packaged. The courier can also be held liable
and subject to fines and other penalties. Operators must:
1. Inspect packages for damage or leakage and detect errors
2. Use acceptance checklist
3. Ensure safe loading, storage and transport
4. Report any issues with the proper authorities
5. Be appropriately trained
Receiver (consignee) Responsibilities
The receiver or consignee is the party associated with the final destination. The receiver can
also be held liable and subject to fines and other penalties. Receivers must:
1. Help obtain any permits or documents
2. Inspect the packaging for damage or leakage
3. Verify the itemized list of contents
4. Open the package in an appropriate environment
5. Report back to the shipper regardless of results
6. Notify the proper authorities, operator and the shipper if incidents occur
7. Be appropriately trained
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Shipping Biological
Material Policy
SECTION V
PERSONNEL TRAINING
Anyone who handles, offers for transportation, or transports dangerous goods must have
documented training and re-trained every 3 years per DOT, Joint Commission and College of
Pathologists - CAP or 2 years per IATA in the safe transportation of hazardous materials. The
trainee must verify they understand the training. Records must be retained for the entire
employment period and 90 days thereafter (DOT). KUMC will choose to retain records for the
entire employment period and for at least 5 years thereafter, and will require recurrent training
every 2 years to satisfy all regulations.
The KUMC training for shipping hazardous materials can be found here. The below areas of
training will be covered (with the exception of bullet #5, reserved for enhanced hazards).
1. General Awareness/Familiarization Training
This training allows for the general knowledge to enable the employee to recognize and
identify hazardous materials.
2. Function-Specific Training
This training addresses the specific functions in which the employee must perform in
order to successfully conduct their duties in regards to the shipment.
3. Safety Training
This training addresses the hazards associated with the dangerous goods and the safe
handling and emergency response procedures (OSHA Bloodborne Pathogen Standard
training may fulfill the DOT’s safety training (49 CFR 172.704(b)). Additionally, the
training must include emergency response information, measures to protect the
employee from hazards in the workplace and procedures for avoiding accidents.
4. Security Training
This training addresses the security concerns applicable to hazardous materials.
5. In-depth Security Training
Required for shipments involving Select Agents & Toxins, this training concentrates
more in-depth on security.
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Shipping Biological
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SECTION VI
SHIPPING PROCEDURES
The following procedures will be implemented for all shipments of biological material at KUMC.
For the purpose of this section, the term “shipper” shall represent the researcher unless noted.
1. Shipping Risk Assessment
The shipper will submit a completed Shipping Risk Assessment to ehs@kumc.edu.
2. Material Transfer Agreement (MTA)
The shipper will contact the KU Innovation & Collaboration Department (785-864-6401)
to inquire if a Material Transfer Agreement (MTA) is required.
3. Export Controls
The shipper will contact the Office of Export Compliance (ueco@ku.edu, 913-588-7281
or 785-864-3276) to inquire if there are any concerns in regards to Export Controls.
4. Classification Flow Charts
The Biosafety Officer (BSO) or designee will utilize Classification Flow Charts combined
with the risk assessment to identify and assign an appropriate shipment type.
5. Personnel Training
All KUMC individuals involved in the shipping process will be confirmed to have the
appropriate training necessary.
6. Packaging & Labeling
The shipper (in some cases the BSO) will properly package, label and mark the material.
Note: only packaging and labels from an approved vendor will be utilized.
7. Package Shipped
The shipper will ship the packaging through an appropriate courier.
8. Shipment Confirmation
The shipper shall confirm that the shipment has arrived at its location in a safe manner.
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Material Policy
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Shipping Biological
Material Policy
2015-04-20
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Shipping Biological
Material Policy
2015-04-20
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Shipping Biological
Material Policy
2015-04-20
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Shipping Biological
Material Policy
SECTION VII
SHIPMENT TYPES
Category A Infectious Substances
Classified in Division 6.2, “Infectious Substance - Category A” is defined as having the capability
of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans
or animals. These shipments must be coordinated through EHS and must be shipped by FedEx.
Packaging
Specific “Category A” Infectious Substances Packaging Kits that are compliant with Packing
Instructions 620 shall be purchased by the shipper from the KUMC approved vendor SAF-T-PAK
and the manufactures instructions must be kept for 2 years after the package has been sent.
o
o
o
o
o
o
o
o
o
o
o
o
Fragile packages must be individually wrapped.
Primary receptacle is glass, metal or plastic (when shipping at ambient temperatures).
Primary receptacle is leak-proof (if liquid, secured with positive means, tape or paraffin).
Primary receptacle is packed in leak-proof secondary packaging.
Secondary packaging is placed securely, with cushioning, inside an outer packaging.
Either primary or secondary packaging must be able to withstand an internal pressure of 95kPa
and a temperature range of -40oF to 130oF.
Liquids have sufficient absorbent material between primary and secondary packaging.
Outer packaging must be rigid with dimensions of at least 4”x4”.
Package shall not contain any other unrelated dangerous good.
An itemized list of contents is placed between the secondary and outer packaging.
The technical name of the hazard is NOT recorded on the outer package.
All refrigerants must be placed outside the secondary package.
Labels, Markings, & Shipping Information Required
o
o
o
o
o
Outer - Senders, Recipients, & Person Responsible name, telephone number and address.
Outer - Emergency contact information on outer packaging or shipping paper work (air waybill).
Outer - UN specification mark (different from the UN Number).
Outer - Infectious substance label.
Outer - Proper Shipping Name “UN 2814 Infectious substance, affecting humans” or “UN 2900
Infectious Substance, affecting animals” adjacent to the infectious substance label.
o Outer - Orientation arrows if primary package volume exceeds 50mL.
o Shippers Declaration for Dangerous Goods (three copies).
o Quantity of infectious substance (only if shipped with dry ice or liquid nitrogen).
o Outer - All appropriate labeling and markings associated with dry ice.
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Shipping Biological
Material Policy
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Shipping Biological
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Shipping Biological
Material Policy
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Shipping Biological
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Category B Biological Substances
Classified in Division Class 6.2, “Biological Substance, Category B” is defined as a dangerous
good not meeting the criteria for both “Category A” and “Exempt, Patient Specimen”, but can
cause disease in humans.
Packaging
Specific “Category B” Infectious Substances Packaging Kits that are compliant with Packing
Instructions 650 shall be purchased by the shipper from the KUMC approved vendor SAF-T-PAK
and the manufactures instructions must be kept for 2 years after the package has been sent.
o
o
o
o
o
o
o
o
o
Fragile packages must be individually wrapped.
Primary receptacle is leak-proof (if liquid, secured with positive means, tape or paraffin).
Primary receptacle is packed in leak-proof secondary packaging.
Secondary packaging is placed securely, with cushioning, inside an outer packaging.
Liquids have sufficient absorbent material between primary and secondary packaging.
Outer packaging must be rigid with dimensions of at least 4”x4”.
Package shall not contain any other unrelated dangerous good.
An itemized list of contents is placed between the secondary and outer packaging.
All refrigerants must be placed outside the secondary package.
Labels, Markings, & Shipping Information Required
o
o
o
o
o
o
o
o
o
Outer - Senders, Recipients, & Person Responsible name, telephone number and address.
Outer - Emergency contact information on outer packaging or shipping paper work (air waybill).
Outer - The UN 3373 marking (diamond hazard label).
Outer - Proper Shipping Name “Biological Substance, Category B” adjacent to UN 3373 label.
Outer - Orientation arrows if primary package volume exceeds 50mL.
Outer - The word “Overpack”, if applicable.
Outer - All appropriate labeling and markings associated with dry ice.
Quantity of infectious substance (only if shipped with dry ice or liquid nitrogen).
Shippers Declaration for Dangerous Goods not required (data on the waybill –three copies).
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Exempt Patient Specimens
Patient specimens not likely to contain a pathogen are either “Exempt human specimens” or
“Exempt animal specimens”. Note: this status can only be applied to specimens taken directly
from patients. If a specimen is cultured from a patient, it cannot be classified as exempt and
therefore, must either be a Category A or Category B substance.
If transporting exempt patient specimens by ground, then no packaging, marking or labeling is
required by DOT. However, USPS and IATA do have minimum requirements. The following are
the minimum requirements for shipping exempt patient specimens transported by air (IATA).
o
o
o
o
o
o
o
o
Fragile packages must be individually wrapped.
Primary receptacle is leak-proof.
Primary receptacle is packed in leak-proof secondary packaging.
Liquids have sufficient absorbent material between primary and secondary packaging.
The outer packaging must be adequate strength for its contents and one surface area must be at
least 4”x4” (the packaging can be flexible and not necessarily rigid).
The term “Exempt human specimen(s) or “Exempt animal specimen(s)” must appear on the
outer package.
There must be an Air waybill utilized.
No more than 500ml of material can be placed in any one receptacle.
Per the OSHA BBP Standard – a biohazard symbol may be required (e.g. if urine is visibly
contaminated with blood); therefore, KUMC will default to utilizing this symbol on the
secondary packaging for all exempt specimens.
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Exclusive Motor Vehicle Exception
DOT permits ground transport of some infectious substances to be exempted from the
regulations if they are transported in a private vehicle or contract motor vehicle used for that
purpose only. The material must not be Category A or a culture of a pathogen. It must be a
patient specimen transported for research, diagnoses, investigational activities, disease
treatment or prevention. However, OSHA BBP Standard may apply and therefore, biohazard
labeling requirements would apply.
Biological Products
These products are derived from living organisms (e.g. non-pathogenic viruses, toxins, serums,
vaccines, blood). Products that are prepared in accordance to national authorities are not
regulated (e.g. non-infectious, federally approved vaccine). Biological products meeting the
Category A or B criteria must be classified as infectious (e.g. vaccine containing a live virus,
which can cause disease in humans or animals). In order to be exempt from regulation, they
must be approved by the FDA, HHS or USDA.
Genetically Modified Organisms (or Micro-Organisms)
Pathogenic GMO’s must be classified as either Category A or Cat B Infectious Substances. IATA
considers GMO’s hazardous materials unless the GMO has been approved by a national
authority. DOT does not consider non-pathogenic GMO’s hazardous and therefore, are not
regulated when transported by ground. “UN3245 Genitally Modified Organisms” or “UN3245
Genitally Modified Micro-Organisms” are the proper shipping names, members of the Class 9
hazardous materials and use Packing Instructions 959.
Purified Toxins
Toxins from plant, animal or bacterial sources that do not contain infectious substances and are
not contained in substances that are infectious are transported as Division 6.1 UN3172.
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Regulated Medical Waste (RMW)
RMW is considered all solid waste that is generated in the research, diagnosis, treatment or
immunization of human beings or animals or in the production or testing of biologicals. Sharps
containers also fall in this category. Considered a Division 6.2 RMW UN3291 if Category B and
RMW UN2814 or 2900 if Category A and must meet Packaging Group (PQ) II. KUMC contracts
the vendor Stericycle for all medical waste disposal.
Non-Regulated Materials
These materials are not subject to regulations unless they meet the criteria for inclusion in
another Class or Division of dangerous goods (example: dry ice or formalin) and therefore, are
not regulated (49 CFR 173.134(b)). Materials considered non-regulated include:
 microorganisms that do not cause disease in humans or animals
 substances that have been sterilized, neutralized or deactivated
 dried blood spots, tissues or organs collected for transfusion/transplantation purposes
 any agricultural product or food as defined by and approved through the FDA
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Shipping Biological
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SECTION VIII
SPECIAL CONSIDERATIONS
Dry Ice
A Class 9 hazard, dry ice may be required at times for sample integrity. Packages must be
accompanied by a “Miscellaneous Hazard Class” label and the phrase “UN 1845 Carbon Dioxide,
Solid”.
Safety Concerns
As dry ice sublimates (changes from solid to gas immediately), packaging must allow for some
gas escape and never be sealed. The by-product, carbon dioxide gas, could accumulate to a
level that exceeds an occupational exposure limit (5000 ppm, expressed as an 8 hour TimeWeighted Average (TWA) or 30,000 ppm as a ceiling limit). Breathing high concentrations of
carbon dioxide can lead to labored breathing, increased pulse rate, headache, increased blood
pressure, muscle twitching or asphyxiation. Additionally, dry ice is extremely cold at -109.3°F (78.5°C). Touching dry ice unprotected can lead to frostbite. Always handle dry ice with care
while donning thermally protective gloves or tongs and use eyewear.
New Minimum Marking Sizes for UN 1845 (as of October 1, 2014)
o Package capacity greater than 30 KG requires 12 mm type or larger.
o Package capacity greater than 5 KG up to 30 KG requires 6 mm type or larger.
o Package capacity < (less than) 5 KG requires the marking to be of adequate size.
o overpack used markings should be 12 mm or larger if package capacity is greater than
30 kg, 6 mm or larger for package capacity at 30 kg or less
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Shipping Biological
Material Policy
Liquid Nitrogen
Liquid nitrogen is classified as a non-flammable gas and cryogenic liquid. There are
extensive regulations pertaining to shipping liquid nitrogen in open and closed cryogenic
receptacles. If you wish to ship liquid nitrogen, contact EHS for details on proper
procedures.
You also have the option of using a Vapor Shipper as liquid nitrogen is not subject to
these regulations if it is shipped in an approved Vapor Shipper. A Vapor Shipper is an
insulated package containing liquid nitrogen fully absorbed in a porous material and is
intended for transport at low temperatures of non‐dangerous products. A Vapor
Shipper must be constructed so it does not allow pressure to build up within the
container and will not permit the release of liquid nitrogen regardless of how the
package is oriented. If you are using a Vapor Shipper the words “Not Restricted” and
special provision number A152 must be included in the description on the waybill. Not
all Vapor Shippers are constructed to transport infectious substances. If you are
shipping an infectious or potentially infectious substance make sure the Vapor Shipper
you have selected is properly constructed to contain infectious materials.
List of Dangerous Goods
UN
ID
Number
UN1977
Shipping
Name
Nitrogen
Refrigerant
Liquid
Class
Number
Hazard
Labels
Packing
Group
Excepted
Quantities
Packaging
Instruction
Max Qty.
Passenger
Air Carriage
Max Qty.
Cargo
Air Carriage
2.2
Nonflammable
Gas &
Cryogenic
Liquid
---
---
954
200 kg
200kg
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Shipping Biological
Material Policy
Formalin & Formaldehyde
Title 49 CFR provides two entries for formaldehyde solutions in the Hazardous Materials
Table Part 172.101:
o Formaldehyde solutions, flammable, e.g. full strength formalin 37% (UN1198)
o Formaldehyde solutions not less than 25% Formaldehyde (UN2209)
o Formaldehyde solutions 10-24.9% (25% formalin) (UN3334), shipped by air
Shipments of 10-24.9% formaldehyde solutions shipped by highway only do not require
classification as a hazardous material. 10% Formalin solutions containing 3-4%
Formaldehyde and are not regulated for transport by air or highway.
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Shipping Biological
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Shipment Risk Assessment
Sender’s Information
Name (PI)
Phone
Emergency Phone
Email
Address
Recipient’s Information
Name
Phone
Email
Organization Name
Address
Safety Officer Name
Safety Officer Phone
Safety Officer Email
What is the mode of transportation (airline, courier, ground, FedEx, etc.)
Have you contacted KU Innovation & Collaboration Department and the Office of Export Compliance to
satisfy all MTA, export control and other legal requirements? If not, please note this is requirement.
Packaging & Labeling Information
The sender is responsible for purchasing approved packaging and labels from a reputable
vendor. KUMC’s preferred vendor for such materials is Saf-T-Pak (www.saftpak.com).
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Shipping Biological
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Material Information
Describe (in detail) what is the material to be shipped (you must be specific).
Does the material contain any pathogens that may cause disease in humans or animals? If yes, explain.
If no, explain how this is known and whether there is documentation to support this determination.
Was the material taken DIRECTLY from an animal/human or is the material a culture?
What is the quantity of material (e.g. volume) and how is it packaged (e.g. vial or culture) and how many
packages are there?
Has the material been preserved, is currently in a preservative or will be shipped within a preservative
(e.g. formalin)? If yes, describe – include the quantity and percentage of each preservative.
Will this shipment involve dry ice or other temperature controlled material? If yes, describe.
Additional Information
Please provide any additional comments in which you feel necessary for personnel to be informed
in regards to this shipment. Feel free to be as specific, detailed and descriptive as possible as this
assessments integrity greatly relies on the information you provide.
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