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S h i p p i n g B i o l o g i c a l M a t e r i a l P a g e | 1

Shipping Biological Materials

2016-03-25The University of Kansas Medical Center, Environment, Health & Safety (EHS)3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, [email protected], Website

http://www.kumc.edu/compliance/environment-health-and-safety-office-.html


Table of Contents

Section I: Purpose

Section II: Definitions Air WaybillCulturesDangerous GoodEtiological AgentsExcepted Quantity LimitsHazMat EmployeeInfectious SubstancesOverpackPatient Specimens

Section III: RegulationsDepartment 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 BureauUS Department of Interior, Fish & Wildlife Services (USFWS)

Section IV: ResponsibilitiesShippers ResponsibilitiesOperators ResponsibilitiesReceivers Responsibilities




Section V: Personnel TrainingGeneral Awareness/FamiliarizationFunction-Specific TrainingSafety TrainingSecurity Training

Section VI: Shipping ProceduresShipping Risk AssessmentMaterial Transfer AgreementExport ControlsClassification Flow ChartsPersonnel TrainingPackaging & LabelingPackage ShippedShipment Confirmation

Section VII: Shipment TypesCategory A Infectious SubstancesCategory B Biological SubstancesExempt Patient SpecimensExclusive Motor Vehicle ExceptionBiological ProductsGenetically Modified Organisms (or Micro-Organisms)Purified ToxinsRegulated Medical Waste (RMW)Non-Regulated Materials

Section VIII: Special ConsiderationsCarbon Dioxide (Dry-ice)Liquid NitrogenFormalin & Formaldehyde

Appendix: Shipment Risk Assessment




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 correctly in a timely manner.

Shipping hazardous materials incorrectly can have serious consequences (monetary, criminal and life threatening), therefore, individuals are strongly encouraged to contact the Environment, Health & Safety office (8-1081, [email protected]) 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.



mailto:[email protected]

http://www.ecfr.gov/


SECTION II Definitions

Air WaybillA document with sender and recipient information, tracking number, and package details filled out by the shipper or the carrier for air shipments.

CulturesFlasks 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 are further subdivided into Divisions. This policy will primarily discuss Class 6, Division 6.2 Infectious Substances (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 MaterialsClass 8 – Corrosive Materials Class 9 – Miscellaneous Hazardous Materials

Etiological AgentsSee “infectious substance”.



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HazMat EmployeeA 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 Prepare a shipping paper (e.g. a shipper’s declaration form or air waybill)o Sign a shipper’s declaration formo Classify Division 6.2 materialso Select packaging for Division 6.2 materialso Pack hazardous materials for transporto Label or mark a package that contains hazardous materialso 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.

Patient SpecimensMaterial 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.



http://www.ecfr.gov/cgi-bin/text-idx?SID=db4e0f5c2437e6a38e345ff5181affb4&node=se49.2.171_18&rgn=div8


Universal PrecautionsAs 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.



https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051#1910.1030(d)(1)

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051#1910.1030(d)(1)


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.



http://www.iata.org/whatwedo/cargo/dgr/Pages/index.aspx

http://www.iata.org/whatwedo/cargo/dgr/Pages/index.aspx

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051

http://www.icao.int/safety/DangerousGoods/Pages/technical-instructions.aspx

http://www.icao.int/safety/DangerousGoods/Pages/technical-instructions.aspx

http://pe.usps.gov/widgets/hyperlinking/highlighted-viewserver.jsp?id=339&title=USPS%20Packaging%20Instruction%206H&url=56.42.48.41:9080/text/pub52/pub52apxc_023.htm&links=EXEMPT%20MATERIALS#hit0

http://pe.usps.gov/text/pub52/pub52c3_023.htm

http://pe.usps.gov/text/pub52/pub52c3_023.htm

http://www.ecfr.gov/cgi-bin/text-idx?sid=585c275ee19254ba07625d8c92fe925f&c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2_02.tpl

http://www.ecfr.gov/cgi-bin/text-idx?sid=585c275ee19254ba07625d8c92fe925f&c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2_02.tpl

http://www.phmsa.dot.gov/

http://www.phmsa.dot.gov/


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 & non-human 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.

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).



http://www.ecfr.gov/cgi-bin/text-idx?SID=bcbcc37cb57d790d1d0ee50f5fa8f479&node=pt9.1.121&rgn=div5




http://www.ecfr.gov/cgi-bin/text-idx?SID=bcbcc37cb57d790d1d0ee50f5fa8f479&tpl=/ecfrbrowse/Title09/9tab_02.tpl

http://www.aphis.usda.gov/wps/portal/aphis/home/

http://www.kdheks.gov/

http://www.epa.gov/

http://www.aphis.usda.gov/animal_health/vet_biologics/publications/vsta.pdf

http://www.gpo.gov/fdsys/granule/USCODE-2010-title42/USCODE-2010-title42-chap6A-subchapII-partF-subpart1-sec262

http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=e170ce9bdb27d491a0e1d31d7bffeb2f&ty=HTML&h=L&r=SECTION&n=42y1.0.1.6.59.6.19.5

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=e170ce9bdb27d491a0e1d31d7bffeb2f&ty=HTML&h=L&r=SECTION&n=42y1.0.1.6.59.6.19.5

http://www.cdc.gov/od/eaipp/

http://www.selectagents.gov/

http://www.selectagents.gov/


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 BureauIf 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 (1-800-344-WILD).



http://www.fws.gov/

http://www.census.gov/foreign-trade/regulations/index.html

http://www.bis.doc.licensing/

http://www.bis.doc.licensing/

http://www.cpsc.gov/


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 goods3. Arrange legal requirements4. Document the shipment5. 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 errors2. Use acceptance checklist3. Ensure safe loading, storage and transport4. Report any issues with the proper authorities5. 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 documents2. Inspect the packaging for damage or leakage3. Verify the itemized list of contents4. Open the package in an appropriate environment5. Report back to the shipper regardless of results 6. Notify the proper authorities, operator and the shipper if incidents occur7. Be appropriately trained




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 University DOT 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 TrainingThis training allows for the general knowledge to enable the employee to recognize and identify hazardous materials.

2. Function-Specific TrainingThis 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 TrainingThis 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 TrainingThis training addresses the security concerns applicable to hazardous materials.

5. In-depth Security TrainingRequired for shipments involving Select Agents & Toxins, this training concentrates more in-depth on security.



http://www.ecfr.gov/cgi-bin/text-idx?SID=939b2417dc014fb6a8eabe0c78b43d78&node=se49.2.172_1704&rgn=div8

https://www2.kumc.edu/chalk3/training/safety_kumc/Shipping_biologicals/index.html


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 AssessmentThe shipper will submit a completed Shipping Risk Assessment to [email protected].

2. Material Transfer Agreement (MTA)The shipper will contact the KU Innovation & Collaboration Department ([email protected], 785-864-6401) to inquire if a Material Transfer Agreement (MTA) is required.

3. Export ControlsThe shipper will contact the Office of Export Compliance ([email protected], 913-588-7281 or 785-864-3276) to inquire if there are any concerns in regards to Export Controls.

4. Classification Flow ChartsThe 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 & LabelingThe 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 ConfirmationThe shipper shall confirm that the shipment has arrived at its location in a safe manner.



















SECTION VII Shipment Types

Category A Infectious SubstancesClassified 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.

PackagingSpecific “Category A” Infectious Substances Packaging Kits that are compliant with Packing Instructions 620 shall be purchased by the shipper from an approved vendor (e.g. SAF-T-PAK) and the manufactures instructions must be kept for 2 years after the package has been sent.

o Fragile packages must be individually wrapped. o Primary receptacle is glass, metal or plastic (when shipping at ambient temperatures). o Primary receptacle is leak-proof (if liquid, secured with positive means, tape or paraffin). o Primary receptacle is packed in leak-proof secondary packaging.o Secondary packaging is placed securely, with cushioning, inside an outer packaging.o Either primary or secondary packaging must be able to withstand an internal pressure of 95kPa

and a temperature range of -40oF to 130oF. o Liquids have sufficient absorbent material between primary and secondary packaging.o Outer packaging must be rigid with dimensions of at least 4”x4”.o Package shall not contain any other unrelated dangerous good.o An itemized list of contents is placed between the secondary and outer packaging. o The technical name of the hazard is NOT recorded on the outer package.o All refrigerants must be placed outside the secondary package.

Labels, Markings, & Shipping Information Required o Outer - Senders, Recipients, & Person Responsible name, telephone number and address. o Outer - Emergency contact information on outer packaging or shipping paper work (air waybill).o Outer - UN specification mark (different from the UN Number).o Outer - Infectious substance label.o 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.



http://www.saftpak.com/

http://www.fedex.com/us/service-guide/our-services/dangerous-goods/index.html














Category B Biological SubstancesClassified 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.

PackagingSpecific “Category B” Infectious Substances Packaging Kits that are compliant with Packing Instructions 650 shall be purchased by the shipper from an approved vendor (e.g. SAF-T-PAK) and the manufactures instructions must be kept for 2 years after the package has been sent.

o Fragile packages must be individually wrapped. o Primary receptacle is leak-proof (if liquid, secured with positive means, tape or paraffin). o Primary receptacle is packed in leak-proof secondary packaging.o Secondary packaging is placed securely, with cushioning, inside an outer packaging.o Liquids have sufficient absorbent material between primary and secondary packaging.o Outer packaging must be rigid with dimensions of at least 4”x4”.o Package shall not contain any other unrelated dangerous good.o An itemized list of contents is placed between the secondary and outer packaging. o All refrigerants must be placed outside the secondary package.

Labels, Markings, & Shipping Information Required o Outer - Senders, Recipients, & Person Responsible name, telephone number and address. o Outer - Emergency contact information on outer packaging or shipping paper work (air waybill).o Outer - The UN 3373 marking (diamond hazard label). o Outer - Proper Shipping Name “Biological Substance, Category B” adjacent to UN 3373 label.o Outer - Orientation arrows if primary package volume exceeds 50mL.o Outer - The word “Overpack”, if applicable.o Outer - All appropriate labeling and markings associated with dry ice. o Quantity of infectious substance (only if shipped with dry ice or liquid nitrogen).o Shippers Declaration for Dangerous Goods not required (data on the waybill –three copies).








Exempt Patient SpecimensPatient 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. Additionally, the sample must not be expected to contain any bloodborne pathogens.

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 Fragile packages must be individually wrapped. o Primary receptacle is leak-proof.o Primary receptacle is packed in leak-proof secondary packaging.o Liquids have sufficient absorbent material between primary and secondary packaging.o 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).o The term “Exempt human specimen(s) or “Exempt animal specimen(s)” must appear on the

outer package. o There must be an Air waybill utilized. o 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.







Exclusive Motor Vehicle ExceptionDOT 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 ProductsThese 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 ToxinsToxins 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.

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 disposals.



http://www.stericycle.com/


Non-Regulated MaterialsThese 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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SECTION VIII Special Considerations

Dry IceA 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” must be denoted.

Safety ConcernsAs 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 Time-Weighted 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




Liquid NitrogenLiquid 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 GoodsUNID

Number

ShippingName

ClassNumber

Hazard Labels

PackingGroup

ExceptedQuantities

Packaging Instruction

Max Qty.Passenger

Air Carriage

Max Qty.Cargo

Air Carriage

UN1977Nitrogen

Refrigerant Liquid

2.2

Non-flammable

Gas & Cryogenic

Liquid

--- --- 954 200 kg 200kg




Formalin & FormaldehydeTitle 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 are not regulated for transport by air or highway.




Shipment Risk Assessment

Sender’s InformationName (PI)PhoneEmergency PhoneEmailAddress

Recipient’s InformationNamePhoneEmailOrganization NameAddressSafety Officer NameSafety Officer PhoneSafety Officer Email

Have you satisfied all requirements associated with the KU Innovation & Collaboration Department ([email protected], 785-864-6401) in regards to MTA and other legal requirements?

Yes No If not, please describe why below:

Have you satisfied all requirements associated with the Office of Export Compliance ([email protected], 913-588-7281 or 785-864-3276) in regards to export control requirements?

Yes No If not, please describe why below:

Packaging & Labeling InformationThe researcher 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).







Material InformationWhat is the material to be shipped (you must be specific)?

What is the mode of transportation (airline, courier, ground, FedEx, etc.)?

What is the quantity of material (e.g. volume) and how is it packaged (e.g. vial or culture)?

How many total packages (e.g. vials, plates) are being shipped?

Does the material contain any pathogens that may cause disease in humans or animals? Yes No If yes, please describe below:

Has the material been tested or screened for pathogens and determined to be negative? Yes No If yes, is there documentation to support this determination?

Was the material taken DIRECTLY from an animal/human?Yes No If yes, please describe below:

Is the material a culture (or ever been cultured or was originated from a culture)?Yes No If yes, please describe below:

Is the material currently in a preservative or will it be shipped within a preservative (e.g. formalin)? Yes No If yes, describe below: include the quantity and percentage of any preservative.

Will this shipment involve dry ice or other temperature controlled material? Yes No If yes, please describe below:

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 relies on the information you provide.



Date post:	04-Mar-2018
Category:	Documents
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