University of Louisville Department of Environmental Health & Safety

Transcription

1 Shipping Biological Materials by Air Biological Substance, Category B; Genetically Modified Microorganisms; Exempt Human or Animal Specimens; and Dry Ice University of Louisville Department of Environmental Health & Safety

2 Note Retraining is mandatory every 3 years Who Must Attend Training? Employees who perform any of the following activities with hazardous materials must be trained on a regular basis: Prepares the Package (lab personnel, clinicians, nurses, research coordinators, etc.) Marks and/or Labels the Package (anyone who applies labels or puts any markings on the outside of the package) Prepares Shipping Paperwork (Administrative assistants, UBMs, etc.) Handles (usually not a UofL employee) Transports (this is the carrier, not UofL employee) Receives (any UofL employee signing for package and/or opening packages)

3 What Must Training Cover? Individuals must receive the level of training necessary to perform their duties or responsibilities. The training must include: General Familiarization Training provide information on the overall requirements and aspects related to the transportation of hazardous materials (dangerous goods). Function Specific Training detailed training on the requirements applicable to the function for which an individual is responsible Safety Training to include the hazards presented by the materials being transported, safe handling and emergency response procedures.

4 Training Goals After reviewing the slides in this training module and passing the corresponding quiz, you will be certified to ship any of the following materials: Biological Substance, Category B (UN3373) Genetically Modified Microorganisms (GMMOs) Exempt Human Specimens Exempt Animal Specimens Dry Ice (UN1845) NOTE: This training module does NOT qualify you to ship Infectious Substance, Category A materials.

5 Decision Making Flow Chart

6 Decision Making Flow Chart *The following substances are exempt from Hazardous Material Regulations; environmental samples (including food and water samples) which are not considered to pose a significant risk of infection, material collected for transplant or transfusion, material that has been neutralized or inactivated to no longer pose a health risk, organisms that are non-pathogenic to humans or animals, dried blood spots, and fecal occult screening tests. 1) Patient specimens are material 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 (excluding fixed slides). 2) In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. If there is reason to suspect that the specimen contains a pathogen, it cannot be shipped as exempt from Class 6.2. For shipping purposes, patient samples are not assumed to be there is a specific reason to believe they are.

7 Selected Carrier Restrictions for Domestic US Shipments (UPS and FedEx do NOT ship biological samples by Highway!) for Ground Service. Sample Classification UPS FedEx Infectious Substance, Category A NO YES Biological Substance, Category B YES YES Exempt Human or Exempt Animal YES YES Dry Ice, under 5.5 lbs (2.5 kg) YES YES Dry Ice, over 5.5 lbs (2.5 kg) YES* YES *Requires UPS Dangerous Goods Agreement (Contact DEHS)

8 *Agencies regulating transportation Shipping Regulations A variety of national and international agencies regulate the transport, exporting and importing of research materials. These agencies include: International Air Transport Association (IATA)* U.S. Department of Transportation (DOT)* U.S. Environmental Protection Agency - Toxic Substances Control Act (TSCA) U.S. Department of Commerce (DOC) U.S. Department of Agriculture (USDA) Centers for Disease Control and Prevention (CDC) U.S. Fish and Wildlife Service (USFWS) U.S. Department of State

9 Purpose of Shipping Regulations Ensure safe shipment of biological materials through: Training people involved in any aspect of shipping Properly classifying biological materials Packaging biological materials to prevent release during transport Identifying biological materials on the package and shipping papers Only trained personnel may be involved in biological material shipping or transport

10 Definition of Hazardous Material A hazardous material (dangerous good) is defined as a substance or material, that when transported in commerce, is capable of posing a risk to health, safety or property. Hazardous materials include biological, chemical and radioactive materials. DOT Hazardous Materials = IATA Dangerous Goods

11 State and Operator Variations (Country and Carrier) Each country and/or hazardous material carrier (e.g. FedEx, UPS) can have their own regulations that are in addition to the US Federal regulations and International transport regulations Some Examples Include: Australia requires an import permit to bring infectious agents into the country FedEx requires three copies of shipping declaration form instead of two as required in the regulations

12 U.S. Import Permits DHHS (CDC) required before importing any etiologic agents/infectious substances or materials that may include them USDA - required before importing any animal agent or product/item that has been in contact with an animal APHIS - required before importing any plant pests, pathogens, noxious weeds or related products U. S. Fish and Wildlife and CITES Endangered Species Permits - international import/export permits for endangered species, wildlife, reptiles, Convention on International Trade in Endangered Species (CITES), plants, pet birds, museum specimens and exhibits for scientific exchange. A permit is required for individuals or businesses that import or export wildlife.

13 Export Regulations (Controls) Department of Commerce (DOC) - issues Export Licenses of research materials and equipment. Dual Use Licenses are required in certain situations involving national security and foreign policy, short-supply. Department of State - Export of defense articles Directorate of Defense Trade Controls at the U.S. Department of State Nuclear Regulatory Commission - Licensing of the export of nuclear materials and equipment is the responsibility of the Nuclear Regulatory Commission.

14 Export Regulations (Controls) Department of Energy - The Office of Imports and Exports, under the Office of Fossil Energy, in the Department of Energy, regulates the export of natural gas and electric power. The Department of Energy s Office of Export Control Policy and Cooperation authorizes the use of nuclear technology and technical data for nuclear power, as well as special nuclear materials. Drug Enforcement Administration The U.S. Drug Enforcement Administration regulates the export of controlled substances and precursor chemicals.

15 What is an Export? An item, such as biological, chemical, or radioactive material, sent from the United States to a foreign destination. These items are generally sent using a carrier such as FedEx, World Courier, the US Postal Service or DHL. It can also be transfer of technical data not already in the public domain to a foreign person, whether in the U.S. or abroad. This is referred to as a deemed export.

16 Export Controls Licensing requirements depend on: What is being exported is the item regulated by the DOC, International Traffic in Arms Regulations (ITAR) or Office of Foreign Assets Control (OFAC)? Where the item is being exported to the following countries are restricted as of January 2010: Cuba, Iran, North Korea, Sudan, Syria. Some items are regulated regardless of the county being shipped to. Who the item is being exported to there are lists of individuals and organizations that are prohibited from receiving exports: Entity List DOC Treasury Department Specially Designated Foreign Nationals and Blocked Persons The Unverified List DOC Denied Persons - DOC How the item will be used - exporter ensures that the end use of the item is not related to terrorist activity or weapons production and that the end user has the qualifications to use the item.

17 Export Penalties Violation of Export regulations can be assessed against individuals and/or the University: Fines up to $1,000,000 Imprisonment Export privileges revoked Negative publicity

18 Export Penalties The following is from the DOC web site: Illegal Exports of Biotoxins to Canada On May 9, 2005, EMD Biosciences, Inc. (EMD) of San Diego, California, was ordered to pay a $904,500 administrative penalty to settle charges that it exported biological toxins to Canada in violation of the Export Administration Regulation (EAR). EMD also received a two year suspended denial of export privileges. Between June 2002 and July 2003, EMD committed 134 violations of the EAR stemming from 67 exports of biological toxins to Canada without licenses. Umass Lowell - As a result of export violations, the Center for Atmospheric Research at UMass Lowell recently entered into a settlement agreement with the U.S. government. The institution agreed to a fine of $100,000. UMass Lowell also agreed to make the details of the violations and the terms of the settlement agreement public information, as an example for others to learn from.

19 Impact on Research Failure to follow shipping/export regulations may result in the following: Package delays during transport Mishandling by the courier Potential for an inadvertent release of the contents Criminal and civil penalties Complying with shipping regulations protects the material being shipped, individuals handling the package and controls the potential for negative impacts on the environment.

20 What Do You Need To Do? Complete the DEHS Shipment Request Form for Biological Samples (see Appendix A) and return form to DEHS. If there are any issues identified during the automated export control review the shipment will be routed to DEHS and OEC for review.

21 What Will DEHS and OEC do? DEHS and OEC will research the request and, if necessary, apply for an export license on behalf of the PI. DEHS will send you a DEHS Shipping Requirements for Requests of Biological Samples form (see Appendix B) that lists what s required. If necessary, DEHS will help you package the item for shipment and assist with the shipping documentation.

22 Additional Contact Information If exporting animals please contact DEHS Biosafety ( ) and OEC ( ) or see their web site at for DEHS and for OEC. For other materials or deemed exports please contact OEC at For issues related to Third Party Billing Shipments, please see Appendix C.

23 Responsibility The SHIPPER is responsible for complying with all applicable shipping regulations including permits and export licenses. DEHS and OEC are here to help shippers understand their responsibilities. This means activities such as: preparing the package: applying labels and markings; and completing required paperwork are all the responsibility of the Shipper!

24 Shipping Penalties There are criminal and civil penalties of up to $500,000 and/or imprisonment of up to 5 years for certain violations of shipping regulations. A Florida company was fined $220,000 for improperly offering for shipment milliliter bottles of a flammable liquid to be transported by air. The Company failed to properly: Package, mark, classify, describe, and document the shipment as required by regulations. Ensure employees were trained to properly package and handle hazardous materials Make available at all times the required emergency response information.

25 Classifying Hazardous Material: Nine Hazard Classes 1 - Explosives 2 - Gases Liquid Nitrogen 3 - Flammable liquids Alcohol, formaldehyde 4 - Flammable solids 5 - Oxidizing substances and Organic peroxides 6 - Toxic & infectious substances Infectious substances 7 - Radioactive 8 - Corrosives 9 - Miscellaneous dangerous goods Dry Ice Genetically modified organisms

26 Classifying Hazardous Material: Hidden Dangerous Goods When evaluating research materials to be shipped, the shipper must also consider possible hidden dangerous goods: Cryogenic liquids Preservatives such as ethanol or formaldehyde Pharmaceuticals Medical Supplies Lithium batteries, mercury containing devices Alcohol for consumption

27 Limited Quantity Exemptions Formaldehyde <10% not regulated for shipment > 10% and < 25% regulated by air - Class 9 label, orientation arrows, UN3334, Aviation Regulated Liquid Call DEHS for assistance if this applies Ethanol < 30 ml per vial is regulated as an excepted quantity, but there are still specific regulations associated with these shipments Call DEHS for assistance if this applies

28 Classifying Hazardous Material: UN Numbers Each hazardous material listed in the DOT and/or IATA hazardous materials table is assigned a UN (United Nations) number. These numbers identify each material and are used by emergency responders to obtain response information in the event of an incident

29 Hazardous Material Identification Each UN number has a proper shipping name associated with it. Some items are regulated but are not specifically listed in the regulations; these materials are not assigned a UN number. Often they are exempt from some sections of the regulations. Examples of UN numbers and proper shipping names are on the next slide.

30 Hazardous Material Identification UN Number UN2814 UN2900 UN3373 UN3245 None None UN1845 Proper Shipping Name Infectious substance, affecting humans Infectious substance, affecting animals Biological substance, Category B Genetically Modified Microorganism Exempt Human Specimen Exempt Animal Specimen Dry Ice

31 Packaging Packaging (a receptacle and any components necessary to contain the hazardous material) is an essential component of safe transport, as it protects handlers, passengers and the environment. New packaging materials are strongly recommended. A packaging being re-used must be in like-new condition with all labels and markings completely obliterated. The following slides show examples (good and bad) of reused packaging for shipments of hazardous materials, several of which have been stopped by the carrier and did not make it to the recipient.

32 Re-use of Packaging with Prior Labels NOT Obliterated Crossing out of prior labels with marker or pen is NOT sufficient obliteration. If a carrier can see prior labels, they will assume the package contains the content identified by the label. When the paperwork, labels and marking on the outer package aren t in agreement, the carrier will stop shipment and notify the shipper that the package is being held.

33 Re-use of Packaging WITH Prior Labels Obliterated Any prior labels were completely obliterated and are no longer viewable. The paperwork and labels and marking on the package are in agreement. The package will continue throughout the shipping process and will arrive at its destination without being singled out by the carrier..

34 Outer Packaging in Good Condition for Re-use Box is being re-used, since it is clean and has no prior labels remaining. Integrity of box was not compromised by the removal of prior labels or tapes. If any doubt remains about integrity of the box, don t use and get new packagings instead.

35 Packaging Selections Once a dangerous good is properly identified, the regulations will specify the appropriate nature and type of packaging. (See Appendix D for list of packaging suppliers) IATA does this using Packing Instructions DOT does this in 49CFR173. This training will specify the types of packaging required for the materials or substances you are shipping.

36 Shipping Restrictions Research materials (DOT 6.2 Hazard Class) may NOT be: Hand carried aboard an aircraft, train or vessel, Transported on the University of Louisville Shuttle or other public transportation, or Transported in personal vehicles.

37 Dry Ice Dry ice (Carbon Dioxide, solid) is classified by DOT and IATA as a miscellaneous hazard, class 9. Dry ice is considered hazardous during transportation for three reasons: Explosion hazard: as dry ice sublimates it releases carbon dioxide gas. If the packaging does not allow for release of the gas, it may explode, causing personal injury or property damage. Suffocation hazard: a large volume of carbon dioxide gas emitted in a confined space may create an oxygen deficient atmosphere. Contact hazard: dry ice is a cryogenic material that causes severe frostbite upon contact with skin.

38 Packaging Dry Ice Packaging dry ice properly will minimize the risk to personnel transporting the material. The following must be considered when selecting packaging for dry ice: Gas venting: packages must allow for release of carbon dioxide gas. Dry ice must never be sealed in a container with an airtight seal such as a jar with a threaded lid or a plastic cooler. Package integrity: Packaging must be of adequate strength for intended use, including the loading and unloading normally encountered in transport, and constructed and closed to prevent loss of contents during transport. Package materials: do not use plastics that can be rendered brittle or permeable by the temperature of dry ice. Commercially available packages intended to contain dry ice are recommended. NOTE: UN Packaging is NOT required for Dry Ice.

39 Packaging Dry Ice Secure your samples in such a way that when the dry ice sublimates, they will not move freely inside of the insulated box. This can be accomplished by wedging your samples in place with cardboard or Styrofoam. Fragile containers such as glass tubes or vials must be wrapped with cushioning material.

40 Labeling for Dry Ice The outermost container must be labeled with: Name and address of shipper and recipient (in addition to being on the air waybill.) Class 9 label, UN 1845, The words Dry Ice, and net weight of dry ice in kilograms. The above information must be affixed to a vertical side of the box (not the top or bottom). The maximum allowable net quantity of dry ice allowed per package is 200 kg. NOTE: the following slide presents the requirements of UPS and FedEx for shipping dry ice.

41 FedEx and UPS Requirements for Domestic Shipments of Dry Ice Each carrier has specific requirements when shipping dry ice: UPS allows styrofoam as the outer package, FedEx does not. UPS requires only marking Dry Ice and net quantity of dry ice in kg and must not apply DOT Class 9 label for packages with 5.5 lbs (2.5 kg) of dry ice. For any dry ice amount, FedEx requires the marking UN1845: Dry Ice and the net quantity of dry ice in kilograms (Kg) within each package and DOT Class 9 label on all dry ice packages, regardless of quantity. These markings and labeling should all be on the same side of the package. For UPS packages with 5.5 lbs ( 2.5 kg) dry ice, the same requirements for any FedEx package with dry ice applies. However, UPS requires the shipper to establish a Hazardous Materials Agreement with them.

42 Marking and Labeling for Dry Ice DOT Label for Dry Ice

43 Proper Markings and Labeling for a Dry Ice Package Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

44 Dry Ice Shipment Documentation UN1845, Dry ice, 9, <number of packages> X <net weight in kilograms>

45 FedEx Label for Dry Ice Package UN1845, Dry Ice, 9, 1 X 3.2Kg

46 Requirements Comparison Biological Materials Shipping Regulations Quick Comparison Chart Infectious Substance, Category A Biological Substance, Category B Exempt Human or Animal Specimen GMMOs UN # UN2814 or UN2900 UN3373 NONE 3245 UN Approved Packaging Packaging Performance Tests Name of Shipper and Consignee on Package Name and Phone Number of Responsible Person on Package YES NO No No Must use UN certified packaging that passed the tests specified in the IATA Dangerous Goods Regulation Triple packaging must pass a 1.8 meter or 4 foot drop test. Packages shipped by air must meet a 95 kpa or 14 psi pressure test of primary or secondary container. None Triple packaging (leak proof primary, leak proof secondary, and sturdy outer container) None Triple packaging (leak proof primary, leak proof secondary, and sturdy outer container) YES YES YES YES YES YES NO NO

47 Requirements Comparison Biological Materials Shipping Regulations Quick Comparison Chart Infectious Substance, Category A Biological Substance, Category B Exempt Human or Animal Specimen GMMOs Marking on Package UN2814, Infectious substance, affecting humans Or UN2900, Infectious substance, affecting animals Biological Substance, Category B Exempt Human Specimen Or Exempt Animal Specimen NONE Label Required NO UN 3245 Shipper s Declaration of Dangerous Goods Required YES NO, but: UN3373 Biological Substance, Category B must be on the airway bill NO NO

48 Definition: Exempt Human or Animal Specimen Human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) being transported for routine testing and for which there is low probability the sample contains an infectious agent such as: drug/alcohol testing, cholesterol testing, blood glucose level testing, tests for diagnosis of non-infectious diseases, such as cancer biopsies, Testing not related to the diagnosis of an infectious disease. For shipping purposes, patient samples are not assumed to be pathogenic unless there is a specific reason to believe they are.

49 Exempt Human or Animal Specimen Packaging There is no packing instruction for exempt human or animal specimens, but IATA requires the following triple packaging: Leak-proof primary receptacle(s) Leak-proof secondary packaging An outer packaging with adequate strength for its capacity, mass and intended use, with at least one surface of the outer packaging must have a minimum dimension of 100mm X 100mm

50 Example of Triple Packaging

51 Exempt Human or Animal Specimen Packaging If multiple fragile primary receptacles are placed into a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. For liquids, absorbent material must be placed between the primary receptacle and secondary packaging in sufficient quantity to absorb the entire contents of the primary receptacle(s) and prevent damage to the cushioning material, if used, or to the outer packaging.

52 Exempt Human or Animal Specimen Package Labeling The following must be on one side of the outer package: Name address and telephone number of shipper and receiver (Consignee), this is in addition to being on the air waybill The words Exempt Human Specimen or Exempt Animal Specimen as appropriate Dry ice labels and information if applicable NOTE: UN Packaging is NOT required for Exempt Human or Exempt Animal shipments.

53 Properly Marked and Labeled Exempt Human Specimen Package Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

54 Properly Marked and Labeled Exempt Animal Specimen Package Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

55 Proper Marking and Labeling for an Exempt Human Specimen on Dry Ice Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

56 Proper Marking and Labeling for an Exempt Animal Specimen on Dry Ice Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

57 Requirements Comparison Biological Materials Shipping Regulations Quick Comparison Chart Infectious Substance, Category A Biological Substance, Category B Exempt Human or Animal Specimen GMMOs UN # UN2814 or UN2900 UN3373 NONE 3245 UN Approved Packaging Packaging Performance Tests Name of Shipper and Consignee on Package Name and Phone Number of Responsible Person on Package YES NO No No Must use UN certified packaging that passed the tests specified in the IATA Dangerous Goods Regulation Triple packaging must pass a 1.8 meter or 4 foot drop test. Packages shipped by air must meet a 95 kpa or 14 psi pressure test of primary or secondary container. None Triple packaging (leak proof primary, leak proof secondary, and sturdy outer container) None Triple packaging (leak proof primary, leak proof secondary, and sturdy outer container) YES YES YES YES YES YES NO NO

58 Requirements Comparison Biological Materials Shipping Regulations Quick Comparison Chart Infectious Substance, Category A Biological Substance, Category B Exempt Human or Animal Specimen GMMOs Marking on Package UN2814, Infectious substance, affecting humans Or UN2900, Infectious substance, affecting animals Biological Substance, Category B Exempt Human Specimen Or Exempt Animal Specimen NONE Label Required NO UN 3245 Shipper s Declaration of Dangerous Goods Required YES NO, but: UN3373 Biological Substance, Category B must be on the airway bill NO NO

59 Genetically Modified Microorganisms (GMMOs) Definition: Genetically modified microorganisms are microorganisms in which genetic material has been purposely altered through genetic engineering in a way that does not normally occur naturally (in nature).

60 Definition: Genetically Modified Microorganisms (GMMOs) Description GMMOs that meet the definition of an infectious substance (e.g. recombinant VSV lab strains). GMMO s that are defective but can still alter a cell that do not meet the description above (e.g. defective pathogen vectors, such as adenovirus, herpesvirus, retrovirus, AAV, etc.). Standard bacterial cloning vectors and plasmids that are not associated with pathogenic organisms. Organisms that are genetically altered in a way that does not occur naturally that are not categorized above. Shipping Category Infectious Substance, Affecting Humans or Animals (UN 2814 or 2900) Genetically Modified Microorganism (UN 3245) Genetically Modified Microorganism (UN 3245)

61 Genetically Modified Microorganism Packaging IATA Packing Instruction 959 requires the same triple packaging as required for Exempt Human or Animal Specimens: Leak-proof primary receptacle(s) Leak-proof secondary packaging An outer packaging with adequate strength for its capacity, mass and intended use with at least one surface of the outer packaging must have a minimum dimension of 100mm X 100mm NOTE: UN Packaging is NOT required for Genetically Modified Microorganism (UN3245) shipments.

62 Genetically Modified Microorganism Packaging If multiple fragile primary receptacles are placed into a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. For liquids, absorbent material must be placed between the primary receptacle and secondary packaging in sufficient quantity to absorb the entire contents of the primary receptacle(s) and prevent damage to the cushioning material, if used, or to the outer packaging.

63 Genetically Modified Microorganism Package Marking and Labeling The following must be on one vertical side of the outer package: Name and address of shipper and receiver, in addition to being on the air waybill The UN 3245 label Dry ice label and information, if applicable UN 3245

64 Properly Marked and Labeled Genetically Modified Microorganism Package Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

65 Properly Marked and Labeled Genetically Modified Microorganism Package with Dry Ice Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

66 Requirements Comparison Biological Materials Shipping Regulations Quick Comparison Chart Infectious Substance, Category A Biological Substance, Category B Exempt Human or Animal Specimen GMMOs UN # UN2814 or UN2900 UN3373 NONE 3245 UN Approved Packaging Packaging Performance Tests Name of Shipper and Consignee on Package Name and Phone Number of Responsible Person on Package YES NO No No Must use UN certified packaging that passed the tests specified in the IATA Dangerous Goods Regulation Triple packaging must pass a 1.8 meter or 4 foot drop test. Packages shipped by air must meet a 95 kpa or 14 psi pressure test of primary or secondary container. None Triple packaging (leak proof primary, leak proof secondary, and sturdy outer container) None Triple packaging (leak proof primary, leak proof secondary, and sturdy outer container) YES YES YES YES YES YES NO NO

67 Requirements Comparison Biological Materials Shipping Regulations Quick Comparison Chart Infectious Substance, Category A Biological Substance, Category B Exempt Human or Animal Specimen GMMOs Marking on Package UN2814, Infectious substance, affecting humans Or UN2900, Infectious substance, affecting animals Biological Substance, Category B Exempt Human Specimen Or Exempt Animal Specimen NONE Label Required NO UN 3245 Shipper s Declaration of Dangerous Goods Required YES NO, but: UN3373 Biological Substance, Category B must be on the airway bill NO NO

68 Definition: Biological Substance, Category B An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Biological Substance, Category B material is assigned the UN identification number UN Examples of Biological Substance, Category B materials are on the following slide.

69 Examples of Biological Substance, Category B Materials Human or animal material being transported for diagnostic or investigational purposes (excluding live animals). Material can include known or potential Risk Group (RG) RG2 or RG3 specimens if transported for diagnostic or investigational purposes. Genetically Modified Organisms or Microorganisms that are defective but can still alter a cell (e.g. defective pathogen vectors, such as adenovirus, herpesvirus, retrovirus, AAV, etc.) In conclusion, Category B materials: an Infectious Substance which does not meet the criteria for inclusion in Category A.

70 Biological Products Biological products are divided into two groups: Those manufactured/packaged according to appropriate governmental standards and transported for final packaging or distribution, and used for personal health care by medical professionals or individuals. These are not regulated by shipping regulations. Those that do not fall under the above definition and are known or reasonably expected to contain substances meeting the definition of a Biological Substance, Category B material. These must be shipped as a Biological Substance, Category B.

71 IATA Packaging Instruction 650 Biological Substance, Category B The following are the requirements for Biological Substance, Category B material packaging: Triple packaging required Primary receptacle(s) Secondary packaging Rigid outer packaging Primary receptacles must be placed into secondary packaging in such a way that they can not be damaged during transport; Secondary packaging must be secured in the outer packaging to prevent movement during transport; NOTE: UN Packaging is NOT required for Biological Substance, Category B.

72 IATA Packaging Instruction 650 Biological Substance, Category B An itemized list of contents must be enclosed between the secondary and outer packaging; At least one surface of the outer packaging must have a minimum dimension of 100mm X 100mm; Triple packaging is required to pass series of 4 drop tests. Testing must be documented on a package identical to the one being used for the shipment. NOTE: Neither live animals, infected with pathogens, nor Biological Substance, Category B substances can be transported in the cargo section of passenger aircraft, in carry on luggage, checked luggage or on person.

73 IATA Packaging Instruction 650 Biological Substance, Category B Liquids Primary receptacle(s) must be leak-proof and must not contain more than 1 liter; Secondary packaging must be leak-proof; Primary or secondary container must be capable of withstanding a pressure differential of 95kPa in the range of -40 F to 130 F when shipped by air; Note A list of packaging suppliers is provided in Appendix D.

74 Liquids IATA Packaging Instruction 650 Biological Substance, Category B If multiple fragile primary receptacles are placed into a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them; Absorbent material must be placed between the primary receptacle and secondary packaging in sufficient quantity to absorb the entire contents of the primary receptacle(s) and prevent damage to the cushioning material, if used, or to the outer packaging; The outer packaging must not contain more that 4 liters. Up Arrow Label must be placed on outside of box on two opposing sides.

75 IATA Packaging Instruction 650 Biological Substance, Category B Solids Primary receptacle(s) must be sift-proof and must not contain more than 4 Kg; Secondary packaging must be sift-proof; If multiple fragile primary receptacles are placed into a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them; Outer packaging must not contain more that 4 Kg.

76 Biological Substance, Category B Packaging Culture Biological Substance, Category B 95 kpa (13.8 psi) rated primary or secondary container for shipments of liquids by air

77 Biological Substance, Category B Outer Package Marking and Labeling The following must be on one side of the outer package: Name address and telephone number of shipper and receiver (this is in addition to the airway bill); Responsible person and their phone number also needed (may be the shipper). This phone number must be answered 24/7; UN3373 label and words Biological Substance, Category B Orientation arrows on opposite sides of package (for liquids > 50 ml); Dry ice labels and information if applicable.

78 Properly Marked and Labeled Biological Substance, Category B Package Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill. Up Arrow label must be placed on two opposing sides of box

79 Proper Marking and Labeling for a Biological Substance, Category B on Dry Ice Please note that the name and address of the shipper and consignee on the package are in addition to being on the air waybill.

80 Shipping Documentation Biological Substance, Category B: The following information must be on the air waybill: UN3373, Biological Substance, Category B Dry Ice and Biological Substance, Category B: Entries for both materials must be on the air waybill.

81 FedEx Label for Category B Material Biological Substance, Category B, UN 3373

82 FedEx Label for Category B Material and Dry Ice

83 Overpack An overpack is an enclosure, usually a fiberboard box, commonly used to contain a package that needs to be shipped on dry ice. An overpack can also be used to contain one or more packages to make handling or shipping the package(s) more convenient.

84 Entering an Overpack Shipment

85 Using an Overpack Prepare inner packages as if they were being shipped without an overpack. Apply all necessary labels and use the appropriate packaging. All labels required for the inner packages must be placed on the exterior of the overpack as well. A label with the word Overpack must be attached to the outside of the overpack.

86 Overpack Example Properly marked and labeled overpack Properly marked and labeled inner package to be placed into the overpack with dry ice

87 New Procedure for Shipments Between All University of Louisville Campuses DEHS has a system for intra campus transport of regulated hazmat shipments via the DEHS Emergency Response vehicle. To arrange for intra campus HIGHWAY transport of hazardous materials, shippers must complete the DEHS Shipment Request Form for Biological Samples Research/clinical materials must NOT be transported on public transportation, including University of Louisville shuttles, or in personal vehicles, etc.

88 New Procedure for Shipments Between All University of Louisville Campuses University personnel CAN transport hazardous materials within their lab building and even between certain buildings, if they are in close proximity, and are NOT moving the materials by motorized vehicles over the road. When doing so, personnel must ensure that the hazardous material(s) is secured in leak-proof, properly labeled secondary containment. If transporting the container(s) by cart, personnel must ensure that each container is securely braced within the cart. University personnel are NOT allowed to transport hazardous material in their privately-own vehicle, University shuttle or TARC bus.

89 Intra-Campus Shipping Process The training requirements for Intra-Campus shipments are the same as shipping with any other carrier (e.g. FedEx, UPS). Some shipments will require DEHS review and approval prior to the shipment being completed. If shipping Intra-campus, please indicate this on line 5 of DEHS Shipment Request Form for Biological Samples (see Appendix A). Once approved, the shipper will receive an indicating the shipment was approved and DEHS will be automatically notified of the shipment request.

90 Intra-Campus Shipping Process Once the shipment is approved, you will receive a completed DEHS Shipping Requirements for Requests of Biological Samples form from DEHS (see Appendix B). This form will provide you with information needed to prepare and ship your materials.

91 Packaging for Intra-Campus Shipments Research materials must be packaged, marked and labeled according to the information presented in this training. In addition, the volume or weight of materials (e.g. human or animal materials, dry ice) must be placed on the outer package.

92 Transporting Research Materials Between Campuses Materials must be packaged, marked and labeled by trained lab staff. DEHS will prepare a Bill of Lading for the package, so it can be transported by DEHS personnel.

93 Completing the Bill of Lading The shipper must agree that: The materials are properly: Classified Described Packaged And that the package is: Marked and labeled correctly In the proper condition for transportation This is done by printing their name, applying their signature, and indicating the date on the bill of lading in the area indicated.

94 Remember All research/clinical material shipments must be processed and approved by DEHS and OEC. Only trained/certified researchers and clinicians can ship research/clinical materials. Research/clinical materials must not be transported on public transportation, including University of Louisville shuttles, or in personal vehicles, etc.

95 Receipt of a Dry Ice Package Open package carefully in a well ventilated area. Wear closed toed shoes, long pants, face shield or safety glasses, and insulated gloves when handling dry ice. Always carry or transport dry ice in insulated containers. Do not place dry ice in sink to evaporate

96 Receipt of a Dry Ice Package Dry ice continuously sublimates, moving from solid to vapor/gas phase. Poorly ventilated areas immediately in or around dry ice may experience oxygen displacement, so use caution. Never place your head directly into or near a dry ice vessel. Avoid overpressurization conditions by not hermetically sealing containers holding dry ice.

97 Receipt of a Biological Material Procedure: Open in a certified biological safety cabinet. Wipe secondary container with an appropriate disinfectant prior to opening. If the primary container has leaked, place all the packaging material into an autoclave bag and autoclave prior to disposal. Dispose contaminated personal protective equipment (PPE) and wash hands. Don new PPE and disinfect the BSC.

98 Report of Spill/Exposure Mitigation Isolate and restrict access to the area by posting signage Notify the Principal Investigator/Supervisor of the spill Provide identity of spilled material to responders Notify DEHS of spill and request assistance when on campus Only allow trained responders (public health authority, DEHS HAZMAT team, approved contract responders, etc.)

99 Shipment Checklists Recent experience has shown that there are less shipment delays when the checklists are completed.

100 Security Awareness If you ship any Infectious Substance, Category A material, or a Select Agent or Toxin regulated by the CDC or USDA, the DOT and IATA require additional Security Plan training prior to shipment. UofL requires all to receive Security Plan Training. Security Plan Training Topics: 1. University of Louisville s Security Plan Objective - The objective of the Security Plan is To ensure the protection of hazardous materials stored on the premises and offered for transportation. 2. Employee Responsibility Shippers of Class 6.2 hazardous materials that require the in-depth security training need to know that they must accept the responsibility to undertake the actions described in items 3. and 4. that follow.

101 Security Awareness 3. The shipper will follow the security awareness protective measures listed on a latter slide. 4. In the event of a security breach (stolen/lost package, unauthorized person interfering with package preparation, etc.) take the appropriate action of calling University of Louisville Police Department (ULPD) at To describe the organizational security structure at the University of Louisville to hazmat shippers.

102 Security Awareness Individuals have used hazardous materials from research and clinical laboratories with harmful and lethal results over the past 25 years on U.S. soil. A cult in Oregon poisoned over 700 citizens with Salmonella typhimurium in an attempt to influence a local election. The strain of Salmonella typhimurium was obtained from the American Type Culture Collection and was grown in a lab at the cult compound for poisoning through local buffet style restaurants. An employee from a clinical lab in Texas was arrested for infecting 13 people who ate donuts that were inoculated with Salmonella typhi. The researcher had secretly grown their own cultures for this purpose from a small aliquot obtained from the laboratories stocks.

103 Security Awareness Evidence of an attempted murder was found at a New England college after a man used saxitoxin taken from his research laboratory and placed it in leftover food in his exgirlfriend s apartment. The poisoning was discovered only after the I-125 radiolabeled saxitoxin resulted in elevated radioiodine levels discovered during thyroid monitoring. Five Americans were killed and 17 others hospitalized after letters containing anthrax spores were placed in the U.S. Mail. This terrorist act remains unsolved. Local, state and federal law enforcement officials continue to uncover plots to use hazardous materials with explosive devices to create dirty bombs. Many in law enforcement believe that academic institutions are a potential source of these hazardous materials as security at these locations may not be as hardened as federal research locations.

104 University of Louisville Organizational Security Structure The University of Louisville Police Department (ULPD) is responsible for overall security at the University of Louisville. They work in partnership with the Louisville Metro Police Department to maintain a safe environment. ULPD is comprised of uniformed and armed law enforcement professionals. University police officers are sworn peace officers in the State of Kentucky. When appropriate, ULPD works in partnership with the Louisville Metro Police Department to address criminal activity on or near the University of Louisville s three campuses.

105 University of Louisville Organizational Security Structure The University of Louisville Chief of Police reports directly to the Vice President for Business Affairs. University of Louisville Police Department Security Officers, while not police officers, provide services which include building patrols and building access. This adds an additional level of security at the University.

106 Protective Measures In addition to this security presence, each employee involved in the transport of hazardous materials can play a key role in preventing unauthorized access to these packages. Protective measures include: Restrict access to your laboratory to authorized personnel only. Avoid discussing the nature of your research with those you are not familiar with. Report suspicious activities, events, and people to ULPD at This would include lost or damaged packages. Keep packages of hazardous materials in a secure location or under direct guidance of laboratory staff at all times. Select a courier that will keep the package secure during transport and can track the package at all points from collection through delivery. Verify the chain of custody and security by having the package recipient notify you once it has been received in good condition. Periodically remind your staff and fellow employees of these basic security measures and follow them whenever shipping or transporting a package of hazardous materials.

107 Suspicious Activities Report suspicious activities, events, and people to ULPD at Suspicious activities include: An unauthorized person asking for access to, or loitering near, a laboratory or other area where hazardous shipments are prepared and/or stored prior to pick-up. This could include a vehicle into which materials will be loaded. An unauthorized person interfering with the packaging, loading or transportation of hazardous materials. An unauthorized person taking photographs of a hazardous shipping facility, vehicle, or package. An unauthorized person asking questions about the contents of a hazmat shipment, the function of hazmat shipping employees, or about other activities of a hazardous materials shipping facility or vehicle. An unauthorized person following a hazmat employee, shipper, carrier, or vehicle.

108 Shipping Research Materials at Liquid Nitrogen Temperatures Dry Nitrogen Shippers Exempt from Shipping Regulations if completely devoid of liquid N2! (Labels and markings shown at right are NOT required) Up to day temperature retention advertised Airbill must be marked with Not Restricted, as per Special Provision A152 The following slide shows an Acceptable Dry Dewar For additional assistance, please contact DEHS UN 1977, Liquid Nitrogen, 1 L

109 Acceptable Dry Dewar Dry Nitrogen aka Dry dewar Shippers Exempt from Shipping Regulations if completely devoid of liquid N2! No DOT Class 9 label or dry ice label or marking required Up to day temperature retention advertised Airbill must be marked with Not Restricted, as per Special Provision A152

110 Example of Dry Dewar FedEx Airbill A Ship to/from info B Not restricted, as per Special Provision A152 C Other Packaging D No (dangerous goods) E Number and Weight of Packages

111 Thank You Full credit will not be given for this training until you complete and pass the required quiz. Prior to shipping a research material you must complete and submit a DEHS Shipment Request Form for Biological Samples. For more information or assistance please contact DEHS at

112 Appendix A DEHS Shipment Request Form for Biological Samples Please complete all questions below to ensure that your request is processed promptly A. This is a preliminary request, I do not have a set shipment date. YES NO B. This is an actual shipment request, I have a set ship date of (MM/DD/YY): C. This is an international shipment YES NO 1 What material is being shipped (please be descriptive, attach MSDS if available): a 1 b Material is derived from University research? Please indicate YES NO 1 c Is the material of biological, chemical, select agent, or radioactive origin? YES NO Specify: If hazardous chemical, provide DOT information if available: X If radioactive material, STOP. Contact the University Radiation Safety Office at for shipping assistance. If chemical material, STOP. Contact University Hazardous Waste Office at If biological, go to 1d. 1 If the material is of biological origin, is it: d A select agent? Yes No Infectious to humans? Yes No Infectious to Animals? Yes No Genetically modified? Yes No A known biological or infectious hazard? Yes No If other known biological hazard, specify: 1 Is the sample fixed or contained in a chemical preservative? Yes No e 1 If fixed or contained in a chemical preservative, provide fixative/chemical name and/or attach product MSDS f 1 Number of samples to be shipped (number/container size): QTY x ml g 1 Sample container type (i.e. plastic vial): h Additional material listed in addendum to this form YES NO 2 Will you ship sample(s) with Dry Ice? Please indicate Yes No If yes, indicate amount of much dry ice (in lbs or kg) : 3 Who is the shipper (name, department, phone): 4 Who is the recipient (institution or company name, address, phone)? 5 Which carrier will be used to transport shipment (i.e. UPS, FedEx, Roadway, etc): 6 Will sample shipment transport be by Air or Ground? Please specify: 7 What is the monetary value of the shipment (for international commercial invoice use): $

113 Appendix B DEHS Shipping Requirements for Requests of Biological Samples DEHS Shipping Requirements for Requests of Biological Samples The shipment is NOT REGULATED as a Hazardous Material, based on the information supplied. The material being shipped is not hazardous, but the shipment contains DRY ICE, and is regulated only if shipped by air. Please contact DEHS for specific instructions. The material IS REGULATED. Please follow the instructions listed below. Shipping Information For Regulated Shipments of Biological Samples Based on the information provided to DEHS, your shipment was determined to be a regulated and must be shipped according to the information provided in the following steps. The information is unique to the mode of transportation selected, and should you decide to change the mode of transportation, you should contact DEHS for additional guidance. Background Information Type of Shipment: Hazardous Non-Hazardous Mode of Transport: Highway Air Destination: Domestic International Shipper s Name, Address and Phone Number: