Transportation and Shipping
This appendix provides requirements, guidelines, and direction on transporting and shipping biological materials as needed to safely move the material from one location to another. This includes:
- Employee transport of biological materials between laboratories, between buildings, in motor vehicles, and on LBNL buses
- Use of LBNL Receiving, Transportation, and Shipping
- Shipping through LBNL Shipping by a contracted shipping company (e.g., common carrier such as FedEx or UPS)
- Packaging, transportation, and shipping in accordance with:
- U.S. Department of Transportation (DOT) Hazardous Material Regulations (HMR) for movement of biological materials in public right-of-ways within the U.S.
- International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) for shipment of biological materials (e.g., infectious substances) by air.
Employees who wish to transport or ship a biological material should use this appendix (starting in Section H.2) to assess if the material is a regulated biological material and select a mode and process for moving the material. Modes and processes detailed in this appendix cover safe movement of all biological materials and potential shipping and transportation regulatory issues, although most LBNL biological materials that need to be moved are not regulated. Regulatory requirements for packaging, transporting, and shipping are applicable only if the material is:
- Moved in vehicles, airplanes, railcars, or vessels via public right-of-ways such as roadways, airways, railways, and sea lanes that are accessible to the public, and
- A regulated biological material (i.e., categorized by DOT HMR or IATA DGR as an infectious substance or genetically modified organism).
This appendix does not cover the following topics:
- Transportation and shipping of nonbiological hazardous materials. These topics are covered in the following LBNL documents:
- The PUB-3000, Sections 5.8.11 and 5.8.13: Provides overview of services provided by the LBNL Environment, Health, and Safety (EH&S) Division to transport radioactive and hazardous materials, and by LBNL Transportation Services to ship them.
- The Chemical Hygiene and Safety Plan (CHSP), “Chemical Procurement, Transportation, and Inventory”: Provides instructions for moving hazardous material research samples and small quantities by hand or in a passenger vehicle.
- Other regulatory requirements related to the import, export, and transfer of biological materials. See Appendix I of this manual for information on these topics.
LBNL employees should use the following steps to determine the transportation mode and requirements needed to transport or ship a biological material:
- Determine the desired mode of transportation or shipping.
- Use Table H-1 to determine if the desired transportation mode can be used. If needed, use Section H.4 to determine if the material is subject to IATA or DOT shipping regulations. Section H.4 can also be used for definitions of terms.
- Use Section H.3 to determine the requirements or process for packaging, labeling, transporting, or shipping the material.
Biological Materials that are
Hand carry between laboratories
No restrictions on types of biological materials.
Hand carry between buildings
No restrictions on types of biological materials.
Personal motor vehicle*
Regulated** biological materials are not allowed except for regulated materials contained in human or animal samples (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, cells, and body parts) being transported for research, diagnosis, investigational activities, or disease treatment or prevention; or that are biological products. Samples containing Category A infectious substances are not allowed.
LBNL bus or other public transportation
Regulated** biological materials or other biological materials that may present a detrimental risk to the health of humans or other organisms either directly through infection or indirectly through damage to the environment are not allowed.
LBNL Transportation Department
No restrictions on types of biological materials.
No restrictions on types of biological materials unless restricted by the carrier.
|*||Personal transport in a motor vehicle means transportation in a private or government passenger vehicle such as a car, van, or pickup truck.|
|**||Materials that are and are not subject to DOT and IATA regulations are described in Section H.4 of this appendix.|
Here is an example of how to apply Steps 1, 2, and 3 above:
An LBNL research employee wants to transport his established human cells in a personal vehicle between two LBNL sites in direct support of his research project. According to Table H-1, this is allowable because it is a human sample being transported solely for the purpose of research, regardless of whether or not the human cells are a regulated biological material. According to the second bullet in Section H.4.1, these cells would not be considered regulated biological materials unless they contained infectious agents or were collected from individuals suspected of having an infectious disease; however, this determination does not matter, because this is a human sample being transported in direct support of a research project. The researcher must package and label the human cells according to Section H.3.1.3 (Personal Transport in Motor Vehicle). The researcher may then give the packaged cells to another person who is affiliated with the research for transport in a personal vehicle if this individual knows the cells are in the vehicle, is informed of the applicable requirements in this appendix, and is doing the transport solely for the purpose of supporting the research.
This section presents requirements and processes related to receiving, transporting, and shipping biological materials by an LBNL employee, LBNL Transportation or Shipping Groups, or a common carrier. See Section H.2 to determine if the desired mode of transportation or shipping can be used to transport the biological material.
This section covers minimum requirements for transporting biological materials by an LBNL employee without the use of the LBNL Transportation Group or a common carrier. General objectives that should be accomplished whenever employees transport biological materials include:
- Biological materials will not be spilled in the event of accident (e.g., due to a person tripping or a vehicle accident).
- The identity of biological materials, their hazards or lack of hazards, and owners may be explained by people transporting the materials and determined by other people who may find the materials.
- Exterior surfaces of containers will not be contaminated with biological materials.
- Regulated biological materials being transported in public right-of-ways (e.g., in vehicles on roads or in airplanes) will be packaged and transported in accordance with DOT and IATA regulations.
Hand-carry transport between laboratories generally means an LBNL employee is hand-carrying the biological material in a container and walking between laboratories in the same building or buildings that are closely connected and designed for pedestrian traffic. Requirements and precautions for such transport include:
- Primary or secondary containers that prevent leakage are required. When Risk Group (RG) 2 or bloodborne pathogen (BBP) materials are transported, a biohazard label must be displayed on the exterior of the outermost container. When possible and appropriate for the work and risk:
- Primary containers of biological material should be break-resistant (e.g., plastic), leakproof, have secure caps or lids, and be disinfected on the outside.
- Primary containers of biological material should be placed in a secondary container that prevents leakage. Racks or packing should be used inside the secondary container as needed to keep the primary containers upright and prevent breakage.
- The primary or secondary containers should be labeled with the identity of the contents, ownership information, and any appropriate biohazard information. Such labeling may not be needed if the primary container(s) and secondary container will remain in continuous possession of the person(s) transporting and processing the materials.
- Remove gloves and wash hands after preparing biological materials for transport. Lab coat, clean gloves, and eye protection should be worn during transport if there is a risk of unexpected exposure, contamination, or spillage.
- Medical/biohazardous waste must be transported in accordance with the container and labeling requirements in Medical and Biohazardous Waste Generator’s Guide (PUB-3095).
Hand-carry transport between buildings generally means the packaged biological material is carried by an LBNL employee who is walking between nonadjacent LBNL or University of California, Berkeley (UCB) buildings. Requirements and precautions for such transport include:
- Biological materials transported by this means are not subject to DOT and IATA regulations, but the biological materials should be transported according to the packaging and labeling criteria described in Section H.3.1.3 (Personal Transportation in Motor Vehicle) of this appendix.
- Employees transporting materials by this means should take precautions to ensure they can walk safely between buildings. Precautions may include having one hand free to open doors and hold stair rails, use of a hand truck, and wearing slip-resistant shoes.
- Medical/biohazardous waste cannot be transported off LBNL sites (e.g., between discontinuous LBNL locations or different institutions). Medical/biohazardous waste must be transported in accordance with the container and labeling requirements in Medical and Biohazardous Waste Generator’s Guide (PUB-3095).
Personal transportation in a motor vehicle means transportation by an LBNL employee in a private or government passenger vehicle such as a car, van, or pickup truck. Requirements for such transport of biological materials are described in this section. These requirements meet the DOT HMR requirements for transporting materials of trade:
Materials allowed. Materials that may be transported in a motor vehicle include unregulated biological materials noted in Section H.4.1, the regulated materials noted as an exception in Table H-1, and dry ice. Other regulated biological materials or medical/biohazardous waste are not allowed. Transportation of any regulated biological material must be in direct support of a principal business (e.g., research project), and the principal business must not be motor vehicle transportation (e.g., a company paid to transport items).
Packaging and labeling. An inner container and outer package are required.
- Manufacturer’s packaging. When applicable, each regulated biological material must be contained and packaged in the manufacturer’s original container and packaging, or a container and packaging of equal or greater strength and integrity.
- Inner containers:
- Use break-resistant (e.g., plastic) containers, if possible.
- Liquids must be in a leakproof container. Lids on inner containers must have a positive means of closure. For example, a screw-type cap should be used instead of parafilm, aluminum foil, or a stopper.
- Container(s) must be disinfected as needed for safety and should be placed in a Ziploc® bag or an equivalent secondary spill container.
- Information must be placed on or with the container(s) as needed to clearly communicate the container’s contents, hazards, and ownership. Each individual container must be labeled with enough information to identify its contents. In addition, the container(s) or secondary bag(s) must also be labeled with the identity of the material, the name and phone number of the sender, the name and phone number of the recipient (if different than the sender), and hazard information. Hazard information includes a biohazard label if the material is biohazardous (e.g., RG2), any words needed to explain the hazard, or words indicating the material is not hazardous.
- Containers for sharps (i.e., sharps container) must be constructed of a rigid material resistant to punctures and securely closed to prevent leaks or punctures.
Leakproof plastic containers Containers inside break-resistant
with screw caps. Source: VWR. and leakproof carrier. Source: VWR (May 2010).
Ice chest with secure lid as an outer Biohazard label for inner and outer
package. Source: unidentified. containers. Source: 29 CFR 1910.1030(g)(1)
- Outer packaging:
- The outer packaging must be a strong and tight packaging made of a rigid material. It must also be securely closed. Examples include a cardboard, plastic, or metal box or pail with a secure lid. A plastic carrier that is leakproof, easy to clean, and has a secure lid is typically the best package for biological materials (e.g., ice chest or enclosed laboratory tube carrier).
- Packing material or racks must be used between the inner container(s) and outer packaging as needed to keep the container(s) upright, cushion the container(s), and prevent the container(s) from shifting or damage.
- Sufficient absorbent material must be inside the outer packaging to absorb the entire contents of all inner liquid container(s).
- The exterior of the outer packaging must be labeled with the same information required for the inner container. The common name(s) or shipping name(s) of the materials must be used.
- Outer packaging must be secured against shifting inside the vehicle during transport. Generally, the safest place to secure biological materials is in a vehicle trunk. If hazardous materials are also transported, these materials must be placed in the trunk or truck bed.
Material quantity of regulated biological material:
- Each inner container must not be more than 0.5 kg (1.1 lbs) or 0.5 L (17 ounces), and an aggregate contained within the entire outer package must not be more than 4 kg (8.8 lbs) or 4 L (1 gallon), or
- A single inner container containing not more than 16 kg (35.2 lbs) or 16 L (4.2 gallons) that is inside a single outer package.
Ice and dry Ice. Ice and dry ice may be used inside the package to keep the biological materials cold. Ice must be packaged so that any melting water will be contained inside the outer packaging. Dry ice is frozen carbon dioxide that will sublimate into gas, so dry ice must be placed in packaging that is not gas-tight (e.g., ice chest). Dry ice is only regulated as a hazardous material in air transport, but is not regulated in ground (e.g., motor vehicle) transport in the U.S.
Hazard communication. The operator of a motor vehicle that contains a regulated biological material must be informed of the presence of the material, and must be informed of the requirements in this section.
Personal transportation on an LBNL bus means the packaged biological material is carried by an LBNL employee on an LBNL shuttle bus. The following materials must not be transported on an LBNL bus: regulated biological materials, medical/biohazardous waste, or other biological materials that may present a detrimental risk to the health of humans or other organisms, either directly through infection or indirectly through damage to the environment. Any other biological materials transported by this means are not subject to transportation regulations, but the biological materials should be transported according to the packaging and labeling criteria described in Section H.3.1.3 (Personal Transportation in a Motor Vehicle) above.
Receiving, transportation, and shipping of biological materials are conducted institutionally from Building 69 by Resource Services in the Facilities Division. These services are conducted in accordance with PUB-3000, Section 5.8 (Traffic and Transportation), DOT HMR, IATA DGR, and by personnel with appropriate regulatory qualifications. For questions about shipping or receiving biological materials, contact LBNL Shipping at 510-486-5084 or LBNL Receiving at 510-486-4935.
Biological materials that are shipped by a contracted shipping company (i.e., common carrier) to LBNL must be received by LBNL Receiving and are typically delivered to the requestor via LBNL Transportation in the packaging and with the documentation that was received from the common carrier.
This section covers the pickup and delivery of biological materials or items that contain biological materials (e.g., freezers) within LBNL by LBNL Transportation or a carrier authorized by Transportation. Transportation of materials must be requested through the Facilities Work Request Center, and a completed Transportation Authorization Form (TAF) must be attached to each item to be transported. Additional directions include:
- When placing a work request for transportation, the requestor will be asked if the item to be transported contains hazardous materials. The requestor should declare that the item does not contain hazardous materials if the item to be transported does not contain regulated biological material as described in Section H.4 or other hazardous materials.
- If the item does not contain a regulated biological or other hazardous material, the requestor should package and label the biological materials as described in Section H.3.1.3 (Personal Transportation in Motor Vehicle) of this appendix.
- If the item contains a regulated biological or other hazardous material, the requestor should consider personal transportation of the item in a motor vehicle (see Section H.3.1.3 of this appendix) if allowed (see Table H-1), or contact LBNL Shipping for advice and directions.
- See Section H.3.2.3 below if the item will also be shipped by a common carrier after transportation within LBNL.
Shipment of biological materials by a common carrier out of LBNL must be conducted by LBNL Shipping. Information and assistance must be provided by the sender. Use the following guidelines for shipping:
- Note directions for transportation and pickup of materials in Section H.3.2.2.
- An LBNL Shipping Document must also accompany all material leaving LBNL. Directions for completing this form can be found on the LBNL Shipping Web site. This form requires the sender to describe the item and material to be shipped, and asks if the item and material is a regulated hazardous material (i.e., contains Dangerous Goods).
- The sender may use the lists of unregulated and regulated materials in Section H.4 to answer the Dangerous Goods question on the form in regards to biological materials. Section H.4 can also be used to determine what information should be included in the form’s description section. The sender is responsible for providing a description of the item and biological material and its potential biological or hazardous materials risks so that LBNL Shipping can correctly categorize and ship the material.
- Trained personnel in LBNL Shipping determine if the material is subject to DOT and IATA shipping regulations. They also ensure the material is correctly packaged, labeled, and documented for shipment. If the material is a regulated biological material, LBNL Shipping will work with the sender to ensure the shipping requirements are implemented at the sender’s LBNL location.
Packaging and labeling as an infectious substance. Transporting Infectious Substances Safely, US DOT Document PHH50-0079-0706 (October 1, 2006).
This section provides information on which biological materials are or are not subject to DOT HMR and IATA DGR infectious substance and genetically modified organism shipping regulations. LBNL employees should use this information to assist in selecting or requesting appropriate modes of transport for their biological materials.
The following materials are not subject to DOT and IATA infectious substance shipping regulations:
- Substances that do not contain infectious substances or that are unlikely to cause disease in humans or animals.
- Noninfectious biological materials from humans, animals, or plants. Examples include noninfectious cells, tissue culture, blood, or plasma from individuals not suspected of having an infectious disease, DNA, RNA, or other genetic elements.
- Substances containing microorganisms that are nonpathogenic to humans or animals.
- Substances that have been neutralized or inactivated so that they no longer pose a health risk.
- Environmental samples that are not considered to pose a significant risk of infection (e.g., food and water samples).
- Dried blood spots.
- Fecal occult blood screening tests.
- An infectious substance (other than a Category A infectious substance) contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment and prevention; or a biological product when such materials are being transported by a private carrier in a motor vehicle used exclusively to transport such materials.
- Blood or blood components that have been collected for the purpose of transfusion or the preparation of blood products to be used for transfusion or transplantation.
- Tissues or organs intended for use in transplantation.
- A material with a low probability of containing an infectious disease, or where the concentration of the infectious substance is at a level that naturally occurs in the environment and cannot cause disease when exposure to it occurs. Examples of these materials include foodstuffs and environmental samples (e.g., samples of water, dust, or mold).
- A biological product, including an experimental or investigational product or component of a product, subject to federal approval, permit, review, or licensing requirements such as those required by the Food and Drug Administration (FDA) or U.S. Department of Agriculture (USDA).
The materials presented below are subject to DOT and IATA shipping regulations for infectious substances and genetically modified organisms:
Infectious substances are materials regulated for shipping. These materials are known to be, or are reasonably suspected to contain, an animal or human pathogen. A pathogen is a virus, microorganism (including bacteria, plasmids, or other genetic elements), proteinaceous infectious particle (prion), or a recombinant microorganism (hybrid or mutant) that is known or reasonably expected to cause disease in humans or animals. Microorganisms that are unlikely to cause human or animal diseases are not subject to biological shipping regulations.
- Category A infectious substances are materials capable of causing permanent disability, or a life threatening or fatal disease in humans or animals when exposure to them occurs. Category A infectious substances are shipped as infectious substances affecting humans (UN2814) or infectious substances affecting animals (UN2900). Examples of Category A infectious substances are listed in a table in the infectious substances section of the IATA Dangerous Goods Regulations.
- Category B infectious substances are materials that do not meet Category A criteria. Category B infectious substances are shipped as UN3373.
Patient specimens or diagnostic specimens are any human or animal materials including but not limited to excreta, secreta, blood, blood components, tissue, and tissue fluids being shipped for the purpose of diagnosis. Patient specimens that have a minimal likelihood of containing pathogens are regulated materials, but they are also exempt from many shipping requirements. Professional judgment is used to determine if a specimen contains pathogens and should be based on the patient’s medical history, symptoms, local conditions, and individual circumstances. The outer package must be marked “Exempt human specimen” or “Exempt animal specimen.” If there is more than a “minimal likelihood” that a patient specimen contains pathogens, it must be shipped as a Category A or Category B infectious substance.
Biological products are materials that are derived from living organisms and manufactured for use in the prevention, diagnosis, treatment, or cure of disease in humans or animals and are certified by the USDA, FDA, or other national authority. Examples of biological products include certain viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, and blood products. Biological products transported for final packaging, distribution, or use by medical professionals are not subject to biological shipping regulations. Biological products that do not meet these criteria must be shipped as UN2814, UN2900, or UN3373 when appropriate.
Genetically Modified Organisms (GMO) or microorganisms (GMMO) are organisms whose genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. GMOs and GMMOs that are not infectious but that can alter animals, plants, or microorganisms in a way that is not normally the result of natural reproduction are considered a miscellaneous hazard (Class 9) and are shipped as UN3245. GMOs and GMMOs that are infectious must be shipped as UN2814, UN2900, or UN3373.
- International Air Transport Association (IATA) Dangerous Goods Regulations (DGR), Section 3.6.2, “Division 6.2 : Infectious Substances,” and Section 3.9, “Class 9: Miscellaneous Dangerous Goods, Genetically Modified Microorganisms and Genetically Modified Organisms”
- PUB-3095, Medical and Biohazardous Waste Generator Guidelines, LBNL, latest revision
- Transporting Infectious Substances Safely, guide to changes effective October 1, 2006, US DOT Document PHH50-0079-0706
- UNH Shipment of Biological Materials Manual,University of New Hampshire, updated March 30, 2007
- UNH Guide to Shipping with Dry Ice, April 9, 2007
- U.S. Department of Transportation (DOT) Hazardous Material Regulations (HMR), 49 CFR 171.8 (Definitions), 173.134 (Infectious Substances), and 173.6 (Materials of Trade)
- U.S. Postal Service (USPS) Domestic Mail Manual Section 10.17 (Infectious Substances)