Chapter 26

BIOSAFETY

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Appendix H. Transportation and Shipping

H.1 Introduction and Scope

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:

o   U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR) for movement of biological materials in public right-of-ways within the U.S.

o   International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) for shipment of biological materials (e.g., infectious substances) by air.

        Truck 12     

 

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:

 

This appendix does not cover the following topics:

 

H.2 How to Determine Transportation Mode and Requirements

LBNL employees should use the following steps to determine the transportation mode and requirements needed to transport or ship a biological material:

  1. Determine the desired mode of transportation or shipping.
  2. Use Table H-1 to determine whether the desired transportation mode can be used. If needed, use Section H.4 to determine whether the material is subject to IATA or DOT shipping regulations. Section H.4 can also be used for definitions of terms.
  3. Use Section H.3 to determine the requirements or process for packaging, labeling, transporting, or shipping the material.

 

Table H-1. Transportation Modes and Biological Materials Not Allowed

 

General

Transport Mode

Specific

Transport Mode

Biological Materials That Are

Not Allowed

Personal Transportation

 

 

 

 

 

 

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 shuttle 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.

Licensed Transporter

 

LBNL Transportation Department

No restrictions on types of biological materials.

Common carrier

No restrictions on types of biological materials unless restricted by the carrier.

Footnotes:

*  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 affiliated with the research for transport in a personal vehicle if this individual is affiliated with the research, 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.

H.3 Requirements and Processes for Receiving, Transporting, and Shipping

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 whether the desired mode of transportation or shipping can be used to transport the biological material.

H.3.1 Employee Transportation of Materials 

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. The following are objectives that should be accomplished whenever employees transport biological materials:

 

H.3.1.1 Hand-Carry Transport between Laboratories      

Text Box:  
Ice chest with secured lid used as an outer package. Source: unidentified.
Primary container example. Text Box:  
Ice chest with secured lid used as an outer package. Source: unidentified.
Secondary container used to transport materials between laboratories. Source: Berkeley Lab EHS. Text Box:  
Ice chest with secured lid used as an outer package. Source: unidentified.
Containers inside a break-resistant and leak-proof carrier. Source: VWR (2010).

 

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:

 

H.3.1.2 Hand-Carry Transport between Buildings       

 

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:

 

H.3.1.3 Personal Transportation in a Motor Vehicle   

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.

 

 

Text Box: Packaging and Labeling Biological Materials
for Transportation
Example of packaging and labeling of unregulated biological materials for
transportation in a motor vehicle. See text for criteria and requirements.
Source: Berkeley Lab EHS.

 

Material quantity of regulated biological material:

 

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.

 

H.3.1.4 Personal Transportation on an LBNL Shuttle Bus   

Personal transportation on an LBNL shuttle 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.

 

H.3.2 LBNL Receiving, Transportation, and Shipping      

Receiving, transportation, and shipping of biological materials are conducted institutionally from Building 69 by Shipping/Receiving/Transportation within the Facilities Division. These services are conducted in accordance with ESH Manual Transporting and Shipping Hazardous Materials program, 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.

H.3.2.1 LBNL Receiving

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.

H.3.2.2 LBNL Transportation

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:

H.3.2.3 LBNL and Common Carrier Shipping

Text Box:  
Trained person in LBNL Shipping ensures the material is correctly packaged, labeled, and documented. Source: Berkeley Lab EHS.
Trained person in LBNL Shipping ensures the material is correctly packaged, labeled, and documented. Source: Berkeley Lab EHS.

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:

 

Packaging and labeling as an infectious substance. Transporting Infectious Substances Safely, US DOT Document PHH50-0079-0706 (October 1, 2006).

 

H.4 Unregulated and Regulated Materials

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.

 

H.4.1 Unregulated Biological Materials

The following materials are not subject to DOT and IATA infectious substance shipping regulations:

 

H.4.2  Regulated Biological Materials

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.

 

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 do not meet the definition of toxic or infectious substances but 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 must be shipped as UN3245. GMOs and GMMOs that are infectious must be shipped as UN2814, UN2900, or UN3373.

H.5 References and Resources

 

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