International Biohazard SymbolBiological Safety

Transport of Biological Materials

Introduction

The packaging and transportation of biological materials are subject to strict State, Federal, and international regulations. Individuals involved in the packaging, transportation and shipment of infectious substances must receive training on proper packaging, labeling, and documentation according to the applicable regulations and requirements before shipping such materials.

Failure to comply with these regulations may result in individual fines up to $250,000 and a maximum of one year in jail. Organizations could be fined up to $500,000 per incident. Several agencies regulate the shipment of biological materials including:

The intent of the packaging and transportation regulations is to prevent accidental exposure to personnel who may handle the material during its shipment. If you wish to ship an infectious material or you are not sure if your material is regulated, contact DRS-BSS at 333-2755 or via e-mail.

Classification

Infectious substances, Class 6, Division 6.2, are divided into a two-tiered classification system - Category A and Category B. For shipment purposes, all biological materials fall into one of the following categories:

Proper classification of biological materials is a crucial step in the transportation of biological materials. Packaging, labeling, and documentation requirements are based directly on accurately categorizing the biological material. BSS has developed a Classification Guide for Infectious Substances to illustrate how to classify biological materials for shipment.

PDF
Are you shipping pathogens or anything that may contain pathogens?
No
Yes
Are you shipping non-infectious micro-organisms or organisms in which genetic material has been purposely altered through genetic engineering?
Yes
Yes
Ship as Genetically Modified Micro-organism (GMMO) or Genetically Modified Organism (GMO)
DownYes   DownNo    
Is this material on the list of unregulated biological materials?
Yes
Yes
The substance is not subject to the DOT or IATA regulations. Ship as unregulated biological materials    
NoNo        
Are you shipping any patient specimens (human or animal) unlikely to contain pathogens?
Yes
Yes
Ship as Exempt Human Specimens or Exempt Animal Specimens    
NoNo        
Is it an infectious substance that, when exposure to it, is capable of causing permanent disability, life-threatening or fatal disease in humans or animals?
Yes
Yes
Ship as Infectious Substance, Category A: Human or Animal    
NoNo        
It is regulated medical waste or 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.
Yes
Yes
Ship as Biological Substance, Category B:    

Training and Certification Requirements

The DOT has established regulations for domestic transport (within the United States) of hazardous materials by rail, air, vessel (ships), and motor carrier (ground). IATA has established guidelines exclusively for the transport of dangerous goods by air (both domestic and international).*

Federal and international regulations require that anyone wishing to ship infectious materials must first receive function-specific shipping training. Individuals wishing to ship infectious materials classified as hazardous material (dangerous goods) must receive certified shipping training every 2 years.

*The DOT term "Hazardous Material" and IATA term "Dangerous Good" are used interchangeably in this document.

General Awareness Training

Anyone whose job duties include contact with hazardous materials must receive DRS Awareness Training for the Transport of Hazardous Materials. Additional training is required if you wish to ship infectious substances.

Infectious Substances, Category B

DRS has developed an on-line training entitled; Transportation of Infectious Substances, Category B for shipping infectious substances that qualify as Category B material According to the requirements outlined by the US Department of Transportation (DOT) at 49 CFR 173.199, 172.700 and IATA 1.5 Dangerous Goods Regulations. This training covers how to; classify biological materials, select proper shipping names, select approved packaging materials, mark and label packages, and complete all required documentation. This training also provides training to ship samples on dry ice.

All category B materials must be registered with the Institutional Biosafety Committee (IBC), with the exception of those exclusively shipping regulated medical waste through Stericycle.

Instructions for Certification

Before shipping any infectious substance or genetically modified organism or microorganism (GMO/GMMO), personnel must demonstrate that they understand and will comply with the regulations outlined in this training.

As a University of Illinois employee or student, you can be certified, at no charge, by receiving an Authorized Certificate from DRS to those who complete the following;

Once approved by BSS, an Authorized Certificate will be issued electronically and/or by paper which certifies you to ship infectious materials (excluding category A) and GMO/GMMO. An authorized certificate is valid for 2 years after which time the training and certification process must be repeated if shipping is to continue.

Keep your Authorized Certificate for your records.

Infectious Substances, Category A

Shipping Category A infectious substances requires the highest level of oversight due to the increase risk of infection if the package is compromised in transit. Accordingly, Category A materials requires more extensive training, packaging, and documentation than Category B.

All Category A materials must be registered with the Institutional Biosafety Committee (IBC).

Instructions for Certification

As a University of Illinois Principal Investigator, DRS will provide resources for one person in your lab to be certified, at no charge, by receiving comprehensive shipping training. To receive training, follow the instructions below;

The signed Saf-T-Pak certificate is valid for 2 years after which time the training and certification process must be repeated if shipping is to continue.

Keep your signed Saf-T-Pak Certificate for your records.

Intra-campus Transportation

Biological materials transported by laboratory personnel between buildings must be contained in such a way as to prevent release to the environment in case of an accident by following the procedure below:

  1. Biological samples must be placed in a primary container or vessel that is a securely closed, leak-proof (or o-ring) tube, vial or ampoule, which is then placed in an unbreakable, lidded, watertight, secondary container (e.g. Rubbermaid tote or Playmate-type cooler).
  2. If the outside of the primary container or vessel is suspected of being contaminated, decontaminate prior to placing in secondary container using 10% bleach solution, an EPA approved disinfectant, or a disinfectant appropriate for the biological material in use.
  3. All biohazards must be labeled with the international biohazard symbol on the outside of the secondary container.
  4. When transporting liquids in glass vials/containers, place enough absorbent material, such as paper towels, in the space at the top, bottom, and sides between the primary and secondary containers to absorb the entire contents of the primary container(s) in case of breakage or leakage.
  5. The outside of the secondary container must be free of any biohazardous material so that the package can be carried safely between buildings without wearing gloves or lab coats outside.
  6. The package must be taken directly to its intended location.
  7. If a spill occurs during transport, do not attempt to clean it up without appropriate spill response material and PPE. Keep other persons clear of the spill.

Transport by Personal or University Vehicle

Unregulated or exempted biological materials may be transported either on campus or to off-site research locations for university business in a personal or University vehicle as long as they meet all packaging, labeling, and training requirements. However, insurance companies may not cover an accident where hazardous materials were transported in a personal vehicle.

For materials that qualify for transport in a personal or university vehicles, the following precautions should be followed:

Materials meeting the definition of Category B, biological substances are only excepted by vehicle when the material is packaged and labeled according to DOT 173.199 and PI 650 and the driver has received proper training (certified to ship).

Category A material is prohibited by personal vehicle.

Packaging Unregulated Biological Materials

All biological materials must be packaged according to a triple packaging system. The three components of a triple packaging system are;

  1. Primary receptacle
  2. Leak-proof secondary container
  3. Rigid outer container

The primary receptacle holds the biological material and must be leak-proof, or siftproof and secured with tape or parafilm to secure closures from opening due to vibration during transport. It is packed in the secondary container in such a way that, under normal conditions of transport, they will not break, be punctured, or leak their contents into the secondary container. If the primary receptacle is fragile, it must be individually wrapped or separated to prevent contact between multiple primary receptacles.

The secondary container is a durable, watertight, leak-proof container that encloses and protects the primary receptacle(s). Several cushioned primary receptacles may be placed in one secondary container. If the primary receptacle contains any liquid, the secondary container must contain enough absorbent material to absorb all of the fluid from the primary receptacle(s) in case of breakage.

The outer container is a rigid and durable container with one side that is at least 10 cm x 10 cm (or 4 inches by 4 inches) that houses the secondary container. The outer package should be properly marked and labeled. It should be able to withstand outside influences such as physical damage while in transit. An itemized list of package contents must be included between the outer and secondary container.

Helpful Links and Resources

Center for Disease Control (CDC)
Transport of Infectious Substances
http://www.cdc.gov/od/eaipp/shipping/
Department of Transportation (DOT)
Hazardous Materials: Infectious Substances (49 CFR Parts 171 et.al.)
http://www.gpo.gov/fdsys/pkg/FR-2006-06-02/pdf/06-4992.pdf
World Health Organization (WHO)
Guidance on Regulations for the Transport of Infectious Substances 2011-2012
http://whqlibdoc.who.int/hq/2010/WHO_HSE_IHR_2010.8_eng.pdf

Import and Export

CDC
http://www.cdc.gov/od/eaipp/importApplication/agents.htm
USDA-APHIS
http://www.aphis.usda.gov/import_export/
Fish & Wildlife Services
http://www.fws.gov/permits/ImportExport/ImportExport.html
US Department of Commerce
Bureau of Industry and Security (BIS)
http://www.bis.doc.gov/licensing/exportingbasics.htm

Quick Links

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