Biological 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:
- US Department of Transportation (DOT)
- International Civil Aviation Organization (ICAO)
- International Air Transport Association (IATA)
- US Public Health Services (PHS)
- Occupational Health and Safety Administration (OSHA)
- United States Postal Services (USPS)
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:
- Category A infectious substances
- Category B infectious substances
- Regulated medical waste
- Patient specimens
- Genetically modified organisms or micro-organisms
- Unregulated biological materials
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.
| Are you shipping pathogens or anything that may contain pathogens? | No  |
Are you shipping non-infectious micro-organisms or organisms in which genetic material has been purposely altered through genetic engineering? | Yes |
Ship as Genetically Modified Micro-organism (GMMO) or Genetically Modified Organism (GMO) |
 Yes |
No |
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| Is this material on the list of unregulated biological materials? | Yes |
The substance is not subject to the DOT or IATA regulations. Ship as unregulated biological materials | ||
| No |
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| Are you shipping any patient specimens (human or animal) unlikely to contain pathogens? | Yes |
Ship as Exempt Human Specimens or Exempt Animal Specimens | ||
| No |
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| 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 |
Ship as Infectious Substance, Category A: Human or Animal | ||
| No |
||||
| 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 |
Ship as Biological Substance, Category B: |
Training
Additional training is required beyond the online DRS training entitled; Awareness Training for the Transport of Hazardous Materials to include a function-specific online training entitled; Transportation of Infectious Substances, Category B. Training must occur every 2 years.
Packaging
All shipments containing GMMOs or GMOs must be packaged according DOT and IATA regulations according to packaging instructions 959 (PI 959) which is a triple packaging system. All GMMO and GMO packages must be marked as with an appropriate UN 3245 diamond label. The three components of a triple packaging system are;
The primary receptacle holds the biological material and must be leak-proof container (watertight for liquids or sift-proof for solids). 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 leak-proof container for liquids and sift-proof for solids 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 a smallest external dimension of at least 100 mm (or 4 inches) that houses the secondary container. It must be strong enough for its capacity, weight, and intended use. 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.
Labeling & Markings
All GMMOs and GMOs must be marked with a UN3245 diamond-shaped label (see Figure 1) that is in accordance with the IATA regulation.
Figure 1. GMMO/GMO diamond-shaped shipping label
This is a list of biological materials that are not subject to the DOT and IATA Division 6.2 regulations.
- Substances which do not contain infectious substances or which are unlikely to cause disease in humans or animals;
- Substances containing microorganisms, which are non-pathogenic to humans or animals;
- Substances that have been neutralized or inactivated such that they no longer pose a health risk;
- Dried blood spots;
- Fecal occult blood screening tests;
- Blood or blood components which 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 naturally occurring in the environment so it cannot cause disease when exposure to it occurs. Examples of these materials include foodstuffs and environmental samples such as water or a sample of dust of mold; or
- A biological product1.
1Biological Products: Derivations of living organisms and manufactured for use in the prevention, diagnosis, treatment, or cure of diseases 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.
Packaging
All biological materials must be packaged according to a triple packaging system. The three components of a triple packaging system are;
- Primary receptacle
- Leak-proof secondary container
- Rigid outer container
The primary receptacle holds the biological material and must be leak-proof, watertight. 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.
Human or animal materials collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimens include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g. transwabs, culture media, and blood culture bottles).
Patient specimens that have a minimal likelihood of containing pathogens via professional judgment are exempt from the hazardous materials regulation but do have packaging and labeling requirements.
Packaging
All biological materials that qualify as patient specimens (human and animal sources) must be packaged according to a triple packaging system and must be marked as "Exempt human specimen" or Exempt animal specimen" depending on the source. The three components of a triple packaging system are;
- Primary receptacle
- Leak-proof secondary container
- Rigid outer container
The primary receptacle holds the biological material and must be leak-proof, watertight. 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. For human origin samples, an international biohazard symbol must be displayed on the secondary container to be in accordance with the OSHA bloodborne pathogen standard 29 CFR 1910.1030.
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. 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.
Labeling
The outer container must be properly marked and labeled with the words "Exempt human specimens" or "Exempt animal specimens"
Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with human or animals. Classification must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal. Category A poses a higher degree of risk than Category B.
| INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED | |
| UN Number and Proper Shipping Name | Microorganism |
| Infectious substances affecting humans UN 2814 | Bacillus anthracis (cultures only) |
| Brucella abortus (cultures only) | |
| Brucella melitensis (cultures only) | |
| Brucella suis (cultures only) | |
| Burkholderia mallei ? Pseudomonas mallei ? glanders (cultures only) | |
| Burkholderia pseudomallei ? Pseudomonas pseudomallei (cultures only) only) | |
| Chlamydia psittaci ? avian strains (cultures only) | |
| Clostridium botulinum (cultures only) | |
| Coccidioides immitis (cultures only) | |
| Coxiella burnetii (cultures only) | |
| Crimean-Congo haemorrhagic fever virus | |
| Dengue virus (cultures only) | |
| Eastern equine encephalitis virus (cultures only) | |
| Escherichia coli, verotoxigenic (cultures only)* | |
| Ebola virus | |
| Flexal virus | |
| Francisella tularensis (cultures only) | |
| Guanarito virus | |
| Hantaan virus | |
| Hantaviruses causing haemorrhagic fever with renal syndrome | |
| Hendra virus | |
| Hepatitis B virus (cultures only) | |
| Herpes B virus (cultures only) | |
| Human immunodeficiency virus (cultures only) | |
| Highly pathogenic avian influenza virus (cultures only) | |
| Japanese Encephalitis virus (cultures only) | |
| Junin virus | |
| Kyasanur Forest disease virus | |
| Lassa virus | |
| Machupo virus | |
| Marburg virus | |
| Monkeypox virus | |
| Mycobacterium tuberculosis (cultures only)* | |
| Nipah virus | |
| Omsk haemorrhagic fever virus | |
| Poliovirus (cultures only) | |
| Rabies virus (cultures only) | |
| INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED | |
| UN Number and Proper Shipping Name | Microorganism |
| Infectious substances affecting humans UN 2814 | Rickettsia prowazekii (cultures only) |
| Rickettsia rickettsii (cultures only) | |
| Rift Valley fever virus (cultures only) | |
| Russian spring-summer encephalitis virus (cultures only) | |
| Sabia virus | |
| Shigella dysenteriae type 1 (cultures only)* | |
| Tick-borne encephalitis virus (cultures only) | |
| Variola virus | |
| Venezuelan equine encephalitis virus (cultures only) | |
| West Nile virus (cultures only) | |
| Yellow fever virus (cultures only) | |
| Yersinia pestis (cultures only) | |
| Infectious substances affecting animals only UN 2900 | African swine fever virus (cultures only) |
| Avian paramyxovirus Type 1 ? Velogenic Newcastle disease virus (cultures only) | |
| Classical swine fever virus (cultures only) | |
| Foot and mouth disease virus (cultures only) | |
| Lumpy skin disease virus (cultures only) | |
| Mycoplasma mycoides ? contagious bovine pleuropneumonia (cultures only) | |
| Peste des petits ruminants virus (cultures only) | |
| Rinderpest virus (cultures only) | |
| Sheep-pox virus (cultures only) | |
| Goatpox virus (cultures only) | |
| Swine vesicular disease virus (cultures only) | |
| Vesicular stomatitis virus (cultures only) | |
* For ground transport, when the cultures are intended for diagnostic or clinical purposes, they may be classified as Biological Substances, Category B (UN 3373).
Training
Additional certified training is required beyond the online DRS trainings entitled; Awareness Training for the Transport of Hazardous Materials and Transportation of Infectious Substances, Category B prior to shipping any Category A, infectious substance. The Biosafety Section will provide a cd-rom for individual PI's to complete. Training must occur every 2 years. Please contact the Biological Safety Section for more information on how to receive certified training.
Packaging
All shipments containing Category A, infectious substances must meet the DOT and IATA regulations according to Packaging Instructions 620 (PI620). In addition to a triple packaging system, quantity limitations and certified packaging that meet stringent drop test also exist.
Labeling & Documentation
All Category A, infectious substances must be marked with a class 6 infectious substance label that is in accordance with DOT and IATA regulations. A shipper's declaration is also required. Documentation for infectious substances must be marked with the identifier "UN2814, Infectious substance, affecting humans" or "UN2900, Infectious substance, affecting animals.
Regulated Medical Waste
Regulated medical waste or clinical waste or (bio) medical waste means a waste or reusable material derived from the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical research, which includes the production and testing of biological products. Regulated medical waste or clinical waste or (bio) medical waste containing a Category A infectious substance must be classed as an infectious substance, and assigned to UN2814 or UN2900, as appropriate. Typically, regulated medical waste is classified as category B and is assigned UN3291.
Infectious Substances (Division 6.2): A material known or reasonably expected to contain a pathogen. A pathogen is a micro-organism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that can cause disease in humans or animals.
Category B: An infectious substance 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. This includes Category B infectious substances transported for diagnostic or investigational purposes.
Culture: An infectious substance containing a pathogen that is intentionally propagated. Culture does not include a human or animal patient specimen. Cultures may be categorized as A or B depending on the microorganism concerned.
Training
Additional training is required beyond the online DRS training entitled; Awareness Training for the Transport of Hazardous Materials to include a function-specific online training entitled; Transportation of Infectious Substances, Category B. BSS will verify all required trainings before issuing an Authorized Certificate to ship Category B materials. This must be completed prior to shipping any Category B, infectious substance. Training must occur every 2 years.
Packaging
All shipments containing Category B, infectious substances must meet the DOT and IATA regulations according to Packaging Instructions 650 (PI650). In addition to a triple packaging system, quantity limitations and certified packaging that meet stringent drop test are also required.
Labeling & Documentation
All Category B, infectious substances must be marked with a UN3373, Biological Substance, Category B label (see figure 1) that is in accordance with the IATA regulation. The UN number for regulated medical waste is UN3291. Vendors such as Stericycle ship regulated medical waste.
Figure 1. Biological Substance, Category B diamond-shaped shipping label
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;
- Complete both DRS training courses ; Awareness Training for the Transport of Hazardous Materials and Transport of Infectious Substances, Category B,
- Contact Biological Safety Section (BSS) to notify your intentions to ship infectious materials which includes regulated medical waste.
- Communicate by phone or email with BSS to assure that there is a clear understanding of what will be shipped and how it will be packaged.
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;
- Contact Biological Safety Section (BSS) to notify your intentions to ship infectious materials that qualifies as Category A.
- BSS will Loan (one person per laboratory) a Saf-T-Pak cd rom for Shipping Class 6.2 Dangerous Goods training. This training includes certified training for all 6.2 biological materials.
- Complete the training, and pass the quiz with a score of 85% or better to demonstrate competency.
- Print a copy of the Saf-T-Pak certificate and sign (employee). Return Saf-T-Pak cd and the signed Saf-T-Pak certificate to BSS.
- BSS will certify your training by signing the certificate (employer) and return the signed copy to you for your records.
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:
- 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).
- 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.
- All biohazards must be labeled with the international biohazard symbol on the outside of the secondary container.
- 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.
- 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.
- The package must be taken directly to its intended location.
- 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:
- All materials must be packaged according to a triple packaging system or more restrictive packaging requirements.
- Hazardous materials should be transported in the trunk, or as far away from passengers as possible.
- All containers should be clearly labeled.
- A complete inventory of the material must accompany the package.
- The vehicle must be driven directly from the point of origin to the intended destination without stopping at other locations on the way.
- Materials needed to contain or clean-up a spill, such as sorbent pads, gloves, and eye protection, should be available in the vehicle.
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;
- Primary receptacle
- Leak-proof secondary container
- 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.
