Classification

The Department of Transportation (DOT) classifies infectious substances as Class 6, Division 6.2 materials. These are further divided into two categories: Category A, Infectious Substances and Category B, Biological Substances. Regulated medical waste may be classified as category A or B depending on the infectious agent. Patient specimens may be classified as Biological Substances, Category B or exempt depending on the health status of the patient. International shipments of non-infectious genetically modified organisms or micro-organisms (GMOs/GMMOs) are assigned to Class 9, Miscellaneous by the International Air Transport Association (IATA). For shipment purposes, all biological materials fall into one of the following categories:

• Infectious substances, Category A;
• Biological substances, Category B;
• GMOs or GMMOs;
• Regulated medical waste;
• Patient specimens (human or animal);
• Unregulated biological materials.

Classification Guide

Proper classification of biological materials is a crucial step in the transportation of biological materials. The category determines the packaging, labeling, and documentation requirements. The Division of Research Safety (DRS) has developed a Classification Guide for Infectious Substances to illustrate how to properly classify biological materials for shipment.

Required Training and Certification

Infectious Substances, Category A

The DOT and the IATA require the highest level of training and certification for people handling Category A Infectious Substances due to the increase risk of infection if the package is compromised in transit. Certified training ensures that the shipper understands the strict packaging, labeling, and documentation requirements.

For University of Illinois principal investigators who need to ship material as Infectious Substances, Category A, contact the DRS at 217-333-2755 or via email to make arrangements for training.

Infectious Substances, Category B

The DRS has developed an on-line training on Transportation of Infectious Substances, Category B for shipping infectious substances that qualify as Category B material according to the requirements outlined by the 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 to ship the following biological materials:

• Biological substances, category B;
• GMOs/GMMOs;
• Regulated medical waste;
• Dry ice.

All category B materials must be registered with the Institutional Biosafety Committee (IBC) except for regulated medical waste shipped exclusively through Stericycle.

Instructions for Certification

Before shipping any Category B biological substance or GMOs/GMMOs internationally, personnel must complete certified training.

University of Illinois Urbana-Champaign employees and students can be certified at no charge by completing the following two DRS online training modules:

• Awareness Training for the Transport of Hazardous Materials and
• Transport of Infectious Substances, Category B.

Certified training is valid for two years, after which time the training modules must be repeated if shipping is to continue.

Intra-campus Transportation

Laboratory personnel transporting biological material between buildings must follow the procedure below to ensure that the materials are contained in a way that will prevent release to the environment:

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 there is a possibility that the outside of the primary container or vessel is contaminated, use 10% bleach solution, an EPA approved disinfectant, or a disinfectant appropriate for the biological material in use to decontaminate it prior to placing it in a secondary container.
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 personnel can carry the package 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 if they meet all packaging and labeling training requirements and the personnel transporting them are properly training. 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:

• At a minimum, a triple packaging system must be used for all materials.
• 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 shall accompany the package.
• The vehicle shall be driven directly from the point of origin to the intended destination without stopping at other locations on the way.

Materials meeting the definition of Category B biological substances may only be transported by personal or university vehicle if they are packaged and labeled according to DOT 173.199 and PI 650 and the driver has received proper training (certified to ship/transport category B material).

Transport of Category A material by personal vehicle is prohibited.

Packaging Requirements for 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 sift-proof. The closures should be secured with tape or parafilm to prevent them from opening due to vibration during transport. It is packed in the secondary container in such a way that, under normal conditions of transport, it will not break, be punctured, or leak its contents into the secondary container. If there are multiple fragile primary receptacles, they must be individually wrapped or separated to prevent contact.

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 by 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

Transporting Infectious Substances Safely

https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/Transporting_Infectious_Substances_brochure.pdf

Department of Transportation (DOT)

Hazardous Materials: Infectious Substances (49 CFR Parts 171 et al.)

https://www.phmsa.dot.gov/standards-rulemaking/hazmat/hazardous-materials-regulations

World Health Organization (WHO)

Guidance on Regulations for the Transport of Infectious Substances 2021-2022

https://iris.who.int/bitstream/handle/10665/339825/9789240019720-eng.pdf?sequence=1 

Import and Export

CDC

https://www.cdc.gov/cpr/ipp/index.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) Export Control

http://www.bis.doc.gov/licensing/exportingbasics.htm