Biological Safety

Transport of Biological Materials

Introduction
Classification
Training Requirements
Intra-campus Transportation
Transport by Personal or University Vehicle
Packaging Unregulated Biological Materials
Helpful Links and Resources
Import and Export

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 (217) 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
Patient specimens
Biological products
Unregulated biological materials
Regulated medical waste
Genetically modified organisms or 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.

Classification Guide for Infectious Substances ¹

Are you shipping pathogens or anything that may contain pathogens?	No	The substance is not subject to the DOT or IATA regulations. Packaging
Yes	Yes
Is this material on the list of unregulated biological materials?	Yes
No
Are you shipping any patient specimens (human or animal) unlikely to contain pathogens?	Yes	Ship as Exempt Human Specimens or Exempt Animal Specimens Packaging & Labeling
No
Is it an infectious substance that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in humans or animals? List of examples	Yes	Infectious Substance, Category A: Human or Animal Training, Packaging, & Labeling
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	Biological Substance, Category B: Training, Packaging, & Labeling

Training 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 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.

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 which may be transported with or without dry ice in accordance with the requirements of 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.

According to the DOT & IATA regulations, the shipper must be certified to ship Infectious Substances. To become certified to ship infectious substances as Category B at the University of Illinois at Urbana-Champaign, you must;

Complete the prerequisite session Awareness Training for the Transport of Hazardous Materials.
Complete this session (Transportation of Infectious Substances, Category B)
Notify BSS by via e-mail that you have completed the required trainings. In the body of the email, indicate the following information:

Principal Investigator (PI)
Valid IBC registration title(s) & approval date(s)
Anticipated Category B material(s) to ship over two year period
Anticipated shipping destination(s) over two year period

BSS will review and verify your records. Once verified, BSS will send you an Authorized Certificate to ship Category B Infectious Substances. You cannot ship Category B materials until you receive an authorize certificate from BSS. Keep this certificate for your records.

An Authorized Certificate to ship Category B material is valid for 2 years.

Infectious Substances, Category A

To ship an infectious substance that qualifies as a Category A material, you must also be a certified shipper. Because Category A material requires more comprehensive certified training and documentation than Category B, you must complete the following training:

Complete the DRS online training; Awareness Training for the Transport of Hazardous Material
Complete the DRS online training; Transportation of Infectious Substances, Category B
Notify BSS by via e-mail that you have completed the required trainings. In the body of the email, indicate the following information:
- Principal Investigator (PI)
- Valid IBC registration title(s) & approval date(s)
- Anticipated Category B material(s) to ship over two year period
- Anticipated shipping destination(s) over two year period
BSS will Loan (one person per laboratory) a Saf-T-Pak cd rom for Shipping Class 6.2 Dangerous Goods
- Complete the training, and pass the quiz with a score of 85% or better to demonstrate competency
- Print two (2) copies of the Saf-T-Pak certificate (one for you and one for DRS records) and return Saf-T-Pak cd to DRS

BSS will verify that all trainings have been completed. You cannot ship Category A materials until you complete all required trainings. Keep all certificates for your records.

A Saf-T-Pak certificate to ship Category A material is valid for 2 years.

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

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 with content information.
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.

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, 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.

Helpful Links and Resources

Center for Disease Control (CDC)
Transport of Infectious Substances
http://www.cdc.gov/od/ohs/biosfty/shipregs.htm

Department of Transportation (DOT)
Hazardous Materials: Infectious Substances (49 CFR Parts 171 et.al.)
http://hazmat.dot.gov/regs/rules/final/71fr/docs/71fr-32243.pdf

World Health Organization (WHO)
Guidance on Regulations for the Transport of Infectious Substances 2007-2008
http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2007_2cc.pdf