Shipping & Transport of Biological Materials
The shipping and transport of dangerous goods is a highly regulated activity. A large number of people will handle or be in proximity to your package as it travels to its destination. All that protects these people from any hazards within the package is the information you provide on or with your package and the packaging itself.
The following regulations apply to the packaging and shipment of biological materials:
- U.S. Department of Transportation, 49 CFR Parts 171-180 and amendments
- U.S. Public Health Service, 42 CFR Part 72, Interstate Shipment of Etiologic Agents
- U.S. Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Bloodborne Pathogens
- International Air Transport Association (IATA), Dangerous Goods Regulations
- U.S. Postal Service, 39 CFR Part 111, Mailability of Etiologic Agents, Mailability of Sharps and Other Medical Devices, and Publication 52, Acceptance of Hazardous, Restricted or Perishable Matter
- International Civil Aviation Organization, Technical Instructions for the Safe Transport of Dangerous Goods by Air
- United Nations, Recommendations of the Committee of Experts on the Transportation of Dangerous Goods
All North American airlines and FedEx, the largest shipper of infectious materials, use the IATA regulation (also referred to as the Dangerous Goods Regulation or DGR) as their standard. Meeting the conditions of this standard will ensure meeting the provisions of the other US regulations.
Many biological materials fall into the category of “dangerous goods” for shipping purposes. All individuals involved in the transport of dangerous goods or the preparation of dangerous goods for transport must be trained to do so properly and safely. In addition, we require safe transport of items within facilities and around campus. These topics are covered in the “Shipping and Transport of Biological Materials” training given by the Biosafety Office.
You must have a Shipping and Transport of Biological Materials Training Certificate (online course) from UF EH&S to ship biological materials. Training is valid for 2 years. It is a federal requirement and the training is designed to protect yourself, your co-workers, and the public – drivers, airline staff, crew, pilots, passengers, and package recipients.
All individuals involved in the transport of dangerous goods or the preparation of dangerous goods for transport must abide by the International Air Transport / International Civil Aviation and Dept. of Transportation regulations.
- To Register: Email email@example.com and provide your First Name, Last Name, and UFID number.
- Successful shipments
Carriers or Federal regulators may open, delay, or reject your shipment if it’s not correct
- Penalties for violations
Civil penalties $250 –$27,500 per violation per day
Criminal penalties (willful violations) up to $500K, 5 yr in jail
Training Learning Objectives
- Classifying the material – Is it regulated? Is it forbidden for transport?
- Identifying the material – select the proper shipping name
- Choosing the right packaging
- Packaging it correctly
- Marking & Labeling the shipment correctly
- Supplying additional required documentation – dangerous goods declaration forms
- Making shipping arrangements – i.e. permits, customs documents for overseas shipments
- Transporting things safely around UF – hand carrying & vehicle transport
Biological Material Subject to Shipping & Transport Regulations
In the context of shipping regulations, “Dangerous Goods” are “Articles or substances which are capable of posing a risk to health, safety, property or the environment & which are shown in the list of dangerous goods in the Regulations or which are classified according to these Regulations.” (49 CFR Parts 100-185 & IATA 1.0).
Biological Materials Under This Definition
Genetically Modified Organisms
Other Regulated Biological Material
Other Regulated Items Accompanying Biological Material Shipment
Environmental pollutants (formalin)
Federal or state permits may be required for some biological materials. See below or contact us at 392-1591 for more information. Permits are issued in the name of the PI who is required to keep them updated and current as necessary; the Biosafety Office does not hold any “centralized” permits.
CDC Import Permit for import of etiological agents causing disease in humans, non-sterilized human or animal tissues/fluids known or suspected to contain disease agents, hosts/vectors known or suspected to contain disease agents.
USDA/APHIS Veterinary Permit is needed for import of materials derived from (livestock/poultry) animals or exposed to (livestock/poultry) animal-source materials, including: animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species, certain polyclonal antibodies and antisera, bulk shipments of test kit reagents, arthropod vectors of livestock diseases, and microorganisms infectious to livestock including bacteria, viruses, protozoa, and fungi.
Interstate movement of microorganisms infectious to livestock/poultry including bacteria, viruses, protozoa, and fungi, arthropod vectors of livestock/poultry diseases, and tissues, blood, serum, or cells from known infected livestock/poultry.
Note: A courtesy letter to the Florida Department of Agriculture and Consumer Services Division of Animal Industry is required for possession or use of any of the State of Florida reportable animal diseases.
USDA/APHIS Plant, organism and Soil Permit is needed for import or interstate movement of plant pests, plant pathogens, biological control agents, bees, plant pest diagnostic laboratories, soil microbe isolation laboratories, federal noxious weeds and parasitic plants.
USDA Biotechnology regulatory Services Notification or Permit for the import, interstate movement, or field release of genetically engineered plants, arthropods, and plant-associated microorganisms.
Florida Department of Agriculture and Consumer Services Division of Plant Industry Permit for the import into Florida of: arthropods, plant pathogens, nematodes, noxious weeds, genetically altered (insects, nematodes, plants, plant pests) organisms, biological control agents.
The transfer of Select Infectious Agents and Toxins is also regulated by the USDA/CDC. Each shipment of listed agents must be registered with the USDA/CDC through a responsible facility official at both the shipping and receiving entities. Please contact EH&S Biosafety before sending or requesting any Select Agents. The current list of Select Agents and Toxins can be found on our website at http://www.ehs.ufl.edu/programs/bio/select_agents.
Export of Etiologic Agents of Humans, Animals, Plants and Related Materials is regulated by the US Department of Commerce, Dept. of State, and Dept. of the Treasury. Export to certain countries is prohibited. A wide variety of etiologic agents of human, plant and animal diseases, including genetic material, and products which might be used for culture or production biological agents, will require an export license. Check the BioAgent Export Control List . Additional information may be obtained by calling the Biosafety Office at 352-392-1591.
Transporting Biological Material Within and Around UF
Double contain the items in plastic leak-proof containers within sturdy outer packaging. Include absorbent material within the containers as well as padding to minimize movement of the container(s) within the outer packaging. Wipe the outer container with an appropriate disinfectant before removing it from the laboratory and apply a biohazard sticker if applicable. Put your name and contact information on the package. Individuals transporting biohazardous agents should be knowledgeable about handling spills.
UF policy states that dangerous goods are not to be transported in your personal vehicle. This is both a safety and liability issue. Use a state vehicle instead.
- Shipping radioactives?
- Shipping chemicals?