University departments ship a variety of hazardous materials (HazMat), also termed dangerous goods. Hazardous materials may include such items as:
These shipments are highly regulated by the U.S. Department of Transportation (USDOT) and/or international agencies (IATA, ICAO). And requirements vary depending upon the material, the mode of transportation, the commercial carrier, and the destination.
To comply with shipping regulations, these materials must be properly classified, packaged, documented, and handled by trained employees. Anyone who ships HazMat can be subject to inspection by federal enforcement officers (e.g., FAA or PHMSA/DOT). Failure to meet regulatory requirements may result in citations, fines, and/or imprisonment. Fines can range from $250 to $250,000 per violation.
EHS can provide guidance and support services for the proper shipping of these materials. Researchers must also be cognizant of relevant import, export, permit, licensing (FDA) or transfer requirements (i.e., MTA) that involve their research materials.
All shipments of chemical or radiological materials MUST be shipped by EHS personnel. Unregulated materials on dry ice can also be shipped by EHS upon request. The lab will provide a PTAO or FedEx account number to EHS to pay for shipping costs.
|Hazardous Chemicals||Flammables, corrosives, biotoxins1, laboratory reagents comprised of hazardous chemicals, newly synthesized materials3||Adam Peters
|EHS personnel only4|
Dry Ice only
printable label (pdf)2
|Unregulated biological materials (e.g., proteins, antibodies, DNA) that must be shipped frozen on dry ice||Adam Peters
|EHS personnel upon request4
Trained shipper in lab or department4
Online training is available (log-in)
|Radiological materials||Radioligands, radioactively labeled materials, tissues, medical devices, instruments and articles etc.||Trevor Thomas
|EHS personnel only4|
Infectious Substances or Other Biological Materials
printable label (pdf)2
|Infectious microorganisms, viral vectors, human cell lines and other human derived materials
Other: Exempt Patient or Animal Specimens, GMO/GMMO or unregulated biologicals
Trained shipper in lab or department4
Online training is available, see Category A and B options above
In addition to the online training, EHS will provide in-person training for those groups (minimum of 10) who request in-person training.
Information on Shipping Infectious Substances by Air can be found here.
1Biotoxins (biologically-derived) or those that are from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances meet Category 6.1 classification and are hazardous chemicals that MUST be shipped by designated EHS personnel. Contact EHS before shipping any biotoxin.
2You may print and affix to your shipment using packing tape.
3The Toxic Substances Control Act (TSCA) requires newly synthesized chemicals to be registered with the United States Environmental Protection Agency (EPA). UVA is exempt from the (TSCA) reporting requirements for newly synthesized chemicals as long as certain requirements are met.
4Carrier Liability and Declared Value Coverage: Per the UVA Office of Risk Management, when shipping research samples for laboratory testing via a common commercial company, such as FedEx, it is advised that the shipper purchase additional insurance to ensure adequate monetary coverage in case of damage to the package or loss of specimens during shipment.
Information for Travelers
Hazardous Materials Regulations forbid most items in carry-on and/or checked baggage. This include chemicals, biological materials, and lithium batteries. Passengers violating these regulations can be fined from $250 to $50,000. Before traveling, make sure that all materials in your carry-on/checked baggage are permitted.
For information on which materials are forbidden in carry-on and/or checked baggage see the FAA Pack Safe website.
Biological Substance, Category A: Infectious substance known to contain or suspected of containing a pathogen (e.g., bacteria, viruses, rickettsiae, parasites, fungi, prions).
A specimen that is transported in a form that is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. For a complete list, refer to the EHS Shipping Infectious Substances training module (attachments can be downloaded and printed) or the IATA Dangerous Goods Regulations. Note that Category A microorganisms are almost exclusively in cultured form, with a few exceptions.
Note: A list of approved dangerous goods shipping application vendors can be reviewed at www.fedex.com/us; dangerous goods (keyword); Saf-T-Pak also provides an online Shippers Declaration tool accepted by FedEx.
Biological Substance, Category B: Is an infectious substance which contains or is suspected to contain a pathogen and is in a form that is not found on the Category A List.
Genetically-Modified Organisms/Microorganisms (GMO/GMMO): are non-pathogenic organisms or microorganisms whose genetic material has been intentionally altered in a manner (i.e., recombinant DNA techniques) that would not occur naturally. Pathogenic GMO/GMMO must be classified as either Category A or B. Replication defective vectors typically handled at BSL2 can be considered Category B.
GMO/GMMO are not regulated in the U.S. when transported by ground. IATA guidelines and UN 3245 apply for air shipments.
Exempt Patient and Animal Specimens: are patient specimens not likely to contain a pathogen. Although they fall under exemptions, it is not the same as "unregulated". Specific criteria have to be satisfied in order for the material to meet the exempt status. In determining the likelihood that a pathogen is present, professional judgment is based on known patient medical history, symptoms and individual circumstances of the source, and the human or animal endemic local conditions.
Biological Products: are those products derived from living organism that are manufactured and distributed in accordance with the requirements of appropriate national authorities, and are applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals. In the U.S., biological products must be approved by the Food and Drug Administration (FDA), Department of Health and Human Services (HHS) or United States Department of Agriculture (USDA).
Used Medical Devices: are those that have been in contact with a patient or clinical specimen (Category B or Exempt Human Specimen) and are being returned to the manufacturer for repair, sterilization, or evaluation. These devices must not have been in contact with a Category A Infectious substance. DOT uses the phrase "Used Healthcare Products" to designate these exempted materials.
Many research-related materials that are biologically-derived are not regulated. The following are not subject to the regulations, unless they meet the criteria for another type of dangerous good (e.g., contain a preservative, fixative).
Other exempt biological or non-regulated materials may be subject to the regulations when shipped on dry ice or with preservatives from other classes of dangerous goods (e.g., ethanol, methanol, formalin, phenol). For shipments containing chemicals, contact Trevor Thomas at email@example.com or Jennifer Kershner at firstname.lastname@example.org.
Shipping and receiving infectious or biohazardous agents, animal specimens, and genetically modified organisms may require the approval of federal agencies, both domestic and foreign. Regulations that govern the transfer of biological materials help to minimize or eliminate the possible threats to public health and agriculture.
Note: While EHS shipping consultants make reasonable efforts to provide accurate and up-to-date information on permitting and customs compliance, these are separate from IATA shipping requirements and are the researcher’s responsibility to obtain. The FedEx International Reference Guide. provides assistance, or by calling 1-800-GO-FEDEX (choose Dangerous Goods, International options).
In addition to the IATA Dangerous Goods Regulations, many import and/or customs regulations may apply to materials your lab is importing. Principal Investigators are required to apply for and maintain valid permits and may contact EHS Biosafety for information on obtaining the necessary permits.
These additional requirements take time, therefore it is advisable to allow at least 4-6 weeks to obtain either a USDA or CDC permit before making arrangement to receive shipments. Canada, Australia, and the EU have similar import regulations. Please verify with the receiving lab before you ship for country-specific importation rules.
CDC permits are required, when importing into the United States, any known or suspected material capable of causing disease in humans or transferring an infectious biological agent to a human:
CDC's Etiologic Agent Import Permit Program
Use the E-tool to determine if you need a CDC Import Permit
When importing or domestically transferring live animals or animal products, animal pathogens or materials containing pathogens that affect poultry, livestock, a plant pest, or plant biological agent a permit from the USDA Animal and Plant Health Inspection Service (APHIS) is needed. Please note that any material containing fetal calf serum or bovine serum may require an APHIS permit.
Note: an import permit may be required for interstate transfer (state to state, or to Hawaii) of USDA/APHIS regulated materials.
Plant Import Permits
Plant Protection and Quarantine (PPQ) regulates the importation of plants and plant products under the authority of the Plan Protection Act.
These materials do not require a USDA import permit, but do require a guidance letter that will be reviewed by APHIS inspectors at the port of entry. The sending lab should provide a letter containing specific information (see below) about the material and should be easily accessible.
All food (except most meat and poultry), drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation require a permit or registration before importation into the United States.
U.S. Fish and Wildlife Service - Permit Program
Importation of Select Agents (42 CFR part 73, 7 CFR Part 331 and 9 CFR Part 121) requires special approvals and transfer documentation. Contact EHS Biosafety before planning to import or transfer any Select Agent or SA Toxin. A CDC import permit is no longer required if it is a select agent that has been authorized for transfer by the Division of Select Agents and Toxins (DSAT) with a Form 2.
Universities are subject to the same export controls as other U.S. companies, organizations and individuals. The Department of Commerce, State Department, or other federal agency licenses may be required when exporting specific biological agents, genetic elements of these agents, toxins, or certain chemicals and equipment. Contact The Office of Export Controls (email@example.com) prior to exporting materials from your lab for an evaluation and guidance on obtaining any necessary licenses.
A Material Transfer Agreement (MTA) is a contract that governs the transfer of research materials between two organizations, or within an institution, and defines the rights of the provider and the recipient with respect to the materials and any derivatives.
Although not directly related to biosafety, EHS is providing contact information for obtaining an MTA since many biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials. Materials derived from human subjects and slated for transfer, may be subject to additional approvals.
View more information on UVA MTAs here.