Additional Info - Biosafety
Shipping & Permits
If you intend to ship and/or receive biological materials as part of your reach endeavor, there are several items for you to be aware of so that you materials are shipped in a safe, secure and timely manner. In order for us to facilitate you in ascertaining what items might be necessary for your shipping needs, the following preliminary information you provide will better assist us in facilitating your research efforts involving your shipping needs.
- What materials are you shipping? (e.g. cell lines, microorganisms, vectors, clinical specimen, etc)
- What form is the specimen/material? Is it frozen? Is it neutralized, inactivated, fixed? Cell culture? Serum? Environmental specimen? etc.
- Is the biological material from a human or animal source; are the materials pathogenic for humans and or animals or both? This will help to determine whether any permits maybe required for these materials.
- From where and to where are you shipping it? Intrastate? Interstate? International? (e.g import or export). This is additional information necessary to determine what if any permits may be required.
- Are you the shipper? Is someone in your laboratory IATA/DOT certified to package and ship?
- What time frame do you need to have the item shipped?
- Does the material contain recombinant DNA?
- Who is shipping or receiving the item? A researcher? Institute?
The shipment of hazardous materials is regulated by the U.S. Department of Transportation (DOT) and International Civil Aviation Organization (ICAO). Shipments are shipped in accordance with the International Air Transport Association (IATA) guidelines.
The DOT defines hazardous material as substances that are capable of posing an unreasonable risk to health, safety, and property when transported in commerce. This includes diagnostic specimens, infectious agents, biological products, and dry ice. Such shipments must arrive at their destination in good condition and present no hazard during shipment.
Individuals who ship hazardous materials are required to comply with these regulatory requirements:
- Hazardous material shipments must be properly packaged, marked, documented, and labeled.
- Individuals who offer hazardous materials for shipment must receive training biannually.
After completion of the Shipping training the shipper will be able to properly:
- Classify and identification
- Mark and Label hazardous materials for shipment
Several agencies regulate the shipment of biological materials including:
- The International Air and Transport Association (IATA)
- The US Department of Transportation (DOT)
- US Public Health Service (PHS)
- International Civil Aviation Organization (ICAO)
Classification: The most important responsibility of the shipper is classification. This involves the knowledge of the materials being shipped in addition to the regulations. This establishes whether or not an item is a dangerous good. A flowchart to assist in the classification of dangerous goods can be found here: IATA Classification Flow Chart (PDF) . Reference Information: SafTPak Compliance Training Reference Manual
- Category A (An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals)
- Category B (An infectious substance which does not meet the criteria for inclusion in Category A)
- Exempt Human or animal specimen (A human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) being transported for routine testing not related to the diagnosis of an infectious disease.
- Genetically modified organism or microorganism (Genetically modified microorganisms not meeting the definition of an infectious substance)
- Unregulated biological materials (e.g. non-infectious biological materials from plants, animals or humans; 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-threat)
Please note, irrespective of classification, "biological materials" cannot be carried on the airplane by passengers. They must be shipped using an authorized courier (such as FedEx). As per IATA regulations: Dangerous Goods (such as dry ice and other biological material) are not permitted for transport in carry-on or checked baggage and must not be carried on a person.
Identification: The shipper is responsible for identifying the material by its proper shipping name. e.g. UN 2814 Infectious substances, affecting humans, UN 2900 Infectious substances, affecting animals only, UN 3373 Biological substance, Category B, UN3245 Genetically modified organism, UN3245 Genetically modified micro-organism.
Packaging: The materials being shipped must be properly packaged according to the classification. Each proper shipping name is associated with a specific packaging instruction. Although the University of South Florida does not endorse any specific supplier, packaging materials can be found from these vendors: SafTPak, ExaktPak, and Inmark Packaging.
Marking and Labeling: Proper labeling of the packages for shipment is a very important step. The labels affixed to the outside of the box communicate the hazards that are contained within the package. The shipper is responsible for making sure all regulations are met and that they are correct.
There are several guidance documents available for shipping dangerous goods:
All USF personnel who ship and/or receive potentially biohazardous materials must complete this course biannually: Comprehensive Guide to Shipping Infectious Substances and Diagnostic Specimens.
The Materials used in our course meet the requirements of 49CFR 172.700 and IATA 1.5 for handling, packaging, and offering for transport Infectious Substances (Div. 6.2) and Dry Ice (Div. 9). Topics covered: General Awareness, Identification, & Classification of Infectious Substances, Biological Materials, & Dry Ice; Function Specific Requirements; and Requirements for Marking, Labeling, & Packaging, Documentation & Permits, Safe Handling, Security, Reporting, and Emergency Response.
The training is completed on an individual basis (no group training), and is an interactive, computer-based training program provides a practical, hands-on approach. This training is a self-paced training module that can be reviewed on your own (average allotted time of 2-3 hours) and testing is conducted at our office location 3702 Spectrum Blvd., University Technology Center, Suite 155. There is an open-book exam at the end of the training and you must score 85% or better to earn your certificate. The training is good for two years
There is no cost for employees of USF and its affiliates (Moffitt, VA, ACH, etc.) to take the course offered by Research Integrity and Compliance for shipping biohazardous materials.
At the completion of the program, you will be able to package, label, prepare documentation,
and ship hazardous materials in compliance with the U.S. DOT and IATA shipping regulations.
You can register for this course on the registration page. For more information, please
contact the Biosafety Office by email.
If biological materials will be shipped from USF or received there is a possibility that a permit may be required for the biological material. The agencies that may require permits are:
- CDC may be required for imports into the US
- USDA/ APHIS may be required for all imports/ exports, and inter-state transports
- US Department of Commerce for exports
If a CDC permit is required, the investigator must secure a CDC import permit prior to transport. Infectious microorganisms and biological materials are regulated by the CDC import permit program.
CDC Import Permit Is required if you import:
- any etiologic agent
- any arthropod or other animal host or vector of human disease
- any exotic living arthropod or other animal capable of being a host or
- vector of human disease
- unsterilized biological human/animal specimens (such as blood, body discharges, fluids, excretions or similar material) containing an infectious or etiologic agent
It takes At least 3 weeks to process import permit applications and there is no cost for the CDC permit application. The CDC permit is issued to an investigator/person and not the institution. Here is the information to apply for the CDC permit.
CDC: Etiologic Agent Import Permit Program:
- Website for Etiologic Agent Import Permit Program (EAIPP)
- Telephone: 404-498-2260; Fax: 404-498-2275
- Import Permit Applications
Once the CDC permit is received, please send the Biosafety Program Support staff a copy.
A USDA import permit is required when using avian or livestock products/cells/cultures etc. Materials which require a USDA permit include but not limited to, 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, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi that is known to cause infectious, contagious, or communicable diseases of livestock or poultry.
It may take up to 5 weeks to receive permits. In addition the USDA may choose to inspect lab prior to permit. Review USDA Permits Costs.
USDA permits must be obtained through at the following website Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), National Center for Import and Export (NCIE).
Once the CDC permit is received, please send the Biosafety Program Support staff a copy.
Any time you are exporting an item to another country; an export permit may be required. Export permits are issued by the U.S. Bureau of Industry and Security a part of the US Department of Commerce. For information and or assistance in determining if an export permit is required, please contact USF Office of Export Controls. Information related to exports can be found on the web site for the USF Office of Export Controls.
Material Transfer Agreements (MTAs):
A transfer of biological materials to non-USF organizations or institutions may require an MTA. We assess and provide guidance regarding the biosafety risks of the shipment of the agents. For the specifics relating to MTAs please contact Edita Dautovic in Patents & Licensing.
For Additional Information:
For additional information, please contact IBC program support staff.