Biological specimen shipments in the United States and internationally are regulated under either the hazardous materials regulations (US) or dangerous goods regulations (international). These specimens require packaging that meets Department of Transportation (DOT) (domestic shipments in the United States) Transportation of Hazardous Materials Regulations (HMR) and International Air Transport Association (IATA) (international air shipments worldwide) Dangerous Goods Regulations (DGR).
DOT Hazardous Materials Division 6.2 materials can include:
- Biological products
- Cultures and stocks
- Diagnostic specimens
- Material of trade
- Regulated medical waste
- Used health care product
The packaging of these materials must be of good quality and be strong enough to withstand leakage of contents, shocks, pressure changes, humidity, vibration and manual or mechanical handling considered incident to ordinary transportation; the contents should not leak to the outside of the shipping container, even if there should be leakage of the primary receptacle(s) during transit. The packaging should be resilient enough to withstand rough handling, passage through cancellation machines, sorters, conveyors and other similar equipment.
Due to the need for strict compliance to these regulations, the following criteria must be met in order to ship biologicals from Syracuse University. All individuals involved in the packing, labeling and shipping:
- Must be faculty, post-doc, senior graduate student, and/or an authorized employee.
- Must have completed the CDC training entitled “Packaging and Shipping Division 6.2 Materials: What the Laboratorian Should Know” and successfully passed the final examination.
- Must provide the Certificate of Completion from the CDC training to the EHSS office, where it will be kept on record for 3 years. After 3 years, the certification is considered expired by EHSS and individuals must re-certify through the CDC.
- Must attend a biosafety training provided by the University or provide proof of training to EHSS.
- Are responsible for providing their own packaging materials and packing their specimen to the standard that their carrier of choice requires.
- Must ensure that a Material Transfer Agreement (MTA) between Syracuse University and the recipient of the package has been put in place. Contact the Office of Technology Transfer at 315.443.5196 for assistance with MTA’s.
- Must ensure shipments outside the United States comply with US export control regulations. Contact the The Office of Research Integrity and Protections at 315.443.2066 for more information on export control requirements.
The International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) classifies infectious substances into two categories, Biological substance, Category A and Biological substances, Category B. Be advised, it is not permissible to ship any Category of Division 6.2 Materials through FedEx Ground.
Note: Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are generally not subject to the IATA or USDOT shipping requirements and labeled as “exempt.”
Biological substances included in Category A are infectious substances which are in a form that, when exposure to it occurs, are capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. The proper shipping names for these substances are: UN2814 (infectious substances, affecting humans) and UN2900 (infectious substances, affecting animals). Category A shipments must have a shippers Declaration [PDF].
Biological substances included in Category B are very generally infectious substances which do not meet the criteria for inclusion in Category A. Infectious substances in category B must be assigned to UN 3373. Be sure to review the detailed explanation on how to ship Category B substances through FedEx Express [PDF].
- No one can ship biological specimen from Syracuse University without prior training.
- If an individual has shown to be incompetent in appropriate packaging, they may not ship biological specimen.
- Pathogens of high consequence, as defined and regulated by the USDA and CDC, may not be shipped without prior notification and approval of EHSS.
For all other questions or concerns regarding the shipping of biological materials, contact EHSS at 315.443.4132.