General Information
The recent changes in U.S. Department of Transportation regulations and International Air and Transportation Association regulations detail how clinical and diagnostic specimens must be packaged and shipped. Changes to the U.S. Department of Transportation regulations can be found in Title 49 CFR parts 171-180 and changes to IATA regulations can be found in IATA Dangerous Goods Regulations, 48th Edition and Addendums. We have prepared this information and associated links to assist you with the preparation of your patient specimens for mailing.
Patient specimens are now listed as Hazardous Materials: "Patient Specimens", previously exempt from regulation will now be listed in the Hazardous Material Tables of Title 49 CFR and will be subject to the new rules summarized there. These rules relate to those specimens that are potentially infectious. Formalin-fixed tissues (for example) are exempted, but should still be packaged in leak-proof containers with adequate absorbent material for the entire volume of liquid in the package. This document is a summary of the regulations, but the complete regulation (Title 49 CFR parts 171-180) should be examined to ensure accurate interpretation:
A Patient Specimen is defined as "those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention." (IATA 46th Edition)
Note: Plates or cultures of bacterial or viral organisms are not included in the definition of "Patient Specimen" and may only be shipped under much more stringent requirements and regulations.
Note: Specimens from suspected cases of foreign animal diseases (FADs) and other very highly infectious and virulent diseases do not fall within the guidelines in this document. Contact your State Veterinarian or the Federal Veterinarian-in-Charge if an FAD is suspected.
In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt. That judgment should be based on the known medical history, symptoms, and individual circumstances of the source, whether human or animal, and endemic local conditions. (IATA, 46th Edition, Amendment III)
Specimens sent to this laboratory should conform to the standards listed below.
Note: These regulations apply to FedEx and other commercial shipping companies. The stringent parcel size limitation is important for any company that routinely ships by air. Ask your carrier for a copy of the document "IATA Packing Instruction 650" (PDF) for shipping diagnostic specimens or "IATA Packing Instruction 602" (PDF) for shipping infectious agents.
Note: The US Postal Service also has additional regulations that may be found at www.usps.com/cpim/ftp/pubs/pub52.pdf (PDF)
Packaging Instructions
Many of you are already preparing your specimens in a manner that complies with the new regulations. In most cases compliance is a matter of common sense.
Packaging must be leak-proof.
There must be absorbent material in sufficient quantities to absorb all enclosed liquids. (e.g. blood, saline, formalin, etc.)
Packages need to be able to withstand all of the normal bumps, vibrations, and drops. In the case of air transport, pressure and temperature changes to which packages are likely to be exposed must be considered in accordance with IATA regulations.
Triple layer packaging of the specimen(s) is mandatory in all cases. The primary (1°) container is the blood tube, formalin jar, etc. The primary is placed in a leak-proof secondary container (2°) with adequate absorbent material surrounding the primary in the secondary. The secondary is placed in a tertiary (3°) container, usually a sealable plastic bag, with adequate absorbent material surrounding the secondary in the tertiary.
In some instances specially manufactured and rated packaging materials may be necessary.
See link for shipping scenarios (PDF) listed and additional details.
All responsibility for packaging compliance rests with the individual sending the package. The commercial shipping company is not responsible for improperly packaged materials that are transported. In addition, the couriers face stiff fines and the temporary loss and use of transport vehicles if they carry leaking packages or if they do not adequately protect their employees. These costs can be charged to the individual sending the package. The commercial shipping companies have the right to question and refuse packages, and are likely to do so if a shipper is known to carelessly package specimens. Even leaking ice packs will not be tolerated. Fines can be imposed on shippers and instances of leaking packages are reportable to the Center for Disease Control.
Although no specific training is required, persons preparing to transport diagnostic specimens must know about and be able to apply the requirements of Section 173.199 (Title 49 CFR) to specific shipments. Fines and penalties can be applied to anyone "who knowingly violates a requirement of the Federal hazardous material transportation law."
Contact Information
Please read the documents listed below and share them with all members of your clinic or organization who may be involved in shipping samples. Call us if you have any questions at 541-737-3261. We have contact information for most of the commercial carriers listed below. We also sell shipping materials and are trying to obtain appropriate materials to assist you in compliance with the "Patient Specimen" rules, particularly for the shipment of samples from a large number of animals, such as would be expected from herds or referral laboratories.
Common Shipping Scenarios (PDF) for Submitting Hazardous Materials to the Oregon State University Veterinary Diagnostic Laboratory.
Classification of Biohazardous Agents by Category (PDF)
For more information on domestic and international shipping regulations, please contact:
Additional contact information:
**For worker exposure to infectious agents and bloodborne pathogens.