Diagnostic Specimens Shipping Regulations
Effective October 1, 2006, a new final rule by the U.S. Department of Transportation (DOT) went into effect, modifying the way diagnostic specimens are defined, classified, packaged, and transported.
Diagnostic Specimens are listed under Hazardous Materials and are listed in the DOT Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) and will be subject to the rules summarized here. These rules apply both to samples that are considered potentially infectious and samples that are not considered infectious. These are rules set forth by the DOT; specific couriers including the U.S. Postal Service (USPS), FedEx, and UPS may have more stringent requirements.
This document is only a summary. A guide to the changes is provided by
the DOT and should be examined to ensure accurate interpretation at:
US Dept of Transportation: Transporting Infectious Substances Safely:
or the regulations may be reviewed by searching the Code of Federal Regulations database: http://www.gpoaccess.gov/cfr/index.html for HMR 49 CRF.
I. Definition of Diagnostic Specimen:
A Diagnostic Specimen is “any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected animals.”
Note: Plates or cultures of bacterial or viral organisms are NOT included in the definition of ‘Diagnostic Specimen’ and may only be shipped under much more stringent requirements and regulations.
Note: Specimens from suspected cases of foreign animal diseases (FADs), reportable diseases, and other very highly infectious and virulent diseases do not fall within these guidelines. Contact your State Veterinarian or the Federal Veterinarian-in-charge if an FAD is suspected.
II. Packaging Required for shipment of Diagnostic Specimens:
Unless diagnostic specimens are transported by ‘ground based private or contract carriers using dedicated vehicles’, these materials must conform to the standards listed below.
Note: These are federal regulations and APPLY to FedEx and other commercial shipping companies. The stringent parcel size limitation in the section “Shipments by Air of Diagnostic Specimens” below is important for any company that routinely ships by air. Ask your carrier for details on their shipping requirements for diagnostic specimens.
A. Diagnostic specimens must be packaged in triple packaging consisting of:
1. A primary receptacle: Primary receptacles must be packaged in such a way that under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging.
2. Leak-proof secondary packaging: Secondary packaging(s) must be secured in outer packaging(s) with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or outer packaging. If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated to prevent contact between them.
3. Outer packaging:
-Outer packing must be clearly and durably marked with the words “Biological Specimen, Category B”, and ‘UN3373’ if the contents include diagnostic specimens that may contain any pathogenic organism that may cause disease in humans or animals. In addition, a name and number of a contact person must be provided on the outer packaging or on a written document such as an air waybill. If the specimen has minimal or no chance of containing a pathogen, or if potential pathogens have been inactivated (e.g. formalin-fixed), then the outer packaging may be marked with ‘Exempt animal specimen’.
- The completed package must be capable of passing the drop test at a drop height of at least 1.2 meters (3.9 feet).
4. Liquid Diagnostic Specimens must be also packaged where:
-Primary receptacle is leak-proof with a volumetric capacity of not more than 500 ml (16.9 ounces).
-Absorbent material of sufficient quantity to absorb the entire contents of the primary receptacle(s) is placed between the primary receptacle and secondary packaging.
-Multiple fragile primary receptacles placed in a single secondary package must be individually wrapped or separated as to prevent contact between them.
5. Shipments by air of Diagnostic Specimens additionally require that:
-The primary receptacle or the secondary container is capable of withstanding without leakage an internal pressure difference of 95 kPa (14 psi).
-The outer packaging does not exceed 4 L (1 gallon) capacity. Note: This volume limitation does not apply to parcels containing animal body parts, whole organs, or whole bodies even if known to contain an “infectious substance”. However, the outer package must be labeled to indicate that the “contents are subject to special provision 49 CFR A82”.
III. Training requirements:
Although no specific training is required, persons preparing or transporting diagnostic specimens must know about and apply the requirements of Sec 173.199 (49 CFR) (summarized above).
IV. Fines and penalties:
According to 49 CFR Sec. 171.1 (g) “Any person who knowingly violates a requirement of the Federal hazardous material transport law… is liable for a civil penalty of not more than… $32,500… and not less than $275 for each violation… (and) shall be fined under Title 18, United States code, or imprisoned for not more than 5 years, or both.”