"Exempt specimen" is a specimen category that is used by both IATA and the US Postal Service (USPS) to indicate a patient specimen that is unlikely to cause disease in humans or animals or for which there is only a minimal likelihood that pathogens are present. Requirements for packaging exempt specimens are shown below (Table 1).
The US Department of Transportation (DOT) has no "Exempt Specimen" classification, and there are no DOT guidelines for packaging non-regulated* specimens. According to the DOT, if a package is marked as "Exempt Human/Animal Specimen," the understanding is that it contains no infectious substance.
Table 1. Requirements for Packaging Exempt Specimens.Packaging Issue | IATA | USPS |
Type of packaging required | Triple packaging, as shown on the right
| Triple packaging, as shown on the right
|
Outer container | - One dimension must be a minimum of 100 mm × 100 mm (approximately 4 × 4 inches)
- Must be able to survive a drop test of 4 feet
| - One dimension must be a minimum of 100 mm × 100 mm (approximately 4 × 4 inches)
- Must be able to survive a drop test of 4 feet
|
Quantity limits: outer container | None | None |
Quantity limits: Primary receptacle | None | 500 mL |
Quantity limits: secondary packaging | None | 500 mL |
*Non-regulated specimens may become regulated because of preservatives, such as 10% formaldehyde (class 9) or 25% formaldehyde (class 8); or 25% ethanol (class 3). Note that 10% formalin, which is often used as a preservative in biopsy specimens, only contains 3-4% formaldehyde. Anything under 10% formaldehyde is not regulated.