If you’re reading this, you’re planning to ship an “exempt” biological substance, one that doesn’t fall into Category A or B. If you need a refresher on which category your substance falls under, see our companion article.
Here, we’ll review requirements for packaging, labeling, marking and documentation for shipping exempt biological substances.
“Exempt” materials are a broad and common categorization, yet this category is often the most unfamiliar to many. Exempt materials are defined as “those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissues and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment, and prevention.” IATA/DOT/USPS doesn’t want to overburden medical professionals shipping relatively benign samples, so these fall under more lax regulations.
Some examples of Exempt Patient/Human/Animal Specimens:
If you’re unable to make a professional judgment on the presence of pathogens, don’t use the “exempt” classification, instead use UN3373 Category B unless there is a pathogen on the Category A list.
Follow and save any instructions provided with boxes and validated thermal shippers you purchase, so you always have something to reference. Triple packaging is the best practice for all classifications of biological shipments. Here are the four elements you need for your packaging:
1. Leak-proof Primary Receptacle
This contains your sample — make sure it has a leak-proof seal, tape or parafilm screw cap.
2. Leak-proof Secondary Packaging
This is your inner container. Ensure the primary or secondary receptacle can withstand:
Pressure: not less than 95kPa.
Temperature:- 40°C to 55°C
3. Cushioning and Absorbent Material
If you have a liquid substance, sufficient absorbent material must be included to absorb the entire contents of all primary receptacles. Acceptable absorbent materials include cellulose wadding, cotton balls, super-absorbent packets, and paper towels. This generally goes in between the primary and secondary packaging.
Cushioning material is also necessary — and needs to be distinct from absorbent material. Generally this is between the secondary and outer packaging.
4. Rigid Outer Packaging
The outer box must be able to meet a drop test of 1.2m.
The smallest external dimension must be at least 100x100mm — look to the manufacturer’s instructions for this info.
Before sealing the outer packaging, you must make an itemized list of the contents of the package and enclose the list between the secondary packaging and outer packaging.
Note: This does not include Styrofoam layer, if using wet/dry ice. Express carriers such as FedEx and UPS do not accept packages with a Styrofoam container as the outside packaging so add rigid outer packaging such as a cardboard box or validated thermal shipper.
Disposing of or Repurposing Rigid Outer Packaging
Before empty packaging is returned to the consignor, or sent elsewhere, it must be disinfected or sterilized to nullify any hazard and any label or mark indicating that it contained an infectious substance must be removed.
When Shipping Blood Samples
A biohazard symbol is required on any sample that contains human blood and other potentially infectious materials (OPIM). This label must be affixed to the primary receptacle or secondary packaging.
An overpack is an extra outside packaging used when shipping multiple boxes to the same address or used to refrigerate materials being shipped in a smaller box. All markings and labels must be on the outside of the box along with the word “OVERPACK”. Since your inside package is the “triple package” you need all markings and labels on that package as well.
Standardized labeling must be affixed to the outside. When the package dimensions are adequate, labels must be located on the same surface of the package near the Proper Shipping Name mark.
Except for the orientation arrows, mount all labels and markings on the front side of the box — all on one surface area. “Cargo Aircraft Only” labels are required when applicable.
The outer shipping container must be marked on the address side with the words “Exempt human specimen” or “Exempt animal specimen,” as appropriate.
If you are shipping a liquid, orientation arrows are required. Label must be affixed on 2 opposite sides and perpendicular to the front of the package. Orientation arrows should be red or black on a contrasting background.
Overpack labels have a height Requirement of 12mm (~0.5 inch). Either of these styles is acceptable:
All Shipments must include:
Contact the Receivers
Make sure you contact the receivers prior to shipping. Keep in mind that some labs only receive Monday to Thursday. If you ship on Friday, it might sit over the weekend, or arrive on Saturday and nobody's there. If they are open on Saturday, make sure you label for Saturday delivery so the carrier knows they can deliver on Saturday and not hold the package over the weekend.
Know the stability of your sample and how long it can last, roughly 6% of Express Carrier shipments are not delivered on the requested date for a variety of reasons. Think carefully of the day you’re shipping and the stability of the shipment to avoid a potential re-draw from the patient.
Other FedEx and UPS Requirements
Penalties and Fines
Shipping biological substances is a tightly regulated activity. If you need more reasons to get it right, here is a list of violations and the minimum assessments for each:
Category B (UN 3373) Packaging & Shipping
How To Classify Biological Substances For Shipment
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