Guide for Shipping Biological Specimens with UPS

Shipping biological specimens, such as diagnostic and research samples, requires strict adherence to safety and regulatory guidelines to protect public health and ensure compliance. United Parcel Service (UPS) facilitates the transportation of certain biological specimens, particularly those classified as Infectious Substances, Category B (UN3373) and Exempt Human or Animal Specimens. This comprehensive guide is designed for medical laboratory personnel and provides detailed instructions on UPS’s policies, packaging specifications, labeling requirements, prohibited items, shipper responsibilities, necessary documentation, and step-by-step operational procedures for shipping biological specimens.

1. UPS Policy and Scope for Shipping Biological Specimens
   UPS permits the transportation of specific biological substances under defined conditions, focusing on diagnostic and research samples. The following categories are relevant:
   Infectious Substances, Category B (UN3373): These are biological materials, such as blood, urine, tissues, or other fluids, that do not meet the criteria for Category A but may still cause infection. They are commonly shipped for diagnostic or research purposes and are assigned the UN3373 designation with the proper shipping name “Biological Substance, Category B.”
   Exempt Human or Animal Specimens: These are patient specimens with a minimal likelihood of containing pathogens, such as samples for routine tests (e.g., cholesterol, glucose, or pregnancy tests). They must be marked as “Exempt Human Specimen” or “Exempt Animal Specimen” and meet specific packaging requirements.
   Infectious Substances, Category A: These are highly infectious materials capable of causing permanent disability or life-threatening diseases. UPS restricts their transport to within the U.S. and Puerto Rico, requiring a signed agreement and excluding “Select Agents or Toxins” as defined by 42 CFR Part 73 and 9 CFR Part 121. Due to these restrictions, this guide focuses on Category B and exempt specimens.
   Medical, Clinical, or Regulated Waste: UPS does not accept any form of medical, clinical, or regulated waste, including reclassified waste under alternative shipping names.
   For diagnostic and research purposes, Category B (UN3373) specimens are the most commonly shipped, and this guide emphasizes their requirements while briefly addressing exempt specimens.

Packaging Specifications for Biological Specimens
For Infectious Substances, Category B (UN3373), UPS mandates the use of a triple packaging system as specified in the International Air Transport Association (IATA) Packing Instruction 650. This system ensures the safe containment of specimens during transport. The components of the triple packaging system are:

Additional Packaging Requirements
For Liquid Specimens:
Absorbent Material: Place sufficient absorbent material (e.g., cellulose wadding, cotton balls, or super-absorbent packets) between the primary and secondary packaging to absorb the entire contents of the primary receptacle in case of a leak.
Cushioning Material: Use cushioning material (distinct from absorbent material) between the secondary and outer packaging to prevent movement during transit.
For Solid Specimens:
Both primary and secondary packaging must be sift-proof (preventing the escape of dry contents).
If there is any doubt about residual liquid, use packaging suitable for liquids, including absorbent materials.
Maximum Quantities (for air transport, e.g., UPS Air):
Liquids: 1L per primary receptacle, 4L per outer container (or 4x1L bottles).
Solids: 4kg per primary receptacle, 4kg per outer container.
Temperature-Controlled Specimens:
If refrigeration is required (e.g., using ice or dry ice), place the refrigerant outside the secondary packaging or in an overpack.
For ice, the outer packaging must be leak-proof.
For dry ice, the packaging must allow the release of carbon dioxide gas and be marked with “Dry Ice” or “Carbon dioxide, solid,” UN1845, and the net quantity in kilograms, accompanied by a Class 9 Miscellaneous Dangerous Goods label.

For Exempt Human or Animal Specimens, packaging must include leak-proof primary and secondary containers, adequate absorbent material for liquids, and outer packaging with sufficient strength. These specimens do not require the full triple packaging system but must be marked appropriately (see Section 3).

Labeling Requirements
Proper labeling is critical to identify biological specimens and ensure compliance with regulations. For UN3373 (Category B) shipments, the outer packaging must display:
UN3373 Diamond Label: A diamond-shaped label, 50mm x 50mm, with a line width of at least 2mm and the text “UN3373” in letters at least 6mm high. The label must be clearly visible, legible, and placed on a contrasting background.
Proper Shipping Name: The text “BIOLOGICAL SUBSTANCE, CATEGORY B” must be marked adjacent to the UN3373 label, with letters at least 6mm high. This can be handwritten, pre-printed on a label, or pre-printed on the packaging, but the label must remain diamond-shaped (not square).
Biohazard Symbol: For specimens containing blood or blood products, a biohazard symbol must be displayed on the primary receptacle or secondary packaging.
For Exempt Human or Animal Specimens, the outer packaging must be marked with “Exempt Human Specimen” or “Exempt Animal Specimen” as appropriate, instead of the UN3373 label.
If dry ice is used, the outer packaging must also include:
The text “Dry Ice” or “Carbon dioxide, solid,” UN1845, with the net quantity in kilograms.
A Class 9 Miscellaneous Dangerous Goods label.

Prohibited Biological Specimens
UPS strictly prohibits the transportation of the following biological materials:

Shipper’s Responsibilities
The shipper bears full responsibility for ensuring compliance with UPS policies and applicable regulations. Key responsibilities include:
Classification: Accurately classify the biological substance based on its risk level (e.g., Category B, Exempt, or Category A). Professional judgment is required for exempt specimens, considering medical history, symptoms, and local conditions.
Packaging: Use the triple packaging system for UN3373 specimens or appropriate packaging for exempt specimens, ensuring compliance with IATA Packing Instruction 650 or 49 CFR § 173.199 for domestic ground transport.
Labeling: Apply the correct labels (e.g., UN3373 diamond label, proper shipping name, biohazard symbol) as required.
Documentation: Prepare and include all necessary shipping documents (see Section 6).
Compliance: Adhere to:
IATA Dangerous Goods Regulations for air transport.
49 CFR (U.S. Department of Transportation) for domestic ground transport.
UPS-specific requirements, such as verifying serviceable destinations and obtaining an International Special Commodities (ISC) Contract for international shipments.
Training: While not explicitly required by UPS for UN3373, it is strongly recommended that shippers receive training on handling and shipping hazardous materials, including biological substances, to ensure compliance and safety.

Necessary Shipping Documents
The following documents are required for shipping UN3373 (Category B) specimens with UPS:

Retention: All shipping documentation, including airway bills, bills of lading, commercial invoices, and itemized lists, must be retained for at least 2 years.

For Exempt Human or Animal Specimens, documentation requirements are minimal, but an itemized list of contents is recommended to facilitate customs clearance for international shipments.

Operational Steps for Shipping Biological Specimens

To ship biological specimens with UPS, follow these step-by-step procedures:

1. Classify the Specimen:
   • Determine if the specimen is Category B (UN3373) or Exempt Human/Animal Specimen based on its risk level.
   • Ensure the specimen is not prohibited (e.g., medical waste or Category A without proper authorization).
2. Prepare the Packaging:
   • For UN3373:
     • Use a leak-proof primary receptacle to hold the specimen.
     • Place the primary receptacle in a leak-proof secondary container with sufficient absorbent material for liquids.
     • Enclose the secondary container in a rigid outer box capable of passing a 1.2m drop test, with cushioning material to prevent movement.
   • For Exempt Specimens:
     • Use leak-proof primary and secondary containers with adequate absorbent material for liquids.
     • Ensure the outer packaging is strong enough for transport and marked as “Exempt Human Specimen” or “Exempt Animal Specimen.”
3. Label the Package:
   • For UN3373:
     • Affix the UN3373 diamond label (50mm x 50mm) on the outer packaging.
     • Mark “BIOLOGICAL SUBSTANCE, CATEGORY B” adjacent to the label in letters at least 6mm high.
     • Include a biohazard symbol on the primary or secondary packaging for blood-containing specimens.
   • For Exempt Specimens: ទ
     • Mark the outer packaging with “Exempt Human Specimen” or “Exempt Animal Specimen.”
   • For temperature-controlled shipments, add appropriate markings (e.g., “Dry Ice,” UN1845, with net quantity for dry ice).
4. Prepare Documentation:
   • Complete the Airway Bill (air) or Bill of Lading (ground) with “UN 3373 Category B Biological Substance x 1 pkg.”
   • For international shipments, prepare five copies of a Commercial Invoice.
   • Enclose an itemized list of contents between the secondary and outer packaging.
   • Retain all documents for at least 2 years.
5. Verify Destination:
   • Check the UPS Approved Country List to confirm the destination is serviceable (Approved Country List).
   • For international shipments, obtain an International Special Commodities (ISC) Contract from UPS (Contact UPS).
6. Schedule Pickup:
   • Contact UPS to schedule a pickup and inform them you are shipping UN3373 Category B specimens, as only certified drivers can handle hazardous materials.
   • Do not use UPS drop boxes for these shipments.
7. Ship the Package:
   • Ensure the package is handed over to a certified UPS driver or delivered to a UPS facility that accepts hazardous materials.
   • For international shipments, verify compliance with destination country regulations.