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Bioterrorism Information: Shipping Guidelines

Overview

Shipping regulations have been put in place by international/national regulators to provide the shipper with procedures to ensure that hazardous materials can be safely transported by air or ground. A hazardous material is any substance that poses a significant risk to health, safety, property or the environment when transported by surface or air. It is important to note that anyone involved with any step of the shipping process of these hazardous materials MUST be trained.

Although biological specimens, transported by dedicated motor vehicles (private or contract carriers) are exempted from most requirements of the Hazardous Materials Regulations (HMR), these specimens are required to meet new IATA, DOT, and USPS regulations if transported by air. Thus, for the safety of all personnel involved in packing, shipping and receiving these specimens, the following shipping and packing guidelines are recommended:

Shipping and Packing Guidelines

Step 1: Classify the type of specimen you will be transporting:

  • Infectious Substance, Category A
  • Biological Substance, Category B
  • Patient Specimens (can be classified as Category A, Category B, or Exempt)

Step 2: Assign the appropriate UN identification number with its proper shipping name:

  • Infectious Substance, Category A: UN 2814, Infectious Substance Affecting Humans
  • Biological Substance, Category B: UN 3373, Biological Substance Category B
  • Dry Ice (if used): UN 1845 Dry Ice or Carbon Dioxide, solid

Step 3: Package, mark and label according to the appropriate packing instructions:

Step 4: Fill out the required shipping documents.

Infectious Substance, Category A

An infectious substance in a form capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans when exposure to it occurs.

The UN identification number and proper shipping name for Infectious Substances, Category A is UN 2814, Infectious Substance Affecting Humans and must be used to identify these substances on outer packaging and shipping documents.

IATA Packaging Instruction 620 must be followed for Infectious Substances, Category A. These samples must be triple-packaged.

  • Primary receptacle must be leak-proof and sealed, and labeled with the biohazard label.
  • Secondary receptacle must be leak-proof and contain sufficient absorbent material to absorb entire contents of primary receptacle. Multiple primary containers must be individually wrapped. For surface transport, no quantity limits per package. For air transport, < 50 mL or < 50 g for passenger aircraft AND < 4 L or 4 kg for cargo aircraft.
  • Outer packaging must be UN Certified packaging, rigid and measuring not less than 100 mm. MUST use one manufacturers complete packaging; do not mix Category A shipping material from different manufacturers. An itemized list of contents must be enclosed between the secondary and outer packaging. When the infectious substance is unknown but suspected of meeting the criteria for Category A, the words "Suspected Category A Infectious Substance" must be included in parentheses on the itemized list of contents inside the outer packaging, as well as the Shippers Declaration.
  • Outer packaging must be labeled with the Infectious Substance diamond hazard label and the UN ID # with its proper shipping name adjacent, UN 2814 "Infectious Substance, Affecting Humans", To/From addresses with phone numbers, and responsible person name with a 24/7 phone number.
  • Must complete a DHHS 5010 BTEP Submission form, a Shipper's Declaration for Dangerous Goods form (sign in or register to access SafTPak’s Shipping Document Assistant, a FedEx approved, FX-18 compliant application for creating a shipper’s declaration) for all Category A substances and if shipping by air, a carrier-specific air waybill.

Biological Substance, Category B

An infectious substance NOT in a form capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans when exposure to it occurs.

The UN identification number and proper shipping name for Biological Substance, Category B is UN 3373, "Biological Substance, Category B" and must be used to identify these substances on outer packaging and shipping documents.

IATA Packaging Instruction 650 must be followed for Biological Substance, Category B. These samples must be triple-packaged.

  • Primary Receptacle must be leak-proof, maximum quantity 1 L, with biohazard label. The biohazard label may be placed on the primary or secondary receptacle.
  • Secondary receptacle must be leak-proof, contain cushioning material, and contain sufficient absorbent material to absorb entire contents of primary receptacle, maximum quantity per outer package 4 L, excluding ice or dry ice used to keep specimens cold. Multiple primary containers must be individually wrapped.
  • Outer packaging must rigid and measuring not less than 100 mm. An itemized list of contents must be enclosed between the secondary and outer packaging. If used, wet ice or Dry Ice must be placed between the secondary and outer packaging; wet ice must be placed into a leak proof container and dry ice must be allowed to vent during transport.
  • Outer packaging must be labeled with the diamond UN 3373 label and its proper shipping name adjacent "Biological Substance, Category B", To/From addresses with phone numbers, and responsible person name with an 8-5 phone number.
  • Must complete a DHHS 5010 BTEP Submission form, and if shipping by air, a carrier- specific air waybill, noting on the waybill the substance is UN 3373, Biological Substance, Category B.

Patient Specimens

Material collected directly from humans, 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 diagnosis, research, investigational activities, disease treatment and prevention.

Patient specimens can be considered Exempt, Category A or Category B.

After careful consideration, using professional judgment based on known medical history, symptoms and individual circumstances of the source, and endemic local conditions, if the patient specimen is NOT EXPECTED to be infectious, it can be considered Exempt; however, Exempt specimens are still required to be triple-packaged, and the outer package must be labeled "Exempt human specimen". ALL cultures must be classified as Category B, unless they are found on the Category A lists and then they must be classified as Category A.

If the patient specimen is KNOWN to contain or REASONABLY EXPECTED to contain a pathogen listed on either IATA or DOTs Category A list, this patient specimen must be packaged, marked and labeled appropriately as Category A.

Additional Information

Further information can be found at the following web sites:
www.saftpak.com, www.dot.gov, and www.iata.org.


SLPH Bioterrorism Information