Shipment of Infectious Substances and Clinical Specimens

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Shipment of Infectious Substances and Clinical
Specimens

• Enhancing the Security of Dangerous Pathogens
• October 15-18, 2000
• Barbara Johnson, Ph.D., RBP
  
  SAIC-TRSC

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Dangerous Goods Classification Flow Chart
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Responsibilities of the Shipper

• Classify the material appropriately
• Identify the contents (genus,species)
• Package the material
• Mark and label the package correctly
• Document the shipment
• Comply with Permit requirements

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Collaborator Responsibility

• Obtain Import Permit/Letter of Authorization from
  CDC
• Etiologic Agents
• Biological Materials known or suspected of
  infection with disease agents transmissible to man

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Collaborator Responsibility (cont)

• Import Permit from USDA/APHIS
• Infectious agents of Livestock
• Biological material containing livestock derived
  material
• Export Permit from Dept Commerce
• Infectious material

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Permit Points of Contact

• CDC automated Fax infromation system
• [phone]
• Request Document 101001
• For document and full instructions request
  document 101000
• USDA/APHIS
• [phone] phone
• [phone] fax

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Regulations Governing the Shipment of Infectious
Materials
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Regulations on the Shipping of Infectious
Substances

• PHS 42 CFR Part 72.
• DOT 49 CFR Part 171-178
• USPS Domestic Mail Manual
• IATA International Air Transport Association
• ICAO International Civil Aviation Organization

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Choosing the Correct Packing Instruction

• Material
• Infectious Substance
• Non-Infectious Diagnostic Specimen
• Use of Dry Ice

• Packing Instruction/Location in IATA DGR
• PI 602 page 390
• PI 650 page 423
• PI 904 page 470

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What Material is Considered an Infectious
Substance?

• Contains or has high probability of containing an
  infectious materialknown or reasonably believed
  to cause disease in humans or animals
• virus, prion, genetic elements
• bacterium, rickettsia, parasite, fungus
• Contains a microbial toxin known to be pathogenic

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Packaging of Infectious Substances

• Primary Container
• Positive seal
• Absorbent material

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Packaging of Infectious Substances

• Secondary packaging
• Watertight/leakproof

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Packaging of Infectious Substances

• Between Secondary and Outer Box
• List of Contents
• Shippers label
• Name
• Address
• Phone number

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Packaging of Infectious Substances
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Packaging of Infectious Substances

• Performance tests
• 49 CFR 178.609

PACKAGE SHALL NOT LEAK
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Packaging of Infectious Substances

• Packaging label

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Packaging of Infectious Substances (cont.)
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Special Infectious Substances

• Can cause serious illness or death
• List of agents provided
• Package, label as infectious substances
• Track during shipment
• Confirm receipt-notify CDC if not received

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Special Infectious Substances

• Includes Select Agents42 CFR 72.6
• Shipped as infectious substances
• Shipping and receiving laboratories must be
  registered with CDC
• CDC notified of all shipments (Form EA101)

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What Material is packaged as a Clinical Specimen?

• Human or animal materialcollected for the
  purpose of diagnosis or research.not known to
  contain viable infectious agents

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Packaging of Clinical Specimens

• Primary receptacle
• Positive seal
• Biohazard label
• Absorbent material

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Packaging of Clinical Specimens

• Secondary packaging
• Watertight/leakproof

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Packaging of Clinical Specimens

• Between the secondary and outer packaging
• List of contents

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Packaging of Clinical Specimens

• Outer packaging

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Packaging of Clinical Specimens
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Packaging of Clinical Specimens

• Performance test

PACKAGE SHALL NOT LEAK