# Presentation: 685344

## Shipment of  Infectious Substances and Clinical  Specimens

***Shipment of  Infectious Substances****** and Clinical  Specimens***

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

## Dangerous Goods Classification Flow Chart

##  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

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

***Responsibilities of the Shipper***

## 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*

## 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*

## Permit Points of Contact

* **CDC automated Fax infromation system*
*(404) 639-3883*
*Request Document #101001*
*For document and full instructions request document #101000*
*USDA/APHIS*
*(301) 734-7830 phone*
*(301) 734-8226 fax*

## Regulations Governing the Shipment of Infectious Materials

***Regulations Governing the Shipment****** of Infectious Materials***

## 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*

## 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*

## What Material is Considered an Infectious Substance?

*Contains or has high probability of containing an infectious material...known 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*

## Packaging of Infectious Substances

***Packaging of Infectious Substances***

*Primary Container*
*Positive seal*
*Absorbent material*

## Packaging of Infectious Substances

***Packaging of Infectious Substances***

*Secondary packaging*
*Watertight/leakproof*

## Packaging of Infectious Substances

***Packaging of Infectious Substances***

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

## Packaging of Infectious Substances

***Packaging of Infectious Substances***

## Packaging of Infectious Substances

***Packaging of Infectious Substances***

*Performance tests*
*49 CFR 178.609*

- PACKAGE SHALL NOT LEAK

## Packaging of Infectious Substances

***Packaging of Infectious Substances***

*Packaging label*

## Packaging of Infectious Substances (cont.)

## Special Infectious Substances

***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*

## Includes Select Agents42 CFR 72.6
Shipped as infectious substances
Shipping and receiving laboratories must be registered with CDC
CDC notified of all shipments (Form EA101)

*Shipped as infectious substances*
*Shipping and receiving laboratories must be registered with CDC*
*CDC notified of all shipments (Form EA101)*

***Special Infectious Substances***

## What Material is packaged as a Clinical Specimen?

*Human or animal material...collected for the purpose of diagnosis or research....not known to contain viable infectious agents*

## Packaging of Clinical Specimens

***Packaging of Clinical Specimens***

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

## Packaging of Clinical Specimens

***Packaging of Clinical Specimens***

*Secondary packaging*
*Watertight/leakproof*

## Packaging of Clinical Specimens

***Packaging of Clinical Specimens***

*Between the secondary and outer packaging*
*List of contents*

## Packaging of Clinical Specimens

***Packaging of Clinical Specimens***

*Outer packaging*

## Packaging of Clinical Specimens

***Packaging of Clinical Specimens***

## Packaging of Clinical Specimens

***Packaging of Clinical Specimens***

*Performance test*

- PACKAGE SHALL NOT LEAK