Guidelines for Shipping/Receiving Biological Materials

Guidelines for Shipping/Receiving Biological Materials | Regulatory Doctor

Applicable Transportation Regulations

Table of Contents

  1. Introduction

Hazardous Material Shipping Program

  1. Training Requirements
  2. Permits to Receive Biological Material

A.                USDA/APHIS transport Permits ( United States Department of Agriculture/Animal & Plant Health Inspection Service)

B.                 Centers For Disease Control (CDC)

C.                 Phytosanitary Certificate

D.                Material Transfer Agreement

  1. Classification of Hazardous Material

 .                    Category A Infectious Substances

A.                Category B Infectious Substance (Previously Called Diagnostic/Clinical Specimens)

B.                 Non-infectious Exempt Patient Specimens

C.                 Toxins

D.                Genetically Modified Organisms (GMOs)

E.                 Select Agents

  1. Packing Instructions

 .                    Category A Infectious Substance: Packing Instruction 620

A.                Category B Infectious Substance (Previously Called Diagnostic/Clinical Specimens): Packing Instruction 650

B.                 Non-infectious Exempt Patient Specimens

C.                 Toxins

D.                Genetically Modified Organisms: Packing Instructions 959

E.                 Dry ice: Packing Instruction 954

F.                  Liquid Nitrogen

G.                Transporting Infectious Substances Safely

H.                New Excepted Quantities Labels 2009

  1. International Shipment Regulations and Permits

 .                    United States Department of Agriculture/Animal & Plant Health Inspection Service (USDA/APHIS)

A.                Department of Commerce

B.                 U.S. Fish and Wildlife

C.                 Food and Drug Administration (FDA)

D.                Canadian Import Regulations

  1. Receipt of Leaking or Damaged Package

 .                    Leaking or Damaged Package

A.                Suspicious Package

  1. Transporting Infectious Substances by Ground

 .                    Packaging and Training Requirements

A.                Means of Transport

Appendices

Appendix 1 – Materials Exempt From USDA/APHIS Import/Transport Permits
Appendix 2 – Center For Veterinary Biologics Notice No. 02-15
Appendix 3 – Application For Permit To Import/Transport Controlled Material Or Organisms Or Vectors
Appendix 4 – Sample Importation Notification Letter
Appendix 5 – Sample Interstate Movement Letter
Appendix 6 – Application for Permit to Import of Transport Agents or Vectors of Human Disease
Appendix 7 – Examples of Infectious Substances Included in Category A
Appendix 8 – Record of Transfer of Select Agent
Appendix 9 – Summary of IATA (International Air Transport Association) Shipping Information
Appendix 10 – USDA/APHIS Courtesy Form Letter
Appendix 11 – USDA/APHIS Application for Courtesy Permit
Appendix 12 – How to Recognize and Handle a Suspicious Package or Envelope
Appendix 13 – Infectious Substance Classification Flow Chart
Appendix 14 – Shipper’s Declaration of Dangerous Goods  (Note: must use proprietory software to fill these out call (612) 626-1604)
Appendix 15 – Transporting Infectious Substances Safely
Appendix 16 – Sample of a Customs Courtesy Letter
Appendix 17 – New Excepted Quantities Labels 2009

via Shipping.

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