PADLS
User Guide
General Information
Labeling and Packaging
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PADLS
User Guide
General Information
Labeling and Packaging
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All submissions require:
For comprehensive details on shipping Infectious Substances and Biological Materials please see http://www.ehrs.upenn.edu/resources/docs/biosafety/ShippingManual_April_2007.pdf
Training is mandatory for anyone involved with the shipping of “Dangerous Goods”.
A “shipper” is defined as someone that does any of the following jobs:
Training is an essential element in maintaining a safe regulatory regime. It is necessary for all individuals involved in the preparation or transport of dangerous goods to be properly trained to carry out these responsibilities prior to shipping. Also, if you are a shipper, the carrier relies on your ability to properly package, label and declare goods.
It is the responsibility of the shipper to receive training on the proper packaging, documentation and shipping requirements in order to comply with the International Air Transport Association (IATA) and the Federal Department of Transportation (DOT). IATA requires training every two years for shipments by air and DOT requires training every three years.
Non-compliance to these regulations can result in significant penalties and fines:
Purpose of shipping regulations Shipping regulations have been published by international and national regulators in order to provide procedures for the shipper by which articles and substances with hazardous properties can be safely transported by air or surface. “In the interest of global pubic health, of progress in scientific research, and of the development of new drugs and treatments to combat diseases, human and animal specimens need to be transported safely, timely, and efficiently from the place where they are collected to the place where they will be analyzed. Regardless of the presumed infection status of the patient, specimens of human and animal origin should be packaged and transported in such a way as to protect those engaged in transportation from the risk of infection. Risks of infections of personnel involved in transport may not be fully eliminated. However, they can undoubtedly be kept to a minimum.” (World Health Organization; Transport of Infectious Substances.)
What are “Dangerous Goods” and who regulates them?
Dangerous Goods are defined as “articles or substances which are capable of posing a significant risk to health, safety, property or the environment when transported by surface or air”. The recommendations for the transport of Dangerous Goods were first initiated to facilitate transport of those goods while ensuring the safety of people, property and the environment.
The United Nations publishes recommendations for packing and shipping Dangerous Goods. Although the International Civil Aviation Organization (ICAO) writes the technical instructions for the Safe Transport of Dangerous Goods by Air, the international community follows the IATA regulations.
The International Air Transport Association (IATA) is composed of the world’s major airlines. They write the “IATA Dangerous Goods Regulations” which are based on the ICAO Technical Instructions. The IATA Dangerous Goods Regulations designate the shipper as having the responsibility for making sure all packaging is done properly. The Department of Transportation (DOT) regulates the transport of “Hazardous Materials” in the United States. The Federal Regulations (49 CFR) also defer to the Technical Instructions from ICAO. DOT uses the term “Hazardous Materials” instead of “Dangerous Goods”. Hazardous Materials are defined as a substance or material the Secretary of Transportation has determined as capable of posing an unreasonable risk to health, safety, and property when transported by commerce.
Infectious Substances are materials which are known or are reasonably expected to contain an animal or human pathogen. Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions or recombinant microorganisms, which can cause disease in humans or animals. There are two divisions in Class 6. Class 6.1 is dedicated to toxins while 6.2 is for Infectious Substances. Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1.
Infectious Substances are divided into two categories, Category A and Category B.
These categories are based on a detailed, case-by-case, risk assessment of microorganisms known to be pathogens.
The categorization is the result of the consideration of scientific data concerning the risks of transmission and infection posed during
transport of each species of microorganism.
Category A - an infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.
Category B – an infectious substance that does not meet the criteria for inclusion in Category A. These are referred to as Biological Substances.
Biological substances, category B, are substances that do not fall into infectious substances, category A.
Category A and Category B can be……
Federal regulations govern the packaging and labeling of diagnostic specimens. If spillage that damages mail or equipment occurs during the shipment, the shipper may face prosecution, even if the material involved was not hazardous.
Samples that may contain an agent infectious for humans or animals must be shipped by International Air Transportation Association, IATA, regulations if they are to be shipped by any common carrier (even if not by air). These regulations include:
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