shipping of infectious substances and other biomedical materials annual update
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Shipping of Infectious Substances and Other Biomedical Materials
The purpose of this program is to:
ensure the safe handling of hazardous materials using good sensible practices.
recognize hazardous materials and realize there are special requirements
comply with Federal and International regulations
The basic goal for this training is to provide a framework for decisions
Is material to be shipped a dangerous good, genetically modified, biological
substance category B, or an exempt human specimen?
Upon completion you will receive certification to ship hazardous materials
This training will increase your awareness of safety and compliance issues. If you need more information or help
with shipping your package you can e-mail the EHS Shipping Specialist. The training will cover the topics
listed below. Classification, identification, and packaging are three of the most important topics covered.
Dangerous Goods/Hazardous Materials
Shippers & Operators Responsibilities
Shipping with dry ice and Overpacks
Marking & labeling packages
Accept or reject shipments by use of checklist
U.S. Dept. of Transportation (DOT) 49 CFR
Other federal requirements: CDC, OSHA, USDA, Department of Commerce, International Traffic and Arms
(ITAR) and Toxic Substance Control Act (TSCA)
DOT regulations primarily cover ground transportation. DOT is the organization that has the authority to fine you
for violations. Their authority extends well beyond US boundaries. Import permits from the CDC or USDA
may be needed if you are importing human etiological organisms or plant or animal pathogens.
Department of Commerce licenses may be needed to export organisms, genetic elements, chemicals,
technology or other commodities. TSCA Certification may be needed to import or export certain chemicals.
International Regulations (Air shipments)
International Civil Aviation Organization (ICAO)
International Air Transport Association (IATA)
Dangerous Goods Regulations (DGR)
Internationally, the UN Committee of Experts (CoE) develops recommended procedures for the transport of all
types of dangerous good except Radioactive material. The International Civil Aviation Organization (ICAO)
uses the UN recommendations as the basis for developing the regulations for the safe transport of
dangerous goods by air. IATA is the international trade organization that interprets ICAO regulations and
provides the Dangerous Goods Regulations (DGR). The IATA regulations are more stringent than DOT. This
training program follows the IATA regulations. IATA regulations are minimal requirements - your carrier can
be more stringent.
Fines and Penalties
"Violations contrary to the U.S. Code of Federal Regulations
(CFR) 49, if substantiated, may result in the assessment of a
civil penalty of up to $37,500 per violation, and deliberate
violations may result in criminal prosecution of up to
$500,000 and 5 years in prison."
There has been an increase in the number of Federal
Aviation Inspections (FAA) in response to the 1996 ValuJet
crash, the September 11, 2001 attacks, and the UPS
package bomb scare in November 2010.
If you are receiving a HazMat package it is your
responsibility to ensure the sender packages it correctly.
Oxygen-generating canister like the ones on board the
ValuJet flight 592
Infectious Substance - Class 6.2 Definition:
Infectious substances are substances known to contain, or reasonably expected to
Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia,
parasites, fungi) and other agents such as prions which can cause disease in humans
Critical to the infectious substance definition is the ability to cause disease.
Note the reliance on your professional judgment when the words reasonably
expected are used.
The IATA definition for infectious substances leaves out toxins. Toxins are placed in a
separate category. They are treated like chemicals.
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 and assignment to
UN 3172 (for liquids) or UN 3462 (for solids).
Contact EHS if you are shipping toxins as instructions for shipping toxins is not covered
in this training module. Please be aware that many toxins (if shipped out of the US)
are regulated by the Department of Commerce. There are significant fines
associated with exporting toxins without a license
Those products derived from living organisms which are manufactured and distributed in
accordance with the requirements of appropriate national authorities, which may have special
licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in
humans or animals, or for development, experimental or investigational purposes related thereto.
They include, but are not limited to, finished or unfinished products such as vaccines.
Patient Specimens are human or animal materials, collected directly from humans or animals,
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 research, diagnosis,
investigational activities, disease treatment and prevention.
Laboratory stocks are the result of a process by which pathogens are intentionally propagated in
order to generate high concentrations. This increases the risk of infection when exposure to
them occurs. An example of this would be a patient sample of TB that has been cultured.
You must be currently certified to legally ship dangerous goods.
Who needs to be certified?
or offers a dangerous good for transport.
Certification is valid for 2 years. Completing this training one time is not enough. It must be renewed every 2 years to maintain shipping certification.
Classification and Identification of
What is a dangerous good?
Any material that the Secretary of Transportation
determines poses a risk to health, safety, property,
or the environment.
A dangerous good is any article or substance
capable of posing a risk to health, safety, property,
or the environment (IATA).
A material or substance posing an unreasonable risk
to health, safety, and property when transported
Classification of Infectious
Infectious substances are divided into the following categories,
Category A and Category B. The following are the proper
shipping names for each category:
Infectious substances, affecting humans, UN 2814
Infectious substances affecting animals, UN 2900
Biological Substances Category B, UN 3373
Category A Infectious Substances - an infectious substance which is transported in a
form that when exposure occurs, is capable of causing permanent disability, life
threatening or fatal disease in otherwise healthy humans or animals. Examples of
substances that meet this criteria are located in this table: Table 3.6.D.
NOTE: An exposure occurs when an infectious substance is released outside of the
protective packaging, resulting in physical contact with humans or animals.
Infectious substances meeting the Category A criteria which cause disease in humans or
both in humans and animals must be assigned to UN 2814 (Infectious substance,
Infectious substances which cause disease only in animals must be assigned to UN 2900
(Infectious substance, affecting animals).
Assignment to UN 2814 or UN 2900 must be based on the known medical history and
symptoms of the source human or animal, endemic local conditions, or professional
judgment concerning individual circumstances of the source human or animal.
Example: A patient from a foreign country is admitted to the hospital. You think
they may have Ebola. You will ship all body fluids as infectious substances
(Category A) using all the applicable packaging and paperwork.
Category B, Biological substance is an infectious substance which does no meet the
criteria for inclusion in Category A.
Example: A patient's body fluid infected with mycobacterium tuberculosis. A culture of
this same organism would be a Category A infectious