This article will provide you with an overview of the different definitions and categories of biological substances, and how to determine the category, name and number for each. For next steps in packaging, marking/labeling and documentation requirements, see our companion article.
Shipping biological substances has lots of regulations and terminology. It's important to follow these rules, as the shipper is responsible for the package and can face delays, fines, or liability if they are not followed. Once you review some basics, the process is straightforward.
First, let’s take a look at some common terms and broad definitions you are bound to encounter. The first are dangerous goods, a very broad category which includes dry ice, batteries, metals, paints and some biological substances. According to the International Air Transport Association, dangerous goods are “articles or substances which are capable of posing a risk to health, safety, property or to the environment and which are shown in the list of dangerous goods in these regulations or which are classified according to these regulations.”
According to the IATA, infectious substances are “Substances which are known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals.”
Before shipping, you must identify which of the following categories your substance falls under:
Category B (UN 3373) Packaging & Shipping
Shipping Exempt Human & Animal Specimen
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Some shipped substances are classified as either Category A infectious substances or Category B biological substances. The difference is the risk posed to humans or animals if the substance leaks. Certain higher risk substances are defined as Category A (UN2814 for humans and UN 2900 for animals). Category A is defined as: “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.” This includes cultures, or intentionally propagated pathogens include lab stock cultures or presumptive positive diagnostic cultures. For the specific list of Category A substances see the IATA document here (source: iata.org).
Category B substances are considered a dangerous good, yet deemed somewhat less dangerous than Category A. Category B is broadly defined as an “infectious substance which does not meet the criteria for inclusion in Category A.”
GMMOs and GMOs are microorganisms or organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally.
These might meet previous definitions of Category A or Category B. If so, then classify them under those other categories — always according to the highest applicable risk.
“Exempt” materials are a broad and common categorization, yet this category is often the most unfamiliar to many. Exempt materials are defined as “those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissues and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment, and prevention.” IATA and the DOT don't want to overburden medical professionals shipping relatively benign samples, so these fall under more lax regulations.
Some examples of Exempt Patient/Human/Animal Specimen:
If you’re unable to make a professional judgment on the presence of pathogens, don’t use the exempt classification and use the Category B classification unless the substance is listed on the Category A list. Just remember that triple packaging is still required. Learn more about exempt specimen shipments.
You’ve determined which classification best describes your material, now you’ve got to give it an official name and number. All dangerous goods are assigned both:
UN 3373 Biological Substance Category B
GMOs and GMMOs:
Exempt Human or Animal Specimen:
Let’s say you want to ship 5X5 mL of mouse blood for a routine blood chemistry panel:
Let’s say you want to ship 1mL of an E.Coli strain (K12) which has been genetically modified to produce a common human enzyme that is not hazardous:
You want to ship 1mL of human serum from a patient suffering from a genetic disease to see if an enzyme is present.
You want to ship 1mL of human serum from a patient suffering from a genetic disease to see if an enzyme is present. However, the patient has a known COVID-19 infection.
You want to ship 1mL of a S. pneumoniae strain which has been genetically modified:
You want to ship 1mL of a research stock culture with Rabies:
Remember: Always classify materials according to the greatest potential risk. Once you identify and classify your materials, see our article on packaging, shipping and documenting biological substances.
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