Special Case Compliance: How to Ship Exempt Animal and Human Specimen and GMO Substances
The United Nations has split its guidelines for shipping infectious substances (6.2 Toxic and Infectious Substances) into two primary sub-categories: Category A, Category B.
However, within class 6.2 there are specific category B exception substances and additional classifications including biological products, GMO/GMMO, medical wastes and infected live animals. These ‘special case’ substances which are ‘reasonably believed to have a low probability of containing infectious substances’ or ‘not meeting the definition of an infectious substance’ may be assigned a different UN Number and/or be classified under Class 9 – Miscellaneous Dangerous Goods.
Category B is known as UN3373 and is described as: ‘an infectious substance which does not meet the criteria for inclusion in Category A.’ Class 6.2 outlines criteria for Category B Exception Substances. These include, but are not limited to, Exempt Human Specimens and Exempt Animal Specimens. These are described as: ‘Patient samples for which there is minimal likelihood that pathogens are present’
GMO and GMMOs are microorganisms and organisms in which genetic material has been ‘purposely altered through genetic engineering in a way that does not occur naturally’. They are assigned to Class 9 – UN 3245 if they do not meet the definition of toxic substances or of infectious substances, but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction.
When we talk about Class 6.2 ‘special case’ compliance, we explicitly refer to the label and packaging compliance required to ship Category B exception substances and other Biological Products including non-infectious GMO.
Are you unsure whether your sample is Category A, Category B, Class B Exception or other ‘special case’ substance? Try using our simple UN Class 6.2 Classification chart below.
Class 6.2 Classification Chart
ADR and IATA
Adherence to Class 6.2 Special Case compliance is overseen by the bodies responsible for the transportation of dangerous goods via road and air: The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and The International Air Transport Association (IATA), which supports aviation with global standards for airline safety, security, efficiency, and sustainability. These bodies have separate, relevant guidelines to transport Special Case samples either by land or air, related specifically to the quality of the packaging used and the labels applied to that packaging. These packing instructions are known as:
- P650 Exception Instruction outlined in DGR 188.8.131.52.3 for UN3373 exception Exempt Animal or Human Specimen
- P959 (or ADR P904) for Genetically Modified Micro-Organisms (GMMOs) or Genetically Modified Organisms (GMOs) (Class 9, UN 3245)
How to Ship Exempt Human or Animal Specimen
If a substance is classified as Exempt Animal or Exempt Human Specimen, it must be packed for transport according to UN3373 (PI650) Exception Packing Instruction guidelines outlined in DGR 184.108.40.206.3. This is a list of requirements covering the quality and construction of the packaging used for transport. P650 is split into guidelines for ADR and IATA, with each having slightly different demands.
Packaging must consist of three components:
- A leak-proof primary receptacle(s) (multiple fragile primary receptacles must be individually wrapped or separated)
- Leak-proof secondary packaging containing sufficient absorbent material to absorb the entire liquid contents of the primary receptacle(s) if required.
- An outer packaging of adequate strength for its capacity, mass and intended use with one surface having minimum dimensions of 100 x 100 mm.
The packaging must be clearly labelled with the words “Exempt Human Specimen” or “Exempt Animal Specimen” as appropriate.
Most of the guidelines for road and air transport are the same; however, there are some differences. Please see “How to achieve UN3373 Compliance” for further details.
How to Ship Genetically Modified Micro-Organisms and Organisms
If a substance is classified as non-toxic/non-infectious Genetically Modified Micro-Organism (GMMO) or Organism (GMO), it must be packed for transport according to guidelines known as Packing Instruction ADR PI 904 (Road) or IATA PI 959 (Air). This is a list of requirements covering the quality and construction of the packaging used for transport.
Packaging must consist of three components:
- Primary receptacle(s) and a secondary packaging, the primary receptacle(s) must be leakproof for liquids or sift proof for solids.
- For liquids, absorbent material placed between the primary receptacle(s) and the secondary packaging in a quantity sufficient to absorb the entire contents of the primary receptacle(s)
- An outer packaging of adequate strength for its capacity, mass and intended use with a smallest external dimension of at least 100 mm.
For transport, the mark illustrated below must be displayed on the external surface of the outer packaging on a background of a contrasting colour and must be clearly visible and legible. The mark must be in the form of a square set at an angle of 45° (diamond-shaped) with each side having a length of at least 50 mm; the width of the line must be at least 2 mm and the letters and numbers must be at least 6 mm high.
If you’re not 100% confident with the terms, phrases, and words associated with the sector, we have created this helpful guide to simplify some of the sector jargon you may encounter on this page or any of the pages we’ve linked in this resource.
Special Case Label Compliance
We design complete sample transport solutions with the correct UN labelling built into the service; however, we have created a helpful guide if you’d like to inquire specifically about label compliance.
Label Compliance Guide
ORCA STP Labelling Guide
Intelsius Special Case Packaging
Intelsius have a full range of UN3373 compliant solutions which can be adapted to ship Exempt Specimen, GMOs and other ‘special case’ shipments. At Intelsius, we’ve been designing and manufacturing compliant packaging for over 20 years. We’re experts in ensuring your samples are shipped adhering to strict label and packaging compliance. To view our full range of UN3373 solutions, visit our dedicated webpage.
To continue the conversation or inquire further about our range of packaging solutions, get in touch with your local Intelsius branch member.
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