Criteria
The heading of Class 6.2 covers infectious substances. For the purposes of ADR, infectious substancesare substances which are known or are reasonably expected to contain pathogens. Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals.
NOTE 1:Genetically modified microorganisms and organisms, biological products, diagnostic specimens and intentionally infected live animals shall be assigned to this Class if they meet the conditions for this Class.
The carriage of unintentionally or naturally infected live animals is subject only to the relevant rules and regulations of the respectivecountries of origin, transit and destination.
NOTE 2:Toxins from plant, animal or bacterial sources which do not contain any infectious substances or organisms or which are not contained in them are substances of Class 6.1, UNNos. 3172 or 3462.
Substances of Class6.2 are subdivided as follows:
I1 Infectious substances affecting humans;
I2 Infectious substances affecting animals only;
I3 Clinical waste;
I4 Biological substances.
Definitions
For the purposes of ADR,
"Biological products" are 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;
"Cultures"are the result of aprocess by which pathogens are intentionally propagated. This definition does not include human or animal patient specimens as defined in this paragraph;
"Medical or clinical wastes" are wastes derived from the medical treatment of animals or humans or from bio-research;
"Patient specimens"are thosecollected 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 carried for purposes such as research,diagnosis, investigational activities, disease treatment and prevention.
Classification
Infectious substances shall be classified in Class 6.2 and assigned to UNNos. 2814, 2900, 3291 or 3373, as appropriate.Infectious substances are divided into the following categories:
Category A: An infectious substance which is carried 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. Indicative examples of substances that meet these criteria are given in the table in this paragraph.
NOTE: An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.
(a) Infectious substances meeting these criteria which cause disease in humans or both in humansand animals shall be assigned to UN No. 2814. Infectious substances which cause disease onlyin animals shall be assigned to UN No.2900;
(b) Assignment to UN No. 2814 or UN No. 2900 shall be based on the known medical history andsymptoms of the source human or animal, endemic local conditions, or professional judgementconcerning individual circumstances of the source human or animal.
NOTE 1:The proper shipping name for UN No. 2814 is "INFECTIOUS SUBSTANCE, AFFECTING HUMANS". The proper shipping name for UN No. 2900 is "INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only".
NOTE 2:The following table is not exhaustive. Infectious substances, including new or emerging pathogens, which do not appear in the table but which meet the samecriteria shall be assigned to Category A. In addition, if there is doubt as to whether or not a substance meets the criteria it shall be included in CategoryA.
NOTE 3: In the following table, the microorganisms written in italics are bacteria, mycoplasmas, rickettsia or fungi.
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INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED (2.2.62.1.4.1) |
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UN Number and name |
Microorganism |
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UN No. 2814 Infectious substances affecting humans |
Bacillus anthracis (cultures only) Brucella abortus (cultures only) Brucella melitensis (cultures only) Brucella suis (cultures only) Burkholderia mallei - Pseudomonas mallei – Glanders (cultures only) Burkholderia pseudomallei – Pseudomonas pseudomallei (cultures only) Chlamydia psittaci - avian strains (cultures only) Clostridium botulinum (cultures only) Coccidioides immitis (cultures only) Coxiella burnetii (cultures only) Crimean-Congo haemorrhagic fever virus Dengue virus (cultures only) Eastern equine encephalitis virus (cultures only) Escherichia coli, verotoxigenic (cultures only) a Ebola virus Flexal virus Francisella tularensis (cultures only) Guanarito virus Hantaan virus Hantavirus causing haemorrhagic fever with renal syndrome Hendra virus Hepatitis B virus (cultures only) Herpes B virus (cultures only) Human immunodeficiency virus (cultures only) Highly pathogenic avian influenza virus (cultures only) Japanese Encephalitis virus (cultures only) Junin virus Kyasanur Forest disease virus Lassa virus Machupo virus Marburg virus |
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Monkeypox virus Mycobacterium tuberculosis (cultures only) a Nipah virus Omsk haemorrhagic fever virus Poliovirus (cultures only) Rabies virus (cultures only) Rickettsia prowazekii (cultures only) Rickettsia rickettsii (cultures only) Rift Valley fever virus (cultures only) Russian spring-summer encephalitis virus (cultures only) Sabia virus Shigella dysenteriae type 1 (cultures only) a Tick-borne encephalitis virus (cultures only) Variola virus Venezuelan equine encephalitis virus (cultures only) West Nile virus (cultures only) Yellow fever virus (cultures only) Yersinia pestis (cultures only) |
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a Nevertheless, when the cultures are intended for diagnostic or clinical purposes, they may be classified as infectious substances of Category B.
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INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED (2.2.62.1.4.1) |
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UN Number and name |
Microorganism |
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UN No. 2900 |
African swine fever virus (cultures only) |
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Infectious |
Avian paramyxovirus Type 1 - Velogenic Newcastle disease virus (cultures only) |
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substances affecting animals only |
Classical swine fever virus (cultures only) Foot and mouth disease virus (cultures only) |
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Lumpy skin disease virus (cultures only) |
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Mycoplasma mycoides - Contagious bovine pleuropneumonia (cultures only) |
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Peste des petits ruminants virus (cultures only) |
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Rinderpest virus (cultures only) |
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Sheep-pox virus (cultures only) |
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Goatpox virus (cultures only) |
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Swine vesicular disease virus (cultures only) |
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Vesicular stomatitis virus (cultures only) |
Category B: An infectious substance which does not meet the criteria for inclusion in CategoryA. Infectious substances in Category B shall be assigned to UN No. 3373.
NOTE:The proper shipping name of UN No. 3373 is "BIOLOGICAL SUBSTANCE, CATEGORY B".
Exemptions
Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to the provisions of ADR unless they meet the criteria for inclusion in another class.
Substances containing microorganisms which are non-pathogenic to humans or animals are not subject to ADR unless they meet the criteria for inclusion in another class.
Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to ADR unless they meet the criteria for inclusion in another class.
NOTE:Medical equipment which has been drained of free liquid is deemed to meet the requirements of this paragraph and is not subject to the provisions of ADR.
Substances where the concentration of pathogens is at a level naturally encountered (including foodstuff and watersamples) and which are not considered to pose a significant risk of infection are not subject to ADR unless they meet the criteria for inclusion in another class.
Dried blood spots, collected by applying a drop of blood onto absorbent material, are not subject to ADR.
Faecal occult blood screening samples are not subject to ADR.
Blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation as well as samples drawn in connection with such purposes are not subject to ADR.