For the purposes of these Regulations:
22.214.171.124.1 Infectious substances are substances which are known or are reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in
humans or animals.
Note: 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 assigned to UN3172.
126.96.36.199.2 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.
188.8.131.52.3 Cultures are the result of a process by which pathogens are intentionally. This definition does not include patient specimens as defined in 184.108.40.206.4.
220.127.116.11.4 Patient specimens are those 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.
18.104.22.168.5 Medical or clinical wastes are wastes derived from the medical treatment of animals or humans or from bio-research.
22.214.171.124 Classification of Infectious Substances
126.96.36.199.1 Infectious substances must be classified in Division 6.2 and assigned to UN2814, UN2900, UN 3291 or UN3373, as appropriate.
188.8.131.52.2 Infectious substances are divided into the following categories.
184.108.40.206.2.1 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. Indicative examples of substances that meet these criteria are given in 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.
(a) Infectious substances meeting these criteria which cause disease in humans or both in humans and animals must be assigned to UN 2814. Infectious substances which cause disease only in animals must be assigned to UN 2900.
(b) 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 judgement concerning individual circumstances of the source human oranimal.
1. The proper shipping name for UN 2814 is Infectious substance, affecting humans. The proper shipping name for UN 2900 is Infectious substance, affecting animals only.
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 same criteria must be assigned to Category A. In addition, if there is doubt as to whether or not a substance meets the criteria it must be included in Category A.
3. In the following list, the micro-organisms written in italics are bacteria, mycoplasma, rickettsia or fungi.
220.127.116.11.2.2 Category B:
An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373.
Note: The proper shipping name of UN 3373 is Diagnostic specimens or Clinical specimens or Biological substance, category B. On 1 January 2007, it is anticipated that the use of the shipping names Diagnostic specimens and Clinical specimens will no longer be permitted.
18.104.22.168.3.1 Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class.
22.214.171.124.3.2 Substances containing microorganisms which are non-pathogenic to humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class.
126.96.36.199.3.3 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 these Regulations unless they meet the criteria for inclusion in another class.
188.8.131.52.3.4 Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are not subject to these Regulations unless they meet the criteria for inclusion in another class.
184.108.40.206.3.5 Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests and 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 are not subject to these Regulations.
220.127.116.11.3.6 Patient specimens for which there is minimal likelihood that pathogens are present are not subject to these Regulations if the specimen is packed in a packaging which will prevent any leakage and which is marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate. The packaging must meet the following conditions:
(a) The packaging must consist of three components:
(i) a leak-proof primary receptacle(s);
(ii) a leak-proof secondary packaging; and
(iii) an outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100 mm × 100 mm;
(b) For liquids, absorbent material in sufficient quantity to absorb the entire contents must be
placed between the primary receptacle(s) and the secondary packaging so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material;
(c) When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them..
NOTE: In determining whether a patient specimen has a minimum likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt under this paragraph. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions.
Examples of specimens which may be transported under this paragraph include the blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antigens (PSA); those required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring; those conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy test; biopsies to detect cancer; and antibody detection in humans or animals.
18.104.22.168 Biological Products
22.214.171.124.1 For the purposes of these Regulations, biological products are divided into the following groups:
(a) those which are manufactured and packaged in accordance with the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals. Substances in this group are not subject to these Regulations
(b) those which do not fall under paragraph (a) and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B. Substances in this group must be assigned to UN2814, UN2900 or UN3373, as appropriate.
Note: Some licensed biological products may present a biohazard only in certain parts of the world. In that case, competent authorities may require these biological products to be in compliance with local requirements for infectious substances or may impose other restrictions.
126.96.36.199 Genetically Modified Micro-organisms and Organisms
188.8.131.52.1 Genetically modified micro-organisms not meeting the definition of an infectious substance must be classified according to Subsection 3.9.
184.108.40.206 Medical or Clinical Wastes
220.127.116.11.1 Medical or clinical wastes containing Category A infectious substances must be assigned to UN2814 or UN2900, as appropriate. Medical or clinical wastes containing infectious substances in Category B, must be assigned to UN3291.
18.104.22.168.2 Medical or clinical wastes which are reasonably believed to have a low probability of containing infectious substances must be assigned to UN3291. Note: The proper shipping name for UN3291 is Clinical waste, unspecified, n.o.s. or (Bio) Medical waste, n.o.s. or Regulated medical waste, n.o.s..
22.214.171.124.3 Decontaminated medical or clinical wastes which previously contained infectious substances are not subject to these Regulations unless they meet the criteria for inclusion in another class.
126.96.36.199 Infected Animals
188.8.131.52.1 A live animal that has been intentionally infected and is known or suspected to contain an infectious substance must not be transported by air unless the infectious substance contained cannot be consigned by any other means. Infected animals may only be transported under terms and conditions approved by the appropriate national authority.
184.108.40.206.2 Unless an infectious substance cannot be consigned by any other means, live animals must not be used to consign such a substance.
220.127.116.11.3 Animal carcasses affected by pathogens of category A or which would be assigned to category A in cultures only, must be assigned to UN 2814 or UN 2900 as appropriate. Other animal carcasses affected by pathogens included in Category B must be transported in accordance with provisions determined by the competent authority.
18.104.22.168 Patient Specimens Patient specimens must be assigned to UN 2814, UN 2900 or UN 3373 as appropriate except if they comply with 22.214.171.124.3