Chapter 2.6

  2.6.2.2.4.5 Amend "2.6.2.2.4.1" to read "2.6.2.2.4.3".

  2.6.2.2.4.1 Amend the table to read as follows:

  2.6.2.2.4.7.1 In the explanation of "f _i", replace "liquid" with "mixture".

  2.6.2.2.4.7.2 Insert "comprising the mixture" after "component substance" and before "using the formula".

  2.6.3.1.3 Amend to read as follows:

 "Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include human or animal patient specimens as defined in 2.6.3.1.4.".

  2.6.3.1.4 Add a new 2.6.3.1.4 to read as follows and renumber subsequent paragraphs accordingly:

  "2.6.3.1.4 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.".

  2.6.3.2.1 Insert ", UN 3291" after "UN 2900".

  2.6.3.2.2.1 In the first sentence, replace "disease to humans or animals" with "disease in otherwise healthy humans or animals".

 In the Table with the indicative examples:

 Under UN 2814:

 - Replace "Hantaviruses causing hantavirus pulmonary syndrome" with "Hantavirus causing hemorragic fever with renal syndrome".

 - Add "(cultures only)" after "Rabies virus", "Rift Valley fever virus" and "Venezuelan equine encephalitis virus".

 Under UN 2900:

 - Delete "African horse sickness virus" and "Bluetongue virus".

 - Insert "Velogenic" before "Newcastle disease virus".

 - Add "(cultures only)" after each micro-organism in the list.

  2.6.3.2.2.2 Delete "except that cultures, as defined in 2.6.3.1.3, shall be assigned to UN 2814 or UN 2900 as appropriate".

 In the Note amend the proper shipping name to read: "BIOLOGICAL SUBSTANCE, CATEGORY B".

  2.6.3.2.3 Renumber current 2.6.3.2.3 as 2.6.3.2.3.1 and add a new 2.6.3.2.3 to read as follows:

  "2.6.3.2.3 Exemptions".

 Insert the following new subparagraphs:

  "2.6.3.2.3.2 Substances containing micro-organisms which are non-pathogenic to humans or animals are not subject to the provisions of this Code unless they meet the criteria for inclusion in another class.

  2.6.3.2.3.3 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 the provisions of this Code unless they meet the criteria for inclusion in another class.

  2.6.3.2.3.4 Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are not subject to the provisions of this Code unless they meet the criteria for inclusion in another class.".

  2.6.3.2.4 Current 2.6.3.2.4 becomes new 2.6.3.2.3.5. Amend the beginning of the paragraph to read as follows: "Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests and blood or blood components…".

 Current 2.6.3.2.5 Delete.

  2.6.3.2.3.6 Add a new paragraph to read as follows:

  "2.6.3.2.3.6 Human or animal specimens for which there is minimal likelihood that pathogens are present are not subject to the provisions of this Code if the specimen is transported 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 should meet the following conditions:

• (a) The packaging should 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 x 100 mm;

• (b) For liquids, absorbent material in sufficient quantity to absorb the entire contents should 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 should be either individually wrapped or separated to prevent contact between them.

  NOTE: 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 antibodies (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."

  2.6.3.5.1 Delete "or containing Category B infectious substances in cultures" in the first sentence and ", other than in cultures," in the last sentence.

  2.6.3.6 Add the following new title:

  "2.6.3.6 Infected animals"

  2.6.3.6.1 Current 2.6.3.2.6 becomes new 2.6.3.6.1. In new 2.6.3.6.1 add the following new first sentence: "Unless an infectious substance cannot be consigned by any other means, live animals shall not be used to consign such a substance.".

  2.6.3.6.2 Add a new 2.6.3.6.2 to read as follows:

  "2.6.3.6.2 Animal carcasses affected by pathogens of category A or which would be assigned to Category A in cultures only, shall be assigned to UN 2814 or UN 2900 as appropriate.

 Other animal carcasses affected by pathogens included in Category B shall be transported in accordance with provisions determined by the competent authority.".