IMO Classes

Class 6: Toxic and infectious substances

Subclass 6.1: Toxic, poison substances

Conosciuto per essere tossico per l'uomo in modo da costituire un pericolo per la salute durante il trasporto o è presunto essere tossico per l'uomo perché rientra in una categoria tossica quando viene testato su animali da laboratorio.

An irritating material such as tear gas that causes extreme irritation, especially in confined spaces

Subclass 6.2: Biohazard

6.2.1 Definitions

Ai fini del presente regolamento:

6.2.1.1 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

umani o animali.

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.

6.2.1.2 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.

6.2.1.3 Cultures are the result of a process by which pathogens are intentionally. This definition does not include patient specimens as defined in 6.2.1.4.

6.2.1.4 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.

6.2.1.5 Medical or clinical wastes are wastes derived from the medical treatment of animals or humans or from bio-research.

6.2.2 Classification of Infectious Substances

6.2.2.1 Infectious substances must be classified in Division 6.2 and assigned to UN2814, UN2900, UN 3291 or UN3373, as appropriate.

6.2.2.2 Infectious substances are divided into the following categories.

6.2.2.2.1 Category A:

Una sostanza infettiva che viene trasportata in una forma che, in caso di esposizione ad essa, è in grado di provocare invalidità permanente, malattie mortali o mortali in esseri umani o animali altrimenti sani. Esempi indicativi di sostanze che soddisfano questi criteri sono riportati nella tabella 3.6.D.

Nota: si verifica un'esposizione quando una sostanza infettiva viene rilasciata all'esterno dell'imballaggio protettivo, con conseguente contatto fisico con persone o animali.

a) Le sostanze infettive che soddisfano questi criteri e che causano malattie nell'uomo o nell'uomo e negli animali devono essere assegnate alla voce UN 2814. Le sostanze infettive che causano malattie solo negli animali devono essere assegnate all'ONU 2900.

b) L'assegnazione alle Nazioni Unite 2814 o 2900 deve essere basata sulla storia medica nota e sui sintomi della fonte umana o animale, su condizioni locali endemiche o su un giudizio professionale in merito alle circostanze individuali della fonte umana o animale.

Note:

1. Il nome di spedizione corretto per UN 2814 è sostanza infettiva, che colpisce l'uomo. La denominazione di spedizione corretta per UN 2900 è sostanza infettiva, che colpisce solo gli animali.

2. La tabella che segue non è esaustiva. Le sostanze infettive, compresi gli agenti patogeni nuovi o emergenti, che non figurano nella tabella, ma che soddisfano gli stessi criteri, devono essere assegnate alla categoria A. Inoltre, se sussistono dubbi sul fatto che una sostanza soddisfi o meno i criteri, essa deve essere inclusa nella categoria A.

3. Nell'elenco che segue, i microrganismi scritti in corsivo sono batteri, micoplasmi, rickettsia o funghi.

Bacillus anthracis (cultures only)
Infectious substance
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 hemorrhagic fever virus
Dengue virus (cultures only)
Eastern equine encephalitis virus (cultures only)
Escherichia coli, verotoxigenic (cultures only)
Ebola virus
Flexal virus
Francisella tularensis (cultures only)
Guanarito virus
Hantaan virus
Hantavirus causing hemorragic 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
Monkeypox virus
Mycobacterium tuberculosis (cultures only)
Nipah virus
Omsk hemorrhagic fever virus
Poliovirus (cultures only)
Rabies virus
Rickettsia prowazekii (cultures only)
Rickettsia rickettsii (cultures only)
Rift Valley fever virus
Russian spring-summer encephalitis virus (cultures only)
Sabia virus
Shigella dysenteriae type 1 (cultures only)
Tick-borne encephalitis virus (cultures only)
Variola virus
Venezuelan equine encephalitis virus
West Nile virus (cultures only)
Yellow fever virus (cultures only)
Yersinia pestis (cultures only)
African swine fever virus (cultures only)
Avian paramyxovirus Type 1 – Velogenic Newcastle disease virus (cultures only)
Classical swine fever virus (cultures only)
Foot and mouth disease virus (cultures only)
Goatpox virus (cultures only)
Lumpy skin disease virus (cultures only)
Mycoplasma mycoides – Contagious bovine pleuropneumonia(cultures only)
Peste des petits ruminants virus (cultures only)
Rinderpest virus (cultures only)
Sheep-pox virus (cultures only)
Swine vesicular disease virus (cultures only)
Vesicular stomatitis virus (cultures only)

6.2.2.2.2 Category B:

Una sostanza infettiva che non soddisfa i criteri per l'inclusione nella categoria A. Le sostanze infettive della categoria B devono essere assegnate al n. ONU 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.

6.2.2.3 Exemptions

6.2.2.3.1 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.

6.2.2.3.2 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.

6.2.2.3.3 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 these Regulations unless they meet the criteria for inclusion in another class.

6.2.2.3.4 Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are not subject to these Regulations unless they meet the criteria for inclusion in another class.

6.2.2.3.5 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.

6.2.2.3.6 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) L'imballaggio deve essere costituito da tre componenti:

1. A leak-proof primary receptacle(s);

2. A leak-proof secondary packaging; and

3. 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) Per i liquidi, il materiale assorbente in quantità sufficiente ad assorbire l'intero contenuto deve essere

collocati tra il recipiente o i recipienti primari e l'imballaggio secondario in modo che, durante il trasporto, qualsiasi fuoriuscita o perdita di una sostanza liquida non raggiunga l'imballaggio esterno e non comprometta l'integrità del materiale di imbottitura;

c) Quando più recipienti primari fragili sono collocati in un unico imballaggio secondario, essi devono essere imballati individualmente o separati per evitare il contatto tra loro.

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.

Esempi di campioni che possono essere trasportati ai sensi del presente paragrafo comprendono i test del sangue o delle urine per monitorare i livelli di colesterolo, i livelli di glucosio nel sangue, i livelli ormonali o gli antigeni specifici della prostata (PSA); quelli necessari per monitorare le funzioni degli organi, come la funzione cardiaca, epatica o renale per gli esseri umani o animali con malattie non infettive, o il monitoraggio terapeutico dei farmaci; quelli condotti a fini assicurativi o di lavoro e sono destinati a determinare la presenza di droghe o alcool; test di gravidanza; biopsie per rilevare il cancro; e la rilevazione di anticorpi negli esseri umani o animali.

6.2.3 Biological Products

6.2.3.1 For the purposes of these Regulations, biological products are divided into the following groups:

a) quelli fabbricati e imballati conformemente alle prescrizioni delle autorità nazionali competenti e trasportati ai fini dell'imballaggio o della distribuzione finale, e utilizzati per l'assistenza sanitaria personale da parte di medici o privati. Le sostanze di questo gruppo non sono soggette ai seguenti regolamenti

b) quelle che non rientrano nel campo di applicazione della lettera a) e che, a quanto è noto o che si ritiene ragionevolmente che contengano sostanze infettive e che soddisfano i criteri per l'inclusione nelle categorie A o B. Le sostanze di questo gruppo devono essere assegnate, a seconda dei casi, alle categorie UN2814, UN2900 o UN3373.

Nota: Alcuni prodotti biologici autorizzati possono presentare un rischio biologico solo in alcune parti del mondo. In tal caso, le autorità competenti possono esigere che tali prodotti biologici siano conformi ai requisiti locali per le sostanze infettive o possono imporre altre restrizioni.

6.2.4 Genetically Modified Micro-organisms and Organisms

6.2.4.1 Genetically modified micro-organisms not meeting the definition of an infectious substance must be classified according to Subsection 3.9.

6.2.5 Medical or Clinical Wastes

6.2.5.1 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.

6.2.5.2 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..

6.2.5.3

6.2.6 Infected Animals

6.2.6.1 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.

6.2.6.2 Unless an infectious substance cannot be consigned by any other means, live animals must not be used to consign such a substance.

6.2.6.3 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.

6.2.7 Patient Specimens Patient specimens must be assigned to UN 2814, UN 2900 or UN 3373 as appropriate except if they comply with 6.2.2.3