Note: This document is only valid for the period of 1 January 2003 through 31 December 2004
The 2003-2004 ICAO Technical Instructions include amendments
for diagnostic specimens. The purpose of
this document is to provide information and guidance for complying with the
amendments. Specifically the document
provides guidance on:
The previous references to risk groups for determining if a substance may be transported as a diagnostic specimen have been removed (see 2;6.3.1.3.2) The 2003-2004 edition of the Technical Instructions maintains the risk group criteria for classifying infectious substances but it is anticipated that the classification criteria will be replaced in the 2005-2006 edition of the Technical Instructions when the ICAO Dangerous Goods Panel considers the infectious substances requirements that were recently adopted for the 13th revised edition of the UN Model Regulations. As a result of the 2003-2004 amendments, specimens known or suspected of containing pathogens meeting the criteria for risk groups 2 or 3 may be transported as diagnostic specimens when they are transported for diagnostic or investigational purposes. Specimens known or suspected of containing risk group 4 pathogens must be classified in Division 6.2 under UN 2814 or UN 2900, as appropriate and transported according to the requirements for these substances.
The text below is provided to explain the impact of the amendments to the diagnostic specimens requirements in the Technical Instructions. The new requirements for diagnostic specimens that were adopted by the 12th revised edition of the UN Model Regulations have been adopted in other modal regulations and in certain national and regional transport regulations effective January 1, 2003.
6.3.1.3.1
Diagnostic specimens are any human or animal material including, but not
limited to, excreta, secreta, blood and its components, tissue and tissue
fluids being transported for diagnostic or investigational purposes,
but excluding live infected animals.
6.3.1.3.2
Diagnostic specimens must be assigned to UN 3373
unless the source patient or animal has or may have a serious human or
animal disease which can be readily
transmitted from one individual to another, directly or indirectly, and for which effective treatment and preventative measures are not usually available, in which case they must
be assigned to UN 2814 or UN 2900
Note
1. — Blood which has been
collected for the purpose of blood
transfusion or for the preparation of blood products, and blood
products and any tissues or organs intended for use in transplants are not
subject to these Instructions.
Note 2. — Assignment to UN 2814 or
UN 2900 must be based on
known medical history of the patient
or animal, endemic local conditions, symptoms of the patient or animal, or professional judgement concerning
individual circumstances of the patient or animal.
Diagnostic specimens, including those taken from apparently
healthy individuals, may contain pathogens that meet the criteria for risk
groups 1, 2, 3 or 4. Pathogens are
defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as
prions, that can cause disease in humans or animals. Pathogens are carried in blood, on the skin, in saliva or
faeces. Specimens containing risk group
1 pathogens are not subject to the Technical Instructions. Specimens containing
risk group 4 pathogens are not permitted for transport as diagnostic
specimens. Diagnostic specimens
containing risk group 2 or 3 pathogens
present a lower risk in transport as compared to infectious substances
containing risk group 4 pathogens or pathogens that are in intentionally
propagated in high concentrations such as those being transported for medical
research. Effective treatments are available and the risk of the spread of
infection is limited for risk group 2 or 3 pathogens. Additionally, the risk of transmission from one infected individual
to another is not as great for these pathogens. Since the packaging requirements of packing instruction 650
afford a high level of safety the probability of exposure is relatively
low. The probability of transmission of
an infection or disease to an exposed individual from a diagnostic specimen is
also relatively low. Effective and cautious emergency response procedures and
employee training significantly minimize the risk of exposure and subsequent
transmission of infection or disease.
Consignors, who would normally be health care professionals,
must make a judgement about the presence of pathogens of risk group 4, However,
such judgement is not required in respect of risk group 2 or 3, provided the
specimens are being transported for diagnostic or investigational purposes.
Specimens containing pathogens of risk group 2 or 3 transported for any other
purpose must be consigned as UN2814 or UN2900.
These requirements were developed in coordination with
experts from the World Health Organization (WHO) and provide a level of safety
commensurate with the risk in transport without imposing an undue burden on
those who are required to determine whether an infectious substance may be
transported as a diagnostic specimen. In particular the amendments:
- avoid direct reference to WHO Risk Groups, which had been developed by WHO for purposes other than transport and remove ambiguity related to the previous use of the terms “reasonably expected to contain” or “those where a relatively low probability exists” ;
- limit the application of requirements in transport to those commensurate with the actual , rather than the perceived, risk;
- require easily obtainable, suitable packaging affording a high level of safety appropriate to the degree of hazard and conditions of transport. Packing instruction 650 is appropriate for the transport of diagnostic specimens containing pathogens belonging to risk group 2 and 3;
- permit ready consignment and provide for the universal and effective treatment of individuals in the healthcare system.
It should be noted that determining if a substance is infectious has always included subjective analysis in the absence of actual testing. The 2003-2004 amendment minimizes the subjectivity relative to determining if a substance may be transported as a diagnostic specimen. Classifying these materials based on the level of risk and applying transport requirements commensurate with that risk should ensure an adequate level of safety.
Packaging and consignment procedures
Packing Instruction 650 is intended to provide all the information necessary to prepare and transport safely a consignment of diagnostic specimens. Among other requirements:
· the packaging must be of good quality capable of passing a 1.2m drop test and must consist of three components:
· a primary receptacle containing the diagnostic specimen;
· a secondary packaging, and an outer packaging with suitable cushioning material.
Either the primary or secondary receptacle must be capable of withstanding an internal pressure producing a pressure differential of not less than 95kPa for liquids.
· the package must be marked “DIAGNOSTIC SPECIMEN”. The UN number is not required to be shown.
Passenger and Operator Provisions
Diagnostic specimens are not permitted for transport in carry-on or checked baggage and must not be carried on a person. Operators must not load or transport diagnostic specimens unless they are transported as cargo in accordance with the provisions of 7;2.1 of the Technical Instructions.
NOTE
1: The following list is not exhaustive.
Infectious substances, including those containing new or emerging
pathogens, which do not appear in the following list but which meet the same
criteria mustl not be transported as a diagnostic
specimen. In addition, if there is
doubt as to whether or not a pathogen falls within this category it must not be
transported as a diagnostic specimen.
NOTE 2: In the following
table, the micro-organisms indicated in italics are bacteria, mycoplasmas,
rickettsiae or fungi.
NOTE 3: Cultures
(laboratory stocks) are the result of a process by which pathogens are
amplified or propagated in order to generate high concentrations, thereby
increasing the risk of infection when exposure to them occurs. This refers to
cultures prepared for the intentional generation of pathogens and does not
include cultures intended for diagnostic and clinical purposes. Cultures prepared for the intentional
generation of pathogens may not be transported as diagnostic specimens.
NOTE 4: If a health authority list is
available that shows other pathogens regarded as Risk Group 4 this should also
be taken into account and the substances should not be transported as diagnostic specimens.
INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES FORBIDDEN AS DIAGNOSTIC SPECIMENSIN ANY FORM UNLESS OTHERWISE INDICATED |
|
|
UN
Number and Proper Shipping Name |
Micro-organism |
|
UN 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
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 Hantaviruses
causing hantavirus pulmonary syndrome 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 |
|
UN 2814 Infectious substances affecting humans (cont'd) |
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 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) |
|
UN 2900 Infectious
substances affecting animals |
African horse sickness virus African swine
fever virus Avian
paramyxovirus Type 1 - Newcastle disease virus Bluetongue
virus Classical
swine fever virus Foot and mouth
disease virus Lumpy skin disease virus Mycoplasma
mycoides - Contagious bovine pleuropneumonia Peste des petits ruminants virus Rinderpest
virus Sheep-pox
virus Goatpox virus Swine
vesicular disease virus Vesicular
stomatitis virus |
Mitigation
procedures:
Isolate spill or leak area immediately in all directions.
Keep unauthorized personnel away.
Obtain identity of substance involved if possible and report the spill to the appropriate authorities.
Do not touch or walk through spilled material.
Do not touch damaged containers or spilled material unless wearing appropriate protective clothing.
Be particularly careful to avoid contact with broken glass or sharp objects that may cause cuts or abrasions that could significantly increase the risk of exposure.
Damaged packages containing solid CO2 as a refrigerant may produce water or frost from condensation of air. Do not touch this liquid as it could be contaminated by the contents of the parcel.
Liquid nitrogen may be present and can cause severe burns.
Absorb spilled materials with earth, sand or other non-combustible material while avoiding direct contact.
Cover damaged package or spilled material with damp towel or rag and keep wet with liquid bleach or other disinfectant. Liquid bleach will generally effectively inactivate the released substance.
DO NOT CLEAN-UP OR DISPOSE OF, EXCEPT UNDER SUPERVISION OF A
SPECIALIST.
First Aid:
Move exposed person(s) to a safe isolated area.
CAUTION: Exposed person(s) may be a source of contamination.
Call emergency medical services.
Remove and isolate contaminated clothing and shoes.
In case of contact with substance, immediately flush skin or eyes with running water for at least 20 minutes.
Effects of exposure (inhalation, ingestion or skin contact) to substance may be delayed.
For further assistance, contact the appropriate public health authority.
Ensure that medical personnel are aware of the substances involved, and take precautions to protect themselves.