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LRN Level A Bioterrorism Procedure Manual
Procedure – Packaging and Shipping
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Title:
Guidelines for Referring Biomedical Material: Packaging and Shipping
Prepared by:
Minnesota Department of Health
I.
Date: July 2005
Rationale:
The Federal Government has mandated that specific guidelines be followed when
packaging and shipping biological materials. The Department of Transportation (DOT),
the International Air Transport Association (IATA), the United States Postal Service
(USPS) and the Public Health Service, designated as the Centers for Disease Control and
Prevention (CDC), have all published documents regarding packaging and shipping of
diagnostic specimens and infectious agents. These regulations have been created to ensure
safe handling and transport of such materials. This document will incorporate the various
regulations together to provide one unified approach to safe packaging and transport of
biological materials.
II.
Definitions: As of January 2005, IATA dropped the classification of infectious agents on
the basis of risk groups. They now classify infectious organisms as Category A or
Category B. In May, 2005, DOT proposed changes in their regulations to incorporate the
same classification terms.
A. 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 to humans or
animals.
B. Category B
An infectious substance which does not meet the criteria for inclusion in Category A.
C. Infectious Substances
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.
D. Cultures (laboratory stocks)
Cultures 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 definition refers to cultures prepared for the intentional
generation of pathogens and does not include cultures intended for diagnostic and clinical
purposes.
E. IATA Packing Instructions (PI)
PI 650 is the packing instruction for diagnostic substances and PI 602 is the packing
instruction for infectious substances.
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F. Select Agents
Select agents are a group of biological agents and toxins that have the potential to pose a
severe threat to public health and safety.
III.
Summary of Regulations:
The regulations divide infectious substances into two categories – A (infectious), and B
(diagnostic). When clinical specimens are being shipped for the diagnosis and treatment of
a patient and are not known to contain a Category A organism, they may be treated as
diagnostic and shipped under IATA packing instruction 650. Specimens known to contain
or suspected of containing Category A organisms must be treated as infectious substances
and shipped under IATA packing instruction 602. Cultures that are sent for diagnostic or
investigational purposes can be sent as diagnostic specimens as long as they do not fall
into the Category A definition.
The guidelines incorporated in this procedure represent the best opinion of the MDH
Public Health Laboratory. The responsibility for determining appropriate packaging lies
with the submitter and they must exercise their best professional judgment in deciding to
package as diagnostic or infectious. In each case, the same careful leakproof triple
packaging must be used. Infectious packaging carries more labeling and marking
requirements, more stringent outer package strength testing, as well as completing a
shipper’s declaration.
Figure 1 is an algorithm for selecting packing instructions. The purpose of this algorithm
is to simplify the text of this protocol and is offered as a guideline. It is NOT a substitute
for interpretation of applicable regulations as they apply to individual situations, in which
case applicable governing regulations should be followed. (This figure is used with
permission from of the Michigan Department of Health.) Table III is a list of organisms
that are forbidden to be shipped as diagnostic. (From IATA Dangerous Goods
Regulations 46th Edition page 96)
Figure 1:
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IV.
Regulations:
A. Department of Transportation. 49 CFR Parts 171-180. Hazardous Materials
Regulations. http://www.saftpak.com/hm226-final.pdf
This regulation is designed to enhance the safe transportation of hazardous materials,
including infectious substances, and to harmonize the regulations with international
transportation standards. The rule applies to infectious substances, including
diagnostic specimens, biological products, regulated medical waste, and to genetically
modified micro-organisms.
B. United States Postal Service. 39 CFR Part 111. Mailability of Etiologic Agents.
Codified in the Domestic Mail Manual DMM Issue 57, June 2003. A copy may be
obtained by calling 1-202-512-1800 or http://www.saftpak.com/usps.pdf
Postal regulations stipulate that any clinical specimen or biological product that is
known or reasonably believed to contain an infectious substance must be shipped as an
“infectious substance”. These regulations have also been revised to harmonize with
the DOT 49 CFR.
C. Dangerous Goods Regulations (DGR). International Air Transport Association
(IATA). A copy may be obtained by calling 1-800-716-6326, or http://www.iata.org or
http://www.iata.org/ps/publications/9065.htm
The International Air Transport Association (IATA) has stringent and specific
regulations for packaging and shipping infectious substances and clinical/diagnostic
specimens. These regulations are written for packages that are being shipped by air
via commercial and cargo carriers such as Federal Express and passenger aircraft.
These regulations have been revised effective January 2005.
D. Public Health Service 42 CFR Part 73 Possession, Use, and Transfer of Select
Agents and Toxins. http://www.cdc.gov/od/sap/
This rule, known as the “Select Agent” rule, establishes requirements regarding
possession and use in the United States, receipt from outside the United States, and
transfer within the United States, of select agents and toxins. This includes
requirements concerning registration, security risk assessments, safety plans, security
plans, emergency response plans, training, transfers, record keeping, inspections, and
notifications. See Table I for a list of the select agents.
V.
Procedure for Packaging and Labeling Clinical/Diagnostic Specimens (Category B):
Suitable packaging containers and kits are available in most laboratory supply catalogues.
A. Primary Container/Vial: For liquid diagnostic samples, the primary receptacle must be
leakproof with a volumetric capacity of not more than 1L. The primary receptacle for solid
diagnostic specimens must be siftproof with a capacity of not more than 4 kg. It must be
labeled appropriately with patient name, organism name etc. Several primary
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containers/vials may be placed in the secondary container if they are carefully packaged
with shock-absorbent material between them to prevent breakage.
B. Secondary Container: For liquid samples the container must be water tight. Absorbent
material must surround the primary container and be sufficient to absorb the total contents
of the primary container. The secondary container must be labeled with the universal
biohazard label. (Figure 2 below).
C. An itemized list of contents must be enclosed between the secondary packaging and the
outer packaging. (new from IATA 2005)
D. Outer Packaging: The secondary container is placed into the outer package. The outer
package may be any sturdy container such as Styrofoam, fiber-board, cardboard, or plastic.
Although the outer container does not need to be water tight, it must be able to withstand the
rigors of shipment. The total volume must not exceed 4L (1 gallon) for liquid specimens or
4 kg (8.8 lbs) for solid specimens.
E. At least one surface of the outer packaging must have a minimum dimension of 100 mm x
100 mm. (new from IATA 2005)
F. Outer Packaging Labeling and Marking:
1. The outer shipping container must be labeled “diagnostic specimen”. This can be a box
marking by the manufacturer or your own applied label.
2. 2005 IATA regulations require a diamond shaped label with the inscription UN 3373
(this is the UN number for diagnostic specimens). (Figure 3 below)
3. 2005 IATA regulations also require the use of a label on the outer container denoting the
responsible person with address and telephone number
G. For shipments by aircraft, the primary receptacle or the secondary receptacle must be
certified to withstand without leakage an internal pressure producing a pressure differential
of not less than 95 kPa (0.95 bar, 14 psi). US mail regulations also require pressure
certification for the primary or secondary container.
H. Training: Each person who offers or transports a diagnostic specimen must be
knowledgeable about the regulations in 49 CFR parts 173.199.
I. A shipper’s declaration is not required for diagnostic samples.
Figure 2
Figure 3
UN 3373
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VI.
Procedure for Packaging and Labeling Infectious Substances (Category A):
Suitable packaging containers and kits are available in most laboratory supply catalogues.
Clinical specimens or cultures meeting the definition of a Category A material must be
classed and transported as “infectious substances”, UN 2814 (human) or UN 2900 (animal)
as appropriate.
A. Packaging (Figure 4)
1. The contents should not leak to the outside of the shipping container, even if there
should be leakage of the primary container(s) during transit, unless the package is
severely damaged, e.g., being run over by a transport vehicle. These packages should
withstand rough handling and passage through cancellation machines, sorters,
conveyors, etc.
2. Primary Container
a. Material shall be placed in a securely closed (screw caps must be fastened with
shrink seals, or comparable device), watertight, leak proof container such as a test
tube, vial, ampoule or equivalent.
b. Single primary containers shall not contain more than 50 mL of material.
c. Primary container must be labeled appropriately (e.g.: patient name, organism name
etc.).
3. Secondary Container
a. A durable watertight container, which the primary container is then placed into. If
multiple primary containers are placed into a single secondary container, they must
be wrapped individually.
b. The space at the top, bottom, and sides between the primary and secondary
containers shall contain sufficient nonparticulate absorbent material (e.g. paper
towel) to absorb the entire contents of the primary container(s) in case of breakage or
leakage.
c. An itemized list of contents (e.g., 10-1 mL slants of B. anthracis) must be affixed to
the secondary packaging.
4. Outer Packaging
a. Each set of secondary containers is then placed in an outer shipping container
constructed of corrugated fiberboard, cardboard, wood, or other material of
equivalent strength. Therefore, bags, envelopes, and the like are not acceptable outer
shipping containers.
b. The maximum amount of etiologic agent that may be enclosed within a single outer
shipping container shall not exceed 4,000 mL. (4 kg. for solids)
5. At least one surface of the outer packaging must have a minimum dimension of 100 mm
x 100 mm.
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Figure 4: Example of Approved Infectious Shipping Container
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6. Dry Ice
a. If dry ice is used as a refrigerant, it must be placed between the secondary
container and the outer shipping container. The outer container must be
allowed to vent the CO2 as it evaporates.
b. Shock absorbent material shall be placed so that the secondary container(s) do
not become loose inside the outer shipping container as the dry ice sublimates.
B. Labeling the Outer Shipping Container
The following pieces of information must be on all outer shipping containers.
1. Hazard label for infectious substances (Figure 5)
a. Must be on one side of the outer shipping container oriented as seen below.
b. CDC phone number on the package is not for emergencies, it is solely for
statistical information.
Figure 5: Hazard Label for Infectious Substances
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2. United Nations (UN) Certification (Figure 6)
The outer shipping containers of all materials containing “infectious substances”
transported in interstate traffic must be UN certified for infectious substances,
designated as: UN 4G/CLASS 6.2. The outer shipping containers must bear a label
reflecting this certification. Example below:
Figure 6: UN Certification Label
UN = United Nations
Class 6.2 = regulation number
96 = year manufactured
CAN/8-2 = country authorizing
the markings
SAF-T-PAK = Manufacturer of
packing material
3. UN 2814 Label (Figure 7)
a. The shipping name: “Infectious substance, affecting humans” followed by the
technical (scientific) name of the substance (e.g.: Bacillus anthracis) and the UN
number 2814, which designates the substance as affecting humans. IATA special
provision A140 permits shippers of category A infectious substances (UN 2814 and
UN 2900) to omit the technical name from the proper shipping name marking on the
package. If you use this provision you must document it on the shipper’s declaration
under the column headed “Authorization”.
b. The quantity must also be documented on this label, i.e. 10 mL.
Note: In IATA regulations, a comma must follow “Infectious substance”
c. This label must be affixed or written on the side of the outer container adjacent to the
“infectious substance” label.
Figure 7: Example of Infectious Substance Statement
Infectious Substance, Affecting Humans
(Bacillus anthracis), UN2814 10 mL
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4. Address Label (Figure 8)
a. Affixed or written on one side of the outer container, opposite of “Infectious
substance label.
b. The Receiver’s (To/consignee)
i. Name
ii. Address
iii. Telephone number
c. The Shipper’s (From/consignor)
i. Name
ii. Address
iii. Responsible person and phone number
Figure 8: Example of Address Label
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5. Package Orientation Arrows (Figure 9)
a. Packages containing liquid cultures of infectious organisms and genetically modified
microorganisms must be packed so that the closure(s) of the inner packaging(s) are
upward.
b. The upright position of the packaging must be indicated by two “package
orientation” labels (either black or red) affixed on opposite sides of the packaging.
Figure 9:
Package Orientation Labels
6. Hazard label for dry ice (Figure 10 and 11)
a. This label, or the middle symbol on this label, is necessary only when dry ice is
used.
b. If hazard label for dry ice does not have within it UN 1845 information, then the
information must be affixed or written adjacent to it:
Carbon dioxide, solid
(Dry ice) UN1845
Figure 10: Example of Dry Ice
Statement That Must Be Written or
Affixed If Not On Dry Ice Label
Figure 11: Dry Ice Label
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7. Overpacks
a. Overpacks are used to combine several triple packs into one outer unit.
b. Each triple pack within the overpack must be properly labeled as described above.
The IATA 2005 regulations have changed the marking on overpacks from the “Inner
Packages Comply” label to just the word “Overpack” as shown in figure 12. In
addition, the Class 6 Infectious Substance Hazard Label and the Proper Shipping
Name and UN number label must be on the overpack. (also the dry ice label if
appropriate).
c. Individual inner packages must not exceed the maximum quantities of 4 L or 4 kg.
Figure 12: Labeling necessary for an Overpack Box
Overpack
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C. Shipper’s Declaration of Dangerous Goods:
Any infectious substance must be accompanied by a Shipper’s Declaration of Dangerous
Goods. This includes infectious substances shipped by FedEx or the U.S. Mail or even a private
or contract courier. The Shipper’s Declaration forms may be obtained from the shipper or
purchased from package supply vendors.
A. The form must be filled out completely with the following information (refer to Figure 13):
1. Shipper: Full name, address, and telephone number of the shipper.
2. Consignee: Full name, address, and telephone number of the receiver.
3. Transport details:
a. Passenger and cargo aircraft: the maximum quantity that may be shipped in one
secondary container or overpack is 50 mL or 50 g for passenger aircraft.
b. Cargo aircraft only: The limit is 4L or 4 Kg for cargo aircraft.
(Cross out the option which does not apply, either ‘a’ or ‘b’)
c. Airport of departure: May be filled in by the carrier.
d. Airport of destination: Document city of destination airport.
4. Shipment type: Cross out the option which does not apply, either “non-radioactive” or
“radioactive”
5. Nature and quantity of dangerous goods
a. Proper Shipping Name:
i. Infectious substance: Enter “Infectious substance, affecting humans (Bacillus
anthracis)”
Note: You must put in the comma after substance and the brackets around the
technical name; according to IATA rules.
ii. 2005 IATA regulations found in Special Provision A140 permits shippers of
category A infectious substances (UN 2814 and UN 2900) to omit the technical
name from the proper shipping name marking on the package. In addition,
where the name of the pathogen is not known, this provision also permits
shippers to omit the technical name from the proper shipping name on the
Shipper’s Declaration and instead show “suspected category A infectious
substance”. Note: this applies to air transport only.
iii. Dry ice: Enter “Carbon dioxide, solid (Dry ice)” Entries must be on separate
line as shown on Figure 13.
b. Class or Division:
i. Infectious substance: Enter 6.2
ii. Dry ice: Enter 9
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c. UN or ID No.:
i. Infectious substance: Enter UN2814
ii. Dry ice: Enter UN1845
d. Packaging Group:
i. Infectious substance: Not applicable, leave blank
ii. Dry ice: Enter III
e. Subsidiary risk: Not applicable, leave blank
f. Quantity and type of packaging:
i. Infectious substance: must note the type of material of the outer container
and the total quantity of dangerous goods; example: “One fibreboard box
x 10 mL specimen” (note: IATA requires the English spelling of
“fibreboard).
ii. Dry ice: Enter total quantity of dry ice used; example: “x 2.5 kg”, an
additional statement “ALL packed in one fibreboard box” must be added.
iii. If overpack is used, include the statement: “Overpack used”
g. Packaging instructions:
i. Infectious substance: Enter 602
ii. Dry ice: Enter 904
h. Authorization: Leave blank
6. Additional Handling Information:
2005 IATA regulations require the statement “I declare that all of the applicable air
transport requirements have been met”. The previous statement “Prior
arrangements as required by the IATA Dangerous Goods Regulations ….” has
been omitted.
7. Emergency telephone number:
24 hour emergency contact number for the shipper
8. Name and Title of signatory:
Enter name and title of person shipping and signing the declaration
9. Place and Date:
Enter city, state, and date of the signing.
10. Signature:
Declaration must be signed by the shipper.
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Figure 13: Properly Filled Out Shipper’s Declaration of Dangerous Goods
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VII.
Notification:
As noted above, IATA has deleted the requirement to notify the receiver prior to shipment.
However, it is still a sensible and reasonable procedure to follow when you are sending an
infectious package and especially if the package is sent refrigerated or frozen. The Select Agent
regulations have very detailed notification protocols for security reasons.
VIII. Damaged Packages:
The carrier shall promptly, upon discovery of evidence of leakage or any other damage to
packages bearing a hazard label for infectious substances, isolate the package and call the
person listed as responsible person on the box and the shipper’s declaration. In addition, the
Director, Centers for Disease Control and Prevention, 1600 Clifton Road, N.E., Atlanta,
Georgia 30333, by telephone, (404) 633-5313, should be informed for statistical purposes.
IX.
Additional Requirements for Facilities Transferring or Receiving Select Infectious Agents:
The Centers for Disease Control and Prevention (CDC) is required to regulate the possession of
biological agents and toxins that have the potential to pose a severe threat to public health and
safety. CDC’s Select Agent Program oversees these activities. The Select Agent Program
currently requires registration of facilities including government agencies, universities, research
institutions, and commercial entities that possess, use or transfer biologic agents and toxins that
pose a significant threat to public health. The rule has specific requirements for safety and
security for any registered facilities that includes requirements for security risk assessments
conducted by the Department of Justice.
The rule is aimed at ensuring that the change in possession of biological materials is within the
best interest of the public and the nation. It requires documentation of all aspects of the transfer
process including notification of CDC before any transfers are authorized. Recipients must
send specific documentation to both CDC and the sender when the select agent package is
received. All select agents must be packaged and shipped as infectious substances. See Table I
for a list of select agents.
The Select Agent Rule contains an exemption for clinical laboratories that may isolate a select
agent as part of the diagnostic process. (paragraph 73.5). The rule requires the laboratory
isolating a suspected select agent to transfer it within seven days to a registered laboratory
and/or destroy any cultures left on-site by a recognized sterilization or inactivation process. In
addition, the diagnostic laboratory must document the transfer and/or destruction using form 4
found on the CDC select agent web site: http://www.cdc.gov/od/sap/
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X.
Reportable Diseases, MN Rule #4605.7040:
Under this state rule laboratories must submit certain isolates/clinical materials to the MDH.
Table II is a listing of these agents. Cultures sent for clinical or investigational purposes may
be sent as diagnostic specimens (Category B) as long as they are not in the select agent
category, in Category A, or on the list of forbidden agents found in table III.
XI.
MLS Courier Network Initiative:
The regulations in 49 CFR 173.134 state that diagnostic specimens, when transported by
private or contract carriers in a motor vehicle used exclusively to transport diagnostic
specimens or biological products, are exempt from the regulations. MDH is working to
establish a courier network utilizing existing couriers in hub cities. Surrounding communities
send samples to the hub city by existing private couriers (e.g. hospital couriers). Samples are
pooled in the hub city and transported to MDH using a private contract courier serving the
laboratory in that city. Where private couriers cannot be used, MDH is providing transport
using UPS. UPS will transport only diagnostic packages.
Packaging requirements for a private exempt courier consist of safe triple packaging described
for both infectious and diagnostic packaging. Label with the biohazard symbol as required by
OSHA regulations. Certified packaging materials and shipping papers are not required. As
long as the shipping does not involve air transportation, pressure certified containers are not
required.
XII.
References:
•
•
•
•
•
•
The 2003 Comprehensive Guide to Shipping Infectious Substances SAF-T-PAK, Inc.,
2003.
Public Health Service 42 CFR Part 73. Possession, Use, and Transfer of Select Agents
and Toxins. Revised December 2002. http://www.cdc.gov/od/sap/
United States Postal Service. 39 CFR Part 111 Revised June 6, 2003. Mailability of
Etiologic Agents codified in the Domestic Mail Manual (DMM) Issue 57 January 2002
49 CFR Parts 171-178: Hazardous Materials: Revision to Standards for Infectious
Substances. Revised proposed regulations May 2005
ASM guidelines for Sentinel Laboratories for Packing and Shipping, Nov. 2003
IATA Dangerous Goods Regulations , 46th Edition January 2005
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Table I: Select Agents
Bacterial Agents
Fungal Agents
Bacillus anthracis
Brucella abortus
Brucella melitensis
Brucella suis,
Burkholderia mallei (formerly Pseudomonas mallei)
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
Botulinum neurotoxin producing species of Clostridium
Coxiella burnetii
Francisella (Pasteurella) tularensis
Yersinia pestis
Rickettsia prowazekii
Rickettsia rickettsii
Coccidioides immitis
Coccidoidies posadasii
Viral Agents
Toxins
Abrin
Conotoxins
Diacetoxyscirpenol
Ricin
Saxitoxin
Tetrodotoxin
Shiga-Like ribosome inactivating
proteins
Botulinum neurotoxins
Clostridium perfringens
epsilon toxin
Crimean-Congo haemorrhagic fever virus
Shigatoxin
Ebola viruses
Staphylococcal enterotoxin
Ceropithecine herpevirus 1 (Herpes B virus)
T-2 toxin
Lassa fever virus
Marburg virus
Monkeypox virus
South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
Tick-borne encephalitis complex (flavi) viruses (Central European Tick-Borne encephalitis, Far Eastern Tick-borne
encephalisit(Russina Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever)
Variola major virus (Smallpox) and Variola minor virus (Alastrim)
Eastern Equine Encephalitis virus
Nipah and Hendra Complex viruses
Rift Valley fever virus
Venezuelan Equine Encephalitis
Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms:
1. Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented,
in host chromosomes or in expression vectors) that can encode infectious and/or
replication competent forms of any of the select agent viruses.
2.
Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any
of the toxins listed above.
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Table II. Emerging Infectious Pathogens Required to be sent to MDH per Minnesota
Reportable Disease Rule #4605.7040
The newly revised reportable disease rule of 2005 mandates disease reporters and medical
laboratories to submit “clinical materials” rather that “isolates”, as previously required, to
MDH. Clinical materials mean a clinical isolate or, if an isolate is not available, material
containing the infectious agent for which submission of material is required, in the following
order of preference: a patient specimen, nucleic acid, or other laboratory materials.
The following list contains those isolates or clinical materials required to be submitted as per
rule #4605.7040.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Anthrax (Bacillus anthracis)
Brucellosis (Brucella spp.)
Cholera (Vibrio cholerae)
Diphtheria (Corynebacterium diphtheriae)
Measles (rubeola)
Meningococcal disease (Neisseria meningitidis)
Orthopox virus
Plague (Yersinia pestis)
Poliomyelitis
Q fever (Coxiella burnetii)
Rubella and congenital rubella syndrome
Severe acute respiratory syndrome (SARS)
Smallpox (variola)
Tularemia (Francisella tularensis)
Campylobacteriosis (Campylobacter spp.)
Cryptosporidiosis (Cryptosporidium spp.)
Cyclosporiasis (Cyclospora spp.)
Enteric Escherichia coli infection (E. coli 0157:H7), other enterohemorrhagic (Shiga
toxin-producing) E.coli, enteropathogenic E. coli, enterovinvasive E. coli, and
enterotoxigenic E. coli.)
Enterobacter sakazakii in infants under one year of age.
Haemophilus influenzae disease
Human immunodeficiency virus (HIV)
Influenza (unusual case incidence, critical illness, or laboratory confirmed cases)
Kingella spp. (invasive only)
Legionellosis (Legionella spp.)
Listeriosis (Listeria monocytogenes)
Neonatal sepsis (bacteria isolated from a sterile site, excluding coagulase-negative
Staphylococcus) less than seven days after birth.
Pertussis (Bordetella pertussis)
Salmonellosis, including typhoid (Salmonella spp.)
Shigellosis (Shigella spp.)
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•
•
•
•
•
•
•
•
Staphylococcus aureus (only vancomycin-intermediate Staphylococcus aureus
(VISA),
vancomycin-resistant Staphylococcus aureus (VRSA), and death or critical illness due
to community-associated Staphylococcus aureus in a previously healthy individual.
Streptococcal disease (all invasive disease caused by Groups A and B streptococci and
S. pneumoniae.)
Toxic shock syndrome
Tuberculosis (Mycobacterium tuberculosis complex) pulmonary or extrapulmonary
sites of disease, including laboratoy confirmed or clinically diagnosed disease. Latent
tuberculosis infection is not reportable.
Varicella zoster disease (primary – chickenpox and recurrent – shingles)
Vibrio spp.
Yersiniosis, enteric (Yersinia spp.)
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Table III. Examples of infectious substance forbidden to be shipped as diagnostic
specimens.
This 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 must 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.
Ref: IATA Dangerous Goods Regulation 46th Edition, January 2005: 3.6.2.2 Classification of
Infectious Substances Table 3.6 D
UN number and proper shipping name
Organism
UN 2814
Infectious substance, affecting humans
Bacillus anthracis (cultures only)
Brucella abortus (cultures only)
Brucella melitensis (cultures only)
Brucella suis (cultures only)
Burkholderia mallei (cultures only)
Burkholderia pseudomallei (cultures only)
Chlamydia psittaci (avian) (cultures only)
Clostridium botulinum (cultures only)
Coccidioides immitis (cultures only)
Coxiella burnetii (cultures only)
Crimean-congo hemorrhagic fever virus
Dengue virus (cultures)
Eastern equine encephalitis virus (cultures only)
Escherichia coli, verotoxigenic (cultures only)
Ebola virus
Francisella tularensis (cultures only)
Hantaan virus
Hepatitis B virus (cultures only)
Herpes B virus (cultures only)
Human immunodeficiency virus (cultures only)
Lassa virus
Marburg virus
Mycobacaterium tuberculosis (cultures only)
Poliovirus (cultures only)
Rabies virus
Rickettsia prowazekii (cultures only)
Shigella dysenteriae type 1 (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 substance, affecting animals
Bluetongue virus
Classical swine fever virus
Foot-and –mouth disease virus
Goatpox virus
Lumpy skin disease virus
Newcastle disease virus
Sheeppox virus
Swine vesicular disease virus
Vesicular stomatitis virus