Guidelines for LRN Advanced Sentinel Laboratories

Guidelines for LRN Advanced Sentinel Laboratories Packaging and Shipping The delivery addresses for MDH Lab building: Courier: MDH PUBLIC HEALTH LABORATORY 601 ROBERT ST N ST PAUL MN 55155-2531 U.S. Mail: MDH PUBLIC HEALTH LABORATORY 601 ROBERT ST N PO BOX 64899 ST PAUL MN 55164-0899 For Packaging and Shipping assistance call: MDH-PHL Biological Accessioning 651-201-4953 Packaging and Shipping Guidelines July 2005 Page 1 of 23

Packaging and Shipping Guidelines July 2005 Page 2 of 23

Title: Guidelines for Referring Biomedical Material: Packaging and Shipping Prepared by: Minnesota Department of Health Date: July 2005 I. 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. Packaging and Shipping Guidelines July 2005 Page 3 of 23

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 46 th Edition page 96) Packaging and Shipping Guidelines July 2005 Page 4 of 23

Figure 1: Packaging and Shipping Guidelines July 2005 Page 5 of 23

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 Packaging and Shipping Guidelines July 2005 Page 6 of 23

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 Packaging and Shipping Guidelines July 2005 Page 7 of 23

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. Packaging and Shipping Guidelines July 2005 Page 8 of 23

Figure 4: Example of Approved Infectious Shipping Container Packaging and Shipping Guidelines July 2005 Page 9 of 23

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 CO 2 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 Packaging and Shipping Guidelines July 2005 Page 10 of 23

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 Packaging and Shipping Guidelines July 2005 Page 11 of 23

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 Packaging and Shipping Guidelines July 2005 Page 12 of 23

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 Packaging and Shipping Guidelines July 2005 Page 13 of 23

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 Packaging and Shipping Guidelines July 2005 Page 14 of 23

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 Packaging and Shipping Guidelines July 2005 Page 15 of 23

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. Packaging and Shipping Guidelines July 2005 Page 16 of 23

Figure 13: Properly Filled Out Shipper s Declaration of Dangerous Goods Packaging and Shipping Guidelines July 2005 Page 17 of 23

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/ Packaging and Shipping Guidelines July 2005 Page 18 of 23

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, 46 th Edition January 2005 Packaging and Shipping Guidelines July 2005 Page 19 of 23

Table I: Select Agents Bacterial 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 Fungal Agents Coccidioides immitis Coccidoidies posadasii Toxins Abrin Conotoxins Diacetoxyscirpenol Ricin Saxitoxin Tetrodotoxin Shiga-Like ribosome inactivating proteins Botulinum neurotoxins Viral Agents 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. Packaging and Shipping Guidelines July 2005 Page 20 of 23

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.) Packaging and Shipping Guidelines July 2005 Page 21 of 23

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.) Packaging and Shipping Guidelines July 2005 Page 22 of 23

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 46 th Edition, January 2005: 3.6.2.2 Classification of Infectious Substances Table 3.6 D UN number and proper shipping name UN 2814 Infectious substance, affecting humans UN 2900 Infectious substance, affecting animals Organism 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) 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 Packaging and Shipping Guidelines July 2005 Page 23 of 23