Shipping protocol template for avian influenza specimens SPC LRD-AHP/PRIPPP Version 20 Mar 2009 How to use this document This template document has been prepared for the Pacific Animal Health Laboratory Network (PAHLNet), specifically to guide animal health laboratory staff in packing avian influenza specimens for local transport and air transport to overseas laboratories. The document was compiled by the Animal Health and Production (AH&P) team of the Secretariat of the Pacific Community (SPC) under the Pacific Regional Influenza Pandemic Preparedness Project (PRIPPP). It is designed to be edited by animal health laboratory focal person(s) in PICTs to adapt to PICTs’ specific conditions and arrangements with collaborating laboratories and agencies. The official seal, agency name and address should be inserted accordingly. For queries about this document and a copy of the editable version in MS Word 97 format, please email elvab@spc.int. Page 1 of 29 Shipping protocol template for avian influenza SECRETARIAT OF THE PACIFIC COMMUNITY Animal Health and Production Team 3 Luke Street Nabua Fiji Islands Shipping protocol for avian influenza specimens Introduction This shipping protocol is specifically designed to guide animal health laboratory staff in packing animal specimens for local transport and air transport to overseas laboratories. The objective is to be able to send animal specimens appropriate for laboratory diagnosis and confirmation of avian influenza. The procedures outlined in this document are intended to follow the guidelines set by the International Air Transport Association (IATA) in its Dangerous Goods Regulations (DGR) Manual (50th edition) and the World Health Organization (WHO) in its Guidance on Regulations for the Transport of Infectious Substances 2009–2010. Safety information Only culture specimens of highly pathogenic avian influenza (HPAI) are classified under Category A, ‘Infectious substances affecting humans and animals’. Packing Category A infectious substances (i.e. cultures of HPAI specimens) requires personnel to undergo training and may involve attendance at approved courses and passing examinations. None of the specimens listed in this document are considered cultures, and they are therefore classified as patient (animal) specimens labelled as ‘UN 3373 Infectious substance, Category B’. WHO’s Guidance on Regulations for the Transport of Infectious Substances 2009–2010 indicates that for transport of Category B infectious substances, there is a requirement that clear instructions on the use of packaging are supplied to the user and this is regarded as sufficient ‘training’ for shipping of the substances. If the specimens are packed with other dangerous goods (e.g. dry ice, liquid nitrogen), the personnel must be trained in the proper procedures for their transport. Prior to preparing avian influenza specimens for shipment, please review the Pathogen Safety Data Sheet for avian influenza (Annex 13). Shippers are expected to know the hazards of the materials that are being transported and to be prepared to respond to emergency situations involving the materials being transported. Basic personal protective equipment (i.e. gloves, protective eyewear, protective outer garment, mask) should be worn during packing of materials. Hand-washing should be performed after handling specimens. Page 2 of 29 Shipping protocol template for avian influenza Packaging of specimens For the purpose of avian influenza routine animal disease surveillance and investigations in the Pacific, the following specimens can be collected as required by referral/reference laboratories: 1. 2. 3. 4. 5. serum samples (for serology); tracheal or cloacal swabs (for rapid test kit); tracheal or cloacal swabs in virus transport medium or RLT buffer (for PCR); tissue specimens in sterile containers (for virus isolation and PCR); and environmental specimens (e.g. fresh faeces) if specimens 1–4 are not available. Animal specimens collected for the purposes indicated above are screen-tested for avian influenza A using Anigen rapid test kits (or other diagnostic procedure available in the PICT). No other procedures are conducted to determine the presence of infectious substances. Animal specimens classified as Category B should be packed using basic triple packaging, as described in Packaging Instruction (PI) 650 of the IATA DGR manual. Basic triple packaging (PI 650) 1. Primary receptacle o Maximum liquid content of 1 litre o Sealed, watertight, leak-proof or sift-proof o Secured cap (e.g. Parafilm tape) o Labelled o Individually wrapped in cushioning or absorbent material sufficient to absorb entire contents in case of leak o Able to withstand internal pressure of 95 kPa in the range of -40oC to 55oC (-40oF to 130oF) 2. Secondary receptacle/packaging o Watertight, leak-proof o Itemised list of contents attached o Able to withstand internal pressure of 95 kPa in the range of -40oC to 55oC (-40oF to 130oF) 3. Outer packaging o Maximum content of 4 litres or 4 kg including: a. Secondary receptacle/packaging containing primary receptacle inside b. Cushioning material c. Ice, dry ice or liquid nitrogen (refrigerants) o Smallest overall external dimension of 10 x 10 cm (100 x 100 mm; 4 x 4 in) o Markings and labels placed appropriately Important note: Inner packaging containing infectious substances shall not be consolidated with inner packaging containing unrelated types of goods. Page 3 of 29 Shipping protocol template for avian influenza Additional packaging: Overpack is the term used when several packages are combined to form one unit and sent to the same destination by a single shipper. An overpack should have: 1. the same markings and labels shown on the outer packaging (of a basic triple packaging); and 2. OVERPACK marking attached to the outermost box. Important information UN number: UN 3373 Proper shipping name: Biological substance, Category B Markings: (1) Sender’s name, address, telephone number (2) Telephone number of responsible person knowledgeable about the shipment (3) Receiver’s name, address, telephone number (4) Proper shipping name, adjacent to (5) UN number Additional markings: (1) Dry ice or liquid nitrogen – technical name of refrigerant, appropriate UN number and net quantity Labelling: A. Hazard label: o o o o UN 3373 in diamond-shaped outline Overpack (if appropriate) Dry ice (if packed) Liquid nitrogen (if packed) B. Handling labels: o Orientation label Proper labels and markings are illustrated in Figure 1 (page 5). Templates for markings and actual specification of labels to use for packaging can be found in the annexes. Markings and labels available in the annexes can be reproduced and directly used for labelling packages. Documentation A. To be prepared by shipper: (1) Packing list/pro forma invoice, which includes (Annex 5): a) sender’s address b) receiver’s address c) number of packages d) detail of contents e) weight f) value (indicate ‘No commercial value’ if items are supplied free of charge). Page 4 of 29 Shipping protocol template for avian influenza (2) Import* and export permit (Annexes 6–8) (3) Import and export declaration, if required (Annex 9) * An import permit can be acquired in advance from the receiving laboratory. Prearrangements for import permits should be made with the sub-regional, referral and reference laboratories selected by the PICT. B. To be prepared by carrier* (freight service provider): * Prearrangement with a carrier (TNT or DHL) should be made by the PICT or in collaboration with SPC. (1) Airway bill for air transport (Annex 11) Figure 1. Example of triple packaging system for packing and labelling of Category B infectious substances (Adapted from WHO Guidelines on Regulations for Transport of Infectious Substances, originally sourced from IATA, Montreal, Canada) Duties of shipper/sender o o o o o o o o Notify receiving laboratory of planned shipment Notify carrier (TNT or DHL) of planned shipment Collect specimen(s) Prepare documents Package specimen(s) Arrange for shipment Follow up laboratory results Record results Page 5 of 29 Shipping protocol template for avian influenza Reusing and shipping empty packaging Shipping packaging can be reused and empty packages can be returned to the source or sent to other locations. Before reusing and returning packaging, it should be disinfected or sterilised to remove any substance or hazard. All non-applicable markings and labels must be removed. Incident reporting In case of accidental spills of specimens in transport, a proper clean-up procedure should be advised (Annex 12). Either of the following should be contacted and informed: Local transport Local laboratory focal person (name, address, 24-hour telephone number) 24-hour emergency number: International shipment Local laboratory focal person (name, address, 24-hour telephone number) Receiving laboratory contact person 24-hour emergency number: 24-hour emergency number: SPC 24-hour emergency number: Other individuals In cases of being contacted for incident reports of spills, advice should be given to the caller on proper spill clean-up. Various international modal regulations require the reporting of incidents to relevant competent transport authorities in addition to necessary health authorities. Efficient packaging of specimens compliant to PI 650 of IATA DGR will ensure that specimens are transported with the minimum possibility of accidental spillage. References WHO. 2008. Guidance on Regulations for Transport of Infectious Substances 2009–2010. World Health Organization, Geneva. http://www.who.int/csr/resources/publications/biosafety/WHO_HSE_EPR_2008_10/en/index.html IATA. 2008. IATA Dangerous Goods Regulation Manual, 50th edition. International Air Transport Association, Montreal. Page 6 of 29 Shipping protocol template for avian influenza This shipping protocol is approved for use by: Head of Agriculture Department: Date: (Signature) Head of Public Health Department: Date: (Signature) Chief Laboratory Officer: Date: (Signature) Affix official stamp/common seal here Page 7 of 29 Shipping protocol template for avian influenza Annex 1. Hazard label and marking for Category B infectious substances UN 3373 cut along dotted lines cut along dotted lines BIOLOGICAL SUBSTANCE CATEGORY B UN 3373 ~50 mm x 50 mm Hazard label Marking Minimum dimension (air transport): length of each side of square is at least 50 mm Colour: none specified, contrasting colour to external surface of external packaging, clearly visible and legible Markings: BIOLOGICAL SUBSTANCE, CATEGORY B letters at least 6 mm high displayed adjacent to hazard label No. of labels per package: 1 No. of markings per package: 1 Page 8 of 29 Shipping protocol template for avian influenza Annex 2. Overpack hazard label cut along dotted lines OVERPACK Colour: none specified, contrasting colour to external surface of external packaging, clearly visible and legible No. of labels per package: 1 Page 9 of 29 Shipping protocol template for avian influenza Annex 3. Orientation label and marking cut along dotted lines cut along dotted lines THIS SIDE UP ~ 74 mm x 105 mm Minimum dimension: standard A7 (74 x 105 mm) Colour: green and white or green and black Markings: THIS SIDE UP or THIS END UP on top cover of package No. of labels per package: 2 on opposite sides Page 10 of 29 Shipping protocol template for avian influenza Annex 4. Other markings Cut along dotted line Sender’s name: Address: Contact person: Telephone #: Figure 2. Sender’s information template Cut along dotted line Receiver’s name: Address: Contact person: Telephone #: Figure 4. Receiver’s information template Cut along dotted line Emergency contact information: Responsible person: Telephone #: Figure 3. Responsible person information template Page 11 of 29 Shipping protocol template for avian influenza Annex 5. Pro forma invoice/packing list template Insert agency name here Insert agency logo here Insert agency address here SPECIMEN PACKING LIST Sender’s information: Receiver’s information: Number of packages: Detail of contents Quantity Description of primary receptacle Description of content Purpose/lab test Total weight of package: Value: NO COMMERCIAL VALUE Page 12 of 29 Shipping protocol template for avian influenza Annex 6. Import permit (ex. Australia – Queensland Department of Primary Industry) Page 13 of 29 Shipping protocol template for avian influenza Page 14 of 29 Shipping protocol template for avian influenza Page 15 of 29 Shipping protocol template for avian influenza Page 16 of 29 Shipping protocol template for avian influenza Annex 7. Import permit (ex. Australia – CSIRO Australian Animal Health Laboratory, Geelong) Page 17 of 29 Shipping protocol template for avian influenza Page 18 of 29 Shipping protocol template for avian influenza Annex 8. Export permit of local laboratory (if necessary) Page 19 of 29 Shipping protocol template for avian influenza Annex 9. Import and export declaration Page 20 of 29 Shipping protocol template for avian influenza Annex 10. Sender’s information sheet (ex. TNT) Annex 11. Airway bill (ex. Air Pacific) Page 21 of 29 Shipping protocol template for avian influenza Page 22 of 29 Shipping protocol template for avian influenza Annex 12. Spill clean-up procedure SPILL CLEAN-UP PROCEDURE (Adapted from WHO Guidance on Regulations for the Transport of Infectious Substances 2009–2010) The appropriate response in the event of exposure to any infectious substance is to wash or disinfect the affected area as soon as possible, regardless of the agent. Even if an infectious substance comes into contact with non-intact skin, washing of the affected area with soap and water or with an antiseptic solution can reduce the risk of infection. Medical advice should be obtained any time there is suspected exposure to an infectious substance resulting from a damaged package. The following procedure for clean-up can be used for spills of all infectious substances, including blood. 1. Wear gloves and protective clothing, including face and eye protection if indicated. 2. Cover the spill with cloth or paper towels to contain it. 3. Pour an appropriate disinfectant over the cloth or paper towels and the immediate surrounding area (5% bleach solutions are generally appropriate; for aircraft spills use quaternary ammonium disinfectant). 4. Apply the disinfectant concentrically, beginning at the outer margin of the spill area and working towards the centre. 5. After about 30 minutes, clear away the materials. If there is broken glass or other sharp objects are involved, use a dustpan or a piece of stiff cardboard to collect the materials and deposit them in a puncture-resistant container for disposal. 6. Clean and disinfect the area of the spillage (if necessary, repeat steps 2–5). 7. Dispose of contaminated materials into a leak-proof, puncture-resistant waste disposal container. 8. After successful disinfection, report the incident to the competent authority and inform them that the site has been decontaminated (see Incident Reporting, page 6). Detailed information on disinfectants and their recommended use can be found in Laboratory Biosafety Manual (3rd ed.), World Health Organization, Geneva, 2004. Page 23 of 29 Shipping protocol template for avian influenza Annex 13. Pathogen safety data sheet for avian influenza Pathogen Safety Data Sheet - Highly Pathogenic Avian Influenza (HPAI)1 SECTION I: DISEASE / INFECTIOUS AGENT SYNONYM / CROSS REFERENCE: bird flu, fowl plague ETIOLOGY / TAXONOMY (1,2): Family: Orthomyxoviridae Genus: Influenzavirus A, B All highly pathogenic isolates have been Influenza A viruses of subtypes H5 & H7 ORGANISM CHARACTERISTICS: single stranded, negative sense RNA virus, segmented, enveloped, highly pleiomorphic. low pathogenic strains may change rapidly through antigenic shift or drift to become highly pathogenic (1, 3, 4) described by hemagglutination (H) and neuraminidase (N) antigens (5) SURVEILLANCE : HPAI is a reportable disease in Canada. Animal owners, veterinarians and laboratories are required to immediately report the presence of an animal that is contaminated or suspected of being contaminated to a CFIA district veterinarian. Control or eradication measures will be applied immediately (http://laws.justice.gc.ca/en/H-3.3/fulltoc.html). DISTRIBUTION : worldwide low pathogenic strains may change rapidly through antigenic shift or drift to become highly pathogenic (1, 3, 4) SECTION II: ANIMAL HEALTH HAZARD AND EPIDEMIOLOGY CLINICAL DISEASE / PATHOGENESIS: 1) Clinical signs (1, 2, 6, 7): can range from mild disease with little or no mortality to highly fatal rapidly spreading epidemic sudden decrease in egg production swollen and cyanotic wattles and combs depression coughing and sneezing seroconversion 1 http://www.inspection.gc.ca/english/sci/bio/anima/disemala/avflue.shtml Page 24 of 29 Shipping protocol template for avian influenza 2) Infectious dose: Unknown 3) Incubation period: short 3-5 days (1, 2) SOURCE / MODE OF TRANSMISSION / COMMUNICABILITY: contact with wild birds (especially waterfowl) and their faeces (1) contact with infected poultry and poultry products, contaminated clothing, footwear, vehicles, equipment and feed (1, 6) VECTORS: none HOST RANGE : migratory waterfowl natural host range (especially ducks) (8) all species of birds susceptible (including chickens, turkeys, pet birds and wild birds)(1) humans other known species: cats, dogs, pigs ZOONOSIS : HPAI virus can be transmitted to humans, however the transmission occurred in rare cases where people had prolonged contact with heavily contaminated environments (6). RESERVOIR : generally waterfowl Section III: DIAGNOSIS NECROPSY / HISTOPATHOLOGY FINDINGS (1, 2, 3): vascular disturbances leading to edema, hemorrhage especially in myocardium, spleen, lungs, brains and wattles necrotic foci present in lungs, liver and kidneys LABORATORY DIAGNOSIS (3): haemagglutination immunofluorescence ELISA serotyping PCR gene sequencing DRUG SUSCEPTIBILITY: for humans: Influenza A susceptible to amantadine and rimantadine (not licenced for use in food animals) (4, 5). vaccination may be used to supplement control measures (4). DIFFERENTIAL DIAGNOSIS: The following diseases may show clinical similarity to HPAI. Associated with high mortality: Newcastle disease Infectious laryngotracheitis Duck plague Acute poisoning Associated with swelling of combs and wattles: Bacterial cellulitis of combs and wattles Acute fowl cholera SECTION IV: DECONTAMINATION PROCEDURES Page 25 of 29 Shipping protocol template for avian influenza Select a registered disinfectant with a drug identification number (DIN). Use according to label directions for concentration and contact time. Consider organic load and temperature. It is recommended that laboratories evaluate the effectiveness of the disinfectant using a validated method (e.g. Quantitative Carrier Test). See table 1 to help select a registered disinfectant for use against HPAI virus. ACTIVE INGREDIENT CONCENTRATION CONTACT TIME Oxidising agents: Sodium Hypochlorite 10,000 ppm (1%) 10 minutes (9) Alcohols: ethanol 70% 10 minutes (9) Synthetic phenols: Ortho phenylphenol 1200 ppm 10 minutes (9) Quaternary ammonium salts: Benzalkonium chloride 1000 ppm 10 minutes (9) PHYSICAL INACTIVATION: (1) Temperature pH 121ºC for 15 minutes (autoclaving) 56ºC for 3 hours 60ºC for 30 minutes inactivated by acid pH SURVIVAL OUTSIDE OF HOST: remains viable for long periods in tissues, feces and water (manure 105 days, dried mucous several hours) (7, 5). SECTION V: LABORATORY HAZARDS FOR HUMANS LABORATORY ACQUIRED INFECTIONS: No documentation of laboratory acquired infections but there are informal accounts (5) BIOSAFETY PRECAUTIONS : Avoid any direct contact with virus, especially through feces (3). Limit the generation of aerosols (5, 3). SECTION VI: PHYSICAL AND OPERATIONAL REQUIREMENTS CONTAINMENT REQUIREMENTS: All physical containment and operational practices for containment level 3, indigenous agents, as per the Containment Standards for Veterinary Facilities must be met. The Standards can be accessed at : http://www.inspection.gc.ca/english/sci/lab/convet/convete.shtml. PROTECTIVE CLOTHING: Laboratory: Page 26 of 29 Shipping protocol template for avian influenza Primary layer of protective clothing should include dedicated laboratory clothing (e.g. scrubs and headwear) and laboratory dedicated footwear. Secondary layer of protective clothing (e.g. solid-front gowns with tight-fitting wrists, 2 pairs of gloves) should be worn over laboratory clothing when directly handling infectious materials. Adequate respiratory protection should be worn when directly handling infectious material outside BSC. When full body protective clothing is not worn a shower is required on exit; where a known or suspected aerosol exposure has occurred a shower is required on exit. Post Mortem: Primary layer of protective clothing should include dedicated laboratory clothing (e.g. scrubs and headwear) and laboratory dedicated footwear. Secondary layer of protective clothing (e.g. solid-front gowns with tight-fitting wrists, 2 pairs of gloves) should be worn over laboratory clothing when directly handling infectious materials. Cut resistant gloves, adequate respiratory protection, steel toed/steel shanked rubber boots. A shower is required on exit. HANDLING INFORMATION: Spills in laboratory: Allow aerosols to settle; wearing appropriate personal protective equipment (PPE), gently cover spill with absorbent paper towel and apply 2% sodium hypochlorite, starting at perimeter and working towards the centre; allow 30 minutes contact time (4). Spill protocol must be in place and include the following scenarios: spills inside the Biological Safety Cabinet (BSC) spills outside the BSC spills while performing aerosol generating procedures also consider entry and exit procedure modifications if necessary, appropriate PPE, disinfection of spill and surroundings including contact time, flow (pattern) of the clean up and disposal of contaminated materials. Refer to Table 1 for inactivation of HPAI. STORAGE: All cultures and infected material should be stored in leakproof, sealed containers that are accurately labeled and clearly identified as a biohazard risk. The access to infectious material should be controlled at all times. Records must be kept to describe the use, inventory and disposal of infectious material. DISPOSAL: Decontaminate all infectious material prior to disposal. Use steam sterilization, incineration or chemical disinfection. REFERENCES: Page 27 of 29 Shipping protocol template for avian influenza 1. 2. 3. 4. 5. 6. 7. 8. 9. Highly pathogenic avian influenza technical card, Office International des Epizooties updated 22-042002, http://www.oie.int/eng/maladies/fiches/a_A150.htm AusVetPlan, Edition 2.0, 1996: http://www.animalhealthaustralia.com.au/shadomx/apps/fms/ fmsdownload.cfm?file_uuid=D4552211-C369-9A31-F51B3DB61D0CCB39&siteName=aahc Avian Influenza animal health disease card, Food Agriculture Organization of the United Nations, http://www.fao.org/ag/againfo/subjects/en/health/diseases-cards/ avian.html Zoonoses and Communicable Diseases Common to Man and Animals, Second Edition, PAHO publication # 503 Influenza virus MSDS, Public Health Agency of Canada, May 2000, http://www.phac-aspc.gc.ca/msdsftss/msds88e.html Avian Influenza fact sheet, Animal Health CFIA, April 2003, http://www.inspection.gc.ca/english/anima/heasan/disemalae.shtml Avian Influenza fact sheet, UC Davis Veterinary Medicine, http://www.vetmed.ucdavis.edu/vetext/INF-PO_AvianInfluenzaFS.html Avian Influenza fact sheet WHO, http://www.who.int/csr/disease/avian_influenza/avian_faqs/ en/index.html Prince H, Prince D, Principles of Viral Control and Transmission. In: Block SS, ed. Disinfection, Sterilization and Preservation, Fifth Edition, 2001:543-571 LAST UPDATED (DATE): March 30th, 2005 PREPARED BY: The Biohazard Containment and Safety Unit, CFIA Disclaimer: Although the information and recommendations in this Pathogen Safety Data Sheet are compiled from reliable sources, there is no guarantee, warranty or any assurance that the information and recommendations are correct, accurate, sufficient, reliable or current and the Canadian Food Inspection Agency shall not be responsible for any loss or damage resulting from or in connection with the use of or reliance upon the information and recommendations. The user assumes all risks and responsibility for and shall be liable for the use of and any reliance on the information and recommendations and the results thereof and any loss or damage resulting therefrom. Main Page - Avian Influenza Page 28 of 29 Shipping protocol template for avian influenza Annex 14. Example of contact list of collaborating laboratories and agencies Name of agency Contact person/title Secretariat of the Pacific Community Animal Health & Production Team Dr Elva Borja Animal Health Laboratory Scientist Contact details 3 Luke Street, Nabua, Fiji Tel: +679 337 0733 ext.284 Fax: +679 337 0721 24hr: +679 974 7840 Email: elvab@spc.int Reference animal health laboratory Referral animal health laboratory WHO Public Health Office Page 29 of 29 Shipping protocol template for avian influenza