Mount Sinai Medical Center Environmental Health & Safety (EnvHS)
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1 Mount Sinai Medical Center Environmental Health & Safety (EnvHS) Chemical / Infectious / Biological and Radiological Materials Shipment Approval Form I. GENERAL INFORMATION Shipment Date Requestor s Name Department / Laboratory Department Chairman Department Administrator II. SHIPMENT INFORMATION (See Notes) CHEMICAL (including Dry Ice, Liquid Nitrogen) Material Name (no abbreviations, acronyms): INFECTIOUS (Category A / B) Category A (UN2814) Infectious to Humans *See Note (B)(1) Type of Virus (no abbreviations, acronyms): Category A (UN2900) Infectious to Animals *See Note (B)(2) Type of Virus (no abbreviations, acronyms): (Circle One) Category B (UN3373) Infectious (Not CAT A) *See Note (C)(1) Type of Virus (no abbreviations, acronyms): Version IV 2-Nov-10 Page 1
2 PATIENT SPECIMENS Exempt Human Specimen Not Infectious *See Note (D) & Page 6 Name / Type of Specimen (no abbreviations, acronyms): Exempt Animal Specimen Not Infectious *See Note (D) & Page 6 Name / Type of Specimen (no abbreviations, acronyms): OTHER SHIPMENTS Biological Product Not Infectious / Not Regulated *See Note (E)(1) Name of Product (no abbreviations, acronyms): Radioactive Material *See Note (F) Isotope Name (no abbreviations, acronyms): Transportation by: Specific Activity (mcurries / gram) Total Activity (mcurries) Half Life ( Number of Months / Years) III. SHIPMENT DESTINATION Consignee Full Name: Institution Name: Address: Country: Telephone: Additional Information: Version IV 2-Nov-10 Page 2
3 IV. DEPARTMENT APPROVAL Principal Investigator: Date: Signature: V. ENVIRONMENTAL HEALTH & SAFETY APPROVAL EnvHS Authorized Shipper: Date: Signature: EnvHS MUST REVIEW & APPROVAL THIS FORM PRIOR TO ANY EXTERNAL SHIPMENT AS DEFINED IN THE FOLLOWING NOTES & DEFINITIONS: Notes & Definitions: A. Division 6.2 (INFECTIOUS SUBSTANCE) means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion), that can cause disease in humans or animals. An infectious substance must be assigned to one of the categories that follow: B. Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. Assignment to one of the UN classes below must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgement concerning the individual circumstances of the source human or animal. Examples that are indicative of substances included in Category A are included in Appendix A. 1. UN2814 Infectious substances that infect humans Examples: *Hepatitis B virus (cultures only) *Variola virus *West Nile virus (cultures only) i. The Correct Shipping Name is Infectious substance, affecting humans 2. UN2900 Infectious substances that infect animals Examples: *Classical swine flu virus (culture only) *Foot & Mouth disease virus (culture only) i. The Correct Shipping Name is Infectious substance, affecting animals Version IV 2-Nov-10 Page 3
4 C. Category B: An infectious substance which does not meet the criteria for inclusion in Category A. 1. UN3373 An infectious substance that IS NOT in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes. Examples: *A blood sample from a patient known / suspected of having Hepatitis B virus or HIV *A culture of Bovine Tuberculosis Laboratory stock culture of circulating Influenza virus. i. The Correct Shipping Name is Biological substance Category B D. Patient specimens for which there is minimal likelihood that pathogens are present are to be packed in a packaging which will prevent any leakage and which is marked with the words Exempt human specimen or Exempt animal specimen as appropriate. E. Biological Products are divided into the following groups: 1. Those which are manufactured and packaged in accordance with the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution and used for personal health care by medical professionals or individuals. This group is NOT SUBJECT TO REGULATION. 2. Those which do not fall under paragraph (1) and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B. Substances in this group must be assigned UN2814, UN2900 or UN3373 as appropriate. F. Radioactive Material means any material containing radionuclides where both the activity concentration and the total activity in the consignment exceed the values specified in IATA G. For Biological Materials, both Category A & B shipments overseas, the MSMC / Requestor MUST have a Department of Commerce Export Permit. H. You must use full Chemical / Infectious / Biological / Radiological names NO abbreviations. I. Environmental Health & Safety will complete all appropriate regulatory and courier documentation upon review and approval of the above shipment information. J. All shipment approval forms will be filed by Originating Department for future auditing and monitoring. K. Submit this completed form for an initial review by sending via to askehs@mssm.edu at least 24 hours prior to desired shipping date. Please contact Mark Matthews (x 45909), Phil Hauck (x45169) or Walter Julias (x2846) for any questions regarding completion of this form. Bring the completed form, package and any other shipment related documentation to the Centralized Shipping Area for final approval. Version IV 2-Nov-10 Page 4
5 ADDITIONAL DEFINITIONS: a. Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include human or animal patient specimens. b. Patient specimens are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. EXCEPTIONS: a. Substances, which do not contain infectious substances, or substances, which are unlikely to cause disease in humans or animals, are not subject to the ICAO Technical Instructions unless they meet the criteria for inclusion in another class. b. Substances containing microorganisms which are non-pathogenic to humans or animals are not subject to the ICAO Technical Instructions unless they meet the criteria for inclusion in another class. c. Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to the ICAO Technical Instructions unless they meet the criteria for inclusion in another class. d. Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are not subject to the ICAO Technical Instructions unless they meet the criteria for inclusion in another class. e. Dried blood spots, collected by applying a drop of blood onto absorbent material, or fecal occult blood screening tests and blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation are not subject to the ICAO Technical Instructions. f. Patient specimens for which there is minimal likelihood that pathogens are present are not subject to the ICAO Technical Instructions if the specimen is transported in Packaging for Exempt Patient Specimens (See below for the Packaging requirements for Exempt Patient Specimens.) Note: In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgement is required. That judgement should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Examples of specimens which may be transported as a patient specimen for which there is a minimal likelihood that pathogens are present include blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antibodies (PSA); tests required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring; tests conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy tests; biopsies to detect cancer; and antibody detection in humans or animals. Version IV 2-Nov-10 Page 5
6 PACKAGING FOR EXEMPT PATIENT SPECIMENS: Patient specimens (human or animal) that have a minimal likelihood of containing pathogens must be packaged appropriately to further minimize the risk of exposure. While these specimens have a minimal likelihood of containing infectious pathogens in a form that would cause infection, appropriate packaging further minimizes the risk of exposure. Effective with the publication of Addendum No. 2, dated 30/6/05, the ICAO Technical Instructions require exempt human or animal specimens to be packaged and marked according to the following: (i) a leak-proof primary receptacle(s); (ii) a leak-proof secondary packaging; and (iii) an outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100 mm 100 mm; For liquids, absorbent material in sufficient quantity to absorb the entire contents must be placed between the primary receptacle(s) and the secondary packaging so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material. When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. If such a packaging is used it must be marked "Exempt human specimen" or "Exempt animal specimen", as appropriate. If other dangerous goods (i.e., Dry Ice) are present with patient specimens the relevant provisions of regulations apply to those goods. Version IV 2-Nov-10 Page 6
7 CLASSIFICATION SCENARIOS: a. A blood sample known or reasonably suspected to contain EBOLA VIRUS. Appropriate classification: Infectious Substances, affecting humans UN b. A culture of FOOT AND MOUTH DISEASE. Appropriate classification: Infectious Substances, affecting animals, UN c. A blood sample taken from a patient known or suspected to have a Category B pathogen, such as HEPATITIS B or HIV. Appropriate classification: Biological Substances, Category B*, UN d. Culture of BOVINE TUBERCULOSIS. Appropriate classification: Biological Substances, Category B*, UN e. Laboratory stock culture of a pathogen in Category B, e.g. INFLUENZA VIRUS. Appropriate classification: Biological Substances, Category B*, UN f. Specimen containing a Category A or B infectious substance, treated so as to inactivate or neutralise the pathogens such that they no longer pose a health risk. Appropriate classification: Not subject to the transport requirements for dangerous goods, unless meeting the criteria for another class or division. g. Patient specimens other than those known or reasonably suspected to contain a Category A infectious substance e.g. those sent for testing for Cholesterol (blood), diabetes (urine), bowel cancer (faecal). Appropriate classification: this will depend on professional judgement: (i) If a professional judgement is made that there is only a minimal likelihood that pathogens are present, the specimen is not subject to the provisions of the regulations, providing they are packed in accordance with the provisions detailed under Packaging for Exempt Patient Specimens. (ii) If no professional judgement is made, the specimen must be classified as UN3373, Biological substance Category B. Version IV 2-Nov-10 Page 7
8 APPENDIX A INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES ASSIGNED TO CATEGORY A These entries are for infectious substances carried in any form, unless otherwise indicated. Note: 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, must be transported as a Category A infectious substance. In addition, if there is doubt as to whether or not a pathogen falls within this category it must be transported as a Category A infectious substance. UN2814 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 haemorrhagic fever virus Dengue virus (cultures only) Eastern equine encephalitis virus (cultures only) Escherichia coli, verotoxigenic (cultures only) * Ebola virus Flexal virus Francisella tularensis (cultures only) Guanarito virus Hantaan virus Hantavirus causing haemorrhagic fever with renal syndrome Hendra virus Hepatitis B virus (cultures only) Herpes B virus (cultures only) Human immunodeficiency virus (cultures only) Highly pathogenic avian influenza virus (cultures only) Japanese Encephalitis virus (cultures only) Junin virus Kyasanur Forest disease virus Lassa virus Machupo virus Marburg virus Monkeypox virus Mycobacterium tuberculosis (cultures only) * Nipah virus Omsk haemorrhagic fever virus Version IV 2-Nov-10 Page 8
9 Poliovirus (cultures only) Rabies virus (cultures only) Rickettsia prowazekii (cultures only) Rickettsia rickettsii (cultures only) Rift Valley fever virus (cultures only) Russian spring-summer encephalitis virus (cultures only) Sabia virus Shigella dysenteriae type 1 (cultures only) Tick-borne encephalitis virus (cultures only) Variola virus Venezuelan equine encephalitis virus (cultures only) West Nile virus (cultures only) Yellow fever virus (cultures only) Yersinia pestis (cultures only) UN 2900 INFECTIOUS SUBSTANCE AFFECTING ANIMALS only: African swine fever virus (cultures only) Avian paramyxovirus Type 1 - Velogenic Newcastle disease virus (cultures only) Classical swine fever virus (cultures only) Foot and mouth disease virus (cultures only) Lumpy skin disease virus (cultures only) Mycoplasma mycoides - Contagious bovine pleuropneumonia (cultures only) Peste des petits ruminants virus (cultures only) Rinderpest virus (cultures only) Sheep-pox virus (cultures only) Goatpox virus (cultures only) Swine vesicular disease virus (cultures only) Vesicular stomatitis virus (cultures only) Version IV 2-Nov-10 Page 9
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