Fill and Sign the Tsa 403b Policy Loan Request Form Bis

Frequently Asked Questions concerning Etiologic Agent Import Permits What type of material requires an Etiologic Agent Import Permit? Etiologic Agents – a microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment. Materials would include unsterilized specimens of human and animal matter including tissue, blood, body discharges, fluids, excretions or similar material, when known or suspected of containing a biological organism capable of causing disease in humans. Animals – Any animal capable of being a host or vector of human disease. Arthropods – Any living insect including crustaceans, spiders, scorpions, etc. capable of being a host or vector of human disease. Snails – Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis. Bats – All live bats. See below for further information on obtaining an import permit for live bats. Bats may also require a permit from the U.S. Department of Interior, Fish and Wildlife Service. For additional information, see http://www.fws.gov/permits/importexport/importexport.shtml Non-human primate material – all non-human primate material (e.g. blood, plasma, tissue, urine, feces) requires an import permit, unless it has been specifically treated and rendered non-infectious. Please note that the described material may require a permit from the United States Department of Agriculture(USDA)/Animal and Plant Health Inspection Service (APHIS) or be prohibited from importation under the USDA regulations. Information on USDA transport or import permits is available at: http://www.aphis.usda.gov/import_export/index.shtml. Is a USDA permit also required for pandemic novel H1N1 influenza virus strains? Yes. The novel H1N1 influenza virus has genetic components of both swine and avian influenza viruses in it which result in causing infections in those species. APHIS has authority over all organisms which cause or have the potential to cause disease in animals, and so they do issue permits for novel H1N1 influenza. For further information, contact APHIS at 301-734-3277. What are the requirements for importation of live bats into the U.S.? An importer must demonstrate appreciation for the many risks which bats pose to the public health and all efforts taken to protect the importer and the public from such risks. In order to make the determination that an importer will protect public health, through this notice, and in addition to a completed application, CDC requires: a. A Standard Operating Procedure (SOP) describing how the bats will be cared for, what personal protective equipment (PPE) will be worn during care, how the cages and exhibit will be cleaned and how the waste will be handled for both the quarantine period and post quarantine; b. An SOP describing how the bats will be contained and how escapes will be prevented; c. An SOP for veterinary care, including procedures for what will be done with sick or dead bats, including a necropsy when a bat dies; d. An SOP of an Occupational Health Plan including a risk assessment for exposure and a plan should an exposure occur; e. An SOP explaining that the bats will not be re-distributed after importation; and f. An SOP detailing what will be done with the Bats when they are no longer being used for Science, Education, or Exhibition. What type of material does NOT require an Etiologic Agent Import Permit? Non-infectious materials – e.g., formalin-fixed specimens, tissues, or slides, or noninfectious human stem cells or non-infectious human organs for transplantation. Human or animal diagnostic specimens such as blood, urine, and tissues in which there is no evidence or indication that such material contain an infectious agent. Note that specimens from humans may be subject to the Bloodborne Pathogens Standard (29 C.F.R. 1910.1030) and that specimens from animals may require a permit from APHIS. Laboratory mice, rats, and hamsters reared under specific pathogen-free (SPF) conditions. In addition, genetically altered animals (e.g., “knockout” or “transgenic”) do not require a CDC import permit provided that the animals contain no pathogens known to be transmissible to humans. NOTE: If the rodents are to be imported from Africa or are species of African origin, they may only be imported for scientific, education, or exhibition purposes with permission granted from CDC’s Division of Global Migration and Quarantine. Information regarding DGMQ is available at: http://www.cdc.gov/ncidod/dq/index.htm. Fully taxidermied or treated non-human primates trophies, skins, or skulls – any nonhuman primates trophies, skins or skulls that have been either fully taxidermied or treated to render them non-infectious may be imported without a CDC import permit. CDC advises that importers of materials that do not require a CDC import permit include a signed statement, on their official letterhead, from the person responsible for the shipment of this material with the following information: (a) A description of the material; (b) A statement that this material meets one of the above criteria (e.g., human urine diagnostic specimens in which there is no evidence that such material contain an etiologic agent); and, (c) Verification that the material has been packaged, labeled, and transported in accordance with all applicable regulations. Where can I find the import permit application? Application forms are available at the following link: CDC - EAIPP-Import Permit Applications or www.cdc.gov/od/eaipp/ A guidance document for applicants filling out the import permit application is available here: CDC - EAIPP-Guidance or www.cdc.gov/od/eaipp/forms/Guidance_Document_for_the_Completion_of_EAIPP_for m_03-15-10.pdf How do I submit the import permit application? Completed applications may be submitted by EITHER mail, fax or e-mail to: Centers for Disease Control and Prevention Etiologic Agent Import Permit Program 1600 Clifton Road NE, Mailstop A-46 Atlanta, GA 30333 FAX: 404-718-2093 Email: importpermit@cdc.gov NOTE: It is not necessary to mail in the original copy of a permit application after submission via fax or e-mail.Is there a fee for obtaining a CDC import permit? No. Currently, there is no fee for processing a CDC import permit. Is a CDC import permit required for the interstate transfer of an etiologic agent? It depends on the material to be transferred. An additional CDC import permit will be required if the original CDC import permit had as a condition of issuance that any subsequent transfer of the material would require a permit. What are the responsibilities of the importer once an import permit has been issued? The CDC import permit is issued only to the importer located in the United States. The importer is responsible for assuring that the foreign personnel package, label, and ship the infectious material according to Federal regulations and international standards. Shipping labels with the universal biohazard symbol and a copy of the issued CDC import permit should accompany the package being imported into the United States. The permit and labels inform the U.S. Customs and Border Protection personnel and quarantine officers of the package contents. Please see below for further details on package labeling and other shipping requirements. I have an existing import permit that is about to expire. How do I request a renewal? All requests for renewal of an existing import permit require the submission of a new application and current signature of the permittee. To prevent lapses in the import permit status, it is recommended that permit renewal applications be submitted at least 30 days prior to the expiration date on the current permit. Are there any restrictions on material that can be imported into the United States? The importation of specific animals and animal products from specific geographical areas into the United States is currently restricted. For more information on the current list of embargoed items, go to www.cdc.gov/od/eaipp/embargoes.htm. What are some of the specific measures required to ensure that infectious substances are shipped safely? Department of Transportation Hazardous Materials Regulations (49 CFR Parts 171-180) The Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) has specific requirements for transporting infectious substances safely by motor vehicle, railcar, vessel, and aircraft. These requirements must be followed by domestic and international shippers and carriers. They also contain provisions on how to apply international regulations for hazardous materials. PHMSA’s requirements for infectious substances are outlined below and explained in detail in the Department of Transportation (DOT) publication, “Transporting Infectious Substances Safely.” Category A Infectious Substances Category A infectious substances are capable of causing permanent disability, life threatening or fatal disease to humans or animals when exposure to them occurs. Category A infectious substances have two shipping names: “Infectious substances, affecting humans (UN 2814)” or “Infectious substances, affecting animals (UN 2900).” Examples of Category A substances can be found in the DOT publication “Transporting Infectious Substances Safely.” Packaging of Category A Infectious Substances Category A infectious substances must be shipped in a triple package that consists of a watertight primary receptacle or receptacles; a watertight secondary packaging (for liquid materials, the secondary packaging must contain absorbent material in sufficient quantities to absorb the entire contents of the primary receptacles); and a rigid outer packaging which must be of adequate strength for its capacity, mass, and intended use. Page 29 of the DOT “Transporting Infectious Substances Safely” document provides a diagram of how to properly package a Category A infectious substance. The maximum quantity of Category A infectious substance that can be shipped by air in one package is 4 L or 4 kg. The maximum allowable quantity on passenger aircraft is 50 ml or 50 g. Labeling of Category A Infectious Substances The outer container of all Category A infectious substance packages must display the following on one side of the package: Sender’s name and address Recipient’s name and address Infectious substance label Proper shipping name, UN number, and net quantity of infectious substance Name and telephone number of person responsible for shipment Cargo Aircraft Only label when shipping over 50 ml or 50 g Class 9 label, including UN 1845, and net weight if packaged with dry ice and identified as Carbon Dioxide, solid Category B Infectious Substances Category B infectious substances are infectious substances 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. Category B infectious substances have the proper shipping name “Biological Substance, Category B” and the identification number UN 3373. Packaging of Category B Infectious Substances Category B infectious substances must be shipped in a triple package consisting of a leak proof primary receptacle or receptacles; leak proof secondary packaging (for liquid materials, the secondary packaging must contain absorbent material in sufficient quantities to absorb the entire contents of the primary receptacles); and rigid outer packaging. Page 31 of the DOT “Transporting Infectious Substances Safely” document provides a diagram of how to properly package a Category B infectious substance. The maximum quantity for a primary receptacle is 500 ml or 500g and outer packaging must not contain more than 4 L or 4 kg. Labeling of Category B Infectious Substances The outer container of all Category B infectious substance packages must display the following on one side of the package: Sender’s name and address Recipient’s name and address The words “Biological Substance, Category B” UN 3373 label Class 9 label, including UN 1845, and net weight if packaged with dry ice and identified as Carbon Dioxide, solid Diagnostic/Clinical Specimens Any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposed, but excluding live infected animals. Diagnostic specimens must be assigned to UN3373 unless the source patient or animal has or may have a serious human or animal disease which can be readily transmitted form one individual to another, directly or indirectly and for which effective treatment and preventable measures are not usually available in which case they must be assigned to UN2814 or UN 2900 and shipped as a Category A infectious substance. Packaging of Diagnostic/Clinical Specimens Diagnostic and clinical specimens must be shipped in a triple package consisting of a leak proof primary receptacle or receptacles; leak proof secondary packaging (for liquid materials, the secondary packaging must contain absorbent material in sufficient quantities to absorb the entire contents of the primary receptacles); and rigid outer packaging. Page 31 of the DOT publication “Transporting Infectious Substances Safely” document provides a diagram of how to properly package a Diagnostic Specimen. The maximum quantity for a primary receptacle is 500 ml or 500g and outer packaging must not contain more than 4 L or 4 kg. Labeling of Diagnostic/Clinical Specimens The outer container of all diagnostic/clinical specimen packages must display the following on one side of the package: Sender’s name and address Recipient’s name and address The words “Biological Substance, Category B” UN 3373 label Class 9 label, including UN 1845, and net weight if packaged with dry ice and identified as Carbon Dioxide, solid Biological Products The DOT regulations (49 CFR 173.134(a)(2), http://edocket.access.gpo.gov/cfr_2007/octqtr/pdf/49cfr173.134.pdf) describe a biological product as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals. These are products derived from living organisms that are manufactured and distributed in accordance with special licensing requirements, and are used either for prevention, treatment or diagnosis of disease in human or animals, or for development, experimental or investigational purpose. They include, but are not limited to, finished or unfinished products such as vaccines and diagnostic products. Packaging, Labeling and Shipping of Biological Materials A biological product that is suspected to contain a pathogen that meets the definition of a Category A or B infectious substance must be assigned to UN 2814, UN 2900, or UN 3373 as appropriate and shipped and packaging in accordance with those criteria. Biological products transported for final packaging, distribution, or uses by medical professionals are not subject to shipping regulations. Genetically Modified Organisms and Micro-organisms These are microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. They are divided into the following categories: 1. Genetically modified microorganisms, which meet the definition of an infectious agent, must be classified as Category A or Category B and assigned UN 2814 or UN 2900. 2. Animals, which contain or are contaminated with genetically modified microorganisms or organisms that meet the definition of an infectious substance. They must not be transported by air unless exempted by the States concerned. 3. Genetically modified organisms, which are known or suspected to be dangerous to humans, animals or the environment, must not be transported by air unless exempted by the States concerned. 4. Except when authorized for unconditional use by the states of origin, transit, and destination, genetically modified microorganisms which do not meet the definition of infectious substances but which are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction must be classified as Class 9. Genetically modified organisms, which do not meet the definition of an infectious substance and which are not otherwise included under (a) to (d) above, are not subject to these regulations. Packaging of Genetically Modified Organisms and Micro-organisms These materials must be packaged in the same manner as Category B infectious substances except there are no testing requirements for the packaging. The maximum allowable quantity per primary receptacle is 100 ml or 100 g. There is no maximum net quantity per package. Labeling of Genetically Modified Organisms and Micro-organisms The outer container of a genetically modified organism assigned to UN 3245 must have the following labels: Sender’s name and address Recipient’s name and address Class 9 label Definitions of Watertight/Leakproof Although the PHMSA’s Hazardous Materials Regulations (HMR; 49 CFR Parts 171180), do not specifically define the terms “watertight” and “leakproof,” these terms under the HMR essentially mean the receptacles and packaging are designed and constructed in a manner that does not permit a liquid material to enter or escape. These regulations are available electronically at the U.S. Government Printing Office’s website at: http://ecfr.gpoaccess.gov/cgi/t/text/textidx?sid=585c275ee19254ba07625d8c92fe925f&c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2 _02.tpl. What happens if a package containing an etiologic agent is lost or damaged during shipment? Requirements for All Infectious Substances The DOT regulations (49 CFR 171.15 and 171.16) require each person in physical possession of a hazardous material, including an infectious substance, to report specific types of transportation incidents that involve these materials. Immediate reporting by telephone (1-800-424-8802) is required for incidents where fire, breakage, spillage, or suspected contamination occurs that involves the shipment of infectious substances other than a patient specimen or regulated medical waste (See 49 CFR 171.15(b)(3)). In addition, a written report to DOT is required within 30 days of the discovery of the incident for any unintentional release of hazardous material from a packaging during transportation, including those covered under 49 CFR 171.15 (See 49 CFR 171.16(a)). DOT regulations also require packages that contain infectious substances to be accompanied by several forms of hazard communication, as applicable, as well as labeled to indicate the infectious hazard (See 49 CFR 172.432 for a depiction of the required label). This label currently includes a statement for reporting a damaged package. The WHO “Guidance on Regulations for the Transport of Infectious Substances,” September 2005, also provides specific recommended procedures for spill cleanup. This guidance is available to the agencies that govern land, vessel, and air shipments. The recommended procedures reflect those contained in the WHO Laboratory Biosafety Manual, Third Edition, 2004. What is the status of the Department of Health and Human Services’ (HHS) Transportation Regulation (42 CFR 72: Interstate Shipment of Etiologic Agents)? HHS has removed Part 72 of Title 42, Code of Federal Regulations because DOT already has in effect a more comprehensive set of regulations applicable to the transport of infectious substances in commerce. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescission of the rule eliminated duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, commercial transport. What are the specific regulations that govern the shipment of infectious substances? There are several domestic and international regulations that govern the shipment of infectious substances. These include: Domestic Regulations Department of Transportation. 49 CFR Part 171-180, Hazardous Materials Regulations. Applies to the shipment of infectious substances in commercial transportation to, from, or within the United States. These regulations also authorize, with certain conditions and limitations, the commercial transportation of hazardous materials in accordance with the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), the International Maritime Dangerous Goods Code (IMDG Code), Transport Canada's Transportation of Dangerous Goods Regulations (Transport Canada TDG Regulations), and the International Atomic Energy Agency Regulations for the Safe Transport of Radioactive Material (IAEA Regulations). See 49 CFR 171.12(a) and 49 CFR Part 171, Subpart C. Information on these regulations may be obtained by calling (800) 467-4922 (Toll free) or (202) 366-4488 from 9:00 AM to 5:00 PM Eastern time, or at the Internet website: http://www.phmsa.dot.gov/hazmat. United States Postal Service (USPS). 39 CFR Part 20, International Postal Service (International Mail Manual), and Part 111, General Information on Postal Service (Domestic Mail Manual). Regulations on transporting infectious substances through the USPS are codified in Section 601.10.17 of the Domestic Mail Manual and Section 135 of the International Mail Manual. A copy of the Domestic and International Mail Manuals may be obtained from the Government Printing Office by calling Monday through Friday, 7:30 a.m. - 9:00 p.m. EST: (202) 512-1800 or (866) 512-1800 (Toll free). The Domestic Mail Manual can be found on the Internet at: http://pe.usps.gov/text/dmm300/dmm300_landing.htm. The International Mail Manual can be found at http://pe.usps.gov/text/imm/welcome.htm. Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens. These regulations provide minimal packaging and labeling for blood and body fluids when transported within a laboratory or outside of it. Information may be obtained from your local OSHA office or from the Internet website: http://www.osha.gov/. International Regulations Technical Instructions for the Safe Transport of Dangerous Goods by Air (Technical Instructions). International Civil Aviation Organization (ICAO). Applies to the shipment of infectious substances by aircraft and is recognized in the United States and by most countries worldwide. The HMR recognize and authorize the Technical Instructions as an alternative to complying with the HMR for packaging, marking, labeling, classifying, and describing hazardous materials transported by aircraft and by motor vehicle either before or after being transported by aircraft. See 49 CFR Part 171, Subpart C. A copy of these regulations may be obtained from the ICAO Document Sales Unit at (514) 954- 8022, Fax: (514) 954-6769, E-Mail: sales_unit@icao.int, or from the Internet website: http://www.icao.int. Dangerous Goods Regulations. International Air Transport Association (IATA). These instructions are issued by an airline association, based on the ICAO Technical Instructions, and followed by most airline carriers. However they do not have official standing under the HMR. A copy of these regulations can be obtained from the Internet websites: http://www.iata.org/index.htm or http://www.who.int/en/, or by contacting the IATA Customer Care office at: Tel: (514) 390-6726 or (800) 716-6326 (Toll free), Fax: (514) 874-9659, or E-mail: custserv@iata.org. The International Maritime Dangerous Goods Code. International Maritime Organization (IMO). This code is of mandatory application for all 155 contracting parties to the International Convention for the Safety of Life at Sea (SOLAS). Information on this code can be found at http://www.imo.org/home.asp. The Letter Post Manual. Universal Postal Union (UPU). This manual reflects the United Nations Recommendations using the ICAO provisions as the basis for shipments. The manual can be found at http://www.upu.int/acts/en/2_letter_en.pdf.