Welcome to the Occupational Health and Safety Shipping Infectious Substances, course. This is the PDF version of the online course. A glossary is located at the end of this document and on the OH&S website. Terms from this glossary will be on the quiz. When shipping Infectious Substances, you are bound by regulations that come from several national and international agencies as well as governing bodies. Even though there are multiple agencies and regulations, they have been coordinated (or harmonized) to cause as little confusion as possible. These regulatory bodies ensure that infectious substances or materials are transported as safely as possible, most notably, by air. In the United States, these regulations are federal law. Failure to comply with these laws can mean fines and/or imprisonment. Regarding the shipping and receiving of Infectious Substances,, the University of Alabama at Birmingham follows both the International Air Transportation Association Dangerous Goods Regulations and the United States Department of Transportation Hazardous Materials Title 49 Code of Federal Regulations Parts 171-180. Course Materials Page 1 Last Updated: 07/02/2012
Title 49 Code of Federal Regulations (49CFR 171.8) and IATA 1.0 define a Dangerous Good (DG or DGs) as a substance or material which has been determined by the Secretary of Transportation to be capable of posing an unreasonable risk to health safety and property when transported in commerce and which are shown in the list of dangerous goods in the IATA DGR or which fall under the classifications according to the DGR. (Paraphrased from the CFR) A PDF chart of the Dangerous Goods List (DGR) can be found on home page of this course and on the OH&S website. Any UAB employee who participates in the shipping process for an Infectious Substances, must complete training every two years or if regulations change. The shipping process can include packaging, preparing the paperwork, assembling the package, labeling, or any other activity associated with the transport of, Infectious Substances. This is required by ICAO and IATA. A copy of the completed training certificate must be maintained in the laboratory files and presented to the proper authorities upon request. When shipping packages containing Infectious Substances, from UAB, you have the responsibility to properly: Classify the substance or material, Identify the substance or material, Select appropriate packaging, Pack the substance or material, Mark and label the package correctly, Complete documentation, and Make arrangements with your chosen courier and receiver. This includes obtaining permits if required. For example, both the USDA and CDC have permit requirements. Course Materials Page 2 Last Updated: 07/02/2012
If you receive packages containing an Infectious Substances, you have the responsibility to: Inspect the documents, Inspect the package, Get an import permit if necessary, Report any damages to the shipper, UAB Biosafety, and the Center for Disease Control (or CDC) Notify the sender that the package has arrived, and Keep all shipping documents for a minimum of two years The airline industry is very strict about transporting Infectious Substances,. You CAN NOT carry an Infectious Substance, package onto a passenger plane no matter how it is packaged. You MUST use a commercial airline courier such as FedEx or DHL. UPS and the United States Postal Service will not accept an Infectious Substance, package. There are quantity limitations for certain items. If you have questions or need more information, please check with OH&S and/or your courier. Not all couriers/carriers will transport all Infectious Substances, materials. AND not all countries or states in the U.S. accept Infectious Substances, packages. Where there are variations (restrictions) by a state/country or courier/carrier, they may be more restrictive than the IATA DGR or ICAO TI, but never less restrictive. An example of this would be Federal Express s forms. When shipping by FedEx, ONLY typed or computergenerated forms are allowed. Packages with handwritten forms will not be accepted. Course Materials Page 3 Last Updated: 07/02/2012
Additional documentation (i.e., permits or certificates) may be required when shipping Infectious Substances,. Permits or Certificates Required Shipper s Responsibility Receivers Responsibility If you are shipping Select Agents/Toxins, a certificate is required. Per regulations by the USDA or the CDC, Select Agents/ Toxins require a certificate of registration for Possession, Use, or Transfer (Note that a transfer requires a CDC/APHIS Form 2 transfer document.) When shipping internationally, the shipper is responsible for obtaining an export permit. The receiver is responsible for obtaining all permits necessary for any countries through which the package will travel including USDA permits required for interstate transport. Contact OH&S at (205) 934-2487 for details regarding registration. Classification is necessary in order to follow both national and international regulations. Classification of an item to be shipped is used to, Identify the actual hazard NOT the substance itself. X Infectious Substances, are those which are capable of posing a risk to health and safety. Uncontrolled release of these substances into the environment may be life-threatening to humans and/or have similar high consequences for property, animals, and the environment. Work with these substances usually requires high containment. Course Materials Page 4 Last Updated: 07/02/2012
You must use the definitions, the Examples of Infectious/Biological Substances Included in or B PDF file, and the classification flowchart to properly classify your sample. Links to these files can be found on the home page of this course and on the OH&S website. If you have questions, please call OH&S. If your sample happens to be a Genetically Modified Organisms (or GMO) AND meets the classification of a Infectious Substances,, then it MUST be classified and shipped as a Infectious Substances,. UN numbers are required as a part of the identification process. These numbers are taken from the List of Dangerous Goods, and are used to identify a substance or group of substances. UN 2900 refers to infectious substances that affect animals while UN 2814 refers to infectious substances affecting humans. This UN Number always precedes the Proper Shipping Name or PSN. The Proper Shipping Name (or PSN) is assigned by IATA, ICAO, and 49 CFR, and is the name used on shipping documents to describe substances. Infectious Substances, have two proper shipping names one refers to infectious substances affecting animals and the other affecting humans. The PSN, Infectious substance, affecting animals (along with the preceding UN 2900 number), refers to infectious substances that affect animals and is only allowed if the infectious substance is an animal pathogen and can in no way pose a threat to humans. The PSN, Infectious substance, affecting humans (along with the preceding UN 2814 number), is used if the infectious substance can pose a threat to humans as well as animals. The technical name is the substance s genus and species. This must be added to the end of the Proper Shipping Name when shipping substances. It should be written or typed in parentheses. For example, a isolate of West Nile virus cultured from a mouse has the ability to affect a human. Therefore, the Shipping Document for this sample would show: UN 2814 Infectious substance, affecting humans (West Nile Virus) Course Materials Page 5 Last Updated: 07/02/2012
Remember, the technical name goes in the documentation NOT on the package! Either the primary or secondary container must be able to withstand internal pressure of 95kPa (kilopascal) in a temperature of -40 degrees Centigrade (-40⁰ C) to 55 degrees Centigrade (55⁰ C). kpa is a unit of pressure measurement like PSI or pounds per square inch. When choosing the correct packing materials, only use packaging in the tested and certified configuration. For example, you cannot ship an Infectious Substance, in an EXAKT-PAK secondary container and in a SAF-T-PAK outer container (fiberboard box) unless both containers have been tested and certified together. NOTE: Disposable components of a packaging system must be replaced by components from the same vendor that have been tested and certified for that packaging system. Most manufacturers will not test their products with those of their competitors. If you have questions about your containers and/or boxes, contact the manufacturer about their testing results. If the package contains less than 50 milliliters or 50 grams per package, then it can be shipped in the cargo hold of a passenger airplane. Packages exceeding 50 milliliters or 50 grams must be shipped by cargo aircraft only and have the black on orange Cargo Aircraft Only sticker affixed by the shipper. Packages exceeding 4 liters or 4 kilograms must be shipped by ground transportation or divided to remain under the limit. When assembling the package, meet the provisions of national and international regulations. When packing Infectious Substances,, use IATA Packing Instructions 620 to assist you. To be precise, UN 2900 Infectious Substances, affecting animals and UN 2814 Infectious Substances, affecting humans must be triple packaged. Course Materials Page 6 Last Updated: 07/02/2012
The following steps show you how to triple pack those substances. 1. Start with a leak proof primary container. 2. Place sufficient absorbent material inside the secondary container to completely absorb the contents should the primary container fail. Foam protectors, provided by the manufacturer, can be used as the absorbent material. 3. Place the foam container inside a plastic bag, provided by the manufacturer. While this plastic bag is not required, it serves to provide an extra measure against spills or breakage. 4. Seal the plastic bag just as an extra precaution to prevent leakage. 5. Place the primary container, wrapped in absorbent material, into a secondary container. The secondary container must be leak proof. In this example, an O-ring, the black rubber gasket around the top of the container, produces a leak proof seal when it is tightly secured. 6. Securely tighten the secondary container. 7. Spray the secondary container with the appropriate disinfectant. 8. Wipe down the container after waiting the designated time listed on the disinfectant. Remember to always follow laboratory standard operating procedures (SOPs) for removal of samples from the biosafety cabinet or other primary containment. 9. Place the secondary container into a tertiary (or third) container. The third container must be tested and approved by the manufacturer. 10. Place the required list of contents between the second and third containers. The required list of contents must be: the name of the substances, the volume, and the number of items. Never use boxes except those that conform to approved standards. Always look for the UN mark. It indicates that the box has been tested and meets standards. If you have questions about which boxes are approved, please call OH&S at (205) 934-2487. Course Materials Page 7 Last Updated: 07/02/2012
Marks and labels should be 1) durable, 2) placed so that they are completely visible and not obscured by any other label or marking, and 3) placed all on the same face of the package, if possible. Packages containing an Infectious Substances, MUST have the following information on the outer package: The complete name and address of the shipper and consignee (receiver) The name and telephone number of a responsible person unless it is on the waybill No voice mail, no answering machines; the responsible person is one who can answer questions about the content, shipper or recipient details, and/or permit inquiries 24 hours a day until the shipment reaches it s destination. The Proper Shipping Name UN 2900 Infectious substance, affecting animals OR UN 2814 Infectious substance, affecting humans The quantity of the dangerous good A black and white diamond-on-point Infectious Substance Label printed with the words: In case of damage or leakage, immediately notify a Public Health Authority In U.S.A. notify director CDC, ATLANTA, GA 1-800-232-0124. Orientation marks or the words THIS SIDE UP on packages containing liquids. o o o Two orientation marks or the words This side up should be on two opposite sides of the box. However, they must match. Both sides must be orientation marks or both sides must be marked This side up. The word OVERPACK should also be on the box if an overpack is being used. All labels and marks must be durable. Remember to remove or completely cover any irrelevant marks or labels. Try to place all marks and labels on the same face of the package if possible. When labeling and marking, certain information is required on the outer package. These marks and labels are used to provide information about the contents of the package, the nature of the hazard, and any special handling requirements. Course Materials Page 8 Last Updated: 07/02/2012
However, in the event of an emergency, additional information may be needed. For that reason, a contact name and phone number must be listed on either the package or the waybill. This must be a responsible person who will answer the phone regardless of the time of day if there are any questions about the package. Documentation A Shipper s Declaration for Dangerous Goods is a legal document that is sometimes called a Shipper s Declaration. It is required for each shipment of Infectious Substances,. It is also one of the main reasons packages get rejected because they are incorrectly prepared! To keep your Shipper s Declaration from being rejected, here are some things that you must do: 1. Prepare three copies one for the shipper and two for the carrier. However, some carriers may require more. Check before submitting. 2. Keep your copies for two years in case there are questions later. You are required to maintain all shipping paperwork for at least 2 years. 3. IF you have made prior arrangements with the courier, submit your shipper s declaration information electronically. 4. Fill out each line or space correctly. An interactive form is available on the home page of this course and on the OH&S website. The form is for FedEx, but it should give you a general idea of how to complete a Shipper s Declaration. Before handing the package over to the carrier for shipment, ensure that the responsibilities for packing are completely satisfied. After preparing the package for shipment, the package must remain under the direct control of trained personnel until it is handed over to the carrier. This reduces the chances of tampering, theft, destruction, or invalidating the shipper s signature that signifies the package has been prepared in accordance with 49 CFR/ IATA regulations. If you suspect a package has been tampered with notify UAB OH&S at once. Use the checklist on the home page of this course under Resources as well as on the OH&S website to fulfill courier/carrier variations. Course Materials Page 9 Last Updated: 07/02/2012
Spills happen both large and small. When these accidents happen, you should have a biological spill kit prepared and stored nearby. Follow these steps to ensure that the spill is cleaned up properly. 1. Open the spill kit and remove the door signage that tells others NOT to enter due to a spill. 2. Post the sign on the door. 3. Cover the spill with absorbent material. 4. Pour the appropriate disinfectant over the spill starting from the outside spiraling inward. 5. Wait for the designated amount of contact time specified on the disinfectant. 6. Pick up any broken glass or sharps using tongs or hemostats, and place in a sharps container. 7. Pick up the absorbent materials and place in a red biohazard bag. 8. Thoroughly disinfect the work surface inside the biosafety cabinet. 9. Properly disinfect and dispose of the biohazard bag. 10. For spills within containment, report the spill to OH&S Biosafety within 24 hours of the spill. Spills outside of containment or involving an injury MUST be reported immediately. For more information about types of spills, spill cleanups, and spill kits, please review the information on the OH&S website. This information will be included on the quiz. The appropriate disinfectant is critical to ensuring that the work surface is clean especially after a spill. For proper disinfection, there are three major factors to consider: choosing the appropriate disinfectant, using the correct concentration of the disinfectant, and providing adequate contact time. A PDF file is available on the home page as well as on the OH&S website to assist you with spill cleanups. This information will be on the quiz. Course Materials Page 10 Last Updated: 07/02/2012
Accidents happen, and too often we are not prepared when they do. Make sure that YOU know what to do in case of a biohazardous incident. If a biohazardous substance splashes into the eyes, o Promptly flush the eyes with water for 15 minutes and seek medical attention. If a biohazardous substance enters the mouth, o o o o Try not to swallow. Rinse the mouth with water immediately. Don t swallow the rinse water! Seek medical attention. If a biohazardous substance comes in contact with the skin, o Promptly and thoroughly wash the affected area with soap and water and remove any contaminated clothing. Report the accident or injury as soon as possible by following the On-the-Job-Injury (OJI) procedure. o This information can be found on the HRM website under HRM Programs On-the- Job Injury/Illness. You ve just received an Infectious Substances, package from the courier at the door. The fire alarm goes off. Do you know what to do next? Normally, you would leave the building according to the fire alarm procedures. However, since you are holding an Infectious Substances, package, you must: 1. Secure it in a biosafety cabinet. 2. Make sure that the biosafety cabinet is on and running. 3. Pull the sash down and then 4. Exit the building. Do NOT take an Infectious Substances, package outside with you! In summary Infectious Substances,, if improperly packaged, may be extremely dangerous not only to you, but also to those around you including property, animals, and the environment. Course Materials Page 11 Last Updated: 07/02/2012
If it very important that you and those who encounter the substances or materials and their packaging handle, pack, ship, and receive them with care using all safety precautions. Everything is done to protect YOU! When shipping, Infectious Substances or Materials, you are obligated by international and national regulations to package such material so that anyone who may be near or comes in contact with that package is safe. Some carriers/couriers and some states have their own unique set of rules or procedures. These must be followed as well. Protect yourself and others around you by wearing the proper PPE, knowing first aid procedures, and knowing what to do in case of emergencies when shipping and/or receiving, Infectious Substances or Materials. This concludes the OH&S Shipping Infectious Substances, course. Recertification is required every two years or if regulations change. Go to the home page of the course to take the quiz. 85% or higher is required to pass. The Shipping Glossary follows this page. Course Materials Page 12 Last Updated: 07/02/2012
Introduction This is a list of terms you should know when transporting or B, Infectious Substances or Materials or when shipping with dry ice. These terms and their definitions will be on the quiz. Animal and Plant Health Inspection Services (US) Also known as APHIS (pronounced A FIS) Biological Product (IATA 3.6.2.3) Biological products are those products derived from living organisms which are manufactured and distributed in accordance with the requirements of appropriate national authorities, which may have special licensing requirements, and are used either for or for prevention, treatment, or diagnosis of disease in humans or animals, development, experimental, or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines. Biological Substance, Category B (IATA 3.6.2.2.2.2) 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 occurs Carrier Any commercial company that transports goods In this context, a carrier (or courier) refers to companies such as Federal Express (FedEx), DHL, the United States Postal Service (USPS), etc. who transport Category B, Infectious Substances. Also known as a courier Centers for Disease Control and Prevention (US) The Centers for Disease Control and Prevention (or CDC) requires permits when shipping some Category B packages. Check with the UAB OH&S or your carrier/courier for more information. Course Materials Page 13 Last Updated: 07/02/2012
Courier OH&S Biosafety BIO202 Shipping Infectious Substances, Any commercial company that transports goods In this course, a courier (or carrier) refers to companies such as Federal Express (FedEx), DHL, the United States Postal Service (USPS), etc. who transport infectious substances or materials. Also known as a carrier Cultures The result of a process by which pathogens are intentionally propagated Does not include specimens as in IATA 3.6.2.1.4 Dangerous Goods DGR DOT IATA Articles or substances which are capable of posing a risk to health, safety, property or the environment and which are shown in the list of dangerous goods in the IATA DGR or which fall under the classifications according to the IATA DGR. Dangerous Goods Regulations Department of Transportation Dry Ice Dry Ice is a refrigerant made from carbon dioxide gas and can be dangerous to work with if not handled properly. Exempt Specimens (IATA 3.6.2.2.3.6) Patient specimens for which there is minimal likelihood that pathogens are present AND when packed in packaging that will prevent leakage AND is marked with the words Exempt human specimen or Exempt animal specimen Genetically Modified Organism (GMO) An organism whose genetic material has had the genetic material of another organism inserted into its own. Course Materials Page 14 Last Updated: 07/02/2012
Governing Agencies There are several international and national agencies that regulate the shipment of Category B, Infectious Substances and Materials. Among these are: International Air Transportation Association (IATA), International Civil Aviation Organization (ICAO), The United States Department of Transportion (DOT), and The United Nations. Harmonization The coordination of multiple agencies and regulations to cause as little confusion as possible IATA (Dangerous Goods Regulations) DGR Hazardous Materials HHS HIV HMR Hazardous Materials (or HazMat) US Department of Health and Human Services Human immunodeficiency virus Hazardous Materials Regulations IATA - International Air Transportation Association Trade association of the world s major airlines IATA (Dangerous Goods Regulations) DGR Contains all of the requirements from the ICAO Technical Instructions, plus more restrictive regulations for shipping Following the IATA DGR ensures that you are following federal law. Course Materials Page 15 Last Updated: 07/02/2012
ICAO - International Civil Aviation Organization The part of the United Nations that governs all international matters related to flight Infectious Substance, (IATA 3.6.2.2.2.1) An infectious substance which is transported in a form that, when exposure occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans (UN 2814) or animals (UN 2900). Kilogram (Kg) Metric measurement of weight; equal to 1000 grams May - a regulatory term When used within a regulation, indicates a preferred, but not mandatory requirement Example: "The complete shipper's address MUST be placed on the outside of the package. A shipper's phone number May be included, but is not required." (From the DRG) MRSE Methicillin-Resistant Staphylococcus aureus Must - a regulatory term When used within a regulation, indicates a mandatory requirement Example: "The complete shipper's address MUST be placed on the outside of the package. A shipper's phone number MAY be included, but is not required." From the DRG Numerical cross reference An IATA list that will allow the user to the look up a Proper Shipping Name using a UN number OHSA US Department of Occupational Safety and Health Administration Overpack An overpack is a fiberboard box or container designed to hold packages and/or some type of refrigerant (dry ice or gel packs) during shipment and remain leak proof. Course Materials Page 16 Last Updated: 07/02/2012
Package OH&S Biosafety BIO202 Shipping Infectious Substances, The completed product of packaging combined with the method of packing to make an item ready for transport Packaging The materials necessary for a completed package to comply with minimum packing requirements of regulations (amount of containment, absorbent materials, pressure test) Packing The method that is used to enclose articles or substances in packaging Packing Instructions (PI) A set of specific instructions for packing material for transport by air Examples include: PI 650 for Biological Substances, Category B PI 959 for GMOs PI 954, Dry Ice PI 620, PI can also indicate a researcher who is the Principal Investigator - the person whose name appears as the lead or primary person on the grant or contract. Make sure you read the material in context. Pathogen A microbial agent (bacteria, virus, parasite, fungus, prion) capable of causing disease Patient specimens (IATA 3.6.2.1.4) A specimen 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, Course Materials Page 17 Last Updated: 07/02/2012
Permits PG diagnosis, investigational activities, disease treatment or prevention. Documentation that may be required when shipping some Category B packages An example of this would be Select Agents/Toxins. Packing Group PHMSA US Pipeline and Hazardous Materials Safety Administration Primary container The tube, container, or vial in which an item is placed for shipment Proper Shipping Name (PSN) PSN Is a name which is used in shipping documents and, when required, on a package. Proper shipping names are designated by IATA and may be found in the IATA DGR list 4.2 or 49CFR 172.101 Proper Shipping Name Receiver The person accepting the Category B package from the courier/carrier Restrictions Some states/countries or couriers/carriers may have more variations of the regulations (i.e. restrictive regulations) than IATA DGR or ICAO TI. These restrictions (i.e. variations of the regulations ) still apply no matter how restrictive they may seem. Course Materials Page 18 Last Updated: 07/02/2012
RMW OH&S Biosafety BIO202 Shipping Infectious Substances, Regulated Medical Waste Secondary container This is also known as the inner container. The secondary container is a container, inside a shipping container that holds the primary container, along with enough material to absorb the entire contents of the primary container, if liquid, and also withstand pressure requirements. Select Agents/Toxins Shall These are highly regulated materials that may be classified as or B substances. They require a laboratory certificate of registration from federal agencies and a permit in order to be transported. When used within a regulation, indicates a mandatory requirement Should When used within a regulation, indicates a preferred, but not mandatory requirement Sublimate TDG A physical reaction where a solid turns directly into a gas For example, dry ice sublimates into carbon dioxide gas. Transportation of Dangerous Goods TDGR Transport of Dangerous Good Regulations Clear Language Edition (Canada) Technical Instructions (TI) Regulations set forth by ICAO. The source of US Department of Transportation federal laws regarding transport of dangerous goods Course Materials Page 19 Last Updated: 07/02/2012
The United Nations (UN) This international organization seeks cooperation from all parties involved in determining international law that affects everyone - as in the transportation of Biological Substances, Category B and Materials. Title 49 Code of Federal Regulations (49CFR) The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Title 49 covers Transportation. This is also known as 49CFR. UN Mark The marking that appears on all approved boxes used for shipping Category B packages In this example, the UN is in a circle at the bottom of the box. UN Number UPU The letters UN followed by a four digit number. UN numbers are another method used to identify Dangerous Goods. Every dangerous good has a unique UN number, to match a unique Proper Shipping Name. The letters UN must appear before the number to be considered correct. Universal Postal Union US DOT The United States Department of Transportation It is the federal cabinet department of the United States government concerned with transportation. USDA US Department of Agriculture Course Materials Page 20 Last Updated: 07/02/2012
USPHS USPS OH&S Biosafety BIO202 Shipping Infectious Substances, US Public Health Service Commissioned Corps The United States Postal Service The United States Postal Service (or USPS) has specific guidelines for packing, labeling, and marking Category B packages. See the course material for more information or contact the UAB OH&S. Variations Some states/countries or couriers/carriers may have more restrictive regulations than IATA DGR or ICAO TI. These variations of the regulations (or restrictions) still apply no matter how restrictive they may seem. Waybill A waybill is documentation of a contract for the transport of cargo. It contains information such as the nature and amount of a dangerous good. Course Materials Page 21 Last Updated: 07/02/2012