OH&S Transporting Biological Substances, Category B

Welcome to the Occupational Health and Safety Transporting Biological Substances, Category B course. A glossary is located at the end of this document as well as in a separate document on the OH&S website. These terms will be on the quiz. When shipping Biological Substances, Category B, 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 Biological Substances Category B, 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. Title 49 Code of Federal Regulations (49CFR 171.8) and IATA DGR 1.0, define a Dangerous Good (DG or DGs) as Course Materials Page 1 Last Updated: 07/02/2012

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. A PDF chart of the Dangerous Goods List (DGR) can be found on the home page and the OH&S website. Any UAB employee who handles or offers for transport a Biological Substance, Category B must complete training every two years or if regulations change. 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 Biological Substances, Category B from UAB, you have the responsibility to properly: Classify the substance or material, Identify the substance or material, Select appropriate packaging system, 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 are expecting to receive packages containing Biological Substances, Category B at UAB, you have the responsibility to: Inspect the documents, Inspect the package, Get an import permit if necessary, Report any damages to the shipper and UAB Biosafety, Notify the sender that the package has arrived, and Keep all shipping documents for a minimum of three years The airline industry is very strict about transporting Biological Substances, Category B. You CAN NOT carry Biological Substances, Category B package onto a passenger plane no matter how it is packaged. You MUST use a commercial airline courier such as UPS, FedEx, or DHL. There are quantity limitations for certain items. If you have questions or need more information, please check with OH&S and/or your courier. Biological Substances, Category B may be shipped through the United States Postal Service (USPS). However, there are packaging requirements that MUST be met. Packages must be packed, labeled, and marked according to 49 CFR 173.199. Packaging Components of a Biological Substance, Category B packaging system must never be interchanged or altered. Follow manufacturer s instructions for package assembly. A single primary container must not contain more than 1 liter (L) or 4 kilograms (kg). The secondary container must be marked with the International Biohazard symbol. The package must be marked UN 3373 Biological Substance, Category B. The package must display the name and telephone number of a responsible person. Packages must be sent as First Class, Priority, or Express Mail. Course Materials Page 3 Last Updated: 07/02/2012

Not all couriers/carriers will transport all Biological Substances, Category B. AND not all countries or states in the U.S. accept Biological Substances, Category B. 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 computer-generated forms are allowed. Packages with handwritten forms will not be accepted. Additional documentation (i.e., permits or certificates) may be required when shipping Biological Substances, Category B. For example, 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 Category B package will travel including USDA permits required for interstate transport. Permits or Certificates Required Shipper s Responsibility Receivers Responsibility USDA permits required for certain human or animal pathogens. Per regulations by the USDA or the CDC, Select Agents/ Toxins require a certificate of registration for Possession, Use, or Transfer. When shipping internationally, the shipper is responsible for obtaining the import and/or export permit. The receiver is responsible for obtaining all permits necessary for any countries through which the Category B package will travel. Course Materials Page 4 Last Updated: 07/02/2012

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. Samples that DO NOT MEET the criteria for Infectious Substances, Category A may qualify for classification as Biological Substances, Category B. This means that your specimen is not known or reasonably expected to contain pathogens. Use the Classification Flowchart on the website to assist you. Sample chart X If your sample is NOT Category A or B, it may fall under the definition of an exempt patient specimen. Exempt patient specimens are those which have a minimal likelihood of pathogens being present. Exempt Patient Specimens are those for which there is minimal likelihood that pathogens are present. In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of judgment is required to determine if a substance is exempt. Judgment should be based on known medical history, symptoms, and circumstances of the source. Examples of Exempt Patient Specimens are: Blood or urine to monitor: cholesterol levels, blood glucose, and hormone levels. Course Materials Page 5 Last Updated: 07/02/2012

Other examples are biopsies to detect cancer and tests to monitor organ function in humans and animals with non-infectious diseases. Do not assume your sample is an Exempt Patient Specimen. For example, your specimen may be just a blood sample for hormones. On the other hand, if samples are collected from areas of the world where life-threatening pathogens are endemic or if the patient exhibits symptoms, you MUST use the provided definitions to properly classify your sample. If you have questions, please call the Occupational Health and Safety office to get further clarification. As a part of the identification process, you must know the proper shipping name. The Proper Shipping Name (PSN): is assigned by IATA, ICAO, and 49 CFR, and is the name used on shipping documents to describe substances. The words Diagnostic Specimen and Clinical Specimen are NO LONGER ALLOWED as proper shipping names. UN numbers are also 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. This UN Number always precedes the Proper Shipping Name or PSN as in: UN 3373 Biological Substance, Category B UN 3245 Genetically modified micro-organisms Exempt Patient Specimens do not have a UN number. UN3373 BIOLOGICAL SUBSTANCE CATEGORY B Course Materials Page 6 Last Updated: 07/02/2012

Genetically modified organisms that do not meet the definition of Category A or B Infectious Substances are assigned to Class 9 (miscellaneous hazard). Class 9 Miscellaneous Hazard When assembling the package, meet the provisions of national and international regulations. Use the Packing Instructions to assist you. To be precise: Biological Substances, Category B are shipped using Packing Instructions 650 (or PI 650). Exempt Patient Specimens are triple-packed to prevent any release or leak of substance. One surface of the outer package must measure 100mm X 100mm. Non-infectious Genetically Modified Organisms (GMOs) are packed using PI 959. The maximum quantity per GMO primary container is 100 milliliters or 100 grams. When choosing the correct packing materials, only use packaging in the tested and certified configuration. For example, you cannot ship Biological Substances, Category B 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. Course Materials Page 7 Last Updated: 07/02/2012

Any substance identified as UN 3373 must be triple packaged in approved boxes only. Shipping liquids are of special concern when traveling by air due to air pressure changes that may occur during a flight. If the shipment is liquid, then the primary or secondary container must be able to withstand air pressure changes without leakage. Documentation of testing is available from the manufacturer. 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 8 Last Updated: 07/02/2012

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. 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 to answer questions about the package. 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 its destination. Marks and labels should be durable, placed so that they are completely visible and not obscured by any other label or marking, and, placed all on the same face of the package, if possible. Packages containing a Biological Substances, Category B MUST have the following information on the outer package: Complete name and address of the shipper and consignee (receiver) Name and telephone number of a responsible person unless it is on the waybill. Proper Shipping Name UN 3373 Biological Substance, Category B UN 3373 Diamond-on-Point label Remember to remove or completely cover any irrelevant marks or labels. Packages containing Exempt Patient Specimens must be: Packed to prevent leakage Include the complete the name and address of the shipper and consignee and Marked with the Proper Shipping Name either o Exempt Human Specimen or Course Materials Page 9 Last Updated: 07/02/2012

o Exempt Animal Specimen Do NOT use a UN 3373 Diamond-on-Point label. Remember to remove or completely cover any irrelevant marks or labels. Packages containing Genetically Modified Micro-Organisms should include: The complete name and address of the shipper and consignee (receiver) The name and telephone number of a responsible person The UN 3245 Genetically Modified Micro-Organisms mark The Class 9 Miscellaneous Hazard black-and-white label Remove or completely cover any irrelevant marks or labels. SECURITY of the package is the shipper s responsibility until it is handed off to the authorized carrier! 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. Before handing the package over to the carrier for shipment, it is the shippers responsibility to ensure that all Federal and International regulations are met; International shipments may require additional permits Use the checklist to fulfill courier/carrier variations. Course Materials Page 10 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. First, determine if the spill is large or small. A large spill is generally defined as sufficient quantity that if spilled, tends to seek its own level. In other words, it runs to a low point. Large spills are treated differently due to containment issues. The spill should not spread and contaminate other areas. Small or large? Second, warn others and clear the area if necessary. Posting a sign on the door stating Warning Spill Inside. Do not enter. is recommended. Third and most importantly, if infectious aerosols could have been generated, wait about 30 minutes. This allows aerosols to settle or be captured by the building exhaust. Fourth, don the proper PPE, re-enter the area, and clean up the spill. 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. When cleaning up a spill, there are specific steps that you should follow to ensure that the area is thoroughly cleaned. One of these is to make sure that you use the appropriate disinfectant. Course Materials Page 11 Last Updated: 07/02/2012

Remember, there are three factors associated with proper disinfection: 1. choosing the appropriate disinfectant, 2. using the correct concentration of the disinfectant, and 3. providing adequate contact time. A PDF file is available on the website to assist you with biological spill cleanups. This information will be on the quiz. When a spill occurs that contains contaminated broken glass, NEVER pick it up with your hands even if you are wearing gloves! After disinfecting the area where the spill occurred: Use tongs or hemostats to pick up broken glass. Place the broken glass in an approved sharps container. Put the rest of the spill cleanup waste and disposable PPE in red bags for proper disposal as medical waste. Wash your hands thoroughly with soap and water. Report the incident to the lab manager or PI as soon as possible. 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. Eyes If a biohazardous substance splashes into the eyes, promptly flush the eyes with water for 15 minutes and seek medical attention. Mouth Skin If a biohazardous substance enters the mouth, try not to swallow. Rinse the mouth with water immediately. Don t swallow the rinse water! And seek medical attention. If a biohazardous substance comes in contact with the skin, 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. This information can be found on the HRM website under HRM Programs On-the- Job Injury/Illness. Course Materials Page 12 Last Updated: 07/02/2012

You ve just received a Biological Substance, Category B 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 a Biological Substance, Category B package, you must: First, secure it in a biosafety cabinet. Second, make sure that the biosafety cabinet is on and running. Third, pull the sash down and then Exit the building. Do NOT take the package outside with you! One, while transporting Biological Substance, Category B may not be considered as dangerous as transporting Category A, they still should be handled, packed, shipped, and received with care using all safety precautions. Two, there are international and national regulations that must be followed when shipping and receiving these packages. However, carriers/couriers and some states have their own unique set of rules or procedures that must be followed as well. Third, protect yourself and others around you by wearing the proper PPE, knowing first aid procedures and what to do in case of emergencies when shipping and/or receiving Category B, Infectious Substances or Materials. This concludes the OH&S Transporting Biological Substances, Category B course. Recertification is required every two years or if regulations change. Please return to the home page of this course to take the quiz. 85% or higher is required to pass. The Shipping Glossary follows this page. Course Materials Page 13 Last Updated: 07/02/2012

Introduction OH&S Transporting Biological Substances, Category B This is a list of terms you should know when transporting Category A 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. Course Materials Page 14 Last Updated: 07/02/2012

Check with the UAB OH&S or your carrier/courier for more information. Courier 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 15 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 16 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, Category A (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 17 Last Updated: 07/02/2012

Package OH&S Transporting Biological Substances, Category B 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, Category A 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 Course Materials Page 18 Last Updated: 07/02/2012

Permits PG research, 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 19 Last Updated: 07/02/2012

RMW 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 Category A 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 20 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 21 Last Updated: 07/02/2012

USPHS USPS 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 22 Last Updated: 07/02/2012