Issues of ConcernTransport Regulations Show The packaging and shipping of infectious substances are under strict regulation as the potential consequences of exposure during transport can be devastating for both the environment and those who are exposed. The UN Model Regulations were created by the Committee of Experts on the Transport of Dangerous Goods (UNCETDG) to provide recommendations for the safe transport of dangerous goods.[2] The goal of the UN Model Regulations is to provide a foundation for transportation recommendations to create uniformity on the national and international levels. The UN Model Regulations may require further modifications or additions by local governments and international organizations depending on the full requirements for transport. Companies involved in transporting dangerous goods, such as airlines or couriers, may also enforce additional requirements. Also, international modal agreements created by international law provide guidelines for all acceptable modes of transportation, including air, rail, road, sea, and post. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] Lab personnel should refer to the guidelines specific to the necessary form of transportation when preparing an infectious substance for shipment. Transportation Stakeholders and Training Federal hazardous materials transportation law states that all persons involved in the packaging and shipping process of hazardous materials qualify as transportation stakeholders and must receive the necessary training. Those who receive training are referred to as hazmat employees/workers. A hazmat employer is any person involved at any point in the process of transporting hazardous materials, including but not limited to shipping, transportation, manufacturing, certifying, repairing, etc. Hazmat training must include developing competencies in general awareness/familiarization, function-specific, safety, security awareness, security training, and driving training for those driving vehicles.[3] [See U.S. Department of Transportation. (2016, October 1). Hazmat Transportation Training Requirements. Pipeline and Hazardous Materials Safety Administration. Retrieved February 10, 2022] Training is crucial as lab workers are always at risk of self-exposure, and improper biocontainment increases the risk of environmental exposure.[4] Employees can receive training under the Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), or any other Federal or international agency to satisfy the required competencies. Training should be completed within 90 days of employment and must be renewed every three years. Hazmat employees must keep training records that include the employee’s name, training completion date, training details, hazmat trainer information, and training certification. Records should be kept for three years after the most recent training and up to 90 days after an employee leaves. Employees who have not fully completed training can only work under the direct supervision of a fully trained hazmat employee. [See U.S. Department of Transportation. (2016, October 1). Hazmat Transportation Training Requirements. Pipeline and Hazardous Materials Safety Administration. Retrieved February 10, 2022] Classification System Infectious substances must be correctly defined for transport before the packaging process can begin. Materials that qualify as infectious substances include cultures, patient specimens, biological products, medical or clinical wastes, and medical devices or equipment. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] These materials are then classified under Category A or Category B to determine the proper packaging and shipping methods. Category A classifies an infectious substance as one that can result in permanent disability or life-threatening disease in healthy humans or animals upon exposure. [2][5] Classification requires knowledge of the medical history of the source of the material or the use of professional judgment. Some examples of Category A substances include cultures of Mycobacterium tuberculosis, Human immunodeficiency virus (HIV) and Coccidioides immitis, and the Ebola virus. (A more complete list can be found towards the end of this paper. [See U.S. Department of Transportation. (2020, April 28). Transporting infectious substances safely. Pipeline and Hazardous Materials Safety Administration. Retrieved January 2, 2022] The proper shipping names and identification numbers for Category A substances include:
Category B classifies an infectious substance as a material incapable of causing permanent disability or life-threatening disease in healthy humans or animals. Category B substances do not meet the Category A criteria. Examples of Category B substances include Mycobacterium tuberculosis and HIV clinical specimens, Arbovirus, and Hepatitis A, B, and C.[2][3] Category B includes materials transported for diagnostic purposes. [2] The proper shipping names and identification numbers for Category B substances include:
Exceptions Despite establishing a classification system, it may not always be clear whether a substance is infectious and requires strict regulations for packaging and shipping. Furthermore, exceptions exist for transporting medical or laboratory waste that does not meet the criteria of Category A or Category B infectious substances. Section 173.134(b) of the HMR provides exceptions for materials that are not bound by the requirements of infectious substances. [See U.S. Department of Transportation. (2020, April 28). Transporting infectious substances safely. Pipeline and Hazardous Materials Safety Administration. Retrieved January 2, 2022] Substances exempt from strict regulations do not contain biological agents, or any biological agents present are incapable of causing disease. Therefore, these materials do not have to follow transport regulations if certain protocols are followed. Examples of exempt materials include:
If transported by air, these exemptions are subject to modal regulations requiring a triple packaging system. Liquids also require the use of absorbent material. Besides the triple packaging system, these substances are exempt from all other infectious substances regulations. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] The IATA and United States Postal Service (USPS) define human or animal samples transported for routine testing unrelated to diagnosing an infectious disease as exempt specimens. This includes specimens for drug, alcohol, cholesterol, blood glucose level, prostate-specific antibody (PSA), kidney function, liver function, pregnancy, and non-infectious disease testing. IATA requirements for exempt specimens include:
USPS requirements for exempt specimens include:
Shipment Requirements Infectious substances must meet packaging, marking, and labeling requirements to be transported. Packaging infectious substances involve using a triple packaging system that consists of a primary receptacle, secondary container, and rigid outer packaging. [See Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of High-Consequence Pathogens and Pathology (DHCPP). (2016, December 1); Packaging and transporting infectious substances. Centers for Disease Control and Prevention. Retrieved January 2, 2022] The primary receptacle contains infectious material and must be leakproof. Liquids require packaging with an absorbent material capable of absorbing the entirety of the specimen if a leak occurs. The secondary container must also be leakproof and enclose the primary receptacle. Cushioning may also be necessary to firmly secure a primary receptacle within the secondary container. Multiple primary receptacles can be placed in the secondary container if the substances are of the same class. If the receptacles are fragile, each must be individually wrapped or supplemented with cushioning to prevent contact. Documentation should be placed between the secondary container and rigid outer packaging. The third layer, the rigid outer packaging, must protect the secondary container from damage. It must have the appropriate dimensions and strength to contain the primary and secondary containers. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] In addition to the triple packaging system, infectious substances may require a preservative to maintain integrity throughout transport. Some examples of packaging preservatives include coolants and stabilizers. A coolant/refrigerant is used to maintain a cool temperature during transportation. Coolants often also qualify as dangerous goods and are subject to packaging requirements. The requirements of packaging an infectious substance with a coolant include:
Coolants frequently used include wet ice, dry ice, and liquid nitrogen. Dry ice and Liquid Nitrogen are considered dangerous goods. The proper shipping name for dry ice is “dry ice” or “carbon dioxide, solid.” The UN number is UN 1845. The proper shipping name for liquid nitrogen is “nitrogen refrigerated liquid.” The UN number is UN 1977. A stabilizer is a chemical used to prevent the degradation or neutralize the hazards of an infectious substance. Stabilizers frequently used include sorbitol, fetal bovine serum, alcohol, and formaldehyde. Stabilizers can also qualify as dangerous goods and must be added in appropriate quantities to the primary receptacle holding the infectious substance. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] Category A Packaging Requirements Category A infectious substance packaging requirements can be found in Section 173.196 of HMR and must:
Primary or secondary packaging and temperatures ranging from -40 C to +55 C. Shipments transported at these temperatures must be glass, metal, or plastic. Heat seal, skirted stopper, or metal crimp seals should be used when necessary to form a leakproof seal. Screw caps must be secured with paraffin sealing tape or a manufactured locking closer. The outer packaging must be rigid and have at least one surface with a minimum dimension of 100 mm x 100 mm (3.9 in x 3.9 in). ) [See U.S. Department of Transportation. (2020, April 28). Transporting infectious substances safely. Pipeline and Hazardous Materials Safety Administration. Retrieved January 2, 2022] Category B Packaging Requirements Category B infectious substances do not have to follow requirements of HMR but must:
The primary or secondary package must be able to withstand an internal pressure that produces a pressure difference that is not less than 95 kPa. For surface transport (road, train, or ship), either the secondary or outer packaging should be rigid. If the secondary packaging is soft, the outer packaging must be rigid and vice versa. For air transport, the outer packaging must always be rigid. The packaging must also pass a 1.2-meter drop test to ensure it is strong enough to withstand transport. Medical or clinical waste categorized as Category B substances (UN3921) does not have to follow the triple packaging system. ) [See U.S. Department of Transportation. (2020, April 28). Transporting infectious substances safely. Pipeline and Hazardous Materials Safety Administration. Retrieved January 2, 2022] Marking and Labeling After an infectious substance has been packaged, lab personnel must place the correct marks and labels that provide information about the package, the infectious substance, and packaging standards. Packages containing infectious substances should be marked with the following:
Specifically, Category A marking should include the UN packaging symbol and certification and the name and contact information of the person responsible for the shipment. Category B Marking should include UN3373 mark with the correct dimensions, mark on outer packaging that is visible, and the proper shipping name, biological substance category B. In addition to correct markers, packages may require hazard labels, handling labels, or both. Hazard labels consist of a diamond shape with minimum dimensions of 100mm x 100mm. There should be one hazard label for each dangerous substance; therefore, a package may have more than one label. Handling labels describe how the package should be handled during transport. Examples include orientation arrows, Cargo Aircraft Only (CAO) labels, and cryogenic liquid warning labels. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] Documenting Shipments Packages carrying infectious substances require documentation regarding the contents and package preparation. The UN Model Regulations require a Dangerous Goods Transport Document (DGTD) for all Category A substances. The DGTD must contain the sender and receiver information, the date the document was signed, a description of the contents, the NET quantity of dangerous goods, handling requirements, emergency response information, and certification/shipper’s declaration. Category B substances do not require a DGTD. Dangerous goods transported internationally by air require an air waybill in addition to the DGTD. An air waybill is a requirement for transporting all goods by air. For the shipment of dangerous goods, the “Handling Information” box and the “Nature and Quantity of Goods” box must be filled on the air waybill. [See World Health Organization. (2021, February 25). Guidance on regulations for the transport of infectious substances 2021-2022. World Health Organization. Retrieved January 2, 2022] List of Category A Infectious Substances Category A substances affecting humans (UN3814)
Category A Substances Affecting Animals (UN2900)
List adapted from: [U.S. Department of Transportation. (2020, April 28). Transporting infectious substances safely. Pipeline and Hazardous Materials Safety Administration. Retrieved January 2, 2022] Clinical SignificanceThe packaging and shipment of infectious substances are critical as possible exposure can have devastating consequences. Different labs across the world, including research, diagnostic, hospital, and national laboratories, must be equipped to handle a variety of substances to maintain safety. Previous studies have shown that laboratories have not always been prepared to handle infectious substances, resulting in unintentional exposures.[4][7] For example, mishandling and improper containment of Salmonella samples resulted in community outbreaks in 2013 that were traced back to certain teaching laboratories across the U.S. . Investigation of these incidents unveiled that the involved labs lacked consistent biosafety practices and emergency response procedures.[4] It is paramount that all labs handling dangerous substances have specific protocols in place that follow the appropriate national and international regulations to ensure containment and prevent environmental exposure. Furthermore, the proper handling of infectious substances has increased in importance in recent years due to the emergence of viruses that have devastated countries worldwide. Some examples include the Ebola epidemic, Zika epidemic, and current COVID-19 pandemic. During these public health crises, contaminated specimens are frequently shipped to the CDC in Atlanta, Georgia, for confirmatory diagnosis and have also been shipped across the world for research purposes. Therefore, laboratories must be prepared to handle these substances before a devastating outbreak. After the Ebola epidemic from 2014 to 2016, research showed that many medical laboratories in the U.S. were ill-prepared to handle Ebola specimens and other Category A infectious substances. Many facilities did not have the protocols and skills to handle and transport these substances nor workers who were properly trained to handle the infectious waste.[8] Previous laboratory outbreaks and epidemics like the Ebola virus have exposed gaps in knowledge and training that increase the risk of environmental exposure. Such missteps have forced labs to improve biosafety guidelines and ultimately resulted in safer practices. These advances are even more important amid the current COVID-19 pandemic, which has caused hospitals to develop protocols for the proper disposal of COVID waste.[9][10] What is a Category B infectious substance?Category B classifies an infectious substance as 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.
When packing Category B what should be marked on the package?Category B infectious substances have the proper shipping name “Biological Substance, Category B” and the identification number UN 3373.
Does category B requires a Class 6 infectious label on the box?If the culture being sent is not listed by IATA as a Category A infectious substance, then it can legally be sent as a “Biological Substance, Category B,” eliminating the need to prepare a Shipper's Declaration for Dangerous Goods or to use a UN-certified container with the Class 6 hazard label.
Which labels are required when shipping a Category B substance dry ice?In the “Nature and Quantity of Goods” box of the air waybill you must show the text “DIAGNOSTIC SPECIMEN” or “Clinical Specimen” or “Biological Substance, Category B” and “UN3373” If your package contains dry ice, you would also need to write “Dry Ice 9 UN1845” and the number of packages and the net quantity of dry ice ...
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Which of the following marks and or labels must be displayed on a package when shipping 500 ml of a category B infectious substance?
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