a. Infectious substance means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism that can cause disease in humans or animals. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. An infectious substance must be assigned to one of the following two categories:
1. Category A: An infectious substance transported in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure occurs. Category A infectious substances are not mailable. A Category A infectious substance is assigned the identification number UN 2814 or UN 2900, based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal.
2. Category B: An infectious substance that does not meet the criteria for inclusion in Category A. A mailpiece known or suspected to contain a Category B infectious substance must bear the proper shipping name "Biological substance, Category B" on the address side of the mailpiece and must be assigned to and marked with identification number UN 3373 or, for regulated medical waste and sharps medical waste, identification number UN 3291.
b. Biological product means 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) intended to prevent, treat, or cure a disease or condition of humans or animals. A biological product includes a material subject to regulation under 42 U.S.C. 262 or 21 U.S.C. 151-159. Unless otherwise excepted, mark these mailpieces with identification number UN 3373 when they contain a biological product known or reasonably expected to contain a pathogen that meets the definition of a Category B infectious substance.
c. Cultures are infectious substances that result from a process by which pathogens are intentionally propagated. This definition does not include a human or animal patient specimen as defined in 10.17.2e.
d. Exempt human or animal specimen means a human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) transported for routine testing not related to the diagnosis of an infectious disease. Typically, exempt human specimens are specimens for which there is a low probability that the sample is infectious, such as specimens for drug or alcohol testing; cholesterol testing; blood glucose level testing; prostate-specific antigens (PSA) testing; testing to monitor heart, kidney, or liver function; pregnancy testing; and testing for diagnosis of noninfectious diseases such as cancer biopsies. Exempt human or animal specimens are not subject to regulation as hazardous materials but must be packaged according to 10.17.10.
e. Patient specimen means material that is collected directly from humans or animals and transported for purposes such as diagnosis and research. Patient specimens include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (such as transwabs, culture media, and blood culture bottles).
f. Regulated medical waste, for USPS purposes, means a soft waste material (other than a sharp) derived from the medical treatment, diagnosis, immunization, or biomedical research of a human or animal. Soft medical waste includes items such as used rubber gloves, swabs, gauze, tongue depressors, and other similar material. Mark these mailpieces with identification number UN 3291.
g. Sharps medical waste, for USPS purposes, means a medical waste object that is capable of cutting or penetrating skin or packaging material and that is contaminated with a pathogen or may become contaminated with a pathogen derived from the medical treatment, diagnosis, immunization, or biomedical research of a human or animal. Sharps include used medical waste such as needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires. Mark these mailpieces with identification number UN 3291.
h. Toxin means a Division 6.1 material from a plant, animal, or bacterial source. A toxin containing an infectious substance or a toxin contained in an infectious substance must be classed as Division 6.2, described as an infectious substance, and assigned to UN 2814, UN 2900, or UN 3373, as appropriate. A toxin known or suspected to contain a Category A infectious substance is not mailable. A toxin known or suspected to contain a Category B infectious substance must be marked UN 3373 and packaged under 10.17.5. Toxins from plant, animal, or bacterial sources that do not contain an infectious substance, and are not contained in an infectious substance, may be considered for classification as Division 6.1 toxic substances under 10.16.
i. Used health care product means a medical, diagnostic, or research device or piece of equipment, or a personal care product used by consumers, medical professionals, or pharmaceutical providers that does not meet the definition of a diagnostic specimen, biological product, regulated medical waste, or sharps waste, is contaminated with potentially infectious body fluids or materials, and is not decontaminated or disinfected to remove or mitigate the infectious hazard prior to transport.