This chapter identifies those solid wastes that are subject to regulation as special medical wastes under COMAR 26.13.12 and 26.13.13. In this chapter: Regulation .02 defines the terms “solid waste” and “special medical waste”, identifies those wastes that are excluded, and establishes management requirements for special medical waste; Regulations .02 and .03 set forth the criteria used by the Department to identify special medical wastes; Special medical wastes are Controlled Hazardous Substances (CHS) and are subject to the provisions of COMAR 26.13.1126.13.13, 26.13.02.02A, and the applicable provisions of 26.13.01; Special medical waste is hereby exempted from the requirements of Environment Article, §§7-205, 7-224, 7-226, 7-232, and §7-253(4), Annotated Code of Maryland. The following terms have the meanings indicated. Terms Defined. “Anatomical material” means human or animal body parts, including tissues and organs. “Blood” means human blood, human blood components, and products made from human blood. “Blood-soiled article” means any article that contains blood in any form as a result of contact with blood. “Contaminated item” means an item for which it is known or reasonably anticipated that blood or other potentially infectious material is present on the item. “Contaminated material” means: Microbiological laboratory waste; The feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces; An article soiled with the feces of an individual diagnosed as having a disease that may be transmitted to another human being through the feces; or An article that has come into contact with a known human pathogen. “Generator” means any person whose act or process produces a special medical waste. “Infectious substance” means a material known or reasonably expected to contain a pathogen. “Microbiological laboratory waste” means waste from a microbiological laboratory that contains a human pathogen and includes cultures and stocks of pathogens and associated biologicals. “Other potentially infectious material” means: The following human body fluids: Amniotic fluid; A body fluid that is visibly contaminated with blood; A body fluid that cannot be readily identified; Cerebrospinal fluid; Pericardial fluid; Peritoneal fluid; Pleural fluid; Saliva generated in the performance of dental procedures; Semen; Synovial fluid; and Vaginal secretions; A tissue or organ from a living or dead human, not including intact skin, that has not been preserved by a chemical additive or preservative; The following items relating to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus: HIV-containing cell, tissue, or organ cultures; Media or other solutions containing HIV, Hepatitis B, or Hepatitis C; and Blood, organs, or other tissues, including blood, organs or other tissues from experimental animals infected with HIV or hepatitis B virus; and Microbiological laboratory waste. “Pathogen” means a microorganism, including bacteria, viruses, rickettsiae, parasites, and fungi, or other agent, such as a proteinaceous infectious particle, also known as a prion, that can cause disease in humans or animals. “Person” means an individual, trust, firm, joint stock company, federal agency, corporation (including a government corporation), partnership, association, state, municipality, political subdivision of a state, any interstate body, and any combination of persons using a common disposal collection device. Sharp. “Sharp” means an object that: Is capable of cutting or penetrating skin or a packaging material, and Either is known, suspected, or reasonably anticipated to be contaminated with a human pathogen, blood, or other potentially infectious material or may become contaminated with a human pathogen through handling or during transportation; “Sharp” includes needles, syringes with an attached needle or other sharp, scalpels, surgical instruments, broken glass, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires. “Sharp” includes an item that is capable of cutting or penetrating skin or a packaging material if the item is not in its original, intact packaging unless the item: Is not commonly associated with blood, other potentially infectious material or infectious substances, such as, for example, broken glass from beverage containers or disposable blades used by a contractor in building maintenance; and Has not been exposed to or commingled with special medical waste; and “Sharp” does not include an item in its original, intact packaging. “Shipping paper” means a shipping order, bill of lading, manifest, or other shipping document serving a similar purpose and containing the information required by 49 CFR §§172.202, 172.203, and 172.204, which are incorporated by reference in COMAR 26.13.12.01B(5) and 26.13.13.01G. “Solid waste” means any waste defined by COMAR 26.13.02.02. “Special medical waste” means a solid waste that is not excluded under Regulation .03 of this chapter and is composed of: Anatomical material; Blood that is in a liquid or semiliquid state; Blood-soiled articles that: Would release blood in a liquid or semiliquid state if compressed; or Are caked with dried blood and are capable of releasing the blood during handling of the items; A contaminated item that: Would release other potentially infectious material in a liquid or semiliquid state if compressed; or Is caked with other potentially infectious material and is capable of releasing the other potentially infectious material during handling of the item; Contaminated material; An infectious substance that can cause disease in humans; Microbiological laboratory waste; Other potentially infectious material that is in a liquid or semiliquid state; Pathological and microbiological waste that contains blood or other potentially infectious material; or Sharps. “Sterilize” means to use a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. The following solid wastes are not special medical wastes: Household waste, including household waste that has been collected, transported, stored, treated, disposed of, recovered, or reused. “Household waste” means any waste material (including garbage, trash, and sanitary wastes in septic tanks) derived from households (including single and multiple residences, hotels, and motels). Wastes generated in the handling of an animal unless the generator knows or has reason to know that the animal has a disease that is capable of being transmitted to humans. The ash or by-product from an incinerator authorized by a state to burn special medical waste. Wastes not generated in the ordinary course of business. Except as otherwise provided in this regulation, if a person generates, in a calendar month, a total of less than 50 pounds of special medical wastes, those wastes are not subject to regulation under COMAR 26.13.12 and 26.13.13, except as provided in §§C and D of this regulation. If a person whose waste has been excluded from regulation under §B of this regulation accumulates special medical wastes in quantities greater than 50 pounds, those accumulated wastes are subject to regulation under COMAR 26.13.12 and 26.13.13. In order for special medical waste to be excluded from regulation under §B of this regulation, the generator shall comply with COMAR 26.13.12.02 and .05A and C. If a person sterilizes special medical wastes, those wastes are excluded from the requirements of COMAR 26.13.12 and 26.13.13, except for COMAR 26.13.12.02 and .05A and C. Environment Article, §§7-104, 7-201 et seq., 9-252, and 9-314, Annotated Code of Maryland Effective date: Regulations .01—.03 adopted as an emergency provision effective September 28, 1988 (15:22 Md. R. 2549); emergency status extended at 16:4 Md. R. 493 (Emergency provisions are temporary and not printed in COMAR) Regulations .01—.03 adopted effective April 3, 1989 (16:6 Md. R. 733) Regulation .01 amended effective October 1, 2025 (52:17 Md. R. 876) Regulation .02 amended effective April 20, 1998 (25:8 Md. R. 599) Regulation .02B amended effective April 21, 2008 (35:8 Md. R. 812) Regulation .03E amended effective December 23, 1991 (18:25 Md. R. 2759)