# COMAR Title 26 — Department of the Environment ## Subtitle 13 — Disposal of Controlled Hazardous Substances ### Chapter 12 — Standards Applicable to Generators of Special Medical Waste **Authority:** Environment Article, §§7-104, 7-201 et seq., 9-252, and 9-314, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective September 28, 1988 (15:22 Md. R. 2549); emergency status extended at 16:4 Md. R. 493 **Administrative History:** Regulations .01—.07 adopted effective April 3, 1989 (16:6 Md. R. 733) **Administrative History:** Regulation .01B amended effective April 20, 1998 (25:8 Md. R. 599) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective April 20, 1998 (25:8 Md. R. 599) **Administrative History:** Regulation .05 amended effective April 21, 2008 (35:8 Md. R. 812) **Administrative History:** Regulation .06 amended effective April 20, 1998 (25:8 Md. R. 599) **Administrative History:** Regulation .07 amended effective April 20, 1998 (25:8 Md. R. 599) #### Regulation .01 Purpose, Scope, and Applicability. *COMAR 26.13.12.01* A. These regulations establish standards for generators of special medical waste. B. A generator who treats, stores, or disposes of special medical wastes on-site shall only comply with the following regulations of this chapter with regard to that waste: (1) Regulation .02 of this chapter for determining whether or not the generator has special medical waste; (2) Regulation .03 of this chapter for obtaining an identification number; (3) Regulation .06A(2) and (3) of this chapter for record keeping; (4) Regulation .06B of this chapter for additional reporting; and (5) Applicable requirements of U.S. Department of Transportation Hazardous Materials Regulations, 49 CFR 171—178, which are incorporated by reference. C. An owner or operator who initiates a shipment of special medical waste from a treatment, storage, or disposal facility shall comply with the generator standards established in this chapter. #### Regulation .02 Special Medical Waste Determination. *COMAR 26.13.12.02* A person who generates a solid waste, as defined in COMAR 26.13.02.02, shall determine if that waste is a special medical waste using the following method. A person shall: A. First determine if the waste is excluded from regulation under COMAR 26.13.11.03; B. Then determine if the waste is a special medical waste pursuant to COMAR 26.13.11.02. #### Regulation .03 Maryland Identification Numbers. *COMAR 26.13.12.03* A. A generator may not treat, store, dispose of, transport, or offer for transportation, special medical waste without having received a Maryland identification number from the Secretary. B. A generator who has not received a Maryland identification number may obtain one by applying to the Secretary. Upon receiving the request the Secretary will assign an identification number to the generator. C. A generator may not offer his special medical waste to transporters that have not received a Maryland identification number. #### Regulation .04 Shipping Papers. *COMAR 26.13.12.04* A generator of special medical waste who transports, or offers for transportation, special medical waste for off-site treatment, storage, or disposal shall prepare shipping papers in accordance with the requirements of 49 CFR §§172.200—172.204, which are incorporated by reference in COMAR 26.13.12.01B(5). #### Regulation .05 Pretreatment Requirements. *COMAR 26.13.12.05* A. Classification of Special Medical Waste for Transport. (1) Before transporting special medical waste off-site or offering special medical waste for transport off-site, a generator shall classify the waste and assign a proper shipping name under the U.S. Department of Transportation Hazardous Materials Transportation Regulations, 49 CFR 171—178, which are incorporated by reference in Regulation .01B(5) of this chapter. (2) In complying with §A(1) of this regulation, a generator shall determine the hazardous material description under the U.S. Department of Transportation Hazardous Materials Regulations, including: (a) Proper shipping name; (b) Hazard class or division; (c) Identification number assigned to the proper shipping name; and (d) Packing group, if any. Agency note: Generally, special medical waste will be classified as “infectious substances, affecting humans” or “regulated medical waste, n.o.s.” under the federal hazardous materials transportation regulations unless the special medical waste is regulated as a hazardous material for an additional reason, such as because of its chemical nature or because it is also a radioactive material. B. Packaging, Marking, and Labeling. Before transporting special medical waste off-site or offering special medical waste for transport off-site, a generator shall: (1) Package the waste in accordance with 49 CFR Part 173; (2) Comply with the marking requirements of 49 CFR Part 172, Subpart D; and (3) Comply with the labeling requirements of 49 CFR Part 172, Subpart E. C. Treating. (1) If a generator treats special medical waste before transporting it off-site, offering it for transport off-site, disposing of it, or arranging for disposal of it, then the generator: (a) May treat the special medical waste only as provided in COMAR 10.06.06; and (b) Shall, in complying with the requirements of COMAR 10.06.06 as required by §C(1)(a) of this regulation, interpret “special medical waste” and “sharp” to have the meanings given in COMAR 26.13.11.02B. (2) A generator may not dispose of sharps in a solid waste landfill unless the generator incinerates the sharps or first sterilizes and then mechanically destroys the sharps. #### Regulation .06 Record Keeping and Reporting. *COMAR 26.13.12.06* A. Record Keeping. (1) A generator shall keep a copy of each annual report and exception report for a period of at least 3 years from the date of the report. (2) A generator shall keep records of any test results, waste analyses, or other determinations made in accordance with Regulation .02 of this chapter for at least 3 years from the date that the waste was last sent to on-site or off-site treatment, storage, or disposal. (3) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary. B. Additional Reporting. The Secretary, as the Secretary deems necessary, may require generators to furnish additional reports concerning the quantities and disposition of special medical wastes. #### Regulation .07 International Shipments. *COMAR 26.13.12.07* A. A person who exports special medical waste to a foreign country or imports special medical waste from a foreign country into the State shall comply with the requirements of this chapter and with the requirements of this regulation. B. When shipping special medical waste outside the United States the generator shall: (1) Notify the Secretary in writing 4 weeks before the initial shipment of special medical waste to each country in each calendar year; (2) Include in the notification required by §B(1) of this regulation: (a) An identification of the waste to be shipped, and (b) The name and address of the foreign consignee; (3) Require that the foreign consignee confirm the delivery of the waste in the foreign country by providing the generator with a copy of the shipping papers signed by the foreign consignee or by other appropriate means; and (4) Meet the requirements under Regulation .04 of this chapter. C. When importing special medical waste, a person shall meet all requirements of Regulation .04 of this chapter.