DISTRICT DEPARTMENT OF THE ENVIRONMENT

DISTRICT DEPARTMENT OF THE ENVIRONMENT

NOTICE OF PROPOSED RULEMAKING

Change of the Definition of Regulated Medical Waste

The Interim Director of the District Department of the Environment ("the Department"), pursuant to the authority set forth in section 7 of the Illegal Dumping Enforcement Act of 1994, effective May 20, 1994 (D.C. Law 10-117; D.C. Official Code § 8-906 (2008 Repl.)), Mayor's Order 96-160, dated October 31, 1996, as amended by Mayor's Order 2000-54, dated April 12, 2000, as amended by Mayor's Order 2006-61, dated June 14, 2006, section 6 of the District of Columbia Hazardous Waste Management Act of 1977, effective March 16, 1978 (D.C. Law 2-64; D.C. Official Code § 8-1305 (2008 Repl.)), section 2(21) of the Solid Waste Facility Permit Act of 1995, effective February 27, 1996 (D.C. Law 11-94; D.C. Official Code § 8-1051(21) (2008 Repl.)), Mayor's Order 98-53, dated April 15, 1998, as amended by Mayor's Order 2006-61, dated June 14, 2006, and section 107(4) of the District Department of the Environment Establishment Act of 2005, effective February 15, 2006 (D.C. Law 16-51; D.C. Official Code § 8-151.07(4) (2008 Repl.)), hereby gives notice of the intent to amend Title 20, Chapter 43, of the District of Columbia Municipal Regulations ("DCMR"), to change the definition of "regulated medical waste." The amendments shall take effect in not less than thirty (30) days from the date of publication of this notice in the D.C. Register.

The Illegal Dumping Enforcement Act, the above cited Mayor's Orders, and the Hazardous Waste Management Act authorize the Department to manage, implement, enforce and promulgate rules pertaining to the disposal of hazardous waste, including certain regulated medical waste. D.C. Official Code § 8-906 authorizes the Department to promulgate regulations implementing the programs and plans described in the Illegal Dumping Enforcement Act whereas D.C. Official Code § 8-1305 authorizes the Department to promulgate regulations implementing the programs and plans described in the Hazardous Waste Management Act.

The definition of "regulated medical waste" (referred to as "Regulated Waste" in 29 C.F.R. 1910.1030(b) (2011)) is an important aspect of hazardous waste management programs because under federal law, regulated medical waste must be disposed of in a particular manner (i.e. "red-bags") to ensure the biological hazards are properly disposed of. The proposed amendment to the definition of "regulated medical waste" will provide greater clarity to the existing definition, and correspondingly allow hospitals and other medical facilities to understand better what is considered regulated medical waste. The current definition in 20 DCMR § 4399.1 combines two concepts from the D.C. Official Code into a definition that too broadly affects the regulated community. The definition in 20 DCMR § 4399.1 combines the definitions of "infectious waste," D.C. Official Code § 8-1051(21) and ordinary "medical waste," D.C. Official Code § 8-901(3A) into "regulated medical waste." As a result, a medical facility could erroneously conclude that they were required to treat a used band-aid with the same precautions as a used syringe. This over broad definition causes hospitals and other medical facilities to use more stringent standards than would otherwise be necessary to protect human health and the environment.

Thus, the purpose of this proposed rulemaking is to change the definition of "Regulated Medical Waste" to conform with the definition used by a number of States (See e.g., Virginia 9 VAC 20-120-150 and New York 10 NYCRR, 70-1), the Center for Disease Control (CDC/NIH Manual for Biosafety in Microbiological and Biomedical Laboratories), the United States Environmental Protection Agency (See 40 C.F.R. § 60.51c), and the Occupational Safety and Health Administration (Bloodborne Pathogen Standard, 29 C.F.R. 1910.1030).

This rulemaking proposes to reorganize and update the regulations that define certain terms used in 20 DCMR Chapters 42 and 43, and specifically to update the definition of "regulated medical waste."

TITLE 20 DCMR (ENVIRONMENT), CHAPTER 43 (HAZARDOUS WASTE MANAGEMENT REGULATIONS ADMINISTRATION AND ENFORCEMENT), SECTION 4399 is deleted in its entirety and replaced with the following:

4399 DEFINITIONS

4399.1 Terms not defined in this chapter shall have the meanings ascribed in § 3 of the District of Columbia Hazardous Waste Management Act, D.C. Official Code § 8‑1302; § 2 of the Illegal Dumping Enforcement Act, D.C. Official Code § 8‑901; § 2 of the District of Columbia Solid Waste Facility Permit Act, D.C. Official Code § 8‑1051; and 20 DCMR chapter 42.

4399.2 When used in this chapter and 20 DCMR chapter 42, the following terms have the meanings ascribed in the subsections below:

CFR - the Code of Federal Regulations, including the most recently updated volumes and any amendments thereto.

Department - the District Department of the Environment, or its successor agency.

Director - the Director of the District Department of the Environment, or its successor agency.

Regulated Medical Waste - shall mean:

(a) Cultures and stock of microorganisms and biologicals including:

(1) Discarded cultures, stocks, specimens, vaccines, and associated items likely to have been contaminated by them, if they are likely to contain organisms likely to be pathogenic to healthy humans;

(2) Discarded etiologic agents;

(3) Wastes from the production of biologicals and antibiotics likely to have been contaminated by organisms likely to be pathogenic to healthy humans;

(b) Liquid or semi-liquid blood or other potentially infectious materials including:

(1) Contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed;

(2) Items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling;

(3) Contaminated sharps, pathological and microbiological wastes containing blood or other potentially infectious materials;

(c) Tissues and all human anatomical wastes and all wastes that are human tissue including:

(1) Pathological and microbiological wastes containing blood or other potentially infectious materials;

(2) Organs; and

(3) Body parts;

(d) Potentially infectious materials including the following human body fluids:

(1) Semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;

(2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and HIV-containing cell, tissue, or organ cultures;

(3) HIV, HBV, or Hepatitis C-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV;

(e) Sharps likely to be contaminated with organisms that are pathogenic to healthy humans, including:

(1) All needles, syringes with attached needles, suture needles, and scalpels; and

(2) Sharps generated through veterinary practice;

(f) Animal carcasses, body parts, bedding, and related wastes:

(1) When animals are intentionally infected with organisms likely to be pathogenic to healthy humans for the purposes of research, in vivo testing, production of biological materials, or any other reason;

(2) The animal carcasses, body parts, bedding material, and all other wastes likely to have been contaminated, when discarded, disposed of, or placed in accumulated storage;

(g) Any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill of any regulated medical waste; and

(h) Any solid waste contaminated by or mixed with regulated medical waste.

Responsible Person - a person who is or has been the generator of hazardous waste, used oil, or regulated medical waste; the owner or operator of a site that contains, or a vehicle that transports, hazardous waste, used oil, or regulated medical waste; or a person who by contract, agreement, or otherwise arranges for the storage, treatment, or disposal of hazardous waste, used oil, or regulated medical waste.

How to Submit Comments:

The Department is committed to considering the public's comments in a rulemaking process that is open and observes the privacy rights of commenters. A person desiring to comment on the proposed rulemaking must file comments in writing by thirty (30) days after the date of publication of this notice in the D.C. Register.

Comments should identify the commenter and be clearly marked "Regulated Medical Waste Comments" and either: (1) mailed or hand-delivered to the Department's Toxic Substances Division, 1200 First Street, N.E., 5th Floor, Washington, DC 20002, Attention: Mary Begin, RE: Regulated Medical Waste ; or (2) e-mailed to mary.begin@dc.gov, with the subject indicated as "Regulated Medical Waste Comments."

The Department will consider all timely received comments before publishing a final rule. All comments will be treated as public documents and will be made available for public viewing on the Department's website. When the Department identifies a comment containing copyrighted material, the Department will provide a reference to that material on the website. The Department will look for the commenter's name and address on the comment. If a comment is sent by e-mail, the email address will be automatically captured and included as part of the comment that is placed in the public record and made available on the Department's website. If the Department cannot read a comment due to technical difficulties, and the email address contains an error, the Department may not be able to contact the commenter for clarification and may not be able to consider the comment. Including the commenter's name and contact information in the comment will avoid this difficulty.