Chapter 438 of the Laws of 1993 amended both the Environmental Conservation Law (ECL) and the Public Health Law (PHL) concerning regulated medical waste (RMW). To address changes resulting from the enactment of Chapter 438, the New York State Department of Health (DOH) collaborated with the New York State Department of Environmental Conservation (DEC) on RMW issues and developed guidelines entitled, "Managing Regulated Medical Waste, Interpretive Guidelines for Implementing Revisions to PHL 1389AA-GG" (December 1995). In addition, Federal regulations govern RMW management and disposal, including the federal Occupational Safety and Health Administration (OSHA) Exposure to Bloodborne Pathogens regulations at 29 CFR Part 1910.1030 and federal Department of Transportation (DOT) regulation in 49 CFR Parts 171, 172, 173, and 178. These regulations require the University to manage the handling and disposal of RMW.

Regulated Medical Waste is defined as: any waste which is generated in the diagnosis, treatment or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, when listed by the Department of Environmental Conservation, provided, however, that regulated medical waste shall not include any hazardous waste identified or listed by the Department of Environmental Conservation, or any household waste defined by the Department of Environmental Conservation and shall include the following:

1)       Cultures and stocks (those that require biosafety level II-IV containment) in the CDC/NIH Manual for Biosafety in microbiological and Biomedical Laboratories (3rd edition, May 1993) and also contagious agents listed in Section 2.1 of the New York State Sanitary Code and assorted biologicals, including cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes used to transfer, inoculate, and mix cultures;

2)       Human pathological waste, including tissues, organs, body parts and body fluids that are removed during surgery or autopsy or other medical procedures, and specimens of body fluids and their containers;

3)       Waste human blood and products of blood, including serum, plasma, and other blood components and their containers;

4)       Sharps that have been used in animal or human patient care or in clinical laboratories, including hypodermic needles, syringes, pasteur pipettes, broken glassware and scalpel blades, blood vials, test tubes, needles with attached tubing, and such unused sharps that have been discarded;

5)       Contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research, production of biologicals, or testing of pharmaceuticals;

6)       Wastes from surgery or autopsy that were in contact with infectious agents, including soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, and surgical gloves;

7)       Cell lines - human, primate, and any other animal (mammalian) cell lines, even in the absence of overt contamination, may contain latent viruses and/or other opportunistic pathogens or zoonotic agents (capable of transmitting disease from animals to humans). Therefore these materials must be disposed of as RMW in New York state.       

8)       Laboratory wastes from clinical laboratories that were in contact with infectious agents, including slides and cover slips, disposable gloves, laboratory coats and aprons;

9)       Dialysis waste that were in contact with the blood of patients undergoing hemodialysis or renal dialysis, including contaminated disposable equipment and supplies such as tubing, filters, disposable sheets, towels, gloves, aprons and laboratory coats;

10)       Biological waste and discarded materials contaminated with blood, excretion, exudates or secretion from human beings or animals who are isolated to protect others from highly communicable diseases; and

11)     Any other waste material designated by the administrator of the U.S. Environmental Protection Agency as a "regulated medical waste."

Laboratory Procedure

All regulated medical waste must be collected in a manner and location which affords protection from the environment and limits exposure to others.

Regulated medical waste shall be separated from all other wastes in the laboratory.

Regulated medical waste, except for discarded sharps, shall be contained in bags which are impervious to moisture and have strength and sufficient to resist ripping, tearing or bursting under normal conditions of usage and of handling.  The bags shall be secured so as to prevent leakage during storage, handling or transport.  All bags used for containment and disposal of regulated medical waste shall be red in color.  Red bags shall not be used for any other use.  All such bags shall have affixed a label indicating the word "biohazard," or the universal biohazard symbol/the generators name and telephone number.

All discarded sharps shall be contained for disposal in leak proof, rigid, puncture-resistant containers which are secured to preclude loss of the contents.  Such containers shall be red in color and labeled with the word "biohazard" or the universal biohazard symbol/the generators name and telephone number.

All medical waste shall be stored in containers which shall be marked with prominent warning signs on the containers with the word "biohazard" or the universal biohazard symbol.

Regulated medical waste shall be transferred to the regulated medical waste holding area in accordance with procedures distributed by applicable administrative offices.

Regulated Medical Waste Holding Area Procedure

The regulated medical waste holding area will be located in Science III, room B-27A.  The area will be equipped with an appropriate sign, prevent unauthorized access, protect wastes from the elements and prevent access by vermin.

Containers used for the containment of regulated medical waste shall be marked with prominent warning signs on the containers with the word "biohazard" or the universal biohazard symbol.

Regulated medical waste exceeding 50 pounds in any month shall not be stored on the premises for more than 30 days.

Transportation of regulated medical waste from the University to off-site treatment, storage or disposal facilities shall be in accordance with the regulations of the Department of Environmental Conservation as set forth in Part 364 of Title 6 of the New York State Codes, Rules and Regulations.

Only authorized regulated medical waste haulers will transport regulated medical waste to off-site facilities.

All off-site shipments will be documented with appropriate manifests.  The signed and dated initiation copy (copy 5) will be retained by the RMW manager. A final destination copy (copy 1) will be returned to the RMW manager indicating disposal. Both copies will be maintained as a part of the permanent record for a minimum of three years.

Appropriate records must be maintained.

Record Keeping

All generators of regulated medical waste are required to maintain a record of the quantity of regulated medical waste generated, and the disposition of such wastes.