TAGM SW-97-10 Disposal of Regulated Medical Waste Sharps

Effective Date: May 3, 2001 (supersedes TAGM DSHM-97-04)

I. PURPOSE
TAGMs are developed to provide guidance and clarify program issues to facilitate compliance with statutory and regulatory requirements. They also provide assistance to Department staff and the regulated community in interpreting and applying regulations and to Division of Solid & Hazardous Materials (DSHM) staff in achieving program uniformity throughout the state. A TAGM cannot impose new requirements beyond those contained in existing regulations or statutes. Furthermore, a TAGM is not a fixed rule; therefore, it does not create any enforceable right by any party using the TAGM.

The purpose of this TAGM is to provide guidance on the methods for proper disposal of regulated medical waste (RMW) which contains hypodermic syringes with the needle attached, medical needles, scalpel blades, blood vials, disposable hypodermic units and broken or unbroken glassware in contact with infectious agents (i.e., sharps).

All TAGMs are in effect until revised or rescinded.

II. BACKGROUND
Section 27-1507 of the Environmental Conservation Law (ECL) requires that "All sharps must be rendered unrecognizable prior to disposal." When the Federal Medical Waste Tracking Act demonstration program was in effect (June 22, 1989 to June 22, 1991), the United States Environmental Protection Agency (USEPA) was asked if the needle of a syringe was broken and the plunger was separated from the barrel of a syringe, would this technique qualify as "destruction"? USEPA responded that such separation did not render the syringe unrecognizable and, therefore, did not meet the definition of destroyed regulated medical waste. ECL requires that all RMW sharps be rendered unrecognizable prior to disposal.

The Department requires that all sharps be destroyed prior to disposal, pursuant to 6 NYCRR Part 360 Solid Waste Management Facilities (Part 360). Sharps are required to be destroyed because of concern for the safety of RMW handlers throughout the storage, collection, treatment, and disposal processes (i.e., particularly from injuries caused by needle sticks and cuts from sharp materials). Also, hypodermic syringes, needles, and disposable hypodermic units are required to be destroyed under Public Health Law Section 3381-a based upon a concern for the use of such instruments for administering narcotic drugs.

III. GUIDANCE

A. Definition of Sharps
The term "sharps" as contained in the definition of "Regulated Medical Waste" in Public Health Law Section 1389-aa is as follows: "This waste shall include but not be limited to discarded unused sharps and sharps used in animal or patient care, medical research, or clinical or pharmaceutical laboratories, hypodermic, intravenous, or other medical needles, hypodermic or intravenous syringes to which a needle or other sharp is still attached, Pasteur pipettes, scalpel blades, or blood vials. This waste shall include, but not be limited to, other types of broken or unbroken glass (including slides and cover slips) in contact with infectious agents. This waste shall not include those parts of syringes from which sharps are specifically designed to be easily removed and from which sharps have actually been removed, and which are intended for recycling or other disposal, so long as such syringes have not come in contact with infectious agents." Although syringes with attached needles are classic examples of sharps, other items used in the delivery of health care or in research which have come in contact with infectious agents (e.g., glass or rigid plastic culture tubes, flasks, beakers, lancets, etc.) must also be considered as sharps and be disposed accordingly.

Sharps that are generated as a result of household use (household medical waste) are excluded from the definition of RMW, as stated in clause 360-17.2(h)(2)(i)(b). Sharps that have been both treated and destroyed are not RMW, but are considered a commercial/industrial solid waste, as specified by clause 360-17.2(h)(2)(i)(d). Sharps generated as a result of household use and sharps that have been both treated and destroyed do not require transport by a hauler regulated by a 6 NYCRR Part 364 Waste Transporter Permit (Part 364).

B. Treatment of Sharps

Sharps, other than those generated as a result of household use, must be properly treated and destroyed before disposal. Methods of treatment include incineration, autoclaving, or any other New York State Department of Health (NYSDOH) approved method. A list of approved alternative treatment methods may be obtained from the NYSDOH, Director of Regulated Medical Waste Program, Wadsworth Center, Empire State Plaza, Albany, New York 12201-0509, telephone 518-486-6885. RMW treatment aims to substantially reduce or eliminate the potential for causing disease. It does not, however, qualify as destruction (except for incineration which is both).

C. Destruction of Sharps

After sharps have been properly treated at a Department or NYSDOH-approved facility, all sharps, other than those generated as a result of household use, must be destroyed prior to disposal at an authorized facility. Pursuant to subdivision 360-17.2(e), RMW that is destroyed must be rendered generally unrecognizable as medical waste. The term "Destroyed RMW", as defined in subdivision 360-17.2(e), "means RMW that has been ruined, torn apart, or mutilated through processes such as thermal treatment, melting, shredding, grinding, tearing, or breaking, so that it is no longer generally recognizable as RMW. It does not mean compaction." Generally, "unrecognizable" means destroyed with the intent to render the RMW material unusable and not recognizable as RMW (e.g., 100 percent of sharps must be rendered unrecognizable as intact sharps devices).

D. Transport and Disposal

Generators of RMW must comply with the requirements of subdivisions 364.9(d) and (e) prior to shipping the waste off-site. Those generators storing RMW on-site prior to treatment or destruction must specifically comply with paragraph 364.9(d)(3). Additionally, generators who treat and destroy RMW on-site by a method or process, other than incineration, must comply with the record keeping requirements of subparagraph 364.9(e)(5)(ii). Generators who treat or dispose of RMW on-site may be subject to additional federal, State or local laws and regulations.

The transportation of RMW is subject to Section 364.9 as well. Transporters, intermediate handlers (i.e., treatment and destruction facilities) and destination facilities must comply with the applicable requirements in subdivision 364.9(f), (g) or (h).

Once RMW sharps have been properly treated and destroyed, they may be disposed of in a Department authorized solid waste management facility (i.e., a solid waste incinerator or landfill). However, a Regulated Medical Waste Treatment Certification form as developed by the NYSDOH (see sample copy attached), must accompany the treated and destroyed RMW to the authorized solid waste management facility. The transportation of such treated material does not require a Part 364 permit, and tracking by manifest is not required.

A regulated medical waste treatment certification form is not required to accompany ash residue generated in an incineration process.