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Guidance for Regulated Medical Waste Treatment, Storage, Containment, Transport and Disposal

Guidance for Regulated Medical Waste Treatment, Storage, Containment, Transport and Disposal

New York State Department of Environmental Conservation

Division of Materials Management

Albany, New York 12233-7260

GUIDANCE FOR
REGULATED MEDICAL WASTE
TREATMENT, STORAGE, CONTAINMENT,
TRANSPORT AND DISPOSAL

February 1999

Preface

Title 15 of Article 27 of the Environmental Conservation Law was added by Chapter 431 of the Laws of 1987, providing jurisdiction to the New York State Department of Environmental Conservation (DEC) for regulating the storage, containment, treatment and disposal of infectious waste. Pursuant to Chapter 431, the DEC promulgated regulations under 6 NYCRR Part 360 Solid Waste Management Facilities (Part 360) to establish requirements for storage, containment, treatment and disposal facilities not regulated by the Public Health Law.

On November 1, 1988, the federal Medical Waste Tracking Act of 1988 (MWTA) was enacted into law. The MWTA established a two-year demonstration program for tracking medical waste generated in New York State and other states subject to the program. In response to the MWTA, New York State again amended the Environmental Conservation Law through Chapter 180 of the Laws of 1989. This amendment substituted the words regulated medical waste for infectious waste, revised the definition of RMW, established the RMW tracking program, added transportation of RMW to the applicability section, and added standards applicable to generators of RMW. Subsequently, the DEC revised the Part 360 and Part 364 Waste Transporter Permits regulations to conform with Chapter 180 and the MWTA.

The Environmental Conservation Law, Part 360 and Part 364 regulations, in conjunction with the Public Health Law and 10 NYCRR Part 70 Regulated Medical Waste, govern the activities of the New York State regulated community to properly manage RMW. However, Chapter 438 of the Laws of 1993 amended both the Environmental Conservation Law and Public Health Law concerning RMW, and together with new federal requirements for transport of RMW, raised concerns regarding the applicability of the existing New York State regulations. To address this issue, and to clarify any potential confusion until revised regulations are promulgated, this guidance document was developed. This document provides guidance on RMW storage, containment, transport, and disposal, and will serve as a valuable resource document for generators, transporters and disposal facilities.

Introduction

Chapter 438 of the Laws of 1993 (Chapter 438) amended both the Environmental Conservation Law (ECL) and the Public Health Law (PHL) concerning regulated medical waste (RMW), to reduce the types of materials defined as RMW, and to allow properly treated RMW to be disposed of as a solid waste, provided it is not a hazardous waste and is accompanied to a disposal facility by a New York State Department of Health (DOH) approved certification form that evidences such treatment (certificate of treatment form).

In addition to both ECL and PHL, 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. These are designed to protect workers from exposure to bloodborne pathogens which may include RMW, and the new U.S. Department of Transportation (DOT) regulations in 49 CFR Parts 171, 172, 173 and 178, as amended by Docket No. HM-181G regarding the interstate shipment of RMW. The DOT regulations in part, provide uniform transportation standards (medical waste tracking requirements) and packaging standards for RMW. Both Chapter 438 and the federal regulations have impacted New York State's program for RMW, and raised concern in the regulated community over the applicability of existing State regulations, caused misconceptions about what materials are RMW, or whether there are hazards associated with its disposal.

For example, with the revision to the definition of RMW, some materials that were previously RMW are now allowed to be disposed of as solid waste. Under the previous definition, which conformed with the federal MWTA, materials generated in healthcare did not have to come in contact with a patient to be considered RMW. An example of this is IV bags and bottles. The sterile solutions found in these containers are used to provide a vehicle for delivery of medication. Although such items never came into contact with a patient, the federal government believed that because they "looked medical" they must be included as RMW. Under the revised ECL and PHL these items are not considered RMW. Another example would be materials which have come into contact with small quantities of body fluids such as blood. Under the revised definition, unless completely saturated to the point of dripping, these materials are not considered RMW. Therefore, items such as bandages and gauze pads which are tinged with blood (or other body fluids) may now be placed in the general commercial waste stream.

Similarly, there is a need to identify the real risks of infection from managing RMW. A lack of understanding of the modes of disease transmission, the fear of fatal disease and a mistrust of generating facilities to properly manage RMW has fueled concerns in the solid waste industry and general public with respect to the public health and environmental hazards associated with the disposal of RMW. Such concerns have been further accentuated by misleading media coverage and has resulted in hasty and negative decisions regarding the acceptance of RMW at solid waste disposal facilities. The environmental and occupational health concerns for those individuals with the task of managing RMW can best be addressed through communication and training of employees on the potential hazards that may be associated with this unique subset of solid waste. Such potential hazards are commonplace in the everyday municipal solid waste stream and therefore, training is essential irrespective of where the waste originates. Additionally, an intensive public education program regarding the actual issues posed by RMW coupled with guidance on its proper management and disposal may reduce the level of concerns of the public and solid waste industry.

To initiate a public education program and to address the changes resulting from the enactment of Chapter 438, the 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). The DOH guidelines provide an interpretation of Chapter 438, including new definitions and examples of RMW, discuss relevant OSHA standards, and offer guidance on various treatment and disposal strategies for the healthcare community. The DOH guidelines have been distributed to all New York State healthcare facilities and represent a very useful tool for properly identifying and segregating RMW. All other RMW generators are encouraged to review and become familiar with the DOH guidelines since such information can be used as a template for managing RMW in their own facilities. Solid waste disposal facilities are also encouraged to review the DOH guidelines to become familiar with what is now allowed to be disposed as solid waste and to help alleviate concerns or misconceptions about the hazards associated with disposal of properly treated RMW at such facilities.

In order to conform with both Chapter 438 of the Laws of 1993, and the federal DOT regulations, the existing 6 NYCRR Part 360 Solid Waste Management Facilities (Part 360) and Part 364 Waste Transporter Permits (Part 364) regulations pertaining to the storage, containment, transportation, treatment and disposal of RMW will need revision. Therefore, until revisions to these regulations are promulgated, this Interpretive Guidance Document should be used regarding Chapter 438 and the federal DOT regulations.

These DEC interpretive guidelines are applicable to all generators of RMW and are intended to communicate policy determinations and interpretation concerning changes relating to Chapter 438, and also discuss the federal regulations at 49 CFR Parts 172 and 173. Furthermore, these DEC interpretive guidelines are intended to help generators of RMW, commercially operated RMW storage, treatment and destruction facilities, RMW transporters, and solid waste haulers, transfer stations and disposal facilities comply with the ECL and 49 CFR Parts 172 and 173.

These DEC interpretive guidelines include commonly asked questions about the management and disposal of RMW. The response provided to each question represents DEC's current policy and interpretation to conform with the ECL and 49 CFR Parts 172 and 173. However, these interpretive guidelines are not intended as legal advice, but as an aid to understanding the law and DEC regulations. It is also important to understand that the information contained in these interpretive guidelines should not be considered a substitute for the existing laws and regulations, but should be used with the appropriate ECL, Parts 360 and 364 regulations, and if applicable, 10 NYCRR Part 70 Regulated Medical Waste (Part 70) regulations and the DOH Interpretive Guidelines for Implementing Revisions to PHL and managing RMW.

Regulatory Authority and Jurisdiction

It is important to recognize that both the DOH and DEC jointly administer New York State's RMW program. For example, the DOH has jurisdiction for all treatment, storage and destruction processes located on-site of, and operated by health care facilities licensed pursuant to Article 28 of the PHL, and clinical laboratories licensed pursuant to Subsections 571 through 580 of the PHL. In addition to administering the Part 70 regulations, the DOH is responsible for developing treatment standards, approving alternative RMW treatment processes, developing and approving the certificate of treatment form, and responding to incidents involving physical injury associated with exposure to RMW. The DEC has jurisdiction for all storage, treatment and destruction processes located on-site of facilities not under DOH jurisdiction, for off-site transport of treated and untreated RMW for all generators, tracking, responding to illegal disposal incidents, and for all off-site treatment, storage, transfer and disposal facilities.

Generator Standards - Questions Commonly Asked

WHAT IS A RMW GENERATOR?

A RMW generator is an institution which through its activities creates RMW. Examples of such institutions include, but are not limited to, hospitals, clinical laboratories, veterinarians, funeral homes, nursing homes, home healthcare providers, physician's offices, research laboratories, pharmaceutical companies, colleges and universities (including basic medical or clinical microbiology laboratories), blood banks, company infirmaries, and correctional facilities.

DO RMW GENERATORS NEED TO REGISTER WITH THE DEC?

No. RMW generators are not required to register with the DEC.

WHAT ARE THE RMW GENERATOR'S RESPONSIBILITIES?

Each generator is responsible for properly packaging and labeling RMW for off-site transport and for completing an approved Medical Waste Tracking Form (MWTF). To simplify this requirement, each generator of RMW is encouraged to identify and segregate RMW from other solid waste at the point of origin within the facility, thus keeping the total amount of RMW to a minimum. In addition, to ensure safe handling and transport within the generating facility, all employees involved with the on-site management of RMW must be trained in accordance with the requirements of the OSHA Exposure to Bloodborne Pathogens regulations in 29 CFR Part 1910.1030.

CAN OTHER TYPES OF WASTE BE MIXED WITH RMW?

If RMW is a hazardous waste or a radioactive waste, or is mixed with hazardous or radioactive waste, it must be managed as either a hazardous waste or radioactive waste, respectively. If untreated RMW is mixed with other forms of solid waste, then the combined waste must also be managed as a RMW. However, properly treated RMW from facilities with approved treatment processes may mix the treated RMW with other solid waste in accordance with DEC regulations, if a certificate of treatment form accompanies the waste to the authorized disposal facility.

DOES UNTREATED RMW HAVE TO BE PACKAGED IN RED BAGS AND LABELED FOR TRANSPORT OFF-SITE?

Yes. Untreated RMW, except sharps, must be placed in impermeable red plastic bags (of sufficient strength to prevent tearing or bursting under normal conditions of use and handling) that include as an integral part of the bag, the word biohazard or the universal biohazard symbol. Existing stocks of bags which were previously required to be labeled with either the word "infectious" or the words "regulated medical waste" may be used until supplies are depleted. When reordering bags, institutions must acquire bags which meet the labeling requirements of the ECL. Each bag containing untreated RMW must be labeled and placed in a secondary rigid type container according to DEC regulations before off-site transport. The rigid containers used for disposal of RMW may be any color, but must be leakproof, have tight fitting covers, and if reusable, must be kept clean, and in good repair. Each container must be conspicuously labeled with the word biohazard or with the universal biohazard symbol. In addition, the waste must be stored in a package labeled according to DEC regulations and 49 CFR Part 172. Sharps [e.g., discarded syringes (barrel and/or needle) and those other sharps that have come in contact with infectious agents] must be packaged in rigid, puncture and break resistant, and leakproof containers labeled with the word biohazard or the universal biohazard symbol, and conform to the DEC regulations and the 49 CFR Part 172 Packing Group II performance level before off-site transport. The packaging group number indicates the degree of danger presented by a material. Packing Group II is considered to signify medium danger. These sharps containers must also be labeled and placed in a secondary rigid type container (or DEC authorized alternative) in accordance with DEC regulations before off-site transport.

WHAT TYPE OF INFORMATION SHOULD BE INCLUDED ON THE PACKAGED RMW CONTAINER?

Under the DEC regulations, each primary container (a red bag), sharps or fluid container destined for off-site treatment and disposal must include the generator facility name and address. Each secondary container must include the generator facility name and address, the transporter's name and permit number, the date of shipment and identification of the RMW contents (e.g., sharps, chemotherapeutic waste, and pathological waste), and include the word biohazard or the universal biohazard symbol. In addition, a MWTF is also required.

IS MEDICAL WASTE GENERATED IN THE HOME REGULATED AS RMW?

No. The State of New York does not consider medical waste (e.g., sharps, IV bags, etc.) generated in the home to be included in the definition of RMW. However, if a home healthcare provider or hospice organization generates medical waste in the home, they are encouraged to transport it (or use an authorized courier service that complies with the Part 364 regulations) to their office or an Article 28 facility for proper packaging for disposal. Note: Upon consolidation, such home generated medical waste is no longer exempt and must be packaged, labeled and transported in accordance with Part 364. Also, if the medical waste generated in the home is separated and collected from multiple residences and then consolidated, such as in an apartment building or dormitory, it is suggested that such consolidated RMW be packaged, labeled and transported as RMW. These suggestions are made to prevent public exposure from RMW generated in the home (e.g., needle-stick incidents, spilled fluid containers, etc.).

Storage and Containment of RMW

CAN ANYONE STORE RMW?

Large quantity generators (e.g., more than 50 pounds per month) may store RMW generated at their own facility, or may accept for the purposes of consolidation, RMW from off-site small quantity generators (e.g., less than 50 pounds per month) who are under common ownership and control of the parent facility. Licensed healthcare providers may function as collection stations and accept for storage, on-site treatment, off-site transport and disposal, untreated RMW generated by one or more small quantity generators (professional practices) who have written agreements with the facility. No approval is required for this activity, but the facility functioning as a collection station must, in accordance with Part 360 regulations, notify both the DEC and the DOH of this activity. In addition, such large quantity generators must keep track of all incoming waste, and the off-site small quantity generators are subject to all packaging, labeling, transportation, and record keeping requirements. Large quantity generators and commercially operated RMW storage facilities must also comply with the applicable requirements of Part 360 and Part 364 for packaging, labeling, transportation, storage, treatment, and record keeping.

HOW LONG CAN A GENERATOR OR COMMERCIALLY OPERATED RMW STORAGE FACILITY STORE RMW AND UNDER WHAT CONDITIONS BEFORE OFF-SITE TRANSPORT?

There are no maximum time limits that RMW may be stored by generators. All storage of RMW must be in an area that is designated and clearly labeled with the word biohazard or the universal biohazard symbol, that is properly ventilated, located to minimize exposure to the public and that is accessible only to authorized personnel. Such waste must be maintained in a nonputrescent state, using refrigeration when necessary, and must be contained so that no discharge or release of any waste occurs, affords protection from the environment, and limits exposure to the public. Such areas must be maintained in a sanitary condition, be free of rodents and insects, and secure from vandalism. All outdoor RMW storage areas must be kept locked when unattended. In addition, RMW must not be stored with other solid wastes unless such waste is properly separated by barriers or unless all of the waste is to be treated or disposed of as RMW. Authorized commercially operated facilities must comply with the storage requirements provided in Part 360.

WHAT SHOULD BE DONE WITH USED RMW CONTAINERS?

Disposable (rigid cardboard, etc.) single-use containers used for RMW storage must be disposed with the RMW. Reusable containers that have been damaged and are unable to be repaired, that have come in direct contact with RMW, must be appropriately treated and disposed.

HOW SHOULD REUSABLE RMW CONTAINERS BE CLEANED OR DECONTAMINATED?

RMW reusable containers, if visibly contaminated, must be cleaned with a disinfectant registered with the United States Environmental Protection Agency (EPA) or disinfected using a DOH approved non-chemical alternative (e.g., steam sterilization, etc.). If any reusable container used for the storage or transport of RMW is unable to be decontaminated, such containers must be packaged, labeled, treated and disposed of as RMW.

CAN CONTAINERS OF RMW BE COMPACTED BEFORE DISPOSAL?

No. Containers of RMW must not be compacted and must remain intact until treatment or disposal, and therefore, must be handled and transferred in a way that does not damage the integrity of the packaging. Single use containers contaminated with spilled or leaked RMW, and damaged containers, must be repackaged before transport. To minimize exposure during repackaging of the materials, it is recommended that appropriate personal protective devices be used.

Off-Site RMW Transport

WHAT ARE THE MEDICAL WASTE TRACKING AND REPORTING REQUIREMENTS?

All RMW generators, including facilities under DOH jurisdiction, who package untreated RMW (including sharps) for off-site transport must complete an approved MWTF. All MWTFs must be retained by the generator for three years and made available for examination by DOH and DEC staff upon request. Pursuant to the ECL, generator and transporter annual reports are required to be submitted to the DEC. However, the DEC is suggesting to the legislature that this section of the ECL be amended such that reports are no longer required to be submitted. In the interim, DEC is not requiring submittal of generator annual reports. Nonetheless, facilities must comply with the Part 364 record keeping requirements and are encouraged to develop generator annual reports for their own purposes. Such reports may be useful for determining costs associated with the disposal and may assist in properly managing RMW. Transporter annual reports are still required to be submitted.

WILL DEC DISTRIBUTE COPIES OF THE REQUIRED MEDICAL WASTE TRACKING FORMS?

The DEC no longer distributes MWTFs. Information required on a MWTF, as required by State and federal (49 CFR Part 172) regulations are provided in the sample Medical Waste Tracking Form included with these guidelines (see last page). Facilities are encouraged to copy this form for their use.

CAN GENERATORS TRANSPORT THEIR OWN RMW OR CENTRALIZE THEIR RMW COLLECTION?

All off-site transport of more than 50 pounds per month of RMW from any generator must be with a hauler authorized by the DEC to transport RMW. RMW generators may transport small quantities (e.g., less than 50 pounds per month) of their own RMW, in their own transport vehicle, but must carry the MWTF with each load. In addition, small quantity generators who self transport must notify the DEC in accordance with Section 27-1511 of the ECL. Such small quantities of RMW may be transported between facilities (if accompanied by a MWTF) under one ownership for the purposes of consolidating RMW at one location, if such transport is conducted in a not-for-profit capacity and records are kept (for a minimum of three years) of the transaction. In any event, no RMW may be transported off-site unless properly segregated, packaged, labeled and is accompanied by a MWTF. Generators located in the same building may share a common storage area before the waste is transported off-site with an authorized RMW transporter.

DOES RMW HAVE TO BE COVERED DURING TRANSPORT?

Yes. In accordance with the ECL, all properly contained untreated RMW (including roll off containers) must be transported in leakproof, fully enclosed containers or vehicles and must be secured when unattended.

CAN ANYONE, SUCH AS A SOLID WASTE HAULER, ACCEPT RMW FOR TRANSPORT?

No. Untreated RMW (other than that generated in the home, as previously discussed) may only be transported or accepted for disposal by an authorized RMW transporter. RMW may not be transported or accepted by any person for transport unless it has been properly segregated, packaged, labeled and is accompanied by a MWTF. Untreated RMW must not be transported in the same transport vehicle with other treated RMW or non-RMW solid waste unless it has been properly separated by barriers, or unless all of the waste is to be treated or disposed of as RMW. Transport vehicles must be properly placarded in accordance with Part 364, and Section 14-f of the New York State Transportation Law and all rules and regulations promulgated thereunder.

CAN RMW BE DISPOSED AT ANY COMMERCIAL OR MUNICIPAL OPERATED SOLID WASTE DISPOSAL FACILITY?

RMW may only be delivered to a storage, treatment or disposal facility in New York State that has DEC authorization allowing the facility to manage RMW. In addition, RMW may not be disposed of by burial at a disposal facility unless treated in accordance with Part 360 or Part 70.

Treatment and Disposal

CAN LARGE QUANTITY GENERATORS TREAT RMW ON-SITE?

Yes. Large quantity generators (small quantity generators see next page), except for facilities working with infectious agents at biosafety levels 3 or 4, may treat RMW on-site of the facility if the approved treatment equipment is available and the facility has been approved to treat RMW in writing by the DOH (for facilities under DOH jurisdiction), or has been so authorized by the DEC (for facilities under DEC jurisdiction). All facilities, under DEC jurisdiction, that are working with infectious agents at biosafety levels 3 or 4 must obtain a Part 360 permit to treat RMW on-site.

WHAT ARE THE REQUIREMENTS FOR TREATING RMW ON-SITE?

Facilities that generate RMW that are under DOH jurisdiction must prepare and submit an operation plan to the DOH for approval as required and described in Part 70. Such facilities must have written approval from the DOH on file before treatment commences. Facilities under DEC jurisdiction that treat RMW only generated at that facility, and generate more than 50 pounds per month (except for facilities working with infectious agents at biosafety level 3 or 4), must prepare and submit an operation plan to the DEC for approval. Such operation plans must meet the requirements of Part 360 and include a validation testing program. These facilities must have written approval from the DEC on file before treatment commences. A summary of the DEC requirements for on-site treatment of RMW is included in this document. On-site incineration facilities must also comply with applicable air pollution control requirements set forth in Title 6 NYCRR Parts 201 and 219.

WHAT ARE THE RECORD KEEPING REQUIREMENTS FOR GENERATORS THAT TREAT RMW ON-SITE?

Each generator that is authorized by the DEC to treat RMW on-site must maintain a copy of the certificate of treatment form for a period of at least three years from the date the waste was treated.

CAN A FACILITY AUTHORIZED TO TREAT RMW ON-SITE, ACCEPT FOR TREATMENT, RMW FROM OTHER GENERATORS?

Facilities authorized by the DEC to treat or destroy RMW on-site may not accept RMW from other generators for treatment and/or destruction purposes unless authorized in accordance with Part 360. RMW treatment facilities and destruction processes that are located on-site of licensed health care facilities that as a community service, accept for treatment or disposal, RMW from off-site generators, must comply with subdivision 360-17.1(c) and Part 364. [Note: Healthcare facilities that treat or destroy RMW received from off-site generators that receive a fee or payment above the cost for this service may be operating as a commercial RMW treatment and or destruction facility. In addition, healthcare facilities that import RMW that exceeds the storage and treatment capacity of the host facility, or accepts RMW from generators located outside of the host facility's geographic location (DEC Region) may be operating as a commercial RMW treatment or destruction facility. As a commercial entity, these facilities may be subject to additional requirements which may include but not be limited to the submittal of operation, contingency and personnel training plans, environmental assessments, reviews, or required to obtain a Part 360 permit. Such facilities must contact the Bureau of Permitting and Planning, DEC Division of Materials Management, phone (518) 402-8678, for a determination.]

DO SMALL QUANTITY RMW GENERATORS NEED APPROVAL TO DISPOSE OF PROPERLY TREATED RMW AS A SOLID WASTE?

Small quantity generators (e.g., less than 50 pounds per month), that do not work with infectious agents at biosafety levels 3 or 4 and are not located on-site of, or under common ownership and control of a parent facility, may treat RMW on-site with a DOH approved treatment technology. Such generators are required to develop and maintain operation plans but are exempt from the solid waste requirements for DEC permitting and/or authorization to treat RMW on-site. However, all facilities must use the certificate of treatment form (as approved by the DOH) for each shipment of waste. Such form must be given to their refuse hauler and accompany the treated RMW to the authorized disposal facility. In addition, all sharps which have been in contact with potentially infectious agents, and infectious substances must be managed as a RMW unless both treated and destroyed (rendered unrecognizable) prior to disposal. All packaging, labeling, transportation, storage, treatment and record keeping requirements apply to infectious substances and to those sharps that have not been both treated and destroyed.

CAN A FACILITY THAT TREATS RMW ON-SITE, WITHOUT AUTHORIZATION, DISPOSE OF THE TREATED RMW AS SOLID WASTE?

No. A facility that generates more than 50 pounds per month of RMW must have written authorization to treat RMW by the DOH (facilities under DOH jurisdiction) or the DEC (facilities under DEC jurisdiction) before treated RMW may be disposed as a solid waste. Any treated RMW from unauthorized facilities must be packaged, labeled, and transported as untreated RMW in accordance with DEC regulations.

MUST RED BAGS BE USED FOR DISPOSAL OF PROPERLY TREATED RMW?

Red bags, associated with untreated RMW, have previously been prohibited from landfill disposal, and must be used for containment, storage, transport and disposal of untreated RMW. Facilities authorized to treat RMW on-site may find it easier to use waste bags that are not red in color. Such bags must be labeled with the word biohazard or the universal biohazard symbol. However, facilities that transport their untreated RMW to an off-site facility for treatment must use red bags.

ARE THERE DEC PERMITTING REQUIREMENTS FOR COMMERCIALLY OPERATED RMW TREATMENT AND DESTRUCTION FACILITIES?

Yes. All commercially operated RMW treatment and destruction facilities (including facilities under DOH jurisdiction) must comply with the permitting requirements provided in 6 NYCRR Part 360 and Part 219. All packaging, labeling, transportation, storage, treatment and record keeping requirements apply.

IS TREATED RMW SHIPPED OFF-SITE FOR DISPOSAL SUBJECT TO THE SAME PACKAGING, LABELING, TRACKING AND TRANSPORTING REQUIREMENTS AS UNTREATED RMW?

No. RMW, except RMW sharps which must be both treated and destroyed before disposal, treated at an authorized facility by autoclaving or by other treatment technologies approved by the DOH, may be disposed of as solid waste provided it is not otherwise a hazardous waste as defined in ECL section 27-0903 or the regulations promulgated thereunder, and is accompanied by a certificate, in a form prescribed by the Commissioner of DOH, that evidences such treatment. Generators who treat their RMW on-site must notify the refuse collection company that treated RMW is being disposed and give them the certificate of treatment form upon collection of each load of waste.

IS HOUSEHOLD MEDICAL WASTE SHARPS CONSOLIDATED DURING LOCALLY SPONSORED HOUSEHOLD HAZARDOUS AND MEDICAL WASTE COLLECTION DAYS SUBJECT TO THE SAME REQUIREMENTS AS RMW SHARPS?

Yes. All RMW packaging, labeling, transportation, storage, treatment, disposal and tracking requirements apply to consolidated sharps generated from multiple residences and obtained during government sponsored household hazardous and medical waste collection events.

CAN TREATED RMW BE COMMINGLED WITH OTHER SOLID WASTE AT THE GENERATING FACILITY?

Yes. Treated RMW (except RMW sharps unless destroyed and rendered unrecognizable) may be commingled with other solid waste at the generating facility if such facility is authorized to treat RMW and the commingled waste is destined for direct transfer or disposal at an authorized solid waste disposal facility and is accompanied by a certificate of treatment form. Commingled treated RMW and solid waste may not be taken to transfer stations where recycling or sorting activities are ongoing unless the DEC has authorized such facility in writing to accept treated RMW. Facilities approved for on-site treatment must notify their refuse collection company regarding the need for direct disposal of treated RMW.

CAN TREATED RMW BE COMMINGLED WITH WASTE FROM MULTIPLE FACILITIES?

Yes. Treated RMW, except sharps, may be commingled with other solid waste or treated RMW and/or commingled waste from multiple facilities if each facility, except small quantity generators, is authorized to treat RMW on-site, and an approved certificate of treatment form accompanies the mixed loads of waste from each authorized facility. The commingled treated RMW from multiple facilities can either go to an authorized transfer station or directly to an authorized solid waste disposal facility. Such waste may not be disposed at transfer stations where recycling and/or sorting activities are ongoing. Facilities approved to treat RMW on-site must notify their refuse collection company regarding the need for direct disposal.

CAN A SOLID WASTE TRANSFER STATION OR LANDFILL REJECT PROPERLY TREATED RMW FOR DISPOSAL?

Yes. Solid waste disposal facility owners and operators have the right to reject any waste (including treated RMW) for disposal, even if State laws and regulations allow disposal of such waste. The DEC has alerted all solid waste disposal facility owners and operators about the amendments to the ECL regarding treated RMW, and the disposal of such waste at DEC authorized disposal facilities. Solid waste disposal facilities initially may not be willing to accept treated RMW due to a lack of information or public perception issues. However, this unwillingness may be reversed through education, local discussions and planning. DEC staff is available to provide technical assistance, and education for landfill owners and operators concerned about accepting treated RMW.

WHERE CAN TREATED RMW BE DISPOSED?

After treatment at an authorized treatment facility (including small quantity generators), treated RMW may be disposed, if accompanied by an approved certificate of treatment form, at an authorized solid waste landfill or incinerator pursuant to Parts 360 and 219. Such authorized solid waste landfills or incinerators must notify refuse haulers of the requirement for the certificate of treatment form.

WHY DO SOLID WASTE DISPOSAL FACILITIES NEED TO BE AUTHORIZED TO ACCEPT TREATED RMW?

In accordance with DEC regulations (6 NYCRR section 360-2.9), all solid waste disposal facilities are required to develop an operation and maintenance manual which, in part, characterizes the solid waste stream to be received based on type. Such characterization is necessary to identify the solid waste that needs to be restricted, identify those wastes required to undergo special handling or treatment before acceptance, inform personnel of any potential risks associated with the waste, and determine if the waste is compatible with the disposal facility.

HOW CAN SOLID WASTE TRANSFER STATIONS AND DISPOSAL FACILITIES OBTAIN AUTHORIZATION TO ACCEPT TREATED RMW FOR DISPOSAL?

A solid waste transfer station and disposal facility that has a Part 360 permit to operate can request a modification of their permit to include acceptance of treated RMW. Such permit modification is a procedural issue and is necessary in order for the solid waste transfer and disposal facility to develop procedures for recognizing whether the RMW has been properly treated, for handling unauthorized waste, and for providing training for personnel. Since facility personnel may occasionally come in contact with untreated RMW, training should include use of personal protective clothing, discussion of potential hazards associated with the waste, and a review of the OSHA Exposure to Bloodborne Pathogens regulations.

WHAT ARE THE PROCEDURES FOR OBTAINING DEC AUTHORIZATION TO ACCEPT TREATED RMW FOR DISPOSAL?

The procedures for the authorization include developing an addendum to each of the facilities existing operation, contingency and personnel training plans that address the following criteria: 1) proposed handling and processing procedures for treated RMW; 2) methods of informing refuse haulers of the required certificate of treatment forms. (Note: Not withstanding the statutory requirements for the form, the use of this form by a treatment facility will not only serve as a notice that treated RMW is being delivered to a disposal facility, but will provide assurance that the treated RMW has been properly treated so as not to pose a threat to the safety and public health of employees working at such transfer/disposal facility.); 3) a description of the operating and waste handling procedures necessary to manage the treated RMW effectively; and, 4) procedures to be used for emergencies and other situations, such as receipt of unauthorized waste, improperly treated RMW, and treated RMW that is not accompanied by a certificate of treatment form. (Note: Disposal of improperly treated RMW into the solid waste stream should be very obvious to the operator of the disposal facility even without a thorough examination (i.e., manual handling) of the entire waste stream). A summary of the authorization process is included with this document.

CAN SOLID WASTE DISPOSAL FACILITIES VISUALLY DETERMINE IF RMW WASTE HAS BEEN PROPERLY TREATED?

No. However, most facilities that treat RMW will probably use a steam sterilizer (autoclave) which combines the effects of heat from saturated steam and pressure to destroy microorganisms. Treated bags of RMW from autoclaves may be shrunken in appearance. Also, these bags may or may not have indicator strips in or on the bags that will change color or may have the word treated appearing on the strip after the bags have been autoclaved. In addition, certain types of bags may change color as a result of autoclaving. In any event, the certificate of treatment form that accompanies the treated RMW to the disposal facility should be the only indicator that RMW has been properly treated if it is signed, certifying that the waste has been properly treated. The assurance that the waste was treated properly is in the treatment procedure that was approved by the DEC or DOH. Such approvals require facilities to conduct tests on their treatment equipment in accordance with strict standards before treatment commences.

Management of RMW Spills or Inappropriately Disposed RMW

HOW SHOULD RMW SPILLS BE MANAGED?

In all cases of spills, the generator (if at a generating facility), the transporter (if in transit) or the RMW transfer and disposal facility must immediately take steps to contain, disinfect if necessary, and clean up the spilled materials. A generator under DEC's jurisdiction (facilities under DOH jurisdiction must notify the DOH) is not required to report spills that occur at the facility to the DEC unless public health or the environment is at risk. All other spills must be reported to the DEC's spill hotline (1-800-457-7362) or the appropriate DEC Regional Materials Management Engineer within 48 hours of the spill. A list of the DEC regional phone numbers is included with these guidelines. The responsible party must develop a report of the incident, identifying the measures used to clean up and dispose of the RMW, and must retain the incident report for three years. All spilled materials must be packaged, labeled and transported according to DEC and DOT regulations.

HOW SHOULD ILLEGALLY DISPOSED OR ABANDONED RMW BE MANAGED WHEN NO RESPONSIBLE PARTY HAS BEEN IDENTIFIED?

All events involving illegal disposal of small quantities of RMW such as items found on roads (e.g., syringes, culture plates or blood vials) where no responsible party has been identified should be reported to the local government agency having jurisdiction where the material was spilled or found. Disposal of such small quantities of RMW is the responsibility of local government. Large quantities (many bags or boxes) of RMW that have been illegally disposed should be reported to the appropriate DEC Regional Law Enforcement Office for further investigation.

WHO SHOULD BE CONTACTED IF THE PUBLIC IS BELIEVED TO HAVE BEEN EXPOSED TO RMW OR A NEEDLE STICK INCIDENT OCCURS?

In all matters involving human exposure to RMW, the DOH Clinical Laboratory Evaluation Program should be contacted at (518) 485-5378. The DOH will evaluate the incident, and if necessary, will contact the DEC Division of Law Enforcement for further investigation.

Questions and Comments

If any RMW generator, storage facility, transporter, treatment and destruction facility or solid waste transfer or disposal facility have questions concerning the information contained in these guidelines regarding the management of RMW, they may contact the DEC Division of Materials Management, Bureau of Permitting and Planning, at (518) 402-8678.

Questions concerning what is a medical waste and appropriate RMW treatment practices should be directed to the DOH Clinical Laboratory Evaluation Program, at (518) 485-5378 or (518) 486-2593.

If any questions should occur regarding the household sharps program, contact the DOH NYS Safe Sharps Collection Program at (518) 417-4746.

Summary of DOH/DEC Regulatory Authority and Jurisdiction
DOH DEC
Applicable Regulations - 10 NYCRR Part 70
Supplemented with Interpretive Guidelines
"Managing Regulated Medical Waste."
Applicable Regulations - 6 NYCRR
Parts 360 and 364 Supplemented with
Interpretive "Guidance for Regulated
Medical Waste Treatment, Storage,
Containment, Transport and Disposal"
On-site RMW Management at Licensed
Hospitals, Nursing Homes and Clinical Labs
On-site RMW Management by
All Other Generators
Off-site Transport of Treated and
Untreated RMW for all
Generators/Tracking Form (TF)
Treatment Standards Commercial RMW Storage,
Transfer, Treatment and
Destruction Facilities
Approving Alternative Treatment Technologies Solid Waste Transfer Stations &
Disposal Facilities
Developing/Approving
Certificate of Treatment Forms (CT)
Response to Incidents Involving
Physical Injury Associated with RMW
Response to Illegal Disposal
Incidents

Summary of DEC
Authorization Process to Accept Treated RMW

1. Request modification of permit through DEC Regional Permit Administrator.

2. Include with request three copies of the following:

A. A description of treated RMW handling and processing procedures. Include discussion of proposed new construction, if applicable.

B. Description of operational changes to accommodate treated RMW.

C. Description of additional personnel training, if relevant. Such description must be included for all transfer stations.

D. Description of procedures to be used for emergencies or receipt and handling of unauthorized waste, improperly treated RMW, and treated RMW not accompanied by a certificate of treatment form.

3. DEC conducts review of permit modification request.

NOTE: A Professional Engineering certification may not be required for the above modification unless new construction is planned to accommodate the treated RMW.

Summary of Requirements for On-Site Treatment of RMW at DEC Regulated Facilities

1. Develop operation plan which includes the following elements:

A. Designation of RMW to be treated.

B. Methods for segregating and handling RMW to be treated.

C. Schedule for staff training on handling and/or treatment procedures.

D. Storage and containment procedures prior to treatment.

E. Identification of treatment techniques and/or equipment.

F. Procedures for validation testing.

G. Operating instructions/safety procedures for treatment equipment.

H. Procedures for monitoring treatment effectiveness/frequency of challenge testing.

I. Disposal methods for treated RMW.

J. Emergency or contingency planning.

2. If a large quantity generator and under DEC jurisdiction, submit operation plan to the local DEC Regional Office and the DEC Division of Materials Management, Bureau of Permitting and Planning, Albany, NY 12233-7260 for approval.

3. Obtain written approval of operation plan before treatment commences.

DEC Regional Offices

(Ask For Regional Materials Management Engineer)

Region 1 Nassau, Suffolk
(631) 444-0375
SUNY @ Stony Brook
50 Circle Road
Stony Brook, NY 11790 - 3409

Region 2 Bronx, Kings, Queens, New York, Richmond
(718) 482-4900
One Hunters Point Plaza
47-40 21st Street
Long Island City, NY 11101-5407

Region 3 Dutchess, Orange, Putnam, Rockland, Sullivan, Ulster, Westchester
(914) 256-3000
21 South Putt Corners Road
New Paltz, NY 12561-1696

Region 4 Albany, Columbia, Delaware, Greene, Montgomery, Otsego, Rensselaer, Schoharie, Schenectady
(518) 357-2234
1130 North Westcott Road
Schenectady, NY 12306-2014

Region 5 Clinton, Essex, Franklin, Fulton, Hamilton, Saratoga, Warren, Washington
(518) 897-1200
Route 86, PO Box 296
Raybrook, NY 12977-0296

Region 6 Herkimer, Jefferson, Lewis, Oneida, St. Lawrence
(315) 785-2238
State Office Building Oneida,
317 Washington Street
Watertown, NY 13601-3787

Region 7 Broome, Cayuga, Chenango, Cortland, Madison, Onondaga, Oswego, Tioga, Tompkins
(315) 426-7400
615 Erie Blvd West
Syracuse, NY 13204-2400

Region 8 Chemung, Genesee, Livingston, Monroe, Ontario, Orleans, Schuyler, Seneca, Steuben, Wayne, Yates
(716) 226-2466
6274 E. Avon-Lima Rd
Avon, NY 14414-9519

Region 9 Allegany, Cattaraugus, Chautauqua, Erie, Niagara, Wyoming
(716) 851-7220
270 Michigan Ave.
Buffalo, NY 14203-2999


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