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New York

Regulated Medical Waste

Background Information
Definition of Regulated Medical Waste
Managing Regulated Medical Waste
Treatment & Disposal
Contacts
Statutes, Regulations & Guidelines
OSHA Requirements
Additional Resources

Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Regulated Medical Waste

There are five categories of regulated medical wastes in New York:

  • Cultures and stocks of infectious agents
  • Human pathological wastes
  • Human blood and blood products
  • Sharps
  • Animal waste

In addition to these five categories, the Commissioner of Health may designate specific items as RMW.  For the complete definition of regulated medical waste see Statutes, regulations and guidelines below.

Managing Regulated Medical Wastes

In this section, you will find the key rules that apply to the management of the Regulated Medical Waste (RMW) stream inside your facility.

Registration, Permits

Generators of regulated medical waste are not required to register with the state of New York and no RMW generator permits are required by the state of New York.  Facilities that want to perform on-site treatment of RMW must submit a plan to DEC (see on-site treatment requirements above).

Storage

  • RMW must be kept separate from other wastes in an area that is designated and clearly labeled with the universal warning sign or the word “biohazard.”  The storage area must be ventilated and located to minimize exposure to the public and is accessible only to authorized personnel.
  • There are no maximum time limits for storage of RMW and no approval is required for this activity. The waste must be maintained in a nonputrescent state, using refrigeration, when necessary.
  • Containers for RWM must be prominently marked with the universal warning sign or the word “biohazard.”

Training Requirements

  • 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 (29 CFR 1910.1030).

Recordkeeping and Reporting

Generators must maintain records of the quantity of regulated medical waste generated, and the disposition of those wastes.  An annual report must be submitted to the Commissioner of Environmental Conservation indicating the quantity of regulated medical waste and its disposition.  A copy of each report to the Commissioner of Environmental Conservation must be submitted to the Commissioner of Health.

Treatment and Disposal of Regulated Medical Waste

In this section, you will find information on the proper final disposition of the Regulated Medical Waste (RMW) stream, including RMW sent off-site and RMW treated on-site.

Off-Site Transport/Disposal

  • The generator is responsible for properly packaging and labeling RWM for off-site transport and for completing a Medical Waste Tracking Form (MWTF).  For transport off-site, untreated RMW must be placed in impermeable red plastic bags and labeled with the universal warning sign or the word “biohazard.”  Each bag containing untreated RMW must be labeled and placed in a secondary rigid type container before off-site transport.  The rigid containers may be of any color, but must be leak proof and labeled with the universal warning sign or the word “biohazard.” Sharps must be packaged in rigid, puncture and break resistance, and leak proof containers labeled with the universal warning sign or the word “biohazard.”  These sharps containers must also be labeled and placed in a secondary rigid type container before off-site transport.
  • Each primary container (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, pathological waste), and include the universal warning sign or the word “biohazard.”  In addition, a MWTF is also required.
  • Containers of RMW must not be compacted and must remain intact until transfer or disposal.
  • Containers contaminated with spilled or leaked RMW must be repackaged before transport.
  • If RMW is mixed with hazardous or radioactive waste it must be managed as hazardous or radioactive waste.

On-site Treatment Requirements

  • Before treating RMW on-site, a facility must develop an operational plan that contains specific elements (e.g., type of waste, methods of segregation, training schedule, storage/containment procedures, treatment methods, disposal method, and emergency/contingency plan).  The plan must be submitted to a local DEC office and the DEC Division of Solid & Hazardous Materials, for approval.
  • Treatment or disposal of RWM must be done by autoclaving or other techniques approved by the Department of Public Health to render the waste noninfectious.  A list of approved treatment technologies is available by calling 518-485-5378.
  • Properly treated RMW should be disposed of as solid waste , provided it does not meet the definition of hazardous waste and is accompanied by a certificate, which evidences such treatment.  All sharps must be rendered unrecognizable prior to disposal (i.e., sharps that are merely treated are still considered RMW and cannot be disposed of in a landfill).
  • Properly treated RMW from facilities with approved treatment processes may mix the treated RMW with other solid waste if a certificate of treatment form accompanies the waste to the authorized disposal facility.

More Information

In this section, you will find links to points of contacts at the New York State agencies responsible for regulating healthcare facility waste, links to the text of the regulations, and additional resources that you might find of interest on this topic.

Contacts

New York State Department of Environmental Conservation.  Contact NYDEC for questions regarding waste categorization, storage and disposal.

New York State Department of Health.  Contact NYDOH for questions regarding definitions of regulated medical waste, on-site treatment and disposal strategies (see bottom of NYDOH for points of contact).

Statutes, Regulations and Guidelines

Management of Regulated Medical Waste. (Part 70 of Title 10 of New York Code of Rules and Regulations, 10 NYCRR Part 70).  (To access Part 70 from this link, select "Search Title 10", enter "Part 70" in the search box, and select "Part 70 - Regulated Medical Waste" to reach the desired contents page.)

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  New York is one of 24 states operating an approved occupational safety and health program.  However, the New York program only covers the workplace safety and health of public sector employees only. Private sector employees in New York are covered by Federal OSHA. OSHA state and federal rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training. 

Additional Resources

Managing Regulated Medical Waste.  Regulated medical waste information provided by the New York Department of Health.  Includes details on definitions of regulated medical wastes, management guidelines and disposal options.

Regulated Medical Waste.  Regulated medical waste information provided by the New York Department of Environmental Conservation.  Includes links to various guidance documents covering RMA storage and disposal.

Regulated Medical Waste tracking Form.  Use this form for shipping RMW off-site.