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New Jersey

Regulated Medical Waste


Definition of Regulated Medical Waste
Managing Regulated Medical Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information



Definition of Regulated Medical Waste

A regulated medical waste is any solid waste, generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, that is not excluded or exempted, and that is listed or meets any waste characteristic classification criteria as described below:

  • Cultures and Stocks: Cultures and stocks of infectious agents and associated biologicals, including: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures.
  • Pathological Wastes: Human pathological wastes, including tissues, organs, and body party and body fluids that are removed during surgery or autopsy, or other medical procedures, and specimens of body fluids and their containers.
  • Human Blood and Blood Products: Liquid waste human blood; blood; items saturated and/or dripping with human blood; or items that were saturated and/or dripping with human blood that are now caked with dried human blood; including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals. Intravenous bags (only if they have come into contact with blood or other regulated body fluid), soft plastic pipettes and plastic blood vials are also included in this category.
  • Sharps: Sharps that were used in animal or human patient care or treatment or in medical research, or industrial laboratories, including sharp, or potentially sharp if broken, items such as, but not limited to, hypodermic needles, all syringes to which a needle can be attached (with or without the attached needle) and their  components, including those from manufacturing research, manufacturing and marketing, pasteur pipettes, scalpel blades, blood vials, carpules, needles with attached tubing, acupuncture needles and culture dishes (regardless of presence of infectious agents). Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips.
  • Animal Wastes: Contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceuticals. Carcasses that are not known to have been exposed to agents infectious to humans are considered Waste Type ID 25, and, therefore, are not included in this class.
  • Isolation Wastes: Biological waste and discarded materials contaminated with blood, excretion, exudates, or secretions from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases.
  • Unused Sharps: The following unused, discarded sharps, that were intended to be used: hypodermic needles, suture needles, syringes, and scalpel blades.

Exclusions

The following are excluded from the definition of regulated medical waste:

  • Hazardous waste identified or listed under the federal regulations;
  • Household waste, generated in households utilizing home self-care;
  • Ash from incineration of regulated medical waste once the incineration process has been completed;
  • Residues from treatment and destruction processes once the regulated medical waste has been both treated and destroyed;
  • Human corpses, remains and anatomical parts that are intended for interment or cremation;
  • Biological materials, including, blood or blood products and pathological waste, intended for use, reuse or recycling as raw materials or products, except materials classified as Class-6, Isolation Waste, if the following conditions are met:
    • The materials are used, reused or recycled in accordance with all applicable Federal, State and local statutes and regulations for handling and managing the materials;
    • The materials and their by-products are managed as regulated medical waste when discarded after use, reuse or recycling if not treated and destroyed as those terms are defined in the regulations; and
    • The generator of the materials reports the type, destination, and method of use, reuse or recycling of the materials to the Bureau of Medical Waste and Technical Assistance in the Department at the address given in the regulations and the district solid waste coordinator of the district where the material originated at least once per year, or on request of the Department or any other agency
  • Nonbiological materials intended for use, reuse or recycling, except materials classified as Class-6, Isolation Waste, if the following conditions are met:
    • The generator treats all used materials, or any unused materials, that have come into contact with a regulated body fluid or blood, or pathological waste at the site of generation before shipping the materials off site;
    • The generator destroys all sharps at the site of generation before shipping the destroyed sharps off site for recycling of the devices' component raw materials; and
    • The generator of the materials reports the type, quantity, destination, and method of use, reuse or recycling of the materials to the Bureau of Medical Waste and Technical Assistance in the Department at the address given in the regulations and the district solid waste coordinator of the district where the material originated at least once per year, or on request of the Department or any other agency; and
    • RMW, or non-regulated medical waste managed as RMW, that is either generated by a person and is less than 100 pounds or has become the property of a person other than the original generator except through the sale or transfer of assets, and where such person has not generated RMW within a two year period prior to requesting the exemption nor to the best of their knowledge plans to generate RMW in the future, may have a “one-time only” exemption from registering as a generator and may offer RMW to a licensed RMW transporter using its own number as the generator number. The Department shall issue an authorization for this exemption in response to written notification sent to the address listed in the regulations prior to the disposal of the RMW in order for a one-time exemption of this type to be valid.  Authorizations for registration exemption will not be granted to persons the Department expects will generate RMW in the future.

Exemptions

The following are exempted from the definition of regulated medical waste:

  • Etiologic agents being transported interstate pursuant to the requirements of the U.S. Department of Transportation, U.S. Department of Health and Human Services, and all other applicable shipping requirements are exempt from the requirements; and
  • Samples of regulated medical waste transported off-site by the EPA, the Department, the Department of Health or the New Jersey Department of Law and Public Safety for enforcement purposes are exempt from the requirements during the enforcement proceeding.

Unless the waste is hazardous, mixtures of solid waste and regulated medical waste are considered a regulated medical waste.

Managing Regulated Medical Waste

New Jersey has developed a  comprehensive, cradle-to-grave, regulated medical waste (RMW) management program.

Medical Waste Generators

Generator means any person, by site, whose act or process produces RMW or whose act first causes a RMW to become subject to regulation. Noncontiguous properties owned or operated by the same person are separate sites and in the case where more than one person (for example, doctors with separate medial practices) are located in the same building and office, each individual business entity is a separate generator for the purposes of this subchapter. However, households utilizing home self-care exclusively are not generators.

Regulated Medical Waste Tracking Form

The New Jersey medical waste regulations require all medical waste generators, transporters, intermediate handlers and destination facilities to track RMW, no matter how small the amount generated. Each generator shipping RMW off-site is responsible for initiating the New Jersey RMW Tracking Form. Each person in the chain of custody (handling process) of RMW assumes the responsibility for getting the waste to the proper destination facility for treatment, destruction or disposal.

Waste Classification

Portions of the New Jersey RMW Tracking Form must be completed by the RMW generators, transporters, intermediate handlers and by destination or disposal facilities.  In addition, RMW generated in New Jersey, but transported for disposal to another state, which prints and requires use of its own tracking form, must also be reported on that state's tracking form.

Segregation of Waste

Generators must segregate RMW intended for transport off-site, to the extent practicable, prior to placement in containers. * Generators must segregate RMW into:

  • Sharps (Classes 4 and 7 as defined at N.J.A.C. 7:26-3A.6(a)) including sharps containing residual fluids;
  • Fluids (quantities greater than 20 cubic centimeters); and
  • Other RMW.

If waste other than RMW is placed in the same container(s) as RMW then the generator must package, label and mark the container and its entire contents according to the RMW rule requirements.

Storage Requirements

Any person who stores RMW prior to treatment or disposal on-site or for transport off-site must:

  • Store the RMW in a manner and location that maintains the integrity of the packaging and provides protection from the elements;
  • Maintain the RMW in a nonputrescent state using refrigeration if necessary;
  • Lock any outdoor storage areas containing RMW to prevent unauthorized access;
  • Limit access to on-site storage areas only to authorized employees;
  • Store the RMW in a manner that provides protection from animals and does not provide a breeding place or a food source for insects and rodents;
  • Dispose of RMW immediately if it becomes putrescent; and
  • Store RMW for no longer than one year.

Packaging Requirements

Generators must ensure that all RMW is placed in containers * that are:

  • Rigid;
  • Leak-resistant;
  • Impervious to moisture;
  • Sufficiently strong to prevent tearing or bursting under normal conditions of use and handling;
  • Sealed to prevent leakage during transport;
  • Puncture resistant for packaging sharps and sharps with residual fluids; and
  • Break-resistant and tightly lidded or stoppered for packaging fluids (quantities greater than 20 cubic centimeters).

Solid waste that is not managed as RMW shall not be packaged for shipment inside a RMW container or in containers attached to, or part of an RMW container. * Oversized RMW need not be placed in containers.

Transporting Regulated Medical Waste

Generators must use only medical waste transporters that are registered with the Division of Solid and Hazardous Waste, NJDEP and who possess a Certificate of Public Convenience and Necessity.

Exemptions: Generators of less than 3 cubic feet (50 pounds) of RMW per month that transport only their own RMW to another generator for  storage or disposal are exempt from transporter registration requirements provided:

  • The RMW is transported by the generator or authorized employee in a vehicle with a gross weight of less than 8,000 pounds, owned by the generator or an authorized employee;
  • The original generation point and the storage point or disposal facility are located in New Jersey; and
  • The generator completes a New Jersey Tracking Form.

Labeling and Marking Requirements

Transporters may not accept any shipment of RMW from a generator unless the outer surface of the container is properly labeled and marked.

  • Labeling refers to the designation of the contents as "medical waste" or "infectious waste". Labeling means each generator must, prior to offering for transport off-site, label each container of untreated RMW with a water-resistant label affixed to or printed on the outside of the container. The label shall include the words "Medical Waste", or "Infectious Waste", or display the universal biohazard symbol. Containers of treated medical waste or red plastic bags used as inner packaging are not required to be labeled.
  • Marking refers to the use of a name and address. Treated RMW is required to be marked. Marking means the generator, including an intermediate handler must mark the outermost surface of the outer container of RMW prepared for shipment with a water-resistant identification tag containing the generator's or intermediate handler's name and address, the transporter's name and NJDEP solid waste registration number, date of shipment, and identification of the contents as RMW.

Tracking Forms

Each New Jersey RMW Tracking Form contains 6 copies to be distributed as follows:

  • Copy 6 Generator Copy - retained by generator;
  • Copy 3,4 & 5 Transporter Copy - retained by transporter;
  • Copy 2 Destination Facility Copy - retained by destination facility owner/operator; and
  • Copy 1 Generator Copy - mailed by destination facility back to generator.
    • The Generator completes items 1 through 15, including signing the certification at Item 15;
    • The Transporter verifies the quantity, notes any discrepancies in Item 23, and completes and signs item 16:
    • The Generator removes copy 6 and keeps it; and
    • The Transporter retains copies 3, 4 and 5 and delivers the waste to the approved destination facility.

Generators must complete the generator portion of the tracking form and sign the certification. A licensed medical waste transporter may complete the generator section of the tracking form but it is the generator who is ultimately responsible for ensuring the information is accurate. A properly completed tracking form must accompany all RMW that is shipped off the site of generation. Certification should be completed at the time that the RMW is picked up by the licensed transporter.

Record Keeping Requirements

Retain a copy of each tracking form for at least three years from the date the waste was accepted by the initial transporter unless the Department specifically requires an additional retention period.

Receipt of Destination

If a copy of the completed tracking form is not received from the destination facility within 35 days of acceptance of waste by the initial transporter, contact the transporter or facility to determine the status of the tracked waste.

Exception Report

If a signed copy of the tracking form is not received from the destination facility within 45 days of acceptance of the waste by the transporter, the generator must submit a Generator Exception Report to the NJDEP Division of Enforcement Field Operations, Bureau of Inspections and Investigations. The Exception Report must be postmarked on or before the 46th day and include:

  • A legible copy of the original tracking form for which the generator does not have confirmation;
  • A cover letter signed by the generator explaining the efforts taken and the results to locate the RMW.

A copy of the Exception Report must be kept for at least 3 years from the date of the report.

Annual Reports

All generators of RMW must complete and submit an Annual Generator Report to the Department.

Treatment of Regulated Medical Waste

Treatment shall mean to change the biological character or composition of any regulated medical waste to reduce or eliminate its potential for causing diseases through such methods, techniques or processes as:

  • Incineration;
  • Steam sterilization;
  • Chemical disinfection;
  • Irradiation;
  • Thermal inactivation; or
  • Any other effective method as approved by the State Department of Health.

If antimicrobial chemicals are used in regulated medical waste treatment the chemicals must be registered under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) program.

Generators with On-Site Incinerators ­ Operating Log

Generators of RMW with on-site incinerators must keep a Generator On-Site Incinerator Operating Log at their facility that includes: date, duration and quantity (in pounds) of the incineration cycle, the quantity of ash generated and transported off site, including dates of transport and identification of the transporter and disposal facility.

Operators with On-Site Incinerators that Accept RMW from other Generators

Generators of RMW with on-site incinerators that accept RMW from other generators must maintain information on: the date of waste acceptance and the origin and quantity of the RMW. Generators must also register with the NJDEP and declare intent to operate on a commercial or non-commercial basis. Additional information on registration as a disposal facility may be obtained by calling 609-984-6620.

Generator On-Site Reports

Generators of RMW with on-site incinerators must submit annual on-site incinerator reports and be submitted to the NJDEP. 

Releases of Regulated Medical Waste

Reports all incidents concerning releases of RMW by calling the NJDEP 24-Hour emergency hotline at 877-927-6337.

OSHA Regulations HERC OSHA State Page

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 Jersey is one of 24 states operating an approved occupational safety and health program.  However, the New Jersey program only covers the workplace safety and health of public sector employees only. Private sector employees in New Jersey 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.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Solid Waste Regulations N.J.A.C. 7:26 Subchapter 3A. Regulated Medical Wastes

Contacts

More Information

NJDEP Guidance Document For Regulated Medical Waste

Generator Registration

List of Treatment Vendors

Regulated Medical Waste Data