New Jersey

Regulated Medical Waste

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

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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).

• 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 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.

• 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.

• 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.

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