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Massachusetts

Infectious Waste


Definition of Infectious Medical Waste

Managing Infectious Medical Waste
Disposal of Infectious Medical Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

 


Definition of Infectious Medical Waste

In Massachusetts, infectious medical waste is considered a special solid waste. Infectious or Physically Dangerous Medical or Biological Waste is waste, which because of its characteristics may: cause, or significantly contribute to an increase in mortality or an increase in serious irreversible or incapacitating reversible illness; or pose a substantial present potential hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.

The following types of waste are identified and defined as infectious or physically dangerous medical or biological waste:

  • Blood and Blood Products: Discarded bulk human blood and blood products in free draining, liquid state; body fluids contaminated with visible blood; and materials saturated/dripping with blood;
  • Pathological Waste: Human anatomical parts, organs, tissues and body fluids removed and discarded during surgery or autopsy, or other medical procedures and specimens of body fluids and their containers;
  • Cultures and Stocks of Infectious Agents and Associated Biologicals: All discarded cultures and stocks of infectious agents and associated biologicals, biotechnological by-product effluents, cultures of specimens from medical and pathological laboratories, cultures and stocks of infectious agents from research laboratories, wastes from the production of biologicals, and discarded live and attenuated vaccines intended for human use;
  • Contaminated Animal Carcasses, Body Parts and Bedding: The contaminated carcasses and body parts and bedding of all research animals known to be exposed to pathogens;
  • Sharps: Discarded medical articles that may cause puncture or cuts, including but not limited to all used and discarded hypodermic needles and syringes, pasteur pipettes, broken medical glassware, scalpel blades, disposable razors, and suture needles; and
  • Biotechnological By-Product Effluents: Any discarded preparations made from genetically altered living organisms and their products.

Managing Infectious Medical Waste

Massachusetts’ medical waste regulations set forth the requirements for the storage and disposal of infectious or physically dangerous medical or biological waste. The regulations apply to all generators of infectious or physically dangerous medical or biological waste, except for private residences.

Generators and facilities that manage medical waste must follow rules that are administered and enforced by the Department of Public Health.

Storage of Infectious Medical Waste

  • All medical or biological waste, except sharps, shall be contained in a primary container which is a red, fluorescent orange or orange-red plastic bag that is impervious to moisture and has sufficient strength to resist ripping, tearing, or bursting under normal conditions of use and handling, and which meets the American Society for Testing Materials (ASTM) standard D1922-06a and ASTM D1709-04. Each primary container shall:

    • Be marked prominently with the universal biohazard warning symbol and the word “Biohazard” in a contrasting color; and
    • Be secured so as to prevent leakage and to preclude loss of contents during handling, storage, and/or transport.
  • All areas for on-site storage of containers of medical or biological waste, excluding kiosks dedicated for the sole purpose of collecting home sharps pursuant to M.G.L. c. 94C, § 27A, shall be in an uncarpeted room or area with impervious, cleanable, non-absorbent flooring, used exclusively for waste storage.
  • All on-site storage areas shall:
    • Have prominent signage indicating the space is used for the storage of regulated medical or biological waste;
    • Be designed or equipped to prevent unauthorized access;
    • Be designed or located to protect the waste from the elements and prevent access by vermin;
    • Provide sufficient space to allow for clear separation of regulated medical or biological waste from any other waste, when applicable;
    • Be adequate to accommodate the volume of regulated medical or biological waste generated prior to removal of waste for either waste transport off-site or on-site treatment, and
    • Be maintained such that there is no putrescence of off-site odors, using refrigeration when necessary.
  • Sharps shall be segregated from other wastes and aggregated immediately after use in red, fluorescent orange or orange-red leakproof, rigid, puncture-resistant, shatterproof containers that resist breaking under normal conditions of use and handling, meet ASTM standard F2132-0I, and that are marked prominently with the universal biohazard warning symbol and the word "Biohazard" in a contrasting color.
  • Free draining blood and blood products and biotechnology by-product effluents shall be stored at all times in leakproof containers that are securely sealed.
  • Compactors or grinders shall not be used to process medical or biological waste until it has been rendered noninfectious and safe for disposal in accordance with 105 CMR 480.150.
  • All medical or biological waste, except from home sharps users, must be treated on-site or transported off-site for treatment at a minimum once per calendar year.

Disposal of Infectious Medical Waste

  • Blood and Blood Products
    • If the waste generator is connected to a municipal sewerage system or septic system, free draining blood and blood products except blood saturated materials may be disposed of directly into these systems unless such disposal is otherwise restricted by the authorized approving agency.
    • If the waste generator is prohibited by the authorized approving agency from disposing of blood and blood products into the municipal sewerage system or septic system, blood and blood products, except blood saturated materials, shall be sent to an approved incineration facility for incineration or shall be rendered noninfectious by gas, chemical or steam sterilization prior to disposal and disposed of in a sanitary landfill approved by the Department of Environmental Protection or in case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.
  • Sharps. Containers of sharps shall either be:
    • Disposed of by incineration at an approved incineration facility; or
    • Rendered noninfectious as set forth in 105 CMR 480.100(F) and processed by grinding or other effective method to eliminate the physical hazard of the sharps and disposed of in a sanitary landfill approved by the Department of  Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.
  • Blood Saturated Materials, Cultures and Stocks of Infectious Agents and Associated Biologicals, Dialysis Waste and Laboratory Waste. These wastes shall either be:
    • Rendered noninfectious on site by steam sterilization, incineration, thermal inactivation, or chemical disinfection and disposed of in a sanitary landfill approved by the Department of Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval; or
    • Disposed of onsite at an approved incineration facility, or placed in a second 3 mil bag for transport to an approved incineration facility off-site.
  • Biotechnology By-Product Effluents. These wastes shall not be removed from the site of the waste generator unless the viable organism containing recombinant DNA molecules have been rendered noninfectious by a validated method. The following methods shall be used as appropriate:
    • Steam sterilization;
    • Chemical disinfection;
    • Incineration at an approved incineration facility; or
    • Other methods approved by the Department.
    • The methods, which rely on heat, shall be evaluated mechanically and biologically by using a recording thermometer and indicator microorganism with a defined heat susceptibility pattern.
    • If these wastes are rendered noninfectious by chemical disinfection, the chemical used shall be of demonstrated efficacy against the target or indicator organism.
    • Once rendered noninfectious, biotechnology by-product effluents may be disposed of directly into the waste generator's connection to the municipal sewerage system or septic system unless such disposal is otherwise restricted by the authorized approving agency.
    • If the generator is prohibited by the authorized approving agency from disposing of biotechnology by-product effluents through the municipal sewerage system or septic system, these wastes shall be rendered noninfectious and disposed of in a sanitary landfill approved by the Department of Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.
  • Pathological waste and contaminated animal carcasses shall be disposed of at an approved incineration facility or by interment provided however that liquid pathological waste may also be disposed in accordance with the regulations and discarded teeth and tissue may also be disposed of in accordance with the regulations. These wastes shall be placed in a second three-mil bag if they are to be transported off-site for disposal.

Labeling

Every container or bag of waste, which has not been rendered noninfectious shall:

  • Be distinctively marked with the international biohazard symbol and colored red to indicate that it contains waste; and
  • In the case of sharp wastes, be distinctively labeled to indicate that it contains sharp waste capable of inflicting punctures or cuts.
Every container or bag of waste which has not been rendered noninfectious and which will be transported off the premises of the waste generator shall in addition to the requirements of the regulations, be placed in containers which are:
  • Rigid;
  • Leak resistant;
  • Impervious to moisture;
  • Of sufficient strength to prevent tearing or bursting under normal conditions of use and handling, and
  • Sealed to prevent leakage during transport.
  • Bear a label that states the name, address and telephone number of the generator. The label shall be affixed in a manner that ensures that it cannot be easily removed.

Prior to transport for off-site disposal, waste that has been rendered noninfectious by a method other than incineration, shall be labeled or otherwise marked so as to clearly identify it as noninfectious medical or biological waste and to identify the waste generator responsible for the treatment. Such waste may be disposed of in the same manner as waste that is not regulated, except for sharps, which shall be disposed of in accordance with the requirements of the regulations

Policies and Procedures; Records

  • Written policies and procedures for rendering waste noninfectious shall be developed that assure effectiveness and compliance with the requirements.
  • The waste generator shall maintain records of temperature and dwell times used in each instance where waste has been rendered noninfectious by gas or steam sterilization and records of each biological spore test culture result. Such records shall be retained for at least three years.
  • The waste generator shall maintain records of volume and type of waste rendered noninfectious on-site which shall be available for Department review. Such records shall be retained for at least three years.

Manifests

  • Generators shall prepare manifests before shipping waste, which has not been rendered noninfectious off-site. The manifest is a tracking document designed to record the movement of waste from the generator through its trip with a transporter to an approved disposal facility and final disposal. The generator shall appoint a designee to prepare, sign and maintain such manifests. The manifest must include the following information:
    • Description of waste to be shipped;
    • Total quantity of waste; and
    • Type of container in which waste is transported.
  • A generator shall designate on the manifest the address of the site to which the waste is to be delivered and sign it. The transporter of the waste or an agent of the transporter shall sign the manifest to indicate that the transporter has received the waste and will comply with the generator's transportation instructions. When the waste arrives at the approved off-site disposal facility, and has been disposed of, the disposal facility owner or agent of the owner shall sign the manifest and return the original to the generator.
  • If the generator does not receive the manifest from the disposal facility within 30 days after shipment of waste by the generator, the generator shall report this fact to the Department of Public Health.
  • The generator shall maintain a copy of the manifest both as initially sent out and as returned by the disposal facility for a period of three years.
  • In the absence of any restriction concerning individuals who are authorized to transport waste, including but not limited to those imposed by boards of health or the Department of Environmental Protection, generators who transport their own waste shall follow the manifest requirements set forth in the regulations.

Approval of Additional Methods of Treatment, Storage and Disposal

The Department may approve additional methods for the treatment, storage or disposal of infectious or physically dangerous medical or biological waste under the following conditions: The method has been validated through scientific studies acceptable to the Department, and, if the waste is to be transported off-site, the waste treatment facility has been approved by the Department of Environmental Protection, or if the waste is to be transported out-of-state, the waste treatment facility has been approved by the appropriate regulatory agency in that state.

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.  Massachusetts is one of 26 states covered entirely by the federal OSHA program. This program is operated by the Occupational Safety and Health Administration.  OSHA 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

Storage and Disposal of Infectious or Physically Dangerous Medical or Biological Waste (105 CMR 480.000)

Solid Waste Management - Special Waste and Facility Requirements (310 CMR 19.000)

Contacts

Massachusetts Department of Public Health, Division of Community Sanitation

Massachusetts Department of Environmental Protection

More Information

Infectious Waste Information Web Page