Biohazard Infectious Waste Sign. This warning sign includes the message Biohazard: infectious waste. Free to download and print. Or, download the editable version for just $3.99. The following section reviews how to process and discard biohazardous waste appropriately, as well as other types of waste frequently generated in biomedical.

Maine

Biomedical Waste

Managing Biomedical Waste
Labeling
Storage
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

Definition of Biomedical Waste

Biomedical waste means a waste that may contain human pathogens of sufficient virulence and in sufficient concentrations that exposure to it by a susceptible host could result in disease. The following wastes may contain human pathogens of sufficient virulence and in sufficient concentrations that exposure to them by a susceptible host could result in disease and are therefore, biomedical wastes:

  • Discarded Human Blood, Blood Products, and Body Fluids: Discarded blood, serum, plasma, blood products, and body fluids. Body-fluids are defined as fluids which are generated or removed during surgery, autopsy, obstetrics, emergency care, or embalming and include cerebrospinal fluid, synovial fluid, pleural fluid; peritonea fluid, pericardial fluid and amniotic fluid.
  • Waste Saturated With Human Blood, Blood Products, or Body Fluids: These may include items such as sponges, surgical gloves and masks, drapes, aprons, dressings, disposable sheets and towels, underpads, plastic tubing, and dialysis unit waste. *The intent is to include waste which at the time of generation is soaked or dripping with human blood, blood products or body fluids. An example of material which may be included is a first change surgical dressing.
  • Pathological Waste: Human tissues, organs, and anatomical parts including teeth, discarded from surgery, autopsy, obstetrical procedures, and laboratory procedures.
  • Discarded Sharps Used In Patient, Animal, Cadaver Care or In Medical and Biomedical Research Laboratories: These include, but are not limited to, hypodermic needles, syringes, scalpel blades, suture needles, disposable razors, lancets, capillary tubes, Pasteur pipettes, broken glassware, IV tubing with needles attached, and dialysis bags with needles attached.
  • Discarded cultures and stocks of infectious agents and the culture dishes and devices used to transfer, inoculate and mix cultures; discarded clinical specimens and the associated containers or vials; discarded biologicals; and waste from the production of biologicals and recombinant DNA research.
  • Discarded Carcasses, Body Parts, Bedding and 0ther Waste Generated By Research Facilities From Animals Containing Organisms or Agents Not Usual To The Normal Animal Environment And Which Are Pathogenic or Hazardous to Humans.
  • Cytotoxic Drugs, Chemotherapy Waste. The following wastes may be managed as biomedical waste for the purpose of this rule:
    • Cytotoxic (antineoplastic) drugs not identified as hazardous wastes in Chapter 850 of the Department's regulations.
    • Chemotherapy waste - All materials that have come in contact with, and have no more than trace amounts of, cytotoxic (antineoplastic) agents.

Exclusions

The following wastes are not biomedical waste for the purpose of the regulations:

  • Human remains. Human remains that are stored, transported or otherwise handled for the purpose of internment or cremation are not subject to the requirements of this rule.
  • Urine and feces.
  • Sludge and septage. Sludge means the semi-solid or liquid residual generated from a municipal, commercial or industrial wastewater treatment plant. Septage means waste, refuse, effluent, sludge and any other materials from septic tanks, cesspools, or any other similar facilities.
  • Water and wastewater samples. Wastes generated as a result of the routine screening of environmental samples of water and wastewater are not subject to the requirements of this rule.

Managing Biomedical Waste

Maine’s biomedical waste rules identifies biomedical waste subject to regulation; requires the registration of biomedical waste generators; and establishes packaging, labeling, handling, storage, transportation, treatment and disposal requirements. The rule requires all transporters and owners or operators of transfer facilities and/or treatment and disposal facilities to obtain a license. The rule specifies siting, operating and reporting requirements and establishes a biomedical waste tracking or manifest system.

Exemptions

A medical facility that generates less than a total of 50 pounds of biomedical waste in any one month is exempt from the requirements of the biomedical waste rules for that month with the following exceptions:

  • The facility shall register in accordance with the regulations;
  • Discarded sharps and discarded cultures and stocks of infectious agents, shall be packaged, labeled and disposed of in accordance with the regulations; and
  • Transport of biomedical waste shall be by a licensed biomedical waste transporter and accompanied by a manifest unless the biomedical waste is taken by the generator to another medical facility or to a permitted biomedical waste transfer, treatment or disposal facility and the amount transported is less than 50 pounds.

Prohibitions

  • A biomedical waste shall not be mixed with hazardous wastes (other than infectious or pathogenic) or radioactive waste.
  • Where a biomedical waste has been inadvertently or intentionally mixed with hazardous wastes (other than infectious or pathogenic) or radioactive waste, all appropriate rules shall apply to the management of the mixed waste. In instances where there is a conflict between the requirements of the rules, the more stringent requirement shall apply. For example, if biomedical waste is mixed with hazardous waste, both the Biomedical Waste Management Rules and the Hazardous Waste Management Rules would apply to the management of the waste.

Treatment and Disposal Methods for Biomedical Waste

Biomedical waste shall be treated or disposed of as follows:

  • Pathological waste shall be incinerated or interred.
  • Discarded blood, blood products and body fluids shall be:
    • Incinerated;
    • Discharged through a sewer to a publicly owned treatment works (POTW) provided that it is discharged in accordance with the Clean Water Act as amended and local ordinances; or
    • To a septic system, provided that the septic system is in compliance with Department of Human Services standards and provided that it is discharged in compliance with local ordinances.
  • All other biomedical waste shall be incinerated.
  • All incineration of biomedical waste shall be in a licensed biomedical waste incinerator. *Existing facilities which are in the process of obtaining a license may accept for treatment biomedical waste generated either on-site or off‑site.

A person may petition and apply to the Board for approval to use a treatment and/or disposal method other than incineration.

*The Department recommends that discarded cultures and stocks of infectious agents be transported off-site for treatment and disposal be pre-treated by steam sterilization to reduce the concentration of pathogens prior to packaging.

Bio

Registration of Generators

Each medical facility that generates a biomedical waste shall register with the Department. The Department will assign a biomedical waste generator registration number to each medical facility that registers, and will notify each such facility in writing of such assigned registration number. Upon receiving such notification, the facility shall include the assigned registration number in or on manifests, labels affixed to packages of biomedical waste, and tags enclosed in each package of biomedical waste.

Biomedical Waste Management Plan

Unless exempt, each facility that generates biomedical waste shall prepare a written biomedical waste management plan appropriate for the size and type of facility. The plan shall set forth policies and procedures for managing biomedical waste. The biomedical waste management plan shall include, at a minimum, the following:

The facility shall certify, at the time of registration, that a biomedical waste management plan has been developed.

The facility biomedical waste management plan shall be available for inspection by a public safety officer or authorized representative of the Department.

Packaging

Biomedical waste shall be properly packaged to assure effective containment throughout the handling, storage, transport, treatment, and disposal processes.

Labeling

Biomedical waste to be transported off-site shall be labeled immediately after packaging in accordance with the regulations. The label shall be securely attached to the outer layer of packaging and be clearly legible. Indelible ink shall be used to complete the information on the label, and the label shall be at least three inches by five inches in size. The following information shall be included on the label:

Handling

Storage

Manifests and Record Keeping Requirements

Licensing of Transporters

Unless exempt, all persons seeking to transport biomedical waste, shall obtain a one-year, biomedical waste transporter license for a non-refundable fee. The application for a biomedical waste transporter license shall be made on a form obtained from the Department.

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. Maine 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

Waste
Biomedical Waste Management Rules (Chapter 900)

Contacts

Maine Department of Environmental Protection, Remediation and Waste Management - or call (207) 287-2651

More Information

Maine’s Biomedical Waste Website
Biomedical Waste Generator Registration Form - (Instructions for filling out the form)