Regulated Medical Waste

Maine

Biomedical Waste

Background Information
Managing Biomedical Waste
Labeling
Storage
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.

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.

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.

Facilities that generate biomedical waste shall notify the Department in writing within 30 days of a change in majority ownership, name, location or operational status of the facility.
The registration numbers assigned under this subsection are not transferable.
The registration fee shall be a one-time fee of fifty dollars ($50.00) per facility.

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:

A description of the biomedical waste generated by the facility including type and volume of biomedical waste;
A description of any biomedical waste handling procedures, in addition to those required by this rule, which are specific to that facility including such information as location of storage area, etc.;
The treatment/disposal methods for each type of biomedical waste;
Personnel training procedures;
Spill containment and cleanup procedures and equipment; and
The name, address, and telephone number of the person(s) responsible for biomedical waste management at the facility.

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.

Biomedical wastes, other than sharps and bulk liquids, shall be packaged in bags that are impervious to moisture and have a strength sufficient to resist ripping, tearing or bursting under normal conditions of usage and handling.
All bags containing biomedical waste shall be red in color and imprinted with the international biohazard symbol and the words "biomedical waste" or "infectious waste." Waste in red bags shall be considered biomedical waste and shall be managed as biomedical waste.
Bags shall be sealed by forming a secure closure that results in a leak-resistant seal.
Discarded sharps shall be segregated from other biomedical waste at the point of generation. Discarded sharps shall be placed directly into leak-resistant, rigid, puncture-resistant containers without clipping or breaking. These containers shall be taped closed or tightly lidded to preclude loss or leakage of contents. After proper packaging, sharps containers may be placed in biomedical waste bags.
Discarded bulk blood and other liquids which is to be transported off-site shall be packaged in tightly stoppered, unbreakable flasks or bottles.
All biomedical waste bagged, sharps containerized, and bulk liquids containerized in accordance with the regulations, that are to be transported off-site shall also be packaged for storage or handling by placement in disposable corrugated fiberboard boxes or equivalent rigid containers such as reusable pails, cartons, drums, or portable bins. The box or container shall be leak-resistant or lined with a bag which is impervious to moisture and has a 200-pound burst strength as measured by the industry's Mullen test.
Reusable containers used for the handling of biomedical waste shall be thoroughly washed and disinfected each time they are emptied unless the surfaces of the containers have been effectively protected from contamination by disposable liners, bags or other devices that are removed and disposed of with the waste. *A red bag may not be enclosed in a bag of another color.
Reusable containers used for the handling of biomedical waste shall not be used for containment of waste to be disposed of as non-biomedical waste or for any other purpose except after being disinfected.

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:

The name, address, business telephone number, and registration number of the generator;
"Biomedical Waste" or "Infectious Waste" in large print;
"Refrigeration Required", in large print if pathological waste, cultures, or animal carcasses or body parts are included in the contents;
The name, address, business telephone number, and registration number of the person or persons to whose control the biomedical waste is to be transferred;
The international biohazard symbol; and
The date upon which the biomedical waste was packaged.

Handling

Packages of biomedical waste shall be handled in a manner that does not impair the integrity of the packaging.
Trash chutes shall not be used to transfer biomedical waste between locations where it is contained.
Compactors shall not be used in the handling of biomedical waste. Biomedical waste in bags or other disposal containers shall not be subjected to compaction by any compacting device and shall not be placed for storage or transport in a portable or mobile trash compactor.

Storage

Biomedical waste shall be segregated from other wastes.
All on-site storage of containers of biomedical waste shall be in a designated area away from general traffic flow patterns and, where possible, in a room reserved for this purpose. The manner of storage shall prevent access to or contact with such waste by unauthorized persons.
Biomedical waste shall be stored in a manner that preserves the integrity of the container and is not conducive to rapid microbial growth and/or putrefaction. Pathological waste, cultures, and discarded animal carcasses and body parts stored for more than 24 hours after packaging shall be refrigerated at a temperature of 45° F or below in a refrigerator or refrigerated space used only for biomedical waste.
All areas used for the storage of biomedical waste shall be capable of being readily maintained in a sanitary condition.
All biomedical waste containers must be stored in a manner that allows access for inspection.
Biohazard signs shall be posted wherever biomedical waste is stored or contained, including on storage rooms doors, refrigerators, bins and other containers.

Manifests and Record Keeping Requirements

Unless exempt, the generator of biomedical waste that is to be transported off-site for treatment or disposal shall initiate a biomedical waste 4‑part manifest available from the Department. Copy 4 of the biomedical waste manifest is to be retained by the generator; Copy 3, by the transporter; Copy 2, by the treatment, storage or disposal facility; and Copy 1 is to be returned to the generator.
If the generator does not receive the completed manifest from the treatment or disposal facility within 35 days after the date the waste was accepted by the transporter, the generator shall report this fact to the Department.
Manifests must be retained by the licensee for a period of not less than three years. The period of retention of records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Commissioner. These records shall be made available for inspection by the Department upon request.
Transporters of biomedical waste must also follow manifest 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.

Packaging, labeling, handling, and storage requirements apply to the transportation of biomedical waste.
Unless otherwise allowed by regulation, biomedical waste shall only be transported from the point of generation by transporters who are licensed by the Department.
No person shall transport or receive for transport any biomedical waste that is not packaged and labeled in accordance with the regulations.
Conveyances that transport biomedical waste shall include a cargo-carrying portion that must be closed and secured except when loading or unloading waste to prevent unauthorized access and exposure to wind and/or precipitation; shall be designed and constructed so as to contain any spillage; shall be cleaned and disinfected following leakage or spills; and shall be cleaned and disinfected prior to using the conveyance for any other purpose.
The identity of the biomedical waste hauler and the international biohazard symbol shall appear on three sides and the door of the cab of conveyances used to transport biomedical waste. The lettering of such identification shall be clearly legible during daylight from a distance of 50 feet.
Vehicles used to transport biomedical wastes shall carry an appropriate spill containment and clean up kit.
Biomedical waste shall not be compacted or subjected to violent mechanical stress during transport.
Biomedical waste shall not be transported in the same vehicle with other waste unless the biomedical waste is separately contained in rigid reusable containers or kept separate by barriers from other waste, or unless all of the waste is to be treated and disposed of as biomedical waste in accordance with this rule.

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.