Statutes, Regulations and Guidelines
Definition of 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.
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
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.
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
- 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.
- 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.
and Disposal Methods for Biomedical Waste
shall be treated or disposed of as follows:
- Pathological waste shall be incinerated or interred.
- Discarded blood, blood products and body fluids
- 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.
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.
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.
Waste Management Plan
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
- Personnel training procedures;
- Spill containment and cleanup procedures and equipment;
- The name, address, and telephone number of the person(s)
responsible for biomedical waste management at the facility.
shall certify, at the time of registration, that a biomedical waste management
plan has been developed.
biomedical waste management plan shall be available for inspection by
a public safety officer or authorized representative of the Department.
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
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.
- 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
- Biomedical waste shall be segregated from other
- 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
- 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.
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
- Transporters of biomedical waste must also follow
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.
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
Management Rules (Chapter 900)
Maine Department of Environmental
Protection, Remediation and Waste Management - or call (207) 287-2651
Maine’s Biomedical Waste Website
Biomedical Waste Generator Registration Form - (Instructions for filling out the form)
Application for Biomedical Waste Transporter License