Code of Maine Rules
06 - DEPARTMENT OF ENVIRONMENTAL PROTECTION
096 - DEPARTMENT OF ENVIRONMENTAL PROTECTION - GENERAL
Chapter 900 - BIOMEDICAL WASTE MANAGEMENT RULES
Section 096-900-18 - Standards for Treatment Facilities
Universal Citation: 06 ME Code Rules ยง 096-900-18
Current through 2024-38, September 18, 2024
A. Applicability of the Standards of the Site Location of Development Law
All new biomedical waste treatment facilities as well as substantial modifications to existing facilities are subject to the standards of the Site Location of Development Law, 38 M.R.S.A. §484, which are incorporated herein by reference. The findings and conclusions required to be made for issuance of a permit under section 484 of the Site Location of Development Law must be made for issuance of a license under this rule.
B. Facility Location Criteria
(1) Environmental Performance
Standards. All biomedical waste treatment facilities must be located, designed,
constructed, altered, operated, maintained, and closed in a manner that will
ensure protection of public health and welfare and the environment. Protection
of health and welfare and the environment must include, but not be limited to:
(a) prevention of adverse effects on ground
water quality;
(b) prevention of
adverse effects on surface water quality;
(c) prevention of adverse effects on air
quality; and
(d) prevention of
adverse effects due to migration of waste constituents in the subsurface
environment.
(2)
Rebuttable Presumptions: All new biomedical waste treatment facilities as well
as substantial modifications to existing facilities are subject to the
following rebuttable presumptions governing facility location.
(a) A biomedical waste treatment facility
located in the following areas is presumed to pose a serious threat to public
health or welfare or to the environment such that a license for a facility
cannot be issued. The presumption applies if:
(i) The facility or facility property
overlies any portion of a significant surface or subsurface sand and gravel
aquifer or its primary recharge zone or a high yield bedrock aquifer;
NOTE: Maps of significant sand and gravel aquifers are available from the Maine Geological Survey, Department of Conservation, Augusta.
(ii) The facility
or facility property is located within 1,500 feet of any underground source of
potable water for people;
(iii) The
facility property is located on land defined as a wetland under statutes or
regulations administered by the following Departments: Environmental
Protection, Conservation (Land Use Regulation Commission-LURC), Inland
Fisheries & Wildlife, Marine Resources or the State Planning
office;
(iv) The facility or
facility property is located within 100 feet of any 100 year flood plain or
within 100 feet of the level of any actual documented flood of a greater
magnitude;
(v) The facility or
facility property is located such that it may pose a threat to the fisheries,
wildlife or other natural resources of a sanctuary, refuge, preserve, state or
federal park, designated wilderness area, critical area or fish
hatchery;
(vi) The facility
property is located within the boundaries of a state or federal park or
designated wilderness area.
(b) An applicant seeking a license to
establish, construct, alter or operate a biomedical waste treatment facility in
such a location must overcome this presumption by clear and convincing evidence
that the facility is unique in some way that allows for compliance with the
intent of this rule.
C. General Design Standards
(1) Biomedical waste must be stored in
conveyances or buildings that are leak-proof and equipped with locks.
(2) If the treatment facility is not located
at a medical facility, it must be enclosed by a chain link fence, at least six
feet in height, and access will be controlled by a locking gate or an
alternative Department approved security system that offers equivalent
protection.
(3) The fence,
conveyances or buildings must be posted with warning signs which indicate a
potential biological hazard.
(4)
All biomedical waste conveyances and buildings used primarily for the storage
of biomedical waste and biomedical waste treatment areas must be located at
least 50 feet from the facility property boundaries. In addition, storage and
treatment areas must be located at least 300 feet from the nearest residence in
existence at the time of application except that existing facilities which
cannot meet the 300 foot requirement must locate treatment and storage areas as
far as possible from the nearest residence in existence at the time of
application.
(5) Provision must be
made for the proper storage of biomedical waste prior to treatment, including
the refrigeration of pathological waste, cultures, and animal carcasses and
body parts.
D. Operating Standards
The following operational requirements apply to biomedical waste treatment facilities:
(1) The
packaging, labeling, handling, and storage requirements specified in Sections
12(A), 12(B), 12(C), and 12(D) of this rule apply to biomedical waste treatment
facilities.
(2) An operator of a
biomedical waste treatment facility may not accept any biomedical waste that is
not packaged and labeled in accordance with these rules and accompanied by a
properly completed manifest except as provided for in Section 4 of this
rule.
(3) The facility access gate
and all biomedical waste conveyances and storage buildings must be closed
except when loading or unloading wastes and will be locked whenever an operator
is not in attendance at the facility.
(4) Pathological wastes, cultures, and
discarded animal carcasses and body parts must be stored in refrigerated
conveyances, or storage buildings in a frozen state.
(5) All areas used for the storage of
biomedical waste must be maintained in a sanitary condition and must be
designed to control or contain any spillage of such wastes.
(6) The on-site population of disease vectors
must be controlled to protect public health.
(7) Biomedical waste may not be compacted or
subjected to violent mechanical stress during transfer, storage or any time
prior to final treatment and disposal.
E. Design Standards for Biomedical Waste Treatment Facilities
(1) The
types, amounts (by weight and/or volume), and characteristics of all biomedical
waste expected to be processed will be determined by survey.
(2) Facility design capacity must consider
such items as waste quantity and characteristics, variations in waste
generation, equipment downtime, and availability of alternate storage,
processing, or disposal capability.
(3) Facility systems and subsystems must be
designed to assure standby capability in the event of breakdown.
(4) Audible signals must be provided to alert
operating personnel of critical operating unit malfunctions.
F. Operating Standards for Biomedical Waste Treatment Facilities Using Non-Incineration Treatment Technologies
(1) Prior to accepting
biomedical waste for treatment, the operator of a biomedical waste treatment
facility using an approved treatment technology shall perform challenge testing
using a Bacillus species spore specified by the Department to demonstrate that
the technology can meet the standard specified in Section 19.
(2) Every 30 days, the licensee of a
biomedical waste treatment facility using an approved non-incineration
treatment technology shall perform challenge testing using a test organism
prescribed by the Department. After 1 year of successful challenge tests, a
licensee may request in writing to the Department for permission to reduce the
frequency of challenge testing by demonstrating to the Department that an
effective instrument calibration program is in place.
(3) The sharps portion of the biomedical
waste stream may be required to be rendered unrecognizable and shredded into
pieces less than 1/34 inch in diameter as a component of the treatment process
and prior to removal from the facility. The remainder of the treated biomedical
waste stream must be handled in a manner approved by the Department.
(4) All operating parameter records must be
maintained for 3 years or until the resolution of any enforcement action,
whichever is longer, and be available to a representative of the
Department.
(5) Chemotherapy waste
and pathological waste must not be treated in a non-incineration treatment
unit. Chemotherapy waste and pathological waste may be stored at a treatment
facility for a maximum of 30 days provided that the pathological waste is
maintained in a frozen state.
(6)
The facility will develop and implement a program to educate generators on the
requirement for source segregation. The program will educate generators on what
material must be managed as biomedical waste as well as the dangers and
repercussions of shipping hazardous waste, universal waste, radioactive waste
and other unauthorized waste to a biomedical waste treatment
facility.
G. Closure
When plans are made for termination of a biomedical waste treatment facility, the Department must be notified in writing a minimum of 60 days prior to the proposed termination date. A plan outlining the closing operation must be submitted to the Department for review and approval. The plan must demonstrate that the facility will be closed in a manner that will protect public health, safety and welfare and the environment.
A closure plan must include the following as a minimum:
(1) A description of how and
when the facility will be closed including a schedule of closure.
(2) A description of how disposal and
decontamination of equipment and structures will occur.
(3) The maximum inventory of waste in storage
and treatment at any time during the life of the facility.
(4) A cost estimate for closure of the
facility in accordance with the closure plan.
(5) Sufficient financial assurance for
completion of closure activities.
(6) Liability insurance for sudden
accidents.
(7) Provision for
certification by the facility owner and an independent professional engineer
that the facility was closed in accordance with the approved closure plan and
that no biomedical waste or biomedical waste residues remain on site.
H. Manifests, Record Keeping and Reporting
(1) A biomedical waste
treatment facility may not accept more than 50 pounds of biomedical waste from
a biomedical waste generator or any quantity of biomedical waste from a
transporter unless it is accompanied by a properly completed manifest.
A treatment facility operator shall, in the presence of the generator or transporter, complete the appropriate treatment facility portion of the manifest, including handwritten acceptance signature and date of acceptance, and immediately give a signed copy of the manifest to the generator or transporter, noting any discrepancies in manifest information.
(2) In instances where a facility
accepts less than 50 pounds of waste from a generator, the facility must
maintain a log of such receipts which includes, at a minimum, the following:
(a) The name, address and identification
number of the treatment facility;
(b) The type and volume of waste
received;
(c) The date of receipt
of such waste;
(d) The name,
location and identification number of the generator; and
(e) The signature of the person receiving the
waste.
(3) The facility
shall record on the manifest the date on which the shipment was received and
accepted by the facility.
(4) The
facility shall keep a copy of the completed manifest as part of the facility
operating record and shall forward a completed copy to the generator within 35
days after the date the waste was accepted by the transporter.
(5) Retention of Records. Manifests, logs and
operational records must be retained by the licensee for a period of not less
than three (3) 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 Department. These records must be
available for inspection by the Department, upon request.
(6) Annual Report
The owner or operator of a biomedical waste treatment facility shall submit an annual report to the Department. The report must contain, at a minimum, the following information:
(a) Name, location and identification number
of the facility.
(b) Sources, types
and quantities of biomedical waste received.
(c) Method of treatment for each category of
biomedical waste.
(d) Type and
amount of specific wastes shipped from the facility.
(e) Name and location of treatment or
disposal facility.
(f) Proof of
liability insurance.
(g) A
demonstration of financial capacity to construct, operate, maintain and close
the facility.
(h) The facility
shall report to the Department incidents whereby the facility has received
hazardous, hazardous universal and radioactive wastes or other unauthorized
wastes. The report must identify what steps were taken to prevent
reoccurrence.
(i) The facility
shall report efforts to educate the generators on waste segregation.
Disclaimer: These regulations may not be the most recent version. Maine may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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