06- 096 C.M.R. ch. 900, § 18

Current through 2024-51, December 18, 2024

Section 096-900-18 - Standards for Treatment Facilities

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.

06- 096 C.M.R. ch. 900, § 18